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VIDEO: Public reporting of congenital heart disease outcomes should be easily understood
HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.
Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.
“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”
Dr. Irons reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.
Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.
“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”
Dr. Irons reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.
Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.
“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”
Dr. Irons reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
FROM THE STS ANNUAL MEETING HOUSTON
Travel ban affects international medical meetings
President Trump’s executive order blocking travelers from seven Muslim-majority countries from entering the United States has landed a damaging blow to global cooperation in scientific research and could impede assemblies of the world’s top medical experts.
“We are offering assistance as needed, and as each unique situation requires,” IAS-USA executive director and president Donna M. Jacobsen said in an interview. “Apart from that, we are establishing a list of individuals who may have contacts at the U.S. embassies, and will seek assistance from them as needed. Also, we are providing a letter documenting the individual as having been vetted as a legitimate scientist or researcher in the field, and having been approved to attend CROI.”
“We are monitoring the situation closely, however, and will offer whatever assistance we can to conference attendees, regardless of their point of origin, to ensure the free exchange of scientific information,” she said.
The travel ban could have detrimental effects on future collaboration between U.S. and international scientists and ultimately endanger the health and well-being of patients, Ms. Jacobsen said.
“Beyond the immediate possible impact on individuals intending to attend CROI who might be directly affected by the ban, there is serious reason for concern that the policy will dissuade other scientists and researchers from traveling to the U.S. in the future overall and sharing their work with colleagues here,” she said in an interview. “Such a response to the U.S. action would needlessly damage our global leadership in science and medicine.”
Thousands of academics from around the world, including physicians, researchers, and professors, have already vowed to boycott U.S.-based conferences until the travel ban is lifted. A Google Docs petition started shortly after the ban was announced has garnered more than 5,000 signatures by professionals acting in solidarity with those affected by the travel restrictions. It’s unclear who started the petition.
The academicians who signed the petition say they will not attend international conferences in the United States until those restricted from participating can rejoin their colleagues and freely share their ideas, said Charles R. Rogers, PhD, of the University of Minnesota, Minneapolis.
President Trump’s executive order, signed Jan. 27, bars refugees from entering the country for 120 days and bans immigrants from seven predominantly Muslim nations out for 3 months. The countries include Iran, Iraq, Syria, Sudan, Libya, Yemen and Somalia.
In a Feb. 1 press conference, White House press secretary Sean Spicer said the president’s intent is to ensure national security and prevent terrorists from entering the country.
“The president has been very clear that his No. 1 goal is not to target any one religion but places and areas where we believe that there is an issue,” Mr. Spicer said. “The president’s No. 1 goal has always been to focus on the safety of America, not the religion. He understands that it’s not a religious problem, it’s a radicalization problem. There’s a big difference between Islam, the religion, and radical Islamic terrorists that come here to seek to do us harm.”
[email protected]
On Twitter @legal_med
President Trump’s executive order blocking travelers from seven Muslim-majority countries from entering the United States has landed a damaging blow to global cooperation in scientific research and could impede assemblies of the world’s top medical experts.
“We are offering assistance as needed, and as each unique situation requires,” IAS-USA executive director and president Donna M. Jacobsen said in an interview. “Apart from that, we are establishing a list of individuals who may have contacts at the U.S. embassies, and will seek assistance from them as needed. Also, we are providing a letter documenting the individual as having been vetted as a legitimate scientist or researcher in the field, and having been approved to attend CROI.”
“We are monitoring the situation closely, however, and will offer whatever assistance we can to conference attendees, regardless of their point of origin, to ensure the free exchange of scientific information,” she said.
The travel ban could have detrimental effects on future collaboration between U.S. and international scientists and ultimately endanger the health and well-being of patients, Ms. Jacobsen said.
“Beyond the immediate possible impact on individuals intending to attend CROI who might be directly affected by the ban, there is serious reason for concern that the policy will dissuade other scientists and researchers from traveling to the U.S. in the future overall and sharing their work with colleagues here,” she said in an interview. “Such a response to the U.S. action would needlessly damage our global leadership in science and medicine.”
Thousands of academics from around the world, including physicians, researchers, and professors, have already vowed to boycott U.S.-based conferences until the travel ban is lifted. A Google Docs petition started shortly after the ban was announced has garnered more than 5,000 signatures by professionals acting in solidarity with those affected by the travel restrictions. It’s unclear who started the petition.
The academicians who signed the petition say they will not attend international conferences in the United States until those restricted from participating can rejoin their colleagues and freely share their ideas, said Charles R. Rogers, PhD, of the University of Minnesota, Minneapolis.
President Trump’s executive order, signed Jan. 27, bars refugees from entering the country for 120 days and bans immigrants from seven predominantly Muslim nations out for 3 months. The countries include Iran, Iraq, Syria, Sudan, Libya, Yemen and Somalia.
In a Feb. 1 press conference, White House press secretary Sean Spicer said the president’s intent is to ensure national security and prevent terrorists from entering the country.
“The president has been very clear that his No. 1 goal is not to target any one religion but places and areas where we believe that there is an issue,” Mr. Spicer said. “The president’s No. 1 goal has always been to focus on the safety of America, not the religion. He understands that it’s not a religious problem, it’s a radicalization problem. There’s a big difference between Islam, the religion, and radical Islamic terrorists that come here to seek to do us harm.”
[email protected]
On Twitter @legal_med
President Trump’s executive order blocking travelers from seven Muslim-majority countries from entering the United States has landed a damaging blow to global cooperation in scientific research and could impede assemblies of the world’s top medical experts.
