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ORLANDO – What doctors think they know to be true in medicine has changed dramatically in the past several decades and will be different again in the decades to come, leaving them with a dilemma, according to Kevin T. Powell, MD, PhD, a pediatric hospitalist in St. Louis. If half of what doctors teach or know in medicine today will ultimately end up not being true, how do they know what to believe or accept?

While there is not a single satisfactory answer to that question, researchers can select research that gets doctors closer to reliable findings and steer them away from the barrage of poor-quality research that emerges from the current publish-or-perish system, Dr. Powell told his colleagues at the annual meeting of the American Academy of Pediatrics.

During his talk, Dr. Powell discussed the challenges and flaws with medical research as it is currently conducted, citing Doug Altman’s writings on these problems as early as 1994.

“The poor quality of much medical research is widely acknowledged, yet disturbingly the leaders of the medical profession seem only minimally concerned about the problem and make no apparent effort to find a solution,” wrote Mr. Altman, an English medical statistician (BMJ. 1994;308:283).

“We need less research, better research, and research done for the right reasons,” Mr. Altman concluded. “Abandoning using the number of publications as a measure of ability would be a start.”

In an interview, Dr. Powell described an unfortunate consequence of the publish-or-perish pressure in academic medicine: A glut of short-term, small studies with little clinical utility that researchers can complete in 1 or 2 years rather than the large, multicenter studies that take several years – and produce higher-quality findings – but cannot be turned into as many publications.

“We’re generating a lot of medical research findings that end up being false,” he said. “It’s a random walk in terms of getting to the truth rather than having an accurate process of getting to truth through evidence-based medicine.”

But he was hopeful, not cynical, about the way forward. By persuading people that medical research has changed for the worse over time and can change into something better, Dr. Powell saw potential for future research resulting in the same sort of public health achievements that research produced in the past, such as big reductions in smoking or sudden infant death syndrome.

Dr. Powell concluded his talk with a riff on Martin Luther’s 95 Theses, the 9.5 Theses, for a reformation of evidence-based medicine that together address the various shortcomings he discussed.

1. Recognize academic promotion as a bias, just like drug money.

2. Don’t confound statistically significant and clinically significant.

3. Use only significant figures.

4. Use the phrase “we did not DETECT a difference” and include power calculations.

5. Use confidence intervals instead of P values.

6. Use number needed to harm and number needed to treat instead of relative risk.

7. Absence of proof is not proof of absence. When there is insufficient randomized, controlled trial evidence, have an independent party estimate an effect based on non-RCT articles.

8. Any article implying clinical practice should change must include a counterpoint and a benefit cost analysis. Consider both effectiveness and safety.

9. Use postmarketing peer review.

9.5. Beware of research based on surveys.

Dr. Powell reported no relevant financial disclosures.
 

ORLANDO – What doctors think they know to be true in medicine has changed dramatically in the past several decades and will be different again in the decades to come, leaving them with a dilemma, according to Kevin T. Powell, MD, PhD, a pediatric hospitalist in St. Louis. If half of what doctors teach or know in medicine today will ultimately end up not being true, how do they know what to believe or accept?

While there is not a single satisfactory answer to that question, researchers can select research that gets doctors closer to reliable findings and steer them away from the barrage of poor-quality research that emerges from the current publish-or-perish system, Dr. Powell told his colleagues at the annual meeting of the American Academy of Pediatrics.

During his talk, Dr. Powell discussed the challenges and flaws with medical research as it is currently conducted, citing Doug Altman’s writings on these problems as early as 1994.

“The poor quality of much medical research is widely acknowledged, yet disturbingly the leaders of the medical profession seem only minimally concerned about the problem and make no apparent effort to find a solution,” wrote Mr. Altman, an English medical statistician (BMJ. 1994;308:283).

“We need less research, better research, and research done for the right reasons,” Mr. Altman concluded. “Abandoning using the number of publications as a measure of ability would be a start.”

In an interview, Dr. Powell described an unfortunate consequence of the publish-or-perish pressure in academic medicine: A glut of short-term, small studies with little clinical utility that researchers can complete in 1 or 2 years rather than the large, multicenter studies that take several years – and produce higher-quality findings – but cannot be turned into as many publications.

“We’re generating a lot of medical research findings that end up being false,” he said. “It’s a random walk in terms of getting to the truth rather than having an accurate process of getting to truth through evidence-based medicine.”

