Posterior wall isolation via a multi-electrode radiofrequency balloon catheter: feasibility, technical considerations, endoscopic findings and comparison with cryoballoon technologies.

BACKGROUND: Posterior wall (PW) isolation is an important adjunctive ablation target in patients with non-paroxysmal atrial fibrillation (AF). Traditionally performed with point-by-point radiofrequency (RF) ablation, PW isolation has also been performed with different cryoballoon technologies. We aimed at assessing the feasibility of PW isolation with the novel RF balloon catheter Heliostar™ (Biosense Webster, CA, USA). METHODS: We prospectively enrolled 32 consecutive patients with persistent AF scheduled for first-time ablation with the Heliostar™ device. Procedural data were compared with those from 96 consecutive persistent AF patients undergoing pulmonary vein (PV) plus PW isolation with a cryoballoon device. The ratio RF balloon/cryoballoon was 1:3 for each operator involved in the study, aiming at avoiding any imbalance related to different experience. RESULTS: Single-shot PV isolation was documented in a significantly higher number of cases with the RF balloon technology compared to cryoballoon ablation (89.8% vs. 81.0%; p = 0.02, respectively). PW isolation was achieved with a similar number of balloon applications between the two groups (11 ± 4 with the RF balloon versus 11 ± 2 with the cryoballoon; p = 0.16), but in a significantly shorter time among RF balloon patients (228 ± 72 s versus 1274 ± 277 s with cryoballoon; p < 0.001). Primary safety endpoint occurred in none of the RF balloon patients versus 5 (5.2%) patients in the cryoballoon group (p = 0.33). Primary efficacy endpoint was achieved in all (100%) RF balloon patients versus 93 (96.9%) cryoballoon ones (p = 0.57). Oesophageal endoscopy did not show any signs of thermal lesions in RF balloon patients with luminal temperature rise. CONCLUSIONS: RF balloon-based PW isolation was safe and promoted shorter procedure times compared to similar cryoballoon-based ablation procedures.

3D mapping challenges in hybrid video-assisted thoracoscopic surgical ablation of Brugada syndrome.

OBJECTIVES: Brugada syndrome is a life-threatening disease with an arrhythmogenic substrate located in the epicardium of right ventricle outflow tract. Therefore, the correct region identification is crucial for a successful ablation procedure. Various mapping techniques can be adopted to elaborate this issue, but they were all initially developed for endovascular use. METHODS: In this study, we analysed 21 consecutive hybrid video-assisted thoracoscopic ablation of Brugada syndrome, performed using different mapping systems to identify the ablation target and confirm the elimination of arrhythmogenic substrate; 35 maps have been analysed. RESULTS: Acute success of epicardial right ventricle outflow tract ablation has been achieved in 100% of procedures, no periprocedural complications have been observed; HD Grid catheter showed higher area identification speed and faster fractionated potentials visualization; Rhythmia system has demonstrated the best map density; Carto 3 system showed a significant advantage in patient preparation time, but mapping speed was reduced due to focal catheter use only. CONCLUSIONS: All tested electro anatomical mapping systems can be used for hybrid video-assisted thoracoscopic ablation with same clinical success; however, accuracy and efficacy of mapping systems are heterogenous and highly dependent on proper patient preparation, mapping system and physician skills.

Predictors of late pulmonary vein reconnection in patients with arrhythmia recurrence after cryoballoon ablation-per vein analysis including cardiac computed tomography-based anatomic factors.

AIMS: To identify predictors of individual late pulmonary vein (PV) reconnection after second-generation cryoballoon (CB2) ablation. Anatomic indicators of late pulmonary vein reconnection (LPVR) post-CB2 ablation have not yet been studied on an individual PV level, nor weighed against clinical and procedural factors. METHODS AND RESULTS: Clinical, procedural, and PV anatomic data from 125 patients with a repeat procedure for arrhythmia recurrence after index CB2 ablation were analyzed. Preprocedural computed tomography (CT) evaluated 486 PVs for measurement of size; shape (ovality index); carina width; and orientation angle in frontal (superior/inferior) and transversal (anterior/posterior) plane (with horizontal line 0° as reference and upper/lower half circle as positive/negative value, respectively). Durable isolation in all PVs was demonstrated in 50/125 (40%) patients. Late reconnection rates at the different PVs were as follows: 16% left superior (LS), 12% left inferior (LI), 17% right superior (RS), and 31% right inferior (RI) PV. Multivariable analysis performed per vein showed following independent determinants predicting LPVR: ovality index [odds ratio (OR) 1.61, 95% confidence interval (CI) 1.07-2.41, P = 0.022] and carina width (OR 0.75, CI 0.59-0.96, P = 0.024) for LSPV; carina width (OR 0.71, CI 0.53-0.95, P = 0.020) for LIPV; frontal angle (OR 0.91, CI 0.87-0.95, P < 0.001) for RIPV; and transversal angle (OR 1.15, CI 1.03-1.31, P = 0.032) for RSPV. CONCLUSION: Cardiac CT-based evaluation of anatomic PV characteristics presented higher predictive value compared to clinical and procedural variables for individual LPVR after CB2 ablation. Pre-procedural identification of unfavourable PV anatomy might be important to tailor the ablation approach.

Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison.

AIMS: Pulsed field ablation (PFA) has emerged as a novel, non-thermal energy source to selectively ablate cardiac tissue. We describe a multicentre experience on pulmonary vein isolation (PVI) via the pentaspline Farapulse™ PFA system vs. thermal-based technologies in a propensity score-matched population of paroxysmal atrial fibrillation (PAF) patients. METHODS AND RESULTS: Propensity score matching was adopted to compare PVI-only ablation outcomes via the Farawave™ system (Group PFA), cryoballoon (Group CRYO), or focal radiofrequency (Group RF) (PFA:CRYO:RF ratio = 1:2:2). Among 1572 (mean age: 62.4 ± 11.3 years; 42.5% females) PAF patients undergoing first time PVI with either PFA (n = 174), CRYO (n = 655), or RF (n = 743), propensity score matching yielded 174 PFA, 348 CRYO, and 348 RF patients. First-pass isolation was achieved in 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CRYO, and 73.1% with RF (P < 0.001). Procedural and dwell times were significantly shorter with PFA, whereas the availability of a 3D mapping system led to a significant reduction in X-ray exposure with RF. Overall complication rates were 3.4% (n = 6) with PFA, 8.6% (n = 30) with CRYO, and 5.5% (n = 19) with RF (P = 0.052). The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CRYO, and 72.4% with RF (log-rank P-value: 0.24). Among 145 repeat ablation procedures, PV reconnection rate was 19.1% after PFA, 27.5% after CRYO, and 34.8% after RF (P = 0.01). CONCLUSION: Pulsed field ablation contributed to significantly shorter procedural times. Follow-up data showed a similar arrhythmia freedom, although a higher rate of PV reconnection was documented in post-CRYO and post-RF redo procedures.

Hybrid-Approach Ablation in Drug-Refractory Arrhythmogenic Right Ventricular Cardiomyopathy.

Management of ventricular arrhythmias (VAs) beyond implantable cardioverter-defibrillator positioning in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) is challenging. Catheter ablation of the ventricular substrate often requires a combination of endocardial and epicardial approaches, with disappointing outcomes due to the progressive nature of the disease. We report the Universitair Ziekenhuis Brussel experience through a case series of 16 patients with drug-refractory ARVC, who have undergone endocardial and/or epicardial catheter ablation of VAs with a thoracoscopic hybrid-approach. After a mean follow-up time of 5.16 years (SD 2.9 years) from the first hybrid-approach ablation, VA recurrence was observed in 5 patients (31.25%): among these, patients 4 patients (80%) received a previous ablation and 1 of 11 patients (9.09%) who had a hybrid ablation as first approach had a VA recurrence (80% vs 9.09%; log-rank p = 0.04). Despite the recurrence rate of arrhythmic events, all patients had a significant reduction in the arrhythmic burden after ablation, with a mean of 4.65 years (SD 2.9 years) of freedom from clinically significant arrhythmias, defined as symptomatic VAs or implantable cardioverter-defibrillator-delivered therapies. In conclusion, our case series confirms that management of VAs in patients with ARVC is difficult because patients do not always respond to antiarrhythmic medications and can require multiple invasive procedures. A multidisciplinary approach involving cardiologists, cardiac surgeons, and cardiac electrophysiologists, together with recent cardiac mapping techniques and ablation tools, might mitigate these difficulties and improve outcomes.

Long-Term Outcomes of Pulmonary Vein Isolation in Patients With Brugada Syndrome and Paroxysmal Atrial Fibrillation.

