Pulmonary Vein Isolation in Elderly Patients ≥ 75 Years: A Propensity Score-Matched Analysis With Focus on Differences Among Atrial Fibrillation Types.

BACKGROUND: Age is a major risk factor for development of atrial fibrillation (AF) and associated with increased recurrence rates in the setting of rhythm control. Current data tend to support catheter ablation in elderly patients, but uncertainties exist regarding efficacy and safety of ablation in elderly patients. METHODS: This was a prospective single-centre observational study with propensity score matching (PSM) to investigate the influence of age on efficacy and safety of cryoballoon ablation (CBA) stratified by age (< 75 years vs ≥ 75 years) and AF phenotype (paroxysmal vs persistent). Primary efficacy endpoint was recurrence of atrial arrhythmia after a 90-day blanking period. Safety endpoints were death, stroke, or procedure-associated complications. RESULTS: Consecutive patients (n = 953) underwent CBA for first-time AF ablation. Median follow-up was 18 months. By means of PSM, 268 matches were formed. At 1 year, primary efficacy endpoint occurred in 22.4% of young vs 33.2% of elderly patients, including both AF phenotypes (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.47-0.90; P = 0.01). AF relapse occurred in 19.7% of young vs 28.5% of elderly patients with paroxysmal (HR, 0.63; 95% CI, 0.40-0.99; P = 0.046) compared with 25.9% (30 of 116, young) vs 38.8% (45 of 116, elderly) patients with persistent AF (HR, 0.62; 95% CI, 0.39-0.97; P = 0.038). No difference was observed regarding the incidence of safety endpoints between young and elderly patients (P = 0.38). CONCLUSIONS: CBA is associated with higher recurrence rates in elderly (≥ 75 years) than in younger patients, with highest recurrence rates in elderly patients with persistent AF.

Zero-fluoro atrioventricular-nodal reentrant tachycardia ablation.

BACKGROUND: Atrioventricular-nodal reentrant tachycardia (AVNRT) is a common supraventricular tachycardia, particularly in younger patients. The treatment of choice is radiofrequency catheter ablation (RFCA), traditionally necessitating ionizing radiation for catheter guidance. OBJECTIVE: The authors aimed to demonstrate the feasibility and safety of zero-fluoroscopy RFCA of AVNRT using EnSite™ NavX™ as a three-dimensional (3D) electroanatomical mapping system (EAM). METHODS: The authors retrospectively analyzed 68 patients that underwent AVNRT-RFCA. One group was a priori allocated to conventional fluoroscopy mapping (convFluoro, n = 30). In 38 cases, the electrophysiologist chose to use 3D-EAM for ablation. Of these patients, 20 could be ablated without fluoroscopy use (zeroFluoro). In 18 cases that were initially intended as 3D-EAM, additional fluoroscopy use was necessary due to difficult anatomic conditions (convertedFluoro). Procedure duration, fluoroscopy duration and dose, as well as complications were analyzed. RESULTS: Procedure duration was similar for the convFluoro and zeroFluoro groups (74 ± 24 min vs. 80 ± 26 min, p = ns). The convertedFluoro group showed longer procedure duration compared to the convFluoro group (94 ± 30 min vs. 74 ± 24 min, p < 0.05). The use of 3D-EAM significantly reduced fluoroscopy duration comparing the convFluoro with the convertedFluoro group (12 ± 9 min vs. 7 ± 6 min, p < 0.05). The difference in fluoroscopy dose between convFluoro and convertedFluoro did not reach significance (169 ± 166 cGycm2 vs. 134 ± 137 cGycm2, p = ns). In zeroFluoro cases, no radiation was used at all. 3D-EAM-guided RFCA was primarily successful in all patients. Overall, there were only few minor complications in the different groups. No major complications occurred. CONCLUSION: Zero-fluoro RFCA in patients with AVNRT is feasible and safe. 3D-EAM can reduce radiation exposure in the majority of patients without prolonging procedure duration or increasing complications.