“We are offering assistance as needed, and as each unique situation requires,” IAS-USA executive director and president Donna M. Jacobsen said in an interview. “Apart from that, we are establishing a list of individuals who may have contacts at the U.S. embassies, and will seek assistance from them as needed. Also, we are providing a letter documenting the individual as having been vetted as a legitimate scientist or researcher in the field, and having been approved to attend CROI.”
“We are monitoring the situation closely, however, and will offer whatever assistance we can to conference attendees, regardless of their point of origin, to ensure the free exchange of scientific information,” she said.
The travel ban could have detrimental effects on future collaboration between U.S. and international scientists and ultimately endanger the health and well-being of patients, Ms. Jacobsen said.
“Beyond the immediate possible impact on individuals intending to attend CROI who might be directly affected by the ban, there is serious reason for concern that the policy will dissuade other scientists and researchers from traveling to the U.S. in the future overall and sharing their work with colleagues here,” she said in an interview. “Such a response to the U.S. action would needlessly damage our global leadership in science and medicine.”
Thousands of academics from around the world, including physicians, researchers, and professors, have already vowed to boycott U.S.-based conferences until the travel ban is lifted. A Google Docs petition started shortly after the ban was announced has garnered more than 5,000 signatures by professionals acting in solidarity with those affected by the travel restrictions. It’s unclear who started the petition.
The academicians who signed the petition say they will not attend international conferences in the United States until those restricted from participating can rejoin their colleagues and freely share their ideas, said Charles R. Rogers, PhD, of the University of Minnesota, Minneapolis.
President Trump’s executive order, signed Jan. 27, bars refugees from entering the country for 120 days and bans immigrants from seven predominantly Muslim nations out for 3 months. The countries include Iran, Iraq, Syria, Sudan, Libya, Yemen and Somalia.
In a Feb. 1 press conference, White House press secretary Sean Spicer said the president’s intent is to ensure national security and prevent terrorists from entering the country.
“The president has been very clear that his No. 1 goal is not to target any one religion but places and areas where we believe that there is an issue,” Mr. Spicer said. “The president’s No. 1 goal has always been to focus on the safety of America, not the religion. He understands that it’s not a religious problem, it’s a radicalization problem. There’s a big difference between Islam, the religion, and radical Islamic terrorists that come here to seek to do us harm.”
[email protected]
On Twitter @legal_med
Register for the AATS Mitral Conclave
Registration and housing are now available for AATS Mitral Conclave, which immediately precedes the AATS Centennial.
Thursday, April 27 – Friday, April 28, 2017
New York Hilton Midtown Hotel
New York, NY
Program Overview
The AATS Mitral Conclave will bring the world’s leading figures in mitral valve disease together for two days to discuss the latest information regarding management guidelines, imaging, pathology, minimally invasive and percutaneous approaches, surgical techniques, devices, and long-term results. Faculty will present the latest available data, techniques, and state of the art reviews, supplemented by abstract and video presentations selected by the program committee from submitted original work.
Course Director
David H. Adams
Program Committee
Anelechi C. Anyanwu
Tirone E. David
Pedro J. del Nido
Gilles D. Dreyfus
Khalil Fattouch
D. Craig Miller
Rakesh M. Suri
Vinod H. Thourani
Registration and housing are now available for AATS Mitral Conclave, which immediately precedes the AATS Centennial.
Thursday, April 27 – Friday, April 28, 2017
New York Hilton Midtown Hotel
New York, NY
Program Overview
The AATS Mitral Conclave will bring the world’s leading figures in mitral valve disease together for two days to discuss the latest information regarding management guidelines, imaging, pathology, minimally invasive and percutaneous approaches, surgical techniques, devices, and long-term results. Faculty will present the latest available data, techniques, and state of the art reviews, supplemented by abstract and video presentations selected by the program committee from submitted original work.
Course Director
David H. Adams
Program Committee
Anelechi C. Anyanwu
Tirone E. David
Pedro J. del Nido
Gilles D. Dreyfus
Khalil Fattouch
D. Craig Miller
Rakesh M. Suri
Vinod H. Thourani
Registration and housing are now available for AATS Mitral Conclave, which immediately precedes the AATS Centennial.
Thursday, April 27 – Friday, April 28, 2017
New York Hilton Midtown Hotel
New York, NY
Program Overview
The AATS Mitral Conclave will bring the world’s leading figures in mitral valve disease together for two days to discuss the latest information regarding management guidelines, imaging, pathology, minimally invasive and percutaneous approaches, surgical techniques, devices, and long-term results. Faculty will present the latest available data, techniques, and state of the art reviews, supplemented by abstract and video presentations selected by the program committee from submitted original work.
Course Director
David H. Adams
Program Committee
Anelechi C. Anyanwu
Tirone E. David
Pedro J. del Nido
Gilles D. Dreyfus
Khalil Fattouch
D. Craig Miller
Rakesh M. Suri
Vinod H. Thourani
AATS Week 2017 Registration Now Open
AATS Week 2017 will bring together the world’s foremost CT surgery scientists and medical professionals for seven days at three important events:
Mitral Conclave
April 27 – 28, 2017
New York, NY
AATS Innovation Summit
April 29, 2017
Boston, MA
The AATS Centennial
April 29 – May 3
Boston, MA
Registration is now open.