Background Pharmacological treatment of atrial fibrillation (AF) in the setting of Brugada syndrome (BrS) is challenging. In addition, patients with BrS with an implantable cardioverter-defibrillator (ICD) might experience inappropriate shocks for fast AF. Long-term outcome of pulmonary vein isolation in BrS has not been well established yet, and it is still unclear whether pulmonary vein triggers are the only pathophysiological mechanism of AF in BrS. The aim of the study is to assess the long-term outcomes in patients with BrS undergoing pulmonary vein isolation for paroxysmal AF compared with a matched cohort of patients without BrS. Methods and Results Sixty patients with BrS undergoing pulmonary vein isolation with cryoballoon catheter ablation for paroxysmal AF were matched with 60 patients without BrS, who underwent the same procedure. After a mean follow-up of 58.2±31.7 months, freedom from atrial tachyarrhythmias was achieved in 61.7% in the BrS group and in 78.3% in the non-BrS group (log-rank P=0.047). In particular, freedom from AF was 76.7% in the first group and in 83.3% in the second (P=0.27), while freedom from atrial tachycardia/atrial flutter was 85% and 95% (P=0.057). In the BrS group, 29 patients (48.3%) had an ICD and 8 (27.6%) had a previous ICD-inappropriate shock for fast AF. In the BrS cohort, ICD-inappropriate interventions for AF were significantly reduced after ablation (3.4% versus 27.6%; P=0.01). Conclusions Pulmonary vein isolation in patients with BrS was associated with higher rate of arrhythmic recurrence. Despite this, catheter ablation significantly reduced inappropriate ICD interventions in BrS patients and can be considered a therapeutic strategy to prevent inappropriate device therapies.

Safety and long-term efficacy of cryoballoon ablation for atrial fibrillation in octogenarians: a multicenter experience.

BACKGROUND: Cryoballoon technology (CB-A) has become a cornerstone of atrial fibrillation (AF) ablation in terms of safety and efficacy. Data regarding CB-A in octogenarians are still scarce and limited to single center experiences. The present study sought to analyze the performances of index CB-A in patients older than 80 years-old referring to 3 high-volume European centers. METHODS AND RESULTS: We retrospectively enrolled 95 patients with a median age of 81 [80, 83] years. 62 (65.3%) patients presented with paroxysmal AF and 33 (33.7%) with persistent AF. Mean procedure and fluoroscopy times were 73.8 ± 25.2 and 15.3 ± 7.5 min, respectively. At 12 months and 24 months of follow-up, the overall freedom from AF was 81.1% and 66.6%, respectively. When divided for AF type, freedom from AF was higher in patients with paroxysmal AF (p = 0.007). Cryoballoon ablation was able to significantly improve AF-related symptoms as proven by the significant decrease in EHRA score during the follow-up (p < 0.0001). Phrenic nerve palsy occurred in 8 (8.5%) patients and always resolved during the procedure without affecting procedural outcome. Two major complications occurred (2.1%); one patient experienced pneumonia, successfully treated with antibiotics and non-invasive mechanical ventilation, the latter one experienced acute kidney failure secondary to urosepsis successfully treated by renal replacement therapy. CONCLUSIONS: The present study showed that CB-A is a feasible and effective procedure among octogenarians with a low complication rate. Contemporarily, CB-A can help to alleviate arrhythmia-related symptoms also among this group of subjects.

Feasibility and safety of left atrial posterior wall isolation with a new Cryoballoon technology in patients with persistent atrial fibrillation.

BACKGROUND: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) in the setting of persistent atrial fibrillation (AF) ablation. The aim of this study was to evaluate the feasibility and safety of a new cryoballoon ablation system in achieving PVI + LAPWI isolation. METHODS: The study was a prospective, non-randomized, single center study. Forty consecutive patients, undergoing PVI + LAPWI with the novel POLARx™, were compared to 40 consecutive patients who underwent the same procedure with the established Arctic Front Advance PRO™. RESULTS: Acute isolation was achieved in all PVs in both groups and left posterior wall isolation (LAPWI) was achieved in 38 patients (95%) in the POLARx group and in 36 patients (90%) in Arctic Front group. Procedural outcomes were similar between both groups, except for lower temperatures during cryoenergy in the POLARx group, for both pulmonary vein isolation (PVI) and LAPWI. CONCLUSION: LAPWI + PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system.

Single procedural outcomes in the setting of percutaneous ablation for persistent atrial fibrillation: a propensity-matched score comparison between different strategies.

