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At 10 years, reintervention rate for EVAR is 20%
NEW YORK – A clever strategy to evaluate long term outcomes in patients undergoing endovascular abdominal aortic aneurysm repair identified a 20% rate of reintervention, according to data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation by Philip P. Goodney, MD.
In this video interview with Dr. Goodney, an associate professor of vascular surgery at Geisel School of Medicine at Dartmouth, Hanover, N.H., he explains how Medicare data were employed to track patients long term, even when they had moved to other hospital systems.
The main message from the long-term follow-up is that there is a persistent risk of recurrence and need for reintervention, according to Dr. Goodney. The hypothesis was that there would be an early risk of failure, followed by a diminishing need for reintervention over time, but this was not what was observed.Rather, the findings suggest that the rate of reinterventions was relatively steady over the course of follow-up, suggesting that patients should be informed of a persistent risk. However, Dr. Goodney reports that age was not a predictor of reintervention, so that older patients were at no greater risk.
NEW YORK – A clever strategy to evaluate long term outcomes in patients undergoing endovascular abdominal aortic aneurysm repair identified a 20% rate of reintervention, according to data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation by Philip P. Goodney, MD.
In this video interview with Dr. Goodney, an associate professor of vascular surgery at Geisel School of Medicine at Dartmouth, Hanover, N.H., he explains how Medicare data were employed to track patients long term, even when they had moved to other hospital systems.
The main message from the long-term follow-up is that there is a persistent risk of recurrence and need for reintervention, according to Dr. Goodney. The hypothesis was that there would be an early risk of failure, followed by a diminishing need for reintervention over time, but this was not what was observed.Rather, the findings suggest that the rate of reinterventions was relatively steady over the course of follow-up, suggesting that patients should be informed of a persistent risk. However, Dr. Goodney reports that age was not a predictor of reintervention, so that older patients were at no greater risk.
NEW YORK – A clever strategy to evaluate long term outcomes in patients undergoing endovascular abdominal aortic aneurysm repair identified a 20% rate of reintervention, according to data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation by Philip P. Goodney, MD.
In this video interview with Dr. Goodney, an associate professor of vascular surgery at Geisel School of Medicine at Dartmouth, Hanover, N.H., he explains how Medicare data were employed to track patients long term, even when they had moved to other hospital systems.
The main message from the long-term follow-up is that there is a persistent risk of recurrence and need for reintervention, according to Dr. Goodney. The hypothesis was that there would be an early risk of failure, followed by a diminishing need for reintervention over time, but this was not what was observed.Rather, the findings suggest that the rate of reinterventions was relatively steady over the course of follow-up, suggesting that patients should be informed of a persistent risk. However, Dr. Goodney reports that age was not a predictor of reintervention, so that older patients were at no greater risk.
FROM 2018 VEITH SYMPOSIUM
Snorkel/chimney repair of aortic aneurysms is still effective after 4 years
NEW YORK – With a median follow-up of almost 4 years in more than 200 patients, the snorkel/chimney technique of endovascular repair of complex abdominal aortic aneurysms continues to generate very good results, according data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
In a video interview with Jason T. Lee, MD, professor of vascular surgery, Stanford (Calif.) University, who presented the long-term results, he explains why these findings are important.
After several single-center studies associated the snorkel/chimney technique with good rates of patency and durability, the PERICLES Registry was created almost 10 years ago to test whether these data could be reproduced in the real world.The data presented by Dr. Lee involved outcomes in 244 patients who were followed for at least 2.5 years. The median follow-up is 47 months.
The results overall confirm that this is a viable technique, according to Dr. Lee who noted very little diminution of patency rates in this long-term cohort relative to the previously published follow-up of 17.1 months.
He acknowledged that the snorkel/chimney repair is not free of potential complications, particularly gutter endovascular leaks, but he recounted that at least some resolve over time. Moreover, he suggests that several strategies are being pursued that appear promising for avoiding this risk.
Most importantly, the registry, which captured the experience at 13 centers in the United States and Europe, shows outcomes that are similar to those reported at centers where the techniques were developed and championed.
NEW YORK – With a median follow-up of almost 4 years in more than 200 patients, the snorkel/chimney technique of endovascular repair of complex abdominal aortic aneurysms continues to generate very good results, according data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
In a video interview with Jason T. Lee, MD, professor of vascular surgery, Stanford (Calif.) University, who presented the long-term results, he explains why these findings are important.
After several single-center studies associated the snorkel/chimney technique with good rates of patency and durability, the PERICLES Registry was created almost 10 years ago to test whether these data could be reproduced in the real world.The data presented by Dr. Lee involved outcomes in 244 patients who were followed for at least 2.5 years. The median follow-up is 47 months.
The results overall confirm that this is a viable technique, according to Dr. Lee who noted very little diminution of patency rates in this long-term cohort relative to the previously published follow-up of 17.1 months.
He acknowledged that the snorkel/chimney repair is not free of potential complications, particularly gutter endovascular leaks, but he recounted that at least some resolve over time. Moreover, he suggests that several strategies are being pursued that appear promising for avoiding this risk.
Most importantly, the registry, which captured the experience at 13 centers in the United States and Europe, shows outcomes that are similar to those reported at centers where the techniques were developed and championed.
NEW YORK – With a median follow-up of almost 4 years in more than 200 patients, the snorkel/chimney technique of endovascular repair of complex abdominal aortic aneurysms continues to generate very good results, according data presented at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
In a video interview with Jason T. Lee, MD, professor of vascular surgery, Stanford (Calif.) University, who presented the long-term results, he explains why these findings are important.
After several single-center studies associated the snorkel/chimney technique with good rates of patency and durability, the PERICLES Registry was created almost 10 years ago to test whether these data could be reproduced in the real world.The data presented by Dr. Lee involved outcomes in 244 patients who were followed for at least 2.5 years. The median follow-up is 47 months.
The results overall confirm that this is a viable technique, according to Dr. Lee who noted very little diminution of patency rates in this long-term cohort relative to the previously published follow-up of 17.1 months.
He acknowledged that the snorkel/chimney repair is not free of potential complications, particularly gutter endovascular leaks, but he recounted that at least some resolve over time. Moreover, he suggests that several strategies are being pursued that appear promising for avoiding this risk.
Most importantly, the registry, which captured the experience at 13 centers in the United States and Europe, shows outcomes that are similar to those reported at centers where the techniques were developed and championed.
FROM 2018 VEITH SYMPOSIUM
A bovine arch predicts worse outcomes with type B aortic dissections
NEW YORK – The presence of a bovine arch predicts higher mortality in patients with a type B aortic dissection (TBAD), according to a study presented by Jan S. Brunkwall, MD, at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
The bovine arch is a congenital interruption in the evolution of the arch, and is a misnomer because it does not actually reflect the arch branching pattern found in cattle. It represents the most common variation of the aortic arch, with a prevalence of 1%-41%, depending on the literature, according to a study published by Dr. Brunkwall, chairman of the department of vascular and endovascular surgery at the University of Cologne (Germany), and his colleagues (Eur J Vasc Endovasc Surg. 2018; 55:385-391).
In order to assess the effect of the bovine arch on survival, Dr. Brunkwall and his colleagues performed a retrospective cohort analysis of patients with TBAD admitted at two centers. CT angiograms (CTAs) of patients referred because of aortic dissection were also reevaluated with regard to the presence of a bovine arch.
A total of 154 patients with TBAD and 168 with type A aortic dissection were assessed, and 110 oncologic patients who had undergone a chest CTA for disease staging during the study period acted as a control group.
There was an overall prevalence of 17.6% for bovine arch variants, with no statistical difference in prevalence between patients with a dissection and those in the control group, or between patients with a type A or type B dissection. However, mortality was 34.5% in patients with TBAD who had a bovine arch versus 16% in patients without a bovine arch. This was a significant difference (P =.04), according to Dr. Brunkwall.
Multivariate analysis showed that the presence of a bovine arch with TBAD was an independent predictor of mortality. “The reason for the high mortality cannot be explained by our data,” said Dr. Brunkwall, “but there has been a suggestion that the shear stress is different and higher in patients with a bovine arch leading to a stiffer aorta and more endothelial damage.”
Dr. Brunkwall reported that he had no disclosures.
NEW YORK – The presence of a bovine arch predicts higher mortality in patients with a type B aortic dissection (TBAD), according to a study presented by Jan S. Brunkwall, MD, at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
The bovine arch is a congenital interruption in the evolution of the arch, and is a misnomer because it does not actually reflect the arch branching pattern found in cattle. It represents the most common variation of the aortic arch, with a prevalence of 1%-41%, depending on the literature, according to a study published by Dr. Brunkwall, chairman of the department of vascular and endovascular surgery at the University of Cologne (Germany), and his colleagues (Eur J Vasc Endovasc Surg. 2018; 55:385-391).
In order to assess the effect of the bovine arch on survival, Dr. Brunkwall and his colleagues performed a retrospective cohort analysis of patients with TBAD admitted at two centers. CT angiograms (CTAs) of patients referred because of aortic dissection were also reevaluated with regard to the presence of a bovine arch.
A total of 154 patients with TBAD and 168 with type A aortic dissection were assessed, and 110 oncologic patients who had undergone a chest CTA for disease staging during the study period acted as a control group.
There was an overall prevalence of 17.6% for bovine arch variants, with no statistical difference in prevalence between patients with a dissection and those in the control group, or between patients with a type A or type B dissection. However, mortality was 34.5% in patients with TBAD who had a bovine arch versus 16% in patients without a bovine arch. This was a significant difference (P =.04), according to Dr. Brunkwall.
Multivariate analysis showed that the presence of a bovine arch with TBAD was an independent predictor of mortality. “The reason for the high mortality cannot be explained by our data,” said Dr. Brunkwall, “but there has been a suggestion that the shear stress is different and higher in patients with a bovine arch leading to a stiffer aorta and more endothelial damage.”
Dr. Brunkwall reported that he had no disclosures.
NEW YORK – The presence of a bovine arch predicts higher mortality in patients with a type B aortic dissection (TBAD), according to a study presented by Jan S. Brunkwall, MD, at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.
The bovine arch is a congenital interruption in the evolution of the arch, and is a misnomer because it does not actually reflect the arch branching pattern found in cattle. It represents the most common variation of the aortic arch, with a prevalence of 1%-41%, depending on the literature, according to a study published by Dr. Brunkwall, chairman of the department of vascular and endovascular surgery at the University of Cologne (Germany), and his colleagues (Eur J Vasc Endovasc Surg. 2018; 55:385-391).
In order to assess the effect of the bovine arch on survival, Dr. Brunkwall and his colleagues performed a retrospective cohort analysis of patients with TBAD admitted at two centers. CT angiograms (CTAs) of patients referred because of aortic dissection were also reevaluated with regard to the presence of a bovine arch.
A total of 154 patients with TBAD and 168 with type A aortic dissection were assessed, and 110 oncologic patients who had undergone a chest CTA for disease staging during the study period acted as a control group.
There was an overall prevalence of 17.6% for bovine arch variants, with no statistical difference in prevalence between patients with a dissection and those in the control group, or between patients with a type A or type B dissection. However, mortality was 34.5% in patients with TBAD who had a bovine arch versus 16% in patients without a bovine arch. This was a significant difference (P =.04), according to Dr. Brunkwall.
Multivariate analysis showed that the presence of a bovine arch with TBAD was an independent predictor of mortality. “The reason for the high mortality cannot be explained by our data,” said Dr. Brunkwall, “but there has been a suggestion that the shear stress is different and higher in patients with a bovine arch leading to a stiffer aorta and more endothelial damage.”
Dr. Brunkwall reported that he had no disclosures.
REPORTING FROM VEITHSYMPOSIUM
INPACT SFA 5-year results: Drug-coated balloon treatment remains safe, durable
The INPACT SFA trial demonstrated the long-term safety of the IN.PACT Admiral drug-coated balloon (DCB) through 5 years, with no device-, procedure-, or paclitaxel-related deaths seen, coupled with continued low thrombosis rates throughout 5 years, according to John R. Laird, MD, of the Adventist Heart & Vascular Institute, St. Helena, Calif.
Dr. Laird presented the final, 5-year results of the combined INPACT SFA I and II trials at the 2018 Vascular Interventional Vascular Advances meeting.
The combined studies compared 220 patients treated with DCB and 111 treated with standard percutaneous transluminal angioplasty (PTA) who were followed out to 5 years. The patient population was 65% men, had a mean age of about 68 years, and none of the baseline characteristics followed were statistically significant between the treatment groups. The mean total lesion length treated was 8.9 cm for the DCB group and 8.8 cm for the PTA group, also a nonsignificant difference.
