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Biomedical subjects

Michael D Holzman

Publications and source records attributed to Michael D Holzman.

14 recordsLinked to original sources

Optimizing choledocholithiasis management: a cost-effectiveness analysis.

HYPOTHESIS: Endoscopic retrograde cholangiopancreatography (ERCP) is more cost-effective for managing incidental choledocholithiasis (CDL) after laparoscopic cholecystectomy and intraoperative cholangiogram (LC/IOC) than laparoscopic common bile duct exploration (LCBDE). DESIGN: A cost-effectiveness analysis was performed to compare ERCP with LCBDE. Sensitivity analyses were performed to determine the key contributors to cost-effectiveness between the 2 treatment options. SETTING: Costs were approached from the institutional perspective considering a typical patient undergoing LC/IOC at a large referral center. PATIENTS: The base case patient evaluated was a woman 18 years of age or older with symptomatic cholelithiasis and incidental CDL discovered at the time of LC/IOC. INTERVENTIONS: Endoscopic retrograde cholangiopancreatography with drainage procedure performed after LC/IOC or LCBDE during LC/IOC. MAIN OUTCOME MEASURES: Costs, quality-adjusted life years gained, mean cost-effectiveness ratios, and incremental cost-effectiveness ratios. RESULTS: In the base case analysis, ERCP was the optimal treatment choice with a cost of $24 300 for 0.9 quality-adjusted life years gained compared with $28 400 and 0.88 quality-adjusted life years for LCBDE. Endoscopic retrograde cholangiopancreatography remained the optimal strategy for CDL in multiway probabilistic sensitivity analysis. If LCBDE were performed and the cost of a potential operative case lost was $3100 or less and the cost of ERCP hospitalization was $18 000 or more, then LCBDE became the preferred treatment for CDL. CONCLUSIONS: Endoscopic retrograde cholangiopancreatography was both less costly and more effective than LCBDE. Factors important to choosing the best strategy for CDL management included the cost of a potential case lost due to LCBDE performance and the cost of ERCP hospitalization.

Cholangiopancreatography, Endoscopic Retrograde↗

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 < or =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.

Adolescent↗

Risk factors for post-operative mortality in bariatric surgery.

BACKGROUND: Appropriate patient selection is crucial to the success of bariatric surgery (BaS). The objective of this study was to identify risk factors for increased post-operative mortality in patients undergoing BaS using a nationally representative sample. MATERIALS AND METHODS: BaS patients > or = 18 years old in the United States were identified from the 2001 Nationwide Inpatient Sample (NIS). The effect of gender, age, insurance status, and need for re-operation on post-operative mortality was examined using a multivariate logistic regression model. RESULTS: A national cohort of 54,878 patients was identified with age 41 +/- 0.2 years (mean +/- SE), 84% women, length of stay (LOS) 3.9 +/- 0.2 days, and overall mortality of 4 per 1,000 BaS patients. Mean LOS of those who died was 17.6 +/- 3.7 days. Adjusting for comorbidities and demographics, men had increased likelihood of death [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.1-4.3, P < 0.05]. Compared to younger patients, those aged above 39 years had over two-fold risk of death [ages 40-49: OR 2.6, 95% CI 1.1-6.5, P < 0.05; ages 50-59: OR 4.3, 95% CI 1.7-11, P < 0.05]. Medicaid patients [OR 4.7, 95% CI 1.2-13, P < 0.05 compared to privately insured] and those requiring re-operation [OR 22, 95% CI 5.4-88, P < 0.05] had higher odds of dying. CONCLUSION: Based on national data, risk factors for increased post-operative mortality in BaS patients include male gender, age > 39 years, Medicaid insured, and need for re-operation. These data can assist in optimizing BaS patient outcomes.

Adult↗

National variations in morbid obesity and bariatric surgery use.

BACKGROUND: Exploring bariatric surgery use provides data on effective treatment allocation. This study analyzed national rates of bariatric surgery use and the burden of morbid obesity by gender, census region, and age. STUDY DESIGN: Patients 18 years of age or older undergoing bariatric surgery were identified from the US 2002 Nationwide Inpatient Sample, and the national morbidly obese population 18 years of age or older was determined using the Centers for Disease Control and Prevention 2002 Behavioral Risk Factor Surveillance System databases. General population data were obtained from 2000 census data. Annual rates of bariatric surgery procedures were determined by gender, age group, and census region (Northeast, Midwest, South, and West). Rate ratios were calculated and significance tested through 95% confidence intervals (95% CI), accounting for the Nationwide Inpatient Sample and Behavioral Risk Factor Surveillance System sampling design. RESULTS: In 2002, a national cohort of 69,490 bariatric surgery patients was identified. Of these patients 85% were women and 76% were ages 18 to 49 years. The prevalence of morbid obesity (body mass index > or = 40 kg/m(2)) in the US in 2002 was 1.8%; 60% of morbidly obese people were women, and 63% were ages 18 to 49 years. The rates of bariatric surgery procedures per 100,000 morbidly obese individuals ranged from a low of 139 in men aged 60 years and older in the Midwest to a high of 5,156 in women ages 40 to 49 years in the Northeast. For both men and women, bariatric surgery rates in the West and Northeast were 1.35 (95% CI 1.31 to 1.40, p < 0.05) to 4.51 (95% CI 4.15 to 4.89, p < 0.05) times higher than in the South, respectively; rates in the Midwest were similar to those in the South. CONCLUSIONS: National estimates suggest that bariatric surgery rates do not parallel the burden of morbid obesity by region or age. Additional evaluation of these differences is necessary for optimal bariatric surgery use.

