Background Bariatric surgery (BAR) has been established as an effective treatment for type 2 diabetes mellitus (T2DM) in obese patients. However, few studies have examined the mid- to long-term ...outcomes of bariatric surgery in diabetic populations. Specifically, no comparative studies have broadly examined major macrovascular and microvascular complications in bariatric surgical patients vs similar, nonbariatric surgery controls. Study Design We conducted a large, population-based, retrospective cohort study of adult obese patients with T2DM, from 1996 to 2009, using UB-04 administrative data and vital records. Eligible patients undergoing bariatric surgery (BAR n = 2,580) were compared with nonbariatric surgery controls (CON n = 13,371) for the outcomes of any first major macrovascular event (myocardial infarction, stroke, or all-cause death) or microvascular event (new diagnosis of blindness, laser eye or retinal surgery, nontraumatic amputation, or creation of permanent arteriovenous access for hemodialysis), assessed in combination and separately, as well as other vascular events (carotid, coronary or lower extremity revascularization or new diagnosis of congestive heart failure or angina pectoris). Results Bariatric surgery was associated with favorable unadjusted 5-year event-free survival estimates for the combined primary outcome (95% ± 1% vs 81% ± 1%, log-rank p < 0.01) and each secondary outcome (log-rank p < 0.01). Multivariate-adjusted and propensity-based relative risk estimates showed BAR to be associated with a 60% to 70% reduction (adjusted hazard ratio HR 0.36, 95% CI 0.27 to 0.47) in the combined primary outcome and 60% to 80% risk reductions for each secondary outcome (macrovascular events adjusted HR 0.39, 95% CI 0.29 to 0.51; microvascular events adjusted HR 0.22, 95% CI 0.09 to 0.49; and other vascular events adjusted HR 0.25, 95% CI 0.19 to 0.32). Conclusions Bariatric surgery is associated with a 65% reduction in major macrovascular and microvascular events in moderately and severely obese patients with T2DM.
Background Outcomes after lower extremity revascularization are usually reported according to the level of peripheral arterial disease (PAD, aortoiliac or infrainguinal) or the method of treatment ...(open or endovascular surgery). Outcomes stratified by indication, ie, claudication or critical limb ischemia (rest pain and tissue loss), have not been well studied. The purpose of this study was to compare postoperative outcomes according to the preoperative indications. Study Design Outcomes of 2,240 consecutive limb revascularizations in 1,732 patients from January 1998 through December 2005 were stratified and examined according to preoperative indication: claudication (n = 999 limbs), ischemic rest pain (n = 464 limbs), or tissue loss (n = 777 limbs). End points measured included primary and secondary interventional or operative patency, limb salvage, survival, amputation-free survival, maintenance of ambulation, maintenance of independence, and resolution of presenting symptoms. Results The proportion of medical comorbidities and the severity of disease increased significantly by cohort from claudication to rest pain to tissue loss. With a mean followup of 1,089 days (range 0 to 3,689 days), overall outcomes performance declined consistently according to indication for all end points measured at 5 years (claudication, rest pain, tissue loss, p value): secondary reconstruction patency (93%, 80%, 66%, respectively; p < 0.001), limb salvage (99%, 81%, 68%, respectively; p < 0.001), survival (78%, 46%, 30%, respectively; p < 0.001), amputation-free survival (78%, 42%, 25%, respectively; p < 0.001), maintenance of ambulation (96%, 78%, 68%, respectively; p < 0.001), maintenance of independence (98%, 85%, 75%, respectively; p < 0.001), and resolution of presenting symptoms (79%, 61%, 42%, respectively; p < 0.001). Conclusions There is a declining spectrum of outcomes performance from claudication to rest pain to tissue loss. These findings question the accuracy of all previously published data for critical limb ischemia, for which rest pain and tissue loss are usually blended and reported as a single outcomes value.
