Evaluation of the effects of implementing an electronic early warning score system: protocol for a stepped wedge study

Background: An Early Warning Score is a clinical risk score based upon vital signs intended to aid recognition of patients in need of urgent medical attention. The use of an escalation of care policy based upon an Early Warning Score is mandated as the standard of practice in British hospitals. Electronic systems for recording vital sign observations and Early Warning Score calculation offer theoretical benefits over paper-based systems. However, the evidence for their clinical benefit is limited. Previous studies have shown inconsistent results. The majority have employed a “before and after” study design, which may be strongly confounded by simultaneously occurring events. This study aims to examine how the implementation of an electronic early warning score system, System for Notification and Documentation (SEND), affects the recognition of clinical deterioration occurring in hospitalised adult patients. Methods: This study is a non-randomised stepped wedge evaluation carried out across the four hospitals of the Oxford University Hospitals NHS Trust, comparing charting on paper and charting using SEND. We assume that more frequent monitoring of acutely ill patients is associated with better recognition of patient deterioration. The primary outcome measure is the time between a patient’s first observations set with an Early Warning Score above the alerting threshold and their subsequent set of observations. Secondary outcome measures are in-hospital mortality, cardiac arrest and Intensive Care admission rates, hospital length of stay and system usability measured using the System Usability Scale. We will also measure Intensive Care length of stay, Intensive Care mortality, Acute Physiology and Chronic Health Evaluation (APACHE) II acute physiology score on admission, to examine whether the introduction of SEND has any effect on Intensive Care-related outcomes. Discussion: The development of this protocol has been informed by guidance from the Agency for Healthcare Research and Quality (AHRQ) Health Information Technology Evaluation Toolkit and Delone and McLeans’s Model of Information System Success. Our chosen trial design, a stepped wedge study, is well suited to the study of a phased roll out. The choice of primary endpoint is challenging. We have selected the time from the first triggering observation set to the subsequent observation set. This has the benefit of being easy to measure on both paper and electronic charting and having a straightforward interpretation. We have collected qualitative measures of system quality via a user questionnaire and organisational descriptors to help readers understand the context in which SEND has been implemented

Robot-assisted transthoracic first rib resection for venous thoracic outlet syndrome

Background: Venous thoracic outlet syndrome (vTOS) is caused by external compression of the subclavian vein at the costoclavicular junction. It can be subdivided in McCleery Syndrome and Paget-Schroetter Syndrome (PSS). To improve the venous outflow of the arm and to prevent recurrent thrombosis, first rib resection with venolysis of the subclavian vein can be performed. Open transaxillary, supraclavicular, infraclavicular or combined paraclavicular approaches are well known, but more recent robot-assisted techniques are introduced. We report our short- and long-term results of a minimal invasive transthoracic approach for resection of the anteromedial part of the first rib using the DaVinci surgical robot, performed through three trocars. Methods: We analyzed all patients with vTOS who were scheduled to undergo robot-assisted transthoracic first rib resection in the period July 2012 to May 2016. Outcomes were: technical success, operation time, blood loss, hospital stay, 30-day complications and patency. Functional outcomes were assessed using the “Disability of the Arm, Shoulder and Hand” (DASH) questionnaire. Results: Fifteen patients (8 male, 7 female; mean age 32.9 years, range 20–54 years) underwent robot-assisted transthoracic first rib resection. Conversion to transaxillary resection was necessary in three patients. Average operation time was 147.9 min (range 88–320 min) with a mean blood loss of 79.5 cc (range 10–550 cc). Mean hospital stay was 3.5 days (range 2–9). In three patients, complications were reported (Clavien-Dindo grade 2–3a). Patency was 91% at 15.5 months’ follow-up. DASH scores at one and three years showed excellent functional outcomes (7.1 (SD= 6.9, range 0–20.8) and 6.0 (SD= 6.4, range 0–25)) and are comparable to the scores of the normative general population. Conclusion: Robot-assisted transthoracic first rib resection with only three trocars is a feasible minimal invasive approach for first rib resection in the management of vTOS. This technique enables the surgeon to perform venolysis under direct 3D vision with good patency and long-term functional outcome. Studies with larger cohort size are needed to compare the outcomes of this robot-assisted technique with other more established approaches

Direct videoscopic approach to the descending thoracic aorta for aortic arch endograft delivery: Evaluation in a porcine model

