Devices and Endoscopic Bariatric Therapies for Obesity.

PURPOSE OF REVIEW: In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data. RECENT FINDINGS: Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.

Estudio multicéntrico de seguridad en endoscopia bariátrica / Multicenter study on the safety of bariatric endoscopy

Introducción: la endoscopia bariátrica abarca una serie de técnicas específicas encaminadas al tratamiento del paciente obeso. Como criterios de calidad, además de eficacia debe exigirse seguridad, expresada por una mínima incidencia de complicaciones graves. Métodos: revisión descriptiva y retrospectiva, multicéntrica, incluyendo la experiencia de siete hospitales que forman parte del Grupo Español de Endoscopia Bariátrica (GETTEMO) para documentar la incidencia, causa y resolución (y sus consecuencias médico-legales) de las complicaciones graves detectadas con cada una de las distintas técnicas de endoscopia bariátrica, diferenciadas además en función de la experiencia del endoscopista. Resultados: se recogieron 6.771 procedimientos endoscópicos bariátricos, entre los que se detectaron 57 complicaciones graves (0,84%). Balones: Orbera(R)-Medsil(R): 5/5.589; Spatz2(R) (modelo antiguo): 44/225; Heliosphere(R): 1/70; O’balon(R): 0/107. Suturas: POSE(R): 5/679; gastroplastia en manga con sistema Apollo(R): 0/55. Prótesis: Endobarrier(R): 2/46. Todas ellas se resolvieron con tratamiento médico/ endoscópico, excepto cinco casos (0,07%) que requirieron cirugía. Existió una única demanda judicial (perforación esofágica con balón Spatz2(R)), con resolución judicial favorable. No hubo mortalidad ni aparentemente diferencias en relación con la experiencia de los endoscopistas. Conclusiones: en nuestra experiencia multicéntrica, la endoscopia bariátrica puede considerarse un procedimiento seguro (0,84% total de complicaciones graves). Sin embargo, algunos dispositivos pueden presentar un mayor porcentaje de complicaciones, como en el 19,55% de balones Spatz2(R) (ya sustituido) o en el 4,34% del Endobarrier(R) (en el límite alto de la seguridad aceptada), aunque en este dispositivo nuestra casuística es limitada. Todas las complicaciones se resolvieron con tratamiento médico conservador, requiriendo cirugía solo de forma excepcional (0,07%). No se observó mortalidad relacionada con las técnicas y solo un único caso de demanda judicial. Se requieren más estudios evolutivos de las novedosas técnicas endoscópicas emergentes que corroboren estos resultados (AU)

Introduction: Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. Methods: A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise. Results: In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera(R)-Medsil(R), 5/5,589; Spatz2(R) (older model): 44/225; Heliosphere(R): 1/70; Obalon(R): 0/107. Sutures: POSE(R), 5/679; sleeve gastroplasty with Apollo(R) system: 0/55. Prostheses: Endobarrier(R): 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2(R) balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level. Conclusions: In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2(R) balloons (already replaced) or 4.34% for Endobarrier(R) sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results (AU)

Current and Future Medical Treatment of Obesity.

Obesity is a major health crisis resulting in comorbidities such as hypertension, type 2 diabetes, and obstructive sleep apnea. The need for safe and efficacious drugs to help assist with weight loss and reduce cardiometabolic risk factors is great. With several FDA-approved drugs on the market, there is still a great need to develop long-term obesity treatments or noninvasive oral agents to help assist individuals with obesity when used in conjunction with lifestyle modifications.

Anesthesia for bariatric surgery: 8-Year retrospective study: are our patients now easier to manage? / Anestesia para la cirugía bariátrica, estudio retrospectivo de 8 años: ¿son más fáciles de tratar nuestros pacientes en la actualidad?

