Real-world comparative claims analysis of a novel single-branched aortic stent graft device versus thoracic endograft placement with extra-anatomic debranching/revascularization in zone 2 aortic disease.

Background: Thoracic endovascular aortic repair (TEVAR) involving landing zone 2 can require extra-anatomic debranching (SR-TEVAR) to ensure left subclavian artery perfusion, resulting in increased costs. A single-branch device (Thoracic Branch Endoprosthesis [TBE], WL Gore, Flagstaff, AZ) provides a total endovascular solution. Comparative cost analysis of patients undergoing zone 2 TEVAR requiring left subclavian artery preservation with TBE versus SR-TEVAR is presented. Methods: A single-center retrospective cost analysis was performed for aortic diseases requiring a zone 2 landing zone (TBE vs. SR-TEVAR) from 2014 to 2019. Facility charges were collected from the universal billing form UB-04 (form CMS 1450). Results: Twenty-four patients were included in each arm. There were no significant differences in the overall mean procedural charges between the two groups: TBE, $209,736 ($57,761) vs. SR-TEVAR $209,025 ($93,943), P = 0.94. TBE resulted in reduced operating room charges ($36,849 [$8750] vs. $48,073 [$10,825], P = 0.02) and reduced intensive care unit and telemetry room charges, which did not reach statistical significance (P = 0.23 and 0.12, respectively). Device/implant charges were the primary cost driver in both groups. Charges associated with TBE were significantly higher: $105,525 ($36,137) vs. $51,605 ($31,326), P > 0.01. Conclusions: TBE had similar overall procedural charges despite higher device/implant-related expenses and reduced facility resource utilization (lower operating room, intensive care unit, telemetry, and pharmacy charges).

Surgical debranching versus branched endografting in zone 2 thoracic endovascular aortic repair.

BACKGROUND: Left subclavian artery (LSA) revascularization has been recommended for patients undergoing elective thoracic endovascular aortic repair (TEVAR) with a proximal zone 2 landing requiring coverage of the LSA. The clinical standard of care remains surgical LSA revascularization. However, recently, the feasibility of using branched endografts has been demonstrated. We compared the perioperative and mid-term outcomes of these approaches. METHODS: We performed a retrospective review of consecutive patients who underwent TEVAR with a proximal zone 2 landing at a single center from 2014 to 2020. The patients were divided into cohorts for comparison: those who underwent surgical revascularization (SR-TEVAR group) and those who underwent thoracic branched endografting with an investigational device (TBE group). Those patients who did not undergo LSA revascularization were excluded. Perioperative outcomes, including procedural success, death, stroke, limb ischemia, and length of stay, were compared. Kaplan-Meier survival curves were compared using the log-rank test. The cumulative incidence of device-related endoleak (types I and III) and device-related reintervention, accounting for death as a competing hazard, were compared using the Fine-Gray test. RESULTS: A total of 55 patients were included: 31 (56%) in the SR-TEVAR group and 24 (44%) in the TBE group. The preoperative demographics and comorbidities were similar between the two groups. Procedural success was 100% in both cohorts, with no periprocedural strokes or left upper extremity ischemic events. One operative or 30-day death (TBE, 4.2%; vs SR-TEVAR, 3.2%; P = .99) occurred in each cohort. The total operative time (TBE, 203 ± 79 minutes; vs SR-TEVAR, 250 ± 79 minutes; P = .03) and total length of stay (TBE, 5.2 ± 3.6 days; vs SR-TEVAR, 9.9 ± 7.2 minutes; P = .004) were both significantly shorter in the TBE group. No difference was found in mid-term survival (log-rank test, P = .50) nor the cumulative incidence of device-related endoleak (Fine-Gray test, P = .51) or reintervention (Fine-Gray test, P = .72). No occlusions of the TBE graft or surgical bypass or transpositions had occurred after a mean follow-up of 28 ± 16 and 34 ± 24 months, respectively. CONCLUSIONS: TBE can be performed with procedural success rate and safety profile comparable to those of TEVAR with surgical revascularization, with a decreased total length of stay, for patients requiring proximal zone 2 coverage. The mid-term outcomes for each approach were also similar. Prospective, randomized comparisons of these techniques are warranted.

Comparison of the Bentall procedure versus valve-sparing aortic root replacement.

Bentall and valve-sparing root replacement (VSRR) procedures are established treatments for aortic root disease. We present a single-center retrospective analysis comparing outcomes of bioprosthetic Bentall (BB), mechanical Bentall (MB), and VSRR patients from November 2007 to October 2016. Survival analysis was performed to evaluate the composite endpoint of freedom from recurrent aortic insufficiency, reoperation, or death. Of the 170 patients, BB was performed in 36 patients, MB in 63 patients, and VSRR in 71 patients. For BB, MB, and VSRR, the mean age was 63.8, 45.5, and 49.2 years (P < 0.001), respectively. Additionally, significantly more patients in the MB group (n = 32, 50.8%, P < 0.001) than in the BB and VSRR groups had prior cardiac surgeries. Cardiopulmonary bypass time and cross-clamp time were significantly longer in the VSRR group (P = 0.04 and 0.0005, respectively). Despite the complexity of the procedure, VSRR patients had higher combined freedom from death and reoperation than patients in the BB or MB groups. Elective Bentall root replacement is an excellent option for patients with root disease. Patients undergoing Bentall tend to have more severe or emergent cases, making them unlikely candidates for VSRR. VSRR in experienced centers carries equivalent morbidity and mortality and improved survival.

Comparison of Frequency of Vascular Complications With Ultrasound-Guided Versus Fluroscopic Roadmap-Guided Femoral Arterial Access in Patients Who Underwent Transcatheter Aortic Valve Implantation.

To compare outcomes of ultrasound guidance (USG) versus fluoroscopy roadmap guidance (FG) angiography for femoral artery access in patients who underwent transfemoral (TF) transcatheter aortic valve implantation (TAVI) to determine whether routine USG use was associated with fewer vascular complications. Vascular complications are the most frequent procedural adverse events associated with TAVI. USG may provide a decreased rate of access site complications during vascular access compared with FG. Patients who underwent TF TAVI between July 2012 and July 2017 were reviewed and outcomes were compared. Vascular complications were categorized by Valve Academic Research Consortium-2 criteria and analyzed by a multivariable logistic regression adjusting for potential confounding risk factors including age, gender, body mass index, peripheral vascular disease, Society of Thoracic Surgeons score and sheath to femoral artery ratio. Of the 612 TAVI patients treated, 380 (63.1%) were performed using USG for access. Routine use of USG began in March 2015 and increased over time. Vascular complications occurred in 63 (10.3%) patients and decreased from 20% to 3.9% during the study period. There were fewer vascular complications with USG versus FG (7.9% vs 14.2%, p = 0.014). After adjusting for potential confounding risk factors that included newer valve systems, smaller sheath sizes and lower risk patients, there was still a 49% reduction in vascular complications with USG (odds ratio 0.51, 95% confidence interval 0.29 to 0.88, p = 0.02). In conclusion, USG for TF TAVI was associated with reduced vascular access site complications compared with FG access even after accounting for potential confounding risk factors and should be considered for routine use for TF TAVI.