Importance Implementation of bariatric surgery on an outpatient basis is hampered by concerns about timely detection of postoperative complications. Telemonitoring could enhance detection and support transition to an outpatient recovery pathway. Objective This study aimed to evaluate non-inferiority and feasibility of an outpatient recovery pathway after bariatric surgery, supported by remote monitoring compared to standard care. Design Preference-based non-inferiority randomized trial. Setting Center for obesity and metabolic surgery, Catharina hospital Eindhoven, the Netherlands. Participants Adult patients scheduled for primary gastric bypass or sleeve gastrectomy. Interventions Same-day discharge with one week ongoing Remote Monitoring (RM) of vital parameters or Standard Care (SC) with discharge on postoperative day one. Main outcomes Primary outcome was a thirty-day composite Textbook Outcome score encompassing mortality, mild and severe complications, readmission and prolonged length-of-stay. Non-inferiority of same-day discharge and remote monitoring was accepted below the selected margin of 7% upper limit of confidence interval. Secondary outcomes included admission duration, post-discharge opioid use and patients’ satisfaction. Results Textbook Outcome was achieved in 94% (n = 102) in RM versus 98% (n = 100) in SC (RR 2.9; 95% CI, 0.60–14.23, p = 0.22). The non-inferiority margin was exceeded which is a statistically inconclusive result. Both Textbook Outcome measures were above Dutch average (5% RM and 9% SC). Same-day discharge reduced hospitalization days by 61% (p<0.001) and by 58% with re-admission days included (p<0.001). Post-discharge opioid use and satisfaction scores were equal (p = 0.82 and p = 0.86). Conclusion In conclusion, outpatient bariatric surgery supported with telemonitoring is clinically comparable to standard overnight bariatrics in terms of textbook-outcome. Both approaches reached primary endpoint results above Dutch average. However, statistically the outpatient surgery protocol was neither inferior, nor non-inferior to the standard pathway. Additionally, offering same-day discharge reduces the total hospitalization days while maintaining patient satisfaction and safety.
Background Remote monitoring is increasingly used to support postoperative care. This study aimed to describe the lessons learned from the use of telemonitoring in an outpatient bariatric surgery pathway. Materials and Methods Patients were assigned based on their preference to an intervention cohort of same-day discharge after bariatric surgery. In total, 102 patients were monitored continuously for 7 days using a wearable monitoring device with a Continuous and Remote Early Warning Score–based notification protocol (CREWS). Outcome measures included missing data, course of postoperative heart and respiration rate, false positive notification and specificity analysis, and vital sign assessment during teleconsultation. Results In 14.7% of the patients, data for heart rate was missing for > 8 h. A day-night-rhythm of heart rate and respiration rate reappeared on average on postoperative day 2 with heart rate amplitude increasing after day 3. CREWS notification had a specificity of 98%. Of the 17 notifications, 70% was false positive. Half of them occurred between day 4 and 7 and were accompanied with surrounding reassuring values. Comparable postoperative complaints were encountered between patients with normal and deviated data. Conclusion Telemonitoring after outpatient bariatric surgery is feasible. It supports clinical decisions, however does not replace nurse or physician care. Although infrequent, the false notification rate was high. We suggested additional contact may not be necessary when notifications occur after restoration of circadian rhythm or when surrounding reassuring vital signs are present. CREWS supports ruling out serious complications, what may reduce in-hospital re-evaluations. Following these lessons learned, increased patients’ comfort and decreased clinical workload could be expected. Trial Registration ClinicalTrials.gov. Identifier: NCT04754893. Graphical Abstract
Background Non-AT-III mediated heparin-resistance during CPB occurs by complex-forming with heparin-binding proteins. Currently, there are no specific recommendations for non-AT-III mediated heparin-resistance. Case presentation We present a fatal case of a 70-yr-old male-patient undergoing cardiac-surgery in which refractory heparin-resistance was observed. The massive AL amyloidosis found at autopsy is thought to be responsible and illustrates that awareness and knowledge of the etiology and perioperative strategies of non-AT-III mediated heparin-resistance is important. Conclusion For anticoagulation during cardiopulmonary bypass surgery in case of a non-AT-III medicated heparin resistance, we refer to the decision tree added to this manuscript and if necessary to consider direct thrombin inhibitors, such as bivalirudin or argatroban, as it bypasses the complexing pathway.
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