Background
The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease.
Methods
We performed a single‐center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity‐matched cohort. Data on procedural metrics and outcomes up to 30‐days were abstracted.
Results
There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30‐days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30‐day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79).
Conclusion
In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.
Background
Sleep apnea is a predictor of adverse cardiovascular outcome in many cardiovascular diseases but whether it is associated with worse health status outcomes or mortality in peripheral artery disease (PAD) is unknown.
Methods
PORTRAIT is an international (US, Netherlands, Australia) prospective PAD registry that consecutively enrolled patients who presented with new-onset or recent exacerbations of PAD symptoms to any of 16 vascular specialty clinics. Health status was assessed upon presentation and at 12 months with the disease-specific Peripheral Artery Questionnaire (PAQ). Higher PAQ scores indicate better health status. A sequentially-adjusted hierarchical linear regression model examined the association between sleep apnea and 1-year PAQ symptoms, quality of life, and summary scores. Five-year survival curves by comorbid sleep apnea status for US patients were compared using the log-rank test.
Results
The mean age of the 1204 PORTRAIT participants was 67.6 ± 9.4 years with 37.5% women and 8.3% (n = 100) having sleep apnea. Patients with sleep apnea were more likely to be from the US, more sedentary, and to have diabetes, obesity, coronary disease, more depressive symptoms and a history of prior peripheral interventions. Paradoxically, they also had higher ankle-brachial indices, but lower PAQ Summary scores at presentation and 12 months (41.2 ± 22.0 vs. 49. 9± 21.6 and 58.6 ± 27.9 vs. 71.3 ± 24.9, respectively, p = <0.05). The association between sleep apnea and 1-year health status persisted after multivariable adjustment, but there were no differences in all-cause mortality over 5 years (28.0% vs. 23.4%, p = 0.76).
Conclusion
In patients presenting with PAD, comorbid sleep apnea is independently associated with worse health status over time. Future studies should test whether better treatment of sleep apnea can improve the health status of patients with PAD.
Clinical trial registration
NCT01419080
ABSTRACT. Here, we report intermediate follow-up details after using a technique of confluent posterior left atrial wall epicardial ablation designed to eliminate both existing and future atrial fibrillation (AF) substrates. The method is part of the Convergent hybrid procedure for AF ablation. In this study, multiple confluent epicardial ablations with radiofrequency energy were delivered, spanning the vertical and transverse dimensions of the posterior left atrium, along with facilitated pulmonary vein isolation (PVI). Endocardial mapping and ablation were performed to complete PVI and to ablate the cavotricuspid isthmus. All patients were followed clinically and using two-to-four weeks of continuous monitoring at six, 12, and 24 months, respectively. The average length of follow-up was 488 days. Of the 57 largely unselected patients with persistent or longstanding persistent AF (NPAF), mean duration of AF was 5.6 years. Single procedure freedom from AF through 24 months was 64.5%, and that for all arrhythmias, was 58.9%. Sixty-eight percent of patients were off antiarrhythmic drugs. Four patients (7%) required a second endocardial ablation procedure. A sub-analysis of the observed arrhythmia burden present through follow-up showed this to be small (ie, o1%) in the majority of patients involved in this study. In conclusion, the extended posterior left atrial wall ablation technique discussed here, as part of the Convergent hybrid method, achieved notable single-procedure success in a particularly challenging series of patients with NPAF.
Introduction:
Guideline-recommended medical therapy (GDMT) for cardiovascular risk reduction remains sub-optimally prescribed in patients with peripheral artery disease (PAD). To begin addressing this issue, it is key as a health system to be able to monitor electronic health record (EHR)-based real-world data to assess GDMT usage rates and its association with long-term mortality and amputation.
Methods:
We included all patients with PAD who underwent peripheral vascular interventions (PVI) across the Yale New Haven Health System in 2016-2022. GDMT at PVI discharge was defined as having all 3 of: angiotensin converting enzyme inhibitor/angiotensin receptor blocker (if hypertensive), antiplatelet, and statin. Propensity scores were calculated based on age, sex, race, ethnicity, and Elixhauser comorbidities. Inverse probability weighted Cox regression models with a random effect for site and provider were constructed to evaluate the relationship between GDMT and 2-year mortality and major amputation.
Results:
A total of 3,741 patients with PAD underwent PVI. The average age was 72.3 (± 12.9) years, and 39% were female. GDMT rates at PVI discharge ranged from 24% to 40% during the study period. Lack of GDMT at discharge had a statistically insignificant association 2-year mortality risk (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.98-1.50, p=0.07; figure top) and a significant positive association with 2-year major amputation risk (HR: 2.73, 95% CI:1.51-4.94, p<0.001; figure bottom).
Conclusions:
This study leveraged system-wide EHR data to study GDMT use and its association with mortality and major amputation, which may serve as a metric for quality of PAD care.
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