- Email: [email protected]
The NCDR ICD Registry
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
VOL. 70, NO. 13, 2017
ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 0735-1097/$36.00
PUBLISHED BY ELSEVIER
http://dx.doi.org/10.1016/j.jacc.2017.08.021
LEADERSHIP PAGE
The NCDR ICD Registry A Foundation for Quality Improvement Frederick M. Masoudi, MD, MSPH, FACC a William J. Oetgen, MD, MBA, FACC,b Executive Vice President, Science & Quality, Education and Publications, American College of Cardiology
W
ith the publication of the SCD-HeFT
placement (4). The original CMS criteria and the
(Sudden Cardiac Death in Heart Failure
criteria recommended by the ACC and Heart Rhythm
Trial) in 2005 (1), the Centers for Medi-
Society are summarized in Tables 1 and 2.
care & Medicaid Services (CMS) issued a National
Given that the CMS NCD, including the registry
Coverage Decision (NCD) for the implantation of
CED mandate, is under review, it is timely to consider
implantable cardioverter-defibrillators (ICDs) that
the
contributions
of
the
ICD
Registry
to
our
expanded payment for primary prevention defibrillators in patients with nonischemic cardiomyopathy and severe left ventricular systolic dysfunction (2). This expansion in coverage was accompanied by a coverage
with
evidence
decision
(CED),
which
required patients receiving ICDs for primary prevention in the Medicare population to be enrolled in either an approved clinical trial or in a national reg-
T A B L E 1 CMS Criteria for ICD Implantation Payment—2005
Patients with ischemic dilated cardiomyopathy, documented prior MI, NYHA functional class II and III heart failure, and measured LVEF #35%. Patients with nonischemic dilated cardiomyopathy >9 months, NYHA functional class II and III heart failure, and measured LVEF #35%.
outcomes of patients receiving this therapy (2). Sub-
Patients who meet all current CMS coverage requirements for a cardiac resynchronization therapy device and have NYHA functional class IV heart failure.
sequently, the American College of Cardiology (ACC)
Patients must be able to give informed consent.
developed the National Cardiovascular Data Registry
Patients must not have: B Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; B Had a coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months; B Had an acute MI within the past 40 days; B Clinical symptoms or findings that would make them a candidate for coronary revascularization; B Irreversible brain damage from pre-existing cerebral disease; or B Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival <1 year.
istry that would support the understanding of the
(NCDR) ICD Registry (3), which was recognized by the CMS as a qualifying data collection system for the purposes of the CED. Since that time, the NCDR ICD Registry has been the standard for understanding patient selection, care, and outcomes in patients receiving ICD therapy. In May 2017, CMS announced a review of the NCD for ICDs and requested comments from the public and the profession. In June 2017, the ACC and the Heart Rhythm Society crafted and submitted a joint comment letter signed by their respective presidents, Mary Norine Walsh, MD, FACC, and George Van Hare, MD, FHRS. With respect to the clinical evidence, the comment recommends updated indications for ICD
From the aDivision of Cardiology, Department of Medicine, University of b
Colorado Denver, Aurora, Colorado; and the American College of Cardiology, Washington, DC.
Ejection fraction must be measured by angiography, radionuclide scanning, or echocardiography. MI must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. The beneficiary receiving the ICD implantation for primary prevention is enrolled in a qualifying data collection system including approved clinical trials and registries. CMS ¼ Centers for Medicare & Medicaid Services; ICD ¼ implantable cardioverterdefibrillator; LVEF ¼ left ventricular ejection fraction; MI ¼ myocardial infarction; NYHA ¼ New York Heart Association.
1674
Masoudi and Oetgen
JACC VOL. 70, NO. 13, 2017 SEPTEMBER 26, 2017:1673–4
Leadership Page
T A B L E 2 ACC-HRS Recommended Criteria for ICD Implantation Payment—2017
Patients who have experienced a cardiac arrest because of ventricular arrhythmias or an episode of sustained ventricular tachycardia without a known reversible cause. ACC-HRS Recommended Criteria—2017
these data have been linked to Medicare claims for the purposes of ascertaining outcomes after the implantation procedure, the program has yielded more than
75
peer-reviewed
scientific
papers.
