Safety and feasibility of percutaneous closure of patent foramen ovale without intra-procedural echocardiography in 825 patients

BACKGROUND: Percutaneous closure of patent foramen ovale (PFO) is generally performed using intra-procedural guidance by transoesophageal (TEE) or intracardiac (ICE) echocardiography. While TEE requires sedation or general anaesthesia, ICE is costly and adds incremental risk, and both imaging modalities lengthen the procedure. METHODS: A total of 825 consecutive patients (age 51 +/- 13 years; 58% male) underwent percutaneous PFO closure solely under fluoroscopic guidance, without intra-procedural echocardiography. The indications for PFO closure were presumed paradoxical embolism in 698 patients (95% cerebral, 5% other locations), an embolic event with concurrent aetiologies in 47, diving in 51, migraine headaches in 13, and other reasons in 16. An atrial septal aneurysm was associated with the PFO in 242 patients (29%). RESULTS: Permanent device implantation failed in two patients (0.2%). There were 18 procedural complications (2.2%), including embolization of the device or parts of it in five patients with successful percutaneous removal in all cases, air embolism with transient symptoms in four patients, pericardial tamponade requiring pericardiocentesis in one patient, a transient ischaemic attack with visual symptoms in one patient, and vascular access site problems in seven patients. There were no long-term sequelae. Contrast TEE at six months showed complete abolition of right-to-left shunt via PFO in 88% of patients, whereas a minimal, moderate or large residual shunt persisted in 7%, 3%, and 2%, respectively. CONCLUSIONS: This study confirms the safety and feasibility of percutaneous PFO closure without intra-procedural echocardiographic guidance in a large cohort of consecutive patients.

Device-less patent foramen ovale closure by radiofrequency thermal energy

The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). METHODS: Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. RESULTS: There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. CONCLUSIONS: The results confirm that radiofrequency closure of the PFO is safe albeit less efficacious and more complex than device closure. The technique in its current state should not be attempted in patients with a balloon-stretched PFO diameter >7 mm and an ASA.

Development of Hardware-In-the-Loop Simulation System for Hybrid Electric Vehicle Study

The development of embedded control systems for a Hybrid Electric Vehicle (HEV) is a challenging task due to the multidisciplinary nature of HEV powertrain and its complex structures. Hardware-In-the-Loop (HIL) simulation provides an open and convenient environment for the modeling, prototyping, testing and analyzing HEV control systems. This thesis focuses on the development of such a HIL system for the hybrid electric vehicle study. The hardware architecture of the HIL system, including dSPACE eDrive HIL simulator, MicroAutoBox II and MotoTron Engine Control Module (ECM), is introduced. Software used in the system includes dSPACE Real-Time Interface (RTI) blockset, Automotive Simulation Models (ASM), Matlab/Simulink/Stateflow, Real-time Workshop, ControlDesk Next Generation, ModelDesk and MotoHawk/MotoTune. A case study of the development of control systems for a single shaft parallel hybrid electric vehicle is presented to summarize the functionality of this HIL system.

Complications associated with the arterial puncture closure device--Angio-Seal

BACKGROUND: Arterial puncture closure devices (APCD) are frequently used after cardiac catheterization. Here, the diagnosis and therapy of femoral artery complications after the use of the Angio-Seal APCD is reported. PATIENTS AND METHODS: The Angio-Seal APCD was deployed in 1600 patients undergoing transfemoral catheterization. RESULTS: In 7 of 1600 cases (0.4%) vascular complications occurred following Angio-Seal deployment. Diagnosis was made by duplex sonography. Intraoperative findings consisted of a complete occlusion with dissection of the femoral artery in all patients. In 6 cases, the femoral bifurcation had to be reconstructed after endarterectomy. Follow-up is complete with a mean of 6 months. CONCLUSION: The Angio-Seal device should not be used for closure of the superficial femoral artery and in patients with severe arteriosclerosis. The application of arteriography as well as the use of ultrasound-guided puncture is advisable. In all cases, surgical intervention was successful and an adequate therapy for management of complications.

