Surgical complications of vagus nerve stimulation surgery: A 14-years single-center experience.

Introduction: Vagus nerve stimulation (VNS) is the most frequently used neuromodulation treatment for Drug-Resistant Epilepsy (DRE) patients. Complications of VNS surgery include surgical site infection and unilateral vocal cord paresis. Complication rates vary across studies. Research question: What is the safety profile of VNS related surgeries? Materials and methods: Retrospective cohort study using patient files of DRE-patients who had undergone primary implantation of a VNS-system, replacement of the VNS pulse generator, replacement of the lead, replacement of both pulse generator and lead, or VNS removal surgery in the Maastricht UMC+. Multiple Imputation was used for missing data. Univariable and multivariable logistic regression analysis were performed to analyze possible risk factors, in case of a small sample size, an independent-samples t-test and Fisher's exact test or Pearson's X2-test were used. The complication rate was calculated as percentage. Results: This study included a total of 606 VNS surgical procedures, leading to 67 complications of which 3 permanent complications. Complication rate after primary implantation was 13.4%; 2,5% for pulse generator replacement; 21.4% for lead revision and 27.3% for complete VNS removal. No statistically significant results were found when analyzing the results of adults and children <18 years separately. Discussion and conclusion: Complication rates of VNS-related surgeries in our own institutional series are low and comparable to previously reported series. VNS surgery is a relatively safe procedure. The complication rate differs per type of surgery and mean surgery duration was longer for patients with complications after lead revision surgery compared to patients without complications.

Cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: 12-month and cost-effectiveness results from the multicenter COCOGEN trial.

BACKGROUND: Radiofrequency (RF) treatment of the genicular nerves reduces chronic knee pain in patients with osteoarthritis (OA) or persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The objective of this study is to compare long-term outcomes of cooled and conventional RF and perform an economic evaluation. METHODS: The COCOGEN trial is a double-blinded, non-inferiority, pilot, randomized controlled trial that compared the effects up to 12 months of cooled and conventional RF in patients with chronic knee pain suffering from OA or PPSP after TKA following a 1:1 randomization rate. Outcomes were knee pain, functionality, quality of life, emotional health, medication use, and adverse events. A trial-based economic evaluation was performed with a 12-month societal perspective. Here, the primary outcome was the incremental costs per quality-adjusted life year (QALY). RESULTS: 41 of the 49 included patients completed the 12-month follow-up. One patient in the PPSP cooled RF group had substantial missing data at 12-month follow-up. The proportion of patients with ≥50% pain reduction at 12 months was 22.2% (4/18) in patients treated with conventional RF versus 22.7% (5/22) in patients treated with cooled RF (p>0.05). There was a statistically significant difference in the mean absolute numerical rating scale at 12 months after cooled RF and conventional RF in patients with PPSP (p=0.02). Differences between other outcomes were not statistically significant. The health economic analysis indicated that cooled RF resulted in lower costs and improved QALYs compared with conventional RF in PPSP but not in OA. There were no serious adverse events. CONCLUSIONS: Both RF treatments demonstrated in approximately 22% of patients a ≥50% pain reduction at 12 months. In patients with PPSP, contrary to OA, cooled RF seems to be more effective than conventional RF. Additionally, cooled RF has in patients with PPSP, as opposed to OA, greater effectiveness at lower costs compared with conventional RF. TRIAL REGISTRATION NUMBER: NCT03865849.

Prevalence of dyspnea in general adult populations: A systematic review and meta-analysis.