Adolescent↗

Physiologic properties of small intestine submucosa.

BACKGROUND: Porcine small intestine submucosa (SiS) has been introduced as a bioprosthesis in herniorrhaphy. This study evaluates in vivo properties of SiS that would affect clinical use. MATERIALS AND METHODS: Twelve pigs underwent implantation of SiS (perforated and nonperforated) on the peritoneal surface. Gross characteristics were evaluated and random samples harvested for histological study at 2 (n = 6) and 8 (n = 6) weeks. Collagen deposition was determined by polarized microscopy. Neovascularity (percent area blood vessels, %A(bv)) was determined by immunohistochemical staining with a polyclonal CD-31 antibody. RESULTS: Perforated SiS had a higher density of capillary ingrowth compared with nonperforated at both 2 (5.6%A(bv) versus 1.4%A(bv), P < 0.05) and 8 weeks (6.0%A(bv) versus 1.6%A(bv), P < 0.05). Compared with 2 weeks, 8-week SiS had a larger proportion of incorporation (25% versus 83%, P < 0.05) and new collagen deposition (50% versus 94%, P < 0.05). Significant contraction was observed in SiS 8 weeks after implantation (preimplant area 98 cm2 versus post-implant area 50 cm2, P < 0.05). CONCLUSION: SiS incorporated well 8 weeks after implantation, with deposition of new collagen. Perforated SiS demonstrated a more rapid and greater amount of neovascularity. The degree of contraction suggests that larger areas of SiS should be selected for herniorrhaphy than would be necessary if synthetic materials were used.

Absorbable Implants↗

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 were analyzed 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.

Adult↗

National analysis of adverse patient safety for events in bariatric surgery.

Identifying risk factors for adverse events after bariatric surgery (BaS) can help define high-risk groups to improve patient safety. We calculated cumulative incidence of adverse events and identified risk factors for these events using validated surgical patient safety indicators (PSIs) developed by the Agency for Healthcare Research and Quality. BaS patients > or =18 years old were identified using the 2002 Nationwide Inpatient Sample. Cumulative incidence at discharge was calculated for accidental puncture or laceration (APL), pulmonary embolus or deep venous thrombosis (PE/DVT), and postoperative respiratory failure (RF). Factors predictive of these PSIs were identified. From 7,853,982 discharges, a national cohort of 69,490 BaS patients was identified. During BaS hospitalization, the cumulative incidences per 1000 discharges of APL, PE/DVT, and RF were 12.6, 3.4, and 7.3, respectively. Risk factors for APL included male gender (odds ratio [OR] 1.6, 95% confidence interval 1.1-2.3, P < 0.05) and age of 40-49 years (OR 1.6 [1.1-2.3], P < 0.05) compared to ages 18-39 years. Patients aged 50-59 years (OR 3.5 [1.6-7.7], P < 0.05) had a higher chance of PE/DVT compared to those 18-39 years. Male gender (OR 1.8 [1.1-2.9], P < 0.05), ages 40-49 (OR 2.1 [1.1-4.2], P < 0.05) and 50-59 (OR 3.8 [2.1-6.9], P < 0.05), a history of chronic lung disease (OR 1.7 [1.1-2.7], P < 0.05), and Medicare coverage compared to private insurance (OR 2.2 [1.2-3.8], P < 0.05) were predictive of RF. This study established national measures for BaS adverse events. Further, risk factors associated with adverse events varied by gender, age, insurance status, and comorbidity. Evaluation of these higher risk BaS groups is needed to improve patient safety.

Adolescent↗

Long-term detrimental effect of bile duct injury on health-related quality of life.

HYPOTHESIS: Long-term quality of life (QOL) in patients undergoing laparoscopic cholecystectomy (LC) incurring bile duct injury (BDI) and repair is comparable to that of patients undergoing uncomplicated LC. DESIGN: Case comparison study. SETTING: Secondary and tertiary care centers. PATIENTS: Eighty-six patients incurring BDI during LC between January 1, 1991, and July 31, 2003, were surveyed. Comparison subjects underwent uncomplicated LC during the same period. MAIN OUTCOME MEASURES: Health-related QOL as assessed by the Karnofsky Performance Scale, Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), and Psychosocial Adjustment to Illness Scale. RESULTS: Fifty patients with BDI (39 [78%] female; mean +/- SEM age, 55 +/- 2 years) and 74 patients with uncomplicated LC (51 [69%] female, mean +/- SEM age, 52 +/- 2 years) responded. Of the 50 BDI patients, 48 (96%) had no stricture and normal liver function at QOL assessment. The mean +/- SEM follow-up period to QOL assessment for the BDI and uncomplicated LC groups was 62 +/- 6 and 47 +/- 3 months, respectively. The mean +/- SD Karnofsky Performance Scale scores were 77 +/- 9 vs 93 +/- 8 for the 2 groups, respectively (P <.001). The mean +/- SD SF-36 physical component scale scores after BDI vs uncomplicated LC were 36 +/- 11 vs 47 +/- 12, respectively (P <.001), compared with 50 +/- 10 for the normal population (P <.001). The mean +/- SD SF-36 mental component scale scores were 43 +/- 14 vs 49 +/- 11 for the 2 groups, respectively (P =.02), compared with 50 +/- 10 for the normal population (P =.01). Patients with BDI scored poorer on the Psychosocial Adjustment to Illness Scale health care orientation and domestic environment scales (P=.01). CONCLUSION: After BDI and repair, there are long-term detrimental effects of BDI on health-related QOL.

