An In-Vitro Comparison of Steady State Leakage Rates through Introducer Sheaths Used for Fenestrated Endovascular Aortic Aneurysm Repair.

BACKGROUND: Fenestrated Endovascular Aneurysm Repair (fEVAR) involves deploying a covered stent into the aorta followed by multiple visceral stents through fenestrations in the main body of graft. The most commonly used large sheaths for cannulation of visceral vessels are the Gore DrySeal Flex, Cook Performer Check-Flo, and Medtronic Sentrant. None of these sheaths were designed for the insertion of multiple sheaths, and so a slow but steady leakage of blood occurs during the procedure. The aim of this paper is to assess in an in vitro setting which large bore sheath has the best valve for use when multiple smaller sheaths are inserted through it. METHODS: Three large bore introducer sheaths (LBISs) were used for this study, The Gore DrySeal Flex LBIS, Medtronic Sentrant LBIS and Cook Performer Check-Flo LBIS. A test rig was constructed, made of an 18-liter fluid reservoir mounted vertically and receiving a constant supply of water from a domestic water supply which flowed into the reservoir and out of an overflow. The reservoir was connected to the LBIS by a vertical plastic pipe with an internal diameter of 40 mm and an isolation valve. The LBIS was connected to the isolation valve by inserting the LBIS up a flexible silicone tube connected to the isolation valve. The LBIS was subject to a constant column/pressure of water and fluid leakage from the LBIS was collected in a plastic pot/tray placed underneath the LBIS. The leakage rates through each LBIS were determined for the following smaller diameter sheath combinations inserted through the valve, one 6 French Sheath, two 6 French Sheaths, two 6 French Sheaths and one 7 French Sheath. This was done to closely mimic a fEVAR procedure in vitro. The procedure was to insert different sheath combinations through the nonreturn valves in the LBIS and measure the volume of fluid that leaked through the valves. The leaked fluid was weighed, and the weight was converted to volume using the density of water (1 g/ml). RESULTS: The average (mean) leakage rates for each LBIS and each sheath combination showed that leakage rates when only one sheath was inserted were very low. For all 3 LBIS's tested, the leakage rates increased dramatically when multiple sheaths were inserted. The Medtronic LBIS leaked the most, followed by Cook, followed by Gore. For the Cook LBIS, the leakage rates exhibited with 2 × 6 French sheaths were approx. 106 times greater than those for the Gore LBIS and 5 times greater for the 2 × 6 French +1 × 7 French sheath combination. A similar comparison for the Medtronic LBIS versus the Gore LBIS yields factors of 132 and 8. CONCLUSIONS: Leakage rates increase significantly when multiple sheaths are inserted and the Gore LBIS demonstrates significantly lower leakage than both the Cook and Medtronic during procedures that require simultaneous, multiple insertions of smaller sheaths. Although the Gore Dryseal has by far the lowest leakage rate when 3 small diameter sheaths are inserted (just under 1 ml/s), depending on the duration of the procedure this could still result in significant blood loss.

In Vivo Measurement of Surface Pressures and Retraction Distances Applied on Abdominal Organs During Surgery.

This study undertook the in vivo measurement of surface pressures applied by the fingers of the surgeon during typical representative retraction movements of key human abdominal organs during both open and hand-assisted laparoscopic surgery. Surface pressures were measured using a flexible thin-film pressure sensor for 35 typical liver retractions to access the gall bladder, 36 bowel retractions, 9 kidney retractions, 8 stomach retractions, and 5 spleen retractions across 12 patients undergoing open and laparoscopic abdominal surgery. The maximum and root mean square surface pressures were calculated for each organ retraction. The maximum surface pressures applied to these key abdominal organs are in the range 1 to 41 kPa, and the average maximum surface pressure for all organs and procedures was 14 ± 3 kPa. Surface pressure relaxation during the retraction hold period was observed. Generally, the surface pressures are higher, and the rate of surface pressure relaxation is lower, in the more confined hand-assisted laparoscopic procedures than in open surgery. Combined video footage and pressure sensor data for retraction of the liver in open surgery enabled correlation of organ retraction distance with surface pressure application. The data provide a platform to design strategies for the prevention of retraction injuries. They also form a basis for the design of next-generation organ retraction and space creation surgical devices with embedded sensors that can further quantify intraoperative retraction forces to reduce injury or trauma to organs and surrounding tissues.

Simplified electrocardiogram sampling maintains high diagnostic capability for atrial fibrillation: implications for opportunistic atrial fibrillation screening in primary care.

AIMS: Atrial fibrillation (AF) is a major cause of morbidity, mortality, and health resource consumption. However, as many patients with chronic AF are asymptomatic, rapid, accurate opportunistic screening is needed in primary care to detect AF. Conventional electrocardiogram (ECG) technology is too clumsy and time consuming for mass opportunistic screening, thus technology that allows easy, rapid, yet accurate AF screening is required. To address this requirement a prototype hand-held electrode assembly was developed. We hypothesized that a 6-lead frontal-plane ECG acquired from this apparatus in a seated, clothed patient would be as accurate at detecting AF as conventional 12-lead ECG in the undressed, supine patient (the 'gold standard'). METHODS AND RESULTS: Electrocardiograms were obtained from 78 patients with AF and 79 with sinus rhythm (SR). All had a conventional 12-lead ECG, a 6-lead ECG from conventionally positioned limb electrodes, a supine 6-lead recording using the prototype recorder placed on the lower thorax/upper abdomen, and a 6-lead prototype recording in the seated patient, the latter with loosened clothing only. Electrocardiograms were randomly and blindly assessed by two cardiologists for (i) diagnosis of AF vs. SR and (ii) tracing quality (subjectively assessed as good, adequate, or bad). Compared with conventional 12-lead ECG recordings, all 'new' recording methods performed satisfactorily with sensitivities ≥90% (90-99%), specificities ≥94% (94-100%), positive predictive values ≥94% (94-100%), negative predictive values ≥90% (90-99%), and accuracies ≥93% (93-99%). Tracing quality was higher in conventional 12-lead recordings (71 and 80% were assessed as good by the two observers) compared with conventional 6-lead (57 and 59%), supine prototype (41 and 31%), and sitting prototype (39 and 19%). CONCLUSIONS: Despite inferior electrocardiographic quality a 6-lead frontal plane ECG acquired by a simple prototype hand-held electrode assembly allowed reliable differentiation of AF from SR compared with standard 12-lead ECG.