Clinical outcomes following responsive neurostimulation implantation: a single center experience
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PROVIDER: S-EPMC10557254 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:Transcatheter aortic valve implantation (TAVI) has been recognized as a valid alternative to surgery for severe aortic valve stenosis (AS) in high-risk surgical patients.Determine first-year clinical outcomes for TAVI at Madinah Cardiac Center (MMC) in Saudi Arabia.Retrospective, analytical cross-sectional.Tertiary cardiac care center.All patients who underwent TAVI for severe AS between February 2013 and December 2016 were included. Clinical, imaging, and laboratory information at baseline and at one year follow-up were analyzed.Clinical and echocardiography out.comes at discharge, at 1-month, and at end of follow-up; one-year mortality, complications and clinical response to TAVI procedure.N=80, mean (SD) age 79.5 (10.6) years, with severe AS and high-surgical risk.Fifty-five (69.2%) patients received Core valves, and 25 (30.8%) received Edward valves. Peri-procedure mortality was 3.8% and 1-year post-operative mortality was 13.8%. Ten patients (12.5%) had life-threatening or major bleeding. Nineteen (23.8%) patients had vascular complications, which were mostly minor. Fourteen patients (17.5%) developed acute kidney injury and 86% of these patients recovered. Five patients (6.25%) had pericardial effusion. Two patients (2.5%) developed endocarditis and another 2 patients (2.5%) had cerebrovascular accidents. Five patients (6.25%) received pacemakers. Mean aortic valve gradient significantly reduced from a mean (SD) 47.6 (19) mm Hg to 10.7 (6.0) mm Hg (P less than .001). New York Heart Association functional class was significantly reduced (P less than .001).The TAVI experience at MCC is encouraging and comparable to international outcomes in terms of success, morbidity, and mortality rate.Retrospective, relatively small sample size. Rate of minor bleeding was overestimated.None.
| S-EPMC6074303 | biostudies-other
Project description:Background and objectivesAlthough the shortage of donor is a common problem worldwide, a significant portion of unutilized hearts are classified as marginal donor (MD) hearts. However, research on the correlation between the MD and the prognosis of heart transplantation (HTx) is lacking. This study was conducted to investigate the clinical impact of MD in HTx.MethodsConsecutive 73 HTxs during 2014 and 2021 in a tertiary hospital were analyzed. MD was defined as follows; a donor age >55 years, left ventricular ejection fraction <50%, cold ischemic time >240 minutes, or significant cardiac structural problems. Preoperative characteristics and postoperative hemodynamic data, primary graft dysfunction (PGD), and the survival rate were analyzed. Risk stratification by Index for Mortality Prediction after Cardiac Transplantation (IMPACT) score was performed to examine the outcomes according to the recipient state. Each group was sub-divided into 2 risk groups according to the IMPACT score (low <10 vs. high ≥10).ResultsA total of 32 (43.8%) patients received an organ from MDs. Extracorporeal membrane oxygenation was more frequent in the non-MD group (34.4% vs. 70.7, p=0.007) There was no significant difference in PGD, 30-day mortality and long-term survival between groups. In the subgroup analysis, early outcomes did not differ between low- and high-risk groups. However, the long-term survival was better in the low-risk group (p=0.01).ConclusionsThe outcomes of MD group were not significantly different from non-MD group. Particularly, in low-risk recipient, the MD group showed excellent early and long-term outcomes. These results suggest the usability of selected MD hearts without increasing adverse events.
| S-EPMC10172206 | biostudies-literature
Project description:Neurostimulation is now an established therapy for the treatment of movement disorders, pain, and epilepsy. While most neurostimulation systems available today provide stimulation in an open-loop manner (i.e., therapy is delivered according to preprogrammed settings and is unaffected by changes in the patient's clinical symptoms or in the underlying disease), closed-loop neurostimulation systems, which modulate or adapt therapy in response to physiological changes, may provide more effective and efficient therapy. At present, few such systems exist owing to the complexities of designing and implementing implantable closed-loop systems. This review focuses on the clinical experience of four implantable closed-loop neurostimulation systems: positional-adaptive spinal cord stimulation for treatment of pain, responsive cortical stimulation for treatment of epilepsy, closed-loop vagus nerve stimulation for treatment of epilepsy, and concurrent sensing and stimulation for treatment of Parkinson disease. The history that led to the development of the closed-loop systems, the sensing, detection, and stimulation technology that closes the loop, and the clinical experiences are presented.
