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.

Vagal Nerve Stimulator Placement by a Vascular Surgeon.

BACKGROUND: Refractory seizure activity represents a difficult problem for both patients and practitioners. Implantation of the vagal nerve stimulator has been posited as an effective treatment for refractory seizure activity. These devices are inserted by placing leads into the carotid sheath along the vagus nerve. We evaluated a vascular surgeon's experience placing vagal nerve stimulators. METHODS: We examined all patients treated with placement of vagal nerve stimulator by a single surgeon from October 2016 to October 2018. Data collected included demographics, medical and surgical history, intraoperative variables, and complications. RESULTS: Thirty-four patients underwent placement of a vagal nerve stimulator. About 29.4% had a previous vagal nerve stimulator placed on the ipsilateral side. Intraoperative bradycardia was seen in 1 patient. Postoperative complications were identified in 5 patients, all of which were transient dysphagia or changes in voice quality which did not require intervention. There was no significant difference between patients with the previous operation and those without for developing postoperative complications (P = .138). Average blood loss was higher in patients who had undergone previous stimulator placement than those who had not (P = .0223), and the operative time was longer (P ≤ .0001). DISCUSSION: Given the anatomical location of placement, vascular surgeons may be called upon to place these devices. In our single surgeon series, we found that the placement was safe, with minimal complications. Intraoperatively, this case appears to be more difficult (with higher blood loss and longer operative time) in patients who have had previous device placement, but this does not appear to lead to increased complications.

Surgical Interventions During End-of-Life Hospitalizations in Children's Hospitals.

OBJECTIVES: To characterize patterns of surgery among pediatric patients during terminal hospitalizations in children's hospitals. METHODS: We reviewed patients ≤20 years of age who died among 4 424 886 hospitalizations from January 2013-December 2019 within 49 US children's hospitals in the Pediatric Health Information System database. Surgical procedures, identified by International Classification of Diseases procedure codes, were classified by type and purpose. Descriptive statistics characterized procedures, and hypothesis testing determined if undergoing surgery varied by patient age, race and ethnicity, or the presence of chronic complex conditions (CCCs). RESULTS: Among 33 693 terminal hospitalizations, the majority (n = 30 440, 90.3%) of children were admitted for nontraumatic causes. Of these children, 15 142 (49.7%) underwent surgery during the hospitalization, with the percentage declining over time (P < .001). When surgical procedures were classified according to likely purpose, the most common were to insert or address hardware or catheters (31%), explore or aid in diagnosis (14%), attempt to rescue patient from mortality (13%), or obtain a biopsy (13%). Specific CCC types were associated with undergoing surgery. Surgery during terminal hospitalization was less likely among Hispanic children (47.8%; P < .001), increasingly less likely as patient age increased, and more so for Black, Asian American, and Hispanic patients compared with white patients (P < .001). CONCLUSIONS: Nearly half of children undergo surgery during their terminal hospitalization, and accordingly, pediatric surgical care is an important aspect of end-of-life care in hospital settings. Differences observed across race and ethnicity categories of patients may reflect different preferences for and access to nonhospital-based palliative, hospice, and end-of-life care.

Association between early ventricular arrhythmias and mortality in destination vs. bridge patients on continuous flow LVAD support.

The association between ventricular arrhythmias (VAs) and mortality in patients supported by continuous flow left ventricular assist devices (LVAD) remains controversial. To evaluate the association between pre-implantation, early (≤ 30 day) post-implantation VAs and mortality in bridge to transplant (BTT) and destination therapy (DT) LVAD patients, separately. The risk factors for post LVAD VAs were also investigated. In this observational cohort study, we included 341 patients who received a first time, continuous flow LVAD between January 1st 2010 and July 30th 2018. We used Kaplan-Meier curves and multivariable cox regression analyses to study the association between VAs and mortality in the BTT and DT populations. The mean age of the cohort was 58 ± 14 years, with 82% males, 53% had ischemic cardiomyopathy, and 45% were DT. The mean follow-up was 2.2 ± 2.1 years. In both BTT and DT cohorts, pre LVAD VAs were not associated with mortality after LVAD implantation (log-rank p = 0.95 and p = 0.089, respectively). In the BTT population, early post-LVAD VAs were not statistically associated with increased mortality (log rank p = 0.072). In the DT patients, early post LVAD VAs were associated with a 67% increase in the hazards rate of mortality on LVAD support (HR 1.67 [1.05-2.65], p = 0.029). The final model was adjusted for type of cardiomyopathy, INTERMACS profile, glomerular filtration rate, post LVAD atrial fibrillation, age and cerebrovascular events. Early post-LVAD VA is common after LVAD implantation and is an independent predictor of mortality in the DT LVAD population.

