What Is the Innovation? Anastomotic leak or intestinal perforation remains a major complication of surgery of the gastrointestinal tract and usually requires operative intervention. Complex management pathways for iatrogenic or failed anastomosis of the gastrointestinal tract, which are innovative and less invasive, need to be tested and implemented. The use of endoluminal vacuum (E-Vac) therapy accomplishes that goal. This technology uses negative pressure vacuum therapy through a natural orifice, such as the rectum or mouth, to control contamination through the intestinal opening and allows second-intention healing to perforations or leaks of the gastrointestinal tract. We are able to assemble the technology out of presently available wound care supplies used for traditional superficial wound closure modified for endoluminal placement. The technology entails delivery of a granulofoam endosponge secured to the tip of a well-tolerated, Silastic nasogastric tube that is placed at the site of gastrointestinal disruption after copious irrigation of the cavity. Negative pressure is applied to gain the desired effect similar to that observed for superficial wound management. This delivery is done endoscopically under general anesthesia, and the E-Vac materials are removed after the cavity has sealed (Figure). This article focuses on the use of E-Vac therapy for esophageal, gastric, and small intestine leaks or perforations. What Are the Key Advantages Over Existing Approaches? The use of E-Vac therapy at our institution was pioneered for a patient who had exhausted surgical and endoscopic options for an esophageal perforation. The E-Vac therapy was instituted with extraordinary outcome in a rescue attempt that succeeded; we avoided a total esophagectomy with later staged reconstruction that the patient would not have tolerated. The potential of E-Vac was immediately recognized and put into algorithms for patient care. This was done as a collaborative effort with the divisions of minimally invasive surgery and gastroenterology. Institutional review board registries were created, patients were tracked for outcomes, and our technique was refined. The technique’s particular advantage is its minimally invasive aspect. Often, there are no further surgical incisions or procedures needed, and large, morbid procedures can be avoided. Percutaneous drain placement is usually avoided owing to the adequate contamination control provided by the negative pressure of E-Vac therapy. How Will This Impact Clinical Care? Patients with complications undergoing E-Vac therapy intervention have had worthwhile outcomes, few adverse events, high likelihood of avoiding major operations, and eventual restoration of regular diet. Our registries currently include 38 patients. We recognize the need for generating randomized data comparing traditional surgical and endoscopic methods. Our experience with 11 esophageal, 17 gastric, and 10 intestinal leaks has supported integration of E-Vac therapy as an option for patient treatment algorithms with successful healing in 34 patients (89%), complications in 4 patients (11%), and avoided major operations in 31 patients (82%). Is There Evidence Supporting the Benefits of the Innovation? Surgical intervention and endoscopic stent placement for esophageal perforations have a track record of good results that spans decades. Review articles and meta-analyses have documented their feasibility, efficacy, and outcomes.2,3 Endoluminal vacuum therapy was originated in Europe by Weidenhagen et al4 with use in the rectum and by Wedemeyer et al5 with use in the foregut in 2008. Their work addressed dramatic complications from rectal and esophageal leaks. In 2013, Brangewitz et al1 showed E-Vac therapy to be superior to the use of self-expanding metal stents in esophageal leaks, with a higher closure rate (84% vs 53%), lower mortality (15% vs 25%), shorter median treatment (23 vs 33 days), and lower stricture rate (9% vs 28%). Also in 2013, Schniewind et al6 analyzed patients with anastomotic leak after esophagectomy and their results of treatment including surgical revision, E-Vac therapy, stent placement, and conservative management. The E-Vac therapy was shown to be superior with regard to mortality when compared with stent placement and surgical revision (12%, 42%, and 50%, respectively). Conservative management resulted in no mortality in a group of patients with predominantly cervical anastomotic leaks and low Acute Physiology and Chronic Health Evaluation scores. The literature documenting the use of E-Vac therapy is promising.7 What Are the Barriers to Implementing This Innovation More Broadly? Abandoning traditional modalities, especially in a patient who is hemodynamically unstable or