The role of sealants for achieving anastomotic hemostasis in vascular surgery.

BACKGROUND: During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients. OBJECTIVES: To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023. SELECTION CRITERIA: We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients. DATA COLLECTION AND ANALYSIS: We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes. AUTHORS' CONCLUSIONS: Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.

General versus loco-regional anesthesia for endovascular aortic aneurysm repair.

BACKGROUND: Aortic aneurysms occur when the aorta, the body's largest artery, grows in size, and can occur in the thoracic or abdominal aorta. The approaches to repair aortic aneurysms include directly exposing the aorta and replacing the diseased segment via open repair, or endovascular repair. Endovascular repair uses fluoroscopic-guidance to access the aorta and deliver a device to exclude the aneurysmal aortic segment without requiring a large surgical incision. Endovascular repair can be performed under a general anesthetic, during which the unconscious patient is paralyzed and reliant on an anesthetic machine to maintain the airway and provide oxygen to the lungs, or a loco-regional anesethetic, for which medications are administered to provide the person with sufficient sedation and pain control without requiring a general anesthetic. While people undergoing general anesthesia are more likely to remain still during surgery and have a well-controlled airway in the event of unanticipated complications, loco-regional anesthesia is associated with fewer postoperative complications in some studies. It remains unclear which anesthetic technique is associated with better outcomes following the endovascular repair of aortic aneurysms. OBJECTIVES: To evaluate the benefits and harms of general anesthesia compared to loco-regional anesthesia for endovascular aortic aneurysm repair. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was 11 March 2022. SELECTION CRITERIA: We searched for all randomized controlled trials that assessed the effects of general anesthesia compared to loco-regional anesthesia for endovascular aortic aneurysm repairs. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were: all-cause mortality, length of hospital stay, length of intensive care unit stay. Our secondary outcomes were: incidence of endoleaks, requirement for re-intervention, incidence of myocardial infarction, quality of life, incidence of respiratory complications, incidence of pulmonary embolism, incidence of deep vein thrombosis, and length of procedure. We planned to use GRADE methodology to assess the certainty of evidence for each outcome. MAIN RESULTS: We found no studies, published or ongoing, that met our inclusion criteria. AUTHORS' CONCLUSIONS: We did not identify any randomized controlled trials that compared general versus loco-regional anesthesia for endovascular aortic aneurysm repair. There is currently insufficient high-quality evidence to determine the benefits or harms of either anesthetic approach during endovascular aortic aneurysm repair. Well-designed prospective randomized trials with relevant clinical outcomes are needed to adequately address this.

Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in-stent restenosis of the femoropopliteal arteries.

