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We compared the efficacy and complication rates of quantitative radiofrequency ablation guided by ablation index (RFCA-AI) with those of second-generation cryoballoon ablation (CBA-2). Consecutive patients (n = 230) with symptomatic atrial fibrillation (AF) undergoing a first ablation CBA-2 (92 patients) or RFCA-AI (138 patients) procedure were enrolled in this study. The late recurrence rate in the CBA-2 group was higher than that in the RFCA-AI group (P =.012). Subgroup analysis showed the same result in patients with paroxysmal AF (PAF) (P =.039), but no difference was found in patients with persistent AF (P =.21). The average operation duration in the CBA-2 group (85 [75-99.5] minutes) was shorter than that in the RFCA-AI group (100 [84.5-120] minutes) (P <.0001), but the average exposure time (17.36(13.87-22.49) vs 5.49(4.00-8.24) minutes) in the CBA-2 group and X-ray dose (223.25(149.15-336.95) vs 109.15(80.75-168.7) mGym) were significantly longer than those in RFCA-AI group (P <.0001). Multivariate logistic regression analysis showed that left atrial diameter (LAD), early recurrence, and methods of ablation (cryoballoon ablation) were independent risk factors for late recurrence after AF ablation. Early recurrence of AF and LAD were independent risk factors for predicting late recurrence after AF ablation. [ABSTRACT FROM AUTHOR]

Objective To compare the effectiveness and safety of second-generation cryoballoon ablation and conventional drug therapy separately as the initial treatment for patients with paroxysmal atrial fibrillation (AF). Methods We selected 44 patients with paroxysmal AF who had been initially treated by second-generation cryoballoon ablation as the ablation group. The operation time, ablation time, X-ray fluoroscopy time, pulmonary vein isolation rate, and surgical complications were observed. We selected another 44 inpatients with paroxysmal AF who had been initially treated by drug therapy during the same period as the medication group. The two groups were followed up separately one month, and 3, 6 and 12 months after discharge to observe the recurrence rate and complications of AF. The efficacy and safety of treatment were further compared between the two groups. Results The operation time, ablation time and X-ray fluoroscopy time of the ablation group were (108. 0±39. 0) minutes, (35. 0±11. 7) minutes and (10. 0±6. 9) minutes, respectively; the immediate isolation rate of pulmonary vein was 100%; there were 3 cases (6. 8%) of operation-related complications, including one case of vagus reflex and 2 cases of transient phrenic nerve injury. In the medication group, drug-induced sinus bradycardia occurred in 2 cases, QTc was prolonged in one case, and thyroid function was decreased in one case. After a mean follow-up of (12. 0±5. 9) months, the recurrence rate of AF was 11. 4% in the ablation group while the rate was 20. 5% in the medication group. The recurrence rate in the ablation group was significantly lower than that in the medication group (P = 0. 033). The incidence of complications or adverse reactions did not vary significantly from the ablation group to the medication group (6. 8% vs 9. 1%, P = 0. 108). Conclusion Compared with drug therapy, the secondgeneration cryoballoon ablation has a higher success rate for paroxysmal AF without increased risk of complications. The second-generation cryoballoon ablation can be considered as one of the initial treatment strategies for paroxysmal AF. [ABSTRACT FROM AUTHOR]

Objectives: The study aimed at assessing the outcome of pulmonary vein isolation (PVI) using second-generation cryoballoon, Arctic Front Advance, Medtronic (CB-Adv) as a rhythm control strategy for drug-resistant paroxysmal atrial fibrillation (PAF) in a cardiac tertiary care center of Pakistan. Methodology: Fifty patients had PVI with CB-Adv for symptomatic drug-resistant PAF at the National Institute of Cardiovascular Diseases, Karachi, Pakistan, during 2017-2022. Patients were followed-up in the clinic on the 1st, 3rd, and 6th month after the ablation. Twenty-four hours of Holter monitoring of electrocardiogram was obtained on each visit. We conducted a retrospective chart review after approval from the ethical review committee. We collected all the patients' demographic and clinical data, procedural results, and reports of Holter monitoring. The primary outcome was successful PVI and freedom from atrial tachyarrhythmia (Ata) on a 6-month follow-up. Results: We enrolled all 50 patients (34 male, 68%; mean age 55.14 ± 7.94 years) treated with PVI using CB-Adv. The mean duration of symptoms was 30.28 ± 13.48 months. PVI with CBAdv was found to be curative in 49 patients (98%). Following the procedure, pericardial effusion was found in one patient (2%), whereas one patient (2%) had a retroperitoneal hematoma. On a six-month follow-up, only one patient (2%) had a recurrence of Ata, which was PAF. Conclusion: Our experience of PVI with CB-Adv has shown a high success rate of the procedure for rhythm control in patients who have PAF, which is resistant to antiarrhythmic drugs (AADs). [ABSTRACT FROM AUTHOR]

Background: Damage to the sinus node (SN) has been described as a potential complication of superior vena cava (SVC) isolation. There have been reports of permanent SN injury requiring pacemaker implantation during isolation of the SVC. Hypothesis: It is safe and effective to isolate SVC with the second‐generation 28‐mm cryoballoon by using a novel method. Methods: Forty‐three patients (including six redo cases) with SVC‐related atrial fibrillation (AF) from a consecutive series of 650 patients who underwent cryoballoon ablation were included. After pulmonary vein isolation was achieved, if the SVC trigger was identified, the SVC was electrically isolated using the cryoballoon. First, the cryoballoon was inflated in the right atrium (RA) and advanced towards the SVC‐RA junction. After total occlusion was confirmed by dye injection with total retention of contrast in the SVC, the SVC‐RA junction was determined. Next, the cryoballoon was deflated, advanced into SVC, then reinflated, and pulled back gently. The equatorial band of the cryoballoon was then set slightly (4.32 ± 0.71 mm) above the SVC‐RA junction for isolation of the SVC. Results: Real‐time SVC potential was observed in all patients during ablation. The mean time to isolation was 24.5 ± 10.7 s. The SVC was successfully isolated in all patients. The mean number of freeze cycles was 2.5 ± 1.4 per patient, and the mean ablation time was 99.8 ± 22.7 s. A transient phrenic nerve (PN) injury occurred in one patient (2.33%). There were no SN injuries. Freedom from AF rates at 6 and 12 months was 97.7% and 93.0%, respectively. Conclusions: This novel method for SVC isolation using the cryoballoon is safe and feasible when the SVC driver during AF is determined and could avoid SN injury. PN function should still be carefully monitored during an SVC isolation procedure. [ABSTRACT FROM AUTHOR]

Background: Paroxysmal atrial fibrillation (PAF) can be triggered by non-pulmonary vein foci, like the superior vena cava (SVC). The latter is correlated with improved result in terms of freedom from atrial tachycardias (ATs), when electrical isolation of this vessel utilizing radiofrequency energy (RF) is achieved. Objectives: Evaluate the clinical impact, in patients with PAF, of the SVC isolation (SVCi) in addition to ordinary pulmonary vein isolation (PVI) by means of the second-generation cryoballoon (CB) Methods: A total of 100 consecutive patients that underwent CB ablation for PAF were retrospectively selected. Fifty consecutive patients received PVI followed by SVCi by CB application, and the following 50 consecutive patients received standard PVI. All patients were followed 12 months. Results: The mean time to SVCi was 36.7 ± 29.0 s and temperature at SVC isolation was − 35 (− 18 to − 40) °C. Real-time recording (RTR) during SVCi was observed in 42 (84.0%) patients. At the end of 12 months of follow-up, freedom from ATs was achieved in 36 (72%) patients in the PVI only group and in 45 (90%) patients of the SVC and PV isolation group (Fisher's exact test p = 0.039, binary logistic regression: p = 0.027, OR = 0.28, 95%CI = 0.09–0.86). In survival analysis, SVC and PV isolation group was also associated with improved freedom from ATs (log-rank test: p = 0.017, Cox regression: p = 0.026, HR = 0.31, 95%CI = 0.11–0.87). Conclusion: Superior vena cava isolation with the CB in addition to PVI might improve freedom from ATs if compared to PVI alone at 1-year follow-up. [ABSTRACT FROM AUTHOR]