Purpose: To examine the feasibility of a direct videoscopic approach to the descending thoracic aorta for endograft delivery to the aortic arch. Methods: A double purse-string suture was placed on the aorta of 3 pigs via a thoracoscopic approach. Subsequently, the aorta was cannulated in the center of the purse-string. A 22-F delivery catheter was advanced under fluoroscopic control over a guidewire via a trocar into the proximal aorta. After deployment of a tubular endograft, the catheter was withdrawn from the aorta while simultaneously tightening the purse-string suture, without aortic cross clamping. The outcome was evaluated by post implant angiography and autopsy results. Results: The procedure was successfully completed in all animals, with a mean total procedure time of 126 minutes (range 118-137). Mean endograft implantation time from needle puncture to catheter extraction was 27 minutes (range 21-37). Hemostasis was obtained in all animals after withdrawal of the delivery catheter and tightening the purse-string suture. The mean blood loss was 143 mL (range 80-220). Autopsy proved all purse-string sutures to be adequately placed and all endografts deployed in the correct position. Conclusion: A direct videoscopic approach to the descending thoracic aorta proved a feasible technique for endograft delivery to the aortic arch in a porcine model

Catheter Directed Thrombolysis Protocols for Peripheral Arterial Occlusions: a Systematic Review

Objective: Catheter directed thrombolysis (CDT)for peripheral arterial occlusions is a well established alternative to thrombo-embolectomy in patients with (sub)acute limb ischaemia. However, protocols are heterogeneous and need optimisation to improve results and lower bleeding risks. The objective was to review the results and outcomes of different CDT protocols for patients with peripheral arterial occlusions. Data sources: Electronic information sources (MEDLINE, Embase, Cochrane)and reference lists were searched to identify studies reporting results of CDT of peripheral arterial occlusions. Methods: Two independent observers performed study selection, quality assessment and data extraction. Primary outcomes were treatment duration, success rates, and bleeding complications. Secondary outcomes were mortality and amputation rates. Results: One hundred and six studies were included: 19 randomised controlled trials (RCTs), 38 prospective studies, 48 retrospective studies, and one mixed cohort study. The studies comprised a total number of 10,643 cases of which 9877 received CDT for lower extremity arterial occlusion, with a mean treatment duration of 21.4 h (95% confidence interval [CI]21.0–21.8), an angiographic patency of 75% (95% CI 74.6–75.1), and freedom from amputation rate of 91% (95% CI 90.3–90.7). Pooled results showed a thrombolysis duration with high dose protocols of 21.9 h (95% CI 21.4–22.5)and 32.7 h with low dose protocols, with bleeding rates of 16.7% (95% CI 16.3–17.1)and 13.4% (95% CI 12.8–14.0), respectively. Weighted mean results for all RCTs and prospective cohorts of >100 cases analysed separately, showed comparable results to all observational cohorts pooled. Bleeding complications occurred in 18% (95% CI 17.8–18.3)of patients and remain an important risk of CDT. Conclusion: CDT is an effective treatment for peripheral arterial occlusions, the main concern is bleeding complications. Although no formal meta-analysis could be performed, the pooled results suggest that lower doses of fibrinolytics lead to similar success rates at a cost of longer treatment duration but with less bleeding. There is large variation in treatment protocols and the available literature suffers from absence of reporting standards and high heterogeneity

No Concluding Evidence on Optimal Activated Clotting Time for Non-cardiac Arterial Procedures

Objectives: Heparin has a non-predictable effect in the individual patient. The activated clotting time (ACT) is used to measure the level of anticoagulation after administration of heparin. To date, appropriate heparin dose protocols and corresponding therapeutic ACT values have not been established in non-cardiac arterial procedures (NCAP). The aim of this review was to study the use of ACT monitoring during NCAP, and whether an optimal ACT could be determined based on the fewest arterial thrombo-embolic complications (ATEC) and bleeding complications. Methods: This systematic review was performed in accordance with the PRISMA Guidelines. A systematic search was conducted in MEDLINE, EMBASE, and the Cochrane database. Any associations were evaluated between peri-procedural ACT levels and ATEC and bleeding complications detected during the same admission as the primary procedure or during 30 day follow up. Also, heparin dose protocols, peri-procedural target ACTs, different ACT devices, protamine use and pre-, peri-, and post-procedural anticoagulation therapy were evaluated. Results: In total, 21 studies with 3982 patients were included, on both open and endovascular NCAP. Four studies were primarily designed to correlate peak peri-procedural ACT with clinical outcomes; however, the definitions of the results and the clinical outcomes were too heterogeneous for analysis. There was major variability in all studied aspects of ACT measurement, heparin and protamine use, and in the type of procedures in the included studies. Overall methodological quality of the included studies was poor. No randomised controlled trials were found. Studies were at a high risk of bias. Conclusions: This systematic review demonstrates a lack of data and no consensus in the literature concerning the optimal ACT, and the possible association with haemorrhagic complications and ATEC during NCAP

