Michael D. Holzman

Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: a prospective randomized double-blind clinical trial.

Objective:We sought to determine the impact of the addition of Dor fundoplication on the incidence of postoperative gastroesophageal reflux (GER) after Heller myotomy. Summary Background Data:Based only on case series, many surgeons believe that an antireflux procedure should be added to the Heller myotomy. However, no prospective randomized data support this approach. Patients and Methods:In this prospective, randomized, double-blind, institutional review board-approved clinical trial, patients with achalasia were assigned to undergo Heller myotomy or Heller myotomy plus Dor fundoplication. Patients were studied via 24-hour pH study and manometry at 6 months postoperatively. Pathologic GER was defined as distal esophageal time acid exposure time greater than 4.2% per 24-hour period. The outcome variables were analyzed on an intention-to-treat basis. Results:Forty-three patients were enrolled. There were no differences in the baseline characteristics between study groups. Pathologic GER occurred in 10 of 21 patients (47.6%) after Heller and in 2 of 22 patients (9.1%) after Heller plus Dor (P = 0.005). Heller plus Dor was associated with a significant reduction in the risk of GER (relative risk 0.11; 95% confidence interval 0.02–0.59; P = 0.01). Median distal esophageal acid exposure time was lower in the Heller plus Dor (0.4%; range, 0–16.7) compared with the Heller group (4.9%; range, 0.1–43.6; P = 0.001). No significant difference in surgical outcome between the 2 techniques with respect to postoperative lower-esophageal sphincter pressure or postoperative dysphagia score was observed. Conclusions:Heller Myotomy plus Dor Fundoplication was superior to Heller myotomy alone in regard to the incidence of postoperative GER.

100 Consecutive Minimally Invasive Heller Myotomies: Lessons Learned

ObjectiveTo evaluate the authors’ first 100 patients treated for achalasia by a minimally invasive approach. MethodsBetween November 1992 and February 2001, the authors performed 95 laparoscopic and 5 thoracoscopic Heller myotomies in 100 patients (age 49.5 ± 1.5 years) with manometrically confirmed achalasia. Before presentation, 51 patients had previous dilation, 23 had been treated with botulinum toxin (Botox), and 4 had undergone prior myotomy. Laparoscopic myotomy was performed by incising the distal 4 to 6 cm of esophageal musculature and extended 1 to 2 cm onto the cardia under endoscopic guidance. Fifteen patients underwent antireflux procedures. ResultsThere were eight intraoperative perforations and only four conversions to open surgery. Follow-up is 10.8 ± 1 months; 75% of the patients have been followed up for at least 14 months. Outcomes assessed by patient questionnaires revealed satisfactory relief of dysphagia in 93 patients and “poor” relief in 7 patients. Postoperative heartburn symptoms were reported as “moderate to severe” in 14 patients and “none or mild” in 86 patients. Fourteen patients required postoperative procedures for continued symptoms of dysphagia after myotomy. Esophageal manometry studies revealed a decrease in lower esophageal sphincter pressure (LESP) from 37 ± 1 mm Hg to 14 ± 1 mm Hg. Patients with a decrease in LESP of more than 18 mm Hg and whose absolute postoperative LESP was 18 or less were more likely to have relief of dysphagia after surgery. Thirty-one patients who underwent Heller alone were studied with a 24-hour esophageal pH probe and had a median Johnson-DeMeester score of 10 (normal <22.0). Mean esophageal acid exposure time was 3 ± 0.6% (normal 4.2%). Symptoms did not correlate with esophageal acid exposure. ConclusionsThe results after minimally invasive treatment for achalasia are equivalent to historical outcomes with open techniques. Satisfactory outcomes occurred in 93% of patients. Patients whose postoperative LESP was less than 18 mm Hg reported the fewest symptoms. After myotomy, patients rarely have abnormal esophageal acid exposure, and the addition of an antireflux procedure is not required.

