First 5-year TAVR/TAVI Outcomes from the South African SHARE-TAVI national registry and the influence of malignancy on late outcomes

Abstract

Abstract Introduction The South African (SA) national prospective multicentre observational SHARE-TAVI registry aims to provide local outcomes data on all TAVIs in State & Private sectors, to support local evidence-based policy evaluations, comparing outcomes to international data & identifying local variations. Method All 20 implant centres voluntarily capture all-comers data into the web-based registry. 2266 patients from 1 Sept 2014 to 28 Feb 2022 had pre-TAVI clinical evaluations and 1502 proceeded to TAVI & had procedural data & complications (VARC2 criteria), 30d & annual follow up recorded. The 5-yr cohort of 289 patients have clinical history and profile similar to international data (Table 1). Results Procedural success of 93.43% and 1-year mortality of 15.92% in the 5-yr cohort (STS score 8.85%) are similar to reported international data in early TAVI programmes. All-cause mortality at 5-years is 44.3% (in PARTNER 1 – 67.8%, PARTNER 2.0 – 46.0%), and the greatest proportion of non-cardiac mortality (38.5%) occurs in period >1–2yr post-TAVI (lowest proportion 29.4% in >3–4yr period). Outcomes measures in a more recent 2020 patient cohort (n=219, success 98.63% and 1-yr mortality 8.85%, STS risk score 5.51%) have improved compared to the 5-yr cohort. Patients with “Prior or current malignancy” (POCM) at TAVI evaluation have increased mortality in both the 1-yr outcome (n=637) cohort, 18.7% 1-yr mortality vs 9.3% in those without POCM, and same trend in the 2-year outcome cohort n=443 (28.0% 2-year mortality vs 12.8% without malignancy). Frail patients with POCM in the 2-yr cohort have substantially higher mortality at 2 years, 34.8% than frail patients without POCM 15.9% At evaluation 66% of patients are NYHA class III+IV, post-TAVI only 5.9% at 30d & 8.8% at 1-year, at 1-year 30% of patients have maintained improvement by 2 or 3 NYHA classes. Conclusion 5-yr outcomes in SA are comparable to international data, and procedural outcomes have improved further as to be expected with maturation of the programme and technology. The NYHA class distribution at 1-yr shows improvements which should translate into improved quality of life, future studies should include patient self-reported quality of life assessments to verify this benefit. Malignancy, even if prior, may predict poorer outcomes in the longer term, possibly due to reported higher frailty in these patients. Amongst other factors, prior or current malignancy may be considered relevant when assessing patients for futility for TAVI in SA's severely constrained healthcare resource environment. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): Educational and Research Grants from SA Heart Association and Medtronic, Edwards Life Sciences