Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial.

AIMS Device-based pacing-induced diaphragmatic stimulation (PIDS) may have therapeutic potential for chronic heart failure (HF) patients. We studied the effects of PIDS on cardiac function and functional outcomes. METHODS AND RESULTS In 24 chronic HF patients with CRT, an additional electrode was attached to the left diaphragm. Randomized into two groups, patients received the following PIDS modes for 3 weeks in a different sequence: (i) PIDS off (control group); (ii) PIDS 0 ms mode (PIDS simultaneously with ventricular CRT pulse); or (iii) PIDS optimized mode (PIDS with optimized delay to ventricular CRT pulse). For PIDS optimization, acoustic cardiography was used. Effects of each PIDS mode on dyspnoea, power during exercise testing, and LVEF were assessed. Dyspnoea improved with the PIDS 0 ms mode (P = 0.057) and the PIDS optimized mode (P = 0.034) as compared with the control group. Maximal power increased from median 100.5 W in the control group to 104.0 W in the PIDS 0 ms mode (P = 0.092) and 109.5 W in the PIDS optimized mode (P = 0.022). Median LVEF was 33.5% in the control group, 33.0% in the PIDS 0 ms mode, and 37.0% in the PIDS optimized mode (P = 0.763 and P = 0.009 as compared with the control group, respectively). PIDS was asymptomatic in all patients. CONCLUSION PIDS improves dyspnoea, working capacity, and LVEF in chronic HF patients over a 3 week period in addition to CRT. This pilot study demonstrates proof of principle of an innovative technology which should be confirmed in a larger sample. TRIAL REGISTRATION NCT00769678.

First Clinical Experience With Celt ACD(®) : A Femoral Arterial Puncture Closure Device

Introduction This prospective nonrandomized study compared the safety and efficacy of a novel arterial closure device (ACD) in common femoral artery procedures to that of the FDA submitted historical manual pressure control group, who underwent either a diagnostic angiogram (DA) or a percutaneous coronary intervention (PCI) procedure. Methods and Results A total of 55 patients were enrolled in this study of the novel ACD. Of the 55 patients, 39 were enrolled in the DA group and 16 were enrolled in the PCI group. Six patients were excluded. A device was deployed in 49 patients. Time to hemostasis (TTH), time to ambulation (TTA), device function, and device-related vascular complications were measured. In the device group, the TTH for the combined DA and PCI patients was 32 seconds (0.54 ± 0.93 minutes), significantly lower when compared with 16.0 ± 12.2 minutes (P < 0.0001) for the control group. Overall major vascular complication rate did not differ significantly, device group (1/49) and the historical control group (1/217). TTA in the combined PCI and DA device group was 226.4 ± 231.9 at the German site (site ambulation policy). In the Irish site, the average TTA in the PCI group was 187 minutes (n = 8) and 85 minutes (n = 14) in the DA group. Conclusion The Celt ACD® device is safe, effective, and significantly decreases the TTH compared to manual pressure and has a low vascular complications rate. The device may be effective in early ambulation and discharge of patients postcoronary intervention procedures.

Effects of arm training with the robotic device ARMin I in chronic stroke: three single cases

BACKGROUND: Several clinical studies on chronic stroke conducted with end-effector-based robots showed improvement of the motor function in the affected arm. Compared to end-effector-based robots, exoskeleton robots provide improved guidance of the human limb and are better suited to train task-oriented movements with a large range of motions. OBJECTIVE: To test whether intensive arm training with the arm exoskeleton ARMin I is feasible with chronic-stroke patients and whether it improves motor function in the paretic arm. METHODS: Three single cases with chronic hemiparesis resulting from unilateral stroke (at least 14 months after stroke). A-B design with 2 weeks of multiple baseline measurements (A), 8 weeks of training (B) with repetitive measurements and a follow-up measurement 8 weeks after training. The training included shoulder and elbow movements with the robotic rehabilitation device ARMin I. Two subjects had three 1-hour sessions per week and 1 subject received five 1-hour sessions per week. The main outcome measurement was the upper-limb part of the Fugl-Meyer Assessment (FMA). RESULTS: The ARMin training was well tolerated by the patients, and the FMA showed moderate, but significant improvements for all 3 subjects (p < 0.05). Most improvements were maintained 8 weeks after discharge. CONCLUSIONS: This study indicates that intensive training with an arm exoskeleton is feasible with chronic-stroke patients. Moderate improvements were found in all 3 subjects, thus further clinical investigations are justified.

