• Costs of Periprocedural Complications in Patients Treated with Transcatheter Aortic Valve Replacement

    Costs of Periprocedural Complications in Patients Treated with Transcatheter Aortic Valve Replacement- Suzanne V. Arnold, MD on behalf of The PARTNER Trial Investigators and The PARTNER Publications Office Results from The PARTNER Trial Transcatheter aortic valve replacement (TAVR) improves survival and quality of life compared with nonsurgical therapy in patients with severe aortic stenosis TAVR is associated with high in-hospital and long-term costs A formal economic evaluation demonstrated that the benefits of TAVR were achieved at an acceptable incremental cost to society Reynolds et al. Circulation. 2012;125-1102-9. With any emerging technology, complications should decrease with greater operator and site experience as well as improved devices Since complications were not rare in PARTNER, the costs of treating complications could have substantially impacted the overall cost of TAVR To estimate the incremental cost of specific peri-procedural complications of TAVR To estimate the contribution of peri-procedural complications to the overall cost of TAVR in The PARTNER Trial Patient Population As-treated TAVR patients in PARTNER I Cohorts A & B with billing data available Costs U.S. health care perspective 2010 U.S. dollars Combination of hospital billing data and resource-based accounting methods Death CVA major and minor Myocardial infarction Vascular complication major and minor Renal insufficiency serum creatinine >3 mg/dL Renal failure need for dialysis Major bleeding Arrhythmia high-degree AV block, atrial fibrillation or flutter, or ventricular tachycardia New permanent pacemaker Repeat TAVR Surgical AVR Incremental costs and LOS of each complication, independent of demographic and clinical factors and other complications Series of models to identify patient predictors of complications, patient predictors of costs in patients without complications, potential interactions Saturated model included all complications Reduced model identified only complications significantly associated with costs (or LOS) Considered both log-transformed and untransformed costs Enrolled in PARTNER N=1057 TAVR Patients N=519 Billing Data Available N=406 No Complications N=225 =1 Complication N=181 (45%) 1 Complication N=79 (20%) 2 Complications N=36 (9%) = 3 Complications N=66 (16%) –113 patients without billing data Mean age- 84 years 47% female Mean AVA- 0.66 cm2 95% NYHA III-IV Mean cost for the initial hospitalization was $78,282 ± 40,790 ($47,322 excluding the valve) and the mean LOS was 10.3 days Patients with a complication had higher costs and longer LOS compared with those who did not Unadjusted incremental cost of $33,196 Unadjusted incremental LOS of 6.6 days *Adjusted for age, sex, prior bypass surgery, peripheral vascular disease, diabetes, and STS mortality risk score; R2=0.41 *Adjusted for age, sex, prior bypass surgery, peripheral vascular disease, diabetes, and STS mortality risk score; R2=0.41 *Adjusted for age, sex, prior bypass surgery, peripheral vascular disease, diabetes, and STS mortality risk score; R2=0.29 Attributable costs and LOS were calculated by multiplying the independent cost of the event from the regression model coefficients by its frequency in the study population This allows us to better understand the contribution of specific complications to the overall cost and LOS for the patients in PARTNER Cost data were available for only 406 patients, which limits our ability to obtain precise estimates of the costs associated with rare complications These will need to be examined in larger datasets All patients were enrolled in a clinical trial, representing the earliest experience with TAVR at most sites Should have primarily affected rates of complications and the costs of uncomplicated hospitalizations Complications were defined by PARTNER Trial protocol, prior to VARC publication Peri-procedural complications were common and associated with substantial costs and increased LOS both on a per event basis (i.e., incremental cost or LOS) as well as on a per hospitalization basis (i.e., attributable cost or LOS) Bleeding, death, and post-procedure renal failure led to the greatest increases in overall costs Interventions targeted to reduce these complications would be expected to yield the greatest benefit in terms of improving the cost-effectiveness of TAVR Complications accounted for nearly 20% of non-implant related hospital costs Since ~80% of hospitalization costs were not related to complications, reductions in the cost of uncomplicated TAVR will also be necessary to optimize the value of the technology Unadjusted hospital cost and LOS for all patients and for the complication categories are presented as mean ± standard deviation Unadjusted incremental costs and LOS of each complication- Mean cost or LOS of patients with complication – mean cost or LOS of patients without complication Step 1- Identify patient factors associated with complications Logistic regression model with backwards selection p<0.1 with “any complication” as the dependent variable Step 2- Identify patient factors associated with costs in patients without complications GLM model with log-link with backward selection p<0.1 with costs as the dependent variable Step 3- Independent predictors of costs reduced Linear regression model including age, sex, all covariates identified in Steps 1 & 2 all forced in Peri-procedural complications were included with backwards selection p<0.1 Interactions between vascular complications and bleeding and between arrhythmias and pacemaker were considered and retained if p<0.1 Step 4- Independent predictors of costs saturated Repeat Step 3 with all peri-procedural complications *Adjusted for age, sex, prior bypass surgery, peripheral vascular disease, diabetes, and STS mortality risk score R2=0.30

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