Risk factors associated with venous thromboembolism in laparoscopic surgery in non-obese patients with benign disease.

INTRODUCTION: Few studies have focused on intraoperative positioning as a risk factor for venous thromboembolism (VTE). Positioning that places the legs in a dependent position may be a risk factor. We theorized that the reverse-Trendelenburg position specifically would increase the risk of postoperative VTE. METHODS AND PROCEDURES: 374,017 subjects undergoing laparoscopic surgery in the 2015-2018 NSQIP database were included. Diagnosis of cancer and BMI ≥ 30 were excluded. Subjects were grouped based on positioning: reverse-Trendelenburg (RT), supine (S), and Trendelenburg (T). RESULTS: The RT, S, and T groups consisted of 117,887, 66,511, and 189,619 subjects, respectively. Overall median BMI was 25.7, and 82.8% of subjects were non-smokers. VTE within 30 days postoperative was seen in 0.25% RT, 0.23% S, and 0.4% T (p < 0.0001); 30-day mortality was 0.34% RT, 0.25% S, and 0.19% T (p < 0.0001). After adjusting for potential confounders and other risk factors, RT position was associated with a lower risk of VTE compared to S (OR 1.49 with 95% CI 1.16, 1.93) and T (OR 1.34 with 95% CI 1.15, 1.56) positions. VTE risk was significantly different across the three groups (p = 0.0001). Inpatient procedures had a higher VTE risk vs outpatient (OR 2.49 with 95% CI 2.10, 2.95). Increasing operative time was associated with higher VTE risk [4th (> 106 min) vs 1st (≤ 40 min) quartiles (OR 3.54 with 95% CI 2.79, 4.48)]. CONCLUSIONS: Among other risk factors, inpatient procedures and longer operative times are associated with higher VTE risk in laparoscopic surgery performed for benign disease in non-obese patients. The risk was significantly different across the three positioning groups with lowest risk in the RT group and highest risk in the S group.

What are essential laparoscopic skills these days? Results of the SAGES Fundamentals of Laparoscopic Surgery (FLS) Committee technical skills survey.

INTRODUCTION: The Fundamentals of Laparoscopic Surgery (FLS) program tests basic knowledge and skills required to perform laparoscopic surgery. Educational experiences in laparoscopic training and development of associated competencies have evolved since FLS inception, making it important to review the definition of fundamental laparoscopic skills. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) assigned an FLS Technical Skills Working Group to characterize technical skills used in basic laparoscopic surgery in current practice contexts and their possible application to future FLS tests. METHODS: A group of subject matter experts defined an inventory of 65 laparoscopic skills using a Nominal Group Technique. From these, a survey was developed rating these items for importance, frequency of use, and priority for testing for FLS certification. This survey was distributed to SAGES members, recent recipients of FLS certification, and members of the Association of Program Directors in Surgery (APDS). Results were collected using a secure web-based survey platform. RESULTS: Complete data were available for 1742 surveys. Of these, 1143 comprised results for post-residency participants who performed advanced procedures. Seventeen competencies were identified for FLS testing prioritization by determining the proportion of respondents who identified them of highest priority, at median (50th percentile) of the maximum survey scale rating. These included basic peritoneal access, laparoscope and instrument use, tissue manipulation, and specific problem management skills. Sixteen could be used to show appropriateness of the domain construct by confirmatory factor analysis. Of these 8 could be characterized as manipulative tasks. Of these 5 mapped to current FLS tasks. CONCLUSIONS: This survey-identified competencies, some of which are currently assessed in FLS, with a high level of priority for testing. Further work is needed to determine if this should prompt consideration of changes or additions to the FLS technical skills test component.

Comparison of preoperative, intraoperative, and follow-up functional luminal imaging probe measurements in patients undergoing myotomy for achalasia.

