Comparação entre os resultados do implante de um segmento de arco longo versus dois segmentos de arco tradicional no tratamento de pacientes com ceratocone / Comparison between the results of implanting a long-arch segment versus two standard arch segments for treatment of keratoconus patients

RESUMO Objetivo: Analisar retrospectivamente as alterações na ceratometria e no astigmatismo corneano obtidas após cirurgia de implante de anel intraestromal, comparando o uso de um segmento de arco longo versus o implante de dois segmentos de comprimento de arco tradicional. Métodos: A partir de um estudo transversal, obtivemos os dados de 94 olhos de pacientes diagnosticados com ceratocone, que foram submetidos ao implante de anel corneano. Eles foram divididos em dois grupos, dependendo do tipo de implante recebido: Grupo A, um segmento de arco longo; Grupo B, dois segmentos tradicionais. Todos os segmentos implantados possuíam 250µ de espessura. Os dados do pré-operatório dos dois grupos foram comparados, para garantir que as amostras eram similares (as diferenças encontradas entre os dois grupos não eram estatisticamente significativas). As variáveis analisadas no pré e no pós-operatório foram acuidade visual com correção, ceratometria, astigmatismo corneano e refração. Resultados: A amostra que recebeu apenas um segmento de arco longo (Grupo A) obteve redução da ceratometria média de 4,42D (8,7%) e do astigmatismo corneano de 2,43D (40,4%). Já na amostra dos olhos que receberam dois segmentos de arco tradicional (Grupo B), houve redução média de 2,66D (5,1%) em relação à ceratometria média e redução média de 2,11D (34,8%) em relação ao astigmatismo corneano. A redução obtida na ceratometria média no Grupo A foi maior que a obtida no Grupo B (diferença estatisticamente significativa). A redução obtida no astigmatismo do Grupo A não foi estatisticamente significante, se comparada com o resultado obtido no Grupo B (considerando p≤0,05). Conclusão: Foi demonstrado que o uso de um segmento de arco longo possui maior capacidade de aplanação corneana, se comparado com o uso de dois segmentos com comprimento de arco tradicional. Em relação à redução do astigmatismo, os dois grupos mostraram resultados equivalentes.

ABSTRACT Purpose: To retrospectively analyze the changes in corneal keratometry and astigmatism after intrastromal ring surgery, comparing the use of one long arch segment versus two traditional arc length segments. Methods: A cross-sectional study obtained data from 94 eyes of patients diagnosed with keratoconus that underwent surgical treatment with corneal ring implant. They were divided into two groups according to the type of implant received: one long-arch segment (Group A) or two traditional segments (Group B), both 250 microns thick. Preoperative data from the two groups were compared to ensure that the samples were similar (the differences between the two groups were not statistically significant). The variables (pre and post-operatively) analyzed were: best corrected visual acuity, keratometry, corneal astigmatism and refraction. Results: Group A, which received one long arch segment, showed a Km decrease of 4.42D (8.7%) and a corneal astigmatism reduction of 2.43D (40.4%). Group B, where the eyes acquired two traditional arch segments, showed an average Km decrease of 2.66D (5.1%) and corneal astigmatism reduction of 2.11D (34.8%). The mean keratometry (Km) reduction obtained was statistically significant (p≤0.05) when comparing both groups (A and B). The mean corneal astigmatism reduction was not statistically significant (p≤0.05) when comparing both groups (A and B). Conclusions: One long-arch segment has been demonstrated to have a greater capacity to reduce corneal curvature when compared to the use of two traditional-sized arch segments. No significant differences were found regarding the reduction of corneal astigmatism after comparing the results obtained in both groups.

Hypoglossal Nerve Stimulator Implantation in an Ambulatory Surgery Center Versus Hospital.

