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      Timing of cardiac resynchronization therapy device implantation in heart failure patients and its association with outcomes

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          Abstract

          Background

          When used in appropriately selected heart failure (HF) patients, cardiac resynchronization therapy (CRT) reduces mortality and hospitalization. It is not understood whether CRT implantation during hospitalization for HF is associated with similar benefits.

          Hypothesis

          Timing of CRT implantation relative to hospitalization for HF is associated with clinical outcomes.

          Methods

          This analysis included patients eligible for CRT and discharged alive between January 2005 and December 2012 from 388 hospitals in Get With The Guidelines‐HF. Participants were linked with Centers for Medicare and Medicaid Services data to evaluate outcomes of all‐cause mortality and HF re‐hospitalization based on CRT status (present on admission, placed during hospitalization, and prescribed at discharge; reference = no CRT).

          Results

          Of 15 619 CRT‐eligible HF patients, 2408 (15%) had CRT on admission, 1269 (8%) underwent CRT implantation during hospitalization and 643 (4%) had CRT prescribed at discharge. Compared with patients without CRT, mortality was lower in those who received CRT implantation during HF hospitalization (adjusted hazard ratio [HR] 0.63; P < 0.0001) and those prescribed CRT at discharge (adjusted HR 0.78; P = 0.048). A reduction in HF re‐hospitalization was observed in patients with CRT implanted during hospitalization (adjusted HR 0.64; P < 0.0001), but not in those who were prescribed CRT at discharge (adjusted HR 1.02; P = 0.77).

          Conclusion

          CRT implantation during HF hospitalization was associated with lower rates of mortality and HF re‐hospitalization. These data suggest that a CRT utilization strategy that does not delay implantation to the post‐discharge period may be appropriate. Randomized data are needed to definitively identify optimal timing of CRT implantation.

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          Most cited references11

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          Cardiac-resynchronization therapy for the prevention of heart-failure events.

          This trial was designed to determine whether cardiac-resynchronization therapy (CRT) with biventricular pacing would reduce the risk of death or heart-failure events in patients with mild cardiac symptoms, a reduced ejection fraction, and a wide QRS complex. During a 4.5-year period, we enrolled and followed 1820 patients with ischemic or nonischemic cardiomyopathy, an ejection fraction of 30% or less, a QRS duration of 130 msec or more, and New York Heart Association class I or II symptoms. Patients were randomly assigned in a 3:2 ratio to receive CRT plus an implantable cardioverter-defibrillator (ICD) (1089 patients) or an ICD alone (731 patients). The primary end point was death from any cause or a nonfatal heart-failure event (whichever came first). Heart-failure events were diagnosed by physicians who were aware of the treatment assignments, but they were adjudicated by a committee that was unaware of assignments. During an average follow-up of 2.4 years, the primary end point occurred in 187 of 1089 patients in the CRT-ICD group (17.2%) and 185 of 731 patients in the ICD-only group (25.3%) (hazard ratio in the CRT-ICD group, 0.66; 95% confidence interval [CI], 0.52 to 0.84; P=0.001). The benefit did not differ significantly between patients with ischemic cardiomyopathy and those with nonischemic cardiomyopathy. The superiority of CRT was driven by a 41% reduction in the risk of heart-failure events, a finding that was evident primarily in a prespecified subgroup of patients with a QRS duration of 150 msec or more. CRT was associated with a significant reduction in left ventricular volumes and improvement in the ejection fraction. There was no significant difference between the two groups in the overall risk of death, with a 3% annual mortality rate in each treatment group. Serious adverse events were infrequent in the two groups. CRT combined with ICD decreased the risk of heart-failure events in relatively asymptomatic patients with a low ejection fraction and wide QRS complex. (ClinicalTrials.gov number, NCT00180271.) 2009 Massachusetts Medical Society
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            Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review.