Cryoballoon pulmonary vein isolation for atrial fibrillation in obese patients: A non-inferiority analysis.

Background: Patients with obesity are at higher risk of developing atrial fibrillation (AF) and benefit from radiofrequency ablation. Potentially, cryoballoon ablation (CBA) may be equally effective and safe in such patients. Methods: We conducted a prospective, single-center study to investigate whether CBA for pulmonary vein isolation is as effective and safe in obese patients as it is in non-obese controls. Primary efficacy endpoint was recurrence of AF, atrial flutter or atrial tachycardia after a 90-day blanking period. Safety endpoints were death, stroke or procedure-associated complications. Conduction of a subgroup analysis regarding the impact of additional diabetes was predefined in case the primary efficacy endpoint was met. The study was event driven and powered for noninferiority. Results: A total of 949 patients underwent CBA (251 obese with mean body-mass-index 33.5 ± 3 kg/m2 and 698 non-obese with mean body-mass-index 25.3 ± 3 kg/m2) during a 5-year recruitment period. Median follow-up was 15 months. The primary efficacy endpoint occurred in 78/251 obese and 247/698 non-obese patients (12-months Kaplan-Meier event-rate estimates, hazard ratio 0.79; 95% confidence interval [CI], 0.58 to 1.07; log-rank P = 0.0002 for noninferiority). No differences were observed in safety end point occurrence (P = 0.78). The occurrence of primary efficacy end point was found to be unaffected by the presence of diabetes in the prespecified subgroup analysis (log-rank P = 0.57). Conclusion: CBA is effective and safe in obese and DM patients. Weighing the high cardiovascular risk of obese patients against a reduction of cardiovascular events by early rhythm control, CBA should be offered to this patient population.

Frame-rate reduction to reduce radiation dose for cardiac device implantation is safe.

Background: Radiation exposure to patient and surgeon during cardiac implantable electrical device (CIED) procedures remains a substantial health hazard to date. Advanced technical options for radiation dose reduction often pose considerable financial hurdles. We propose a near-zero cost, low-effort modification to a clinical x-ray system significantly reducing radiation dose during CIED implantation. Objective: We aim to evaluate a reduced frame rate protocol in CIED implantation for complication rates and reduction in radiation exposure. Methods: Starting May 2019, the frame rate during CIED implantations at our hospital was halved from 7.5 frames/s to 3.8 frames/s, and no further technical changes were made. During the following year, 264 patients were operated using this protocol and retrospectively compared with 231 cases implanted in the year before the protocol change, totaling 495 cases. Of these, 17%, 63%, and 19% were single-chamber, dual-chamber, or resynchronization devices, respectively. Incidence of complication prior to hospital discharge was considered the primary endpoint of the analysis. Radiation dose and procedural parameters were secondary endpoints. Results: There was no increase in complications with the reduced frame rate protocol. Regression analysis further supported that the reduced frame rate radiation protocol was not associated with complication rates. Radiation exposure measured as dose area product was significantly reduced by ∼62% (median 369 [interquartile range 154-1207] cGy·cm2 via the reduced frame rate protocol vs median 970 [interquartile range 400-1906] cGy·cm2 with the standard frame rate; P < 0.01). Conclusion: A reduction of frame rate during CIED implantation is safe in terms of complication incidence and effective in terms of reducing radiation exposure.

Persistent Atrial Fibrillation in Elderly Patients: Limited Efficacy of Pulmonary Vein Isolation.