OBJECTIVES/HYPOTHESIS: Hypoglossal nerve stimulator (HGNS) implantation is highly effective in treating obstructive sleep apnea (OSA) in select patient populations that are intolerant of continuous positive airway pressure. Implantation surgery is traditionally performed in hospital outpatient departments (HOPD) due to concern about anesthetic effects and airway manipulation in an OSA population. In this study, we examined complications and efficiency of HGNS implantation in an ambulatory surgery center (ASC) versus HOPD. STUDY DESIGN: Retrospective cohort study. METHODS: Patients with HGNS implantation performed between May 2015-January 2021 at our HOPD or ACS were included. Patient-related characteristics, surgical times, and postoperative complications were obtained via chart review. Reimbursement data on a national level for Medicare patients were calculated based on publicly available data from the Center for Medicare Services. Patient characteristics, surgical times, and complications were summarized as medians with interquartile ranges (IQRs) and proportions in each surgical setting group as appropriate. These were compared between surgical setting groups via Wilcoxon rank-sum testing and χ2 testing. RESULTS: A total of 122 patients were included. Patients in the HOPD group had significantly higher median apnea-hypopnea index (AHI) (42.0 [IQR 27.9-51.0]) compared to the ASC group (31.0 [IQR 21.0-44.2], P = .005). The intervals between in-room and case start, case finish and out-of-room, and time in the postoperative area were significantly shorter in the ASC group compared to the HOPD group. Reimbursement on a national level was estimated at 18% lower for patients with surgery performed at the ASC. There was no significant difference in postoperative complications. CONCLUSIONS: HGNS implantation in an ASC is safe and more efficient than in a HOPD, and may also be more cost-effective. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:706-710, 2022.

Electrophysiological Study-Guided Permanent Pacemaker Implantation in Patients With Conduction Disturbances Following Transcatheter Aortic Valve Implantation.

Conduction disturbances remain common following transcatheter aortic valve implantation (TAVI). Aside from high-degree atrioventricular block (HAVB), their optimal management remains elusive. Invasive electrophysiological studies (EPS) may help stratify patients at low or high risk of HAVB allowing for an early discharge or permanent pacemaker (PPM) implantation among patients with conduction disturbances. We evaluated the safety and diagnostic performances of an EPS-guided PPM implantation strategy among TAVI recipients with conduction disturbances not representing absolute indications for PPM. All patients who underwent TAVI at a single expert center from June 2017 to July 2020 who underwent an EPS during the index hospitalization were included in the present study. False negative outcomes were defined as patients discharged without PPM implantation who required PPM for HAVB within 6 months of the initial EPS. False positive outcomes were defined as patients discharged with a PPM with a ventricular pacing percentage <1% at follow-up. A total of 78 patients were included (median age 83.5, 39% female), among whom 35 patients (45%) received a PPM following EPS. The sensitivity, specificity, positive and negative predictive values of the EPS-guided PPM implantation strategy were 100%, 89.6%, 81.5%, and 100%, respectively. Six patients suffered a mechanical HAVB during EPS and received a PPM. These 6 patients showed PPM dependency at follow-up. In conclusion, an EPS-guided PPM implantation strategy for managing post-TAVI conduction disturbances appears effective to identify patients who can be safely discharged without PPM implantation.

Randomized Pilot Study: Anal Inserts Versus Percutaneous Tibial Nerve Stimulation in Patients With Fecal Incontinence.