The primary efficacy endpoint for the study was primary patency within 12 months, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and duplex ultrasound–derived restenosis. The primary safety endpoint was freedom from device-and procedure-related death through 30 days, and freedom from target limb major amputation and CD-TLR within 12 months.
Although there were no significant differences seen between DCB and placebo for CD-TLR or any TLR, there was a significant difference seen in the time to CD-TLR over 1,800 days: 808 days for DCB versus 475 days for placebo (P less than .001).
There were no significant differences seen between the DCB and placebo for any of the safety endpoint components over 5 years.
INPACT SFA was the “first independently adjudicated, blinded, randomized trial to demonstrate superior effectiveness of a drug-coated balloon through 5 years,” and the “results support DCB as a first-line strategy for the treatment of femoropopliteal disease,” Dr. Laird concluded.
The trial was sponsored by Medtronic Endovascular. Dr. Laird reported that he is a consultant/advisory board member for Abbott Vascular, Bard, Boston Scientific, and Medtronic.
The INPACT SFA trial demonstrated the long-term safety of the IN.PACT Admiral drug-coated balloon (DCB) through 5 years, with no device-, procedure-, or paclitaxel-related deaths seen, coupled with continued low thrombosis rates throughout 5 years, according to John R. Laird, MD, of the Adventist Heart & Vascular Institute, St. Helena, Calif.
Dr. Laird presented the final, 5-year results of the combined INPACT SFA I and II trials at the 2018 Vascular Interventional Vascular Advances meeting.
The combined studies compared 220 patients treated with DCB and 111 treated with standard percutaneous transluminal angioplasty (PTA) who were followed out to 5 years. The patient population was 65% men, had a mean age of about 68 years, and none of the baseline characteristics followed were statistically significant between the treatment groups. The mean total lesion length treated was 8.9 cm for the DCB group and 8.8 cm for the PTA group, also a nonsignificant difference.
The primary efficacy endpoint for the study was primary patency within 12 months, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and duplex ultrasound–derived restenosis. The primary safety endpoint was freedom from device-and procedure-related death through 30 days, and freedom from target limb major amputation and CD-TLR within 12 months.
Although there were no significant differences seen between DCB and placebo for CD-TLR or any TLR, there was a significant difference seen in the time to CD-TLR over 1,800 days: 808 days for DCB versus 475 days for placebo (P less than .001).
There were no significant differences seen between the DCB and placebo for any of the safety endpoint components over 5 years.
INPACT SFA was the “first independently adjudicated, blinded, randomized trial to demonstrate superior effectiveness of a drug-coated balloon through 5 years,” and the “results support DCB as a first-line strategy for the treatment of femoropopliteal disease,” Dr. Laird concluded.
The trial was sponsored by Medtronic Endovascular. Dr. Laird reported that he is a consultant/advisory board member for Abbott Vascular, Bard, Boston Scientific, and Medtronic.
The INPACT SFA trial demonstrated the long-term safety of the IN.PACT Admiral drug-coated balloon (DCB) through 5 years, with no device-, procedure-, or paclitaxel-related deaths seen, coupled with continued low thrombosis rates throughout 5 years, according to John R. Laird, MD, of the Adventist Heart & Vascular Institute, St. Helena, Calif.
Dr. Laird presented the final, 5-year results of the combined INPACT SFA I and II trials at the 2018 Vascular Interventional Vascular Advances meeting.
The combined studies compared 220 patients treated with DCB and 111 treated with standard percutaneous transluminal angioplasty (PTA) who were followed out to 5 years. The patient population was 65% men, had a mean age of about 68 years, and none of the baseline characteristics followed were statistically significant between the treatment groups. The mean total lesion length treated was 8.9 cm for the DCB group and 8.8 cm for the PTA group, also a nonsignificant difference.
The primary efficacy endpoint for the study was primary patency within 12 months, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and duplex ultrasound–derived restenosis. The primary safety endpoint was freedom from device-and procedure-related death through 30 days, and freedom from target limb major amputation and CD-TLR within 12 months.
Although there were no significant differences seen between DCB and placebo for CD-TLR or any TLR, there was a significant difference seen in the time to CD-TLR over 1,800 days: 808 days for DCB versus 475 days for placebo (P less than .001).
There were no significant differences seen between the DCB and placebo for any of the safety endpoint components over 5 years.
INPACT SFA was the “first independently adjudicated, blinded, randomized trial to demonstrate superior effectiveness of a drug-coated balloon through 5 years,” and the “results support DCB as a first-line strategy for the treatment of femoropopliteal disease,” Dr. Laird concluded.
The trial was sponsored by Medtronic Endovascular. Dr. Laird reported that he is a consultant/advisory board member for Abbott Vascular, Bard, Boston Scientific, and Medtronic.
FROM VIVA 2018
Key clinical point: Use of a drug-coated balloon was effective and safe over 5 years for the treatment of superficial femoral artery lesions.
Major finding: There was a significant difference seen in the time to clinically driven target lesion revascularization: 808 days for drug-coated balloon versus 475 days for placebo (P less than .001).
Study details: A pair of trials that included 331 patients with superficial femoral artery lesions
Disclosures: The INPACT SFA trial was sponsored by Medtronic Endovascular. Dr. Laird disclosed that he is a consultant/advisory board member for Abbott Vascular, Bard, Boston Scientific, and Medtronic.
Endoscopic vein-graft harvest equals open harvest at 3 years
CHICAGO – Patients who underwent coronary artery bypass grafting using saphenous veins harvested endoscopically had similar clinical outcomes after nearly 3 years of follow-up as those seen with patients who received vein grafts taken by open harvesting in a multicenter, randomized trial in the United States with 1,150 patients.
As expected, follow-up also showed that endoscopic vein-graft harvesting (EVH) resulted in about half the number of wound infections as did open vein-graft harvesting (OVH). This combination of similar clinical outcomes after a median 2.8 years of follow-up, as well as fewer leg-wound adverse events, makes EVH “the preferred vein-harvesting modality,” Marco A. Zenati, MD, said at the American Heart Association scientific sessions.
Although patients far and away prefer EVH because of the reduced pain and faster healing, questions about its clinical efficacy when compared with that of OVH have lingered. That’s because observational data published almost a decade ago taken from the PREVENT IV (Project of Ex-Vivo Vein Graft Engineering via Transfection IV) trial suggested that patients who underwent coronary artery bypass grafting (CABG) using vein grafts collected by EVH had more vein-graft failures after 12-18 months and a higher rate of death, MI, or need for revascularization after 3 years, compared with patients treated using OVH (N Engl J Med. 2009 July 16;361[3]:235-44).
The results from the prospective, randomized trial reported by Dr. Zenati “take the cloud away from endovascular vein-graft harvesting that PREVENT IV had made,” commented Timothy J. Gardner, MD, a cardiac surgeon who chaired the session.
“I think this answers the question,” commented Marc Ruel, MD, a professor of surgery and the chief of cardiac surgery at the University of Ottawa. “The results show that endoscopic harvesting of vein grafts is as good as open harvesting for preventing major adverse cardiac events, which is the goal of CABG. This is a definitive trial, with no trend toward more events with endoscopic harvested vein grafts,” said Dr. Ruel, the designated discussant for Dr. Zenati’s report.
However, the study did have some significant limitations, Dr. Ruel added. The new, randomized trial, run at 16 U.S. VA cardiac surgery centers, exclusively used surgeons who were experts in endovascular vein harvesting, which could have meant that they and their surgical teams were not as expert in open vein harvesting, he said. Also, in the broader context of CABG and conduit selection, new evidence suggests the superiority of pedicled vein grafts (Ann Thoracic Surg. 2017 Oct;104[4]1313-17), and “we could also do better by using the radial artery” rather than a saphenous vein graft, Dr. Ruel said. He cited a meta-analysis published in 2018 that showed the superiority of CABG when it combined an internal thoracic artery graft with a radial artery graft rather than with a vein graft (N Engl J Med. 2018 May 31;378[22]:2069-77).
“The operation of the future is not necessarily what you saw” in Dr. Zenati’s study, Dr. Ruel cautioned.
The results Dr. Zenati reported came from the REGROUP (Randomized End-Vein Graft Prospective) trial, which enrolled patients who underwent CABG during 2014-2017. All patients received an internal thoracic artery graft and were randomized to receive additional saphenous vein grafts with the conduits collected either by the EVH or OVH method. The study’s primary endpoint of all-cause death, nonfatal MI, or need for repeat revascularization after a median follow-up of 2.8 years occurred in 14% of the patients who received vein grafts with EVH and in 16% of the patients who received grafts with OVH, a difference that was not statistically significant, reported Dr. Zenati, a professor of surgery at Harvard Medical School in Boston and the chief of cardiothoracic surgery for the VA Boston Health System. The incidence of wound infection was 3.1% in the OVH patients and 1.4% in the EVH patients, a difference that came close to but did not reach statistical significance. Concurrently with Dr. Zenati’s report, an article with the results appeared online (N Engl J Med. 2018 Nov 11. doi: 0.1056/NEJMoa1812390).
The REGROUP trial did not collect data on vein-graft patency following CABG. The investigators were concerned about having enough patients return for follow-up angiography to produce a meaningful result for this endpoint, and they believed that the clinical endpoint they used sufficed for demonstrating equivalence of the two harvesting methods, Dr. Zenati said during his talk.
“The more arterial conduit used in CABG, the better the durability of the grafts, but often surgeons use vein grafts because there is not enough arterial conduit,” commented Donald M. Lloyd-Jones, MD, professor and chair of preventive medicine at Northwestern University in Chicago.* “The recovery from endoscopic vein-graft harvesting is very different from open harvesting. Endoscopic harvesting produces much less pain and infection, and recovery is much easier for patients, so it’s reassuring to see that the quality of the vein is not affected by endoscopic harvesting when done by experts,” he said.
Dr. Zenati, Dr. Gardner, Dr. Ruel, and Dr. Lloyd-Jones had no disclosures.
SOURCE: Zenati M et al. AHA 2018, Abstract 19055.
*Correction, 11/12/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
This article was updated 11/14/18.
The results from the REGROUP trial are interesting and open the field for additional comparisons of endoscopic and open saphenous vein-graft harvesting, but this trial is not the definitive answer regarding whether these two harvesting approaches produce similar results. Greater reassurance of equivalence would come from studies that included more patients and a more diverse patient population; REGROUP largely enrolled male veterans and patients with multiple comorbidities. Longer follow-up is also needed. A median follow-up of 3 years is too brief for complete reassurance that long-term patency is the same with both approaches. It would also help to have follow-up data on graft patency. Many factors besides patency can lead to differences in clinical outcomes following coronary bypass surgery.
Endoscopic vein harvesting is preferred by patients, and it results in fewer wound infections, as was confirmed in REGROUP. Because of these advantages for endoscopic harvesting, it would be great if we could definitively document that these vein grafts functioned as well as those taken with open harvesting.
Evidence now suggests that the more arterial conduits used during coronary bypass, the better. If I were having triple-vessel bypass surgery, I’d want to get two thoracic-artery bypass grafts and a radial artery graft. But studies like REGROUP are important because a majority of heart surgeons use vein grafts for several reasons including convenience. Surgeons will likely continue to use vein grafts for the foreseeable future, so we need to know whether endoscopic harvesting is an acceptable approach.
Jennifer S. Lawton, MD , is a professor of surgery and chief of cardiac surgery at Johns Hopkins Medicine in Baltimore. She had no disclosures. She made these comments in an interview.
The results from the REGROUP trial are interesting and open the field for additional comparisons of endoscopic and open saphenous vein-graft harvesting, but this trial is not the definitive answer regarding whether these two harvesting approaches produce similar results. Greater reassurance of equivalence would come from studies that included more patients and a more diverse patient population; REGROUP largely enrolled male veterans and patients with multiple comorbidities. Longer follow-up is also needed. A median follow-up of 3 years is too brief for complete reassurance that long-term patency is the same with both approaches. It would also help to have follow-up data on graft patency. Many factors besides patency can lead to differences in clinical outcomes following coronary bypass surgery.
Endoscopic vein harvesting is preferred by patients, and it results in fewer wound infections, as was confirmed in REGROUP. Because of these advantages for endoscopic harvesting, it would be great if we could definitively document that these vein grafts functioned as well as those taken with open harvesting.
Evidence now suggests that the more arterial conduits used during coronary bypass, the better. If I were having triple-vessel bypass surgery, I’d want to get two thoracic-artery bypass grafts and a radial artery graft. But studies like REGROUP are important because a majority of heart surgeons use vein grafts for several reasons including convenience. Surgeons will likely continue to use vein grafts for the foreseeable future, so we need to know whether endoscopic harvesting is an acceptable approach.
