OBJECTIVE: The left atrial appendage is a significant source of cardioembolic thrombi. Open mitral valve surgery presents an opportune time to exclude this appendage from cardiovascular circulation. However, sparse randomized trial support exists for this concomitant procedure. We therefore designed a randomized controlled trial to assess the short- and long-term outcomes of concomitant left atrial appendage exclusion. This report details early outcomes of the pilot trial. METHODS: Forty-three patients were randomized to either undergo concomitant suture exclusion of their left atrial appendage under direct vision or not during their open mitral valve surgery. Clinical and biochemical postoperative outcomes, including hemodynamic and hemostatic parameters, were analyzed. RESULTS: There were no deaths in either group. The incidence of cerebrovascular events, myocardial infarction, respiratory failure, and acute renal injury were similar between groups; a composite outcome of 10 major postoperative complications occurred in 32% of the left atrial appendage exclusion group versus 38% of the control group (p=0.75). Intensive care (median stay 2 days vs 1 day in the control group, p=0.55) and hospital lengths of stay (median stay 9 days in both groups, p=0.98) were also similar between groups. Specifically, no additional hemodynamic alterations (need for intra-aortic balloon pump in 1 vs 2 patients in the control group, p=0.61) or hemostatic complications (no re-operations for bleeding in either group, need for blood product transfusion in 2 vs 1 patient in the control group, p=1.0) were noted in the left atrial appendage exclusion group. CONCLUSIONS: This pilot trial demonstrates the safety of and feasibility of a larger trial powered to detect clinically relevant short- and long-term outcomes of concomitant left atrial appendage exclusion with open mitral valve surgery.
RCT Entities:
OBJECTIVE: The left atrial appendage is a significant source of cardioembolic thrombi. Open mitral valve surgery presents an opportune time to exclude this appendage from cardiovascular circulation. However, sparse randomized trial support exists for this concomitant procedure. We therefore designed a randomized controlled trial to assess the short- and long-term outcomes of concomitant left atrial appendage exclusion. This report details early outcomes of the pilot trial. METHODS: Forty-three patients were randomized to either undergo concomitant suture exclusion of their left atrial appendage under direct vision or not during their open mitral valve surgery. Clinical and biochemical postoperative outcomes, including hemodynamic and hemostatic parameters, were analyzed. RESULTS: There were no deaths in either group. The incidence of cerebrovascular events, myocardial infarction, respiratory failure, and acute renal injury were similar between groups; a composite outcome of 10 major postoperative complications occurred in 32% of the left atrial appendage exclusion group versus 38% of the control group (p=0.75). Intensive care (median stay 2 days vs 1 day in the control group, p=0.55) and hospital lengths of stay (median stay 9 days in both groups, p=0.98) were also similar between groups. Specifically, no additional hemodynamic alterations (need for intra-aortic balloon pump in 1 vs 2 patients in the control group, p=0.61) or hemostatic complications (no re-operations for bleeding in either group, need for blood product transfusion in 2 vs 1 patient in the control group, p=1.0) were noted in the left atrial appendage exclusion group. CONCLUSIONS: This pilot trial demonstrates the safety of and feasibility of a larger trial powered to detect clinically relevant short- and long-term outcomes of concomitant left atrial appendage exclusion with open mitral valve surgery.
Authors: Mark D Huffman; Kunal N Karmali; Mark A Berendsen; Adin-Cristian Andrei; Jane Kruse; Patrick M McCarthy; S C Malaisrie Journal: Cochrane Database Syst Rev Date: 2016-08-22
Authors: Gavino Casu; Michele Massimo Gulizia; Giulio Molon; Patrizio Mazzone; Andrea Audo; Giancarlo Casolo; Emilio Di Lorenzo; Michele Portoghese; Christian Pristipino; Renato Pietro Ricci; Sakis Themistoclakis; Luigi Padeletti; Claudio Tondo; Sergio Berti; Jacopo Andrea Oreglia; Gino Gerosa; Marco Zanobini; Gian Paolo Ussia; Giuseppe Musumeci; Francesco Romeo; Roberto Di Bartolomeo Journal: Eur Heart J Suppl Date: 2017-05-02 Impact factor: 1.803
Authors: Varunsiri Atti; Mahesh Anantha-Narayanan; Mohit K Turagam; Scott Koerber; Sunil Rao; Juan F Viles-Gonzalez; Rakesh M Suri; Poonam Velagapudi; Dhanunjaya Lakkireddy; David G Benditt Journal: World J Cardiol Date: 2018-11-26
Authors: Mariusz Kowalewski; Wojciech Wańha; Radoslaw Litwinowicz; Michalina Kołodziejczak; Michal Pasierski; Rafal Januszek; Łukasz Kuźma; Marek Grygier; Maciej Lesiak; Agnieszka Kapłon-Cieślicka; Krzysztof Reczuch; Robert Gil; Tomasz Pawłowski; Krzysztof Bartuś; Sławomir Dobrzycki; Roberto Lorusso; Stanislaw Bartuś; Marek Andrzej Deja; Grzegorz Smolka; Wojciech Wojakowski; Piotr Suwalski Journal: BMJ Open Date: 2022-09-21 Impact factor: 3.006