BACKGROUND: Catheter ablation for persistent atrial fibrillation (persAF) is associated with less favorable outcomes than for paroxysmal AF. To improve success rates, left atrial (LA) substrate modification is frequently performed in addition to pulmonary vein isolation (PVI). The purpose of the study was to compare 4 different ablation approaches using radiofrequency catheter ablation (RFCA) or cryoballoon ablation (CB-A) for persAF and to evaluate the respective outcomes on a midterm follow-up of 12 months. METHODS: We did a propensity score-matched comparison of 30 patients undergoing PVI + LA posterior wall isolation (LAPWI) with CB-A, 30 patients who underwent PVI + linear ablation (roof and mitral lines) using RFCA, 60 patients with PVI alone using CB-A, and 60 patients who had PVI alone using RFCA. The endpoint was recurrence of documented atrial tachyarrhythmias (ATas) > 30 s at 1-year follow-up. RESULTS: After 12 months, freedom from ATas after a single procedure was 83.3% in the PVI + LAPWI group, 46.7% in the PVI + linear ablation group, 58.3% in the PVI-alone CB-A group, and 61.6% PVI-alone RFCA (p = 0.03). Moreover, freedom from ATas was significantly higher comparing the PVI + LAPWI group with each of the other groups. CONCLUSIONS: In this propensity-matched comparison of strategies for persAF, LAPW ablation in addition to PVI with CB-A seems to improve 1-year outcome in comparison to PVI + linear ablation using RFCA and to PVI alone using RFCA or CB-A. Randomized comparisons are eagerly awaited.

Sinus node sparing novel hybrid approach for treatment of inappropriate sinus tachycardia/postural sinus tachycardia: multicenter experience.

BACKGROUND: The ideal treatment of inappropriate sinus tachycardia (IST) and postural orthostatic tachycardia syndrome (POTS) still needs to be defined. Medical treatments yield suboptimal results. Endocardial catheter ablation of the sinus node (SN) may risk phrenic nerve damage and open-heart surgery may be accompanied by unjustified invasive risks. METHODS: We describe our first multicenter experience of 255 consecutive patients (235 females, 25.94 ± 3.84 years) having undergone a novel SN sparing hybrid thoracoscopic ablation for drug-resistant IST (n = 204, 80%) or POTS (n = 51, 20%). As previously described, the SN was identified with 3D mapping. Surgery was performed through three 5-mm ports from the right side. A minimally invasive approach with a bipolar radiofrequency clamp was used to ablate targeted areas while sparing the SN region. The targeted areas included isolation of the superior and the inferior caval veins, and a crista terminalis line was made. All lines were interconnected. RESULTS: Normal sinus rhythm (SR) was restored in all patients at the end of the procedure. All patients discontinued medication during the follow-up. After a blanking period of 6 months, all patients presented stable SR. At a mean of 4.07 ± 1.8 years, normal SN reduction and chronotropic response to exercise were present. In the 51 patients initially diagnosed with POTS, no syncope occurred. During follow-up, pericarditis was the most common complication (121 patients: 47%), with complete resolution in all cases. Pneumothorax was observed in 5 patients (1.9%), only 3 (1.1%) required surgical drainage. Five patients (1.9%) required a dual-chamber pacemaker due to sinus arrest > 5 s. CONCLUSIONS: Preliminary results of this multicenter experience with a novel SN sparing hybrid ablation of IST/POTS, using surgical thoracoscopic video-assisted epicardial ablation combined with simultaneous endocardial 3D mapping may prove to be an efficient and safe therapeutic option in patients with symptomatic drug-resistant IST and POTS. Importantly, in our study, all patients had a complete resolution of the symptoms and restored normal SN activity.

High vagal tone predicts pulmonary vein reconnection after cryoballoon ablation for paroxysmal atrial fibrillation.

