Partial versus Complete Sternotomy for Aortic Valve Replacement-Multicenter Study.

BACKGROUND: The benefits of minimally invasive techniques in cardiac surgery remain poorly defined. We evaluated the short- and mid-term outcomes after surgical aortic valve replacement through partial upper versus complete median sternotomy (MS) in a large, German multicenter cohort. METHODS: A total of 2,929 patients underwent isolated surgical aortic valve replacement via partial upper sternotomy (PUS, n = 1,764) or MS (n = 1,165) at nine participating heart centers between 2016 and 2020. After propensity-score matching, 1,990 patients were eligible for analysis. The primary end point was major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction, and stroke at 30 days and in follow-up, up to 5 years. Secondary end points were acute kidney injury, length of hospital stay, transfusions, deep sternal wound infection, Dressler's syndrome, rehospitalization, and conversion to sternotomy. RESULTS: Unadjusted MACCE rates were significantly lower in the PUS group both at 30 days (p = 0.02) and in 5-year follow-up (p = 0.01). However, after propensity-score matching, differences between the groups were no more statistically significant: MACCE rates were 3.9% (PUS) versus 5.4% (MS, p = 0.14) at 30 days, and 9.9 versus 11.3% in 5-year follow-up (p = 0.36). In the minimally invasive group, length of intensive care unit (ICU) stay was shorter (p = 0.03), Dressler's syndrome occurred less frequently (p = 0.006), and the rate of rehospitalization was reduced significantly (p < 0.001). There were 3.8% conversions to full sternotomy. CONCLUSION: In a large, German multicenter cohort, MACCE rates were comparable in surgical aortic valve replacement through partial upper and complete sternotomies. Shorter ICU stay and lower rates of Dressler's syndrome and rehospitalization were in favor of the partial sternotomy group.

Procedural outcome & risk prediction in young patients undergoing transvenous lead extraction-a GALLERY subgroup analysis.

Background: The prevalence of young patients with cardiac implantable electronic devices (CIED) is steadily increasing, accompanied by a rise in the occurrence of complications related to CIEDs. Consequently, transvenous lead extraction (TLE) has become a crucial treatment approach for such individuals. Objective: The purpose of this study was to examine the characteristics and procedural outcomes of young patients who undergo TLE, with a specific focus on identifying independent risk factors associated with adverse events. Methods: All patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) were categorized into two groups based on their age at the time of enrollment: 45 years or younger, and over 45 years. A subgroup analysis was conducted specifically for the younger population. In this analysis, predictor variables for all-cause mortality, procedural complications, and procedural failure were evaluated using multivariable analyses. Results: We identified 160 patients aged 45 years or younger with a mean age of 35.3 ± 7.6 years and 42.5% (n = 68) female patients. Leading extraction indication was lead dysfunction in 51.3% of cases, followed by local infections in 20.6% and systemic infections in 16.9%. The most common device to be extracted were implantable cardioverter-defibrillators (ICD) with 52.5%. Mean number of leads per patient was 2.2 ± 1.0. Median age of the oldest indwelling lead was 91.5 [54.75-137.5] months. Overall complication rate was 3.8% with 1.9% minor and 1.9% major complications. Complete procedural success was achieved in 90.6% of cases. Clinical procedural success rate was 98.1%. Procedure-related mortality was 0.0%. The all-cause in-hospital mortality rate was 2.5%, with septic shock identified as the primary cause of mortality. Multivariable analysis revealed CKD (OR: 19.0; 95% CI: 1.84-194.9; p = 0.018) and systemic infection (OR: 12.7; 95% CI: 1.14-142.8; p = 0.039) as independent predictor for all-cause mortality. Lead age ≥ 10 years (OR: 14.58, 95% CI: 1.36-156.2; p = 0.027) was identified as sole independent risk factor for procedural complication. Conclusion: TLE in young patients is safe and effective with a procedure-related mortality rate of 0.0%. CKD and systemic infection are predictors for all-cause mortality, whereas lead age ≥ 10 years was identified as independent risk factor for procedural complications in young patients undergoing TLE.

