Emerging Topics in Heart Failure: Interventional Heart Failure Therapies

Keywords
Mitral valve insufficiency; Pacemaker, Artificial; Catheter ablation; Defibrillators, Implantable; Tricuspid valve insufficiency

Treatment of Secondary Mitral Regurgitation

Before considering percutaneous treatment of mitral regurgitation (MR) for patients with heart failure (HF) with reduced ejection fraction (HFrEF) and severe MR,¹ we recommend that guideline-directed medical therapy be optimized, including cardiac resynchronization therapy and revascularization, where appropriate.

The use of the edge-to-edge device could benefit patients with moderately severe or severe secondary MR (effective regurgitant orifice area [EROA] ≥ 30 mm² and/or regurgitant volume > 45 mL) with a left ventricular ejection fraction (LVEF) of 20 to 50%, left ventricular (LV) end-systolic diameter < 7.0 cm, and persistent symptoms despite maximized evidence-based medical therapy, with the participation of an experienced multidisciplinary team in the evaluation and treatment of HF and MR.²

The COAPT trial included patients with more severe MR and less advanced LV disease (dilatation/dysfunction) compared to patients of the MITRA-FR trial, creating the concept of disproportionate MR (Table 1).

Table 1
Comparison of the characteristics and results of the COAPT and MITRA-FR trials

	MITRA-FR	COAPT
Total number of patients	304	614
Medical therapy	Adjusted in the trial	Optimized therapy
≥ moderate to severe (3+) iMR	EROA > 20 mm2 and/or RV > 30 mL	EROA > 30 mm2 and/or RV > 45 mL
LVESD, mm (LV size)	Without limit	< 70 upon inclusion
NYHA class > II, %	67.0	60.4
Hospital in previous years, %	100	57.1
EROA, mm2	31 ± 10	41 ± 15
Severe (EROA ≥ 40 mm2), %	16	41
iLVEDV, mL/m2	135 ± 35	101 ± 34
1-year mortality (IvsC), %	24.2 ± 22.4	19.1 vs 23.2 (p < 0.001)
1-year HF hospitalization (IvsC), %	48.7 ± 47.4	35.8 vs 67.9 (p < 0.001) Primary objective
Annual mortality/ HF hospitalization (IvsC), %	54.6 vs 51.3 (p = 0.53) Primary objective	33.9 vs 46.5 (p < 0.001)

• iMR: ischemic mitral regurgitation; EROA: effective regurgitant orifice area; RV: regurgitant volume; LVESD: left ventricular end-systolic diameter; NYHA: New York Heart Association; iLVEDV: indexed left ventricular end-diastolic volume; IvsC: Invasive vs Control; HF: heart failure.

When to Indicate an Implantable Cardioverter Defibrillator (ICD) in Face of New Medications in HFrEF?

Ischemic Cardiomyopathy

The randomized MADIT II and SCD-HeFT trials,^3,4 conducted more than 15 years ago, validated the indication of ICDs for the primary prevention of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy with an ejection fraction ≤ 35% in New York Heart Association (NYHA) class II or III after optimization of medical therapy, after at least 40 days of the acute phase of myocardial infarction and at least 90 days of any myocardial revascularization procedure, without severe comorbidities and with good 1-year life expectancy. These trials were conducted at a time when pharmacologic treatment was far less than desirable in terms of doses. Currently, medications can promote a substantial reduction in the annual rate of SCD.^5,6

Nonischemic Cardiomyopathy

Small randomized trials (CAT, AMIOVIRT, and DEFINITE), conducted more than 10 years ago, were unable to demonstrate a reduction in mortality with the use of ICDs for primary prevention of SCD in nonischemic cardiomyopathy.⁵ Recently, the DANISH trial,⁷ with a robust sample of properly treated patients, also demonstrated that ICDs did not reduce total mortality or cardiovascular death in this population. We should consider greater risk stratification in these patients by incorporating magnetic resonance imaging quantification of fibrosis, which has shown to be associated with cardiovascular death and SCD in patients with nonischemic cardiomyopathy.⁸

Pulmonary-vein Isolation for the Treatment of Atrial Fibrillation (AF) in Patients with HFrEF

AF ablation in patients with HF provides greater benefit than the use of antiarrhythmic medications due to higher sinus rhythm maintenance rate, improved functional capacity and quality of life, improved NYHA class, longer 6-minute-walk distance, improved peak VO₂,⁹ reduced biomarker (brain natriuretic peptide [BNP]) levels, increased ejection fraction,^9,10 and reduced HF hospitalization, HF death or hospitalization, and death from any cause.^9–11 However, the success rate ranges from 60 to 80% at 1 year, when structural heart disease is a risk factor for recurrence.¹² Pulmonary-vein isolation can be achieved by radiofrequency or cryoablation, and these techniques can be combined with ablation of other substrates. Benefits include symptom control in patients with paroxysmal/persistent AF and the promotion of reverse remodeling in patients with ventricular dysfunction due to AF-induced tachycardiomyopathy, regardless of symptoms.

