Objective: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). Methods: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6–67.0) and was completed in 91.2% (177/194) of patients. Results: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76–0.70]) and 56.6% (95% CI = [0.57–0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07–0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21–0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004–0.05]) and 3.9% (95% CI = [0.007–0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. Conclusions: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies.
Background: Coexistence of atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) is common, affecting morbidity and prognosis. This study evaluates outcome after cryoballoon ablation for AF in HFpEF compared with patients without heart failure. Methods: A total of 102 AF patients with left ventricular ejection fraction ≥50% undergoing cryoballoon ablation were prospectively enrolled. Baseline evaluation included echocardiography, stress echocardiography, 6-minute walk test, biomarkers, and quality of life assessment (Short-Form-36). Procedural parameters and clinical, functional and echocardiographic end points at follow-up ≥12 months after AF ablation were compared between patients with and without HFpEF. Results: Patients with HFpEF (n=24) were older (median, 74 years versus 65 years; P =0.001) more often female (83% versus 28%; P <0.001) and characterized by more pronounced AF-related symptoms (median European Heart Rhythm Association score 3 versus 2; P <0.001), higher left atrial pressures (median, 14 mm Hg versus 10 mm Hg; P =0.008), reduced left atrial-appendage velocity (median, 36 cm/s versus 59 cm/s; P <0.001), and reduced distance in the 6-minute walk test (median, 488 m versus 539 m; P <0.001). Patients with HFpEF more often experienced AF recurrence (57% versus 23%; P =0.003), repeat AF ablation (39% versus 14%; P =0.01) and AF-related rehospitalization (26% versus 7%; P =0.016). Heart failure symptoms and elevated cardiac biomarkers persisted, even in patients with HFpEF with successful rhythm control at follow-up. Echocardiographic follow-up showed progression of adverse left atrial remodeling and no relevant improvement in diastolic function in HFpEF. Quality of life improved in patients without HFpEF, whereas patients with HFpEF still exhibited a lower physical component summary score (median, 41.5 versus 53.4; P <0.004). Conclusions: Patients with HFpEF constitute a distinct subgroup with elevated risk for AF recurrence after cryoballon ablation. Functional hallmarks of HFpEF persist, irrespective of rhythm status at follow-up. Future research is needed to optimize treatment strategies in patients with HFpEF. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04317911.
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