Conradi L, et al. - The safety and efficacy of a novel low-profile, 22-Fr transapical delivery system together with the ACURATE neo-resheathable transcatheter heart valve were determined. Transapical aortic valve implantation using a novel low-profile delivery system appeared safe and efficacious. High procedural success, short implantation times, and a low rate of apical access site complications were observed, which highlighted the favorable safety profile and ease of use.

Methods

• Researchers performed a prospective, single-arm, multicentre study.
• They enrolled 60 patients with severe symptomatic aortic stenosis and high surgical risk ineligible for transfemoral access.
• Six-month mortality and procedural success were the primary end points.

Results

• The mean age of patients was 79.8 ± 4.7 years.
• The patients had severe comorbidities including coronary artery disease (71.7%), diabetes (38.3%), atrial fibrillation (30.0%) and chronic obstructive pulmonary disease (21.7%); logistic EuroSCORE-I, -II and the Society of Thoracic Surgeons (STS) scores were 20.9 ± 8.9%, 6.1 ± 5.0%, and 4.3 ± 2.9%, respectively.
• In 88.3% of patients, a non-rib spreading approach using soft tissue retractors only was performed (n = 53).
• In 6.7% of cases, resheathing and repositioning of transcatheter heart valves were used (n = 4); the device implantation time was 3 ± 2 min.
• Researchers noted apical access site complications in 1.7% (n = 1).
• Procedural success was 98.3% (n = 59); in the absence of major adverse cardiac and cerebrovascular events at 30 days, procedural success was 90.0% (n = 54).
• Findings revealed cardiovascular and overall mortality of 8.3% (n = 5) and stroke rate of 1.7% (n = 1) at 30 days.
• At 30 days, 17.2% of patients (n = 10) received a permanent pacemaker implant.
• They observed no paravalvular leakage ≥2+; the mean transvalvular gradient was 5.9 ± 2.7 mmHg.
• Survival was 84.3% with sustained haemodynamic results at 6 months.