The PAUSE study: Safety of perioperative DOAC management in patients with atrial fibrillation

A discussion during a previous conference included the perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant (DOAC).


Reference: Douketis JD, et al. Perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant. JAMA Internal Medicine. 2019 Aug 5; doi:10/1001/jamainternmed.2019.2431

Summary: Each year, 1 in 6 patients with AF, or an estimated 6 million patients worldwide, will require perioperative anticoagulant management. When DOAC regimens became available for clinical use in AF, starting in 2010, no studies had been conducted to inform the timing of perioperative DOAC therapy interruption and resumption, whether heparin bridging should be given, and whether preoperative coagulation function testing was needed. Uncertainty about the perioperative management of DOACs may be associated with unsubstantiated practices and increased harm to patients.

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Open vs endovascular revascularization for ALI: a review of major trials

One discussion this week involved open surgical versus endovascular revascularization for acute limb ischemia (ALI).

Reference: Wang JC, Kim AH, Kashyap VS. Open surgical or endovascular revascularization for acute limb ischemia. Journal of Vascular Surgery. 2016 Jan;63(1):270-278. doi:10/1016/j.jvs.2015.09.055.

Summary: Peripheral arterial disease affects approximately 10 million Americans. It can lead to lower extremity ischemic rest pain or tissue loss (Rutherford classification 4 to 6, or Fontaine classification III and IV). Acute limb ischemia (ALI) is defined as the presence of symptoms within 2 weeks of onset. ALI pathogenesis includes vascular stenoses with subsequent in situ thrombosis or thromboembolism from a cardiac or aortoiliac source. Stenotic lesions may indicate untreated comorbidities (eg, hypertension, hypercholesterolemia, diabetes, or tobacco use), whereas thromboembolisms implicate undiagnosed cardiac arrhythmias, myocardial infarction (MI), or mural thrombus. Limb loss risk due to ALI can be as high as 40% with an attendant mortality rate of 15% to 20% (p.270).

Limb salvage (LS) revascularization is traditionally achieved with emergent surgical thromboembolectomy or bypass. Catheter-based technologic advancements have afforded a wide array of endovascular therapy (ET) amenable for treating ALI, including catheter-directed thrombolysis (CDT), pharmacomechanical thrombolysis (PMT), angioplasty, and stenting.

For this review, a systematic literature review using MEDLINE (1990-
2014) was performed with querying keywords acute limb ischemia, acute occlusion, peripheral arteries, thrombectomy, thrombolysis, and complications. Clinical trials, registry reports, open vs endovascular arterial revascularization, and review articles were included. Attention was given to revascularization techniques, short- and long-term patency, LS rates, amputation-free survival (AFS), overall survival (OS), and complications. Four RCTs and 5 other study types were analyzed.

RCTs1

 

RCTs2

 

CONCLUSION: ALI remains a morbid condition with high risk for limb loss and death. Based on the current evidence, ET is effective for LS and safer in the short term than urgent open revascularization in the studied patients. Still, individual patient factors need to be carefully considered for further generalization. ET and surgery are complementary rather than competing strategies for treating ALI. Further good-quality clinical trial data are required to define longer term outcomes.

The benefit of urinary alkalinization and mannitol in the treatment of rhabdomyolysis

One discussion this week included the benefits of urinary alkalinization and mannitol in treating rhabdomyolysis (RM).


Reference: Bada A, Smith N, and Surgical Critical Care Guidelines Committee. Rhabdomyolysis: Prevention and Treatment. SurgicalCritical Care.net. 2018, Jul 24.

Summary: RM is the dissolution muscle and release of potentially toxic intracellular components into the systemic circulation. RM has the potential to cause myoglobinuric ARF in 10-15% of such patients. Overall, 10-15% of ARF in the United States is from RM.

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Upper GI bleeding: CTA prior to flouroscopic angiography?

A discussion this week included a diagnostic CTA prior to flourscopic angiography.


Reference: Wells ML, et al. CT for evaluation of acute gastrointestinal bleeding. RadioGraphics. 2018 Jul-Aug;38(4):1089-1107. doi:10.1148/rg.2018170138

Summary: “Teaching point: CT angiography is gaining popularity for use in emergent evaluations of acute GI bleeding. It has potential for use in the first-line evaluation of acute LGIB and the evaluation of UGIB after failed or nondiagnostic endoscopy.”

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Balanced crystalloids vs saline in adult ICU patients

One discussion this week included the question of balanced crystalloids vs saline in ICU and non-ICU patients.


Reference: Semler MW, et al. Balanced crystalloids versus saline in critically ill adults. NEJM. 2018 Mar 1;378:829-839. doi:10.1056/NEJMoa1711584

Summary: Although both saline and balanced crystalloids have been administered to patients in clinical practice for decades, few trials have addressed the effects of crystalloid composition on clinical outcomes.

The authors conducted an unblinded, cluster-randomized, multiple-crossover trial in which the use of balanced crystalloids was compared with saline for intravenous fluid administration among critically ill adults admitted to five ICUs at Vanderbilt University Medical Center between June 1, 2015, and April 30, 2017. A total of 15,802 patients were enrolled. The median age was 58, and 57.6% of patients were men.

The primary outcome was the proportion of patients who met one or more criteria for a major adverse kidney event within 30 days — the composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value) — all censored at hospital discharge or 30 days after enrollment, whichever came first.

Among the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P=0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P=0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P=0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P=0.60).

In this trial of critically ill adults, the intravenous administration of balanced crystalloids rather than saline had a favorable effect on the composite outcome of death, new renal-replacement therapy, or persistent renal dysfunction.