Histomorphometric and Radiographical Changes After Lumbar Implantation of the PEEK Nonfusion Interspinous Device in the BB.4S Rat Model

Study Design. An experimental animal study. Objective. To investigate histomorphometric and radiographical changes in the BB.4S rat model after PEEK (polyetheretherketone) nonfusion interspinous device implantation. Summary of Background Data. Clinical effectiveness of the PEEK nonfusion spine implant Wallis (Abbott, Bordeaux, France; now Zimmer, Warsaw, IN) is well documented. However, there is a lack of evidence on the long-term effects of this implant on bone, in particular its influence on structural changes of bone elements of the lumbar spine. Methods. Twenty-four male BB.4S rats aged 11 weeks underwent surgery for implantation of a PEEK nonfusion interspinous device or for a sham procedure in 3 groups of 8 animals each: 1) implantation at level L4–L5; 2) implantation at level L5–L6; and 3) sham surgery. Eleven weeks postoperatively osteolyses at the implant-bone interface were measured via radiograph, bone mineral density of vertebral bodies was analyzed using osteodensitometry, and bone mineral content as well as resorption of the spinous processes were examined by histomorphometry. Results. Resorption of the spinous processes at the site of the interspinous implant was found in all treated segments. There was no significant difference in either bone density of vertebral bodies or histomorphometric structure of the spinous processes between adjacent vertebral bodies, between treated and untreated segments and between groups. Conclusion. These findings indicate that resorption of spinous processes because of a result of implant loosening, inhibit the targeted load redistribution through the PEEK nonfusion interspinous device in the lumbar spinal segment of the rat. This leads to reduced long-term stability of the implant in the animal model. These results suggest that PEEK nonfusion interspinous devices like the Wallis implants may have time-limited effects and should only be used for specified indications.

A new rechargeable device for deep brain stimulation: a prospective patient satisfaction survey

Background: Deep brain stimulation (DBS) is highly successful in treating Parkinson's disease (PD), dystonia, and essential tremor (ET). Until recently implantable neurostimulators were nonrechargeable, battery-driven devices, with a lifetime of about 3-5 years. This relatively short duration causes problems for patients (e.g. programming and device-use limitations, unpredictable expiration, surgeries to replace depleted batteries). Additionally, these batteries (relatively large with considerable weight) may cause discomfort. To overcome these issues, the first rechargeable DBS device was introduced: smaller, lighter and intended to function for 9 years. Methods: Of 35 patients implanted with the rechargeable device, 21 (including 8 PD, 10 dystonia, 2 ET) were followed before and 3 months after surgery and completed a systematic survey of satisfaction with the rechargeable device. Results: Overall patient satisfaction was high (83.3 ± 18.3). Dystonia patients tended to have lower satisfaction values for fit and comfort of the system than PD patients. Age was significantly negatively correlated with satisfaction regarding process of battery recharging. Conclusions: Dystonia patients (generally high-energy consumption, severe problems at the DBS device end-of-life) are good, reliable candidates for a rechargeable DBS system. In PD, younger patients, without signs of dementia and good technical understanding, might have highest benefit.

Effects of Thoratec pulsatile ventricular assist device (PVAD) timing on the abdominal aortic wave intensity pattern

Arterial waves are seen as possible independent mediators of cardiovascular risks, and the wave intensity analysis (WIA) has therefore been proposed as a method for patient selection for ventricular assist device (VAD) implantation. Interpreting measured wave intensity (WI) is challenging and complexity is increased by the implantation of a VAD. The waves generated by the VAD interact with the waves generated by the native heart, and this interaction varies with changing VAD settings. Eight sheep were implanted with a pulsatile VAD (PVAD) through ventriculo-aortic cannulation. The start of PVAD ejection was synchronized to the native R-wave and delayed between 0 % - 90 % of the cardiac cycle in 10 % steps or phase shifts (PS). Pressure and velocity signals were registered, using a combined Doppler and pressure wire positioned in the abdominal aorta, and used to calculate the WI. Depending on the PS, different wave interference phenomena occurred. Maximum unloading of the left ventricle (LV) coincided with constructive interference and maximum blood flow pulsatility, and maximum loading of the LV coincided with destructive interference and minimum blood flow pulsatility. We believe, that non-invasive WIA could potentially be used clinically to assess the mechanical load of the LV, and to monitor the peripheral hemodynamics such as blood flow pulsatility and risk of intestinal bleeding.

Temporary anchorage device usage: a survey among Swiss orthodontists.

