Fluoroscopy-only guided transcatheter patent foramen ovale closure: the importance of pre-procedural echocardiography.

Objectives: Percutaneous closure of a patent foramen ovale (PFO) to prevent recurrent paradoxical thromboembolic events has become the standard of care. However, it remains uncertain if transesophageal echocardiography (TOE) guidance improves procedural success with an existing comprehensive pre-procedural TOE. The aim of the study was to compare the effectiveness of percutaneous PFO closure guided by fluoroscopy (FS) only vs TOE plus FS. Methods: Consecutive patients undergoing percutaneous PFO closure between February 2017 and April 2023 were analyzed. Based on pre-procedural echocardiography, patients were scheduled either for an FS-only or TOE/FS-guided procedure. The primary-endpoint was effective PFO-closure (residual-shunt grade 0/1 at 6-month follow-up). The secondary-endpoints included procedural safety/efficacy and major adverse cardiovascular events during hospital stay and at the 6-month follow-up. Results: Two hundred-three patients (mean age 51.8 ± 12.5 years, 39.4% women, Risk of Paradoxical Embolism score = 7 [IQR = 6-7]) underwent PFO closure with FS-only guidance (88 patients, 43.3%) or TOE/FS guidance (115 patients, 56.7%). The main indications for PFO closure were cryptogenic stroke (179 patients, 88.2%) and peripheral embolism (13 patients, 6.4%). At baseline, a right-to-left shunt of grade 2 or higher was present in 199 patients (98%). The procedure time in the FS group was shorter (13 minutes in the FS group vs 16.5 minutes in the TOE/FS group, P = .002). The immediate procedural success was 99.5%. At 6 months, effective closure was achieved in 195 patients (96.1% [FS group: 97.7% vs TOE/FS group 97.8%, P = .29]). The rates of atrial fibrillation and recurrent thromboembolic events were not different among the procedural strategies (3.9% [P = .47] and 0.5% [P = .43]). Conclusions: After comprehensive pre-procedural echocardiography workup, PFO closure with FS guidance only seems equally safe and effective as TOE/FS guidance. A standardized pre-procedural echocardiography protocol facilitates procedural planning with excellent echocardiographic and clinical outcomes.

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

OBJECTIVES: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders. METHODS: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up. RESULTS: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively. CONCLUSIONS: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

The Allegra transcatheter heart valve: Long-term clinical and echocardiographic outcomes.

OBJECTIVES: The Allegra-THV is a novel, self-expanding THV with supra-annular bovine leaflets. The valve is available in 3 different sizes and is delivered through an 18 French sheath. To determine the safety and efficacy of the Allegra transcatheter heart valve (THV; Biosensors) for the treatment of severe aortic valve stenosis under real-world conditions. METHODS: Consecutive patients undergoing transcatheter aortic valve replacement (TAVR) at the Heart-Centre Lucerne with the Allegra-THV were included. Echocardiographic data were collected at baseline, before discharge, and at 1-year follow-up; clinical outcomes were recorded for up to 3 years. Clinical endpoints were defined according to the definitions of the Valve-Academic-Research-Consortium. RESULTS: One hundred-three patients (age 81 ± 7 years, 63% women) were enrolled. Median European System for Cardiac Operative Risk Evaluation II score was 4.1% (IQR 1.8%-4.2%). Mean aortic valve gradient was 6.9 ± 3.3 mm Hg and 7.7 ± 3.3 mm Hg, and an effective orifice area was 2.1 ± 0.5 cm2 and 2.0 ± 0.5 cm2 at 30 days and 1-year follow-up, respectively. More than mild paravalvular leak was observed in 2.0% of patients at 30 days and 3.3% at 1 year. At 1-year follow-up, 14.7% of patients required implantation of a new permanent pacemaker, 1 patient had endocarditis with an uneventful clinical course and good THV-function after antibiotic therapy, and no thrombosis, structural-valve-detoriation (SVD), or non-SVD had occurred. At 3-year follow-up, rates of all-cause and cardiovascular mortality were 31.4% and 18.8%, respectively. CONCLUSIONS: Transfemoral implantation of the Allegra-THV resulted in favorable clinical and echocardiographic outcomes at up to 3-year follow-up. Head-to-head randomized clinical trials are necessary to determine if the Allegra-THV valve performs as well as current generation valves.