Randall R. DeMartino

Validation of the Society for Vascular Surgery's Objective Performance Goals for critical limb ischemia in everyday vascular surgery practice

BACKGROUND To develop standardized metrics for expected outcomes in lower extremity revascularization for critical limb ischemia (CLI), the Society for Vascular Surgery (SVS) has developed objective performance goals (OPGs) based on aggregate data from randomized trials of lower extremity bypass (LEB). It remains unknown, however, if these targets can be achieved in everyday vascular surgery practice. METHODS We applied SVS OPG criteria to 1039 patients undergoing 1039 LEB operations for CLI with autogenous vein (excluding patients on dialysis) within the Vascular Study Group of New England (VSGNE). Each of the individual OPGs was calculated within the VSGNE dataset, along with its surrounding 95% confidence intervals (CIs) and compared to published SVS OPGs using χ(2) comparisons and survival analysis. RESULTS Across most risk strata, patients in the VSGNE and SVS OPG cohorts were similar (clinical high-risk [age >80 years and tissue loss]: 15.3% VSGNE; 16.2% SVS OPG; P = .58; anatomic high risk [infrapopliteal target artery]: 57.8% VSGNE; 60.2% SVS OPG; P = .32). However, the proportion of VSGNE patients designated as conduit high-risk (lack of single-segment great saphenous vein) was lower (10.2% VSGNE; 26.9% SVS OPG;P < .001). The primary safety endpoint, major adverse limb events (MALE) at 30 days, was lower in the VSGNE cohort (3.2%; 95% CI, 2.3-4.6) than the SVS OPG cohort (6.2%; 95% CI, 4.2-8.1; P = .05). The primary efficacy OPG endpoint, freedom from any MALE or postoperative death within the first year (MALE + postoperative death [POD]), was similar between VSGNE and SVS OPG cohorts (77%; 95% CI, 74%-80%) SVS OPG, 74% (95% CI, 71%-77%) VSGNE, P = .58). In the remaining safety and efficacy OPGs, the VSGNE cohort met or exceeded the benchmarks established by the SVS OPG cohort. CONCLUSION Community and academic centers in everyday vascular surgery practice can meet OPGs derived from centers of excellence in LEB. Quality improvement initiatives, as well as clinical trials, should incorporate OPGs in their outcome measures to facilitate communication and comparison of risk-adjusted outcomes in the treatment of CLI.

Early Primary Care Provider Follow-up and Readmission After High-Risk Surgery

IMPORTANCE Follow-up with a primary care provider (PCP) in addition to the surgical team is routinely recommended to patients discharged after major surgery despite no clear evidence that it improves outcomes. OBJECTIVE To test whether PCP follow-up is associated with lower 30-day readmission rates after open thoracic aortic aneurysm (TAA) repair and ventral hernia repair (VHR), surgical procedures known to have a high and low risk of readmission, respectively. DESIGN, SETTING, AND PARTICIPANTS In a cohort of Medicare beneficiaries discharged to home after open TAA repair (n = 12 679) and VHR (n = 52 807) between 2003 to 2010, we compared 30-day readmission rates between patients seen and not seen by a PCP within 30 days of discharge and across tertiles of regional primary care use. We stratified our analysis by the presence of complications during the surgical (index) admission. MAIN OUTCOMES AND MEASURES Thirty-day readmission rate. RESULTS Overall, 2619 patients (20.6%) undergoing open TAA repair and 4927 patients (9.3%) undergoing VHR were readmitted within 30 days after surgery. Complications occurred in 4649 patients (36.6%) undergoing open TAA repair and 4528 patients (8.6%) undergoing VHR during their surgical admission. Early follow-up with a PCP significantly reduced the risk of readmission among open TAA patients who experienced perioperative complications, from 35.0% (without follow-up) to 20.4% (with follow-up) (P < .001). However, PCP follow-up made no significant difference in patients whose hospital course was uncomplicated (19.4% with follow-up vs 21.9% without follow-up; P = .31). In comparison, early follow-up with a PCP after VHR did not reduce the risk of readmission, regardless of complications. In adjusted regional analyses, undergoing open TAA repair in regions with high compared with low primary care use was associated with an 18% lower likelihood of 30-day readmission (odds ratio, 0.82; 95% CI, 0.71-0.96; P = .02), whereas no significant difference was found among patients after VHR. CONCLUSIONS AND RELEVANCE Follow-up with a PCP after high-risk surgery (eg, open TAA repair), especially among patients with complications, is associated with a lower risk of hospital readmission. Patients undergoing lower-risk surgery (eg, VHR) do not receive the same benefit from early PCP follow-up. Identifying high-risk surgical patients who will benefit from PCP integration during care transitions may offer a low-cost solution toward limiting readmissions.