This randomized study aims to compare the left atrial (LA) lesion size, function, and tissue damage following pulmonary vein isolation (PVI) by high-power short-duration (HPSD) radiofrequency (RF) and second-generation cryoballoon (CB2) ablation. We enrolled 40 patients with paroxysmal atrial fibrillation who underwent PVI by HPSD RF (n = 21) or CB2 (n = 19). Every patient underwent LA CT angiography and transthoracic echocardiography (TTE) to assess the LA anatomy and function. Biomarker levels (hs-cTnT, hs-CRP, LDH) were compared pre- and post-procedurally. Pre- and post-ablation high-density mapping (HDM) was performed. The isolation area was defined under 0.2 mV bipolar voltage (low voltage area, LVA). We calculated the post-PVI LVA/LA surface ratio using LA CT-HDM merge images. At 3-month follow-up, TTE was performed to assess the changes in LA function. Post-ablation hs-cTnT level was significantly higher in the RF group (RF: 1249 ± 469 ng/L, CB2: 995 ± 280 ng/L, p = 0.024). Post-PVI hs-CRP (RF: 9.53 ± 10.30 mg/L, CB2: 12.36 ± 5.76 mg/L, p = 0.034) and LDH levels (RF: 349.9 ± 65.6 U/L, CB2: 451.6 ± 91.3 U/L, p < 0.001) were significantly higher following CB2 ablation. Post-PVI LVA/LA surface ratios were 8.37 ± 6.42% in the RF group and 13.58 ± 8.92% in the CB2 group (p = 0.022). LA function did not change significantly after the PVI procedure. Our data indicate that second-generation cryoballoon ablation produces a significantly larger LA lesion size compared to “point-by-point” HPSD radiofrequency. Both techniques preserve LA function. The myocardial component of tissue loss appears to be higher using HPSD radiofrequency ablation, with less collateral damage.

Purpose: The purpose of this study was to evaluate the feasibility and safety of superior vena cava (SVC) isolation in addition to standard pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB) in patients with paroxysmal atrial fibrillation. Methods: Thirty-seven consecutive patients that underwent CB ablation for paroxysmal atrial fibrillation (PAF) were prospectively enrolled in our study. After PVI the SVC was mapped for potentials. If the SVC exhibited electrical activity, isolation was achieved performing a single 180-s balloon application. Results: Regarding SVC isolation, 180-s freeze in the SVC could be completed in 32 (86.4%) patients, and 5 patients had at least 120 s of freezing application (13.5%). Real-time recording during SVC isolation was observed in 30 (81.0%) patients. The mean time to isolation was 36.9 ± 28.7 s and the temperature at isolation was − 33 (− 15 to − 40) °C. No cases developed persistent phrenic nerve palsy (PNP) or any other complication. Conclusions: Superior vena cava isolation proved to be safe and feasible with the second generation cryoballoon in a prospective series of patients affected by PAF. [ABSTRACT FROM AUTHOR]

Objectives: It is imperative to understand the influence of second-generation cryoballoon (CB-2) and contact-force sensing radiofrequency ablation (CF-RF) on clinical outcomes in atrial fibrillation (AF). This updated meta-analysis of randomized controlled trials (RCTs) examined the efficacy and safety of CB-2 vs. CF-RF in patients with AF. Methods: RCTs on the use of CB-2 vs. CF-RF in patients with AF were included. The primary outcome was the recurrence of AF, and the key secondary outcomes included serious complications, acute pulmonary vein isolation (PVI), procedure duration, and fluoroscopy time. Results: A total of 261 articles were identified, and five studies with a total of 845 participants were included in the study. A total of 93% of participants had paroxysmal AF, 7% of participants had persistent AF, and none of participants had permanent AF. There were 499 participants in the CB-2 arm and 346 in the CF-RF arm. AF recurrence was comparable in the CB-2 group (30.3%) and the CF-RF group (29.2%) (OR = 0.93; 95%CI = 0.56–1.54; P = 0.79; I2 = 48%). There were no statistical differences in acute PVI (P = 0.92; I2 = 0%) and serious complications (P = 0.87; I2 = 47%) between the two groups. The procedure duration was shorter in the CB-2 group than in the CF-RF group (MD = − 13.39; 95%CI = − 15.58, − 7.19; P < 0.0001; I2 = 59%). Conclusion: Our study demonstrated that CB-2 and CF-RF had comparable recurrences of AF and similar incidences of serious complications in AF patients during the ablation process. [ABSTRACT FROM AUTHOR]

Introduction: Cryoballoon ablation (CBA) and radiofrequency ablation (RFA) are the preferred modalities for catheter ablation of atrial fibrillation (AF). Technological advances have improved procedural outcomes, warranting an updated comparison. We sought to evaluate the efficacy and safety of CBA–2nd generation (CBA‐2G) in comparison to RFA‐contact force (RFA‐CF) in patients with AF. Methods: MEDLINE, Cochrane, and ClinicalTrials.gov databases were searched until 03/01/2020 for relevant studies comparing CBA‐2G versus RFA‐CF in patients undergoing initial catheter ablation for AF. Results: A total of 17 studies, involving 11 793 patients were included. There was no difference between the two groups in the outcomes of freedom from atrial arrhythmia (p =.67) and total procedural complications (p =.65). There was a higher incidence of phrenic nerve palsy in CBA‐2G (odds ratio: 10.7; 95% confidence interval [CI]: 5.85 to 19.55; p <.001). Procedure duration was shorter (mean difference: −31.32 min; 95% CI: −40.73 to −21.92; p <.001) and fluoroscopy duration was longer (+3.21 min; 95% CI: 1.09 to 5.33; p =.003) in CBA‐2G compared to RFA‐CF. In the subgroup analyses of patients with persistent AF and >1 freeze lesion delivered per vein, there was no difference in freedom from atrial arrhythmia. Conclusions: In AF patients undergoing initial ablation, CBA‐2G and RFA‐CF were equally efficacious. The procedure duration was shorter, but with a higher incidence of phrenic nerve palsy in CBA‐2G. In patients with persistent AF, there was no difference in the efficacy between CBA‐2G or RFA‐CF techniques. [ABSTRACT FROM AUTHOR]

Introduction: It is unknown whether left atrial (LA) roof ablation combined with pulmonary vein isolation (PVI) using a second-generation cryoballoon provides additional benefit beyond that of PVI alone in patients with persistent atrial fibrillation (AF). The aim of this study was to compare arrhythmia recurrence rates after PVI alone versus PVI plus LA roof ablation. Methods and results: In this observational study, we analyzed 399 symptomatic patients with persistent AF treated with cryoballoon ablation. After univariate and multivariate analyses of the entire cohort, propensity score matching resulted in two groups of 86 patients each: (1) PVI plus LA roof ablation (PVI-plus group) and (2) PVI alone (PVI-only group). The primary endpoint was the first documented > 30-s arrhythmia recurrence after a 3-month blanking period. PVI was successful in all patients. A bidirectional conduction block across the LA roof was verified in 91.9% of patients in the PVI-plus group. During a median mid-term follow-up of 33 months, 21 patients (24.4%) in the PVI-plus group and 37 patients (43.0%) in the PVI-only group (P = 0.01) reached the primary endpoint. Multivariate analysis revealed AF history > 2 years (hazard ratio [HR] = 2.04, P < 0.01), LA area > 21 cm2 (HR = 2.36, P < 0.01), female sex (HR = 1.92, P = 0.02), and LA roof ablation (HR = 0.47, P < 0.01) as significant predictors of outcome. Conclusions: We observed a significant difference in arrhythmia recurrence rates between the two groups. LA roof ablation is an effective adjuvant treatment option that shows improved outcome compared with PVI alone. [ABSTRACT FROM AUTHOR]

