bluuebunny/crossref_metadata_2025_split huggingface dataset:
Flecainide is well-tolerated and effective in patient with atrial fibrillation at 12 months: a retrospective study
Authors: Muzzey Mikayla , Tellor Katie B. , Ramaswamy Karthik , Schwarze Martin , Armbruster Anastasia L. 
Published: July 2020

Introduction: Current atrial fibrillation (AF) guidelines recommend flecainide as a first-line rhythm control option in patients without structural heart disease. While there is proven efficacy in clinical trials and guideline support, it is hypothesized that flecainide may be underutilized due to negative outcomes in the CAST trial and that adverse effects are less common than previously perceived. Methods: This retrospective chart review evaluated patients ⩾18 years initiated on flecainide for AF from August 2011 to October 2016 by a cardiology provider at the study site. Exclusion criteria included: <5 days of flecainide therapy, AF due to a reversible cause, and inadequate documentation. The primary outcome was efficacy of flecainide at maintaining symptomatic control at 6 and 12 months. Secondary outcomes included characterization of alterations in rhythm control strategies and documented normal sinus rhythm per electrocardiogram at 6 and 12 months. Results: Of the 326 patients identified, 144 patients were included. After 6 and 12 months, 102 patients (70.8%) and 89 patients (61.8%) of the 144 were symptomatically controlled. Atenolol use ( p = 0.024), female sex ( p = 0.006), hypertension ( p = 0.040), and dronedarone failure ( p = 0.012) were associated with flecainide discontinuation at 6 months. At 12 months, only previous propafenone failure ( p = 0.032) was significant. Of the 144 patients, 16 (11.1%) reported adverse effects with dizziness, hot flashes, bradycardia, and headache (1.4% each) being the most common. Conclusion: Flecainide is a well-tolerated medication, even at 12 months, with very minor adverse effects. These results support the utility of flecainide in guideline recommended patient populations.
Prostanoids in pediatric pulmonary hypertension: clinical response, time‐to‐effect, and dose–response
Authors: Tella Joseph B. , Kulik Thomas J. , McSweeney Julia E. , Sleeper Lynn A. , Lu Minmin , Mullen Mary P. 
Published: July 2020

For pediatric pulmonary arterial hypertension (PAH) patients treated with parenteral prostanoids, response predictors, and the dose–effect relationship are ill defined. We determined the following: (1) which pulmonary vascular hemodynamic variable, after initiating prostanoids, best correlates with a significant clinical response; (2) the time interval after treatment when if no pulmonary hemodynamic improvement has occurred, none is ever likely to; and (3) the relationship between the prostanoid dose and its hemodynamic effects. This is a retrospective cohort study of 31 pediatric patients with Group 1 PAH treated with parenteral prostanoids. We found the following: (1) A fall in mean pulmonary arterial pressure (mPAP) of ≥25% predicted freedom from adverse clinical events with 80.7% accuracy and was also associated with improved functional class. (2) Thirty‐three percent of patients who avoided an adverse clinical event demonstrated a ≥25% reduction in mPAP after 1 year of treatment, and 65% by 2 years. (3) Lower mPAP was seldom seen with doses of epoprostenol >60 ng/kg/min (100 ng/kg/min for treprostinil). Cardiac index was positively correlated with the dose of epoprostenol but not treprostinil; cardiac index >4 l/min/m2 was seen at modest as well as high doses. We conclude that a ≥25% fall in mPAP on prostanoids indicates a positive clinical response which, if validated in other studies, may be useful for patient management or clinical trials. Some patients take more than 2 years for this change. Exceptionally high doses were generally not more effective than lower, although we could not determine whether lower doses would have been as effective.
Pancreatic exocrine insufficiency and pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer: A systematic review and meta‐analysis
Authors: de la Iglesia Daniel , Avci Bartu , Kiriukova Mariia , Panic Nikola , Bozhychko Maryana , Sandru Vasile , de Madaria Enrique , Capurso Gabriele 
Published: July 2020

