Penn Evidence-Based Literature Review (PEBLR)

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

Pediatric Surgery

Association of operative approach with outcomes in neonates with esophageal atresia and tracheoesophageal fistula
Etchill EW, et al. J Pediatr Surg. 2021 Dec;56(12):2172-2179. doi: 10.1016/j.jpedsurg.2021.04.006. 
Contributor: Cara Berkowitz, Val Luks

Brief Synopsis

This retrospective cohort study using the ACS-NSQIP-P database found that thoracoscopy for treatment of neonates with esophageal atresia and tracheoesophageal fistula was not superior to thoracotomy, but rather was associated with a high conversion rate to thoracotomy, longer operative time, and no significant post-operative benefit – highlighting the potential value of treatment at high-volume centers with greater experience in thoracoscopy.

Summary:
Esophageal Atresia and Tracheoesophageal Fistula (EA/TEF) is a congenital anomaly that requires surgical repair by ligation of the fistula and creation of an esophagoesophagostomy. While initially performed via open thoracotomy, over the past 30 years some pediatric surgeons have turned to thoracoscopic surgery as a possible way to improve short-term and long-term outcomes compared to open repair. This retrospective cohort study sought to compare thoracotomy versus thoracoscopy for the treatment of EA/TEF in neonates and to evaluate the subsequent perioperative and post-operative outcomes.

Retrospective analysis was performed using the American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) database from 2014 to 2018. Patients who were more than 30 days old when the repair took place, who underwent an exclusively cervical repair, or who had pure esophageal atresia were excluded from the study. 855 neonates met criteria and were included in the study and analyzed based on their intention-to-treat cohort.

Initial thoracoscopic repair was performed in only 15.6% of cases. Of the patients who underwent thoracoscopic repair, 53% were converted to open. Thoracoscopically repaired infants were significantly more likely to be full term; within this cohort, however, the infants that were converted to open were more likely to be premature and to weigh less than those with successful thoracoscopic procedures. Of the measured outcomes, only operative time was significantly different: 217 minutes for thoracoscopic surgery versus 180 minutes for thoracotomy. There were otherwise no significant differences in other examined perioperative outcomes, including intraoperative blood transfusions, post-operative complications, total ventilator days, length of stay, readmission, or death between the two groups.

One of the inherent limitations of a database study is the inability to generalize between patients and among centers. The study notes that the national conversion rate of 53% is much higher than individual case series from specialized institutions. Given the rarity of this medically and surgically complex disease, patients may benefit from care at high volume surgical centers with greater experience in thoracoscopic surgery.

As a field, we continue to move in the direction of minimally invasive surgery with many proven benefits as far as patient comfort and outcomes. However, in the case of EA/TEF, this study demonstrates that thoracoscopic surgery has a high conversion rate to thoracotomy, longer operative time, and no significant post-operative benefit compared to thoracotomy. While future advances and improvement in technique may make the thoracoscopic approach more valuable, at this time thoracotomy remains an acceptable and safe approach for EA/TEF. 

Vascular Surgery

Acute limb ischemia among patients with COVID-19 infection
Galyfos G, et al. J Vasc Surg. 2022 Jan;75(1):326-342. doi: 10.1016/j.jvs.2021.07.222.
Contributor: Ziad Al Adas, Gina Biagetti

Brief Synopsis

This review of COVID-19 patients with acute limb ischemia found that this population suffered a higher rate of amputation and mortality compared to rates among limb ischemia patients prior to the pandemic, a finding that at the very least highlights the need to establish universal guidelines for prophylactic anticoagulation in COVID-19.

Summary:
Over the past two years, the medical community has been studying the overwhelming SARS-CoV-2 virus (COVID-19) pandemic and its associated complications. While respiratory and flu-like symptoms are predominant, the disease has been associated with a high incidence of thrombotic complications such as stroke, deep vein thrombosis, myocardial infarction, and pulmonary parenchymal thrombosis. Recently, there have been multiple studies reporting episodes of acute limb ischemia (ALI) in infected patients. In this article, the authors present a systematic review of all documented case series and reports on ALI in COVID-19 patients.