Contemporary Left Ventricular Assist Device Outcomes in an Aging Population: An STS INTERMACS Analysis.

BACKGROUND: Survival, functional outcomes, and quality of life after left ventricular assist device (LVAD) are ill-defined in elderly patients, and with new-generation devices. OBJECTIVES: This study sought to evaluate survival, functional outcomes, and quality of life after LVAD in contemporary practice. METHODS: Adults receiving durable LVADs between January 1, 2010, and March 1, 2020, were identified from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The primary outcome was adjusted survival; secondary outcomes included quality of life rated using a visual analogue scale (where 0 represents "worst health" and 100 "best health"); 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age. Median follow-up was 15 months (IQR: 6-32 months). RESULTS: The cohort comprised 68.9% (n = 16,808) patients aged <65 years, 26.3% (n = 6,418) patients aged 65-75 years, and 4.8% (n = 1,182) patients aged >75 years, who were predominantly male (n = 19,119, 78%) and on destination therapy (n = 12,425, 51%). Competing outcomes analysis demonstrated mortality (70% CIs) of 34% (33%-34%), 54% (54%-55%), and 66% (64%-68%) for patients aged <65, 65-75, and >75 years, respectively, which improved during the study in patients aged >75 years. Newer-generation devices were associated with reduced late mortality (HR: 0.35; 95% CI: 0.25-0.49). Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age (all P < 0.01). Median 6-minute walk distance increased from 0 feet (IQR: 0-665 feet) to 1,065 feet (IQR: 642-1,313 feet) (P < 0.001), and quality of life improved from 40 (IQR: 15-60) to 75 (IQR: 60-90) (P < 0.001) after LVAD in all age groups. CONCLUSIONS: In elderly patients, LVADs are associated with increased functional capacity, similar improvements in quality of life, and fewer complications compared with younger patients.

Relationship between septo-valvular angle and risk of pacemaker implantation after transcatheter aortic valve implantation: a preliminary study.

AIM: Pre-transcatheter aortic valve implantation (TAVI) computed tomography (CT) has proven to be crucial in identifying pre- and post-procedural predicting factors predisposing the onset of major arrhythmias that require permanent pacemaker (PPM) implantation caused by the compressive effects of the prostheses on the conduction system at the membranous septum (MS) and the muscular crest of the interventricular septum.Our analysis aims to verify if the pre-TAVI assessment of the angle between the MS and the aortic annulus (SVA) might be a predictive factor for the onset of arrhythmias that requires PPM. METHODS: Two cardiovascular specialist radiologists retrospectively and double-blind evaluated a randomized list of preprocedural CT of 57 patients who underwent TAVI with a self-expandable valve from April 2019 to February 2020. Two anatomical features were measured by readers: width of the SVA and MS length (MSL). RESULTS: A PPM was implanted in 18 patients (31%) after the procedure. There was no significant difference in the anatomical measurements performed between the two observers, regarding both anatomical measurements (intraclass correlation coefficient was 0.944 for the SVA and 0.774 for the MSL]. Receiver-operating characteristic curves (ROC) performed for both measurements have documented: for the SVA sensitivity 94% and Negative predictive value (NPV) 96% (area under the curve: 0.77; 95% confidence interval 0.66-0.90). The MSL ROC was not significant. The mean SVA value stratified for patients who did not undergo PPM implantation and patients who did resulted as significant (P < 0.005). CONCLUSION: Measurement of the SVA performed in preprocedural CT scans has proven to be related to the onset of major arrhythmias after TAVI requiring permanent pacemaker implantation with high sensitivity (94%) and NPV (96%).