(1) Background: Cryoballoon pulmonary vein isolation (cryoPVI) is established for symptomatic paroxysmal atrial fibrillation (AF) treatment, but its value in persistent AF is less clear. In particular, limited data are available on its efficacy in elderly patients (≥75 years) with persistent AF. Age is an important modifier of AF progression and represents a risk-factor for AF recurrence. (2) Methods: Prospective, single-center observational study to evaluate the impact of age on efficacy and safety of cryoPVI in elderly patients. Primary efficacy endpoint was symptomatic AF recurrence after 90-day blanking period. Primary safety endpoints were death from any cause, procedure-associated complications or stroke/transient ischemic attack. Median follow-up was 17 months (range 3−24). (3) Results: We included 268 patients with persistent AF (94 ≥ 75 years of age). Multivariate Cox regression analysis identified age as the only independent factor influencing AF recurrence in the overall cohort (p = 0.006). To minimize confounding bias in efficacy and safety analysis of cryoPVI, we matched younger and elderly patients with respect to baseline characteristics. At 24 months, primary efficacy endpoint occurred in 13/69 patients <75 years and 31/69 patients ≥75 years of age (24 months Kaplan−Meier event-rate estimates, HR 0.34; 95% CI, 0.19 to 0.62; log-rank p = 0.0004). No differences were observed in the occurrence of safety end points. (4) Conclusions: Elderly (≥75 years) patients with persistent AF undergoing cryoPVI had an approximately threefold higher risk of symptomatic AF recurrence than matched younger patients. Accordingly, other treatment modalities may be evaluated in this population.

Process optimization for atrial fibrillation ablation.

AIMS: In the light of an increasing prevalence of atrial fibrillation (AF) and growing evidence for the superiority of early invasive rhythm control, the demand for ablation therapy is rising. Accordingly, ablation centres will have to maximize their capacity by either adding electrophysiology laboratory resources or optimizing process management. In order to optimize process management, we applied "Lean Six Sigma" method to a single ablation center. We compared procedural parameters, acute efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) before and after modifications. METHODS AND RESULTS: Patients (n = 713) undergoing cryoPVI (108 before and 605 after process optimization) were analysed. Within 3 years of process optimization, electrophysiology laboratory occupancy time (150.7 ± 44.4 vs. 94 ± 22.1 min, P < 0.001), procedure time (84.5 ± 21-47.4 ± 12 min, P < 0.001), left-atrial dwell time (53.9 ± 18.4-31.9 ± 9.9 min, P < 0.001), and fluoroscopy time (15.8 ± 5.1 vs. 6.2 ± 2.8 min, P < 0.001) decreased. Contrast dye use (116 ± 35 vs. 27 ± 15 mL, P < 0.001) and radiation dose (893 ± 1078 vs. 253 ± 249 cGy cm2, P < 0.001) were reduced by ∼77 and ∼72%, respectively. There was no difference in safety endpoint occurrence (3.7 vs. 1.5%, P = 0.11). CONCLUSION: The process optimization of cryoPVI for AF therapy using the 'Lean Six Sigma' method significantly increases efficiency without compromising patient safety.

Prospective randomized trial of skin closure for pacemaker implantation: absorbable vs. non-absorbable suture : PRO-PACE.

BACKGROUND: Pacemaker implantations have been performed for > 50 years, reaching 1.25 million implants worldwide per year. Despite this, only few randomized studies exist regarding technical aspects of the implantation procedure-in particular, wound closure. Accordingly, the authors compared absorbable vs. non-absorbable suture regarding wound healing. METHODS: Consecutive patients scheduled for de novo pacemaker implantation without defibrillation therapy were prospectively randomized into two groups: non-absorbable (Prolene®, Ethicon Inc.) or absorbable suture (Monocryl®, Ethicon Inc.). The wound was systematically assessed for cosmetic outcome at 1 day, 6 weeks, and 1 year post implantation using the patient and observer scar assessment scale (POSAS). Adverse events noted included bleeding, pocket hematoma, infection, suture insufficiency, and revision surgery. RESULTS: A total of 114 patients (mean age: 79 ± 10 years, n = 60 male) were randomized into the two groups. Of these, 105 completed follow-up (lost to follow-up: 7.9%). Groups were comparable for clinical characteristics or use of oral anticoagulants. There was no difference in cosmetic outcome and incidence of adverse events at any follow-up visit. POSAS scores were: 1 day: 1.4 ± 0.4 vs. 1.3 ± 0.4, P = 0.44, 6 weeks: 1.4 ± 0.6 vs. 1.4 ± 0.7, P = 0.57; 1 year: 1.4 ± 1.4 vs. 2.1 ± 3, P = 0.60. No pocket hematoma or infection occurred in either group. No additional surgery was necessary for local findings. Retrospectively, scar development was straight in the Prolene® group and slightly wavy with Monocryl®. CONCLUSION: Suture material does not influence wound healing as represented by the cosmetic result and the occurrence of adverse events. The choice of suture material used should be left to the physician's discretion.