Jennifer S. Lawton, MD , is a professor of surgery and chief of cardiac surgery at Johns Hopkins Medicine in Baltimore. She had no disclosures. She made these comments in an interview.
The results from the REGROUP trial are interesting and open the field for additional comparisons of endoscopic and open saphenous vein-graft harvesting, but this trial is not the definitive answer regarding whether these two harvesting approaches produce similar results. Greater reassurance of equivalence would come from studies that included more patients and a more diverse patient population; REGROUP largely enrolled male veterans and patients with multiple comorbidities. Longer follow-up is also needed. A median follow-up of 3 years is too brief for complete reassurance that long-term patency is the same with both approaches. It would also help to have follow-up data on graft patency. Many factors besides patency can lead to differences in clinical outcomes following coronary bypass surgery.
Endoscopic vein harvesting is preferred by patients, and it results in fewer wound infections, as was confirmed in REGROUP. Because of these advantages for endoscopic harvesting, it would be great if we could definitively document that these vein grafts functioned as well as those taken with open harvesting.
Evidence now suggests that the more arterial conduits used during coronary bypass, the better. If I were having triple-vessel bypass surgery, I’d want to get two thoracic-artery bypass grafts and a radial artery graft. But studies like REGROUP are important because a majority of heart surgeons use vein grafts for several reasons including convenience. Surgeons will likely continue to use vein grafts for the foreseeable future, so we need to know whether endoscopic harvesting is an acceptable approach.
Jennifer S. Lawton, MD , is a professor of surgery and chief of cardiac surgery at Johns Hopkins Medicine in Baltimore. She had no disclosures. She made these comments in an interview.
CHICAGO – Patients who underwent coronary artery bypass grafting using saphenous veins harvested endoscopically had similar clinical outcomes after nearly 3 years of follow-up as those seen with patients who received vein grafts taken by open harvesting in a multicenter, randomized trial in the United States with 1,150 patients.
As expected, follow-up also showed that endoscopic vein-graft harvesting (EVH) resulted in about half the number of wound infections as did open vein-graft harvesting (OVH). This combination of similar clinical outcomes after a median 2.8 years of follow-up, as well as fewer leg-wound adverse events, makes EVH “the preferred vein-harvesting modality,” Marco A. Zenati, MD, said at the American Heart Association scientific sessions.
Although patients far and away prefer EVH because of the reduced pain and faster healing, questions about its clinical efficacy when compared with that of OVH have lingered. That’s because observational data published almost a decade ago taken from the PREVENT IV (Project of Ex-Vivo Vein Graft Engineering via Transfection IV) trial suggested that patients who underwent coronary artery bypass grafting (CABG) using vein grafts collected by EVH had more vein-graft failures after 12-18 months and a higher rate of death, MI, or need for revascularization after 3 years, compared with patients treated using OVH (N Engl J Med. 2009 July 16;361[3]:235-44).
The results from the prospective, randomized trial reported by Dr. Zenati “take the cloud away from endovascular vein-graft harvesting that PREVENT IV had made,” commented Timothy J. Gardner, MD, a cardiac surgeon who chaired the session.
“I think this answers the question,” commented Marc Ruel, MD, a professor of surgery and the chief of cardiac surgery at the University of Ottawa. “The results show that endoscopic harvesting of vein grafts is as good as open harvesting for preventing major adverse cardiac events, which is the goal of CABG. This is a definitive trial, with no trend toward more events with endoscopic harvested vein grafts,” said Dr. Ruel, the designated discussant for Dr. Zenati’s report.
However, the study did have some significant limitations, Dr. Ruel added. The new, randomized trial, run at 16 U.S. VA cardiac surgery centers, exclusively used surgeons who were experts in endovascular vein harvesting, which could have meant that they and their surgical teams were not as expert in open vein harvesting, he said. Also, in the broader context of CABG and conduit selection, new evidence suggests the superiority of pedicled vein grafts (Ann Thoracic Surg. 2017 Oct;104[4]1313-17), and “we could also do better by using the radial artery” rather than a saphenous vein graft, Dr. Ruel said. He cited a meta-analysis published in 2018 that showed the superiority of CABG when it combined an internal thoracic artery graft with a radial artery graft rather than with a vein graft (N Engl J Med. 2018 May 31;378[22]:2069-77).
“The operation of the future is not necessarily what you saw” in Dr. Zenati’s study, Dr. Ruel cautioned.
The results Dr. Zenati reported came from the REGROUP (Randomized End-Vein Graft Prospective) trial, which enrolled patients who underwent CABG during 2014-2017. All patients received an internal thoracic artery graft and were randomized to receive additional saphenous vein grafts with the conduits collected either by the EVH or OVH method. The study’s primary endpoint of all-cause death, nonfatal MI, or need for repeat revascularization after a median follow-up of 2.8 years occurred in 14% of the patients who received vein grafts with EVH and in 16% of the patients who received grafts with OVH, a difference that was not statistically significant, reported Dr. Zenati, a professor of surgery at Harvard Medical School in Boston and the chief of cardiothoracic surgery for the VA Boston Health System. The incidence of wound infection was 3.1% in the OVH patients and 1.4% in the EVH patients, a difference that came close to but did not reach statistical significance. Concurrently with Dr. Zenati’s report, an article with the results appeared online (N Engl J Med. 2018 Nov 11. doi: 0.1056/NEJMoa1812390).
The REGROUP trial did not collect data on vein-graft patency following CABG. The investigators were concerned about having enough patients return for follow-up angiography to produce a meaningful result for this endpoint, and they believed that the clinical endpoint they used sufficed for demonstrating equivalence of the two harvesting methods, Dr. Zenati said during his talk.
“The more arterial conduit used in CABG, the better the durability of the grafts, but often surgeons use vein grafts because there is not enough arterial conduit,” commented Donald M. Lloyd-Jones, MD, professor and chair of preventive medicine at Northwestern University in Chicago.* “The recovery from endoscopic vein-graft harvesting is very different from open harvesting. Endoscopic harvesting produces much less pain and infection, and recovery is much easier for patients, so it’s reassuring to see that the quality of the vein is not affected by endoscopic harvesting when done by experts,” he said.
Dr. Zenati, Dr. Gardner, Dr. Ruel, and Dr. Lloyd-Jones had no disclosures.
SOURCE: Zenati M et al. AHA 2018, Abstract 19055.
*Correction, 11/12/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
This article was updated 11/14/18.
CHICAGO – Patients who underwent coronary artery bypass grafting using saphenous veins harvested endoscopically had similar clinical outcomes after nearly 3 years of follow-up as those seen with patients who received vein grafts taken by open harvesting in a multicenter, randomized trial in the United States with 1,150 patients.
As expected, follow-up also showed that endoscopic vein-graft harvesting (EVH) resulted in about half the number of wound infections as did open vein-graft harvesting (OVH). This combination of similar clinical outcomes after a median 2.8 years of follow-up, as well as fewer leg-wound adverse events, makes EVH “the preferred vein-harvesting modality,” Marco A. Zenati, MD, said at the American Heart Association scientific sessions.
Although patients far and away prefer EVH because of the reduced pain and faster healing, questions about its clinical efficacy when compared with that of OVH have lingered. That’s because observational data published almost a decade ago taken from the PREVENT IV (Project of Ex-Vivo Vein Graft Engineering via Transfection IV) trial suggested that patients who underwent coronary artery bypass grafting (CABG) using vein grafts collected by EVH had more vein-graft failures after 12-18 months and a higher rate of death, MI, or need for revascularization after 3 years, compared with patients treated using OVH (N Engl J Med. 2009 July 16;361[3]:235-44).
The results from the prospective, randomized trial reported by Dr. Zenati “take the cloud away from endovascular vein-graft harvesting that PREVENT IV had made,” commented Timothy J. Gardner, MD, a cardiac surgeon who chaired the session.
“I think this answers the question,” commented Marc Ruel, MD, a professor of surgery and the chief of cardiac surgery at the University of Ottawa. “The results show that endoscopic harvesting of vein grafts is as good as open harvesting for preventing major adverse cardiac events, which is the goal of CABG. This is a definitive trial, with no trend toward more events with endoscopic harvested vein grafts,” said Dr. Ruel, the designated discussant for Dr. Zenati’s report.
However, the study did have some significant limitations, Dr. Ruel added. The new, randomized trial, run at 16 U.S. VA cardiac surgery centers, exclusively used surgeons who were experts in endovascular vein harvesting, which could have meant that they and their surgical teams were not as expert in open vein harvesting, he said. Also, in the broader context of CABG and conduit selection, new evidence suggests the superiority of pedicled vein grafts (Ann Thoracic Surg. 2017 Oct;104[4]1313-17), and “we could also do better by using the radial artery” rather than a saphenous vein graft, Dr. Ruel said. He cited a meta-analysis published in 2018 that showed the superiority of CABG when it combined an internal thoracic artery graft with a radial artery graft rather than with a vein graft (N Engl J Med. 2018 May 31;378[22]:2069-77).
“The operation of the future is not necessarily what you saw” in Dr. Zenati’s study, Dr. Ruel cautioned.
The results Dr. Zenati reported came from the REGROUP (Randomized End-Vein Graft Prospective) trial, which enrolled patients who underwent CABG during 2014-2017. All patients received an internal thoracic artery graft and were randomized to receive additional saphenous vein grafts with the conduits collected either by the EVH or OVH method. The study’s primary endpoint of all-cause death, nonfatal MI, or need for repeat revascularization after a median follow-up of 2.8 years occurred in 14% of the patients who received vein grafts with EVH and in 16% of the patients who received grafts with OVH, a difference that was not statistically significant, reported Dr. Zenati, a professor of surgery at Harvard Medical School in Boston and the chief of cardiothoracic surgery for the VA Boston Health System. The incidence of wound infection was 3.1% in the OVH patients and 1.4% in the EVH patients, a difference that came close to but did not reach statistical significance. Concurrently with Dr. Zenati’s report, an article with the results appeared online (N Engl J Med. 2018 Nov 11. doi: 0.1056/NEJMoa1812390).
The REGROUP trial did not collect data on vein-graft patency following CABG. The investigators were concerned about having enough patients return for follow-up angiography to produce a meaningful result for this endpoint, and they believed that the clinical endpoint they used sufficed for demonstrating equivalence of the two harvesting methods, Dr. Zenati said during his talk.
“The more arterial conduit used in CABG, the better the durability of the grafts, but often surgeons use vein grafts because there is not enough arterial conduit,” commented Donald M. Lloyd-Jones, MD, professor and chair of preventive medicine at Northwestern University in Chicago.* “The recovery from endoscopic vein-graft harvesting is very different from open harvesting. Endoscopic harvesting produces much less pain and infection, and recovery is much easier for patients, so it’s reassuring to see that the quality of the vein is not affected by endoscopic harvesting when done by experts,” he said.
Dr. Zenati, Dr. Gardner, Dr. Ruel, and Dr. Lloyd-Jones had no disclosures.
SOURCE: Zenati M et al. AHA 2018, Abstract 19055.
*Correction, 11/12/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
This article was updated 11/14/18.
REPORTING FROM THE AHA SCIENTIFIC SESSION
Key clinical point:
Major finding: Clinical events occurred in 16% of open-harvest vein-graft patients and in 14% who received endoscopically harvested veins.
Study details: REGROUP, a multicenter, randomized trial with 1,150 patients.
Disclosures: Dr. Zenati, Dr. Gardner, Dr. Ruel, and Dr. Lloyd-Jones had no disclosures.
Source: Zenati M et al. AHA 2018, Abstract 19055.
Valve-in-valve TAVR benefits maintained at 3 years
SAN DIEGO – Early benefits of valve-in-valve transcatheter aortic valve replacement (TAVR) for patients with failing surgical aortic bioprosthetic valves are sustained for at least 3 years, based on results presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Previously published data for the 365 patients from the PARTNER Valve-in-Valve study showed dramatic improvements at 30 days and 1 year in hemodynamic measures, mitral and tricuspid regurgitation, and quality of life (J Am Coll Cardiol. 2017;69:2253-62).
At the 3-year mark, about one-third of patients had died, reported lead investigator John G. Webb, MD, a professor at the University of British Columbia, Vancouver. “I think we can say that this reflects multiple comorbidities in this high-risk patient population with an STS [Society of Thoracic Surgery] risk score of 1.9%. Patients were selected for being at extreme risk,” he commented. “This is not unexpected. ... This is very comparable to what we saw in the early PARTNER trials as well.”
