Periprocedural TAVR Complications Common, Costly

A large percentage of patients undergoing transcatheter aortic valve replacement (TAVR) experience periprocedural complications—including bleeding, death, arrhythmias, and renal failure—that are associated with substantial costs and longer hospital stays, according to an analysis of the PARTNER trial published online October 21, 2014, ahead of print in Circulation: Cardiovascular Interventions.

Investigators led by Suzanne V. Arnold, MD, MHA, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), say “a reduction in these complications could have a substantial effect on the overall costs of the initial hospitalization for TAVR and on the ultimate cost-effectiveness of the procedure.”

Methods
The researchers used detailed cost data from 406 patients enrolled in Cohorts A or B of the PARTNER I trial to develop models for estimating incremental cost and length of stay associated with periprocedural complications of TAVR.
 The mean age of patients was 83 years, and 47% were women. Mean aortic valve area was 0.65 cm2, and 94% of patients were in NYHA functional class III to IV.


Complications Not Uncommon

Overall, 48.9% of patients experienced 1 or more periprocedural complications during the index hospitalization, with 21.4% having 1 complication and 17.5% having 3 or more. The most common complications were major arrhythmias (17%), major vascular complications (13%), major bleeding (12%), and minor vascular complications (8%).

Patients with complications were more likely to be women and inoperable and less likely to have undergone previous CABG.

Mean cost of the index hospitalization was $79,619 ($50,891, if excluding the cost of the valve), and mean length of stay was 10.4 days. Occurrence of any complication added $33,196 to the total hospital cost and 6.6 days to the length of stay.

On multivariable analysis, 7 complications were independently associated with increased hospitalization costs (table 1).

 Table 1. Effect of TAVR Complications

Overall, complications cost $12,475 per patient, representing 15.7% of the total hospitalization cost and 24.5% of the non–implant-related costs of TAVR.

Major bleeding complications were the most important driver of both initial hospital cost and length of stay. Overall, 2.4 hospital days were attributable to periprocedural complications, which represents 23.1% of the total length of stay.

Incentive to Reduce Complications

According to the study authors, since “75% of nonimplant hospitalization costs were not related to complications, reductions in the cost of uncomplicated TAVR (either by reducing postprocedural length of stay or through a minimalist approach to the implant procedure) will also be necessary to optimize the value of the technology.”

Dr. Arnold and colleagues note that several recent studies have demonstrated reductions in vascular complications and major bleeding with greater operator and institutional experience, a shift that should reduce costs. Additionally, they say, reductions in some complications may have a “multiplicative effect on overall hospital cost” by mediating other complications—eg, less bleeding may result in less renal failure or short-term mortality.

From the hospital’s perspective, the economic effect of these complications can be complex, the authors observe. For example, they write, “under the current Medicare diagnosis-related group-based reimbursement system, some complications that lead to substantial increases in hospital costs also result in reclassification of patients into a higher paying diagnosis-related group (eg, acute renal failure, stroke). Nonetheless, because the incremental cost of these complications is generally much higher than the payment differential, hospitals will still derive meaningful economic benefit from efforts to reduce these complications.”

Additionally, Dr. Arnold and colleagues predict that analyses like the current one will be useful in the construction of cost-effectiveness models since data “derived from patients actually undergoing TAVR should yield more valid… estimates than has been possible previously.”

Good ‘Yardstick’ of Procedural Costs

In a telephone interview with TCTMD, David P. Faxon, MD, of Brigham and Women’s Hospital (Boston, MA), said that while the finding that complications increase costs is unsurprising, the breakdown of those costs provides a different perspective from some previous economic analyses of TAVR.

“This is a very well done study that gives you a yardstick of some of these associated costs,” he said. “I didn’t really know prior to looking at this how much some of these individual things cost. What’s more important, though, is that most of the complications they identified as increasing costs are things we can do something about.”

Dr. Faxon agreed with the study authors that there is clearly a “cascading effect” of certain complications, such as bleeding, where improvement is needed and possible.

However, he also noted that the analysis included both arms of PARTNER and thus is likely to overestimate the number of complications that would be expected in less sick TAVR populations.

Peter C. Block, MD, of Emory University Hospital (Atlanta, GA), concurred. “These were all high-risk patients who had a lot of comorbidities, and when you look at where the major complications are, excluding death, the big hitters here are stroke, vascular problems, and renal insufficiency/renal failure,” he said in a telephone interview with TCTMD. “In the future as far as TAVR is concerned, major stroke and minor stroke hopefully will become less of an issue with the newer protection devices currently being evaluated in Europe. Additionally, the smaller [profile] of the devices will help minimize the vascular complications, so we can get people out of the hospital a lot sooner.”

Dr. Block added that renal insufficiency has been pinpointed as a problem in all economic analyses of TAVR thus far. “We need a better understanding of which patients will have renal failure and possibly need to just say no [to doing TAVR] in some of these patients because the risk is not going to be worth the benefit,” he said.

Note: Coauthors Susheel K. Kodali, MD, and Martin B. Leon, MD, are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source:
Arnold SV, Lei Y, Reynolds MR, et al. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial. Circ Cardiovasc Interv. 2014; Epub ahead of print.

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Disclosures
  • The PARTNER trial was sponsored by Edwards Lifesciences.
  • Drs. Arnold, Faxon, and Block report no relevant conflicts of interest.

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