Author + information
- Lakshmana K. Pendyala,
- Israel Barbash,
- Sa'ar Minha,
- Joshua Loh,
- Hironori Kitabata,
- Salem Badr,
- Danny Dvir,
- Rebecca Torguson,
- Satler Lowell,
- Augusto Pichard and
- Ron Waksman
Edwards Sapien transcatheter valve is FDA approved for commercial use in non-operable patients with severe symptomatic aortic stenosis (AS) via the transfemoral approach.
To assess the clinical profile and in-hospital complications in patients treated with commercial valve compared to PARTNER cohort B.
Study included all consecutive patients treated with commercial Sapien valve at our institution. Baseline characteristics, clinical presentation and in-hospital complications were analyzed. Among all trasfemoral cases 37 commercial valve patients were compared to 54 patients in cohort B.
All clinical variables are similar between the groups including STS score (9.4±4 vs. 10.7±5, p=0.24) except commercial patients had more insulin dependent diabetes mellitus and dialysis dependent renal failure. In majority of the patients in the commercial arm the procedure was done with conscious sedation (81% vs. 56%, p=0.02). The use of planned surgical cut down for vascular access is also rare (4% vs. 85%, P<0.001) in commercial group. 100% procedural success in both the groups with valve deployment. There is trend for lower vascular and bleeding complications with less blood transfusion rates (27% vs. 59%, p=0.007) in the commercial patients. The in-hospital mortality and stroke rates are similar between the groups.
The initial commercial use of the Edwards Sapien valve for inoperable patients reported to have similar success rates in valve deployment, in-hospital mortality and stroke rate when compared to PARTNER cohort B patients. The refinement in the procedure with more conscious sedation, experience of the operators and careful vascular planning with more percutaneous access in the commercial group lead to the trends for lower vascular complications and the requirement of blood transfusions.
|Variable||Commercial Valve (n=37)||Cohort B (n=54)||p value|
|Mean age (years±SD)||83±8||83±7||0.87|
|Planned surgical cut down||4%||85%||<0.001|
|VARC major vascular complication||5%||22%||0.14|
|VARC life threatening bleed||9%||13%||0.69|
- 2013 American College of Cardiology Foundation