But he was hopeful, not cynical, about the way forward. By persuading people that medical research has changed for the worse over time and can change into something better, Dr. Powell saw potential for future research resulting in the same sort of public health achievements that research produced in the past, such as big reductions in smoking or sudden infant death syndrome.

Dr. Powell concluded his talk with a riff on Martin Luther’s 95 Theses, the 9.5 Theses, for a reformation of evidence-based medicine that together address the various shortcomings he discussed.

1. Recognize academic promotion as a bias, just like drug money.

2. Don’t confound statistically significant and clinically significant.

3. Use only significant figures.

4. Use the phrase “we did not DETECT a difference” and include power calculations.

5. Use confidence intervals instead of P values.

6. Use number needed to harm and number needed to treat instead of relative risk.

7. Absence of proof is not proof of absence. When there is insufficient randomized, controlled trial evidence, have an independent party estimate an effect based on non-RCT articles.

8. Any article implying clinical practice should change must include a counterpoint and a benefit cost analysis. Consider both effectiveness and safety.

9. Use postmarketing peer review.

9.5. Beware of research based on surveys.

Dr. Powell reported no relevant financial disclosures.
 

ORLANDO – What doctors think they know to be true in medicine has changed dramatically in the past several decades and will be different again in the decades to come, leaving them with a dilemma, according to Kevin T. Powell, MD, PhD, a pediatric hospitalist in St. Louis. If half of what doctors teach or know in medicine today will ultimately end up not being true, how do they know what to believe or accept?

While there is not a single satisfactory answer to that question, researchers can select research that gets doctors closer to reliable findings and steer them away from the barrage of poor-quality research that emerges from the current publish-or-perish system, Dr. Powell told his colleagues at the annual meeting of the American Academy of Pediatrics.

During his talk, Dr. Powell discussed the challenges and flaws with medical research as it is currently conducted, citing Doug Altman’s writings on these problems as early as 1994.

“The poor quality of much medical research is widely acknowledged, yet disturbingly the leaders of the medical profession seem only minimally concerned about the problem and make no apparent effort to find a solution,” wrote Mr. Altman, an English medical statistician (BMJ. 1994;308:283).

“We need less research, better research, and research done for the right reasons,” Mr. Altman concluded. “Abandoning using the number of publications as a measure of ability would be a start.”

In an interview, Dr. Powell described an unfortunate consequence of the publish-or-perish pressure in academic medicine: A glut of short-term, small studies with little clinical utility that researchers can complete in 1 or 2 years rather than the large, multicenter studies that take several years – and produce higher-quality findings – but cannot be turned into as many publications.

“We’re generating a lot of medical research findings that end up being false,” he said. “It’s a random walk in terms of getting to the truth rather than having an accurate process of getting to truth through evidence-based medicine.”

But he was hopeful, not cynical, about the way forward. By persuading people that medical research has changed for the worse over time and can change into something better, Dr. Powell saw potential for future research resulting in the same sort of public health achievements that research produced in the past, such as big reductions in smoking or sudden infant death syndrome.

Dr. Powell concluded his talk with a riff on Martin Luther’s 95 Theses, the 9.5 Theses, for a reformation of evidence-based medicine that together address the various shortcomings he discussed.

1. Recognize academic promotion as a bias, just like drug money.

2. Don’t confound statistically significant and clinically significant.

3. Use only significant figures.

4. Use the phrase “we did not DETECT a difference” and include power calculations.

5. Use confidence intervals instead of P values.

6. Use number needed to harm and number needed to treat instead of relative risk.

7. Absence of proof is not proof of absence. When there is insufficient randomized, controlled trial evidence, have an independent party estimate an effect based on non-RCT articles.

8. Any article implying clinical practice should change must include a counterpoint and a benefit cost analysis. Consider both effectiveness and safety.

9. Use postmarketing peer review.

9.5. Beware of research based on surveys.

Dr. Powell reported no relevant financial disclosures.
 

NEW YORK – Strategies for growing the pool of academic vascular surgeons might help avert the expected scarcity of physicians in this specialty, according to Peter K. Henke, MD, a professor of vascular surgery at the University of Michigan, Ann Arbor.
 

Dr. Henke recounted in a video interview key messages he delivered at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. He argued for going back to basics to enlist residents and fellows completing their training to stay in the specialty and consider an academic position.

Many of these steps are known, such as verifying that mentors are available to encourage skill acquisition and providing adequate time to achieve an acceptable balance of research and clinical work.