BACKGROUND: Pulmonary vein (PV) isolation is an established treatment for paroxysmal drug-refractory atrial fibrillation (AF). High parasympathetic tone and reconnection of PVs have demonstrated to be possible culprits of AF recurrence after ablation. Our aim was to investigate the association between parasympathetic tone and reconnected PVs in patients with paroxysmal AF. METHODS: Consecutive patients who underwent a redo catheter ablation procedure for atrial tachyarrhythmia recurrence by means of 3D electroanatomic mapping with documentation of presence or absence of PVs reconnection following an initial procedure of cryoballoon (CB) ablation for symptomatic drug-refractory paroxysmal AF were screened for the study. RESULTS: A total of 92 patients were included, of whom 50 (54.35%) were males. Reconnected PVs were found in 64 (69%) patients. PVs reconnection could be predicted by DC (C-statistic = .770), by SDNNI (C-statistic = .714) and by absolute VLF power (C-statistic = .722), while right-sided PVs reconnection could be better predicted by DC (C-statistic = .848) and by SDNNI (C-statistic = .761). In multivariate binary logistic regression analysis, a DC value ≥6.45 ms and an absolute VLF power value ≥160 ms2 were associated with three times and five times higher odds of PVs reconnection, respectively. On a vein-per-vein analysis, absolute VLF power ≥160 ms2 was associated with three times higher odds, while reaching of -40°C within 60 s was associated with three times lower odds of PVs reconnection. CONCLUSION: High parasympathetic tonus accurately predicts PVs reconnection. On a vein-per-vein analysis, parasympathetic markers along with biophysical parameters predicted PVs reconnection. On a case-by-case analysis, parasympathetic markers were the only predictors of PVs reconnection, thus being a robust PVs reconnection prediction tool.

Comparison between superior vena cava ablation in addition to pulmonary vein isolation and standard pulmonary vein isolation in patients with paroxysmal atrial fibrillation with the cryoballoon technique.

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.

Phrenic nerve palsy during right-sided pulmonary veins cryoapplications: new insights from pulmonary vein anatomy addressed by computed tomography.

PURPOSE: There is still sparse information regarding phrenic nerve palsy (PNP) during the cryoablation of both right-sided pulmonary vein (PV) and its anatomical predictors. METHODS: Consecutive patients who had undergone pulmonary vein isolation (PVI) using CB-A and suffered PNP during both right-sided PVs were retrospectively included in our study. Two other groups were then selected among patients who experienced PNP during RIPV application only (group 2) and RSPV application only (group 3). RESULTS: The incidence of PNI during both right-sided PVs cryoapplications was 2.1%, (32 of 1542 patients). There were no significant clinical differences between the 3 groups. Time from basal temperature to -40 °C significantly differed among the groups for both RIPV (p = 0.0026) and RSPV applications (p = 0.0382). Patients with PNP occurring during RSPV applications had significantly larger RSPV cross-sectional area compared to patients without PNP (p = 0.0116), while in patients with PNP during RIPV application, the angle of RIPV ostium on the transverse plane was significantly smaller compared to patients without PNP (p = 0.0035). The carina width was significantly smaller in patients with PNP occurring during both right-sided PVs cryoapplications compared to patients in which PNP occurred only during one right-sided PV application (p < 0.0001); a cutoff value of 8.5 mm had a sensitivity of 87.3% and a specificity of 75.0%. CONCLUSION: PNP in both right-sided PVs applications is a complication that occurred in 2.1% of cases during CB-A. Pre-procedural evaluation of right PVs anatomy might be useful in evaluating the risk of PNP.

Long-term clinical outcomes after single freeze cryoballoon ablation for paroxysmal atrial fibrillation: a 5-year follow-up.

BACKGROUND: The second-generation cryoballoon ablation (CB-A) has been proven to be safe and effective for pulmonary vein (PV) isolation. Little is known regarding the long-term outcome following CB-A ablation for paroxysmal atrial fibrillation (AF). The aim of the study was to evaluate the freedom from atrial arrhythmias during a 5-year follow-up period among consecutive patients having undergone PV isolation with the CB-A for paroxysmal AF METHODS AND RESULTS: A total of 208 consecutive patients having undergone index PV isolation using CB-A (138 males, 66%; mean age 59.0 ± 12.6 years) were included in our retrospective analysis. Follow-up was based on outpatient clinic visits including Holter electrocardiograms. Recurrence of atrial tachyarrhythmias was defined as a symptomatic or documented episode of > 30 s. At a median follow-up of 62 months, freedom from atrial arrhythmias after a single procedure was achieved in 57.2% of patients. Multivariate analysis demonstrated that obesity, left atrial diameter, and duration of symptoms before AF ablation were independent predictors of ATas recurrences. Major complications occurred in 2.4% of patients. CONCLUSIONS: The present study found a 5-year single-procedure success rate of 57.2% following CB-A ablation procedure. Obesity, higher LA dimensions, and longer duration of symptoms before ablation independently predicted the outcome.

