Penn Evidence-Based Literature Review (PEBLR)

Summarized highlights from contemporary literature in surgical and allied disciplines for general surgery residents.

Critical Care

Platelet transfusion before CVC Placement in patients with thrombocytopenia
van Baarle FLF, van de Weerdt EK, van der Velden WJFM, Ruiterkamp RA, Tuinman PR, et al. N Engl J Med. 2023 May 25;388(21):1956-1965 (PubMed)
Contributor: Anna Garcia Whitlock

Brief Synopsis

Prophylactic platelet transfusion in the hour before central venous line placement in medicine patients with thrombocytopenia resulted in a greater than 50% reduction in bleeding events (4.7 vs 11.9%), including a reduction in events that required operative or radiologic intervention or red blood cell transfusion (2.1 vs 4.9%).

Summary: Approximately 18% of patients undergo central venous catheter placement (CVC) while in the hospital, many of whom are thrombocytopenic and at greater risk of bleeding complications. This multicenter randomized control trial was conducted to determine if preoperative platelet infusion in this population could decrease complications. Patients with platelet counts of 10,000 to 50,000 per cubic millimeter who needed a central line for at least 24 hours were recruited into the study. Exclusion criteria included an INR >1.5, administration of an anticoagulant, or prior history of an acquired or congenital coagulation factor deficiency. Primary outcome was catheter-related bleeding within 24 hours of CVC placement. Recruited patients were randomized to either receive a platelet transfusion or not, and they received their treatment 1 hour prior to CVC placement. Providers placing the central line had to use an ultrasound and be experienced (>50 central line placements in their career). Lines placed included tunneled and non-tunneled lines, large bore-dialysis catheters, and smaller regular catheters at the internal jugular, subclavian, and femoral veins.

To gauge bleeding complications, the authors used the Common Terminology Criteria for Averse Events, which used a gradation system. Grade 0 was no bleeding, while Grade 1 bleeding required minor intervention such as pressure being held <20 minutes. Grade 2 bleeding was that requiring manual compression >20 minutes or other similar level interventions while Grade 3 bleeding required radiologic or elective operative intervention or red-cell transfusion without hemodynamic instability. Grade 4 was bleeding associated with severe hemodynamic instability which was not observed in this study. 

This study recruited 188 patients to receive platelets prior to CVC placement and 185 who did not. Patients were predominately male and slightly more likely to be on the hematology ward versus in the intensive care unit in both the treatment and non-treatment arms (~56 and 57% respectively). Patients in the transfusion group were less likely to have Grade 2-4 bleeding (4.8% vs. 11.9%). Again, no Grade 4 bleeding was observed, but Grade 3 bleeding events were lower in the transfused group (2.1 vs. 4.9%). Subgroup analysis found that for both groups patients treated on the hematology ward or receiving tunneled catheters were more likely to experience bleeding than those in the ICU or receiving non-tunneled catheters, respectively.  Cost analysis found that prophylactic platelet transfusion cost about $410 per line. 

Limitations of the study include that some patients with low platelets received platelets within 24 hours of the line in addition to within the hour before CVC placement when they were randomized to receive the prophylactic platelets or not. The authors suggest that future studies should consider looking at platelet trajectory in addition to individual numbers. In addition, the study was done in hematology oncology patients and bears repeating in different populations – including our surgical patients with varied causes of thrombocytopenia to determine wider clinical applicability. Regardless, this is a first step suggesting that prophylactic platelet transfusion reduces bleeding complications and may be worth the cost. 

Bottom line: Prophylactic platelet transfusion before central line placement in patients with thrombocytopenia may result in less bleeding events. 

GI Surgery

Long-term Safety and Efficacy of Closure of Mesenteric Defects in Laparoscopic Gastric Bypass Surgery: A Randomized Clinical Trial
Stenberg E, Ottosson J, Magnuson A, et al. JAMA Surg. 2023;158(7):709–717. (PubMed)
Contributor: Cimarron Sharon

Brief Synopsis

This is a randomized control trial (RCT) of almost 2,500 Roux-en-Y gastric bypass (RYGB) patients who were assigned to either mesenteric defect closure or not at the time of index surgery. The authors found that closure of the mesenteric defects is associated with decreased risk of small bowel obstruction (SBO) and internal hernia at 10 years follow-up. 

