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      Cardiac resynchronization therapy in New York Heart Association class‐IV patients dependent on intravenous drugs or invasive supportive treatments

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          Abstract

          Aims

          We sought to evaluate the effectiveness of cardiac resynchronization therapy (CRT) in far‐advanced heart failure (FA‐HF) patients with New York Heart Association (NYHA) class‐IV status and dependency on intravenous drugs (IVDs) and/or invasive supportive treatments (ISTs).

          Methods and results

          Among 305 patients who underwent CRT implantation between October 2005 to December 2019, we identified 17 FA‐HF patients with NYHA class‐IV status and dependency on IVDs (inotropes, diuretics, vasopressors, or vasodilators) and/or ISTs (extracorporeal membranous oxygenator or continuous renal replacement therapy). All patients (median age = 68.7 years, non‐ischaemic cardiomyopathy = 15) remained dependent on several IVDs (2.2 ± 1.3 per patient) and/or ISTs for 11.3 ± 7.8 days due to multiple tapering failure (4.3 ± 3.2 per patient) before CRT implantation. However, 14 (82%) patients were successfully weaned from IVDs/ISTs within 5.2 ± 5.3 days following CRT, and 12 (71%) stayed alive for more than 1 year free of ventricular assist device or heart transplantation with symptom improvement (≥1 NYHA class) and a reduced annual HF hospitalization rate ( P = 0.002). Considerable improvements in ventricular systolic function ( P = 0.004) and volumetric reverse remodelling ( P = 0.007) were noticed during the long‐term follow‐up period (35 ± 15 months post‐CRT). The ventricular assist device/heart transplantation/death‐free survival rate post‐CRT was 71% and 65% at 1 and 3 years, respectively.

          Conclusions

          Cardiac resynchronization therapy implantation may be a feasible treatment that can offer short‐term and long‐term clinical benefits for NYHA class‐IV FA‐HF patients who are dependent on IVDs/ISTs. When considering treatment options, CRT should not be prematurely excluded solely based on a patient's dependency on IVDs/ISTs without first attempting to identify favourable CRT response factors.

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          Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure.

          Joseph Rogers, Francis Pagani, Antone J Tatooles … (2017)
          Background Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow device) against existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation. Methods We conducted a multicenter randomized trial involving 446 patients who were assigned, in a 2:1 ratio, to the study (centrifugal-flow) device or the control (axial-flow) device. Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial. The primary end point was survival at 2 years free from disabling stroke or device removal for malfunction or failure. The trial was powered to show noninferiority with a margin of 15 percentage points. Results The intention-to treat-population included 297 participants assigned to the study device and 148 participants assigned to the control device. The primary end point was achieved in 164 patients in the study group and 85 patients in the control group. The analysis of the primary end point showed noninferiority of the study device relative to the control device (estimated success rates, 55.4% and 59.1%, respectively, calculated by the Weibull model; absolute difference, 3.7 percentage points; 95% upper confidence limit, 12.56 percentage points; P=0.01 for noninferiority). More patients in the control group than in the study group had device malfunction or device failure requiring replacement (16.2% vs. 8.8%), and more patients in the study group had strokes (29.7% vs. 12.1%). Quality of life and functional capacity improved to a similar degree in the two groups. Conclusions In this trial involving patients with advanced heart failure who were ineligible for heart transplantation, a small, intrapericardial, centrifugal-flow LVAD was found to be noninferior to an axial-flow LVAD with respect to survival free from disabling stroke or device removal for malfunction or failure. (Funded by HeartWare; ENDURANCE ClinicalTrials.gov number, NCT01166347 .).
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            Defining left bundle branch block in the era of cardiac resynchronization therapy.

            David Strauss, Ronald Selvester, Galen Wagner (2011)
            Cardiac resynchronization therapy (CRT) has emerged as an attractive intervention to improve left ventricular mechanical function by changing the sequence of electrical activation. Unfortunately, many patients receiving CRT do not benefit but are subjected to device complications and costs. Thus, there is a need for better selection criteria. Current criteria for CRT eligibility include a QRS duration ≥ 120 ms. However, QRS morphology is not considered, although it can indicate the cause of delayed conduction. Recent studies have suggested that only patients with left bundle branch block (LBBB) benefit from CRT, and not patients with right bundle branch block or nonspecific intraventricular conduction delay. The authors review the pathophysiologic and clinical evidence supporting why only patients with complete LBBB benefit from CRT. Furthermore, they review how the threshold of 120 ms to define LBBB was derived subjectively at a time when criteria for LBBB and right bundle branch block were mistakenly reversed. Three key studies over the past 65 years have suggested that 1/3 of patients diagnosed with LBBB by conventional electrocardiographic criteria may not have true complete LBBB, but likely have a combination of left ventricular hypertrophy and left anterior fascicular block. On the basis of additional insights from computer simulations, the investigators propose stricter criteria for complete LBBB that include a QRS duration ≥ 140 ms for men and ≥ 130 ms for women, along with mid-QRS notching or slurring in ≥ 2 contiguous leads. Further studies are needed to reinvestigate the electrocardiographic criteria for complete LBBB and the implications of these criteria for selecting patients for CRT. Published by Elsevier Inc.
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              An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure

              John Cleland, William T. Abraham, Cecilia Linde … (2013)
              Aims Cardiac resynchronization therapy (CRT) with or without a defibrillator reduces morbidity and mortality in selected patients with heart failure (HF) but response can be variable. We sought to identify pre-implantation variables that predict the response to CRT in a meta-analysis using individual patient-data. Methods and results An individual patient meta-analysis of five randomized trials, funded by Medtronic, comparing CRT either with no active device or with a defibrillator was conducted, including the following baseline variables: age, sex, New York Heart Association class, aetiology, QRS morphology, QRS duration, left ventricular ejection fraction (LVEF), and systolic blood pressure. Outcomes were all-cause mortality and first hospitalization for HF or death. Of 3782 patients in sinus rhythm, median (inter-quartile range) age was 66 (58–73) years, QRS duration was 160 (146–176) ms, LVEF was 24 (20–28)%, and 78% had left bundle branch block. A multivariable model suggested that only QRS duration predicted the magnitude of the effect of CRT on outcomes. Further analysis produced estimated hazard ratios for the effect of CRT on all-cause mortality and on the composite of first hospitalization for HF or death that suggested increasing benefit with increasing QRS duration, the 95% confidence bounds excluding 1.0 at ∼140 ms for each endpoint, suggesting a high probability of substantial benefit from CRT when QRS duration exceeds this value. Conclusion QRS duration is a powerful predictor of the effects of CRT on morbidity and mortality in patients with symptomatic HF and left ventricular systolic dysfunction who are in sinus rhythm. QRS morphology did not provide additional information about clinical response. ClinicalTrials.gov numbers NCT00170300, NCT00271154, NCT00251251.
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                Author and article information

                Contributors
                Seung‐Jung Park: orthovics@skku.edu , orthovics@gmail.com
                Journal
                Journal ID (nlm-ta): ESC Heart Fail
                Journal ID (iso-abbrev): ESC Heart Fail
                Journal ID (doi): 10.1002/(ISSN)2055-5822
                Journal ID (publisher-id): EHF2
                Title: ESC Heart Failure
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Electronic): 2055-5822
                Publication date (Electronic): 13 August 2020
                Publication date Collection: October 2020
                Volume: 7
                Issue: 5 ( doiID: 10.1002/ehf2.v7.5 )
                Pages: 3109-3118
                Affiliations
                [ 1 ] Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center Sungkyunkwan University School of Medicine 81, Irwon‐ro, Gangnam‐gu Seoul 06351 Korea
                Author notes
                [*] [* ] Correspondence to: Seung‐Jung Park, Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon‐ro, Gangnam‐gu, Seoul 06351, Korea. Tel: 82‐2‐3410‐7145; Fax: 82‐2‐3410‐3849. Email: orthovics@ 123456skku.edu , orthovics@ 123456gmail.com

                Article
                Publisher ID: EHF212940 Other ID: ESCHF-20-00250
                DOI: 10.1002/ehf2.12940
                PMC ID: 7524047
                PubMed ID: 32790157
                SO-VID: 9839fff0-de7c-427f-ac8d-6311b779d04e
                Copyright © © 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                Date received : 03 April 2020
                Date revision received : 03 June 2020
                Date accepted : 19 July 2020
                Page count
                Figures: 3, Tables: 3, Pages: 10, Words: 4152
                Categories
                Subject: Original Research Article
                Subject: Original Research Articles
                Custom metadata
                source-schema-version-number 2.0
                cover-date October 2020
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.1 mode:remove_FC converted:29.09.2020

                Keywords: cardiac resynchronization therapy,far‐advanced heart failure,new york heart association class iv,prognosis
                Data availability:
                Keywords: cardiac resynchronization therapy, far‐advanced heart failure, new york heart association class iv, prognosis

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