David Desilets

Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia

IntroductionHigh-resolution esophageal manometry (HREM) is essential in characterizing achalasia subtype and the extent of affected segment to plan the myotomy starting point during per-oral endoscopic myotomy (POEM). However, evidence is lacking that efficacy is improved by tailoring myotomy to the length of the spastic segment on HREM. We sought to investigate whether utilizing HREM to dictate myotomy length in POEM impacts postoperative outcomes.MethodsComparative analysis of HREM-tailored to non-tailored patients from a prospectively collected database of all POEMs at our institution January 2011 through July 2017. A tailored myotomy is defined as extending at least the length of the diseased segment, as initially measured on HREM.ResultsForty patients were included (11 tailored versus 29 non-tailored). There were no differences in patient age (pu2009=u20090.6491) or BMI (pu2009=u20090.0677). Myotomy lengths were significantly longer for tailored compared to non-tailored overall (16.6u2009±u20092.2 versus 13.5u2009±u20091.8; pu2009<u20090.0001), and for only type III achalasia (15.9u2009±u20092.4 versus 12.7u2009±u20091.2; pu2009=u20090.0453), likely due to more proximal starting position in tailored cases (26.0u2009±u20092.2 versus 30.0u2009±u20092.7; pu2009<u20090.0001). Procedure success (Eckardtu2009<u20093) was equivalent across groups overall (pu2009=u20090.5558), as was postoperative Eckardt score (0.2u2009±u20090.4 versus 0.8u2009±u20092.3; pu2009=u20090.4004). Postoperative Eckardt score was significantly improved in the tailored group versus non-tailored for type III only (0.2u2009±u20090.4 versus 1.3u2009±u20091.5; pu2009=u20090.0435). A linear correlation was seen between increased length and greater improvement in Eckardt score in the non-tailored group (pu2009=u20090.0170).ConclusionsUsing HREM to inform surgeons of the proximal location of the diseased segment resulted in longer myotomies, spanning the entire affected segment in type III achalasia, and in lower postoperative Eckardt scores. Longer myotomy length is often more easily achieved with POEM than with Heller myotomy, which raises the question of whether POEM results in better outcomes for type III achalasia, as types I and II do not generally have measurable spastic segments.

Treatment of Achalasia with Per-Oral Endoscopic Myotomy: Analysis of 50 Consecutive Patients

BACKGROUNDnPeroral endoscopic myotomy (POEM) has become an acceptable incisionless treatment for achalasia based on encouraging outcomes in multiple series worldwide. This report reflects our early experience.nnnMETHODSnData were collected prospectively on all patients undergoing POEM between June 2011 and April 2016 under IRB approval. Diagnosis of achalasia was confirmed by standard preoperative work-up. Primary outcome was symptom relief, measured by Eckardt score. Secondary outcomes were operative time, length of stay (LOS), adverse events, failure, and recurrence.nnnRESULTSnFifty patients were included; 30 were female. Mean age was 55.7u2009±u200917.7 years. Mean BMI was 29.5u2009±u20099.2. Median OR time was 133.5 minutes (range 70-462); average myotomy was 13.1u2009±u20092.3u2009cm. One early case was converted to a laparoscopic Heller myotomy due to extensive submucosal fibrosis from a recent Botox injection. Two cases were aborted; one due to extensive submucosal fibrosis and the other to intraoperative capnopericardium. Median LOS was 1 day (range 0.8-8). Two major complications occurred: intraoperative cardiac arrest due to capnopericardium and postoperative submucosal hemorrhage. There were no deaths. Mean postoperative Eckardt score was 1.0u2009±u20091.9 (range 0-8) at 2-6 weeks (vs. preoperative score 7.7u2009±u20092.8; Pu2009<u2009.0001); mean dysphagia component 0.35u2009±u20090.28 (vs. preoperative score 2.6u2009±u20090.7; Pu2009<u2009.0001). Two recurrences were identified, both at 6 months.nnnCONCLUSIONSnPOEM is a safe and durable treatment for achalasia in the short term. We demonstrated marked improvement of symptoms in all completed cases. There was an acceptable serious adverse event rate of 4%, failure of 6% due to patient selection, and recurrences occurring in only 4% of cases.

The NOVEL trial: natural orifice versus laparoscopic cholecystectomy—a prospective, randomized evaluation

Introduction The evolution of Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies, and followed by the creation of the NOSCAR® collaboration between The Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy, procedural development followed a stepwise incremental pathway. The work of this consortium has included white paper analyses, obtaining outside independent funding for basic science and procedural development, and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES® cholecystectomy as an alternative procedure to laparoscopic cholecystectomy.MethodsNinety patients were randomized into a randomized clinical trial with the primary objective of demonstrating non-inferiority of the transvaginal and transgastric arms to the laparoscopic arm. In the original trial design, there were both transgastric and transvaginal groups to be compared to the laparoscopic control group. However, after enrollment and randomization of 6 laparoscopic controls and 4 transgastric cases into the transgastric group, this arm was ultimately deemed not practical due to lagging enrollment, and the arm was closed. Three transgastric via the transgastric approach were performed in total with 9 laparoscopic control cases enrolled through the TG arm. Overall a total of 41 transvaginal and their 39 laparoscopic cholecystectomy controls were randomized into the study with 37 transvaginal and 33 laparoscopic cholecystectomies being ultimately performed. Overall total operating time was statistically longer in the NOTES® group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes.ResultsThere were no major adverse events such as common bile duct injury or return to the operating room for hemorrhage. Intraoperative blood loss, length of stay, and total medication given in the PACU were not statistically different. There were no conversions in the NOTES® group to a laparoscopic or open procedure, nor were there any injuries, bile leaks, hemorrhagic complications, wound infections, or wound dehiscence in either group. There were no readmissions. Visual Analogue Scale (VAS) pain scores were 3.4 (CI 2.82) in the laparoscopic group and 2.9 (CI 1.96) in the transvaginal group (pu2009=u20090.41). The clinical assessment on cosmesis scores was not statistically different when recorded by clinical observers for most characteristics measured when the transvaginal group was compared to the laparoscopic group. Taken as a whole, the results slightly favor the transvaginal group. SF-12 scores were not statistically different at all postoperative time points except for the SF-12 mental component which was superior in the transvaginal group at all time points (pu2009<u20090.05).ConclusionThe safety profile for transvaginal cholecystectomy demonstrates that this approach is safe and produces at least non-inferior clinical results with superior cosmesis, with a transient reduction in discomfort. The transvaginal approach to cholecystectomy should no longer be considered experimental. As a model for intersociety collaboration, the study demonstrated the ultimate feasibility and success of partnership as a model for basic research, procedural development, fundraising, and clinical trial execution for novel interventional concepts, regardless of physician board certification.