Covered vs bare stent for distal malignant biliary obstruction due to primary common biliary cancer.

ABSTRACT: This study was designed as a means of comparing the clinical efficacy and long-term outcomes of covered vs bare stent insertion as a treatment for distal malignant biliary obstruction (DMBO) caused by primary common biliary cancer (PCBC).This retrospective study was designed using data collected between January 2012 and December 2019 to assess the short- and long-term outcomes in patients with DMBO caused by PCBC treated by inserting either bare or covered stents were compared.Ninety two patients with DMBO caused by PCBC were divided between bare (n = 51) or covered (n = 41) stent groups. Technical success rates in both groups were 100%. Clinical success of bare vs covered stent use were 96.1% and 97.6% (P = 1.00). Stent dysfunction was seen in 17 and 6 patients in the bare and covered stent groups, respectively (P = .04). The median stent patency for bare and covered stents was 177 and 195 days, respectively (P = .51). The median survival was 188 and 200 days in the bare and covered stent groups, respectively (P = .85).For patients with DMBO caused by PCBC, using bare vs covered stents yields similar clinical efficacy and long term outcomes.

Machine learning method for predicting pacemaker implantation following transcatheter aortic valve replacement.

BACKGROUND: An accurate assessment of permanent pacemaker implantation (PPI) risk following transcatheter aortic valve replacement (TAVR) is important for clinical decision making. The aims of this study were to investigate the significance and utility of pre- and post-TAVR ECG data and compare machine learning approaches with traditional logistic regression in predicting pacemaker risk following TAVR. METHODS: Five hundred fifity seven patients in sinus rhythm undergoing TAVR for severe aortic stenosis (AS) were included in the analysis. Baseline demographics, clinical, pre-TAVR ECG, post-TAVR data, post-TAVR ECGs (24 h following TAVR and before PPI), and echocardiographic data were recorded. A Random Forest (RF) algorithm and logistic regression were used to train models for assessing the likelihood of PPI following TAVR. RESULTS: Average age was 80 ± 9 years, with 52% male. PPI after TAVR occurred in 95 patients (17.1%). The optimal cutoff of delta PR (difference between post and pre TAVR PR intervals) to predict PPI was 20 ms with a sensitivity of 0.82, a specificity of 0.66. With regard to delta QRS, the optimal cutoff was 13 ms with a sensitivity of 0.68 and a specificity of 0.59. The RF model that incorporated post-TAVR ECG data (AUC 0.81) more accurately predicted PPI risk compared to the RF model without post-TAVR ECG data (AUC 0.72). Moreover, the RF model performed better than logistic regression model in predicting PPI risk (AUC: 0.81 vs. 0.69). CONCLUSIONS: Machine learning using RF methodology is significantly more powerful than traditional logistic regression in predicting PPI risk following TAVR.

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.

