Michael Tarnoff

First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve

BACKGROUND We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital. METHODS The DJBS is a 60-cm sleeve anchored in the duodenum to create a duodenal-jejunal bypass. In a 12-patient prospective, open-label, single-center, 12-week study, the device was endoscopically implanted, left in situ, and retrieved. The study included 5 men and 7 women, with a mean body mass index of 43 kg/m(2). Of the 12 patients, 4 had type 2 diabetes. The primary endpoints were the incidence and severity of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in co-morbid status. RESULTS The DJBS was endoscopically delivered and retrieved in all patients (mean implant/explant time of 26.6 and 43.3 min, respectively). Of the 12 patients, 10 were able to maintain the device for 12 weeks and 2 underwent explantation after 9 days secondary to poor device placement. Several self-limited adverse events were possibly or definitely related to the device, including 6 episodes of abdominal pain, 18 of nausea, and 16 of vomiting, mainly within 2 weeks of implantation. Two partial pharyngeal tears occurred during explantation. Implant site inflammation was encountered in all patients. No device-related event was considered severe. The average percentage of excess weight loss for the 10 patients with the device in place for 12 weeks was 23.6%, with all patients achieving at least 10% excess weight loss. All 4 diabetic patients had normal fasting plasma glucose levels without hypoglycemic medication for the entire 12 weeks. Of these 4 patients, 3 had decreased hemoglobin A(1c) of > or =.5% by week 12. CONCLUSION The DJBS can be safely delivered and removed endoscopically and left in situ for 12 weeks. The device had a favorable safety and encouraging efficacy profile. Randomized prospective trials are warranted.

Open label, prospective, randomized controlled trial of an endoscopic duodenal-jejunal bypass sleeve versus low calorie diet for pre-operative weight loss in bariatric surgery

BackgroundThe duodenal-jejunal bypass sleeve (DJBS) has been shown to achieve a completely endoscopic duodenal exclusion without the need for stapling. This report is the first randomized controlled trial for weight loss.MethodsIn a 12-week, prospective, randomized study, subjects received either a low fat diet and the DJBS or a low fat diet control (no device). Twenty-five patients were implanted with the device and 14 received the control. The groups were demographically similar. Both groups received counseling at baseline only, which consisted of a low calorie diet, and exercise/behavior modification advice. No additional counseling occurred in either group. Measurements included starting and monthly body weight and serum blood tests. The device group also had a plain abdominal film post implant, a monthly KUB and a 4-week post explant EGD.ResultsTwenty device (80%) subjects maintained the DJBS without a significant adverse event for the 12-week duration. At 12 weeks, the mean excess weight loss was 22% and 5% for the device and control groups, respectively (p < 0.001). Five subjects (20%) were endoscopically explanted early secondary to upper GI (UGI) bleeding (n = 3), anchor migration (n = 1) and sleeve obstruction (n = 1). The UGI bleeding occurred at a mean of 13.8 days post implant. EGD was performed in each of these cases with no distinct bleeding source identified. No blood transfusion was required. The migration occurred on day 47 and manifested as abdominal pain. The subject with the sleeve obstruction presented with abdominal pain and vomiting on day 30. Eight subjects (40%) underwent the 4 week post explant EGD at which time mild degrees of residual duodenal inflammation was noted.ConclusionThe DJBS achieves noninvasive duodenal exclusion and short term weight loss efficacy. Longer term randomized controlled sham trials for weight loss and treatment of T2DM are underway.

Outcome of laparoscopic splenectomy based on hematologic indication

Background: Laparoscopic splenectomy is the procedure of choice for elective splenectomy at the Cleveland Clinic Foundation. Although the literature clearly documents the technical feasibility and safety of laparoscopic splenectomy, little data exists concerning the results of this procedure based on the hematologic indication for splenectomy. We sought to examine the clinical experience with laparoscopic splenectomy in a single institution, with particular attention to morbidity and clinical outcomes based on hematologic disease process. Methods: This study retrospectively reviewed a consecutive series of laparoscopic splenectomies performed for nontraumatic, splenic pathology at the Cleveland Clinic Foundation from August 1995 to January 2001. Patient demographics, operative indications, morbidity, mortality, and clinical outcome were evaluated. Hematologic diagnostic groups were compared using Fisher’s exact tests and Wilcoxon rank-sum tests. Results: A total of 147 laparoscopic splenectomies were performed. Seven patients (5%) required conversion to open splenectomy. Indications for splenectomy included idiopathic thrombocytopenic purpura (ITP) in 65 patients, hematologic malignancy in 43 patients, autoimmune hemolytic anemia (AIHA) in 9 patients, thrombotic thrombocytopenic purpura (TTP) in 9 patients, splenomegaly in 5 patients, splenic cyst in 4 patients, splenic abscess in 3 patients, hereditary spherocytosis in 2 patients, splenic artery aneurysm in 2 patients, Felty’s syndrome in 1 patient, myelofibrosis in 1 patient, and other in 3 patients. Accessory spleens were identified in 20 patients (14%). Postoperative complications occurred in 23 (16%) patients. Patients with ITP had significantly shorter operation times (134 vs 163 min; p = 0.001), decreased estimated blood loss (126 vs 307 ml; p = 0.001), decreased length of hospital stay (2.8 vs 4.6 days; p < 0.001), and less chance of conversion (0 vs 7; p = 0.02) than patients with any other diagnosis. A mean follow-up period of 20 ± 14 months showed an 85% rate of remission for ITP, 89% for TTP, and 89% for AIHA. Patients with malignant disease had significantly larger spleens (822 vs 313 g; p < 0.001), more estimated blood loss (380 vs 168 ml; p = 0.04), and longer operative times (170 vs 142 min; p = 0.009), as compared patients treated for benign disease. However, the length of hospital stay (4.3 vs 3.6 days; p = 0.06) and complication rates (19% vs 14%; p = 0.08) were not significantly different between the two groups. Conclusions: When performed for ITP, laparoscopic splenectomy resulted in shorter operations, minimal blood loss, earlier discharge, no conversions, and excellent remission rates, as compared with other hematologic indications. Despite larger spleens, more blood loss, and longer operations in patients with hematologic malignancies, morbidity and length of hospital stay still were similar to those associated with benign indications for laparoscopic splenectomy. In conclusion, laparoscopic splenectomy is safe and efficacious for a multitude of benign and malignant hematologic indications, and our data compares favorably to those for open series.

