Gianluca Bonitta

Removal of the Magnetic Sphincter Augmentation Device: Surgical Technique and Results of a Single-Center Cohort Study.

Objective: The aim of this study was to identify patients’ characteristics that may predict failure and removal of the Linx sphincter augmentation device, and to report the results of 1-stage laparoscopic removal and fundoplication. Background: The Linx device is a long-term magnetic implant that was developed as a less disruptive and more reproducible surgical option for patients with early-stage gastroesophageal reflux disease (GERD). Removal of the device has been shown to be feasible, but no long-term results of this procedure have been reported yet. Methods: A review of the prospectively collected research database of antireflux surgery was performed to identify all patients who underwent a Linx implant between 2007 and 2015 in our Institution. Demographics, duration of symptoms and proton pump inhibitor (PPI) therapy, GERD-Health Related Quality of Life scores, esophageal acid exposure, lower esophageal sphincter pressure, number of beads (size) of the implanted device, concurrent crura repair, angle of inclination of the device at postoperative chest film, operative time, postoperative complications, and length of stay were recorded. Data of the explanted patients were compared with those with the device in situ in an attempt to identify factors associated with Linx removal. Results: Over the study period, 164 patients underwent a laparoscopic Linx implant and had a median follow-up of 48 months [interquartile range (IQR) 36]. Eleven (6.7%) of these patients were explanted at a later date. The estimated removal-free probability at 80 months was 0.91 [confidence interval (CI) 0.86–0.96]. Supine esophageal acid exposure before the index operation was associated with Linx removal (odds ratio 1.05, CI 1.01–1.11, P = 0.037). The main presenting symptom requiring device removal was recurrence of heartburn or regurgitation in 5 patients (46%), followed by dysphagia (n = 4, 37%) and chest pain (n = 2, 18%). In 2 patients, full-thickness erosion of the esophageal wall with partial endoluminal penetration of the device occurred. The median implant duration was 20 months, with 82% of the patients being explanted between 12 and 24 months after the implant. Device removal was most commonly combined with partial fundoplication. There were no conversions to laparotomy and the postoperative course was uneventful in all patients. At the latest follow-up, ranging from 12 to 58 months, the GERD-HRQL score was within normal limits in all patients. Conclusions: Laparoscopic removal of the Linx device can be safely performed as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion.

Early outcome of thoracoscopic and hybrid esophagectomy: Propensity-matched comparative analysis

BACKGROUND Transthoracic esophagectomy remains the current therapeutic standard for localized esophageal carcinoma. Minimally invasive surgery has proven at least equivalent to open surgery regarding the early outcomes, but only 1 randomized study has compared the thoracoscopic with the thoracotomy approach. The primary objective of this study was to assess the early outcome of the thoracoscopic prone esophagectomy (TPE) and the hybrid Ivor Lewis (HIL) esophagectomy in 2 concurrent patient cohorts. METHODS We compared the 1-year outcome of 3-stage TPE and 2-stage HIL done over the same time period in a single center. The propensity score matching method was used to reduce selection bias by creating 2 groups of patients similarly likely to receive a treatment on the basis of measured baseline characteristics. After generating propensity scores using the covariates of age, sex, body mass index, forced expiration volume at 1 second, Charlson comorbidity index, American Society of Anesthesiologists score, histologic tumor type, tumor site, pTNM stage, and neoadjuvant therapy, 93 TPE patients were matched with 197 HIL patients using a 1:1 ratio and the nearest-neighbor score matching. Main outcome measure was the incidence of postoperative complications. RESULTS Operative time was longer in TPE patients (P < .01). All postoperative outcomes, including morbidity, mortality, nodal harvest, R0 resection rate, and 1-year survival rates were similar in the 2 matched groups. CONCLUSION Both operative approaches are safe and effective; using 1 or the other depends on the tumor site, surgeon experience and preference, and patient expectations.

Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis.

