Purpose The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE). Methods One-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE. Results The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 +/- 22.38 vs 58.38 +/- 17.85 min,p < 0.001), while the fluoroscopy time was longer (12.25 +/- 6.84 vs 5.32 +/- 4.42 min,p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%,p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%,p = 0.02) and long-term complications in three patients (3%,p = 0.24), needing for a system revision in 6 cases (6%,p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 +/- 0.21 vs 0.26 +/- 0.22 mu J,p < 0.001). Conclusion Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE.

Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction

Zucchelli, Giulio;Tolve, Silvio;Barletta, Valentina;Di Cori, Andrea;Parollo, Matteo;Della Tommasina, Veronica;Giannotti Santoro, Mario;Cellamaro, Tea;Segreti, Luca;Paperini, Luca;Bongiorni, Maria Grazia
2021-01-01

Abstract

Purpose The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE). Methods One-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE. Results The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 +/- 22.38 vs 58.38 +/- 17.85 min,p < 0.001), while the fluoroscopy time was longer (12.25 +/- 6.84 vs 5.32 +/- 4.42 min,p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%,p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%,p = 0.02) and long-term complications in three patients (3%,p = 0.24), needing for a system revision in 6 cases (6%,p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 +/- 0.21 vs 0.26 +/- 0.22 mu J,p < 0.001). Conclusion Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE.
2021
Zucchelli, Giulio; Tolve, Silvio; Barletta, Valentina; Di Cori, Andrea; Parollo, Matteo; De Lucia, Raffaele; Della Tommasina, Veronica; Giannotti Santoro, Mario; Viani, Stefano; Cellamaro, Tea; Segreti, Luca; Paperini, Luca; Soldati, Ezio; Bongiorni, Maria Grazia
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11568/1159129
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