Background For patients with diabetic neuropathic foot ulceration, the current treatment paradigm is heavily weighted toward limb revascularization; aligning incentives to perform more surgery and ...less ulcer management/prevention. Our purpose was to perform an analysis of functional outcomes to assess this current treatment paradigm. Study Design Nine hundred and seventeen neuropathic ulcerated feet in 706 patients with diabetes were analyzed. Four hundred and sixty limbs (50.2%) had concomitant ischemia, 219 of which were revascularized (137 angioplasty and 82 open surgery). Outcomes measured included ulcer healing, survival, limb salvage, amputation-free survival, maintenance of ambulation, and independence. Independent predictors of outcomes were measured using an Extended Cox Model. Results Overall outcomes (n = 917) were: ulcer healed, n = 250 (27%; mean time to healing 33 weeks); functionally healed, n = 488 (53%; mean time to functional healing 29 weeks); 5-year limb salvage, 68%; survival, 38%; amputation-free survival, 30%; maintenance of ambulation, 64%; and maintenance of independence, 74%. There was little difference in ulcer healing rates for patients with or without ischemia (28.5% versus 26%; p = 0.4). However, ischemia was a significant marker of poor outcomes (nonischemic ulcer, ischemic ulcer revascularized, and ischemic ulcer not revascularized: 5-year limb salvage of 80%, 61%, and 51%; p < 0.001); survival (47%, 37%, and 24%; p = 0.03); amputation-free survival (37%, 28%, and 17%; p < 0.001); maintenance of ambulation (74%, 55%, and 55%; p < 0.001); and maintenance of independence (82%, 72%, and 58%; p = 0.01). Wound healing was an independent predictor of survival and amputation-free survival (survival: hazard ratio = 0.58; 95% CI,0.46–0.73; amputation-free survival: hazard ratio = 0.42; 95% CI, 0.33–0.53). Conclusions The current treatment paradigm is associated with relatively poor healing rates and substantial late morbidity and mortality. Although revascularization is effective treatment for ischemia, it is probably overvalued when compared with the potential improvement afforded by better medical foot wound management.
Background The purpose of this study was to reconsider current recommended treatment guidelines for vasculogenic claudication by examining the contemporary results of surgical intervention. Study ...Design We performed a retrospective review of 1,000 consecutive limbs in 669 patients treated for medically refractory vasculogenic claudication and prospectively followed. Outcomes measured included procedural complication rates, reconstruction patency, limb salvage, maintenance of ambulatory status, maintenance of independent living status, survival, symptom resolution, and symptom recurrence. Results Of the 1,000 limbs treated, endovascular therapy was used in 64.3% and open surgery in 35.7% of patients; aortoiliac occlusive disease was treated in 70.1% and infrainguinal disease in 29.9% of patients. The overall 30-day periprocedural complication rate was 7.5%, with no notable difference in complication rates when comparing types of treatment or levels of disease. Overall reconstruction primary patency rates were 87.7% and 70.8%; secondary patencies were 97.8% and 93.9%; limb salvage, 100% and 98.8%; and survivals, 95.4% and 76.9%, at 1 and 5 years, respectively. More than 96% of patients maintained independence and ambulatory ability at 5 years. Overall symptom resolution occurred in 78.8%, and symptom recurrence occurred in 18.1% of limbs treated, with slightly higher resolution and recurrence noted in patients treated with endovascular therapy. Conclusions Contemporary treatment of vasculogenic claudication is safe, effective, and predominantly endovascular. These data support a more liberal use of revascularization for patients with claudication and suggest that current nonoperative treatment guidelines may be based more on surgical dogma than on achievable outcomes.
Background Success after surgical revascularization of the lower extremities, traditionally defined by graft patency or limb salvage, fails to consider other intuitive measures of importance. The ...purpose of the study was to construct a more comprehensive definition of clinical success and to identify clinical predictors of failure. Study design For the purpose of this study, clinical success was defined as achieving all of the following criteria: graft patency to the point of wound healing; limb salvage for 1 year; maintenance of ambulatory status for 1 year; and survival for 6 months. Between 1998 and 2004, 331 consecutive patients undergoing bypass for Rutherford III critical limb ischemia were measured for clinical success. Bivariate and logistic regression analyses were performed to determine demographic differences between success and failure. Results Despite achieving acceptable graft patency (72.7% at 36 months) and limb salvage (73.3% at 36 months), clinical success combining all 4 defined parameters was only 44.4%. Independent predictors of failure included impaired ambulatory status at presentation (odds ratio OR = 6.44), presence of infrainguinal disease (OR = 3.93), end-stage renal disease (OR = 2.48), presence of gangrene (OR = 2.40), and hyperlipidemia (OR = 0.56). Probability of failure in patients possessing every predictor except hyperlipidemia at presentation was 97% (OR = 150.6). Conclusions Despite achieving acceptable graft patency and limb salvage, fewer than half of the patients achieved success when using a definition combining multiple parameters. A reappraisal of our current approach to critical limb ischemia in certain high-risk patients is warranted.