BACKGROUND AND AIMS: The functional luminal imaging probe (FLIP) is a novel catheter-based device that measures esophagogastric junction (EGJ) distensibility index (DI) in real time. Previous studies have demonstrated DI to be a predictor of post-treatment clinical outcomes in patients with achalasia. We sought to evaluate EGJ DI in patients with achalasia before, during, and after peroral endoscopic myotomy (POEM) and laparoscopic Heller myotomy (LHM) and to assess the correlation of DI with postoperative outcomes. METHODS: DI (defined as the minimum cross-sectional area at the EGJ divided by distensive pressure) was measured at 4 time points in patients undergoing surgical myotomy for achalasia: (1) during outpatient preoperative endoscopy (preoperative DI), (2) at the start of each operation after the induction of anesthesia (induction DI), (3) at the conclusion of each operation (postmyotomy DI), and (4) at routine follow-up endoscopy 12 months postoperatively (follow-up DI). Routine Eckardt symptom score, endoscopy, timed barium esophagram, and pH study were obtained 12 months postoperatively. RESULTS: Forty-six patients (35 POEM, 11 LHM) underwent FLIP measurements at all 4 time points. Preoperative and induction mean DI were similar for both groups (POEM, 1 vs .9 mm2/mm Hg; LHM, 1.7 vs 1.5 mm2/mm Hg). POEM resulted in a significant increase in DI (induction .9 vs postmyotomy 7 mm2/mm Hg, P < .001). There was a subsequent decrease in DI in the follow-up period (postmyotomy 7 vs follow-up 4.8 mm2/mm Hg, P < .01), but DI at follow-up was still significantly improved from preoperative values (P < .001). For LHM patients, DI also increased as a result of surgery (induction 1.5 vs postmyotomy 5.9 mm2/mm Hg, P < .001); however, the increase was smaller than in POEM patients (DI increase 4.4 vs 6.2 mm2/mm Hg, P < .05). After LHM, DI also decreased in the follow-up period, but this change was not statistically significant (5.9 vs 4.4 mm2/mm Hg, P = .29). LHM patients with erosive esophagitis on follow-up endoscopy had a significantly higher postmyotomy DI compared with those without esophagitis (9.3 vs 4.8 mm2/mm Hg, P < .05). CONCLUSIONS: EGJ DI improved dramatically as a result of both POEM and LHM, with POEM resulting in a larger increase. Mean DI decreased at intermediate follow-up but remained well above previously established thresholds for symptom recurrence. DI at the conclusion of LHM was predictive of erosive esophagitis in the postoperative period, which supports the potential use of FLIP for calibration of partial fundoplication construction during LHM.

Physician perceptions of a multidisciplinary endocarditis team.

Infectious endocarditis is a highly morbid infection that requires coordination of care across medical and surgical specialties, often through the use of a multidisciplinary team model. Multiple studies have demonstrated that such conferences can improve clinical outcomes. However, little is known about physicians' impressions of these groups. We surveyed 126 (response rate of 30%) internal medicine, infectious diseases, cardiology, and cardiac surgery providers 1 year after the implementation of an endocarditis team at the University of Michigan. Ninety-eight percent of physicians felt that the endocarditis team improved communication between specialties. Additionally, over 85% of respondents agreed that the group influenced diagnostic evaluation, reduced management errors, increased access to surgery, and decreased in-hospital mortality for endocarditis patients. These results suggest that multidisciplinary endocarditis teams are valued by physicians as a tool to improve patient care and serve an important role in increasing communication between providers.

Association between surgical approach and survival following resection of abdominopelvic malignancies.