AbstractOnly a minority of patients with gastro-esophageal reflux disease (GERD) are offered a surgical option. This is mostly due to the fear of potential side effects, the variable success rate, and the extreme alteration of gastric anatomy with the current gold standard, the laparoscopic Nissen fundoplication. It has been reported that laparoscopic Toupet fundoplication (LTF) and laparoscopic sphincter augmentation using a magnetic device (LINX) can treat reflux more physiologically and with a lower incidence of side-effects and reoperation rate. We present the first comparing quality of life in patients undergoing LTF versus LINX.Observational cohort study. Consecutive patients undergoing LTF or LINX over the same time period were compared by using the propensity score full matching method and generalized estimating equation. Criteria of exclusion were >3 cm hiatal hernia, grade C–D esophagitis, ineffective esophageal motility, body mass index >35, and previous upper abdominal surgery. The primary study outcome was quality of life measured with the Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire. Secondary outcomes were proton pump inhibitors (PPI) use, presence of gas-related symptoms or dysphagia, and reoperation-free probability.Between March 2007 and July 2014, 238 patients with GERD met the criteria of inclusion in the study. Of these, 103 underwent an LTF and 135 a LINX procedure. All patients had a minimum 1-year follow-up. Over time, patients in both groups had similar GERD-HRQL scores (odds ratio [OR] 1.04, confidence interval [CI] 0.89–1.27; P = 0.578), PPI use (OR 1.18, CI 0.81–1.70; P = 0.388), gas-related symptoms (OR 0.69, CI 0.21–2.28; P = 0.542), dysphagia (OR 0.62, CI 0.26–1.30; P = 0.241), and reoperation-free probability (stratified log-rank test = 0.556).In 2 concurrent cohorts of patients with early stage GERD undergoing LTF or LINX and matched by propensity score analysis, health-related quality of life significantly improved and GERD-HRQL scores had a similar decreasing trend over time up to 7 years of follow-up. We conclude that LTF and LINX provide similar disease-specific quality of life over time in patients with early stage GERD.

Health-related quality of life after laparoscopic Heller myotomy and Dor fundoplication for achalasia

Background. In addition to symptom scores, a persons perception of health and quality of life assessment is an important indicator of quality of treatment and can provide an efficient index to compare different therapeutic modalities in chronic disease states. Only a few studies have investigated quality of life comprehensively in patients with achalasia, and therefore the controversy regarding the best treatment algorithm continues. The primary study outcome was pre‐ and postoperative quality of life in patients with achalasia undergoing laparoscopic Heller myotomy and Dor fundoplication. Methods. The study is a retrospective, observational cohort. The hospital registry and the updated research database were reviewed to identify all patients who were treated for achalasia between 2010 and 2015. Patients were eligible for the study if they had a minimum 1‐year follow‐up and had pre‐and postoperative Eckardt, Short Form‐36, and Gastro‐Esophageal Reflux Disease Health‐Related Quality of Life scores. Patients with previous operative and/or endoscopic treatments for achalasia were excluded. Results. One‐hundred and eighteen patients were identified. The median follow‐up was 40 months (interquartile range 27). The proportion of patients with Eckardt stage II–III decreased from 94.9–13% (P < .001). The mean Eckardt score decreased from 6.9 ± 1.9 to 1.7 ± 1.2 (P < .001); the mean Short Form‐36 scores significantly increased in all 8 domains; the mean Gastro‐Esophageal Reflux Disease Health‐Related Quality of Life score decreased from 13.9 ± 5.7 to 5.5 ± 5.4 (P < .001). Finally, 88% (confidence interval 81–93) of patients were satisfied regarding their present condition. Conclusion. Quality of life assessed with generic and disease‐specific validated instruments significantly improved after laparoscopic Heller myotomy combined with Dor fundoplication.

Esophagectomy for End-Stage Achalasia: Systematic Review and Meta-analysis

BackgroundIndications for surgery and clinical outcomes of esophagectomy in the management of end-stage achalasia are not clearly defined. The aim of this systematic review and meta-analysis was to provide evidence-based information to help in the decision-making and in the choice of surgical technique.MethodsAn extensive literature search was conducted to identify all reports on esophagectomy for end-stage achalasia patients over the past three decades. MEDLINE, Embase and Cochrane databases were thoroughly consulted matching the terms “achalasia,” “end-stage achalasia,” “esophagectomy” and “esophageal resection” with “AND” and “OR.” Short- and long-term outcome data were extracted. Pooled prevalence of pneumonia, anastomotic leakage and mortality were calculated using Freeman–Tukey double arcsine transformation and DerSimonian–Laird estimator in random effect meta-analysis. Heterogeneity among studies was evaluated using I2-index and Cochrane Q test. Meta-regression was used to address the effect of potential confounders.ResultsEight papers published between 1989 and 2014 matched the inclusion criteria. In total, 1307 patients were included. Esophagectomy was performed through a transthoracic (78.7%) or a transhiatal (21.3%) approach. The stomach was used as an esophageal substitute in 95% of patients. Pooled prevalence of pneumonia, anastomotic leakage and mortality were 10% (95% CI 4–18%), 7% (95% CI 4–10%) and 2% (95% CI 1–3%), respectively.ConclusionsEsophagectomy for end-stage achalasia is safe and effective. Based on the results of this study, esophagectomy should be performed without hesitation in patients who are fit for major surgery and present with disabling symptoms, poor quality of life and dolichomegaesophagus recalcitrant to multiple endoscopic dilatations and/or surgical myotomies.

