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4604 citation(s) found for "Na, Brian".

NCCN Guidelines® Insights: Myeloproliferative Neoplasms, Version 2.2026
Gerds, Aaron T., Gotlib, J, Abdelmessieh, Peter, Ali, Haris, Castells, Mariana, Chernak, Brian , Espinoza-Gutarra, Manuel R., Revell, Rebecca, Green, Steven, Gundabolu, Krishna , Hexner, Elizabeth, Jamieson, Catriona H., Khan, Irum, Kuykendall, Andrew T., McMahon, Brandon, Mohan, Sanjay R., Nadiminti, Kalyan V., Oh, Stephen, Palmer, Jeanne, Patel, Ami B. , Patel, Anand A., Rein, Lindsay, Salit, Rachel, Sehl, Mary, Wadleigh, Martha, Wall, Sarah A., Bergman, Mary Anne, Hochstetler, Cindy, Patel, Anand , Patel, Anand , Gerds, Aaron T. , Gotlib, Jason , Ali, Haris , Espinoza‐Gutarra, Manuel , Green, S, Hexner, Elizabeth O. , Jain, Tania , Khan, Irum , Kuykendall, Andrew , Madanat, Yazan F. , Masárová, Lucia , Mohan, Sanjay R., Nadiminti, Kalyan, Palmer, Jeanne , Podoltsev, Nikolai , Salit, Rachel B. , Sehl, Mary E. , Talpaz, Moshe , Wadleigh, Martha , Wall, Sarah

Journal of the National Comprehensive Cancer Network | July 9, 2026 | Volume: 24 | Issue: 7 | Pages: No page available

10.6004/jnccn.2026.0034 | PMID 42425157 Get It

The Philadelphia chromosome-negative myeloproliferative neoplasms (MPN) are a group of heterogenous hematologic malignancies characterized by the proliferation of blood cells and consist of myelofibrosis, polycythemia vera, and essential thrombocythemia. The NCCN Guidelines for MPN were developed as a result of meetings convened by a multidisciplinary panel with expertise in MPN, with the aim of providing recommendations for the comprehensive care of adults with these diseases. The panel of experts convenes at least once a year to discuss requested changes to the Guidelines and to evaluate emerging data. These Guideline Insights focus on some of the recent updates for myelofibrosis.
Early Versus Late Recurrence in Olfactory Neuroblastoma: A Multi‐Institutional Analysis of Predictive Risk Factors
Harris, Alexandria , Tang, Anthony, Fung, Nicholas , Champagne, Pierre‐Olivier, Fernandez-Miranda, Juan, Gardner, Paul A. , Hwang, Peter H. , Kalyvas, Aristotelis, Patel, Zara M. , Patel, Zara M., Celda, María Peris, Pinheiro-Neto, Carlos D., Sanusi, Olabisi, Thorp, Brian D., Gompel, Jamie J. Van, Zenonos, Georgios, Zwagerman, Nathan T., Bell, Diana, Kuan, Edward C., Geltzeiler, Mathew, Hwang, Peter H , Patel, Zara , Snyderman, Carl H , Wang, Eric W , Choby, Garret , Tang, Anthony , Almeida, João Paulo , Champagne, Pierre‐Olivier , Kalyvas, Aristotelis , Pinheiro‐Neto, Carlos , Sanusi, Olabisi , Thorp, Brian D. , Gompel, Jamie J. Van , Zenonos, Georgios A. , Zwagerman, Nathan T. , Bell, Diana , Kuan, Edward C , Geltzeiler, Mathew , Choby, Garret

International Forum of Allergy & Rhinology | July 9, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1002/alr.70216 | PMID 42422976 Get It

