Mitral Valve Repair Replacement Mitra Clip in patients

Mitral Valve Repair / Replacement / Mitra. Clip in patients advanced heart failure and severe mitral regurgitation reverses LV remodeling and improves symptoms Basil Mantas Paulus, MD Todd Edwards, MD

Disclosures: I have no conflicts of interest for this discussion. However, I will be discussing indications for the Mitra. Clip that are not FDA approved.

Mitra. Clip Indications for Use

Mitra. Clip Indications for Use

Types of Mitral Regurgitation

Secondary Mitral Regurgitation / Functional MR

Functional MR leads to Poor Outcomes… Grigioni F, et al. Circulation 2001; 103: 175964. Basket JF, et al. Can J Cardiol 2007; 23: 797800.

Functional MR leads to Poor Outcomes… 1. 2. Rossi A, et al. “Independent prognostic value of functional mitral regurgitation in patients with heart failure: a quantitative analysis of 1256 patients with ischemic and nonischemic dilated cardiomyopathy. ” Heart 2011; 97 (20): 1675 -80. Bursi F, et al. “Prognostic implications of functional mitral regurgitation according to the severity of the underlying chronic heart failure: a long term outcome study. ” Eur J Heart Fail 2010; 12(4): 382 -8.

Functional MR after Cardiac Resynchronization Therapy • 1313 patients with ischemic and non-ischemic cardiomyopathy treated with CRT were evaluated • Four groups of patients: • None/mild MR that remained unchanged at 6 months • None/mild MR that worsened to moderate/severe MR • Moderate/severe MR that improved to none/mild MR • Moderate/severe MR that remained unchanged at 6 months “Functional Mitral Regurgitation and Cardiac Resynchronization Therapy: Evolution and Impact on Outcome. ” van der Bijl, P, et al. J Am Coll Cardiol 2017; 69: 695.

Why Dr. Edwards is Wrong…

Why Dr. Edwards is Wrong… ACC / AHA Guidelines • Mitral valve surgery is reasonable for patients with symptomatic, severe functional mitral regurgitation who are undergoing CABG or AVR (Class IIa, level of evidence C). • Mitral surgery can be considered for severely symptomatic patients (NYHA Class III or IV) with chronic severe functional mitral regurgitation (Class IIb, level of evidence B) • In patients with chronic moderate ischemic mitral regurgitation who are undergoing CABG, the usefulness of mitral valve repair is uncertain (Class IIb, level of evidence B)

Why Dr. Edwards is wrong… • Heart Transplantation is an established therapy for cardiomyopathy. • However, heart transplantation is limited by a very limited supply of organs, expense, consequences and expense of chronic immunosuppressive therapy, as well as the long term risks of rejection, infection, and graft vasculopathy. • There about 3500 heart transplants done world-wide per year and about 2200 -2300 in the USA. About 800, 000 people have NYHA Class IV heart failure symptoms. • Comparing heart transplantation versus CABG, surgical mitral valve repair, or LV reconstruction in 268 patients with cardiomyopathy and LVEF <30%, the patients that had a heart transplantation had a total hospital cost that was significantly greater than the other groups, but there were no survival difference between the various groups up to 80 months. “A cost comparison of heart transplantation versus alternative operations for cardiomyopathy. ” Cope JT, et al. Ann Thorac Surg 2001; 72: 1298 -305.

Why Dr. Edwards is wrong… A: CABG B: Mitral Valve Repair C: LV reconstruction D: Orthotopic Heart Transplant “A cost comparison of heart transplantation versus alternative operations for cardiomyopathy. ” Cope JT, et al. Ann Thorac Surg 2001; 72: 1298 -305.

Why Dr. Edwards is wrong… “Mechanism of Symptomatic Improvement after Percutaneous Therapy for Secondary Mitral Regurgitation. ” Van De Heyning CM. J Am Coll Cardiol 2016; 68: 128 -9.

Why Dr. Edwards is wrong… Correction of Mitral Regurgitation in Nonresponders to cardiac resynchronization therapy by Mitra. Clip “Correction of Mitral Regurgitation in Nonresponders to Cardiac Resynchronization Therapy by Mitra. Clip Improves Symptoms and Promotes Reverse Remodeling. ” Auricchio A, et al. J Am Coll Cardiol 2011; 58: 2183 -9.

Why Dr. Edwards is wrong… ACCESS EU Study “Percutaneous Mitral Valve Interventions in the Real World, Early and One Year Results from the ACCESS-EU, A Prospective Multicenter Nonrandomized Post-approval Study of the Mitra. Clip therapy in Europe. ” Maisano F, et al. J Am Coll Cardiol 2013; 62: 1052 -61.

Why Dr. Edwards is wrong… ACCESS EU Study “Percutaneous Mitral Valve Interventions in the Real World, Early and One Year Results from the ACCESS-EU, A Prospective Multicenter Nonrandomized Post-approval Study of the Mitra. Clip therapy in Europe. ” Maisano F, et al. J Am Coll Cardiol 2013; 62: 1052 -61.

Why Dr. Edwards is wrong… ACCESS EU Study “Percutaneous Mitral Valve Interventions in the Real World, Early and One Year Results from the ACCESS-EU, A Prospective Multicenter Nonrandomized Post-approval Study of the Mitra. Clip therapy in Europe. ” Maisano F, et al. J Am Coll Cardiol 2013; 62: 1052 -61.