INTRODUCTION: Dyspnea is a commonly described symptom in various chronic and acute conditions. Despite its frequency, relatively little is known about the prevalence and assessment of dyspnea in general populations. The aims of this review were: 1) to estimate the prevalence of dyspnea in general adult populations; 2) to identify associated factors; and 3) to identify used methods for dyspnea assessment. METHODS: A systematic literature search was conducted using MEDLINE/PubMed, Embase, CINAHL and JAMA network. Records were screened by two independent reviewers and quality was assessed by using the Joanna Briggs Institute checklist for risk of bias in prevalence studies. Multi-level meta-analysis was performed to estimate pooled prevalence. The protocol was registered on PROSPERO (CRD42021275499). RESULTS: Twenty original articles, all from studies in high-income countries, met the criteria for inclusion. Overall, their quality was good. Pooled prevalence of dyspnea in general adult populations based on 11 studies was 10% (95% CI 7, 15), but heterogeneity across studies was high. The most frequently reported risk factors were increasing age, female sex, higher BMI and respiratory or cardiac disease. The MRC or the modified MRC scale was the most used tool to assess dyspnea in general populations. CONCLUSIONS: Dyspnea is a common symptom in adults in high-income countries. However, the high heterogeneity across studies and the lack of data from low- and middle-income countries limit the generalizability of our findings. Therefore, more research is needed to unveil the prevalence of dyspnea and its main risk factors in general populations around the world.

Cerebrovascular glycocalyx damage and microcirculation impairment in patients with temporal lobe epilepsy.

Temporal lobe epilepsy (TLE) is increasingly associated with blood-brain barrier dysfunction and microvascular alterations, yet the pathophysiological link is missing. An important barrier function is exerted by the glycocalyx, a gel-like layer coating the endothelium. To explore such associations, we used intraoperative videomicroscopy to quantify glycocalyx and microcirculation properties of the neocortex and hippocampus of 15 patients undergoing resective brain surgery as treatment for drug-resistant TLE, and 15 non-epileptic controls. Fluorescent lectin staining of neocortex and hippocampal tissue was used for blood vessel surface area quantification. Neocortical perfused boundary region, the thickness of the glycocalyx' impaired layer, was higher in patients (2.64 ± 0.52 µm) compared to controls (1.31 ± 0.29 µm), P < 0.01, indicative of reduced glycocalyx integrity in patients. Moreover, erythrocyte flow velocity analysis revealed an impaired ability of TLE patients to (de-)recruit capillaries in response to changing metabolic demands (R2 = 0.75, P < 0.01), indicating failure of neurovascular coupling mechanisms. Blood vessel quantification comparison between intraoperative measurements and resected tissue showed strong correlation (R2 = 0.94, P < 0.01). This is the first report on in vivo assessment of glycocalyx and microcirculation properties in TLE patients, confirming the pivotal role of cerebrovascular changes. Further assessment of the cerebral microcirculation in relation to epileptogenesis might open avenues for new therapeutic targets for drug-resistant epilepsy.

Variation in on-scene time of emergency medical services and the extent of the difference of on-scene time between genders: a retrospective population-based registry study in Riyadh Province, Saudi Arabia.

OBJECTIVES: To identify the intergender variation of on-scene time (OST) for highly urgent emergency cases conveyed by emergency medical services (EMS) in Saudi Arabia and to assess other predictors of OST and hypothesise for possible factors delaying OST. DESIGN: A retrospective population-based registry study. SETTING: Riyadh Province is the largest province in terms of population and the second in terms of geographical area. PARTICIPANTS: All highly urgent transported patients from the scene to emergency departments, be they medical emergencies or trauma emergencies during 2018. OUTCOME MEASURE: OST difference between men and women transported by EMS. RESULTS: In total, 21 878 patients were included for analysis: 33.9% women and 66.1% men. The median OST for women was 22 min (IQR 15-30) and 18 min (IQR 11-26) for men (p<0.001); for medical cases, median OST was 23 min (IQR 16-31) for women compared with 20 min (IQR 13 - 29) for men (p<0.001); for trauma cases, the median OST of both sexes was equal. We found the following additional predictors of OST: factors of emergency type, sex, age category, geographical areas, type of ambulance vehicle and hospital type were all significantly associated with OST in the crude or adjusted analyses. Factors of emergency type, sex, age category, geographical areas, type of ambulance vehicle and hospital type were also significantly associated with the odds of OST of more than 15 min in the crude and adjusted regression analyses. CONCLUSIONS: The median OST was longer than 15 min for more than half of transported cases. For medical cases, women had a longer median OST than men. Additional predictors associated with prolonged OST were the patient's age, area (ie, urban vs rural), type of ambulance vehicle and season. These findings are hypothesis generating and require further studies.

