Mortality and major postoperative complications within 1 year after vascular surgery: a prospective cohort study.

INTRODUCTION: Patients undergoing vascular procedures are prone to developing postoperative complications affecting their short­term mortality. Prospective reports describing the incidence of long­term complications after vascular surgery are lacking. OBJECTIVES: We aimed to describe the incidence of complications 1 year after vascular surgery and to evaluate an association between myocardial injury after noncardiac surgery (MINS) and 1­year mortality. PATIENTS AND METHODS: This is a substudy of a large prospective cohort study Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION). Recruitment took place in 28 centers across 14 countries from August 2007 to November 2013. We enrolled patients aged 45 years or older undergoing vascular surgery, receiving general or regional anesthesia, and hospitalized for at least 1 night postoperatively. Plasma cardiac troponin T concentration was measured before the surgery and on the first, second, and third postoperative day. The patients or their relatives were contacted 1 year after the procedure to assess the incidence of major postoperative complications. RESULTS: We enrolled 2641 patients who underwent vascular surgery, 2534 (95.9%) of whom completed 1­year follow­up. Their mean (SD) age was 68.2 (9.8) years, and the cohort was predominantly male (77.5%). The most frequent 1­year complications were myocardial infarction (224/2534, 8.8%), amputation (187/2534, 7.4%), and congestive heart failure (67/2534, 2.6%). The 1­year mortality rate was 8.8% (223/2534). MINS occurred in 633 patients (24%) and was associated with an increased 1­year mortality (hazard ratio, 2.82; 95% CI, 2.14-3.72; P <0.001). CONCLUSIONS: The incidence of major postoperative complications after vascular surgery is high. The occurrence of MINS is associated with a nearly 3­fold increase in 1­year mortality.

Cannabis use disorder and perioperative outcomes in vascular surgery.

BACKGROUND: Heavy cannabis use is known to have an adverse impact on cardiovascular and cerebrovascular outcomes in the general population and in patients presenting for surgery. However, there have been no studies that have focused on patients undergoing vascular surgical procedures. The objective of this study was to determine the perioperative risk of cannabis use disorder (CUD), primarily cardiovascular risk, in perioperative vascular surgery patients. METHODS: Using the National Inpatient Sample from 2006 to 2015, we conducted a retrospective cohort study involving those undergoing one of six elective and emergent vascular surgical procedures (carotid endarterectomy [CEA], infrainguinal bypasses, open abdominal aortic aneurysm repair, aortobifemoral bypass, endovascular aortic aneurysm repair, or peripheral arterial endovascular procedures). Patients with CUD identified by the International Classification of Diseases, 9th edition, were matched with patients without CUD in a 1:1 ratio using propensity scores. The primary outcome was perioperative myocardial infarction (MI). Secondary outcomes include stroke, sepsis, deep vein thrombosis, pulmonary embolus, acute kidney injury requiring dialysis, respiratory failure, in-hospital mortality, total cost, and length of stay. RESULTS: We identified a total cohort of 510,007 patients. Over the study period, the recorded prevalence of CUD increased from 1.3/1000 to 10.3/1000 admissions (P < .001). After propensity score matching the cohort consisted of 4684 patients. Those with CUD had a higher incidence of perioperative MI (3.3% vs 2.1%; odds ratio [OR], 1.56; 95% confidence interval [CI], 1.09-2.24; P = .016) and perioperative stroke (5.5% vs 3.5%; OR, 1.59; 95% CI, 1.20-2.12; P = .0013) than patients without CUD. In a sensitivity analysis, where the risk was evaluated separately by type of procedure, the higher incidence of perioperative stroke was primarily seen among those undergoing CEA. Patients with CUD had a lower incidence of sepsis (3.3% vs 5.1%; OR, 0.64; 95% CI, 0.47-0.85; P = .0024). We obtained similar results in a sensitivity analysis that included all patients in the complete unmatched cohort and adjusted for confounding using logistic regression models accounting for the survey design, although the findings of sepsis and stroke failed to reach statistical significance after correcting for multiple testing (MI P = .001; stroke P = .031; sepsis P = .009). CONCLUSIONS: CUD was associated with a significantly higher incidence of perioperative MI in vascular surgery patients. Those with CUD had a greater incidence of diagnosis of acute perioperative stroke when undergoing CEA. Owing to limitations in administrative data, it is unclear if this represents a true effect or selection bias. These findings warrant further investigation in a prospective cohort.

