Periprocedural embolic events related to carotid artery stenting detected by diffusion-weighted MRI: comparison between proximal and distal embolus protection devices

PURPOSE: To evaluate and compare the efficacy of proximal versus distal embolus protection devices (EPD) during carotid artery angioplasty/stenting (CAS) based on diffusion-weighted magnetic resonance imaging (DW-MRI). METHODS: Forty-four patients (31 men; mean age 68 years, range 48-85) underwent protected CAS and had DW-MRI before and after the intervention. The cohort was analyzed according to the type of EPD used: a proximal EPD was deployed in 25 (56.8%) patients (17 men; mean age 66 years, range 48-85) and a distal filter in 19 (14 men; mean age 70 years, range 58-79). Fifteen (60.0%) patients with proximal protection were symptomatic of the target lesion; in the distal protection group, 10 (52.6%) were symptomatic. RESULTS: New lesions were seen on the postinterventional DW-MRI in 28.0% (7/25) of the proximal EPD group versus 32.6% (6/19) of those with a distal filter (p = NS). The majority were clinically silent. The new lesions in the vascular territory of the stented carotid artery in the group as a whole and per patient were fewer in the proximal EPD group (p = NS). No significant differences were noted in the T(2) appearance of the new lesions or the number of new lesions observed away from the vascular territory of the stented artery. CONCLUSION: Proximal embolus protection devices show a nonsignificant trend toward fewer embolic events, which warrants large-scale studies. Furthermore, proximal protection devices can be useful to control and treat acute in-stent thrombosis.

Safety of diagnostic balloon occlusion in normal coronary arteries

Diagnostic coronary balloon occlusion (CBO) is mandatory for collateral function assessment, during angioscopy and optical coherence imaging, and when using certain coronary protection devices against emboli. Thus far, the safety of diagnostic CBO regarding procedural and long-term complications in normal coronary arteries has not been studied. In 316 patients, diagnostic CBO was performed for collateral function measurement in 426 angiographically normal vessels. The angioplasty balloon was inflated for 60 to 120 seconds using inflation pressures of 1 to 3 atm, followed by control angiography during and after CBO. Patients were divided into groups with entirely normal (n = 133) and partially normal (n = 183) vessels. Primary end points were procedural and long-term complications. De novo stenosis development was assessed by quantitative coronary angiography in 35% of the patients. Secondary end points were cardiac events at 5 years of follow-up. Procedural complications occurred in 1 patient (0.2%). In 150 repeat angiographic procedures in 92 patients (follow-up duration 10 +/- 15 months), quantitative coronary angiography revealed no difference in percentage diameter narrowing between baseline and follow-up (4.1% vs 3.9%, p = 0.69). During follow-up periods of 14 and 72 months, respectively, a new stenotic lesion was detected in 1 patient in each group (1.3%). Major cardiac events and percutaneous coronary intervention for stable angina were less frequent in the group with entirely normal than with partially normal vessels (0.8% vs 5.5%, p = 0.02, and 0.8% vs 18%, p <0.0001). In conclusion, low-inflation pressure diagnostic CBO in angiographically normal coronary arteries bears a minimal risk for procedural and long-term complications and can therefore be regarded as a safe procedure.

Secondary stroke prevention: patent foramen ovale, aortic plaque, and carotid stenosis

Stroke is the most debilitating cardiovascular event. It has a variety of causes that may be present simultaneously. In young or otherwise healthy people, the search for a patent foramen ovale (PFO) has become standard. In stroke of the elderly, atherosclerosis and atrial fibrillation are in the foreground but the PFO should not be ignored. The risk of a PFO-related stroke over time is controversial and so is its prevention by device closure. The association of proximal aortic plaques in arteries subtending the brain and stroke is considered strong, ignoring that it is as putative as that of the PFO. Statins can prevent progression of such plaques. Antiplatelet agents in asymptomatic and surgical endarterectomy in symptomatic patients or highly ulcerated lesions are the treatment of choice. Stenting with protection devices was shown competitive in selected patients.