Background: Cryoballoon ablation (CBA) is gaining increasing acceptance in the treatment of persistent (per) atrial fibrillation (AF). The cardiac autonomic nervous system plays a pivotal role in the regulation of AF.Objective: We evaluated the impact of vagal reactions (VRs), as a surrogate marker for autonomic nervous system modulation, on the outcome of CBA in patients (pts) with perAF.Methods: A total of 250 consecutive pts (mean age 63.9 ± 10.0 years; 175 pts, 70% male) undergoing primary second-generation CBA for perAF were studied. VRs were defined as bradycardia <40 beats/min, asystole, or higher-degree atrioventricular block. Follow-up visits at 3, 6, and 12 months included 7-day Holter electrocardiograms.Results: VRs were recorded in 61 pts (24%). These pts showed a significantly reduced recurrence rate of AF (5%) than did those without VRs (log-rank, P < .01). Univariate Cox regression analyses confirmed VRs as a strong predictor of AF-free survival (hazard ratio [HR] 0.10; P < .01). Female sex (HR 1.71; P = .02), preprocedural tachycardia (HR 1.01; P = .01), and AF (HR 1.75; P = .01) before CBA at admission were revealed as predictors of AF recurrence. Multivariate regression model calculation solely identified VRs (HR 0.11; 95% confidence interval 0.03-0.34; P < .01) and male sex (HR 0.57; 95% confidence interval 0.36-0.89; P = .01) as independent predictors of AF-free survival.Conclusion: VR is an independent predictor of AF-free survival after CBA for perAF. [ABSTRACT FROM AUTHOR]

Introduction: Pulmonary vein isolation (PVI) using cryoballoon is effective for patients with paroxysmal atrial fibrillation (PAF); however, few reports have evaluated the non‐pulmonary vein (PV) foci after cryoballoon ablation. We aimed to evaluate the characteristics of non‐PV foci and predictors of atrial fibrillation (AF) recurrence after cryoballoon ablation. Methods and Results: This was a single‐center retrospective study of 647 patients with PAF who underwent initial PVI using a second‐generation cryoballoon. After PVI, all patients underwent high‐dose isoproterenol infusion to assess the existence of non‐PV foci. Non‐PV foci were observed in 211 patients (32.6%), which were most frequently observed in the superior vena cava. Higher age (odds ratio [OR] = 1.02; 95% confidence interval [CI] = 1.00‐1.04; P =.025), female sex (OR = 1.65; 95% CI = 1.13‐2.41; P =.009), and lower body mass index (OR = 0.95; 95% CI = 0.89‐1.00; P =.049) were significantly associated with non‐PV foci. The existence of non‐PV foci was an independent predictor of AF recurrence (Hazard's ratio = 1.70; 95% CI = 1.12‐2.60; P =.014). When non‐PV foci were mappable and successfully ablated, patients with non‐PV foci showed similar outcomes with those without non‐PV foci (1‐year AF‐free survival rates of 88.5% vs 91.5%; P =.338). Conversely, when we failed to detect and eliminate non‐PV foci because they had multiple origins and were not consistently inducible (multichanging non‐PV foci), the 1‐year AF‐free survival rate was 56.4% even after substrate modification. Conclusion: Non‐PV foci were observed in one‐third of patients with PAF after cryoballoon ablation and were associated with AF recurrence. Catheter ablation for non‐PV foci was effective when they were mappable; however, multichanging non‐PV foci were associated with worse prognosis. [ABSTRACT FROM AUTHOR]

Background: A left common pulmonary vein (LCPV) accounts as the most frequent pulmonary vein (PV) variation. Our aim was to compare the performance of radiofrequency (RF) versus second‐generation cryoballoon (CB‐A) ablation in patients with atrial fibrillation (AF) and LCPVs. Methods: In a total cohort of 716 patients undergoing PV isolation with preprocedural CT‐scanning, LCPV+ patients were selected with measurement of PV ostial area and trunk distance. All LCPV+ patients were matched between RF and CB‐A group in a 1:1 ratio based on propensity scores, and compared for outcome. Results: Left common pulmonary veins were found in 31% (88/283) RF versus 34% (146/433) CB‐A patients, respectively, (P = .44). In the matched population of 83 LCPV+ patients in each group, electrical isolation could be achieved in all left‐sided PVs. No significant difference was noted for the rate of AF/left atrial tachyarrhythmia (LAT) recurrence between RF and CB‐A group (30% vs 28%, P = .86), with similar AF/LAT‐free survival (log rank, P = .71). There were 48 patients with AF/LAT recurrence (29%) during the follow‐up. Recurrence rate between paroxysmal versus persistent AF was 27/120 (22.5%) versus 21/46 (46%), P = .004. Cox proportional regression analysis withheld LA volume and persistent AF as independent variables to predict AF/LAT recurrence. No increased hazard for AF/LAT recurrence was observed for patients with a long (>15 mm) vs short (5‐15 mm) LCPV trunk (OR 1.14, 95% CI 0.6‐2.2, P = .7). Conclusions: In our study, equal efficacy and outcome was noted in LCPV+ patients between RF and CB‐A technology. [ABSTRACT FROM AUTHOR]

There are no data concerning clinical outcome and left atrial (LA) function after LA roof ablation using a second-generation cryoballoon (CB) for treatment of persistent atrial fibrillation (AF). Here, we report the first follow-up results after pulmonary vein isolation (PVI) plus LA roof ablation with the CB technique in patients with symptomatic persistent AF. We enrolled 107 consecutive patients who underwent CB ablation at our institution with the aim of PVI and bidirectional conduction block across the LA roof. Clinical success was defined as freedom from >30-s recurrence of AF, atrial flutter, or atrial tachycardia after a 3-month blanking period. Follow-up data were collected during outpatient clinic visits. LA volume, LA emptying fraction, and LA expansion index (parameters of LA function) were evaluated by echocardiography before and 3 months after ablation. PVI was achieved in all patients, and bidirectional conduction block was verified in 91.6%. Median follow-up duration was 31 (interquartile range 11/44) months. PVI plus LA roof ablation was sufficient to restore and maintain sinus rhythm in 72.9% (n = 78) of patients. The overall complication rate was 1.8%. LA volumes decreased significantly after ablation (P < 0.05), whereas total LA emptying fraction (P = 0.25) and LA expansion index (P = 0.32) were preserved within the 3-month follow-up. LA roof ablation combined with PVI using the CB technique is a safe and effective adjuvant treatment with a promising midterm outcome and preserved LA function 3 months after ablation. • Left atrial roof ablation using second-generation cryoballoon was safe and effective. • Pulmonary vein isolation plus roof line ablation showed a promising outcome. • Left atrial function was not impaired during short-term follow-up. [ABSTRACT FROM AUTHOR]

Aims: The purpose of this study was to evaluate the contribution in the acute loss in vagal innervation after ablation with the second generation cryoballoon (CB-A) in each distinct pulmonary vein (PV) by means of external cardiac vagal stimulation (ECVS) by positioning a catheter in the internal jugular vein in a cohort of 60 patients. Methods: Sixty patients, 50 starting from the left superior pulmonary vein (LSPV) and 10 from the right superior pulmonary vein with symptomatic paroxysmal atrial fibrillation (PAF), having undergone ECVS before the first and after each PV ablation by means of CB-A ablation, were included. Results: The ECVS performed pre-ablation provoked cardioinhibitory responses in all cases with mean pause duration of 10251.83 ms ± 2826.23 ms. At the end of the procedure, the vagal reactions (VR) were significantly diminished. Specifically, compared against the initial pause, responses were 8957.06 ± 2711.66 ms (p < 0.01) after left superior PV, 10017.36 ± 9127.0 ms (p = 0.88) after left inferior PV, 6020.16 ± 3780.709 ms (p < 0.001) after right inferior PV and 1687.5 ± 2183.7 ms (p < 0.001) after right superior PV. Noteworthy, if starting with ablation in the RSPV, VR was immediately reduced by 90.34%, 990.7 ± 379.78 ms (p < 0.001) as compared to baseline response. Conclusions: Although not directly targeting the ganglion plexuses, AF ablation with the CB-A causes a significant acute loss in parasympathetic innervation. The RSPV showed to be associated with the most significant reduction of acute loss in parasympathetic innervation. [ABSTRACT FROM AUTHOR]