Nutrition and Gastrointestinal Complications of Bariatric Surgery

At present, bariatric surgery is the only treatment that can achieve meaningful and sustainable weight loss for the millions of morbidly obese individuals. The current popular operative procedures (the Roux-en-y gastric bypass, laparoscopic adjustable gastric band, and the biliopancreatic diversion with or without duodenal switch) are all relatively safe and effective. However, all of these procedures, to variable degrees, alter the anatomy and physiology of the gastrointestinal tract. This fact, along with postoperative dietary changes, makes these patients vulnerable to a multitude of potential complications. As more and more patients undergo these procedures, an increasing number of clinicians will be asked to care for them. It is therefore imperative that all clinicians have a general understanding of the operative procedures and the potential problems these patients may develop. This article will describe these operative procedures and will discuss the more common consequences.

Reinforcing Gastric Staple-Lines with Bovine Pericardial Strips May Decrease the Likelihood of Gastric Leak after Laparoscopic Roux-en-Y Gastric Bypass

Background: Staple-line leakage is a potentially devastating complication of Roux-en-Y gastric bypass (RYGBP). Bovine pericardial strips (BPS) have been used to reinforce staple-lines in pulmonary resections and have been shown to decrease air-leaks.This study examined the use of BPS to decrease gastric staple-line leaks. Methods: 250 consecutive patients undergoing laparoscopic RYGBP had BPS used for the gastric pouch. Ease of use, operative complications, and visual bleeding were recorded. In addition, the postoperative leak rate was compared to 100 consecutive patients operated on prior to the study when BPS was not used. Results: Patient characteristics were the same for both groups and comparable with most published data. With the use of BPS, there were no operative complications and no meaningful increase in operating time. BPS reinforced staple-lines had no visual bleeding. In the 100 cases without BPS, there were 2 staple-line leaks (2%) both of which required emergency exploration. One additional patient was subsequently found to have a gastrogastric fistula. In the 250 patients who had BPS-reinforced staple-lines, there were no acute leaks.Three patients were subsequently found to have gastrogastric fistula. None required emergency surgery. Conclusion: In this non-randomized trial, BPS were found to be easy and safe to use. In addition, staple-line hemorrhage was essentially non-existent. Although the reduction in gastric staple-line leak rate may also be attributed to learning curve, there were no acute leaks in 250 patients with BPS, which is below the published norms.

Effect of advance directives on the management of elderly critically ill patients.

OBJECTIVE To evaluate the effects of advance directives on the management of elderly, critically ill patients. DESIGN Retrospective chart review. SETTING Teaching hospital medical/surgical, noncardiac intensive care unit (ICU). PATIENTS The medical records of 401 patients, > or =65 yrs of age, admitted to the ICU between 1992 and 1995 were reviewed. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Advance directive statements included refusal of cardiopulmonary resuscitation (CPR), nutrition, intravenous medications, antibiotics, mechanical ventilation, and blood products. Nineteen (5%) patients had advance directives (study group). These patients were compared with 28 case-matched (age, Acute Physiology and Chronic Health Evaluation II score, and diagnosis) critically ill patients without advance directives (control group). We compared the following data: cost per day; number of surgical procedures; number of radiographic studies; number of central venous and pulmonary artery catheter insertions; number of complete blood counts, electrolytes, and cultures sent for laboratory testing; number of days in the ICU/hospital; and mortality rates. Statistical analysis was performed using the Students t-test for independent means and the chi-square equation. For all observed parameters, quantitative and dichotomous differences between study and control groups were not statistically significant. Two patients received CPR, despite advance directive statements refusing this treatment. CONCLUSIONS Few critically ill seniors have advance directives. As assessed by objectively documented information, the level of care delivered to elderly ICU patients is not affected by the presence or absence of advance directive statements. Medical personnel need to be aware of whether or not patients have advance directive statements, as unauthorized CPR was administered to 11% of the patients who died with advance directives.

