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Background: The 3M-TAVR trial (3M-Transcatheter Aortic Valve Replacement) demonstrated the feasibility and safety of next-day hospital discharge after transfemoral TAVR with implementation of a minimalist pathway. However, the economic impact of this approach is unknown. Therefore, we evaluated costs for patients undergoing minimalist TAVR compared with conventional TAVR. Methods: We used propensity matching to compare resource utilization and costs (from a US health care system perspective) for patients in the 3M-TAVR trial with those for transfemoral TAVR patients enrolled in the contemporaneous S3i trial (PARTNER SAPIEN-3 Intermediate Risk). Procedural costs were estimated using measured resource utilization for both groups. For the S3i group, all other costs through 30-day follow-up were assessed by linkage with Medicare claims; for 3M, these costs were assessed using regression models derived from S3i cost and resource utilization data. Results: After 1:1 propensity matching, 351 pairs were included in our study (mean age 82, mean Society of Thoracic Surgery risk score 5.3%). There were no differences in death, stroke, or rehospitalization between the 3M-TAVR and S3i groups through 30-day follow-up. Index hospitalization costs were $10 843/patient lower in the 3M-TAVR cohort, driven by reductions in procedure duration, anesthesia costs, and length of stay. Between discharge and 30 days, costs were similar for the 2 groups such that cumulative 30-day costs were $11 305/patient lower in the 3M-TAVR cohort compared with the S3i cohort ($49 425 versus $60 729, 95% CI for difference $9378 to $13 138; P Conclusions: Compared with conventional transfemoral TAVR, use of a minimalist pathway in intermediate-risk patients was associated with similar clinical outcomes and substantial in-hospital cost savings, which were sustained through 30 days. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02287662.

Background: The COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI) demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular events in patients with ST-segment–elevation myocardial infarction and multivessel coronary artery disease. It is unclear whether consistent benefit is observed in patients undergoing a pharmacoinvasive strategy compared with primary PCI. Methods: Following culprit lesion PCI, 4041 patients with ST-segment–elevation myocardial infarction and multivessel coronary artery disease were randomized to either routine nonculprit lesion PCI or culprit lesion only PCI. In a prespecified analysis, we determined the treatment effect in 303 patients undergoing a pharmacoinvasive strategy versus 3738 patients undergoing primary PCI on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Results: The first coprimary was reduced with complete revascularization both in the patients undergoing a pharmacoinvasive strategy (2.1%/y versus 4.7%/y, hazard ratio, 0.45 [95% CI, 0.21–0.97]) and in patients undergoing primary PCI (2.7%/y versus 3.6%/y, hazard ratio, 0.77 [95% CI, 0.62–0.95]; interaction P =0.18). The second coprimary outcome was reduced with complete revascularization in patients undergoing a pharmacoinvasive strategy (2.3%/y versus 8.5%/y, hazard ratio, 0.28 [95% CI, 0.14–0.56]), and in patients undergoing primary PCI (3.2%/y versus 6.0%/y, hazard ratio, 0.53 [95% CI, 0.44–0.64], interaction P =0.07). Conclusions: Among patients with ST-segment–elevation myocardial infarction and multivessel disease, complete revascularization with multivessel PCI consistently reduces major cardiovascular events in patients undergoing an initial pharmacoinvasive strategy as well as in those undergoing primary PCI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01740479.

Background— Interventional cardiologists receive one of the highest levels of annual occupational radiation exposure. Further measures to protect healthcare workers are needed. Methods and Results— We evaluated the efficacy of a pelvic lead shield and a novel surgical cap in reducing operators’ radiation exposure. Patients undergoing coronary angiography or percutaneous coronary intervention (n=230) were randomized to have their procedure with or without a lead shield (Ultraray Medical, Oakville, Canada) placed over the patient. During all procedures, operators wore the No Brainer surgical cap (Worldwide Innovations and Technology, Kansas City, KS) designed to protect the head from radiation exposure. The coprimary outcomes for the lead shield comparison were (1) operator dose (µSv) and (2) operator dose indexed for air kerma (µSv/mGy). For the cap comparison, the primary outcome was the difference between total radiation dose (µSv; internal and external to cap). The lead shield use resulted in a 76% reduction in operator dose (mean dose, 3.07; 95% confidence interval [CI], 2.00–4.71 µSv lead shield group versus 12.57; 95% CI, 8.14–19.40 µSv control group; P P P Conclusions— The use of a pelvic lead shield and the cap reduced significantly the operator radiation exposure and can be easily incorporated into clinical practice. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02128035.