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Propensity Score Analysis of Possible Medication Effects on Outcomes in Patients With Systemic Right Ventricles.
No full textBACKGROUND: Patients with systemic right ventricle (SRV), either d-transposition of the great arteries following an atrial switch procedure or congenitally corrected transposition of the great arteries, develop severe right ventricular dysfunction, prompting appropriate medical therapy. However, the efficacy of beta-blockers and angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (ACEI) in SRV patients is unproven.
OBJECTIVES: The objective of this study was to determine the effects of ACEI/ARB and beta-blockers on outcomes in SRV patients after accounting for likely cofounders affecting their use.
METHODS: From a retrospective, multicenter study on heart failure-related outcome in individuals with SRV, those who were taking an ACEI/ARB, beta-blocker, or both of these medication were identified. We performed a propensity analysis to match them to those not using these medications at their initial visit. Matching was based on a propensity score, which captured co-morbidities, demographics, and baseline echocardiographic parameters. Primary outcome of death, transplant, or mechanical circulatory support, and secondary outcomes of heart failure hospitalizations/atrial arrhythmias were analyzed respectively.
RESULTS: We identified 393 patients taking ACEI/ARB or beta-blocker, or taking both a beta-blocker and ACEI/ARB (62.1% male, median age 31.3 years) and 484 patients (56.4% male, median age of 26.0 years) who were neither on a beta-blocker nor on ACEI/ARB at the time of initial clinic visit. Median follow-up was ∼8 years. After propensity matching, medication use was not associated with decreased mortality, heart failure hospitalizations, or arrhythmias. Hazard ratios remained positive for beta blockers, implying potential harm rather than benefit.
CONCLUSIONS: In this large multicenter propensity-matched observational study, patients with SRV taking beta-blockers or ACEI/ARB did not have a benefit in survival or reduced hospitalization. The likelihood of demonstrating favorable effects in larger studies appears remote
Six-month safety and efficacy outcomes from the randomized-controlled arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial.
No full textStenosis within the arteriovenous fistula (AVF) of hemodialysis patients leads to vascular access dysfunction and inadequate hemodialysis. Percutaneous transluminal angioplasty (PTA) is the standard therapy for stenosis. However, rates of restenosis and loss of access patency remain high. Outcomes of a novel cell-impermeable endoprosthesis (CIE) have not been investigated in this setting. Therefore, our study was designed to address this as a prospective, international, multicenter pivotal trial (NCT04540302) with 245 patients with stenosis in their venous outflow circuit randomized to treatment: 122 receiving CIE and 123 receiving PTA across 43 international centers. Primary endpoints included target lesion primary patency (TLPP) at six months (freedom from clinically driven target lesion revascularization or target lesion thrombosis) and freedom from safety events through 30 days post-index procedure that affected the access circuit and resulted in reintervention, hospitalization, or death. Access circuit primary patency (ACPP) was evaluated as a secondary efficacy endpoint. Six-month TLPP and ACPP were significantly higher for the CIE cohort versus PTA (TLPP: 89.6% vs. 62.3%; ACPP: 72.2% vs. 57.0%). Thirty days post-index procedure, there was no statistically significant difference in the freedom from safety events for the CIE versus PTA (96.6 vs. 95.0%). No differences were observed in adverse events between either cohort. Our study shows that among patients with stenosis in their AVF, the CIE was superior to PTA with respect to six-month TLPP and ACPP with no observed difference in 30-day primary safety events
How to educate patients and caregivers on end-of-life nutrition care and support.
No full textBACKGROUND: There are numerous articles, book chapters, and published guidelines on the topic of clinical ethics in the use of artificially administered nutrition and hydration, which often incorporates end-of-life (EOL) nutrition care and support. Components of clinical ethics involve the importance of ethical principles, patient-centered care, and shared decision-making. However, there is sparse information on how to educate patients and caregivers on this subject.
METHODS: Initially, PubMed and the Cochrane Library were used to find articles on the subject. Articles were reviewed and new concepts were identified to include.
