Cryoballoon ablation has emerged as a novel treatment strategy for patients with atrial fibrillation (AF).
The purpose of this study was to compare pulmonary vein isolation (PVI) using cryoballoon ...ablation versus RF ablation with regard to myocardial injury, pulmonary vein (PV) reconnection patterns, and outcome.
Fifty patients (age 59 ± 9 years, ejection fraction 0.59 ± 0.06, left atrial size 41 ± 5 mm) with paroxysmal AF were studied. Twenty-five patients underwent PVI using a 28-mm cryoballoon. A control group of 25 patients underwent PVI using an open-irrigation RF ablation catheter. Myocardial injury was determined by measuring troponin T (TnT). PV reconnection patterns were studied in case of repeat procedures.
Procedure duration was 166 ± 32 minutes in the cryoballoon group versus 197 ± 52 minutes in the RF group (P = .014), with similar ablation times (cryoballoon: 45 minutes interquartile range 40-52.5 minutes; RF: 47 minutes interquartile range 44-65 minutes, P = .17). Postprocedural TnT in the RF group was 1.29 ± 0.41 μg/L versus 0.76 ± 0.55 μg/L in the cryoballoon group (P = .002). In 12 patients who underwent repeat ablation, 74% of PV reconnection sites were inferiorly located in the cryoballoon group compared to 17% in the RF group (P = .0004). With 1.2 ± 0.4 and 1.3 ± 0.6 procedures per patient, 88% of patients in the cryoballoon group and 92% in the RF group were in stable sinus rhythm after follow-up of 12 ± 3 months (P = NS).
Differences in the extent of myocardial injury and patterns of PV reconnection were observed between cryoballoon ablation and RF ablation of paroxysmal AF.
Therapy with an implantable cardioverter defibrillator (ICD) is established for the prevention of sudden cardiac death (SCD) in high risk patients. We aimed to determine the effectiveness of primary ...prevention ICD therapy by analysing registry data from 14 centres in 11 European countries compiled between 2002 and 2014, with emphasis on outcomes in women who have been underrepresented in all trials.
Retrospective data of 14 local registries of primary prevention ICD implantations between 2002 and 2014 were compiled in a central database. Predefined primary outcome measures were overall mortality and first appropriate and first inappropriate shocks. A multivariable model enforcing a common hazard ratio for sex category across the centres, but allowing for centre-specific baseline hazards and centre specific effects of other covariates, was adjusted for age, the presence of ischaemic cardiomyopathy or a CRT-D, and left ventricular ejection fraction ≤25%. Of the 5033 patients, 957 (19%) were women. During a median follow-up of 33 months (IQR 16-55 months) 129 women (13%) and 807 men (20%) died (HR 0.65; 95% CI: 0.53, 0.79, P-value < 0.0001). An appropriate ICD shock occurred in 66 women (8%) and 514 men (14%; HR 0.61; 95% CI: 0.47-0.79; P = 0.0002).
Our retrospective analysis of 14 local registries in 11 European countries demonstrates that fewer women than men undergo ICD implantation for primary prevention. After multivariate adjustment, women have a significantly lower mortality and receive fewer appropriate ICD shocks.
The Heart Failure (HF) Meta-score may be useful in predicting prognosis in patients with primary prevention cardiac resynchronization defibrillators (CRT-D) considering the competing risk of ...appropriate defibrillator shock versus mortality.
Data from 648 consecutive patients from two centers were used for the evaluation of the performance of the HF Meta-score. The primary endpoint was mortality and the secondary endpoint was time to first appropriate implantable cardioverter-defibrillator (ICD) shock or death without prior appropriate ICD shock. Fine-Gray model was used for competing risk regression analysis.
