493
Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study VIVEK Y. REDDY, M.D.,∗ LUCIE SEDIVA, M.D.,† JAN PETRU, M.D., Ph.D.,† JAN SKODA, M.D.,† MILAN CHOVANEC, M.D.,† ZITA CHITOVOVA, M.D.,† PAOLA DI STEFANO, Ph.D.,‡ ETHEL RUBIN, Ph.D.,§ SRINIVAS DUKKIPATI, M.D.,∗ and PETR NEUZIL, M.D., Ph.D.† From the ∗ Cardiac Arrhythmia Service of the Mt. Sinai Hospital, New York, New York, USA; †Homolka Hospital, Prague, Czech Republic; ‡EMEA Regional Clinical Center, Medtronic Clinical Research Institute, Milan, Italy; and §Medtronic Inc., Minneapolis, Minnesota, USA
Durability of Pulmonary Vein Isolation with Cryoballoon Ablation. Introduction: Pulmonary vein (PV) reconnection remains the most important cause of AF recurrence after AF ablation. The secondgeneration cryoballoon catheter’s ability to achieve durable PV isolation was assessed in a prospective nonrandomized clinical trial. Methods and Results: PV isolation was performed by 4-minute ablations. Following verification of electrical isolation by a multielectrode mapping catheter, 1 additional lesion per PV was applied. Esophageal temperatures were monitored and all patients underwent postprocedure esophageal endoscopy. All patients underwent a second PV remapping procedure at 3 months to assess for PVI durability. Eighty-four (100%) veins were acutely isolated using only the 28 mm cryoballoon in 21 consecutive PAF patients with 2.2 ± 0.6 cryoapplications per vein, with the majority (83%) occurring after a single freeze. One patient presented with hematemesis and an esophageal ulceration that was treated conservatively; there were no episodes of esophageal fistula or phrenic nerve palsy. At 3.4 (2.9–4.1) months postablation, 68/75 veins (91%) remained electrically isolated; all PVs remained durably isolated in 79% of patients. Two patients accounted for 5 of 7 reconducting veins. The most common site for reconnection was the inferior aspect of the RIPV (3/7 reconnections). Reconnected veins had poorer occlusion at the index ablation procedure than veins that maintained chronic isolation (occlusion grade 2.9 ± 0.7 vs. 3.4 ± 0.7, P = 0.001). Clinical AF recurrence was detected in 2 patients (11%) at follow-up. Conclusions: The improved thermodynamic characteristics of the second-generation cryoballoon led to a high rate of both single-shot PVI and chronic lesion durability. This high rate of durable PV isolation is anticipated to translate to improved clinical outcome. (J Cardiovasc Electrophysiol, Vol. 26, pp. 493-500, May 2015) atrial fibrillation, cryoablation, cryoballoon, pulmonary vein isolation, recurrence Introduction The durability of pulmonary vein (PV) lesions is one of the most important goals during catheter ablation of atrial fibrillation (AF), as arrhythmia recurrence is most frequently a result of electrical reconduction from triggers originating in PVs.1-3 Emerging data from the GAP AF study (NCT00293943) reinforce the concept that the completion of encircling PV lesions is required for maintenance of This study was sponsored by Medtronic International Trading Sarl. V.Y.R. and S.D. have served as consultants to Medtronic. V.Y.R., S.D., and P.N. have received grant support from Medtronic. Other authors: No disclosures. Clinicaltrials.gov NCT01645917. Address for correspondence: Vivek Y. Reddy, M.D., Director, Cardiac Arrhythmia Service, Professor of Medicine, The Mount Sinai School of Medicine, 1190 Fifth Avenue – 1 South, New York, NY 10029. Fax: 1-646537-9691; E-mail: [email protected] Manuscript received 22 May 2014; Revised manuscript received 30 November 2014; Accepted for publication 12 December 2014. doi: 10.1111/jce.12626
electrical isolation following PV isolation (PVI).4 Developments in balloon technologies provide an anatomic approach to circumferential PVI, with the goal of simplifying the procedure, while optimizing the durability of PV lesions. Catheter ablation with the first-generation system achieved 69.9% freedom from AF of at 12 months postablation, as reported from the STOP AF trial.5 However, in this first iteration of the device, there was nonhomogeneous distribution of the refrigerant, which could have compromised efficacy. To this end, the second-generation cryoballoon was developed with a re-engineered cryorefrigerant dispersion capability and improved thermodynamic profile.6 By doubling the number of cryogen ports it was hypothesized that improved lesion durability would result from a more homogeneous cooling surface, as well as a distal zone of cooling. To test its effects on lesion contiguity and durability, we conducted the Sustained PV Isolation with Arctic Front Advance (SUPIR) study. This prospective, nonrandomized trial mandated a second procedure of invasive electrophysiology (EP) mapping at approximately 3 months following the index ablation of paroxysmal atrial fibrillation (PAF) for all patients, regardless of symptoms, to objectively measure PV lesion durability.