BackgroundPancreatic cancer is the fourth leading cause of cancer mortality. Most patients are diagnosed with advanced pancreatic cancer, either at locally advanced or metastatic stages, and have a high rate of malnutrition and weight loss which are associated with poor outcomes. Pancreatic exocrine insufficiency is one of the causes of malnutrition and weight loss in these patients. The prevalence and clinical consequences of pancreatic exocrine insufficiency in advanced pancreatic cancer are poorly investigated with heterogeneous results. We sought to determine the prevalence and clinical consequences of pancreatic exocrine insufficiency and the effect of pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer by systematic review and meta‐analysis.MethodsScopus, Medline, and Embase were searched for cohort studies or randomised clinical trials reporting pancreatic exocrine insufficiency and/or the effect of pancreatic enzyme replacement therapy in patients with advanced pancreatic cancer. We considered pancreatic exocrine insufficiency as an abnormal result on direct and/or indirect pancreatic exocrine function tests. Pancreatic enzyme replacement therapy was evaluated by its effect on survival and quality of life in patients with advanced pancreatic cancer.ResultsA total of 11 studies were included; seven studies reported the prevalence of pancreatic exocrine insufficiency and seven the effect of pancreatic enzyme replacement therapy in advanced pancreatic cancer. The pooled prevalence of pancreatic exocrine insufficiency in advanced pancreatic cancer was 72% (95% confidence interval: 55–86%), being significantly higher when tumours were located in the pancreatic head (relative risk = 3.36, 1.07–10.54; p  = 0.04) six studies investigated the impact of pancreatic enzyme replacement therapy on survival/quality of life. Pancreatic enzyme replacement therapy was associated with 3.8 months (95% confidence interval: 1.37–6.19) survival benefit. Patients receiving pancreatic enzyme replacement therapy had a trend towards a better quality of life.Conclusions The prevalence of pancreatic exocrine insufficiency in advanced pancreatic cancer is substantial and its treatment can improve the outcomes of these patients.
A single-centre experience of the management of inguinal lymph nodes associated with penile squamous-cell carcinoma
Authors: Sharma Amit , Parab Sandesh , Goyal Gaurav , Patel Ajit , Andankar Mukund , Pathak Hemant 
Published: July 2020

Background: Twenty-two cases of penile carcinoma that were managed at our institution over a 5-year period were analysed on the basis of inguinal lymph node dissection (ILND), complications and follow-up. Methods: A total of 22 cases post penectomy were stratified into low risk (T1 G1 or G2 without lympho-vascular invasion and negative on fine-needle aspiration cytology (FNAC)) and high risk (T1 G3 and above and/or lympho-vascular invasion). Low-risk patients having palpable lymphadenopathy were given a course of antibiotics. If the lymph nodes were still palpable, FNAC was done, and patients then underwent superficial ILND (SILND) or even ILND in cases with positive frozen-section reports. In the high-risk group, all patients underwent SILND, and if required, underwent ILND. Two patients in the high-risk group were lost to follow-up after 9 months. Histopathology reports were noted, and patients were followed up for 2 years. Results: In the low-risk group, seven patients had palpable lymph nodes and underwent SILND. The remaining five patients were put on surveillance. Amongst the seven who underwent SILND, six were positive at frozen section, requiring ILND. Nine patients in the high-risk group underwent ILND. Four patients in the ILND group had a minor wound infection. Lymphoedema was seen in two patients which was managed conservatively, and lymphorrhoea was seen in one patient. Flap necrosis occurred in one patient. Recurrences were seen in three patients in the high-risk group. Two who had deep node involvement and who had early nodal recurrence underwent bilateral ILND. One patient in the high-risk group had late ipsilateral nodal recurrence and underwent ipsilateral ILND. There were no regional recurrences. Conclusion: Carcinoma of the penis has high morbidity because of delayed presentation, lack of awareness and poor compliance. This necessitates staging SILND in all high-risk cases for therapeutic and prognostic purposes.
Surgical Valvuloplasty Versus Balloon Dilation for Congenital Aortic Stenosis in Pediatric Patients
Authors: Herrmann Jeremy L. , Clark Aaron J. , Colgate Cameron , Rodefeld Mark D. , Hoyer Mark H. , Turrentine Mark W. , Brown John W. 
Published: July 2020