In the entire cohort, 237 patients died over a median follow-up of 5.2 years. Five-year cumulative incidence of mortality ranged from 12% to 53%, for quintiles 1 through 5 of the HF Meta-score, respectively (log-rank P < 0.001). Compared with the lowest quintile, mortality risk was higher in the highest quintile (HR 6.9; 95%CI 3.7–12.8). The HF Meta-score had excellent calibration, accuracy, and good discrimination in predicting mortality (C-statistic 0.76 at 1-year and 0.71 at 5-year). The risk of death without appropriate ICD shock was higher in risk quintile 5 compared to quintile 1 (sub HR 5.8; 95%CI 3.1–11.0, P < 0.001).
Our study demonstrated a good ability of the HF Meta-score to predict survival in HF patients treated with CRT-D as primary prevention. The HF Meta-score proved to be useful in identifying a subgroup with a significantly poor prognosis despite a CRT-D.
•The Heart Failure Meta-score reliably predicts survival in patients who received a CRT-D as primary prevention of SCD.•The Heart Failure Meta-score is able to discriminate between patients with a low or high risk for mortality•The majority of patients died without experiencing an appropriate ICD shock•The Heart Failure Meta-score can be used to identify a subgroup with a significantly poor prognosis despite a CRT-D
Defibrillator lead malfunction is a potential long-term complication in patients with an implantable cardioverter-defibrillator (ICD). The aim of this study was to determine the incidence and causes ...of lead malfunction necessitating surgical revision and to evaluate 2 approaches to treat lead malfunction.
We included 1317 consecutive patients with an ICD implanted at 3 European centers between 1993 and 2004. The types and causes of lead malfunction were recorded. If the integrity of the high-voltage part of the lead could be ascertained, an additional pace/sense lead was implanted. Otherwise, the patients received a new ICD lead. Of the 1317 patients, 38 experienced lead malfunction requiring surgical revision and 315 died during a median follow-up of 6.4 years. At 5 years, the cumulative incidence was 2.5% (95% confidence interval, 1.5 to 3.6). Lead malfunction resulted in inappropriate ICD therapies in 76% of the cases. Implantation of a pace/sense lead was feasible in 63%. Both lead revision strategies were similar with regard to lead malfunction recurrence (P=0.8). However, the cumulative incidence of recurrence was high (20% at 5 years; 95% confidence interval, 1.7 to 37.7).
ICD lead malfunction necessitating surgical revision becomes a clinically relevant problem in 2.5% of ICD recipients within 5 years. In selected cases, simple implantation of an additional pace/sense lead is feasible. Regardless of the chosen approach, the incidence of recurrent ICD lead-related problems after lead revision is 8-fold higher in this population.
Anatomical Predictors for Acute and Mid‐Term Success of Cryoballoon Ablation. Introduction: Cryoballoon (CB) pulmonary vein isolation (CB‐PVI) for the treatment of paroxysmal atrial fibrillation (AF) ...has been demonstrated to be safe and reliable. Preprocedural patient selection to address the high variability in pulmonary vein (PV) anatomy may improve the acute and chronic success of CB‐PVI. The purpose of this study was to identify anatomical predictors for CB‐PVI failure using the 28 mm balloon.
Methods and Results
: We included 47 patients with paroxysmal AF undergoing CB‐PVI with the 28 mm CB. Anatomical global left atrial and PV selective parameters were quantified from 3‐dimensional reconstructed preprocedural computed tomography or magnetic resonance imaging data. The mean follow‐up was 26 ± 9 months (range: 12–32 months). Multivariate logistic regression analysis revealed that a continuous sharp left lateral ridge between the left PVs and the left lateral appendage (OR, 7.09; 95% CI, 1.17–43.47) and a sharp carina between the left superior and left inferior PV (OR, 5.99; 95% CI, 1.33–27.03) predict acute and mid‐term failure. For the right inferior PVs, a non‐perpendicular angle between the axis of the PV and the ostial plane (OR, 6.33; 95% CI, 1.20–33.33) and an early branching PV with change in the axis angle (OR, 7.41; 95% CI, 1.44–38.46) were predictors of acute and mid‐term failure.
