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Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

Objective To assess the three year clinical outcomes and cost effectiveness of a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair for patients with suspected ruptured abdominal aortic aneurysm.Design Randomised controlled trial.Setting 30 vascular centres (29 in UK, one in Canada), 2009-16.Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture.Interventions 316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture).Main outcome measures Mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years as secondary measures.Results The maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years. After similar mortality by 90 days, in the mid-term (three months to three years) there were fewer deaths in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90), leading to lower mortality at three years (48% v 56%), but by seven years mortality was about 60% in each group (hazard ratio 0.92, 0.75 to 1.13). Results for the 502 patients with repaired ruptures were more pronounced: three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years there was no clear difference between the groups (hazard ratio 0.86, 0.68 to 1.08). Reintervention rates up to three years were not significantly different between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups. The early higher average quality of life in the endovascular strategy versus open repair group, coupled with the lower mortality at three years, led to a gain in average quality adjusted life years (QALYs) at three years of 0.17 (95% confidence interval 0.00 to 0.33). The endovascular strategy group spent fewer days in hospital and had lower average costs of −£2605 (95% confidence interval −£5966 to £702) (about €2813; $3439). The probability that the endovascular strategy is cost effective was >90% at all levels of willingness to pay for a QALY gain.Conclusions At three years, compared with open repair, an endovascular strategy for suspected ruptured abdominal aortic aneurysm was associated with a survival advantage, a gain in QALYs, similar levels of reintervention, and reduced costs, and this strategy was cost effective. These findings support the increasing use of an endovascular strategy, with wider availability of emergency endovascular repair.Trial registration Current Controlled Trials ISRCTN48334791; ClinicalTrials NCT00746122.

In this trial, 1150 patients undergoing coronary-artery bypass grafting were assigned to open or endoscopic vein-graft harvesting. At a median of 2.78 years, there was no significant difference between the groups in the rate of the composite of death from any cause, nonfatal myocardial infarction, or repeat revascularization.

Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique). We undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245. Between March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35–0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3% vs 16% for the standard treatment; OR 0·16, 95% CI 0·05–0·49) and recurrence of twin-to-twin transfusion syndrome (1% vs 7%; 0·21, 0·04–0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred. Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome. Netherlands Organization for the Health Research and Development (ZonMw 92003545).

Endovascular repair of abdominal aortic aneurysms avoids much of the risk associated with conventional surgical repair. In two randomized trials, this technique has been shown to be associated with lower rates of perioperative morbidity and mortality. Longer-term follow-up data from one of these trials (the Dutch Randomized Endovascular Aneurysm Management [DREAM] trial) show that the survival advantage of endovascular repair is not sustained after the first postoperative year. Endovascular repair of abdominal aortic aneurysms has been shown to be associated with lower rates of perioperative morbidity and mortality. Longer-term follow-up data show that the survival advantage of endovascular repair is not sustained after the first postoperative year. Two randomized trials have demonstrated better outcomes with elective endovascular repair of abdominal aortic aneurysms than with conventional open repair in the first month after the procedure. 1 , 2 The reported in-hospital mortality rates in these two trials were 4.6 percent and 6.0 percent for open repair and 1.6 percent and 1.2 percent for endovascular repair, respectively. Although the relevance of a reduction in perioperative risk should not be underestimated from the patient's perspective, the improvement in early survival with the use of a less invasive technique is not surprising. 3 Consequently, both reports stressed the need for longer-term data before a . . .

Abdominal aortic aneurysms greater than 5 cm in diameter are usually repaired surgically. This study compared open surgical repair with endovascular repair through the femoral artery, a less invasive approach. After 30 days, mortality and rates of major complications were significantly lower with endovascular than with open repair. Although the operative mortality is decreased, longer follow-up is needed to confirm the durability of these results. This study compared open surgical repair with endovascular repair through the femoral artery. Mortality and rates of major complications were lower with endovascular repair. Elective surgical repair is indicated in patients with a large abdominal aortic aneurysm. The threshold for surgery is still a subject of debate but varies between 5.0 and 5.5 cm in diameter. 1 – 4 Endovascular repair, pioneered by Parodi and Volodos in the early 1990s, is a less invasive alternative to conventional open repair. 5 , 6 Endovascular repair usually involves two small incisions made in the groin to expose the femoral arteries. With the use of guidewires, catheters, and specially designed introducer systems, a so-called endograft is assembled inside the abdominal aortic aneurysm under fluoroscopic guidance, thus excluding the aneurysm sac without . . .