BACKGROUND: Anal inserts and percutaneous tibial nerve stimulation may be offered to those with fecal incontinence in whom other conservative treatments have failed. OBJECTIVE: We aimed to compare anal inserts and percutaneous tibial nerve stimulation. DESIGN: This was an investigator-blinded randomized pilot study. SETTINGS: The study was conducted at a large tertiary care hospital. PATIENTS: Adult patients with passive or mixed fecal incontinence were recruited. INTERVENTIONS: Patients were randomly assigned to receive either the anal inserts or weekly percutaneous tibial nerve stimulation for a period of 3 months. MAIN OUTCOME MEASURES: The primary end point was a 50% reduction of episodes of fecal incontinence per week as calculated by a prospectively completed 2-week bowel diary. Secondary end points were St Mark's incontinence score, International Consultation on Incontinence Questionnaire-Bowel scores (for bowel pattern, bowel control, and quality of life), use of antidiarrheal agents, estimates of comfort and acceptability. RESULTS: Fifty patients were recruited: 25 were randomly assigned to anal inserts and 25 were randomly assigned to percutaneous tibial nerve stimulation. All completed treatment. A significant improvement of scores in the 2-week bowel diary, the St Mark's scores and the International Consultation on Incontinence Questionnaire-Bowel scores, was seen in both groups after 3 months of treatment. A reduction of ≥50% fecal incontinence episodes was reached by 76% (n = 19/25) by the anal insert group, compared with 48% (n = 12/25) of those in the percutaneous tibial nerve stimulation group (p = 0.04). The St Mark's fecal incontinence scores and the International Consultation on Incontinence Questionnaire-Bowel scores for bowel pattern, bowel control, and quality of life (p = 0.01) suggest similar improvement for each group. LIMITATIONS: A realistic sample size calculation could not be performed because of the paucity of objective prospective studies assessing the effect of the insert device and percutaneous tibial nerve stimulation. CONCLUSIONS: Both anal insert and percutaneous tibial nerve stimulation improved the symptoms of fecal incontinence after 3 months of treatment. The insert device appeared to be more effective than percutaneous tibial nerve stimulation. Larger studies are needed to investigate this further. See Video Abstract at http://links.lww.com/DCR/B460. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov No. NCT04273009. ESTUDIO PILOTO ALEATORIZADO DE INSERCIONES ANALES CONTRA LA ESTIMULACIN PERCUTNEA DEL NERVIO TIBIAL EN PACIENTES CON INCONTINENCIA FECAL: ANTECEDENTES:Las inserciones anales y la estimulación percutánea del nervio tibial (PTNS) se pueden ofrecer a las personas con incontinencia fecal que han fallado en otros tratamientos conservadores.OBJETIVO:Nuestro objetivo fue comparar inserciones anales y estimulación percutánea del nervio tibial.DISEÑO:Este fue un estudio piloto aleatorio ciego para investigadores.AJUSTE:El estudio se realizó en un hospital de atención terciaria.PACIENTES:Se reclutaron pacientes adultos con incontinencia fecal pasiva o mixta.INTERVENCIONES:Los pacientes fueron asignados al azar para recibir inserciones anales o estimulación del nervio tibial percutáneo semanal durante un período de tres meses.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue una reducción del 50% de los episodios de incontinencia fecal por semana, según lo calculado mediante un diario intestinal de dos semanas completado de forma prospectiva. Los criterios de valoración secundarios fueron la puntuación de incontinencia de St Mark, las puntuaciones del ICIQ-B (para patrón intestinal, control intestinal y calidad de vida), uso de agentes antidiarreicos, estimaciones de comodidad y aceptabilidad.RESULTADOS:Se reclutaron 50 pacientes: 25 fueron asignados al azar a inserciones anales y 25 a PTNS. Todo el tratamiento completado. Se observó una mejora significativa de las puntuaciones en el diario intestinal de dos semanas, la puntuación de St Mark y la puntuación del ICIQ-B en ambos grupos después de 3 meses de tratamiento. Se alcanzó una reducción de ≥ 50% de los episodios de incontinencia fecal en un 76% (n = 19/25) en el grupo de inserción anal, en comparación con el 48% (n = 12/25) de los del grupo de estimulación percutánea del nervio tibial (p = 0,04). Las puntuaciones de incontinencia fecal de St Mark, las puntuaciones del ICIQ-B para el patrón intestinal, el control intestinal y la calidad de vida (p = 0,01) sugieren una mejora similar para cada grupo.LIMITACIONES:No se pudo realizar un cálculo realista del tamaño de la muestra debido a la escasez de estudios prospectivos objetivos que evaluaran el efecto del dispositivo de inserción y la estimulación percutánea del nervio tibial.CONCLUSIONES:Tanto la inserción anal como la estimulación percutánea del nervio tibial mejoraron los síntomas de incontinencia fecal después de 3 meses de tratamiento. El dispositivo de inserción parecia ser más efectivo que la estimulación percutánea del nervio tibial. Se necesitan estudios más amplios para investigar esto más a fondo. Consulte Video Resumen en http://links.lww.com/DCR/B460.NÚMERO DE REGISTRO DE PRUEBA:Clinicaltrials.gov No. NCT04273009.

