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Video: SHM provides resources and community for practice administrators
ORLANDO – In a video interview, Ms. Tiffani Panek, SFHM, CLHM, who is the division manager of administration at the Johns Hopkins Bayview Medical Center, Baltimore, discussed the scope of SHM resources available for practice administrators.
She details how there are “an incredible number of resources for practice administrators that are available from SHM,” and she recommends the SHM website’s practice administrator’s page, with helpful links, including to their mentorship program. She describes how, just this year, “we are launching a podcast series called ‘The Leadership Launchpad Essentials.’ ”
In addition: “We [also] have our own HMX [Hospital Medicine Exchange] community, and I would say of any resource the practice administrator should access on a regular basis, that would be the one.” That’s the place that practice managers can go to network with their community, according to Ms. Panek.
ORLANDO – In a video interview, Ms. Tiffani Panek, SFHM, CLHM, who is the division manager of administration at the Johns Hopkins Bayview Medical Center, Baltimore, discussed the scope of SHM resources available for practice administrators.
She details how there are “an incredible number of resources for practice administrators that are available from SHM,” and she recommends the SHM website’s practice administrator’s page, with helpful links, including to their mentorship program. She describes how, just this year, “we are launching a podcast series called ‘The Leadership Launchpad Essentials.’ ”
In addition: “We [also] have our own HMX [Hospital Medicine Exchange] community, and I would say of any resource the practice administrator should access on a regular basis, that would be the one.” That’s the place that practice managers can go to network with their community, according to Ms. Panek.
ORLANDO – In a video interview, Ms. Tiffani Panek, SFHM, CLHM, who is the division manager of administration at the Johns Hopkins Bayview Medical Center, Baltimore, discussed the scope of SHM resources available for practice administrators.
She details how there are “an incredible number of resources for practice administrators that are available from SHM,” and she recommends the SHM website’s practice administrator’s page, with helpful links, including to their mentorship program. She describes how, just this year, “we are launching a podcast series called ‘The Leadership Launchpad Essentials.’ ”
In addition: “We [also] have our own HMX [Hospital Medicine Exchange] community, and I would say of any resource the practice administrator should access on a regular basis, that would be the one.” That’s the place that practice managers can go to network with their community, according to Ms. Panek.
REPORTING FROM HM18
Video: The SHM Physicians in Training Committee – increasing the hospitalist pipeline
ORLANDO – In a video interview, Brian Kwan, MD, SFHM, of the University of California, San Diego, discusses the role of the SHM Physicians in Training Committee in “increasing the hospitalist pipeline.”
In discussing the work of the committee, Dr. Kwan describes how “a lot of our initiatives really focus on the training and development and basically nurturing them from becoming students to residents to early-career hospitalists.”
Two of the key programs he discusses are the Student Scholarship Program and the “new-this-year” Resident Travel Grant, among other initiatives that the committee is exploring.
ORLANDO – In a video interview, Brian Kwan, MD, SFHM, of the University of California, San Diego, discusses the role of the SHM Physicians in Training Committee in “increasing the hospitalist pipeline.”
In discussing the work of the committee, Dr. Kwan describes how “a lot of our initiatives really focus on the training and development and basically nurturing them from becoming students to residents to early-career hospitalists.”
Two of the key programs he discusses are the Student Scholarship Program and the “new-this-year” Resident Travel Grant, among other initiatives that the committee is exploring.
ORLANDO – In a video interview, Brian Kwan, MD, SFHM, of the University of California, San Diego, discusses the role of the SHM Physicians in Training Committee in “increasing the hospitalist pipeline.”
In discussing the work of the committee, Dr. Kwan describes how “a lot of our initiatives really focus on the training and development and basically nurturing them from becoming students to residents to early-career hospitalists.”
Two of the key programs he discusses are the Student Scholarship Program and the “new-this-year” Resident Travel Grant, among other initiatives that the committee is exploring.