ABSTRACT Background Olfactory neuroblastoma (ONB) exhibits variable recurrence patterns, with significant late recurrences occurring years after treatment. We investigated cutoff periods to define late recurrence and identified predictors that distinguish patients at risk of late recurrence from those considered cured. Methods From a multi‐institutional cohort of 219 ONB patients treated at nine centers, we analyzed 77 patients with documented recurrence. Using a 48‐month cutoff to define early (< 48 months) versus late (≥ 48 months) recurrence, we evaluated 35 clinical, anatomic, and treatment variables using Firth penalized logistic regression across three comparisons: (1) late versus early recurrence timing, (2) late recurrence versus no recurrence, and (3) early recurrence versus no recurrence. Results Thirty‐four of the 77 (44.2%) recurrences were classified as late. Among the 77 patients who recurred, smaller tumor volume (OR 0.243, p = 0.035) and lower novel Dulguerov staging (OR 0.802, p = 0.038) were associated with late, rather than early recurrence. When patients with late recurrence were compared to those who remained disease‐free, radiographic skull base bone involvement was the strongest independent predictor (OR 2.90, 95% CI 1.14–8.64, p = 0.025), and this effect strengthened after adjusting for tumor volume (OR 3.80, p = 0.029). Pathologic dural invasion (OR 3.29, p = 0.013), Kadish stage (OR 2.02, p = 0.026), and T‐stage (OR 1.32, p = 0.040) were also significant. Conclusions A 48‐month cutoff effectively stratifies ONB recurrence risk. Skull base bone involvement independently predicts recurrence when compared to nonrecurrent cases and uniquely persists as a risk factor for late recurrence. These findings establish skull base bone involvement as a novel biomarker for risk‐stratified surveillance protocols.
Availability and Use of Social Determinants of Health Data in Alliance Gastrointestinal Cancer Clinical Trials
Lewis, Kever A. , Colgrove, Brian A., Nelson, Garth D. , Shi, Qian , Edwards, Gretchen C. , Chang, George J. , Paskett, Electra D. , Snyder, Rebecca A. , Katz, Matthew H G , Chang, George , Paskett, Electra D , Meyerhardt, Jeffrey A , O'Reilly, Eileen M , Snyder, Rebecca A , Shi, Qian , Colgrove, B., Katz, Matthew H. G. , Meyerhardt, Jeffrey A. , O’Reilly, Eileen M. , Snyder, Rebecca A.

JCO Oncology Practice | July 7, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1200/op-25-01376 | PMID 42413064 Get It

PURPOSE Social determinants of health (SDOH) shape cancer treatment access, adherence, and outcomes, yet their collection and use within National Clinical Trials Network (NCTN) studies remain poorly defined. This study examined how demographic and SDOH-related variables were historically collected and published to identify gaps that constrain the study of social context within NCTN trials. METHODS Participant-level data from completed phase III trials for gastrointestinal (GI) cancers conducted by the Alliance for Clinical Trials in Oncology (Alliance) or its legacy groups from 1999 to 2018 were pooled. Thirteen measures were assessed: four demographic and nine SDOH-related. The proportion of individual participants with data collected for each measure was evaluated. Data utilization was evaluated for all primary articles and via targeted review of related publications using the number either reporting subgroups or publishing analyses for each measure. RESULTS A total of 12,701 participants across 11 trials were included. All trials collected demographic measures (<2% of patients missing), insurance status (1% missing), and ZIP code (3% missing). Education level was collected in two trials (28% missing) with marital and employment status collected in one trial (41% missing for both). No trials collected data on other SDOH-related measures. Education level was the only SDOH-related measure reported in primary articles, and none reported analysis of SDOH-related measures. Of the 149 related publications, <2% reported or analyzed any SDOH-related measure. CONCLUSION Across Alliance and NCTN legacy group phase III trials for GI cancers, demographic variables have been consistently collected and frequently reported or analyzed, whereas SDOH-related measures are inconsistently collected and rarely published in the literature. These findings demonstrate a historical absence of routine SDOH data capture and utilization within NCTN trials.
Consensus Recommendations for Clinical Pharmacist Integration into the Acute Stroke Care Team: Endorsed by the American College of Clinical Pharmacy, Neurocritical Care Society, Society for Academic Emergency Medicine, and Society of Critical Care Medicine
Gilbert, Brian W. , Brown, Caitlin S. , Acquisto, Nicole M. , Engstrom, Kellyn , Mercer, Kevin , Howington, Gavin T. , Zimmerman, David E. , Gottlieb, Michael, Mattson, Alicia E , Rech, Megan A. , Wieruszewski, Erin D. , Ray, Lance C., Voetsch, Barbara, Gerberi, Dana, Cole, Kristin, Ray, Lance , Engstrom, Kellyn K , Mercer, Kevin , Faine, Brett A , Rech, Megan A , Acquisto, Nicole M , Gottlieb, Michael , Webb, Andrew , Faine, Brett , Owusu, Kent A. , Voetsch, Barbara , Gerberi, Danielle J , Bellolio, Fernanda