Safety and Long-term Outcomes of Defibrillator Therapy in Patients With Right-Sided Implantable Cardiac Devices in Adults With Congenital Heart Disease.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) have been proven to prevent sudden cardiac death in adult congenital heart disease (ACHD) patients. Although the left side is chosen by default, implantation from the right side is often required. However, little is known about the efficacy and safety of right-sided ICDs in ACHD patients. METHODS: In this study we reviewed a total of 191 ACHD patients undergoing ICD/cardioverter resynchronisation therapy-defibrillator (CRT-D) implantation at our hospital between 2001 and 2019 (134 men and 57 women; age [mean ± standard deviation], 41.5 ± 14.8 years). RESULTS: Twenty-seven patients (14.1%) had right-sided devices. The most common causes of right-sided implantation were persistent left superior vena cava and vein occlusion (37.0%). Although procedure time (202.8 ± 60.5 minutes vs 143.8 ± 69.1 minutes, P = 0.008) was longer and the procedural success was lower (92.6% vs 99.4%, P = 0.008) for right-sided devices, no difference in R-wave and pacing threshold were noted. Among the 47 patients (24.6%) who underwent defibrillation threshold testing (DFT), no difference in DFT was observed (25.2 ± 5.3 J vs 23.8 ± 4.1 J, P = 0.460). During the median follow-up of 42.4 months, appropriate ICD therapy was observed in 5 (18.5%) and 30 (18.3%) patients for right- and left-sided ICDs/CRTDs, respectively (P = 0.978). No significant difference was seen in complications between them. CONCLUSIONS: Implantation of an ICD on the right side is technically challenging, but it is feasible as an alternative approach for ACHD patients with contraindications to left-sided device implantation.

Normal imaging findings after aortic valve implantation on 18F-Fluorodeoxyglucose positron emission tomography with computed tomography.

BACKGROUND: To determine the normal perivalvular 18F-Fluorodeoxyglucose (18F-FDG) uptake on positron emission tomography (PET) with computed tomography (CT) within one year after aortic prosthetic heart valve (PHV) implantation. METHODS: Patients with uncomplicated aortic PHV implantation were prospectively included and underwent 18F-FDG PET/CT at either 5 (± 1) weeks (group 1), 12 (± 2) weeks (group 2) or 52 (± 8) weeks (group 3) after implantation. 18F-FDG uptake around the PHV was scored qualitatively (none/low/intermediate/high) and quantitatively by measuring the maximum Standardized Uptake Value (SUVmax) and target to background ratio (SUVratio). RESULTS: In total, 37 patients (group 1: n = 12, group 2: n = 12, group 3: n = 13) (mean age 66 ± 8 years) were prospectively included. Perivalvular 18F-FDG uptake was low (8/12 (67%)) and intermediate (4/12 (33%)) in group 1, low (7/12 (58%)) and intermediate (5/12 (42%)) in group 2, and low (8/13 (62%)) and intermediate (5/13 (38%)) in group 3 (P = 0.91). SUVmax was 4.1 ± 0.7, 4.6 ± 0.9 and 3.8 ± 0.7 (mean ± SD, P = 0.08), and SUVratio was 2.0 [1.9 to 2.2], 2.0 [1.8 to 2.6], and 1.9 [1.7 to 2.0] (median [IQR], P = 0.81) for groups 1, 2, and 3, respectively. CONCLUSION: Non-infected aortic PHV have similar low to intermediate perivalvular 18F-FDG uptake with similar SUVmax and SUVratio at 5, 12, and 52 weeks after implantation.

Outcomes of heart transplantation in patients bridged with Impella 5.0: Comparison with native chest transplanted patients without preoperative mechanical circulatory support.

The Impella (Abiomed, Danvers, MA, USA) has become an important adjunct treatment modality in bridging patients with end-stage heart failure to recovery or orthotopic heart transplantation (HTx). We compared the outcome of patients directly bridged to HTx with the Impella 5.0 versus patients without mechanical circulatory support (MCS). Patients with no previous sternotomy or MCS, who were transplanted between September 2014 and March 2019 were included in this retrospective analysis. Impella 5.0 was implanted using surgical access and transesophageal echocardiography guidance. Forty-two out of 155 transplanted patients fulfilled the insertion criteria. Eight (19%) were bridged with Impella 5.0 to HTx. Recipient and donor baseline characteristics were comparable in both groups. There were no significant differences in survival between the groups at 30-day (94% no MCS vs. 87.5% Impella group, P = .47) or 6 months (94% vs. 87.5%, P = .51). Patients on Impella 5.0 showed a significant recovery of hemodynamic parameters and end-organ function. Average duration of support to HTx was 16 ± 17 days. Impella 5.0, when used in suitable patients in a timely fashion can be a good strategy for bridging patients to HTx. The axillary approach allows for early extubation and mobilization. Outcomes of patients bridged to HTx with Impella 5.0 in acute cardiogenic shock are comparable to those of patients with no MCS.