Why Dr. Edwards is wrong… “The evolution of percutaneous mitral valve repair therapy. ” Beigel R, et al. J Am Coll Cardiol 2014; 64: 2688 -700.

Why Dr. Edwards is wrong… Mitra. Clip vs Surgery for Primary and Secondary Mitral Regurgitation Asgar AW, et al. “Secondary Mitral Regurgitation in Heart Failure: Pathophysiology, Prognosis, and Therapeutic Considerations. ” J Am Coll Cardiol 2015; 65: 1231 -48.

Why Dr. Edwards is wrong… Mc. Gee EC. “Surgery, Mitral Regurgitation, and Heart Failure. The Valves are all repairable but the patients are not. ” Circ Heart Fail 2008; 1: 285 -9.

Why Dr. Edwards is wrong… Mc. Gee EC. “Surgery, Mitral Regurgitation, and Heart Failure. The Valves are all repairable but the patients are not. ” Circ Heart Fail 2008; 1: 285 -9.

Why Dr. Edwards is Wrong… Mitral Valve Surgery in patients with severe LV dysfunction Between 1990 and 1998, 44 patients with severe MR and LVEF < 35% underwent isolated mitral repair (35) or replacement (9) at the Cleveland Clinic. 7 patients were initially referred for a heart transplant. Following 5 year follow up, none of these patients were listed for a transplant. 1 year survival – 89%, 2 year survival – 86%, and 5 year survival – 67% Bishay ES, et al. “Mitral Valve Surgery in patients with severe left ventricular dysfunction. ” European Journal of Cardio-thoracic Surgery 17 (2000) 213 -221.

Why Dr. Edwards is Wrong… • In a single center retrospective analysis by Wu, et al, mitral valve annuloplasty failed to show benefit over medical therapy in the primary end point of death, LV assist device implantation, or heart transplantation. • However, in the ACORN trial, mitral valve repair, with or without an external cardiac restraint device in patients with NYHA Class III or IV heart failure, LVEF <35%, and LV dilation, was associated with reduction in LV mass, increased LVEF, and sphericity index • In a sub study of the STICH trial, there was a strong trend towards benefit to adding mitral valve repair to CABG vs medical therapy in patients with severe mitral regurgitation. After adjustments for baseline variables in groups, CABG with mitral surgery was superior to CABG alone in patients with severe mitral regurgitation. • In the RIME trial, 73 patients with moderate functional MR were randomized to CABG along vs CABG + Mitral Valve Repair. The trial was stopped early due to an early benefit in the primary endpoint of peak O 2 consumption. LV remodeling, MR severity, and functional class were all better with mitral valve repair, but the trial was not powered to find a mortality benefit.

Surgery… Mitral Repair versus Replacement • Currently MV replacement is usually reserved for situations where the mitral valve cannot be reasonably repaired, or repair is unlikely to be tolerated clinically. MVR without preservation of the mitral apparatus and cordal structures is not recommended because preservation of the mitral apparatus has been shown to preserve LV geometry and systolic function and improve survival. • Mitral repair was previously preferred when possible based on valve pathology and patient stability because it avoids long term anticoagulation needed for mechanical valves, decreases the risk of endocarditis with a foreign object (valve), and provides greater leaflet durability. Ring annuloplasty is usually considered the gold standard for repair and partial ring annuloplasty and flexible rings are not used much anymore, due to increased risk of recurrence of mitral regurgitation over time. • In the Cardiothoracic Surgical Trials Network comparing 251 patients with ischemic MR and CAD between 2009 and 2011 that were getting mitral valve repair or replacement, there was no statistically significant different in 1 year mortality between the two groups (14. 3% - repair, 17. 6% - replacement), but the repair group showed a higher rate of recurrence of moderate or severe MR at 12 months (32. 6% - repair, 2. 3% replacement). There were no statistically significant differences in major adverse cardiac or cerebrovascular events, functional status, or quality of life at 12 months. • Therefore, the most recent AHA/ACC focused update on valvular heart disease stated that it is reasonable to choose chordal sparing mitral valve replacement over downsized annuloplasty repair if operation is considered for severely symptomatic patients with NYHA Class III or IV with chronic severe ischemic mitral regurgitation and symptoms despite optimal medical therapy.

Current and Future Technologies 1. 2. Feldman T, et al. “Percutaneous approaches to valve repair for mitral regurgitation. ” J Am Coll Cardiol 2014; 63: 2057 -68. Tomás Benito-González, et al (2017). Percutaneous Treatment of Mitral and Tricuspid Regurgitation in Heart Failure, Interventional Cardiology, Prof. Ibrahim Akin (Ed. ), In. Tech, DOI: 10. 5772/intechopen. 68493. Available from: https: //www. intechopen. com/books/interventionalcardiology/percutaneous-treatment-of-mitral-and-tricuspidregurgitation-in-heart-failure

Back to Degenerative Mitral Regurgitation… The EVEREST Trial

EVEREST TRIAL - high risk DMR patients

EVEREST TRIAL

EVEREST TRIAL

EVEREST TRIAL

EVEREST TRIAL

COAPT Trial

COAPT Trial

COAPT Trial

COAPT Trial

COAPT Trial

Back to Dr. Edwards…

Thank you!