Toxidrome of an Easily Obtainable Nootropic: A Case Report of Phenibut Intoxication and Withdrawal Delirium.

PURPOSE/BACKGROUND: Phenibut (4-amino-3-phenyl-butyric acid) is a structural analog of GABA with central nervous system depressant and anxiolytic properties, developed in the former Soviet Union for anxiety, insomnia, and alcohol withdrawal. Its primary mechanism of action is believed to be a GABA-B receptor agonist-with high affinity at the α 2 δ subunit-containing voltage-dependent calcium channels and therefore gabapentinoid activity-as well as, to a lesser extent, GABA-A agonist activity. While not approved or regulated by the FDA, phenibut is easily obtainable online, where it is marketed as a nootropic, or cognitive enhancer. However, phenibut can lead to problems related to intoxication, dependency, and withdrawal, similar to other sedatives. METHODS/PROCEDURES: We present a case of phenibut intoxication and withdrawal delirium that provided diagnostic and management challenges because of a patient that was initially not forthcoming about his phenibut use which resulted in five presentations to the hospital including two admissions. FINDINGS/RESULTS: Initial differential including adrenergic, serotonergic or anticholinergic toxidrome based on clinical picture and history reported at that time, however phenibut use of 50 g daily was eventually revealed, an amount exceeding the highest reported cases in our review of the English literature. IMPLICATIONS/CONCLUSIONS: High-dose phenibut intoxication and withdrawal can appear as dramatic and dangerous as high-dose sedative withdrawal, however given its specified receptor affinity and binding profile we found that a pharmacotherapeutic approach targeting GABA-B, GABA-A, and gabapentenoid receptors were effective in stabilizing this patient, eventually leading to the patient's full and sustained recovery.

Optimizing multiparametric magnetic resonance imaging-targeted biopsy and detection of clinically significant prostate cancer: the role of core number and location.

PURPOSE: There is currently no consensus regarding the optimal number of multiparametric magnetic resonance imaging (MRI)-targeted biopsy (TB) cores and their spatial distribution within the MRI lesion. We aim to determine the number of TB cores and location needed to adequately detect csPCa. METHODS: We conducted a retrospective cohort study of 505 consecutive patients undergoing TB for positive MRI lesions defined by a PI-RADS score ≥ 3 between June 2016 and January 2022. Cores chronology and locations were prospectively recorded. The co-primary outcomes were the first core to detect clinically significant prostate cancer (csPCa) and the first highest ISUP grade group. The incremental benefit of each additional core was evaluated. Analysis was then performed by distinguishing central (cTB) and peripheral (pTB) within the MRI lesion. RESULTS: Overall, csPCa was detected in 37% of patients. To reach a csPCa detection rate of 95%, a 3-core strategy was required, except for patients with PI-RADS 5 lesions and those with PSA density ≥ 0.2 ng/ml/cc who benefited from a fourth TB core. At multivariable analysis, only a PSA density ≥ 0.2 ng/ml/cc was an independent predictive factor of having the highest ISUP grade group on the fourth TB cores (p = 0.03). No significant difference in the cancer detection rate was found between cTB and pTB (p = 0.9). Omitting pTB would miss 18% of all csPCa. CONCLUSION: A 3-core strategy should be considered for TB to optimize csPCa detection with additional cores needed for PI-RADS 5 lesions and high PSA density. Biopsy cores from both central and peripheral zones are required.

Automatic Body Segment and Side Recognition of an Inertial Measurement Unit Sensor during Gait.

Inertial measurement unit (IMU) sensors are widely used for motion analysis in sports and rehabilitation. The attachment of IMU sensors to predefined body segments and sides (left/right) is complex, time-consuming, and error-prone. Methods for solving the IMU-2-segment (I2S) pairing work properly only for a limited range of gait speeds or require a similar sensor configuration. Our goal was to propose an algorithm that works over a wide range of gait speeds with different sensor configurations while being robust to footwear type and generalizable to pathologic gait patterns. Eight IMU sensors were attached to both feet, shanks, thighs, sacrum, and trunk, and 12 healthy subjects (training dataset) and 22 patients (test dataset) with medial compartment knee osteoarthritis walked at different speeds with/without insole. First, the mean stride time was estimated and IMU signals were scaled. Using a decision tree, the body segment was recognized, followed by the side of the lower limb sensor. The accuracy and precision of the whole algorithm were 99.7% and 99.0%, respectively, for gait speeds ranging from 0.5 to 2.2 m/s. In conclusion, the proposed algorithm was robust to gait speed and footwear type and can be widely used for different sensor configurations.