actively decompensating, requires the new procedure to provide superior outcomes and to have a remarkably good safety profile. Increasing knowledge and data accumulated for E-Vac therapy will aid in its acceptance. Traditional approaches allow the surgeon to place hands on the problem and divert the luminal contents without constant monitoring interventions. Maintaining control of the lumen contents is facilitated by E-Vac therapy. These patients require constant attention that can span weeks to months. Repeated sedation, intubation, and endoscopic evaluation will be required anywhere from every 3 to 7 days to evaluate their internal wound. These patients tend to accrue a hospital stay that can develop an overwhelming cost and poor reimbursement. Further cost analyses are needed. Currently, continued endoscopic evaluations are not seen as reimbursable. On the other hand, surgical intervention is reimbursed. Early cost evaluations, without focus on quality of life and avoidance of other resources needed in invasive surgical therapy, will hinder the acceptance of E-Vac therapy. In What Time Frame Will This Innovation Likely Be Applied Routinely? Currently, E-Vac therapy is used in our institution as one of the primary modalities for esophageal, gastric, and rectal anastomotic leaks or perforations. The experimental nature of this procedure requires institutional review board approval. Close monitoring of outcomes during meetings between the investigator team is mandatory to discuss outcomes and adverse events. Publication of clinical experience has slowly caused institutions around the United States to become curious, to reach out and inquire about our technique, and to implement it in their own institution. Endoluminal vacuum therapy is available now, but it should be done under institutional review board approval and in conjunction with a research team including multidisciplinary evaluation. Our technique has evolved, yielding improvement in our clinical experience. Section Editor: Justin B. Dimick, MD, MPH. Submissions: Authors should contact Justin B. Dimick, MD, MPH, at firstname.lastname@example.org if they wish to submit Surgical Innovation papers. Back to top Article Information Corresponding Author: Steven G. Leeds, MD, Department of Minimally Invasive Surgery, Baylor University Medical Center at Dallas, 3500 Gaston Ave, First Floor, Roberts Hospital, Dallas, TX 75246 (email@example.com). Published Online: April 13, 2016. doi:10.1001/jamasurg.2016.0255. Conflict of Interest Disclosures: None reported. References 1. Brangewitz M, Voigtländer T, Helfritz FA, et al. Endoscopic closure of esophageal intrathoracic leaks: stent versus endoscopic vacuum-assisted closure, a retrospective analysis. Endoscopy. 2013;45(6):433-438.PubMedGoogle ScholarCrossref 2. Biancari F, D’Andrea V, Paone R, et al. Current treatment and outcome of esophageal perforations in adults: systematic review and meta-analysis of 75 studies. World J Surg. 2013;37(5):1051-1059.PubMedGoogle ScholarCrossref 3. van Boeckel PG, Sijbring A, Vleggaar FP, Siersema PD. Systematic review: temporary stent placement for benign rupture or anastomotic leak of the oesophagus. Aliment Pharmacol Ther. 2011;33(12):1292-1301.PubMedGoogle ScholarCrossref 4. Weidenhagen R, Gruetzner KU, Wiecken T, Spelsberg F, Jauch KW. Endoscopic vacuum-assisted closure of anastomotic leakage following anterior resection of the rectum: a new method. Surg Endosc. 2008;22(8):1818-1825.PubMedGoogle ScholarCrossref 5. Wedemeyer J, Schneider A, Manns MP, Jackobs S. Endoscopic vacuum-assisted closure of upper intestinal anastomotic leaks. Gastrointest Endosc. 2008;67(4):708-711.PubMedGoogle ScholarCrossref 6. Schniewind B, Schafmayer C, Voehrs G, et al. Endoscopic endoluminal vacuum therapy is superior to other regimens in managing anastomotic leakage after esophagectomy: a comparative retrospective study. Surg Endosc. 2013;27(10):3883-3890.PubMedGoogle ScholarCrossref 7. Smallwood NR, Fleshman JW, Leeds SG, Burdick JS. The use of endoluminal vacuum (E-Vac) therapy in the management of upper gastrointestinal leaks and perforations. [published online September 30, 2015]. Surg Endosc. doi:10.1007/s00464-015-4501-6.PubMedGoogle Scholar
JAMA Surgery – American Medical Association
Published: Jun 1, 2016
Keywords: surgical procedures, minimally invasive,endoluminal repair,postoperative complications,endoscopy,diffusion of innovation,endoscopy, digestive system,endoscopy, gastrointestinal,esophageal perforation,intestinal perforation,intestines,outcome assessment,suction drainage,surgical procedures, operative,vacuum,wound healing,anastomotic leak,gastrointestinal perforation,gastrointestinal complications,intestine, small
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