[Supraventricular tachycardia - ECG interpretation and clinical management]. / Vorgehen und Behandlungsoptionen bei supraventrikulären Tachykardien.

Supraventricular tachycardia (SVT) is a very common cause of hospital admission and its diagnostic and treatment may be difficult sometimes. While vagal maneuvers or intravenous adenosis administration during 12-lead ECG recording should be performed in hemodynamically stable patients for diagnosis and treatment, hemodynamically unstable patients should be carioverted immediately. The new ESC guideline (2019) on diagnosis and clinical management of SVT significantly upgrades catheter ablation and gives it a new preferential status. For example, in patients with symptomatic recurrence, atrioventricular nodal re-entrant tachycardia should be ablated due to the very low risk of AV block. Furthermore, catheter ablation should also be offered as first-line therapy to patients with reentrant and focal arrhythmias. The diagnosis and therapy of tachycardiomyopathy is of particular importance and treatment should incorporate the ablation of the underlying supraventricular tachycardia. The therapy of supraventricular tachycardia during pregnancy should be free of antiarrhythmic medication, especially in the first trimester. If ablation is necessary during pregnancy, only fluoroscopy-free mapping systems should be used. This review covers aspects of ECG diagnosis and guideline-based treatment of SVT.

Percutaneous transluminal renal angioplasty of global kidney ischemia improves renal function and blood pressure.

BACKGROUND: Renal artery stenosis (RAS) can lead to hypertension and renal failure. Nevertheless, its treatment by percutaneous transluminal renal angioplasty (PTRA) remains controversial. It is unknown, whether patients with global kidney ischemia (GKI), that means patients with bilateral RAS or RAS with a single functioning kidney, may benefit from PTRA or not. METHODS: We retrospectively analyzed 93 patients with RAS (25 bilateral or single functioning kidney) undergoing PTRA. Patients had refractory hypertension (≥3 medications). Blood pressure, antihypertensive drugs and serum-creatinine were compared pre-/post-intervention and at 1 year's follow-up. RESULTS: At 1 year after PTRA of patients with GKI, systolic and diastolic blood pressure were significantly reduced compared to patients with unilateral PTRA (systolic: -19.1 ± 10.5 [bilateral] vs. -11.4 ± 12.1 mmHg [unilateral], P < 0.01; diastolic: -10.1 ± 6.8 mmHg vs. -6.3 ± 6.6 mmHg, P < 0.05). The number of antihypertensive drugs was reduced by -0.8 ± 3.0 at 1 year in patients with GKI, while it increased by +0.1 ± 3.5 in the unilateral RAS group (P < 0.001). Furthermore, post-interventional serum-creatinine decreased by -34.6 ± 31.4 µmol/I after of patients with GKI (P < 0.001 vs. baseline). In patients with unilateral PTRA, a non-significant increase in serum-creatinine was observed (+8.3 ± 2 µmol/l). CONCLUSION: PTRA in patients with GKI led to improved blood pressure and renal function. A large, well-designed, randomized clinical trial targeting this population is still needed. The benefit of PTRA should be measured with the risks in each patient individually.

KCND3 potassium channel gene variant confers susceptibility to electrocardiographic early repolarization pattern.

