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

• Published in: International journal of cardiology Vol. 170; no. 3; pp. 406 - 412
• Main Authors: Walters, D.L, 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.P
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier 01.01.2014
• Subjects: Aged, 80 and over; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - surgery; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular; Endocardial and cardiac valvular diseases; Female; Heart; Heart Valve Prosthesis - adverse effects; Heart Valve Prosthesis - statistics & numerical data; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - methods; Heart Valve Prosthesis Implantation - mortality; Humans; Kaplan-Meier Estimate; Male; Medical sciences; Postoperative Complications - diagnostic imaging; Postoperative Complications - mortality; Prevalence; Prospective Studies; Registries - statistics & numerical data; Risk Factors; Treatment Outcome; Ultrasonography; New Zealand; Australia; Oceania; Valvular heart disease; Aortic stenosis; Aortic valve disease; TAVI; Prognosis; Cardiovascular disease; Heart valve; Source; Experience; Cardiac valvular disease; Register; Sounding balloon; Evolution; Cardiology; Day
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2013.11.027

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 Results The total enrolment for the study was 132 patients, 63 patients treated by TF, 56 by TA, and 2 patients were withdrawn from the study.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