Background: For children with congenital aortic stenosis (AS) who are candidates for biventricular repair, valvuloplasty can be achieved by surgical aortic valvuloplasty (SAV) or by transcatheter balloon aortic dilation (BAD). We aimed to evaluate the longer term outcomes of SAV versus BAD at our institution. Methods: We retrospectively reviewed the outcomes of 2 months to 18 years old patients who underwent SAV or BAD at our institution between January 1990 and July 2018. Baseline and follow-up characteristics were assessed by echocardiography. Long-term survival, freedom from reintervention, freedom from aortic valve replacement (AVR), and aortic regurgitation were evaluated. Results: A total of 212 patients met inclusion criteria (SAV = 123; BAD = 89). Age, sex, aortic insufficiency (AI), and aortic valve gradient were similar between the groups. At 10 years, 27.9% (19/68) of SAV patients and 58.3% (28/48) of BAD patients had moderate or worse AI ( P = .001), and reintervention occurred in 39.2% (29/74) of SAV patients and 78.6% (44/56) of BAD patients ( P < .001). Kaplan-Meier analysis revealed overall survival was 96.8% (119/123) for SAV and 95.5% (85/89) for SAV ( P = .87). At 10 years, 35% (23/66) of SAV patients and 54% (23/43) of BAD patients underwent AVR ( P = .213). Conclusions: Surgical aortic valvuloplasty demonstrated greater gradient reduction, less postoperative and long-term AI, and a lower reintervention rate at 10 years than BAD. There was no difference in survival or AVR reintervention rate. Surgical aortic valvuloplasty is a durable and efficacious intervention and should continue to be considered a favorable choice for palliation of valvular AS.
Higher Paraspinal Muscle Density Effect on Outcomes After Anterior Cervical Discectomy and Fusion
Authors: Pinter Zachariah W. , Wagner Scott C. , Fredericks Donald R. , Xiong Ashley , Freedman Brett A. , Elder Benjamin D. , Nassr Ahmad , Bydon Mohamad , Kepler Christopher K. , Sebastian Arjun S. 
Published: July 2020

Study Design: Retrospective cohort study. Objectives: Studies in the lumbar spine suggest a correlation between sarcopenia and worse patient outcomes. The purpose of this study was to determine whether paraspinal Goutalier grade of fat degeneration is associated with patient-reported outcomes in patients undergoing anterior cervical discectomy and fusion (ACDF). Methods: We performed a retrospective review of a prospective cohort of patients undergoing 1- to 3-level ACDF at a single institution between the years 2011-2014. We utilized preoperative magnetic resonance images to classify patients into Goutalier grades. Patient-reported outcomes, including Neck Disability Index (NDI), RAND score, and EQ-5D score were collected and analyzed according to patients’ Goutalier grade. Results: We identified 69 patients for inclusion. A total of 29 patients were classified as Goutalier 0-1 (group 1), 29 were Goutalier 1.5-2 (group 2), and 11 were Goutalier 2.5-4.0 (group 3). All Goutalier groups experienced significant improvement in all 3 outcome scores. Average postoperative NDI scores were 25.3 in group 1, 13.9 in group 2, and 25.1 in group 3 ( P = .02). The percentage of patients in each group reporting worse disability after surgery was 17.2%, 3.3%, and 9.1%, respectively ( P = .05). No statistically significant difference was seen between groups in postoperative EQ-5D ( P = .07) or RAND scores ( P > .05). Conclusions: The present study is the first to assess the association between cervical paraspinal muscle Goutalier grade and patient-reported outcomes following ACDF. Based on our study, patients with worse cervical paraspinal degeneration may benefit from improved symptom relief in comparison to patients with a lesser degree of degeneration undergoing ACDF.
An Assessment of Nonoperative Management Strategies in a Herniated Lumbar Disc Population: Successes Versus Failures
Authors: Lilly Daniel T. , Davison Mark A. , Eldridge Cody M. , Singh Ravinderjit , Montgomery Eric Y. , Bagley Carlos , Adogwa Owoicho 
Published: July 2020

