Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial

Gerald Yong; Tony Walton; Martin Ng; Ronen Gurvitch; Stephen Worthley; Robert Whitbourn; Nigel Jepson; Ravinay Bhindi; Kan Shang; Ajay Sinhal

doi:10.1016/j.hlc.2020.04.010

Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial

Heart Lung Circ. 2020 Dec;29(12):1839-1846. doi: 10.1016/j.hlc.2020.04.010. Epub 2020 Jun 11.

Authors

Gerald Yong¹, Tony Walton², Martin Ng³, Ronen Gurvitch⁴, Stephen Worthley⁵, Robert Whitbourn⁶, Nigel Jepson⁷, Ravinay Bhindi⁸, Kan Shang⁹, Ajay Sinhal¹⁰

Affiliations

¹ Fiona Stanley Hospital, Perth, WA, Australia. Electronic address: gstyong@gmail.com.
² Alfred Health, Melbourne, Vic, Australia.
³ Royal Prince Alfred Hospital, Sydney, NSW, Australia.
⁴ Royal Melbourne Hospital, Melbourne, Vic, Australia.
⁵ GenesisCare Cardiology, Sydney, NSW, Australia.
⁶ St Vincent's Hospital Melbourne & Melbourne University, Melbourne, Vic, Australia.
⁷ Prince of Wales Public Hospital and Eastern Heart Clinic, Sydney, NSW, Australia; University of NSW, Sydney, NSW, Australia.
⁸ North Shore Private Hospital, Sydney, NSW, Australia.
⁹ Edwards Lifesciences, Irvine, CA, USA.
¹⁰ Flinders Medical Centre, Flinders University, Adelaide, SA, Australia.

PMID: 32712017
DOI: 10.1016/j.hlc.2020.04.010

Abstract

Background: To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk.

Methods: Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure. Other endpoints were device success (successful vascular access, delivery, and deployment; correct position; intended performance mean aortic valve gradient <20 mmHg, mild or less paravalvular aortic regurgitation [PAR]; and only one valve implanted) and New York Heart Association functional class (NYHA). Kaplan-Meier (KM) estimates were calculated for the primary endpoint.

Results: At baseline, mean patient (N=199) age was 85.5 years, mean Society of Thoracic Surgeon score was 5.9, and 78.4% were in NYHA class III/IV. The primary composite endpoint KM estimate was 12.1%. Device success was 88.8%. SAPIEN XT was implanted in the proper location in 98.5% (n=2: valve-in-valve procedures, n=1: no implant due to left main coronary artery occlusion). No device malfunctions were reported. The post procedure PAR was mild or less in 93.8% of patients. Mean aortic gradient decreased from baseline (50.0 mmHg) to 2 years (10.3 mmHg). Most patients (90.9%) were in NYHA class I/II at 30 days. New permanent pacemaker rate was 8.1%. Stroke at 30 days was 3.5% (1.5% disabling).

Conclusion: SAPIEN XT was safe and improved heart failure symptoms and valve haemodynamics in this cohort of Australian patients.

Keywords: Aortic stenosis; Intermediate surgical risk; TAVI; Transcatheter aortic valve implantation.

Publication types

Clinical Trial
Multicenter Study

MeSH terms

Aged
Aged, 80 and over
Aortic Valve / surgery*
Aortic Valve Stenosis / diagnosis
Aortic Valve Stenosis / surgery*
Australia
Cardiac Catheterization / methods*
Echocardiography
Female
Femoral Artery
Humans
Male
Prospective Studies
Prosthesis Design
Risk Factors
Severity of Illness Index
Transcatheter Aortic Valve Replacement / methods*
Treatment Outcome