Circulation: Cardiovascular Interventions最新文献

Background: Current national performance metrics rank transcatheter aortic valve replacement (TAVR) centers based on risk-adjusted outcomes. This could make operators/centers less inclined to offer TAVR in high-risk cases.

Methods: We used simulation models based on registry data to explore whether avoiding high-risk TAVR cases would improve the hospitals' comparative risk-adjusted TAVR outcomes. This multicenter, retrospective cohort study included all adults (≥18 years) who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry in 2021. We evaluated hospital-level, risk-adjusted outcomes, before and after simulating the omission of the top 10% highest risk patients. The primary outcome was a 30-day composite of death, stroke, VARC major/life-threatening/disabling bleeding, renal failure, or moderate/severe para-valvular leak. The secondary outcome was 30-day death. We used the mean difference±SD in the win ratio and observed/expected ratio for evaluation of the primary and secondary outcomes, respectively.

Results: There were 43 907 TAVR cases with available primary outcome data and 56 982 cases with available secondary outcome data. Median age was 79 (73-84) years, 57% were men, and 93% were White race. Our simulation demonstrates that, on average, excluding the top 10% highest risk patients from centers' case mix would not change their hospital-level, risk-adjusted win ratio (mean difference, 0.002±0.067; P=0.60) or observed/expected ratio (mean difference, 0.003±0.633; P=0.90).

Conclusions: Hospital-level, risk-adjusted TAVR outcomes did not consistently improve with simulated strategies of avoiding the highest-risk cases. Operators and centers can be reassured that they can continue to offer TAVR to high-risk patients, as clinically indicated, without the sole focus on being penalized via quality measures.

Background: The treatment of calcified coronary lesions requires optimal lesion preparation to achieve a larger minimal stent area (MSA), the strongest predictor of long-term outcomes. The comparative mechanisms of action of calcium-modifying therapies have not been well defined.

Methods: In a prospective, multicenter ECLIPSE trial (Evaluation of Treatment Strategies for Severe Calcific Coronary Arteries: Orbital Atherectomy Versus Conventional Angioplasty Technique Before Implantation of Drug-Eluting Stents), 2005 patients with severely calcified lesions were randomized to vessel preparation with orbital atherectomy (OA) versus balloon angioplasty (BA) before drug-eluting stent implantation. The primary end point of the optical coherence tomography (OCT) substudy was the MSA at the site of maximal calcification; MSA across the entire stent was also assessed.

Results: Postprocedural OCT images were available in 286 lesions in 276 patients treated with OA and 292 lesions in 279 patients treated with BA. By angiographic core laboratory analysis, 567 (98.1%) of lesions were severely calcified. By postprocedural OCT, the maximal calcium arc, maximal calcium thickness, and total calcium length measured 204° (149°-268°), 0.85 mm (°0.69-1.03°), and 22.0 (16.0-31.0) mm. Compared with BA, calcium modification was greater in the OA group (greater number, total length, and maximal depth of calcium fractures), especially in lesions with thicker calcium. Nonetheless, the MSA at the site of maximal calcification was large in both groups and not different (median [interquartile range], 7.44 [6.03-8.94] mm² versus 7.05 [5.78-8.66] mm²; P=0.08). Similar results were observed for the MSA across the entire stent (5.86 [4.60-7.38] mm² versus 5.57 [4.50-6.97] mm²; P=0.10). Among patients in the OCT substudy, 1-year target-vessel failure rates were low and not different between the groups (7.8% with OA and 6.6% with BA, P=0.61).

Conclusions: In lesions that are severely calcified by angiography, the extent of calcification by OCT was highly variable. Despite greater calcium modification after OA, the acute MSA and 1-year target-vessel failure rates were not different between OA and BA.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03108456.