Search

Left ventricular (LV) lead optimal positioning is one of the most important determinants of cardiac resynchronization therapy (CRT) success. LV quadripolar active fixation (QAF) leads have been designed to ensure stable LV pacing in the target area and reduce the likelihood of phrenic nerve stimulation (PNS). The aim of this analysis is to compare performances, safety, and clinical outcomes of QAF with those of quadripolar passive fixation leads (QPL) and bipolar active fixation (BAF) leads in a real-world cohort of CRT patients.This retrospective analysis compared the procedure and follow-up data of 117 QAF included in the One Hospital ClinicalService project from nine Italian hospitals with two historical cohorts of 261 BAF and 124 QPL. QAF enabled basal pacing more frequently than QPL (24.1% vs. 6.5%, p .001) but not differently from BAF (p = .981). At implant, mean QAF LV myocardial threshold (LVMT) was 1.21 ± 0.8 V at 0.4 ms, not different from that of BAF (p = .346) and QPL (p = .333). At a median follow-up of 22 months, LVMT was 1.37 ± 0.90 V (p = .036 vs. implant). Acute LV lead dislodgment occurrence was low in all cohorts: 1 (0.9%) in QAF, 4 in BAF (1.5%), and none (0.0%) in QPL. During follow-up, total LV-related complication rate was lower in QAF (0.5/100 patient-years) than in BAF (4.2/100 patient-years, p = .014) and QPL (3.6/100 patient-years, p = .055). QAF, BAF, and QPL annual rate of heart failure hospitalization were respectively 6.1/100 patient-years, 2.5/100 patient-years (p = .081), and 3.6/100 patient-years (p = .346). CRT responders' rate in QAF was 69.9%, with no difference in comparison to BAF (p = .998) and QPL (p = .509). During follow-up, mean left ventricular ejection fraction (LVEF) of QAF increased from 31.8 ± 10.1% to 40.3 ± 10.7% (p .001). The average degree of echocardiographic response (ΔLVEF) did not differ between QAF and other cohorts; however, LVEF CRT responder's distribution of QAF differs from those of BAF (p = .003) and QPL (p = .022), due to a higher percentage of super-responders.QAF with short interelectrode spacing resulted in non-inferior clinical outcomes and CRT responders' rate in comparison to BAF and QPL, while reducing complication rate during follow-up and increasing the possibilities of electronic repositioning to manage PNS or to optimize resynchronization therapy.

(1) Introduction: Cancer and atrial fibrillation (AF) are increasingly coexisting medical challenges. These two conditions share an increased thrombotic and bleeding risk. Although optimal regimens of the most suitable anti-thrombotic therapy are now affirmed in the general population, cancer patients are still particularly understudied on the matter; (2) Aims And Methodology: This metanalysis (11 studies (incl. 266,865 patients)) aims at evaluating the ischemic-hemorrhagic risk profile of oncologic patients with AF treated with oral anticoagulants (vitamin K antagonists vs. direct oral anticoagulants); (3) Results: In the oncological population, DOACs confer a benefit in terms of the reduction in ischemic, hemorrhagic and venous thromboembolic events. However, ischemic prevention has a non-insignificant bleeding risk, lower than Warfarin but significant and higher than the non-oncological patients; (4) Conclusions: Anticoagulation with DOACs provides a higher safety profile with respect to VKAs in terms of stroke reduction and a relative bleeding reduction risk. Further studies are needed to better assess the optimal anticoagulation strategy in cancer patients with AF.

About 4.5-20% of patients after heart transplant require pacemaker (PM) implantation. The high infective risk profile and the low probability of pacing dependency make heart-transplanted patients the ideal candidates for a leadless single-chamber PM. We report the first multicenter experience of leadless PM implantation in a series of heart-transplanted patients with a long-term follow-up. Our data confirm the feasibility and acceptable safety of leadless device in this peculiar kind of patients, despite implantation seems to be slightly more challenging with respect to non-transplanted patients. Although more data are required, a leadless single-chamber surveillance PM seems a valuable option for heart-transplanted patients.