| S-EPMC4121459 | biostudies-literature
Project description:Solitary fibrous tumor (SFT) is a mesenchymal neoplasm of fibrous origin. The 2013 WHO classification of soft tissue tumors defines malignant forms as hypercellular, mitotically active (>4 mitosis/10 high-power fields), with cytological atypia, tumor necrosis, and/or infiltrative margins. With an IRB-approved protocol, we investigated patient records and clinicopathologic data from our Sarcoma Database to describe the clinical characteristics of both benign and malignant SFT. All pathology specimens were reviewed by two pathologists. Descriptive statistics and univariate/multivariate survival analysis were performed. Patient records and Social Security Death Index were used to evaluate vital status. Of 82 patients, 47 (57%) were women and 73 (89%) were Caucasian. Median age was 62 years (range, 20 to 89). Thirty-two (39%) patients succumbed to the disease. Primary tumor site was lung/pleura in 28 (34%), abdomen/pelvis in 23 (28%), extremity in 13 (16%), and head/neck in 9 (11%) patients. Pathology was described as benign in 42 (51%) and malignant in 40 (49%) patients. Compared to benign SFT, malignant histology is associated with larger tumor size, higher mitotic counts, metastatic disease at diagnosis, and greater use of chemotherapy and radiation therapy. Gender, age, and tumor site were not significantly different between benign and malignant subtypes. By univariate analysis, only benign vs. malignant variant and complete resection positively impacted overall survival (P = 0.02 and P<0.0001, respectively). In the multivariable analysis of overall survival, receiving chemotherapy or not receiving surgery were two variables significantly associated with higher failure rate in overall survival: patients with chemotherapy vs. no chemotherapy (P = 0.003, HR = 4.55, with 95% CI: 1.68-12.34) and patients without surgery vs. with surgery (P = 0.005, HR = 25.49, with 95% CI: 2.62-247.57). Clear survival differences exist between benign and malignant SFT. While surgery appears to be the best treatment option for benign and malignant SFT, better systemic therapies are needed to improve outcomes of patients with metastatic, malignant SFT.
| S-EPMC4607370 | biostudies-literature
Project description:ObjectiveOvarian clear cell carcinoma (OCCC) is associated with chemoresistance. Limited data exists regarding the efficacy of targeted therapies such as immune checkpoint inhibitors (ICI) and bevacizumab, and the role of secondary cytoreductive surgery (SCS).MethodsWe retrospectively analyzed genomic features and treatment outcomes of 172 OCCC patients treated at our institution from January 2000 to May 2022. Next-generation sequencing (NGS) was performed where sufficient archival tissue was available.Results64.0% of patients were diagnosed at an early stage, and 36.0% at an advanced stage. Patients with advanced/relapsed OCCC who received platinum-based chemotherapy plus bevacizumab followed by maintenance bevacizumab had a median first-line progression-free survival (PFS) of 12.2 months, compared with 9.3 months for chemotherapy alone (hazard ratio=0.69; 95% confidence interval [CI]=0.33, 1.45). In 27 patients who received an ICI, the overall response rate was 18.5% and median duration of response was 7.4 months (95% CI=6.5, 8.3). In 17 carefully selected patients with fewer than 3 sites of relapse, median PFS was 35 months (95% CI=0, 73.5) and median overall survival was 96.8 months (95% CI=44.6, 149.0) after SCS. NGS on 58 tumors revealed common mutations in ARID1A (48.3%), PIK3CA (46.6%), and KRAS (20.7%). Pathogenic alterations in PIK3CA, FGFR2, and NBN were associated with worse survival outcomes. Median tumor mutational burden was 3.78 (range, 0-16). All 26 patients with available loss of heterozygosity (LOH) scores had LOH <16%.ConclusionOur study demonstrates encouraging outcomes with bevacizumab and ICI, and SCS in select relapsed OCCC patients. Prospective trials are warranted.
