Total IN.PACT All-Subjects One-Year Analysis and Standard vs Broader Implications.

Drug-coated balloons (DCBs) have been shown to be superior to percutaneous transluminal angioplasty (PTA) for symptomatic femoropopliteal disease in randomized clinical trials; however, their clinical effectiveness and safety in more complex disease is less defined. The study sought to conduct a patient-level pooled analysis of all prospective randomized and single-arm studies evaluating the safety and efficacy of IN.PACT Admiral DCB (Medtronic) worldwide and in patients with complex disease. Subjects were treated with either IN.PACT Admiral DCB (n = 1837) or PTA (n = 143). The primary endpoint was freedom from clinically driven target-lesion revascularization (CD-TLR) within 12 months. The primary safety composite endpoint was freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months. Subsequently, we examined "real-life" complex lesions in a subgroup analysis, with standard use defined as simple, single de novo lesions (n = 712) and broader use defined as bilateral or multiple lesions (n = 1125). DCB when compared with PTA had significantly higher rates of freedom from CD-TLR through 12 months (93.8% vs 80.2%, respectively; P<.001). The DCB group did note higher rates of mortality at 1 year (3.1% DCB vs 0.0% PTA; P=.03). Notably, the broader use group showed superiority over the PTA group for freedom from CD-TLR (91.7% vs 80.2%; P<.001). IN.PACT Admiral DCB showed clinical superiority to PTA in the largest patient-level pooled analysis. Additionally, despite more complex and challenging lesions, DCB was superior to PTA. However, further adequately powered randomized studies are needed to confirm these results.

Transcatheter Valve Implantation for Failed Surgical Aortic and Mitral Bioprostheses: A Single-Center Experience.

OBJECTIVES: We share our center's experience with the use of transcatheter valvular therapies in the setting of failed bioprostheses. BACKGROUND: As medicine continues to advance, the lifespan of individuals continues to increase, and current surgical valvular therapies begin to degrade prior to a person's end of life. It is important to evaluate the efficacy and durability of transcatheter valves within failed surgical bioprostheses. METHODS: Baseline characteristics, periprocedural complications, and long-term outcomes were collected and assessed in patients who received transcatheter valves for failing surgical aortic valve bioprostheses and mitral valve and ring bioprostheses from March 2011 to July 2018. RESULTS: From our cohort of 1048 patients, we identified 45 individuals (4.3%) who underwent transcatheter replacement of a failed bioprosthetic valve or ring. Mean age at presentation was 80.8 ± 10.7 years and 75.5 ± 9.3 years, mean STS score was 9.3 ± 5.1 and 13.3 ± 8.7, and mean time to failure was 12.0 ± 5.2 years and 7.3 ± 4.5 years for aortic and mitral positions, respectively. At 1 year, time to event analysis suggested a 16.4% mortality rate for aortic replacement and 12.8% mortality rate for mitral replacement. CONCLUSIONS: We demonstrate outcomes from one of the largest single-center United States based cohorts of transcatheter replacements of failed surgical bioprostheses. Our center has demonstrated that it is feasible to pursue the replacement of failed surgical bioprostheses in the aortic and mitral positions with transcatheter valves given appropriate patient selection.

Short-Term and Long-Term Outcomes of Patients Undergoing Urgent Transcatheter Aortic Valve Replacement Under a Minimalist Strategy.

OBJECTIVES: Urgent transcatheter aortic valve replacement (TAVR) is associated with worse short-term outcomes compared with elective TAVR; however, little is known about long-term outcomes or the safety of the minimalist strategy in this setting. This study investigated the short-term and long-term outcomes of urgent TAVR compared with elective TAVR under a minimalist strategy (transfemoral [TF] approach with conscious sedation and no transesophageal echocardiography guidance). METHODS: After excluding 2 emergent patients requiring immediate procedures, a total of 474 consecutive patients underwent elective TF-TAVR (396 patients; 83.6%) or urgent TF-TAVR (78 patients; 16.4%). Urgent TAVR was defined as a procedure performed in the same hospitalization in patients emergently admitted due to cardiac arrest, severe acute decompensated heart failure, acute coronary syndrome, or repeated syncopal episodes. RESULTS: A minimalist approach was used in 77 patients (98.7%) undergoing urgent TAVR and in 392 patients (99.0%) undergoing elective TAVR (P=.59). Urgent TAVR had similar procedure-related complications, such as stroke, myocardial infarction, bleeding or vascular complications, and in-hospital mortality compared with elective TAVR (mortality, 1.3% vs 0.8%; P=.51) with no intraprocedural cross-over from conscious sedation to general anesthesia. However, 30-day and 1-year survival rates were reduced in patients undergoing urgent TAVR. After adjustment with baseline and procedural factors, urgent TAVR remained significantly predictive of 1-year mortality (adjusted hazard ratio, 2.26; 95% confidence interval, 1.16-4.23; P=.01). CONCLUSIONS: Urgent minimalist TAVR can be safely performed with favorable in-hospital outcomes, while increased 30-day and 1-year mortality rates suggest the importance of appropriate diagnosis and timely treatment of severe aortic stenosis.

Patient Insurance Profiles: A Tertiary Care Compared to Three Freestanding Emergency Departments.

BACKGROUND: It has been speculated that freestanding emergency departments (FEDs) draw more affluent, better-insured patients away from urban hospital EDs. It is believed that this leaves urban hospital-based EDs less financially secure. OBJECTIVE: We examined whether the distribution of patients with four types of insurance (self-pay, Medicaid, Medicare, and private) at the main ED changed after opening three affiliated FEDs, and whether the insurance type distribution was different between main ED and FEDs and between individual FEDs. METHODS: A retrospective analysis of insurance status of all patients presenting to our EDs from July 2006 through August 2013. Insurance was divided into self-pay, Medicare, Medicaid, and private insurance across three time periods, which reflect the sequential opening of each FED. Insurance types for each facility were compared for individual time periods and across time periods. χ2 was used to analyze the data. RESULTS: In the three studied time frames (periods B, C, and D), there were less privately insured patients and more self-pay, Medicaid, and Medicare patients at the main than at each FED (p < 0.001). Insurance types were significantly different between each of the three FEDs and the main ED (p < 0.001) and between each of the three FEDs (p < 0.001). CONCLUSIONS: There were less privately insured patients and more self-pay, Medicaid, and Medicare patients at the main ED compared to the FEDs. Privately insured patients decreased at both the FEDs and main ED during the study. Insurance distribution was significantly different between the main ED, and three FEDs, and between individual FEDs.