Statin therapy after infrainguinal bypass surgery for critical limb ischemia is associated with improved 5-year survival

OBJECTIVE Although statin therapy has been linked to fewer short-term complications after infrainguinal bypass, its effect on long-term survival remains unclear. We therefore examined associations between statin use and long-term mortality, graft occlusion, and amputation after infrainguinal bypass. METHODS We used the Vascular Study Group of New England registry to study 2067 patients (71% male; mean age, 67 ± 11 years; 67% with critical limb ischemia [CLI]) who underwent infrainguinal bypass from 2003 to 2011. Of these, 1537 (74%) were on statins perioperatively and at 1-year follow-up, and 530 received no statin. We examined crude, adjusted, and propensity-matched rates of 5-year surviva1, 1-year amputation, graft occlusion, and perioperative myocardial infarction. RESULTS Patients taking statins at the time of surgery and at the 1-year follow-up were more likely to have coronary disease (38% vs 22%; P < .001), diabetes (51% vs 36%; P < .001), hypertension (89% vs 77%; P < .001), and prior revascularization procedures (50% vs 38%; P < .001). Despite higher comorbidity burdens, long-term survival was better for patients taking statins in crude (risk ratio [RR], 0.7; P < .001), adjusted (hazard ratio, 0.7; P = .001), and propensity-matched analyses (hazard ratio, 0.7; P = .03). In subgroup analysis, a survival advantage was evident in patients on statins with CLI (5-year survival rate, 63% vs 54%; log-rank, P = .01) but not claudication (5-year survival rate, 84% vs 80%; log-rank, P = .59). Statin therapy was not associated with 1-year rates of major amputation (12% vs 11%; P = .84) or graft occlusion (20% vs 18%; P = .58) in CLI patients. Perioperative myocardial infarction occurred more frequently in patients on a statin in crude analysis (RR, 2.2; P = .01) but not in the matched cohort (RR, 1.9; P = .17). CONCLUSIONS Statin therapy is associated with a 5-year survival benefit after infrainguinal bypass in patients with CLI. However, 1-year limb-related outcomes were not influenced by statin use in our large observational cohort of patients undergoing revascularization in New England.

Relationship between regional spending on vascular care and amputation rate.

IMPORTANCE Although lower extremity revascularization is effective in preventing amputation, the relationship between spending on vascular care and regional amputation rates remains unclear. OBJECTIVE To test the hypothesis that higher regional spending on vascular care is associated with lower amputation rates for patients with severe peripheral arterial disease. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of 18,463 US Medicare patients who underwent a major peripheral arterial disease-related amputation during the period between 2003 and 2010. EXPOSURE Price-adjusted Medicare spending on revascularization procedures and related vascular care in the year before lower extremity amputation, across hospital referral regions. MAIN OUTCOMES AND MEASURES Correlation coefficient between regional spending on vascular care and regional rates of peripheral arterial disease-related amputation. RESULTS Among patients who ultimately underwent an amputation, 64% were admitted to the hospital in the year prior to the amputation for revascularization, wound-related care, or both; 36% were admitted only for their amputation. The mean cost of inpatient care in the year before amputation, including costs related to the amputation procedure itself, was

Association of Statin Dose With Amputation and Survival in Patients With Peripheral Artery Disease

22,405, but it varied from

A multi-institutional experience in adventitial cystic disease.

11,077 (Bismarck, North Dakota) to

Preventive Measures for Patients at Risk for Amputation From Diabetes and Peripheral Arterial Disease

42,613 (Salinas, California) (P < .001). Patients in high-spending regions were more likely to undergo vascular procedures as determined by crude analyses (12.0 procedures per 10,000 patients in the lowest quintile of spending and 20.4 procedures per 10,000 patients in the highest quintile of spending; P < .001) and by risk-adjusted analyses (adjusted odds ratio for receiving a vascular procedure in highest quintile of spending, 3.5 [95% CI, 3.2-3.8]; P < .001). Although revascularization was associated with higher spending (R = 0.38, P < .001), higher spending was not associated with lower regional amputation rates (R = 0.10, P = .06). The regions that were most aggressive in the use of endovascular interventions were the regions that were most likely to have high spending (R = 0.42, P = .002) and high amputation rates (R = 0.40, P = .004). CONCLUSIONS AND RELEVANCE Regions that spend the most on vascular care perform the most procedures, especially endovascular interventions, in the year before amputation. However, there is little evidence that higher regional spending is associated with lower amputation rates. This suggests an opportunity to limit costs in vascular care without compromising quality.

Insight into the cerebral hyperperfusion syndrome following carotid endarterectomy from the national Vascular Quality Initiative