Activation of healing and reduction of pain by single-use automated microcurrent electrical stimulation therapy in patients with hard-to-heal wounds.

Evidence shows that Electrical Stimulation Therapy (EST) accelerates healing and reduces pain, but EST has yet to become widely used. One reason is the historical use of complex, clinic-based EST devices. This evaluation assessed the early response of different hard-to-heal wounds to a simple, wearable, single-use, automated microcurrent EST device (Accel-Heal, Accel-Heal Technologies Limited - Hever, UK). Forty wounds (39 patients: 18 female - 21 male), mean age 68.9 ± 14.0 years comprised of: seven post-surgical, three trauma, 12 diabetic foot (DFU), 10 venous (VLU), four pressure injuries (PI), four mixed venous or arterial ulcers (VLU/arterial) received automated microcurrent EST for 12 days. Early clinical responses were scored on a 0-5 scale (5-excellent-0-no response). Pain was assessed at 48 h, seven days, and 14 days on a 0-10 visual analogue scale (VAS). Overall, 78% of wounds showed a marked positive clinical response (scores of 5 and 4). Sixty eight percent of wounds were painful with a mean VAS score of 5.5. Almost every patient (96%) with pain experienced reduction within 48 h. All patients with painful wounds experienced pain reduction after seven days: 2.50 VAS (45% reduction) and further pain reduction after 14 days: 1.83 VAS (33%).

[Treatment of extensive chondral and osteochondral knee defects with autologous chondrocytes implantation]. / Grands défects chondraux et ostéochondraux du genou : traitement par greffe chondrocytaire autologue.

Treatment of extensive chondral and osteochondral defects in the knee remains a challenge. The traditional bone marrow stimulation and osteochondral mosaicplasty are effective but this is indicated only for lesions smaller than 4 cm2. In addition, while they are offered in young patients, functional deterioration is often observed after 2 years. In contrast, Autologous Chondrocyte Implantation (ACI) has proven to be efficient and durable even in larger lesions. These factors have encouraged our team to consider ACI as a valuable tool, but it was not readily available in Switzerland. In this article, we describe why and how we have developed and refined the technique in our University Hospital for the clinical implementation of this cell-based therapy, performed under a quality assurance system and following good manufacturing practices.

Dans le traitement des défects chondraux et ostéochondraux du genou, les techniques classiques de réparation par stimulation de la moelle osseuse et de greffe ostéochondrale autologue (mosaicplastie) présentent d'importantes limites quant à la taille des lésions traitables (< 4 cm2, soit < 22 mm de diamètre). De plus, alors qu'elles sont destinées à des patients jeunes, une dégradation des résultats a été rapportée après 2 ans. Ces éléments nous ont incités à nous orienter vers la greffe chondrocytaire autologue afin de pouvoir proposer aux patients le traitement de lésions plus étendues avec une meilleure durabilité. Cet article décrit pourquoi et comment nous avons implémenté cette voie thérapeutique dans notre centre universitaire, en assurant une traçabilité et des contrôles qualités stricts tout au long de la chaîne de production.

Electrical stimulation for pain reduction in hard-to-heal wound healing.

