Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies.

AIMS: The ultra-low-temperature cryoablation (ULTC) ablation system using -196°C N2 cryogen has been reported to create lesions with freeze duration-dependent depth titratable to over 10 mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evaluating the safety and efficacy of a novel, purpose-built ULTC catheter in endocardial ablation of scar-dependent ventricular tachycardias (VTs). METHODS AND RESULTS: This prospective, multi-centre study enrolled patients referred for de novo or second ablations of recurrent monomorphic VT of both ischaemic and non-ischaemic aetiologies. Primary safety and efficacy endpoints of the study were freedom from device- or procedure-related major adverse events (MAEs) up to 30 days post-ablation, acute non-inducibility of clinical VTs at the end of the procedure, and freedom from sustained VT or implantable defibrillator intervention at 6 months. Ultra-low-temperature cryoablation was performed in 64 patients (age 67 ± 11 years, 78% ischaemic, ejection fraction = 35 ± 10%) at 9 centres. The primary acute effectiveness endpoint was achieved in 94% (51/54) of patients in whom post-ablation induction was attempted. There were no protocol-defined MAEs; four procedure-related serious adverse events resolved without clinical sequelae. At 6-month follow-up, 38 patients (60.3%) remained VT-free, and freedom from defibrillator shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts. In 47 patients with defibrillator for at least 6 months prior to the ablation, the VT burden was reduced from median of 4, inter-quartile range (IQR, 1-9) to 0, IQR (0-2). CONCLUSION: In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients with both ischaemic-cardiomyopathy and non-ischaemic-cardiomyopathy. CLINICAL TRIAL REGISTRATION: NCT04893317.

Incidence and predictors of thermal oesophageal and vagus nerve injuries in Ablation Index-guided high-power-short-duration ablation of atrial fibrillation: a prospective study.

AIMS: High-power-short-duration (HPSD) ablation is an effective treatment for atrial fibrillation but poses risks of thermal injuries to the oesophagus and vagus nerve. This study aims to investigate incidence and predictors of thermal injuries, employing machine learning. METHODS AND RESULTS: A prospective observational study was conducted at Leipzig Heart Centre, Germany, excluding patients with multiple prior ablations. All patients received Ablation Index-guided HPSD ablation and subsequent oesophagogastroduodenoscopy. A machine learning algorithm categorized ablation points by atrial location and analysed ablation data, including Ablation Index, focusing on the posterior wall. The study is registered in clinicaltrials.gov (NCT05709756). Between February 2021 and August 2023, 238 patients were enrolled, of whom 18 (7.6%; nine oesophagus, eight vagus nerve, one both) developed thermal injuries, including eight oesophageal erythemata, two ulcers, and no fistula. Higher mean force (15.8 ± 3.9 g vs. 13.6 ± 3.9 g, P = 0.022), ablation point quantity (61.50 ± 20.45 vs. 48.16 ± 19.60, P = 0.007), and total and maximum Ablation Index (24 114 ± 8765 vs. 18 894 ± 7863, P = 0.008; 499 ± 95 vs. 473 ± 44, P = 0.04, respectively) at the posterior wall, but not oesophagus location, correlated significantly with thermal injury occurrence. Patients with thermal injuries had significantly lower distances between left atrium and oesophagus (3.0 ± 1.5 mm vs. 4.4 ± 2.1 mm, P = 0.012) and smaller atrial surface areas (24.9 ± 6.5 cm2 vs. 29.5 ± 7.5 cm2, P = 0.032). CONCLUSION: The low thermal lesion's rate (7.6%) during Ablation Index-guided HPSD ablation for atrial fibrillation is noteworthy. Machine learning based ablation data analysis identified several potential predictors of thermal injuries. The correlation between machine learning output and injury development suggests the potential for a clinical tool to enhance procedural safety.

Cardiac tamponade complicating ventricular arrhythmia ablation: Real life data on incidence, management, and outcome.