Choose from one of several registration packages:
AATS Week 2017 Package
Register and receive a $100 discount*
*Discount does not apply to Residents/Fellows or Medical Students. The discount is applied to the AATS Mitral Conclave registration fee.
Genius Pass
The Genius Pass provides access to almost every offering at the AATS Centennial. The package includes:
** Access to Saturday Skills Courses and Sunday Symposia
** Access to all simulation sessions (Monday – Wednesday)
** Exhibit Hall admission
** Lunch in the Exhibit Hall (Monday & Tuesday)
** Welcome Reception
Innovation Pass
Ignite your spirit for innovation with Course Director W. Randolph Chitwood Jr. at this one-day program assisting cardiothoracic surgeons to develop new clinically applicable technology by obtaining the cross-specialty knowledge needed for novel idea generation, protecting intellectual property, developmental funding, clinical trials, regulatory pathways and industry relations.
Innovation Pass Registration includes:
** Registration for the Saturday AATS Innovation Summit
** Access to all Sunday Symposia
** Access to all simulations sessions (Monday- Wednesday)
** Exhibit Hall admission
** Lunch in the Exhibit Hall (Monday and Tuesday)
** Welcome Reception
Note: You can only attend the AATS Innovation Summit or the Saturday Skills Courses. You cannot choose to attend both events on Saturday.
Resident/Fellows and Medical Students: Can only attend the AATS Centennial by choosing the AATS Genius or Innovation Pass.
Separate registration is required for: Saturday hands-on sessions, Member for a Day session, Survival Guide for the Cardiothoracic Surgical Team, MOC Breakfast, Cardiothoracic Residents & Ethics Forum Luncheons, and all social events and tours.
Conference Flex Pass
This pass is best suited for those who want to attend some, but not all, offerings.
Customize your AATS Centennial participation by adding individual educational events to your cart — any combination of the Saturday Courses, Sunday Symposia, and Monday-Wednesday simultaneous sessions.
Saturday Courses and Sunday Symposium Registration
Register for a Saturday course and/or a Sunday symposium and receive access to all other courses/symposia taking place that day.
Note: Registration for the Saturday courses and/or Sunday symposium is separate from the Annual Meeting registration rate.
Registration & Housing information
AATS Week 2017 will bring together the world’s foremost CT surgery scientists and medical professionals for seven days at three important events:
Mitral Conclave
April 27 – 28, 2017
New York, NY
AATS Innovation Summit
April 29, 2017
Boston, MA
The AATS Centennial
April 29 – May 3
Boston, MA
Registration is now open.
Choose from one of several registration packages:
AATS Week 2017 Package
Register and receive a $100 discount*
*Discount does not apply to Residents/Fellows or Medical Students. The discount is applied to the AATS Mitral Conclave registration fee.
Genius Pass
The Genius Pass provides access to almost every offering at the AATS Centennial. The package includes:
** Access to Saturday Skills Courses and Sunday Symposia
** Access to all simulation sessions (Monday – Wednesday)
** Exhibit Hall admission
** Lunch in the Exhibit Hall (Monday & Tuesday)
** Welcome Reception
Innovation Pass
Ignite your spirit for innovation with Course Director W. Randolph Chitwood Jr. at this one-day program assisting cardiothoracic surgeons to develop new clinically applicable technology by obtaining the cross-specialty knowledge needed for novel idea generation, protecting intellectual property, developmental funding, clinical trials, regulatory pathways and industry relations.
Innovation Pass Registration includes:
** Registration for the Saturday AATS Innovation Summit
** Access to all Sunday Symposia
** Access to all simulations sessions (Monday- Wednesday)
** Exhibit Hall admission
** Lunch in the Exhibit Hall (Monday and Tuesday)
** Welcome Reception
Note: You can only attend the AATS Innovation Summit or the Saturday Skills Courses. You cannot choose to attend both events on Saturday.
Resident/Fellows and Medical Students: Can only attend the AATS Centennial by choosing the AATS Genius or Innovation Pass.
Separate registration is required for: Saturday hands-on sessions, Member for a Day session, Survival Guide for the Cardiothoracic Surgical Team, MOC Breakfast, Cardiothoracic Residents & Ethics Forum Luncheons, and all social events and tours.
Conference Flex Pass
This pass is best suited for those who want to attend some, but not all, offerings.
Customize your AATS Centennial participation by adding individual educational events to your cart — any combination of the Saturday Courses, Sunday Symposia, and Monday-Wednesday simultaneous sessions.
Saturday Courses and Sunday Symposium Registration
Register for a Saturday course and/or a Sunday symposium and receive access to all other courses/symposia taking place that day.
Note: Registration for the Saturday courses and/or Sunday symposium is separate from the Annual Meeting registration rate.
Registration & Housing information
AATS Week 2017 will bring together the world’s foremost CT surgery scientists and medical professionals for seven days at three important events:
Mitral Conclave
April 27 – 28, 2017
New York, NY
AATS Innovation Summit
April 29, 2017
Boston, MA
The AATS Centennial
April 29 – May 3
Boston, MA
Registration is now open.
Choose from one of several registration packages:
AATS Week 2017 Package
Register and receive a $100 discount*
*Discount does not apply to Residents/Fellows or Medical Students. The discount is applied to the AATS Mitral Conclave registration fee.