Objectives. To review the perioperative management of patients who had undergone bariatric surgery in our institution during an 8-year period, with the aim of identifying variables that correlated with improved clinical outcomes and changes in perioperative practice. Methods. This was a retrospective observational study of 437 patients who had undergone bariatric surgery from January 2005 to June 2013. Of these patients, 163 had undergone open or laparoscopic biliopancreatic diversion (Group 1), and 274 had been managed according to a Tailored Laparoscopic Approach Program (TLAP) (Group 2). We analyzed major cardiocirculatory, pulmonary, and surgery-related complications, mortality rate, intensive care unit (ICU) admissions, post-anesthetic care unit (PACU) length of stay, and perioperative management standards, throughout the study period. Results. Changes were observed in anesthetic patterns and perioperative care standards during the study period: 25% of patients had combined epidural anesthesia in 2005, compared with none at present; ICU admissions decreased from 28.6% in 2005 to 3.1% at present; and time in PACU declined from a median of 23 h in 2005 to 5.12 h at present. Duration of postoperative opioid therapy was also significantly reduced (from 48 h to 6 h). Group 2 had a significantly lower mortality rate than Group 1 (0.37% versus 4.3%, respectively, P = 0.004). Conclusions. In our institution, adoption of a TLAP for bariatric surgery has led to changes in perioperative care standards that have been followed by clear improvements according to morbidity, mortality and management indicators (AU)

Objetivos. Analizar el tratamiento perioperatorio de los pacientes que hayan sido intervenidos de cirugía bariátrica en nuestro centro durante un período de 8 años de duración, con el objetivo de identificar variables que puedan guardar relación con resultados clínicos mejorados y cambios en la práctica perioperatoria. Metodología. Estudio de observación retrospectivo de 437 pacientes que se sometieron a cirugía bariátrica entre enero de 2005 y junio de 2013. De ellos, 163 fueron intervenidos mediante derivación biliopancreática abierta o laparoscópica (Grupo 1) y 274 fueron tratados conforme al Programa de Abordaje LaparoscópicoPersonalizado (Grupo 2). Analizamos las principales complicaciones cardiovasculares, pulmonares y quirúrgicas, la tasa de mortalidad, los ingresos en UCI, el tiempo en la Unidad de Reanimación y las pautas del tratamiento perioperatorio durante el período del estudio. Resultados. Apreciamos cambios en los patrones de anestesia y las pautas de tratamiento perioperatorio durante el período del estudio: un 25% de los pacientes combinaron la anestesia epidural en 2005 en comparación con ninguno en la actualidad; los ingresos en la UCI disminuyeron del 28,6% en 2005 al 3,1% en la actualidad; y la estancia en la Unidad de Reanimación se redujo en una mediana de 23 h en 2005 a 5,12 h en la actualidad. La duración del tratamiento perioperatorio con opiodes también se acortó de manera significativa (de 48 a 6 h). El Grupo 2 presentó una tasa de mortalidad considerablemente más baja que el Grupo 1 (0,37 frente a 4,3%, respectivamente; p = 0,004). Conclusiones. En nuestro centro, la implantación del Programa de Abordaje Laparoscópico Personalizado para la cirugía bariátrica ha fraguado cambios en las pautas de tratamiento perioperatorio que han supuesto mejoras evidentes en lo que a morbimorbilidad e indicadores de gestión se refiere (AU)

Bariatric surgery, a risk factor for rhabdomyolysis

La rabdomiolisis tras cirugía bariatrica es una complicación rara pero posible. Presentamos un caso de rabdomiolisis y fallo renal agudo tras by-pass gástrico laparoscópico en paciente con obesidad mórbida. Su conocimiento puede ayudar a predecir y manejar esta complicación infradiagnosticada cuyo diagnostico precoz mejora el tratamiento de estos pacientes y previene las complicaciones posteriores (AU)

Rhabdomyolysis has been increasingly recognized as a complication of bariatric surgery. We report a case of this complication and its consequences, in a patient who had undergone bariatric surgery, with a very high creatine kinase (CK) concentration, and whose renal function failed. Obesity causes a range of effects on all major organ systems. Knowledge of these effects and issues specific to the intensive care unit care of bariatric patients can help to predict and manage this underestimated complication in this population in which early diagnosis can alter the outcome (AU)

Estudio descriptivo de la mejora de la calidad percibida en los pacientes sometidos a cirugía bariátrica tras la implantación de una vía clínica / Descriptive study on the improvement of quality perceived after the introduction of a clinical pathway by patients subjected to bariatric surgery