New Forms of Cardiac Pacing in HF

Ventricular pacing through the native His-Purkinje conduction system may be an option for patients with pacemaker indication, given the deleterious effects of isolated right ventricular (RV) pacing in patients with HF.¹³ Small trials suggest that His bundle pacing may result in a decrease in the incidence of cardiomyopathy, reduction in the combined endpoint of hospitalization or death, and improvement in LV dimensions and HF symptoms compared to isolated RV pacing.^13,14 The American guideline for the management of bradycardia recommends His bundle pacing or cardiac resynchronization therapy for patients with ventricular dysfunction who have atrioventricular block with an indication for permanent pacemaker instead of isolated RV pacing.¹⁵ Compared to cardiac resynchronization therapy, His bundle pacing had an equivalent effect, with a significant reduction in QRS duration and improvement in LVEF, HF symptoms, and quality of life.^16,17 His bundle pacing was also tested in patients with HFrEF and right bundle branch block, leading to increased LVEF and narrowing of QRS duration.¹⁸

Percutaneous Treatment of Tricuspid Regurgitation in HF

The advent of percutaneous treatment of functional tricuspid regurgitation is attractive in selected patients at high surgical risk, for an expected improvement of symptoms. Patients who may benefit from this treatment include those with HF refractory to optimized medical therapy or with early signs of RV dysfunction, who are considered at high risk for conventional cardiac surgery or inoperable. Devices are divided into annuloplasty systems, tricuspid valve repair systems, and prosthetic valves for vena cava stenting. Although safety and efficacy clinical trials appear to be promising, the available evidence is based on single-center observational studies or registries. Therefore, more robust evidence is needed before we can confidently indicate any treatment.¹⁹

List of Participants of the Heart Failure Summit Brazil. 2020 / Heart Failure Department - Brazilian Society of Cardiology

Aguinaldo Freitas Junior, Andréia Biolo, Antonio Carlos Pereira Barretto, Antônio Lagoeiro Jorge, Bruno Biselli. Carlos Eduardo Montenegro, Denilson Campos de Albuquerque, Dirceu Rodrigues de Almeida, Edimar Alcides Bocchi, Edval Gomes dos Santos Júnior, Estêvão Lanna Figueiredo, Evandro Tinoco Mesquita, Fabiana G. Marcondes-Braga, Fábio Fernandes, Fabio Serra Silveira, Felix José Alvarez Ramires, Fernando Atik, Fernando Bacal, Flávio de Souza Brito, Germano Emilio Conceição Souza, Gustavo Calado de Aguiar Ribeiro, Humberto Villacorta Jr., Jefferson Luis Vieira, João David de Souza Neto, João Manoel Rossi Neto, José Albuquerque de Figueiredo Neto, Lídia Ana Zytynski Moura, Livia Adams Goldraich, Luís Beck-da-Silva Neto, Luís Eduardo Paim Rohde, Luiz Claudio Danzmann, Manoel Fernandes Canesin, Marcelo Bittencourt, Marcelo Westerlund Montera, Marcely Gimenes Bonatto, Marcus Vinicius Simões, Maria da Consolação Vieira Moreira, Miguel Morita Fernandes da Silva, Monica Samuel Avila, Mucio Tavares de Oliveira Junior, Nadine Clausell, Odilson Marcos Silvestre, Otavio Rizzi Coelho Filho, Pedro Vellosa Schwartzmann, Reinaldo Bulgarelli Bestetti, Ricardo Mourilhe Rocha, Sabrina Bernadez Pereira, Salvador Rassi, Sandrigo Mangini, Silvia Marinho Martins, Silvia Moreira Ayub Ferreira, Victor Sarli Issa.

• Research letter related to Heart Failure Summit Brazil 2020 / Heart Failure Department - Brazilian Society of Cardiology
• Sources of Funding
  There were no external funding sources for this study.
• Study Association
  This study is not associated with any thesis or dissertation work.