Transvenous lead extraction of implantable cardioverter-defibrillators: A comprehensive outcome-and risk factor analysis.

BACKGROUND: Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising amongst patients with transvenous implantable-cardioverter-defibrillator (ICD). OBJECTIVES: Aim of this study was to characterize the procedural outcome and risk-factors of patients with indwelling 1- and 2-chamber ICD undergoing TLE. METHODS: We conducted a subgroup analysis of all ICD patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for procedural failure and all-cause mortality were assessed. RESULTS: We identified 842 patients with an ICD undergoing TLE with the mean age of 62.8 ± 13.8 years. A total number of 1610 leads were treated with lead dysfunction (48.5%) as leading indication for extraction, followed by device-related infection (45.4%). Lead-per-patient ratio was 1.91 ± 0.88 and 60.0% of patients had dual-coil defibrillator leads. Additional extraction tools, such as mechanical rotating dilator sheaths and snares were utilized in 6.5% of cases. Overall procedural complications occurred in 4.3% with 2.0% major complications and a procedure-related mortality of 0.8%. Clinical success rate was 97.9%. All-cause in-hospital mortality was 3.4%, with sepsis being the leading cause for mortality. Multivariate analysis revealed lead-age ≥10 years (OR:5.82, 95%CI:2.1-16.6; p = .001) as independent predictor for procedural failure. Systemic infection (OR:9.57, 95%CI:2.2-42.4; p < .001) and procedural complications (OR:8.0, 95%CI:2.8-23.3; p < .001) were identified as risk factors for all-cause mortality. CONCLUSIONS: TLE is safe and efficacious in patients with 1- and 2-chamber ICD. Although lead dysfunction is the leading indication for extraction, systemic device-related infection is the main driver of all-cause mortality for ICD patients undergoing TLE.

Laser lead extraction in octo- and nonagenarians. A subgroup analysis from the GALLERY registry.

INTRODUCTION: In an aging population with cardiac implantable electronic devices, an increasing number of octo- and even nonagenarians present for lead extraction procedures. Those patients are considered at increased risk for surgical procedures including lead extraction. Here, we investigated safety and efficacy of transvenous lead extraction in a large patient cohort of octo- and nonagenarians. METHODS AND RESULTS: A subgroup analysis of all patients aged ≥80 years (n = 499) in the German Laser Lead Extraction Registry (GALLERY) was performed. Outcomes were compared to the nonoctogenarians from the registry. Primary extraction method was Laser lead extraction, with additional use of mechanical rotational sheaths or femoral snares, if necessary. An analysis of patient- and device characteristics, as well as an assessment of predictors for adverse events via multivariate analyses was conducted. Mean patients age was 84.3 ± 3.7 years in the octogenarians group and 64.1 ± 12.4 years in the nonoctogenarians group. The median lead dwell time was 118.0 months (78; 167) and 92.0 months [60; 133], p < .001 in the octogenarians and nonoctogenarians group, respectively. Clinical procedural success rate was achieved in 97.6% of the cases in octogenarians and 97.9% in nonoctogenarians (p = .70). Overall complication rate was 4.4% in octogenarians and 4.3% in nonoctogenarians (0.91). In octogenarians procedure-related mortality was 0.8% and all-cause in-hospital mortality was 5.4%, while in nonoctogenarians, procedure related and all-cause in-hospital mortality were 0.5% and 3.1%, respectively. A body mass index (BMI) <20 kg/m2 , was the only statistically significant predictor for procedure-related complications in octogenarians, while systemic infection, BMI ≤20 kg/m2 , procedural complications and chronic kidney disease were predictors for in-hospital mortality. CONCLUSIONS: Laser lead extraction in octo- and nonagenarians is safe and effective. BMI ≤20 kg/m2 was the only statistically significant predictor for procedural complications. According to our data, advanced age should not be considered as contraindication for laser lead extraction.

Safety and Efficacy of Excimer Laser Powered Lead Extractions in Obese Patients: A GALLERY Subgroup Analysis.

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.

Think outside the box: a case report of utilization of an excimer laser sheath as an intracardiac bioptome.

