SAN FRANCISCO—The cost effectiveness of transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) depends on whether TAVI is performed via the femoral artery or transapically, through a small incision in the chest, according to a late-breaking clinical trial that evaluated the data from Cohort A of PARTNER, presented Nov. 10 at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

The PARTNER A trial randomized patients with severe, symptomatic aortic stenosis and high surgical risk to either TAVI (348 patients) or SAVR (351 patients) and followed them for a minimum of 12 months. The researchers collected detailed medical resource utilization data on all study patients, and hospital billing data were collected for both index and follow-up hospitalizations for any cause from consenting U.S. patients.

The study’s lead author Matthew R. Reynolds, MD, of the health economics and technology assessment research group at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., pointed out that this cost-effectiveness analysis assessed costs to the overall U.S. healthcare system, using 2010 charges and rates, during the press conference. The researchers also estimated the commercial price of the Sapien valve (Edwards Lifesciences) at $30,000, based on the price in Europe.

For the trial, they measured resource utilization (including procedure duration and supplies) multiplied by unit costs. They took into consideration cath lab overhead used for all transfemoral-TAVI cases, cardiac or overhead used for SAVR and transapical-TAVI cases. For other costs for index admission, bills were collected from consenting patients enrolled at participating U.S. sites (541 of 699 intention-to-treat subjects). The itemized charges were multiplied by hospital and department-specific cost-to-charge ratios. Where billing data were unavailable, regression models derived from subjects with bills were used to impute costs separately for TAVI and SAVR groups. For follow-up costs, the researchers included costs from billing data or from average Medicare reimbursement for respective DRG and resource-based costs (which included for rehabilitation days, SNF days, outpatient visits, ER visits and outpatient cardiac testing) when bills were unavailable.

For the transfemoral approach, the TAVI procedure took 87 minutes less than SAVR, 6.2 fewer days in the hospital with 2.3 fewer days in the ICU and four fewer non-ICU days. Also, post-procedurally, transfemoral TAVI resulted in 6.1 fewer days than SAVR. For complications, TAVI resulted in 10.1 percent more major vascular complications, but 13.2 percent fewer major bleeding events than SAVR.

Overall, the transfemoral TAVI approach resulted in a difference of $2,496, compared with SAVR, with the total transfemoral TAVI costs at $71,955 and the total SAVR costs at $74,452. However, the one-year follow-up costs were just slightly higher in the TAVI group ($22,251 vs. $21,965)—resulting a $287 difference.

For the transapical approach, the TAVI procedure took 130 minutes less than SAVR, 1.4 fewer days in the hospital with 1.4 fewer days in the ICU and the same amount of non-ICU days. Also, post-procedurally, transapical TAVI resulted in two fewer days than SAVR. For complications, TAVI resulted in 0.4 percent fewer major vascular complications, but 14.9 percent fewer major bleeding events than SAVR.

Overall, the transapical TAVI approach resulted in an increase of costs of $11,008, compared with SAVR, with the total transapical TAVI costs at $90,548 and the total SAVR costs at $79,540. The procedure costs with the transpical approach were more than double the procedure costs of SAVR ($39,998 vs. $15,271). However, the one-year follow-up were less in the TAVI group ($17,231 vs. $18,643)—resulting a $1,412 difference, mainly due to the high SAVR rehabilitation costs.

“Results of this trial indicate that for patients with severe aortic stenosis and high surgical risk, TAVI is an economically attractive and possibly dominant strategy compared with surgical aortic valve replacement, provided that patients are suitable for the transfemoral approach,” said Reynolds. “Current results for transcatheter aortic valve replacement via the transapical approach, compared with surgical aortic valve replacement, are unattractive from a health economic perspective.”

During the press conference, John A. Ormiston, MD, a cardiologist at Auckland City Hospital in Australia, suggested that these figures with the transapical approach may start to shift as U.S. operators become more familiar with the technique. Reynolds concurs that the lengths of stay with the transpical approach even out after 20 cases on the part of the operator.

Panelist Joseph E. Bavaria, MD, a cardiovascular surgeon at Penn Medicine in Philadelphia, said that these healthcare system analyses don’t reflect the hospital’s bottom line.

He added that the cost point in this study is higher than the average $1,200 to 1,400 per day costs at his site, which was involved with the PARTNER trial. Reynolds said that that $1,200 to $1,400 per day for all hospital costs is comparatively very low to the other PARTNER sites. “The key cost of these regression models is the cost involved with hospital stay, and the general costs of the PARTNER were closer to $3,000 to $4,000 per day.”