In vivo performance of Al2O3-Ti bone implants in the rat femur.

BACKGROUND: Alumina-titanium (Al2O3-Ti) biocomposites have been recently developed with improved mechanical properties for use in heavily loaded orthopedic sites. Their biological performance, however, has not been investigated yet. METHODS: The aim of the present study was to evaluate the in vivo biological interaction of Al2O3-Ti. Spark plasma sintering (SPS) was used to fabricate Al2O3-Ti composites with 25 vol.%, 50 vol.%, and 75 vol.% Ti content. Pure alumina and titanium were also fabricated by the same procedure for comparison. The fabricated composite disks were cut into small bars and implanted into medullary canals of rat femurs. The histological analysis and scanning electron microscopy (SEM) observation were carried out to determine the bone formation ability of these materials and to evaluate the bone-implant interfaces. RESULTS: The histological observation showed the formation of osteoblast, osteocytes with lacuna, bone with lamellar structures, and blood vessels indicating that the healing and remodeling of the bone, and vasculature reconstruction occurred after 4 and 8 weeks of implantation. However, superior bone formation and maturation were obtained after 8 weeks. SEM images also showed stronger interfaces at week 8. There were differences between the composites in percentages of bone area (TB%) and the number of osteocytes. The 50Ti composite showed higher TB% at week 4, while 25Ti and 75Ti represented higher TB% at week 8. All the composites showed a higher number of osteocytes compared to 100Ti, particularly 75Ti. CONCLUSIONS: The fabricated composites have the potential to be used in load-bearing orthopedic applications.

Contemporaneous evaluation of patient experience, surgical strategy, and seizure outcomes in patients undergoing stereoelectroencephalography or subdural electrode monitoring.

OBJECTIVE: Intracranial electrographic localization of the seizure onset zone (SOZ) can guide surgical approaches for medically refractory epilepsy patients, especially when the presurgical workup is discordant or functional cortical mapping is required. Minimally invasive stereotactic placement of depth electrodes, stereoelectroencephalography (SEEG), has garnered increasing use, but limited data exist to evaluate its postoperative outcomes in the context of the contemporaneous availability of both SEEG and subdural electrode (SDE) monitoring. We aimed to assess the patient experience, surgical intervention, and seizure outcomes associated with these two epileptic focus mapping techniques during a period of rapid adoption of neuromodulatory and ablative epilepsy treatments. METHODS: We retrospectively reviewed 66 consecutive adult intracranial electrode monitoring cases at our institution between 2014 and 2017. Monitoring was performed with either SEEG (n = 47) or SDEs (n = 19). RESULTS: Both groups had high rates of SOZ identification (SEEG 91.5%, SDE 88.2%, P = .69). The majority of patients achieved Engel class I (SEEG 29.3%, SDE 35.3%) or II outcomes (SEEG 31.7%, SDE 29.4%) after epilepsy surgery, with no significant difference between groups (P = .79). SEEG patients reported lower median pain scores (P = .03) and required less narcotic pain medication (median = 94.5 vs 594.6 milligram morphine equivalents, P = .0003). Both groups had low rates of symptomatic hemorrhage (SEEG 0%, SDE 5.3%, P = .11). On multivariate logistic regression, undergoing resection or ablation (vs responsive neurostimulation/vagus nerve stimulation) was the only significant independent predictor of a favorable outcome (adjusted odds ratio = 25.4, 95% confidence interval = 3.48-185.7, P = .001). SIGNIFICANCE: Although both SEEG and SDE monitoring result in favorable seizure control, SEEG has the advantage of superior pain control, decreased narcotic usage, and lack of routine need for intensive care unit stay. Despite a heterogenous collection of epileptic semiologies, seizure outcome was associated with the therapeutic surgical modality and not the intracranial monitoring technique. The potential for an improved postoperative experience makes SEEG a promising method for intracranial electrode monitoring.

The practicality of a two-incision surgical approach for hypoglossal nerve stimulator implantation.

