Transfemoral, But Not Transapical TAVR, 'Economically Attractive'

November 11, 2011

November 10, 2011 (San Francisco, California) — An economic analysis of the PARTNER cohort A trial of patients with severe aortic stenosis and high surgical risk reveals that transcatheter aortic valve replacement (TAVR) via the femoral artery is an "economically attractive" option compared with aortic valve replacement surgery. Transapical TAVR, however, does not share the same financial upside, with researchers reporting that the transapical approach is "unattractive from a health economic perspective."

Lead investigator Dr Matthew Reynolds (Harvard Clinical Research Institute, Boston, MA) called the economic analysis of TAVR patients treated via the femoral artery a win–win situation.

"For a technology in its early stage like this, it's a very good and very encouraging result because this is a first-generation device and the PARTNER trial still represents an early experience," Reynolds told heartwire . "We're comparing it against surgical valve replacement, which is a mature and well-worn procedure with systems of care built around it. It's conceivable that things will get better in time, but right now it's certainly a very acceptable result. There is no suggestion that this is adding cost in any significant way in transfemoral patients. The story is different in transapical patients, however."

The major difference, explained Reynolds, is that transapical TAVR did not reduce hospital length-of-stay as much as patients treated with TAVR via the femoral artery. As a result, the smaller reduction in hospital length-of-stay failed to offset the cost of the procedure, resulting in an economic scenario that was not nearly as advantageous as when patients were treated with transfemoral TAVR.

Economic Analysis of PARTNER Cohort A

The PARTNER A study was designed to test the Sapien valve (Edwards Lifesciences) against surgery in high-risk patients randomized to TAVI undergoing a transfemoral procedure, if appropriate, or a transapical procedure, if the patient was unsuitable for a transfemoral approach. At one year, as previously reported by heartwire , the transcatheter procedures were found to be noninferior to surgical replacement for the primary end point of one-year mortality.

Reynolds explained that there was a small difference in the 30-day quality of life in the transfemoral arm, suggesting transcatheter patients recover faster and are feeling better at 30 days. In fact, Dr David Cohen (Saint Luke's Mid America Heart Institute, Kansas City, MO) presented the PARTNER A quality-of-life data showing just that, a study previously reported by heartwire . He explained that based on the effectiveness data, this translates into a small but significant improvement in quality-adjusted life-years (QALYs) compared with surgery, within the range of 0.6 to 0.7 QALYs.

Overall, the transfemoral TAVR procedural costs were significantly higher compared with surgery ($34 863 vs $14 451, respectively), but this was offset by a significant reduction in nonprocedural costs ($31 192 vs $54 228, respectively), namely the result of the large reduction in hospital length-of-stay. Patients treated with transfemoral TAVR stayed in hospital six days less than patients who underwent surgery, and this translated into an overall cost savings of $2496.

While TAVR might not save a lot of money, Reynolds told heartwire it's not costing money, with an incremental cost-effectiveness ratio of 0.60, meaning the procedure is "economically dominant."

Transapical TAVR: A Different Procedure

As reported by Cohen in the quality-of-life analysis of PARTNER cohort A patients, there was no benefit of TAVR over surgical aortic-valve replacement at any time point. On the cost side of the equation, Reynolds explained that the increased cost of the transapical TAVR procedure over surgery ($39 998 vs $15 271, respectively) was accompanied by only a slight reduction in hospital length-of-stay. In the transapical TAVR arm, patients remained in hospital 14.7 days compared with 16.1 days for those treated surgically. As a result, nonprocedural hospital costs remained high ($44 940 in the TAVR arm vs $58 139 in the surgery arm), and this resulted in TAVR costing approximately $10 000 more than aortic-valve replacement surgery.

"These are different procedures," said Reynolds of the transapical and transfemoral approaches. "You're replacing the valve in the same way, but it's a fundamentally different procedure and the recovery from them is clearly not the same. It's not the same in the way patients report their quality of life, and it's not the same in terms of how long they stay in the hospital."

Reynolds said that the study includes a small sample of transapical TAVR patients, and that there is a learning curve with the procedure. The PARTNER cohort A analysis includes the first 104 patients enrolled across 20 clinical centers. While he acknowledged it might be too early to perform such an economic analysis, he said this is a trial-based analysis and that these data indicate transapical TAVR does not appear to be favorable in this setting.

Dr Michael Mack

Two surgeons, Dr Michael Mack (Baylor Health Care System, TX) and Dr Joseph Bavaria (University of Pennsylvania, Philadelphia), made exactly that point during a morning press conference, noting that many of the US PARTNER centers performed very few procedures over the course of the trial, such that the transapical results represent a very early experience with the procedure. "This is two years ago now that these patients were treated, and 50% of all patients treated in the US are treated with the transapical approach," said Mack. "I think we've already learned a lot about the things that were causing us problems early on. I think it's a different operation now."

Bavaria added that when his center performed a similar analysis, but excluded the first 20 patients treated with transapical TAVR to eliminate the learning curve, they observed a four-day reduction in hospital length-of-stay, which would put them in the same ballpark with regard to hospital length-of-stay as transfemoral TAVR.


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