Despite the lack of strong medical evidence percutaneous mitral valve repair (PMVR) using the MitraClip®-system is increasingly performed in patients.
PERCUTANEOUS MITRAL VALVE REPAIR IN FUNCTIONAL MITRAL REGURGITATION: PRELIMINARY RESULTS FROM THE SWISS NATIONWIDE INVESTIGATOR-INITIATED PROSPECTIVE MITRACLIP® REGISTRY (MITRASWISS) D. Sürder, R. Corti, C. Klersy, T. Moccetti, S. Toggweiler, P.Jamshidi, F. Praz, S. Windecker, A. Vuilliomenet, S. Noble, O. Mueller, B. Naegeli, O. Bertel, R. Jeger, P.Buser, O. Gaemperli, F. Maisano, J. Grünenfelder, P. Erne and G. Pedrazzini on behalf of the MitraSwiss Investigators Cardiocentro Ticino, Lugano – Cantonal Hospital Lucerne – Inselspital Bern – Cantonal Hospital Aarau – HUG Geneva – CHUV Lausanne – Klinik im Park Zurich – University Hospital Basel – University Hospital Zurich – Heart Clinic Hirslanden Zurich – Switzerland – IRCCS Fonzazione Policlinico San Matteo, Pavia – Italy
INTRODUCTION
NYHA class
Despite the lack of strong medical evidence percutaneous mitral valve repair (PMVR) using the MitraClip®-system is increasingly performed in patients with functional mitral regurgitation (FMR). Retrospective data in high-risk patients confirm its validity but prospective data from large registries are still lacking. Herein, we report preliminary results of the prospective Swiss nationwide investigator-initiated MitraClip® registry (MitraSwiss).
I / II
22.8
III
59.3
IV
17.8
MR grade at baseline, a0er discharge, a0er 6 and 12 months 81%
Moderate
Among the patients included in the MitraSwiss registry we analyzed those presenting with either ischemic-function or pure FMR in the clinical context of advanced heart failure. In all patients PMVR was performed under general anesthesia in the cath-lab or hybrid operating room with fluoroscopic and transesophageal echocardiography guidance.
17.9
Severe
80.2 52.6
Functional non ischemic
47.4
From 2011 until 2015, a total of 249 patients (corresponding to 53% of the entire registry population) with FMR (53% ischemic, 47% non ischemic etiology) and a median left ventricular ejection fraction (LVEF) of 35% (range 26-47%) were included in the current analysis. In 87% of the patients, a good result of the procedure was achieved (residual MR grade 1+ or 2+). Improvement sustained at 6 and 12 months follow-up, respectively, with 75% and 78% of the patients presenting residual MR grade of 2+ or better. A functional class of NYHA I or II was therefore achieved for 77% of the patients after 6 months and for 73% of the patients at 12 months. These results did not differ substantially when comparing them to the entire registry population. 12 months survival was (89.3%; 95%CI: 84.9-92.5%). A trend towards a lower mortality of the patients with ischemic origin of the FMR at 6 months disappeared at 12 months.
LVEF (%)
35.0 (27-48) **
LVEDV (ml)
172 (125-224) *
LVESV (ml)
118 (81-165) *
RV-RA gradient (mmHg)
51%
Age – years
76 (69-81) **
BMI - kg/m2
25.3 (22.5-28.7)
Gender (male) - % Hypertension - %
68.1 * 73.8
Hyperlipidemia - %
53.2 *
Diabetes - %
31.8 *
Coronary artery disease - %
68.4 *
Prev. myocardial infarction - %
43.4 *
Prev. PCI - %
49.2 *
Prev. CABG - %
30.4 *
Prev. valve surgery - %
22% Log rank: ns Stra8fied log rank: ns Cox-‐model: ns Corr. Cox-‐model: ns
56%
funct. Ischemic funct. non ischemic
funct. Isch. funct. non isch.
40 (31-52)
Functional, biologic parameters and quality of life 6MWD (m) MLWHF score (points) Nt-proBNP (pg/ml)
325 (225-390) 37 (25-51) 3911 (1832-7205)
18% 59%
BASELINE CHARACTERISTICS OF THE TREATED PATIENTS WITH FUNCTIONAL ORIGIN OF THE MITRAL REGURGITATION (N = 264)
14%
18%
Echocardiography parameters
RESULTS
20%
67%
MR etiology - % Functional ischemic
8%
24%
1.9
Moderate to severe
5%
21%
Mitral valve - grade of mitral regurgitation at baseline - %
METHODS
2% 10%
Kaplan Meier curves for event-‐free survival depending on origin of FMR (func8onal ischemic vs. func8onal non ischemic)
BMI: body mass index; PCI: Percutaneous coronary intervention; CABG: coronary artery bypass graft; PM: pacemaker; ICD: implantable cardioverter defibrillator; CRT: cardiac resynchronization therapy; LVEF: left ventricular ejection fraction; LVEDV: left ventricular end-diastolic volume; LVESV: left ventricular end-systolic volume; COPD: chronic obstructive lung disease; CVI: cerebro-vascular injury; Grad. RV-RA: pressure gradient measured between right ventricle and right atrium using the continuous wave Doppler; 6MWD: 6 minutes walking distance; MLWHF: Minnesota living with heart failure score for the assessment of the quality of life; nt-proBNP: n-terminal brain natriuretic peptide
21%
3.6% 19%
3.2% 23%
51%
48%
26%
25%
1.9%
* : Value significantly higher than in non functional MR patients **: Value significantly lower than in non functional MR patients
9.1
Surgical risk Prev. episode of cong. heart failure - % Logistic EuroScore (%)
37.0 7.9 (4.5-22)
Euro Score II (%)
5.5 (3.7-9.9) *
STS Score (%)
5.4 (2.8-11.8)
Rhythm Chronic / intermittent AF - % Prev. PM or ICD implantation - % CRT - %
55.2 40.0 * 26.1 *
Co-morbidities COPD - %
11.6
Prev. CVI - %
12.0
Renal failure - % Cancer of any type - %
64.3 * 13.6
CONCLUSION Patients with FMR undergoing PMVR in Switzerland are younger than those with degenerative origin of MR. They seem to present, however, more severe heart disease. PMVR in patients with FMR provide similar improvement of MR grade and symptoms at short term, after 6 and 12 months as compared to the entire MitraSwiss registry population.