BACKGROUND: Stents are placed in the femoropopliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as "in-stent stenosis." It is thought that in-stent restenosis is caused by a process known as "intimal hyperplasia" rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (DEBs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. It is important to perform this systematic review to evaluate the efficacy of DEB because of the potential for increased expenses associated with DEBs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (POBA). OBJECTIVES: To assess the safety and efficacy of DEBs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoropopliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, target lesion revascularization, binary restenosis rate, and death. We define "in-stent restenosis" as 50% or greater narrowing of a previously stented vessel by duplex ultrasound or angiography. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to November 28, 2017. Review authors also undertook reference checking to identify additional studies. SELECTION CRITERIA: We included all randomized controlled trials that compared DEBs versus uncoated balloon angioplasty for treatment of in-stent restenosis in the femoropopliteal arteries. DATA COLLECTION AND ANALYSIS: Two review authors (AK, WA) independently selected appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (AD) adjudicated any disagreements. MAIN RESULTS: Three trials that randomized a combined total of 263 participants met the review inclusion criteria. All three trials examined the treatment of symptomatic in-stent restenosis within the femoropopliteal arteries. These trials were carried out in Germany and Austria and used paclitaxel as the agent in the drug-eluting balloons. Two of the three trials were industry sponsored. Two companies manufactured the drug-eluting balloons (Eurocor, Bonn, Germany; Medtronic, Fridley, Minnesota, USA). The trials examined both anatomical and clinical endpoints. We noted heterogeneity in the frequency of bailout stenting deployment between studies as well as in the dosage of paclitaxel applied by the DEBs. Using GRADE assessment criteria, we determined that the certainty of evidence presented was very low for the outcomes of amputation, target lesion revascularization, binary restenosis, death, and improvement of one or more Rutherford categories. Most participants were followed up to 12 months, but one trial followed participants for up to 24 months.Trial results show no difference in the incidence of amputation between DEBs and uncoated balloon angioplasty. DEBs showed better outcomes for up to 24 months for target lesion revascularization (odds ratio (OR) 0.05, 95% confidence Interval (CI) 0.00 to 0.92 at six months; OR 0.24, 95% CI 0.08 to 0.70 at 24 months) and at six and 12 months for binary restenosis (OR 0.28, 95% CI 0.14 to 0.56 at six months; OR 0.34, 95% CI 0.15 to 0.76 at 12 months). Participants treated with DEBs also showed improvement of one or more Rutherford categories at six and 12 months (OR 1.81, 95% CI 1.02 to 3.21 at six months; OR 2.08, 95% CI 1.13 to 3.83 at 12 months). Data show no clear differences in death between DEBs and uncoated balloon angioplasty. Data were insufficient for subgroup or sensitivity analyses to be conducted. AUTHORS' CONCLUSIONS: Based on a meta-analysis of three trials with 263 participants, evidence suggests an advantage for DEBs compared with uncoated balloon angioplasty for anatomical endpoints such as target lesion revascularization (TLR) and binary restenosis, and for one clinical endpoint - improvement in Rutherford category post intervention for up to 24 months. However, the certainty of evidence for all these outcomes is very low due to the small number of included studies and participants and the high risk of bias in study design. Adequately powered and carefully constructed randomized controlled trials are needed to adequately investigate the role of drug-eluting technologies in the management of in-stent restenosis.

Long-term survival and temporal trends in patient and surgeon factors after elective and ruptured abdominal aortic aneurysm surgery.

OBJECTIVE: Records for all patients in Ontario who underwent elective repair of abdominal aortic aneurysms (AAAs) or repair of ruptured AAAs between 1993 and 1999 were studied to determine whether the profile of surgeons or patients changed and to determine whether postoperative mortality changed over time. The secondary objective was to describe long-term survival after AAA surgery. METHODS: A population-based retrospective cohort was assembled from administrative data. Surgeon billing records were used to identify operations performed between 1993 and 1999. Chi(2) and linear regression analyses were used to determine whether variables changed over time. Kaplan-Meier survival curves were used to estimate long-term survival. RESULTS: For patients undergoing elective AAA repair, average annual surgeon volume (P <.0001) and proportion of patients operated on by vascular surgeons (P =.02) increased over the study period; similar trends were noted for patients undergoing repair of ruptured AAAs. Surgeon volume was clearly correlated with mortality after both elective AAA repair and repair of ruptured AAAs; however, the benefit of this effect was modest beyond a surgeon volume of 6 to 10 ruptured AAA repairs per year or 20 to 30 elective AAA repairs per year. No change in crude 30-day mortality (4.5% for elective AAA repair and 40.4% for repair of ruptured AAAs) was noted during the study. CONCLUSION: Despite the finding that surgery to repair ruptured AAAs and elective repair of AAAs is being increasingly performed by high-volume vascular surgeons, there was no change in early mortality between 1993 and 1999. This may have been because average surgeon volume was already relatively high at the beginning of the study period, which translated into only modest benefit to further increases in surgeon volume.

Survival after ruptured abdominal aortic aneurysm: effect of patient, surgeon, and hospital factors.