A preoperative modified Allen test result may be associated with long term mortality after hemodialysis access construction.

BACKGROUND: The modified Allen test (MAT) is a simple bedside method determining collateral hand circulation prior to hemodialysis (HD) access surgery. Hand ischemia as reflected by low systolic finger pressures (Pdig) is associated with high mortality rates in severe kidney disease (CKD) patients. Aim of the present study was to assess a possible relation between absolute finger pressure drop (∂Pdig) during a preoperative MAT and mortality after a first HD access construction. METHODS: Pdig (systolic pressure, mmHg) was measured using digital plethysmography following compression of radial and ulnar arteries in CKD patients just before access surgery between January 2009 and December 2018 in one center. The greatest ∂Pdig of both index fingers was used for analysis. Cardiovascular and overall mortality were assessed during the following 4 years using the ERA-EDTA classification system (codes 11, 14-16, 18, 22-26, 29). Cox regression analysis determined possible associations between ∂Pdig and mortality. RESULTS: Complete data sets were available in 108 patients (male n = 71; age 70 years ±12; mean follow up (FU) 1.6 years ±0.1; FU index 99% ±1). Median ∂Pdig was 31 mmHg (range 0-167 mmHg). Patients having cardiovascular disease (CV+) demonstrated higher ∂Pdig values (CV+ 44 ± 5 mmHg vs CV- 29 ± 3 mmHg, p = 0.012). A total of 26 patients (24%) died during FU (CV+ death, n = 16; 62%). For each 10 mmHg ∂Pdig increase, overall mortality increased by 10%, and CV+ mortality by 15% (overall mortality: HR 1.10 [1.01-1.22], p = 0.048; CV+ mortality: 1.15 [1.03-1.29], p = 0.017). Following correction for age, ∂Pdig remained associated with CV+ mortality (HR 1.13 [1.00-1.26], p = 0.043). CONCLUSIONS: A large drop in systolic finger pressure during a preoperative MAT is related to mortality after primary HD access surgery. The role of this potential novel risk parameter requires confirmation in a larger population.

Incidence and predictors of permanent pacemaker implantation after surgical aortic v alve replacement: Data of the Netherlands Heart Registration (NHR).

OBJECTIVE: Permanent pacemaker implantation (PPI) after surgical aortic valve replacement (SAVR) remains a frequent complication. Predictors, however, have been mainly investigated in single-center studies. Therefore, nationwide data were used to identify patients-and procedural risk factors for postoperative PPI. MATERIALS AND METHODS: Data were retrospectively collected from the Netherlands Heart Registration (NHR). Patients enrolled in the NHR undergoing isolated SAVR from 2013 to 2019 were analyzed. Primary endpoint was in-hospital PPI during hospitalization after SAVR. RESULTS: From the NHR database, 5600 patients with symptomatic aortic valve stenosis were included in the study. Crude incidence of post-SAVR PPI was 4.0%. Backward regression analysis identified previous cardiac surgery (odds ratio [OR]: 1.80; 95% confidence interval [CI]: 1.18-2.76), extra-corporeal circulation time (OR: 1.01; 95% CI: 1.00-1.01), vasopressor use (OR: 2.66; 95% CI: 1.79-3.96) and in-hospital cardiac conduction abnormalities (OR: 4.48; 95% CI: 3.36-5.98) as potential predictors for PPI. Across the time, PPI after SAVR significantly increased (OR: 1.11; 95% CI: 1.03-1.21). CONCLUSIONS: From this nationwide analysis, PPI after SAVR remains a low but increasingly frequent complication. Several predictive factors for postoperative PPI after SAVR have been identified and might be useful for patient informed consent about potential adverse event rate.

Breast-related and body-related quality of life following autologous breast reconstruction is superior to implant-based breast reconstruction - A long-term follow-up study.