Posterior box isolation as an adjunctive ablation strategy with the second-generation cryoballoon for paroxysmal atrial fibrillation: a comparison with standard cryoballoon pulmonary vein isolation.

PURPOSE: The purpose of the study was to evaluate the impact of left atrial posterior wall isolation (LAPWI) in addition to pulmonary vein isolation (PVI) vs PVI alone, performed using CB-A, in patients with PAF on a midterm follow-up of 12 months. METHODS: Eighty consecutive patients indicated to index cryoballoon ablation (CB-A) for the treatment of drug resistant PAF were included. The first 50 (62.5%) underwent PVI only, and the following 30 patients (37.5%) underwent LAPWI + PVI. RESULTS: Acute isolation was achieved in all PVs in both groups. The LAPW was successfully isolated in 29 out of 30 (97%) patients; in the remaining patient, adjunct radiofrequency ablation was required. The total procedure time and the mean fluoroscopy time were significantly shorter in patients who underwent PV isolation only (p < 0.001). The freedom from atrial fibrillation (AF) at 12 months was not significantly different between the 2 groups (LAPW + PVI = 90% vs PVI = 88%) (log-rank p = 0.816). CONCLUSION: LAPW ablation in addition to PVI by the means of CB-A does not seem to reduce the risk of AF recurrence if compared with the standard PVI on a midterm follow-up of 12 months.

Safety and feasibility of electrical isolation of the superior vena cava in addition to pulmonary vein ablation for paroxysmal atrial fibrillation using the cryoballoon: lessons from a prospective study.

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.

Temperature-guided ablation with the second-generation cryoballoon for paroxysmal atrial fibrillation: 3-year follow-up in a multicenter experience.

PURPOSE: A strategy based on the attainment of the specific parameter of - 40 °C within the first 60 s during cryoenergy applications in the setting of cryoballoon ablation (CB-A) without the use of an inner lumen mapping catheter (ILMC) (Achieve; Medtronic, USA) for the visualization of real-time recordings (RTR) has been previously described. The latter has proven to be very effective in guaranteeing freedom from atrial arrhythmias in patients affected by paroxysmal atrial fibrillation (PAF) at 1-year follow-up. The purpose of this retrospective observational study was to evaluate the clinical outcomes of this strategy in a multicenter experience on a long-term follow-up of 3 years. METHODS: A total of 192 patients having undergone CB ablation for paroxysmal AF (PAF) starting from September 2015 to November 2016 that underwent a temperature-guided approach were included. RESULTS: Mean procedural time was 68.77 ± 18.88. The mean number of freezes in the LSPV was 1.2 ± 0.4, 1.2 ± 0.4 in the LIPV, 1.1 ± 0.4 in the RSPV, and 1.2 ± 0.4 in the RIPV. Considering a blanking period of 3 months, freedom from AF off-AAD was achieved in 77.6% (149/192) at mean 34.5 ± 5.5 months and median 35.1 months (IQR, 32.3-37.0 months) follow-up after 1 procedure. CONCLUSIONS: A temperature-guided approach affords freedom from AF at a 3-year follow-up period in a large majority of patients affected by PAF having undergone a single CB-A procedure.

Electrophysiological findings in patients with isolated veins after cryoablation for paroxysmal atrial fibrillation.

AIMS: The main cause of atrial fibrillation recurrence after catheter ablation is pulmonary vein reconnection. The purpose of this retrospective study was to analyse the electophysiological findings in patients undergoing repeat procedures after an index cryoballoon ablation (CB-A) and presenting with permanency of pulmonary vein isolation (PVI) in all veins. In addition, we sought to compare the latter with a similar group of patients with reconnected veins at the redo procedure. METHODS: A total of 132 patients (81 men, 60.7 ±â€Š12.4 years) who underwent CB-A for paroxysmal atrial fibrillation (PAF) were enrolled. Indication for the redo procedure was symptomatic PAF in 83 (63%), persistent atrial fibrillation (PerAF) in 32 (24%) or persistent regular atrial tachycardia (RAT) in 17 (13%) patients. RESULTS: Seventy-five (57%) patients presented a pulmonary vein reconnection (pulmonary vein group) during the redo procedure, whereas 57 (43%) had no pulmonary vein reconnection (non-pulmonary vein group). The non-pulmonary vein group exhibited significantly more non-pulmonary vein foci and atrial flutters than the pulmonary vein group after induction protocol (51 vs. 24%, P = 0.002 and 67 vs. 36%, P = 0.003, respectively). Twenty-two (29.3%) patients of the pulmonary vein group and 20 (35%) patients of the non-pulmonary vein group had atrial fibrillation/RAT recurrence after a mean follow-up of 12.5 ±â€Š8 months. The survival analysis demonstrated no statistical significance in recurrence between both groups (log rank P = 0.358). CONCLUSION: Atrial fibrillation/RAT recurrence in patients after CB-A with durable PVI is significantly associated with non-pulmonary vein foci and atrial flutters. No statistically different success rate regarding atrial fibrillation/RAT freedom was detected between the pulmonary vein and non-pulmonary vein groups after redoing RF-CA.