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 of17.3 [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.

Aims: The single-freeze strategy using the second-generation cryoballoon (CB-A, Arctic Front Advance, Medtronic, Minneapolis, MN, USA) has been reported to be as effective as the recommended double-freeze approach in several single-centre studies. In this retrospective, international, multicentre study, we compare the 3-min single-freeze strategy with the 4-min single-freeze strategy. Methods and results: Four hundred and thirty-two patients having undergone pulmonary vein isolation (PVI) by means of CB-A using a single-freeze strategy were considered for this analysis. A cohort of patients who were treated with a 3-min strategy (Group 1) was compared with a propensity score-matched cohort of patients who underwent a 4-min strategy (Group 2). Pulmonary vein isolation was successfully achieved in all the veins using the 28-mm CB-A. The procedural and fluoroscopy times were lower in Group 1 (67.8 ± 17 vs. 73.8 ± 26.3, P

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.

This study analyzes the natural history of a large cohort of probands with Brugada syndrome (BrS) to assess the predictive value of different clinical and electrocardiographic parameters for the development of ventricular fibrillation (VF) or sudden cardiac death (SCD) during a long-term follow-up. Baseline characteristics of 289 consecutive probands (203 men; mean age 45 ± 16 years) with a Brugada type 1 electrocardiogram were analyzed. After a mean follow-up of 10.1 ± 4.6 years, 29 malignant arrhythmias occurred. On multivariate analysis, a history of VF and syncopal episodes, fragmented QRS (f-QRS), spontaneous type 1 electrocardiogram, and early repolarization pattern were significantly associated with later occurrence of VF/SCD. In patients with drug-induced BrS, the accentuation or de novo appearance of f-QRS in other leads was always associated with VF/SCD. Cerebrovascular events occurred in 8 patients with atrial fibrillation (15.1%), most of them (75%) presenting as the first clinical manifestation. The time-to-diagnosis was found to be significantly shorter in those patients who directly came to our center than in those who referred to our center for a second opinion. In conclusion, systematic use of the pharmacologic challenge in patients with unexplained cardiovascular symptoms and/or atrial fibrillation might significantly improve the identification of BrS with a shortening of the time-to-diagnosis. The CHA2DS2VASc score might be inappropriate for predicting transient ischemic attack or stroke in BrS. This study confirms the independent predictive value of previous VF and syncopal episodes, f-QRS, type 1 electrocardiogram, and early repolarization pattern. In BrS a sufficiently long follow-up is necessary before conclusions on prognosis are apparent.

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.

Vasovagal syncope is characterized by vasodilatation and/or bradycardia and thereby a fall in arterial BP and global cerebral perfusion in response to a trigger. Although it is a benign condition, patients with frequent and traumatic episodes need treatment in order to improve quality of life. We describe the case of a 17-years-old boy suffering from cardioinhibitory syncope. At the end of a complete negative cardiac and neurological examination, a loop recorder was implanted. During the subsequent follow-up the ILR documented a 9-s pause. To improve the patient's compliance, and considering cardioinhibitory syncope as a temporary condition, a leadless pacemaker was eventually implanted.

Key Clinical Message After transvenous lead extraction, leadless pacemaker might be a valid alternative to the traditional two‐step strategy including an active fixation leads temporary PM and subsequent contralateral permanent implantation in patients who are pacemaker‐dependent. Moreover, leadless PM might be of great importance in patients presenting with congenital vascular or cardiac abnormality.