OBJECTIVE: Despite treatment advances over the past 30 years, the societal impact of hard-to-heal wounds is increasingly burdensome. An unresolved issue is wound pain, which can make many treatments, such as compression in venous leg ulcers, intolerable. The aim of this review is to present the evidence and stimulate thinking on the use of electrical stimulation devices as a treatment technology with the potential to reduce pain, improve adherence and thus hard-to-heal wound outcomes. METHOD: A literature search was conducted for clinical studies up to August 2020 reporting the effects of electrical stimulation devices on wound pain. Devices evoking neuromuscular contraction or direct spinal cord stimulation were excluded. RESULTS: A total of seven publications (three non-comparative and four randomised trials) were identified with four studies reporting a rapid (within 14 days) reduction in hard-to-heal wound pain. Electrical stimulation is more widely known for accelerated healing and is one of the most evidence-based technologies in wound management, supported by numerous in vitro molecular studies, five meta-analyses, six systematic reviews and 30 randomised controlled trials (RCTs). Despite this wealth of supportive evidence, electrical stimulation has not yet been adopted into everyday practice. Some features of electrical stimulation devices may have hampered adoption in the past. CONCLUSION: As new, pocket-sized, portable devices allowing convenient patient treatment and better patient adherence become more widely available and studied in larger RCTs, the evidence to date suggests that electrical stimulation should be considered part of the treatment options to address the challenges of managing and treating painful hard-to-heal wounds.

An audience survey of practice relating to pain in the management of chronic venous leg ulcers.

Venous leg ulcers (VLU) respond well to compression, yet many ulcers remain unhealed after 1 year. Practitioners could be reluctant to apply compression to patients with significant ulcer pain. This study aimed to capture the views of practitioners on compression therapy for patients with painful VLU. A survey was conducted at a UK meeting in 2019 using handheld voting pads to capture the anonymous responses to four questions to which a mean of 90 practitioners responded. Nearly 40% of practitioners treat six or more patients a day with painful lower-limb ulcers. Some 80% felt confident in managing patients with painful ulcers; yet, most practitioners suggested they would refer onward for pain management. Some 40% would omit or reduce compression therapy as a pain management strategy. This survey supports the need for technological solutions that reduce VLU pain so that patients receive effective compression therapy.

[Degenerative lesions of the anterior cruciate ligament: a frequent but poorly understood phenomenon]. / Lésions dégénératives du ligament croisé antérieur : un spectre d'entités mal connues en orthopédie.

Making more use of MRI, degenerative lesions of the anterior cruciate ligament are more frequently diagnosed. Three separates entities are reported (mucoid degeneration, ganglion cyst and mucoid degeneration with ganglion cysts) but it is probably a continuum of the same degenerative process. In middle aged individuals, it would result of repeated microtrauma in the setting of a narrow intercondylar notch and/or increased posterior tibial slope. In the older patient, it would be part of a whole organ disease with the onset of osteoarthritis. Most cases are incidental findings. For symptomatic patients, a complete resection of the ligament is our first option when conservative treatment failed. It is effective for pain relief and motion recovery. Although it produces postoperative instability, secondary reconstruction is not always required.

En raison du recours plus fréquent à l'IRM, le diagnostic de lésion dégénérative du ligament croisé antérieur augmente. La littérature distingue trois entités (dégénérescence mucoïde, kyste mucoïde, dégénérescence mucoïde et polykystique) mais il s'agit probablement d'un continuum d'atteintes dégénératives. Chez les patients jeunes, elle résulterait de microtraumatismes favorisés par une pente tibiale majorée et/ou une échancrure intercondylienne étroite. Chez les patients âgés, cette dégénérescence accompagne souvent une gonarthrose. La majorité des cas est asymptomatique. En cas d'échec du traitement conservateur, nous proposons une résection complète. Elle permet une régression nette des douleurs. Même si elle génère une instabilité, celle-ci est rarement symptomatique et une reconstruction secondaire n'est pas toujours nécessaire.

Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial.