However, a successful program would not solely focus on luring young and promising junior faculty, he said. A supportive atmosphere requires collaboration and support to flow both up and down the ranks of seniority where everyone benefits.As an example, he singled out midlevel faculty as vulnerable when programs are not developed to ensure support is equally distributed. He explained that midlevel faculty members denied the encouragement available to surgeons just initiating their career can feel abandoned when they are skilled but not yet leaders in their program.

The Society of Vascular Surgery is pursing several initiatives to address the projected shortage within this specialty, according to Dr. Henke, but he argues that leaders of academic programs have a role to play in helping make the specialty attractive, particularly for those considering an academic career.

NEW YORK – Strategies for growing the pool of academic vascular surgeons might help avert the expected scarcity of physicians in this specialty, according to Peter K. Henke, MD, a professor of vascular surgery at the University of Michigan, Ann Arbor.
 

Dr. Henke recounted in a video interview key messages he delivered at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. He argued for going back to basics to enlist residents and fellows completing their training to stay in the specialty and consider an academic position.

Many of these steps are known, such as verifying that mentors are available to encourage skill acquisition and providing adequate time to achieve an acceptable balance of research and clinical work.

However, a successful program would not solely focus on luring young and promising junior faculty, he said. A supportive atmosphere requires collaboration and support to flow both up and down the ranks of seniority where everyone benefits.As an example, he singled out midlevel faculty as vulnerable when programs are not developed to ensure support is equally distributed. He explained that midlevel faculty members denied the encouragement available to surgeons just initiating their career can feel abandoned when they are skilled but not yet leaders in their program.

The Society of Vascular Surgery is pursing several initiatives to address the projected shortage within this specialty, according to Dr. Henke, but he argues that leaders of academic programs have a role to play in helping make the specialty attractive, particularly for those considering an academic career.

NEW YORK – Strategies for growing the pool of academic vascular surgeons might help avert the expected scarcity of physicians in this specialty, according to Peter K. Henke, MD, a professor of vascular surgery at the University of Michigan, Ann Arbor.
 

Dr. Henke recounted in a video interview key messages he delivered at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. He argued for going back to basics to enlist residents and fellows completing their training to stay in the specialty and consider an academic position.

Many of these steps are known, such as verifying that mentors are available to encourage skill acquisition and providing adequate time to achieve an acceptable balance of research and clinical work.

However, a successful program would not solely focus on luring young and promising junior faculty, he said. A supportive atmosphere requires collaboration and support to flow both up and down the ranks of seniority where everyone benefits.As an example, he singled out midlevel faculty as vulnerable when programs are not developed to ensure support is equally distributed. He explained that midlevel faculty members denied the encouragement available to surgeons just initiating their career can feel abandoned when they are skilled but not yet leaders in their program.

The Society of Vascular Surgery is pursing several initiatives to address the projected shortage within this specialty, according to Dr. Henke, but he argues that leaders of academic programs have a role to play in helping make the specialty attractive, particularly for those considering an academic career.

NEW YORK – Follow-up to 5 years is now available for a drug-coated balloon (DCB) device used to treat superficial femoral artery (SFA) occlusion. John Laird, MD, of the Adventist Heart Institute, St. Helena, Calif., presented the data at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.

The data were drawn from the IN.PACT trial. In this trial, 331 patients were randomized to a paclitaxel-coated DCB device or standard percutaneous balloon angioplasty (PCBA), Dr. Laird explained.

The 5-year results are consistent with those previously reported at 1, 2, and 3 years. According to Dr. Laird, DCB continues to show an advantage for major outcomes over PCBA, and adverse events remain low.

Three DCB devices now available in the United States for dilatation of narrowed SFA. Although all have been associated with a reduced risk of target lesion revascularization relative to standard PCBA, the long-term follow-up presented from IN.PACT by Dr. Laird are the first to document 5-year outcomes.

In a video interview, Dr. Laird reported that there have been no thrombotic events since the 3-year results were presented.

Overall, he explains that the long-term outcomes provide additional confirmation that DCB is a safe procedure that reduces the need for stenting in SFA occlusions. Although he believes there might be clinically significant differences between available DCB devices, he concludes that DCB can be considered the first-line therapy for treating occluded femoral-popliteal arteries.

NEW YORK – Follow-up to 5 years is now available for a drug-coated balloon (DCB) device used to treat superficial femoral artery (SFA) occlusion. John Laird, MD, of the Adventist Heart Institute, St. Helena, Calif., presented the data at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.

The data were drawn from the IN.PACT trial. In this trial, 331 patients were randomized to a paclitaxel-coated DCB device or standard percutaneous balloon angioplasty (PCBA), Dr. Laird explained.