Study Design: Retrospective cohort study. Objective: To compare the utilization of conservative treatments in patients with lumbar intervertebral disc herniations who were successfully managed nonoperatively versus patients who failed conservative therapies and elected to undergo surgery (microdiscectomy). Methods: Clinical records from adult patients with an initial herniated lumbar disc between 2007 and 2017 were selected from a large insurance database. Patients were divided into 2 cohorts: patients treated successfully with nonoperative therapies and patients that failed conservative management and opted for microdiscectomy surgery. Nonoperative treatments utilized by the 2 groups were collected over a 2-year surveillance window. “Utilization” was defined by cost billed to patients, prescriptions written, and number of units disbursed. Results: A total of 277 941 patients with lumbar intervertebral disc herniations were included. Of these, 269 713 (97.0%) were successfully managed with nonoperative treatments, while 8228 (3.0%) failed maximal nonoperative therapy (MNT) and underwent a lumbar microdiscectomy. MNT failures occurred more frequently in males (3.7%), and patients with a history of lumbar epidural steroid injections (4.5%) or preoperative opioid use (3.6%). In a logistic multivariate regression analysis, male sex and utilization of opioids were independent predictors of conservative management failure. Furthermore, a cost analysis indicated that patients who failed nonoperative treatments billed for nearly double ($1718/patient) compared to patients who were successfully treated ($906/patient). Conclusion: Our results suggest that the majority of patients are successfully managed nonoperatively. However, in the subset of patients that fail conservative management, male sex and prior opioid use appear to be independent predictors of treatment failure.
Radiographic Outcomes after Flexible Flatfoot Reconstruction with and without Spring Ligament Reconstruction
Authors: Kohring Jessica M. , MacDonald Ashlee , Karnyski Steven , Oh Irvin , Baumhauer Judith F. , Ketz John P. , Flemister Adolph S. 
Published: July 2020

Category: Hindfoot Introduction/Purpose: The purpose of this study was to determine postoperative radiographic differences between patients who underwent flexible flatfoot reconstruction and spring ligament repair with a FiberTape suture device versus those who underwent spring ligament reconstruction with suture repair alone or those without reconstruction of the spring ligament for patients with Stage II adult acquired flatfoot deformity (AAFD). Methods: 84 patients with Stage II AAFD met inclusion criteria with 18 undergoing flatfoot reconstruction and spring ligament (SL) repair with a FiberTape suture device (SL+FT), 12 with suture repair alone (SL+suture), and 54 without repair of the SL. Radiographic measurements were made on weight bearing radiographs pre- and postoperatively at an average of 90 ±108 weeks after surgery. The radiographic measurements included tibiotalar tilt (TT), talar-first metatarsal angle (T1M), talar-second metatarsal angle (T2M), talonavicular uncoverage angle (TN), Meary’s angle (MA), calcaneal pitch (CP), medial column height (MCH), and lateral column height (LCH). Statistical analysis was performed using two-way ANOVA. Results: There were no differences in preoperative radiographic measurements between the three groups. Postoperatively, the SL+FT and SL+suture groups had statistically significantly improved radiographic outcomes for T1M, T2M, TN, MA, CP, and LCH when compared to the no SL repair group (p<0.05). There were no differences in any radiographic outcomes between the SL+FT and SL+suture groups ( Figure 1 ). Conclusion: Spring ligament reconstruction with either a FiberTape construct or suture repair alone demonstrates significant improvements in postoperative radiographic outcomes after undergoing flexible flatfoot reconstruction at an average of 2 years after surgery as compared to patients that did not have SL repair. The results of our study support spring ligament repair or reconstruction for patients when performing flexible flatfoot surgery for Stage II AAFD.
Real-world data confirm the effectiveness of caplacizumab in acquired thrombotic thrombocytopenic purpura
Authors: Völker Linus A. , Kaufeld Jessica , Miesbach Wolfgang , Brähler Sebastian , Reinhardt Martin , Kühne Lucas , Mühlfeld Anja , Schreiber Adrian , Gaedeke Jens , Tölle Markus , Jabs Wolfram J. , Özcan Fedai , Markau Silke , Girndt Matthias , Bauer Frederic , Westhoff Timm H. , Felten Helmut , Hausberg Martin , Brand Marcus , Gerth Jens , Bieringer Markus , Bommer Martin , Zschiedrich Stefan , Schneider Johanna , Elitok Saban , Gawlik Alexander , Gäckler Anja , Kribben Andreas , Schwenger Vedat , Schoenermarck Ulf , Roeder Maximilian , Radermacher Jörg , Bramstedt Jörn , Morgner Anke , Herbst Regina , Harth Ana , Potthoff Sebastian A. , von Auer Charis , Wendt Ralph , Christ Hildegard , Brinkkoetter Paul T. , Menne Jan 
Published: July 2020