BACKGROUND AND OBJECTIVES: Recent studies demonstrating decreased survival following minimally invasive surgery (MIS) for cervical cancer have generated concern regarding oncologic efficacy of MIS. Our objective was to evaluate the association between surgical approach and 5-year survival following resection of abdominopelvic malignancies. METHODS: Patients with stage I or II adenocarcinoma of the prostate, colon, rectum, and stage IA2 or IB1 cervical cancer from 2010-2015 were identified from the National Cancer Data Base. The association between surgical approach and 5-year survival was assessed using propensity-score-matched cohorts. Distributions were compared using logistic regression. Hazard ratio for death was estimated using Cox proportional-hazard models. RESULTS: The rate of deaths at 5 years was 3.4% following radical prostatectomy, 22.9% following colectomy, 18.6% following proctectomy, and 6.8% following radical hysterectomy. Open surgery was associated with worse survival following radical prostatectomy (HR, 1.18; 95% CI, 1.05-1.33; P = .005), colectomy (HR, 1.45; 95% CI, 1.39-1.51; P < .001), and proctectomy (HR, 1.28; 95% CI, 1.10-1.50; P = .002); however, open surgery was associated with improved survival following radical hysterectomy (HR, 0.61; 95% CI, 0.44-0.82; P = .003). CONCLUSIONS: These results suggest that MIS is an acceptable approach in selected patients with prostate, colon, and rectal cancers, while concerns regarding MIS resection of cervical cancer appear warranted.

Post-operative complications and readmissions following outpatient elective Nissen fundoplication.

INTRODUCTION: Traditionally, laparoscopic Nissen fundoplication (LNF) has been considered an inpatient procedure. Advances in surgical and anesthetic techniques have led to a shift towards outpatient LNF procedures. However, differences in surgical outcomes between outpatient and inpatient LNF are poorly understood. The objectives of this study were (1) to describe the frequency of outpatient LNF in a national cohort and (2) to identify any differences in complications or readmission rates between outpatient and inpatient LNF. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was used to identify elective LNF cases from 2012 to 2016. Patients discharged on the day of surgery were compared to those discharged 24-48 h post-operatively. Outcomes included 30-day readmission and death or serious morbidity (DSM). Bivariate analyses were completed with Chi squared testing for categorical variables and two sided t tests for continuous variables. Associations between outpatient surgery and outcomes were assessed using multivariable logistic regression. Differences in readmission were analyzed using Kaplan-Meier failure estimates and log-rank tests. RESULTS: Of 7734 patients who underwent elective LNF, 568 (7.3%) were discharged on the day of surgery. The overall 30-day readmission rate was 4.1% (n = 316) and the overall rate of DSM was 1.0% (n = 79). The most common 30-day readmission diagnoses overall were infectious complications (16.1%), dysphagia (12.9%), and abdominal pain (11.7%). On multivariable analysis, there was no association between outpatient surgery and 30-day readmission (3.9% vs. 4.1%; aOR 0.97, 95% CI 0.62-1.52, p = 0.908) or DSM (1.1% vs. 1.0%; aOR 0.91, 95%CI 0.36-2.29, p = 0.848). Kaplan-Meier analysis showed no difference in rates of hospital readmission between groups at 30-days from discharge (3.9% vs. 4.1%, p = 0.325). CONCLUSIONS: Among patients undergoing elective LNF, there were no significant differences in post-operative complications and 30-day readmission when compared to traditional inpatient postoperative care. Further consideration should be given to transitioning LNF to an outpatient procedure.

Intraoperative assessment of esophageal motility using FLIP during myotomy for achalasia.

