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Sustained Effectiveness, Tolerability, and Safety of Long-Term Prophylaxis with Lanadelumab in Hereditary Angioedema: The Prospective, Phase 4, Noninterventional EMPOWER Real-World Study
No full textINTRODUCTION: Lanadelumab is approved for long-term prophylaxis of hereditary angioedema (HAE) attacks in patients aged ≥ 2 years in the USA and aged ≥ 12 years in Canada. The EMPOWER Study (NCT03845400) evaluated the real-world effectiveness and safety of lanadelumab in male and female patients with HAE due to C1 inhibitor deficiency type 1 or 2 from the USA and Canada. Here, we report final, up to 36-month, data.
METHODS: Patients aged ≥ 12 years were classified as newly treated with lanadelumab or established on lanadelumab (receiving \u3c 4 and ≥ 4 lanadelumab doses at enrollment, respectively). The primary objective was effectiveness of lanadelumab as measured by HAE attack rate before and after lanadelumab initiation. Safety data were collected.
RESULTS: A total of 109 patients received ≥ 1 lanadelumab dose and had ≥ 1 post-baseline safety assessment. Patients were 40.9 (17.4) years of age (mean [standard deviation (SD)]), majority (72/109; 66.1%) female, 37/109 (33.9%) male, and over 90% white. Patients newly treated with and established on lanadelumab received lanadelumab for 737.7 (374.5) (mean [SD]) and 907.1 (469.3) days, respectively, during the study. In patients newly treated with lanadelumab, the mean (95% confidence interval) observed attack rate (attacks/month) decreased by 85% after lanadelumab initiation, from 1.42 (0.34-2.50) pre-lanadelumab to 0.20 (0.02-0.38) post-lanadelumab initiation (cumulative period). Patients established on lanadelumab had an observed attack rate of 0.20 (0.10-0.30) during 36 months\u27 follow-up. Of 154 treatment-emergent adverse events (TEAEs), no injection site reactions were reported and 6 (in 2 patients) were considered related to lanadelumab; no lanadelumab-related TEAEs were serious.
CONCLUSION: Real-world data from EMPOWER showed marked HAE attack rate reduction up to 36 months after initiating lanadelumab in patients newly treated with lanadelumab and maintenance of low attack rates in patients established on lanadelumab. No new safety signals were identified.
TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT03845400. Graphical abstract available for this article
Highlights from the American College of Cardiology and American Heart Association 2024 Guideline for Perioperative Cardiovascular Management for Noncardiac Surgery
No full textIncreasing noncardiac surgery volumes globally combined with the growing prevalence of cardiovascular risk factors continues to pose a challenge for anesthesiologists caring for patients in the perioperative period. Forty-five percent of all patients \u3e45 years old have multiple cardiovascular risk factors, with cardiovascular complications reported in three percent of surgical admissions. In 2024, the American College of Cardiology and the American Heart Association, in collaboration with several subspecialty societies, updated the 2014 guidelines on the management of cardiovascular diseases in the perioperative period for patients undergoing noncardiac surgery. Some of the topics covered include perioperative risk calculators, guidelines for diagnostic testing, perioperative considerations for cardiovascular comorbidities, management of medical therapies, and anesthetic/intraoperative management strategies. Since the guidelines are broad and detailed, this article highlights essential recommendations that are especially relevant to the busy perioperative physician
What Is the Role for TAVI in Failing Surgical Aortic Valves? A Review on Valve-in-Valve Interventions
No full textBioprosthetic surgical aortic valve failure represents a significant clinical challenge that necessitates timely and effective intervention to restore valve function and ensure patient well-being. Use of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) has emerged as a feasible alternative to reoperation surgical aortic valve replacement (SAVR). By providing a less invasive option, this approach offers the opportunity to reduce the potential risks of a reoperation surgery. However, it is important to note that implementing ViV-TAVI requires careful preparation. This review outlines a thorough approach to ViV-TAVI, encompassing preprocedural planning, valve selection, implantation procedure, and its complications. With the availability of updated clinical data supporting long-term outcomes, this particular strategy is an excellent choice for the treatment of failed surgical aortic bioprostheses
Barlow\u27s Transcatheter Edge-to-Edge Repair in Mitral Annular Calcification: Intracardiac Echocardiography-Guided
No full textOBJECTIVE: The presence of Barlow\u27s and mitral annular calcification poses significant challenges in mitral transcatheter edge-to-edge repair (M-TEER). Our case involved a patient with both pathologies who underwent successful 3-dimensional intracardiac echocardiography (ICE)-guided M-TEER technique with the PASCAL Precision system (Edwards Lifesciences).