Trends in utilization, mortality, and resource use after implantation of left ventricular assist devices in the United States.

OBJECTIVES: Adoption of implantable left ventricular assist devices has dramatically improved survival and quality of life in suitable patients with end-stage heart failure. In the era of value-based healthcare delivery, assessment of clinical outcomes and resource use associated with left ventricular assist devices is warranted. METHODS: Adult patients undergoing left ventricular assist device implantation from 2008 to 2016 were identified using the National Inpatient Sample. Hospitals were designated as low-volume, medium-volume, or high-volume institutions based on annual institutional left ventricular assist device case volume. Multivariable logistic regression was used to evaluate adjusted odds of mortality across left ventricular assist device volume tertiles. RESULTS: Over the study period, an estimated 23,972 patients underwent left ventricular assist device implantation with an approximately 3-fold increase in the number of annual left ventricular assist device implantations performed (P for trend <.001). In-hospital mortality in patients with left ventricular assist devices decreased from 19.6% in 2008 to 8.1% in 2016 (P for trend <.001) and was higher at low-volume institutions compared with high-volume institutions (12.0% vs 9.2%, P < .001). Although the overall adjusted mortality was higher at low-volume compared with high-volume institutions (adjusted odds ratio, 1.66; 95% confidence interval, 1.28-2.15), this discrepancy was only significant for 2008 and 2009 (low-volume 2008 adjusted odds ratio, 5.5; 95% confidence interval, 1.9-15.8; low-volume 2009 adjusted odds ratio, 2.3; 95% confidence interval, 1.4-3.8). CONCLUSIONS: Left ventricular assist device use has rapidly increased in the United States with a concomitant reduction in mortality and morbidity. With maturation of left ventricular assist device technology and increasing experience, volume-related variation in mortality and resource use has diminished. Whether the apparent uniformity in outcomes is related to patient selection or hospital quality deserves further investigation.

UK practice for penile prosthesis surgery: baseline analysis of the British Association of Urological Surgeons (BAUS) Penile Prosthesis Audit.

OBJECTIVES: To undertake a prospective multicentre national audit of penile prosthesis practice in the UK over a 3-year period. PATIENTS AND METHODS: Data were submitted by urological surgeons as part of the British Association of Urological Surgeons Penile Prosthesis National Audit. Patients receiving a penile prosthesis (inflatable or malleable) were included as part of a prospective registry over a 3-year period. Data were validated and then analysed using a software package (Tableau). RESULTS: A total of 1071 penile prosthesis procedures were included from 22 centres. The three commonest aetiological factors for erectile dysfunction were diabetes, prostate surgery and Peyronie's disease. Of the recorded data, inflatable penile prostheses were the commonest devices implanted, with 665 devices used (62.1%), whereas malleable prostheses accounted for 14.2% of the implants. Recorded intra-operative complications included urethral injury (0.7%, n = 7), corporal perforation (1.1%, n = 12) and cross-over (0.6%, n = 6). Known postoperative complications were recorded in 9.8% of patients (74/752), with the two most frequently reported being postoperative penile pain (n = 11) and scrotal haematoma (n = 14). CONCLUSION: This baseline analysis is the largest prospective registry of penile prostheses procedures to date. The data show that, over the 3-year collection period in the UK, there are now fewer surgeons performing the procedure, together with a reduction in the number of centres. Peri-operative complications were infrequent, and the rate of implant abortion (e.g. as a result of urethral injury) was very low. Further follow-up data will be required to publish long-term outcomes and patient satisfaction.

Long-term follow up of intracorneal ring segment implantation in 932 keratoconus eyes.

