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Download ONLINE APPENDIX Supplemental Table 1. Participating centers
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ONLINE APPENDIX Supplemental Table 1. Participating centers and recruitment numbers Site Name # Subject s 9 Enrolled Study # Site # Location Asklepios Klinik St. Georg 005 00002 Hamburg, Germany Instituto Dante Pazzanese de Cardiologia 005 00003 Sao Paolo, Brazil 8 Elisabeth Krankenhaus 005 00005 Essen, Germany 3 University Hospital Bonn 005 00006 Bonn, Germany 15 Sanatorio Italiano 007 00071 Asuncion, Paraguay 3 Angiographia de Occidente 007 00072 Cali, Colombia 14 Clinica CardioVID – Santa Maria 007 00073 Medellin, Colombia 2 National Institute of Cardiology 007 00074 Warsaw, Poland 5 Centrum Medical Center HCP 007 00075 Poznan, Poland 6 American Heart of Poland 007 00076 Bielsko-Biala, Poland 6 TOTALS 10 71 Supplemental Table 2. Detailed inclusion and exclusion criteria Inclusion: Subject with chronic functional mitral regurgitation (FMR) Subject is ≥18 years old Documented symptoms of CHF (NYHA II-IV) Symptomatic despite stable (at least 30 day’s duration) optimal medical regimen per applicable standard for subject’s heart failure stage and NHYA classification Symptomatic despite at least 90 days of treatment with CRT, if indicated (i.e., QRS ≥120 ms, LVEF ≤35%, etc.) In the opinion of the heart team (minimum of one thoracic surgeon, one interventional cardiologist and one cardiologist) the subject is not eligible or recommended for corrective intervention on the valve via a surgical approach; Left ventricular ejection fraction (LVEF) of 20% and < 45% Mitral regurgitation grade 2 with regurgitant volume > 30ml and EROA > 20mm2 Subject has a mitral plane to apex dimension 5.0 cm Structurally normal mitral valve Left ventricular end diastolic diameter (LVEDD) ≥ 5.0 cm and ≤ 7.5 cm Exclusion: Significant organic mitral valve pathology (e.g. rheumatic, myxomatous degeneration, mitral valve prolapse or flail leaflets), moderate or severe valve calcifications, ruptured or otherwise non-functional papillary muscles and/or chordae tendinae. Previous mitral valve repair or mitral valve replacement Bio-prosthetic or mechanical aortic valve Endocarditis MI within the 30 days prior to the index procedure Known unstable angina within 30 days prior to index procedure Any PCI within 30 days prior to the index procedure CABG within 3 months prior to the index procedure Any planned PCI within 30 days post index procedure Planned CABG ≤ 6-months post-index procedure Subject with severe, multi-vessel coronary artery disease who cannot tolerate sudden hemodynamic changes or acute hemoglobin drop Cardiogenic shock characterized by systolic pressure <80 mm Hg, or cardiac index <1.8 liters/minute/m2, or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure ≥80 mm Hg and a cardiac index ≥1.8 liters/minute/m2 Subject with peripheral vascular disease or tortuosity that would prevent percutaneous access with a 14 Fr introducer sheath or intervention with the Mitralign system Cerebrovascular Accident (CVA) within the past 6 months Serum creatinine >2.5 mg/dL (or 221 µmol/L) Subject is on chronic kidney dialysis Anemia (Hb < 9 g/L) Thrombocytopenia (platelet count <100,000/mm3) or thrombocytosis (>750,000/mm3) Bleeding disorders or hypercoaguable state Active peptic ulcer or active gastrointestinal (GI) bleeding Contraindication to therapy with aspirin, antiplatelets or anticoagulants Contraindications to or subject’s refusal of blood transfusions Known allergy to stainless steel or platinum iridium or polyester Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactic or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study related radiation exposure Co-morbid condition(s) that, in the judgment of the Investigator, could limit the subject’s ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study Life expectancy of less than 12 months Subject has impaired judgment and/or is undergoing emergency treatment Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study. Thrombus in left ventricle or left atrium Echocardiographic evidence of congenital, pericardial or infiltrative heart disease Suboptimal trans-thoracic echocardiographic (TTE) windows, leading to incomplete quantification of FMR or anatomic assessment Significant subvalvular trabecularization or muscle bridges Subject with mitral stenosis Subject with moderate or severe aortic or tricuspid stenosis and/or moderate or severe aortic or tricuspid regurgitation Supplemental Table 3. Definition of study endpoints. Primary Endpoints Safety: Major adverse events (MAE) within 30 days post index procedure MAE defined as occurrence of any of the following: Urgent mitral valverelated cardiac surgery/intervention, myocardial infarction, cardiac tamponade, stroke, or device/procedure-related death. Performance: Freedom from the following at 6 months - mitral valve-related cardiac surgery/intervention, device and/or procedure-related death; and an increase in ventricular diameter Secondary Endpoints Device success Implantation and plication of at least one pair of pledgets and retrieval of all non-implantable system components Procedure success Device success and no MAE prior to hospital discharge Clinical outcomes at discharge, 1, 6, 12, and 24 months post index procedure All-cause mortality MI Cardiac tamponade Re-hospitalization for CHF and/or mitral valve-related cardiac surgery/intervention Stroke Renal function MAE NYHA classification MLHF (QOL Questionnaire) 6-Minute Walk Distance (6MWD) Tenting area and distance Left ventricular regurgitant fraction Mitral annular diameter Left ventricular volumes and diameters Hemodynamics Effective regurgitant orifice area (EROA) Vena contracta Coaptation MR grade Supplemental Table 4. Reasons for incomplete plication procedures. 20 subjects resulted in only a single plication. 16 of these subjects only had one set of pledgets implanted for the following reasons: - 8 anatomical challenges - 4 prolonged procedures > 3 hours - 2 procedure stopped for clinical event (1 pericardial effusion, 1 ventricular fibrillation) - 1 fibrous annulus (difficulty crossing) - 1 incorrect positioning of the first pledget in second set Four patients with two sets implanted had only one plication due to the following reasons: - 2 single pledget annular detachment - 2 plications resulted in suboptimal valve changes (device locked without plication) Supplemental Table 5. Clinical outcomes and left ventricular remodelling of patients with or without implants. LVEDV mean [ml] 6 MWD mean [m] MR Grade mean NYHA Grade mean 30 Day Change No Implant/ Plication (n) Plication (n) - 8.6 ± 35.5 (9) -18.5 ± 31.0 (31) 17.9 ± 110.1 (9) 43.3 ± 115.0 (24) -0.4 ± 1.2 (9) -0.4 ± 1.1 (36) -0.1 ± 0.6 (9) 0.0 ± 1.0 (38) 6 Months No Implant/ Plication (n) Plication (n) -14.6 ± 36.1 (8) -21.6 ± 28.6 (27) 69.4 ± 116.1 (5) 56.5 ± 92.0 (24) -0.2 ± 1.3 (6) -0.5 ± 1.2 (27) -0.3 ± 0.7 (7) -0.4 ± 0.7 (30) LVEDV, left ventricular end-diastolic volume; 6MWD, six minute walking distances; MR, mitral regurgitation; NYHA, New York Heart Failure classification.