INTRODUCTION: The better survival rates after breast cancer allow for setting of long-term goals, such as Quality of Life (QoL) and aesthetic outcomes following breast reconstruction. Studies find a higher breast-related QoL and greater satisfaction with breasts following autologous breast reconstruction (ABR) compared to implant-based breast reconstruction (IBR). However, aesthetic results from donor sites can influence body image. This concern is little addressed in the literature. Therefore, the aim of this study was to compare the long-term breast-related and body-related QoL of women who underwent ABR to women who underwent IBR. MATERIAL AND METHODS: A multicenter, cross-sectional survey was conducted between November and December 2020 among women who underwent postmastectomy breast reconstruction between January 2015 and December 2018. A general questionnaire, the BREAST-Q, and the BODY-Q were used to collect data. Multivariable linear regression was performed to adjust differences in Q-scores for potential confounders. RESULTS: In total, 336 patients were included (112 IBR, 224 ABR). Autologous reconstruction resulted in significantly higher mean scores in all subdomains of the BREAST-Q. On the BODY-Q, IBR scored significantly higher on scars, while ABR scored moderately to significantly higher on all other scales. Despite a lower mean score on Hips & outer thighs in women with Lateral Thigh Perforator (LTP) flap reconstruction, no negative influence on body image was found in these women. CONCLUSIONS: Long-term breast-related and body-related outcomes of ABR are superior to IBR. Donor site aesthetic does not adversely affect body image in women who underwent free flap breast reconstruction.

Ultrasound evaluation of the placenta in healthy and placental syndrome pregnancies: A systematic review.

INTRODUCTION: An antepartum screening method to determine normal and abnormal placental function is desirable in the prevention of maternal and fetal pregnancy complications. Placental appearance can easily be obtained and evaluated using 2D ultrasonography, but surprisingly little is known about the change in placental appearance during gestation. Aim of this systematic review was to describe the antepartum placental appearance in placenta syndrome (PS) pregnancies, and to compare this to the appearance in healthy pregnancies. METHODS: A systematic review investigating placental thickness, -lakes and/or -calcifications by ultrasound examination in both uncomplicated (reference group) and PS pregnancies in relation to gestational age was performed. English literature was searched using PubMed (NCBI), EMBASE (Ovid) and the Cochrane Library, from database inception until September 2020. Data on placental thickness was presented as a continuous variable or as the proportion of abnormal placental thickness. Data on placental lakes and -calcifications was presented as prevalence (%). There was no restriction applied on the definition of placental lakes or -calcifications. Due to heterogeneity, pooling of the results was not performed. RESULTS: A total of 28 studies were included describing 1719 PS cases; consisting of 370 (21 %) cases with preeclampsia or pregnancy induced hypertension, 1341 (78 %) cases with fetal growth restriction (FGR) or small for gestational age (SGA), and 8 (1%) cases with combined clinical expressions. In addition, the reference group comprised 3315 pregnant women. Placental thickness showed an increase between the first and second trimester, which was higher in PS- compared to uncomplicated pregnancies. Placental lakes were frequently observed in FGR and SGA pregnancies, especially in the second trimester. Grade 3 calcifications were most prominent in the PS pregnancies, specifically in the late second and third trimester. Moreover, in the reference group, no grade 3 calcifications were reported before 35 weeks of gestation. CONCLUSION: Placental appearance in PS-pregnancies shows higher placental thickness and greater presence of placental lakes and -calcifications compared to uncomplicated pregnancies. Standardized definitions of (ab-)normal placental appearance and longitudinal research in both healthy and complicated pregnancies are needed to improve personalized obstetric care.

Value of biomarkers in predicting mortality in older medical emergency department patients: a Dutch prospective study.

