Comparison of lower extremity bypass and peripheral vascular intervention for chronic limb-threatening ischemia in the Medicare-linked Vascular Quality Initiative.

OBJECTIVE: There is a relative lack of comparative effectiveness research on revascularization for patients with chronic limb-threatening ischemia (CLTI). We examined the association between lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) for CLTI and 30-day and 5-year all-cause mortality and 30-day and 5-year amputation. METHODS: Patients undergoing LEB and PVI of the below-the-knee popliteal and infrapopliteal arteries between 2014 and 2019 were queried from the Vascular Quality Initiative, and outcomes data were obtained from the Medicare claims-linked Vascular Implant Surveillance and Interventional Outcomes Network database. Propensity scores were calculated on 15 variables using a logistic regression model to control for imbalances between treatment groups. A 1:1 matching method was used. Kaplan-Meier survival curves and hierarchical Cox proportional hazards regression with a random intercept for site and operator nested in site to account for clustered data compared 30-day and 5-year all-cause mortality between groups. Thirty-day and 5-year amputation were subsequently compared using competing risk analysis to account for the competing risk of death. RESULTS: There was a total of 2075 patients in each group. The overall mean age was 71 ± 11 years, 69% were male, and 76% were white, 18% were black, and 6% were of Hispanic ethnicity. Baseline clinical and demographic characteristics in the matched cohort were balanced between groups. There was no association between all-cause mortality over 30 days and LEB vs PVI (cumulative incidence, 2.3% vs 2.3% by Kaplan Meier; log-rank P-value = .906; hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.62-1.44; P-value = .80). All-cause mortality over 5 years was lower for LEB vs PVI (cumulative incidence, 55.9% vs 60.1% by Kaplan Meier; log-rank P-value < .001; HR, 0.77; 95% CI, 0.70-0.86; P-value < .001). Accounting for competing risk of death, amputation over 30 days was also lower in LEB vs PVI (cumulative incidence function, 1.9% vs 3.0%; Fine and Gray P-value = .025; subHR, 0.63; 95% CI, 0.42-0.95; P-value = .025). There was no association between amputation over 5 years and LEB vs PVI (cumulative incidence function, 22.6% vs 23.4%; Fine and Gray P-value = .184; subHR, 0.91; 95% CI, 0.79-1.05; P-value = .184). CONCLUSIONS: In the Vascular Quality Initiative-linked Medicare registry, LEB vs PVI for CLTI was associated with a lower risk of 30-day amputation and 5-year all-cause mortality. These results will serve as a foundation to validate recently published randomized controlled trial data, and to broaden the comparative effectiveness evidence base for CLTI.

Costs and complications of hospital admissions for inferior vena cava filter malfunction.

OBJECTIVE: Inferior vena cava filter (IVCF) malfunction can result from penetration, fracture, or migration of the device necessitating retrieval. Endovascular and open retrieval of IVCF have been described in institutional series without comparison. This study examines national hospital admissions for IVCF malfunction and compares the outcomes of open and endovascular retrieval. METHODS: The National Inpatient Sample database (2016-2017) was reviewed for admissions with International Classification of Diseases, Tenth Revision (ICD-10) codes specific for IVCF malfunction. All ICD-10 procedural codes were reviewed, and patients were divided based on open or endovascular IVCF retrieval. Patient characteristics, outcomes, and costs of hospitalization were compared between the two groups. RESULTS: There were 665 patients admitted with a diagnosis of IVCF malfunction. Open IVCF retrieval was performed in 100 patients and endovascular removal in 90 patients. Of those undergoing open surgery, 45 patients (45%) required median sternotomy and 55 (55%) required abdominal surgeries. Most patients were white females with a mean age of 54.4 years (range, 49.3-59.6 years) with a history of deep venous thrombosis (55.3%) or pulmonary embolism (31.6%). Most patients with IVCF malfunction were treated in large (81.6%) or urban teaching (94.7%) hospitals situated most commonly in the South (42.1%) and Northeast (29.0%) with no difference in characteristics of the patients or the centers between the two groups. Patients undergoing open IVCF retrieval were more likely to undergo surgery on an elective basis compared with endovascular IVCF retrieval (75.0% vs 11.1%; P < .001). Open IVCF retrieval was associated with a higher likelihood of thromboembolic complication compared with endovascular retrieval (20% vs 0%; P = .04). There was a trend toward higher infectious complications and overall complications with endovascular removal, but this difference did not reach statistical significance. Open retrieval was associated with a mortality of 5.0% compared with no inpatient mortality with endovascular retrieval (P = .33). The mean hospital length of stay was no difference between the two groups. Open retrieval was associated with significantly higher hospital costs than endovascular retrieval ($34,276 vs $19,758; P = .05). CONCLUSIONS: Filter removal for patients with IVCF malfunction is associated with significant morbidity and cost, regardless of modality of retrieval. The introduction of specific ICD-10 codes for IVCF malfunction allows researchers to study these events. The development of effective tools for outpatient retrieval of malfunctioning IVCF could decrease related hospitalization and have potential savings for the healthcare system.

Duplex scan-directed placement of inferior vena cava filters: a five-year institutional experience.

PURPOSE: The purpose of this study was the assessment of the safety, efficacy, and hospital charges of bedside duplex ultrasound-directed inferior vena cava (IVC) filter placement. METHODS: All duplex ultrasound-directed IVC filters that were placed from August 8, 1995, to December 31, 2000, are reviewed. Chart review combined with mailed questionnaires and telephone follow-up examinations were used to collect demographic and outcome data. RESULTS: Three hundred twenty-five patients underwent evaluation, and 284 underwent duplex ultrasound-directed IVC filter placement. Two hundred three (71%) were male patients, and 81 (29%) were female patients. Poor IVC visualization, IVC thrombosis, and unsuitable anatomy prevented duplex-directed filter placement in 41 patients (12%). Indication for filter placement included venous prophylaxis in the absence of thromboembolism in 235 patients (83%), contraindication to anticoagulation therapy in 34 patients (12%), prophylaxis with therapeutic anticoagulation therapy in the presence of thromboembolism in 7 patients (2%), and complication of anticoagulation therapy in 8 patients (3%). There were no procedure-related deaths or septic complications. Technical complications occurred in 12 patients (4%). Filter misplacement occurred in 6 patients (2%), access thrombosis in 1 (<1%), migration in 1 (<1%), bleeding in 1 (<1%), and IVC occlusion in 3 (1%). Pulmonary emboli after IVC filter placement occurred in one patient with a misplaced filter. Average hospital charges related to duplex ultrasound-directed filter placement were $2388 less than fluoroscopic placement charges in the year 2000. CONCLUSION: Our experience indicates that duplex ultrasound-directed IVC filter placement is safe, cost-effective, and convenient for patients who need IVC filter placement.