Impaired smooth muscle cell contractility as a novel concept of abdominal aortic aneurysm pathophysiology

Ruptured abdominal aortic aneurysms (AAA) are associated with overall mortality rates up to 90%. Despite extensive research, mechanisms leading to AAA formation and advancement are still poorly understood. Smooth muscle cells (SMC) are predominant in the aortic medial layer and maintain the wall structure. Apoptosis of SMC is a well-known phenomenon in the pathophysiology of AAA. However, remaining SMC function is less extensively studied. The aim of this study is to assess the in vitro contractility of human AAA and non-pathologic aortic SMC. Biopsies were perioperatively harvested from AAA patients (n = 21) and controls (n = 6) and clinical data were collected. Contractility was measured using Electric Cell-substrate Impedance Sensing (ECIS) upon ionomycin stimulation. Additionally, SMC of 23% (5 out of 21) of AAA patients showed impaired maximum contraction compared to controls. Also, SMC from patients who underwent open repair after earlier endovascular repair and SMC from current smokers showed decreased maximum contraction vs. controls (p = 0.050 and p = 0.030, respectively). Our application of ECIS can be used to study contractility in other vascular diseases. Finally, our study provides with first proof that impaired SMC contractility might play a role in AAA pathophysiology

Repeat Rupture of a Giant Abdominal Aortic Aneurysm after EVAR

Introduction: Ruptured abdominal aortic aneurysms (AAAs) are known to be associated with high fatal outcomes. Giant AAAs are often defined as having a maximum diameter over 13 cm. Large AAAs over 8 cm have demonstrated a yearly rupture rate of 30–50%, which explains the rarity of giant AAAs. Endovascular repair of ruptured AAAs (rAAAs) is increasingly advocated because of the shorter hospital stay and fewer post-operative complications. Nonetheless, outcomes regarding mortality and cost-effectiveness show a large variability and long-term outcomes are lacking. Few data have been published on treatment of giant AAAs and rAAAs; however, open surgery is generally the preferred option. Report: An 83 year old presented to the Emergency Department with a history of ruptured abdominal aortic aneurysm treated with an aorto-uni-iliac endograft and a femorofemoral crossover bypass. During follow up, this was complicated by a symptomatic type III endoleak, which was treated by endovascular repair. During the current admission, he presented with a re-rupture of his former aneurysm, which now was 18 cm diameter because of a type IA endoleak. Open surgical repair was performed and the post-operative course was without complications. Discussion: The current case underlines the value of vascular surgeons being able to perform both open and endovascular surgery in rAAA. Keywords: Giant abdominal aorta aneurysm, Re-rupture, Endoleak, EVAR, Open repai

Survival and Living Situation After Ruptured Abdominal Aneurysm Repair in Octogenarians

Objective: To determine the 30 day and one year mortality and post-operative living situation in octogenarians treated for ruptured abdominal aortic aneurysm (rAAA). Methods: A retrospective study was performed at four centres in the Netherlands. All consecutive patients aged ≥80 years, presenting with a rAAA between January 2013 and October 2018, were included. The primary outcomes were post-operative living situation and one year mortality. Results: In total, 157 patients were included. Forty-seven received palliative care and 110 patients had surgery. After endovascular or open repair, the one year mortality rate was 50.0%. The 30 day mortality rate was 40.8% (95% confidence interval [CI] 27–55) and 31.7% (95% CI 20–44), for endovascular and open repair, respectively (p =.32). Sixty-five per cent of survivors were discharged home, while 34.8% went to a nursing home for rehabilitation. Of the surviving patients, 82.6% went back to living in their pre-rupture home situation. Of the investigated variables, only a high body mass index proved a significant predictor of death at 30 days and one year. Compared with operated patients, patients turned down for surgery were older (mean age 87.5 ± 3.8 vs. 84.0 ± 3.5; p 80% returned to their own home after rehabilitation