Resident Work Hour Limits and Patient Safety

Objective:This study evaluates the effect of resident physician work hour limits on surgical patient safety. Background:Resident work hour limits have been enforced in New York State since 1998 and nationwide from 2003. A primary assumption of these limits is that these changes will improve patient safety. We examined effects of this policy in New York on standardized surgical Patient Safety Indicators (PSIs). Methods:An interrupted time series analysis was performed using 1995 to 2001 Nationwide Inpatient Sample data. The intervention studied was resident work hour limit enforcement in New York teaching hospitals. PSIs included rates of accidental puncture or laceration (APL), postoperative pulmonary embolus or deep venous thrombosis (PEDVT), foreign body left during procedure (FB), iatrogenic pneumothorax (PTX), and postoperative wound dehiscence (WD). PSI trends were compared pre- versus postintervention in New York teaching hospitals and in 2 control groups: New York nonteaching hospitals and California teaching hospitals. Results:A mean of 2.6 million New York discharges per year wereanalyzed with cumulative events of 33,756 (APL), 36,970 (PEDVT), 1,447 (FB), 10,727 (PTX), and 2,520 (WD). Increased rates over time (expressed per 1000 discharges each quarter) were observed in both APL (0.15, 95% confidence interval, 0.09–0.20, P<0.05) and PEDVT (0.43, 95% confidence interval, 0.03–0.83, P<0.05) after policy enforcement in New York teaching hospitals. No changes were observed in either control group for these events or New York teaching hospital rates of FB, PTX, or WD. Conclusions:Resident work hour limits in New York teaching hospitals were not associated with improvements in surgical patient safety measures, with worsening trends observed in APL and PEDVT corresponding with enforcement.

Laparoscopic Myotomy for Achalasia: Predictors of Successful Outcome After 200 Cases

Objective:Laparoscopic myotomy is the preferred treatment of achalasia. Our objectives were to assess the long-term outcome of esophageal myotomy and to identify preoperative factors influencing the outcome. Methods:Preoperative and long-term outcome data were collected from patients undergoing laparoscopic myotomy for achalasia at our institution. The primary endpoint of the study was the postoperative change (delta) in dysphagia score. This score was calculated by combining the frequency and the severity of dysphagia. Persistent postoperative dysphagia was defined as 1 standard deviation less than the mean delta score of all patients. Logistic regression was used to identify independent preoperative factors associated with successful myotomy. Results:A total of 200 consecutive patients were included in the study. At a mean follow-up of 42.1 months, the mean delta dysphagia score was 7.1 ± 2.6; therefore, the myotomy was considered successful when the delta score was >4.5. According to this definition, 170 (85%) patients achieved excellent dysphagia relief (responders). Responders had higher preoperative low esophageal sphincter (LES) pressure than nonresponders: 42.6 ± 13.1 versus 23.8 ± 7.0 mm Hg (P = 0.001). High preoperative LES pressure remained an independent predictor of excellent response in the multivariate logistic regression model. Patients with LES pressure >35 mm Hg had an odds ratio of 21.3, making more likely to achieve excellent dysphagia relief after myotomy compared with those with LES pressure ≤35 mm Hg (odds ratio, 21.3; 95% confidence interval, 6.1–73.5, P = 0.0001). Conclusion:Laparoscopic myotomy can durably relieve symptoms of dysphagia. Elevated preoperative LES pressure represents the strongest positive outcome predictor.

Selective intraportal hepatocyte transplantation in analbuminemic and Gunn rats.

Although significant progress has been achieved in isolated hepatocyte transplantation, the optimal site of cell implantation has not yet been determined. We have developed a novel experimental method of intraportal hepatocyte transplantation that allows easy assessment of the morphology and function of transplanted hepatocytes. Donor hepatocytes were harvested from Sprague-Dawley rats by in situ EDTA/collagenase perfusion. Fifteen recipient Nagase analbuminemic rats (NAR) underwent cannulation of the gastroduodenal vein under ether anesthesia. Either the posterior or anterior liver lobes were selectively infused with cells by occluding the portal venous supply of the nontransplanted liver lobes. Normal donor hepatocytes (2±107) suspended in normal saline were infused over 1 min (4 ml). Recipients were treated with cyclosporine for the duration of the experiment. Plasma albumin levels were determined by ELISA, before and at various intervals after transplantation. In NAR rats transplanted with normal hepatocytes, there was a significant (P<0.003) and sustained (12 weeks) increase in plasma albumin levels. Control NAR rats transplanted with NAR hepatocytes (n=8) showed no significant changes in plasma albumin levels. Similarly, normal Wistar hepatocytes were infused in-traportally into the posterior lobes of Gunn rats (n=4), which lack the ability to conjugate bilirubin. Pre-and posttransplantation bile was collected following bile duct cannulation. Bile analysis by HPLC, demonstrated a significant (P=0.04) increase in the level of bilirubin conjugates following transplantation and a corresponding decrease in total serum bilirubin (P=0.04). Our experimental data demonstrate that direct selective intraportal infusion of hepatocytes is an effective technique of hepatocyte transplantation in the rat.