Genius Pass
The Genius Pass provides access to almost every offering at the AATS Centennial. The package includes:
** Access to Saturday Skills Courses and Sunday Symposia
** Access to all simulation sessions (Monday – Wednesday)
** Exhibit Hall admission
** Lunch in the Exhibit Hall (Monday & Tuesday)
** Welcome Reception
Innovation Pass
Ignite your spirit for innovation with Course Director W. Randolph Chitwood Jr. at this one-day program assisting cardiothoracic surgeons to develop new clinically applicable technology by obtaining the cross-specialty knowledge needed for novel idea generation, protecting intellectual property, developmental funding, clinical trials, regulatory pathways and industry relations.
Innovation Pass Registration includes:
** Registration for the Saturday AATS Innovation Summit
** Access to all Sunday Symposia
** Access to all simulations sessions (Monday- Wednesday)
** Exhibit Hall admission
** Lunch in the Exhibit Hall (Monday and Tuesday)
** Welcome Reception
Note: You can only attend the AATS Innovation Summit or the Saturday Skills Courses. You cannot choose to attend both events on Saturday.
Resident/Fellows and Medical Students: Can only attend the AATS Centennial by choosing the AATS Genius or Innovation Pass.
Separate registration is required for: Saturday hands-on sessions, Member for a Day session, Survival Guide for the Cardiothoracic Surgical Team, MOC Breakfast, Cardiothoracic Residents & Ethics Forum Luncheons, and all social events and tours.
Conference Flex Pass
This pass is best suited for those who want to attend some, but not all, offerings.
Customize your AATS Centennial participation by adding individual educational events to your cart — any combination of the Saturday Courses, Sunday Symposia, and Monday-Wednesday simultaneous sessions.
Saturday Courses and Sunday Symposium Registration
Register for a Saturday course and/or a Sunday symposium and receive access to all other courses/symposia taking place that day.
Note: Registration for the Saturday courses and/or Sunday symposium is separate from the Annual Meeting registration rate.
Registration & Housing information
Don’t Miss the Celebration: AATS Centennial
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery.
April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA
A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.
AATS President & Annual Meeting Chair
Thoralf M. Sundt, III
AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers
AmSECT President
Kenneth Shann
AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi
Smaller, intrapericardial LVAD noninferior to HeartMate II
A smaller, centrifugal-flow left ventricular assist device that lies entirely within the pericardial space was found noninferior to the HeartMate II axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant, according to a report published online Feb. 2 in the New England Journal of Medicine.
The two LVADs were compared in ENDURANCE (A Clinical Trial to Evaluate the HeartWare Ventricular Assist System), a prospective, randomized trial in 445 patients who were treated at 48 U.S. sites and followed for 2 years. The study participants had an LV ejection fraction of 25% or less and high prevalences of abnormal renal function and dependence on intravenous inotropic support, said Joseph G. Rogers, MD, of Duke University, Durham, N.C., and his associates.
The study participants were randomly assigned to receive the HeartWare, an investigational centrifugal-flow LVAD (297 patients) or the standard axial-flow HeartMate II LVAD (148 patients). In the intention-to-treat analysis, the primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group. The results were similar in the per-protocol and the as-treated analyses, demonstrating that the new device was noninferior but not superior to the axial-flow LVAD, the investigators said (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMoa1602954).
There were significantly more cases of device malfunction or failure requiring urgent surgery in the control group than in the centrifugal-flow group (16.2% vs 8.8%), but significantly more cases of stroke (29.7% vs 12.1%), sepsis, and right heart failure. Rates of major bleeding, cardiac arrhythmia, renal dysfunction, and infection were similar between the two study groups. Overall survival* also was not significantly different (60.2% with the new LVAD and 67.6% in the control group).
Both study groups showed significant and comparable improvement after LVAD implantation. Functional status improved to New York Heart Association class I or II in roughly 80% of patients. Mean 6-minute walk distance improved from 100.2 to 199.4 meters with the new device and from 91.9 to 190.1 meters in the control group, a change that was noted within 3 months of surgery and persisted through the end of follow-up. Similarly, mean scores on the Kansas City Cardiomyopathy Questionnaire improved by 25.8 points and 25.3 points, respectively, and mean scores on the European Quality of Life 5 Dimensions scale improved by 22.5 points and 25.5 points, respectively.
This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
*Correction 2/2/17: An earlier version of this article misidentified survival rates as mortality rates.
The smaller, fully intrapericardial, centrifugal-flow LVAD met one of its goals: Compared with the existing LVAD, it significantly reduced the need for urgent reoperation due to device malfunction or failure.
However, it did not resolve some of the most important problems with LVAD support. It didn’t reduce stroke risk; in fact, the overall risk of stroke was higher with the new device. It also failed to reduce the risk of bleeding, sepsis, or right heart failure.
It appears that no LVAD is fully superior to the others.
Roland Hetzer, MD, PhD, and Eva M. Delmo Walter, MD, PhD, of Cardio Centrum in Berlin, made these remarks in an accompanying editorial (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMe1613755). They reported having no relevant financial disclosures.
The smaller, fully intrapericardial, centrifugal-flow LVAD met one of its goals: Compared with the existing LVAD, it significantly reduced the need for urgent reoperation due to device malfunction or failure.
However, it did not resolve some of the most important problems with LVAD support. It didn’t reduce stroke risk; in fact, the overall risk of stroke was higher with the new device. It also failed to reduce the risk of bleeding, sepsis, or right heart failure.
It appears that no LVAD is fully superior to the others.
Roland Hetzer, MD, PhD, and Eva M. Delmo Walter, MD, PhD, of Cardio Centrum in Berlin, made these remarks in an accompanying editorial (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMe1613755). They reported having no relevant financial disclosures.