Postoperative Remote Automated Monitoring and Virtual Hospital-to-Home Care System Following Cardiac and Major Vascular Surgery: User Testing Study.

BACKGROUND: Cardiac and major vascular surgeries are common surgical procedures associated with high rates of postsurgical complications and related hospital readmission. In-hospital remote automated monitoring (RAM) and virtual hospital-to-home patient care systems have major potential to improve patient outcomes following cardiac and major vascular surgery. However, the science of deploying and evaluating these systems is complex and subject to risk of implementation failure. OBJECTIVE: As a precursor to a randomized controlled trial (RCT), this user testing study aimed to examine user performance and acceptance of a RAM and virtual hospital-to-home care intervention, using Philip's Guardian and Electronic Transition to Ambulatory Care (eTrAC) technologies, respectively. METHODS: Nurses and patients participated in systems training and individual case-based user testing at two participating sites in Canada and the United Kingdom. Participants were video recorded and asked to think aloud while completing required user tasks and while being rated on user performance. Feedback was also solicited about the user experience, including user satisfaction and acceptance, through use of the Net Promoter Scale (NPS) survey and debrief interviews. RESULTS: A total of 37 participants (26 nurses and 11 patients) completed user testing. The majority of nurse and patient participants were able to complete most required tasks independently, demonstrating comprehension and retention of required Guardian and eTrAC system workflows. Tasks which required additional prompting by the facilitator, for some, were related to the use of system features that enable continuous transmission of patient vital signs (eg, pairing wireless sensors to the patient) and assigning remote patient monitoring protocols. NPS scores by user group (nurses using Guardian: mean 8.8, SD 0.89; nurses using eTrAC: mean 7.7, SD 1.4; patients using eTrAC: mean 9.2, SD 0.75), overall NPS scores, and participant debrief interviews indicated nurse and patient satisfaction and acceptance of the Guardian and eTrAC systems. Both user groups stressed the need for additional opportunities to practice in order to become comfortable and proficient in the use of these systems. CONCLUSIONS: User testing indicated a high degree of user acceptance of Philips' Guardian and eTrAC systems among nurses and patients. Key insights were provided that informed refinement of clinical workflow training and systems implementation. These results were used to optimize workflows before the launch of an international RCT of in-hospital RAM and virtual hospital-to-home care for patients undergoing cardiac and major vascular surgery.

A comparison of duplex ultrasound findings after cyanoacrylate embolization versus endovenous laser ablation of the great saphenous vein.

BACKGROUND: Whereas numerous studies have demonstrated noninferiority of cyanoacrylate embolization (CAE) relative to endovenous laser ablation (EVLA), little is known about the natural history of the vein or the glue that is implanted. This study provides the first description of duplex ultrasound changes of the great saphenous vein (GSV) after CAE relative to EVLA as well as a pragmatic view of outcomes in clinical practice. METHODS: Patients treated with CAE and EVLA at our institution were matched by time of procedure and vein size. GSV diameter was measured at the saphenofemoral junction, midthigh, and knee. Duplex ultrasound imaging was repeated after treatment in the same noninvasive laboratory with an identical protocol. Clinical data were collected by retrospective chart review. RESULTS: Of 481 eligible patients, 119 underwent postoperative duplex ultrasound imaging. Although there was a trend toward decreased vein diameter over time in CAE patients relative to their preoperative vein diameter, this failed to reach statistical significance at the midthigh (P = .32) or at the knee (P = .511). In EVLA patients, as follow-up interval increased, the vein was less frequently visualized on ultrasound at the midthigh (P = .046) and knee (P = .038). At >2 years of follow-up, >80% of EVLA patients had no visible vein segment. Anatomic recurrence was observed in 10.5% of CAE patients and 8.2% of EVLA patients, which was not statistically significantly different (P = .60). The majority of recurrence was observed in the presence of incompetent tributaries. CONCLUSIONS: After CAE of the GSV, our results indicate that the glue cast remains for at least 3 years. Although our results suggest that the glue is broken down over time, this process is much slower than expected. In contrast, after EVLA, the vein tissue is remodeled and is no longer visible with time. In our study, which represents a pragmatic clinical population with a large (median, 9.2 mm) vein diameter, we again demonstrate no statistically significant difference in recurrence rates. Whereas CAE offers an attractive treatment option for GSV incompetence, the glue cast remains for a prolonged time, and longer follow-up studies than those currently available are indicated.