BACKGROUNDThe presence of an early repolarization pattern (ERP) on the surface ECG is associated with risk of ventricular fibrillation and sudden cardiac death. Family studies have shown that ERP is a highly heritable trait, but molecular genetic determinants are unknown.METHODSTo identify genetic susceptibility loci for ERP, we performed a GWAS and meta-analysis in 2,181 cases and 23,641 controls of European ancestry.RESULTSWe identified a genome-wide significant (P < 5 × 10-8) locus in the potassium voltage-gated channel subfamily D member 3 (KCND3) gene that was successfully replicated in additional 1,124 cases and 12,510 controls. A subsequent joint meta-analysis of the discovery and replication cohorts identified rs1545300 as the lead SNP at the KCND3 locus (OR 0.82 per minor T allele, P = 7.7 × 10-12) but did not reveal additional loci. Colocalization analyses indicate causal effects of KCND3 gene expression levels on ERP in both cardiac left ventricle and tibial artery.CONCLUSIONSIn this study, we identified for the first time to our knowledge a genome-wide significant association of a genetic variant with ERP. Our findings of a locus in the KCND3 gene provide insights not only into the genetic determinants but also into the pathophysiological mechanism of ERP, discovering a promising candidate for functional studies.FUNDINGThis project was funded by the German Center for Cardiovascular Research (DZHK Shared Expertise SE081 - STATS). For detailed funding information per study, see the Supplemental Acknowledgments.

Evaluación multicéntrica del sobredimensionamiento de la prótesis transcatéter SAPIEN 3. Impacto en el fallo del dispositivo y nuevos implantes de marcapasos / Multicenter evaluation of prosthesis oversizing of the SAPIEN 3 transcatheter heart valve. Impact on device failure and new pacemaker implantations

Introducción y objetivos: Para lograr el éxito del dispositivo, se recomienda cierto sobredimensionamiento de la prótesis (SP) SAPIEN 3. Sin embargo, un aumento en el SP puede incrementar las tasas de implante de marcapasos definitivo (IMD). Por lo tanto, se investiga la influencia del SP en el fallo del dispositivo y el IMD. Métodos: Se trató con SAPIEN 3 a 804 pacientes en 3 centros. El SP, determinado mediante tomografía computarizada multicorte, se calculó y analizó como variable continua y categorizada en incrementos del 5%, con -4% a 0 como referencia. Resultados: Se produjo fallo del dispositivo en el 8,8% de los pacientes. La mediana de SP fue menor en los pacientes con fallo del dispositivo que en aquellos con éxito (el +4 frente al +8%; p=0,038). El SP mostró un patrón de riesgo no lineal, con una tasa de fallo del dispositivo significativamente reducida para valores entre el +4 y el +22%. No hubo ningún caso de fuga paravalvular II+ entre un +10 y un +20% de SP. La tasa general de IMD fue del 16,2% y la mediana de SP fue significativamente mayor en los pacientes con IMD (IMD, el +9% frente a no IMD, el +7%; p=0,025), mientras que la profundidad del implante no varió entre pacientes con y sin IMD (6,9+/-1,7 frente a 6,6+/-1,9mm; p=0,101). El riesgo de IMD aumentó con el aumento del SP y fue mayor en las 2 categorías más altas. Conclusiones: El incremento en el SP reduce el riesgo de fallo del dispositivo, pero aumenta el de IMD. No se halló un intervalo de SP ideal para minimizar los riesgos de fallo del dispositivo e IMD

Introduction and objectives: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI. Methods: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with −4% to 0% as reference. Results: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P=.038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9+/-1.7 mm vs 6.6+/-1.9 mm; P=.101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories. Conclusions: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI

Familial Clustering of Cardiac Conduction Defects and Pacemaker Insertion.