            Left ventricular (LV) systolic dysfunction causes substantial morbidity and mortality, even with optimal pharmacotherapy. Atrial-synchronized biventricular pacemakers (cardiac resynchronization therapy [CRT]) received US Food and Drug Administration (FDA) approval for use in selected patients with LV systolic dysfunction in 2001. To summarize the current evidence base for the efficacy, effectiveness, and safety of CRT in patients with LV systolic dysfunction. A search of multiple electronic databases until November 2006 was supplemented by hand searches of reference lists of included studies and review articles, proceedings booklets from meetings, FDA reports, and contact with primary study authors and device manufacturers. A total of 14 randomized trials (4420 patients) were included for the CRT efficacy review, 106 studies (9209 patients) for the CRT effectiveness review, and 89 studies (9677 patients) reported safety outcomes with implantation of a CRT device. All patients in the CRT studies had LV systolic dysfunction (mean LV ejection fraction [LVEF] range, 21%-30%), prolonged QRS duration (mean range, 155-209 milliseconds), and 91% had New York Heart Association (NYHA) class 3 or 4 heart failure symptoms despite optimal pharmacotherapy. CRT improved LVEF (weighted mean difference, 3.0%; 95% confidence interval [CI], 0.9%-5.1%), quality of life (weighted mean reduction in Minnesota Living With Heart Failure Questionnaire, 8.0 points; 95% CI, 5.6-10.4 points), and functional status (improvements of >/=1 NYHA class were observed in 59% of CRT recipients in the randomized trials). CRT decreased hospitalizations by 37% (95% CI, 7%-57%), and all-cause mortality decreased by 22% (95% CI, 9%-33%). Implant success rate was 93.0% (95% CI, 92.2%-93.7%) and 0.3% of patients died during implantation (95% CI, 0.1%-0.6%). During a median 11-month follow-up, 6.6% (95% CI, 5.6%-7.4%) of CRT devices exhibited lead problems and 5% (95% CI, 4%-7%) malfunctioned. CRT reduces morbidity and mortality in patients with LV systolic dysfunction, prolonged QRS duration, and NYHA class 3 or 4 symptoms when combined with optimal pharmacotherapy. The incremental benefits of combined CRT plus implantable cardioverter-defibrillator devices vs CRT-alone devices in patients with LV systolic dysfunction remain uncertain.
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              The American Heart Association Get With The Guidelines program.

              , Lynn A Smaha (2004)
              Get With The Guidelines (GWTG) is a hospital-based quality improvement initiative created by the American Heart Association (AHA) and the American Stroke Association (ASA) to improve the care of patients with cardiac diseases and stroke. It supports the AHA mission to reduce death and disability due to cardiovascular diseases and stroke. It is evidence-based and founded on the American College of Cardiology/American Heart Association Guidelines for secondary prevention of cardiovascular diseases and is designed to help health care providers consistently treat patients in accordance with these accepted guidelines.
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                Author and article information

                Contributors
                sarah.goldstein@duke.edu
                Journal
                Clin Cardiol
                Clin Cardiol
                10.1002/(ISSN)1932-8737
                CLC
                Clinical Cardiology
                Wiley Periodicals, Inc. (New York )
                0160-9289
                1932-8737
                26 December 2018
                February 2019
                : 42
                : 2 ( doiID: 10.1002/clc.2019.42.issue-2 )
                : 256-263
                Affiliations
                [ 1 ] Division of Cardiology Duke University Hospital Durham North Carolina
                [ 2 ] Duke Clinical Research Institute Durham North Carolina
                [ 3 ] Division of Cardiology Ronald Reagan UCLA Medical Center, Ahmanson‐UCLA Cardiomyopathy Center Los Angeles California
                [ 4 ] Division of Cardiology Northwestern University Medical Center Chicago Illinois
                Author notes
                [*] [* ] Correspondence

                Sarah A. Goldstein, MD, Duke University Medical Center, Division of Cardiology, P.O. Box 3845, 2301 Erwin Rd., Durham, NC 27710.

                Email: sarah.goldstein@ 123456duke.edu

                Author information
                https://orcid.org/0000-0002-7789-4773
                https://orcid.org/0000-0002-3192-8093
                https://orcid.org/0000-0003-3387-9616
                Article
                CLC23135
                10.1002/clc.23135
                6386168
                30548280
                fb28e922-df13-4f4e-a215-33f18bf61363
                © 2018 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 16 August 2018
                : 04 December 2018
                : 10 December 2018
                Page count
                Figures: 2, Tables: 3, Pages: 8, Words: 5094
                Funding
                Funded by: American Heart Association
                Categories
                Clinical Investigations
                Clinical Investigations
                Custom metadata
                2.0
                clc23135
                February 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.7 mode:remove_FC converted:28.08.2019

                Cardiovascular Medicine
                cardiac resynchronization therapy,crt,heart failure,mortality,outcomes,re‐hospitalization

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