Background: Statin dose guidelines for patients with peripheral artery disease (PAD) are largely based on coronary artery disease and stroke data. The aim of this study is to determine the effect of statin intensity on PAD outcomes of amputation and mortality. Methods: Using an observational cohort study design and a validated algorithm, we identified patients with incident PAD (2003–2014) in the national Veterans Affairs data. Highest statin intensity exposure (high-intensity versus low-to-moderate–intensity versus antiplatelet therapy but no statin use) was determined within 1 year of diagnosis of PAD. Outcomes of interest were lower extremity amputations and death. The association of statin intensity with incident amputation and mortality was assessed with Kaplan-Meier plots, Cox proportional hazards modeling, propensity score–matched analysis, and sensitivity and subgroup analyses, as well, to reduce confounding. Results: In 155 647 patients with incident PAD, more than a quarter (28%) were not on statins. Use of high-intensity statins was lowest in patients with PAD only (6.4%) in comparison with comorbid coronary/carotid disease (18.4%). Incident amputation and mortality risk declined significantly with any statin use in comparison with the antiplatelet therapy–only group. In adjusted Cox models, the high-intensity statin users were associated with lower amputation risk and mortality in comparison with antiplatelet therapy–only users (hazard ratio, 0.67; 95% confidence interval, 0.61–0.74 and hazard ratio, 0.74; 95% confidence interval, 0.70–0.77, respectively). Low-to-moderate–intensity statins also had significant reductions in the risk of amputation and mortality (hazard ratio amputation, 0.81; 95% confidence interval, 0.75– 0.86; hazard ratio death, 0.83; 95% confidence interval, 0.81–0.86) in comparison with no statins (antiplatelet therapy only), but effect size was significantly weaker than the high-intensity statins (P<0.001). The association of high-intensity statins with lower amputation and death risk remained significant and robust in propensity score–matched, sensitivity, and subgroup analyses. Conclusions: Statins, especially high-intensity formulations, are underused in patients with PAD. This is the first population-based study to show that high-intensity statin use at the time of PAD diagnosis is associated with a significant reduction in limb loss and mortality in comparison with low-to-moderate–intensity statin users, and patients treated only with antiplatelet medications but not with statins, as well.

External validation of a 5-year survival prediction model after elective abdominal aortic aneurysm repair

Background: Adventitial cystic disease (ACD) is an unusual arteriopathy; case reports and small series constitute the available literature regarding treatment. We sought to examine the presentation, contemporary management, and long‐term outcomes using a multi‐institutional database. Methods: Using a standardized database, 14 institutions retrospectively collected demographics, comorbidities, presentation/symptoms, imaging, treatment, and follow‐up data on consecutive patients treated for ACD during a 10‐year period, using Society for Vascular Surgery reporting standards for limb ischemia. Univariate and multivariate analyses were performed comparing treatment methods and factors associated with recurrent intervention. Life‐table analysis was performed to estimate the freedom from reintervention in comparing the various treatment modalities. Results: Forty‐seven patients (32 men, 15 women; mean age, 43 years) were identified with ACD involving the popliteal artery (n = 41), radial artery (n = 3), superficial/common femoral artery (n = 2), and common femoral vein (n = 1). Lower extremity claudication was seen in 93% of ACD of the leg arteries, whereas patients with upper extremity ACD had hand or arm pain. Preoperative diagnosis was made in 88% of patients, primarily using cross‐sectional imaging of the lower extremity; mean lower extremity ankle‐brachial index was 0.71 in the affected limb. Forty‐one patients with lower extremity ACD underwent operative repair (resection with interposition graft, 21 patients; cyst resection, 13 patients; cyst resection with bypass graft, 5 patients; cyst resection with patch, 2 patients). Two patients with upper extremity ACD underwent cyst drainage without resection or arterial reconstruction. Complications, including graft infection, thrombosis, hematoma, and wound dehiscence, occurred in 12% of patients. Mean lower extremity ankle‐brachial index at 3 months postoperatively improved to 1.07 (P < .001), with an overall mean follow‐up of 20 months (range, 0.33‐9 years). Eight patients (18%) with lower extremity arterial ACD required reintervention (redo cyst resection, one; thrombectomy, three; redo bypass, one; balloon angioplasty, three) after a mean of 70 days with symptom relief in 88%. Lower extremity patients who underwent cyst resection and interposition or bypass graft were less likely to require reintervention (P = .04). One patient with lower extremity ACD required an above‐knee amputation for extensive tissue loss. Conclusions: This multi‐institutional, contemporary experience of ACD examines the treatment and outcomes of ACD. The majority of patients can be identified preoperatively; surgical repair, consisting of cyst excision with arterial reconstruction or bypass alone, provides the best long‐term symptomatic relief and reduced need for intervention to maintain patency.

Development of a validated model to predict 30-day stroke and 1-year survival after carotid endarterectomy for asymptomatic stenosis using the Vascular Quality Initiative

When patients with diabetes and peripheral arterial disease (PAD) receive treatment for vascular disease, amputation rates tend to be lower, suggesting that greater utilization of vascular care is associated with lower amputation risk (1). However, procedural care is not provided in isolation. Patients should be engaged in a care system where preventive measures, such as hemoglobin A1c testing, podiatric care, and noninvasive vascular testing are routinely provided (2,3). However, it remains unknown how commonly patients at risk for amputation actually receive preventive measures. Therefore, we studied how commonly patients at risk for amputation actually receive evidence-based preventive measures aimed at limiting amputation. We identified a cohort of 52,505 patients with diabetes and PAD in Medicare claims (2008–2009), who had been admitted to the hospital for an episode of lower …