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.

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.

Statistics on the use of cardiac electronic devices and interventional electrophysiological procedures in Africa from 2011 to 2016: report of the Pan African Society of Cardiology (PASCAR) Cardiac Arrhythmias and Pacing Task Forces.

Aims: To provide comprehensive information on the access and use of cardiac implantable electronic devices (CIED) and catheter ablation procedures in Africa. Methods and results: The Pan-African Society of Cardiology (PASCAR) collected data on invasive management of cardiac arrhythmias from 2011 to 2016 from 31 African countries. A specific template was completed by physicians, and additional information obtained from industry. Information on health care systems, demographics, economics, procedure rates, and specific training programs was collected. Considerable heterogeneity in the access to arrhythmia care was observed across Africa. Eight of the 31 countries surveyed (26%) did not perform pacemaker implantations. The median pacemaker implantation rate was 2.66 per million population per country (range: 0.14-233 per million population). Implantable cardioverter-defibrillator and cardiac resynchronization therapy were performed in 12/31 (39%) and 15/31 (48%) countries respectively, mostly by visiting teams. Electrophysiological studies, including complex catheter ablations were performed in all countries from Maghreb, but only one sub-Saharan African country (South Africa). Marked variation in cost (up to 1000-fold) was observed across countries with an inverse correlation between implant rates and the procedure fees standardized to the gross domestic product per capita. Lack of economic resources and facilities, high cost of procedures, deficiency of trained physicians, and non-existent fellowship programs were the main drivers of under-utilization of interventional cardiac arrhythmia care. Conclusion: There is limited access to CIED and ablation procedures in Africa. A quarter of countries did not have pacemaker implantation services, and catheter ablations were only available in one country in sub-Saharan Africa.

Early experience with lateral lumbar total disc replacement: Utility, complications and revision strategies.

Lumbar total disc replacement (TDR) is an alternative to interbody fusion for the treatment of symptomatic degenerative disc disease. Traditionally, lumbar TDR is performed via an anterior retroperitoneal approach with regional risks of vascular and visceral injury. The direct lateral retroperitoneal, transpsoas approach avoids mobilisation of the great vessels and preserves the anterior longitudinal ligament, thereby maintaining physiological limits on motion. This study aimed to (i) report one site's early experience with lateral lumbar TDR and (ii) provide case examples illustrating the utility, complications and revision strategies of the XL-TDR device. Data were collected prospectively on the first 12 consecutive patients treated with XL-TDR. Patient outcomes included pain (VAS), disability (ODI), and quality of life (SF-36 PCS and MCS). Mean follow-up was 27.5months (range 18-48months). Patients had significant improvements in back (74%) and leg (50%) pain, ODI (69%), PCS (50%) and MCS (39%) (P<0.05). Two patients had early prosthesis dislocation due to prosthesis undersizing. The same skin incision was used to retrieve the XL-TDR and perform salvage lateral lumber interbody fusion, with solid fusion by 12months. Lumbar TDR using the XL-TDR via a lateral transpsoas muscle-splitting approach is a minimally invasive alternative to anterior retroperitoneal exposures for motion preservation. Correct sizing of the XL-TDR and complete contralateral annulectomy with annulus box cutters mitigates the risk of lateral dislocation. Revision surgery for lateral dislocation of the XL-TDR is more straightforward compared to anterior TDR dislocation.

Use of fluoroscopy in clinical electrophysiology in Europe: results of the European Heart Rhythm Association Survey.

Despite the advent of non-fluoroscopic technologies, fluoroscopy remains the cornerstone of imaging in most interventional electrophysiological procedures, from diagnostic studies to ablation interventions and device implantation. The purpose of the European Heart Rhythm Association survey was to provide an insight into regulatory policies and physicians' clinical practice when using fluoroscopy during ablation procedures and device implantation. The survey has shown that only 50% of the participating centres worked with low frame rates (3-6 frames per second) and that the left anterior oblique projection, with higher radiation exposure for the physician, is used for nearly every ablation target. Although three-dimensional imaging systems may reduce the radiation exposure, most centres never used these systems for standard ablation procedures and a trend is that non-fluoroscopy technologies are even less frequently used than in 2012, when the use of robotic systems was still rare. Even less costly equipment such as lead gloves, lead glass cabins, or radiation absorbing pads are still not routinely used.