Referências

• ¹
  Comitê Coordenador da Diretriz de Insuficiência Cardíaca, Rohde LEP, Montera MW, Bocchi EA, Clausell NO, Albuquerque DC de, Rassi S, et al. Diretriz Brasileira de Insuficiência Cardíaca Crônica e Aguda. Arq Bras Cardiol. 2018 Sep;111(3):436–539.
• ²
  Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 13;379(24):2307–18.
• ³
  Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877–83.
• ⁴
  Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225–37.
• ⁵
  Tung R, Zimetbaum P, Josephson ME. A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. J Am Coll Cardiol. 2008 Sep 30;52(14):1111–21.
• ⁶
  Shen L, Jhund PS, Petrie MC, Claggett BL, Barlera S, Cleland JGF, et al. Declining Risk of Sudden Death in Heart Failure. N Engl J Med. 2017 06;377(1):41–51.
• ⁷
  Køber L, Thune JJ, Nielsen JC, Haarbo J, Videbæk L, Korup E, et al. Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med. 2016 29;375(13):1221–30.
• ⁸
  Leyva F, Zegard A, Acquaye E, Gubran C, Taylor R, Foley PWX, et al. Outcomes of Cardiac Resynchronization Therapy With or Without Defibrillation in Patients With Nonischemic Cardiomyopathy. J Am Coll Cardiol. 2017 Sep 5;70(10):1216–27.
• ⁹
  Khan MN, Jaïs P, Cummings J, Di Biase L, Sanders P, Martin DO, et al. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. 2008 Oct 23;359(17):1778–85.
• ¹⁰
  Willems S, Meyer C, de Bono J, Brandes A, Eckardt L, Elvan A, et al. Cabins, castles, and constant hearts: rhythm control therapy in patients with atrial fibrillation. Eur Heart J. 2019 07;40(46):3793–3799c.
• ¹¹
  Marrouche NF, Brachmann J, Andresen D, Siebels J, Boersma L, Jordaens L, et al. Catheter Ablation for Atrial Fibrillation with Heart Failure. N Engl J Med. 2018 Feb 1;378(5):417–27.
• ¹²
  Arbelo E, Brugada J, Hindricks G, Maggioni AP, Tavazzi L, Vardas P, et al. The atrial fibrillation ablation pilot study: a European Survey on Methodology and results of catheter ablation for atrial fibrillation conducted by the European Heart Rhythm Association. Eur Heart J. 2014 Jun 7;35(22):1466–78.
• ¹³
  Vijayaraman P, Chung MK, Dandamudi G, Upadhyay GA, Krishnan K, Crossley G, et al. His Bundle Pacing. J Am Coll Cardiol. 2018 21;72(8):927–47.
• ¹⁴
  Vijayaraman P, Naperkowski A, Subzposh FA, Abdelrahman M, Sharma PS, Oren JW, et al. Permanent His-bundle pacing: Long-term lead performance and clinical outcomes. Heart Rhythm. 2018;15(5):696–702.
• ¹⁵
  Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, et al. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 20;74(7):e51–156.
• ¹⁶
  Lustgarten DL, Crespo EM, Arkhipova-Jenkins I, Lobel R, Winget J, Koehler J, et al. His-bundle pacing versus biventricular pacing in cardiac resynchronization therapy patients: A crossover design comparison. Heart Rhythm. 2015 Jul;12(7):1548–57.
• ¹⁷
  Upadhyay GA, Vijayaraman P, Nayak HM, Verma N, Dandamudi G, Sharma PS, et al. His Corrective Pacing or Biventricular Pacing for Cardiac Resynchronization in Heart Failure. J Am Coll Cardiol. 2019 09;74(1):157–9.
• ¹⁸
  Sharma PS, Naperkowski A, Bauch TD, Chan JYS, Arnold AD, Whinnett ZI, et al. Permanent His Bundle Pacing for Cardiac Resynchronization Therapy in Patients With Heart Failure and Right Bundle Branch Block. Circ Arrhythm Electrophysiol. 2018;11(9):e006613.
• ¹⁹
  Orban M, Rommel K-P, Ho EC, Unterhuber M, Pozzoli A, Connelly KA, et al. Transcatheter Edge-to-Edge Tricuspid Repair for Severe Tricuspid Regurgitation Reduces Hospitalizations for Heart Failure. JACC Heart Fail. 2020;8(4):265–76.

Publication Dates

• Publication in this collection
  07 Dec 2020
• Date of issue
  Nov 2020

History

• Received
  07 Oct 2020
• Reviewed
  07 Oct 2020
• Accepted
  07 Oct 2020