Pierre Bordachar1, Daniel Gras2, Nicolas Clementy3, Pascal Defaye4, Pierre Mondoly5, Serge Boveda6, Frederic Anselme7, Didier Klug8, Olivier Piot9, Nicolas Sadoul10, Dominique Babuty11, Christophe Leclercq12. 1. Haut Lévèque University Hospital, Pessac, France. Electronic address: bordacharp@hotmail.com. 2. Hôpital Privé du Confluent, Nantes, France. 3. Trousseau University Hospital, Chambray-les-Tours, France. 4. Michallon University Hospital, Grenoble, France. 5. Rangueil University Hospital, Toulouse, France. 6. Clinique Pasteur, Toulouse, France. 7. Charles Nicolle University Hospital, Rouen, France. 8. Cardiology Hospital, Lille, France. 9. Centre Cardiologique du Nord, Saint-Denis, France. 10. Brabois University Hospital, Vandoeuvre-les-Nancy, France. 11. Haut Lévèque University Hospital, Pessac, France. 12. Pontchaillou University Hospital, Rennes, France.
Abstract
BACKGROUND:Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF), but is limited by a substantial proportion of nonresponders. We hypothesized that adding a second left ventricular (LV) lead to deliver a triple-site CRT (V3 CRT) may improve clinical status of CRT nonresponders. OBJECTIVE: We assessed the feasibility and safety of adding a second LV lead to CRT nonresponders and its clinical impact. METHODS:Eighty-four recipients of a CRT system and considered as nonresponders as per clinical composite score (CCS) were enrolled in this multicenter study. They were randomized to the V3 arm (implantation of an additional LV lead; n = 43) or control arm (no change; n = 41). Implant success rate, incidence of severe adverse events, CCS, and secondary clinical and echocardiographic end points were evaluated at 12 and 24 months. RESULTS: Positioning of a second LV lead was successful at first (40 of 44 - 90.9%) or second (4 of 44 - 9.09%) attempt. The perioperative complication rate (infection, system explant, pneumothorax, and hematoma) was high (procedures or system-related complications for 9 patients- 20.4%). After 24 months, 35 systems (79.5%) were working properly. The multinomial logistic regression model showed that V3 treatment had no significant influence (P = .27) on the CCS, number of HF hospitalizations, time to first HF hospitalization, New York Heart Association class, and LV ejection fraction at 12 and 24 months. CONCLUSION: Although addition of a second LV lead in CRT nonresponders is feasible with a high success rate, this approach is associated with a significant rate of severe adverse events and does not provide significant long-term clinical benefits (ClinicalTrials.gov Identifier No. NCT01059175).
RCT Entities:
BACKGROUND: Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF), but is limited by a substantial proportion of nonresponders. We hypothesized that adding a second left ventricular (LV) lead to deliver a triple-site CRT (V3 CRT) may improve clinical status of CRT nonresponders. OBJECTIVE: We assessed the feasibility and safety of adding a second LV lead to CRT nonresponders and its clinical impact. METHODS: Eighty-four recipients of a CRT system and considered as nonresponders as per clinical composite score (CCS) were enrolled in this multicenter study. They were randomized to the V3 arm (implantation of an additional LV lead; n = 43) or control arm (no change; n = 41). Implant success rate, incidence of severe adverse events, CCS, and secondary clinical and echocardiographic end points were evaluated at 12 and 24 months. RESULTS: Positioning of a second LV lead was successful at first (40 of 44 - 90.9%) or second (4 of 44 - 9.09%) attempt. The perioperative complication rate (infection, system explant, pneumothorax, and hematoma) was high (procedures or system-related complications for 9 patients- 20.4%). After 24 months, 35 systems (79.5%) were working properly. The multinomial logistic regression model showed that V3 treatment had no significant influence (P = .27) on the CCS, number of HF hospitalizations, time to first HF hospitalization, New York Heart Association class, and LV ejection fraction at 12 and 24 months. CONCLUSION: Although addition of a second LV lead in CRT nonresponders is feasible with a high success rate, this approach is associated with a significant rate of severe adverse events and does not provide significant long-term clinical benefits (ClinicalTrials.gov Identifier No. NCT01059175).
Authors: Chin C Lee; Khuyen Do; Sati Patel; Steven K Carlson; Tomas Konecny; Philip M Chang; Rahul N Doshi Journal: J Interv Card Electrophysiol Date: 2019-08-20 Impact factor: 1.900
Authors: Mark K Elliott; Vishal Mehta; Nadeev Wijesuriya; Baldeep S Sidhu; Justin Gould; Steven Niederer; Christopher A Rinaldi Journal: Eur Heart J Open Date: 2022-02-26
Authors: Justin Gould; Simon Claridge; Thomas Jackson; Benjamin J Sieniewicz; Baldeep S Sidhu; Bradley Porter; Mark K Elliott; Vishal Mehta; Steven Niederer; Humra Chadwick; Ravi Kamdar; Shaumik Adhya; Nikhil Patel; Shoaib Hamid; Dominic Rogers; William Nicolson; Cheuk F Chan; Zachary Whinnett; Francis Murgatroyd; Pier D Lambiase; Christopher A Rinaldi Journal: Europace Date: 2022-05-03 Impact factor: 5.214
Authors: Luuk I B Heckman; Marion Kuiper; Frederic Anselme; Filippo Ziglio; Nicolas Shan; Markus Jung; Stef Zeemering; Kevin Vernooy; Frits W Prinzen Journal: Heart Rhythm O2 Date: 2020-06-15