Abstract
Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare but life-threatening condition. In 2018, the nanobody caplacizumab was approved for the treatment of adults experiencing an acute episode of aTTP, in conjunction with plasma exchange (PEX) and immunosuppression for a minimum of 30 days after stopping daily PEX. We performed a retrospective, observational analysis on the use of caplacizumab in 60 patients from 29 medical centers in Germany during acute disease management. Caplacizumab led to a rapid normalization of the platelet count (median, 3 days; mean 3.78 days). One patient died after late treatment initiation due to aTTP-associated complications. In 2 patients with initial disease presentation and in 4 additional patients with laboratory signs of an exacerbation or relapse after the initial therapy, PEX-free treatment regimens could be established with overall favorable outcome. Caplacizumab is efficacious in the treatment of aTTP independent of timing and ancillary treatment modalities. Based on this real-world experience and published literature, we propose to administer caplacizumab immediately to all patients with an acute episode of aTTP. Treatment decisions regarding the use of PEX should be based on the severity of the clinical presentation and known risk factors. PEX might be dispensable in some patients.
ADAMTS13 and VWF activities guide individualized caplacizumab treatment in patients with aTTP
Authors: Völker Linus A. , Kaufeld Jessica , Miesbach Wolfgang , Brähler Sebastian , Reinhardt Martin , Kühne Lucas , Mühlfeld Anja , Schreiber Adrian , Gaedeke Jens , Tölle Markus , Jabs Wolfram J. , Özcan Fedai , Markau Silke , Girndt Matthias , Bauer Frederic , Westhoff Timm H. , Felten Helmut , Hausberg Martin , Brand Marcus , Gerth Jens , Bieringer Markus , Bommer Martin , Zschiedrich Stefan , Schneider Johanna , Elitok Saban , Gawlik Alexander , Gäckler Anja , Kribben Andreas , Schwenger Vedat , Schoenermarck Ulf , Roeder Maximilian , Radermacher Jörg , Bramstedt Jörn , Morgner Anke , Herbst Regina , Harth Ana , Potthoff Sebastian A. , von Auer Charis , Wendt Ralph , Christ Hildegard , Brinkkoetter Paul T. , Menne Jan 
Published: July 2020

Abstract
Introduction of the nanobody caplacizumab was shown to be effective in the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in the acute setting. The official recommendations include plasma exchange (PEX), immunosuppression, and the use of caplacizumab for a minimum of 30 days after stopping daily PEX. This study was a retrospective, observational analysis of the use of caplacizumab in 60 patients from 29 medical centers in Germany. Immunosuppressive treatment led to a rapid normalization of ADAMTS13 activities (calculated median, 21 days). In 35 of 60 patients, ADAMTS13 activities started to normalize before day 30 after PEX; in 11 of 60 patients, the treatment was extended beyond day 30; and in 5 patients, it was extended even beyond day 58 due to persistent autoimmune activity. In 34 of 60 instances, caplacizumab was stopped before day 30 with a favorable outcome whenever ADAMTS13 activities were &gt;10%. In contrast, 11 of 34 patients with ADAMTS13 activities &lt;10% at the time of stopping caplacizumab treatment developed a nonfavorable outcome (disease exacerbation or relapse). In some cases, prolongation of the treatment interval to every other day was feasible and resulted in a sustained reduction of von Willebrand factor activity. ADAMTS13 activity measurements are central for a rapid diagnosis in the acute setting but also to tailor disease management. An ADAMTS13 activity–guided approach seems safe for identifying the individual time point when to stop caplacizumab to prevent overtreatment and undertreatment; this approach will result in significant cost savings without jeopardizing the well-being of patients. In addition, von Willebrand factor activity may serve as a biomarker for drug monitoring.