INTRODUCTION: Determine the feasibility of a two-incision surgical approach to hypoglossal nerve stimulator implantation based on anatomic considerations. METHODS: Upper airway stimulation (UAS) using the Inspire system uses three implanted devices-the implantable pulse generator (IPG), stimulation lead and sensing chest wall lead. The traditional surgical approach requires three skin incisions located on the submandibular neck, anterosuperior chest wall and inferolateral chest wall. Our surgical team sought to determine the anatomic considerations of combining the two chest wall incisions into one. In order to minimize morbidity and reduce operative time, the chest wall sensing lead was placed posterolateral to the IPG site via the same incision. RESULTS: Using an adult cadaver for anatomical analysis, access to the third and fourth intercostal spaces was made more difficult by the pectoralis major humeral head and upper arm. The intercostal space was narrower, the musculature along the anterior axillary line and anterior chest wall was devoid of the innermost intercostal muscle group found more laterally. Furthermore, there were much thinner external and internal intercostal muscle components as they transitioned to a membranous layer anteriorly in comparison to the inferolateral chest wall. CONCLUSION: Lack of the innermost intercostal muscle and thinning of the external and internal intercostal muscles lateral to the IPG site leaves little barrier between the thoracic musculature and parietal pleural increasing the risk of complications such as pleurisy and pneumothorax. Given the anatomical findings, a two-incision surgical approach for UAS therapy is at higher risk for complications.

Ultrasound-guided serratus anterior plane block combined with parasternal block in subcutaneous implantable cardioverter defibrillator implantation: Results of a pilot study.

BACKGROUND: The standard approach to subcutaneous defibrillator (S-ICD) implantation often requires general anesthesia or anesthesiologist-delivered deep sedation. Ultrasound-guided serratus anterior plane block (SAPB) combined with parasternal block (PSB) has been proposed in order to provide anesthesia/analgesia and to reduce the need for sedation during S-ICD implantation. In this pilot study, we compared the double-block approach (SAPB + PSB) with the single-block approach (SAPB only) and with the standard approach involving local anesthesia and sedation. METHODS: We prospectively enrolled 22 patients undergoing S-ICD implantation: in 10, the single-block approach was adopted; in 12, the double-block approach. As a control group, we retrospectively enrolled 14 consecutive patients who had undergone S-ICD implantation under standard local anesthesia and sedation in the previous 6 months. Intra- and postprocedural data, including patient-reported pain intensity, were collected and compared in the three study groups. RESULTS: The double-block approach was associated with a shorter procedure duration than the single-block and standard approaches (63.3 ± 7.9 vs 70.1 ± 6.8 vs 76.9 ± 7.8 min; P < .05) and with a lower dose of local an aesthetic for infiltration (18.9 ± 1.7 vs 27.5 ± 4.6 vs 44.6 ± 4.0 cc; P < .001). Both the double- and single-block approaches were associated with lower pain intensity at the device pocket and the lateral tunneling site (P < .05). The double-block approach proved superior to the other two approaches in controlling intraoperative pain at the parasternal tunneling site (P < .05). CONCLUSIONS: In our study, SAPB combined with PSB was superior to SAPB alone and to the standard approach in controlling intraoperative pain during S-ICD implantation. In addition, this approach resulted in shorter procedure durations.

Loop Recorder Implantation on a Telemetry Ward.

The implantable loop recorder (ILR) is a valuable tool used in the evaluation of syncope, arrhythmia, and cryptogenic stroke. In the inpatient setting, ILRs are routinely implanted in the electrophysiology (EP) lab despite the low complication rate. The purpose of this study was to evaluate the safety, feasibility, and cost of implanting ILRs at the patient's bedside by both electrophysiologists and advanced practice providers (APPs). This was a single center, retrospective study of consecutive ILR implantations performed from February 2018 to May 2019. We examined 3 groups: implantations in the EP lab by electrophysiologists (EP Lab/MD), implantations at the bedside by electrophysiologists (Floor/MD), and implantations at the bedside by APPs (Floor/APP). Over 15 months, 152 patients underwent ILR implantation: 48 in the EP Lab/MD group, 57 in the Floor/MD group, and 47 in the Floor/APP group. The procedure duration was longer in the Floor/APP group (14.2 ± 5.9 minutes) compared with the EP Lab/MD and Floor/MD groups (6.8 ± 4.3 minutes, 9.1 ± 4.9 minutes, p <0.001). The overall complication rate was low (2.6%) with no differences between the groups (p = 0.83). The calculated costs per implant for the EP Lab/MD group, Floor/MD group, and Floor/APP group were $482.05, $162.82, and $73.08, respectively.

