637 Real-world experience with the new watchman FLX device: data from two high volume sicilian centres. The FLX-iest registry

Aims Left Atrial Appendage closure (LAAC) represents a standard therapy for patients with Atrial Fibrillation and contraindication to oral anticoagulation (OAC). The ‘Watchman FLX’ presented innovative features: higher conformability to LAA shapes, reduced length of the device, closed ‘atraumatic’ distal end with ‘flex-ball’ shape during deployment, flattened covered external surface. We report the early ‘real-world’ experience with the innovative Watchman-FLX device, in two centres at high-procedural volume with consolidated LAAC experience. Methods and results From May 2019 to January 2021, we enrolled 200 consecutive patients treated with Watchman FLX in a non-randomized double-centre registry. We collected procedural data and followed up the patients for mid-term clinical outcomes. Mean age was 77 ± 7.18 years (67.5% male). Patients presented hypertension in 93% of cases, CKD in 57.5% (mean creatinine level 2 ± 1.1), Diabetes mellitus in 41.5%, Coronary artery disease and Heart failure in 55%. 29% had previous stroke and 56.5 bleeding events. Mean CHA2DS2-VASc was 5 ± 1.40 and HAS-BLED 4 ± 1.01. LAAC indication was: 39.5% of cases symptomatic Haemorrhage, 39% need for Triple antithrombotic therapy, 32% gastro-intestinal bleeding; 18% of patients presented OAC intolerance. TEE guidance was feasible in 186 cases (93%), of which 96 (48%) in general anesthesia and 90 (45%) in conscious sedation (MID-DEX) protocol. 14 ICE cases (7%) were performed in local anesthesia. FLX device repositioning after first attempt was required in 40 cases (20%) without any complication. Device size change, after first choice was needed in eight cases (4%). In one exceptional case simultaneous implant of two Watchman FLX devices was performed in a bi-lobed LAA. Peri-device leak was found in two cases (1%), one solved by changing FLX size (31 to 35 mm). Final procedural success was 99.5%; one unsuccessful case due to LAA reverse chicken-wing with very short depth; no device embolization. Six complications were related to access-site (3%), two cases of combined LAAC-Mitraclip procedure; two major bleedings occurred and one in-hospital death due to hemorrhagic shock (HAS-BLED = 6). At mean follow-up of 272 ± 172.76 days, only 2% of (non-device-related) stroke and 0.6% fatal bleeding resulted. Conclusions Our registry in a high-risk population treated with the innovative Watchman FLX device, showed high technical procedural success with easy implant and repositioning, no embolization, good LAA sealing and low rate of ischaemic/bleeding complications. 637 Figure

Procedural modeling buildings for finite element method simulation

Finite element methods for heat simulation at urban scale require mesh-volume models, where the meshing process requires a special attention in order to satisfy FEM requirements. In this paper we propose a procedural volume modeling approach for automatic creation of mesh-volume buildings, which are suitable for FEM simulations at urban scale. We develop a basic rule-set library and a building generation procedure that guarantee conforming meshes. In this way, urban models can be easily built for energy analysis. Our test-case shows a street created with building prototypes that fulfill all the requirements for being loaded in a FEM numerical platform such as Cast3M (www-cast3m.cea.fr).

Epidemiology of surgery in a protracted humanitarian setting: a 20-year retrospective study of Nyarugusu Refugee Camp, Kigoma, Western Tanzania

Background There are 80 million forcibly displaced persons worldwide, 26.3 million of whom are refugees. Many refugees live in camps and have complex health needs, including a high burden of non-communicable disease. It is estimated that 3 million procedures are needed for refugees worldwide, yet very few studies exist on surgery in refugee camps, particularly protracted refugee settings. This study utilizes a 20-year dataset, the longest dataset of surgery in a refugee setting to be published to date, to assess surgical output in a setting of protracted displacement. Methods A retrospective review of surgeries performed in Nyarugusu Camp was conducted using paper logbooks containing entries between November 2000 and September 2020 inclusive. Abstracted data were digitized into standard electronic form and included date, patient nationality, sex, age, indication, procedure performed, and anesthesia used. A second reviewer checked 10% of entries for accuracy. Entries illegible to both reviewers were excluded. Demographics, indication for surgery, procedures performed, and type of anesthesia were standardized for descriptive analysis, which was performed in STATA. Results There were 10,799 operations performed over the 20-year period. Tanzanians underwent a quarter of the operations while refugees underwent the remaining 75%. Ninety percent of patients were female and 88% were 18 years of age or older. Caesarean sections were the most common performed procedure followed by herniorrhaphies, tubal ligations, exploratory laparotomies, hysterectomies, appendectomies, and repairs. The most common indications for laparotomy procedures were ectopic pregnancy, uterine rupture, and acute abdomen. Spinal anesthesia was the most common anesthesia type used. Although there was a consistent increase in procedural volume over the study period, this is largely explained by an increase in overall camp population and an increase in caesarean sections rather than increases in other, specific surgical procedures. Conclusion There is significant surgical volume in Nyarugusu Camp, performed by staff physicians and visiting surgeons. Both refugees and the host population utilize these surgical services. This work provides context to the surgical training these settings require, but further study is needed to assess the burden of surgical disease and the extent to which it is met in this setting and others.

Economic burden of enhanced practices of duodenoscopes reprocessing and surveillance: balancing risk and cost containment

Background and study aims Recent outbreaks attributed to contaminated duodenoscopes have led to the development of enhanced surveillance and reprocessing techniques (enhanced-SRT) aimed at minimizing cross-contamination. Common enhanced-SRT include double high-level disinfection (HLD), ethylene oxide (EtO) gas sterilization, and culture-based monitoring of reprocessed scopes. Adoption of these methods adds to the operational costs and we aimed to assess its economic impact to an institution. Methods We compared the estimated costs of three enhanced-SRT versus single-HLD using data from two institutions. We examined the cost of capital measured as scope inventory and frequency of scope use per unit time, the constituent reprocessing costs required on a per-cycle basis, and labor & staffing needs. The economic impact attributable to enhanced-SRT was defined as the difference between the total cost of enhanced-SRT and single HLD. Results Compared to single HLD, adoption of double HLD increased the costs approximately by 47 % ($80 vs $118). Similarly, culture and quarantine and EtO sterilization increased costs by 160 % and 270 %, respectively ($80 vs $208 and $296). Enhanced-SRT introduced significant scope downtime due to prolonged techniques, necessitating a 3.4-fold increase in the number of scopes needed to maintain procedural volume. The additional annual budget required to implement enhanced-SRT approached $406,000 per year in high-volume centers. Conclusions While enhanced-SRT may reduce patient risk of exposure to contaminated duodenoscopes, it significantly increases the cost of performing ERCP. Future innovation should focus on approaches that can ensure patient safety while maintaining the ability to perform ERCP in a cost-effective manner.