Paradigm Shift in the Management of Gastroesophageal Reflux Disease

ObjectiveTo compare the short-term results of the radiofrequency treatment of the gastroesophageal junction known as the Stretta procedure versus laparoscopic fundoplication (LF) in patients with gastroesophageal reflux disease (GERD). Summary Background DataThe Stretta procedure has been shown to be safe, well tolerated, and highly effective in the treatment of GERD. MethodsAll patients presenting to Vanderbilt University Medical Center for surgical evaluation of GERD between August 2000 and March 2002 were prospectively evaluated under an IRB-approved protocol. All patients underwent esophageal motility testing and endoscopy that documented GERD preoperatively, either by a positive 24-hour pH study or biopsy-proven esophagitis. Patients were offered the Stretta procedure if they had documented GERD and did not have a hiatal hernia larger than 2 cm, LES pressure less than 8 mmHg, or Barrett’s esophagus. Patients with larger hiatal hernias, LES pressure less than 8 mmHg, or Barrett’s were offered LF. All patients were studied pre- and postoperatively with validated GERD-specific quality-of-life questionnaires (QOLRAD) and short-form health surveys (SF-12). Current medication use and satisfaction with the procedure was also obtained. ResultsResults are reported as mean ± SEM. Seventy-five patients (age 49 ± 14 years, 44% male, 56% female) underwent LF and 65 patients (age 46 ± 12 years, 42%, 58% female) underwent the Stretta procedure. Preoperative esophageal acid exposure time was higher in the LF group. Preoperative LES pressure was higher in the Stretta group. In the LF group, 41% had large hiatal hernias (>2 cm), 8 patients required Collis gastroplasty, 6 had Barrett’s esophagus, and 10 had undergone previous fundoplication. At 6 months, the QOLRAD and SF-12 scores were significantly improved within both groups. There was an equal magnitude of improvement between pre- and postoperative QOLRAD and SF-12 scores between Stretta and LF patients. Fifty-eight percent of Stretta patients were off proton pump inhibitors, and an additional 31% had reduced their dose significantly; 97% of LF patients were off PPIs. Twenty-two Stretta patients returned for 24-hour pH testing at a mean of 7.2 ± 0.5 months, and there was a significant reduction in esophageal acid exposure time. Both groups were highly satisfied with their procedure. ConclusionsThe addition of a less invasive, endoscopic treatment for GERD to the surgical algorithm has allowed the authors to stratify the management of GERD patients to treatment with either Stretta or LF according to size of hiatal hernia, LES pressure, Barrett’s esophagus, and significant pulmonary symptoms. Patients undergoing Stretta are highly satisfied and have improved GERD symptoms and quality of life comparable to LF. The Stretta procedure is an effective alternative to LF in well-selected patients.

National analysis of in-hospital resource utilization in choledocholithiasis management using propensity scores

BackgroundTwo treatment options exist for choledocholithiasis (CDL): endoscopic retrograde cholangiopancreatography (ERCP) and common bile duct exploration (CBDE). Resource utilization measured by total in-hospital charges (THC) and length of stay (LOS) was compared using the propensity score (PS). In this study, PS was the probability that a patient received CBDE based on comorbidities and demographics. The power of this method lies in balancing groups on variables by PS, resulting in 90% bias reduction and improved inferential validity compared to traditional analytic techniques.MethodsLaparoscopic cholecystectomy (LC) patients with CDL who had ERCP or CBDE were identified in the 2002 U.S. Nationwide Inpatient Sample. Patients were ordered into five PS balanced strata. Mean THC, LOS, and estimated costs were compared. A linear regression model was used to estimate the contribution that LOS had on estimated costs. Monetary values were adjusted to 2004 dollars.ResultsA total of 40,982 patients underwent LC with CDL in 2002; 27,739 had either ERCP (93%) or CBDE (7%). Mean age was 52.7 ± 0.4 years, with 74% women. Mean THC were less for CBDE (

First year experience of patients undergoing the Stretta procedure.

25,200 ±

Initial Experience with the Stretta Procedure for the Treatment of Gastroesophageal Reflux Disease

1,800) than for ERCP (

Prevalence of gastroesophageal reflux after laparoscopic Heller myotomy

29,900 ±