Conclusion:
Anatomical variables preventing maximal heat transfer from the tissue to the CB could be identified as predictors for CB‐PVI failure with the 28 mm balloon. These findings may be a step toward a more tailored ablation strategy based on individual anatomical variations. (J Cardiovasc Electrophysiol, Vol. 24, pp. 132‐138, February 2013)
Different antihypertensive drug classes may alter risk for atrial fibrillation. Some studies suggest that drugs that interfere with the renin-angiotensin system may be favorable because of their ...effect on atrial remodeling.
To assess and compare the relative risk for incident atrial fibrillation among hypertensive patients who receive antihypertensive drugs from different classes.
Nested case-control analysis.
The United Kingdom-based General Practice Research Database, a well-validated primary care database comprising approximately 5 million patient records.
4661 patients with atrial fibrillation and 18,642 matched control participants from a population of 682,993 patients treated for hypertension.
A comparison of the risk for atrial fibrillation among hypertensive users of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II-receptor blockers (ARBs), or beta-blockers with the reference group of users of calcium-channel blockers. Patients with clinical risk factors for atrial fibrillation were excluded.
Current exclusive long-term therapy with ACE inhibitors (odds ratio OR, 0.75 95% CI, 0.65 to 0.87), ARBs (OR, 0.71 CI, 0.57 to 0.89), or beta-blockers (OR, 0.78 CI, 0.67 to 0.92) was associated with a lower risk for atrial fibrillation than current exclusive therapy with calcium-channel blockers.
Blood pressure changes during treatment courses could not be evaluated, and risk for bias by indication cannot be fully excluded in an observational study.
In hypertensive patients, long-term receipt of ACE inhibitors, ARBs, or beta-blockers reduces the risk for atrial fibrillation compared with receipt of calcium-channel blockers.
None.
Longevity of implantable cardioverter defibrillators (ICDs) is crucial for patients and healthcare systems as replacements impact on infection rates and cost-effectiveness. Aim was to determine ...longevity using very large databases of two teaching hospitals with a high number of replacements and a rather homogeneous distribution among manufacturers.
The study population consists of all patients in whom an ICD was inserted in. All ICD manufacturers operating in Switzerland and the Netherlands and all implanted ICDs were included. Implantable cardioverter defibrillator replacements due to normal battery depletion were considered events, and other replacements were censored. Longevity was assessed depending on manufacturers, pacing mode, implant before/after 2006, and all parameters combined. We analysed data from 3436 patients in whom 4881 ICDs 44.2% VVI-ICDs, 27.4% DDD-ICDs, 26.3% cardiac resynchronization therapy (CRT)-ICDs, 2.0% subcutaneous ICDs were implanted. The four major manufacturers had implant shares between 18.4 and 31.5%. Replacement due to battery depletion (27.4%) was performed for 1339 ICDs. Patient survival at 5 years was 80.1%. Longevity at 5 years improved in contemporary compared with elderly ICDs 63.9-80.6% across all ICDs, of 73.7-92.1% in VVIs, 58.2-76.1% in DDDs, and of 47.1-66.3% in CRT defibrillators, all P value < 0.05. Remarkable differences were seen among manufacturers, and those with better performance in elderly ICDs were not those with better performance in contemporary ones.
Implantable cardioverter defibrillator longevity increased in contemporary models independent of manufacturer and pacing mode. Still, significant differences exist among manufacturers. These results might impact on device selection.
The Achieve mapping catheter allows real-time recordings from the pulmonary veins (PVs) during cryoballoon (CB) ablation of atrial fibrillation (AF).
To assess the clinical applicability of the ...Achieve mapping catheter and the value of real-time recordings from the PVs during CB.
Patients with paroxysmal AF undergoing CB ablation were studied. Recordings from the PVs were analyzed during (real-time recordings) and after CB ablation and validated by using a variable circumferential mapping catheter (Achieve group; n = 20). A comparison was made by using a group of patients in whom CB ablation with a guidewire and a variable circumferential mapping catheter was performed (Guidewire group; n = 20).