| S-EPMC11390249 | biostudies-literature
Project description:We describe the epidemiology and incidence of infections following gender-affirming vaginoplasty. Urinary tract and surgical site infections were the most common infections with incidences of 17.5% and 5.5%, respectively. We also identified a significant gap in human immunodeficiency virus screening and prescription of preexposure prophylaxis.
| S-EPMC11474599 | biostudies-literature
Project description:Background and purposeMyasthenia gravis (MG) is clinically heterogeneous and can be classified into subgroups according to the clinical presentation, antibody status, age at onset, and thymic abnormalities. This study aimed to determine the clinical characteristics and outcomes of generalized MG (GMG) patients based on these subgroups.MethodsMedical records of MG patients from 1976 to 2023 were reviewed retrospectively. Patients with pure ocular MG were excluded. Data on demographic, clinical characteristics, laboratory features, and outcomes were analyzed.ResultsThis study included 120 GMG patients. There was a slight preponderance of female patients over male patients (male:female ratio=1:1.3), with the age at onset exhibiting a bimodal distribution. Female patients peaked at a lower age (21-30 years) whereas male patients peaked at a higher age (61-70 years). Most (92%, 105 of 114) patients had positive anti-acetylcholine receptor antibodies. Five patients were also tested for anti-muscle-specific tyrosine kinase antibodies, with two showing positivity. Thymectomy was performed in 62 (52%) patients, of which 30 had thymoma, 16 had thymic hyperplasia, 7 had an involuted thymus, and 6 had a normal thymus. There were significantly more female patients (68% vs. 45%, p=0.011) with early-onset disease (<50 years old) and thymic hyperplasia (33% vs. 0%, p<0.025). Most (71%) of the patients had a good outcome based on the Myasthenia Gravis Foundation of America postintervention status. GMG patients with early-onset disease had a significantly better outcome than patients with a late onset in univariate (58% vs. 37%, p=0.041) and multivariate (odds ratio=4.68, 95% confidence interval=1.17-18.64, p=0.029) analyses.ConclusionsFemale patients with early-onset MG and thymic hyperplasia had significantly better outcomes, but only early-onset disease was independently associated with a good outcome. These findings are comparable with those of other studies.
| S-EPMC11220361 | biostudies-literature
Project description:ObjectiveThe RNS System is a direct brain-responsive neurostimulation system that is US Food and Drug Administration-approved for adults with medically intractable focal onset seizures based on safety and effectiveness data from controlled clinical trials. The purpose of this study was to retrospectively evaluate the real-world safety and effectiveness of the RNS System.MethodsEight comprehensive epilepsy centers conducted a chart review of patients treated with the RNS System for at least 1 year, in accordance with the indication for use. Data included device-related serious adverse events and the median percent change in disabling seizure frequency from baseline at years 1, 2, and 3 of treatment and at the most recent follow-up.ResultsOne hundred fifty patients met the criteria for analysis. The median reduction in seizures was 67% (interquartile range [IQR] = 33%-93%, n = 149) at 1 year, 75% (IQR = 50%-94%, n = 93) at 2 years, 82% (IQR = 50%-96%, n = 38) at ≥3 years, and 74% (IQR = 50%-96%, n = 150) at last follow-up (mean = 2.3 years). Thirty-five percent of patients had a ≥90% seizure frequency reduction, and 18% of patients reported being clinically seizure-free at last follow-up. Seizure frequency reductions were similar regardless of patient age, age at epilepsy onset, duration of epilepsy, seizure onset in mesial temporal or neocortical foci, magnetic resonance imaging findings, prior intracranial monitoring, prior epilepsy surgery, or prior vagus nerve stimulation treatment. The infection rate per procedure was 2.9% (6/150 patients); five of the six patients had an implant site infection, and one had osteomyelitis. Lead revisions were required in 2.7% (4/150), and 2.0% (3/150) of patients had a subdural hemorrhage, none of which had long-lasting neurological consequences.SignificanceIn this real-world experience, safety was similar and clinical seizure outcomes exceeded those of the prospective clinical trials, corroborating effectiveness of this therapy and suggesting that clinical experience has informed more effective programming.