BACKGROUND: Both the adductor canal block (ACB) and local infiltration analgesia (LIA) are effective analgesic techniques after anterior cruciate ligament (ACL) reconstruction, but they have never been compared head-to-head. This randomised controlled triple-blinded trial tested the hypothesis that ACB provides superior analgesia to LIA after ACL reconstruction, with additional focus on postoperative functional outcomes. METHODS: Of 104 enrolled ACL reconstruction patients receiving general anaesthesia, 52 were randomly allocated to either ACB under ultrasound guidance or LIA. For each intervention, ropivacaine 0.5%, 20 ml was injected. Postoperative pain treatment followed a predefined protocol with i.v. patient-controlled morphine, paracetamol, and ibuprofen. The primary outcome was cumulative i.v. morphine consumption at 24 h after operation. Secondary pain-related outcomes included resting and dynamic pain scores (numeric rating scale out of 10) measured 2, 24, and 48 h after operation and cumulative i.v. morphine consumption 2 and 48 h after operation. Early function-related outcomes evaluated were quadriceps strength, walking distance, and range of motion, all measured 24 and 48 h after operation. Late function-related outcomes were concentric quadriceps strength, single-hop test, triple-hop test, cross-over test, and Y balance test, measured at 4 and 8 postoperative months. RESULTS: Cumulative i.v. morphine consumption at 24 h was similar between groups (ACB group: 17.1 mg [95% confidence interval, CI: 13.1, 21.2]; LIA group: 17.7 mg [95% CI: 13.2, 22.6], P=0.84). Similarly, no differences between groups were seen in the secondary pain- or function-related outcomes. CONCLUSIONS: ACB and LIA result in equivalent postoperative opioid consumption with similar impact on postoperative pain scores and functional outcomes. CLINICAL TRIAL REGISTRATION: NCT02524652.

Effects of Cutaneous Negative Pressure Application on Perforator Artery Flow in Healthy Volunteers: A Preliminary Study.

BACKGROUND: The creation of skin flaps based on small perforator vessels is an increasingly popular procedure nowadays; the optimization of their blood supply enhances surgical success. This study evaluates the effects on the flowmetries of 7 days' negative pressure application on the skin surface overlying the muscle fascia emergence of periumbilical perforators of the deep inferior epigastric artery (DIEA). METHODS: Ten volunteer participants were enrolled. In each subject, one periumbilical perforator of the DIEA was identified on each side of the abdomen using an eco-color-Doppler. One of them was used as the control group, while the other (the study group) underwent 80 mm Hg negative pressure for 7 days. The flowmetries of both perforators were measured before and after the application of negative pressure wound therapy. RESULTS: After the application of negative pressure, randomly applied on the skin surface over one of the two selected periumbilical perforators, an increase in the flowmetries was observed in both groups of perforators (2.74 cm/s; p < 0.0001). The relative flowmetry increase in the control group was 9.55% (2.735 cm/s), while in the study group it was 44.03% (8.748 cm/s). CONCLUSION: The application of negative pressure system on the skin surface over the muscle fascia emergence of the selected periumbilical perforators showed an increase in flowmetry. Although this is a preliminary study, this simple and economical procedure before surgery could be usefully employed to increase the rate of success in microsurgical procedures.

[Knee osteotomies : a renaissance ?] / Ostéotomies du genou : une renaissance ?

There is a regain of interest for knee osteotomies over the last decade. A better knowledge of their long-term benefits and potential adverse events has increased their importance in the treatment of unicompartmental osteoarthritis. Emerging indications result from increasing evidence that the control of knee alignment is crucial in knee instability, meniscal transplantation and cartilage repair.

Cette décennie a été marquée par un regain d'intérêt pour les ostéotomies autour du genou. Cet article présente les avancées qui ont permis de confirmer l'importance de cette chirurgie dans son indication historique, l'arthrose unicompartimentale. Il détaillera ensuite pourquoi la correction de l'axe mécanique s'avère de plus en plus indispensable dans le traitement de l'instabilité du genou et comme prérequis dans les procédures de greffe méniscale ou chondrale.

Outcome after transcatheter occlusion of patent ductus arteriosus in infants less than 6 kg: A national study from United Kingdom and Ireland.

OBJECTIVES: This study aimed to report our national experience with transcatheter patent ductus arteriosus (PDA) occlusion in infants weighing <6 kg. BACKGROUND: The technique of transcatheter PDA closure has evolved in the past two decades and is increasingly used in smaller patients but data on safety and efficacy are limited. METHODS: Patients weighing < 6 kg in whom transcatheter PDA occlusion was attempted in 13 tertiary paediatric cardiology units in the United Kingdom and Ireland were retrospectively analyzed to review the outcome and complications. RESULTS: A total of 408 patients underwent attempted transcatheter PDA closure between January 2004 and December 2014. The mean weight at catheterization was 4.9 ± 1.0 kg and mean age was 5.7 ± 3.0 months. Successful device implantation was achieved in 374 (92%) patients without major complication and of these, complete occlusion was achieved in 356 (95%) patients at last available follow-up. Device embolization occurred in 20 cases (5%). The incidence of device related obstruction to the left pulmonary artery or aorta and access related peripheral vascular injury were low. There were no deaths related to the procedure. CONCLUSIONS: Transcatheter closure of PDA can be accomplished in selected infants weighing <6 kg despite the manufacturer's recommended weight limit of 6 kg for most ductal occluders. The embolization rate is higher than previously reported in larger patients. Retrievability of the occluder and duct morphology needs careful consideration before deciding whether surgical ligation or transcatheter therapy is the better treatment option.