REPORTING FROM HOSPITAL MEDICINE 2018
Video : The SHM Research Committee: Expanding the role and footprint of research in hospital medicine
ORLANDO – In a video interview, Stephanie Mueller, MD, SFHM, of Brigham and Women’s Hospital, Boston, discusses the scope and importance of the SHM Research Committee.
One of its most important roles is overseeing the yearly Scientific Abstract and Poster Competition, known as the Research, Innovations and Clinical Vignettes (RIV) portion of the annual conference, which brings the best of current research in hospital medicine, especially in the increasingly important area of value in patient care, to the members.
In discussing the work of the committee, Dr. Mueller – who is in her third year as a member – adds that they “are working to expand the research footprint within the Society of Hospital Medicine,” including implementing initiatives such as the VIP program, which is a visiting professorship in which junior and mid-level faculty can do an exchange program between institutions.
ORLANDO – In a video interview, Stephanie Mueller, MD, SFHM, of Brigham and Women’s Hospital, Boston, discusses the scope and importance of the SHM Research Committee.
One of its most important roles is overseeing the yearly Scientific Abstract and Poster Competition, known as the Research, Innovations and Clinical Vignettes (RIV) portion of the annual conference, which brings the best of current research in hospital medicine, especially in the increasingly important area of value in patient care, to the members.
In discussing the work of the committee, Dr. Mueller – who is in her third year as a member – adds that they “are working to expand the research footprint within the Society of Hospital Medicine,” including implementing initiatives such as the VIP program, which is a visiting professorship in which junior and mid-level faculty can do an exchange program between institutions.
ORLANDO – In a video interview, Stephanie Mueller, MD, SFHM, of Brigham and Women’s Hospital, Boston, discusses the scope and importance of the SHM Research Committee.
One of its most important roles is overseeing the yearly Scientific Abstract and Poster Competition, known as the Research, Innovations and Clinical Vignettes (RIV) portion of the annual conference, which brings the best of current research in hospital medicine, especially in the increasingly important area of value in patient care, to the members.
In discussing the work of the committee, Dr. Mueller – who is in her third year as a member – adds that they “are working to expand the research footprint within the Society of Hospital Medicine,” including implementing initiatives such as the VIP program, which is a visiting professorship in which junior and mid-level faculty can do an exchange program between institutions.
REPORTING FROM HOSPITAL MEDICINE 2018
Video: SHM President Nasim Afsar seeks an “unrelenting focus on delivering value”
ORLANDO – In a video interview, Nasim Afsar, MD, SFHM, details the career road that led her to the “tremendous honor” of becoming president of the Society of Hospital Medicine.
Having been on the board of directors for 6 years was a profound experience, according to Dr. Afsar, and now as president she looks to take what she has learned and focus on the future of the field.
When asked about her overall vision for the coming year for the Society, Dr. Afsar said that she is committed to “an unrelenting focus on delivering value to our patients, our institutions, and society, and the way we do that is through population health management.”
ORLANDO – In a video interview, Nasim Afsar, MD, SFHM, details the career road that led her to the “tremendous honor” of becoming president of the Society of Hospital Medicine.
Having been on the board of directors for 6 years was a profound experience, according to Dr. Afsar, and now as president she looks to take what she has learned and focus on the future of the field.
When asked about her overall vision for the coming year for the Society, Dr. Afsar said that she is committed to “an unrelenting focus on delivering value to our patients, our institutions, and society, and the way we do that is through population health management.”
ORLANDO – In a video interview, Nasim Afsar, MD, SFHM, details the career road that led her to the “tremendous honor” of becoming president of the Society of Hospital Medicine.
Having been on the board of directors for 6 years was a profound experience, according to Dr. Afsar, and now as president she looks to take what she has learned and focus on the future of the field.
When asked about her overall vision for the coming year for the Society, Dr. Afsar said that she is committed to “an unrelenting focus on delivering value to our patients, our institutions, and society, and the way we do that is through population health management.”
REPORTING FROM HOSPITAL MEDICINE 2018
FDA Panel Narrowly Votes Down AbioCor Artificial Heart
GAITHERSBURG, MD. — The AbioCor total artificial heart did not meet the Food and Drug Administration's humanitarian-device exemption requirements, according to the FDA's Circulatory Systems Devices Panel. The vote was 7–6 against, with one abstention.