Background Endovascular techniques are considered by many as the first-line treatment for critical limb ischemia (CLI). The purpose of this study is to assess the impact of endovascular therapy on ...CLI and amputation in South Carolina during the past decade. Study Design This is a retrospective, comparative analysis of treatment outcomes for CLI in the pre-endovascular era and the endovascular era. The South Carolina Office of Research and Statistics database was reviewed using ICD-9 diagnosis and procedure codes to identify patients who underwent limb revascularization in 1996 (pre-endovascular era) and 2005 (endovascular era) for CLI and to determine those who required subsequent limb amputation and additional revascularization. Results The index limb revascularization procedures increased 33% from 571 in 1996 (420 74% open; 151 26% endovascular) to 758 in 2005 (373 49% open; 385 51% endovascular). The demographics and comorbidities for patients who underwent revascularization in 1996 were similar to those in 2005. The amputation rate for patients who underwent a revascularization procedure was 34% at 1 year and 43% at 3 years in 1996, compared with 34% at 1 year and 40% at 3 years in 2005 (p = NS). The percentage of patients who required an additional revascularization in the same calendar year increased from 8% in 1996 to 19% in 2005 (p < 0.001). Conclusions Although there has been an absolute increase in the number of revascularization procedures for CLI, with a clear shift toward endovascular therapy, the amputation rates for these patients have not changed. However, the shift to endovascular interventions has increased the number of secondary procedures required to maintain limb-salvage rates equivalent to those of the pre-endovascular era.
Background Up to 50% of AV fistulas fail to mature, primarily because of problems with fistula cannulation. Fistula elevation procedure (FEP) is a simple superficialization procedure where the ...fistula is surgically exposed, mobilized, and elevated into a more superficial position for the purpose of facilitating AV fistula cannulation. The purpose of this study is to review use of FEP as an adjunct to fistula maturation. Study Design Two hundred ninety-five FEPs were performed between February 1999 and December 2005. FEP was performed if the fistula was considered too deep to cannulate or if nurses were unable to cannulate the fistula. Kaplan-Meier life-table analysis was used to determine patency and for a subanalysis by location of FEP performed (172 brachial-cephalic, 70 brachial-basilic, 46 radial-cephalic, 7 superficial femoral vein). Survival curves were compared using log-rank test. Results Functional primary patency rates for patients undergoing an adjunctive FEP were 73% at 6 months, 60% at 1 year, and 46% at 2 years. Secondary functional patency rates were 81% at 6 months, 71% at 1 year, and 59% at 2 years. There was no statistical significance in any outcomes based on anatomic site of elevation. Conclusions AV fistulas that might otherwise have been abandoned because of excessive depth or tortuosity can be successfully salvaged by an adjunctive FEP and achieve satisfactory longterm functional patency. FEP is a valuable adjunct to AV fistula creation, which will enhance fistula maturation rates.
Background Vascular surgical education for general surgery residents is concerning as endovascular interventions increase and vascular surgery expands. The purpose of this study was to examine the ...effects these factors have on vascular surgery case numbers for general surgery residents and statewide surgeons and to report on former general surgery residents' perceptions of vascular surgery in training and practice. Study Design Case numbers for all general surgery residents graduating from the Greenville Hospital System from 1991 to 2007 and for the vascular surgery fellows graduating from 2003 to 2007 were obtained. A database identified case numbers and physician specialty for vascular procedures from 1997 through 2006. A survey gained perspectives of graduated general surgery residents on the vascular experience during residency and practice and on postresidency vascular caseload. Results There was significant decline in resident participation in open abdominal aortic aneurysm (22.4 versus 7.7), carotid endarterectomy (37.2 versus 31.1), aortobifemoral bypass (18.6 versus 5.5), and lower extremity bypass (42.8 versus 19.1). Numbers for dialysis access creation (49.0 versus 57.1) were maintained. Statewide, comparing 1997 with 2006, the percentages of procedures performed by vascular surgeons were: abdominal aortic aneurysm (29.3% versus 49%; p < 0.001), carotid endarterectomy (28.9% versus 45.5%; p < 0.001), and dialysis access (4.6% versus 12.3%; p = 0.020). The survey of general surgery graduates revealed lower extremity bypass, carotid endarterectomy, abdominal aortic aneurysm, and dialysis access are important in training. Dialysis access was the most common operation performed by the general surgery graduates. Conclusions There is a trend toward vascular surgeons and vascular residents performing most open vascular cases. Currently practicing surgeons believe there is value to vascular exposure for general surgeons in training, and vascular surgery should remain in general surgery training.