Bile Ducts, Extrahepatic↗

Improving documentation of patient acuity level using a progress note template.

BACKGROUND: Accurately documenting patient comorbidities and complications improves case-mix representation, coding accuracy, and risk-adjusted mortality estimates for benchmarking. We hypothesized that a progress note template containing comorbidities and complications would improve documentation and teach residents to correctly document comorbidities and complications. STUDY DESIGN: Surgical residents and patients on three inpatient services were followed for a 1-year prospective cohort study. After a 6-month baseline period, a progress note template was developed and implemented for 6 months, and administrative data were retrieved. Residents were given three case examinations assessing documentation knowledge pre- and postintervention, and a satisfaction survey. Demographics, Charlson comorbidity score, ICD-9 codes, template-specific ICD-9 codes, All Patient Refined (APR)-DRG patient severity, DRG relative weight, predicted mortality (University Healthcare Consortium), pre- and postexam scores, and resident satisfaction were collected. RESULTS: No difference in age, gender, race, or Charlson comorbidity score existed between pre- and postintervention patient groups. The length of stay decreased from 5.5 days to 4.8 days (p = 0.013). In the intervention group, total ICD-9 codes, template-specific ICD-9 codes, APR-DRG, DRG weight, and UHC predicted mortality had significant increases. Residents exposed to the progress note template improved their knowledge scores from 52% to 63% (p < 0.001), and 73% agreed that the progress note template was an improvement over handwritten notes. Residents not exposed to the progress note template did not improve their scores. CONCLUSIONS: A progress note template improves documentation of comorbidities and complications, APR-DRG patient severity for benchmarking, and case-mix index, and increases patient-specific predicted mortality. The progress note template also improves surgical residents' documentation knowledge and satisfaction.

Acute Disease↗

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.

Adult↗

Health care utilization after medical and surgical therapy for gastroesophageal reflux disease: a population-based study, 1996 to 2000.

HYPOTHESIS: Patients who undergo surgical treatment for gastroesophageal reflux disease (GERD) will use fewer health care resources than those who continue to be treated medically during the same follow-up period. DESIGN: Matched cohort study of patients with a diagnosis of GERD receiving surgical therapy or medical therapy. SETTING: Tennessee Medicaid (TennCare) program from 1996 through 2000. PATIENTS: Population-based sample of 7635 TennCare enrollees with a diagnosis of GERD served as the underlying population. Of these, 111 surgical patients who underwent fundoplication in 1996 met inclusion criteria. The 200 patients in the medically treated cohort were randomly matched to patients in the surgical cohort by demographic characteristics and previous use of acid-suppressing drugs. INTERVENTIONS: The surgical group all underwent fundoplication in 1996. The medical group was treated without fundoplication. MAIN OUTCOME MEASURES: Health care utilization (medication use, outpatient visits, hospitalizations, and diagnostic studies) for each cohort through December 2000. RESULTS: In the 4-year follow-up period, the surgical group had fewer GERD-related outpatient physician visits (5.5 +/- 6.9 visits vs 6.7 +/- 6.1 visits; P =.10). Utilization of other types of outpatient and inpatient care was similar. During each year of follow-up, the proportion of persons using GERD medication was lower in the surgical group. (0.67 vs 0.93 in year 1, 0.67 vs 0.91 in year 2, 0.72 vs 0.85 in year 3, and 0.74 vs 0.90 in year 4). CONCLUSION: The utilization of health care resources in patients treated surgically for GERD is associated with a modest decrease in the use of GERD-related medications and GERD-related visits.

Adult↗

Paradigm shift in the management of gastroesophageal reflux disease.

OBJECTIVE: To 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 DATA: The Stretta procedure has been shown to be safe, well tolerated, and highly effective in the treatment of GERD. METHODS: All 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. RESULTS: Results 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. CONCLUSIONS: The 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.

Adult↗

100 consecutive minimally invasive Heller myotomies: lessons learned.

OBJECTIVE: To evaluate the authors' first 100 patients treated for achalasia by a minimally invasive approach. METHODS: Between 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. RESULTS: There 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. CONCLUSIONS: The 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.

Botulinum Toxins, Type A↗