RESULTS: There is a practice gap with not applying clinical ethics in practice. The application of clinical ethics, which includes the teach-back method of education, soft skills and behavioral skills training, and potential sacred moments, is not well addressed in the literature. Demonstration of the process of incorporating clinical ethics into practice is beneficial in helping educate clinicians so they can then effectively educate the patient and caregiver on EOL nutrition care and support. Reasons for not applying clinical ethics in actual clinical practice may be because of clinicians not receiving training, the lack of opportunity to observe the technique applied in actual clinical practice, or possibly concern for the presumed additional time required in clinical practice to apply clinical ethics.
CONCLUSION: Educating patients and caregivers on EOL nutrition care and support presupposes engaging, educating, and empowering clinicians about clinical ethics by demonstrating the process and encouraging educators to incorporate the information in an interdisciplinary/interprofessional curriculum
Importance of Surgical Margins in Patients with Early-Stage Merkel Cell Carcinoma.
No full textINTRODUCTION: The National Comprehensive Cancer Network (NCCN) recommends excision of the primary tumor using 1-2-cm surgical margins and sentinel lymph node biopsy (SLNB) as the initial management of early-stage Merkel cell carcinoma (MCC). However, there is no clear consensus on the appropriate size of the surgical margins and/or the use of Mohs micrographic surgery (MMS). Our aim was to demonstrate that, independent of the type of surgery, obtaining negative surgical margins is associated with enhanced overall survival (OS).
METHODS: A retrospective study was performed using early-stage MCC patients from the National Cancer Database (NCDB) who were diagnosed between 2004 and 2020 and underwent surgical excision (SE) of their primary tumor. Patients were stratified into three groups based on the surgical treatment they received: \u3c 1 cm excision margin, ≥ 1 cm excision margin, or MMS. OS was assessed with Kaplan-Meier curves, log-rank tests, and multivariable risk-adjusted Cox proportional-hazards regression.
RESULTS: Of the 4,607 patients included in this study; 53% underwent SE of ≥ 1 cm (n = 2,474), 41% had SE \u3c 1 cm (n = 1,905), and the remainder had MMS (n = 228). 75% of patients had an SLNB, and 56% received adjuvant radiation to the primary site and/or nodal basin. While no difference in OS was observed between the three surgical treatments, negative surgical margins (hazard ratio (HR) 0.78; 95% confidence interval (CI) 0.65-0.94) and receipt of radiation to the primary site (HR 0.82; 95% CI 0.73-0.92) were both independently associated with improved OS.
CONCLUSION: Achieving negative surgical margins is associated with improved OS in MCC, suggesting that MMS and conventional excision are both suitable approaches for the treatment of primary MCC
Comparative microRNA signatures based on liquid biopsy to identify lymph node metastasis in T1 colorectal cancer patients undergoing upfront surgery or endoscopic resection.
No full textAfter endoscopic resection of T1 colorectal cancer (CRC) with a high risk of lymph node metastasis (LNM), additional surgery is required. However, the actual frequency of LNM based on conventional risk factors is less than 16%. There is a need for biomarkers to identify T1 CRC carrying a high risk of metastasis to avoid unnecessary radical surgery. Based on the comparison of serum miRNA between stage I/II and stage III from a large-scale in silico dataset, we conducted a validation analysis of the selected miRNAs using plasma samples from LNM-positive and LNM-negative T1 CRC patients who underwent endoscopic treatment followed by radical surgery at our hospital. In the validation cohort, the three-miRNA classifiers (miR-195-5p, miR-221-3p, and miR-193b-3p) effectively identified LNM-positive T1 CRC patients who received upfront surgery with an area under the curve (AUC) value of 0.74. Moreover, in T1 CRC patients after endoscopic resection, miR-195-5p and miR-221-3p were able to predict LNM with an AUC of 0.74. Plasma miRNA signatures may serve as effective predictors for LNM in T1 CRC both before upfront surgery and after endoscopic resection
Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study.
No full textBACKGROUND: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE.
METHODS: The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality.
RESULTS: In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0-2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4-9.0] mm, and the median neck width was 3.6 [2.7-5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively.
CONCLUSION: These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs
DISCOntinuation of disease-modifying therapies in MS: The DISCOMS extension trial.