KEY STEPS: Our case was an 87-year-old woman with underlying percutaneous endoscopic gastrostomy feeding tube, failed transesophageal echocardiogram probe insertion, proceeded with 3-dimensional ICE-guided M-TEER. With fluoroscopic and ICE guidance, one PASCAL P10 was deployed at 12-6 o\u27clock lateral A2P2 position, a second PASCAL Ace was deployed at 11-5 o\u27clock at medial A2P2 position, and a third PASCAL Ace was deployed at 10-4 o\u27clock at A3P3 medial commissure position. Reduced mitral regurgitation occurred from severe to trivial-mild, without significantly increasing the mitral gradient.
POTENTIAL PITFALLS: One of the tips in this case would be septostomy using the Armada balloon to facilitate manipulation of the ICE inside the left atrium. Careful manipulation of the delivery system under fluoroscopic guidance was also critical in multiple clips strategy, especially when starting the first clip in lateral position. A combination of P10 and Ace devices would likely be the choice in complex mitral anatomy cases.
TAKE-HOME MESSAGE: Three-dimensional ICE-guided M-TEER with the use of P10 and Ace of PASCAL system in Barlow\u27s with MAC is feasible with improvement in mitral regurgitation without elevating the mitral gradient
Cardiac Computed Tomography for Prosthetic Heart Valve Assessment: An Expert Consensus Document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the European Society of Cardiovascular Radiology (ESCR), the North American Society of Cardiovascular Imaging (NASCI), the Radiological Society of North America (RSNA), the Society for Cardiovascular Angiography & Interventions (SCAI) and Society of Thoracic Surgeons (STS)
No full textProsthetic heart valve (PHV) dysfunction is increasingly seen due to the increase in the number of PHV that are being implanted worldwide. Cardiac CT imaging has emerged as a valuable tool to assess PHVs and determine the cause of dysfunction. This consensus document first summarizes the available techniques for PHV assessment. Then the use of CT in PHV (dys)function assessment is discussed in detail including consensus statements for correct indications and patient selection for CT assessment of PHVs, image acquisition, reconstruction and measurement protocols and how to interpret and report the CT findings for specific types of PHV dysfunction
Patients With Crohn\u27s Disease and Terminal Ileum Resection are at Increased Risk of Colorectal Cancer: A Population-Based Study
No full textPatients with Crohn\u27s disease (CD) who undergo terminal ileum (TI) resection experience altered bile acid absorption, which may influence colorectal cancer (CRC) risk. We conducted a propensity-matched cohort study using TriNetX to compare CRC risk in patients with CD who underwent TI resection versus those who did not. Terminal ileum resection was associated with an increased risk of CRC (aHR = 2.58, 95% CI, 1.72-3.86). Patients with TI resection also had higher odds of colorectal polyps. These findings suggest the need for heightened CRC surveillance in patients with CD undergoing TI resection
Machine learning-based prognostic subgrouping of glioblastoma: A multicenter study
No full textBACKGROUND: Glioblastoma (GBM) is the most aggressive adult primary brain cancer, characterized by significant heterogeneity, posing challenges for patient management, treatment planning, and clinical trial stratification.
METHODS: We developed a highly reproducible, personalized prognostication, and clinical subgrouping system using machine learning (ML) on routine clinical data, magnetic resonance imaging (MRI), and molecular measures from 2838 demographically diverse patients across 22 institutions and 3 continents. Patients were stratified into favorable, intermediate, and poor prognostic subgroups (I, II, and III) using Kaplan-Meier analysis (Cox proportional model and hazard ratios [HR]).
RESULTS: The ML model stratified patients into distinct prognostic subgroups with HRs between subgroups I-II and I-III of 1.62 (95% CI: 1.43-1.84, P \u3c .001) and 3.48 (95% CI: 2.94-4.11, P \u3c .001), respectively. Analysis of imaging features revealed several tumor properties contributing unique prognostic value, supporting the feasibility of a generalizable prognostic classification system in a diverse cohort.
CONCLUSIONS: Our ML model demonstrates extensive reproducibility and online accessibility, utilizing routine imaging data rather than complex imaging protocols. This platform offers a unique approach to personalized patient management and clinical trial stratification in GBM
Extended Endoscopic Posterior Nasal Neurectomy
No full textA surgical technique for extended endoscopic posterior nasal neurectomy (EPNN) is described, which includes transection of both posterior nasal and posterolateral nasal nerves to treat medically refractory chronic rhinitis. This approach targets a broader range of autonomic and sensory fibers than a traditional EPNN. A case example demonstrates complete symptom resolution at 6-month follow-up
Three-Dimensional-Printed Models and Shared Decision-Making: A Cluster Randomized Clinical Trial
No full textIMPORTANCE: Patients undergoing surgery report a lack of involvement in health care decisions and increased anxiety. Three-dimensional (3D)-printed models serve as educational tools to encourage patient engagement, reduce anxiety levels, and aid understanding.
