Cryoballoon Ablation for Persistent and Paroxysmal Atrial Fibrillation: Procedural Differences and Results from the Spanish Registry (RECABA)

Introduction: Cryoballoon ablation (CBA) has become a standard treatment for paroxysmal atrial fibrillation (PaAF) but limited data is available for outcomes in patients with persistent atrial fibrillation (PeAF). Methods: We analyzed the first 944 patients included in the Spanish Prospective Multi-center Observation Post-market Registry to compare characteristics and outcomes of patients undergoing CBA for PeAF versus PaAF. Results: A total of 944 patients (57.8 ± 10.4 years; 70.1% male) with AF (27.9% persistent) were prospectively included from 25 centers. PeAF patients were more likely to have structural heart disease (67.7 vs. 11.4%; p < 0.001) and left atrium dilation (72.6 vs. 43.3%; p < 0.001). CBA of PeAF was less likely to be performed under general anesthesia (10.7 vs. 22.2%; p < 0.001), with an arterial line (32.2 vs. 44.6%; p < 0.001) and assisted transeptal puncture (11.9 vs. 17.9%; p = 0.025). During an application, PeAF patients had a longer time to −30 ◦C (35.91 ± 14.20 vs. 34.93 ± 12.87 s; p = 0.021) and a colder balloon nadir temperature during vein isolation (−35.04 ± 9.58 vs. −33.61 ± 10.32 ◦C; p = 0.004), but received fewer bonus freeze applications (30.7 vs. 41.1%; p < 0.001). There were no differences in acute pulmonary vein isolation and procedure-related complications. Overall, 76.7% of patients were free from AF recurrences at 15-month follow-up (78.9% in PaAF vs. 70.9% in PeAF; p = 0.09). Conclusions: Patients with PeAF have a more diseased substrate, and CBA procedures performed in such patients were more simplified, although longer/colder freeze applications were often applied. The acute efficacy/safety profile of CBA was similar between PaAF and PeAF patients, but long-term results were better in PaAF patients

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use

Time to –30°C as a predictor of acute success during cryoablation in patients with atrial fibrillation

Background: Freezing rate of second-generation cryoballoon (CB) is a biophysical parameter that could assist pulmonary vein isolation. The aim of this study is to assess freezing rate (time to reach –30°C ([TT-30C]) as an early predictor of acute pulmonary vein isolation using the CB. Methods: Biophysical data from CB freeze applications within a multicenter, nation-wide CB ablation registry were gathered. Successful application (SA), was defined as achieving durable intraprocedural vein isolation with time to isolation in under 60 s (SA-TTI&lt;60) as achieving durable vein isolation in under 60 s. Logistic regressions were performed and predictive models were built for the data set. Results: 12,488 CB applications from 1,733 atrial fibrillation (AF) ablation procedures were included within 27 centers from a Spanish CB AF ablation registry. SA was achieved in 6,349 of 9,178 (69.2%) total freeze applications, and SA-TTI&lt;60 was obtained in 2,673 of 4,784 (55.9%) freezes and electrogram monitoring was present. TT-30C was shorter in the SA group (33.4 ± 9.2 vs 39.3 ± 12.1 s; p &lt; 0.001) and SA-TTI&lt;60 group (31.8 ± 7.6 vs. 38.5 ± 11.5 s; p &lt; 0.001). Also, a 10 s increase in TT-30C was associated with a 41% reduction in the odds for an SA (odds ratio [OR] 0.59; 95% confidence interval [CI] 0.56–0.63) and a 57% reduction in the odds for achieving SA-TTI&lt;60 (OR 0.43; 95% CI 0.39–0.49), when corrected for electrogram visualization, vein position, and application order. Conclusions: Time to reach –30°C is an early predictor of the quality of a CB application and can be used to guide the ablation procedure even in the absence of electrogram monitoring.

Repeat cryoablation as a redo procedure for atrial fibrillation ablation: Is it a good choice?

Background: Ablation of atrial fibrillation (AF), both cryoablation ablation (CBA) and radiofrequency catheter ablation (RFCA), have demonstrated to be safe and effective. About 1 in 3 patients may face a redo due to recurrence and the best technique is unknown. The aim of this study is to assess the efficacy of CBA as a repeat procedure in patients with prior CBA or RFCA. Methods: A nation-wide CBA registry (RECABA) was analyzed and patients were compared who had previously undergone CBA (Prior-CB) or RFCA (Prior-RF). The primary endpoint was AF recurrence at 12 months after a 3-month blanking period. A survival analysis was performed, univariate and multivariate Cox models were also built. Results: Seventy-four patients were included. Thirty-three (44.6%) were in the Prior-CB group and 41 (55.4%) in the Prior-RF. There were more reconnected pulmonary veins in the Prior-RF than in Prior-CB group (40.4% vs.16.5%, p = 0.0001). The 12-month Kaplan–Meier estimate of freedom from AF recurrence after the blanking period was 61.0% (95% confidence interval [CI] 41.4–75.8%) in the Prior-CB, and 89.2% (95% CI 73.6–95.9%) in the Prior-RF group (p = 0.002).  Multivariate Cox regression pointed Prior-CB as the sole independent predictor of AF recurrence, with an adjusted HR of 2.67 (95% CI 1.05–6.79). Conclusions: Repeat CBA shows higher rates of AF recurrences compared to CBA after a previous RFCA despite presenting less reconnected veins at the procedure. These data suggest that patients with AF recurrence after CBA may benefit from other ablation techniques after a recurrence. RECABA is registered at clinicaltrials.gov with the Unique Identifier NCT02785991