For survivors, however, the early benefits were still present and largely unattenuated at 3 years. For example, about half of patients were New York Heart Association (NYHA) class I at 30 days, at 1 year, and at 3 years. And Kansas City Cardiomyopathy Questionnaire (KCCQ) score, reflecting heart failure–related quality of life, averaged 70-77 at all three time points.
The proportion of patients needing yet another valve replacement (surgical or transcatheter), possibly signaling structural valve deterioration or degeneration, was less than 2% at 3 years, and hemodynamic parameters remained good.
Practical matters
Valve-in-valve TAVR need not be restricted to academic high-volume centers, according to Dr. Webb. “I run a regional program, and my regional program had a hub-and-spoke model where this was restricted to one institution, and four other institutions just did routine transfemoral TAVR. We had to give up that because these are some of the easiest TAVR procedures that we do. You have a radio-opaque valve, you know the angle, you know the size, it seals well, you don’t get annular rupture, you don’t need pacemakers very often.”
In addition, recent TCT registry data suggest that outcomes with valve-in-valve TAVR are better than those with native-valve TAVR, Dr. Webb noted. “There’s a knowledge base that’s required that routine TAVR operators may not have. But it can be taught, it can be learned, and it’s not a difficult procedure when you know how to do it.”
“This study is very, very useful for all of us,” commented press conference panelist Jeffrey J. Popma, MD, an interventional cardiologist at the Beth Israel Deaconess Medical Center in Boston. “But should we be reconsidering anticoagulation therapy in some of the valve-in-valve procedures? We have learned from the leaflet thrombosis data that one of the risk factors for that is a valve-in-valve procedure. Clinically, we have seen a few cases where thrombus does form in the nidus of all the material that’s there.”
“There was no sign of leaflet thrombosis playing a role in reintervention,” Dr. Webb replied. “[Reintervention] was performed for various reasons, including leaks and valves that were too small. So it wasn’t clear that leaflet thrombosis was a factor in this study. That being said, we weren’t looking for it; we didn’t have sensitive means [to detect it], we weren’t doing transesophageal echoes, we weren’t doing CTs.
“Personally, I suspect that maybe we should be routinely anticoagulating all of our valve implants,” he added. “We certainly do it for our mitral valves routinely, and although I can’t recommend it, I have to admit that we do do this for aortic valves in my particular center. But I have no data from this study to support that either way.”
Study details
The 365 patients studied came from both an initial registry and a continued access registry, but were largely similar on baseline characteristics. All underwent valve-in-valve TAVR with SAPIEN XT transcatheter heart valves.
Mortality in the cohort was 12.1% at 1 year, 22.2% at 2 years, and 32.7% at 3 years, according to results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. In contrast, the rate of stroke was stable over time, at 5.1%, 5.1%, and 6.2%, respectively.
Repeat valve replacement (either surgical or transcatheter) had been performed in 0.6% of patients at 1 year, 0.6% at 2 years, and 1.9% at 3 years. “I think this is comparable to [what is seen in] surgical series,” Dr. Webb commented.
Between 30 days and 3 years, there were insignificant decreases in total aortic regurgitation that was moderate or worse in severity (from 2.9% to 2.5%) and paravalvular aortic regurgitation of these severities (from 2.6% to 1.4%). Although the valve used was older, “still, we had excellent sealing and aortic insufficiency was not a problem with these patients,” he noted.
In “interesting” findings, prevalence of mitral regurgitation that was moderate or worse continued falling, from 17.2% at 30 days to 8.6% at 3 years, and prevalence of tricuspid regurgitation that was moderate or worse did as well, from 21.8% to 18.8%.
“I was a little suspicious this was just a survival issue, that patients with severe mitral or tricuspid regurgitation died and, consequently, the average patient was less likely to have [these findings]. But the analysis that’s being done is linear mixed-effects analysis, which accounts for the survival bias,” Dr. Webb said.
The reasons for these trends are unknown, but possibly improved left ventricular function led to functional (rather than structural) improvements in mitral and tricuspid regurgitation.
At 3 years, proportions of patients with various NYHA classes were much the same as they had been at 30 days: class I (51.4% vs. 53.9%), class II (34.6% vs. 35.7%), and class III (13.0% vs. 9.2%). Similarly, the mean KCCQ overall summary score at 30 days (70.8) was sustained at 3 years (73.1).
Risk of death did not differ significantly according to the surgical valve size as labeled, the surgical valve true internal dimensions, the mode of valve failure, the approach used (transfemoral vs. transthoracic), or the residual gradient after valve implantation.
Analysis of the registry data is ongoing. For example, the investigators will be looking more closely at determinants of outcomes, such as additional characteristics of the surgical valve alone and in combination with those of the new valve. “We are all very aware that a lot of the outcomes have to do with what surgical valves you had to begin with. I think that is really critical – what surgical valve is in there,” he said.
Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for, Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.
SAN DIEGO – Early benefits of valve-in-valve transcatheter aortic valve replacement (TAVR) for patients with failing surgical aortic bioprosthetic valves are sustained for at least 3 years, based on results presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Previously published data for the 365 patients from the PARTNER Valve-in-Valve study showed dramatic improvements at 30 days and 1 year in hemodynamic measures, mitral and tricuspid regurgitation, and quality of life (J Am Coll Cardiol. 2017;69:2253-62).
At the 3-year mark, about one-third of patients had died, reported lead investigator John G. Webb, MD, a professor at the University of British Columbia, Vancouver. “I think we can say that this reflects multiple comorbidities in this high-risk patient population with an STS [Society of Thoracic Surgery] risk score of 1.9%. Patients were selected for being at extreme risk,” he commented. “This is not unexpected. ... This is very comparable to what we saw in the early PARTNER trials as well.”
For survivors, however, the early benefits were still present and largely unattenuated at 3 years. For example, about half of patients were New York Heart Association (NYHA) class I at 30 days, at 1 year, and at 3 years. And Kansas City Cardiomyopathy Questionnaire (KCCQ) score, reflecting heart failure–related quality of life, averaged 70-77 at all three time points.
The proportion of patients needing yet another valve replacement (surgical or transcatheter), possibly signaling structural valve deterioration or degeneration, was less than 2% at 3 years, and hemodynamic parameters remained good.
Practical matters
Valve-in-valve TAVR need not be restricted to academic high-volume centers, according to Dr. Webb. “I run a regional program, and my regional program had a hub-and-spoke model where this was restricted to one institution, and four other institutions just did routine transfemoral TAVR. We had to give up that because these are some of the easiest TAVR procedures that we do. You have a radio-opaque valve, you know the angle, you know the size, it seals well, you don’t get annular rupture, you don’t need pacemakers very often.”
In addition, recent TCT registry data suggest that outcomes with valve-in-valve TAVR are better than those with native-valve TAVR, Dr. Webb noted. “There’s a knowledge base that’s required that routine TAVR operators may not have. But it can be taught, it can be learned, and it’s not a difficult procedure when you know how to do it.”
“This study is very, very useful for all of us,” commented press conference panelist Jeffrey J. Popma, MD, an interventional cardiologist at the Beth Israel Deaconess Medical Center in Boston. “But should we be reconsidering anticoagulation therapy in some of the valve-in-valve procedures? We have learned from the leaflet thrombosis data that one of the risk factors for that is a valve-in-valve procedure. Clinically, we have seen a few cases where thrombus does form in the nidus of all the material that’s there.”
“There was no sign of leaflet thrombosis playing a role in reintervention,” Dr. Webb replied. “[Reintervention] was performed for various reasons, including leaks and valves that were too small. So it wasn’t clear that leaflet thrombosis was a factor in this study. That being said, we weren’t looking for it; we didn’t have sensitive means [to detect it], we weren’t doing transesophageal echoes, we weren’t doing CTs.
“Personally, I suspect that maybe we should be routinely anticoagulating all of our valve implants,” he added. “We certainly do it for our mitral valves routinely, and although I can’t recommend it, I have to admit that we do do this for aortic valves in my particular center. But I have no data from this study to support that either way.”
Study details
The 365 patients studied came from both an initial registry and a continued access registry, but were largely similar on baseline characteristics. All underwent valve-in-valve TAVR with SAPIEN XT transcatheter heart valves.
Mortality in the cohort was 12.1% at 1 year, 22.2% at 2 years, and 32.7% at 3 years, according to results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. In contrast, the rate of stroke was stable over time, at 5.1%, 5.1%, and 6.2%, respectively.
Repeat valve replacement (either surgical or transcatheter) had been performed in 0.6% of patients at 1 year, 0.6% at 2 years, and 1.9% at 3 years. “I think this is comparable to [what is seen in] surgical series,” Dr. Webb commented.
Between 30 days and 3 years, there were insignificant decreases in total aortic regurgitation that was moderate or worse in severity (from 2.9% to 2.5%) and paravalvular aortic regurgitation of these severities (from 2.6% to 1.4%). Although the valve used was older, “still, we had excellent sealing and aortic insufficiency was not a problem with these patients,” he noted.
In “interesting” findings, prevalence of mitral regurgitation that was moderate or worse continued falling, from 17.2% at 30 days to 8.6% at 3 years, and prevalence of tricuspid regurgitation that was moderate or worse did as well, from 21.8% to 18.8%.
“I was a little suspicious this was just a survival issue, that patients with severe mitral or tricuspid regurgitation died and, consequently, the average patient was less likely to have [these findings]. But the analysis that’s being done is linear mixed-effects analysis, which accounts for the survival bias,” Dr. Webb said.
The reasons for these trends are unknown, but possibly improved left ventricular function led to functional (rather than structural) improvements in mitral and tricuspid regurgitation.
At 3 years, proportions of patients with various NYHA classes were much the same as they had been at 30 days: class I (51.4% vs. 53.9%), class II (34.6% vs. 35.7%), and class III (13.0% vs. 9.2%). Similarly, the mean KCCQ overall summary score at 30 days (70.8) was sustained at 3 years (73.1).
Risk of death did not differ significantly according to the surgical valve size as labeled, the surgical valve true internal dimensions, the mode of valve failure, the approach used (transfemoral vs. transthoracic), or the residual gradient after valve implantation.
Analysis of the registry data is ongoing. For example, the investigators will be looking more closely at determinants of outcomes, such as additional characteristics of the surgical valve alone and in combination with those of the new valve. “We are all very aware that a lot of the outcomes have to do with what surgical valves you had to begin with. I think that is really critical – what surgical valve is in there,” he said.
Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for, Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.
SAN DIEGO – Early benefits of valve-in-valve transcatheter aortic valve replacement (TAVR) for patients with failing surgical aortic bioprosthetic valves are sustained for at least 3 years, based on results presented at the Transcatheter Cardiovascular Therapeutics annual meeting.
Previously published data for the 365 patients from the PARTNER Valve-in-Valve study showed dramatic improvements at 30 days and 1 year in hemodynamic measures, mitral and tricuspid regurgitation, and quality of life (J Am Coll Cardiol. 2017;69:2253-62).
At the 3-year mark, about one-third of patients had died, reported lead investigator John G. Webb, MD, a professor at the University of British Columbia, Vancouver. “I think we can say that this reflects multiple comorbidities in this high-risk patient population with an STS [Society of Thoracic Surgery] risk score of 1.9%. Patients were selected for being at extreme risk,” he commented. “This is not unexpected. ... This is very comparable to what we saw in the early PARTNER trials as well.”
For survivors, however, the early benefits were still present and largely unattenuated at 3 years. For example, about half of patients were New York Heart Association (NYHA) class I at 30 days, at 1 year, and at 3 years. And Kansas City Cardiomyopathy Questionnaire (KCCQ) score, reflecting heart failure–related quality of life, averaged 70-77 at all three time points.
The proportion of patients needing yet another valve replacement (surgical or transcatheter), possibly signaling structural valve deterioration or degeneration, was less than 2% at 3 years, and hemodynamic parameters remained good.
Practical matters
Valve-in-valve TAVR need not be restricted to academic high-volume centers, according to Dr. Webb. “I run a regional program, and my regional program had a hub-and-spoke model where this was restricted to one institution, and four other institutions just did routine transfemoral TAVR. We had to give up that because these are some of the easiest TAVR procedures that we do. You have a radio-opaque valve, you know the angle, you know the size, it seals well, you don’t get annular rupture, you don’t need pacemakers very often.”
In addition, recent TCT registry data suggest that outcomes with valve-in-valve TAVR are better than those with native-valve TAVR, Dr. Webb noted. “There’s a knowledge base that’s required that routine TAVR operators may not have. But it can be taught, it can be learned, and it’s not a difficult procedure when you know how to do it.”
“This study is very, very useful for all of us,” commented press conference panelist Jeffrey J. Popma, MD, an interventional cardiologist at the Beth Israel Deaconess Medical Center in Boston. “But should we be reconsidering anticoagulation therapy in some of the valve-in-valve procedures? We have learned from the leaflet thrombosis data that one of the risk factors for that is a valve-in-valve procedure. Clinically, we have seen a few cases where thrombus does form in the nidus of all the material that’s there.”