Objetivo. Evaluar el grado de satisfacción de los pacientes incluidos en una vía clínica de cirugía laparoscópica de la obesidad y analizar los factores relacionados con la satisfacción. Material y métodos. A una cohorte consecutiva de pacientes se les invitó a cumplimentar, de forma anónima y voluntaria, la encuesta SERVQHOS el penúltimo día de su alta hospitalaria. Resultados. De un total de 103 pacientes (53 mujeres), 71 (70%) respondieron la encuesta. Un 97,3% respondió «como se esperaba» o «por encima de las expectativas» a las cuestiones planteadas. El 98,6% se mostró «muy satisfecho» o «satisfecho» con la atención recibida y el 97,2% recomendaría el hospital a otras personas. Las cuestiones mejor relacionadas con la satisfacción global fueron la tecnología empleada (p=0,008), la apariencia del personal (p=0,019), el interés del personal sanitario por cumplir lo que promete (p=0,002) y para solucionar los problemas del enfermo (p=0,021), la información prestada por el equipo médico (p=0,039) y el tiempo de espera para ser atendido por el médico (p=0,002). En el estudio multivariante, la única variable con capacidad predictiva, en relación con la satisfacción global, fue el trato personalizado (r=0,52). La mediana de estancia hospitalaria fue de 3 días, y el 76% de los encuestados la consideró suficiente. El porcentaje de máxima satisfacción fue significativamente inferior en las mujeres, los solteros, aquellos sin ocupación profesional y con estudios universitarios. Conclusiones. Los pacientes obesos mórbidos incluidos en una vía clínica de cirugía bariátrica tienen una buena percepción de la asistencia sanitaria recibida(AU)

Objectives. To evaluate the level of perceived satisfaction in patients undergoing bariatric procedures after implementing a clinical pathway, and to analyse factors related to a high degree of satisfaction. Material and methods. A cohort of patients was invited to fulfil, anonymously and voluntarily, a SERVQHOS survey the day before hospital discharge. Results. Seventy-one (53 female) out of 103 patients (70%) responded to the questionnaire. A total of 97.3% of patients who completed the survey answered to the questions "as expected" or "above expectations". Most (98.6%) of the patients were "very satisfied" or "satisfied" with the care received, and 97.2% would recommend the hospital to others. Questions better related to overall satisfaction were technology used (P=.008), staff appearance (P=.019), the interest of staff to fulfil a promise (P=.002), and to solve the problems of the patient (P=.021), information provided by the medical staff (P=.039) and waiting time until being seen by the doctor (P=.002). In the multivariate study, only the "personalized care" achieved the category of a predictive variable (r=0.52). Median hospital stay was 3 days, and 76% of patients considered it adequate. The percentage of highest satisfaction was significantly lower in female, singles, unemployed, and those with academic studies. Conclusions. Morbid obese patients included in a clinical pathway of bariatric surgery had a good perception with the care received(AU)

Shared medical appointments: new concept for high-volume follow-up for bariatric patients.

BACKGROUND: Shared medical appointments (SMAs) are a new model in patient care. This model was designed to improve patients' access to their physicians and improve physician productivity. The aim of this study was to evaluate patient satisfaction with SMAs after bariatric surgery. METHODS: The medical records of consecutive patients who were followed up after bariatric surgery were retrospectively reviewed. The type of bariatric surgery and type of medical appointment were recorded, as were the patients' replies to the evaluation questionnaires in the SMA group. RESULTS: From April 2004 to December 2004, 277 individual visits were conducted; 242 visits for patients who underwent Roux-en-Y gastric bypass and 35 visits for patients who underwent laparoscopic gastric banding. Thirty-three SMAs occurred during that period--28 SMAs for patients who underwent Roux-en-Y gastric bypass and 5 SMAs for patients who underwent laparoscopic gastric banding. Of the patients who initially participated in an SMA, 91% scheduled a subsequent SMA, and 96% indicated that they would recommend SMAs to others. On a scale of 1 to 5 (1, poor and 5, excellent), patients graded their overall experience with SMAs as 4.5. Other parameters in the questionnaire all ranked between 4 and 5. The average waiting period for an appointment before the implementation of SMAs was 57.7 days (range 50-65) for new patients and 50 days (range 20-72) for former patients. After the implementation of SMAs, the average waiting period was 25 days (range 8-42) for new patients (P = 0.0046) and 20.3 days (range 0-42) for former patients (P = 0.06). CONCLUSION: The SMA offers the patient prompt access to medical care, enables high-volume follow-up, with high satisfaction rates.