The smaller, fully intrapericardial, centrifugal-flow LVAD met one of its goals: Compared with the existing LVAD, it significantly reduced the need for urgent reoperation due to device malfunction or failure.
However, it did not resolve some of the most important problems with LVAD support. It didn’t reduce stroke risk; in fact, the overall risk of stroke was higher with the new device. It also failed to reduce the risk of bleeding, sepsis, or right heart failure.
It appears that no LVAD is fully superior to the others.
Roland Hetzer, MD, PhD, and Eva M. Delmo Walter, MD, PhD, of Cardio Centrum in Berlin, made these remarks in an accompanying editorial (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMe1613755). They reported having no relevant financial disclosures.
A smaller, centrifugal-flow left ventricular assist device that lies entirely within the pericardial space was found noninferior to the HeartMate II axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant, according to a report published online Feb. 2 in the New England Journal of Medicine.
The two LVADs were compared in ENDURANCE (A Clinical Trial to Evaluate the HeartWare Ventricular Assist System), a prospective, randomized trial in 445 patients who were treated at 48 U.S. sites and followed for 2 years. The study participants had an LV ejection fraction of 25% or less and high prevalences of abnormal renal function and dependence on intravenous inotropic support, said Joseph G. Rogers, MD, of Duke University, Durham, N.C., and his associates.
The study participants were randomly assigned to receive the HeartWare, an investigational centrifugal-flow LVAD (297 patients) or the standard axial-flow HeartMate II LVAD (148 patients). In the intention-to-treat analysis, the primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group. The results were similar in the per-protocol and the as-treated analyses, demonstrating that the new device was noninferior but not superior to the axial-flow LVAD, the investigators said (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMoa1602954).
There were significantly more cases of device malfunction or failure requiring urgent surgery in the control group than in the centrifugal-flow group (16.2% vs 8.8%), but significantly more cases of stroke (29.7% vs 12.1%), sepsis, and right heart failure. Rates of major bleeding, cardiac arrhythmia, renal dysfunction, and infection were similar between the two study groups. Overall survival* also was not significantly different (60.2% with the new LVAD and 67.6% in the control group).
Both study groups showed significant and comparable improvement after LVAD implantation. Functional status improved to New York Heart Association class I or II in roughly 80% of patients. Mean 6-minute walk distance improved from 100.2 to 199.4 meters with the new device and from 91.9 to 190.1 meters in the control group, a change that was noted within 3 months of surgery and persisted through the end of follow-up. Similarly, mean scores on the Kansas City Cardiomyopathy Questionnaire improved by 25.8 points and 25.3 points, respectively, and mean scores on the European Quality of Life 5 Dimensions scale improved by 22.5 points and 25.5 points, respectively.
This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
*Correction 2/2/17: An earlier version of this article misidentified survival rates as mortality rates.
A smaller, centrifugal-flow left ventricular assist device that lies entirely within the pericardial space was found noninferior to the HeartMate II axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant, according to a report published online Feb. 2 in the New England Journal of Medicine.
The two LVADs were compared in ENDURANCE (A Clinical Trial to Evaluate the HeartWare Ventricular Assist System), a prospective, randomized trial in 445 patients who were treated at 48 U.S. sites and followed for 2 years. The study participants had an LV ejection fraction of 25% or less and high prevalences of abnormal renal function and dependence on intravenous inotropic support, said Joseph G. Rogers, MD, of Duke University, Durham, N.C., and his associates.
The study participants were randomly assigned to receive the HeartWare, an investigational centrifugal-flow LVAD (297 patients) or the standard axial-flow HeartMate II LVAD (148 patients). In the intention-to-treat analysis, the primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group. The results were similar in the per-protocol and the as-treated analyses, demonstrating that the new device was noninferior but not superior to the axial-flow LVAD, the investigators said (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMoa1602954).
There were significantly more cases of device malfunction or failure requiring urgent surgery in the control group than in the centrifugal-flow group (16.2% vs 8.8%), but significantly more cases of stroke (29.7% vs 12.1%), sepsis, and right heart failure. Rates of major bleeding, cardiac arrhythmia, renal dysfunction, and infection were similar between the two study groups. Overall survival* also was not significantly different (60.2% with the new LVAD and 67.6% in the control group).
Both study groups showed significant and comparable improvement after LVAD implantation. Functional status improved to New York Heart Association class I or II in roughly 80% of patients. Mean 6-minute walk distance improved from 100.2 to 199.4 meters with the new device and from 91.9 to 190.1 meters in the control group, a change that was noted within 3 months of surgery and persisted through the end of follow-up. Similarly, mean scores on the Kansas City Cardiomyopathy Questionnaire improved by 25.8 points and 25.3 points, respectively, and mean scores on the European Quality of Life 5 Dimensions scale improved by 22.5 points and 25.5 points, respectively.
This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
*Correction 2/2/17: An earlier version of this article misidentified survival rates as mortality rates.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: A smaller, centrifugal-flow left ventricular assist device was found noninferior to the existing FDA-approved axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant.
Major finding: The primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group.
Data source: ENDURANCE, a prospective multicenter randomized trial in 445 patients followed for 2 years.
Disclosures: This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
SAVR an option for elderly with aortic stenosis
HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.
“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.
The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).
Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.
The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.
Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.
The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.
The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)
Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.
“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”
Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediaterisk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med. 
This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediaterisk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med.
This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediaterisk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med.
HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.
“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.
The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).
Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.
The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.
Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.
The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.
The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)
Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.
“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”
Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.
“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.
The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).
Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.
The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.
Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.
The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.
The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)
Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.
“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”
Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: All-cause operative mortality was 4.1%, which is lower than STS predicted risk models.
Data source: A study of 937 medium-risk patients with aortic stenosis who were randomized to SAVR in the PARTNER 2A trial.
Disclosures: Dr. Thourani is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
Trump nominates Neil Gorsuch as 9th Supreme Court justice
President Donald Trump has chosen Neil Gorsuch, a conservative judge who presides over Denver’s 10th Circuit as his nominee for U.S. Supreme Court justice. A federal judge for 10 years, Judge Gorsuch is a long-time comrade of deceased Supreme Court Justice Antonin Scalia with a strong record of supporting religious freedom and less government control.
At a White House East Room ceremony on Jan. 31, Judge Gorsuch said he was honored and humbled by President’s Trump’s nomination and that he looked forward to answering questions during his Senate nomination hearing.
President Trump hailed Judge Gorsuch’s credentials as the “best he has ever seen,” and called him more than qualified to take the reins as the next Supreme Court justice.
“He has an extraordinary resume, as good as it gets,” President Trump said. “The qualifications of Judge Gorsuch are beyond dispute. He is a man of our country and a man who our country needs – and needs badly – to uphold the rule of law and the rule of justice.”
Judge Gorsuch, 49,was appointed to the 10th U.S. Circuit Court of Appeals in Denver, by President George W. Bush. His nomination was confirmed unanimously in the Senate. He holds a doctoral degree from Oxford University, (England), a law degree from Harvard Law School, Cambridge, Mass., and an undergraduate degree from Columbia University, New York. Judge Gorsuch began his legal career as a law clerk to Supreme Court justices Byron R. White and Anthony M. Kennedy, as well as to Judge David B. Sentelle of the U.S. Court of Appeals for the D.C. Circuit. Prior to his judicial appointment, Judge Gorsuch served as principal deputy associate attorney general at the Justice Department under George W. Bush.
A Senate confirmation hearing had not been announced at press time. Judge Gorsuch has pledged to work with both parties during the hearing to answer questions and alleviate any concerns.
“I look forward to speaking with members from both sides of the aisle,” he said. “I consider the United States Senate the greatest deliberative body in the world, and I respect the important role the Constitution affords it in the confirmation of our judges.”
Justice Antonin Scalia died suddenly on Feb. 13, 2016, leaving the high court with only eight members. Then-President Barack Obama nominated Judge Merrick Garland of the U.S. Court of Appeals for the District of Columbia Circuit to fill Scalia’s seat. However, the Republican-controlled Senate blocked Judge Garland from ever having a hearing and his nomination was never fully considered.
[email protected]
On Twitter @legal_med
President Donald Trump has chosen Neil Gorsuch, a conservative judge who presides over Denver’s 10th Circuit as his nominee for U.S. Supreme Court justice. A federal judge for 10 years, Judge Gorsuch is a long-time comrade of deceased Supreme Court Justice Antonin Scalia with a strong record of supporting religious freedom and less government control.
At a White House East Room ceremony on Jan. 31, Judge Gorsuch said he was honored and humbled by President’s Trump’s nomination and that he looked forward to answering questions during his Senate nomination hearing.
President Trump hailed Judge Gorsuch’s credentials as the “best he has ever seen,” and called him more than qualified to take the reins as the next Supreme Court justice.
“He has an extraordinary resume, as good as it gets,” President Trump said. “The qualifications of Judge Gorsuch are beyond dispute. He is a man of our country and a man who our country needs – and needs badly – to uphold the rule of law and the rule of justice.”
Judge Gorsuch, 49,was appointed to the 10th U.S. Circuit Court of Appeals in Denver, by President George W. Bush. His nomination was confirmed unanimously in the Senate. He holds a doctoral degree from Oxford University, (England), a law degree from Harvard Law School, Cambridge, Mass., and an undergraduate degree from Columbia University, New York. Judge Gorsuch began his legal career as a law clerk to Supreme Court justices Byron R. White and Anthony M. Kennedy, as well as to Judge David B. Sentelle of the U.S. Court of Appeals for the D.C. Circuit. Prior to his judicial appointment, Judge Gorsuch served as principal deputy associate attorney general at the Justice Department under George W. Bush.
A Senate confirmation hearing had not been announced at press time. Judge Gorsuch has pledged to work with both parties during the hearing to answer questions and alleviate any concerns.
“I look forward to speaking with members from both sides of the aisle,” he said. “I consider the United States Senate the greatest deliberative body in the world, and I respect the important role the Constitution affords it in the confirmation of our judges.”
Justice Antonin Scalia died suddenly on Feb. 13, 2016, leaving the high court with only eight members. Then-President Barack Obama nominated Judge Merrick Garland of the U.S. Court of Appeals for the District of Columbia Circuit to fill Scalia’s seat. However, the Republican-controlled Senate blocked Judge Garland from ever having a hearing and his nomination was never fully considered.
[email protected]
On Twitter @legal_med
President Donald Trump has chosen Neil Gorsuch, a conservative judge who presides over Denver’s 10th Circuit as his nominee for U.S. Supreme Court justice. A federal judge for 10 years, Judge Gorsuch is a long-time comrade of deceased Supreme Court Justice Antonin Scalia with a strong record of supporting religious freedom and less government control.