PURPOSE: To evaluate the progression of keratoconus in 932 eyes of 659 patients through visual, refractive and topographic data after intracorneal ring segment (ICRS) implantation. METHODS: Retrospective review of 659 patients who underwent ICRS (Intacs®) implantation for keratoconus between September 1997 and November 2017. Demographics, preoperative and postoperative uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) in LogMAR, corneal topography parameters (thinnest pachymetry, Kmax), central corneal pachymetry and total follow-up time were evaluated. Statistical analysis was performed using IBM SPSS Statistics 24.0 for windows. RESULTS: Nine hundred and thirty-two eyes of 659 patients, with a mean age of 30.41 years (range 11-76 years), were evaluated. Mean total follow up time was 3.02 years. Forty-one eyes had a total follow up of over 10 years. Both UCVA and BCVA improved significantly after ICRS implantation (P<0.01). Only 18 eyes (2.66% of eyes of patients under 35 years of age) were found to have progression of keratoconus based on postoperative topographic data (Mean age 23.00 years, 55.6% female, total follow-up 2 to 10 years) CONCLUSION: ICRS implantation showed long-term improvement and stability in visual and topographic results in a large case series of patients with keratoconus. Only a minimal rate of progression was detected in young patients. However, further prospective studies need to be conducted to better define predictability of postoperative visual outcomes and progression.

Temporal Trends in the Incidence and Outcomes of Pacemaker Implantation After Transcatheter Aortic Valve Replacement in the United States (2012-2017).

Background Nationwide studies documenting temporal trends in permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) are limited. Methods and Results We selected patients who underwent TAVR between 2012 and 2017 in the National Readmission Database. The primary end point was the 6-year trend in post-TAVR PPMI at index hospitalization and at 30, 90, and 180 days after discharge. The secondary end point was the association between PPMI and in-hospital mortality, stroke, cost, length of stay, and disposition. Among the 89 202 patients who underwent TAVR, 77 405 (86.8%) with no prior pacemaker or defibrillator were included. Patients who required PPMI had a higher prevalence of atrial fibrillation (43.6% versus 38.7%, P<0.001) and conduction abnormalities (28.4% versus 15.3%, P<0.001). The incidence of PPMI during index admission increased from 8.7% in 2012 to 13.2% in 2015, and then decreased to 9.6% in 2017. The incidence of inpatient PPMI within 30 days after discharge increased from 0.5% in 2012 to 1.25% in 2017 (Ptrend<0.001). Inpatient PPMI beyond 30 days remained rare (<0.5%) during the study period. After risk adjustment, PPMI was not associated with in-hospital mortality or stroke but was associated with increased nonhome discharge, longer hospitalization, and higher cost. The incremental expenditure associated with post-TAVR PPMI during index admission increased from $9.6 million to $72.2 million between 2012 and 2017. Conclusions After an upward trend, rates of PPMI after TAVR in the United States stabilized at ~10% in 2016 to 2017, but there was a notable increase in PPMI within 30 days after the index admission. PPMI was not associated with increased in-hospital morbidity or mortality but led to longer hospitalization, higher cost, and more nonhome discharges.

Clinical outcomes of trabecular microbypass stent (iStent) implantation in medically controlled open-angle glaucoma in the Korean population.