“There was no sign of leaflet thrombosis playing a role in reintervention,” Dr. Webb replied. “[Reintervention] was performed for various reasons, including leaks and valves that were too small. So it wasn’t clear that leaflet thrombosis was a factor in this study. That being said, we weren’t looking for it; we didn’t have sensitive means [to detect it], we weren’t doing transesophageal echoes, we weren’t doing CTs.
“Personally, I suspect that maybe we should be routinely anticoagulating all of our valve implants,” he added. “We certainly do it for our mitral valves routinely, and although I can’t recommend it, I have to admit that we do do this for aortic valves in my particular center. But I have no data from this study to support that either way.”
Study details
The 365 patients studied came from both an initial registry and a continued access registry, but were largely similar on baseline characteristics. All underwent valve-in-valve TAVR with SAPIEN XT transcatheter heart valves.
Mortality in the cohort was 12.1% at 1 year, 22.2% at 2 years, and 32.7% at 3 years, according to results reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. In contrast, the rate of stroke was stable over time, at 5.1%, 5.1%, and 6.2%, respectively.
Repeat valve replacement (either surgical or transcatheter) had been performed in 0.6% of patients at 1 year, 0.6% at 2 years, and 1.9% at 3 years. “I think this is comparable to [what is seen in] surgical series,” Dr. Webb commented.
Between 30 days and 3 years, there were insignificant decreases in total aortic regurgitation that was moderate or worse in severity (from 2.9% to 2.5%) and paravalvular aortic regurgitation of these severities (from 2.6% to 1.4%). Although the valve used was older, “still, we had excellent sealing and aortic insufficiency was not a problem with these patients,” he noted.
In “interesting” findings, prevalence of mitral regurgitation that was moderate or worse continued falling, from 17.2% at 30 days to 8.6% at 3 years, and prevalence of tricuspid regurgitation that was moderate or worse did as well, from 21.8% to 18.8%.
“I was a little suspicious this was just a survival issue, that patients with severe mitral or tricuspid regurgitation died and, consequently, the average patient was less likely to have [these findings]. But the analysis that’s being done is linear mixed-effects analysis, which accounts for the survival bias,” Dr. Webb said.
The reasons for these trends are unknown, but possibly improved left ventricular function led to functional (rather than structural) improvements in mitral and tricuspid regurgitation.
At 3 years, proportions of patients with various NYHA classes were much the same as they had been at 30 days: class I (51.4% vs. 53.9%), class II (34.6% vs. 35.7%), and class III (13.0% vs. 9.2%). Similarly, the mean KCCQ overall summary score at 30 days (70.8) was sustained at 3 years (73.1).
Risk of death did not differ significantly according to the surgical valve size as labeled, the surgical valve true internal dimensions, the mode of valve failure, the approach used (transfemoral vs. transthoracic), or the residual gradient after valve implantation.
Analysis of the registry data is ongoing. For example, the investigators will be looking more closely at determinants of outcomes, such as additional characteristics of the surgical valve alone and in combination with those of the new valve. “We are all very aware that a lot of the outcomes have to do with what surgical valves you had to begin with. I think that is really critical – what surgical valve is in there,” he said.
Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for, Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.
REPORTING FROM TCT 2018
Key clinical point: Early improvements in functional status and quality of life measures with valve-in-valve transcatheter aortic valve replacement are maintained longer term.
Major finding: Improvements at 30 days post procedure were maintained at 3 years post procedure; patients had similar distributions of New York Heart Association classes (for example, class I in 53.9% and 51.4%, respectively) and similar heart failure–related quality of life scores (70.8 vs. 73.1, P = .29).
Study details: A multicenter, prospective cohort study of 365 patients who underwent valve-in-valve transcatheter aortic valve replacement because of a failing surgical aortic bioprosthetic valve.
Disclosures: Dr. Webb reported that he receives grant/research support and honoraria from, and is on the steering committee for Edwards Lifesciences. The registry is sponsored by Edwards Lifesciences.
Transcatheter repair for tricuspid regurgitation holds up at 1 year
SAN DIEGO – Findings were reported in a session and press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
Research on the tricuspid valve, “the so-called forgotten valve,” is limited, commented lead investigator Jörg Hausleiter, MD, of the Medizinische Klinik und Poliklinik I at the Klinikum der Universität München and the Munich Heart Alliance. But there is unmet need for transcatheter treatment of high-risk patients having symptomatic tricuspid regurgitation (TR).
“The MitraClip has been used in several sites in off-label and compassionate-use programs to treat these patients,” he noted. “But the data which are available so far are really just looking at the early outcome, like 30 days.”
Dr. Hausleiter and his colleagues undertook a retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic TR from the international, multidevice TriValve Registry. All received conventional MitraClips (Abbott Vascular) through off-label or compassionate-use programs.
The procedure was successful, reducing regurgitation to mild or moderate levels in nearly four-fifths of patients by discharge. And procedural success was associated with lower risk of rehospitalization and death.
At 1 year, more than two-thirds of all patients had achieved a New York Heart Association (NYHA) functional class of I or II. In addition, prevalence of peripheral edema had fallen dramatically.
“We were able to demonstrate that the TR reduction is durable and that this also improves the clinical outcome at 1 year,” Dr. Hausleiter concluded.
Uptake and applicability
This procedure will likely be increasingly used in Europe and will find its way into U.S. practice in the not-so-distant future, Dr. Hausleiter predicted. “The MitraClip actually is being used now in a modified version in trials, so that this edge-to-edge therapy is applied for TR. And the TRILUMINATE trial has just finished its enrollment in Europe. I guess that we are going to see EU Mark approval for this therapy also next year. At the same time, a U.S. study is currently being planned and will start very soon with this device, so you are going to see this type of therapy at least being investigated within the next few months.”
The procedure is applicable to a large proportion of patients with TR, including the sizable share having comorbid mitral regurgitation (MR), according to Dr. Hausleiter. In fact, more than half of the study patients had treatment of MR during the same procedure for their tricuspid valve.
“How were outcomes compared, mitral clip plus tricuspid clip, versus tricuspid clip alone? Could some of this benefit be attributed to the mitral clip procedure?” asked press conference panelist Mayra Guerrero, MD, a senior associate consultant in interventional cardiology in the department of cardiovascular medicine at the Mayo Clinic Hospital, Rochester, Minn.
The two groups had essentially the same mortality rates and improvements in NYHA class, Dr. Hausleiter said. “So we did not observe any difference between those patients who were just treated on the tricuspid side and those patients who had combined treatment. Of course the patients differed a bit in their baseline characteristics, but the outcome was very much the same.”
“With the new data we have, operators and teams may be encouraged to start treating functional MR. I personally think that, if we do that, we should probably evaluate the response and reevaluate the severity of TR after all therapies to the mitral valve have been provided, before we intervene on the tricuspid valve, until we have more data,” Dr. Guerrero further commented. “Do you agree?”
“The tricuspid regurgitation can also improve after treatment of the mitral side. However, when we look at least at the published data, in at least 50% of patients who have severe TR, this TR is not improving,” Dr. Hausleiter replied. In addition, registry data suggest that these patients with severe TR have higher in-hospital, 30-day, and 1-year mortality, compared with patients whose TR is not severe. “Since these are frail patients and you don’t want to bring them too often back to the hospital, if the procedure can be performed very easily, I think there might be a good rationale to combine this.”
Study details
The patients Dr. Hausleiter and his coinvestigators studied had symptomatic TR, predominantly of grade 3+ or 4+, despite receiving adequate medical therapy, as well as a high operative risk, with an average EuroSCORE II of 11.2%. On average, two MitraClips were placed in their tricuspid valve during the procedure.
“We were able to demonstrate that this procedure can be performed very safely. There was a mortality of only 2% in the first 30 days, and one conversion to surgery,” Dr. Hausleiter reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. “We were able to reduce the TR by at least one grade in 89% of patients, and concomitant treatment for mitral regurgitation was also performed in the same procedure in 52%.”
The rate of procedural success, defined as achievement of TR grade of 1+ or 2+ at discharge, was 77%. Independent predictors of procedural failure were noncentral/nonanteroseptal TR jet location and larger TR effective regurgitant orifice area, tenting area, and leaflet gap.
With a mean follow-up of about 10 months, compared with peers in whom the procedure failed, patients in whom it was successful had a higher 1-year rate of freedom from unplanned rehospitalization or death (70.1% vs. 49.7%; P less than .0001).
The 77% rate of procedural success at discharge was largely maintained at 1 year, when it was 72%. There was also a significant improvement in NYHA class distribution in the entire cohort (P less than .001), with 69% of patients attaining class I or II at this time point, compared with virtually none at baseline. Prevalence of peripheral edema fell from 84% to 26% (P less than .001).
Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.
SAN DIEGO – Findings were reported in a session and press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
Research on the tricuspid valve, “the so-called forgotten valve,” is limited, commented lead investigator Jörg Hausleiter, MD, of the Medizinische Klinik und Poliklinik I at the Klinikum der Universität München and the Munich Heart Alliance. But there is unmet need for transcatheter treatment of high-risk patients having symptomatic tricuspid regurgitation (TR).
“The MitraClip has been used in several sites in off-label and compassionate-use programs to treat these patients,” he noted. “But the data which are available so far are really just looking at the early outcome, like 30 days.”
Dr. Hausleiter and his colleagues undertook a retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic TR from the international, multidevice TriValve Registry. All received conventional MitraClips (Abbott Vascular) through off-label or compassionate-use programs.
The procedure was successful, reducing regurgitation to mild or moderate levels in nearly four-fifths of patients by discharge. And procedural success was associated with lower risk of rehospitalization and death.
At 1 year, more than two-thirds of all patients had achieved a New York Heart Association (NYHA) functional class of I or II. In addition, prevalence of peripheral edema had fallen dramatically.
“We were able to demonstrate that the TR reduction is durable and that this also improves the clinical outcome at 1 year,” Dr. Hausleiter concluded.
Uptake and applicability
This procedure will likely be increasingly used in Europe and will find its way into U.S. practice in the not-so-distant future, Dr. Hausleiter predicted. “The MitraClip actually is being used now in a modified version in trials, so that this edge-to-edge therapy is applied for TR. And the TRILUMINATE trial has just finished its enrollment in Europe. I guess that we are going to see EU Mark approval for this therapy also next year. At the same time, a U.S. study is currently being planned and will start very soon with this device, so you are going to see this type of therapy at least being investigated within the next few months.”
The procedure is applicable to a large proportion of patients with TR, including the sizable share having comorbid mitral regurgitation (MR), according to Dr. Hausleiter. In fact, more than half of the study patients had treatment of MR during the same procedure for their tricuspid valve.
“How were outcomes compared, mitral clip plus tricuspid clip, versus tricuspid clip alone? Could some of this benefit be attributed to the mitral clip procedure?” asked press conference panelist Mayra Guerrero, MD, a senior associate consultant in interventional cardiology in the department of cardiovascular medicine at the Mayo Clinic Hospital, Rochester, Minn.
The two groups had essentially the same mortality rates and improvements in NYHA class, Dr. Hausleiter said. “So we did not observe any difference between those patients who were just treated on the tricuspid side and those patients who had combined treatment. Of course the patients differed a bit in their baseline characteristics, but the outcome was very much the same.”
“With the new data we have, operators and teams may be encouraged to start treating functional MR. I personally think that, if we do that, we should probably evaluate the response and reevaluate the severity of TR after all therapies to the mitral valve have been provided, before we intervene on the tricuspid valve, until we have more data,” Dr. Guerrero further commented. “Do you agree?”
“The tricuspid regurgitation can also improve after treatment of the mitral side. However, when we look at least at the published data, in at least 50% of patients who have severe TR, this TR is not improving,” Dr. Hausleiter replied. In addition, registry data suggest that these patients with severe TR have higher in-hospital, 30-day, and 1-year mortality, compared with patients whose TR is not severe. “Since these are frail patients and you don’t want to bring them too often back to the hospital, if the procedure can be performed very easily, I think there might be a good rationale to combine this.”
Study details
The patients Dr. Hausleiter and his coinvestigators studied had symptomatic TR, predominantly of grade 3+ or 4+, despite receiving adequate medical therapy, as well as a high operative risk, with an average EuroSCORE II of 11.2%. On average, two MitraClips were placed in their tricuspid valve during the procedure.