Background: In the setting of second‐generation cryoballoon (CB2) ablation, left atrial (LA) access is generally achieved using a standard sheath (SS) that is exchanged for the 15Fr cryoballoon delivery sheath (CBS) and dilator over a long wire (CBS over‐the‐wire technique, CBS‐W). Our objective was to evaluate the direct use of the CBS to gain LA access, by advancing the latter over the trans‐septal needle (CBS over‐the‐needle technique, CBS‐N), under transesophageal echocardiographic (TEE) guidance. Methods: Consecutive patients who underwent CB2 ablation with the CBS‐N technique were evaluated for feasibility of gaining LA access using TEE guidance and fluoroscopy views. Complications related to the LA access were compared with a matched CBS‐W control group. Subanalysis (30 CBS‐W vs 30 CBS‐N patients) evaluated time‐to‐LA of the CBS: time from superior vena cava (with SS vs CBS) to LA insertion of the CBS, after exchange or directly, respectively. Results: LA access could be achieved in all 505 patients of the CBS‐N group, without technique modification or additional equipment. Challenging interatrial septa were noted in 13% of these patients: previous atrial septal defect repair (1%), hypermobile (10%), aneurysmal (1%), and abnormally thickened/fibrotic (1%). Incidence of complications was similar to the CBS‐W group. Subanalysis showed a shorter time‐to‐LA in the CBS‐N versus CBS‐W group, 72 ± 46 seconds versus 293 ± 180 seconds, P < .001. Conclusions: Our study showed that the CBS‐N technique is feasible and safe under echocardiographic guidance. Without sheath exchange, it simplifies the CB2 procedure, is less costly, time sparing, and might reduce the risk of air embolism. [ABSTRACT FROM AUTHOR]

Aims: Vascular complications are the most common complications of atrial fibrillation (AF) ablation. Cryoballoon (CB) ablation for AF needs the insertion of a large 15 Fr sheath in the femoral vein. Our aim was to investigate the impact of vascular ultrasound (US) in guiding access and evaluating post-procedural subclinical complications in a large, multi-centre patient cohort that underwent CB ablation.Methods and Results: A total cohort of 1435 consecutive patients were subdivided in 870 US -/-, 265 US -/+, and 300 US +/+ patients depending on US performance for: venipuncture guidance/post-procedural evaluation. Major clinical complications (requiring intervention and/or prolonged stay) were assessed. Irrespective of the clinical status, major US events were systematically determined in the subgroups with US evaluation 1 day post-procedure, if evidence of inadvertent artery puncture/cannulation (communication between artery and collection or artery-vein, regardless of the thrombosis state). Major clinical events were encountered in 1.7% (15/870), 1.1% (3/265), and 0% of patients in US -/-, US -/+, and US +/+ group, respectively (P = 0.02 between US -/- and US +/+ group). In the US -/- group, 5/10 (50%) of pseudo-aneurysms were diagnosed during readmission after a mean of 24 ± 11 days post-procedure. No delayed presentation was seen in the US -/+ group. Major US events during the US protocol post-procedure were seen in 3.8% (10/265) vs. 0.3% (1/300) of patients in US -/+ vs. US +/+ group, respectively, P = 0.004.Conclusion: US-guided venipuncture was associated with a near-to-zero risk of vascular complications in our patients undergoing CB ablation. [ABSTRACT FROM AUTHOR]

Background: The second-generation cryoballoon (CB) is effective in achieving pulmonary vein isolation. Continuous monitoring would eliminate any over- or underestimated freedom from atrial fibrillation (AF) postablation.Objective: The purpose of this study was to differentiate between arrhythmias occurring after cryoballoon ablation (CBA), detecting true AF in symptomatic patients and detecting silent subclinical AF.Methods: Between June 2012 and January 2015, 54 patients with a preexisting cardiac implantable electronic device (CIED) who had undergone CBA for paroxysmal atrial fibrillation (PAF) were included in our retrospective study. Regular CIED controls, physical examination, and ECG recordings were performed by an experienced cardiologist blinded to the ablation procedure. Data on any hospitalization during follow-up were gathered. Patients were encouraged to note all clinical symptoms during follow-up.Results: Continuous monitoring showed a success rate of 83.3% after 1 year and 75.93% after 3 years of follow-up. During the first year, 68% of episodes of palpitations after ablation were due to sinus tachycardia, nonsustained ventricular tachycardia, or supraventricular tachycardia. AF recurrence was detected in 15.6% of asymptomatic patients during follow-up. Total AF burden post-CBA had decreased to 0.64% ± 4.34% (P <.001) during long-term follow-up of 3.3 years.Conclusion: Although this is a selected group of patients with a preexisting CIED, continuous monitoring showed freedom from AF in 83.3% of patients post-CBA after 1 year and 75.93% after 3 years of follow-up. [ABSTRACT FROM AUTHOR]

Purpose: Cryoballoon (CB) technology in the context of anatomical pulmonary vein (PV) variants might hypothetically hamper successful PV isolation (PVI). Our aim was to assess the impact of a right middle PV (RMPV) in the setting of second-generation cryoballoon (CB advance-CB-A), on procedural parameters and on mid-term follow-up.Methods: Consecutive patients with AF presenting RMPV (RMPV+) at the pre-procedural computed tomography who underwent PVI by CB-A were enrolled. Comparison with propensity score-matched patients without RMPV (RMPV-) was performed. Acute procedural parameters and clinical follow-up were assessed.Results: A total of 240 patients (80 RMPV+) were included in the analysis. Twelve of 80 (15%) RMPV+ patients underwent a direct cryo-application in this variant and accomplished the isolation without phrenic nerve palsy, whereas in 25 of 80 (31%) RMPV+ patients, the RMPVs were not targeted directly nor indirectly (by co-occlusion during application at a major PV). At a median follow-up of 17.3 [interquartile range 11.3-26.5] months, there was no significant difference in AF-free survival between RMPV+ and RMPV- patients (78.8 vs 78.1%, P = 1.00), and the recurrence of atrial arrhythmias among patients with versus without an intentional or indirect cryo-application to the RMPV was not different (22 vs 20%, P = 1.00).Conclusions: Mid-term outcome after CB-A ablation did not differ between RMPV+ and RMPV- patients. Within RMPV+ patients, outcome was similar between those with versus without a cryo-application (either direct or indirect) to the additional vein. [ABSTRACT FROM AUTHOR]

Introduction: We analyzed the procedural experience and clinical outcome after pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) gained over 5 years using the second‐generation cryoballoon (CB‐Adv). Methods and Results: For this retrospective study, we enrolled 281 patients undergoing PVI at our institution between 2012 and 2016. The analyzed period was divided into 5 calendar years. Follow‐up data, including Holter electrocardiography recordings, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. The median procedure and fluoroscopy times over the years were 90 (72 of 114) and 15 (11 of 21) minutes, respectively. A continuous decline in complication rates and fluoroscopy and procedure times was observed in each subsequent year. During mid‐term follow‐up (33 [25 of 48] months), 178 (63.3%) patients were AF, atrial flutter, or atrial tachycardia free. Multivariate analysis revealed left atrial area (hazard ratio [HR] = 1.05; P < 0.001), female sex (HR = 2.53; P < 0.001), and common ostium (HR = 1.93; P < 0.001) as significant predictors of outcome. The overall 1‐year success rate was 76.2%. A gradual decrease in the 1‐year success rate (from 90.5% in 2012 to 67.9% in 2016) was mainly related to a steady increase of left atrial area in the entire cohort with successive years of the study. Conclusions: PVI using CB‐Adv in patients with persistent AF is accompanied by a learning curve and facilitates a satisfactory outcome, followed by the proper selection of patients. [ABSTRACT FROM AUTHOR]

Aims: Predictors of atrial arrhythmia recurrence have not been described in a long-term follow-up study of patients undergoing pulmonary vein isolation (PVI) using the cryoballoon technique. We aimed to evaluate the efficacy of a second-generation cryoballoon and identify pre-procedural predictors of 3-year outcome after PVI.Methods and results: For this observational cohort study, we enrolled 440 patients ablated at our institution with a second-generation cryoballoon. The endpoint was the first documented recurrence (>30 s) of atrial fibrillation (AF), atrial flutter, or atrial tachycardia after a 3-month blanking period. The impact of several pre-existing variables on clinical outcome was evaluated by univariate and multivariate analyses using the Cox proportional hazards regression model. The PLAAF (persistent AF, left atrial area, abnormal PV anatomy, AF history, female gender) score was defined to predict outcome. After a median follow-up of 36 months (interquartile range 25/75-27/42), the endpoint was achieved in 95 of 440 (21.6%) patients. Cox regression analysis showed that persistent AF, left atrial (LA) area, abnormal PV anatomy, AF history, and female gender independently predicted recurrence. The calculated optimal cut-offs for LA area and AF history were 21 cm2 and 3 years, respectively. Patients with a PLAAF score of 0 showed the best outcome, with an arrhythmia-free survival of 86.7%.Conclusion: PVI using the cryoballoon technique shows acceptable long-term results depending on predictors described by the new PLAAF score, which may facilitate patient selection for PVI. [ABSTRACT FROM AUTHOR]

