Background: Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes. Methods: We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group. Results: A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; P <0.001). There were 5 major complications with 3 vascular lacerations all occurring in zone 2 in the study. Conclusions: Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03772704.

Background: The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval™ (MM) transcatheter heart valve (THV) system for the treatment of severe symptomatic aortic valve stenosis. The MM THV is a novel balloon-expandable valve with an expanded sizing matrix. Contemporary patients undergoing TAVI with the established Edwards Sapien™ (ES) THV served as the comparator group. Methods: Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 ± 6.7 years; EuroScore II 4.7 ± 4.8) underwent TAVI with an MM (95% transfemoral) for severe aortic stenosis at six German tertiary care centers. Results: Correct positioning of the THV was achieved in 98.5% (n = 132). Mean aortic gradients (MPG) were reduced from 42 ± 14 mmHg to 11 ± 5 mmHg. Mild postprocedural paravalvular leak (PVL) was observed in 62% (n = 82) patients, whereas only one patient had more than mild PVL. New permanent pacemaker implantation (PPI) was indicated in 15 patients (11%). Major vascular complications occurred in 6.7% (n = 9) patients. The in-hospital combined incidence of all-cause death and stroke was 4.5% (n = 6). In the comparator group that included 268 patients, the 30-day incidences of PPI, major vascular complications, and the composite of all-cause death and stroke were 16%, 1.9%, and 7.1%, respectively; MPGs were reduced from 44 ± 15 mmHg to 12.8 ± 4.6 mmHg and the more than mild PVL occurred in 0.7%. Conclusions: The MM is a promising novel THV system, with performance comparable to the established ES THVs. These findings await confirmation by ongoing randomized trials.

Anorexia nervosa is a potentially life-threatening eating disorder, characterized by an abnormally low body weight. This case report illustrates a 22-year old female with cardiac arrest due to a refeeding syndrome in a patient with anorexia nervosa. It features the successful use of extracorporeal cardiopulmonary resuscitation in a case of severe left ventricular dysfunction resulting in a favorable outcome. Conclusion. We present the first case of a cardiac arrest due to a refeeding syndrome in anorexia nervosa featuring the successful use of an extracorporeal cardiopulmonary resuscitation approach as a bridge to full recovery.

Background: The number of young patients receiving ICDs or CRT-Ds has been increasing in recent decades and understanding the key characteristics of this special population is paramount to optimized patient care. Methods: The DEVICE I+II registry prospectively enrolled patients undergoing ICD/CRT-D implantation or revision from 50 German centers between 2007 and 2014 Data on patient characteristics, procedural outcome, adverse events, and mortality during the initial stay and 1-year follow-up were collected. All patients under the age of 45 years were identified and included in a comparative analysis with the remaining population. Results: A total number of 5313 patients were enrolled into the registry, of which 339 patients (6.4%) were under the age of 45 years. Mean age was 35.0 ± 8.2 vs. 67.5 ± 9.7 years, compared to older patients (≥45 years). Young patients were more likely to receive an ICD (90.9 vs. 69.9%, p < 0.001) than a CRT-D device (9.1 vs. 30.1%). Coronary artery disease was less common in younger patients (13.6 vs. 63.9%, p < 0.001), whereas hypertrophic cardiomyopathy (10.9 vs. 2.7%, p < 0.001) and primary cardiac electrical diseases (11.2 vs. 1.5%, p < 0.001) were encountered more often. Secondary preventive ICD was more common in younger patients (51.6 vs. 39.9%, p < 0.001). Among those patients, survival of sudden cardiac death (66.7 vs. 45.4%, p < 0.001) due to ventricular fibrillation (60.6 vs. 37.9%, p < 0.001) was the leading cause for admission. There were no detectable differences in postoperative complications requiring intervention (1.5 vs. 1.9%, p = 0.68) or in-hospital mortality (0.0 vs. 0.3%, p = 0.62). Median follow-up duration was 17.9 [13.4–22.9] vs. 16.9 [13.1–23.1] months (p = 0.13). In younger patients, device-associated complications requiring revision were more common (14.1 vs. 8.3%, p < 0.001) and all-cause 1-year-mortality after implantation was lower (2.9 vs. 7.3%, p = 0.003; HR 0.39, 95%CI: 0.2–0.75) than in older patients. Conclusions: Young patients < 45 years of age received defibrillator therapy more often for secondary prevention. Rates for periprocedural complications and in-hospital mortality were very low and without differences between groups. Young patients have lower mortality during follow-up but experienced a higher rate of postoperative complications requiring revision, potentially due to a more active lifestyle.