“We were able to demonstrate that this procedure can be performed very safely. There was a mortality of only 2% in the first 30 days, and one conversion to surgery,” Dr. Hausleiter reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. “We were able to reduce the TR by at least one grade in 89% of patients, and concomitant treatment for mitral regurgitation was also performed in the same procedure in 52%.”
The rate of procedural success, defined as achievement of TR grade of 1+ or 2+ at discharge, was 77%. Independent predictors of procedural failure were noncentral/nonanteroseptal TR jet location and larger TR effective regurgitant orifice area, tenting area, and leaflet gap.
With a mean follow-up of about 10 months, compared with peers in whom the procedure failed, patients in whom it was successful had a higher 1-year rate of freedom from unplanned rehospitalization or death (70.1% vs. 49.7%; P less than .0001).
The 77% rate of procedural success at discharge was largely maintained at 1 year, when it was 72%. There was also a significant improvement in NYHA class distribution in the entire cohort (P less than .001), with 69% of patients attaining class I or II at this time point, compared with virtually none at baseline. Prevalence of peripheral edema fell from 84% to 26% (P less than .001).
Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.
SAN DIEGO – Findings were reported in a session and press conference at the Transcatheter Cardiovascular Therapeutics annual meeting.
Research on the tricuspid valve, “the so-called forgotten valve,” is limited, commented lead investigator Jörg Hausleiter, MD, of the Medizinische Klinik und Poliklinik I at the Klinikum der Universität München and the Munich Heart Alliance. But there is unmet need for transcatheter treatment of high-risk patients having symptomatic tricuspid regurgitation (TR).
“The MitraClip has been used in several sites in off-label and compassionate-use programs to treat these patients,” he noted. “But the data which are available so far are really just looking at the early outcome, like 30 days.”
Dr. Hausleiter and his colleagues undertook a retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic TR from the international, multidevice TriValve Registry. All received conventional MitraClips (Abbott Vascular) through off-label or compassionate-use programs.
The procedure was successful, reducing regurgitation to mild or moderate levels in nearly four-fifths of patients by discharge. And procedural success was associated with lower risk of rehospitalization and death.
At 1 year, more than two-thirds of all patients had achieved a New York Heart Association (NYHA) functional class of I or II. In addition, prevalence of peripheral edema had fallen dramatically.
“We were able to demonstrate that the TR reduction is durable and that this also improves the clinical outcome at 1 year,” Dr. Hausleiter concluded.
Uptake and applicability
This procedure will likely be increasingly used in Europe and will find its way into U.S. practice in the not-so-distant future, Dr. Hausleiter predicted. “The MitraClip actually is being used now in a modified version in trials, so that this edge-to-edge therapy is applied for TR. And the TRILUMINATE trial has just finished its enrollment in Europe. I guess that we are going to see EU Mark approval for this therapy also next year. At the same time, a U.S. study is currently being planned and will start very soon with this device, so you are going to see this type of therapy at least being investigated within the next few months.”
The procedure is applicable to a large proportion of patients with TR, including the sizable share having comorbid mitral regurgitation (MR), according to Dr. Hausleiter. In fact, more than half of the study patients had treatment of MR during the same procedure for their tricuspid valve.
“How were outcomes compared, mitral clip plus tricuspid clip, versus tricuspid clip alone? Could some of this benefit be attributed to the mitral clip procedure?” asked press conference panelist Mayra Guerrero, MD, a senior associate consultant in interventional cardiology in the department of cardiovascular medicine at the Mayo Clinic Hospital, Rochester, Minn.
The two groups had essentially the same mortality rates and improvements in NYHA class, Dr. Hausleiter said. “So we did not observe any difference between those patients who were just treated on the tricuspid side and those patients who had combined treatment. Of course the patients differed a bit in their baseline characteristics, but the outcome was very much the same.”
“With the new data we have, operators and teams may be encouraged to start treating functional MR. I personally think that, if we do that, we should probably evaluate the response and reevaluate the severity of TR after all therapies to the mitral valve have been provided, before we intervene on the tricuspid valve, until we have more data,” Dr. Guerrero further commented. “Do you agree?”
“The tricuspid regurgitation can also improve after treatment of the mitral side. However, when we look at least at the published data, in at least 50% of patients who have severe TR, this TR is not improving,” Dr. Hausleiter replied. In addition, registry data suggest that these patients with severe TR have higher in-hospital, 30-day, and 1-year mortality, compared with patients whose TR is not severe. “Since these are frail patients and you don’t want to bring them too often back to the hospital, if the procedure can be performed very easily, I think there might be a good rationale to combine this.”
Study details
The patients Dr. Hausleiter and his coinvestigators studied had symptomatic TR, predominantly of grade 3+ or 4+, despite receiving adequate medical therapy, as well as a high operative risk, with an average EuroSCORE II of 11.2%. On average, two MitraClips were placed in their tricuspid valve during the procedure.
“We were able to demonstrate that this procedure can be performed very safely. There was a mortality of only 2% in the first 30 days, and one conversion to surgery,” Dr. Hausleiter reported at the meeting, which is sponsored by the Cardiovascular Research Foundation. “We were able to reduce the TR by at least one grade in 89% of patients, and concomitant treatment for mitral regurgitation was also performed in the same procedure in 52%.”
The rate of procedural success, defined as achievement of TR grade of 1+ or 2+ at discharge, was 77%. Independent predictors of procedural failure were noncentral/nonanteroseptal TR jet location and larger TR effective regurgitant orifice area, tenting area, and leaflet gap.
With a mean follow-up of about 10 months, compared with peers in whom the procedure failed, patients in whom it was successful had a higher 1-year rate of freedom from unplanned rehospitalization or death (70.1% vs. 49.7%; P less than .0001).
The 77% rate of procedural success at discharge was largely maintained at 1 year, when it was 72%. There was also a significant improvement in NYHA class distribution in the entire cohort (P less than .001), with 69% of patients attaining class I or II at this time point, compared with virtually none at baseline. Prevalence of peripheral edema fell from 84% to 26% (P less than .001).
Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.
REPORTING FROM TCT 2018
Key clinical point: Transcatheter edge-to-edge valve repair for tricuspid regurgitation is safe and effective at 1 year.
Major finding: The procedure had a success rate of 77% and netted a 1-year improvement in New York Heart Association class (P less than .001), with 69% of patients achieving class I or II.
Study details: A retrospective cohort study of a subgroup of 249 patients undergoing edge-to-edge valve repair for symptomatic tricuspid regurgitation from the TriValve Registry.
Disclosures: Dr. Hausleiter reported that he receives research support and speaker honoraria from Abbott Vascular and Edwards Lifesciences. The registry is sponsored by the University of Zürich.
BIOFLOW V: Orsiro outperforms Xience stent
SAN DIEGO – Seemingly nuanced differences between drug-eluting stents can translate to substantial differences in clinical outcomes longer term, updated results of the BIOFLOW V randomized trial reported at the Transcatheter Cardiovascular Therapeutics annual meeting suggest.
“As we have celebrated recently the 30th year of stent implantation, coronary drug-eluting stent development has included new metal alloys, changes in stent architecture, and bioresorbable polymers,” commented lead investigator David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute, Atlanta. “Yet whether these advancements improve long-term clinical safety and efficacy has been inconsistent in previous studies.”
BIOFLOW V compared the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent with the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing percutaneous coronary intervention.
Initial results showed that the primary outcome of 1-year target lesion failure – the composite of cardiac death, ischemia-driven target lesion revascularization, and target vessel–related myocardial infarction – was significantly lower in the Orsiro stent group (6% vs. 10%, P = .0399) (Lancet. 2017;390:1843-52). Superiority at this time point was mainly driven by a lower rate of target vessel–related MI (5% vs. 8%, P = .0155).
With the update, now at 2 years of follow-up, the significant difference in target lesion failure rate persisted, with a rate of 7.1% with Orsiro stents versus 11.9% with Xience stents (P = .015), according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 19. doi: 10.1016/j.jacc.2018.09.019).
There was likewise still a significant difference in favor of the Orsiro stent in target vessel–related MI, but the rate of ischemia-driven target lesion revascularization was now significantly lower as well. In addition, this stent yielded a lower rate of definite or probable stent thrombosis occurring late or very late.
“Altogether, these results not only advance a standard of comparison for new drug-eluting stents, but they direct our attention to strut thickness and polymer composition as key features for iterative drug-eluting stent development,” Dr. Kandzari summarized. Additional BIOFLOW V follow-up, out to 5 years, is planned, he noted.
Session comoderator Fernando Alfonso, MD, PhD, an interventional cardiologist at the Cardiovascular Institute at San Carlos University Hospital in Madrid, wondered about the role of dual-antiplatelet therapy. “Was that treatment related in some way to events? Was there any kind of interaction between those who were maintained on dual-antiplatelet therapy and those having late events?” he asked.
“Through 2 years of follow-up, adherence to dual-antiplatelet therapy was numerically identical in both groups. But it was not related in any way to either target vessel MI–related events or stent thrombosis events,” Dr. Kandzari replied.
Trial details
The BIOFLOW V trialists recruited patients from 13 countries and enrolled those who had up to three de novo target lesions in up to two native target vessels. Patients were randomized 2:1 to receive Orsiro stents (Biotronik) or Xience stents (Abbott).
At 2 years, 45.6% of those in the former group and 45.1% of those in the latter group were adherent to dual antiplatelet therapy (P = .88), Dr. Kandzari reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The lower 2-year rate of the primary composite outcome of target lesion failure with the Orsiro stent was driven by lower rates of both target vessel–related MI (5.3% vs. 9.5%, P = .01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%, P = .04). There was still no significant difference for cardiac death (0.6% vs. 0.5%, P = 1.0).
The edge of Orsiro stents over Xience stents for target lesion failure was similar across subgroups, with the possible exception of greater benefit of the latter in patients older than 75 (P for interaction = .039).
In landmark analyses, a significant difference in rates of target vessel–related MI favoring Orsiro stents was evident both in the first 30 days after the procedure (P = .04) and from 30 days to 2 years, presumably reflecting fewer spontaneous MIs (P = .01). Ischemia-driven target lesion revascularization did not difference in the first year of follow-up (P = .72) but it did between the first and second years (P = .01).
Most measures of stent thrombosis were similar for the two groups. However, the rate of definite or probable stent thrombosis occurring late or very late (between 30 days and 2 years) was just 0.1% for Orsiro stents, compared with 1.0% for Xience stents (P = .045).
Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.
SAN DIEGO – Seemingly nuanced differences between drug-eluting stents can translate to substantial differences in clinical outcomes longer term, updated results of the BIOFLOW V randomized trial reported at the Transcatheter Cardiovascular Therapeutics annual meeting suggest.
“As we have celebrated recently the 30th year of stent implantation, coronary drug-eluting stent development has included new metal alloys, changes in stent architecture, and bioresorbable polymers,” commented lead investigator David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute, Atlanta. “Yet whether these advancements improve long-term clinical safety and efficacy has been inconsistent in previous studies.”
BIOFLOW V compared the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent with the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing percutaneous coronary intervention.
Initial results showed that the primary outcome of 1-year target lesion failure – the composite of cardiac death, ischemia-driven target lesion revascularization, and target vessel–related myocardial infarction – was significantly lower in the Orsiro stent group (6% vs. 10%, P = .0399) (Lancet. 2017;390:1843-52). Superiority at this time point was mainly driven by a lower rate of target vessel–related MI (5% vs. 8%, P = .0155).
With the update, now at 2 years of follow-up, the significant difference in target lesion failure rate persisted, with a rate of 7.1% with Orsiro stents versus 11.9% with Xience stents (P = .015), according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 19. doi: 10.1016/j.jacc.2018.09.019).
There was likewise still a significant difference in favor of the Orsiro stent in target vessel–related MI, but the rate of ischemia-driven target lesion revascularization was now significantly lower as well. In addition, this stent yielded a lower rate of definite or probable stent thrombosis occurring late or very late.
“Altogether, these results not only advance a standard of comparison for new drug-eluting stents, but they direct our attention to strut thickness and polymer composition as key features for iterative drug-eluting stent development,” Dr. Kandzari summarized. Additional BIOFLOW V follow-up, out to 5 years, is planned, he noted.
Session comoderator Fernando Alfonso, MD, PhD, an interventional cardiologist at the Cardiovascular Institute at San Carlos University Hospital in Madrid, wondered about the role of dual-antiplatelet therapy. “Was that treatment related in some way to events? Was there any kind of interaction between those who were maintained on dual-antiplatelet therapy and those having late events?” he asked.
“Through 2 years of follow-up, adherence to dual-antiplatelet therapy was numerically identical in both groups. But it was not related in any way to either target vessel MI–related events or stent thrombosis events,” Dr. Kandzari replied.