Risk factors for early and late mortality after fenestrated and branched endovascular repair of complex aneurysms.

BACKGROUND: The objective of this study was to evaluate outcomes after fenestrated and branched endovascular aneurysm repair (F-BEVAR) performed in high-risk patients to treat pararenal (PR) aneurysms and thoracoabdominal aortic aneurysms (TAAAs) and to identify those patients likely to benefit from this treatment. METHODS: A prospective single-center review of patients treated electively for PR aneurysm and TAAA using F-BEVAR between 2004 and 2016 was performed. Survival was estimated using the Kaplan-Meier method. Risk factors associated with 30-day morbidity and mortality during follow-up were determined using multivariate statistical techniques and a Cox regression model including all variables that were significant on univariate analysis (P < .05). RESULTS: There were 468 patients (median age, 71.6 years) identified, with American Society of Anesthesiologists score ≥3 in 94.7%. There were 221 (47.2%) type I to type III TAAAs and 247 (52.8%) type IV and type V TAAAs and PR aneurysms, with a median diameter of 58 mm. Technical success for target vessel stenting was 99.1% (1493/1506). The 30-day mortality rate was 4.9% (23 patients). The spinal cord ischemia rate was 3.8% (18 patients). Twenty patients (4.3%) required postoperative dialysis and four patients (0.8%) long-term dialysis after discharge. Median follow-up was 29 months. Survival at 1 year, 3 years, and 5 years was 86.7% (95% confidence interval [CI], 83.1-89.6), 73.3% (95% CI, 68.3-77.6), and 59.6% (95% CI, 53.4-65.2), respectively. Freedom from any target vessel occlusion and freedom from secondary procedures were 96.2% (95% CI, 93.8-97.7) and 88.2% (95% CI, 84.8-90.9) at 1 year and 90.0% (95% CI, 84.5-91.9) and 70.2% (95% CI, 63.9-75.6) at 5 years, respectively. In multivariate analysis, early mortality was associated with procedure time (hazard ratio [HR], 1.007 per minute; 95% CI, 1.003-1.010; P < .001), TAAA preoperative diameter (HR, 1.053 per millimeter; 95% CI, 1.020-1.087; P = .001), and chronic kidney disease (HR, 3.139; 95% CI, 1.369-7.196; P = .007). Mortality during the first 24 months of follow-up was associated with Crawford types I to III (HR, 1.526; 95% CI, 1.061-2.196; P = .023) compared with infradiaphragmatic repairs, chronic kidney disease (HR, 1.874; 95% CI, 1.294-2.712; P < .001), and TAAA preoperative diameter (HR, 1.027 per millimeter; 95% CI, 1.010-1.044; P = .002). In addition to these risk factors, mortality after 24 months of follow-up was also associated with age at repair (HR, 1.055 per year; 95% CI, 1.021-1.090; P = .001). CONCLUSIONS: F-BEVAR performed in high-risk patients is associated with favorable outcomes. Judicious selection of patients should take into consideration the reported risk factors associated with early and late mortality.

Meta-analysis of nontumescent-based versus tumescent-based endovenous therapies for patients with great saphenous insufficiency and varicose veins.