BACKGROUND AND OBJECTIVE: Cardiac tamponade during ablation procedures is a life-threatening complication. While the incidence and management of tamponade in atrial fibrillation ablation have been extensively described, the data on tamponade during ventricular ablations are very limited. The purpose of this study is to shed light on the incidence, typical perforation sites, and optimal management as observed through real-life data in a tertiary referral center for ventricular ablation. METHODS AND RESULTS: Consecutive patients with structural heart disease undergoing ventricular tachycardia ablation from 2008-2020 were analyzed. Of the 1078 patients undergoing 1287 ventricular ablation procedures, 20 procedures (1.5%) were complicated by cardiac tamponade. In all but one patient, the tamponade was treated with emergent pericardial drainage, while nine patients eventually underwent surgical repair. The perforation occurred during transseptal or subxiphoid puncture in six patients, during ventricle mapping in two patients, and during ablation in five patients (predominantly basal left ventricle). Steam pop as definite perforation cause could only be established in two patients. Regardless of the management of the complication, all patients survived to discharge. CONCLUSION: Cardiac tamponade during ventricular ablation occurred in 1.5% of the procedures. In nine patients cardiac repair was necessary. Perforation was mostly associated with subxiphoid puncture or ablation of the basal left ventricle.

Patient perspectives on same-day discharge following catheter ablation for atrial fibrillation: results from a patient survey as part of the monocentric FAST AFA trial.

AIMS: Same-day discharge (SDD) following catheter ablation (CA) of atrial fibrillation (AF) was already introduced in selected facilities in Europe, but a widespread implementation has not yet succeeded. Data on patients' perspectives are lacking. Therefore, we conducted a survey to address patients' beliefs towards SDD and identify variables that are associated with their evaluation. METHODS AND RESULTS: As part of the prospective, monocentric FAST AFA trial, patients aged ≥20 years undergoing left atrial CA for AF were asked to participate in the survey consisting of a study-specific questionnaire, the AF knowledge scale, and pre-defined patient-reported outcome measures. The study cohort was stratified based on SDD willingness, and a logistic regression analysis was used to identify predictors for patients' valuation. Between 26 July 2021 and 01 July 2022, 256 of 376 screened patients consented to study participation of whom 248 (mean age 61.8 years, 33.9% female) completed the SDD survey. Of them, 50.0% were willing to have SDD concepts integrated into their clinical course with increased patient comfort (27.5%), shorter waiting times (14.6%), and a cost-efficient treatment (14.0%) being imaginable benefits. In contrast, expressed concerns included uncertainties with occurring complaints (50.6%), the insufficient recognition (47.8%), and treatment (48.9%) of complications. European Heart Rhythm Association class at baseline and inpatient treatments within the preceding year were predictors for SDD willingness whereas comorbidity burden or AF knowledge were not. CONCLUSION: We provide a detailed survey expressing patients' beliefs towards SDD following left atrial CA. Our findings may facilitate adequate patient selection to improve the future implementation of SDD programs in suitable cohorts.

Left atrial total emptying fraction measured by cardiovascular magnetic resonance imaging predicts low-voltage areas detected during electroanatomical mapping.

AIMS: Low-voltage areas (LVAs) found during left atrial (LA) electroanatomical mapping are increasingly targeted by radiofrequency catheter ablation (RFCA) on top of pulmonary vein isolation to improve arrhythmia-free survival in patients with atrial fibrillation (AF). However, pre-procedural prediction of LVAs remains challenging. The purpose of the present study was to describe the association between parameters of LA function and dimensions, respectively, derived from pre-procedural cardiovascular magnetic resonance (CMR) imaging, and the presence of LVAs on LA voltage mapping. METHODS AND RESULTS: Patients who underwent first-time RFCA for paroxysmal or persistent AF and who were in stable sinus rhythm during pre-procedural CMR imaging were included in this study. Cardiovascular magnetic resonance-derived parameters of LA function and dimensions were calculated. Low-voltage areas were defined as areas with bipolar voltage amplitudes of ≤0.5 mV on electroanatomical mapping. In total, 259 consecutive patients were included in this analysis. Low-voltage areas were found in 25 of 259 patients (9.7%). Compared with those without LVAs, patients with LVAs were significantly older, were more likely to be female, had a higher CHA2DS2-VASc score, had larger LA volumes, and had a lower LA total emptying fraction (TEF). In multivariate analysis, only LA TEF [odds ratio (OR) 0.885, 95% confidence interval (CI) 0.846-0.926, P < 0.001] and the CHA2DS2-VASc score (OR 1.507, 95% CI 1.115-2.038, P = 0.008) remained independently associated with the presence of LVAs. CONCLUSION: Left atrial TEF and the CHA2DS2-VASc score were independently associated with the presence of LVAs found during LA electroanatomical mapping. These findings may help to improve pre-procedural prediction of pro-arrhythmogenic LVAs and to improve peri-procedural patient management.