BACKGROUND: The functional luminal imaging probe (FLIP) can evaluate esophagogastric junction (EGJ) distensibility and esophageal peristalsis in real time. FLIP measurements performed during diagnostic endoscopy can accurately discriminate between healthy controls and patients with achalasia based on EGJ-distensibility and distinct motility patterns termed repetitive antegrade contractions (RACs) and repetitive retrograde contractions (RRCs). We sought to evaluate real-time motility changes in patients undergoing surgical myotomy for achalasia. METHODS: FLIP measurements using a stepwise volumetric distention protocol were performed at three time points during assessment and performance of laparoscopic Heller myotomy and POEM: (1) During preoperative outpatient endoscopy, (2) Intraoperatively following induction of anesthesia, and (3) Intraoperatively after myotomy completion. EGJ-distensibility, contractility, RACs, and RRCs were measured. RESULTS: FLIP measurements were performed in 32 patients. The EGJ-distensibility index was similar between the preoperative and initial operative measurements (1.1 vs 1.4 mm2/mmHg, p = NS). There was a significant increase in distensibility following surgical myotomy (1.4 to 4.7 mm2/mmHg, p < 0.01). Intraoperative contractile patterns varied between achalasia subtypes. Contractility was seen in < 20% of assessments in patients with types I and II achalasia. Type III patients demonstrated contractility in 100% of assessments, with 70% exhibiting RRCs and 60% RACs. There was a reduction in the frequency of RRC presence (70% to 20%), and contractile vigor (80% to 0% of patients with lumen occluding contractions) in type III patients following surgical myotomy. CONCLUSIONS: This first report of real-time intraoperative measurement of esophageal motility using FLIP demonstrates the feasibility of such assessments during surgical myotomy for achalasia. Patients with type I and II achalasia exhibited rare intraoperative contractility, while the presence of motility was the norm in those with type III. Patients with type III achalasia demonstrated an immediate reduction in repetitive contraction motility patterns and contractile vigor following myotomy.

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. METHODS: Ninety 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. RESULTS: There 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 (p = 0.41). 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 (p < 0.05). CONCLUSION: The 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.

Readiness of US General Surgery Residents for Independent Practice.

OBJECTIVE: This study evaluates the current state of the General Surgery (GS) residency training model by investigating resident operative performance and autonomy. BACKGROUND: The American Board of Surgery has designated 132 procedures as being "Core" to the practice of GS. GS residents are expected to be able to safely and independently perform those procedures by the time they graduate. There is growing concern that not all residents achieve that standard. Lack of operative autonomy may play a role. METHODS: Attendings in 14 General Surgery programs were trained to use a) the 5-level System for Improving and Measuring Procedural Learning (SIMPL) Performance scale to assess resident readiness for independent practice and b) the 4-level Zwisch scale to assess the level of guidance (ie, autonomy) they provided to residents during specific procedures. Ratings were collected immediately after cases that involved a categorical GS resident. Data were analyzed using descriptive statistics and supplemented with Bayesian ordinal model-based estimation. RESULTS: A total of 444 attending surgeons rated 536 categorical residents after 10,130 procedures. Performance: from the first to the last year of training, the proportion of Performance ratings for Core procedures (n = 6931) at "Practice Ready" or above increased from 12.3% to 77.1%. The predicted probability that a typical trainee would be rated as Competent after performing an average Core procedure on an average complexity patient during the last week of residency training is 90.5% (95% CI: 85.7%-94%). This falls to 84.6% for more complex patients and to less than 80% for more difficult Core procedures. Autonomy: for all procedures, the proportion of Zwisch ratings indicating meaningful autonomy ("Passive Help" or "Supervision Only") increased from 15.1% to 65.7% from the first to the last year of training. For the Core procedures performed by residents in their final 6 months of training (cholecystectomy, inguinal/femoral hernia repair, appendectomy, ventral hernia repair, and partial colectomy), the proportion of Zwisch ratings (n = 357) indicating near-independence ("Supervision Only") was 33.3%. CONCLUSIONS: US General Surgery residents are not universally ready to independently perform Core procedures by the time they complete residency training. Progressive resident autonomy is also limited. It is unknown if the amount of autonomy residents do achieve is sufficient to ensure readiness for the entire spectrum of independent practice.

Laparoscopic Nephrectomy: Initial Case Report.

A tumor-bearing right kidney was completely excised from an 85-year-old woman using a laparoscopic approach. A newly devised method for intra-abdominal organ entrapment and a recently developed laparoscopic tissue morcellator made it possible to deliver the 190 gm. kidney through an 11 mm. incision.