Is a sustaining rod necessary for diverting loop ileostomy?

Objective: Whether or not a protective stoma reduces the rate of anastomotic leakage after distal colorectal anastomosis is still discussed controversially. It does however facilitate clinical management once leakage has occurred. Loop ileostomies seem to be associated with a lower morbidity and a better quality of life compared to loop colostomies. Generally, diverting loop ileostomies are secured at skin level by means of a supporting device in order to prevent retraction of the ileostomy into the abdomen. However, due to the supporting rod, difficulties may occur in applying a stoma bag correctly and leakage of faeces onto the skin may occur even with correct eversion of the afferent limb. Our aim was to compare morbidity and time to self-sufficient stoma-care in patients having a loop ileostomy with rod to those without rod. Methods: A total of 60 patients necessitating loop ileostomy were analyzed. Patients received surgery in of the two involved institutions according to inhouse standard procedures. 30 patients had an ileostomy with rod (VCHK Inselspital) and a further 30 without rod (KSW Winterthur). Morbidity and time to self-sufficiency regarding stoma care was analyzed during the first 90 postoperative days. Morbidity was determined according to a scoring system ranging from 0 to 4 points for any given set of possible complications (bleeding, necrosis, skin irritation, abscess, stenosis, retraction, fistula, prolapse, parastomal hernia, incomplete diversion), where 0 = no complication and 4 = severe complication. Continuous variables were expressed as median (95% Confidence Interval). For comparisons between the groups the Mann-Whitney U test was used, between categorical variables the X2 test was applied. Results: There were no significant differences in length of hospital stay or time to self-sufficient stoma-care between the groups. Although not significant, patients with a rod ileostomy had a tendency towards more stoma-related complications as well as stoma-related reoperations. The number of patients reaching total self-sufficiency regarding stoma care was higher after rodless ileostomy. Conclusion: According to our data, rodless ileostomies seemto fare just as well as those with a supporting rod, with equal morbidity rates and more patients reaching self-sufficient stoma care. Therefore routine application of a rod for diverting loop ileostomy seems unnecessary

TANK SIZING AND OPTIMIZING LOOP PLACEMENT IN A BRANCHED WATER DISTRIBUTION SYSTEM

More than eighteen percent of the world’s population lives without reliable access to clean water, forced to walk long distances to get small amounts of contaminated surface water. Carrying heavy loads of water long distances and ingesting contaminated water can lead to long-term health problems and even death. These problems affect the most vulnerable populations, women, children, and the elderly, more than anyone else. Water access is one of the most pressing issues in development today. Boajibu, a small village in Sierra Leone, where the author served in Peace Corps for two years, lacks access to clean water. Construction of a water distribution system was halted when a civil war broke out in 1992 and has not been continued since. The community currently relies on hand-dug and borehole wells that can become dirty during the dry season, which forces people to drink contaminated water or to travel a far distance to collect clean water. This report is intended to provide a design the system as it was meant to be built. The water system design was completed based on the taps present, interviews with local community leaders, local surveying, and points taken with a GPS. The design is a gravity-fed branched water system, supplied by a natural spring on a hill adjacent to Boajibu. The system’s source is a natural spring on a hill above Boajibu, but the flow rate of the spring is unknown. There has to be enough flow from the spring over a 24-hour period to meet the demands of the users on a daily basis, or what is called providing continuous flow. If the spring has less than this amount of flow, the system must provide intermittent flow, flow that is restricted to a few hours a day. A minimum flow rate of 2.1 liters per second was found to be necessary to provide continuous flow to the users of Boajibu. If this flow is not met, intermittent flow can be provided to the users. In order to aid the construction of a distribution system in the absence of someone with formal engineering training, a table was created detailing water storage tank sizing based on possible source flow rates. A builder can interpolate using the source flow rate found to get the tank size from the table. However, any flow rate below 2.1 liters per second cannot be used in the table. In this case, the builder should size the tank such that it can take in the water that will be supplied overnight, as all the water will be drained during the day because the users will demand more than the spring can supply through the night. In the developing world, there is often a problem collecting enough money to fund large infrastructure projects, such as a water distribution system. Often there is only enough money to add only one or two loops to a water distribution system. It is helpful to know where these one or two loops can be most effectively placed in the system. Various possible loops were designated for the Boajibu water distribution system and the Adaptive Greedy Heuristic Loop Addition Selection Algorithm (AGHLASA) was used to rank the effectiveness of the possible loops to construct. Loop 1 which was furthest upstream was selected because it benefitted the most people for the least cost. While loops which were further downstream were found to be less effective because they would benefit fewer people. Further studies should be conducted on the water use habits of the people of Boajibu to more accurately predict the demands that will be placed on the system. Further population surveying should also be conducted to predict population change over time so that the appropriate capacity can be built into the system to accommodate future growth. The flow at the spring should be measured using a V-notch weir and the system adjusted accordingly. Future studies can be completed adjusting the loop ranking method so that two users who may be using the water system for different lengths of time are not counted the same and vulnerable users are weighted more heavily than more robust users.