Impact of repeat ablation of ventricular tachycardia in patients with structural heart disease.

AIMS: Recurrences of ventricular tachycardia (VT) after initial catheter ablation is a significant clinical problem. In this study, we report the efficacy and risks of repeat VT ablation in patients with structural heart disease (SHD) in a tertiary single centre over a 7-year period. METHODS AND RESULTS: Two hundred ten consecutive patients referred for repeat VT ablation after previous ablation in our institution were included in the analysis (53% ischaemic cardiomyopathy, 91% males, median age 65 years, mean left ventricular ejection fraction 35%). After performing repeat ablation, the clinical VTs were acutely eliminated in 82% of the patients, but 46% of the cohort presented with VT recurrence during the 25-month follow-up. Repeat ablation led to a 73% reduction of shock burden in the first year and 61% reduction until the end of follow-up. Similarly, VT burden was reduced 55% in the first year and 36% until the end of the study. Fifty-two patients (25%) reached the combined endpoint of ventricular assist device implantation, heart transplantation, or death. Advanced New York Heart Association functional class, anteroseptal substrate, and periprocedural complication after repeat ablation were associated with worse prognosis independently of the type of cardiomyopathy. CONCLUSION: While complete freedom from VT after repeat ablation in SHD was difficult to achieve, ablation led to a significant reduction in VT and shock burden. Besides advanced heart failure characteristics, anteroseptal substrate and periprocedural complications predicted a worse outcome.

Relevance of Chronic Total Occlusion for Outcome of Ventricular Tachycardia Ablation in Ischemic Cardiomyopathy.

Background: Catheter ablation of ventricular tachycardia (VT) in patients with ischemic cardiomyopathy (ICM) is an effective tool to prevent VT recurrences. Chronic total occlusion (CTO) represents a clinically relevant entity in ICM patients and is an independent predictor of ventricular arrhythmia and mortality. The effects of CTO on the outcome of VT ablation are not well-studied. Objective: This analysis aimed to identify the impact of CTO, revascularized, or not revascularized, on the outcome of VT ablation. Methods and Results: Of 385 consecutive subjects with ICM-VT who underwent catheter VT ablation for monomorphic VT at Heart Center Leipzig between 2008 and 2017, 108 patients without CTO and 191 patients with CTO were included in the analysis. Within a median follow-up time of 557 days (IQR 149, 1095), VT recurred in 77 (40%) patients in the CTO and 40 (37.0%) in the non-CTO cohort (p = 0.62). In a multivariable model, a 10% stepwise change in LVEF as well as ICD on admission was associated with VT recurrence (HRadj 1.82, 95% CI 1.04-3.18 and HRadj 1.35, 95% CI 1.23-1.61, respectively). Of the CTO cohort before ablation, 45% had received revascularization, which was independently associated with a higher risk for VT recurrence (HR 2.12, 95% CI 1.35-3.34) as compared to nonrevascularized CTO. Conclusion: In ICM patients with and without CTO, VT ablation was associated with equal effectiveness with regard to VT recurrence. However, in revascularized CTO patients, the risk of recurrence of VT after ablation was significantly increased.

Outcomes following cardiac sympathetic denervation in patients with structural heart disease and refractory ventricular arrhythmia.