Aims: There is still sparse information regarding phrenic nerve injury (PNI) during ablation of the right inferior pulmonary vein (RIPV) by means of the second-generation cryoballoon advance (CB-A). The aim of this study was to describe the procedural, anatomical, and clinical characteristics of patients who experienced PNI during the RIPV ablation.Methods and results: Consecutive patients who had undergone pulmonary vein isolation (PVI) using CB-A and suffered PNI during RIPV ablation were retrospectively included in our study. A cohort of patients who did not suffer any PNI was randomly included in a 1:3 ratio as a control group. The incidence of PNI during RIPV cryoapplication was 3.5%, (34 of 979 patients). There were no significant differences in clinical characteristics between patients with and without PNI. The prevalence of right common ostium (RCO) was significantly higher in patients with a PNI [4 patients (11.8%) vs. 1 patient (1.0%); P < 0.01]. A temperature drop velocity from the basal temperature to - 20 °C of 2.38 °C/s rendered a sensitivity of 82.4% and a specificity of 51.0% with a negative predictive value of 89.7%. Temperature drop velocity from basal to - 20 °C and the presence of an RCO were predictors of PNI in the multivariate analysis [odds ratio (OR) 7.27, 95% confidence interval (CI) 2.54-20.80; P < 0.01 and OR 18.41, 95%CI 1.87-181.23; P = 0.01, respectively).Conclusion: PNI during RIPV freeze might occur in around 3.5% of cases. The presence of an RCO and a fast temperature drop must prompt a careful monitoring of the phrenic nerve function during cryoapplications on the RIPV. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the present study was to assess the long-term success rate of a single 3-min freeze per vein ablation strategy in the setting of pulmonary vein isolation (PVI) by means of second-generation cryoballoon (CB-A; Arctic Front Advance, Medtronic, Minneapolis, MN, USA) in a large cohort of patients.Methods: Three hundred and one patients with drug resistant atrial fibrillation (AF) having undergone PVI by means of CB-A using a single 3-min freeze per vein ablation strategy were included in the analysis.Results: Paroxysmal AF (PAF) was documented in 70.8% of the patients, while 29.2% presented with persistent AF (PersAF). The mean number of CB applications was 1.09 ± 0.3 in the left superior pulmonary vein (LSPV), 1.04 ± 0.2 in the left inferior pulmonary vein (LIPV), 1.12 ± 0.3 in the right superior pulmonary vein (RSPV), and 1.12 ± 0.3 in the right inferior pulmonary vein (RIPV). All PVs were successfully isolated with a 28-mm CB-A only. After a mean follow-up of 38.1 ± 7.5 months, 207 (68.8%) patients were free of atrial tachyarrhythmia (ATa) recurrences following a single procedure. Specifically, 72.8% of patients presenting with PAF and 59.1% of individuals with PersAF did not experience a recurrence.Conclusions: A single 3-min freeze per vein strategy is effective in treating AF on a long term follow-up of 38 months. Specifically, it can afford freedom from ATa recurrences in 72.8% of patients affected by PAF and 59.1% of patients initially presenting with PersAF after a single CB-A procedure. [ABSTRACT FROM AUTHOR]

Aims: Pulmonary vein isolation (PVI) using second-generation cryoballoon (CB2) is associated with improved outcomes compared with first generation (CB1). We aimed at investigating the characteristics of left and right PV reconnections after CB1 and CB2 ablations in patients with clinical recurrences requiring redo ablation.Methods and results: From 2010 to 2016, 776 patients underwent 28-mm cryoballoon PVI for symptomatic paroxysmal atrial fibrillation (AF) in 3 centres, 279 with CB1 and 497 with CB2. Among them, 94 patients (12.1%) had symptomatic AF recurrences requiring a redo ablation [43 (15.4%) CB1 and 51 (10.3%) CB2]. The benefit of CB2 over CB1 was compared for each PV. Durable PVI was confirmed in 7 CB1 (16.3%) and 14 CB2 (27.4%) patients, and 2.7 ± 2.1 and 1.4 ± 1.4 gaps per patient were found, respectively (P = 0.002). Significantly more left superior and left inferior PVs were found to be isolated in CB2 compared with CB1 group (78.4% vs. 48.8%, P = 0.005 and 78.4% vs. 46.5%, P = 0.003, respectively) while the rate of durable right superior and right inferior PVs isolation were similar (68.6% vs. 60.5%, P = 0.542 and 66.7% vs. 55.8%, P = 0.387, respectively). Significantly fewer gaps were found in left PVs in CB2 patients, while there was no significant difference for right PVs. Gaps localization was similar in both groups.Conclusion: Fewer reconnection gaps are observed during redo ablations of paroxysmal AF in patients primarily ablated with CB2. This difference is driven by less reconnection gaps observed in both left PVs, while no difference was observed for right PVs. [ABSTRACT FROM AUTHOR]

Introduction Antiarrhythmic drug (AAD) therapy of patients with atrial fibrillation (AF) has limitations. We investigated the 2-year outcome and pre-procedural predictors of recurrence for first-line catheter ablation using the second-generation cryoballoon (CB-Adv) in a large cohort of patients with symptomatic AF. Methods and results For this prospective observational study, we enrolled 457 patients with symptomatic AF (278 paroxysmal, 179 persistent) who had no history of AAD use and who underwent pulmonary vein isolation (PVI) with the CB-Adv at our institution. Follow-up data, including Holter-ECGs, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated in univariate and multivariate analyses and Cox proportional hazards regression models. Median follow-up duration was 28 (interquartile range 15/42) months. PVI was sufficient in restoring and maintaining sinus rhythm in 79.2% ( n = 362) of patients. The median procedure and fluoroscopy times were 90 (72/120) and 16 (12/21) min, respectively. Phrenic nerve injury occurred in 16 (3.5%) patients, persisting until hospital discharge in 6 (1.3%) patients; phrenic nerve function recovered in all patients during follow-up. Seven patients developed groin hematomas (1.5%). Cox regression analysis showed that left atrial area > 21 cm 2 independently predicted recurrence. Conclusion This is the first demonstration that PVI with CB-Adv is safe and effective as a first-line treatment of symptomatic AF. Sinus rhythm persisted in 79.2% of patients even 2 years after ablation. The success rate was lower in patients with enlarged left atria. [ABSTRACT FROM AUTHOR]

Aims: The predictive value of induction studies after catheter ablation for atrial fibrillation (AF) is still debatable. To date, these studies have not been implemented in patients after cryoballoon (CB) ablation. Our aim was to analyse the clinical value of AF induction in patients treated by second generation CB for paroxysmal AF.Methods and results: Seventy patients underwent at first an isoproterenol challenge after pulmonary vein (PV) isolation to assess AF induction and early PV reconnections (EPVR). Patients without EPVR were evaluated for premature atrial contraction (PAC) induction; atrial ectopy was considered frequent (PAC+) if >1/10 cycles or >6/min. After restitution of baseline heart rate, rapid atrial pacing (RAP) was performed on all patients. AF induction by isoproterenol occurred only in 3/70 (4%) patients of whom 2/3 (66%) patients with an EPVR of a triggering vein. In the 62 patients without EPVR, PAC+ occurred in 17 patients (27%). RAP could induce AF in 23/70 (33%) patients. At a mean follow-up of 13.5 months, there were 11/70 (16%) AF recurrences. There was no significant difference in the AF recurrence rate between RAP inducible vs. non-inducible patients (log-rank P = 0.33). A 41% recurrence rate (7/17 patients) was seen in the PAC+ group with significantly different AF-free survival for PAC+ vs. PAC- patients (log rank P < 0.0001). PAC+ was the only independent determinant to predict AF recurrence after multivariate analysis.Conclusion: PAC occurrence in response to isoproterenol could predict AF recurrence after PV isolation by CB, while RAP showed no prognostic implication. [ABSTRACT FROM AUTHOR]