Trial details
The BIOFLOW V trialists recruited patients from 13 countries and enrolled those who had up to three de novo target lesions in up to two native target vessels. Patients were randomized 2:1 to receive Orsiro stents (Biotronik) or Xience stents (Abbott).
At 2 years, 45.6% of those in the former group and 45.1% of those in the latter group were adherent to dual antiplatelet therapy (P = .88), Dr. Kandzari reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The lower 2-year rate of the primary composite outcome of target lesion failure with the Orsiro stent was driven by lower rates of both target vessel–related MI (5.3% vs. 9.5%, P = .01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%, P = .04). There was still no significant difference for cardiac death (0.6% vs. 0.5%, P = 1.0).
The edge of Orsiro stents over Xience stents for target lesion failure was similar across subgroups, with the possible exception of greater benefit of the latter in patients older than 75 (P for interaction = .039).
In landmark analyses, a significant difference in rates of target vessel–related MI favoring Orsiro stents was evident both in the first 30 days after the procedure (P = .04) and from 30 days to 2 years, presumably reflecting fewer spontaneous MIs (P = .01). Ischemia-driven target lesion revascularization did not difference in the first year of follow-up (P = .72) but it did between the first and second years (P = .01).
Most measures of stent thrombosis were similar for the two groups. However, the rate of definite or probable stent thrombosis occurring late or very late (between 30 days and 2 years) was just 0.1% for Orsiro stents, compared with 1.0% for Xience stents (P = .045).
Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.
SAN DIEGO – Seemingly nuanced differences between drug-eluting stents can translate to substantial differences in clinical outcomes longer term, updated results of the BIOFLOW V randomized trial reported at the Transcatheter Cardiovascular Therapeutics annual meeting suggest.
“As we have celebrated recently the 30th year of stent implantation, coronary drug-eluting stent development has included new metal alloys, changes in stent architecture, and bioresorbable polymers,” commented lead investigator David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute, Atlanta. “Yet whether these advancements improve long-term clinical safety and efficacy has been inconsistent in previous studies.”
BIOFLOW V compared the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent with the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing percutaneous coronary intervention.
Initial results showed that the primary outcome of 1-year target lesion failure – the composite of cardiac death, ischemia-driven target lesion revascularization, and target vessel–related myocardial infarction – was significantly lower in the Orsiro stent group (6% vs. 10%, P = .0399) (Lancet. 2017;390:1843-52). Superiority at this time point was mainly driven by a lower rate of target vessel–related MI (5% vs. 8%, P = .0155).
With the update, now at 2 years of follow-up, the significant difference in target lesion failure rate persisted, with a rate of 7.1% with Orsiro stents versus 11.9% with Xience stents (P = .015), according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 19. doi: 10.1016/j.jacc.2018.09.019).
There was likewise still a significant difference in favor of the Orsiro stent in target vessel–related MI, but the rate of ischemia-driven target lesion revascularization was now significantly lower as well. In addition, this stent yielded a lower rate of definite or probable stent thrombosis occurring late or very late.
“Altogether, these results not only advance a standard of comparison for new drug-eluting stents, but they direct our attention to strut thickness and polymer composition as key features for iterative drug-eluting stent development,” Dr. Kandzari summarized. Additional BIOFLOW V follow-up, out to 5 years, is planned, he noted.
Session comoderator Fernando Alfonso, MD, PhD, an interventional cardiologist at the Cardiovascular Institute at San Carlos University Hospital in Madrid, wondered about the role of dual-antiplatelet therapy. “Was that treatment related in some way to events? Was there any kind of interaction between those who were maintained on dual-antiplatelet therapy and those having late events?” he asked.
“Through 2 years of follow-up, adherence to dual-antiplatelet therapy was numerically identical in both groups. But it was not related in any way to either target vessel MI–related events or stent thrombosis events,” Dr. Kandzari replied.
Trial details
The BIOFLOW V trialists recruited patients from 13 countries and enrolled those who had up to three de novo target lesions in up to two native target vessels. Patients were randomized 2:1 to receive Orsiro stents (Biotronik) or Xience stents (Abbott).
At 2 years, 45.6% of those in the former group and 45.1% of those in the latter group were adherent to dual antiplatelet therapy (P = .88), Dr. Kandzari reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.
The lower 2-year rate of the primary composite outcome of target lesion failure with the Orsiro stent was driven by lower rates of both target vessel–related MI (5.3% vs. 9.5%, P = .01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%, P = .04). There was still no significant difference for cardiac death (0.6% vs. 0.5%, P = 1.0).
The edge of Orsiro stents over Xience stents for target lesion failure was similar across subgroups, with the possible exception of greater benefit of the latter in patients older than 75 (P for interaction = .039).
In landmark analyses, a significant difference in rates of target vessel–related MI favoring Orsiro stents was evident both in the first 30 days after the procedure (P = .04) and from 30 days to 2 years, presumably reflecting fewer spontaneous MIs (P = .01). Ischemia-driven target lesion revascularization did not difference in the first year of follow-up (P = .72) but it did between the first and second years (P = .01).
Most measures of stent thrombosis were similar for the two groups. However, the rate of definite or probable stent thrombosis occurring late or very late (between 30 days and 2 years) was just 0.1% for Orsiro stents, compared with 1.0% for Xience stents (P = .045).
Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.
REPORTING FROM TCT 2018
Key clinical point: The Orsiro stent outperformed the Xience stent in patients undergoing PCI.
Major finding: The 2-year rate of target lesion failure was lower with the Orsiro stent than with the Xience stent (7.5% vs. 11.9%, P = .015).
Study details: A randomized controlled trial comparing the Orsiro ultrathin-strut, bioresorbable-polymer, sirolimus-eluting stent and the Xience thin-strut, durable-polymer, everolimus-eluting stent among 1,334 patients undergoing PCI (BIOFLOW V trial).
Disclosures: Dr. Kandzari disclosed that he receives grant/research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol, and Orbus Neich, and that he receives consulting fees and honoraria from Biotronik, Boston Scientific Corporation, Cardinal Health, and Medtronic CardioVascular. The trial was sponsored by Biotronik.
Ultrasound denervation tops RF ablation for resistant hypertension
SAN DIEGO – Denervation of the main renal arteries with ultrasound is more effective than radiofrequency (RF) ablation at lowering blood pressure in patients with resistant hypertension, according to a single-center, randomized trial from Germany.
Dubbed RADIOSOUND–HTN, it was the first time the two emerging technologies have been pitted against each other. At 3-month follow-up, the 42 patients randomized to ultrasound ablation with the Paradise catheter (ReCor Medical) had a mean systolic daytime blood pressure reduction of 13.2 mm Hg on ambulatory monitoring, vs. 6.5 mm Hg among 39 patients randomized to RF ablation with Medtronic’s Symplicity Spyral catheter (P = .043).
Meanwhile, 39 patients randomized to both main artery and side branch ablation with the Spyral had a mean reduction of 8.3 mm Hg, slightly better than RF ablation of the main renal arteries alone, but the difference was not statistically significant, and “no definite conclusion on the value of an additional side branch ablation can be drawn,” said senior investigator Philipp Lurz , MD, PhD, a cardiologist at the University of Leipzig, Germany, and his colleagues (Circulation. 2018 Sep 25. doi: 10.1161/circulationaha.118.037654).
Denervation was probably more complete with the Paradise catheter, which might explain the results. Ultrasound energy penetrates about 6-7 mm from the lumen, reaching up to 90% of sympathetic nerve fibers, while RF energy penetrates 3-4 mm; indeed, the idea of going into the branches with RF ablation is because nerve fibers are closer to the lumen surface, Dr. Lurz said at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, where he presented the study, which was simultaneously published in Circulation.
Also, the Paradise catheter – an endovascular balloon device inflated to fit the lumen – delivers fully circumferential, ringlike ablations with each application, while the Spyral catheter delivers four ablations simultaneously in a spiral pattern, and requires more ablations to create a similar effect, according to Dr. Lurz.
About two-thirds of patients in all three arms responded to treatment, meaning at least a 5 mm Hg drop in systolic blood pressure. Among the nonresponders, it’s possible that their hypertension wasn’t caused by sympathetic overdrive. “Future trials should focus on identifying these patients to avoid futile” procedures, and define “specific anatomic predictors associated with a more effective” renal denervation, Dr. Lurz and his team said in their study report.
The researchers noted that “the present study included patients with larger renal arteries” – at least one renal artery 5.5 mm or greater in diameter – “based on the assumption that sympathetic fibers are in greater distance from the lumen than in smaller arteries, and therefore ... higher penetration depth would be more relevant ... Results might have differed in a cohort of patients with smaller renal artery diameters.”
Both Paradise and Spyral are in pivotal trials for Food and Drug Administration approval.
The subjects were an average of 64 years. The majority were men, and there were no significant differences in baseline characteristics between the arms. The mean baseline daytime blood pressure was 153/86 mm Hg despite treatment with three or more classes of antihypertensives dosed to at least 50% of their maximum. There was no drug testing to confirm patients were taking their medications, but their general practitioners vouched for their adherence.
One patient in the ultrasound arm group developed a pseudoaneurysm treated successfully by compression. One of the RF subjects developed a postprocedural intracapsular and retroperitoneal hematoma that resolved spontaneously. No renal vascular complications or stenoses were detected at follow-up.
There was no industry funding for the work. Dr. Lurz is a speaker and consultant for both ReCor Medical and Medtronic.
SOURCE: Fengler K et al. TCT 2018, Abstract.
SAN DIEGO – Denervation of the main renal arteries with ultrasound is more effective than radiofrequency (RF) ablation at lowering blood pressure in patients with resistant hypertension, according to a single-center, randomized trial from Germany.
Dubbed RADIOSOUND–HTN, it was the first time the two emerging technologies have been pitted against each other. At 3-month follow-up, the 42 patients randomized to ultrasound ablation with the Paradise catheter (ReCor Medical) had a mean systolic daytime blood pressure reduction of 13.2 mm Hg on ambulatory monitoring, vs. 6.5 mm Hg among 39 patients randomized to RF ablation with Medtronic’s Symplicity Spyral catheter (P = .043).
Meanwhile, 39 patients randomized to both main artery and side branch ablation with the Spyral had a mean reduction of 8.3 mm Hg, slightly better than RF ablation of the main renal arteries alone, but the difference was not statistically significant, and “no definite conclusion on the value of an additional side branch ablation can be drawn,” said senior investigator Philipp Lurz , MD, PhD, a cardiologist at the University of Leipzig, Germany, and his colleagues (Circulation. 2018 Sep 25. doi: 10.1161/circulationaha.118.037654).
Denervation was probably more complete with the Paradise catheter, which might explain the results. Ultrasound energy penetrates about 6-7 mm from the lumen, reaching up to 90% of sympathetic nerve fibers, while RF energy penetrates 3-4 mm; indeed, the idea of going into the branches with RF ablation is because nerve fibers are closer to the lumen surface, Dr. Lurz said at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, where he presented the study, which was simultaneously published in Circulation.
Also, the Paradise catheter – an endovascular balloon device inflated to fit the lumen – delivers fully circumferential, ringlike ablations with each application, while the Spyral catheter delivers four ablations simultaneously in a spiral pattern, and requires more ablations to create a similar effect, according to Dr. Lurz.
About two-thirds of patients in all three arms responded to treatment, meaning at least a 5 mm Hg drop in systolic blood pressure. Among the nonresponders, it’s possible that their hypertension wasn’t caused by sympathetic overdrive. “Future trials should focus on identifying these patients to avoid futile” procedures, and define “specific anatomic predictors associated with a more effective” renal denervation, Dr. Lurz and his team said in their study report.
The researchers noted that “the present study included patients with larger renal arteries” – at least one renal artery 5.5 mm or greater in diameter – “based on the assumption that sympathetic fibers are in greater distance from the lumen than in smaller arteries, and therefore ... higher penetration depth would be more relevant ... Results might have differed in a cohort of patients with smaller renal artery diameters.”
Both Paradise and Spyral are in pivotal trials for Food and Drug Administration approval.
The subjects were an average of 64 years. The majority were men, and there were no significant differences in baseline characteristics between the arms. The mean baseline daytime blood pressure was 153/86 mm Hg despite treatment with three or more classes of antihypertensives dosed to at least 50% of their maximum. There was no drug testing to confirm patients were taking their medications, but their general practitioners vouched for their adherence.
One patient in the ultrasound arm group developed a pseudoaneurysm treated successfully by compression. One of the RF subjects developed a postprocedural intracapsular and retroperitoneal hematoma that resolved spontaneously. No renal vascular complications or stenoses were detected at follow-up.
There was no industry funding for the work. Dr. Lurz is a speaker and consultant for both ReCor Medical and Medtronic.
