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Objectives Subperception spinal cord stimulation (SCS) is described mostly utilizing waveforms that require high energy. However, the necessity of these waveforms for effective subperception has not been established. We aimed to explore whether effective subperception pain relief can be achieved using frequencies below 1 kHz. Materials and methods Thirty chronic pain patients implanted with SCS were enrolled as part of a multicenter, real-world, consecutive, observational case series. An effective stimulation location was determined using a novel electric field shape designed to preferentially modulate dorsal horn elements. Subsequently, programs at lower frequencies (600, 400, 200, 100, 50, and 10 Hz) were provided with pulse-width and amplitude adjusted to optimize response. Results All tested frequencies (1 kHz down to 10 Hz) provided effective subperception relief, yielding a mean of 66-72% reduction in back, leg, and overall pain. It was found that to maintain analgesia, as frequency was decreased, the electrical or "neural" dose had to be adjusted according to parameter relationships described herein. With the reduction of frequency, we observed a net reduction of charge-per-second, which enabled energy savings of 74% (200 Hz) and 97% (10 Hz) relative to 1 kHz. Furthermore, pain reduction was sustained out to one year, with 85% of patients reporting a preference for frequencies of 400 Hz or below. Conclusions We have derived an electric field configuration and, along with previous learnings in the kHz range, a set of neural dosing parameter relationships (10-10,000 Hz), which enable the expansion of effective subperception SCS to low frequency and achieve major energy savings.

Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3-4·7; p0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.Boston Scientific.

Objective The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. Methods WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperception for three months and then crossed over to receive the alternative. Upon completion of crossover period, subjects who preferred subperception were followed up to one year. Overall pain, quality-of-life, and other outcomes were collected in the study. The primary endpoint was the overall pain responder rate (≥50% improvement from baseline) with no increase in medications. Secondary endpoints consisted of pain scores, physical disability, quality of life, and treatment preference. Results The study met its primary endpoint and demonstrated noninferiority between supraperception and subperception in a prespecified cohort of 70 randomized subjects (Interim Analysis). Thirty-nine percent of subjects with subperception settings and 29% with supraperception settings had a greater than or equal to 50% reduction in their overall pain scores with no increase in average daily medication at three-months post-activation as compared with baseline. Further assessment of all participating study subjects (N = 140) revealed similar results. Subjects were previously implanted 3.8 ± 2 years and had a disability score (Oswestry Disability Index) of 70.2 ± 11.4 at study start. Of the randomized subjects that completed the End of Period 2 Visit, 93 (66%) preferred subperception SCS and their mean overall pain reduced from 7.3 ± 1.1 (N = 89) at baseline to 4.0 ± 2.1 (N = 80) at 12-months post-activation. Post hoc analysis also demonstrated that multiple options provide superior outcomes, as supported by a 74% increase in the responder rate when subjects could choose their most effective option (47%) compared with supraperception alone (27%). Discussion Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.

Background The aim of this study was to determine whether spinal cord stimulation (SCS) using 3D neural targeting provided sustained overall and low back pain relief in a broad routine clinical practice population. Study Design and Methods This was a multicenter, open-label observational study with an observational arm and retrospective analysis of a matched cohort. After IPG implantation, programming was done using a patient-specific, model-based algorithm to adjust for lead position (3D neural targeting) or previous generation software (traditional). Demographics, medical histories, SCS parameters, pain locations, pain intensities, disabilities, and safety data were collected for all patients. Results A total of 213 patients using 3D neural targeting were included, with a trial-to-implant ratio of 86%. Patients used seven different lead configurations, with 62% receiving 24 to 32 contacts, and a broad range of stimulation parameters utilizing a mean of 14.3 (±6.1) contacts. At 24 months postimplant, pain intensity decreased significantly from baseline (ΔNRS = 4.2, N = 169, P

