Too Many ICDs? What's Appropriate for Implantation?
Too Many ICDs? What's Appropriate for Implantation?
Brian Olshansky, MD, is a tenured Professor of Medicine and an electrophysiologist at the University of Iowa Hospitals. Dr. Olshansky's expertise and research interests lie in the evaluation and treatment of arrhythmias, including those associated with risk of sudden cardiac death. He has designed and contributed to multicenter randomized, controlled clinical arrhythmia trials, and the use of therapies to treat atrial and ventricular arrhythmias. He is a member of several editorial boards, including The Journal of the American College of Cardiology, HeartRhythm, American Heart Journal, PACE, Journal of Cardiovascular Electrophysiology, eMedicine,and UpToDate. He has lectured internationally and has been a visiting professor at institutions throughout the world. Dr. Olshansky is a Fellow of the Heart Rhythm Society (HRS), American College of Cardiology (ACC), and the American Heart Association (AHA). He is a member of the electrophysiology writing committee of the International Board of Heart Rhythm Examiners (IBHRE).
In January 2011, US researchers reported that among patients who received primary prevention implantable cardioverter defibrillators (ICDs), about 20% did not meet their "evidence-based guidelines" for receipt of an ICD. Sana M. Al-Khatib, MD (Duke Clinical Research Institute, Durham, North Carolina) and colleagues retrospectively examined the number, characteristics, and in-hospital outcomes in the large patient cohort enrolled in the NCDR to determine who received a "nonevidence-based ICD" based on their definition of evidence-based implantation. They created a definition of nonevidence-based ICD implantation distinctly different from the 2006 and 2008 ACC/AHA guidelines for ICD therapy for primary prevention of sudden cardiac death. In Dr. Al Khatib's article, it was stated that ICD implantation was not considered indicated (ie, not evidence-based) in patients recovering from an acute myocardial infarction (MI) within the first 40 days, in patients status post coronary artery bypass graftsurgery within 3 months, in patients with New York Heart Association (NYHA) Class IV disease, and in patients with newly diagnosed heart failure (< 3 months).
The data analyzed were from all cases submitted between January 2006 and June 2009 to the National ICD Registry, a registry of ICD implantations established by the ACC/HRS as part of the National Cardiovascular Data Registry (NCDR). The Registry was required by the Centers for Medicare & Medicaid Services (CMS) in 2005, when coverage was expanded to include ICD implantation for primary prevention of sudden cardiac death.
Dr. Al-Khatib and colleagues stated that out of 111,707 patients, 25,145 (22.5%) had received nonevidence-based ICD implants, 9257 (36.8%) of which were implanted within 40 days of an MI and 15,604 (62.1%) were in patients with newly diagnosed heart failure (< 3 months). Compared with patients who received an evidence-based ICD, those who received a nonevidence-based ICD had a significantly higher risk for in-hospital death (0.57% vs 0.18%; P < .001) and any post-procedure complication (3.23% vs 2.41%; P < .001). The investigators noted, "Although the absolute difference in complications between the 2 groups was small, the complications could have significant effects on patients' quality of life and healthcare use, including length of hospital stay and costs." "While a small risk of complications is acceptable when a procedure has been shown to improve outcomes, no risk is acceptable if a procedure has no demonstrated benefit."
On a different topic, the majority (66%) of ICD implantations studied were performed by electrophysiologists (EPs), 24.8% were performed by non-EP cardiologists, 2.6% by thoracic surgeons, and 6.1% by other specialists. The rate of nonevidence-based ICD implants was significantly lower for EPs (20.8%) than for nonEPs (24.8% for non-EP cardiologists; 36.1% for thoracic surgeons; and 24.9% for other specialties; all P < .001). Dr. Al-Khatib and co-authors suggested, "Potential reasons for this disparity include better knowledge of the data on primary prevention ICDs and increased commitment to adherence to practice guidelines by EPs." There was no clear decrease in the rate of nonevidence-based ICDs over time.
The study investigators and the authors of an accompanying editorial in JAMA, Alan Kadish, MD (Touro College, New York) and Jeffrey Goldberger, MD (Feinberg School of Medicine, Northwestern University, Chicago), pointed out that there are circumstances in which deviations from guidelines are appropriate based on the physician's judgment. However, Drs. Kadish and Goldberger suggested, "It is likely that all physicians require further education to understand the rationale for the guidelines and potential alternative approaches when a patient does not meet guidelines for ICD implantation."
The ACC and HRS issued a joint response in the JAMA article in which they stated "the vast majority of implanting physicians are prescribing ICDs with the confidence that they are providing the best care for their patients." The statement added that, "While guidelines are designed to account for the majority of clinical scenarios, there are clinical challenges in which the guidelines do not address the unique circumstances of a patient's treatment options which require physicians to utilize their clinical expertise and judgment."
In the general media, the results of the study were widely reported as revealing that a certain proportion of ICDs are implanted "improperly" or "unnecessarily," Around the time of the JAMA paper, the US Department of Justice announced that it was conducting a civil investigation of ICD implants related to "proper use of guidelines" in selecting patients for ICDs." Although this appeared to be related to the JAMA paper, Dr. Al-Khatib and others pointed out that this was unlikely, given the time needed to plan such an investigation. However, the study continued to be discussed in the pages of JAMAand it was the subject of a well-attended session at the 2011 HRS annual meeting (May 4-7, San Francisco), where Drs. Al-Khatib and Olshansky debated the issues raised by the JAMA report.
Following the HRS meeting, Dr. Olshansky spoke with Linda Brookes, MSc, for Medscape Cardiology, about his views on the study findings and their implications for ICD use.