OBJECTIVE: The objective of this study was to compare the nontumescent-based endovenous therapies with the standard tumescent-based endovenous therapies in regard to clinical effectiveness and procedural outcomes in patients with saphenofemoral incompetence and varicose veins. METHODS: The following databases were searched for studies that were randomized or quasi-randomized trials comparing nontumescent-based endovenous procedures with those requiring tumescence: Cochrane Central Register of Controlled Trials (1950-January 2017), MEDLINE (1946-January 2017), and Embase (1950-January 2017). There were no restrictions based on language or publication status. In the case of ongoing studies, the World Health Organization's International Clinical Trials Registry Platform and the online ClinicalTrials.gov registry were also searched. We also reviewed reference lists of articles relevant to our study to ensure a more complete review. Two authors independently screened and selected studies to be included. These two authors also independently assessed the risk of bias using the Cochrane risk of bias tool. Data were extracted and pooled using a random-effects model. RESULTS: A total of nine studies were found in the literature search, of which five were included in analysis. Four outcomes were reviewed. A significant difference was found between the comparator groups for mean intraprocedural pain score (effect estimate, -0.66), favoring nontumescent-based therapies. There was no difference for Venous Clinical Severity Score (effect estimate, -0.21) for clinical assessment and the Aberdeen Varicose Vein Questionnaire score (effect estimate, 0.27) for the disease-specific quality of life between the groups. The outcome of failure of truncal ablation at 30 days had no significant difference between the groups (risk ratio, 1.27), although a subgroup analysis demonstrated a trend toward improved results with the novel nontumescent-based treatments (risk ratio, 0.21) compared with the old nontumescent-based treatments (risk ratio, 8.6). CONCLUSIONS: Currently available evidence from reasonable-quality clinical trials comparing tumescent-based with non-tumescent-based endovenous therapies shows no overall difference between the groups on a number of outcomes. Mean intraprocedural pain score appears to favor nontumescent-based interventions. Newer randomized trials comparing the treatment modalities are needed to further clarify the benefits of nontumescent-based therapies, particularly with regard to long-term outcomes.

Myocardial Injury After Noncardiac Surgery (MINS) in Vascular Surgical Patients: A Prospective Observational Cohort Study.

OBJECTIVE: To determine the prognostic relevance, clinical characteristics, and 30-day outcomes associated with myocardial injury after noncardiac surgery (MINS) in vascular surgical patients. BACKGROUND: MINS has been independently associated with 30-day mortality after noncardiac surgery. The characteristics and prognostic importance of MINS in vascular surgery patients are poorly described. METHODS: This was an international prospective cohort study of 15,102 noncardiac surgery patients 45 years or older, of whom 502 patients underwent vascular surgery. All patients had fourth-generation plasma troponin T (TnT) concentrations measured during the first 3 postoperative days. MINS was defined as a TnT of 0.03 ng/mL of higher secondary to ischemia. The objectives of the present study were to determine (i) if MINS is prognostically important in vascular surgical patients, (ii) the clinical characteristics of vascular surgery patients with and without MINS, (iii) the 30-day outcomes for vascular surgery patients with and without MINS, and (iv) the proportion of MINS that probably would have gone undetected without routine troponin monitoring. RESULTS: The incidence of MINS in the vascular surgery patients was 19.1% (95% confidence interval (CI), 15.7%-22.6%). 30-day all-cause mortality in the vascular cohort was 12.5% (95% CI 7.3%-20.6%) in patients with MINS compared with 1.5% (95% CI 0.7%-3.2%) in patients without MINS (P < 0.001). MINS was independently associated with 30-day mortality in vascular patients (odds ratio, 9.48; 95% CI, 3.46-25.96). The 30-day mortality was similar in MINS patients with (15.0%; 95% CI, 7.1-29.1) and without an ischemic feature (12.2%; 95% CI, 5.3-25.5, P = 0.76). The proportion of vascular surgery patients who suffered MINS without overt evidence of myocardial ischemia was 74.1% (95% CI, 63.6-82.4). CONCLUSIONS: Approximately 1 in 5 patients experienced MINS after vascular surgery. MINS was independently associated with 30-day mortality. The majority of patients with MINS were asymptomatic and would have gone undetected without routine postoperative troponin measurement.