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

BACKGROUND The present study sought to evaluate the incidence of cerebrovascular events in a large cohort of patients with Brugada syndrome (BrS) analysing possible predictors, clinical characteristics and prognosis of cardioembolic events secondary to atrial fibrillation. METHODS A total of 671 consecutive patients (age 42.1 ± 17.0 years; men 63%) with a diagnosis of BrS were retrospectively analysed over a mean follow-up period of 10.8 ± 5.5 years. The diagnosis of ischemic stroke was made according to the AHA/ASA guidelines using computed tomography (CT) and angio-CT in the emergency department. RESULTS Among 671 patients with BrS, 79 (11.8%) had atrial fibrillation. The incidence of cardioembolic stroke in patients with BrS and atrial fibrillation was 13.9% (11 events). These patients had a low CHA2DS2Vasc score (82%, 0 and 1). Patients with transient ischemic attack/stroke were more frequently asymptomatic (91 vs. 25%; P

Data indicate that the second-generation cryoballoon (Arctic Front Advance, Medtronic, Minnesota, USA) could be effective for persistent atrial fibrillation. However, electrophysiological findings and the midterm clinical outcome of repeat procedures following second-generation cryoballoon ablation are lacking. Consecutive patients with drug-resistant persistent atrial fibrillation who underwent a repeat ablation due to arrhythmia recurrence following an index procedure with second-generation cryoballoon were retrospectively included in our analysis. A total of 24 patients were included. Twenty underwent repeat procedures because of atrial fibrillation or left atrial arrhythmias and four because of typical atrial flutter. Mean time to recurrence of atrial tachyarrhythmias was 6.6 ± 3 months. Mean redo procedural time was 122 ± 23 min. At a mean follow-up of 11.8 ± 6.5 months, 15 patients (75 %) did not experience recurrence of atrial arrhythmias. Of the five patients (25 %) who had recurrence of atrial tachyarrhythmia, four presented with persistent atrial fibrillation and one with a mitral isthmus-dependent flutter. Of note is that the four patients with typical flutter were free from atrial tachycardia recurrence after the redo procedure. Two patients (9 %) underwent a third procedure. Mean time to recurrence of atrial arrhythmias from the repeat procedure was 9 ± 1 months. Our findings show that repeat ablation procedures following a second-generation cryoballoon ablation for persistent atrial fibrillation result in 75 % of freedom from any atrial tachycardia at 12 months follow-up. Of the recurrences, 63 % were due to new onset of atrial fibrillation and 37 % to organized tachycardias.

Introduction Little is known about the clinical outcome and recurring system-related adverse events (SAE) in cardiac resynchronization therapy (CRT) patients after transvenous lead extraction (TLE). Methods and results From January 2009 to June 2014, 256 consecutive CRT patients (mean age 68.3 ± 11.6 years, 216 male, 88% in New York Heart Association class II–IV, ejection fraction 35.1 ± 10.8%) were treated at four European institutions with TLE. Indications for TLE included systemic (18%) or local (45%) infection, system malfunction (34%), or other (3%). Demographic, clinical, TLE procedural, and follow-up data were collected retrospectively. Adverse events (AE) were considered as death from any cause, cardiovascular hospitalization, and SAE (SAE included pocket and/or systemic infection, lead malfunction, or pocket haematoma requiring revision). Complete removal was achieved for 607 out of 614 leads (98.9%) by using either manual traction (29%), mechanical (43%) or laser (28%) sheaths. Over a median follow-up of 21 (interquartile range 12–29) months, cumulative incidences of any AE and SAE were 39.8% and 21.5%, respectively. Recurring system malfunction occurred in 23 patients (9.0%), infection in 17 patients (6.6%), and pocket haematoma requiring revision in 15 patients (5.9%). Oral anticoagulation therapy was an independent predictor of both any AE [hazard ratio (HR) 2.09, 95% confidence interval (CI) 1.35–3.22, P

Second-Generation Cryoballoon AblationBackground 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.