Forty patients (age 58±11 years; ejection fraction 0.59±0.07; left atrial size 40±6 mm) with paroxysmal AF were included. In the Achieve group, real-time recordings from the PVs could be obtained in 40 of 80 (50%) PVs and could be seen more often at the left-sided PVs (25 of 39, 64%) than at the right-sided PVs (15 of 41, 37%; P = .02). Validation with a standard circumferential mapping catheter confirmed PV isolation in 75 of 80 (93%) PVs. After a single procedure and a follow-up of 14±4 months, 25 of 40 (63%) patients were in sinus rhythm with no significant difference between groups.
The Achieve catheter can be used as a substitute for a guidewire during CB ablation, but real-time recordings can be obtained only in half of the PVs and are not sufficient to accurately confirm isolation of all PVs.
Abstract
Aims
Leadless cardiac pacemaker (PM) implantation differs from conventional PM implantation. While the procedure has been considered safe, recent real-world data raised concerns about the ...learning curve of new operators and their implantation quality. The goal of this study was to investigate the influence of the first operator’s experience on leadless PM implantation quality and procedural efficiency.
Methods and results
We performed a bicentric analysis of all Micra TPS™ implantations in two large tertiary referral hospitals. We assessed both leadless PM implantation quality based on the absence of complications (requiring intervention or prolonged hospitalization), good electrical performance (pacing threshold ≤ 1.5 V/0.24 ms, R-wave amplitude > 5 mV), and acceptable fluoroscopy duration (<10 min) as well as procedural efficiency in relation to the operator’s experience. Univariate and multivariate logistic regression analyses were performed to identify predictors for implantation quality and procedural efficiency. Leadless PM implantation was successful in 106/111 cases (95.5%). Three patients (2.7%) experienced acute complications (one cardiac tamponade, one femoral bleeding, one posture-related PM exit block). Multivariate analysis showed that implantation quality of more experienced first operators was higher odds ratio 1.09 (95% confidence interval 1.00–1.19), P = 0.05. Procedural efficiency increased with operator experience as evidenced by an inverse correlation of procedure time, time to the first deployment, fluoroscopy time, and the number of procedures performed (all P < 0.05).
Conclusion
The operator’s learning curve is a critical factor for leadless PM implantation quality and procedural efficiency.
Several multivariate risk score models were developed to predict prognosis of patients with heart failure (HF). We compared 3 models with regard to prediction of mortality in patients with HF who ...received an implantable defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D), as primary prevention of sudden death. The study cohort consisted of 823 patients (ICD = 410; CRT-D = 413). The evaluated models were the Seattle Heart Failure Model (SHFM), the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) score, and an adjusted Charlson Comorbidity Index (aCCI). End point was the performance of the models to predict all-cause mortality at 5 years. This was determined by c -statistics, for both subgroups. Multivariate analysis was used to analyze the relations between the risk score models, their individual components and mortality, and its applicability to the entire population. Cumulative mortality was 4.9% at 1 year and 21.1% at 5 years. Discriminatory power for 5-year mortality was highest for the SHFM (0.73; p <0.001) compared with the MADIT II score and the aCCI for the entire population. SHFM performed better than the MADIT II score for CRT-D group. In the entire population, the SHFM and the aCCI were significant predictors of mortality in multivariate analysis (hazard ratio 1.90, 95% confidence interval 1.49 to 2.43 vs hazard ratio 1.11, 95% confidence interval 1.01 to 1.22). The strongest individual components were age, HF, impaired renal function, and cancer, whereas CRT-D use was no predictor. In conclusion, the SHFM has the best discriminatory power for 5-year mortality in patients with HF with an ICD or CRT-D. The aCCI and MADIT II scores are less powerful but viable alternatives.
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