Second generation cryoballoon ablation for atrial fibrillation in young adults: midterm outcome in patients under 40 years of age.

Aims: Pulmonary vein isolation (PVI) has been demonstrated more effective in young patients, in which the substrate for atrial fibrillation (AF) is probably more confined to pulmonary vein potentials. The present study sought to focus on the midterm outcomes in patients under 40 years having undergone PVI with the Cryoballoon Advance because of drug resistant AF. Methods and results: Between June 2012 and December 2015, 57 patients having undergone Cryoballoon ablation (CB-A) below 40 years of age for AF in our centre were retrospectively analysed and considered for our analysis. All patients underwent this procedure with the 28 mm Cryoballon Advance. All 227 veins were successfully isolated without the need for additional focal tip ablation. Median follow-up was 18 ±10 months. The freedom from AF after a blanking period of 3 months was 88% in our cohort of patients younger than 40 years old. The most frequent periprocedural complication was related to the groin puncture and occurred in 2 patients. After a single procedure, the only univariate predictor of clinical recurrence was the diagnosis of hypertrophic cardiomyopathy. Conclusion: Young patients affected by AF can be effectively and safely treated with CB-A that grants freedom from AF in 88% of the patients at 18 months follow-up following a 3-month blanking period. All veins could be isolated with the large 28 mm Cryoballoon Advance only.

Long-term outcome of pulmonary vein isolation in patients with paroxysmal atrial fibrillation and Brugada syndrome.

Aims: The therapeutical management of atrial fibrillation (AF) in the setting of Brugada syndrome (BS) might be challenging as many antiarrhythmic drugs (AADs) with sodium channel blocking properties might lead to to the development of ventricular arrhythmias. This study sought to evaluate the clinical outcome in a consecutive series of patients with BS having undergone pulmonary vein (PV) isolation by means of radiofrequency (RF) or cryoballoon (CB) ablation and the efficacy of catheter ablation for preventing inappropriate interventions delivered by implantable cardioverter defibrillators (ICD) on a 3-year follow up. Methods and results: Twenty-three consecutive patients with BS (13 males; mean age was 47 ± 18 years) having undergone PV isolation for drug-resistant paroxysmal AF were enrolled. Eleven patients (48%) had an ICD implanted of whom four had inappropriate shocks secondary to rapid AF. Over a mean follow-up period of 35.0 ± 25.4 months (median 36 months) the freedom from AF recurrence after the index PV isolation procedure was 74% without AADs. Patients with inappropriate ICD interventions for AF did not present futher ICD shocks after AF ablation. No major complications occurred. Conclusion: Catheter ablation is a valid therapeutic choice for patients with BS and paroxysmal AF considering the high success rates, the limitations of the AADs and the safety of the procedure, and it should be taken into consideration especially in those patients presenting inappropriate ICD shocks due to rapid AF.

Efficacy and safety of the second generation cryoballoon ablation for the treatment of paroxysmal atrial fibrillation in patients over 75 years: a comparison with a younger cohort.

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.

Second-Generation Cryoballoon Ablation in the Setting of Lone Paroxysmal Atrial Fibrillation: Single Procedural Outcome at 12 Months.

BACKGROUND: Lone atrial fibrillation (LAF) develops in younger individuals without cardiovascular or pulmonary disease. As pulmonary vein isolation has been recognized as an optimal treatment for drug-resistant atrial fibrillation, cryoballoon ablation with second-generation balloon (CB-A) may be an ideal solution for LAF patients. OBJECTIVE: The aim of this study was to investigate acute success, periprocedural complications and outcome over a 12-month follow-up period in a cohort of patients having undergone PV isolation (PVI) for LAF using CB-A technology. METHODS: A total of 75 consecutive patients (50 male, mean age 47 ± 12 years) with a diagnosis of lone paroxysmal atrial fibrillation who underwent pulmonary vein isolation (PVI) by CB-A from June 2012 were included. All patients underwent this procedure with the 28 mm CB-A. A total of 299 PVs (100%) could be isolated with CB-A alone. RESULTS: The freedom from AF recurrence after a single procedure was 92% of patients during the entire 13-month follow-up. When considering a blanking period (BP) of 3 months, success rate was 93.3%. Transient phrenic nerve palsy (PNP) was the most frequent complication, occurring in 5.3% of individuals (4 patients); complete recovery was documented for all of these patients prior to hospital discharge. CONCLUSIONS: CB-A is extremely effective in achieving PVI and affords freedom from AF at 13-month follow-up in 93% of young patients affected by drug-resistant LPAF following a 3-month BP. The most frequent complication observed was PNP, which reverted prior to discharge in all patients.