OBJECTIVE: To determine the impact of 3D-printed anatomic models on shared decision-making (SDM) and patient anxiety during the preoperative surgical consultation for colon or rectal resection.
DESIGN, SETTING, AND PARTICIPANTS: This single-center cluster randomized clinical trial was conducted from March 2022 to June 2023 at a colorectal surgery clinic at an academic medical institution and included adult patients scheduled for partial or complete colon and/or rectal resection for colorectal cancer, diverticular disease, or inflammatory bowel disease.
INTERVENTION: Six surgeons (clusters) were randomized to counsel patients using a modular 3D-printed model or providing usual care during preoperative clinic visits.
MAIN OUTCOMES AND MEASURES: The primary outcome was the patient\u27s perception of involvement in decision-making using the 9-item Shared Decision Making Questionnaire. The secondary outcome was the change in anxiety level measured using the State-Trait Anxiety Inventory. Patient characteristics were compared between the 3D-printed model and usual care arms using a χ2 test for categorical variables and a t test for comparisons between continuous variables.
RESULTS: Among the 51 patients enrolled (mean [SD] age, 50.7 [14.5] years; 28 female [54.9%]), 28 (54.9%) were in the 3D-printed model arm and 23 (45.1%) were in the usual care arm. Patients counseled with the 3D-printed model reported a significantly higher involvement in SDM compared with those in the usual care group (mean [SD] score, 89.5 [17.6] vs 80.5 [14.4]; P = .01). Additionally, using a 3D-printed model significantly reduced mean anxiety scores (from 53.5 [SD, 21.2] to 44.1 [SD, 15.8]) compared with conventional methods (from 50.4 [SD, 18.3] to 48.0 [SD, 15.3]) (P = .04).
CONCLUSIONS AND RELEVANCE: This cluster randomized clinical trial found that counseling aided with 3D models during preoperative clinic visits improved SDM among patients undergoing colorectal surgery. This study highlights the potential of 3D-printed models as a tool to enhance patient-clinician collaborations. Given the findings, further research into the effectiveness and implementation of these tools is recommended in more diverse clinical settings.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06625008
Evaluating outcomes after metabolic/bariatric surgery among middle Eastern and North African patients in Michigan
No full textBACKGROUND: The Middle Eastern and North African (MENA) population of the United States consists of 3.8 million citizens. This study compares health care outcomes for MENA patients undergoing metabolic and bariatric surgery (MBS) in Michigan to those of non-MENA patients statewide.
OBJECTIVES: To compare outcomes of MBS between MENA and non-MENA patients in Michigan and identify disparities in surgery rates.
SETTING: Michigan Bariatric Surgery Collaborative (MBSC), Ann Arbor, MI.
METHODS: This retrospective cohort study used data from the MBSC database from 2017 to 2024. The cohort consisted of self-identified MENA patients (n = 799), approximately 1.5% of the MBSC total patient cohort. Data collected included demographic information, co-morbidities, type of bariatric procedure performed, adverse events at 30 days and at 1-year postoperative, including weight loss and changes in co-morbid status.
RESULTS: Compared to non-MENA patients, MENA patients were more likely to be males (25.8% vs. 18.5%; P \u3c .0001), present at younger ages (age \u3c 30 years: 21.8% vs. 11.0%, P \u3c .0001), have lower initial body mass index (BMI) (45.1 vs 47.4, P \u3c .001), be active smokers (12.6% vs 8.5%; P \u3c .0001), and undergo sleeve gastrectomy (84.7% vs 80.1%; P = .0011). There were no differences in 30-day complications (5.9% vs. 5.7%, P = .5056), although MENA patients had lower rates of emergency department visits (6.3% vs 7.1%, P = .0139) and healthcare utilization (8.6% vs 10.0%, P = .0117). Overall, there were no differences in weight loss outcomes or rates of comorbidity improvement at 1 year following MBS among MENA patients undergoing gastric bypass specifically, the percent total weight loss at 1 year was lower than non-MENA patients (30.2% vs 33.4%, P = .0168).
CONCLUSION: MENA individuals tend to pursue MBS at a younger age and with a lower BMI. Bariatric surgery appears equally safe and similarly effective in this patient population