Background: Transvenous lead extraction (TLE) in patients with cardiac implantable electronic devices has become a well-established therapy for patients with lead complications. However, there is limited information on specific outcomes for patients with right-sided leads compared to patients with left-sided leads undergoing TLE. Aim: The aim of this study was to analyze patient characteristics, procedural outcomes as well as adverse events and mortality of patients with right-sided leads undergoing TLE with the excimer laser sheath as a first line therapy. Methods: We performed a subgroup analysis of all reported patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) with unilateral right-sided leads (Group 1) or unilateral left-sided leads (Group 2). Results: 2438 patients with unilateral leads were analyzed. 750 patients were in Group 1 and 1688 patients were in Group 2. Patients in Group 1 were older (71.1 ± 13.9 vs. 66.5 ± 13.6; p < 0.001), more patients were female (31.7% vs. 22.1%, p < 0.001), had a lower body-mass-index (26.8 ± 4.5 vs. 27.2 ± 4.7; p=0.03) and more patients were pacemaker dependent (44.9% vs. 25.4%, p< 0.001). The primary indication for TLE was local infection (46.0% vs. 30.6%, p< 0.001) in Group 1 and lead dysfunction (20.0% vs. 36.1%, p< 0.0001) in Group 2. The frequency of TLE for systemic infection was indifferent between groups (28.9% vs. 27.6%, p=0.532). The most common device to be extracted were pacemakers (80.1% vs. 22.7%, p< 0.001) in Group 1 and implantable cardioverter-defibrillators (ICD) (9.7 vs. 45.3%, p< 0.001) and cardiac resynchronization therapy devices (CRT) (9.6 vs. 31.5%); p< 0.001) in Group 2. The mean number of total leads was not different between groups (2.4 ± 0.9 for Group 1 vs. 2.3 ± 1.0 for Group 2; p=0.98), however median lead dwell time (120 vs. 85 months, p< 0.001), patients with abandoned leads (32.0% vs. 25.9%; p=0.0022) and the use of additional extraction tools (8.4% vs. 5.7%, p=0.016) were significantly higher in Group 1. Patients with right-sided leads had a longer median hospital stay (10 vs. 9 [5; 15] p=0.001). Complete procedural success was higher in patients Group 2 (89.1 vs. 93.1%, p=0.001) but there was no difference in clinical success rates (97.7% vs. 98.0%, p=0.74). There was no difference in overall complication rates (4.3% vs. 4.2%, p=0.945). Neither procedure related mortality (0.3% vs. 0.7%, p=0.2940) nor all-cause mortality (3.5% vs. 3.4%, p=0.9101) differed between groups. Conclusion: TLE procedures in patients with right-sided leads showed a lower procedural success rate and a higher need of additional tools. This patient group was older, more often pacemaker dependent and had a higher number of abandoned leads. Despite different patient and lead characteristics, there were no differences in clinical success-rates, procedure related complications or all-cause mortality between groups.

Background: The incidence of cardiac implantable electronic device (CIED)-related complications, as well as the prevalence of obesity, is rising worldwide. Transvenous laser lead extraction (LLE) has grown into a crucial therapeutic option for patients with CIED-related complications but the impact of obesity on LLE is not well understood. Methods and Results: All patients (n = 2524) from the GermAn Laser Lead Extraction RegistrY (GALLERY) were stratified into five groups according to their body mass index (BMI, <18.5; 18.5–24.9; 25–29.9; 30–34.9; ≥35 kg/m²). Patients with a BMI ≥ 35.0 kg/m² had the highest prevalence of arterial hypertension (84.2%, p < 0.001), chronic kidney disease (36.8%, p = 0.020) and diabetes mellitus (51.1%, p < 0.001). The rates for procedural minor (p = 0.684) and major complications (p = 0.498), as well as procedural success (p = 0.437), procedure-related (p = 0.533) and all-cause mortality (p = 0.333) were not different between groups. In obese patients (BMI ≥ 30 kg/m²), lead age ≥10 years was identified as a predictor of procedural failure (OR: 2.99; 95% CI: 1.06–8.45; p = 0.038). Lead age ≥10 years (OR: 3.25; 95% CI: 1,31–8.10; p = 0.011) and abandoned leads (OR: 3.08; 95% CI: 1.03–9.22; p = 0.044) were predictors of procedural complications, while patient age ≥75 years seemed protective (OR: 0.27; 95% CI: 0.08–0.93; p = 0.039). Systemic infection was the only predictor for all-cause mortality (OR: 17.68; 95% CI: 4.03–77.49; p < 0.001). Conclusions: LLE in obese patients is as safe and effective as in other weight classes, if performed in experienced high-volume centers. Systemic infection remains the main cause of in-hospital mortality in obese patients.