Background: Pulmonary vein isolation (PVI) via catheter ablation is an approved therapy for patients with drug-refractory and symptomatic atrial fibrillation (AF). Furthermore, cryoballoon is now considered to be as effective as focal radiofrequency catheter ablation. This study examines the second-generation cryoballoon performance in a US multicenter review of real-world practices.Methods: By retrospective chart collections, the long-term efficacy and safety of the cryoballoon procedure were assessed in 15 US centers. All patients had a history of drug-refractory symptomatic paroxysmal AF and were treated with a cryoballoon PVI strategy at the index ablation.Results: Four hundred fifty-two patients were evaluated, and acute PVI was achieved in 99% of patients by cryoballoon catheter ablation. In 0.88% of patients (4/452), an additional focal ablation catheter was used to achieve acute PVI during the ablation procedure. Average procedure time was 128 (range 82 to 260) min, using an average of 17 (range 1 to 19) min of fluoroscopy. The most frequent adverse event was transient phrenic nerve injury (1.5%; 7/452 patients) which all resolved by the end of the procedure with no diaphragmatic dysfunction at discharge. There were no strokes, transient ischemic attacks, cardiac tamponade, atrioesophageal fistulas, or deaths during the study. At the 12-month efficacy endpoint, single-procedure success of freedom from atrial arrhythmia was 87% (393/452 patients).Conclusions: This real-world examination of the US practice demonstrates that second-generation cryoballoon ablation by PVI strategy is safe and effective among patients with paroxysmal AF. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: We aimed to compare arrhythmia recurrence rates after second‐generation cryoballoon (CB‐Adv) ablation and radiofrequency (RF) ablation in patients with symptomatic persistent atrial fibrillation (AF) and left atrial (LA) enlargement. Methods and results: Persistent AF patients with LA enlargement were compared using a propensity‐score‐matching algorithm, and 111 patients treated with CB‐Adv ablation and 111 patients treated with RF ablation were selected. The primary endpoint was the first documented >30‐second arrhythmia recurrence after a 3‐month blanking period. Median LA area was comparable between the RF and CB‐Adv groups (24.2 vs. 24.0 cm2, P = 0.49). In addition to pulmonary vein isolation, roof lines (RLs) with bidirectional conduction block were created in 48 patients in the CB‐Adv group and 49 patients in the RF group. Midterm outcome after single procedure is characterized by arrhythmia recurrences in 47 patients in the RF group and 32 patients in the CB‐Adv group (P = 0.20). There were no differences in the number of AF recurrences in the two groups (38 vs. 32, P = 0.66), but there were more instances of LA tachycardia (LAT) in the RF group than in the CB‐Adv group (11 vs. 0, P < 0.01). LAT recurrence in RF patients was associated with RL creation (9 with vs. 2 without, P < 0.01). Among patients in whom a RL was created, arrhythmia‐free survival was lower in the RF group than in the CB‐Adv group (44.9% vs. 79.2%, P < 0.01). Conclusions: Arrhythmia recurrence rates in the two groups during midterm follow‐up were comparable. RL creation during CB‐Adv ablation resulted in acceptable outcomes. [ABSTRACT FROM AUTHOR]

Background: Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF.Methods: We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model.Results: A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4–74.7%]. Overall acute success rate was 99.7% (95% CI 99.2–100%). Complications occurred in 5.5% (95% CI 2.4–9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5–5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8–3.9%). No death, stroke or myocardial infarction was reported.Conclusion: The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Data on long‐term outcomes of cryoballoon (CB) ablation for treatment of persistent atrial fibrillation (AF) are sparse. Here, we report the first 3‐year follow‐up results and predictors of success for catheter ablation using the second‐generation CB in patients with persistent AF. Methods and results: For this prospective observational study, we enrolled 101 patients ablated with the second‐generation CB at our institution. The endpoint was the first documented recurrence (> 30 seconds) of AF, atrial flutter, or atrial tachycardia after a 3‐month blanking period. Follow‐up data were collected during outpatient clinic visits and included Holter‐ECG recordings. The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. After a median follow‐up of 37 (31 of 42) months, recurrence was documented in 30 patients (29.7%). The median procedure and fluoroscopy times were 120 (102 of 147) and 20 (16 of 27) minutes, respectively. Phrenic nerve palsy occurred in 2.0% of the patients. Among the 30 patients who experienced recurrence, 16 underwent repeat ablation in radiofrequency technique. Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence. Conclusions: Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation. Patients with a nonenlarged left atrium and short AF history had the best outcome. [ABSTRACT FROM AUTHOR]

Aims: In this double centre, retrospective study, we aimed to analyse the 1-year efficacy and safety of cryoballoon ablation (CB-A) in patients older than 75 years compared with those younger than 75-years old.Methods and Results: Fifty-three consecutive patients aged 75 years or older with drug-resistant paroxysmal AF (PAF) who underwent pulmonary vein isolation (PVI) by the means of second generation CB-A, were compared with 106 patients aged <75 years. The mean age in the study group (>75 years) was 78.19 ± 2.7 years and 58.97 ± 8.5 in the control group. At 1-year follow-up the global success rate was 83.6% and did not significantly differ between older (10/53) and younger patients (16/106) (81.1 vs. 84.9%, P = 0.54). Transient phrenic nerve palsy was the most common complication which occurred in eight patients in the younger group and in three in the older group (7.5 vs. 5.7%, respectively, P = 0.66).Conclusions: The results of our study showed that CB-A for the treatment of PAF is a feasible and safe procedure in elderly patients, with similar success and complications rates when compared with a younger population. [ABSTRACT FROM AUTHOR]

Background: The second-generation cryoballoon (cryoballoon Advance; CB-A) offers excellent outcomes on the mid-term follow-up. To the best of our knowledge, little is known regarding the long-term outcome after CB-A ablation for paroxysmal atrial fibrillation (AF).Objective: The aim of the study was to evaluate the freedom from recurrence of AF during a 3-year follow-up period, among consecutive patients having undergone pulmonary vein isolation (PVI) with the CB-A for paroxysmal AF (PAF).Methods: Consecutive patients with drug-resistant PAF who underwent PVI using CB-A as an index procedure formed the study group. Patients were evaluated with holter ECG recordings at 1, 3, 6 and 12 months and subsequent follow-up was biannual or based on the clinical status and at the physician discretion.Results: Seventy-six consecutive patients were enrolled. Of these patients, 6 were excluded because of lack of long-term follow-up. A total of 70 patients [44 male (63%); mean age 57.9 ± 14.5 years] with a mean follow-up of 38.0 ± 7.4 months were finally included. In total, 278 PVs were depicted on the pre-procedural CT scan. All PVs (100%) could be isolated with the CB-A only. The freedom from AF without antiarrhythmic drug (AADs) after a single procedure was 71.5% of patients at a mean 38.0 ± 7.4 months follow-up. If including repeat procedures, 80% of the patients were free from AF recurrence after 1.11 ± 0.32 procedures without AADs.Conclusion: The second-generation cryoballoon offers long-term freedom from PAF in 71.5% of treated patients with a single procedure without AADs on a 3-year follow-up period. [ABSTRACT FROM AUTHOR]

