Initial experience with the balloon expandable Edwards-SAPIEN Transcatheter Heart Valve in Australia and New Zealand: The SOURCE ANZ registry: Outcomes at 30days and one year

Darren Walters, Ajay Sinhal, D Baron, S Pasupati, S Thambar, G Yong, N Jepson, R Bhindi, Jayme Bennetts, R Larbalestier, A Clarke, P Brady, H Wolfenden, A James, A El Gamel, P Jansz, Derek Chew

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    Abstract

    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 Results The total enrolment for the study was 132 patients, 63 patients treated by TF, 56 by TA, and 2 patients were withdrawn from the study.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.

    Original languageEnglish
    Pages (from-to)406-412
    Number of pages7
    JournalInternational Journal of Cardiology
    Volume170
    Issue number3
    DOIs
    Publication statusPublished - 2014

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    Walters, D., Sinhal, A., Baron, D., Pasupati, S., Thambar, S., Yong, G., Jepson, N., Bhindi, R., Bennetts, J., Larbalestier, R., Clarke, A., Brady, P., Wolfenden, H., James, A., El Gamel, A., Jansz, P., & Chew, D. (2014). Initial experience with the balloon expandable Edwards-SAPIEN Transcatheter Heart Valve in Australia and New Zealand: The SOURCE ANZ registry: Outcomes at 30days and one year. International Journal of Cardiology, 170(3), 406-412. https://doi.org/10.1016/j.ijcard.2013.11.027