Simonetta Genovesi1, Giorgio Slaviero2, Luca Porcu3, Gavino Casu4, Silvio Bertoli5, Antonio Sagone6, Federico Pieruzzi7, Giovanni Rovaris8, Monique Buskermolen9, Paolo Danna10, Alberto Montoli11, Jacopo Oreglia12, Gina Contaldo13, Patrizio Mazzone14. 1. Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy; Nephrology Unit, San Gerardo Hospital, Monza, Italy. Electronic address: simonetta.genovesi@unimib.it. 2. Nephrology Unit, IRCCS Ospedale San Raffaele, Milano, Italy. 3. Statistical consultant of University of Milano-Bicocca, Monza, Italy. 4. San Francesco Hospital, Nuoro. ATS Sardegna Nuoro, Italy. 5. Dialysis and Nephrology Unit, IRCCS Multimedica, Sesto S.Giovanni, Italy. 6. Electrophysiology Unit, IRCCS-Multimedica, Sesto S.Giovanni, Italy. 7. Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy; Nephrology Unit, San Gerardo Hospital, Monza, Italy. 8. Interventional Electrophysiology Unit, San Gerardo Hospital, Monza, Italy. 9. Department of Nephrology and Dialysis, Luigi Sacco Hospital, Milan, Italy. 10. Cardiology Unit, Luigi Sacco Hospital, Milano, Italy. 11. Nephrology Unit, Niguarda Hospital, Milano, Italy. 12. Interventional Cardiology Unit, Niguarda Hospital, Milano, Italy. 13. Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy. 14. Cardiac Pacing Unit, IRCCS Ospedale San Raffaele, Milano, Italy.
Abstract
AIMS: To estimate the safety and the efficacy of the off label left atrial appendage (LAA) occlusion in chronic dialysis patients with atrial fibrillation (AF). In this preliminary paper, we report the design of the study and the data on peri-procedural complications. METHODS: This is a prospective cohort study. Primary endpoints are i) incidence of peri-procedural complications, ii) cumulative incidence of two-year thromboembolic events iii) cumulative incidence of two-year bleedings iiii) mortality at two years. Adverse events and death within 30 days of the procedure were recorded. RESULTS: Fifty patients who underwent LAA occlusion between May 2014 and September 2017 were recruited. Both the mean age of the sample study and the dialysis duration were high [71.8 (9.6) years and 59.4 (78.2) months, respectively]. Most patients (84%) were hypertensive and 62% suffered a previous major bleeding. About half of them presented cardiovascular diseases. CHA2DS2VASCs and HASBLED scores were 4.0 (1.5) and 4.4 (0.9), respectively. Most patients (88%) showed atrial dilatation and 44% left ventricular hypertrophy; 32% had left ventricular ejection fraction <50%. Fifty five percent of patients had permanent AF and 32% paroxysmal AF. All devices were implanted successfully. No deaths or major adverse events were reported during a 30-day follow-up. Three episodes of peri-procedural access site bleeding were reported, requiring no transfusion. CONCLUSIONS: Our preliminary data suggest the feasibility and safety of LAA occlusion in patients undergoing dialysis. Only the follow-up of these patients over time can provide evidence that LAA occlusion is effective in preventing of thromboembolic events in this very high-risk population.
AIMS: To estimate the safety and the efficacy of the off label left atrial appendage (LAA) occlusion in chronic dialysis patients with atrial fibrillation (AF). In this preliminary paper, we report the design of the study and the data on peri-procedural complications. METHODS: This is a prospective cohort study. Primary endpoints are i) incidence of peri-procedural complications, ii) cumulative incidence of two-year thromboembolic events iii) cumulative incidence of two-year bleedings iiii) mortality at two years. Adverse events and death within 30 days of the procedure were recorded. RESULTS: Fifty patients who underwent LAA occlusion between May 2014 and September 2017 were recruited. Both the mean age of the sample study and the dialysis duration were high [71.8 (9.6) years and 59.4 (78.2) months, respectively]. Most patients (84%) were hypertensive and 62% suffered a previous major bleeding. About half of them presented cardiovascular diseases. CHA2DS2VASCs and HASBLED scores were 4.0 (1.5) and 4.4 (0.9), respectively. Most patients (88%) showed atrial dilatation and 44% left ventricular hypertrophy; 32% had left ventricular ejection fraction <50%. Fifty five percent of patients had permanent AF and 32% paroxysmal AF. All devices were implanted successfully. No deaths or major adverse events were reported during a 30-day follow-up. Three episodes of peri-procedural access site bleeding were reported, requiring no transfusion. CONCLUSIONS: Our preliminary data suggest the feasibility and safety of LAA occlusion in patients undergoing dialysis. Only the follow-up of these patients over time can provide evidence that LAA occlusion is effective in preventing of thromboembolic events in this very high-risk population.
Authors: Michael Gotzmann; Dinah S Choudhury; Maximilian Hogeweg; Florian Heringhaus; Andreas Mügge; Andreas Pflaumbaum Journal: Clin Cardiol Date: 2020-01-22 Impact factor: 2.882