AIMS: Leadless pacemaker (LDP) allows implantation using a femoral approach. This access could be utilized for conventional atrioventricular nodal ablation (AVNA). It could facilitate unifying the two procedural components. Data regarding its feasibility and long-term outcomes remain lacking. We aim to evaluate the feasibility and long-term outcomes of sequential LDP and AVNA. METHODS: Prospective, observational multicenter study including consecutive patients with indication for single-chamber pacemaker placement. In those with additional indication for AVNA, ablation was performed immediately after the LPD through the same sheath. RESULTS: A total of 137 patients were included. Mean age was 77.9 ± 10.5 years; 74 (54%) were men. Immediately following LDP implantation, 27 patients (19.7%) underwent concurrent AVNA. There were six (5.5%) complications in patients referred for LDP procedures and three (11%) in those who underwent a combined approach. None of these complications were solely attributable to theadded AVNA component. No mechanical dislodgement, electrical damage to any device, or electromagnetic interference ever took place. During a mean follow-up period of 123 ± 48 days, three patients (3.6%) died of noncardiovascular causes. The remaining population stayed alive without significant arrhythmias. There were no relevant differences with regard to sensing and pacing thresholds between patients in the two groups. CONCLUSIONS: AVNA can safely be performed immediately following LDP. A combined approach obviates the need for additional vascular access and optimizes feasibility and comfort for patients and healthcare providers. It offers an acceptable safety and efficacy profile, both acutely and upon intermediate-term follow-up.

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 meanfollow-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

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.

Background Second generation cryoballoon (CB-A) ablation is highly effective in achieving pulmonary vein (PV) isolation and freedom from atrial fibrillation (AF). However, the ideal freezing strategy is still under debate. Our objective was to investigate the efficacy and outcome between different freezing strategies used with the CB-A in a multicenter, matched population. Methods From a total cohort of 1018 patients having undergone CB-A ablation for drug-refractory AF, 673 patients with follow-up ≥ 6 months were included and stratified according to the applied freezing strategy: bonus freeze (BF) versus single freeze (SF). Final population of 256 BF patients was compared with 256 propensity-score matched SF patients. Results BF strategy consisted of 3 different protocols: 3 cycles of 180 s; 2 cycles of 240 s; and cycles of 240 s followed by 180 s in 99/256 (39%); 42/256 (16%); and 115/256 (45%) patients, respectively. SF approach included cycles of 240 s in 23/256 (9%), and 180 s in 233/256 (91%) patients. Electrical isolation could be achieved in all PVs by both protocols, with shorter procedure and fluoroscopy times in the SF group (mean 106 vs 65 min, and 18 vs 14 min, respectively, P < 0.001). Phrenic nerve palsy persisted after discharge in a total of 11 patients (2.1%): 4 (1.6%) in the BF group vs 7 (2.7%) in the SF group, P = 0.5. AF-free survival was similar between the 2 groups during follow-up (mean 18 ± 10 months) (log rank, P = 0.6). Conclusions CB-A ablation showed equal efficacy and outcome between SF and BF strategy.

AIMS: Real Time Recordings (RTR) of pulmonary vein (PV) activity provide important information in the setting of the 2nd generation Cryoballoon (CB-A), as a funcion of time to isolation. Visualization of RTR with the standard inner lumen mapping catheter (ILMC) 20mm Achieve (AC) is possible in roughly 50% of PVs. A novel 25mm-Achieve Advance (AC-A) has been developed with the aim of increasing the detection of RTR. The purpose of this study is to compare the AC-A with the AC, to feasibility and improvement of RTR. METHODS: We assigned 50 patients with paroxysmal or persistent atrial fibrillation to CB-A PVI, using the AC-A as ILMC. We compared this group with 50 patients, matched for age and left atrial volume, who previously underwent the CB-A PVI using the AC. RESULTS: RTR were more frequently observed with the AC-A than with the AC (74% vs 49%; p= 0.02). RTR in the left superior PVs was similar in both groups (74% vs 72%, p= 0.8). RTR with the AC-A were equally appreciated in left or right sided, superior or inferior PVs. No significant differences were found in terms of feasibility, procedure fluoroscopy and freezing times, nadir temperatures, and acute PVI. CONCLUSIONS: CB-A PVI with the AC-A is feasible and safe in all PVs. The AC-A has proven significantly superior in visualising RTR if compared to the AC, affording RTR in 74% of PVs., Aims: Real Time Recordings (RTR) of pulmonary vein (PV) activity provide important information in the setting of the 2nd generation Cryoballoon (CB-A), as a funcion of time to isolation. Visualization of RTR with the standard inner lumen mapping catheter (ILMC) 20mm Achieve (AC) is possible in roughly 50% of PVs. A novel 25mm-Achieve Advance (AC-A) has been developed with the aim of increasing the detection of RTR. The purpose of this study is to compare the AC-A with the AC, to feasibility and improvement of RTR. Methods: We assigned 50 patients with paroxysmal or persistent atrial fibrillation to CB-A PVI, using the AC-A as ILMC. We compared this group with 50 patients, matched for age and left atrial volume, who previously underwent the CB-A PVI using the AC. Results: RTR were more frequently observed with the AC-A than with the AC (74% vs 49%; p= 0.02). RTR in the left superior PVs was similar in both groups (74% vs 72%, p= 0.8). RTR with the AC-A were equally appreciated in left or right sided, superior or inferior PVs. No significant differences were found in terms of feasibility, procedure fluoroscopy and freezing times, nadir temperatures, and acute PVI. Conclusions: CB-A PVI with the AC-A is feasible and safe in all PVs. The AC-A has proven significantly superior in visualising RTR if compared to the AC, affording RTR in 74% of PVs.