AIM: Cardiac sympathetic denervation (CSD) has been introduced as a bailout therapy in patients with structural heart disease and refractory ventricular arrhythmias (VAs), but available data are scarce. Purpose of this study was to estimate immediate results, complications, and mid-term outcomes of CSD following recurrent VA after catheter ablation. METHODS AND RESULTS: Adult patients who underwent CSD in the Heart Center Leipzig from March 2017 to February 2021 were retrospectively analysed. Follow-up (FU) was executed via implantable cardioverter defibrillator (ICD) interrogation, telephone interviews, and reviewing medical records. Twenty-one patients (age 63.7 ± 14.4 years, all men, 71.4% non-ischaemic cardiomyopathy, left ventricular ejection fraction 31.6 ± 12.6%) received CSD via video-assisted thoracoscopic surgery (90.5% bilateral, 9.5% left-sided only). Indication for CSD was monomorphic ventricular tachycardia in 76.2% and ventricular fibrillation in 23.8 with 71.4% of patients presenting with electrical storm before index hospitalization. Procedure-related major complications occurred in 9.5% of patients. In-hospital adverse events not related to surgery were common (28.6%) and two patients died during the index hospital stay. During FU (mean duration 9.1 ± 6.5 months), five more patients died. Of the remaining patients, 38.5 and 76.9% were free from any VA or ICD shocks, respectively. CONCLUSIONS: The CSD showed additional moderate efficacy to suppress VAs, when performed as a bailout therapy after previously unsuccessful catheter ablation. At 9 months, it was associated with freedom of ICD shocks in two-thirds of patients. In a population with many comorbidities, the rate of CSD-related complications was acceptable, although there was an overall high risk of procedure unrelated adverse events and death.

VT ablation in geriatric patients with structural heart disease: Should there still be an age limit?

INTRODUCTION: This study sought to examine the feasibility and outcome of ablation of ventricular tachycardias (VTs) in a contemporary cohort of geriatric patients with structural heart disease (SHD). BACKGROUND: Geriatric patients are often underrepresented in large studies. As frailty is becoming an increasing problem, we need to examine the best course of action for this population. METHODS AND RESULTS: We investigated 68 SHD-patients ≥ 75 years old undergoing VT-ablation (men 88%, ischemic cardiomyopathy 77%, electrical storm 72%, mean left ventricular ejection fraction 31%) and divided the cohort into two groups: 75-79 years old (n = 51) and ≥80 years old (n = 17). The two groups showed similar results regarding noninducibility as ablation endpoint (p = .693), major procedure-related complications (p = .488), and VT-recurrence (p = .882) during the 39-month follow-up. At the end of the follow-up, 10 patients in the octogenarian group (59%) versus 16 patients of the other group (31%) died. CONCLUSION: Geriatric patients with SHD including octogenarians showed similar results regarding procedural endpoints, freedom of VT, and major procedure-associated complications after VT-ablation. When ablation is indicated, age alone should not be an inhibiting factor to treat these patients.

Gender differences in patients with structural heart disease undergoing VT ablation.

INTRODUCTION: This study sought to examine gender differences in patients with structural heart disease (SHD) referred for ablation of ventricular tachycardia (VT). BACKGROUND: Female patients are often underrepresented in large studies. Significant differences in the clinical presentation, treatment, and prognosis of female patients have been described in previous studies. METHODS AND RESULTS: We investigated 88 female patients with SHD undergoing VT ablation (mean age 59 years, 56% nonischemic cardiomyopathy, mean left ventricular ejection fraction 35%, 82% in electrical storm). A case-control study with 88 male patients was performed and the results regarding clinical and procedural characteristics, acute and long-term results of the two groups were compared. The female patients had more arrhythmogenic substrate, as they more commonly presented with electrical storm (p = .016) and had a higher number of inducible VT morphologies during the procedure (p = .018). Moreover, the female patients were less likely to have an optimized heart failure medical treatment at baseline (p = .030) and required more time from the first manifestation of the VT to ablation referral (p = .034). Although fewer epicardial ablations were performed in female patients (p = .019), the two groups showed similar results regarding VT noninducibility as ablation endpoint (p = .844), major procedure-related complications (p = .719) and freedom from VT during follow-up (p = .268). Moreover, the overall mortality in the two groups was similar (p = .176). Advanced NYHA class was associated with worse transplant and assist-device-free survival in the female group. CONCLUSION: Female patients presenting for VT ablation had more arrhythmogenic substrate and were less likely to have an optimized heart failure medical treatment. Nevertheless, the procedural acute and long-term outcomes between the two genders were similar.

Validation of the VT-LVAD score for prediction of late VAs in LVAD recipients.