BACKGROUND The aim of the survey was to obtain information on the treatment plan preferences, mechanics and characteristics of temporary anchorage device (TAD) application using a single case presented to orthodontists in Switzerland. METHODS A structured questionnaire to be completed by all study participants with case-specific (treatment plan including mechanics and TAD usage) and general questions (general fixed appliance and TAD usage as well as professional, educational and demographic questions) together with an orthodontic borderline case was utilised. The case was a female adult with dental Class II/2, deep bite and maxillary anterior crowing, who had been treated in childhood with extraction of four premolars and fixed appliance followed by wisdom tooth extraction. RESULTS The response rate was 24.4% (108 out of 443). The majority (96.3%, 104) proposed comprehensive treatment, while 3.7% (4) planned only alignment of maxillary teeth. 8.3% (9) included a surgical approach in their treatment plan. An additional 0.9% (1) combined the surgical approach with Class II mechanics. 75.1% (81) decided on distalization on the maxilla using TADs, 7.4% (8) planned various types of Class II appliances and 3.7% (4) combined distalization using TADs or headgear with Class II appliances and surgery. Palatal implants were the most popular choice (70.6%, 60), followed by mini-screws (22.4%, 19) and mini-plates on the infrazygomatic crests (7.0%, 6). The preferred site of TAD insertion showed more variation in sagittal than in transversal dimension, and the median size of mini-screws used was 10.0-mm long (interquartile range (IQR) 2.3 mm) and 2.0-mm wide (IQR 0.3 mm). CONCLUSIONS Distalization against palatal implants and then distalization against mini-screws were the most popular treatment plans. Preferred site for TAD insertion varied depending on type and size but varied more widely in the sagittal than in the transversal dimension.

The use of bougie-guided insertion of a laryngeal mask airway device in neonatal piglets after unexpected complications

After marked airway obstruction with laryngeal mask (LM) placement in neonate piglets, anatomical observations in cadavers revealed a large epiglottis advancing markedly over the soft palate. CT imaging in vivo confirmed that the LM pushes the epiglottis caudally thereby obstructing the larynx. As a new approach, in 20 piglets a flexible PVC bougie placed under laryngoscopy was used to guide the LM to the correct position at the larynx. Placement of the bougie was easy and the LM was positioned successfully in all piglets at first attempt. In 14 piglets, the epiglottis was positioned dorsal to the soft palate before LM insertion and had to be pushed downwards to advance the bougie. In case of failure of LM placement with potential airway obstruction, the use of a bougie to guide the LM over the epiglottis was simple, rapid, and improved the success rate without complication.

[Subcutaneous emphysema following non-surgical peri-implantitis therapy using an air abrasive device: a case report]

Subcutaneous emphysema are rare complications in periodontology. In most cases, they resolve spontaneously. However, air might disperse into deeper facial spaces causing life-threatening complications such as compression of the tracheobronchial tree or the development of pneumomediastinum. Moreover, microorganisms might spread from the oral cavity into deeper spaces. Hence, rapid diagnosis of subcutaneous emphysema is important. Characteristic signs are both a shiftable swelling and a crepitation. In this case report, the case of a 69-year old man with a subcutaneous emphysema immediately after peri-implantitis therapy with the use of a glycine-based powder air-polishing device is described. Following therapy, air accumulated in the left side of the face. Seven days after non-surgical peri-implantitis therapy, the patient was asymptomatic with complete resolution of the emphysema.

Transcatheter mitral valve implantation (TMVI) using the Edwards FORTIS device.

Transcatheter aortic valve implantation (TAVI) has demonstrated the feasibility of treating valvular heart disease with transcatheter therapy. On the back of this success, various transcatheter concepts are being evaluated to treat other valvular disease, especially mitral regurgitation (MR). The concepts currently approved to treat MR replicate surgical mitral valve repair. However, most of them cannot eliminate MR completely. Similar to TAVI, a transcatheter mitral valve implantation may provide a valuable alternative. The FORTIS transcatheter mitral valve (Edwards Lifesciences, Irvine, CA, USA) is a self-expanding device implanted via a transapical approach. We describe our experience and early results in the first five patients treated on compassionate grounds. We also describe the details of the device, selection criteria and technical details of implantation.

Percutaneous management of left atrial appendage perforation during device closure.

A 76-year-old male patient was admitted for percutaneous left atrial appendage (LAA) closure because of chronic atrial fibrillation and a history of gastrointestinal bleeding under oral anticoagulation. The procedure was complicated by perforation of the LAA with the lobe of the closure device being placed in the pericardial space. Keeping access to the pericardial space with the delivery sheath, the LAA closure device was replaced by an atrial septal defect closure device to seal the perforation. Then the initial LAA closure device was reimplanted in a correct position. Needle pericardiocentesis was required but the subsequent course was uneventful.

Transcranial Doppler-guided deairing of a pediatric ventricular assist device: experience with twins

We report the intraoperative courses of 2 consecutive Berlin Heart Excor® Pediatric Ventricular Assist Device implantations, in which transcranial Doppler ultrasonography helped to detect macroscopically undetected residual air bubbles captured in the pump after air removal had been correctly performed according to manufacturer's specifications. Our experience with these cases suggests that a beat-to beat deairing maneuver guided by transcranial Doppler is a useful strategy for reducing cerebral exposure to perioperative gaseous microembolism.