To evaluate the safety and efficacy [intraocular pressure (IOP)-lowering effect and medication use] of a single trabecular microbypass stent (iStent; Glaukos Corp, San Clemente, CA) for medically controlled open-angle glaucoma.This retrospective case series included 42 eyes of 34 patients with medically controlled open-angle glaucoma with IOP less than 21 mm Hg. Clinical outcomes analyzed were IOP, medication use, corrected distance visual acuity (CDVA), and surgical complications. Surgical success was defined according to 4 criteria: IOP < 21 mm Hg without medication; IOP < 18 mm Hg without medication; IOP < 15 mm Hg without medications; and IOP < 18 mm Hg with or without medication. Patients were followed for a minimum of 6 months postoperatively.Mean IOP was reduced from 15.8 ±â€Š2.8 mm Hg to 14.5 ±â€Š2.8 mm Hg (P < .001), while mean number of medications decreased from 2.2 ±â€Š1.2 to 0.8 ±â€Š1.1 at final visit (P < .001). Surgical success rates were 78.6%, 61.9%, 57.1%, and 97.6% at 6 months and 78.6%, 59.5%, 52.4%, and 95.2% at final visits according to criteria A, B, C, and D. Meanwhile, 59.5% of patients were medication-free at their final visit. The relative risk of surgical failure by Criteria B and C was 4.337 (95% confidence interval: 1.799-10.454) and 3.717 (95% confidence interval: 1.516-9.116) times greater in the higher-medication group (3 or more preoperative medications), respectively. CDVA was significantly improved from 0.41 ±â€Š0.10 to 0.09 ±â€Š0.07 LogMAR in the combined phacoemulsification and iStent implantation group (P < .001). There was no case whose vision was threatened (vision loss of 2 or more lines) or who showed severe complications after surgery.Single trabecular microbypass stent implantation was effective in reducing IOP and medication usage in patients with open-angle glaucoma with a low preoperative IOP. Our results imply that it is more difficult to achieve low target IOP control in eyes with higher numbers of preoperative medications.

Prosthetic temporomandibular joint reconstruction in a cohort of adolescent females with juvenile idiopathic arthritis.

BACKGROUND: Temporomandibular joint (TMJ) arthritis and involvement is commonly seen in Juvenile Idiopathic Arthritis (JIA). Therapy includes conservative measures, but also includes intraarticular corticosteroid injections (IASI) and systemic immunosuppressive therapy. Despite aggressive medical therapy, some patients develop arthritic changes and frank TMJ ankylosis that can result in persistent pain and limitation in range of motion (ROM). A surgical option is prosthetic TMJ replacement with concurrent correction of dentofacial deformities, which can be performed simultaneously. The objective of this study was to evaluate the outcomes of prosthetic TMJ replacement in a cohort of adolescent females with JIA and severe TMJ involvement. METHODS: This is a retrospective case series that took place at one tertiary care center. Patients with a diagnosis of JIA who also underwent alloplastic TMJ replacement were identified through electronic medical record system (EMR) and reviewed. Chart review included analysis of all documents in the EMR, including demographic data, JIA history, surgical complications, ROM of TMJ measured by maximal incisal opening in millimeters (mm) and TMJ pain scores (4-point Likert scale: none, mild, moderate, severe) obtained pre- and postoperatively. RESULTS: Five female patients, ages 15-17 year when TMJ replacement was performed, had nine total joints replaced with a post-operative follow-up period of 12-30 months. All patients had polyarticular, seronegative JIA and were treated with IASI and multiple immunosuppressive therapies without resolution of TMJ symptoms. One patient had bilateral TMJ ankylosis. Three of the five patients demonstrated significant dentofacial deformities, and all underwent simultaneous or staged orthognathic surgery. All patients had improvement in TMJ pain with most (80%) reporting no pain, and all had similar or improved ROM of their TMJ postoperatively. There was one delayed postoperative infection with Cutibacterium Acnes that presented 15 months after surgery and required removal and reimplantation of prosthesis. CONCLUSION: The sequelae of TMJ arthritis and involvement from JIA in the adolescent population can be difficult to treat. Current medical therapy can be successful, however, in select cases that develop chronic changes in the TMJ despite extensive medical therapy, early results show that prosthetic joint replacement maybe a reasonable surgical option. With prosthetic joint replacement pain levels were reduced and range of motion was maintained or improved for all patients.

Tracheoesophageal voice prosthesis management in laryngectomy patients during the COVID-19 pandemic.

With the COVID-19 pandemic, there has been significant changes and challenges in the management of oncology patients. One of the major strategies to reduce transmission of the virus between patients and healthcare workers is deferral of follow-up visits. However, deferral may not be possible in total laryngectomy patients. Urgent procedures may be necessary to prevent complications related to ill-fitting tracheoesophageal puncture (TEP) voice prostheses, such as aspiration or loss of voicing. In this paper, we describe the Princess Margaret Cancer Center's approach to managing this unique patient population.