OBJECTIVES: This study sought to validate the performance of the VT-LVAD risk model in predicting late ventricular arrhythmias (VAs) in patients after left ventricular assist device (LVAD) implantation. BACKGROUND: The need for implantable cardioverter-defibrillator (ICD)-implantation in LVAD recipients is not well studied. A better selection of the patients with high risk for late VAs could lead to a more targeted ICD-implantation or replacement. METHODS: The study evaluated the performance of the VT-LVAD prognostic score (VAs prior LVAD, no ACE-inhibitor in medication, heart failure duration > 12 months, early VAs post-LVAD implantation, atrial fibrillation prior LVAD, idiopathic dilated cardiomyopathy) for the endpoint of the occurrence of late VAs in 357 LVAD patients in Heart Centre of Leipzig. RESULTS: From the initial 460 patients, 357 (age: 58 ± 10 years; left ventricular ejection fraction: 20 ± 6%; HeartWare: 50%; HeartMate III: 42%) were assigned to four risk groups according to their VT-LVAD score varying from low risk to very high risk. After 25 months, late VAs occurred in 130 patients. The VT-LVAD score was an independent predictor of late VAs (multivariate analysis; p = < .001; goodness-of-tip p = .347; odds ratio: 4.8). While there was no statistically significant difference between the low- and intermediate-risk group, risk stratification for patients with high risk and very high risk performed more accurately (pairwise comparison p = .005 and p < .001, respectively). CONCLUSIONS: The VT-LVAD score predicted accurately the occurrence of late VAs in high-risk LVAD recipients in a large external cohort of LVAD recipients supporting its utility for more targeted ICD implantations.

Epicardial ablation of ventricular tachycardia in patients with structural heart disease: a single-centre experience over 12 years.

AIMS: Epicardial ablation has risen to an essential part of the treatment of ventricular tachycardias (VTs). In this study, we report the efficacy, risks, and current trends of epicardial ablation in structural heart disease as reported in a tertiary single centre over a 12-year period. METHODS AND RESULTS: Two hundred and thirty-six patients referred for VT ablation underwent a successful epicardial access and were included in the analysis (89% non-ischaemic cardiomyopathy, 90% males, mean age 60 years, mean left ventricular ejection fraction 38.4%). After performing epicardial ablation the clinical VTs were eliminated in 87% of the patients and 71% of the cohort achieved freedom from VT during 22-month follow-up. Twelve patients (5%) suffered major procedure-related complications. Until the end of follow-up 47 (20%) patients died, 9 (4%) underwent a left ventricular assist device implantation and 10 (4%) patients received a heart transplantation. Antiarrhythmic drugs at baseline and during follow-up were independent predictors of VT recurrence. Atrial fibrillation, renal dysfunction, worse New York Heart Association class, and antiarrhythmic drugs at follow-up were associated with worse survival in our cohort. CONCLUSION: In this large tertiary single-centre experience, percutaneous epicardial access was feasible in the large majority of the cohort with acceptably low complications rates. A combined endo-/epicardial approach resulted in 87% acute and 71% long-term success. Further studies are needed to clarify the role of routine combined endo-/epicardial ablation in these complex cardiomyopathies.

Role of inducibility and its dynamic change in the outcome of catheter ablation of atrial fibrillation: a single center prospective study.

BACKGROUND: The role of atrial arrhythmia inducibility as an endpoint of catheter ablation of atrial fibrillation (AF) has been a controversial subject in many studies. Our goal is to evaluate the significance of inducibility, the impact of multiple sites or protocols of stimulation or the change in inducibility status in a prospective study including patients with AF undergoing first catheter ablation. METHODS: We studied 170 consecutive patients with AF (62.9% paroxysmal) undergoing catheter ablation. All patients underwent two separate stimulation protocols before and after the ablation from the coronary sinus ostium and the left atrial appendage: burst pacing at 300, 250, 200 milliseconds (or until refractoriness) for 10 seconds and ramp decrementing from 300 to 200 milliseconds in increments of 10 milliseconds every three beats for 10 seconds. Inducibility was defined as any sustained AF or organized atrial tachycardia (AT) lasting >30 seconds. RESULTS: We had AF/AT inducibility in 55 patients at baseline compared to 36 following ablation. After a mean of 41, 3 months follow-up, 115 patients were free of AF. Inducibility before or after the ablation or change in inducibility status did not influence AF recurrence. There were no significant differences regarding paroxysmal or persistent patients with AF. CONCLUSIONS: Non-inducibility of atrial arrhythmia or change in inducibility status following pulmonary vein (PV) isolation and substrate modification are not associated with long-term freedom from recurrent arrhythmia. Therefore, the use of induction of an endpoint in AF ablation is limited.