Variability Between Direct and Indirect Targeting of the Anterior Nucleus of the Thalamus.

BACKGROUND: Preoperative thalamic targeting methods have historically relied on indirect targeting techniques that do not fully account for variances in anatomy or for thalamic atrophy in epilepsy. We aimed to address variability noted between traditional indirect targeting and direct targeting methods for the anterior nucleus of the thalamus (ANT). METHODS: Fifteen consecutive patients undergoing ANT deep brain stimulator placement were evaluated (30 thalamic nuclei). Direct ANT targeting was performed using a fast gray matter acquisition T1 inversion recovery sequence and compared with standard stereotactic coordinates. Thalamic volumes were calculated for each patient, and degree of thalamic volume loss was assessed compared with matched control subjects. Vertex analysis was performed to assess shape changes in the thalamus compared with age- and sex-matched subjects. RESULTS: There was significant variation between direct and indirect targets in the y-axis and z-axis on both sides. On the left, the direct target was located at y = 2 ± 1.3 mm and z = 9.3 ± 1.8 mm (both P = 0.02). On the right, the direct target was located at y = 2.9 ± 1.8 mm and z = 9.2 ± 2 mm (both P ≤ 0.0003). There was no significant difference in the x-coordinate on either side (P > 0.5). Additionally, there was a correlation between thalamic volume and difference between direct and indirect targets in the y-axis and the z-axis. CONCLUSIONS: We showed a significant difference in direct and indirect targeting in the y-axis and z-axis when targeting the ANT for deep brain stimulation for epilepsy. This difference is correlated to thalamic volume, with a larger difference noted in patients with thalamic atrophy.

Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease.

Magnetic sphincter augmentation is an effective and safe surgical method for the treatment of gastroesophageal reflux disease (GERD). The device has been compared with twice-daily proton pump inhibitor therapy and laparoscopic fundoplication (in randomized trials and prospective cohort studies, respectively). Magnetic sphincter augmentation was superior to medical therapy and equivalent to surgery for the relief of GERD symptoms. Recent research focuses on implanting the device into more complex patients, such as those with larger hiatal hernias or those with Barrett's esophagus. Additional novel research topics include cost analysis and predicting and minimizing postoperative dysphagia.

A Novel Approach to Managing Post Retropubic Vaginal Sling Pain.

OBJECTIVE: To describe a novel technique of using peripheral nerve neuromodulation (PNNM) for the treatment of refractory, mesh-induced chronic pelvic pain. Chronic pelvic pain associated with mesh can be a debilitating complication and there is currently no consensus on treatment. PNNM has been shown to be successful in the treatment of post-traumatic neuralgias but has yet to be studied in mesh complications. MATERIALS AND METHODS: We present a case of a 50-year-old woman who had unrelenting pelvic pain after retropubic sling placement. She failed multiple therapies including medications, mesh removal, pelvic floor physical therapy, pudendal neuromodulation, and pelvic floor onabotulinumtoxinA trigger point injections. RESULTS: The only treatment that provided temporary relief of this patient's pain was transvaginal trigger point injections along with a right pudendal nerve block using 40 mg triamcinolone and 0.5% ropivacaine. To help define if treatment at the site of her pain would provide relief, a series of blocks were done by advancing a needle retropubically to her area of pain and injecting triamcinolone and 0.5% ropivacaine. This injection, which corresponded to the previous tract of her retropubic sling, provided temporary, but profound, relief. PNNM was then done with placement of the electrode in the retropubic space at the site of her pain. This provided instantaneous relief of almost all of her pain symptoms. Twelve months postoperatively, the patient continued to have >90% improvement in her pain. CONCLUSION: Focused PNNM is a simple procedure and can provide symptomatic relief for refractory postvaginal mesh pain.

