The second half of the presentation on aortic-valve intervention included an interesting transcatheter aortic-valve replacement (TAVR) cost analysis and a look at how honing the traditional surgical technique can compete with TAVR outcomes.
If a patient is shopping for a bargain, I'm not sure TAVR is it, at least if you wind up in the complication pool. Dr Suzanne Arnold (Saint Luke's Mid America Heart Institute, Kansas City, MO) presented cost information gathered from 406 patients enrolled in the PARTNER trial, 181 of whom experienced complications including death, cerebrovascular accident, arrhythmia, major vascular injury, major bleeding, permanent pacer implantation, renal insufficiency, repeat TAVR, and conversion to surgical AVR. Of the patients, 20% had only one complication, 9% experienced two complications, but 16% experienced three or more complications.
The mean cost for the initial TAVR hospitalization was $78K ($47K excluding the valve) and the mean length of stay was 10.3 days. With complications, the average cost was approximately $33K more plus an extra 6.6 days in-hospital. The specific breakdown for additional costs for complications were:
Repeat TAVR: $119K.
Conversion to surgical AVR: $26K.
Renal failure: $68K.
With traditional bypass-surgery bills ranging from $71K to $250K, depending on venue and procedure specifics, we still have a way to go before TAVR will be a viewed as more cost-effective. Of course, we must remember as implant techniques improve, so do complication rates, which directly affect cost. Just a simple CT-guided implant can shave both.
And what about that dread of the median sternotomy?
The very first question to ask your doctor is, "Well, do I really need the surgery?" Dr Duk Hyun Kang (Seoul, South Korea) presented a review of the data on watchful observation vs early AVR for symptomatic patients with low gradient severe aortic stenosis in preserved LVEF.
In prior studies, asymptomatic severe aortic-stenosis patients had outcomes similar to moderate aortic-stenosis patients (ie, the SEAS trial). Valve surgery was associated with better survival than medical therapy in the other studies. Kang's subjects were low-gradient severe aortic-stenosis patients age less than 90 (average age 67 years) with symptoms. Severe aortic stenosis was defined as an indexed aortic valve area <0.6 cm2/m2 with a mean gradient of 40 mm Hg and low flow defined as an stroke volume index <45 ml/beat/m2. There were a total of 290 patients, 90 of whom underwent early surgical intervention. The remaining 200 were evaluated with watchful observation. The "surgery" group included 87 patients with traditional surgery and three TAVR patients. There were 33 mechanical valves and 54 bioprosthetics. Those not operated were observed for progression. Surprisingly, the early AVR mortality was 12% vs 2% in the "watchful-waiting" group. Predictors of mortality included age, STS score, and early AVR. Surprisingly, neither the ejection pattern nor flow patterns were associated with higher mortality.
When patients with low-flow tight aortic stenosis are placed in the watchful-observation category, they should be informed that at four years, 81% had progressed to the point that surgery once again had to be considered. Kang advised, however, that a prospective trial is required to evaluate optimal timing of AVR in patients with low flow.
One audience member suggested that patients with normal flow and low gradient have higher valve areas. "Could it be their symptoms were due to other problems? Did you measure BNP? We've seen BNPs of 50 pg/mL and a [pulmonary capillary wedge pressure] PCWP of 10 mm Hg, and they smoke. Maybe that's the issue? And maybe that's why we didn't improve their status in this study?" he offered. Another reason to go hmm. . . .
There are median sternotomies and then there are real median sternotomies.
We were then treated to a Medicare Provider Analysis and Review , in which various surgical techniques of opening the chest were described, including the standard median sternotomy, the upper hemisternotomy, the right minithorocotomy, sutureless valve surgery, and TAVR with all its variations. These choices certainly affected risk favorably. Dr Christina M Vassileva also pointed out that the STS risk calculator could select low-risk re-op aortic-valve–surgery patients even with a prior history of CABG.
Additional consideration as a factor for risk includes the venue chosen for the surgical procedure. The operative mortality for AVR can be more than 200% greater for lower-volume programs. In one study, the operative mortality was 12.9% for those performing fewest procedures annually and 5.8% for the higher-volume centers.
Vassileva then touched on TAVR issues specifically. She pointed out a higher incidence of neurologic complications following TAVR and a failure to improve LVEF after 30 days, with paravalvular leak as a common complication. "While these complications may be a reasonable trade-off for those who are not candidates for surgery or truly are high risk, they warrant serious consideration," she said.
Medicine is fast moving, ever changing. Within a mere decade, sometimes just in the course of a single meeting, our considerations, risks, and outcomes are changed forever. It's certainly fodder to make you go hmm. . . .
Cite this: Things That Make You Go Hmm, Part 2: SAVR vs TAVR Cost and Deciding What's Best - Medscape - Apr 03, 2014.