International audience; INTRODUCTION: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) for the management of motor symptoms of Parkinson disease (PD) is typically performed under conscious sedation with awake evaluation during intraoperative physiologic testing. However, developments in surgical techniques now allow for subjects to be asleep during the procedure using general anesthesia. Previously reported long-term outcomes of subjects who underwent STN-DBS under general anesthesia demonstrated postoperative safety and efficacy out to 1 year. In this study, we examine outcomes between subjects undergoing the STN-DBS procedure who used general anesthesia vs those using conscious sedation with awake evaluation as part of the ongoing VANTAGE clinical trial. METHODS: VANTAGE is a prospective, multicenter, nonrandomized, open-label interventional trial, sponsored by Boston Scientific Corporation. The trial assesses motor improvement in subjects with moderate-to-severe PD following bilateral STN-DBS. Assessments include motor scores such as Unified Parkinson's Disease Rating Scale (UPDRS) and quality-of-life measurements such as PDQ-39. Forty subjects were implanted bilaterally with the Vercise DBS System (Boston Scientific Corporation) at 6 European centers. Of these, 19 (47%) underwent the DBS procedure under general anesthesia. RESULTS: Analysis of both study groups did not indicate a statistically significant difference in motor function outcomes. However, subjects utilizing general anesthesia were found not to display motor function outcomes that were necessarily clinically inferior to those consciously sedated with awake evaluation. Sample size and variation in baseline differences in selected subjects may have contributed to these final results, because a tendency for subjects undergoing general anesthesia to report an improvement in motor function similar to or better than those consciously sedated (vs baseline) was observed. CONCLUSION: No inferiority in clinical outcomes was observed in subjects that underwent general anesthesia vs those that were consciously sedated with awake evaluation.

International audience; INTRODUCTION: Deep brain stimulation (DBS) has been demonstrated to be effective for Parkinson disease (PD) symptom relief. We sought to characterize the benefit of subthalamic nucleus (STN) DBS for PD patients using a recently CE-marked multiple-source, constant-current system that permits a well-defined distribution of applied current. We report the 3-year results of the first clinical trial using multiple independent current control (MICC) DBS in the management of symptoms of PD. METHODS: VANTAGE is a monitored, prospective, multicenter, nonrandomized, open-label interventional trial sponsored by Boston Scientific Corporation. Forty subjects with idiopathic PD were implanted bilaterally with a DBS system (Vercise) targeting the STN and followed up to 3 years after lead placement. Motor improvement was evaluated using Unified Parkinson's Disease Rating Scale (UPDRS) III scores in stim ON/meds OFF in comparison with preoperative scores. Other assessments such as CAPSIT motor tests, Tremor Rating Scale, Dyskinesia Rating Scale, PDQ-39, SF-36, Schwab and England, and resource utilization were administered. Patient motor diaries were collected over 3 days. Adverse events were also recorded. RESULTS: This study will report the safety and effectiveness outcomes of VANTAGE subjects at 3 years postimplantation as compared with baseline. CONCLUSION: The VANTAGE trial is the first reported trial of a multiple-source, constant-current rechargeable system for use in the management of PD symptoms. Study outcomes will inform clinicians on the use of this system and its flexibility to manage the symptoms of idiopathic PD.

International audience; Background High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease. Methods We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21–75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948. Findings Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3–15·7) compared with baseline (37·4 [8·9], 34·5–40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3–27·3; p

Traumatic injuries to the thumb are frequently associated with mutilation of one or more of the remaining digits. The most common digital injuries associated with thumb loss are partial or complete amputation of the index finger or index and long fingers. Occasionally, satisfactory index finger function will be preserved with damage or amputation of the middle or ring fingers, making them the best candidates for transposition. Although pollicization of the index finger has received considerable attention in the literature, pollicization of injured middle and ring finger remnants has not. Transposition of these comparatively useless digital stumps, which may be sacrificed without significant functional deficit to the rest of the hand, may be advantageously performed to create a well-functioning thumb. This procedure facilitates the conversion of a useless, mutilated hand into a well-functioning one in a single operation. We present our experience with pollicization of middle and ring finger remnants in four patients including indications, technique, and functional outcome. Language: en

The axial-pattern reverse radial forearm fasciocutaneous flap has become one of the primary flaps for reconstruction of soft-tissue defects of the hand. The two main disadvantages of this flap are (1) sacrifice of a major artery that may possibly jeopardize hand viability and (2) morbidity and appearance of the donor site. In an effort to overcome these drawbacks, an anatomic study of a distally based radial forearm fasciosubcutaneous flap with preservation of the radial artery was conducted. Seventeen fresh cadaver forearms were dissected to investigate the contribution of the distal radial artery and its superficial and deep branches to the fasciosubcutaneous plexus of the forearm. The blood supply to the radial forearm fasciosubcutaneous tissue was found to emanate from 6 to 10 septocutaneous perforators of the distal radial artery in the vicinity of the anatomic snuff box that "fan out" at the level of the deep fascia to form a rich plexus supplying the forearm fascia, subcutaneous tissue, and skin. There appeared to be a definite directional component, with the arterioles running longitudinally along the intermuscular septum. The deep fascia and subcutaneous tissue were found to have their own venous system accompanying the small perforating arterioles. Encouraged by these findings, we proceeded to utilize this fasciosubcutaneous flap for coverage of the thumb-index web space (three patients), the dorsum of the hand (two patients), and both the palmar and dorsal aspects of the hand (one patient). Five flaps had almost complete survival. The largest flap in our series suffered significant loss. Minor skin-graft loss occurred in a few cases, and we now delay skin grafting for several days. The distally based radial forearm fasciosubcutaneous flap with preservation of the radial artery can be a very useful and reliable alternative for repairing soft-tissue defects of the hand, obviating the need for the classic fasciocutaneous flap or even a free flap. This flap not only preserves the radial artery, which is essential in cases where only the radial artery is functioning, such as following severe hand injuries, but also provides a more acceptable donor site.