Background: Malignant cardiac tumours are rare entities that cause severe morbidity and mortality. Possible treatment options vary between surgical removement, (immuno-) chemotherapy, and palliative care, whilst diagnostic workup comprises of imaging and histopathology analysis. Excimer laser sheaths are a new possibility to extract significant tissue samples to offer adequate treatment. Case summary: A 67-year-old Caucasian female presented with progressive shortness of breath, new onset of fevers, weight loss, and recurrent night sweats. She showed signs of upper venous stasis.Cardiac imaging revealed an obstructive, hypoperfused right atrial mass superior to the tricuspid valve and a sessile structure at the mitral valve. Guideline-directed therapy for endocarditis was started subsequently.A conventional intracardiac biopsy of the tumour was unsuccessful, but an off-label approach using an excimer laser sheath as bioptome leads to the diagnosis of a diffuse large B-cell lymphoma. Immuno-chemotherapy was commenced, leading to reduction in tumour size and rapid improvement in the quality of life. Discussion: Intracardiac biopsies are an important piece of the puzzle in the diagnostic workup of cardiac neoplasms. This case report is the first description of the utilization of a laser lead extraction tool as a bioptome for intracardiac tumours. Two imaging modalities (echocardiogram, fluoroscopy), as well as the precise technique of the excimer laser, ensured safety for the patient. Clinical studies are paramount to further evaluate the laser sheath as a possible new instrument in the toolbox of an interventional cardiologist.

Transvenous lead extraction in patients with systemic cardiac device-related infection-Procedural outcome and risk prediction: A GALLERY subgroup analysis.

BACKGROUND: Transvenous lead extraction (TLE) has evolved as one of the most crucial treatment options for patients with cardiac device-related systemic infection (CDRSI). OBJECTIVE: The aim of this study was to characterize the procedural outcome and risk factors of patients with CDRSI undergoing TLE. METHODS: A subgroup analysis of patients with CDRSI of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was performed. Predictors for complications, procedural failure, and all-cause mortality were evaluated. RESULTS: A total of 722 patients (28.6%) in the GALLERY had "systemic infection" as extraction indication. Patients with CDRSI were older (70.1 ± 12.2 years vs 67.3 ± 14.3 years; P < .001) and had more comorbidities than patients with local infections or noninfectious extraction indications. There were no differences in complete procedural success (90.6% vs 91.7%; P = .328) or major complications (2.5% vs 1.9%; P = .416) but increased procedure-related (1.4% vs 0.3%; P = .003) and all-cause in-hospital mortality (11.1% vs 0.6%; P < .001) for patients with CDRSI. Multivariate analyses revealed lead age ≥10 years as a predictor for procedural complications (odds ratio [OR] 3.23; 95% confidence interval [CI] 1.58-6.60; P = .001). Lead age ≥10 years (OR 2.57; 95% CI 1.03-6.46; P = .04) was also a predictor for procedural failure. We identified left ventricular ejection fraction <30% (OR 1.70; 95% CI 1.00-2.99; P = .049), age ≥75 years (OR 2.1; 95% CI 1.27-3.48; P = .004), chronic kidney disease (OR 1.92; 95% CI 1.17-3.14; P = .01), and overall procedural complications (OR 5.15; 95% CI 2.44-10.84; P < .001) as predictors for all-cause mortality. CONCLUSION: Patients with CDRSI undergoing TLE demonstrate an increased rate of all-cause in-hospital, as well as procedure-related mortality, despite having comparable procedural success rates. Given these data, it seems paramount to develop preventive strategies to detect and treat CDRSI in its earliest stages.

Infection remediation after septic device extractions: analysis of three treatment strategies including a 1-year follow-up.