Additional Reading: Hammond DA, et al. Balanced crystalloids versus saline in critically ill adults: a systematic review and meta-analysis. Annals of Pharmacotherapy. 2019 Jul 31:1060028019866420. doi: 10.1177/1060028019866420.

Intraoperative cardiac arrest: Resuscitation and Management

One discussion this week included intraoperative cardiac arrest.


Reference: Moitra VK, et al. Cardiac arrest in the operating room: resuscitation and management for the anesthesiologist: part 1. Anesthesia & Analgesia. 2018 Mar;126(3):876-888. doi: 10.1213/ANE.0000000000002596.

Summary: Cardiac arrest in the operating room and procedural areas has a different spectrum of causes (ie, hypovolemia, gas embolism, and hyperkalemia), and rapid and appropriate evaluation and management of these causes require modification of traditional cardiac arrest algorithms. There is a small but growing body of literature describing the incidence, causes, treatments, and outcomes of circulatory crisis and perioperative cardiac arrest. These events are almost always witnessed, frequently known, and involve rescuer providers with knowledge of the patient and their procedure.

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What is the risk of rupture for type II endoleaks?

One discussion last week included the risk of rupture with type II endoleaks.

Reference: Brown A, et al. Type II endoleaks: challenges and solutions. Vascular Health Risk Management. 2016;12:53-63.

Summary:  Although type II endoleak appears to be associated with sac expansion (volume changes), the significance of this expansion on risk of aneurysm rupture remains unclear.

Wyss et al found a significant association between sac expansion and rupture.Twenty-seven ruptures occurred in an EVAR population of 848 patients, with an average follow-up of 4.8 years. Sixty-three percent of these ruptures occurred more than 30 days post-repair and were associated with prior complications detected on follow-up imaging. Five of these 17 ruptures demonstrated evidence of type II endoleak with associated sac expansion (four were isolated type II endoleaks and one was associated with a concomitant type Ib endoleak).

Conversely, other authors have shown no correlation. Van Marrewijk et al demonstrated that sac expansion was significantly associated with type II endoleaks; however, there was no correlation with rupture or increase in aneurysm-associated mortality. A recent systematic review reported a low incidence of rupture in patients with isolated type II endoleaks (under 1%) of which 57% were associated with sac expansion.

Sac expansion may therefore be a poor marker of risk in this population of patients; however, we do not currently have a more sensitive way of monitoring risk of rupture. As such, some authors suggest that consideration should be given to prevention of/or treatment for type II endoleak.

D1 vs D2 resection for gastric cancer

One discussion this week included a trial out of Denmark comparing D1 and D2 lymph-node dissection for gastric cancer.

Reference: Bonenkamp JJ, et al. Extended lymph-node dissection for gastric cancer. NEJM. 1999 Mar 25;340(12):908-914.

Summary: Curative resection is the treatment of choice for gastric cancer, but it is unclear whether this operation should include an extended (D2) lymph-node dissection or a limited (D1) dissection. The authors conducted a randomized trial in 80 Dutch hospitals in which they compared D1 with D2 lymph-node dissection for gastric cancer in terms of morbidity, postoperative mortality, long-term survival, and cumulative risk of relapse after surgery.

Between August 1989 and July 1993, 996 patients were enrolled. Of these, 711 underwent randomly assigned treatment (D1 = 380, D2 = 331) and 285 received palliative treatment.

General findings:

  • Complications: 43% in D2, 25% in D1
  • Postoperative deaths: 10% in D2, 4% in D1
  • Length of stay: 16 median days in D2, 14 days in D1
  • 5-year survival rates: 47% in D2, 45% in D1

 

d1 v d2

One of the arguments for D2 dissection is its ability to reduce rates of local recurrence, thereby increasing the quality of life. The distressing finding of local recurrence, usually in a terminal phase of the disease, often leads to second operations to restore gastrointestinal continuity. In this trial, there was a tendency toward a reduced cumulative risk of relapse after D2 dissection, but the rate of relapse remained high and the difference from D1 dissection was not significant. A subgroup analysis indicated a significant or marginally significant difference for patients with disease in UICC stages II and IIIA, but this difference was attributable largely to stage migration.

Are diabetic patients at greater risk for anastomotic leaks and mortality when undergoing colectomies?

One discussion this week included postoperative anastomotic leaks.

Reference: Ziegler MA, et al. Risk factors for anastomotic leak and mortality in diabetic patients undergoing colectomy: analysis from a statewide surgical quality collaborative. Archives of Surgery. 2012 Jul;147(7):600-605. doi: 10.1001/archsurg.2012.77.

Summary: In a database review of patients in Michigan who underwent colectomy, the study aimed to determine risk factors in diabetic patients that are associated with increased postcolectomy mortality and anastomotic leak.

Primary risk factors were diabetes mellitus, hyperglycemia, steroid use, and emergency surgery. Of the 5123 patients, 889 were diabetic, 4234 were nondiabetic.

Diabetes alone was not found to be a risk factor for anastomotic leak in this study.

  • 56% of diabetic patients had preoperative glucose levels of 140 mg/dL or higher
  • Preoperative steroid use led to increased rates of anastomotic leak in diabetic patients
  • Diabetic patients who had a leak had more than a 4-fold higher mortality (26.3% vs 4.5%, P<.001) compared with nondiabetic patients (6.0% vs 2.5%, P<.05).
  • Mortality was associated with hyperglycemia for nondiabetic patients only

The authors conclude that improved screening may identify high-risk patients who would benefit from perioperative intervention.