The committee determined that the device maker Abiomed's submission under the humanitarian-device exemption standards was inadequate. Concerns were based on undefined anticoagulation treatment protocols and the lack of quality of life data. The panel stressed the need for more extensive studies demonstrating the device's safety.
The AbioCor Implantable Replacement Heart is the first fully implantable artificial heart for severe end-stage heart failure patients who are younger than 75 years, not transplant candidates at the time of assessment, and in biventricular failure not treatable by a destination-therapy left ventricular-assist device. The device is designated as a last resort for a small patient population with a poor prognosis of survival within 30 days.
Abiomed submitted data from a clinical trial spanning slightly more than 3 years, from 2001 through 2004. The device was implanted into a total of 14 patients. The trial was initially designed to assess patient survival at 2 months.
Two patients died during implantation, and two others died before the 60-day end point. Three of the patients who survived more than 60 days had strokes prior to 60 days. A device failed in one patient at 5 months, and in another patient, the device wore out expectedly at 17 months. (The average runtime during bench tests was 18.8 months.) Complications included postoperative bleeding requiring reoperation and neurologic events.
Two patients improved enough to be discharged from the hospital—one to the patient's home and the other to a hotel near the hospital.
Although a humanitarian-device exemption is similar in both form and content to an FDA premarket approval application, requiring reasonable assurance of safety and probable benefit, it is exempt from the effectiveness requirements of a premarket approval. The sponsor's representatives stressed this distinction during their presentations to the panel and emphasized the groundbreaking nature of the technology. The FDA's presentation to the panel offered a somewhat mixed evaluation of the device. Biomedical engineer Eric Chen, the FDA's lead reviewer, asserted that the device met the humanitarian device exemption's requisite standards for biocompatibility, electrical safety, and manufacturing, but he said there are still concerns about reliability. Julie Swain, M.D., leading the FDA's clinical review team, said “This device is a real dilemma.” She asserted that the relationship between risk and benefit was very difficult to ascertain, “due to a lack of validated quality of life and functional data.”
Discussion among panel members echoed the uncertainties of the FDA review team. Joanne Lindenfeld, M.D., director of heart transplantation at the University of Colorado, Denver, said, “Safety is the biggest concern here. We see enormous [incidence of] death due to stroke.” Dr. Lindenfeld said that she could not support the device because she was “unconvinced that we've settled the issue of bleeding and stroke.” Thomas B. Ferguson, M.D., of Washington University, St. Louis, spoke to concerns about anticoagulation, telling the sponsor's representatives that he would “like to be reassured that you are totally convinced that … all has been done to minimize the device as a clot producer.”
The FDA usually follows the recommendations of its advisory panels but is under no statutory obligation to do so.
GAITHERSBURG, MD. — The AbioCor total artificial heart did not meet the Food and Drug Administration's humanitarian-device exemption requirements, according to the FDA's Circulatory Systems Devices Panel. The vote was 7–6 against, with one abstention.
The committee determined that the device maker Abiomed's submission under the humanitarian-device exemption standards was inadequate. Concerns were based on undefined anticoagulation treatment protocols and the lack of quality of life data. The panel stressed the need for more extensive studies demonstrating the device's safety.
The AbioCor Implantable Replacement Heart is the first fully implantable artificial heart for severe end-stage heart failure patients who are younger than 75 years, not transplant candidates at the time of assessment, and in biventricular failure not treatable by a destination-therapy left ventricular-assist device. The device is designated as a last resort for a small patient population with a poor prognosis of survival within 30 days.
Abiomed submitted data from a clinical trial spanning slightly more than 3 years, from 2001 through 2004. The device was implanted into a total of 14 patients. The trial was initially designed to assess patient survival at 2 months.
Two patients died during implantation, and two others died before the 60-day end point. Three of the patients who survived more than 60 days had strokes prior to 60 days. A device failed in one patient at 5 months, and in another patient, the device wore out expectedly at 17 months. (The average runtime during bench tests was 18.8 months.) Complications included postoperative bleeding requiring reoperation and neurologic events.