494
Journal of Cardiovascular Electrophysiology
Vol. 26, No. 5, May 2015
Methods Patient Enrollment Twenty-one consecutive patients with symptomatic, drug refractory, recurrent PAF planning to undergo cryoballoon ablation were prospectively enrolled in the SUPIR study (NCT01645917), which was approved by the Ethics Committee at Homolka Hospital in Prague, Czech Republic. Due to the study design, the sample size was determined by the minimum number of patients needed to detect a medium effect size of PVI while accounting for 25% patient attrition. All patients provided written informed consent. Patients were excluded if they had previous AF ablations, or those who had prosthetic valves, previous PV stents or stenosis, structural or congenital heart disease, EF
Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study VIVEK Y. REDDY, M.D.,∗ LUCIE SEDIVA, M.D.,† JAN PETRU, M.D., Ph.D.,† JAN SKODA, M.D.,† MILAN CHOVANEC, M.D.,† ZITA CHITOVOVA, M.D.,† PAOLA DI STEFANO, Ph.D.,‡ ETHEL RUBIN, Ph.D.,§ SRINIVAS DUKKIPATI, M.D.,∗ and PETR NEUZIL, M.D., Ph.D.† From the ∗ Cardiac Arrhythmia Service of the Mt. Sinai Hospital, New York, New York, USA; †Homolka Hospital, Prague, Czech Republic; ‡EMEA Regional Clinical Center, Medtronic Clinical Research Institute, Milan, Italy; and §Medtronic Inc., Minneapolis, Minnesota, USA
Durability of Pulmonary Vein Isolation with Cryoballoon Ablation. Introduction: Pulmonary vein (PV) reconnection remains the most important cause of AF recurrence after AF ablation. The secondgeneration cryoballoon catheter’s ability to achieve durable PV isolation was assessed in a prospective nonrandomized clinical trial. Methods and Results: PV isolation was performed by 4-minute ablations. Following verification of electrical isolation by a multielectrode mapping catheter, 1 additional lesion per PV was applied. Esophageal temperatures were monitored and all patients underwent postprocedure esophageal endoscopy. All patients underwent a second PV remapping procedure at 3 months to assess for PVI durability. Eighty-four (100%) veins were acutely isolated using only the 28 mm cryoballoon in 21 consecutive PAF patients with 2.2 ± 0.6 cryoapplications per vein, with the majority (83%) occurring after a single freeze. One patient presented with hematemesis and an esophageal ulceration that was treated conservatively; there were no episodes of esophageal fistula or phrenic nerve palsy. At 3.4 (2.9–4.1) months postablation, 68/75 veins (91%) remained electrically isolated; all PVs remained durably isolated in 79% of patients. Two patients accounted for 5 of 7 reconducting veins. The most common site for reconnection was the inferior aspect of the RIPV (3/7 reconnections). Reconnected veins had poorer occlusion at the index ablation procedure than veins that maintained chronic isolation (occlusion grade 2.9 ± 0.7 vs. 3.4 ± 0.7, P = 0.001). Clinical AF recurrence was detected in 2 patients (11%) at follow-up. Conclusions: The improved thermodynamic characteristics of the second-generation cryoballoon led to a high rate of both single-shot PVI and chronic lesion durability. This high rate of durable PV isolation is anticipated to translate to improved clinical outcome. (J Cardiovasc Electrophysiol, Vol. 26, pp. 493-500, May 2015) atrial fibrillation, cryoablation, cryoballoon, pulmonary vein isolation, recurrence Introduction The durability of pulmonary vein (PV) lesions is one of the most important goals during catheter ablation of atrial fibrillation (AF), as arrhythmia recurrence is most frequently a result of electrical reconduction from triggers originating in PVs.1-3 Emerging data from the GAP AF study (NCT00293943) reinforce the concept that the completion of encircling PV lesions is required for maintenance of This study was sponsored by Medtronic International Trading Sarl. V.Y.R. and S.D. have served as consultants to Medtronic. V.Y.R., S.D., and P.N. have received grant support from Medtronic. Other authors: No disclosures. Clinicaltrials.gov NCT01645917. Address for correspondence: Vivek Y. Reddy, M.D., Director, Cardiac Arrhythmia Service, Professor of Medicine, The Mount Sinai School of Medicine, 1190 Fifth Avenue – 1 South, New York, NY 10029. Fax: 1-646537-9691; E-mail: [email protected] Manuscript received 22 May 2014; Revised manuscript received 30 November 2014; Accepted for publication 12 December 2014. doi: 10.1111/jce.12626
electrical isolation following PV isolation (PVI).4 Developments in balloon technologies provide an anatomic approach to circumferential PVI, with the goal of simplifying the procedure, while optimizing the durability of PV lesions. Catheter ablation with the first-generation system achieved 69.9% freedom from AF of at 12 months postablation, as reported from the STOP AF trial.5 However, in this first iteration of the device, there was nonhomogeneous distribution of the refrigerant, which could have compromised efficacy. To this end, the second-generation cryoballoon was developed with a re-engineered cryorefrigerant dispersion capability and improved thermodynamic profile.6 By doubling the number of cryogen ports it was hypothesized that improved lesion durability would result from a more homogeneous cooling surface, as well as a distal zone of cooling. To test its effects on lesion contiguity and durability, we conducted the Sustained PV Isolation with Arctic Front Advance (SUPIR) study. This prospective, nonrandomized trial mandated a second procedure of invasive electrophysiology (EP) mapping at approximately 3 months following the index ablation of paroxysmal atrial fibrillation (PAF) for all patients, regardless of symptoms, to objectively measure PV lesion durability.
494
Journal of Cardiovascular Electrophysiology
Vol. 26, No. 5, May 2015
Methods Patient Enrollment Twenty-one consecutive patients with symptomatic, drug refractory, recurrent PAF planning to undergo cryoballoon ablation were prospectively enrolled in the SUPIR study (NCT01645917), which was approved by the Ethics Committee at Homolka Hospital in Prague, Czech Republic. Due to the study design, the sample size was determined by the minimum number of patients needed to detect a medium effect size of PVI while accounting for 25% patient attrition. All patients provided written informed consent. Patients were excluded if they had previous AF ablations, or those who had prosthetic valves, previous PV stents or stenosis, structural or congenital heart disease, EF
