MitraClip. benefit in heart failure patients? No conflict of interest

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1 MitraClip Magnus Settergren MD, PhD Unit for PCI/GUCH Department of Cardiology Karolinska University Hospital Stockholm, Sweden benefit in heart failure patients? No conflict of interest

2 Burden of Valvular Heart Diseases Nkomo et al Lancet 2006

3 Mitral Regurgitation and Heart Failure Prevalent in >50% of the patients with heart failure. Blondheim et al Am Heart J 1991 Trichon et al Am J Cardiol 2003

4 Functional MR

5 Effect of Surgery in Functional MR Wu et al JACC 2005

6 Unmet need? Surgery is denied in 50% of patients with severe symptomatic MR. Mirabel European Heart J Serious complications occur in about 20% of patients who are at increased risk for surgery. Goodney et al Ann Surg 2003 AHA/ACC+ ESC guidelines: Surgery for Functional MR without additional need for CABG, II B indication

7 Is MitraClip an Alternative?

8 Alfieri Stitch

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10 EVEREST II Randomized Clinical Trial EVEREST II Key Inclusion/Exclusion Criteria Inclusion Candidate for MV Surgery Moderate to severe (3+) or severe (4+) MR Symptomatic o >25% EF & LVESD 55mm Asymptomatic with one or more of the following o LVEF 25-60% o LVESD 40mm o New onset atrial fibrillation o Pulmonary hypertension ACC/AHA Guidelines JACC 52:e1-e142, 2008 Exclusion AMI within 12 weeks Need for other cardiac surgery Renal insufficiency Creatinine >2.5mg/dl Endocarditis Rheumatic heart disease MV anatomical exclusions Mitral valve area <4.0cm 2 Leaflet flail width ( 15mm) and gap ( 10mm) Leaflet tethering/coaptation depth (>11mm) and length (<2mm) Feldman et al Lancet 2011 See Disclaimer on Page 2 9