Acute pericarditis following second-generation cryoballoon ablation for atrial fibrillation.

PURPOSE: Acute pericarditis is a minor complication following atrial fibrillation (AF) ablation procedures. The aim of the study was to evaluate the incidence and clinical aspects of pericarditis following cryoballoon (CB) ablation of AF investigating a possible association with procedural characteristics and a possible relationship with post-ablation recurrences. METHODS: Four hundred fifty consecutive patients (male 73%, age 59.9 ± 11.2 years) with drug-resistant paroxysmal AF who underwent CB ablation as index procedure were enrolled. Exclusion criteria were any contraindication for the procedure including the presence of intracavitary thrombus and uncontrolled heart failure and contraindications to general anesthesia. RESULTS: Acute pericarditis following CB ablation occurred in 18 patients (4%) of our study population. Pericardial effusion occurred in 14 patients (78%) and was mild/moderate. The total number of cryoapplications and the total freeze duration were significantly higher in patients with pericarditis compared with those without (respectively, p = 0.0006 and p = 0.01). Specifically, the number of applications and freeze duration in right inferior pulmonary vein were found significantly higher in patients with pericarditis (p = 0.007). The recurrence rate did not significantly differ between the two study groups (respectively, 16.7 vs 18.1%; p = 0.9). CONCLUSIONS: The incidence of acute pericarditis following CB ablation in our study population accounted for 4% and was associated with both total freezing time and number of cryoapplications. The clinical course was favorable in all these patients and the occurrence of acute pericarditis did not affect the outcome during the follow-up period.

Second-generation cryoballoon ablation without the use of real-time recordings: A novel strategy based on a temperature-guided approach to ablation.

BACKGROUND: The achievement of -40°C within the first 60 seconds during cryoenergy applications has proven to independently predict durable pulmonary vein (PV) isolation in the setting of second-generation cryoballoon (CB-A; Medtronic, Minneapolis, MN) ablation. OBJECTIVE: We sought to evaluate a strategy based on the attainment of the specific parameter of -40°C within the first 60 seconds during cryoenergy applications in the setting of CB-A ablation without the use of an inner lumen mapping catheter (Achieve, Medtronic) for the visualization of real-time recordings. METHODS: A total of 52 patients having undergone CB ablation for paroxysmal atrial fibrillation (AF) between 1 February 2015 and 30 June 2015 who underwent a temperature-guided approach based on achieving -40°C within 60 seconds without real-time recordings (wire group) were compared with a cohort of 52 propensity score-matched patients having undergone CB ablation performed with an inner lumen mapping catheter (Achieve group). All PVs were checked for electrical isolation at the end of the procedure with a circular mapping catheter in the wire group. RESULTS: Electrical isolation could be obtained in all patients in the Achieve group and in 99% of PVs in the wire group. Freedom from AF without antiarrhythmic drugs at a mean follow-up of 12.4 ± 3.0 months did not significantly differ between both groups (85% vs 88%, respectively; P = .56). CONCLUSION: A temperature-guided approach based on achieving -40°C within 60 seconds is effective in producing PV isolation and affords freedom from AF at 12-month follow-up in 85% of patients affected by paroxysmal AF after a 3-month blanking period.

Femoral venous pressure waveform as indicator of phrenic nerve injury in the setting of second-generation cryoballoon ablation.

