Douglas, Pamela S

Background— The higher risk of adverse outcomes after transapical (TA) versus transfemoral (TF) transcatheter aortic valve replacement (TAVR) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA- and TF-TAVR patients. We compared outcomes after neutralizing patient differences using propensity score matching. Methods and Results— From April 2007 to February 2012, 1100 Placement of Aortic Transcatheter Valves (PARTNER)-I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses. Propensity matching based on 111 preprocedural variables, exclusive of femoral access morphology, identified 501 well-matched patient pairs (46% of possible matches), 95% of whom had peripheral arterial disease. Matched TA-TAVR patients experienced more adverse procedural events, longer length of stay (5 versus 8 days; P <0.0001), and slower recovery (New York Heart Association class I, 31% versus 38% at 30 days, equalizing by 6 months at 51% versus 47%); stroke risk was similar (3.4% versus 3.3% at 30 days and 6.0% versus 6.7% at 3 years); mortality was elevated for the first 6 postprocedural months (19% versus 12%; P =0.01); but aortic regurgitation was less (34% versus 52% mild and 8.9% versus 12% moderate to severe at discharge, P =0.001; 36% versus 50% mild and 10% versus 15% moderate to severe at 6 months, P <0.0001). Conclusions— The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation is less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

Background— In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR. Methods and Results— Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve (PARTNER) I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79 619±40 570 ($50 891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia, and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12 475 per patient in initial hospital costs and 2.4 days of hospitalization. Conclusions— In the PARTNER trial, periprocedural complications were frequent, costly, and accounted for ≈25% of non-implant–related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

Background— The objective was to evaluate the effects of aortic annulus size on valve hemodynamics and clinical outcomes in those patients included in the Placement of Aortic Transcatheter Valves (PARTNER) randomized controlled trial cohort A and the nonrandomized continued access cohort. Methods and Results— Patients included the randomized controlled trial (n=574) and nonrandomized continued access (n=1358) cohorts were divided in tertiles according to aortic annulus diameter (small aortic annulus tertile, medium aortic annulus tertile, and large aortic annulus tertile [LAA], respectively) as measured by transthoracic echocardiography. Severe prosthesis–patient mismatch was defined as an effective aortic orifice area of <0.65 cm 2 /m 2 . In the randomized controlled trial cohort, patients in the small aortic annulus tertile who underwent transcatheter aortic valve replacement had a lower incidence of severe prosthesis–patient mismatch (19.7% versus 37.5%; P =0.03) and only a trend toward a higher incidence of moderate-to-severe paravalvular leaks compared with surgical aortic valve replacement (5.7% versus 0%; P =0.06). In the LAA tertile, there were no differences in the rate of prosthesis–patient mismatch between groups, and a significant increase in moderate-to-severe paravalvular leaks was associated with transcatheter aortic valve replacement (9% versus 0%; P =0.01). There were no differences in mortality between transcatheter aortic valve replacement and surgical aortic valve replacement. In the nonrandomized continued access cohort, there were no differences in prosthesis–patient mismatch between the small aortic annulus and LAA tertiles, but a higher rate of moderate-to-severe paravalvular leaks was observed in the LAA tertile (5.9% versus 11.5%; P =0.009). Patients in the LAA tertile had a higher mortality rate at 1-year follow-up ( P =0.02), and differences persisted in multivariable analysis ( P =0.048 for LAA versus medium aortic annulus tertile, P =0.035 for LAA versus small aortic annulus tertile). Conclusions— Aortic annulus size had a major impact on valve hemodynamics and clinical outcomes after transcatheter aortic valve replacement and surgical aortic valve replacement. This study highlights the importance of considering aortic annulus size in the evaluation of high-risk patients who are candidates for aortic valve replacement. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00530894.

Background— Measurement of hospital quality has traditionally focused on processes of care and postprocedure outcomes. Appropriateness measures for percutaneous coronary intervention (PCI) assess quality as it relates to patient selection and the decision to perform PCI. The association between patient selection for PCI and processes of care and postprocedural outcomes is unknown. Methods and Results— We included 203 531 patients undergoing nonacute (elective) PCI from 779 hospitals participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry between July 2009 and April 2011. We examined the association between a hospital's proportion of nonacute PCIs categorized as inappropriate by the 2009 Appropriate Use Criteria (AUC) for Coronary Revascularization and in-hospital mortality, bleeding complications, and use of optimal guideline-directed medical therapy at discharge (ie, aspirin, thienopyridines, and statins). When categorized as hospital tertiles, the range of inappropriate PCI was 0.0% to 8.1% in the lowest tertile, 8.1% to 15.2% in the middle tertile, and 15.2% to 58.6% in the highest tertile. Compared with lowest-tertile hospitals, mortality was not significantly different at middle-tertile (adjusted odds ratio [OR], 0.93; 95% confidence interval [CI], 0.73–1.19) or highest-tertile hospitals (OR, 1.12; 95% CI, 0.88–1.43; P =0.35 for differences between tertiles). Similarly, risk-adjusted bleeding did not vary significantly (middle-tertile OR, 1.13; 95% CI, 1.02–1.16; highest-tertile OR, 1.02; 95% CI, 0.91–1.16; P =0.07 for differences between tertiles) nor did use of optimal medical therapy at discharge (85.3% versus 85.7% versus 85.2%; P =0.58). Conclusions— In a national cohort of nonacute PCIs, a hospital's proportion of inappropriate PCIs was not associated with in-hospital mortality, bleeding, or medical therapy at discharge. This suggests PCI appropriateness measures aspects of hospital PCI quality that are independent of how well the procedure is performed. Therefore, PCI appropriateness and postprocedural outcomes are both important metrics to inform PCI quality.