Per-oral Endoscopic Myotomy (POEM) After the Learning Curve: Durable Long-term Results With a Low Complication Rate.

OBJECTIVE: We aimed to report long-term outcomes for patients undergoing per-oral endoscopic myotomy (POEM) after our initial 15-case learning curve. BACKGROUND: POEM has become an established, natural-orifice surgical approach for treating esophageal motility disorders. To date, published outcomes and comparative-effectiveness studies have included patients from the early POEM experience. METHODS: Consecutive patients undergoing POEM after our initial 15 cases, with a minimum of 1-year postoperative follow-up, were included. Treatment success was defined as an Eckardt score ≤3 without reintervention. Gastroesophageal reflux was defined by abnormal pH-testing or reflux esophagitis >Los Angeles grade A. RESULTS: Between January 2012 and March 2015, 115 patients underwent POEM at a single, high-volume center. Operative time was 101 ±â€Š29 minutes, with 95% (109/115) of patients discharged on postoperative day 1. Clavien-Dindo grade III complications occurred in 2.7%, one of which required diagnostic laparoscopy to rule out Veress needle injury to the gall bladder. The rate of grade I complications was 15.2%. At an average of 2.4 years post-POEM (range 12-52 months), the overall success rate was 92%. Objective evidence of reflux was present in 40% for all patients and 33% for patients with a body mass index <35 kg/m and no hiatal hernia. CONCLUSIONS: POEM performed by experienced surgeons provided durable symptomatic relief in 94% of patients with nonspastic achalasia and 90% of patients with type 3 achalasia/spastic esophageal motility disorders, with a low rate of complications. The rate of gastroesophageal reflux was comparable with prior studies of both POEM and laparoscopic Heller myotomy.

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

High-Resolution Impedance Manometry Metrics of the Esophagogastric Junction for the Assessment of Treatment Response in Achalasia.

OBJECTIVES: We aimed to evaluate the value of novel high-resolution impedance manometry (HRIM) metrics, bolus flow time (BFT), and esophagogastric junction (EGJ) contractile integral (CI), as well as EGJ pressure (EGJP) and the integrated relaxation pressure (IRP), as indicators of treatment response in achalasia. METHODS: We prospectively evaluated 75 patients (ages 19-81, 32 female) with achalasia during follow-up after pneumatic dilation or myotomy with Eckardt score (ES), timed-barium esophagram (TBE), and HRIM. Receiver-operating characteristic (ROC) curves for good symptomatic outcome (ES≤3) and good radiographic outcome (TBE column height at 5 min<5 cm) were generated for each potential predictor of treatment response (EGJP, IRP, BFT, and EGJ-CI). RESULTS: Follow-up occurred at a median (range) 12 (3-291) months following treatment. A total of 49 patients had good symptomatic outcome and 46 had good radiographic outcome. The area-under-the-curves (AUCs) on the ROC curve for symptomatic outcome were 0.55 (EGJP), 0.62 (IRP), 0.77 (BFT) and 0.56 (EGJ-CI). The AUCs for radiographic outcome were 0.64 (EGJP), 0.48 (IRP), 0.73 (BFT), and 0.65 (EGJ-CI). Optimal cut-points were determined as 11 mm Hg (EGJP), 12 mm Hg (IRP), 0 s (BFT), and 30 mm Hg•cm (EGJ-CI) that provided sensitivities/specificities of 57%/46% (EGJP), 65%/58% (IRP), 78%/77% (BFT), and 53%/62% (EGJ-CI) to predict symptomatic outcome and 57%/66% (EGJP), 57%/41% (IRP), 76%/69% (BFT), and 57%/66% (EGJ-CI) to predict radiographic outcome. CONCLUSIONS: BFT, a novel HRIM metric, provided an improved functional assessment over manometric measures of EGJP, IRP, and EGJ-CI at follow-up after achalasia treatment and may help direct clinical management.