Open Versus Laparoscopic Management of Incisional Abdominal Hernia: Cohort Study Comparing Quality of Life Outcomes.

BACKGROUND AND AIMS Incisional hernia is a common complication of laparotomy. The long-term effectiveness of the laparoscopic repair compared to the open approach remains to be proven. We investigated the 1-year impact of open and laparoscopic repair of incisional hernia on quality of life outcomes. METHODS Single-center cohort study. The clinical data of patients who underwent open or laparoscopic surgery for primary midline incisional hernia were retrieved from hospital records and from a research database. Criteria of exclusion were emergency procedures, associated bowel resection, and recurrent incisional hernia. Complications and recurrence rates were analyzed. The visual analog scale (VAS) and the Short-Form 36 (SF-36) were used to assess pain and quality of life 1 year after surgery in patients free of recurrence. RESULTS One hundred twenty-four patients were eligible for inclusion in the study. The mean follow-up was 3 ± 2 years (interquartile range [IQR] 2.0). Overall, 9% of patients in the open group and 7% in the laparoscopic group presented with hernia recurrence (P = .685). Sixty-six of the 124 patients, who were operated between 2009 and 2014 by the same surgical team with expertise in advanced laparoscopic surgery, were considered for the study. Nine (14%) of these patients were lost to follow-up and three (5%) had a recurrent hernia, reducing the final sample size to 54 patients of whom 26 operated through an open approach and 28 through laparoscopy. The two groups were comparable according to demographic variables, comorbidity, and postoperative morbidity. The laparoscopic approach required less operative time (<.001) and length of hospital stay (P = .002). The VAS and the SF-36 scores were similar in the 54 patients, 26 in the open group and 28 in the laparoscopic group, who completed the 1-year assessment. CONCLUSIONS Health-related quality of life at 1 year was similar in patients undergoing open or laparoscopic repair of incisional abdominal hernia.

Trans-Gastric ERCP After Roux-en-Y Gastric Bypass: Systematic Review and Meta-Analysis

BackgroundTrans-oral endoscopic access to the pancreaticobiliary system is challenging after Roux-en-Y gastric bypass (RYGB). Trans-gastric ERCP (TG-ERCP) has emerged as a viable option to manage patients with symptomatic post-RYBG choledocolithiasis. The aim of this systematic review and meta-analysis was to examine the outcomes of TG-ERCP to better define the risk-benefit ratio of this procedure and to guide clinical decision-making.MethodsA literature search was conducted to identify all reports on ERCP after RYGB. Pubmed, MEDLINE, Embase, and Cochrane databases were thoroughly consulted matching the terms “ERCP” AND “gastric bypass.” Pooled prevalence of ERCP success rate, ERCP-related morbidity, post-procedural infectious complications, and overall morbidity were calculated using Freeman-Tukey double arcsine transformation and DerSimonian-Laird estimator in random effect meta-analysis. Heterogeneity among studies was evaluated using I2-index and Cochrane Q test. Meta-regression was used to address the effect of potential confounders.ResultsThirteen papers published between 2009 and 2017 matched the inclusion criteria. Eight hundred fifty patients undergoing 931 procedures were included. The most common clinical indications for TG-ERCP were biliary (90%) and pancreatic (10%). The majority of patients underwent an initial laparoscopic approach (90%). Same-day ERCP was successfully achieved in 703 cases (75.5%). Pooled prevalence of ERCP success rate, ERCP-related morbidity, post-procedural infectious complications, and overall morbidity were 99% (95% CI = 98–100%), 3.1% (95% CI = 1.0–5.8%), 3.4% (95% CI = 1.7–5.5%), and 14.2% (95% CI = 8.5–20.8%), respectively.ConclusionTG-ERCP is a safe and effective therapeutic option in patients with symptomatic post-RYGB choledocolithiasis.