At a White House East Room ceremony on Jan. 31, Judge Gorsuch said he was honored and humbled by President’s Trump’s nomination and that he looked forward to answering questions during his Senate nomination hearing.
President Trump hailed Judge Gorsuch’s credentials as the “best he has ever seen,” and called him more than qualified to take the reins as the next Supreme Court justice.
“He has an extraordinary resume, as good as it gets,” President Trump said. “The qualifications of Judge Gorsuch are beyond dispute. He is a man of our country and a man who our country needs – and needs badly – to uphold the rule of law and the rule of justice.”
Judge Gorsuch, 49,was appointed to the 10th U.S. Circuit Court of Appeals in Denver, by President George W. Bush. His nomination was confirmed unanimously in the Senate. He holds a doctoral degree from Oxford University, (England), a law degree from Harvard Law School, Cambridge, Mass., and an undergraduate degree from Columbia University, New York. Judge Gorsuch began his legal career as a law clerk to Supreme Court justices Byron R. White and Anthony M. Kennedy, as well as to Judge David B. Sentelle of the U.S. Court of Appeals for the D.C. Circuit. Prior to his judicial appointment, Judge Gorsuch served as principal deputy associate attorney general at the Justice Department under George W. Bush.
A Senate confirmation hearing had not been announced at press time. Judge Gorsuch has pledged to work with both parties during the hearing to answer questions and alleviate any concerns.
“I look forward to speaking with members from both sides of the aisle,” he said. “I consider the United States Senate the greatest deliberative body in the world, and I respect the important role the Constitution affords it in the confirmation of our judges.”
Justice Antonin Scalia died suddenly on Feb. 13, 2016, leaving the high court with only eight members. Then-President Barack Obama nominated Judge Merrick Garland of the U.S. Court of Appeals for the District of Columbia Circuit to fill Scalia’s seat. However, the Republican-controlled Senate blocked Judge Garland from ever having a hearing and his nomination was never fully considered.
[email protected]
On Twitter @legal_med
Lung cancer screening a challenge to implement
A comprehensive lung cancer screening program carried out at Veterans Health Administration hospitals was taxing to implement and revealed a large number of patients with results requiring follow-up, though only 1.5% had cancers.
Investigators at eight VHA hospitals, led by Linda S. Kinsinger, MD, of the VHA’s National Center for Health Promotion and Disease Prevention in Durham, N.C., looked at records from about 93,000 primary care patients and identified 4,246 eligible for screening, based on age, medical history, and smoking history (JAMA Intern Med. 2017 Jan 30. doi: 10.1001/jamainternmed.2016.9022).
Approximately 58% of the eligible patients consented, and 2,106 underwent screening with low-dose computed tomography (LDCT). The mean age of patients was 65 years, and 96% of patients were male.
Nearly 60% of patients screened (1,257) had nodules, 1,184 patients (56.2%) required tracking, and 31 patients (1.5%) had lung cancer.
The pilot study was developed in response to a 2013 recommendation from the U.S. Preventive Services Task Force favoring annual screening with LDCT in current or former heavy smokers between 55 and 80 years old.
The recommendation sparked concerns about the practicability of implementing large-scale lung cancer screening, which Dr. Kinsinger and her colleagues’ study seemed to underscore. For example, “creating electronic tools to capture the necessary clinical data in real time … proved to be difficult, even with the VHA’s highly regarded electronic medical record,” the investigators wrote. A key measure used in the screening program – cigarette pack-years – was “not fully captured” in the system’s EMR.
The investigators also noted that if the eligibility criteria used in the pilot program were applied to the VHA nationwide, about 900,000 patients would be eligible for LDCT screening, and that fewer than 60% of patients in this study had consented. That meant that “accurately identifying these patients and discussing with them the benefits and harms of [screening] will take significant effort for primary care teams,” the researchers noted.
In addition, the required follow-up “may stress the capacity” of radiology and pulmonology services, the study authors cautioned.
Finally, “primary care will need to be involved in deciding which incidental findings need further evaluation,” they wrote. “These clinical efforts will require coordination and communication among clinical services and between patients and staff, and dedicated coordinators will need to be hired.”
The investigators noted that their findings might not be generalizable to non-VHA health care systems. The experience of the VHA, “owing to its central organizational structure, may represent a best-case scenario,” they wrote.
The Veterans Health Administration funded the study. Two of its coauthors reported commercial conflicts of interest; one of those disclosed a grant application to the Bristol-Myers Squibb Foundation related to lung cancer screening.
A comprehensive lung cancer screening program carried out at Veterans Health Administration hospitals was taxing to implement and revealed a large number of patients with results requiring follow-up, though only 1.5% had cancers.
Investigators at eight VHA hospitals, led by Linda S. Kinsinger, MD, of the VHA’s National Center for Health Promotion and Disease Prevention in Durham, N.C., looked at records from about 93,000 primary care patients and identified 4,246 eligible for screening, based on age, medical history, and smoking history (JAMA Intern Med. 2017 Jan 30. doi: 10.1001/jamainternmed.2016.9022).
Approximately 58% of the eligible patients consented, and 2,106 underwent screening with low-dose computed tomography (LDCT). The mean age of patients was 65 years, and 96% of patients were male.
Nearly 60% of patients screened (1,257) had nodules, 1,184 patients (56.2%) required tracking, and 31 patients (1.5%) had lung cancer.
The pilot study was developed in response to a 2013 recommendation from the U.S. Preventive Services Task Force favoring annual screening with LDCT in current or former heavy smokers between 55 and 80 years old.