Authors reviewed all papers on upper and lower extremity ALI as a result of arterial thrombosis or embolism in patients with COVID-19. They found 34 eligible papers (15 case series and 19 case reports), yielding a total of 199 patients. Mean age was 61.6 years old, and 78.4% were male. Notable comorbidities included hypertension in 49%, diabetes in 29.6%, dyslipidemia in 20.5%, and arrythmias in 14.1%. Of note, 36% of these patients had to be intubated for their COVID-19 respiratory symptoms. For their ALI, medical treatment was undertaken in 42% while the rest underwent surgical or endovascular interventions [thromboembolectomy (81 patients); fasciotomy (9); angioplasty/stenting (7); thrombosuction (2); thrombolysis (7); bypass (3 patients) and endarterectomy (2)]. All patients were anticoagulated. The pooled mortality rate reached 31.4%, the pooled amputation rate was 23.2%, and the pooled re-operation rate was 10.5%. There was no major difference between upper and lower limb outcomes in terms of mortality and amputation. Regarding the treatment strategy, patients managed medically had a much higher odds of mortality compared to those who underwent an intervention (OR 4.04; 1.075-15.197; P = 0.045), although the amputation risk was not different between the 2 groups.

The causative mechanism for COVID-19 associated ALI is thought to be the systemic inflammatory response and resultant hypercoagulable state. In the study, the high percentage of patients treated conservatively is probably due to their critically ill state, and wanting to limit stressful procedures, which by itself explains the much higher mortality rate in these patients. Furthermore, the mortality rate in this study (31%) is much higher than the reported mortality rate of ALI in non-COVID patients (5 to 9%). This study however has multiple limitations; the authors note that only 5 articles were considered high quality, and all studies were case reports and series. The studies included were also heterogeneous and there was a lack of a clear definition of the different variables between the studies.

To conclude, this study showed that COVID-19 associated ALI presents in patients with low baseline comorbidities and is associated with a high risk of amputation and mortality. Despite the widespread thrombotic complications associated with COVID-19, there are no universal guidelines for prophylactic anticoagulation, and such practices are institution-dependent. We need further studies to characterize COVID-19 infected patients at high risk for thrombotic complications who would potentially benefit from prophylactic anticoagulation. 

Vascular Surgery

Effect of Lower Tidal Volume Ventilation Facilitated by Extracorporeal Carbon Dioxide Removal vs Standard Care Ventilation on 90-Day Mortality in Patients With Acute Hypoxemic Respiratory Failure The REST Randomized Clinical Trial
McNamee JJ, et al. JAMA. 2021 Sep 21;326(11):1013-1023. doi: 10.1001/jama.2021.13374.
Contributor: Charles Vasquez

Brief Synopsis

The REST Randomized Clinical Trial found that the use of extracorporeal carbon dioxide removal (ECCO2R) to facilitate lower tidal volume ventilation in mechanically ventilated patients with acute hypoxemic respiratory failure did not result in improved 90-day mortality as compared to conventional strategies, rather was stopped early due to futility and adverse events.

Summary:
Low-tidal volume ventilation targeting 6 ml/kg predicted body reduces mortality in patients with acute hypoxemic respiratory failure requiring mechanical ventilation. The objective of this study was to determine if further reductions in tidal volume, facilitated by extracorporeal carbon dioxide removal (ECCO2R) can further improve outcomes.

The REST trial was a multicenter, randomized, open-label, clinical trial that enrolled 412 adult patients with acute hypoxemic respiratory failure (<48 hr from onset and PaO2/FiO2 ratio <150 mmHg) and randomized them to receive ECCO2R for at least 48 hours (n=202) or standard care (n=210). The primary outcome was all-cause mortality 90 days after randomization. Key secondary outcomes included ventilator-free days at day 28 and adverse event rates.

The mean age was 59, 35% were women. At enrollment, median tidal volumes were similar (6.4 ml/kg ECCO2R vs. 6.3 ml/kg standard care), as were driving pressure (15 cmH2O vs. 16 cmH2O) and P/F ratio (118 mmHg vs. 116 mmHg). Rates of neuromuscular blockade (51% vs. 49%) and prone positioning (11% vs. 11%) were also similar.

