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Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while post-market surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the two sources.Patient-level data from two industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data was matched at the patient-level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention.Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at one year, 82.6% at three years, and 68.1% at five years. Estimates for freedom from reintervention were 90% at one year, 82.4% at three years, and 78.1% at five years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank p=0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at one and five years, respectively (log-rank p=0.13).Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5 years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.

The Vascular Study Group of New England (VSGNE) conducted a pilot study evaluating the feasibility of 30-day data collection in patients undergoing infrainguinal bypass (INFRA) which was subsequently expanded to include a limited number of additional sites within the Vascular Quality Initiative (VQI). The purpose of our study was to use these data to evaluate the incidence of 30-day readmission after infrainguinal bypass. A secondary goal of the study was to perform a critical appraisal of the data elements and definitions in the 30-day dataset.All infrainguinal bypass procedures performed during the pilot study period (7/2008 and 4/2016) were identified and merged with a dataset containing the 30-day data. Incidence and types of readmission were assessed. The primary endpoint was 30-day readmission, defined as any hospital readmission within 30 days of index operation; unplanned 30-day readmission was the secondary endpoint. Covariates tested for association with the primary and secondary endpoints included patient demographics, comorbidities, procedural, and postoperative characteristics. Variables significant on univariate screen (P 0.2) were evaluated with logistic regression to identify independent determinants.Of 9,847 infrainguinal bypass patients, 5,842 (59%) patients were identified with 30-day data, and 907 (16%) were readmitted within 30 days. Of readmissions, 675 (85%) were unplanned. Potentially modifiable independent determinants of any 30-day readmission included 30-day surgical site infection (SSI) (odds ratio [OR]: 10, 95% confidence interval [CI]: 8.2-12, P 0.0001), postoperative acute kidney injury (OR: 1.7, 95% CI: 1.2-2.5, P = 0.002), and discharge anticoagulation (OR: 1.2, 95% CI: 1.04-1.5; P = 0.02). Predictors of unplanned 30-day readmission were very similar but identified in-hospital major amputation as an additional independent predictor (OR: 2.8, 95% CI: 1.6-4.9, P = 0.0002).This study demonstrates the interest in, and value of, 30-day data collection in VSGNE/VQI and documents the frequency of readmission after infrainguinal bypass. Readmission within 30 days is strongly associated with SSI, stressing the importance of efforts to decrease this complication. Given that many other predictors are unmodifiable, 30-day readmission is only appropriate as a quality metric if it is risk adjusted using large, real-world datasets such as VQI. Lessons learned from this analysis can be used to select optimal 30-day data elements.

Background Optimal patient selection for lower extremity bypass surgery requires surgeons to predict which patients will have durable functional outcomes following revascularization. Therefore, we examined risk factors that predict amputation or graft occlusion within the first year following lower extremity bypass. Methods Using our regional quality-improvement initiative in 11 hospitals in northern New England, we studied 2,306 lower extremity bypass procedures performed in 2,031 patients between January 2003 and December 2007. Sixty surgeons contributed to our database, and over 100 demographic and clinical variables were abstracted by trained researchers. Cox proportional hazards models were used to generate hazard ratios and surrounding 95% confidence intervals (CIs) for our combined outcome measure of major amputation (above-knee or below-knee) or permanent graft occlusion (loss of secondary patency) occurring within the first year postoperatively. Results We found that within our cohort of 2,306 bypass procedures 17% resulted in an amputation or graft occlusion within 1 year of surgery. Of the 143 amputations performed (8% of all limbs undergoing bypasses), 17% occurred in the setting of a patent graft. Similarly, of the 277 graft occlusions (12% of all bypasses), 42% resulted in a major amputation. We identified eight preoperative patient characteristics associated with amputation or graft occlusion in multivariate analysis: age

Background Some patients who undergo lower extremity bypass (LEB) for critical limb ischemia ultimately require amputation. The functional outcome achieved by these patients after amputation is not well known. Therefore, we sought to characterize the functional outcome of patients who undergo amputation after LEB, and to describe the pre- and perioperative factors associated with independent ambulation at home after lower extremity amputation. Methods Within a cohort of 3,198 patients who underwent an LEB between January, 2003 and December, 2008, we studied 436 patients who subsequently received an above-knee (AK), below-knee (BK), or minor (forefoot or toe) ipsilateral or contralateral amputation. Our main outcome measure consisted of a “good functional outcome,” defined as living at home and ambulating independently. We calculated univariate and multivariate associations among patient characteristics and our main outcome measure, as well as overall survival. Results Of the 436 patients who underwent amputation within the first year following LEB, 224 of 436 (51.4%) had a minor amputation, 105 of 436 (24.1%) had a BK amputation, and 107 of 436 (24.5%) had an AK amputation. The majority of AK (75 of 107, 72.8%) and BK amputations (72 of 105, 70.6%) occurred in the setting of bypass graft thrombosis, whereas nearly all minor amputations (200 of 224, 89.7%) occurred with a patent bypass graft. By life-table analysis at 1 year, we found that the proportion of surviving patients with a good functional outcome varied by the presence and extent of amputation (proportion surviving with good functional outcome = 88% no amputation, 81% minor amputation, 55% BK amputation, and 45% AK amputation, p = 0.001). Among those analyzed at long-term follow-up, survival was slightly lower for those who had a minor amputation when compared with those who did not receive an amputation after LEB (81 vs. 88%, p = 0.02). Survival among major amputation patients did not significantly differ compared with no amputation (BK amputation 87%, p = 0.14, AK amputation 89%, p = 0.27); however, this part of the analysis was limited by its sample size ( n = 212). In multivariable analysis, we found that the patients most likely to remain ambulatory and live independently despite undergoing a lower extremity amputation were those living at home preoperatively (hazard ratio [HR]: 6.8, 95% confidence interval [CI]: 0.94-49, p = 0.058) and those with preoperative statin use (HR: 1.6, 95% CI: 1.2-2.1, p = 0.003), whereas the presence of several comorbidities identified patients less likely to achieve a good functional outcome: coronary disease (HR: 0.6, 95% CI: 0.5-0.9, p = 0.003), dialysis (HR: 0.5, 95% CI: 0.3-0.9, p = 0.02), and congestive heart failure (HR: 0.5, 95% CI: 0.3-0.8, p = 0.005). Conclusions A postoperative amputation at any level impacts functional outcomes following LEB surgery, and the extent of amputation is directly related to the effect on functional outcome. It is possible, based on preoperative patient characteristics, to identify patients undergoing LEB who are most or least likely to achieve good functional outcomes even if a major amputation is ultimately required. These findings may assist in patient education and surgical decision making in patients who are poor candidates for lower extremity bypass.