Key result
Transfemoral and transapical SAPIEN THV access show similar procedural success and one-year mortality.
Why the study?
The clinical outcomes of the Edwards SAPIEN Transcatheter Heart Valve in the Australian and New Zealand clinical environment had not been reported.
Observational (n=132)
Yes
Absolute Event Rate: 92.4% vs 87.1%
p-value: p=0.32
The initial experience with the Edwards SAPIEN THV in Australia and New Zealand demonstrates excellent procedural success and acceptable 1-year mortality for both transfemoral and transapical approaches.
Supports TAVI rollout in select ANZ patients; extends global SAPIEN registry data to a new region.
BACKGROUND: We report the findings of the SOURCE-ANZ registry of the clinical outcomes of the Edwards SAPIEN™ Transcatheter Heart Valve (THV) in the Australian and New Zealand (ANZ) clinical environment. METHODS: This single arm registry of select patients treated in eight centres, represent the initial experience within ANZ with the balloon expandable Edwards SAPIEN THV delivered by transfemoral (TF) and transapical (TA) access. RESULTS: The total enrolment for the study was 132 patients, 63 patients treated by TF, 56 by TA, and 2 patients were withdrawn from the study. The mean ages: 83.7 (TF) and 81.7 (TA), female: 34.3% (TF) and 61.3% (TA), logistic EuroSCORE: 26.8% (TF) and 28.8% (TA), and with procedural success (successful implant without conversion to surgery or death): 92.4% (TF) and 87.1% (TA) (p=0.32). Outcomes were not significantly different between TF and TA implants. These included one year mortality of 13.6% (TF) and 21.7% (TA) (p=0.24), MACCE: 16.7% (TF) and 28.3% (TA) (p=0.12), pacemaker: 4.6% (TF) and 8.3% (TA) (p=0.39), and VARC major vascular complication of 4.6% (TF) and 5.0% (TA) (p=0.91). CONCLUSION: TAVI in the ANZ clinical environment has demonstrated excellent outcomes for both the TA and TF approaches in highly selected patients. These results are consistent with those demonstrated in European, Canadian registries and the pivotal US clinical trials. ACTRN12611001026910.
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Walters et al. (2013) conducted an observational in Patients requiring Transcatheter Heart Valve (n=132). Transfemoral (TF) access for Edwards SAPIEN THV vs. Transapical (TA) access was evaluated on Procedural success (successful implant without conversion to surgery or death) (p=0.32). Transfemoral and transapical access for the Edwards SAPIEN Transcatheter Heart Valve showed similar procedural success (92.4% vs 87.1%, p=0.32) and one-year mortality (13.6% vs 21.7%, p=0.24).
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