SOURCE: Fengler K et al. TCT 2018, Abstract.
SAN DIEGO – Denervation of the main renal arteries with ultrasound is more effective than radiofrequency (RF) ablation at lowering blood pressure in patients with resistant hypertension, according to a single-center, randomized trial from Germany.
Dubbed RADIOSOUND–HTN, it was the first time the two emerging technologies have been pitted against each other. At 3-month follow-up, the 42 patients randomized to ultrasound ablation with the Paradise catheter (ReCor Medical) had a mean systolic daytime blood pressure reduction of 13.2 mm Hg on ambulatory monitoring, vs. 6.5 mm Hg among 39 patients randomized to RF ablation with Medtronic’s Symplicity Spyral catheter (P = .043).
Meanwhile, 39 patients randomized to both main artery and side branch ablation with the Spyral had a mean reduction of 8.3 mm Hg, slightly better than RF ablation of the main renal arteries alone, but the difference was not statistically significant, and “no definite conclusion on the value of an additional side branch ablation can be drawn,” said senior investigator Philipp Lurz , MD, PhD, a cardiologist at the University of Leipzig, Germany, and his colleagues (Circulation. 2018 Sep 25. doi: 10.1161/circulationaha.118.037654).
Denervation was probably more complete with the Paradise catheter, which might explain the results. Ultrasound energy penetrates about 6-7 mm from the lumen, reaching up to 90% of sympathetic nerve fibers, while RF energy penetrates 3-4 mm; indeed, the idea of going into the branches with RF ablation is because nerve fibers are closer to the lumen surface, Dr. Lurz said at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, where he presented the study, which was simultaneously published in Circulation.
Also, the Paradise catheter – an endovascular balloon device inflated to fit the lumen – delivers fully circumferential, ringlike ablations with each application, while the Spyral catheter delivers four ablations simultaneously in a spiral pattern, and requires more ablations to create a similar effect, according to Dr. Lurz.
About two-thirds of patients in all three arms responded to treatment, meaning at least a 5 mm Hg drop in systolic blood pressure. Among the nonresponders, it’s possible that their hypertension wasn’t caused by sympathetic overdrive. “Future trials should focus on identifying these patients to avoid futile” procedures, and define “specific anatomic predictors associated with a more effective” renal denervation, Dr. Lurz and his team said in their study report.
The researchers noted that “the present study included patients with larger renal arteries” – at least one renal artery 5.5 mm or greater in diameter – “based on the assumption that sympathetic fibers are in greater distance from the lumen than in smaller arteries, and therefore ... higher penetration depth would be more relevant ... Results might have differed in a cohort of patients with smaller renal artery diameters.”
Both Paradise and Spyral are in pivotal trials for Food and Drug Administration approval.
The subjects were an average of 64 years. The majority were men, and there were no significant differences in baseline characteristics between the arms. The mean baseline daytime blood pressure was 153/86 mm Hg despite treatment with three or more classes of antihypertensives dosed to at least 50% of their maximum. There was no drug testing to confirm patients were taking their medications, but their general practitioners vouched for their adherence.
One patient in the ultrasound arm group developed a pseudoaneurysm treated successfully by compression. One of the RF subjects developed a postprocedural intracapsular and retroperitoneal hematoma that resolved spontaneously. No renal vascular complications or stenoses were detected at follow-up.
There was no industry funding for the work. Dr. Lurz is a speaker and consultant for both ReCor Medical and Medtronic.
SOURCE: Fengler K et al. TCT 2018, Abstract.
REPORTING FROM TCT 2018
Key clinical point: Denervation might be more complete with ultrasound.
Major finding: Patients randomized to ultrasound ablation had a mean systolic blood pressure reduction of 13.2 mm Hg, vs. 6.5 mm Hg among patients randomized to RF ablation (P = .043).
Study details: Randomized trial with 120 subjects
Disclosures: There was no industry funding for the work. The senior investigator is a speaker and consultant for both ReCor Medical and Medtronic.
Source: Fengler K et al. TCT 2018, Abstract.
Frailty tied to higher mortality after major vascular surgery
Frailty defined as functional dependence is a predictor of mortality risk in elderly patients having major vascular surgery, a meta-analysis of studies has found
“Functional dependency may be recommended for use in rapid screening for frailty in major vascular surgery because of the high quality of associated evidence. Additionally, information on central muscle mass also adds incremental predictive value to long-term survival of elderly patients after major vascular surgery,” the study investigaters stated. However, they pointed out that “other newly developed frailty tools require further validation in more studies” before they should be adopted.
The report, published in the European Journal of Vascular and Endovascular Surgery, evaluated the effect of frailty in major vascular surgery from a search of MEDLINE, Embase, Cochrane Database, and Scopus through May 2018. Data were extracted from the articles related to surgery for abdominal aortic aneurysms (AAA) and lower extremity artery disease (LEAD), and a modified Newcastle-Ottawa scale was used to assess the quality of the included studies, according to Jiarong Wang, MD, of the department of vascular surgery, Sichuan University, Sichuan Province, China, and colleagues. A total of 22 cohort studies and one randomized controlled trial was used in the final analysis. The reviewers expressed the impact of frailty on outcomes as odds ratios (OR) or hazard ratios (HR) using a random effects model.
The researchers found that frailty, in terms of functional dependence, was associated with a significantly increased 30-day mortality risk in patients with AAA without heterogeneity (OR 5.15) and also in LEAD patients (OR 3.29). Functionally dependent patients also had a significantly increased 30-day mortality risk, compared with independent patients (OR 4.49), and similar results were observed after stratifying those who underwent AAA repair (OR 5.14) or lower extremity revascularization (OR 4.18). Even for patients who underwent endovascular procedures rather than open surgery, functional dependency was also associated with a significantly increased 30-day mortality risk (OR 4.90). In addition, with regard to 30-day morbidity, frailty was associated with a significantly increased risk in both AAA (OR 2.79) and LEAD (OR 1.40) patients.
As far as long-term outcomes were concerned, frailty was associated with a significantly increased risk of long-term all-cause mortality in the overall studied population (HR 2.22), as well as in patients with AAA repair (HR 2.10) and LEAD revascularization (HR 2.46). Dr. Wang and colleagues found that central muscle mass was the only tool with moderate quality of evidence predicting long-term survival after major vascular surgery (HR .48), with other single-domain tools such as nutrition or cognition scoring being of low quality. The modified Frailty Index was the only multi-domain tool with moderate quality in predicting mortality for AAA, while others were scored as low or very low, the authors added.
“Future research is warranted to establish consensus on how to select the optimal frailty tool for certain clinical settings,” they concluded.
The authors reported that they had no conflicts of interest and no funding sources for the study.
SOURCE: Wang, J et al. Eur J Vasc Endovasc Surg. 2018;56:591-602.
Frailty defined as functional dependence is a predictor of mortality risk in elderly patients having major vascular surgery, a meta-analysis of studies has found
“Functional dependency may be recommended for use in rapid screening for frailty in major vascular surgery because of the high quality of associated evidence. Additionally, information on central muscle mass also adds incremental predictive value to long-term survival of elderly patients after major vascular surgery,” the study investigaters stated. However, they pointed out that “other newly developed frailty tools require further validation in more studies” before they should be adopted.
The report, published in the European Journal of Vascular and Endovascular Surgery, evaluated the effect of frailty in major vascular surgery from a search of MEDLINE, Embase, Cochrane Database, and Scopus through May 2018. Data were extracted from the articles related to surgery for abdominal aortic aneurysms (AAA) and lower extremity artery disease (LEAD), and a modified Newcastle-Ottawa scale was used to assess the quality of the included studies, according to Jiarong Wang, MD, of the department of vascular surgery, Sichuan University, Sichuan Province, China, and colleagues. A total of 22 cohort studies and one randomized controlled trial was used in the final analysis. The reviewers expressed the impact of frailty on outcomes as odds ratios (OR) or hazard ratios (HR) using a random effects model.
The researchers found that frailty, in terms of functional dependence, was associated with a significantly increased 30-day mortality risk in patients with AAA without heterogeneity (OR 5.15) and also in LEAD patients (OR 3.29). Functionally dependent patients also had a significantly increased 30-day mortality risk, compared with independent patients (OR 4.49), and similar results were observed after stratifying those who underwent AAA repair (OR 5.14) or lower extremity revascularization (OR 4.18). Even for patients who underwent endovascular procedures rather than open surgery, functional dependency was also associated with a significantly increased 30-day mortality risk (OR 4.90). In addition, with regard to 30-day morbidity, frailty was associated with a significantly increased risk in both AAA (OR 2.79) and LEAD (OR 1.40) patients.
As far as long-term outcomes were concerned, frailty was associated with a significantly increased risk of long-term all-cause mortality in the overall studied population (HR 2.22), as well as in patients with AAA repair (HR 2.10) and LEAD revascularization (HR 2.46). Dr. Wang and colleagues found that central muscle mass was the only tool with moderate quality of evidence predicting long-term survival after major vascular surgery (HR .48), with other single-domain tools such as nutrition or cognition scoring being of low quality. The modified Frailty Index was the only multi-domain tool with moderate quality in predicting mortality for AAA, while others were scored as low or very low, the authors added.
“Future research is warranted to establish consensus on how to select the optimal frailty tool for certain clinical settings,” they concluded.
The authors reported that they had no conflicts of interest and no funding sources for the study.
SOURCE: Wang, J et al. Eur J Vasc Endovasc Surg. 2018;56:591-602.
Frailty defined as functional dependence is a predictor of mortality risk in elderly patients having major vascular surgery, a meta-analysis of studies has found
“Functional dependency may be recommended for use in rapid screening for frailty in major vascular surgery because of the high quality of associated evidence. Additionally, information on central muscle mass also adds incremental predictive value to long-term survival of elderly patients after major vascular surgery,” the study investigaters stated. However, they pointed out that “other newly developed frailty tools require further validation in more studies” before they should be adopted.
The report, published in the European Journal of Vascular and Endovascular Surgery, evaluated the effect of frailty in major vascular surgery from a search of MEDLINE, Embase, Cochrane Database, and Scopus through May 2018. Data were extracted from the articles related to surgery for abdominal aortic aneurysms (AAA) and lower extremity artery disease (LEAD), and a modified Newcastle-Ottawa scale was used to assess the quality of the included studies, according to Jiarong Wang, MD, of the department of vascular surgery, Sichuan University, Sichuan Province, China, and colleagues. A total of 22 cohort studies and one randomized controlled trial was used in the final analysis. The reviewers expressed the impact of frailty on outcomes as odds ratios (OR) or hazard ratios (HR) using a random effects model.
The researchers found that frailty, in terms of functional dependence, was associated with a significantly increased 30-day mortality risk in patients with AAA without heterogeneity (OR 5.15) and also in LEAD patients (OR 3.29). Functionally dependent patients also had a significantly increased 30-day mortality risk, compared with independent patients (OR 4.49), and similar results were observed after stratifying those who underwent AAA repair (OR 5.14) or lower extremity revascularization (OR 4.18). Even for patients who underwent endovascular procedures rather than open surgery, functional dependency was also associated with a significantly increased 30-day mortality risk (OR 4.90). In addition, with regard to 30-day morbidity, frailty was associated with a significantly increased risk in both AAA (OR 2.79) and LEAD (OR 1.40) patients.
As far as long-term outcomes were concerned, frailty was associated with a significantly increased risk of long-term all-cause mortality in the overall studied population (HR 2.22), as well as in patients with AAA repair (HR 2.10) and LEAD revascularization (HR 2.46). Dr. Wang and colleagues found that central muscle mass was the only tool with moderate quality of evidence predicting long-term survival after major vascular surgery (HR .48), with other single-domain tools such as nutrition or cognition scoring being of low quality. The modified Frailty Index was the only multi-domain tool with moderate quality in predicting mortality for AAA, while others were scored as low or very low, the authors added.
“Future research is warranted to establish consensus on how to select the optimal frailty tool for certain clinical settings,” they concluded.
The authors reported that they had no conflicts of interest and no funding sources for the study.
SOURCE: Wang, J et al. Eur J Vasc Endovasc Surg. 2018;56:591-602.
FROM EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Key clinical point: Frailty was associated with increased short- and long-term mortality in major vascular surgery.
Major finding: Frailty was associated with a fourfold increased risk of 30-day mortality and a doubled increased risk of long-term mortality after major vascular surgery.
Study details: A meta-analysis of 22 cohort studies and one randomized controlled trial.
Disclosures: The authors reported that they had no conflicts of interest and no funding sources for the study.
Source: Wang, J et al., 2018. Eur J Vasc Endovasc Surg. 56:591-602.