The 5-year results are consistent with those previously reported at 1, 2, and 3 years. According to Dr. Laird, DCB continues to show an advantage for major outcomes over PCBA, and adverse events remain low.

Three DCB devices now available in the United States for dilatation of narrowed SFA. Although all have been associated with a reduced risk of target lesion revascularization relative to standard PCBA, the long-term follow-up presented from IN.PACT by Dr. Laird are the first to document 5-year outcomes.

In a video interview, Dr. Laird reported that there have been no thrombotic events since the 3-year results were presented.

Overall, he explains that the long-term outcomes provide additional confirmation that DCB is a safe procedure that reduces the need for stenting in SFA occlusions. Although he believes there might be clinically significant differences between available DCB devices, he concludes that DCB can be considered the first-line therapy for treating occluded femoral-popliteal arteries.

NEW YORK – Follow-up to 5 years is now available for a drug-coated balloon (DCB) device used to treat superficial femoral artery (SFA) occlusion. John Laird, MD, of the Adventist Heart Institute, St. Helena, Calif., presented the data at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.

The data were drawn from the IN.PACT trial. In this trial, 331 patients were randomized to a paclitaxel-coated DCB device or standard percutaneous balloon angioplasty (PCBA), Dr. Laird explained.

The 5-year results are consistent with those previously reported at 1, 2, and 3 years. According to Dr. Laird, DCB continues to show an advantage for major outcomes over PCBA, and adverse events remain low.

Three DCB devices now available in the United States for dilatation of narrowed SFA. Although all have been associated with a reduced risk of target lesion revascularization relative to standard PCBA, the long-term follow-up presented from IN.PACT by Dr. Laird are the first to document 5-year outcomes.

In a video interview, Dr. Laird reported that there have been no thrombotic events since the 3-year results were presented.

Overall, he explains that the long-term outcomes provide additional confirmation that DCB is a safe procedure that reduces the need for stenting in SFA occlusions. Although he believes there might be clinically significant differences between available DCB devices, he concludes that DCB can be considered the first-line therapy for treating occluded femoral-popliteal arteries.

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.

Mitchel L. Zoler/MDedge News

“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.

Mitchel L. Zoler/MDedge News

“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.

mzoler@mdedge.com

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.

Mitchel L. Zoler/MDedge News

“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.

Mitchel L. Zoler/MDedge News

“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.

mzoler@mdedge.com

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.

Mitchel L. Zoler/MDedge News

“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.

Mitchel L. Zoler/MDedge News

“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.

mzoler@mdedge.com

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.

BOSTON– Imagine being able to biopsy a tumor and grow it in a lab.
 

The implications are nearly endless. To start, chemotherapy and radiation options could be screened in vitro, much like culture and sensitivity testing of bacteria, to find a patient’s best option. Tumor cultures could be banked for mass screening of new cytotoxic candidates.

It’s already beginning to happen in a few research labs around the world, and it might foretell a breakthrough in cancer treatment.

After decades of failure, the trick to growing tumor cells in culture has finally been figured out. When stem cells are fished out of healthy tissue – from the crypts of the gastrointestinal lining, for instance – and put into a three-dimensional matrix culture with growth factors, they grow into little replications of the organs they came from, called “organoids;” when stem cells are pulled from cancers, they replicate the primary tumor, growing into “tumoroids” ready to be tested against cytotoxic drugs and radiation.

Philip B. Paty, MD, FACS, a colorectal surgeon and organoid researcher at Memorial Sloan Kettering Cancer Center, New York, said he is certain that the person who led the team that figured out the right culture condition – Hans Clevers, MD, PhD, a molecular genetics professor at the University of Utrecht (the Netherlands) – is destined for a Nobel Prize.

Dr. Paty took a few minutes at the annual clinical congress of the American College of Surgeons to explain in an interview why, and what ‘organoid technology’ will likely mean for cancer treatment in a few years.

“The ability to grow and sustain cancer means that we now can start doing real science on human tissues. We could never do this before. We’ve been treating cancer without being able to grow tumors and study them.” The breakthrough opens the door to “clinical trials in a dish,” and will likely take personalized cancer treatment to a new level, he said.

“It remains to be proven that “organoid technology “can change outcomes for patients, but those studies are likely coming,” said Dr. Paty, who investigates tumoroid response to radiation in his own lab work.

aotto@mdedge.com

BOSTON– Imagine being able to biopsy a tumor and grow it in a lab.
 