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.

Background Accuracy in left atrial (LA) anatomical reconstruction is crucial to the safe and effective performance of catheter ablation of atrial fibrillation (AF). The aim of this study was to evaluate the accuracy of LA reconstruction performed with intracardiac echocardiography (ICE) as compared to fast anatomical mapping (FAM) both integrated in the CARTO mapping system (Biosense Webster, Diamond Bar, CA, USA). Methods A multislice computed tomography (MSCT) was preacquired from 29 patients with AF who underwent catheter ablation and 3D-LA geometry was reconstructed using both ICE and FAM separately. The accuracy of the LA anatomical definition was evaluated by comparing LA volumes, LA and pulmonary vein (PV) diameters obtained using ICE and FAM versus MSCT (gold standard). Results Anterior-posterior and superior-inferior LA diameters were shorter in ICE versus MSCT (32 ± 10 vs 46 ± 9 mm and 48 ± 7 vs 53 ± 7 mm, P < 0.01) but similar in FAM versus MSCT (45 ± 9 vs 46 ± 9 mm and 52 ± 10 vs 53 ± 7 mm). Latero-septal LA diameter was similar in ICE versus MSCT (63 ± 11 vs 63 ± 9 mm) but larger in FAM versus MSCT (69 ± 9 vs 63 ± 9 mm, P < 0.001). LA volume was lower in ICE versus MSCT (73 ± 30 mL vs 116 ± 45 mL, P < 0.0001) and slightly larger in FAM versus MSCT (132 ± 45 vs 116 ± 45 mL, P = 0.06). PV diameters were similar in FAM versus MSCT but significantly underestimated with ICE. Conclusions Overall accuracy in the LA and PV anatomical reconstruction was found to be superior with FAM compared to ICE-guided approach. ICE resulted in a significant underestimate of both LA and PV dimensions, while FAM slightly overestimated LA geometry.

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

PURPOSE: Recent data suggests that high burden of premature atrial complexes after pulmonary vein isolation predicts recurrences of atrial arrhythmias. The present study sought to assess the role of premature atrial complexes burden in predicting atrial arrhythmias recurrences in patients with atrial fibrillation (AF) who have undergone second-generation cryoballoon ablation (CB-Adv). METHODS: Consecutive patients with drug-resistant paroxysmal atrial fibrillation who underwent pulmonary vein isolation using CB-Adv technology as the index procedure were retrospectively included. Twenty-four-hour Holter recordings were performed for every patient. Based on previously published data, a burden of more than 76 premature atrial complexes per day was considered as being high. RESULTS: One hundred and seven patients were included in the analysis. The recurrence rate among the group of patients with more than 76 premature atrial complexes per day was significantly higher compared with the group with a lower burden of premature atrial complexes (47.5 vs 11.9%, respectively; p < 0.001). In the multivariate analysis, the documentation of more than 76 premature atrial complexes per day registered at 1 month and at the end of the blanking period, predicted late recurrence of atrial arrhythmias. CONCLUSIONS: Frequent premature atrial complexes in the early stages after CB-Adv ablation strongly predict late recurrences of atrial arrhythmias.