Purpose: Pressure waveform analysis has the potential for facilitated assessment of pulmonary vein occlusion during cryoballoon ablation for atrial fibrillation. Data on clinical outcomes using this method are lacking. We sought to validate through clinical outcomes the use of pressure waveform analysis as the primary method of determining pulmonary vein occlusion during cryoballoon ablation.Methods: A study was performed of 122 consecutive patients with atrial fibrillation (85% paroxysmal) undergoing cryoballoon ablation from May 2014 through July 2015 at a single institution using pressure waveform analysis as the primary method of assessing pulmonary vein occlusion.Results: Cryoballoon ablation, with additional segmental radiofrequency ablation in 13.7%, resulted in complete pulmonary vein isolation in 100% of patients. The single procedure freedom from recurrence of atrial arrhythmia beyond the initial 3-month post-ablation was 81.2% at a mean follow-up of 237 days. Recurrence of atrial arrhythmia within 3-month post-ablation was 11.1%, and predicted recurrence beyond 3 months. Repeat ablation was performed in 12.0% of patients.Conclusions: In the largest study to date on this topic and the only study to focus on clinical outcomes, pressure waveform analysis as the primary method of determining pulmonary vein occlusion in cryoballoon ablation of atrial fibrillation resulted in acute and long-term procedural success rates comparable to those reported with use of routine pulmonary venography. Controlled study is needed to confirm these findings and to determine if this technique affects variables such as procedure duration and radiation exposure. [ABSTRACT FROM AUTHOR]

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Single 3 vs. Double 4 Strategy in CB ablation Introduction Second-generation cryoballoon (CB-Adv) ablation is highly effective in achieving pulmonary vein isolation (PVI) with promising mid-term clinical outcome. However, the ideal freezing strategy is still under debate. The aim of this study was to assess the efficacy of a single 3-minute approach compared to the conventional 4-minute plus bonus application using CB-Adv. Methods and Results One hundred and sixty patients (67% male; mean age 58.0 ± 13.3 years) underwent PVI using CB-Adv for paroxysmal atrial fibrillation (PAF). Among 160 patients, 80 received a single 3-minute approach (3-mns group), while the remaining 80 conventional 4-minute plus bonus-freeze (4-mns group). Mean procedure and fluoroscopy times were 90.6 ± 15.8 and 18.3 ± 6.9 in the 4-mns group, 75.2 ± 17.1 and 13.5 ± 8.7 in the 3-mns group (P < 0.001, respectively). First-freeze isolation rate was 91.6% in the 4- versus 90.6% in the 3-mns group (P = 0.78). Persistent phrenic nerve palsy (PNP) occurred in 6/80 (3.5%) in the 4-mns group and 4/80 in the 3-mns group (P = 0.75). The overall freedom from ATas 2 years after the procedure was 78.1% (125/160): 77.5% (62/80 patients) in the 3-mns and 78.8% (63/80 patients) in the 4-mns group (P = 0.82). In multivariate analysis, time to PVI and nadir temperature independently predicted ATa recurrences (P < 0.001). Conclusions CB-Adv ablation for PAF is highly effective, resulting in 78% 2-year freedom from arrhythmic recurrences. A 'single 3-minute strategy' showed equal efficacy as compared to the conventional 4-minute plus bonus freeze approach at 2-year follow-up, providing shorter procedure and fluoroscopy time. Nadir temperature and time to PVI were predictors of arrhythmic recurrences. 'Bonus-freeze' strategy might be unnecessary. [ABSTRACT FROM AUTHOR]

Background: Although consensus documents on catheter and surgical ablation of atrial fibrillation (AF) suggest a uniform "blanking period" of 3 months, recent evidence suggested that early recurrences of atrial tachyarrhythmias (ERATs) are strongly associated with late recurrences (LRs), especially if ERATs occurred in the last part of the "blanking period". Objective: The present study sought to assess the role of ERATs in predicting LRs in a large cohort of patients with paroxysmal AF who have undergone second-generation cryoballoon ablation. Methods: Consecutive patients with drug-resistant paroxysmal AF who underwent pulmonary vein isolation using CB-A technology as the index procedure were retrospectively included in our analysis. The exclusion criteria were any contraindications for the procedure, including the presence of an intracavitary thrombus, uncontrolled heart failure, contraindications to general anesthesia, and persistent AF. Results: A total of 331 consecutive patients (104 women [31%]; mean age 56.7 ± 13.3 years) were enrolled. Atrial tachyarrhythmias/AF recurrences were detected in 57 patients (17.2%). The highest prevalence of ERATs was observed in the first 2 weeks (55%) after pulmonary vein isolation. Of note, all the ERATs occurring 1.5 months after AF ablation relapsed after 3 months and were confirmed as definitive recurrences. Late recurrence of AF and atrial tachycardia occurred in 20 of 29 patients with ERATs (69.0%) and 28 of 302 patients without ERATs (9.3%) (P < .0001). A multivariate Cox regression analysis showed that the early recurrence within the blanking period was significantly and independently associated with an increased risk of developing a late recurrence (hazard ratio 6.79; 95% confidence interval 3.52-10.14; P < .0001). Conclusion: Our findings reveal that ERATs are strongly associated with an LR after paroxysmal AF ablation using CB-A technology (hazard ratio 6.79; 95% confidence interval 3.52-10.14; P < .0001). Of note, when ERATs occurred later than 1.5 months, patients systematically experienced an LR. [ABSTRACT FROM AUTHOR]

Background The second-generation cryoballoon (CB-2G) is a promising technique to treat atrial fibrillation (AF). It is necessary to summarize and analyze the available data on 1-year clinical outcome of pulmonary vein isolation (PVI) with CB-2G. Methods PubMed and the Web of Science were searched in May 2015. Studies that reported the 1-year clinical success rates after PVI using CB-2G were included. The 1-year clinical success rates were pooled using the random-effect model. Complication rates and acute success rates were also analyzed. Subgroup analyses were conducted based on AF type and ablation strategy. Results Fifteen studies involving 2,363 AF patients met the inclusion criteria. The overall clinical success rate of PVI using CB-2G was 81%. A total of 82% of paroxysmal AF patients and 70% of persistent AF patients were in stable sinus rhythm 1 year after the procedure. The clinical success rates of the 'no-bonus' strategy were 81% in all patients, 82% in paroxysmal AF patients, and 73% in persistent AF patients. The corresponding success rates of the 'bonus' strategy were 81%, 83%, and 63%. Acute success rate was high. The overall rates of phrenic nerve palsy (PNP) and other procedure-related complications were 5.8% and 1.5%, respectively. Compared with 'bonus' strategy, there was a trend of fewer PNPs in 'no-bonus' strategy (4.6% vs 6.5%). Conclusions CB-2G is highly effective in the treatment of both paroxysmal AF and persistent AF. The 'no-bonus' strategy is as effective as the 'bonus' strategy in terms of 1-year clinical outcome. [ABSTRACT FROM AUTHOR]

Aims: To assess the incidence of late pulmonary vein (PV) reconnection following index PV isolation (PVI) procedure initially achieved with radiofrequency contact-force catheter ablation (CFCA) and second-generation cryoballoon ablation (CB-AdvA).Methods and Results: A total of 56 consecutive patients (41 male, 73.2%; mean age 60.8 ± 11.8 years) underwent a repeat ablation because of recurrent atrial tachyarrhythmias (ATas) after index PVI achieved with CFCA (30 patients) or CB-AdvA (26 patients). All repeat procedures were performed by the means of CFCA. In the CFCA group, among 119 PVs, 43 (36.1%) showed conduction gaps in 24 patients (1.8 per patient), whereas in the CB-AdvA group among 103 veins, 21 (20.4%) showed a PV reconnection in 18 patients (1.2 per patient) (P = 0.01). The left superior pulmonary vein was less frequently reconnected following CB-AdvA when compared with CFCA (2/25, 8% vs. 11/29, 37.9%; P = 0.01). In the CFCA group, the mean CF per-vein was lower in reconnecting veins when compared with those persistently isolated (10.9 ± 2.7 vs. 18.6 ± 3.1 g; P < 0.001). In the CB-AdvA group, late PV reconnection was associated with warmer nadir temperature (-48.9 ± 5.1 vs. -51.2 ± 4.7°C; P = 0.05) and longer time-to-isolation (71.1 ± 20.2 vs. 50.2 ± 32.9 s; P = 0.03).Conclusion: The rate of late PV reconnection is significantly lower following CB-AdvA when compared with CFCA as index procedure. Lower CF values and warmer nadir temperature with longer time to effect were more frequently associated with PV reconnections in the setting of CFCA and CB-AdvA. [ABSTRACT FROM AUTHOR]