The implications are nearly endless. To start, chemotherapy and radiation options could be screened in vitro, much like culture and sensitivity testing of bacteria, to find a patient’s best option. Tumor cultures could be banked for mass screening of new cytotoxic candidates.

It’s already beginning to happen in a few research labs around the world, and it might foretell a breakthrough in cancer treatment.

After decades of failure, the trick to growing tumor cells in culture has finally been figured out. When stem cells are fished out of healthy tissue – from the crypts of the gastrointestinal lining, for instance – and put into a three-dimensional matrix culture with growth factors, they grow into little replications of the organs they came from, called “organoids;” when stem cells are pulled from cancers, they replicate the primary tumor, growing into “tumoroids” ready to be tested against cytotoxic drugs and radiation.

Philip B. Paty, MD, FACS, a colorectal surgeon and organoid researcher at Memorial Sloan Kettering Cancer Center, New York, said he is certain that the person who led the team that figured out the right culture condition – Hans Clevers, MD, PhD, a molecular genetics professor at the University of Utrecht (the Netherlands) – is destined for a Nobel Prize.

Dr. Paty took a few minutes at the annual clinical congress of the American College of Surgeons to explain in an interview why, and what ‘organoid technology’ will likely mean for cancer treatment in a few years.

“The ability to grow and sustain cancer means that we now can start doing real science on human tissues. We could never do this before. We’ve been treating cancer without being able to grow tumors and study them.” The breakthrough opens the door to “clinical trials in a dish,” and will likely take personalized cancer treatment to a new level, he said.

“It remains to be proven that “organoid technology “can change outcomes for patients, but those studies are likely coming,” said Dr. Paty, who investigates tumoroid response to radiation in his own lab work.

aotto@mdedge.com

BOSTON– Imagine being able to biopsy a tumor and grow it in a lab.
 

The implications are nearly endless. To start, chemotherapy and radiation options could be screened in vitro, much like culture and sensitivity testing of bacteria, to find a patient’s best option. Tumor cultures could be banked for mass screening of new cytotoxic candidates.

It’s already beginning to happen in a few research labs around the world, and it might foretell a breakthrough in cancer treatment.

After decades of failure, the trick to growing tumor cells in culture has finally been figured out. When stem cells are fished out of healthy tissue – from the crypts of the gastrointestinal lining, for instance – and put into a three-dimensional matrix culture with growth factors, they grow into little replications of the organs they came from, called “organoids;” when stem cells are pulled from cancers, they replicate the primary tumor, growing into “tumoroids” ready to be tested against cytotoxic drugs and radiation.

Philip B. Paty, MD, FACS, a colorectal surgeon and organoid researcher at Memorial Sloan Kettering Cancer Center, New York, said he is certain that the person who led the team that figured out the right culture condition – Hans Clevers, MD, PhD, a molecular genetics professor at the University of Utrecht (the Netherlands) – is destined for a Nobel Prize.

Dr. Paty took a few minutes at the annual clinical congress of the American College of Surgeons to explain in an interview why, and what ‘organoid technology’ will likely mean for cancer treatment in a few years.

“The ability to grow and sustain cancer means that we now can start doing real science on human tissues. We could never do this before. We’ve been treating cancer without being able to grow tumors and study them.” The breakthrough opens the door to “clinical trials in a dish,” and will likely take personalized cancer treatment to a new level, he said.

“It remains to be proven that “organoid technology “can change outcomes for patients, but those studies are likely coming,” said Dr. Paty, who investigates tumoroid response to radiation in his own lab work.

aotto@mdedge.com

BOSTON – Chemotherapy and radiation cure 70%-80% of patients with low rectal cancer.

It’s for them that the watch-and-wait paradigm was established over a decade ago, and widely adopted since then. The idea is to hold off on surgery after a complete response to chemotherapy and radiation, to see if the patient really needs it.

While most do not, tumors regrow in 20%-30%, and when they come back, they tend to be aggressive, with poor outcomes. Patients in those situations would have been better off with upfront surgery.

The problem right now is that there’s no way to predict who will be cured by neoadjuvant therapy and whose tumor will come back, said Philip Paty, MD. FACS, a colorectal surgeon at Memorial Sloan Kettering Cancer Center, New York.

“There are some who are probably harmed by the watch-and-wait paradigm. The risk of local regrowth is hardbaked into [the model]; we haven’t been able to eliminate it,” he said at the annual clinical congress of the American College of Surgeons..