An Evidenced-based Assessment of Preoperative Weight Loss in Bariatric Surgery

Surgeons in all disciplines have always known that obese patients suffer from a higher incidence of perioperative complications than more normal-weight individuals. In addition to the physiologic derangements and comorbid conditions associated with obesity (i.e., type II diabetes, hypertension, sleep apnea, etc.), the presence of excess abdominal fat also increases the technical difficulties of the operative procedure and jeopardizes the healing response thereby compromising the integrity of surgical repairs, organ function and the incisions used in modern surgery [1–7]. Recently, the potential benefits of preoperative weight loss has become of interest to surgeons and in particular, bariatric surgeons who routinely perform complex operative procedures on high-risk severely obese individuals. Traditionally, the concept has been considered controversial. For many bariatric surgeons, the concept of mandatory preoperative weight loss was considered unjustified, an exercise in futility, and even inhumane. Yet, others were convinced of its benefits. In the last few years, several studies have been published demonstrating value to mandatory weight loss prior to bariatric surgery. This review will summarize the current literature on the topic. The Surgical Consequences of Obesity

Predictors of operative outcome in patients with human immunodeficiency virus infection and acquired immunodeficiency syndrome

BACKGROUND Plasma viral load has recently been associated with clinical outcome in patients with human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS). We hypothetized that, in addition to CD4 lymphocytes, plasma HIV-1 RNA counts are predictive of postoperative outcome. METHODS HIV-infected and AIDS patients admitted to a major teaching hospital requiring invasive or surgical procedures were retrospectively analyzed for postoperative outcome. Preoperative and postoperative immune cell counts including plasma HIV-1 RNA counts were recorded. Chi-square analysis, Fishers exact test, and multivariate regression were performed with statistical significance P </=0.05. RESULTS Fifty-five consecutive patients between 14 and 62 years of age were admitted in a 1-year period and underwent 64 diagnostic and therapeutic procedures. Fourteen (22%) postoperative infections and 18 (28%) complications other than infection, with an overall mortality of 11%, were documented. Total preoperative white blood cell count ([WBC] P <0.01), preoperative percent lymphocyte count (P <0.01), absolute postoperative CD4 lymphocyte count (P <0.01), and postoperative plasma viral load (P <0.0001) are associated with mortality. Multivariate regression indicated that postoperative percent CD4 lymphocyte count is an independent predictor of both postoperative infection and other complications (P <0.05, R = 0.848, power = 0.9911), while the decrement in percent CD4 lymphocyte count is an independent predictor of postoperative complications other than infection (P <0.05, R = 0.596, power = 0.7838). CONCLUSIONS In accordance with the medical literature for clinical outcome in HIV-infected and AIDS patients, both immune cell counts and HIV-1 RNA counts were found to associate with postoperative mortality. However, the postoperative and decrement in percent CD4 lymphocyte proved to be the independent predictors of postoperative complications.

Nimodipine enhances new learning after hippocampal damage

Rats were trained to lever press and then were given either bilateral lesions of the hippocampus or control operations. Half of the rats in each group received oral nimodipine, a calcium entry blocker, while the remaining rats received vehicle, over a 14-day period that began the evening of surgery. The rats were studied on a DRL 20-s schedule of reinforcement (differential reinforcement of low rates of responding) that required them to withhold a response for at least 20 s after their last lever press in order to earn a reward. Rats with lesions that did not receive the drug performed poorly on the DRL 20-s schedule. In contrast, rats sustaining the same hippocampal lesions but given the drug showed scores that were virtually equivalent to those of the sham-operated control animals. Similar trends were observed when the rats were then tested on a DRL 40-s schedule of reinforcement. These findings suggest that nimodipine may attenuate the effects of acute, focal brain lesions on new learning of even difficult behavioral and cognitive tasks.

Cost-effectiveness of ambulatory laparoscopic cholecystectomy.

The merits of laparoscopic cholecystectomy include faster recovery, less postoperative pain, earlier return to work, and decreased cost. However, there are few economic data comparing laparoscopic cholecystectomy in an ambulatory versus overnight stay setting. In a 12-month period, 74 consecutive cholecystectomies were performed laparoscopically by one surgeon. The ambulatory group consisted of 36 patients who were discharged from the hospital the same day after a mean recovery time of 5 hours (range, 2.25–10.33). Of the remaining 38 patients, 19 were admitted after surgery on 23-hour observation status, and 19 were inpatients. The average hospital cost was significantly less in the ambulatory group than in the observation group, with an 11% mean reduction in cost per patient (P = 0.0061). No patient in either group was readmitted to the hospital within 30 days of surgery. Laparoscopic cholecystectomy can be performed safely in an outpatient setting. The cost savings of ambulatory care versus observation are clearly shown in this study.