| S-EPMC7496294 | biostudies-literature
Project description:BackgroundThe incidence of infective endocarditis (IE) in pregnancy is rare (0.006%), with increasing prevalence during the opioid epidemic. IE in pregnancy is associated with high rates of mortality and morbidity, and existing data on outcomes in pregnancy are limited. Our study compares the outcomes of pregnant patients with IE with those of nonpregnant patients.MethodsPatients diagnosed with IE during pregnancy and 30 days postpartum between 2014 and 2021 were identified by International Classification of Diseases, Clinical Modification, Ninth and Tenth Edition codes. Pregnant cases were matched to nonpregnant reproductive-age endocarditis patients in a 1:4 ratio. Data were collected and validated through chart review.ResultsOne hundred eighty patients with IE were identified; 34 were pregnant or within 30 days postpartum at diagnosis. There were higher rates of hepatitis C and opioid maintenance therapy in the pregnant patients. The etiology of IE in pregnant patients was predominantly S. aureus (methicillin-resistant/sensitive S. aureus), whereas nonpregnant woman had greater microbiological variation. We observed comparable rates of valve replacement (32.4% vs 29%; P = .84) and 2-year mortality (20.6% vs 17.8%; P > .99) in pregnant patients. There were nonsignificantly higher rates of pulmonary emboli (17.6% vs 7.5%; P = .098) and arrhythmia (17.6% vs 9.6%; P = .222) among pregnant patients. There were high rates of intravenous drug use relapse in both groups (>40%).ConclusionsWe observed similar rates of mortality in the pregnant IE patients. We observed a microbial predilection for S. aureus in pregnancy, suggesting that the pregnancy physiology may select for this microbiologic etiology. This study, which represents the largest single-center retrospective review of IE in pregnancy, suggests that surgical intervention may be performed safely in the postpartum period.
| S-EPMC10538254 | biostudies-literature
Project description:The natural history, prognostication and optimal treatment of Richter transformation developed from chronic lymphocytic leukemia (CLL) are not well defined. We report the clinical characteristics and outcomes of a large series of biopsy-confirmed Richter transformation (diffuse large B-cell lymphoma or high grade B-cell lymphoma, n=204) cases diagnosed from 1993 to 2018. After a median follow up of 67.0 months, the median overall survival (OS) was 12.0 months. Patients who received no prior treatment for CLL had significantly better OS (median 46.3 vs. 7.8 months; P<0.001). Patients with elevated lactate dehydrogenase (median 6.2 vs. 39.9 months; P<0.0001) or TP53 disruption (median 8.3 vs. 12.8 months; P=0.046) had worse OS than those without. Immunoglobulin heavy chain variable region gene mutation, cell of origin, Myc/Bcl-2 double expression and MYC/BCL2/BCL6 double-/triple-hit status were not associated with OS. In multivariable Cox regression, elevated lactate dehydrogenase [Hazard ratio (HR) 2.3, 95% Confidence Interval (CI): 1.3-4.1; P=0.01], prior CLL treatment (HR 2.0, 95%CI: 1.2-3.5; P=0.01), and older age (HR 1.03, 95%CI: 1.01-1.05; P=0.01) were associated with worse OS. Twenty-four (12%) patients underwent stem cell transplant (20 autologous and 4 allogeneic), and had a median post-transplant survival of 55.4 months. In conclusion, the overall outcome of Richter transformation is poor. Richter transformation developed in patients with untreated CLL has significantly better survival. Stem cell transplant may benefit select patients.
| S-EPMC7049354 | biostudies-literature