Patients randomized to receive ECCO2R had a lower tidal volume than those randomized to receive standard care at day 2 (4.5 [95% CI, 4.3-4.8] vs 6.5 [95% CI, 6.3-6.7] mL/kg; mean difference, 2.0 mL/kg [95% CI, 1.7-2.3]). Overall, there was no significant difference in 90-day mortality between the groups (41.5% in the ECCO2R group vs. 39.5% in the standard care group (risk ratio [RR], 1.05 [95% CI, 0.83-1.33]; difference, 2.0% [95% CI, −7.6% to 11.5%]). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs. 9.2 [95% CI, 7.9-10.4] days; mean difference, −2.1 [95% CI, −3.8 to −0.3]).

Serious adverse events were reported for 62 patients (31%) in the ECCO2R group and 18 (9%) in the standard care group, including intracranial hemorrhage in 9 patients (4.5%) vs. 0 (0%) and bleeding at other sites in 6 (3.0%) vs 1 (0.5%) in the ECCO2R group vs. the control group. The trial was stopped early because of futility and feasibility following recommendations from the data monitoring and ethics committee. 

Take-Home Points:

  • In patients with acute hypoxemic respiratory failure, the use of ECCO2R to facilitate lower tidal volume mechanical ventilation, compared to standard care, did not significantly reduce 90-day mortality.
  • Despite achieving lower tidal volumes, use of ECCO2R was associated with significantly higher adverse advent rates, including intra-cranial hemorrhage, higher rates of neuromuscular blockade, and lower rates of prone positioning.
  • Use of ECCO2R in this manner should not be done outside of a clinical trial setting  

Penn Inspired Publications

New Operative Reporting Standards: Where We Stand Now and Opportunities for Innovation
Soegaard Ballester JM, et al. Ann Surg Oncol. 2021 Sep 14. doi: 10.1245/s10434-021-10766-9.
Contributor: Andrew Hanna

Brief Synopsis

In preparation to meet the new operative standards in documentation set forth by the ACS Committee on Cancer, this work identified significant heterogeneity in the current documentation practices at our institution as well as exciting opportunities for improved compliance, including introduction of an electronic synoptic documentation tool.

Summary:
Over the past 10 to 15 years, there has been a considerable push across all of medicine to “standardize” care offered to patients, as this has been shown to improve morbidity and outcomes, even in surgical patients. In fact, standardization itself has become a quality metric for surgery departments (think pre-incision antibiotics or post-operative DVT prophylaxis). One area that has recently seen a push to standardize is operative dictations and notes, especially in cancer care. The American College of Surgeons Commission on Cancer recently released “Optimal Resources for Cancer Care: 2020 Standards”, which details the important elements of several oncologic procedures and how they should be documented. Eventually, centers wishing to be accredited will have to demonstrate a baseline level of compliance with these documentation standards. To that effect, Dr. Jacqueline Soegaard Ballester and her co-authors examined current documentation practices at our institution to assess baseline concordance with these standards.

Using the standards supplied in the manual, 4 common cancer operations were selected to be analyzed: breast sentinel lymph node biopsy, breast axillary dissection, melanoma wide local excision, and colon resections for colon cancer. Up to 100 operative notes for each surgery type was examined and concordance with the standards set forth were recorded as well as the documentation preference for each surgeon (verbal dictation vs EHR template).

Four out of 5 surgeons performing breast cancer sentinel lymph node biopsy were above 70% concordance whereas no surgeon performing breast cancer axillary dissections reached that threshold. The singular melanoma surgeon had a concordance rate of 96% and there was large heterogeneity among colorectal surgeons with concordance levels ranging from 39% to 94%. Interestingly, and rather unexpectedly, there was no correlation between higher concordance and the use of an EHR templated note. In fact, for breast cancer sentinel lymph node biopsies and melanoma excisions, there was one surgeon in each group who preferred verbal dictations, who both exhibited concordance rates of 98%.

Overall, this study lays a nice foundation for future implementation of documentation standards but raises some interesting questions. Is a templated document more “standard” friendly than verbal dictations? How easy or difficult will it be to transition surgeons who prefer verbal dictations to EHR templated dictations? Can templated operative notes be useful in other domains such as research? Regardless of the answers, it is clear that operative documentation standards are here to stay. 

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