BACKGROUND: The etiopathogenesis of electrocardiographic bundle branch and atrioventricular blocks is not fully understood. We investigated familial clustering of cardiac conduction defects and pacemaker insertion in the FHS (Framingham Heart Study). Additionally, we assessed familial clustering of pacemaker insertion in the Danish general population. METHODS: In FHS, we used multivariable-adjusted logistic regression models to investigate the association of parental atrioventricular block (PR interval, ≥0.2 s), complete bundle branch block (QRS, ≥0.12 s), or pacemaker insertion with the occurrence of cardiac conduction abnormalities in their offspring. The Danish nationwide administrative registries were interrogated to assess the relations of parental pacemaker insertion with offspring pacemaker insertion. RESULTS: In FHS (n=371 cases with first-degree atrioventricular block, complete bundle branch block, or pacemaker insertion, and 1471 age- and sex-matched controls), individuals with at least 1 affected parent with a conduction defect had a 1.65-fold odds (odds ratio, 95% CI, 1.32-2.07) for manifesting an atrioventricular block and a 1.62-fold odds (95% CI, 1.08-2.42) for developing a complete bundle branch block. If at least 1 parent had any electrocardiographic conduction defect or pacemaker insertion, the offspring had a 1.62-fold odds (95% CI, 1.31-2.00) for experiencing any of these conditions. In Denmark (n=2 824 199 individuals; 5397 incident pacemaker implantations), individuals with at least 1 first-degree relative with history of pacemaker insertion had a multivariable-adjusted 1.68-fold (incidence rate ratio, 95% CI, 1.49-1.89) risk of undergoing a pacemaker insertion. If the affected relative was ≤45 years of age, the incidence rate ratio was markedly increased to 51.0 (95% CI, 32.7-79.9). CONCLUSIONS: Cardiac conduction blocks and risk for pacemaker insertion cluster within families. A family history of conduction system disturbance or pacemaker insertion should trigger increased awareness of a similar propensity in other family members, especially so when the conduction system disease occurs at a younger age.

Age-related regulation and region-specific distribution of ion channel subunits promoting atrial fibrillation in human left and right atria.

AIMS: Age-induced changes and electrical remodelling are important components of the atrial fibrillation (AF) substrate. To study regional distribution and age-dependent changes in gene expression that may promote AF in human atria. METHODS AND RESULTS: Human left atrial (LA) and right atrial (RA) tissue samples were obtained from donor hearts unsuitable for transplantation and from patients undergoing mitral valve repair. Atrial fibrillation was mimicked in vitro by tachypacing of human atrial tissue slices. Ionic currents were studied by the whole-cell patch-clamp technique; gene expression was analysed by real-time qPCR and immunoblotting. Both healthy RA and RA from older patients showed greater CACNA1c mRNA and CaV1.2 protein expression than LA. No age-dependent changes of Kir2.1 expression in both atria were seen. Remodelling occurred in a qualitatively similar manner in RA and LA. IK1 and Kir2.1 protein expression increased with AF. MiR-1, miR-26a, and miR-26b were down-regulated with AF in both atria. ICa,L was decreased. CACNA1c and CACNA2b expression decreased and miR-328 increased in RA and LA during AF. Ex vivo tachypacing of human atrial slices replicated these findings. There were age-dependent increases in miR-1 and miR-328, while miR-26a decreased with age in atrial tissues from healthy human donor hearts. CONCLUSION: Features of electrical remodelling in man occur in a qualitatively similar manner in both human atria. Age-related miR-328 dysregulation and reduced ICa,L may contribute to increased AF susceptibility with age.

Left ventricular geometry and function in early repolarization: results from the population-based Gutenberg Health Study.

AIMS: The electrocardiographic pattern of early repolarization (ER) is related to increased cardiac mortality in the general population. The pathophysiological basis of ER is largely unknown. We investigated the association of echocardiographic structural and functional parameters of the left ventricle with the presence of ER in the community. METHODS AND RESULTS: The presence of ER (ER+) was assessed in 13,878 participants (mean age 54.6 years, 51.1% women) of the Gutenberg Health Study and related to left ventricular structure and function derived from standard echocardiography. The prevalence of ER was 5.0% (694/13,878), with higher prevalence in men than women (6.6% vs. 3.5%, p < 0.001). In men baseline characteristics differed including a lower BMI and a lower heart rate in ER+ individuals, whereas in women there were only minor differences. Multivariable-adjusted logistic regression analysis in men showed an association of ER with smaller diameters (left-ventricular end-diastolic diameter: OR 0.77 95% CI 0.69-0.86, p < 0.001; left-ventricular end-systolic diameter: OR 0.86 95% CI 0.78-0.95, p = 0.0035), and lower left-ventricular end-diastolic and end-systolic volume (OR 0.72 95% CI 0.65, 0.80, p < 0.001 and OR 0.80 95% CI 0.72, 0.89, p < 0.001). In women, the associations of ER with left ventricular diameters and volumes showed a similar direction, but were not as pronounced. CONCLUSION: In the community, the ER pattern predominantly occurs in men with a low heart rate and a slender habit. Furthermore, ER is not associated with higher left ventricular mass or size but rather with smaller left ventricular diameters and volumes with a regular systolic and diastolic function. Patterns were comparable in women, but less strong.