Predictors of long-term mortality after catheter ablation of ventricular tachycardia in a contemporary cohort of patients with structural heart disease.

AIMS: Ablation of ventricular tachycardias (VTs) in patients with structural heart disease has been established in the past decades as an effective and safe treatment. However, the prognosis and long-term outcome remains poor. METHODS AND RESULTS: We investigated 309 patients with ischaemic cardiomyopathy (ICM) and non-ischaemic cardiomyopathy (NICM) (186 ICM, 123 NICM; 271 males; mean age 64.1 ± 12 years; ejection fraction 34 ± 13%) after ≥1 VT ablations over a mean follow-up period of 34 ± 28 months. Electrical storm was the indication for 224 patients (73%), whereas 86 patients (28%) underwent epicardial as well as endocardial ablation. During follow-up, 132 patients (43%) experienced VT recurrence and 97 (31%) died. Ischaemic cardiomyopathy and NICM patients showed comparable results, regarding procedural endpoints, complications, VT recurrence and survival. The Cox-regression analysis for all-cause mortality revealed that the presence of higher left ventricular end-diastolic volume (LVEDV; P < 0.001), male gender (P = 0.018), atrial fibrillation (AF; P < 0.001), chronic obstructive pulmonary disease (COPD; P = 0.001), antiarrhythmic drugs during the follow-up (P < 0.001), polymorphic VTs (P = 0.028), and periprocedural complications (P = 0.001) were independent predictors of mortality. CONCLUSION: Ischaemic cardiomyopathy and NICM patients undergoing VT ablation had comparable results regarding procedural endpoints, complications, VT recurrence and 3-year mortality. Higher LVEDV, male gender, COPD, AF, polymorphic VTs, use of antiarrhythmics, and periprocedural complications are strong and independent predictors for increased mortality. The PAINESD score accurately predicted the long-term outcome in our cohort.

Outcome in patients undergoing upgrade to cardiac resynchronization therapy: predictors of outcome after upgrade to CRT.

The advantages of upgrade to cardiac resynchronisation therapy (CRT) have not been explored as carefully as the outcomes of de novo CRT implantations. Furthermore selection criteria for patients with the potential to benefit the most from this therapy are unknown. Therefore, we analyzed the long term outcome and its predictors in a real-world cohort receiving a CRT upgrade from previous pacemaker (PM) and defibrillator devices (ICD). We analyzed 86 patients (mean age 68 ± 9 years; 89% male) undergoing CRT upgrade procedures. Response to CRT as well as long term patient outcome was analyzed. NYHA class improved in majority of the patients during short term period (61%), and this trend remained constant during long term follow-up (54%). The observed all-cause mortality was 54% with mean survival of 49 ± 4 months. 11 patients underwent left ventricular assist device implantation or heart transplantation. In the multivariate analysis, only kidney function assessed by GFR (HR 0.97; 95% CI 0.95-0.99; p = 0.009) and LVEF (HR 0.92; 95% CI 0.87-0.97; p = 0.002) remain predictors for mortality. Patients who undergo an upgrade procedure to CRT demonstrate a significant response rate assessed by improvement in NYHA class, with initial baseline parameters such as LVEF and kidney function remaining significant predictors for mortality.

Differences in predictors of implantable cardioverter-defibrillator therapies in patients with ischaemic and non-ischaemic cardiomyopathies.