OBJECTIVE: Older emergency department (ED) patients are at high risk of mortality, and it is important to predict which patients are at highest risk. Biomarkers such as lactate, high-sensitivity cardiac troponin T (hs-cTnT), N-terminal pro-B-type natriuretic peptide (NT-proBNP), D-dimer and procalcitonin may be able to identify those at risk. We aimed to assess the discriminatory value of these biomarkers for 30-day mortality and other adverse outcomes. DESIGN: Prospective cohort study. On arrival of patients, five biomarkers were measured. Area under the curves (AUCs) and interval likelihood ratios (LRs) were calculated to investigate the discriminatory value of the biomarkers. SETTING: ED in the Netherlands. PARTICIPANTS: Older (≥65 years) medical ED patients, referred for internal medicine or gastroenterology. PRIMARY AND SECONDARY OUTCOME MEASURES: 30-day mortality was the primary outcome measure, while other adverse outcomes (intensive care unit/medium care unit admission, prolonged length of hospital stay, loss of independent living and unplanned readmission) were the composite secondary outcome measure. RESULTS: The median age of the 450 included patients was 79 years (IQR 73-85). In total, 51 (11.3%) patients died within 30 days. The AUCs of all biomarkers for prediction of mortality were sufficient to good, with the highest AUC of 0.73 for hs-cTnT and NT-proBNP. Only for the highest lactate values, the LR was high enough (29.0) to be applicable for clinical decision making, but this applied to a minority of patients. The AUC for the composite secondary outcome (intensive and medium care admission, length of hospital stay >7 days, loss of independent living and unplanned readmission within 30 days) was lower, ranging between 0.58 and 0.67. CONCLUSIONS: Although all five biomarkers predict 30-day mortality in older medical ED patients, their individual discriminatory value was not high enough to contribute to clinical decision making. TRIAL REGISTRATION NUMBER: NCT02946398; Results.

Indocyanine green angiography for preventing postoperative mastectomy skin flap necrosis in immediate breast reconstruction.

BACKGROUND: Breast cancer will affect one in eight women during their lifetime. The opportunity to restore the removed tissue and cosmetic appearance is provided by reconstructive breast surgery following skin-sparing mastectomy (SSM). Mastectomy skin flap necrosis (MSFN) is a common complication following SSM breast reconstruction. This postoperative complication can be prevented by intraoperative assessment of mastectomy skin flap viability and intervention when tissue perfusion is compromised. Indocyanine green fluorescence angiography is presumed to be a better predictor of MSFN compared to clinical evaluation alone. OBJECTIVES: To assess the effects of indocyanine green fluorescence angiography (ICGA) for preventing mastectomy skin flap necrosis in women undergoing immediate breast reconstruction following skin-sparing mastectomy. To summarise the different ICGA protocols available for assessment of mastectomy skin flap perfusion in women undergoing immediate breast reconstructions following skin-sparing mastectomy. SEARCH METHODS: We searched the Cochrane Breast Cancer Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL; Issue 3, 2019), MEDLINE, Embase, the World Health Organization's International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov in April 2019. In addition, we searched reference lists of published studies. SELECTION CRITERIA: We included studies that compared the use of ICGA to clinical evaluation to assess mastectomy skin vascularisation and recruited women undergoing immediate autologous or prosthetic reconstructive surgery following SSM for confirmed breast malignancy or high risk of developing breast cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the risk of bias of the included nonrandomised studies and extracted data on postoperative outcomes, including postoperative MSFN, reoperation, autologous flap necrosis, dehiscence, infection, haematoma and seroma, and patient-related outcomes. The quality of the evidence was assessed using the GRADE approach and we constructed two 'Summary of finding's tables: one for the comparison of ICGA to clinical evaluation on a per patient basis and one on a per breast basis. MAIN RESULTS: Nine nonrandomised cohort studies met the inclusion criteria and involved a total of 1589 women with 2199 breast reconstructions. We included seven retrospective and two prospective cohort studies. Six studies reported the number of MSFN on a per breast basis for a total of 1435 breasts and three studies reported the number of MSFN on a per patient basis for a total of 573 women. Five studies reported the number of other complications on a per breast basis for a total of 1370 breasts and four studies reported the number on a per patient basis for a total of 613 patients. Therefore, we decided to pool data separately. Risk of bias for each included nonrandomised study was assessed using the Newcastle-Ottawa Scale for cohort studies. There was serious concern with risk of bias due to the nonrandomised study design of all included studies and the low comparability of cohorts in most studies. The quality of the evidence was found to be very low, after downgrading the quality of evidence twice for imprecision based on the small sample sizes and low number of events in the included studies. Postoperative complications on a per patient basis We are uncertain about the effect of ICGA on MSFN (RR 0.79, 95% CI 0.40 to 1.56; three studies, 573 participants: very low quality of evidence), infection rates (RR 0.91, 95% CI 0.60 to 1.40; four studies, 613 participants: very low quality of evidence), haematoma rates (RR 0.87, 95% CI 0.30 to 2.53; two studies, 459 participants: very low quality of evidence) and seroma rates (RR 1.68, 95% CI 0.41 to 6.80; two studies, 408 participants: very low quality of evidence) compared to the clinical group. We found evidence that ICGA may reduce reoperation rates (RR 0.50, 95% CI 0.35 to 0.72; four studies, 613 participants: very low quality of evidence). One study considered dehiscence as an outcome. In this single study, dehiscence was observed in 2.2% of participants (4/184) in the ICGA group compared to 0.5% of participants (1/184) in the clinical group (P = 0.372). The RR was 4.00 (95% CI 0.45 to 35.45; one study; 368 participants; very low quality of evidence). Postoperative complications on a per breast basis We found evidence that ICGA may reduce MSFN (RR 0.62, 95% CI 0.48 to 0.82; six studies, 1435 breasts: very low quality of evidence), may reduce reoperation rates (RR 0.65, 95% CI 0.47 to 0.92; five studies, 1370 breasts: very low quality of evidence) and may reduce infection rates (RR 0.65, 95% CI 0.44 to 0.97; five studies, 1370 breasts: very low quality of evidence) compared to the clinical group. We are uncertain about the effect of ICGA on haematoma rates (RR 1.53, CI 95% 0.47 to 4.95; four studies, 1042 breasts: very low quality of evidence) and seroma rates (RR 0.71, 95% CI 0.37 to 1.35; two studies, 528 breasts: very low quality of evidence). None of the studies reported patient-related outcomes. ICGA protocols: eight studies used the SPY System and one study used the Photodynamic Eye imaging system (PDE) to assess MSFN. ICGA protocols in the included studies were not extensively described in most studies. AUTHORS' CONCLUSIONS: Although mastectomy skin flap perfusion is performed more frequently using ICGA as a helpful tool, there is a lack of high-quality evidence in the context of randomised controlled trials. The quality of evidence in this review is very low, since only nonrandomised cohort studies have been included. With the results from this review, no conclusions can be drawn about what method of assessment is best to use during breast reconstructive surgery. High-quality randomised controlled studies that compare the use of ICGA to assess MSFN compared to clinical evaluation are needed.