BACKGROUND: A left common pulmonary vein (LCPV) accounts as the most frequent PV variation. The use of the cryoballoon (CB) for isolating these veins, is still debatable. To date, no data are available regarding the feasibility, acute PV isolation, and clinical outcome of the second-generation CB (CB-A) in this setting. OBJECTIVE: To investigate the performance of the CB-A in patients with LCPVs. METHODS: In a total cohort of 433 patients having undergone CB-A ablation for drug-refractory atrial fibrillation (AF) together with pre-procedural CT-scanning, 146 patients presented a LCPV. Measurement of ostial area and trunk distance was performed, together with analysis of procedural and fluoroscopic data in order to determine the ablation strategy. The latter 146 LCPV+ were compared for outcome with a cohort of 146 propensity-score matched LCPV- patients. RESULTS: Electrical isolation could be achieved in all left-sided veins. A long left common trunk (>15mm) was found in 25% (37/146) of the LCPV+ patients. LCPVs treated with a single-shot freeze strategy presented a longer trunk (22 ± 5 mm vs 9 ± 4, P < 0,001) and smaller ostial area (305 ± 109 mm(2) vs 400 ± 108 mm(2), P < 0,001) compared to LCPV patients where a segmental (superior and inferior) freeze was delivered. AF-free survival was similar between LCPV+ and LCPV- patients during follow-up (mean 19 ± 10 months) (log rank, P = 0.33). CONCLUSION: CB-A ablation in LCPV+ patients is effective and showed no difference in clinical outcome compared to LCPV- patients.

PURPOSE: The second-generation cryoballoon (CB-A, Arctic Front Advance, Medtronic, Minneapolis, MN, USA) has proven to be highly effective in achieving freedom from atrial fibrillation; nonetheless, the ideal number and duration of freezing cycles is still a matter of debate. We investigated the acute success, procedural complications, and clinical outcome of a single freeze strategy using the CB-A in a large, retrospective, international multicenter study. METHODS: Between January 2013 and September 2015, 818 consecutive patients (58 ± 12 years, 68% males) with drug-resistant atrial fibrillation (AF) who underwent a CB-A using a single freeze strategy were taken into consideration for our analysis. RESULTS: Paroxysmal AF was documented in 74.1% of the patients, while 25.9% presented with persistent AF. Additional freezes were needed in a mean 1.4 veins per patient. 0.2% of the patients experienced persistent PNP that was still documented at the last follow-up. After a median follow-up of 14 ± 8 months, taking into consideration a blanking period (BP) of 3 months, 692 patients (84.6%) were free from arrhythmia recurrence. After a single procedure, AF recurrence during BP and persistent AF were identified as predictors of clinical recurrence after BP. CONCLUSIONS: Single freeze CB-A ablation is effective in treating drug-resistant AF and affords freedom from arrhythmia recurrences in 84.6% of patients during a 14-month follow-up. Persistent AF and recurrence during BP are predictors of arrhythmia recurrences.

