Access to tertiary cardiac services is limited in South Africa's (SA) resource-constrained system. SHARE-TAVI, a prospective multi-centre observational registry, aims to capture data for all SA TAVI patients, to compare outcomes to international data & define local variations in clinical presentation & outcomes.
Methods and results: Participation in this voluntary registry, with 93% capture compliance, was incentivized by linking the capture of TAVI evaluation data with the funding application process, leading to a reduction in funding decision waiting time from average +180 days (2014) to current average of 92 days. Restrictive funding policies limit the expansion of TAVI in SA, with approximately 200 TAVIs recorded annually each in 2017 and 2018 from combined participation of 8 Private and 3 State TAVI centres, 9 of which do <20 implants/year.
From Sept 2014 to Dec 2018 inclusive, 894 patients were entered into the registry as part of TAVI evaluations, currently 102 patients await funding decisions (outstanding decisions ranging from 2–1185d). Deteriorating patient health during delayed Funder responses resulted in mortality prior to TAVI date for 8 patients whose funding was approved, & ineligibility for TAVI due to deterioration for 9 awaiting decisions (mean wait 115d). Mortality occurred in 21 others awaiting funding approval. 36% of patients declined funding (n=21/59) died within 1 year.
For the 663 patients who received implants, procedural & complications data were entered according to VARC-2 criteria, & postoperative follow-up at 30d & annually to 5 years. The implanted cohort is comparable to similar registry & trial populations (GARY, SOURCE 3, & US Corevalve Pivotal), in mean age [80.1±7.2yrs], gender [54.9% male], & mean risk predictions 7.0±7.4% [STSPROM], 23.0±15.7 [logEuroSCORE] & 6.4±5.0% [EuroSCORE 2], and Clinical History/Risk.
All-cause mortality of 10.48% (n=48/458) at 1-year compares favourably to published TAVI populations [14,2% US Corevalve, 12.6% SOURCE 3, 20% GARY], with non-cardiac mortality at 33% (n=16/48) mostly attributable to cancer, pneumonia and renal failure. State and Private care offer similar procedural success (State 93.1%, Private 93.7%), and hospital stays - mean ICU [State 1.43±1.58d, Private 2.48±1.99d] & total length of stay [State LOS 4.51±2.87d, Private LOS 5.19±4.24d]. At 30d new permanent pacemaker implantation is needed in 7.5% patients (n=50/663), & in 9.85% at 1-year (n=45/458), these comparatively low rates are being investigated in a sub-study of SHARE-TAVI.
Conclusions: Cumbersome TAVI funding processes & funding resistance contribute to unacceptable mortality figures in appropriately selected patients awaiting funding approval decisions, despite the SHARE-TAVI registry offering independent local data that confirms that TAVI in local resource-constrained settings compares favourably to international best practice standards, even with relatively low volumes at both State and Private centres.