In vivo corrosion and damages in modular shoulder prostheses.

Wear and corrosion at taper junctions of orthopaedic endoprostheses remain of great concern and are associated with adverse clinical reactions. Whereas tribocorrosion of hip tapers was extensively investigated, there is only little knowledge regarding the clinical performance of modular total shoulder prostheses. This retrieval study evaluated 35 modular taper junctions of anatomical shoulder explants using stereomicroscopy, confocal microscopy, as well as optical and scanning electron microscopy to determine the damage modes as well as the effects of taper topography and alloy microstructure. Among all humeral head tapers, 89% exhibited material degradation. Different overlapping wear mechanisms were identified such as plastic deformation, adhesive material transfer, microploughing, and fretting damage. Only CoCrMo cast alloy heads showed a susceptibility to electrochemically dominated fretting in comparison to CoCrMo wrought alloy. Moreover, corundum blasted stem tapers show a significantly increased incidence rate for microploughing. To date, this is the most comprehensive study on the damage types of modular taper junctions of anatomical shoulder arthroplasty proving the existence of fretting even on less weight-bearing implants. This study revealed critical fretting factors, such as the surface finish and the alloy type that are essential for the development of countermeasures that avoid any taper corrosion.

Implantation of subcutaneous defibrillator is feasible and safe with monitored anesthesia care.

BACKGROUND: The perioperative anesthesia care during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving. OBJECTIVE: To assess the feasibility and safety of S-ICD implantation with monitored anesthesia care (MAC) versus general anesthesia (GA) in a tertiary care center. METHODS: This is a single-center retrospective study of patients undergoing S-ICD implantation between October 2012 and May 2019. Patients were categorized into MAC and GA group based on the mode of anesthesia. Procedural success without escalation to GA was the primary endpoint of the study, whereas intraprocedural hemodynamics, need of pharmacological support for hypotension and bradycardia, length of the procedure, stay in the post-anesthesia care unit, and postoperative pain were assessed as secondary endpoints. RESULTS: The study comprises 287 patients with MAC in 111 and GA in 176 patients. Compared to MAC, patients in GA group were younger and had a higher body mass index. All patients had successful S-ICD implantation. Only one patient (0.9%) in the MAC group was converted to GA. Despite a similar baseline heart rate (HR) and mean arterial blood pressure (MAP) in both groups, patients with GA had significantly lower HR and MAP during the procedure and more frequently required pharmacological hemodynamic support. Length of the procedure, stay in the postanesthesia care unit, and postoperative pain was similar in both groups. CONCLUSION: This retrospective experience suggests that implantation of S-ICD is feasible and safe with MAC. Use of GA is associated with more frequent administration of hemodynamic drugs during S-ICD implantation.

Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function.

Background and Purpose- Two large, randomized trials indicated that sphenopalatine ganglion (SPG) stimulation improves final disability outcome in acute anterior circulation patients with ischemic stroke with confirmed cortical involvement. This study evaluated 2 refinements in SPG stimulation treatment technique: (1) SPG electrode placement with real-time optical tracking guidance; and (2) stimulation intensity comfortable tolerance level selection using non-noxious facial physiological markers. Methods- This study was a single, active arm trial at 4 centers, enrolling patients with anterior circulation ischemic stroke, National Institutes of Health Stroke Scale 1 to 6 including arm weakness subitem score ≥1, not receiving recanalization therapies, and within 24 hours of onset. Stimulation level was set based on ipsilateral facial tingling sensation or lacrimation. SPG stimulation effects were assessed by measuring volumetric blood flow in the ipsilateral common carotid artery by ultrasound and grasp and pinch strength in the affected hand before and during stimulation, and by change in National Institutes of Health Stroke Scale from day 1 to 7. Results- Among 50 enrolled patients, age was median 66 years (interquartile range, 60-74), 44% were female, National Institutes of Health Stroke Scale median was 5 (interquartile range, 4-5), and median onset-to-screening time was 18 hours (interquartile range, 9-20). Median implantation skin-to-skin time was 4 minutes (interquartile range, 3-7), and all 50 implants were placed correctly. Comfortable tolerance level was found based on physiological biomarkers in 96% of patients, including 86% in the optimal, low-medium intensity range. SPG stimulation significantly increased common carotid artery peak systolic and end-diastolic blood flow (44%, P<0.0001; and 52%, P<0.0001) and improved pinch strength (42%, P<0.0001) and grasp strength (26%, P<0.0001). Degree of National Institutes of Health Stroke Scale recovery by day 7 was greater than in matched historic controls, median 75% versus 50%, P=0.0003. Conclusions- SPG stimulator placement with real-time optical tracking guidance was fast and accurate, and selection of stimulation intensity levels based on non-noxious facial tingling and lacrimation was feasible in nearly all patients. SPG stimulation led to cervico-cranial blood flow augmentation and improved hand motor function. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT03551093.

