Left ventricular assist device and transcatheter edge-to-edge mitral valve repair in advanced heart failure: allies or enemies?

The implantation of left ventricular assist devices (LVADs) has been increasing, with good long-term results, in parallel with a growing population with advanced heart failure (HF). However, in some European countries, LVADs are still underused, with one of the main issues being the patient's late referral. On the contrary, the use of transcatheter edge-to-edge mitral valve repair (TEER) has exponentially increased over the past decade, expanding its potential use even in patients on the heart transplantation waiting list. Even though the study populations of the main trials that investigated the prognostic impact of LVAD and TEER are different, in clinical practice a clear distinction might not be so clear. Therefore, patients with refractory HF symptoms and significant mitral regurgitation should be thoroughly evaluated through a multidisciplinary Heart Team meeting with both an advanced HF specialist and interventional cardiologist, to avoid futile procedures and to define the optimal timing for advanced HF therapies, when they are indicated. We analyzed the main available studies and registries on both TEERs and LVADs and we compared their populations and outcomes, to provide the current evidence on the use of LVAD and TEER in the HF population, especially in the light of the recently released 5-year follow-up results, giving some insights on the Italian situation, and finally to stress the importance of a solid HF network between hospitals, aiming for advanced HF patients’ timely referral for LVAD or heart transplants.

[1]  A. Lorts,et al.  Durable Mechanical Circulatory Support: JACC Scientific Statement. , 2023, Journal of the American College of Cardiology.

[2]  G. Stone,et al.  Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. , 2023, The New England journal of medicine.

[3]  W. Rottbauer,et al.  Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study. , 2023, JACC. Cardiovascular interventions.

[4]  J. Zamorano,et al.  Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study , 2023, ESC heart failure.

[5]  N. Uriel,et al.  Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. , 2022, JAMA.

[6]  M. Metra,et al.  Prognostic impact of the updated 2018 HFA‐ESC definition of advanced heart failure: results from the HELP‐HF registry , 2022, European journal of heart failure.

[7]  L. Lund,et al.  Improved survival of left ventricular assist device carriers in Europe according to implantation eras: results from the PCHF‐VAD registry , 2022, European journal of heart failure.

[8]  M. Link,et al.  2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. , 2022, Journal of the American College of Cardiology.

[9]  G. Sinagra,et al.  [ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: what's new?] , 2022, Giornale italiano di cardiologia.

[10]  Elias Mossialos,et al.  A clinical and cost-effectiveness analysis of the HeartMate 3 left ventricular assist device for transplant-ineligible patients: A United Kingdom perspective. , 2021, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[11]  M. Morshuis,et al.  Safety, Mortality, and Hemodynamic Impact of Patients with MitraClip Undergoing Left Ventricular Assist Device Implantation , 2021, Journal of Cardiovascular Translational Research.

[12]  Natasha Meunier-McVey,et al.  2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure , 2021, EMJ Cardiology.

[13]  S. Russell,et al.  Guidance for Timely and Appropriate Referral of Patients With Advanced Heart Failure: A Scientific Statement From the American Heart Association , 2021, Circulation.

[14]  B. Prendergast,et al.  2021 ESC/EACTS Guidelines for the management of valvular heart disease. , 2021, European heart journal.

[15]  J. Cleveland,et al.  Primary results of long‐term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants , 2021, European Journal of Heart Failure.

[16]  L. Lund,et al.  The Heart Failure Association Atlas: Heart Failure Epidemiology and Management Statistics 2019 , 2021, European journal of heart failure.

[17]  J. Cleveland,et al.  Clinical outcomes and healthcare expenditures in the real world with left ventricular assist devices - The CLEAR-LVAD study. , 2021, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[18]  M. Mack,et al.  2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. , 2020, Circulation.

[19]  H. Katus,et al.  MitraClip implantation followed by insertion of a left ventricular assist device in patients with advanced heart failure , 2020, ESC heart failure.

[20]  M. Morshuis,et al.  Two-year outcome after implantation of a full magnetically levitated left ventricular assist device: results from the ELEVATE Registry. , 2020, European heart journal.

[21]  M. Metra,et al.  MitraClip in secondary mitral regurgitation as a bridge to heart transplantation: 1-year outcomes from the International MitraBridge Registry. , 2020, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[22]  J. Rogers,et al.  Advanced Heart Failure: Epidemiology, Diagnosis, and Therapeutic Approaches. , 2020, JACC. Heart failure.

[23]  J. Cleveland,et al.  Impact of left ventricular assist device implantation on mitral regurgitation: An analysis from the MOMENTUM 3 trial. , 2020, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[24]  M. Mack,et al.  Cost-Effectiveness of Transcatheter Mitral Valve Repair versus Medical Therapy in Patients with Heart Failure and Secondary Mitral Regurgitation: Results from the COAPT Trial. , 2019, Circulation.

[25]  M. Frigerio,et al.  Safety of centrifugal left ventricular assist device in patients previously treated with MitraClip system. , 2019, International journal of cardiology.

[26]  M. Walsh,et al.  A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report , 2019, The New England journal of medicine.

[27]  A. Sannino,et al.  Proportionate and Disproportionate Functional Mitral Regurgitation: A New Conceptual Framework That Reconciles the Results of the MITRA-FR and COAPT Trials. , 2019, JACC. Cardiovascular imaging.

[28]  M. Mack,et al.  Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial , 2018, American heart journal.

[29]  M. Mack,et al.  Transcatheter Mitral‐Valve Repair in Patients with Heart Failure , 2018, The New England journal of medicine.

[30]  D. Maucort-Boulch,et al.  Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation , 2018, The New England journal of medicine.

[31]  G. Filippatos,et al.  Advanced heart failure: a position statement of the Heart Failure Association of the European Society of Cardiology , 2018, European journal of heart failure.

[32]  A. Haverich,et al.  MitraClip procedure prior to left ventricular assist device implantation. , 2018, Journal of thoracic disease.

[33]  M. Metra,et al.  Heart failure , 2017, The Lancet.

[34]  J. Baumwol "I Need Help"-A mnemonic to aid timely referral in advanced heart failure. , 2017, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[35]  Danielle M. Enserro,et al.  Prevalence, Neurohormonal Correlates, and Prognosis of Heart Failure Stages in the Community. , 2016, JACC. Heart failure.

[36]  J. Butler,et al.  Defining Advanced Heart Failure: A Systematic Review of Criteria Used in Clinical Trials. , 2016, Journal of cardiac failure.

[37]  J. Cleveland,et al.  Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. , 2016, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[38]  M. Drazner,et al.  2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. , 2013, Circulation.

[39]  J. Caro ESC/EACTS Guidelines on the management of valvular heart disease , 2012 .