Stent Therapy for Aortic Coarctation in Children <30 kg: Use of the Low Profile Valeo Stent.

To report our experience of coarctation stent therapy in small children weighing less than 30 kg, with the low profile dilatable Valeo stent and review the literature on coarctation stent therapy in this patient population. Coarctation stent implantation was undertaken in 14 consecutive children using the Bard Valeo Stent. Demographic, angiographic, echocardiographic and clinical data were reviewed retrospectively. The median age at the time of procedure was 5.1 (2.6-7.5) years and median weight was 20.8 (14.7-27) kg. There was improvement in median coarctation diameter from 4 (1.3-5.2) to 9.5 (5.8-12.7) mm, p < 0.001; and a reduction in the median peak pressure gradient across the coarctation from 35 (20-49) to 9 (0-15) mmHg, p < 0.001. Median stent recoil was 7.9 (0-20)%. There was one case of access related complication that resolved without sequelae. Follow-up was a median of 15 (3.0-57.2) months. CT angiogram performed at a median time of 3.3 (2.6-10.2) months post procedure showed no aortic wall injury and preserved stent integrity in all cases. Two children underwent re-intervention for stent dilation and further stent implantation due to in-stent stenosis and somatic growth after 3 years. Six of fourteen children remained on a single antihypertensive agent post-intervention at last follow-up. Implantation of the dilatable Valeo stent is a feasible treatment strategy in native or recurrent coarctation in small children, accepting that additional stent implantation may be necessary with somatic growth. Further study is required to determine longer-term stent efficacy and clinical outcome.

[Patellar instability : diagnosis and treatment]. / Instabilité rotulienne : diagnostic et traitement.

The aim of this paper is to present recent advances in surgical management of patellar instability. Several anatomical factors were reported to promote instability. We propose to classify them in two groups. Extra articular factors are valgus and torsion deformity. Articular factors include trochlea and patella dysplasia, tibial tubercle lateralization and medial patellofemoral ligament (MPFL) insufficiency. Acute patellar dislocations are treated conservatively, with exception for osteochondral and MPFL avulsion fractures that require acute reinsertion. Surgery is considered for recurrent instability. As we aim for a correction of all contributing elements, we prefer a two stages approach. Extra articular factors are treated first by osteotomy, followed by articular factors after 4-6 months. This allows separate rehabilitation protocols.

L'objectif de cet article est de détailler les progrès dans la prise en charge chirurgicale de l'instabilité rotulienne. Différents facteurs anatomiques favorisent cette instabilité. Nous proposons de les classer en deux groupes : facteurs extra-articulaires (valgus et troubles de torsion) et articulaires (dysplasies trochléenne et rotulienne, latéralisation de la tubérosité tibiale antérieure, insuffisance du ligament patello-fémoral médial (MPFL)). Le premier épisode de luxation est traité conservativement, à l'exception des fractures-avulsions ostéochondrales et du MPFL qui nécessitent une réinsertion en aigu. L'instabilité rotulienne récidivante est traitée chirurgicalement. Nous proposons une correction en deux étapes, avec un intervalle de 4-6 mois, de l'ensemble des facteurs identifiés, d'abord extra-articulaires puis articulaires.

Longer-term outcome of perventricular device closure of muscular ventricular septal defects in children.