Comparison of posterior subthalamic area deep brain stimulation for tremor using conventional landmarks versus directly targeting the dentatorubrothalamic tract with tractography.

OBJECTIVE: To compare posterior subthalamic area deep brain stimulation (PSA-DBS) performed in the conventional manner against diffusion tensor imaging and tractography (DTIT)-guided lead implantation into the dentatorubrothalamic tract (DRTT). PATIENTS AND METHODS: Double-blind, randomised study involving 34 patients with either tremor-dominant Parkinson's disease or essential tremor. Patients were randomised to Group A (DBS leads inserted using conventional landmarks) or Group B (leads guided into the DRTT using DTIT). Tremor (Fahn-Tolosa-Marin) and quality-of-life (PDQ-39) scores were evaluated 0-, 6-, 12-, 36- and 60-months after surgery. RESULTS: PSA-DBS resulted in marked tremor reduction in both groups. However, Group B patients had significantly better arm tremor control (especially control of intention tremor), increased mobility and activities of daily living, reduced social stigma and need for social support as well as lower stimulation amplitudes and pulse widths compared to Group A patients. The better outcomes were sustained for up to 60-months from surgery. The active contacts of Group B patients were consistently closer to the centre of the DRTT than in Group A. Speech problems were more common in Group A patients. CONCLUSION: DTIT-guided lead placement results in better and more stable tremor control and fewer adverse effects compared to lead placement in the conventional manner. This is because DTIT-guidance allows closer and more consistent placement of leads to the centre of the DRTT than conventional methods.

Electrically vs. imaging-guided left ventricular lead placement in cardiac resynchronization therapy: a randomized controlled trial.

AIMS: To test in a double-blinded, randomized trial whether the combination of electrically guided left ventricular (LV) lead placement and post-implant interventricular pacing delay (VVd) optimization results in superior increase in LV ejection fraction (LVEF) in cardiac resynchronization therapy (CRT) recipients. METHODS AND RESULTS: Stratified according to presence of ischaemic heart disease, 122 patients were randomized 1:1 to LV lead placement targeted towards the latest electrically activated segment identified by systematic mapping of the coronary sinus tributaries during CRT implantation combined with post-implant VVd optimization (intervention group) or imaging-guided LV lead implantation by cardiac computed tomography venography, 82Rubidium myocardial perfusion imaging and speckle tracking echocardiography targeting the LV lead towards the latest mechanically activated non-scarred myocardial segment (control group). Follow-up was 6 months. Primary endpoint was absolute increase in LVEF. Additional outcome measures were changes in New York Heart Association class, 6-minute walk test, and quality of life, LV reverse remodelling, and device related complications. Analysis was intention-to-treat. A larger increase in LVEF was observed in the intervention group (11 ± 10 vs. 7 ± 11%; 95% confidence interval 0.4-7.9%, P = 0.03); when adjusting for pre-specified baseline covariates this difference did not maintain statistical significance (P = 0.09). Clinical response, LV reverse remodelling, and complication rates did not differ between treatment groups. CONCLUSION: Electrically guided CRT implantation appeared non-inferior to an imaging-guided strategy considering the outcomes of change in LVEF, LV reverse remodelling and clinical response. Larger long-term studies are warranted to investigate the effect of an electrically guided CRT strategy.