AIMS: Implantable cardioverter-defibrillators (ICDs) have been shown to reduce mortality in patients with both ischaemic and non-ischaemic cardiomyopathy by terminating life-threatening arrhythmias. However, such arrhythmic events are unequally distributed among different patient subgroups. We aimed to evaluate predictors of appropriate ICD therapies as a step towards risk stratification in a real-world cohort. METHODS AND RESULTS: The prevalence and predictors of appropriate ICD therapies were analysed in 330 consecutive patients (mean age 65 ± 11, 81% male) with implanted ICDs due to ischaemic (n = 204) or dilated (n = 126) cardiomyopathy. During a mean follow-up of 19 ± 9 months, 1545 appropriate ICD therapies (antitachycardia pacing and shocks) were detected in 94 patients (29%). In multivariate analysis applied on the whole cohort, the presence of atrial fibrillation [AF: odds ratio (OR) = 1.906, confidence interval (CI) = 1.143-3.177, P = 0.013] and secondary prevention indication (OR = 1.963, CI = 1.123-3.432, P = 0.018) was associated with ICD therapy. The presence of cardiac resynchronization therapy (CRT) had a protective value (OR = 0.563, CI = 0.327-0.968, P = 0.038). Moreover, the predictors were different depending on the aetiology of the cardiomyopathy: in the ischaemic group, only secondary prevention indication (OR = 2.0, CI = 1.029-3.891, P = 0.041) and the presence of a biventricular system (OR = 0.359, CI = 0.163-0.794, P = 0.011) remained significant, while in the non-ischaemic group, an association with AF was observed (OR = 4.281, CI = 1.632-11.231, P = 0.003). CONCLUSION: The aetiology of cardiomyopathy should be taken into consideration for the therapy of ICD patients. The protective role of CRT devices should be pointed out in ischaemic cardiomyopathy (ICM) and a more rigorous antiarrhythmic treatment should be considered for ICM patients with secondary prevention or for dilated cardiomyopathy patients with AF.

Impact of single atrial fibrillation catheter ablation on implantable cardioverter defibrillator therapies in patients with ischaemic and non-ischaemic cardiomyopathies.

AIMS: Atrial fibrillation (AF) is associated with frequent appropriate and inappropriate implantable cardioverter defibrillator (ICD) therapies. Catheter ablation of AF has been shown to reduce AF burden and improve left ventricular function in heart failure patients but the impact on ICD therapies has not yet been studied. The aim of this study was to test the hypothesis that AF ablation reduces ICD therapies in patients with cardiomyopathies. METHODS AND RESULTS: In 73 consecutive patients (mean age 59 ± 10 years, 85% male) with previously implanted ICD due to ischaemic (n = 30) or dilated cardiomyopathy (n = 43) undergoing AF ablation, the prevalence and frequency of ICD therapies before and after AF ablation were compared. During the total follow-up of 3.3 ± 3 years prior to AF ablation, 5.1 ± 14.7 therapies per patient-year were delivered as opposed to 1.8 ± 10.9 in a period of 1.1 ± 0.9 years after ablation (P = 0.002). Prior to AF ablation, 39 patients (53%) received at least one ICD therapy when compared with 15 patients (21%) after ablation. Atrial fibrillation ablation was associated with freedom from any therapy regardless of appropriateness (odds ratio, OR, 0.366, CI 0.164-0.816, P = 0.014, adjusted for follow-up). Appropriate shocks significantly decreased from 0.3 ± 1.3 to 0.1 ± 0.5 per patient-year (P = 0.030). While heart failure medication and use of antiarrhythmic drugs were comparable during the entire follow-up, a statistically significant improvement of left ventricular ejection fraction (LVEF) from 36.9 ± 12.3% to 40.7 ± 6.7% (P = 0.008) was observed after AF ablation. CONCLUSIONS: In patients with ischaemic or dilated cardiomyopathy, catheter ablation of AF is associated with the reduction of inappropriate and appropriate ICD therapies and improvement of LVEF.

Comparison of dabigatran and uninterrupted warfarin in patients with atrial fibrillation undergoing cardiac rhythm device implantations. Case-control study.

