Initial Experience With Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis in Nicaragua.

Background Aortic stenosis is a progressive valvular disease strongly associated with aging and high mortality once symptoms develop. Surgical aortic valve replacement has traditionally been the standard treatment for symptomatic severe disease; however, transcatheter aortic valve replacement (TAVR) has emerged as an effective, less invasive alternative for patients with increased surgical risk, supported by evidence from major clinical trials. Since its introduction in Nicaragua, procedural volume has steadily increased. This study aimed to describe the initial national experience with TAVR in patients with severe aortic stenosis in Nicaragua. Materials and methods This retrospective descriptive case series included 16 patients with confirmed severe aortic stenosis who underwent TAVR between July 2023 and March 2024 at a single center in Managua, Nicaragua. Baseline clinical and echocardiographic data were obtained from medical records. Outcomes were evaluated using Valve Academic Research Consortium-3 (VARC-3) criteria, including technical success, device success, and early safety at 30 days. Data were analyzed using IBM SPSS Statistics 25 (IBM Corp., Armonk, NY) with categorical variables reported as n (%), continuous variables as mean ± SD, and pre- versus post-procedural mean transaortic pressure gradients compared using the Wilcoxon signed-rank test. Statistical significance was defined as p ≤ 0.05, which was calculated through Fisher's exact test (dichotomous variables) and Fisher-Freeman-Halton exact test (polytomous variables). Institutional review board approval was obtained. Results The majority of participants were in the 61-70 year age group, accounting for 7 (43.8%) patients, with a mean age of 68.9 ± 8.7 years; 9 (56.3%) were male, and 9 (56.3%) were overweight. The most prevalent comorbidities were hypertension in 15 (93.8%) and diabetes mellitus in 6 (37.5%). Dyspnea was the most common symptom, reported in 15 (93.8%), followed by heart failure in 9 (56.3%) and angina in 8 (50%). Baseline hemodynamics showed a mean transaortic gradient of 55.7 ± 21.1 mmHg, with 14 (87.5%) presenting gradients >40 mmHg, and a mean aortic valve area of 0.68 ± 0.3 cm². Self-expanding valves were implanted in 15 (93.8%), predominantly Acurate Neo 2 in 13 (81.3%) (Boston Scientific Corp., Marlborough, MA). Overall, 13 (81.3%) procedures met VARC-3 criteria for technical success. No intraprocedural or 30-day deaths were recorded. At 30 days, device success was achieved in 12 (75%), early safety in 15 (93.8%), and intended valve performance was satisfactory in 14 (87.5%), with a post-procedural mean gradient of 9.08 ± 6.3 mmHg and no moderate-to-severe aortic regurgitation. The median transaortic pressure gradient decreased from baseline to 30 days after TAVR, from 52.5 (IQR 41.5-67.5) to 9.0 (IQR 3.47-11), with p<0.001 indicating a statistically significant change and a substantial clinical impact on patients' hemodynamic status. Permanent pacemaker implantation and paravalvular leak occurred in 1 (6.3%) patient each. Conclusion In this initial single-center experience in Nicaragua, TAVR was feasible and achieved favorable short-term outcomes, with significant improvement in transaortic hemodynamics at 30 days. These findings support the early safety and effectiveness of TAVR in this setting, although larger prospective studies are needed to confirm results and improve generalizability.