Flow impairment during protected carotid artery stenting: impact of filter device design

PURPOSE: To investigate the impact of filter design on blood flow impairment in the internal carotid artery (ICA) among patients undergoing carotid artery stenting (CAS) using filter-type emboli protection devices (EPD). METHODS: Between July 2003 and March 2007, 115 filter-protected CAS procedures were performed at an academic institution in 107 consecutive patients (78 men; mean age 68 years, range 38-87). The Angioguard, FilterWire EZ, and Spider filters were used in 68 (59%), 32 (28%), and 15 (13%) of cases, respectively. Patient characteristics, procedural and angiographic data, and outcomes were prospectively entered into an electronic database and reviewed retrospectively along with all angiograms. RESULTS: Flow impairment while the filter was in place was observed in 25 (22%) cases. The presumptive reason of flow impairment was filter obstruction in 21 (18%) instances and flow-limiting spasm at the level of the filter in 4 (4%). In all cases, flow was restored after retrieval of the filter. Flow obstruction in the ICA occurred more frequently with Angioguard (22/68; 32.3%) than with FilterWire EZ (2/32; 6.2%) or Spider (1/15; 6.7%; p = 0.004). No flow occurred in 13 (19%) procedures, all of them protected with Angioguard; no patient treated with other devices experienced this event (p = 0.007). Two (8.0%) strokes occurred in procedures associated with flow impairment, while 1 (1.1%) event was observed in the presence of preserved flow throughout the intervention (p = 0.11). CONCLUSION: Flow impairment in the ICA during filter-based CAS is common and related to the type of filter used.

Development of an auditory implant manipulator for minimally invasive surgical insertion of implantable hearing devices

To present the auditory implant manipulator, a navigation-controlled mechanical and electronic system which enables minimally invasive ('keyhole') transmastoid access to the tympanic cavity.

Effectiveness of individual resource-oriented joint protection education in people with rheumatoid arthritis. A randomized controlled trial

the modern joint protection (JP) concept for people with rheumatoid arthritis (RA) is an active coping strategy to improve daily tasks and role performance by changing working methods and using assistive devices. Effective group JP education includes psycho-educational interventions. The Pictorial Representation of Illness and Self Measure (PRISM) is an interactive hands-on-tool, assessing (a) the individual's perceived burden of illness and (b) relevant individual resources. Both issues are important for intrinsic motivation to take action and change behaviour. This study compared individual conventional JP education (C-JP) with PRISM-based JP education (PRISM-JP).

Safety of Active Implantable Devices during MRI Examinations: A Finite Element Analysis of an Implantable Pump

The goal of this study was to propose a general numerical analysis methodology to evaluate the magnetic resonance imaging (MRI)-safety of active implants. Numerical models based on the finite element (FE) technique were used to estimate if the normal operation of an active device was altered during MRI imaging. An active implanted pump was chosen to illustrate the method. A set of controlled experiments were proposed and performed to validate the numerical model. The calculated induced voltages in the important electronic components of the device showed dependence with the MRI field strength. For the MRI radiofrequency fields, significant induced voltages of up to 20 V were calculated for a 0.3T field-strength MRI. For the 1.5 and 3.0T MRIs, the calculated voltages were insignificant. On the other hand, induced voltages up to 11 V were calculated in the critical electronic components for the 3.0T MRI due to the gradient fields. Values obtained in this work reflect to the worst case situation which is virtually impossible to achieve in normal scanning situations. Since the calculated voltages may be removed by appropriate protection circuits, no critical problems affecting the normal operation of the pump were identified. This study showed that the proposed methodology helps the identification of the possible incompatibilities between active implants and MR imaging, and can be used to aid the design of critical electronic systems to ensure MRI-safety

The influence of PVC wrapping on the performance of two laser fluorescence devices on occlusal surfaces in vitro