Multicenter Evaluation of Prosthesis Oversizing of the SAPIEN 3 Transcatheter Heart Valve. Impact on Device Failure and New Pacemaker Implantations.

INTRODUCTION AND OBJECTIVES: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI. METHODS: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with -4% to 0% as reference. RESULTS: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P=.038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9±1.7 mm vs 6.6±1.9 mm; P=.101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories. CONCLUSIONS: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI.

The early repolarization pattern: Echocardiographic characteristics in elite athletes.

BACKGROUND: The electrocardiographic early repolarization (ER) pattern is associated with idiopathic ventricular fibrillation and increased long-term cardiovascular mortality. Whether structural cardiac aberrations influence the phenotype is unclear. Since ER is particularly common in athletes, we evaluated its prevalence and investigated predisposing echocardiographic characteristics and cardiopulmonary exercise capacity in a cohort of elite athletes. METHODS: A total of 623 elite athletes (age 21 ± 5 years) were examined during annual preparticipation screening from 2006 until 2012 including electrocardiography, echocardiography, and exercise testing. ECGs were analyzed with focus on ER. All athletes participated in a clinical follow-up. RESULTS: The prevalence of ER was 17% (108/623). ER-positive athletes were predominantly male (71%, 77/108), showed a lower heart rate (57.1 ± 9.3 bpm versus 60.0 ± 11.2 bpm; p = 0.015) and a higher lean body mass compared to ER-negative participants (88.1% ± 5.6% versus 86.5% ± 6.3%; p = 0.015). Echocardiographic measurements and cardiopulmonary exercise capacity in male and female athletes with and without ER largely showed similar results. Only the notching ER subtype (n = 15) was associated with an increased left atrial diameter (OR 7.01, 95%CI 1.65-29.83; p = 0.008), a higher left ventricular mass (OR 1.02, 95%CI 1.00-1.03; p = 0.038) and larger relative heart volume (OR 1.01, 95%CI 1.00-1.01; p = 0.01). During a follow-up of 7.4 ± 1.5 years, no severe cardiovascular event occurred in the study sample. CONCLUSIONS: In elite athletes presence of ER is not associated with distinct alterations in echocardiography and cardiopulmonary exercise. Athletes presenting with ER are rather male, lean with a low heart rate.

Midazolam addition to analgosedation for pulmonary vein isolation may increase risk of hypercapnia and acidosis.

BACKGROUND: Pulmonary vein isolation (PVI) is generally performed under analgosedation, but sedation protocols vary and no optimal protocol has been defined. We investigated procedural, respiratory and hemodynamic parameters in patients undergoing PVI using analgosedation either with or without midazolam. METHODS: In a prospective observational study, we compared n = 43 consecutive patients (54% male, mean age 62 years) undergoing PVI using analgosedation either with or without midazolam added to propofol and fentanyl. A priori defined outcome measures were propofol dose, hypotension (systolic blood pressure <100 mm Hg or >30 mm Hg drop from baseline), acidosis (pH < 7.30), hypercapnia (pC02 > 55 mm Hg) and hypoxemia (transdermal oxygen saturation < 90%). RESULTS: Patients in the midazolam group (n = 22) received a mean dose of 3 ±â€¯1.5 mg midazolam and required less propofol than those in the no-midazolam group (n = 21, 473 ±â€¯189 mg vs. 618 ±â€¯219 mg, p = .03). Incidence of hypotension did not differ between groups (54.5% vs. 61.9%, p = .63). Acidosis was more frequent in the midazolam group (63.6% vs. 28.6%, p = .03), as was hypercapnia (50% vs. 14.3%, p = .03) while occurrence of hypoxemia did not differ between groups (22.7 vs. 33.3%, p = .5). CONCLUSION: Patients receiving midazolam had a more than doubled risk of respiratory depression as mirrored by hypercapnia and acidosis, but not hypoxemia. These observations may help in choosing an analgosedation and monitoring protocol for PVI.