Summary: This RCT included 2,507 patients who received a laparoscopic antecolic Roux-en-Y gastric bypass at 12 centers for bariatric surgery in Sweden between May 2010 and November 2011. Patients were randomized to either closure (n=1,259) or non-closure of mesenteric defects (n=1,248); mesenteric defects included Peterson’s space and beneath the jejunojejunostomy. The primary study endpoint was reoperation for SBO at 10 years after surgery, and a secondary endpoint included reoperation specifically for internal hernia. Internal hernia was defined as the cause of the SBO if the bowel was herniated at the time of surgery. 

After 10 years of follow-up, 7.8% (n=98) of patients with closed defects and 14.9% (n=185) of patients with non-closure underwent a reoperation for SBO. Notably, there was an increased risk for SBO within the first 30 post-operative days for patients with closed defects (subhazard ratio [SHR] 2.62, p=0.02), although closure was protective following the initial 30 post-operative days (SHR 0.42, p<0.001). The most common cause of SBO after 30 days was internal hernia, followed by adhesions. During the study period, closure of mesenteric defects was associated with a reduced risk for internal hernia, with 3.8% (n=47) of patients with closure and 12.9% (n=159) undergoing re-operation for SBO secondary to an internal hernia (SHR 0.28, p<0.001).  

The results of this study demonstrate that closure of the mesenteric defects is associated with decreased rates of SBO and internal hernia at ten years of follow-up, although higher rates of reoperation for SBO are seen in the immediate post-operative period for patients in the closure group. This may be secondary to increased rates of kinking of the jejunojejunostomy, a known risk-factor of closure of the mesenteric defects. A small increase in rates of early post-operative bowel obstruction may be a reasonable trade-off for a long-term reduction in internal hernias and SBO. 

Bottom line: Closure of the mesenteric defects during laparoscopic RYGB decreases rates of SBO and internal hernia after long term follow up but maybe associated with more early post-operative bowel obstructions. 

Vascular Surgery

A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial
Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L, Chetter I, et al. Epub 2023 Apr 25. (Lancet)
Contributor: Jayne Rice

Brief Synopsis

Bypass versus Angioplasty for Severe Ischemia of the Leg (BASIL)-2 is a randomized controlled trial (RCT) that assigns patients with chronic limb-threatening ischemia (CLTI), specifically infra-popliteal peripheral arterial disease, to either vein bypass or best endovascular treatment as their first revascularization with the primary outcome being amputation free survival. This RCT found that a best endovascular treatment first revascularization strategy was associated with improved amputation free survival compared to vein bypass.

Summary: Chronic limb threatening ischemia (CTLI), defined as rest pain or ischemic ulceration/gangrene, affects about 11% of the 200 million patients with PAD worldwide. Without revascularization, amputation is guaranteed 25% within one year. Previous studies have shown either no difference between bypass and angioplasty or, more recently, lower rates of major adverse limb events in patients who have had a bypass, but these data are not widely applicable to patient with severe PAD. To answer this question, BASIL-2 RCT was initiated, which is a multicenter international phase 3 trail that included patients with CLTI due to atherosclerotic disease and required infra-popliteal revascularization, with or without an additional more proximal infrainguinal revascularization. Patients were randomized to either a vein bypass group or best endovascular treatment (defined as the use of any endovascular device) as their first revascularization procedure. The primary outcome was amputation free survival defined as time to major amputation of the trial leg or death from any cause. 345 patients were enrolled and randomly assigned with 172 in the vein bypass group and 173 in the best endovascular treatment group. Of the patients in the bypass cohort, 63% had a major amputation or died compared to 53% of patients in the best endovascular treatment group (HR 1.35, 95% CI: 1.02-1.80, p=0.037). Similarly, 53% of patients in the vein bypass group while 45% of patients in the best endovascular treatment group died from any cause (HR 1.37, 95% CI: 1.00-1.87) and 20% of patients in the bypass group compared to 18% of patients in the endovascular group had a major amputation (HR 1.23, 95% CI: 0.75-2.01). However, patients in the best endovascular group were more likely to have a re-intervention compared to those in the vein bypass group (HR 0.27, 95% CI 0.13 – 0.55). The 30-day post procedure morbidity and mortality were not significantly different and the causes of death in the two groups were not different or unexpected. One notable limitation of this study was that 84% of patients in the best endovascular treatment group had their procedure done by an interventional radiologist and thus, these data are not necessarily generalizable to surgeons.   

Bottom line: Patients with CTLI due to infra-popliteal PAD may be at greater risk of major amputation and death if they undergo vein bypass first as compared to a best endovascular approach for revascularization.

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