Introduction: In CIED infections, all device material needs to be removed. But, especially in pacemaker-dependent patients it is often not possible to realize a device-free interval for infection remediation. In those patients, different treatment options are available, however the ideal solution needs still to be defined. Methods: This retrospective analysis includes 190 patients undergoing CIED extractions due to infection. Three different treatment algorithms were analyzed: Group 1 included 89 patients with system removal only (System removal group). In Group 2, 28 patients received an epicardial electrode during extraction procedure (Epicardial lead group) while 78 patients in group 3 (contralateral reimplantation group) received implantation of a new system contralaterally during extraction procedure. We analyzed peri- and postoperative data as well as 1-year outcomes of the three groups. Results: Patients in the system removal and epicardial lead groups were significantly older, had more comorbidities, and suffered more frequently from systemic infections than those in contralateral reimplantation group. Lead extraction procedures had comparable success rates: 95.5%, 96.4%, and 93.2% of complete lead removal in the System removal, Epicardial Lead, Contralateral re-implantation group respectively. Device reimplantation was performed in all patients in Epicardial lead and Contralateral reimplantation group, whereas only 49.4% in System removal group received device re-implantation. At 1-year follow-up, freedom from infection and absence of pocket irritation were comparable for all groups (94.7% Contralateral reimplantation group and Epicardial lead group, 100% System removal group). No procedure-related mortality was observed, whereas 1-year mortality was 3.4% in System removal group, 4.1% in Contralateral re-implantation group and 21.4% in Epicardial lead group (p < 0.001). Conclusion: In patients with CIED infection, systems should be removed completely and reimplanted after infection remediation. In pacemaker-dependent patients, simultaneous contralateral CIED re-implantation or epicardial lead placement may be performed, depending on route, severity and location of infection.

A Simplified Approach to Pulmonary Vein Visualization during Cryoballoon Ablation of Atrial Fibrillation.

Background and Objectives: Selective pulmonary vein (PV) angiography has been established as the gold standard for PV visualization in cryoballoon (CB)-based pulmonary vein isolation (PVI). We sought to simplify this approach to reduce procedural complexity and radiation exposure. Materials and Methods: Patients with paroxysmal and recently diagnosed persistent AF undergoing CB-based PVI from January 2015 to December 2017 were retrospectively analyzed. Patients underwent either selective PV angiography or conventional left atrial (LA) angiography for PV visualization. Results: A total of 336 patients were analyzed. A total of 87 patients (26%) received PV angiography and 249 (74%) LA angiography. LA angiography required fewer cine-sequences for PV visualization, translating into a significant reduction in procedure duration, fluoroscopy time and dose area product. Additionally, less contrast medium was utilized. PV occlusion by the CB, CB temperature and time to isolation showed no significant differences. The number of CB applications and total application time (LA angiography: 1.4 ± 0.02 vs. PV Angiography: 1.6 ± 0.05; p < 0.0001; LA angiography: 297.9 ± 4.62 vs. PV-Angiography: 348.9 ± 11.03; p < 0.001, respectively) per vein were slightly but significantly higher in the PV angiography group. We observed no difference in late AF recurrence (24.7% LA angiography vs. 21.3% PV angiography; p = 0.2657). Conclusions: A simplified protocol, using LA angiography for PV visualization, entails a reduction in procedure time and radiation exposure while equally maintaining procedural efficiency and safety in both groups.

Atrial Fibrillation and Transvenous Lead Extraction-A Comprehensive Subgroup Analysis of the GermAn Laser Lead Extraction RegistrY (GALLERY).

Background: Atrial fibrillation is the most common arrhythmia and has been described as driver of cardiovascular morbidity and risk factor for cardiac device-related complications, as well as in transvenous lead extraction (TLE). Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with atrial fibrillation (AF) undergoing TLE. Methods: We performed a subgroup analysis of all AF patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for all-cause mortality were assessed. Results: A total number of 510 patients with AF were identified with a mean age of 74.0 ± 10.3 years. Systemic infection (38.4%) was the leading cause for TLE, followed by local infection (37.5%) and lead dysfunction (20.4%). Most of the patients (45.9%) presented with pacemaker systems to be extracted. The total number of leads was 1181 with a 2.3 ± 0.96 leads/patient. Clinical procedural success was achieved in 97.1%. Occurrence of major complications was 1.8% with a procedure-related mortality of 1.0%. All-cause mortality was high with 5.9% and septic shock being the most common cause. Systemic device infection (OR: 49.73; 95% CI: 6.56−377.09, p < 0.001), chronic kidney disease (CKD; OR: 2.67; 95% CI: 1.01−7.03, p = 0.048) and a body mass index < 21 kg/m2 (OR: 6.6; 95% CI: 1.68−25.87, p = 0.007) were identified as independent predictors for all-cause mortality. Conclusions: TLE in AF patients is effective and safe, but in patients with systemic infection the mortality due to septic shock is high. Systemic infection, CKD and body mass index <21 kg/m2 are risk factors for death in patient with AF undergoing TLE.

Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction.

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.

Sleep apnea predicts cardiovascular death in patients with Marfan syndrome: a cohort study.

Background: Surgical replacement of the aortic root is the only intervention that can prevent aortic dissection and cardiovascular death in Marfan syndrome (MFS). However, in some individuals, MFS also causes sleep apnea. If sleep apnea predicts cardiovascular death, a new target for predictive, preventive, and personalized medicine (PPPM) may emerge for those individuals with MFS who have sleep apnea. Methods: This is an investigator-initiated study with long-term follow-up data of 105 individuals with MFS. All individuals were screened for sleep apnea regardless of symptoms. Cardiovascular death served as a primary endpoint, and aortic events as a secondary outcome. Results: Sleep apnea with an apnea-hypopnea index (AHI) > 5/h was observed in 21.0% (22/105) with mild sleep apnea in 13% (14/105) and moderate to severe sleep apnea in 7.6% (8/105). After a median follow-up of 7.76 years (interquartile range: 6.84, 8.41), 10% (10/105) had died, with cardiovascular cause of death in 80% (8/10). After adjusting for age and body mass index (BMI), the AHI score emerged as an independent risk factor for cardiovascular death (hazard ratio 1.712, 95% confidence interval [1.061-2.761], p = 0.0276). The secondary outcome of aortic events occurred in 33% (35/105). There was no effect of the AHI score on aortic events after adjusting for age and BMI (hazard ratio 0.965, 95% confidence interval [0.617-1.509]), possibly due to a high number of patients with prior aortic surgery. Interpretation: Sleep apnea is emerging as an independent predictor of cardiovascular death in MFS. It seems mandatory to screen all individuals with MFS for sleep apnea and to include these individuals, with both MFS and sleep apnea, in further studies to evaluate the impact of preventive measures with regard to cardiovascular death. Supplementary Information: The online version contains supplementary material available at 10.1007/s13167-022-00291-4.

The GermAn Laser Lead Extraction RegistrY: GALLERY.

AIMS: The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. METHODS AND RESULTS: Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. CONCLUSION: In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Age-related differences and associated mid-term outcomes of subcutaneous implantable cardioverter-defibrillators: A propensity-matched analysis from a multicenter European registry.

BACKGROUND: A few limited case series have shown that the subcutaneous implantable cardioverter-defibrillator (S-ICD) system is safe for teenagers and young adults, but a large-scale analysis currently is lacking. OBJECTIVES: The purpose of this study was to compare mid-term device-associated outcomes in a large real-world cohort of S-ICD patients, stratified by age at implantation. METHODS: Two propensity-matched cohorts of teenagers + young adults (≤30 years old) and adults (>30 years old) were retrieved from the ELISIR Registry. The primary outcome was the comparison of inappropriate shock rate. Complications, freedom from sustained ventricular arrhythmias, and overall and cardiovascular mortality were deemed secondary outcomes. RESULTS: Teenagers + young adults represented 11.0% of the entire cohort. Two propensity-matched groups of 161 patients each were used for the analysis. Median follow-up was 23.1 (13.2-40.5) months. In total, 15.2% patients experienced inappropriate shocks, and 9.3% device-related complications were observed, with no age-related differences in inappropriate shocks (16.1% vs 14.3%; P = .642) and complication rates (9.9% vs 8.7%; P = .701). At univariate analysis, young age was not associated with increased rates of inappropriate shocks (hazard ratio [HR] 1.204 [0.675-2.148]: P = .529). At multivariate analysis, use of the SMART Pass algorithm was associated with a strong reduction in inappropriate shocks (adjusted HR 0.292 [0.161-0.525]; P <.001), whereas arrhythmogenic right ventricular cardiomyopathy (ARVC) was associated with higher rates of inappropriate shocks (adjusted HR 2.380 [1.205-4.697]; P = .012). CONCLUSION: In a large multicenter registry of propensity-matched patients, use of the S-ICD in teenagers/young adults was safe and effective. The rates of inappropriate shocks and complications between cohorts were not significantly different. The only predictor of increased inappropriate shocks was a diagnosis of ARVC.

