Despite 'Exploding' Use, TAVI Still Too Costly in Many Countries

Marlene Busko

June 09, 2016

MEXICO CITY, MEXICO — A survey of transcatheter aortic-valve implantation (TAVI) in 2014 in 21 countries excluding Western Europe, Canada, and the United States revealed that less than half of eligible patients underwent this procedure, and the biggest barrier was financial constraints[1].

Market research analyst Dario Remigi (BIBA Medical, London, UK) presented these findings here on June 7, 2016 at the World Heart Federation's World Congress of Cardiology & Cardiovascular Health 2016 (WCC 2016).

The analysts surveyed 100 TAVI centers in Argentina, Brazil, Chile, Czech Republic, Egypt, Hungary, Israel, Japan, Lebanon, Mexico, New Zealand, Peru, Philippines, Poland, Saudi Arabia, Singapore, Slovenia, South Africa, Thailand, Uruguay, and Venezuela. This procedure was most widely adopted in Israel and least likely to be performed in Latin American countries and Mexico.

This study follows a survey in 2012 of 100 TAVI centers in Western Europe, which was presented as a poster at TCT 2013. That survey also showed that fewer than half of eligible patients for TAVI received it, and in 42% of the cases where the procedure was not performed, this was due to budget limitations.

This new, more geographically diverse survey showed that "unfortunately again, less than half the people received the therapy and in 80% of cases this was due to financial constraints," Remigi explained to heartwire from Medscape.

"TAVI is now a well-recognized therapy for aortic stenosis, but it is not available for all populations because this procedure is very expensive," session moderator Dr Ramiro Flores (OCA Hospital, Monterrey, Nuevo Leon, Mexico) summarized to heartwire .

"I agree, the problem is cost," session attendee Dr José Maria Hernandez (Doctors Hospital, Monterrey, Nuevo Leon, Mexico) added. The number of eligible patients is growing, since the device is being indicated for lower-risk patients, so device companies should introduce lower-cost prostheses to countries such as Mexico to allow patients to benefit from this technology, he added.

"I think in the future when this kind of procedure is done on a more regular basis, the cost will come down," Flores speculated.

Identifying Global Barriers to TAVI Adoption

TAVI was commercially launched in Europe in 2007, and then in a 2011 consensus statement the European Society of Cardiology recommended it as the gold standard for patients with inoperable severe aortic stenosis. "Within 4 years, TAVI moved from 20 centers and less than 100 procedures to 200-plus centers and 18,000 procedures, so it was an explosion" in Western Europe, Remigi said.

Their 2012 survey in Western Europe revealed that in addition to budget constraints, TAVI was not being performed in eligible patients due to the presence of other urgent concomitant disease (21.7%), a lack of clinical evidence supporting TAVI (16.9%), inadequate hospital capacity (9.9%), unsuitable currently available TAVI sizes (3.5%), and other reasons (5.2%).

The current survey in countries in Eastern Europe, Latin America, the Asia-Pacific region, Africa, and the Middle East found that 6306 patients assessed by the heart teams in 2014 were diagnosed with severe symptomatic aortic stenosis and were considered inoperable for standard aortic-valve replacement surgery.

However, fewer than half (41%) of these patients were treated with TAVI. About a third (29.6%) received drugs or no treatment, and a fifth (21%) were reassessed and had surgical aortic-valve replacement. The rest (8.4%) had aortic balloon valvuloplasty.

Most patients did not receive TAVI because of budget constraints (80.2%). Other reasons for not performing TAVI included the presence of other concomitant disease (5.1%), a lack of clinical evidence supporting TAVI (0.3%), inadequate hospital capacity (0.2%), or no suitable currently available TAVI sizes (3.8%); or the patients were too frail to undergo the procedure (2.5%) or had a short life expectancy (2.5%); or other reasons (5.5%).

The budget constraints were most often national reimbursement issues (47.1%), followed by hospital budget limits (37.1%), and less often due to limited health insurance (15.7%).

In 2015, 90% of global TAVI implants were performed in Western Europe (52.3%) and North America (37.7%), Remigi reported. Far fewer were done in Japan (3.0%) or in the Middle East, Africa, Eastern Europe, Latin America, and Asia-Pacific countries (1.1% to 2.0% in each area).

The group now plans to examine the US TAVI market, where like in Western Europe TAVR use is "exploding," Remigi said.

The study authors have no relevant financial relationships.

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