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Multicenter Study
. 2020 Jun 1;5(6):643-651.
doi: 10.1001/jamacardio.2020.0391.

Periprocedural Risk and Survival Associated With Implantable Cardioverter-Defibrillator Placement in Older Patients With Advanced Heart Failure

Marat Fudim  1   2 , Fatima Ali-Ahmed  2   3 , Craig S Parzynski  4 , Andrew P Ambrosy  5   6 , Daniel J Friedman  1   2 , Sean D Pokorney  1   2 , Jeptha P Curtis  4 , Gregg C Fonarow  7   8   9 , Frederick A Masoudi  10 , Adrian F Hernandez  1   2   11 , Sana M Al-Khatib  1   2
Affiliations
Multicenter Study

Periprocedural Risk and Survival Associated With Implantable Cardioverter-Defibrillator Placement in Older Patients With Advanced Heart Failure

Marat Fudim et al. JAMA Cardiol. .

Abstract

Importance: Little is known about the utilization rates and outcomes of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) placement among patients with advanced heart failure (HF).

Objective: To examine utilization rates, patient characteristics, and outcomes of ICD and CRT-D placements among patients with advanced HF.

Design, setting, and participants: This cohort study was a post hoc analysis of 81 492 Medicare fee-for-service beneficiaries enrolled in the National Cardiovascular Data Registry ICD Registry between January 2010 and December 2014. Inclusion criteria were patients who had received an HF diagnosis, had a left ventricular ejection fraction of 35% or lower, and showed evidence of advanced HF, which was defined as New York Heart Association (NYHA) class IV symptoms, inotrope use within the last 60 days, left ventricular assist device in situ, or orthotopic heart transplant listing. The comparator group included patients with NYHA class II and no HF hospitalization within the last 12 months, no left ventricular assist device, no orthotopic heart transplant listing, and no current or recent inotrope use. All eligible patients underwent first-time ICD or CRT-D placement for primary prevention of sudden cardiac death. Data were analyzed from January 2010 to December 2014.

Main outcomes and measures: All-cause mortality and periprocedural complications.

Results: Of 81 492 Medicare patients, 3343 had advanced HF (4.1%) and 19 424 were in the comparator group (23.8%). Among the advanced HF population, the mean (SD) age of patients was 74 (9) years, and patients were predominantly white individuals (81.5%) and men (71.1%). The all-cause mortality rate at 30 days was 3.1% (95% CI, 2.6%-3.8%) in the advanced HF group vs 0.5% (0.4%-0.6%) in the comparator group (P < .001). In the advanced HF population, the aggregate in-hospital periprocedural complication rate was 3.74% (95% CI, 3.12%-4.44%) vs 1.10% (95% CI, 0.95%-1.25%) in the comparator group (P < .001). Most adverse events in this group were in-hospital fatality (1.82%; 95% CI, 1.40%-2.34%) and resuscitated cardiac arrest (1.05%; 95% CI, 0.73%-1.45%). Patients with NYHA class IV (hazard ratio, 1.40; 95% CI, 1.02-1.93; P = .04), ischemic heart disease (hazard ratio, 1.24; 95% CI, 1.04-1.48; P = .02), or diabetes (hazard ratio, 1.17; 95% CI, 1.04-1.33; P = .01) had a higher risk of death.

Conclusions and relevance: Among patients undergoing ICD or CRT-D placement for primary prevention of sudden cardiac death, only a small proportion had advanced HF. These patients experienced clinically important periprocedural complication rates associated with in-hospital death and cardiac arrest relative to patients with nonadvanced HF.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Fudim reported being supported by grant 17MCPRP33460225 from the American Heart Association and receiving personal fees from Axon Therapies, Coridea, and Galvani Bioelectronics outside the submitted work. Mr Parzynski reported receiving salary support from a contract with the Yale Center for Outcomes Research and Evaluation via the American College of Cardiology during the conduct of the study. Dr Ambrosy reports significant research funding from Abbott Vascular Inc, Novartis, Amarin Corporation, the National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney, and the Kaiser Permanente Northern California Community Benefit Program and modest reimbursement for travel from Novartis. Dr Friedman reported receiving educational grants from Abbott, Boston Scientific, and Medtronic; research grants from Abbott, Biosense Webster, Boston Scientific, Medtronic, and the National Cardiovascular Data Registry; consulting fees from Abbott and AtriCure outside the submitted work; and filing a provisional patent application pertaining to the use of electrogram analysis for cardiac resynchronization therapy optimization. Dr Pokorney reported receiving research grants from Bristol-Myers Squibb, Boston Scientific, Gilead Sciences Inc, Janssen Pharmaceuticals, Pfizer, and the US Food and Drug Administration and personal fees from Boston Scientific, Bristol-Myers Squibb, Janssen Pharmaceuticals, Medtronic, Pfizer, and Portola Pharmaceuticals. Dr Curtis has a contract with the American College of Cardiology for his role as Senior Medical Officer, NCDR; receives salary support from the American College of Cardiology, NCDR; receives funding from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and holds equity interest in Medtronic. Dr Fonarow reported receiving research grants from the National Institutes of Health and receiving personal fees from Abbott, Amgen, Bayer, Janssen Pharmaceuticals, Medtronic, and Novartis. Dr Masoudi reported receiving financial support from the American College of Cardiology outside the submitted work. Dr Hernandez reported receiving grants and personal fees from AstraZeneca, Merck, and Novartis; personal fees from Bayer and Boston Scientific; and grants from American Regent and Verily outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Survival From All-Cause Death Following Implantable Cardioverter-Defibrillator Placement Among Patients With Advanced or Nonadvanced Heart Failure (HF)
Shaded areas indicate 95% CIs.
Figure 2.
Figure 2.. Survival From All-Cause Death Following Device Placement Among Patients With Advanced or Nonadvanced Heart Failure (HF) by Device
Given that device-specific data were not reported, 47 patients were removed from the analysis: 44 patients in the nonadvanced HF group and 3 patients in the advanced HF group. Shaded areas indicate 95% CIs. CRT-D indicates cardiac resynchronization therapy-defibrillator; ICD, implantable cardioverter-defibrillator.
See this image and copyright information in PMC

References

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