OBJECTIVE: The aim of this study was to determine the influence of polyvinyl chloride (PVC) wrapping on the performance of two laser fluorescence devices (LF and LFpen) by assessing tooth occlusal surfaces. BACKGROUND DATA: Protection of their tips may influence LF measurements. To date there are no studies evaluating the influence of this protection on the performance of the LFpen on permanent teeth, or comparing it to the original LF device. MATERIALS AND METHODS: One hundred nineteen permanent molars were assessed by two experienced dentists using the LF and the LFpen devices, both with and without PVC wrapping. The teeth were histologically prepared and assessed for caries extension. RESULTS: The LF values with and without PVC wrapping were significantly different. For both LF devices, the sensitivity and accuracy were lower when the PVC wrapping was used. The specificity was statistically significantly higher for the LFpen with PVC. No difference was found between the areas under the ROC curves with and without PVC wrapping. The ICC showed excellent interexaminer agreement. The Bland and Altman method showed a range between the upper and the lower limits of agreement of 63.4 and 57.8 units for the LF device, and 49.4 and 74.2 for the LFpen device, with and without PVC wrapping, respectively. CONCLUSIONS: We found an influence of the PVC wrapping on the performance of the LF and LFpen devices. However, since its influence on detection of occlusal caries lesions is considered for, the use of one PVC layer is suggested to avoid cross-contamination in clinical practice.

Hearing performance with 2 different high-power sound processors for osseointegrated auditory implants

OBJECTIVE To compare speech understanding of the BAHA BP110 and BAHA Intenso sound processors. STUDY DESIGN Prospective experimental study. SETTING Tertiary referral center. PATIENTS Twenty experienced user of osseointegrated auditory implants with conductive or mixed hearing loss. INTERVENTIONS In a first session, half of the participants were fitted with an Intenso, the other half with a BP110. After 1 month of use, aided speech understanding in quiet and in noise was measured, and the other test processor was fitted. One month later, speech understanding with the second sound processor was assessed. MAIN OUTCOME MEASURES Speech understanding in quiet and in noise, with noise arriving either from the front, the rear, or the side of the user with the osseointegrated bone conductor. RESULTS Significant improvements were found for both processors for speech understanding in quiet (+9.6 to +34.8 percent points; p = 0.02 to 0.001) and in noise (+6.2 to +13.8 dB, p < 0.001). No significant differences were found between the 2 devices for speech in quiet. For noise from the rear, subjects were able to understand speech at signal-to-noise ratios which were lower (less favorable) by -5.1 dB (p < 0.001) when compared with the Intenso. CONCLUSION Speech understanding is substantially improved by both devices, with no significant differences between the sound processors in quiet. In noise, speech understanding is significantly better with the BP110 when compared to the Intenso for noise from the rear.

Is complex signal processing for bone conduction hearing aids useful?

OBJECTIVES To establish whether complex signal processing is beneficial for users of bone anchored hearing aids. METHODS Review and analysis of two studies from our own group, each comparing a speech processor with basic digital signal processing (either Baha Divino or Baha Intenso) and a processor with complex digital signal processing (either Baha BP100 or Baha BP110 power). The main differences between basic and complex signal processing are the number of audiologist accessible frequency channels and the availability and complexity of the directional multi-microphone noise reduction and loudness compression systems. RESULTS Both studies show a small, statistically non-significant improvement of speech understanding in quiet with the complex digital signal processing. The average improvement for speech in noise is +0.9 dB, if speech and noise are emitted both from the front of the listener. If noise is emitted from the rear and speech from the front of the listener, the advantage of the devices with complex digital signal processing as opposed to those with basic signal processing increases, on average, to +3.2 dB (range +2.3 … +5.1 dB, p ≤ 0.0032). DISCUSSION Complex digital signal processing does indeed improve speech understanding, especially in noise coming from the rear. This finding has been supported by another study, which has been published recently by a different research group. CONCLUSIONS When compared to basic digital signal processing, complex digital signal processing can increase speech understanding of users of bone anchored hearing aids. The benefit is most significant for speech understanding in noise.