Impact of obesity on acute complications of catheter ablation for cardiac arrhythmia.

INTRODUCTION: The prevalence of obesity is increasing. However, data on the periprocedural complication rate of catheter ablation for arrhythmia in patients stratified by body mass index (BMI) are scarce. METHODS: This study included 1000 consecutive patients (age 62.0 ± 14.4 years) undergoing catheter ablation for cardiac arrhythmia. The primary study endpoint was any periprocedural major complication (cardiac tamponade, pseudoaneurysm, arteriovenous fistula, transient ischemic attack, stroke, valve damage, myocardial infarction, or death). RESULTS: The mean BMI was 27.6 ± 5.1 kg/m2 and the majority of patients were overweight (BMI 25.0-29.9 kg/m2 , 43.4%). A BMI of 30.0-34.9 kg/m2 (Class I obesity) was present in 177 (17.7%) of patients, a BMI of 35.0-39.9 kg/m2 (Class II obesity) in 67 (6.7%), and a BMI ≥ 40 kg/m2 (Class III obesity) in 16 (1.6%). There were 31 major complications (3.1%) and one fatality (0.1%) due to terminal heart failure in a patient undergoing palliative ventricular tachycardia ablation. There was no significant impact of the BMI on the rate of major complications (p = .495). Compared to normal weight patients, odds ratios for complications in overweight patients, as well as Class I, II, and III obesity were 1.1 (95% confidence interval (CI): 0.8, 1.7), 1.3 (CI: 0.6, 2.6), 1.4 (CI: 0.5, 4.1), and 1.6 (CI: 0.4, 6.3), respectively. Radiation exposure and procedure duration were significantly increased in obese patients (p < .001 and p = .001, respectively). CONCLUSION: In this study, obesity did not have a significant impact on the incidence of periprocedural complications after CA for cardiac arrhythmia.

Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience.

BACKGROUND: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. OBJECTIVE: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. METHODS: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. RESULTS: A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors. CONCLUSION: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.

Comprehensive echocardiographic prediction of postprocedural transmitral pressure gradient following transcatheter mitral valve repair.

Iatrogenic mitral stenosis following transcatheter mitral valve repair (TMVR) for relevant mitral regurgitation (MR) is a potential adverse side-effect, known to affect long-term outcome. However, only few determinants of an elevated mean transmitral pressure gradient (TMPG) have been described thus far. We sought to develop an integrative model for the prediction of TMPG following MitraClip (MC) therapy. From 01/2013 to 03/2017, a total of 175 consecutive patients were successfully (MR ≤ 2 + at discharge) treated with a MitraClip implantation at our centre. Of these, a total of 148 patients (54% male, 77.0 ± 6.0 years, 58% with secondary MR) had complete echocardiographic data sets comprising pre- and postinterventional two- and three-dimensional transthoracic (TTE) and transoesophageal (TOE) echocardiograms. Comprehensive studies of predefined parameters were performed. An expert-based prediction model including preprocedural variables (annular ellipticity, mitral valve commissure-to-commissure diameter, preprocedural transmitral pressure gradient and MR aetiology) was set up and validated with a total of 200 bootstrap samples. A nomogram was developed to predict the postprocedural TMPG based on selected echocardiographic variables. Introduction of nomogram-based guiding of MC therapy could help identify patients at risk for postprocedural mitral stenosis, have an influence on preprocedural patient selection and intraprocedural decision making.

Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.

BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). CONCLUSIONS: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.