Analysis of large databases in vascular surgery

Large databases can be a rich source of clinical and administrative information on broad populations. These datasets are characterized by demographic and clinical data for over 1000 patients from multiple institutions. Since they are often collected and funded for other purposes, their use for secondary analysis increases their utility at relatively low costs. Advantages of large databases as a source include the very large numbers of available patients and their related medical information. Disadvantages include lack of detailed clinical information and absence of causal descriptions. Researchers working with large databases should also be mindful of data structure design and inherent limitations to large databases, such as treatment bias and systemic sampling errors. Withstanding these limitations, several important studies have been published in vascular care using large databases. They represent timely, “real-world” analyses of questions that may be too difficult or costly to address using prospective randomized methods. Large databases will be an increasingly important analytical resource as we focus on improving national health care efficacy in the setting of limited resources

Impact of postoperative nadir hemoglobin and blood transfusion on outcomes after operations for atherosclerotic vascular disease

ObjectiveControversy surrounds the topic of transfusion policy after noncardiac operations. This study assessed the combined impact of postoperative nadir hemoglobin (nHb) levels and blood transfusion on adverse events after open surgical intervention in patients who undergo operative intervention for atherosclerotic vascular disease.MethodsConsecutive patients who underwent peripheral arterial disease (PAD)-related operations were balanced on baseline characteristics by inverse weighting on propensity score calculated as their probability to have nHb greater than 10 gm/dL on the basis of operation type, demographics, and comorbidities, including the revised cardiac risk index. A multivariate generalized estimating equation analysis was performed to investigate associations between nHb, transfusion, and a composite outcome of perioperative death and myocardial infarction. Logistic and Cox proportional hazards regressions were used to assess the impact of nHb and transfusion on respiratory and wound complications; and a composite end point (CE) of death, myocardial infarction during a 2-year follow-up. Level of statistical significance was set at alpha of 0.0125 to adjust for the increased probability of type I error attributable to multiple comparisons.ResultsThe analysis cohort included 880 patients (1074 operations). After adjusting for nHb level, the number of units transfused was not associated with the perioperative occurrence of the CE (odds ratio [OR], 1.13; P = .025). Adjusted for the number of units transfused, nHb had no impact on the perioperative CE (OR, 0.62; P = .22). An interaction term between transfusion and nHb level remained nonsignificant (P = .312), indicating that the impact of blood transfusion was the same regardless of the nHb level. Perioperative respiratory complications were more likely in patients receiving transfusions (OR, 1.22; P = .009), and perioperative wound infections were less common in patients with nHb >10 gm/dL (OR, 0.65; P = .01). During an average follow-up of 24 months, transfused patients were more likely to develop the CE (hazard ratio [HR], 1.15, P = .009), whereas nHb level did not impact the long-term adverse event rate (HR, 0.78; P = .373). The above associations persisted even after adjusting the Cox regression model for the occurrence of perioperative cardiac events.ConclusionsAlthough nHb less than 10 gm/dL is not associated with death or ACS after PAD-related operations, maintaining nHb greater than 10 gm/dL appears to decrease the risk of wound infection. Blood transfusion is associated with increased risk of perioperative respiratory complications. Until a randomized trial settles this issue definitively, a restrictive transfusion strategy is justified in patients undergoing operations for atherosclerotic vascular disease

Impact of cumulative intravascular contrast exposure on renal function in patients with occlusive and aneurysmal vascular disease