Evaluation of the need for routine esophagram after peroral endoscopic myotomy (POEM).

BACKGROUND: Peroral endoscopic myotomy (POEM) is a novel surgical option for the treatment of achalasia. Most centers perform a routine esophagram on postoperative day (POD) #1 to rule esophageal perforation and leaks. In this study, we sought to determine the clinical utility of routine contrast studies post-POEM. METHODS: POEM was performed using an anterior submucosal tunnel and selective myotomy of the circular muscle layer. A routine contrast esophagram was obtained on POD #1. We conducted a retrospective review of the radiologists' interpretations of these studies and compared them to patient's clinical course. RESULTS: Seventy-eight patients were included. Among these, two complications occurred. One patient was non-compliant with postoperative nil per os orders and developed epigastric pain suspicious for a leak that was demonstrated on esophagram. Another patient had subcutaneous emphysema on POD #1 esophagram, a finding that was also present on physical examination, without esophageal leakage. Another esophagram in an asymptomatic patient was suspicious for submucosal tunnel hematoma which prompted a return to the operating room with negative results. Overall, 56 patients had abnormal studies. POD #1 esophagram demonstrated a sensitivity of 100 % and specificity of 45 % in identifying clinically significant complications. CONCLUSIONS: In this series, we found routine esophagram to have a high sensitivity but a very low specificity in detecting clinically significant complications. Routine esophagram after POEM may not be necessary.

The effect of incremental distal gastric myotomy lengths on EGJ distensibility during POEM for achalasia.

BACKGROUND: During peroral esophageal myotomy (POEM) for the treatment of achalasia, the optimal distal gastric myotomy length is unknown. In this study, we used a functional lumen imaging probe (FLIP) to intraoperatively measure the effect of variable distal myotomy lengths on esophagogastric junction (EGJ) distensibility. METHODS: EGJ distensibility index (DI) (minimum cross-sectional area divided by intrabag pressure) was measured with FLIP after each operative step. Each patient's myotomy was performed in four increments from proximal to distal: (1) an esophageal myotomy (from 6 cm proximal to the EGJ to 1 cm proximal to it), (2) a myotomy ablating the lower esophageal sphincter (LES) complex (from 1 cm proximal to the EGJ to 1 cm distal to it), (3) an initial gastric extension (from 1 cm distal to the EGJ to 2 cm distal), and (4) a final gastric extension (from 2 cm distal to the EGJ to 3 cm distal). RESULTS: Measurements were taken in 16 achalasia patients during POEM. POEM resulted in an overall increase in DI (pre 1.2 vs. post 7.2 mm(2)/mmHg, p < .001). Initial creation of the submucosal tunnel resulted in a threefold increase in DI (1.2 vs. 3.6 mm(2)/mmHg, p < .001). When the myotomy was then performed in a stepwise fashion from proximal to distal, the initial esophageal myotomy component had no effect on DI. Subsequent myotomy extension across the LES complex resulted in an increase in DI, as did the initial gastric myotomy extension (to 2 cm distal to the EGJ). The final gastric myotomy extension (to 3 cm distal) had no further effect. CONCLUSIONS: During POEM, creation of the submucosal tunnel prior to myotomy resulted in a marked improvement in EGJ physiology. Myotomy extension across the LES complex and to 2 cm onto the gastric wall resulted in the normalization of EGJ distensibility, whereas subsequent extension to 3 cm distal to the EGJ did not increase compliance further.

Development of quality measures for the care of patients with gastroesophageal reflux disease.