Adelante / Endavant

Séptimo desafío por la erradicación de la violencia contra las mujeres del Institut Universitari d’Estudis Feministes i de Gènere "Purificación Escribano" de la Universitat Jaume

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study

Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991

Comparison of Radiofrequency Catheter Ablation of Drivers versus Circunferencial Pulmonary Vein Isolation in Patients with Atrial Fibrillation. A Noninferiority Randomized Clinical Trial

BACKGROUND Empiric circumferential pulmonary vein isolation (CPVI) has become the therapy of choice for drugrefractory atrial fibrillation (AF). Although results are suboptimal, it is unknown whether mechanistically-based strategies targeting AF drivers are superior. OBJECTIVES This study sought to determine the efficacy and safety of localized high-frequency source ablation (HFSA) compared with CPVI in patients with drug-refractory AF. METHODS This prospective, multicenter, single-blinded study of 232 patients (age 53 10 years, 186 males) randomized those with paroxysmal AF (n ¼ 115) to CPVI or HFSA-only (noninferiority design) and those with persistent AF (n ¼ 117) to CPVI or a combined ablation approach (CPVI þ HFSA, superiority design). The primary endpoint was freedom from AF at 6 months post-first ablation procedure. Secondary endpoints included freedom from atrial tachyarrhythmias (AT) at 6 and 12 months, periprocedural complications, overall adverse events, and quality of life. RESULTS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months after a single procedure but, after redo procedures, was noninferior to CPVI at 12 months for freedom from AF and AF/AT. Serious adverse events were significantly reduced in the HFSA group versus CPVI patients (p ¼ 0.02). In persistent AF, there were no significant differences between treatment groups for primary and secondary endpoints, but CPVI þ HFSA trended toward more serious adverse events. CONCLUSIONS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months but was noninferior to CPVI at 1 year in achieving freedom of AF/AT and a lower incidence of severe adverse events. In persistent AF, CPVI þ HFSA offered no incremental value. (Radiofrequency Ablation of Drivers of Atrial Fibrillation [RADAR-AF]; NCT00674401) (J Am Coll Cardiol 2014;64:2455–67).This study was funded by the Centro Nacional de Investigaciones Cardiovasculares and by an unrestricted research grant from St. Jude Medical. Dr. Atienza has received research grants from St. Jude Medical; and is on the advisory board of Medtronic, Inc. Dr. Jalife is on the scientific advisory board of Topera, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.Martínez Alzamora, MN.; Atienza, F.; Almendral, J.; Ormaetxe, JM.; Moya, Á.; Martínez-Alday, JD.; Hernández-Madrid, A.... (2014). Comparison of Radiofrequency Catheter Ablation of Drivers versus Circunferencial Pulmonary Vein Isolation in Patients with Atrial Fibrillation. A Noninferiority Randomized Clinical Trial. Journal of the American College of Cardiology. 64(23):2455-2467. doi:10.1016/j.jacc.2014.09.053S24552467642

Cryoballoon ablation for persistent and paroxysmal atrial fibrillation: procedural differences and results from the spanish registry (RECABA)

Introduction: Cryoballoon ablation (CBA) has become a standard treatment for paroxysmal atrial fibrillation (PaAF) but limited data is available for outcomes in patients with persistent atrial fibrillation (PeAF). Methods: We analyzed the first 944 patients included in the Spanish Prospective Multi-center Observation Post-market Registry to compare characteristics and outcomes of patients undergoing CBA for PeAF versus PaAF. Results: A total of 944 patients (57.8 ± 10.4 years; 70.1% male) with AF (27.9% persistent) were prospectively included from 25 centers. PeAF patients were more likely to have structural heart disease (67.7 vs. 11.4%; p &lt; 0.001) and left atrium dilation (72.6 vs. 43.3%; p &lt; 0.001). CBA of PeAF was less likely to be performed under general anesthesia (10.7 vs. 22.2%; p &lt; 0.001), with an arterial line (32.2 vs. 44.6%; p &lt; 0.001) and assisted transeptal puncture (11.9 vs. 17.9%; p = 0.025). During an application, PeAF patients had a longer time to -30 °C (35.91 ± 14.20 vs. 34.93 ± 12.87 s; p = 0.021) and a colder balloon nadir temperature during vein isolation (-35.04 ± 9.58 vs. -33.61 ± 10.32 °C; p = 0.004), but received fewer bonus freeze applications (30.7 vs. 41.1%; p &lt; 0.001). There were no differences in acute pulmonary vein isolation and procedure-related complications. Overall, 76.7% of patients were free from AF recurrences at 15-month follow-up (78.9% in PaAF vs. 70.9% in PeAF; p = 0.09). Conclusions: Patients with PeAF have a more diseased substrate, and CBA procedures performed in such patients were more simplified, although longer/colder freeze applications were often applied. The acute efficacy/safety profile of CBA was similar between PaAF and PeAF patients, but long-term results were better in PaAF patients