Clinical and genetic characteristics of late-onset Huntington's disease.

BACKGROUND: The frequency of late-onset Huntington's disease (>59 years) is assumed to be low and the clinical course milder. However, previous literature on late-onset disease is scarce and inconclusive. OBJECTIVE: Our aim is to study clinical characteristics of late-onset compared to common-onset HD patients in a large cohort of HD patients from the Registry database. METHODS: Participants with late- and common-onset (30-50 years)were compared for first clinical symptoms, disease progression, CAG repeat size and family history. Participants with a missing CAG repeat size, a repeat size of ≤35 or a UHDRS motor score of ≤5 were excluded. RESULTS: Of 6007 eligible participants, 687 had late-onset (11.4%) and 3216 (53.5%) common-onset HD. Late-onset (n = 577) had significantly more gait and balance problems as first symptom compared to common-onset (n = 2408) (P < .001). Overall motor and cognitive performance (P < .001) were worse, however only disease motor progression was slower (coefficient, -0.58; SE 0.16; P < .001) compared to the common-onset group. Repeat size was significantly lower in the late-onset (n = 40.8; SD 1.6) compared to common-onset (n = 44.4; SD 2.8) (P < .001). Fewer late-onset patients (n = 451) had a positive family history compared to common-onset (n = 2940) (P < .001). CONCLUSIONS: Late-onset patients present more frequently with gait and balance problems as first symptom, and disease progression is not milder compared to common-onset HD patients apart from motor progression. The family history is likely to be negative, which might make diagnosing HD more difficult in this population. However, the balance and gait problems might be helpful in diagnosing HD in elderly patients.