The recommendation sparked concerns about the practicability of implementing large-scale lung cancer screening, which Dr. Kinsinger and her colleagues’ study seemed to underscore. For example, “creating electronic tools to capture the necessary clinical data in real time … proved to be difficult, even with the VHA’s highly regarded electronic medical record,” the investigators wrote. A key measure used in the screening program – cigarette pack-years – was “not fully captured” in the system’s EMR.
The investigators also noted that if the eligibility criteria used in the pilot program were applied to the VHA nationwide, about 900,000 patients would be eligible for LDCT screening, and that fewer than 60% of patients in this study had consented. That meant that “accurately identifying these patients and discussing with them the benefits and harms of [screening] will take significant effort for primary care teams,” the researchers noted.
In addition, the required follow-up “may stress the capacity” of radiology and pulmonology services, the study authors cautioned.
Finally, “primary care will need to be involved in deciding which incidental findings need further evaluation,” they wrote. “These clinical efforts will require coordination and communication among clinical services and between patients and staff, and dedicated coordinators will need to be hired.”
The investigators noted that their findings might not be generalizable to non-VHA health care systems. The experience of the VHA, “owing to its central organizational structure, may represent a best-case scenario,” they wrote.
The Veterans Health Administration funded the study. Two of its coauthors reported commercial conflicts of interest; one of those disclosed a grant application to the Bristol-Myers Squibb Foundation related to lung cancer screening.
A comprehensive lung cancer screening program carried out at Veterans Health Administration hospitals was taxing to implement and revealed a large number of patients with results requiring follow-up, though only 1.5% had cancers.
Investigators at eight VHA hospitals, led by Linda S. Kinsinger, MD, of the VHA’s National Center for Health Promotion and Disease Prevention in Durham, N.C., looked at records from about 93,000 primary care patients and identified 4,246 eligible for screening, based on age, medical history, and smoking history (JAMA Intern Med. 2017 Jan 30. doi: 10.1001/jamainternmed.2016.9022).
Approximately 58% of the eligible patients consented, and 2,106 underwent screening with low-dose computed tomography (LDCT). The mean age of patients was 65 years, and 96% of patients were male.
Nearly 60% of patients screened (1,257) had nodules, 1,184 patients (56.2%) required tracking, and 31 patients (1.5%) had lung cancer.
The pilot study was developed in response to a 2013 recommendation from the U.S. Preventive Services Task Force favoring annual screening with LDCT in current or former heavy smokers between 55 and 80 years old.
The recommendation sparked concerns about the practicability of implementing large-scale lung cancer screening, which Dr. Kinsinger and her colleagues’ study seemed to underscore. For example, “creating electronic tools to capture the necessary clinical data in real time … proved to be difficult, even with the VHA’s highly regarded electronic medical record,” the investigators wrote. A key measure used in the screening program – cigarette pack-years – was “not fully captured” in the system’s EMR.
The investigators also noted that if the eligibility criteria used in the pilot program were applied to the VHA nationwide, about 900,000 patients would be eligible for LDCT screening, and that fewer than 60% of patients in this study had consented. That meant that “accurately identifying these patients and discussing with them the benefits and harms of [screening] will take significant effort for primary care teams,” the researchers noted.
In addition, the required follow-up “may stress the capacity” of radiology and pulmonology services, the study authors cautioned.
Finally, “primary care will need to be involved in deciding which incidental findings need further evaluation,” they wrote. “These clinical efforts will require coordination and communication among clinical services and between patients and staff, and dedicated coordinators will need to be hired.”
The investigators noted that their findings might not be generalizable to non-VHA health care systems. The experience of the VHA, “owing to its central organizational structure, may represent a best-case scenario,” they wrote.
The Veterans Health Administration funded the study. Two of its coauthors reported commercial conflicts of interest; one of those disclosed a grant application to the Bristol-Myers Squibb Foundation related to lung cancer screening.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Comprehensive lung cancer screening is complex to implement in hospital primary care settings and may trigger resource-intensive follow-up.
Major finding: Of more than 2,000 patients screened, nearly 60% were positive for nodules, though only 1.5% had cancer.
Data source: A pilot study in 4,246 eligible primary care patients at eight Veterans Health Administration hospitals; 2,106 were screened using low-dose computed tomography.
Disclosures: The Veterans Health Administration funded the study. Two of its coauthors reported commercial conflicts of interest; one of those disclosed a grant application to the Bristol-Myers Squibb Foundation related to lung cancer screening.
STICHES boosts CABG role in severe LV dysfunction
SNOWMASS, COLO. – Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.
Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.
He went on to describe how he applies the key study findings to individual patients.
At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.
For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.
CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).
There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.
“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.
In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).
More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).
“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”
One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.
These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.
“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.
Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.
“I think that’s something we don’t think about enough, quite honestly,” he said.
Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.
SNOWMASS, COLO. – Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.
Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.
He went on to describe how he applies the key study findings to individual patients.
At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.
For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.
CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).
There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.
“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.
In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).
More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).
“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”
One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.
These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.
“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.
Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.
“I think that’s something we don’t think about enough, quite honestly,” he said.
Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.
SNOWMASS, COLO. – Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.
Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.
He went on to describe how he applies the key study findings to individual patients.
At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.
For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.
CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).
There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.
“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.
In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).
More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).
“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”
One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.
These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.
“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.
Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.
“I think that’s something we don’t think about enough, quite honestly,” he said.
Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.
EXPERT ANALYSIS AT THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
