PMID- 31797492 OWN - NLM STAT- MEDLINE DCOM- 20201028 LR - 20201217 IS - 1879-0844 (Electronic) IS - 1388-9842 (Linking) VI - 21 IP - 12 DP - 2019 Dec TI - Less invasive ventricular reconstruction for ischaemic heart failure. PG - 1638-1650 LID - 10.1002/ejhf.1669 [doi] AB - AIMS: Surgical ventricular reconstruction to remodel, reshape, and reduce ventricular volume is an effective therapy in selected patients with chronic heart failure (HF) of ischaemic aetiology. The BioVentrix Revivent TC System offers efficacy comparable to conventional surgical ventricular reconstruction and is less invasive utilizing micro-anchor pairs to exclude scarred myocardium on the beating heart. Here, we present 12-months follow-up data of an international multicenter study. METHODS AND RESULTS: Patients were considered eligible for the procedure when they presented with symptomatic HF [New York Heart Association (NYHA) class >/=II], left ventricular (LV) dilatation and dysfunction caused by myocardial infarction, and akinetic and/or dyskinetic transmural scarred myocardium located in the anteroseptal, anterolateral, and/or apical regions. A total of 89 patients were enrolled and 86 patients were successfully treated (97%). At 12 months, a significant improvement in LV ejection fraction (29 +/- 8% vs. 34 +/- 9%, P < 0.005) and a reduction of LV volumes was observed (LV end-systolic and end-diastolic volume index both decreased: 74 +/- 28 mL/m(2) vs. 54 +/- 23 mL/m(2) , P < 0.001; and 106 +/- 33 mL/m(2) vs. 80 +/- 26 mL/m(2) , respectively, P < 0.0001). Four patients (4.5%) died in hospital and survival at 12 months was 90.6%. At baseline, 59% of HF patients were in NYHA class III compared with 22% at 12-month follow-up. Improvements in quality of life measures (Minnesota Living with Heart Failure Questionnaire 39 vs. 26 points, P < 0.001) and 6-min walking test distance (363 m vs. 416 m, P = <0.001) were also significant. CONCLUSIONS: Treatment with the Revivent TC System in patients with symptomatic HF results in significant and sustained reduction of LV volumes and improvement of LV function, symptoms, and quality of life. CI - (c) 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. FAU - Klein, Patrick AU - Klein P AD - Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, The Netherlands. FAU - Anker, Stefan D AU - Anker SD AD - BIH Center for Regenerative Therapies (BCRT), Charite, Universitatsmedizin Berlin, Berlin, Germany. AD - Division of Cardiology and Metabolism, Department of Cardiology (CVK), Charite, Berlin, Germany. AD - DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Germany. FAU - Wechsler, Andrew AU - Wechsler A AD - Department of Cardiothoracic Surgery, Drexel University College of Medicine, Philadelphia, PA, USA. FAU - Skalsky, Ivo AU - Skalsky I AD - Department of Cardiac Surgery, Na Homolce Hospital, Prague, Czech Republic. FAU - Neuzil, Petr AU - Neuzil P AD - Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. FAU - Annest, Lon S AU - Annest LS AD - BioVentrix, San Ramon, CA, USA. FAU - Bifi, Mauro AU - Bifi M AD - Intituto di Cardiologia, Azienda Ospedaliero, Universitaria di Bologna, Bologna, Italy. FAU - McDonagh, Theresa AU - McDonagh T AD - Department of Cardiology, Kings College Hospital, London, UK. FAU - Frerker, Christian AU - Frerker C AD - Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany. FAU - Schmidt, Tobias AU - Schmidt T AD - Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany. FAU - Sievert, Horst AU - Sievert H AD - CardioVascular Center Frankfurt, Frankfurt am Main, Germany. AD - Anglia Ruskin University, Chelmsford, UK. FAU - Demaria, Anthony N AU - Demaria AN AD - Division of Cardiology, Department of Medicine, University of California, Sulpizio Cardiovascular Center, San Diego, CA, USA. FAU - Kelle, Sebastian AU - Kelle S AD - DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Germany. AD - Department of Internal Medicine, Cardiology German Heart Center Berlin, Berlin, Germany. AD - Department of Internal Medicine/Cardiology, Charite Campus Virchow Clinic, Berlin, Germany. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20191203 PL - England TA - Eur J Heart Fail JT - European journal of heart failure JID - 100887595 SB - IM CIN - Eur J Heart Fail. 2020 Jun;22(6):1053. PMID: 31975568 CIN - Eur J Heart Fail. 2020 Apr;22(4):581-583. PMID: 32086997 CIN - Eur J Heart Fail. 2020 Jun;22(6):1053-1054. PMID: 32463544 MH - Cardiac Surgical Procedures/*instrumentation MH - Equipment Design MH - Female MH - Follow-Up Studies MH - Heart Failure/etiology/physiopathology/*surgery MH - Heart Ventricles/diagnostic imaging/physiopathology/*surgery MH - Humans MH - Male MH - Middle Aged MH - Myocardial Ischemia/*complications/physiopathology MH - Prospective Studies MH - Quality of Life MH - Stroke Volume/*physiology MH - Treatment Outcome MH - Ventricular Function, Left/*physiology MH - *Ventricular Remodeling OTO - NOTNLM OT - Device intervention OT - Heart failure OT - Myocardial infarction OT - Ventricular remodelling OT - Volume reduction EDAT- 2019/12/05 06:00 MHDA- 2020/10/29 06:00 CRDT- 2019/12/05 06:00 PHST- 2019/07/03 00:00 [received] PHST- 2019/10/06 00:00 [revised] PHST- 2019/10/11 00:00 [accepted] PHST- 2019/12/05 06:00 [pubmed] PHST- 2020/10/29 06:00 [medline] PHST- 2019/12/05 06:00 [entrez] AID - 10.1002/ejhf.1669 [doi] PST - ppublish SO - Eur J Heart Fail. 2019 Dec;21(12):1638-1650. doi: 10.1002/ejhf.1669. Epub 2019 Dec 3.