An Expert Interview With Brian Olshansky, MD on Appropriate Implantation of ICDs
About the Interviewee
Brian Olshansky, MD, is a tenured Professor of Medicine and an electrophysiologist at the University of Iowa Hospitals. Dr. Olshansky's expertise and research interests lie in the evaluation and treatment of arrhythmias, including those associated with risk of sudden cardiac death. He has designed and contributed to multicenter randomized, controlled clinical arrhythmia trials, and the use of therapies to treat atrial and ventricular arrhythmias. He is a member of several editorial boards, including The Journal of the American College of Cardiology, HeartRhythm, American Heart Journal, PACE, Journal of Cardiovascular Electrophysiology, eMedicine,and UpToDate. He has lectured internationally and has been a visiting professor at institutions throughout the world. Dr. Olshansky is a Fellow of the Heart Rhythm Society (HRS), American College of Cardiology (ACC), and the American Heart Association (AHA). He is a member of the electrophysiology writing committee of the International Board of Heart Rhythm Examiners (IBHRE).
Background to the Interview
In January 2011, US researchers reported that among patients who received primary prevention implantable cardioverter defibrillators (ICDs), about 20% did not meet their "evidence-based guidelines" for receipt of an ICD. Sana M. Al-Khatib, MD (Duke Clinical Research Institute, Durham, North Carolina) and colleagues retrospectively examined the number, characteristics, and in-hospital outcomes in the large patient cohort enrolled in the NCDR to determine who received a "nonevidence-based ICD" based on their definition of evidence-based implantation. They created a definition of nonevidence-based ICD implantation distinctly different from the 2006 and 2008 ACC/AHA guidelines for ICD therapy for primary prevention of sudden cardiac death. In Dr. Al Khatib's article, it was stated that ICD implantation was not considered indicated (ie, not evidence-based) in patients recovering from an acute myocardial infarction (MI) within the first 40 days, in patients status post coronary artery bypass graftsurgery within 3 months, in patients with New York Heart Association (NYHA) Class IV disease, and in patients with newly diagnosed heart failure (< 3 months).
The data analyzed were from all cases submitted between January 2006 and June 2009 to the National ICD Registry, a registry of ICD implantations established by the ACC/HRS as part of the National Cardiovascular Data Registry (NCDR). The Registry was required by the Centers for Medicare & Medicaid Services (CMS) in 2005, when coverage was expanded to include ICD implantation for primary prevention of sudden cardiac death.
Dr. Al-Khatib and colleagues stated that out of 111,707 patients, 25,145 (22.5%) had received nonevidence-based ICD implants, 9257 (36.8%) of which were implanted within 40 days of an MI and 15,604 (62.1%) were in patients with newly diagnosed heart failure (< 3 months). Compared with patients who received an evidence-based ICD, those who received a nonevidence-based ICD had a significantly higher risk for in-hospital death (0.57% vs 0.18%; P < .001) and any post-procedure complication (3.23% vs 2.41%; P < .001). The investigators noted, "Although the absolute difference in complications between the 2 groups was small, the complications could have significant effects on patients' quality of life and healthcare use, including length of hospital stay and costs." "While a small risk of complications is acceptable when a procedure has been shown to improve outcomes, no risk is acceptable if a procedure has no demonstrated benefit."
On a different topic, the majority (66%) of ICD implantations studied were performed by electrophysiologists (EPs), 24.8% were performed by non-EP cardiologists, 2.6% by thoracic surgeons, and 6.1% by other specialists. The rate of nonevidence-based ICD implants was significantly lower for EPs (20.8%) than for nonEPs (24.8% for non-EP cardiologists; 36.1% for thoracic surgeons; and 24.9% for other specialties; all P < .001). Dr. Al-Khatib and co-authors suggested, "Potential reasons for this disparity include better knowledge of the data on primary prevention ICDs and increased commitment to adherence to practice guidelines by EPs." There was no clear decrease in the rate of nonevidence-based ICDs over time.
The study investigators and the authors of an accompanying editorial in JAMA, Alan Kadish, MD (Touro College, New York) and Jeffrey Goldberger, MD (Feinberg School of Medicine, Northwestern University, Chicago), pointed out that there are circumstances in which deviations from guidelines are appropriate based on the physician's judgment. However, Drs. Kadish and Goldberger suggested, "It is likely that all physicians require further education to understand the rationale for the guidelines and potential alternative approaches when a patient does not meet guidelines for ICD implantation."
The ACC and HRS issued a joint response in the JAMA article in which they stated "the vast majority of implanting physicians are prescribing ICDs with the confidence that they are providing the best care for their patients." The statement added that, "While guidelines are designed to account for the majority of clinical scenarios, there are clinical challenges in which the guidelines do not address the unique circumstances of a patient's treatment options which require physicians to utilize their clinical expertise and judgment."
In the general media, the results of the study were widely reported as revealing that a certain proportion of ICDs are implanted "improperly" or "unnecessarily," Around the time of the JAMA paper, the US Department of Justice announced that it was conducting a civil investigation of ICD implants related to "proper use of guidelines" in selecting patients for ICDs." Although this appeared to be related to the JAMA paper, Dr. Al-Khatib and others pointed out that this was unlikely, given the time needed to plan such an investigation. However, the study continued to be discussed in the pages of JAMAand it was the subject of a well-attended session at the 2011 HRS annual meeting (May 4-7, San Francisco), where Drs. Al-Khatib and Olshansky debated the issues raised by the JAMA report.
Following the HRS meeting, Dr. Olshansky spoke with Linda Brookes, MSc, for Medscape Cardiology, about his views on the study findings and their implications for ICD use.
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