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13 Results

14 Secondary End Points

15 Subgroup analysis

16 Downloaded from eurheartj.oxfordjournals.org at Karolinska Sjukhuset on May 15, 2011 Downloaded from eurheartj.oxfordjournals.org at Stockholms l?ns landsting on May 15, 2011 High risk patients-european experience European Heart Journal (2010) 31, doi: /eurheartj/ehq050 CLIN ICAL RESEARCH Valvular heart disease European Heart Journal (2010) 31, doi: /eurheartj/ehq051 CLIN ICAL RESEARCH Valvular heart disease Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction Olaf Franzen 1 *, Stephan Baldus 1, Volker Rudolph 1, Sven Meyer 1, MalgorzataKnap 1, Dietmar Koschyk 1, Hendrik Treede 2, Achim Barmeyer 1, Joachim Schofer 3, Angelika Costard-Jäckle 1, Michael Schlüter 1, Hermann Reichenspurner 2, and Thomas Meinertz 1 Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting Corrado Tamburino 1,2 *, Gian Paolo Ussia 1, Francesco Maisano 3, Davide Capodanno 1,2, Giovanni La Canna 3,Salvatore Scandura 1, Ant onio Colombo 3,Andrea Giacomini 3, Iassen Michev 3, Sarah Mangiafico 1, Valeria Camm alleri 1, Marco Barbanti 1, and Ottavio Alfieri 3 1 Cardiology Department, Ferrarotto Hospital, University of Catania, Via Citelli 6, Catania, Italy; 2 ETNA Foundation, Catania, Italy; and 3 San Raffaele Hospital, Milan, Italy 1 Department of General and Interventional Cardiology, University Heart Centre, Hamburg, Germany; 2 Department of Cardiovascular Surgery, University Heart Centre, Hamburg, Germany; and 3 Medical Care Centre Prof. Mathey, Prof. Schofer, Hamburg, Germany Received 26 October 2009; revised 21 December 2009; accepted 19 January 2010; online publish-ahead-of-print 10 March 2010 See page 1301 for the editorial comment on this article (doi: /eurhear tj/ehq088) 51 patients Functional/degenerative 69/31% STS score 15 ± 11% EF 36 ± 17% Aims Wesought to assessthefeasibility of catheter-based mitral valverepair usingthemitraclip systeminhigh-surgical-risk patients with mitral regurgitation (MR) grade 3þ.... Met hods MitraClip therapy was performed in 51 consecutive patients [ years; 34 (67%) men] with symptomatic and r esult s functional [n¼ 35 (69%)] or organicmr[n¼ 16 (31%)]. MeanlogisticEuroSCOREwas29+ 22%; SocietyofThoracic Surgeonsscorewas Left ventricular (LV) ejection fraction was36+ 17%.In 35 patients(69%), adverse mitral valve morphology and/or severe LV dysfunction were present. MitraClip implantation was successful in 49 patients (96%). Most patients [n ¼ 34/49 (69%)] were treated with a single clip, whereas 14 patients (29%) received two clips and one patient received three clips. Mean device and fluoroscopy times were min and min, respectively.procedure-relatedreductioninmrseveritywasonegradein16patients(31%), two gradesin24patients (47%), and three gradesin 9 patients (18%). Forty-four of the 49 successfully treated patients (90%) showed clinical improvement at discharge [NYHA functional class III in 48 patients (98%) before and 16 patients (33%) after the procedure (P, )]. Therewere no procedure-related major adverse eventsand no in-hospital mortality.... Conclusion Mitral valve repair using the MitraClip system was shown to be feasible in patients at high surgical risk primarily determined by an adverse mitral valve morphology and/or severe LV dysfunction Keywords Mitral regurgitation Catheter-based mitral valve repair MitraClip Introduction Severe mitral regurgitation (MR) caused by primary valve disease or asconsequence of underlyingleft ventricular (LV) dilatationsubstantially contributes to morbidity and mortality. 1 4 Optimal medical management or cardiac resynchronization therapy can improve symptoms and reduce MR severity in a number of patients. 5,6 However, if these measures fail, mitral valve surgery is the standard therapy. Notably, a large percentage of patients in need of valve reconstruction or replacement do not undergo surgery because of a high perioperative risk. 7,8 Recently, a variety of less invasive, percutaneous, treatment options for mitral valve repair have been developed; most of these techniques are still at an early stage of clinical evaluation The MitraClip w Received 20 November 2009; revised 28 January 2010; accepted 11 February 2010; online publish-ahead-of-print 18 March 2010 See page 1301 for the editorial comment on this article (doi: /eurheartj/ehq088) 31 patients Functional/degenerative 58/42% STS score 10 ± 8.8% EF 42 ± 17% A ims Thisstudy sought to evaluate the feasibility and early outcomes of apercutaneous edge-to-edge repair approach for mitral valve regurgitation with the MitraClip w system (Evalve, Inc., Menlo Park, CA, USA).... Met hods Patients were selected for the procedure based on the consensus of a multidisciplinary team. The primary efficacy and results endpoint was acute device success defined as clip placement with reduction of mitral regurgitation to 2þ. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of. 2 units of blood, ventilation for. 48 h, deep wound infection, septicaemia, and new onset of atrial fibrillation. Thirty-one patients (median age 71, male 81%) were treated between August 2008 and July Eighteen patients (58%) presented with functional disease and 13 patients (42%) presented with organic degenerativedisease. A clip wassuccessfully implanted in 19 patients (61%) and two clips in 12 patients (39%). The median device implantation time was 80 min. At 30 days, there was an intra-procedural cardiac tamponade and a non-cardiac death, resulting in a primary safety endpoint of 93.6% [95% confidence interval (CI) ]. Acute device success was observed in 96.8% of patients (95% CI ). Compared with baseline, left ventricular diameters, diastolic left ventricular volume, diastolic annular septal lateral dimension, and mitral valve area significantly diminished at 30 days.... Conclusion Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-toedge mitral valve repair is feasible and may be accomplished with favourable short-term safety and efficacy results Keywords Introduction Edge-to-edge Percutaneous mitral valve repair MitraClip Moderate or severe mitral regurgitation (MR) is the second most common valve disease requiring surgical treatment in Europe. 1 existsthat valvular surgeryshouldbeadvisedinsymptomaticpatients with severe MR, asshown by the correspondingclassi recommendation in both the American and European clinical guidelines. 2,3 Valve repair, when feasible, is the preferred surgical treatment in

17 Severe Heart Failure 50 patients, 70 ± 11 y LVEF < 25% Logistic EuroSCORE 34% Results 30 day mortality 6% Improved 6 min walk distance Reduced LV volumes Reduced NT-proBNP levels Franzen et al Eur J Heart Fail 2011

18 Acute hemodynamic effects of the MitraClip therapy 107 patients Cardiac cath before and immediately following intervention Results Increase in CO and forward stroke volume No patient developed low CO state. Same results in severe heart failure patients? Siegel et al JACC 2011

19 Conclusion There is an unmet need for an alternative intervention for patients with a functional MR and heart failure. The MitraClip therapy seems to be safe and effective in this patient category There is a need for a RCT comparing the Mitraclip therapy against best medical therapy in patients with functional MR and heart failure