Dr. Paty is one of many investigators working to identify those at risk. In the meantime, watch-and-wait patients need to be followed closely, particularly in the first 2 years. Surgery is the best option at the first sign of regrowth. Dr. Paty explained his follow-up protocol, as well as the current state of watch and wait for low rectal cancer, in an interview at the meeting.

He also talked about overcoming hurdles. The risk of surgery, including permanent bowel and sexual dysfunction, is so great “that many patients latch onto watch and wait and won’t let go. They don’t come back for follow-up, or resist the idea of surgery even if it’s needed,” he said.

aotto@mdedge.com

BOSTON – Chemotherapy and radiation cure 70%-80% of patients with low rectal cancer.

It’s for them that the watch-and-wait paradigm was established over a decade ago, and widely adopted since then. The idea is to hold off on surgery after a complete response to chemotherapy and radiation, to see if the patient really needs it.

While most do not, tumors regrow in 20%-30%, and when they come back, they tend to be aggressive, with poor outcomes. Patients in those situations would have been better off with upfront surgery.

The problem right now is that there’s no way to predict who will be cured by neoadjuvant therapy and whose tumor will come back, said Philip Paty, MD. FACS, a colorectal surgeon at Memorial Sloan Kettering Cancer Center, New York.

“There are some who are probably harmed by the watch-and-wait paradigm. The risk of local regrowth is hardbaked into [the model]; we haven’t been able to eliminate it,” he said at the annual clinical congress of the American College of Surgeons..

Dr. Paty is one of many investigators working to identify those at risk. In the meantime, watch-and-wait patients need to be followed closely, particularly in the first 2 years. Surgery is the best option at the first sign of regrowth. Dr. Paty explained his follow-up protocol, as well as the current state of watch and wait for low rectal cancer, in an interview at the meeting.

He also talked about overcoming hurdles. The risk of surgery, including permanent bowel and sexual dysfunction, is so great “that many patients latch onto watch and wait and won’t let go. They don’t come back for follow-up, or resist the idea of surgery even if it’s needed,” he said.

aotto@mdedge.com

BOSTON – Chemotherapy and radiation cure 70%-80% of patients with low rectal cancer.

It’s for them that the watch-and-wait paradigm was established over a decade ago, and widely adopted since then. The idea is to hold off on surgery after a complete response to chemotherapy and radiation, to see if the patient really needs it.

While most do not, tumors regrow in 20%-30%, and when they come back, they tend to be aggressive, with poor outcomes. Patients in those situations would have been better off with upfront surgery.

The problem right now is that there’s no way to predict who will be cured by neoadjuvant therapy and whose tumor will come back, said Philip Paty, MD. FACS, a colorectal surgeon at Memorial Sloan Kettering Cancer Center, New York.

“There are some who are probably harmed by the watch-and-wait paradigm. The risk of local regrowth is hardbaked into [the model]; we haven’t been able to eliminate it,” he said at the annual clinical congress of the American College of Surgeons..

Dr. Paty is one of many investigators working to identify those at risk. In the meantime, watch-and-wait patients need to be followed closely, particularly in the first 2 years. Surgery is the best option at the first sign of regrowth. Dr. Paty explained his follow-up protocol, as well as the current state of watch and wait for low rectal cancer, in an interview at the meeting.

He also talked about overcoming hurdles. The risk of surgery, including permanent bowel and sexual dysfunction, is so great “that many patients latch onto watch and wait and won’t let go. They don’t come back for follow-up, or resist the idea of surgery even if it’s needed,” he said.

aotto@mdedge.com

BOSTON – A quality improvement project conducted at the Cleveland Clinic dropped the 30-day colorectal surgery infection rate from 11.8% to 6.6%, driven mostly by a reduction in deep organ space infections from 5.5% to 1.7%.

It was a remarkable finding that got the attention of attendees at the annual clinical congress of the American College of Surgeons. The Cleveland Clinic had been an outlier, in the wrong direction, compared with other centers, and administrators wanted a solution.

I. Emre Gorgun, MD, FACS, a colorectal surgeon and quality improvement officer at Cleveland Clinic, led the search for evidence-based interventions. Eventually, big changes were made to perioperative antibiotics, mechanical bowel prep, preop shower routines, and intraoperative procedures. The efforts paid off (Dis Colon Rectum. 2018 Jan;61[1]:89-98).

To help surgeons lower their own infection rates, Dr. Gorgun agreed to an interview at the meeting to explain exactly what was done.