These
Patients at high risk for life-threatening ventricular arrhythmias because of an inherited or familial condition or because of ischemic or nonischemic heart failure with significantly reduced LVEF.
studies have advanced our understanding of device
Patients with LVEF #40% and nonsustained ventricular arrhythmias at least 4 days post-MI or coronary revascularization procedure who have inducible sustained VT or VF at electrophysiological testing.
key questions of the effectiveness, safety, equity, and
Patients with Class IV heart failure who are awaiting heart transplant. Exceptions to the 40-day and 3-month waiting period for patients with existing ICDs or pacemakers that require surgical revisions for reasons such as battery depletion or device malfunctions, and for patients with syncope thought to be due to VT or VF. Inclusion of CMR as an acceptable modality of assessing left ventricular function, in addition to echocardiography, angiography, or radionuclide scanning. ACC-HRS ¼ American College of Cardiology and Heart Rhythm Society; CMR ¼ cardiac magnetic resonance imaging; VF ¼ ventricular fibrillation; VT ¼ ventricular tachycardia; other abbreviations as in Table 1.
selection, care, and outcomes nationally, addressing efficiency of care. These studies have exponentially increased the value of the ICD Registry data well beyond the specific issues outlined in the original CED; their validity has been substantially enhanced with the availability of a true national denominator of patients receiving this therapy. Studies that advance our understanding of the translation of clinical trials and guidelines into contemporary clinical practice on a national scale would have been impossible without
understanding of the care and outcomes of patients receiving this therapy. Currently, more than 1,800 hospitals participate in the program, and 80% of these value the registry beyond the mandate, collecting data for their ICD procedures irrespective of payer or clinical indication for therapy. Participating centers receive nationally benchmarked feedback on the quality of care and outcomes delivered to their patients. Thus, the ICD Registry has served as the foundation for quality improvement of ICD utilization across the country. The model of a national registry to support Food and Drug Administration post-market requirements, CMS coverage with evidence mandates, and national quality improvement has been extended successfully to other cardiovascular pro-
a registry that supported the CED. The ICD Registry has been a model of professional transparency, accountability, and science in exchange for expanded payment for devices. Ultimately, the registry mandate in the original CMS CED has supported
better
patient
care
and
science
to
advance our understanding of the role of ICDs in the care of patients who are at risk for sudden cardiac death. In the re-evaluation of the registry mandate in the CED, these benefits must be considered. Given that the indications for ICD therapy will change with this update, patients, physicians, and policy-makers will need valid contemporary data to ensure the optimal use of these devices and to achieve better outcomes.
cedures, including transcatheter valves (5) and left atrial appendage occlusion devices (3).
ADDRESS FOR CORRESPONDENCE: Dr. William J.
Because more than 1.7 million ICD implantations
Oetgen, American College of Cardiology, 2400 N Street
have been recorded in the ICD Registry, and because
NW, Washington, DC 20037. E-mail: [email protected].
REFERENCES 1. Bardy GH, Lee KL, Mark DB, et al., for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352:225–37. 2. Centers for Medicare & Medicaid Services. Decision memo for implantable defibrillators (CAG-00157R3). January 27, 2005. Available at:
https://www.cms.gov/medicare-coverage-database/ details/nca-decision-memo.aspx?NCAId¼148. Accessed August 3, 2017. 3. American College of Cardiology. NCDR Hospital Registries. Available at: https://cvquality.acc. org/NCDR-Home/Registries/Hospital-Registries. Accessed August 3, 2017. 4. Walsh MN, Van Hare GF. ACC comments on Medicare coverage for ICDs. Available at:
http://www.acc.org/latest-in-cardiology/articles/ 2017/06/29/12/43/acc-comments-on-medicarecoverage-for-icds?w_nav¼LC. June 29, 2017. Accessed August 3, 2017. 5. The Society of Thoracic Surgeons, American College of Cardiology. STS/ACC TVT Registry. Available at: https://www.ncdr.com/webncdr/tvt/ publicpage. Accessed August 3, 2017.