Predictors of cardiac neuromodulation achieved by cryoballoon ablation performed in patients with atrial fibrillation who were in sinus rhythm before the ablation.

BACKGROUND: The impact of pulmonary vein isolation (PVI) performed with cryoballoon (CB) on the intrinsic cardiac autonomic nervous system (ICANS) remains unclear. OBJECTIVE: The purpose of this study was to evaluate the predictors and the clinical meaning of cardiac neuromodulation achieved by CB-ablation as assessed by sinus heart rate (HR) response after the procedure. METHODS: Patients who underwent CB-ablation for drug-resistant atrial fibrillation (AF) from January 2014 to October 2018 were included. Twelve­leads rest ECG was taken both before and after the procedure. After discharge, patients were scheduled for follow-up visits at 1, 3, 6, and 12 months and 24 h Holter recordings were obtained at each follow-up visit. All documented AF episodes of >30 s were considered as recurrence. RESULTS: Four-hundred seventy-two patients (62.3% male, age 56.7 ± 13.6 years, 97.2% paroxysmal AF) were included. Mean HR before the procedure was 60.17 ± 10.4 bpm, while the morning after the procedure mean HR was 75.48 ± 12.0 bpm. Age at enrollment (R = -0.26; p < 0.001), baseline HR before the CB-A (R = -0.32; p < 0.001), nadir temperature in each right pulmonary vein (R = -0.11, p = 0.022; R = -0.16; p = 0.001) were significantly associated with the ∆HR. At 2-year follow-up, freedom from recurrences was 83.1% for the patients with HR increase ≥15 bpm after CB-A and 66.3% in patients with HR increase ˂15 bpm (p = 0.021). CONCLUSION: Sinus HR increase is a frequent phenomenon after CB-A, that can be predicted by both clinical and procedural factors and that correlates with better outcome after cryo-PVI.

Pulmonary veins anatomical determinants of cooling kinetics during second-generation cryoballoon ablation.

AIM: The aim of the study was to investigate the role of anatomical characteristics of the pulmonary veins (PVs) determining cooling kinetics during second-generation cryoballoon ablation (CbA). METHODS AND RESULTS: we enrolled all consecutive patients who underwent CbA for symptomatic atrial fibrillation in our center from January 2019 to March 2019. All patients had complete computed tomography scans of the heart before the ablation. Anatomical characteristics were tested for prediction of a nadir temperature (NT) ≤ -48°C. Significant differences were noted among PV max diameter (20.8 ± 2.8 vs 18.5 ± 2.5 mm; P < .001); PV minimum diameter (15.2 ± 3.0 vs 13.0 ± 3.1 mm; P < .001); PV area (268.1 ± 71.9 vs 206.2 ± 58.7 mm2 ; P < .001); PV ovality (1.4 ± 0.3 vs 1.5 ± 0.3; P = .005); and PV trunk length (27.4 ± 7.4 vs 21.3 ± 6.5 mm; P < .001). A scoring system was created by assigning one point each ranging from 0 (best anatomical combination) to 5. In the group with a score of 0, 94.0% of the CbA could reach a NT ≤ -48°C whereas with a score of 5, only 29.0% (P < .001). Left superior pulmonary vein with short trunk length and acute angle of PV branch was significantly associated with warmer NT (11.8% satisfactory CbA; P = .003). Regarding right inferior pulmonary vein, trunk length (P = .004), maximum diameter (P = .044), and transverse angle (P = .008) were independently associated with good NT. CONCLUSION: Anatomical PV features are associated with cooling kinetics and an anatomical score could predict lower NT during second-generation CbA. Specific characteristics were identified for inferior PV. Although heart imaging is not mandatory prior CbA, it can be a useful tool to predict cooling kinetics.