Background: The second-generation cryoballoon is effective in achieving acute pulmonary vein isolation (PVI) and favorable clinical outcome. To date, no data are available on factors affecting late PV reconnection after second-generation cryoballoon ablation.Methods and Results: A total of 29 consecutive patients (25 male, 86.2%; mean age 57.8±13.8 years) underwent a repeat procedure, after a mean 11.6±4.5 months (range, 3.5-19.7 months), after index ablation using the 28-mm second-generation cryoballoon. All repeat ablations were performed using a 3-dimensional electroanatomical mapping system. Among all 115 PVs, including 1 left common ostiums (LCOs), 25 (21.7%) showed a PV reconnection in 20 patients (1.25 per patient). Persistent PVI could be documented in 90 of 115 PVs (78.2%). In 9 of 29 patients (31%), all PVs were electrically isolated. In the multivariable analysis, time to PVI (P=0.03) and failure to achieve -40°C within 60 s (P=0.05) independently predicted late PV reconnection. At receiver-operator curve analysis, time to PVI <60 s identified the absence of PV reconduction (sensitivity, 86.7%; specificity, 86.2%; positive predictive value, 59.1%; and negative predictive value, 96.4%; area under the curve, 0.85; confidence interval, 0.73-0.97; P<0.001).Conclusions: The rate of late PV reconnection after second-generation cryoballoon ablation is low (1.25 PVs/patient). Faster time to isolation and achievement of -40°C within 60 s independently predict durable PVI. In addition, 60-s cut-off for time to PVI indicates persistent isolation with 96.4% negative predictive value. These parameters might guide the operator whether to perform further applications to ensure a long-lasting PVI. [ABSTRACT FROM AUTHOR]

Background Since the release of the second-generation cryoballoon (CB2; Arctic Front Advance TM , Medtronic Inc) and its design modifications with improved cooling characteristics, the technique, dosing, and complication profile is significantly different from that of the first-generation cryoballoon. A comprehensive report of CB2 procedural recommendations has not been reported. Objective The purpose of this study was to review the current best practices from a group of experienced centers to create a user’s consensus guide for CB2 ablation. Methods/Results High-volume operators with a combined experience of more than 3000 CB2 cases were interviewed, and consensus for technical and procedural best practice was established. Conclusion Comprehensive review of the CB2 ablation best practice guide will provide a detailed technique for achieving safer and more effective outcomes for CB2 atrial fibrillation ablation. [ABSTRACT FROM AUTHOR]

Background The second-generation cryoballoon (CB-Adv) is effective in achieving pulmonary vein isolation (PVI) with encouraging results. The mid-term clinical efficacy of a single 3-minute freeze, without a routine bonus application, has been recently demonstrated. Objective The purpose of this study was to assess long-term clinical outcome after PVI with the CB-Adv using a single 3-minute application. Methods A total of 143 consecutive patients (93 male [65%], mean age 59.6 ± 12.0 years) with paroxysmal atrial fibrillation (PAF; 113/143 [79%]) or early persistent atrial fibrillation (AF; 30/143 [21%]) underwent PVI using CB-Adv with a single 3-minute freeze. Atrial tachyarrhythmia recurrences were defined as symptomatic or documented episodes >30 seconds. Results After a single freeze, isolation could be reached in 94.1% of all identified pulmonary veins. Complete PVI was successfully achieved with 1.1 ± 0.4 mean freezes. Persistent phrenic nerve palsy occurred in 5 of 143 patients (3.5%). At a mean 12.1 ± 4.4 months of follow-up, after a 3-month blanking period (BP), 80.4% (115/143) were in stable sinus rhythm (93/113 [82.3%] for PAF; 22/30 [73.3%] for early persistent AF). Fifteen patients underwent a second procedure with radiofrequency ablation showing reconnection in 7 of 15 right-sided (46.7%) and 6 of 15 left-sided (40%) pulmonary veins. Relapses during BP ( P <.01), time to PVI ( P = .02), and longer AF duration ( P = .04) were independent predictors of recurrences. Conclusion A single 3-minute freeze is highly effective, determining an atrial tachyarrhythmia freedom of 80.4% at 1-year follow-up. The incidence of persistent phrenic nerve palsy is 3.5%. Relapses during BP, time to PVI, and longer AF duration are predictors of recurrences. Routine use of an “insurance freeze” may not be needed. [ABSTRACT FROM AUTHOR]

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. And SA with time to isolation under 60 s (SA-TTI<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<60 was obtained in 2,673 of 4,784 (55.9%) freezes where electrogram monitoring was present. TT-30C was shorter in the SA group (33.4 ± 9.2 vs 39.3 ± 12.1 s; p < 0.001) and SA-TTI<60 group (31.8 ± 7.6 vs. 38.5 ± 11.5 s; p < 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<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.

Background No data are available about the clinical outcome of pulmonary vein isolation (PVI) as an index procedure for persistent atrial fibrillation (PersAF) ablation using the second-generation cryoballoon (CB-Adv). Objective The purpose of this study was to assess the 1-year efficacy of PVI as an index procedure for PersAF ablation using the novel CB-Adv. Methods Sixty-three consecutive patients (45 male [71.4%], mean age 62.7 ± 9.7 years) with drug-refractory PersAF undergoing PVI using the novel CB-Adv were enrolled. Follow-up was based on outpatient clinic visits including Holter ECGs. Recurrence of atrial tachyarrhythmias (ATas) was defined as a symptomatic or documented episode >30 seconds. Results A total of 247 PVs were identified and successfully isolated with a mean of 1.7 ± 0.4 freezes. Mean procedural and fluoroscopy times were 87.1 ± 38.2 minutes and 14.9 ± 6.1 minutes, respectively. Among 26 of 63 patients (41.3%) presenting with AF at the beginning of the procedure, 7 of 26 (26.9%) converted to sinus rhythm during ablation. Phrenic nerve palsy occurred in 4 of 63 patients (6.3%). At 1-year follow-up, after a 3-month blanking period (BP), 38 of 63 patients (60.3%) were in sinus rhythm. Because of ATa recurrences, 9 patients underwent a second procedure with radiofrequency ablation showing a pulmonary vein reconnection in 4 right-sided PVs (44.4%) and 3 left-sided PVs (33.3%). Multivariate analysis demonstrated that PersAF duration ( P = .01) and relapses during BP ( P = .04) were independent predictors of AT recurrences. Conclusion At 1-year follow-up, freedom from ATas following PersAF ablation with the novel CB-Adv is 60%. Phrenic nerve palsy is the most common complication. PersAF duration and relapses during the BP appear to be significant predictors of arrhythmic recurrences. [ABSTRACT FROM AUTHOR]

Second-generation Cryoballoon Ablation and Pulmonary Vein Reconnections Introduction Longer observational time and adenosine challenge have proven to be able to detect pulmonary vein (PV) reconnections. The aim of this study was to assess incidence of spontaneous and adenosine-induced PV reconnection after ablation with second-generation cryoballoon (CB-Adv). Methods and Results Fifty consecutive patients (76% male, mean age 60.5 ± 11.9 years) having undergone PV isolation (PVI) using the CB-Adv were enrolled. After isolation, reconnections were evaluated using the Achieve catheter over 30 minutes observation and adenosine administration during isoproterenol infusion (adenosine challenge). Among 200 PVs, isolation was achieved in 190 (95%) during the first application. Lower nadir temperature and longer rewarming time were associated with successful PVI (P = 0.02 and 0.04). Spontaneous (4 veins) and adenosine-induced (4 veins) PV reconnections occurred in the 4% of initially isolated veins (8 veins) in 6 patients (12%). At receiver-operator curve analysis, nadir temperature <-51 °C and rewarming time >28 seconds identified absence of reconnections (sensitivity 100% and 87%, area under the curve 0.75 and 0.72). Patients with right-sided early branching frequently experienced reconnections (P < 0.01). After a mean follow-up of 7.0 ± 1.7 months, 86% of patients were free from atrial fibrillation. None of those with PV reconnections experienced recurrences. Conclusions The incidence of spontaneous and adenosine-induced PV reconnection following ablation with the novel CB-Adv is very low occurring in 4% of initially isolated veins. Nadir temperature <−51 °C and rewarming time >28 seconds identified absence of acute reconnections, thus avoiding prolonged waiting time and adenosine challenge in such cases. [ABSTRACT FROM AUTHOR]