Background The EMPIRE I study assessed the early (30 days) safety and efficacy of a new fully repositionable delivery system (IMPERIA) for the commercially available ALLEGRA transcatheter aortic valve in patients with either severe native aortic stenosis or a degenerated surgical bioprosthesis.Aim To report the final 1-year results of the EMPIRE I study.Methods EMPIRE I is a pre-market, prospective, multi-center, single-arm study conducted at 11 centers in 3 European countries. There were independent data safety and clinical events committees and an independent echocardiographic core laboratory. In this analysis, VARC-3 definitions of all clinical endpoints and echocardiographic parameters were employed.Results The study recruited 121 patients with severe native aortic stenosis and 16 with degenerated surgical bioprosthesis. At 1 year, the incidence of bioprosthetic valve dysfunction in the native population was 5.9%. No patients developed structural valve deterioration or endocarditis, and there were no patients with haemodynamic valve deterioration or bioprosthetic valve failure. In the valve-in-valve sub-group, 2/14 (14.3%) patients had moderate patient prosthesis mismatch at 30 days with no evidence of new bioprosthetic valve dysfunction at 1 year. In the native population, new permanent pacemaker implantation was 14.3% at 30 days and remained unchanged at 1 year. Cardiovascular mortality was 6.8% in the native population and 0% in the valve-in-valve patients. At 1-year, all-cause mortality was 10.8% (95% CI 6.4%-17.8%) in the native aortic stenosis population and 0% in the valve-in-valve patients.Conclusion After 1 year of follow-up, the results of the EMPIRE 1 study show excellent haemodynamic performance, a low rate of bioprosthetic valve dysfunction, and no bioprosthetic valve failure in patients treated with the ALLEGRATM trans-catheter aortic valve implanted using the new IMPERIATM fully repositionable delivery system.
Der demografische Wandel und der Fachkräftemangel stellen das deutsche Gesundheitssystem vor große Herausforderungen. Physician Assistants (PA) können durch die Übernahme delegierbarer ärztlicher Tätigkeiten zur Entlastung des ärztlichen Personals beitragen. Zur Etablierung und zu den Aufgaben von PAs in der deutschen Herzchirurgie liegen bislang nur wenige Daten vor. Ziel dieser Arbeit ist die Analyse ihres Einsatzes und ihrer Aufgabenbereiche. Im Rahmen einer Online-Befragung wurden 83 herzchirurgische Kliniken kontaktiert. Mit einer Rücklaufquote von 65
The prospective, multi-center, randomized CEASE-AF trial previously reported that hybrid ablation with left atrial appendage exclusion (LAAE) improved freedom from atrial arrhythmias by 32% and 33% through 12- and 24-months compared to endocardial catheter ablation in patients with non-paroxysmal atrial fibrillation (AF). In this analysis, we report 3-year outcomes of CEASE-AF. To evaluate long-term safety and effectiveness of de novo hybrid ablation with LAAE compared to endocardial catheter ablation for non-paroxysmal AF Patients 18-75 years of age with no prior ablation who had symptomatic, drug-refractory persistent AF and enlarged left atrium (>4 cm) or longstanding persistent AF (LSPAF) were eligible. Patients were randomized 2:1 to a) staged epicardial-endocardial (hybrid) ablation to achieve left atrial posterior wall (LAPW) and pulmonary vein isolation (PVI) as well as LAAE or b) endocardial catheter ablation, including repeat ablation with 180 days of the index procedure, to achieve PVI. Effectiveness was freedom from AF, atrial flutter (AFL), or atrial tachycardia (AT) off anti-arrhythmic drugs (AADs) except previously failed AADs at same or lower dose. Rhythm was assessed by 48-hr Holter and adjudicated by an independent core laboratory. The safety endpoint was major complication rate adjudicated by an independent clinical events committee. Reinterventions could include repeat ablations (including epicardial crossover), electrical or pharmaceutical cardioversion, implantation of a permanent pacemaker or implantable cardioverter defibrillator, or other interventions. 102 patients were in the Hybrid Arm and 52 in the Catheter Arm, with similar baseline characteristics. Mean age was 60.7±7.9 years, mean LAD was 4.7±0.4 cm, 74% were male, and 19% had LSPAF. Through 36-months, effectiveness was 61.1% (58/95) in the Hybrid Arm and 27.5% (14/51) in the Catheter Arm (p<0.001), an absolute difference of 33.6% (95% CI: 15.9%-48.5%). In patients with persistent AF, effectiveness was 61.0% (47/77) in the Hybrid Arm and 32.6% (14/43) in the Catheter Arm (p=0.003). In patients with LSPAF, effectiveness was 61.1% (11/18) in the Hybrid Arm and 0% (0/8) in the Catheter Arm (p=0.007). Through 36-mo, safety rates were 12.7% (13/102) and 9.6% (5/52) in the Hybrid and Catheter Arms, respectively (p=0.79). Safety and effectiveness across the trial duration are shown in the Figures. In the Hybrid Arm, 28.4% (27/95) of patients had a reintervention through 36-mo, compared to 56.9% (29/51) in the Catheter Arm (p<0.001). In CEASE-AF, the rhythm control benefit of a hybrid ablation approach exceeded that of an endocardial-only approach for non-paroxysmal AF, and this effect was durable through 36-months without significantly increasing complications.Efficacy Complications
OBJECTIVES:This study investigated the gnder-based difference in three-year clinical outcomes, left ventricular (LV) regression, and quality-of-life (QoL) following surgical aortic valve replacement (SAVR) by propensity score matching (PSM). METHODS:A prospective multicentre study on combined data from two prospective registries, INDURE and IMPACT, resulted in 993 patients (735 males and 258 females). PSM yielded 689 patients: 442 males and 247 females undergoing first-time SAVR using Edwards INSPIRIS RESILIA. RESULTS:In the PSM cohort, females had lower body mass index (median 27.9 vs 28.6 kg/m2; P = 0.004), higher European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (2.4 ± 3.0 % vs 1.8 ± 1.9 %; P < 0.001), Society of Thoracic Surgeons (STS) score (1.8 ± 1.7 % vs 1.3 ± 2.0 %; P < 0.001) and were most often in New York Heart Association class III/IV (45.7 % vs 37.6 %; P < 0.021), angina CCS class III/IV (6.1 % vs 2.9 %; P < 0.001) than males. Post-SAVR clinical outcomes up to three years were similar between both genders. Significant differences existed for LV regression after surgery between genders at up to three years (P < 0.001) with better haemodynamic performance. Hypertension slowed the LV mass regression, mildly affecting LV restoration in females for up to three years. In both genders, New York Heart Association status was restored within one year (P < 0.001) and maintained for up to three years (P < 0.001). At three years, QoL significantly improved. CONCLUSIONS:Despite females presenting with a significantly higher surgical risk profile, three-year outcomes following SAVR were comparable between genders with significant improvement in functional status. However, the degree of QoL improvement differed between genders. CLINICAL TRIAL REGISTRATION NUMBER:ClinicalTrials.gov NCT04053088/-NCT03666741.