BACKGROUND & AIMS: Gastroesophageal reflux disease (GERD) is a common and costly disorder. Symptoms attributed to GERD have a wide spectrum of presentations and complications that have led to complex diagnostic and management algorithms. As such, there is considerable variation in clinical approaches to GERD. In contrast to multiple published guidelines for the management of GERD, there are few validated GERD quality measures. The objective of this study was to use a well-described, formal methodology to develop valid, physician-led quality measures for all aspects of care for patients with GERD. METHODS: Quality measures were identified from the literature, consensus guidelines, and GERD experts. Eight clinical experts ranked potential measures for validity on the basis of the RAND/University of California, Los Angeles Appropriateness Methodology. RESULTS: Of the 52 proposed quality measures, 24 were rated as valid, and 1 new measure was developed. These valid measures were related to initial diagnosis and management (9), monitoring (3), further diagnostic testing (4), proton pump inhibitor refractory symptoms (2), symptoms of chest pain (1), erosive esophagitis (3), esophageal stricture or ring (1), and surgical therapy (2). Fifteen of these measures were ranked with the highest validity. Twenty-seven measures were determined to be equivocal; 89% of these were extracted from guidelines that were based on low or moderate level evidence. CONCLUSIONS: We used RAND/University of California, Los Angeles Appropriateness Methodology to develop quality measures for GERD care. By examining performance on these valid, formally developed quality measures, clinical practices and individual providers can assess their adherence with them and direct quality improvement efforts accordingly.

Esophagogastric junction distensibility measurements during Heller myotomy and POEM for achalasia predict postoperative symptomatic outcomes.

BACKGROUND: The functional lumen imaging probe (FLIP) is a novel diagnostic tool that can be used to measure esophagogastric junction (EGJ) distensibility. In this study, we performed intraoperative FLIP measurements during laparoscopic Heller myotomy (LHM) and peroral esophageal myotomy (POEM) for treatment of achalasia and evaluated the relationship between EGJ distensibility and postoperative symptoms. METHODS: Distensibility index (DI) (defined as the minimum cross-sectional area at the EGJ divided by distensive pressure) was measured with FLIP at two time points during LHM and POEM: (1) at baseline after induction of anesthesia, and (2) after operation completion. RESULTS: Measurements were performed in 20 patients undergoing LHM and 36 undergoing POEM. Both operations resulted in an increase in DI, although this increase was larger with POEM (7 ± 3.1 vs. 5.1 ± 3.4 mm(2)/mmHg, p < .05). The two patients (both LHM) with the smallest increases in DI (1 and 1.6 mm(2)/mmHg) both had persistent symptoms postoperatively and, overall, LHM patients with larger increases in DI had lower postoperative Eckardt scores. In the POEM group, there was no correlation between change in DI and symptoms; however, all POEM patients experienced an increase in DI of >3 mm(2)/mmHg. When all patients were divided into thirds based on final DI, none in the lowest DI group (<6 mm(2)/mmHg) had symptoms suggestive of reflux (i.e., GerdQ score >7), as compared with 20 % in the middle third (6-9 mm(2)/mmHg) and 36 % in the highest third (>9 mm(2)/mmHg). Patients within an "ideal" final DI range (4.5-8.5 mm(2)/mmHg) had optimal symptomatic outcomes (i.e., Eckardt ≤ 1 and GerdQ ≤ 7) in 88 % of cases, compared with 47 % in those with a final DI above or below that range (p < .05). CONCLUSIONS: Intraoperative EGJ distensibility measurements with FLIP were predictive of postoperative symptomatic outcomes. These results provide initial evidence that FLIP has the potential to act as a useful calibration tool during operations for achalasia.

Symptomatic and physiologic outcomes one year after peroral esophageal myotomy (POEM) for treatment of achalasia.