AIMS: Femoral venous pressure waveform (VPW) analysis has been recently described as a novel method to assess phrenic nerve function during atrial fibrillation ablation procedures by means of the cryoballoon technique. In this study, we sought to evaluate the feasibility and effectiveness of this technique, with respect to the incidence of phrenic nerve injury (PNI), in comparison with the traditional abdominal palpation technique alone. METHODS: Consecutive patients undergoing second-generation cryoballoon ablation (CB-A) from June 2014 to June 2015 were retrospectively analyzed. Diagnosis of PNI was made if any reduced motility or paralysis of the hemidiaphragm was detected on fluoroscopy. RESULTS: During the study period, a total of 350 consecutive patients (man 67%, age 57.2 ±â€Š12.9 years) were enrolled (200 using traditional phrenic nerve assessment and 150 using VPW monitoring). The incidence of PNI in the overall population was 8.0% (28/350); of these, eight were impending PNI (2.3%), 14 transient (4.0%), and six persistent (1.7%). Patients having undergone CB-A with traditional assessment experienced 18 phrenic nerve palsies (9.0%) vs two in 'VPW monitoring' group (1.3%; P = 0.002). Specifically, the former presented 12 transient (6.0%) and six persistent (3.0%) phrenic nerve palsies, and the latter exhibited two transient (1.3%; P = 0.03) and no persistent (0%; P = 0.04) phrenic nerve palsies. CONCLUSION: In conclusion, this novel method assessing the VPW for predicting PNI is inexpensive, easily available, with reproducible measurements, and appears to be more effective than traditional assessment methods.

Comparison of the Incidences of Complications After Second-Generation Cryoballoon Ablation of Atrial Fibrillation Using Vitamin K Antagonists Versus Novel Oral Anticoagulants.

Data evaluating the impact of the periprocedural administration of novel oral anticoagulants (NOACs) on complications in the setting of pulmonary vein (PV) isolation using cryoballoon (CB) is limited. In the present study, our aim was to analyze procedural characteristics and incidence of complications in those patients who underwent CB ablation for atrial fibrillation and the impact of NOACs on adverse events compared with vitamin K antagonists (VKAs). Consecutive patients with drug resistant atrial fibrillation who underwent PV isolation by CB as index procedure were retrospectively included in our analysis. In group I, 290 of 454 patients (63.9%) received VKAs (warfarin: n = 222 and acenocoumarol: n = 68), and in group II, 164 of 454 patients (36.1%) were treated with NOACs (rivaroxaban: n = 71; dabigatran: n = 60; and apixaban: n = 33). Age was significantly higher in the group II (62.8 ± 9.7 vs 58.6 ± 11.3; p <0.001). During the study period, 454 consecutive patients (male 71%, age 60.1 ± 10.9 years) were enrolled. Major complications occurred in 9 patients (2.0%): peripheral vascular complications were observed in 6 patients (1.3% per procedure), persistent phrenic nerve palsy occurred in 2 (0.4%), and transient ischemic attacks in 1 (0.2%). In both groups, the incidence of major complications was similar (group I [VKAs]: 7 patients [2.4%] vs group II [NOACs]: 2 patients [1.2%]; p = 0.5). In conclusion, CB ablation is a safe procedure for PV isolation and is associated with low complication rates. The incidence of adverse events in PV isolation using the second-generation CB with the periprocedural administration of NOACs is not significantly different than VKA treatment.

Role of Electrocardiographic Tpeak-Tend for the Prediction of Ventricular Arrhythmic Events in the Brugada Syndrome.

Some previous studies have proposed the electrocardiographic Tpeak-Tend (TpTe) as a possible predictor of ventricular arrhythmic events in patients with Brugada syndrome (BrS). We sought to analyze the association between the parameters of repolarization dispersion (TpTe, TpTe/QT, TpTe dispersion, QTc, and QTd) and ventricular fibrillation/sudden cardiac death in a large cohort of patients with type 1 BrS. A total of 448 consecutive patients with BrS (men 61%, age 45 ± 16 years) with spontaneous (n = 96, 21%) or drug-induced (n = 352, 79%) type 1 electrocardiogram were retrospectively included. At the time of the diagnosis or during a mean follow-up of 93 ± 47 months (median 88 months), 43 patients (9%) documented ventricular arrhythmias. No significant difference was observed in TpTe, TpTe/QT, maximum TpTe, and TpTe dispersion between asymptomatic patients and those with syncope and malignant arrhythmias. TpTe/QT ratio did not also significantly differ between patients with ventricular fibrillation/sudden cardiac death and those asymptomatic ones. In conclusion, TpTe was not significantly prolonged in those patients with type 1 BrS presenting with unexplained syncope or malignant arrhythmic events during follow-up.