BACKGROUND: The incidence of postoperative complications following pacemaker or implantable cardioverter-defibrillator implantations in patients treated with new oral anticoagulation agents has not been studied. Here we present a first comparison of complications after cardiac rhythm device (CRD) implantations in patients with atrial fibrillation (AF) treated with dabigatran or uninterrupted warfarin. METHODS AND RESULTS: Using a case-control study design, we compared complications within 30 days after 236 CRD procedures performed under uninterrupted warfarin (n=118) or interrupted dabigatran (n=118).There were no significant differences in the baseline characteristics of both groups. In the warfarin group, 9 (8%) pocket hematomas were observed vs. 3 (3%) in the dabigatran group (P=0.075). Two complications in the warfarin group necessitated surgical intervention as opposed to none in the dabigatran group (P=0.156). The postprocedural blood loss expressed as a drop in hemoglobin was significantly greater in the warfarin group (-0.9±0.7 vs. -0.5±0.4 mmol/L, P=0.023). In the dabigatran group, 1 case of transient ischemic attack occurred. The mean time to hospital discharge was shorter in patients treated with dabigatran (2.5±2.3 vs. 3.8±4.1 days, P=0.02). CONCLUSIONS: The incidence and severity of bleeding complications may be lower in patients treated with periprocedurally discontinued dabigatran when compared with uninterrupted warfarin therapy. Further evaluation of peri-interventional complications and establishment of an optimal anticoagulation management protocol are needed.

Comparison of Dabigatran and Uninterrupted Warfarin in Patients With Atrial Fibrillation Undergoing Cardiac Rhythm Device Implantations.

Background:The incidence of postoperative complications following pacemaker or implantable cardioverter-defibrillator implantations in patients treated with new oral anticoagulation agents has not been studied. Here we present a first comparison of complications after cardiac rhythm device (CRD) implantations in patients with atrial fibrillation (AF) treated with dabigatran or uninterrupted warfarin.Methods and Results:Using a case-control study design, we compared complications within 30 days after 236 CRD procedures performed under uninterrupted warfarin (n=118) or interrupted dabigatran (n=118).There were no significant differences in the baseline characteristics of both groups. In the warfarin group, 9 (8%) pocket hematomas were observed vs. 3 (3%) in the dabigatran group (P=0.075). Two complications in the warfarin group necessitated surgical intervention as opposed to none in the dabigatran group (P=0.156). The postprocedural blood loss expressed as a drop in hemoglobin was significantly greater in the warfarin group (-0.9±0.7 vs. -0.5±0.4 mmol/L, P=0.023). In the dabigatran group, 1 case of transient ischemic attack occurred. The mean time to hospital discharge was shorter in patients treated with dabigatran (2.5±2.3 vs. 3.8±4.1 days, P=0.02).Conclusions:The incidence and severity of bleeding complications may be lower in patients treated with periprocedurally discontinued dabigatran when compared with uninterrupted warfarin therapy. Further evaluation of peri-interventional complications and establishment of an optimal anticoagulation management protocol are needed.

Single catheter approach for treatment of premature ventricular contractions.

BACKGROUND: Catheter ablation has become one of the main treatment strategies in patients with premature ventricular complexes (PVC). The successful mapping and ablation can be performed with an ablation catheter without additional diagnostic catheters. HYPOTHESIS: We hypothesize that using a single catheter for PVC ablation may decrease complications, procedure time, and fluoroscopy exposure while maintaining comparable success rates. METHODS: Sixty-nine consecutive patients with PVC were treated with a single catheter approach compared to a historical cohort, in which a conventional setup was used. Propensity score matching was conducted with a 1:1 ratio. Outcome parameters included acute procedural success with elimination of all premature ventricular contractions after catheter ablation, procedural data as well as complication rates. RESULTS: Patients treated with a single catheter approach had shorter total procedure (60 minutes [IQR: 47,5-69,0 minutes] vs. 90 minutes [IQR 60-120 minutes]; p = 0.001) and fluoroscopy times (218 seconds [IQR: 110,5-446 seconds] vs. 310 seconds [IQR 190-640 seconds]; p = 0.012), which consecutively leads to a reduction of radiation exposure signified by a lower dose area product (155 cGycm² [IQR 74.4-334.5 cGycm²] vs. 368.4 cGycm² [IQR: 126-905.4 cGycm²]; p value 0.009). Acute procedural success rates were comparable in both groups (54 [84.3%] in the single catheter approach group and 58 [90.6%] in the conventional group; p: 0.287). CONCLUSION: A single catheter approach for the treatment of PVC is associated with a reduction of procedure- and fluoroscopy time, as well as a lesser radiation exposure, while maintaining equivalent acute success and complication rates compared with a conventionally used catheter setup.