Improvement in quality of life with sacubitril/ /valsartan in cardiac resynchronization non-responders: The RESINA (RESynchronization plus an Inhibitor of Neprilysin/Angiotensin) registry
, 2, 1, 2, 1, 1, 1, 1, 2, 1
Abstract
Background: Clinical management of cardiac resynchronization therapy (CRT) non-responders is difficult, and their prognosis is poor. The aim of the present study was to evaluate whether treatment with sacubitril/valsartan can improve quality of life (QoL) parameters in these patients.
Methods: Thirty five non-responders to CRT were included (75 ± 7 years, 28% females, mean left ventricular ejection fraction 28 ± 8%, 54% non-ischemic cardiomyopathy) with maximally optimized drug therapy and New York Heart Association class II–III. They were all on angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers and were switched to sacubitril/valsartan. One week before and 6 months after initiation of the therapy they completed both the Minnesota Living with Heart Failure (MLWHF) and the 12-item Kansas City Cardiomyopathy Questionnaires (KCCQ-12). The primary outcome was the effect of sacubitril/valsartan on the physical, clinical, social and emotional QoL parameters and number of hospitalizations.
Results: The mean total scores of both questionnaires improved from baseline to the follow-up visit at 6-months (KCCQ-12 40 ± 10 to 47 ± 10; p < 0.001; MLWHF 40 ± 15 to 29 ± 15; p < 0.001). The best results were seen in the KCCQ-12 total symptom domains (77% improvement), the MLWHF physical domain (81% improvement), and the MLWHF emotional domain (71% improvement). Two patients died during follow-up. The mean number of hospitalizations reduced significantly (1 ± 0.6 vs. 0.5 ± 0.8; p = 0.003)
Conclusions: In CRT non-responders, sacubitril/valsartan significantly improved overall QoL, physical limitations and emotional domains and reduced the number of hospitalizations.
Keywords: resynchronizationsacubitril/valsartanquality of life
References
- Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013; 34(29): 2281–2329.
- Ponikowski P, Voors A, Anker S, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016; 37(27): 2129–2200.
- Naqvi SY, Jawaid A, Goldenberg I, et al. Non-response to cardiac resynchronization therapy. Curr Heart Fail Rep. 2018; 15(5): 315–321.
- Leong DP, Höke U, Delgado V, et al. Predictors of long-term benefit of cardiac resynchronization therapy in patients with right bundle branch block. Eur Heart J. 2012; 33(15): 1934–1941.
- Daubert C, Behar N, Martins RP, et al. Avoiding non-responders to cardiac resynchronization therapy: a practical guide. Eur Heart J. 2017; 38(19): 1463–1472.
- Packer M, McMurray JJV, Desai AS, et al. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015; 131(1): 54–61.
- Morrow D, Velazquez E, DeVore A, et al. Clinical outcomes in patients with acute decompensated heart failure randomly assigned to sacubitril/valsartan or enalapril in the PIONEER-HF trial. Circulation. 2019; 139(19): 2285–2288.
- Packer M. Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. J Card Fail. 2001; 7(2): 176–182.
- Rector T, Kubo S, Cohn J. Validity of the minnesota living with heart failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol. 1993; 71(12): 1106–1107.
- Spertus JA, Jones PG. Development and validation of a short version of the kansas city cardiomyopathy questionnaire. Circ Cardiovasc Qual Outcomes. 2015; 8(5): 469–476.
- Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Heart J. 1992; 124(4): 1017–1025.
- Garin O, Soriano N, Ribera A, et al. [Validation of the Spanish version of the Minnesota Living with Heart Failure Questionnaire]. Rev Esp Cardiol. 2008; 61(3): 251–259.
- Comín-Colet J, Garin O, Lupón J, et al. Validation of the Spanish version of the Kansas city cardiomyopathy questionnaire. Rev Esp Cardiol. 2011; 64(1): 51–58.
- Sijtsma K, Emons WHM, Bouwmeester S, et al. Nonparametric IRT analysis of Quality-of-Life Scales and its application to the World Health Organization Quality-of-Life Scale (WHOQOL-Bref). Qual Life Res. 2008; 17(2): 275–290.
- Tate CW, Robertson AD, Zolty R, et al. Quality of life and prognosis in heart failure: results of the Beta-Blocker Evaluation of Survival Trial (BEST). J Card Fail. 2007; 13(9): 732–737.
- Rector TS, Carson PE, Anand IS, et al. Assessment of long-term effects of irbesartan on heart failure with preserved ejection fraction as measured by the minnesota living with heart failure questionnaire in the irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial. Circ Heart Fail. 2012; 5(2): 217–225.
- Chandra A, Lewis EF, Claggett BL, et al. Effects of sacubitril/valsartan on physical and social activity limitations in patients with heart failure: a secondary analysis of the PARADIGM-HF trial. JAMA Cardiol. 2018; 3(6): 498–505.
- Lewis EF, Claggett BL, McMurray JJV, et al. Health-Related quality of life outcomes in PARADIGM-HF. Circ Heart Fail. 2017; 10(8).
- Ruschitzka F. The challenge of nonresponders to cardiac resynchronization therapy: lessons learned from oncology. Heart Rhythm. 2012; 9(8 Suppl): S14–S17.
- Kang DH, Park SJ, Shin SH, et al. Angiotensin receptor neprilysin inhibitor for functional mitral regurgitation. Circulation. 2019; 139(11): 1354–1365.
- Kitko L, McIlvennan CK, Bidwell JT, et al. American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; Council on Clinical Cardiology; and Council on Lifestyle and Cardiometabolic Health. Family Caregiving for Individuals With Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2020; 141(22): e864–e878.
- White-Williams C, Rossi LP, Bittner VA, et al. American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Epidemiology and Prevention. Addressing Social Determinants of Health in the Care of Patients With Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2020; 141(22): e841–e863.
- Dereli S, Kılınçel O, Çerik İB, et al. Impact of sacubitril/valsartan treatment on depression and anxiety in heart failure with reduced ejection fraction. Acta Cardiol. 2020; 75(8): 774–782.
- Carels RA. The association between disease severity, functional status, depression and daily quality of life in congestive heart failure patients. Qual Life Res. 2004; 13(1): 63–72.
- Vicent L, Esteban-Fernández A, Gómez-Bueno M, et al. Sacubitril/Valsartan in daily clinical practice: data from a prospective registry. J Cardiovasc Pharmacol. 2019; 73(2): 118–124.
- Velazquez E, Morrow D, DeVore A, et al. Angiotensin–Neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2019; 380(6): 539–548.
- Du AX, Westerhout CM, McAlister FA, et al. Titration and tolerability of sacubitril/valsartan for patients with heart failure in clinical practice. J Cardiovasc Pharmacol. 2019; 73(3): 149–154.
- Vardeny O, Claggett B, Packer M, et al. Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) Investigators. Efficacy of sacubitril/valsartan vs. enalapril at lower than target doses in heart failure with reduced ejection fraction: the PARADIGM-HF trial. Eur J Heart Fail. 2016; 18(10): 1228–1234.
- Senni M, McMurray JJV, Wachter R, et al. Initiating sacubitril/valsartan (LCZ696) in heart failure: results of TITRATION, a double-blind, randomized comparison of two uptitration regimens. Eur J Heart Fail. 2016; 18(9): 1193–1202.