Safety of Uninterrupted Periprocedural Edoxaban Versus Phenprocoumon for Patients Who Underwent Left Atrial Catheter Ablation Procedures.

Data about the safety of edoxaban in patients who underwent left atrial (LA) radiofrequency (RF) ablation procedures are lacking. This study sought to compare the safety of uninterrupted edoxaban with uninterrupted phenprocoumon administration during LA RF ablation for atrial fibrillation and atrial tachycardia. In total, 231 patients (mean age 64 ± 11years, male 71%) who underwent LA RF ablation under continuous oral anticoagulation (OAC) with edoxaban or phenprocoumon were included in the study. Patients on uninterrupted edoxaban (60 mg or 30 mg/day for at least 4 weeks) were matched for gender, age and type of arrhythmia with 2 patients on uninterrupted phenprocoumon (international normalized ratio 2 to 3). We identified 77 consecutive patients on edoxaban and n = 154 patients on phenprocoumon. Heparin was administered periprocedurally to achieve an activated clotting time of 280 to 300 seconds. No protamine was administered periprocedurally. The primary end point was a composite of bleeding, thromboembolic events, and death. The primary end point was met in 9 patients in the edoxaban group and in 22 patients in the phenprocoumon group (p = 0.69). No patient in either group died or had a thromboembolic complication. No major bleeding complication was observed in the edoxaban group, whereas one was found in 1 patient in the phenprocoumon group (p ≥0.99). Minor bleeding complications occurred in 9 patients (12%) in the edoxaban group and in 21 patients (14%) in the phenprocoumon group (p = 0.84). Uninterrupted OAC with edoxaban appeared to be as safe as uninterrupted OAC with phenprocoumon in patients who underwent LA RF ablation procedures.

Irrigated-tip catheters for radiofrequency ablation of right-sided accessory pathways in adolescents.

BACKGROUND: Catheter ablation of right-sided accessory pathways (APs) has lower success and higher recurrence rates compared to left-sided substrates. Irrigated-tip catheter (ITC) ablation might offer an advantage in this setting but data about its use in patients below 18 years are scarce. The aim of this study was to compare an ITC approach to conventional catheter ablation. METHODS: A retrospective analysis of all patients <18 years undergoing radiofrequency ablation (RFA) for right-sided APs from 2004 to 2014 at our institution was performed. Patients either underwent an ITC approach in combination with 3-D mapping (Group 1; n  =  53) or a conventional non-ITC approach (Group 2; n  =  52). Study endpoints were acute procedural success, safety, and recurrence rate. A total of 105 mostly adolescent patients (56.2% male; median age 14 years) with 107 right-sided APs were included. RESULTS: The prevailing anatomic AP locations were right posteroseptal (44.9%), right anterior/anterolateral (24.3%), and right lateral (13.1%). Acute success (94.3% vs 94.2%) did not differ between the groups. One major complication (pericardial effusion) occurred in the non-ITC group. Overall, freedom from AP recurrence was 94% at 4 years in the ITC group, and 81% at 4 years in the non-ITC group (P  =  0.04). CONCLUSIONS: The use of ITCs in combination with 3-D mapping system for ablation of right-sided APs in adolescents has a high acute success rate, is safe, and associated with a significantly reduced recurrence rate compared to a non-ITC/conventional approach. It might be considered as alternative approach in this age group.