Two patients improved enough to be discharged from the hospital—one to the patient's home and the other to a hotel near the hospital.
Although a humanitarian-device exemption is similar in both form and content to an FDA premarket approval application, requiring reasonable assurance of safety and probable benefit, it is exempt from the effectiveness requirements of a premarket approval. The sponsor's representatives stressed this distinction during their presentations to the panel and emphasized the groundbreaking nature of the technology. The FDA's presentation to the panel offered a somewhat mixed evaluation of the device. Biomedical engineer Eric Chen, the FDA's lead reviewer, asserted that the device met the humanitarian device exemption's requisite standards for biocompatibility, electrical safety, and manufacturing, but he said there are still concerns about reliability. Julie Swain, M.D., leading the FDA's clinical review team, said “This device is a real dilemma.” She asserted that the relationship between risk and benefit was very difficult to ascertain, “due to a lack of validated quality of life and functional data.”
Discussion among panel members echoed the uncertainties of the FDA review team. Joanne Lindenfeld, M.D., director of heart transplantation at the University of Colorado, Denver, said, “Safety is the biggest concern here. We see enormous [incidence of] death due to stroke.” Dr. Lindenfeld said that she could not support the device because she was “unconvinced that we've settled the issue of bleeding and stroke.” Thomas B. Ferguson, M.D., of Washington University, St. Louis, spoke to concerns about anticoagulation, telling the sponsor's representatives that he would “like to be reassured that you are totally convinced that … all has been done to minimize the device as a clot producer.”
The FDA usually follows the recommendations of its advisory panels but is under no statutory obligation to do so.
GAITHERSBURG, MD. — The AbioCor total artificial heart did not meet the Food and Drug Administration's humanitarian-device exemption requirements, according to the FDA's Circulatory Systems Devices Panel. The vote was 7–6 against, with one abstention.
The committee determined that the device maker Abiomed's submission under the humanitarian-device exemption standards was inadequate. Concerns were based on undefined anticoagulation treatment protocols and the lack of quality of life data. The panel stressed the need for more extensive studies demonstrating the device's safety.
The AbioCor Implantable Replacement Heart is the first fully implantable artificial heart for severe end-stage heart failure patients who are younger than 75 years, not transplant candidates at the time of assessment, and in biventricular failure not treatable by a destination-therapy left ventricular-assist device. The device is designated as a last resort for a small patient population with a poor prognosis of survival within 30 days.
Abiomed submitted data from a clinical trial spanning slightly more than 3 years, from 2001 through 2004. The device was implanted into a total of 14 patients. The trial was initially designed to assess patient survival at 2 months.
Two patients died during implantation, and two others died before the 60-day end point. Three of the patients who survived more than 60 days had strokes prior to 60 days. A device failed in one patient at 5 months, and in another patient, the device wore out expectedly at 17 months. (The average runtime during bench tests was 18.8 months.) Complications included postoperative bleeding requiring reoperation and neurologic events.
Two patients improved enough to be discharged from the hospital—one to the patient's home and the other to a hotel near the hospital.
Although a humanitarian-device exemption is similar in both form and content to an FDA premarket approval application, requiring reasonable assurance of safety and probable benefit, it is exempt from the effectiveness requirements of a premarket approval. The sponsor's representatives stressed this distinction during their presentations to the panel and emphasized the groundbreaking nature of the technology. The FDA's presentation to the panel offered a somewhat mixed evaluation of the device. Biomedical engineer Eric Chen, the FDA's lead reviewer, asserted that the device met the humanitarian device exemption's requisite standards for biocompatibility, electrical safety, and manufacturing, but he said there are still concerns about reliability. Julie Swain, M.D., leading the FDA's clinical review team, said “This device is a real dilemma.” She asserted that the relationship between risk and benefit was very difficult to ascertain, “due to a lack of validated quality of life and functional data.”