The external ear of the rat is an excellent model for practicing microsurgical dissection and for the refinement of microvascular anastomoses, techniques that are crucial for microvascular en bloc tissue transfer and replantation. Preparation of the rat ear for replantation requires familiarity with the vascular anatomy and gentle tissue handling with atraumatic dissection of arterial and venous pedicles, steps similarly crucial in raising free flaps for microvascular transfer. The strategy of performing accurate reduction and stabilization of the tubal cartilage prior to vessel repairs, anastomosing the more deeply seated external carotid artery prior to the more superficial posterior facial vein, is as critical to rat ear replantation as for digital reattachment. In addition, the rat ear as compared to other animal models such as the rabbit ear or canine hindlimbs is much less expensive. Compared to the rat hindlimb model, rat ears are much easier to observe, which is a distinct advantage when used as a model for long-term study of replantation, revascularization, or transplantation.

The purpose of this article is twofold: (1) to investigate the histomorphology of cartilaginous proliferation using three different otoplasty techniques and (2) to determine whether recurrence is related either to the method of otoplasty or the duration of suture fixation. Eighteen 6-week-old New Zealand white rabbits were divided into three equal groups. In each animal, a skin pocket was developed on the posterior surface of both ears; the perichondrium of the left ear was stripped off, whereas the perichondrium of the right ear was left undisturbed. Otoplasties were performed by inserting permanent mattress sutures with (Converse-Wood-Smith) or without (Mustardé) cartilaginous incisions or by scoring of the anterior cartilaginous surface of the antihelix (Stenstrom). In each group, sutures were cut at 1, 2, 4, and 6 weeks and the animals killed 1 week later. Histomorphometric analysis was performed. Perichondrial stripping stimulated cartilaginous proliferation in all groups. The antihelical fold maintained its shape best in group 3, in which the anterior perichondrium was rasped; a fibrocartilaginous cap formed over the rasped convex surface of the antihelical fold, reinforcing and stabilizing the newly created fold. Groups 1 and 2, in contrast, demonstrated significantly less anterior cartilaginous proliferation than did group 3, and cap formation was not observed. No significant differences were apparent between groups 1 and 2 in either the quantity or quality of cartilaginous proliferation in any of the time periods. Cutting the sutures at 1 week resulted in loss of shape or "flattening" of the fold in all groups; however, increased cartilaginous proliferation between 2 and 6 weeks stabilized the fold, minimizing deformability.(ABSTRACT TRUNCATED AT 250 WORDS)

An innervated bipaddled osteocutaneous radial forearm free flap was combined with a Webster modification lip repair to successfully reconstruct in one stage the lower face following a devastating shotgun injury with loss of the anterior mandible, floor of the mouth, full-thickness chin, and subtotal lower lip. In addition to a pleasing aesthetic appearance with restoration of facial contour, the patient had a sensate flap with intelligible speech and no problems with drooling or mastication. This approach to a most complex reconstructive problem is technically feasible with a satisfactory aesthetic and functional outcome.

The stereomicroscopic appearance of the vasculature and circulation of groin flaps, with their epigastric pedicles divided at various time intervals, is an early diagnostic indication of flap viability. A simple and comprehensive training model, with characteristic vascular and flow changes within a single flap, is provided in rats, with pedicles transected at three to four days after the flap is raised.

This article presents a successful replantation of a completely severed rat ear. The procedure include re-union of the tubal cartilage and anastomosis of the surgically divided external carotid artery and posterior facial vein.

This is an experimental study comparing the suturing time and patency rate of a spiral interrupted suturing technique to those of conventional interrupted and continuous suturing technique in end-to-end as well as end-to-side anastomosis. The spiral interrupted suturing technique requires less time for either end-to-end or end-to-side anastomosis than conventional interrupted suturing technique, and does not result in stenosis as shown in the venous end-to-end anastomosis by continuous suturing technique.