OBJECTIVE: To describe the longer-term clinical experience and follow-up with perventricular device closure of ventricular septal defects (VSD) in children. METHODS: Between January 2005 and December 2013, muscular ventricular septal defect closure with the Amplatzer Muscular VSD Occluder was undertaken using a hybrid perventricular approach. Data including demographic, echocardiographic parameter, and clinical outcome were reviewed retrospectively. RESULTS: Median age at the time of procedure was 8.9 months (range 1.9-31.0 months) and median weight was 6.6 kg (range 4.5-12.9 kg). All had a moderate to large muscular VSD, three had more than one VSD, four had previous coarctation repair, and five had previous pulmonary artery (PA) banding. A single Amplatzer muscular occluder (range 8-18 mm) was deployed in each patient without cardiopulmonary bypass under echocardiographic guidance. Two of ten patients subsequently required a short period of cardiopulmonary bypass for reconstruction of PA after de-banding and closure of atrial septal defect in one. Occluder removal was necessary in one patient due to entrapment of the tricuspid valve and progressive tricuspid regurgitation. This patient underwent surgical repair with a good result and no device-related valve damage. In the remaining nine patients, no severe complications such as device embolization, arrhythmia, or significant valve regurgitation were noted in the post-operative period or follow-up. At a median time of 6.5 years (range 0.9-8.4 years) post device implantation, complete closure was achieved in five patients and four had small residual leaks, which were not hemodynamically significant. CONCLUSION: Perventricular muscular VSD closure is effective in small children with suitable muscular defects and may avoid the morbidity associated with cardiopulmonary bypass and conventional surgical repair. There have been no late complications with this approach.

The CD47-signal regulatory protein alpha (SIRPa) interaction is a therapeutic target for human solid tumors.

CD47, a "don't eat me" signal for phagocytic cells, is expressed on the surface of all human solid tumor cells. Analysis of patient tumor and matched adjacent normal (nontumor) tissue revealed that CD47 is overexpressed on cancer cells. CD47 mRNA expression levels correlated with a decreased probability of survival for multiple types of cancer. CD47 is a ligand for SIRPα, a protein expressed on macrophages and dendritic cells. In vitro, blockade of CD47 signaling using targeted monoclonal antibodies enabled macrophage phagocytosis of tumor cells that were otherwise protected. Administration of anti-CD47 antibodies inhibited tumor growth in orthotopic immunodeficient mouse xenotransplantation models established with patient tumor cells and increased the survival of the mice over time. Anti-CD47 antibody therapy initiated on larger tumors inhibited tumor growth and prevented or treated metastasis, but initiation of the therapy on smaller tumors was potentially curative. The safety and efficacy of targeting CD47 was further tested and validated in immune competent hosts using an orthotopic mouse breast cancer model. These results suggest all human solid tumor cells require CD47 expression to suppress phagocytic innate immune surveillance and elimination. These data, taken together with similar findings with other human neoplasms, show that CD47 is a commonly expressed molecule on all cancers, its function to block phagocytosis is known, and blockade of its function leads to tumor cell phagocytosis and elimination. CD47 is therefore a validated target for cancer therapies.

Simplified negative pressure wound therapy: clinical evaluation of an ultraportable, no-canister system.

The aim of this study was to evaluate a prototype negative pressure wound therapy (NPWT) system that has been developed to simplify NPWT for wounds at the lower end of the acuity scale. The new device has a single preset pressure of -80 mmHg, is single use and operates without an exudate canister. The disposable NPWT system (PICO™) was tested in a prospective, non-comparative, multicentre clinical trial to assess device functionality and clinical acceptance. Twenty patients were recruited for a maximum treatment period of 14 days. The NPWT devices were fitted with data log chips to enable longitudinal assessment of negative pressure and leak rates during therapy. Sixteen (80%) patients had closed surgical wounds, two (10%) patients had traumatic wounds and two (10%) patients received meshed split thickness skin grafts. The mean study duration was 10·7 days (range: 5-14 days) and the mean dressing wear time per individual patient was 4·6 days (range: 2-11). Fifty-five percent of wounds had closed by the end of the 14-day study or earlier, with a further 40% of wounds progressing to closure. Real-time pressure monitoring showed continuous delivery of NPWT. Three cases are discussed representing different wound locations and different patient factors that can increase the risk of post-surgical complications. Clinical studies of the disposable NPWT system confirmed the ability of the simplified single-use device to function consistently over the expected wear time. The anticipated reduced costs, ease of use and increased mobility of patients using this system may enable NPWT benefits to be available to a greater proportion of patients.