VOL. 70, NO. 13, 2017
ª 2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
ISSN 0735-1097/$36.00
PUBLISHED BY ELSEVIER
http://dx.doi.org/10.1016/j.jacc.2017.08.021
LEADERSHIP PAGE
The NCDR ICD Registry A Foundation for Quality Improvement Frederick M. Masoudi, MD, MSPH, FACC a William J. Oetgen, MD, MBA, FACC,b Executive Vice President, Science & Quality, Education and Publications, American College of Cardiology
W
ith the publication of the SCD-HeFT
placement (4). The original CMS criteria and the
(Sudden Cardiac Death in Heart Failure
criteria recommended by the ACC and Heart Rhythm
Trial) in 2005 (1), the Centers for Medi-
Society are summarized in Tables 1 and 2.
care & Medicaid Services (CMS) issued a National
Given that the CMS NCD, including the registry
Coverage Decision (NCD) for the implantation of
CED mandate, is under review, it is timely to consider
implantable cardioverter-defibrillators (ICDs) that
the
contributions
of
the
ICD
Registry
to
our
expanded payment for primary prevention defibrillators in patients with nonischemic cardiomyopathy and severe left ventricular systolic dysfunction (2). This expansion in coverage was accompanied by a coverage
with
evidence
decision
(CED),
which
required patients receiving ICDs for primary prevention in the Medicare population to be enrolled in either an approved clinical trial or in a national reg-
T A B L E 1 CMS Criteria for ICD Implantation Payment—2005
Patients with ischemic dilated cardiomyopathy, documented prior MI, NYHA functional class II and III heart failure, and measured LVEF #35%. Patients with nonischemic dilated cardiomyopathy >9 months, NYHA functional class II and III heart failure, and measured LVEF #35%.
outcomes of patients receiving this therapy (2). Sub-
Patients who meet all current CMS coverage requirements for a cardiac resynchronization therapy device and have NYHA functional class IV heart failure.
sequently, the American College of Cardiology (ACC)
Patients must be able to give informed consent.
developed the National Cardiovascular Data Registry
Patients must not have: B Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; B Had a coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months; B Had an acute MI within the past 40 days; B Clinical symptoms or findings that would make them a candidate for coronary revascularization; B Irreversible brain damage from pre-existing cerebral disease; or B Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival <1 year.
istry that would support the understanding of the
(NCDR) ICD Registry (3), which was recognized by the CMS as a qualifying data collection system for the purposes of the CED. Since that time, the NCDR ICD Registry has been the standard for understanding patient selection, care, and outcomes in patients receiving ICD therapy. In May 2017, CMS announced a review of the NCD for ICDs and requested comments from the public and the profession. In June 2017, the ACC and the Heart Rhythm Society crafted and submitted a joint comment letter signed by their respective presidents, Mary Norine Walsh, MD, FACC, and George Van Hare, MD, FHRS. With respect to the clinical evidence, the comment recommends updated indications for ICD
From the aDivision of Cardiology, Department of Medicine, University of b
Colorado Denver, Aurora, Colorado; and the American College of Cardiology, Washington, DC.
Ejection fraction must be measured by angiography, radionuclide scanning, or echocardiography. MI must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. The beneficiary receiving the ICD implantation for primary prevention is enrolled in a qualifying data collection system including approved clinical trials and registries. CMS ¼ Centers for Medicare & Medicaid Services; ICD ¼ implantable cardioverterdefibrillator; LVEF ¼ left ventricular ejection fraction; MI ¼ myocardial infarction; NYHA ¼ New York Heart Association.
1674
Masoudi and Oetgen
JACC VOL. 70, NO. 13, 2017 SEPTEMBER 26, 2017:1673–4
Leadership Page
T A B L E 2 ACC-HRS Recommended Criteria for ICD Implantation Payment—2017
Patients who have experienced a cardiac arrest because of ventricular arrhythmias or an episode of sustained ventricular tachycardia without a known reversible cause. ACC-HRS Recommended Criteria—2017
these data have been linked to Medicare claims for the purposes of ascertaining outcomes after the implantation procedure, the program has yielded more than
75
peer-reviewed
scientific
papers.