BACKGROUND: Peroral esophageal myotomy (POEM) is a new endoscopic operation for the treatment of achalasia. Here, we report 1-year physiologic and symptomatic outcomes following the procedure. METHODS: POEM patients from a single-institution series who were more than 1 year removed from surgery were studied. Eckardt and GerdQ scores were obtained to assess symptoms. High-resolution manometry (HRM), timed barium esophagram (TBE), and upper endoscopy were preformed preoperatively and at 1-year follow-up. 24-h pH monitoring was also performed at 1 year follow-up. RESULTS: The study population was comprised of 41 patients who were more than 1 year post-POEM. One (2%) major complication, a contained leak at the EGJ requiring re-operation, and 7 (17%) minor complications occurred. Mean length of stay was 1.4 days. At mean 15-month follow-up, Eckardt scores improved from pre-POEM 7 ± 2 to post-POEM 1 ± 2, (scale 0-12, p < .001), and 92% of patients achieved treatment success (Eckardt score <4). Two of the three treatment failures in the series occurred in the initial three patients. 15% of patients had post-POEM symptoms suggestive of gastroesophageal reflux (GerdQ >7). On follow-up HRM, esophagogastric junction integrated relaxation pressure was decreased significantly (pre-POEM 28 ± 12 mmHg vs. post-POEM 11 ± 4 mmHg, p < .001), and 47% of patients studied had partial recovery of peristalsis. On follow-up TBE, barium column heights were decreased compared with preoperatively. Postoperative upper endoscopy revealed esophagitis in 59% of patients (11 LA Grade A, 2 LA Grade D). However, of the 13 24-h pH monitoring studies performed, only four (31%) demonstrated pathologic esophageal acid exposure. CONCLUSIONS: In this series, POEM resulted in greater than 90% symptomatic treatment success at mean 15-month follow-up. Rates of iatrogenic gastroesophageal reflux, as measured both by symptoms and 24-h pH monitoring, appeared to be on par with recent studies of patients undergoing laparoscopic Heller myotomy and pneumatic dilation.

An extended proximal esophageal myotomy is necessary to normalize EGJ distensibility during Heller myotomy for achalasia, but not POEM.

BACKGROUND: For laparoscopic Heller myotomy (LHM), the optimal myotomy length proximal to the esophagogastric junction (EGJ) is unknown. In this study, we used a functional lumen imaging probe (FLIP) to measure EGJ distensibility changes resulting from variable proximal myotomy lengths during LHM and peroral esophageal myotomy (POEM). METHODS: Distensibility index (DI) (defined as the minimum cross-sectional area at the EGJ divided by pressure) was measured with FLIP after each operative step. During LHM and POEM, each patient's myotomy was performed in two stages: first, a myotomy ablating only the EGJ complex was created (EGJ-M), extending from 2 cm proximal to the EGJ, to 3 cm distal to it. Next, the myotomy was lengthened 4 cm further cephalad to create an extended proximal myotomy (EP-M). RESULTS: Measurements were performed in 12 patients undergoing LHM and 19 undergoing POEM. LHM resulted in an overall increase in DI (1.6 ± 1 vs. 6.3 ± 3.4 mm(2)/mmHg, p < 0.001). Creation of an EGJ-M resulted in a small increase (1.6-2.3 mm(2)/mmHg, p < 0.01) and extension to an EP-M resulted in a larger increase (2.3-4.9 mm(2)/mmHg, p < 0.001). This effect was consistent, with 11 (92%) patients experiencing a larger increase after EP-M than after EGJ-M. Fundoplication resulted in a decrease in DI and deinsufflation an increase. POEM resulted in an increase in DI (1.3 ± 1 vs. 9.2 ± 3.9 mm(2)/mmHg, p < 0.001). Both creation of the submucosal tunnel and performing an EGJ-M increased DI, whereas lengthening of the myotomy to an EP-M had no additional effect. POEM resulted in a larger overall increase from baseline than LHM (7.9 ± 3.5 vs. 4.7 ± 3.3 mm(2)/mmHg, p < 0.05). CONCLUSIONS: During LHM, an EP-M was necessary to normalize distensibility, whereas during POEM, a myotomy confined to the EGJ complex was sufficient. In this cohort, POEM resulted in a larger overall increase in EGJ distensibility.