Long-term clinical experience with Amplatzer Ductal Occluder II for closure of the persistent arterial duct in children.

OBJECTIVES: To describe the long-term clinical experience and follow-up with the Amplatzer Ductal Occluder II (ADO II) in children. METHODS: All patients undergoing attempted transcatheter closure of patent arterial duct (PDA) with the ADO II were included. Data collected included demographic, clinical, and echocardiographic parameters. RESULTS: From March 2008 until March 2013, 62 patients with a median age of 1.2 years (range 0.43-11.1 years) and median weight of 9 kg (range 4.7-31.4 kg) underwent the procedure. The median measurement for minimal ductal diameter was 2.7 mm (range 1.3-5 mm). An ADO II was implanted in 60 patients (96.8%). Two patients had significant residual shunting following deployment of the ADO II and underwent closure with the Amplatzer ductal occluder I (ADO I) during the same procedure. In six patients, the initial ADO II was unsatisfactory, and after recapture a different size ADO II was deployed. Device embolization of the ADO II to the pulmonary artery occurred in 6.7% of patients. Of these, one underwent surgical closure and three were closed with an ADO I. Complete occlusion on echocardiography was noted prior to discharge in 87.5% of the deployed occluders and 100% at first follow-up. Five year follow-up (n = 25) revealed a 100% occlusion rate. There were three cases of persistent mild left pulmonary artery stenosis at long-term follow-up. CONCLUSIONS: The ADO II is effective for occlusion of PDA with variable anatomy from either arterial or venous approaches with a low profile delivery system. Stable occluder position is highly dependent on accurate device sizing, good quality imaging to visualize device configuration after deployment and operator experience.

Staged medial opening wedge high tibial osteotomy for bilateral varus gonarthrosis: biomechanical and clinical outcomes.

PURPOSE: (1) To evaluate the effect of staged bilateral medial opening wedge high tibial osteotomy (HTO) on established biomechanical risk factors for disease progression and on validated measures of pain and function and (2) To compare outcomes in patients having the second surgery staged within or beyond 12 months of the first surgery. METHODS: Thirty-seven patients with bilateral varus alignment and medial compartment osteoarthritis underwent staged bilateral medial opening wedge HTO (21 within and 16 beyond 12 months). Patients underwent full-limb standing anteroposterior radiographs to determine frontal plane alignment (mechanical axis angle) and three-dimensional gait analysis to estimate the distribution of load across the tibiofemoral compartments (external knee adduction moment). Patients also completed the Knee Injury and Osteoarthritis Outcomes Scores (KOOS), the Lower Extremity Functional Scale, the Short Form Health Survey and the six-minute walk test (6MWT). Patients (both limbs) were evaluated before and approximately 6, 12 and 24 months after each surgery. RESULTS: There were statistically and clinically significant changes in both limbs that were of similar magnitudes and that remained relatively stable over time postoperatively. Mean (95% CI) improvements in outcomes were as follows. Mechanical axis angle: 9.4° (8.4°, 10.4°) (i.e. average change of both limbs), peak knee adduction moment: -1.7%BW*Ht (-2.1, -1.4 %BW*Ht) (i.e. average change of both limbs), 6MWT: 36.7 m (19.4, 54.0 m), SF-12 Physical Component Summary: 12.0 (8.5, 15.5) and KOOS Pain: 25.4 (19.6, 31.2). Other than the shorter time period to reach maximum benefit of both surgeries, there were no remarkable differences at final assessment between patients having surgeries staged within or beyond 12 months. CONCLUSIONS: The present findings demonstrate that patients with bilateral varus gonarthrosis experience marked improvements in established biomechanical risk factors for disease progression bilaterally (mechanical axis angles and external knee adduction moments), as well as clinically important improvements in patient-important outcomes, after staged medial opening wedge HTO. Current findings suggest no difference in outcomes for patients who have the second surgery staged within or beyond 12 months of the first surgery. LEVEL OF EVIDENCE: IV.