There was resistance at first from surgeons who wanted to stick with their routines, but they came around once they were shown the data backing the changes. Eventually, “everyone was on board. We believe in this,” Dr. Gorgun said.

aotto@mdedge.com

BOSTON – A quality improvement project conducted at the Cleveland Clinic dropped the 30-day colorectal surgery infection rate from 11.8% to 6.6%, driven mostly by a reduction in deep organ space infections from 5.5% to 1.7%.

It was a remarkable finding that got the attention of attendees at the annual clinical congress of the American College of Surgeons. The Cleveland Clinic had been an outlier, in the wrong direction, compared with other centers, and administrators wanted a solution.

I. Emre Gorgun, MD, FACS, a colorectal surgeon and quality improvement officer at Cleveland Clinic, led the search for evidence-based interventions. Eventually, big changes were made to perioperative antibiotics, mechanical bowel prep, preop shower routines, and intraoperative procedures. The efforts paid off (Dis Colon Rectum. 2018 Jan;61[1]:89-98).

To help surgeons lower their own infection rates, Dr. Gorgun agreed to an interview at the meeting to explain exactly what was done.

There was resistance at first from surgeons who wanted to stick with their routines, but they came around once they were shown the data backing the changes. Eventually, “everyone was on board. We believe in this,” Dr. Gorgun said.

aotto@mdedge.com

BOSTON – A quality improvement project conducted at the Cleveland Clinic dropped the 30-day colorectal surgery infection rate from 11.8% to 6.6%, driven mostly by a reduction in deep organ space infections from 5.5% to 1.7%.

It was a remarkable finding that got the attention of attendees at the annual clinical congress of the American College of Surgeons. The Cleveland Clinic had been an outlier, in the wrong direction, compared with other centers, and administrators wanted a solution.

I. Emre Gorgun, MD, FACS, a colorectal surgeon and quality improvement officer at Cleveland Clinic, led the search for evidence-based interventions. Eventually, big changes were made to perioperative antibiotics, mechanical bowel prep, preop shower routines, and intraoperative procedures. The efforts paid off (Dis Colon Rectum. 2018 Jan;61[1]:89-98).

To help surgeons lower their own infection rates, Dr. Gorgun agreed to an interview at the meeting to explain exactly what was done.

There was resistance at first from surgeons who wanted to stick with their routines, but they came around once they were shown the data backing the changes. Eventually, “everyone was on board. We believe in this,” Dr. Gorgun said.

aotto@mdedge.com

BOSTON – Fat grafting has taken off in recent years, especially for breast reconstruction, but it’s become clear that it also has a role in scar treatment, according to Benjamin Levi, MD, director of the burn/wound and regenerative medicine laboratory at the University of Michigan, Ann Arbor.

Some corners of the Internet tout it as “some sort of magic stem cell surgery,” Dr. Levi said, but in reality, for scar surgeons, it’s just another useful tool in the armamentarium, one that excels at filling skin depressions due to underlying tissue loss, whether from burns, trauma, or surgery. Unlike hyaluronic acid and other options, fat grafts last; about half of injected adipocytes remain indefinitely. Fat grafting might also help soften scars, he said.

To get the most out of the procedure, of course, it has to be done correctly, so Dr. Levi took a few minutes at the annual clinical congress of the American College of Surgeons to share his tips on harvesting and spinning down fat grafts, injecting adipocytes, and other matters. Although the concepts of fat grafting are straightforward, the techniques are a bit tricky. Dr. Levi hoped his treatment pearls would help other physicians, especially those considering adding fat grafting to their practice.
 

aotto@mdedge.com

BOSTON – Fat grafting has taken off in recent years, especially for breast reconstruction, but it’s become clear that it also has a role in scar treatment, according to Benjamin Levi, MD, director of the burn/wound and regenerative medicine laboratory at the University of Michigan, Ann Arbor.

Some corners of the Internet tout it as “some sort of magic stem cell surgery,” Dr. Levi said, but in reality, for scar surgeons, it’s just another useful tool in the armamentarium, one that excels at filling skin depressions due to underlying tissue loss, whether from burns, trauma, or surgery. Unlike hyaluronic acid and other options, fat grafts last; about half of injected adipocytes remain indefinitely. Fat grafting might also help soften scars, he said.