No full textBACKGROUND: In the DISCOMS (DISCOntinuation of disease-modifying therapies (DMTs) in multiple sclerosis (MS)) randomized clinical trial, we could not demonstrate that discontinuing MS DMTs in older, stable adults was not inferior to continuing DMTs. Relapses were rare in both groups, and most new disease activity was one to two new brain magnetic resonance imaging (MRI) lesions unassociated with clinical changes.
OBJECTIVE/AIMS: Describe results of the DISCOMS extension study.
METHODS: Among 10/19 of the original sites, we enrolled patients who completed DISCOMS; did not reach the primary endpoint during the original trial; and retained original randomized assignment. Participants completed one study visit and brain MRI at least 30 months after original enrollment in DISCOMS. Primary endpoint was time from entry into the primary study to relapse or new brain MRI activity.
RESULTS: Mean (SD) total follow-up was 40 (11.7) months. There were no relapses, and new brain MRI lesions (1/30 continuer, 2/44 discontinuers) were uncommon during the extension. Time from primary trial entry to disease event was significantly shorter for subjects in the discontinue group (
CONCLUSIONS: From entry into DISCOMS extension study, time to new MS activity remained shorter in discontinuers, but relapses were absent and new brain MRI lesions were rare
Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial.
No full textBACKGROUND: Patients with tricuspid regurgitation (TR) frequently have transvalvular cardiac implantable electronic device (CIEDs).
OBJECTIVES: The aim of this study was to determine the safety and efficacy of tricuspid transcatheter edge-to-edge repair in patients with transvalvular CIED leads.
METHODS: The TRILUMINATE (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) Pivotal Trial (NCT03904147) is an international randomized, controlled trial in symptomatic subjects with severe TR. Subjects with CIED leads were screened by an eligibility committee prior to inclusion into the randomized or single-arm cohorts. Safety events were adjudicated by an independent review committee. All echocardiograms were analyzed by an independent core laboratory.
RESULTS: A total of 98 subjects (of 469) with attempted TriClip procedures had transvalvular CIED leads. CIED+ subjects were older (80.2 ± 8.6 years vs 78.2 ± 7.6 years; P = 0.02), with a higher prevalence of renal disease (46.9% vs 31.5%; P = 0.004) and lower health status (Kansas City Cardiomyopathy Questionnaire overall summary score 51.9 ± 21.0 vs 55.0 ± 23.1) at baseline compared with CIED- subjects. Slightly fewer clips were implanted in CIED+ subjects (mean 1.9) than in CIED- subjects (mean 2.2) (P = 0.0018). Procedural times were significantly shorter in CIED+ subjects (132.9 ± 63.3 minutes vs 155.9 ± 71.9 minutes; P = 0.0043) although greater in those with lead-induced TR (149.5 ± 87.5 minutes). Major adverse events (1.0% vs 1.1%) and major bleeding (3.1% vs 3.0%) were infrequent in CIED+ and CIED- subjects. At 30 days, TR reduction to moderate or less was similar in CIED+ and CIED- subjects (88% vs 87%) and was sustained out to 1 year in the majority of subjects (81% vs 84%). Compared with baseline, Kansas City Cardiomyopathy Questionnaire overall summary score significantly improved through 1 year in CIED+ subjects (18.7 ± 22.6; P \u3c 0.0001) and CIED- subjects (16.8 ± 22.6; P \u3c 0.0001). Heart failure symptoms were reduced in both groups at 30 days, with 85% of CIED+ subjects and 87% of CIED- subjects in NYHA functional class I or II. There were no differences in mortality, heart failure hospitalization, and need for tricuspid valve surgery or intervention between groups. No lead revisions, removals, or replacements were reported through follow-up.
CONCLUSIONS: Tricuspid transcatheter edge-to-edge repair with the TriClip system was safe and effective in selected CIED+ subjects and did not affect CIED function. CIED+ subjects experienced similar TR reduction and quality-of-life improvements as CIED- subjects. Future work should define the treatable scope of patients with transvalvular CIED leads. (TRILUMINATE Pivotal Trial; NCT03904147)