These
Patients at high risk for life-threatening ventricular arrhythmias because of an inherited or familial condition or because of ischemic or nonischemic heart failure with significantly reduced LVEF.
studies have advanced our understanding of device
Patients with LVEF #40% and nonsustained ventricular arrhythmias at least 4 days post-MI or coronary revascularization procedure who have inducible sustained VT or VF at electrophysiological testing.
key questions of the effectiveness, safety, equity, and
Patients with Class IV heart failure who are awaiting heart transplant. Exceptions to the 40-day and 3-month waiting period for patients with existing ICDs or pacemakers that require surgical revisions for reasons such as battery depletion or device malfunctions, and for patients with syncope thought to be due to VT or VF. Inclusion of CMR as an acceptable modality of assessing left ventricular function, in addition to echocardiography, angiography, or radionuclide scanning. ACC-HRS ¼ American College of Cardiology and Heart Rhythm Society; CMR ¼ cardiac magnetic resonance imaging; VF ¼ ventricular fibrillation; VT ¼ ventricular tachycardia; other abbreviations as in Table 1.
selection, care, and outcomes nationally, addressing efficiency of care. These studies have exponentially increased the value of the ICD Registry data well beyond the specific issues outlined in the original CED; their validity has been substantially enhanced with the availability of a true national denominator of patients receiving this therapy. Studies that advance our understanding of the translation of clinical trials and guidelines into contemporary clinical practice on a national scale would have been impossible without
understanding of the care and outcomes of patients receiving this therapy. Currently, more than 1,800 hospitals participate in the program, and 80% of these value the registry beyond the mandate, collecting data for their ICD procedures irrespective of payer or clinical indication for therapy. Participating centers receive nationally benchmarked feedback on the quality of care and outcomes delivered to their patients. Thus, the ICD Registry has served as the foundation for quality improvement of ICD utilization across the country. The model of a national registry to support Food and Drug Administration post-market requirements, CMS coverage with evidence mandates, and national quality improvement has been extended successfully to other cardiovascular pro-
a registry that supported the CED. The ICD Registry has been a model of professional transparency, accountability, and science in exchange for expanded payment for devices. Ultimately, the registry mandate in the original CMS CED has supported
better
patient
care
and
science
to
advance our understanding of the role of ICDs in the care of patients who are at risk for sudden cardiac death. In the re-evaluation of the registry mandate in the CED, these benefits must be considered. Given that the indications for ICD therapy will change with this update, patients, physicians, and policy-makers will need valid contemporary data to ensure the optimal use of these devices and to achieve better outcomes.
cedures, including transcatheter valves (5) and left atrial appendage occlusion devices (3).
ADDRESS FOR CORRESPONDENCE: Dr. William J.
Because more than 1.7 million ICD implantations
Oetgen, American College of Cardiology, 2400 N Street
have been recorded in the ICD Registry, and because
NW, Washington, DC 20037. E-mail: [email protected].
REFERENCES 1. Bardy GH, Lee KL, Mark DB, et al., for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352:225–37. 2. Centers for Medicare & Medicaid Services. Decision memo for implantable defibrillators (CAG-00157R3). January 27, 2005. Available at:
https://www.cms.gov/medicare-coverage-database/ details/nca-decision-memo.aspx?NCAId¼148. Accessed August 3, 2017. 3. American College of Cardiology. NCDR Hospital Registries. Available at: https://cvquality.acc. org/NCDR-Home/Registries/Hospital-Registries. Accessed August 3, 2017. 4. Walsh MN, Van Hare GF. ACC comments on Medicare coverage for ICDs. Available at:
http://www.acc.org/latest-in-cardiology/articles/ 2017/06/29/12/43/acc-comments-on-medicarecoverage-for-icds?w_nav¼LC. June 29, 2017. Accessed August 3, 2017. 5. The Society of Thoracic Surgeons, American College of Cardiology. STS/ACC TVT Registry. Available at: https://www.ncdr.com/webncdr/tvt/ publicpage. Accessed August 3, 2017.