Discussion among panel members echoed the uncertainties of the FDA review team. Joanne Lindenfeld, M.D., director of heart transplantation at the University of Colorado, Denver, said, “Safety is the biggest concern here. We see enormous [incidence of] death due to stroke.” Dr. Lindenfeld said that she could not support the device because she was “unconvinced that we've settled the issue of bleeding and stroke.” Thomas B. Ferguson, M.D., of Washington University, St. Louis, spoke to concerns about anticoagulation, telling the sponsor's representatives that he would “like to be reassured that you are totally convinced that … all has been done to minimize the device as a clot producer.”
The FDA usually follows the recommendations of its advisory panels but is under no statutory obligation to do so.
FDA Panel Cites Missing Key Data, Nixes Mesh Cardiac Support Device
GAITHERSBURG, MD. — By a vote of 9–4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end-point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures.
Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement.
The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) or medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification.
Of patients who were treated with CorCap, 38% improved, compared with 27% of control patients.
Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group.
A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data.
FDA consultant Ileana L. Pina, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.
GAITHERSBURG, MD. — By a vote of 9–4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end-point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures.
Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement.
The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) or medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification.
Of patients who were treated with CorCap, 38% improved, compared with 27% of control patients.
Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group.
A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data.
FDA consultant Ileana L. Pina, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.
GAITHERSBURG, MD. — By a vote of 9–4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end-point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures.
Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement.
The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) or medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification.
Of patients who were treated with CorCap, 38% improved, compared with 27% of control patients.
Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group.
A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data.
FDA consultant Ileana L. Pina, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.
FDA Panel Nixes Mesh Cardiac Support Device
GAITHERSBURG — By a vote of 9-4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures. Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement. The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification. Of patients treated with CorCap, 38% improved, compared with 27% of control patients. Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group. A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data. FDA consultant Ileana L. Piña, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.
GAITHERSBURG — By a vote of 9-4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures. Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement. The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification. Of patients treated with CorCap, 38% improved, compared with 27% of control patients. Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group. A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data. FDA consultant Ileana L. Piña, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.
GAITHERSBURG — By a vote of 9-4, the Food and Drug Administration's Circulatory Systems Devices Panel decided not to recommend the CorCap cardiac support device for approval, citing concerns about missing end point data and uncertainty about the device's effectiveness.
The cardiac support device (CSD), made by Acorn Cardiovascular Inc., is a polyester mesh wrap that is implanted around both ventricles of the heart to stop cardiac enlargement caused by heart failure. It is intended to improve the heart's function by providing beneficial changes in cardiac structure and a decrease in the need for major cardiac procedures. Acorn also claimed that patient quality of life would be improved significantly.
Acorn presented data from a prospective, randomized, controlled trial of 300 heart failure patients. The 193 patients in whom mitral valve repair or replacement was indicated were randomized to undergo surgery with (91) or without (102) CSD placement. The remaining 107 patients were randomized to undergo a thoracotomy for placement of the Acorn device and continued medical therapy (57) medical therapy alone (50).
The primary end point was a composite of survival, the need for additional major cardiac procedures, and change in New York Heart Association (NYHA) classification. Of patients treated with CorCap, 38% improved, compared with 27% of control patients. Additionally, 25% of CorCap recipients remained the same, compared with 28% of patients in the control group. A total of 37% of CorCap recipients were reported to have worsened, compared with 45% of control group patients.
The FDA questioned both the company's statistical analysis and CorCap's clinical efficacy. FDA statistician Laura Thompson, Ph.D., raised concerns that more than a third of patients were missing primary end point measurements, and more than half were missing appropriate baseline NYHA class data. FDA consultant Ileana L. Piña, M.D., professor of medicine at Case Western Reserve University, Cleveland, also highlighted the missing data and pointed out that the only component of the primary end point that was significant was that of major cardiac procedures; there were no significant differences between the CorCap group and the controls in mortality or rehospitalization.
Citing these concerns, the committee voted against approving the device. The FDA usually follows the recommendations of its advisory panels, but is under no statutory obligation to do so.