Use of a computerized closed-loop sodium nitroprusside titration system for antihypertensive treatment after open heart surgery

This study evaluates the clinical applicability of administering sodium nitroprusside by a closed-loop titration system compared with a manually adjusted system. The mean arterial pressure (MAP) was registered every 10 and 30 sec during the first 150 min after open heart surgery in 20 patients (group 1: computer regulation) and in ten patients (group 2: manual regulation). The results (16,343 and 2,912 data points in groups 1 and 2, respectively), were then analyzed in four time frames and five pressure ranges to indicate clinical efficacy. Sixty percent of the measured MAP in both groups was within the desired +/- 10% during the first 10 min. Thereafter until the end of observation, the MAP was maintained within +/- 10% of the desired set-point 90% of the time in group 1 vs. 60% of the time in group 2. One percent and 11% of data points were +/- 20% from the set-point in groups 1 and 2, respectively (p less than .05, chi-square test). The computer-assisted therapy provided better control of MAP, was safe to use, and helped to reduce nursing demands.

Percutaneous PFO closure with Amplatzer PFO occluder: predictors of residual shunts at 6 months follow-up

OBJECTIVE: The objective of this study was to assess predictors of residual shunts after percutaneous patent foramen ovale (PFO) closure with Amplatzer PFO occluder (AGA Medical Corporation, Golden Valley, MN, USA). METHODS: All percutaneous PFO closures, using Amplatzer PFO occluder performed at a tertiary center between May 2002 and August 2006, were reviewed. Follow-up, including saline contrast transesophageal echocardiography, was performed in all patients 6 months after the intervention. PATIENTS: A total of 135 procedures were performed. Mean age of the patients was 51 years. The indication for PFO closure was an ischemic cerebrovascular event in 92%, paradoxical systemic embolism in 4%, and a diving accident in 4%. Recurrent events prior to PFO closure were noted in 34%. A concomitant atrial septal aneurysm was present in 61%. RESULTS: At 6 months follow-up, a residual shunt was detected in 26 patients (19%). Residual shunts were more common in patients with an atrial septal aneurysm (27 vs. 8%, P= .01) and in patients treated with a 35-mm compared with a 25-mm device (39 vs. 15%, P= .01). A concomitant atrial septal aneurysm remained independently associated with residual shunts when controlled for body mass index, gender, age, atrial dimensions, and presence of a Chiari network (odds ratio 4.1, 95% confidence intervals 1.1-15.0). CONCLUSION: The presence of atrial septal aneurysms in patients undergoing percutaneous PFO closure with an Amplatzer PFO occluder significantly increases the rate of residual shunts at 6 months follow-up, even if 35-mm devices are used.