PURPOSE: Pulmonary vein isolation is now widely accepted for the treatment of symptomatic atrial fibrillation refractory to antiarrhythmic drugs. However, multiple procedures are often required to significantly reduce atrial fibrillation (AF) recurrence. In the present study, we analyzed the acute results and the midterm clinical outcome of a second-generation cryoballoon ablation (CB-A) performed during repeat procedures for recurrence of AF after an initial procedure performed with conventional radiofrequency (RF). METHODS: Consecutive patients with paroxysmal and persistent AF who underwent pulmonary vein isolation by CB-A from June 2012 in our hospital as a redo procedure after a previous pulmonary vein isolation with RF were retrospectively included in this analysis. RESULTS: Forty-seven patients having undergone CB-A as a redo procedure were considered for our analysis. Pulmonary vein potentials were documented in 83 pulmonary veins (PV) that were all successfully re-isolated using the CB-A. Transientphrenic nerve palsy was the only complication occurring in our study cohort. After a mean follow-up of 15 ± 8 months, 76.6% of patients were free from recurrence of atrial fibrillation. If taking into consideration a 3-month blanking period, 83% of patients were free from recurrence. The success rate in patients affected by paroxysmal AF was 87% at final follow-up following the blanking period. CONCLUSIONS: The second-generation CB is effective in treating recurrence of AF after a previous ablation performed with conventional RF. Considering a 3-month blanking period, 83% of the patients were free from any atrial tachycardia recurrence during a 15-month follow-up. This approach proved particularly successful in patients affected by paroxysmal AF.

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.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 aged75 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).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.

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

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 ± 12.9 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.

Device related distress negatively affects the quality of life of cardiac device recipients mostly of women. A submammary approach has been proposed to reduce the physical impact of the implantation. Our aim was to assess the safety of this approach and to evaluate the patients' acceptance of the device.We enrolled 42 patients who underwent a submammary device. The primary endpoint was the need for implant revision that was assessed in the study group compared with the overall control group of 72 standard cardiac device recipients (29 females and 43 males)and with the female group (29 females of controls). In the female population (42 women of the submammary group and 29 of controls) patients' acceptance was calculated with the Florida Patient Acceptance Survey (FPAS).The rate of implant revision was similar in the two groups and the revision-free survival was comparable with a median follow-up of about six years (Log rank test p=0.949). Similar results were found when considering only the female population. Patients' acceptance was greater in the submammary group [total FPAS 85 (95%CI 83-86) vs 74.5 (95%CI 70.2-77.3) p0,001] and a strongly significant superiority of the submammary group was found regarding body image concerns [10 (95%CI 10-10) vs 8 (95%CI 8-8) p0.001) and device related distress [23 (95%CI 22-23) vs 1 (95%CI 1-1) p0.001].Submammary device implantation is safe and more accepted than standard approach. Our results should encourage cardiologists to suggest this approach to their patients for a better acceptance of the therapy.

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 withAF; 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.

Little is known about the clinical outcome and recurring system-related adverse events (SAE) in cardiac resynchronization therapy (CRT) patients after transvenous lead extraction (TLE).From January 2009 to June 2014, 256 consecutive CRT patients (mean age 68.3 ± 11.6 years, 216 male, 88% in New York Heart Association class II-IV, ejection fraction 35.1 ± 10.8%) were treated at four European institutions with TLE. Indications for TLE included systemic (18%) or local (45%) infection, system malfunction (34%), or other (3%). Demographic, clinical, TLE procedural, and follow-up data were collected retrospectively. Adverse events (AE) were considered as death from any cause, cardiovascular hospitalization, and SAE (SAE included pocket and/or systemic infection, lead malfunction, or pocket haematoma requiring revision). Complete removal was achieved for 609 out of 614 leads (99.2%) by using either manual traction (28%), mechanical (52%) or laser (20%) sheaths. Over a median follow-up of 21 (interquartile range 12-29) months, cumulative incidences of any AE and SAE were 53.9% and 21.1%, respectively. Recurring system malfunction occurred in 23 patients (9.0%), infection in 16 patients (6.2%), and pocket haematoma requiring revision in 15 patients (5.9%). Oral anticoagulation therapy was an independent predictor of both any AE [hazard ratio (HR) 2.09, 95% confidence interval (CI) 1.35-3.22, P = 0.001] and SAE (HR 2.38, 95% CI 1.21-4.68, P = 0.012) after TLE.Even though TLE is safe and effective to treat CRT patients, a high burden of recurring SAE after TLE was observed at mid-term follow-up. Careful evaluation of both patient characteristics as well as implantation strategy is suggested when indicating TLE in a CRT patient, particularly in patients receiving oral anticoagulation therapy.