Second-generation cryoballoon ablation for paroxysmal atrial fibrillation: Predictive role of atrial arrhythmias occurring in the blanking period on the incidence of late recurrences.

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.

Cryoballoon ablation during atrial fibrillation is associated with faster temperature drop and lower freezing temperatures.

PURPOSE: Our aim was to analyse the temperature behaviour during second-generation cryoballoon ablation (CB-A) in patients with ongoing atrial fibrillation (AF) compared with those in sinus rhythm (SR). METHODS: Consecutive patients with drug-resistant AF who underwent pulmonary vein (PV) isolation by CB-A from April 2014 to May 2015 were analysed. The exclusion criteria were any contraindication for the procedure including the presence of an intracavitary thrombus, uncontrolled heart failure, contraindications to general anaesthesia and cardioversion to SR during the ablation procedure. RESULTS: A total amount of 323 consecutive patients having undergone PV isolation by means of CB-A (male 66 %, age 56.1 ± 13.4 years) was enrolled. During ablation in the left-sided PVs, time needed to reach -20°, -30° and -40° was significantly shorter in patients with AF than those in SR. During ablation in the right superior pulmonary vein (RSPV), time to reach -30° and -40° was also significantly longer in patients with AF; during ablation in the right inferior pulmonary vein (RIPV), although the temperature drop was faster in the AF group, times needed to reach -20°, -30° and -40° were not significantly prolonged compared with those in the SR group. Temperatures attained at 60 s, and minimal temperatures were also significantly lower in the AF group during all PV ablations except RIPV. CONCLUSIONS: The temperature drop during AF cryoablation was significantly faster and attained significantly lower freezing degrees in patients with ongoing AF during the procedure compared with those in SR. This finding resulted markedly significant during each PV isolation except for RIPV cryoablation.

Improved visualisation of real-time recordings during third generation cryoballoon ablation: a comparison between the novel short-tip and the second generation device.

BACKGROUND: The third-generation Cryoballoon Advance Short-tip (CB-ST) has been designed with a 40 % shortened tip length compared with the former second generation CB advance device (CB-A). Ideally, a shorter tip should permit an improved visualisation of real-time recordings in the pulmonary vein (PV) due to a more proximal positioning of the inner lumen mapping catheter. We sought to compare the incidence of visualisation of real-time recordings in patients having undergone ablation with the CB-ST with patients having received CB-A ablation. METHODS: All patients having undergone CB ablation using CB-ST technology and the last 500 consecutive patients having undergone CB-A ablation were analysed. Exclusion criteria were the presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, and contraindications to general anaesthesia. RESULTS: A total of 600 consecutive patients (58.1 ± 12.9 years, 64 % males) were evaluated (100 CB-ST and 500 CB-A ablations). Real-time recordings were significantly more prevalent in the CB-ST population compared with CB-A group (85.7 vs 67.2 %, p < 0.0001). Real-time recordings could be more frequently visualised in the CB-ST group in all types of veins (LSPV 89 vs 73.4 %, p = 0.0005; LIPV 84 vs 65.6 %, p = 0.0002; RSPV 87 vs 67.4 %, p < 0.0001; RIPV 83 vs 62.4 %, p < 0.0001). CONCLUSION: The rate of visualisation of real-time recordings is significantly higher during third-generation CB-ST ablation if compared to the second-generation CB-A device. Real-time recordings can be visualised in approximately 85.7 % of veins with this novel cryoballoon.

Single 3-minute freeze for second-generation cryoballoon ablation: one-year follow-up after pulmonary vein isolation.

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.