To get the most out of the procedure, of course, it has to be done correctly, so Dr. Levi took a few minutes at the annual clinical congress of the American College of Surgeons to share his tips on harvesting and spinning down fat grafts, injecting adipocytes, and other matters. Although the concepts of fat grafting are straightforward, the techniques are a bit tricky. Dr. Levi hoped his treatment pearls would help other physicians, especially those considering adding fat grafting to their practice.
 

aotto@mdedge.com

BOSTON – Fat grafting has taken off in recent years, especially for breast reconstruction, but it’s become clear that it also has a role in scar treatment, according to Benjamin Levi, MD, director of the burn/wound and regenerative medicine laboratory at the University of Michigan, Ann Arbor.

Some corners of the Internet tout it as “some sort of magic stem cell surgery,” Dr. Levi said, but in reality, for scar surgeons, it’s just another useful tool in the armamentarium, one that excels at filling skin depressions due to underlying tissue loss, whether from burns, trauma, or surgery. Unlike hyaluronic acid and other options, fat grafts last; about half of injected adipocytes remain indefinitely. Fat grafting might also help soften scars, he said.

To get the most out of the procedure, of course, it has to be done correctly, so Dr. Levi took a few minutes at the annual clinical congress of the American College of Surgeons to share his tips on harvesting and spinning down fat grafts, injecting adipocytes, and other matters. Although the concepts of fat grafting are straightforward, the techniques are a bit tricky. Dr. Levi hoped his treatment pearls would help other physicians, especially those considering adding fat grafting to their practice.
 

aotto@mdedge.com

CHICAGO – Dr. Larry A. Allen will now have an easier time of treating hospitalized patients with acute decompensated heart failure because of the results of the PIONEER-HF trial.

That study examined whether in-hospital initiation of sacubitril/valsartan compared to enalapril is safe and effective in ADHF, a treatment that hasn’t been studied well or taken up in clinical practice.

In PIONEER-HF, compared with enalipril, sacubitril/valsaran reduced NT-proBNP significantly from baseline to week 8 by 29%, showed comparable safety, and reduced composite endpoint of death, rehospitalization for heart failure, implantation of a left-ventricular implant device, and need for a transplant by 46%.

Dr. Allen, of the University of Colorado, Denver, was the designated discussant for the PIONEER-HF presentation at the American Heart Association scientific sessions. In an interview, he explained how these results will change his practice as a heart failure specialist. “It simplifies things: I don’t have to start on an old therapy in the hospital, get the patients back in clinic, and switch the over to this newer therapy. I can just start from the beginning with the therapy that I think will be most effective.”

To find out why, watch the complete interview.

CHICAGO – Dr. Larry A. Allen will now have an easier time of treating hospitalized patients with acute decompensated heart failure because of the results of the PIONEER-HF trial.

That study examined whether in-hospital initiation of sacubitril/valsartan compared to enalapril is safe and effective in ADHF, a treatment that hasn’t been studied well or taken up in clinical practice.

In PIONEER-HF, compared with enalipril, sacubitril/valsaran reduced NT-proBNP significantly from baseline to week 8 by 29%, showed comparable safety, and reduced composite endpoint of death, rehospitalization for heart failure, implantation of a left-ventricular implant device, and need for a transplant by 46%.

Dr. Allen, of the University of Colorado, Denver, was the designated discussant for the PIONEER-HF presentation at the American Heart Association scientific sessions. In an interview, he explained how these results will change his practice as a heart failure specialist. “It simplifies things: I don’t have to start on an old therapy in the hospital, get the patients back in clinic, and switch the over to this newer therapy. I can just start from the beginning with the therapy that I think will be most effective.”

To find out why, watch the complete interview.

CHICAGO – Dr. Larry A. Allen will now have an easier time of treating hospitalized patients with acute decompensated heart failure because of the results of the PIONEER-HF trial.

That study examined whether in-hospital initiation of sacubitril/valsartan compared to enalapril is safe and effective in ADHF, a treatment that hasn’t been studied well or taken up in clinical practice.

In PIONEER-HF, compared with enalipril, sacubitril/valsaran reduced NT-proBNP significantly from baseline to week 8 by 29%, showed comparable safety, and reduced composite endpoint of death, rehospitalization for heart failure, implantation of a left-ventricular implant device, and need for a transplant by 46%.

Dr. Allen, of the University of Colorado, Denver, was the designated discussant for the PIONEER-HF presentation at the American Heart Association scientific sessions. In an interview, he explained how these results will change his practice as a heart failure specialist. “It simplifies things: I don’t have to start on an old therapy in the hospital, get the patients back in clinic, and switch the over to this newer therapy. I can just start from the beginning with the therapy that I think will be most effective.”

To find out why, watch the complete interview.