Patrick Klein1, Stefan D Anker2,3,4, Andrew Wechsler5, Ivo Skalsky6, Petr Neuzil7, Lon S Annest8, Mauro Bifi9, Theresa McDonagh10, Christian Frerker11, Tobias Schmidt11, Horst Sievert12,13, Anthony N Demaria14, Sebastian Kelle4,15,16. 1. Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, The Netherlands. 2. BIH Center for Regenerative Therapies (BCRT), Charité, Universitätsmedizin Berlin, Berlin, Germany. 3. Division of Cardiology and Metabolism, Department of Cardiology (CVK), Charité, Berlin, Germany. 4. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Germany. 5. Department of Cardiothoracic Surgery, Drexel University College of Medicine, Philadelphia, PA, USA. 6. Department of Cardiac Surgery, Na Homolce Hospital, Prague, Czech Republic. 7. Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic. 8. BioVentrix, San Ramon, CA, USA. 9. Intituto di Cardiologia, Azienda Ospedaliero, Universitaria di Bologna, Bologna, Italy. 10. Department of Cardiology, Kings College Hospital, London, UK. 11. Department of Cardiology, Asklepios Klinik St Georg, Hamburg, Germany. 12. CardioVascular Center Frankfurt, Frankfurt am Main, Germany. 13. Anglia Ruskin University, Chelmsford, UK. 14. Division of Cardiology, Department of Medicine, University of California, Sulpizio Cardiovascular Center, San Diego, CA, USA. 15. Department of Internal Medicine, Cardiology German Heart Center Berlin, Berlin, Germany. 16. Department of Internal Medicine/Cardiology, Charité Campus Virchow Clinic, Berlin, Germany.
Abstract
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/m2 vs. 54 ± 23 mL/m2 , P < 0.001; and 106 ± 33 mL/m2 vs. 80 ± 26 mL/m2 , 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.
RCT Entities:
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/m2 vs. 54 ± 23 mL/m2 , P < 0.001; and 106 ± 33 mL/m2 vs. 80 ± 26 mL/m2 , 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.
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