Background:Pro-inflammatory cytokines contribute to the pathophysiology of heart failure (HF) and are up-regulated in affected patients. We investigated whether pro-inflammatory cytokines might predict the response to cardiac resynchronization therapy (CRT).Methods and Results:Plasma levels of tumor necrosis factor-α (TNF-α) and interleukin-6 were assessed in 91 patients before CRT. Response to CRT was defined as a decrease ≥15% in left ventricular end-systolic volume (LVESV) at 6 months. Baseline TNF-α did correlate with LVESV reduction (P=0.001) after CRT. The subject group was divided according to tertiles of TNF-α. From the lower to the upper tertile LVESV (–31±28%, –17±17%, –9±22%) and LV end-diastolic volume (–23±25%, –14±16%, –4±18%) were progressively less reduced after CRT (P

Accuracy in left atrial (LA) anatomical reconstruction is crucial to the safe and effective performance of catheter ablation of atrial fibrillation (AF). The aim of this study was to evaluate the accuracy of LA reconstruction performed with intracardiac echocardiography (ICE) as compared to fast anatomical mapping (FAM) both integrated in the CARTO mapping system (Biosense Webster, Diamond Bar, CA, USA).A multislice computed tomography (MSCT) was preacquired from 29 patients with AF who underwent catheter ablation and 3D-LA geometry was reconstructed using both ICE and FAM separately. The accuracy of the LA anatomical definition was evaluated by comparing LA volumes, LA and pulmonary vein (PV) diameters obtained using ICE and FAM versus MSCT (gold standard).Anterior-posterior and superior-inferior LA diameters were shorter in ICE versus MSCT (32 ± 10 vs 46 ± 9 mm and 48 ± 7 vs 53 ± 7 mm, P0.01) but similar in FAM versus MSCT (45 ± 9 vs 46 ± 9 mm and 52 ± 10 vs 53 ± 7 mm). Latero-septal LA diameter was similar in ICE versus MSCT (63 ± 11 vs 63 ± 9 mm) but larger in FAM versus MSCT (69 ± 9 vs 63 ± 9 mm, P0.001). LA volume was lower in ICE versus MSCT (73 ± 30 mL vs 116 ± 45 mL, P0.0001) and slightly larger in FAM versus MSCT (132 ± 45 vs 116 ± 45 mL, P = 0.06). PV diameters were similar in FAM versus MSCT but significantly underestimated with ICE.Overall accuracy in the LA and PV anatomical reconstruction was found to be superior with FAM compared to ICE-guided approach. ICE resulted in a significant underestimate of both LA and PV dimensions, while FAM slightly overestimated LA geometry.

Sudden cardiac death (SCD) is the leading cause of death in the age group 20–65 years, in the western world, with an enormous social and economic impact. The majority of the cases of ventricular fibrillation (VF) occur in patients without a preexisting structural heart disease and represent the first manifestation of coronary artery disease. In most of these cases, VF occurs in the early phase of myocardial infarction (MI) and it is then called primary VF. Although several factors have been associated in various studies with primary VF a recent metaanalysis found no evidence for risk factors other than ST elevation and time from onset of symptoms. In the past several years, few studies have found that a family history of sudden cardiac death (SCD) is a risk factor for primary VF suggesting that this dramatic event may be favored by the genetic background. To explore this possibility we designed the ongoing PREDESTINATION Study, enrolling subjects under 75 years of age with a first MI complicated by primary VF and a control group of subjects with a first uncomplicated MI. Data so far available confirm the association between a family history of SCD and primary VF and suggest that hypokalemia and prolonged QT interval may favor its occurrence. The genetic analysis has already provided some interesting suggestions that will need to be confirmed by the continuation of the enrolment and joint analysis with data deriving from similar patient populations.