OBJECTIVE: The purpose of this study was to determine the effects of patient, surgeon, and hospital factors on survival after repair of ruptured abdominal aortic aneurysm (AAA) and to compare them with risk factors for survival after elective AAA repair. It was hypothesized that patients operated on by high-volume surgeons with subspecialty training would have better outcomes, which might argue for regionalization of AAA surgery. METHODS: In this population-based retrospective cohort study, surgeon billing and administrative data were used to identify all patients who had undergone AAA repair between April 1, 1992, and March 31, 2001, in Ontario, Canada. Demographic information was collected for each patient, as well as numerous variables related to the surgeons and hospitals. RESULTS: There were 2601 patients with ruptured AAA repair, with an average 30-day mortality rate of 40.8%. Significant independent predictors of lower survival were older age, female gender, lower patient income quintile, performance of surgery at night or on weekends, repair in larger cities, surgeons with lower annual volume of ruptured AAA operations, and surgeons without vascular or cardiothoracic fellowship training. There were 13,701 patients with elective AAA repair, with an average 30-day mortality rate of 4.5%. Significant independent predictors of lower survival were similar, except gender was not significant, but the Charlson Comorbidity Index was. When the hazard ratios associated with predictive factors were compared, surgeon factors appeared to be more important in ruptured AAA repair, and patient factors appeared more important in elective AAA repair. CONCLUSION: For elective AAA repair, and even more so for ruptured AAA repair, high-volume surgeons with subspecialty training conferred a significant survival benefit for patients. Although this would seem to argue in favor of regionalization, decisions should await a more complete understanding of the relationship between transfer time, delay in treatment, and outcome.

Predictors of repair and effect of gender on treatment of ruptured abdominal aortic aneurysm.

OBJECTIVE: The purpose of this study was to determine factors associated with increased likelihood of patients undergoing surgery to repair ruptured abdominal aortic aneurysms (AAAs). Specifically, we investigated whether men were more likely than women to be selected for surgery after rupture of AAAs. METHODS: All patients with a ruptured AAA who came to a hospital in Ontario between April 1, 1992, and March 31, 2001, were included in this population-based retrospective study. Administrative data were used to identify patients, patient demographic data, and hospital variables. RESULTS: Crude 30-day mortality for the 3570 patients who came to a hospital with a ruptured AAA was 53.4%. Of the 2602 patients (72.9%) who underwent surgical repair, crude 30-day mortality was 41.0%. Older patients (odds ratio [OR], 0.649 per 5 years of age; P<.0001), with a higher Charlson Comorbidity Index (OR, 0.848; P<.0001), were less likely to undergo AAA repair. Patients treated at high-volume centers (OR, 2.674 per 10 cases; P<.0001) and men (OR, 2.214; P<.0001) were more likely to undergo AAA repair. CONCLUSION: Men are more likely to undergo repair of a ruptured AAA than women are, for reasons that are unclear. Given the large magnitude of the effect, further studies are clearly indicated.

Outcome of revascularization procedures for peripheral arterial occlusive disease in Ontario between 1991 and 1998: a population-based study.

PURPOSE: We describe the outcome of revascularization procedures used to treat peripheral arterial occlusive disease (PAOD), using population-based administrative data. METHODS: A retrospective population-based cohort study utilizing administrative databases in Ontario, Canada, was conducted for fiscal years 1991 to 1998 to identify patients who underwent arterial bypass surgery and percutaneous transluminal angioplasty to treat PAOD. The Kaplan-Meier method was used to calculate cumulative survival rate and amputation-free survival rate. To analyze factors that affect these rates, multivariate analysis was performed with Cox proportional hazard models. RESULTS: Over the study period 15,824 patients underwent bypass operations and 11,548 underwent angioplasty. For patients who underwent bypass surgery, 5-year cumulative survival rate was 61.5% and major amputation-free survival rate was 83.4%, compared with 69% and 92.2%, respectively, for patients who underwent angioplasty. Male sex, older age, diabetes, and heart disease were associated with increased risk for death after revascularization procedures. Increased risk for major amputation after revascularization procedures was associated with male sex, older age, and diabetes, whereas hypertension was linked to decreased risk. CONCLUSION: To evaluate the long-term outcome of revascularization procedures for PAOD at the population level, survival and major amputation-free survival rates should be used, because they provide more clinically accepted estimates compared with the correlation between utilization rates for revascularization and amputation procedures, which have been used to describe outcome in previously published reports in the literature.