Flexible versus rigid endoscopy in the management of esophageal foreign body impaction: systematic review and meta-analysis

BackgroundForeign body (FB) impaction accounts for 4% of emergency endoscopies in clinical practice. Flexible endoscopy (FE) is recommended as the first-line therapeutic option because it can be performed under sedation, is cost-effective, and is well tolerated. Rigid endoscopy (RE) under general anesthesia is less used but may be advantageous in some circumstances. The aim of the study was to compare the efficacy and safety of FE and RE in esophageal FB removal.MethodsPubMed, MEDLINE, Embase, and Cochrane databases were consulted matching the terms “Rigid endoscopy AND Flexible endoscopy AND foreign bod*”. Pooled effect measures were calculated using an inverse-variance weighted or Mantel-Haenszel in random effects meta-analysis. Heterogeneity was evaluated using I2 index and Cochrane Q test.ResultsFive observational cohort studies, published between 1993 and 2015, matched the inclusion criteria. One thousand four hundred and two patients were included; FE was performed in 736 patients and RE in 666. Overall, 101 (7.2%) complications occurred. The most frequent complications were mucosal erosion (26.7%), mucosal edema (18.8%), and iatrogenic esophageal perforations (10.9%). Compared to FE, the estimated RE pooled success OR was 1.00 (95% CI 0.48–2.06; p = 1.00). The pooled OR of iatrogenic perforation, other complications, and overall complications were 2.87 (95% CI 0.96–8.61; p = 0.06), 1.09 (95% CI 0.38–3.18; p = 0.87), and 1.50 (95% CI 0.53–4.25; p = 0.44), respectively. There was no mortality.ConclusionsFE and RE are equally safe and effective for the removal of esophageal FB. To provide a tailored or crossover approach, patients should be managed in multidisciplinary centers where expertise in RE is also available. Formal training and certification in RE should probably be re-evaluated.

Extended versus conventional thromboprophylaxis after major abdominal and pelvic surgery: Systematic review and meta-analysis of randomized clinical trials

Background: Venous thromboembolism, presenting as deep vein thrombosis or pulmonary embolism, can be associated with considerable morbidity after major abdominal and pelvic surgery. Perioperative thromboprophylaxis with low‐molecular‐weight heparin is well established, but the duration of treatment remains debated. We aimed to assess the efficacy and safety of extended (4‐week) versus conventional (1‐week) thromboprophylaxis with low‐molecular‐weight heparin in patients undergoing abdominopelvic surgery. Methods: Using MEDLINE databases (PubMed, EMBASE, and Web of Science), we conducted an electronic, systematic search of randomized controlled trials comparing post‐operative extended versus conventional low‐molecular‐weight heparin on venous thromboembolism, deep vein thrombosis, and pulmonary embolism rates. Results: Four randomized controlled trials met the predefined criteria. Extended prophylaxis with low‐molecular‐weight heparin after major abdominal and pelvic surgery decreased rates of postoperative venous thromboembolism, deep vein thrombosis, and proximal deep vein thrombosis without increased postoperative bleeding. Numbers needed to treat to prevent venous thromboembolism, overall deep vein thrombosis, and proximal deep vein thrombosis were 14, 14, and 44, respectively. Rates of postoperative symptomatic PE were rare, and the incidence was similar in both groups. Conclusion: Extended prophylaxis with low‐molecular‐weight heparin is associated with a decrease in asymptomatic venous thromboembolism. There remains sparse evidence regarding its impact on pulmonary embolism because of the overall low incidence. Extended prophylaxis should be considered in high‐risk patients.

Influence of large hiatus hernia on cardiac volumes. A prospective observational cohort study by cardiovascular magnetic resonance

BACKGROUND Large hiatus hernia (LHH) is often associated with post-prandial dyspnea, palpitations or chest discomfort, but its effect on cardiac volumes and performance is still debated. METHODS AND RESULTS Before and 3-months after laparoscopic repair, 35 patients underwent cardiovascular magnetic resonance (CMR) in the fasting state and after a standardized meal. Preoperatively, LHH size increased significantly after meal (p < 0.010). Compared to the fasting state, a systematic trend of volume reduction of the cardiac chambers was observed. In addition, both the left ventricle stroke volume (p = 0.012) and the ejection fraction (p = 0.010) were significantly reduced. At 3-months after surgery there was a statistically significant increase in left atrial volume (p = 0.029), overall left ventricle volume (p < 0.05) and right ventricle end-systolic volume (p = 0.046). Both FEV1 (Forced expiratory volume) (p = 0.02) and FVC (Forced Vital Capacity) (p = 0.01) values significantly improved after surgery. Cardiorespiratory symptoms significantly improved compared to pre-operative values (p < 0.01). CONCLUSIONS The global heart function was significantly impaired by a standardized meal in the presence of a LHH. Restoration of the cardiac physiological status and improvement of clinical symptoms were noted after surgery. A multidisciplinary evaluation and CMR with a challenge meal may be added to routine pre-operative testing to select symptomatic patients for surgical hernia repair.