ObjectivePatients with occlusive or aneurysmal vascular disease are repeatedly exposed to intravascular (IV) contrast for diagnostic or therapeutic purposes. We sought to determine the long-term impact of cumulative iodinated IV contrast exposure (CIVCE) on renal function; the latter was defined by means of National Kidney Foundation (NKF) criteria.MethodsWe performed a longitudinal study of consecutive patients without renal insufficiency at baseline (NFK stage I or II) who underwent interventions for arterial occlusive or aneurysmal disease. We collected detailed data on any IV iodinated contrast exposure (including diagnostic or therapeutic angiography, cardiac catheterization, IV pyelography, computed tomography with IV contrast, computed tomographic angiography); medication exposure throughout the observation period; comorbidities; and demographics. The primary end point was the development of renal failure (RF) (defined as NFK stage 4 or 5). Analysis was performed with the use of a shared frailty model with clustering at the patient level.ResultsPatients (n = 1274) had a mean follow-up of 5.8 (range, 2.2-14) years. In the multivariate model with RF as the dependent variable and after adjusting for the statistically significant covariates of baseline renal function (hazard ratio [HR], 0.95; P < .001), diabetes (HR, 1.8; P = .007), use of an angiotensin-converting enzyme inhibitor (HR, 0.63; P = .03), use of antiplatelets (HR, 0.5; P = .01), cumulative number of open vascular operations performed (HR, 1.2; P = .001), and congestive heart failure (HR, 3.2; P < .001), CIVCE remained an independent predictor for RF development (HR, 1.1; P < .001). In the multivariate survival analysis model and after adjusting for the statistically significant covariates of perioperative myocardial infarction (HR, 3.9; P < .001), age at entry in the cohort (HR, 1.05; P = .035), total number of open operations (HR, 1.51; P < .001), and serum albumin (HR, 0.47; P < .001), CIVCE was an independent predictor of death (HR, 1.07; P < .001).ConclusionsCumulative IV contrast exposure is an independent predictor of RF and death in patients with occlusive and aneurysmal vascular disease

Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications

ObjectiveWound complications negatively affect outcomes of lower extremity arterial reconstruction. By way of an investigator initiated clinical trial, we tested the hypothesis that a silver-eluting alginate topical surgical dressing would lower wound complication rates in patients undergoing open arterial procedures in the lower extremity.MethodsThe study block-randomized 500 patients at three institutions to standard gauze or silver alginate dressings placed over incisions after leg arterial surgery. This original operating room dressing remained until gross soiling, clinical need to remove, or postoperative day 3, whichever was first. Subsequent care was at the provider's discretion. The primary end point was 30-day wound complication incidence generally based on National Surgical Quality Improvement Program guidelines. Demographic, clinical, quality of life, and economic end points were also collected. Wound closure was at the surgeon's discretion.ResultsParticipants (72% male) were 84% white, 45% were diabetic, 41% had critical limb ischemia, and 32% had claudication (with aneurysm, bypass revision, other). The overall 30-day wound complication incidence was 30%, with superficial surgical site infection as the most common. In intent-to-treat analysis, silver alginate had no effect on wound complications. Multivariable analysis showed that Coumadin (Bristol-Myers Squibb, Princeton, NJ; odds ratio [OR], 1.72; 95% confidence interval [CI], 1.03-2.87; P = .03), higher body mass index (OR, 1.05; 95% CI, 1.01-1.09; P = .01), and the use of no conduit/material (OR, 0.12; 95% CI, 0.82-3.59; P < .001) were independently associated with wound complications.ConclusionsThe incidence of wound complications remains high in contemporary open lower extremity arterial surgery. Under the study conditions, a silver-eluting alginate dressing showed no effect on the incidence of wound complications

Long-Term Wound Palliation to Manage Exposed Hardware in the Setting of Peripheral Arterial Disease

Summary:. Exposed orthopedic hardware in the lower extremity complicated by peripheral arterial disease typically demands multiple operative procedures by several disciplines to maintain skeletal integrity and achieve complete wound healing. For ambulatory patients that are either not candidates for lower extremity revascularization or prefer not to pursue surgical attempts at limb preservation, wound palliation is a potential management strategy. We discuss a patient with a history of severe peripheral arterial disease and a left pilon fracture previously treated with open reduction and internal fixation. He presented with a 2-month history of open wounds and exposed hardware over his left tibia. Though he initially underwent surgical revascularization to improve circulation to his lower extremity, the arterial bypass occluded within 6 months of the operation. At that point, the patient decided to forego any additional surgical intervention, including hardware removal, in favor of local wound care and expectant management. Remarkably, the wound remained stable in size over the next 14 years, he remained ambulatory, and never developed a deep wound infection. Though palliative wound care alone is understandably not the recommended first-line therapy for managing nonhealing wounds, it may be a safe and potentially durable alternative to major lower extremity amputation when revascularization and soft-tissue coverage cannot be achieved