Use of interventional procedures for peripheral arterial occlusive disease in Ontario between 1991 and 1998: a population-based study.

PURPOSE: Although peripheral arterial occlusive disease (PAOD) is a public health issue in the elderly population, limited population-based data are available on use of interventional procedures in Canada. We describe trends in use of interventional procedures to treat PAOD in Ontario over the past decade. METHODS: A retrospective population-based cohort study was conducted for fiscal years 1991 to 1998 with Ontario administrative databases to identify all arterial bypass surgeries, angioplasty procedures, and amputations performed. RESULTS: A total of 19,332 bypass operations, 16,334 angioplasty procedures, and 17,534 amputations were identified. Population-based rates showed that angioplasty use peaked at about 110 per 100,000 at age 65 to 74 years, arterial bypass surgery use peaked at 129 per 100,000 at age 75 to 84 years, and amputation use peaked at 138 per 100,000 at age 85 years or older. All types of interventional procedures to treat PAOD were performed more frequently in men than in women. Age-adjusted and sex-adjusted rate of arterial bypass surgery decreased significantly, from 77 to 61 per 100,000 population aged 45 years or older (P =.0002, linear regression analysis), whereas rate for PTA increased significantly, from 59 to 75 per 100,000 population aged 45 years or older (P =.0005). The overall major amputation rate declined slightly over the study period, influenced by the decreased rate in patients aged 85 years or older. The revascularization rate in patients aged 85 years or older increased (P =.055). CONCLUSION: Reduced use of arterial bypass surgery and increased use of angioplasty procedures has occurred over the past decade and may reflect a change in the practice pattern of vascular surgeons in Ontario, who have become more conservative in treating localized disease and reserve surgical interventions for more severe forms of PAOD. The slight reduction in overall major amputation rate, driven by decreased rate in patients aged 85 years or older, may reflect a trend toward a more aggressive revascularization approach in this age group.

A metaanalysis comparing surgical thrombectomy, mechanical thrombectomy, and pharmacomechanical thrombolysis for thrombosed dialysis grafts.

BACKGROUND: The achievement and maintenance of access sites for hemodialysis is a persistent challenge for both the vascular surgeon and the clinical nephrologist. The advent of improved interventional, endovascular, and pharmacomechanical techniques for the treatment of thrombosis has raised questions as to whether surgical thrombectomy is the most effective treatment. OBJECTIVE: The purpose of this study was to determine the role of surgical thrombectomy as the standard of care for the patient with end-stage renal disease and a thrombosed/stenosed arteriovenous graft (AVG). DESIGN AND METHODS: The study was designed as a metaanalysis. All publications that directly or indirectly described randomized controlled trials for the treatment of thrombosed dialysis grafts in patients with end-stage renal disease and AVG were searched. Relative risk (RR) and risk difference were used as the measure of effect for each dichotomous outcome. All of the studies that met the inclusion criteria were limited to prosthetic AVGs. RESULTS: The overall results suggested a clear superiority of surgery over endovascular procedures at 30 days, 60 days, 90 days, and 1 year. The RRs (95% CI) at these time points were 1.32 (1.07, 1.60), 1.34 (1.13, 1.58), 1.22 (1.05, 1.40), and 1.22 (1.07, 140), respectively, and favored surgery in all cases (30 days, P =.010; 60 days, P =.0007; 90 days, P =.007; and 1 year P =.003). The number needed to treat to prevent one endovascular occlusion after thrombectomy was 8 at 30 days, 6 at 60 days, 8 at 90 days, and 7 at 1 year. The rates of technical failure were significantly greater in the endovascular group compared with the surgical group (RR, 1.90; 95% CI, 1.32, 2.73; P =.0005), which generated an absolute risk reduction of 16% (P =.0002). No significant difference was seen in the complication rates between the two groups. CONCLUSION: The analysis of all currently available randomized controlled trials clearly supports the use of surgical thrombectomy for the treatment of thrombosed prosthetic vascular access grafts. The use of endovascular techniques has been found to be inferior to surgery in terms of both primary patency and technical failure rates.