Patients who undergo cardiac surgery have a high risk of significant blood loss and anemia. While allogeneic red blood cell (RBC) transfusions are effective, they are associated with increased morbidity and mortality. Intraoperative cell salvage may reduce reliance on allogeneic transfusions. Although intraoperative RBC salvage is recommended for cardiovascular surgery under cardiopulmonary bypass, there are concerns about increased bleeding due to coagulopathy in patients with a high bleeding risk, and its clinical impact remains unclear. This study aims to evaluate whether salvaged RBC transfusion is noninferior to allogeneic transfusion in terms of postoperative blood loss in patients with a high bleeding risk. This single-center, randomized, two-arm, parallel group, interventional clinical trial will include 142 participants aged ≥ 40 years with a high bleeding risk who undergo elective cardiovascular surgery with cardiopulmonary bypass. Participants will be randomly assigned to receive either salvaged RBC or allogeneic RBC transfusions intraoperatively. The primary outcome is postoperative chest tube blood loss within 12 hours from the end of surgery. Noninferiority will be demonstrated if the upper limit of the 95% confidence interval for the mean difference in blood loss between the salvaged and allogeneic groups is < 200 mL. Secondary outcomes comprise the RBC transfusion volume intraoperatively and for 12 hours from the end of surgery, prevalence of re-thoracotomy within 48 hours from the end of surgery, and prevalence of ≥ 1000 mL postoperative chest tube blood loss within 12 hours from the end of surgery. These outcomes will be analyzed using the modified intention-to-treat set and repeated, for sensitivity reasons, for the per-protocol set. Our trial aims to determine the noninferiority of intraoperative RBC salvage compared with allogeneic blood transfusions regarding postoperative blood loss and to promote its use in surgical procedures with a high bleeding risk. The trial was registered with the Japan Registry of Clinical Trials (jRCT1052240102) on July 30, 2024.

Objective To determine whether recurrence of leg ulcers may be prevented by surgical correction of superficial venous reflux in addition to compression. Design Randomised controlled trial.Setting Specialist nurse led leg ulcer clinics in three UK vascular centres.Participants 500 patients (500 legs) with open or recently healed leg ulcers and superficial venous reflux.Interventions Compression alone or compression plus saphenous surgery. Main outcome measures Primary outcomes were ulcer healing and ulcer recurrence. The secondary outcome was ulcer free time.Results Ulcer healing rates at three years were 89% for the compression group and 93% for the compression plus surgery group (P=0.73, log rank test). Rates of ulcer recurrence at four years were 56% for the compression group and 31% for the compression plus surgery group (P<0.01). For patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). For patients who had superficial with segmental deep reflux, recurrence rates at three years were 52% for the compression group and 24% for the compression plus surgery group (P=0.04). For patients with superficial and total deep reflux, recurrence rates at three years were 46% for the compression group and 32% for the compression plus surgery group (P=0.33). Patients in the compression plus surgery group experienced a greater proportion of ulcer free time after three years compared with patients in the compression group (78% v 71%; P=0.007, Mann-Whitney U test).Conclusion Surgical correction of superficial venous reflux in addition to compression bandaging does not improve ulcer healing but reduces the recurrence of ulcers at four years and results in a greater proportion of ulcer free time. Trial registration Current Controlled Trials ISRCTN07549334.

Mutations in the CYP2C19 gene can affect the conversion of clopidogrel to its active metabolite, leading to varying degrees of platelet inhibition. Based on prior studies evaluating CYP2C19 gene polymorphisms in patients with acute coronary syndrome, we hypothesized that patients with peripheral artery disease (PAD) carrying loss of function (LoF) alleles could experience heightened rates of major adverse cardiac events and those carrying gain of function (GoF) alleles could experience increased rates of major bleeding compared with non-carriers.1-4 EUCLID (NCT01732822) was a double-blind, multicenter, randomized active-comparator trial of 13,885 patients with symptomatic PAD randomly assigned to receive ticagrelor (90 mg twice daily) or clopidogrel (75 mg daily). Eligible patients had to be ≥50 years of age and have symptomatic PAD defined as previous lower extremity revascularization >30 days before randomization or an ankle-brachial index (ABI) of ≤0.80.5

Neurologic deficits are common after surgery for subarachnoid hemorrhage due to a ruptured intracranial aneurysm. In this study, the use of mild intraoperative hypothermia (target body temperature, 33°C) to prevent neurologic deficits after surgery had no protective effect. However, the patients enrolled in this study were at relatively low risk, and it is unclear whether intraoperative hypothermia may have benefits in higher-risk patients. In this study, the use of mild intraoperative hypothermia to prevent neurologic deficits after surgery had no protective effect in patients at relatively low risk. New neurologic deficits are common after intracranial vascular surgery and are due to factors such as brain retraction, vessel occlusion, and intraoperative hemorrhage. Thus, there have been many efforts to protect the brain from such insults. 1 – 6 The use of systemic hypothermia as a protective adjunct in neurosurgery was first reported in 1955 7 but was largely abandoned during the 1970s and 1980s. Interest in this approach was rekindled after the demonstration in the laboratory that the induction of mild hypothermia (a temperature of approximately 33 to 35°C) improved the outcome of ischemic and traumatic insults. 8 – 11 This finding coincided with . . .