A semi-structured survey suggests that more than 15% of patients suffering from severe symptomatic aortic stenosis eligible for transcatheter aortic valve implantation (TAVI) did not receive the treatment for budget-related reasons in 2011.
The survey was designed by Medtronic, in collaboration with BIBA MedTech, and presented in the Poster and Oral Abstractssessionof the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
TAVI was introduced in 2007 to offer a new treatment option to patients who are not eligible for surgical aortic valve replacement (AVR). According to BIBA MedTech’s European TAVI Monitor, in Europe just over 18,000 procedures were performed in 2011.
BIBA MedTech and Medtronic also consider that in 2011 significant disparities in the rate of TAVI adoption were observed across European countries due to different national healthcare systems and macro-economic related factors (Fig. 1)
Fig 1. TAVI rate across Europe in 2011
“We knew that TAVI did not reach all inoperable patients suffering from severe symptomatic aortic stenosis,” said Rachele Busca, Reimbursment manager Cardiovascular Europe, Medtronic, and Medtronic’s coordinator for the research project. “What we did not know was the exact percentage of the potential TAVI population unable to access the therapy, and why.”
Methodology and findings
The survey was conducted with telephone interviews and pre-arranged questionnaires amongst 100 cardio-thoracic centres from eight European countries. Implant data were also submitted by each participant centre independently.
In total, the 100 cardio-thoracic centres assessed 14,805 patients with severe symptomatic aortic stenosis in 2011. From those patients, 4,884 were found not eligible for surgical replacement and were referred to one of the following pathways:
- 3,459 (70.8%) were referred for TAVI
- 466 (9.5%) were treated with balloon aortic valvuloplasty (BAV)
- 959 (19.6%) were treated with drugs only or left untreated.
The decision to treat patients with either BAV or drugs only was based on a number of reasons, as reported in the table below:
|
Reason |
% |
|
Budget constraints |
42.7% |
|
Other urgent concomitant disease |
21.7% |
|
Lack of clinical evidence supporting TAVI |
16.9% |
|
Hospital capacity |
9.9% |
|
Unsuitability of currently available TAVI sizes |
3.5% |
|
Other reasons |
5.2% |
This survey suggests that, despite TAVI being accepted as standard of care for patients suffering from severe aortic stenosis not eligible for surgery, other non-clinical reasons hamper the drive for a wider TAVI adoption in Europe.
“This survey confirms that hospital capacity and budget constraints represent the reasons for denying an eligible TAVI candidate the opportunity to access the therapy in almost 50% of cases. We are looking forward to working together with all relevant stakeholders to address this issue in the future,” concluded Busca.
