Elsevier

Heart Rhythm

Volume 10, Issue 8, August 2013, Pages 1127-1133
Heart Rhythm

Follow-up of patients with new cardiovascular implantable electronic devices: Is adherence to the experts’ recommendations associated with improved outcomes?

https://doi.org/10.1016/j.hrthm.2013.06.009Get rights and content

Background

A 2008 expert consensus statement recommended an in-person follow-up visit between 2 and 12 weeks after the placement of a new cardiovascular implantable electronic device (CIED).

Objective

To assess outcomes associated with adherence to the experts’ recommendations.

Methods

By using data from the National Cardiovascular Data Registry’s (NCDR®) ICD Registry™ linked to Medicare claims, we studied the association between follow-up within 2–12 weeks after CIED placement between January 1, 2005, and September 30, 2008, and all-cause mortality and risk of readmission within 1 year.

Results

Compared with patients who did not receive the recommended follow-up (n = 43,060), those who did (n = 30,256) were more likely to be older, white, to have received a cardiac resynchronization therapy-defibrillator device, to have more advanced heart failure symptoms, and to have nonischemic dilated cardiomyopathy. In Cox proportional hazards models adjusted for patient demographic and clinical factors, mortality was lower (hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.88–0.98; P = .005) but cardiovascular readmission was higher (HR 1.04; 95% CI 1.01–1.08; P = .012) among patients who received initial follow-up within 2–12 weeks after CIED placement compared with those who did not. There was no association between CIED follow-up and readmission for heart failure (HR 1.00; 95% CI 0.96–1.05; P = .878) or device-related infection (HR 1.22; 95% CI 0.98–1.51; P = .075).

Conclusions

Follow-up within 2–12 weeks after CIED placement was independently associated with improved survival but increased cardiovascular readmission. Quality improvement initiatives designed to increase adherence to experts’ recommendations may be warranted.

Introduction

Cardiovascular implantable electronic device (CIED) indications have evolved and expanded over time.1, 2, 3, 4 CIED implantation rates have correspondingly risen. US implantable cardioverter-defibrillator (ICD) placement increased from 92,897 in 2006 to 141,374 in 2009.5 The proportion of these procedures that included cardiac resynchronization therapy-defibrillator (CRT-D) grew from 37.4% to 41.7% during the same time period.5 The number of pacemaker procedures has also increased, particularly among older patients.6

CIED management is becoming increasingly complex. Consequently, the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) issued an expert consensus statement in 2008 detailing the minimum frequency of in-person and remote follow-up of CIEDs. The statement recommends an in-person follow-up visit 2–12 weeks after implantation for patients with a new pacemaker, ICD, or cardiac resynchronization therapy (CRT) device; in-person or remote monitoring every 3–12 months for patients with pacemakers, including CRT; and in-person or remote monitoring every 3–6 months for patients with an ICD with or without CRT.7 A 2012 HRS/EHRA expert consensus statement reinforced the importance of at least biannual in-person clinic visits for CRT recipients.8 Although CIED follow-up is a key element of cardiology and electrophysiology practice and adherence to HRS/EHRA recommendations may improve outcomes, this has not been demonstrated empirically. Using a United States national ICD registry™ and Medicare claims data, we sought to examine the association between the completion of an in-person follow-up visit 2–12 weeks after new ICD or CRT-D placement and death, cardiovascular readmission, heart failure readmission, and readmission for a device-related infection.

Section snippets

Data source

Data for this study included clinical data from the NCDR® ICD Registry™ and Medicare claims data from the US Centers for Medicare & Medicaid Services. The NCDR® ICD Registry™ was established in 2005 through a partnership of the HRS and the American College of Cardiology Foundation and became the sole repository of ICD implantation data for Medicare beneficiaries on April 1, 2006. Although the Centers for Medicare & Medicaid Services mandates hospitals to enter data on Medicare patients

Results

The initial data set included 87,134 patients at 991 hospitals who underwent new transvenous CIED placement between January 1, 2005, and September 30, 2008, and were discharged alive. During the 12-week ascertainment period, 439 patients died, 13,125 had a cardiovascular readmission, 5475 were readmitted for heart failure, and 648 were readmitted with a device-related infection. The final study cohort included 73,316 patients, of which 30,256 (41.3%) received an initial follow-up visit 2–12

Discussion

To our knowledge, this study is the first to examine the association between adherence to the HRS/EHRA recommendations regarding CIED follow-up and clinical outcomes. There are 3 main findings. First, after accounting for patient demographics and comorbid conditions, the completion of an initial in-person follow-up 2–12 weeks after new ICD or CRT-D placement was associated with a significant survival benefit. Second, initial CIED follow-up was also associated with increased cardiovascular

Conclusions

Completion of an in-person CIED follow-up visit 2–12 weeks after new ICD or CRT-D placement was associated with a significant survival benefit and increased cardiovascular readmissions. In contrast, there was no evidence of a link between CIED follow-up and readmission for heart failure or device-related infection. The observed significant survival benefit suggests that quality improvement initiatives designed to increase adherence to experts’ recommendations regarding adequate follow-up of

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This work was primarily funded by the National Heart, Lung, and Blood Institute (grant 5R01HL093071-04). Dr Hess was funded by the National Institutes of Health T-32 training grant HL069749-09. The funding sources had no role in the design, analysis, or interpretation of the data or in the decision to submit the manuscript for publication.

Dr Curtis has received research grants from Medtronic. Dr Wilkoff has received consulting fees/honoraria from Medtronic, St Jude Medical, and SpectraNetics Corp.

ICD Registry™ is an initiative of the American College of Cardiology Foundation and the Heart Rhythm Society. The views expressed in this article represent those of the author(s) and do not necessarily represent the official views of the National Cardiovascular Data Registry® or its associated professional societies identified at www.ncdr.com.

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