Mauro Biffi1, Pascal Defaye2, Pierre Jaïs3, Franco Ruffa4, Christophe Leclercq5, Daniel Gras6, Zhongping Yang7, Bart Gerritse8, Matteo Ziacchi9, John M Morgan10. 1. Policlinico S Orsola-Malpighi University Hospital, Bologna, Italy. Electronic address: mauro.biffi@aosp.bo.it. 2. University Hospital, Grenoble, France. 3. CHU Bordeaux - Bordeaux University, Bordeaux, France. 4. Alessandro Manzoni Hospital, Lecco, Italy. 5. University Hospital Rennes, Rennes, France. 6. Le Confluent Nouvelle Clinique Nantaises, Nantes, France. 7. Medtronic plc, Minneapolis, MN, USA. 8. Medtronic Bakken Research Center, Maastricht, The Netherlands. 9. Policlinico S Orsola-Malpighi University Hospital, Bologna, Italy. 10. University Hospital Southampton, Southampton, United Kingdom.
Abstract
OBJECTIVE: Cardiac resynchronisation therapy (CRT) is limited by a substantial proportion of non-responders. Left ventricular endocardial pacing (LVEP) may offer enhanced possibility to deliver CRT in patients with a failed attempt at implantation and to improve clinical status of CRT non-responders. METHODS: The ALternate Site Cardiac ResYNChronisation (ALSYNC) study was a prospective, multi-centre cohort study that included 118 CRT patients with a successfully implanted endocardial left ventricular (LV) lead, including 90 failed coronary sinus (CS) implants and 28 prior non-responders who had worsened or unchanged heart failure status after at least 6 months of optimal conventional CRT therapy. RESULTS: Patients were followed for 19 ± 9 months. At baseline, prior non-responders were sicker as evidenced by a larger LV end-diastolic diameter (70 ± 12 vs 65 ± 9 mm, p = .03) and a trend towards larger LV end-systolic volume index (LVESVi, 95 ± 51 vs 74 ± 39 ml/m2, p = .07), and were more frequently anti-coagulated (96% vs 72%, p = .008) despite similar history of atrial fibrillation (54% vs 51%, p = .83). At 6 months, LVEP significantly improved LV ejection fraction (2.3 ± 7.5 and 8.6 ± 10.0%), New York Heart Association Class (0.4 ± 0.9 and 0.7 ± 0.8), LVESVi (9 ± 16 and 18 ± 43 ml/m2), and six-minute walk test (56 ± 73 and 54 ± 92 m) in prior non-responders and failed CS implants, relative to baseline (all p < .05), respectively. LVESVi reduction ≥15% was seen in 47% of the prior non-responder patients and 57% of failed CS patients. CONCLUSION: These data suggest that a sizable proportion of CRT non-responders can improve by LVEP, though to a lesser extent than failed CS implants. Clinical trial registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01277783.
OBJECTIVE: Cardiac resynchronisation therapy (CRT) is limited by a substantial proportion of non-responders. Left ventricular endocardial pacing (LVEP) may offer enhanced possibility to deliver CRT in patients with a failed attempt at implantation and to improve clinical status of CRT non-responders. METHODS: The ALternate Site Cardiac ResYNChronisation (ALSYNC) study was a prospective, multi-centre cohort study that included 118 CRT patients with a successfully implanted endocardial left ventricular (LV) lead, including 90 failed coronary sinus (CS) implants and 28 prior non-responders who had worsened or unchanged heart failure status after at least 6 months of optimal conventional CRT therapy. RESULTS:Patients were followed for 19 ± 9 months. At baseline, prior non-responders were sicker as evidenced by a larger LV end-diastolic diameter (70 ± 12 vs 65 ± 9 mm, p = .03) and a trend towards larger LV end-systolic volume index (LVESVi, 95 ± 51 vs 74 ± 39 ml/m2, p = .07), and were more frequently anti-coagulated (96% vs 72%, p = .008) despite similar history of atrial fibrillation (54% vs 51%, p = .83). At 6 months, LVEP significantly improved LV ejection fraction (2.3 ± 7.5 and 8.6 ± 10.0%), New York Heart Association Class (0.4 ± 0.9 and 0.7 ± 0.8), LVESVi (9 ± 16 and 18 ± 43 ml/m2), and six-minute walk test (56 ± 73 and 54 ± 92 m) in prior non-responders and failed CS implants, relative to baseline (all p < .05), respectively. LVESVi reduction ≥15% was seen in 47% of the prior non-responder patients and 57% of failed CS patients. CONCLUSION: These data suggest that a sizable proportion of CRT non-responders can improve by LVEP, though to a lesser extent than failed CS implants. Clinical trial registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01277783.
Authors: László Gellér; Zoltán Salló; Levente Molnár; Tamás Tahin; Emin Evren Özcan; Valentina Kutyifa; István Osztheimer; Szabolcs Szilágyi; Nándor Szegedi; Pál Ábrahám; Astrid Apor; Klaudia Vivien Nagy; Annamária Kosztin; Dávid Becker; Szilvia Herczeg; Endre Zima; Béla Merkely Journal: Europace Date: 2019-08-01 Impact factor: 5.214