JACCP: JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY | July 7, 2026 | Volume: 9 | Issue: 7 | Pages: No page available

10.1002/jac5.70246 | PMID 42409761 Get It

ABSTRACT Clinical pharmacists are increasingly recognized as vital contributors to acute stroke care, yet their role remains inconsistently defined and underutilized across health care systems. This consensus statement explores the expanding presence of clinical pharmacists within interdisciplinary stroke teams, particularly in the management of both acute ischemic stroke ( AIS ) and hemorrhagic stroke. This consensus statement panel was composed of clinical pharmacists, emergency medicine physicians, and a vascular neurologist. The Grading of Recommendations, Assessment, Development, and Evaluation ( GRADE ) approach was used to assess the level of certainty and strength of recommendations. We focused on two questions regarding the clinical pharmacist's role in caring for adult patients presenting to the emergency department ( ED ) with AIS or hemorrhagic stroke. Despite the very low level of evidence, a consensus was reached for the following recommendations: (1) clinical pharmacist involvement in AIS care for adult patients presenting to the ED and (2) clinical pharmacist involvement in hemorrhagic stroke care for adult patients presenting to the ED . Based on the available literature, we believe optimizing the clinical pharmacist role is a critical factor in improving time‐sensitive treatment and equity in care delivery.
Long‐Term Outcomes After Retropubic and Transobturator Sling Procedures: Reoperation for Recurrent Stress Urinary Incontinence
Trad, Ayssa Teles Abrão , Nashar, Sherif A. El, Madsen, Annetta M., Occhino, John A. , Gebhart, John B. , McGree, Michaela E. , Fought, Angela J. , Trabuco, Emanuel C. , El Nashar, Sherif A, Linder, Brian J , El‐Nashar, Sherif A. , Linder, Brian J. , Madsen, Annetta M.

BJOG: An International Journal of Obstetrics & Gynaecology | July 3, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1111/1471-0528.70295 | PMID 42392760 Get It

ABSTRACT Objective To evaluate long‐term failure rates and complications after retropubic and transobturator midurethral sling procedures for primary stress urinary incontinence (SUI). Design Retrospective cohort study. Setting Academic medical centre. Population A previously described cohort of patients ( n = 1881) who underwent midurethral sling procedures (2002–2012) and a covariate‐matched cohort of patients with retropubic ( n = 570) or transobturator ( n = 317) slings. Methods Health record review with follow‐up extended by 9 years (through December 31, 2022). Main Outcome Measures Treatment failure (reoperation for recurrent SUI) and procedure‐associated complications. Results The duration of assessment was extended by 6.9 years for the retropubic group and by 6.4 years for the transobturator group. The median (IQR) follow‐up was 11.1 (5.1–14.5) years (retropubic, 11.4 [5.9–14.6]; transobturator, 9.6 [2.6–13.7]). Higher risk of reoperation was observed with transobturator (8.8%) than retropubic (4.4%) slings (unadjusted hazard ratio [HR], 2.29 [95% CI, 1.49–3.54]; p < 0.001; covariate‐matched analysis HR, 1.91 [95% CI, 1.15–3.17]; p = 0.01). The increased risk of reoperation with a transobturator sling was higher when the procedure was combined with prolapse repair (unadjusted HR, 6.34 [95% CI, 3.09–13.02]; p < 0.001; covariate‐matched analysis HR, 3.96 [95% CI, 1.35–11.58]; p = 0.01). Higher rates of reoperation for urinary retention were observed for the retropubic group than for the transobturator group (covariate‐matched analysis HR, 8.39 [95% CI, 1.11–63.22]; p = 0.04). Conclusion In this long‐term follow‐up study, midurethral slings had a low failure rate. Women with SUI undergoing transobturator sling placement plus prolapse repair had a greater risk of reoperation. However, women with retropubic slings had a greater risk of urinary retention requiring intervention.
Expert Clinical Consensus on Body Surface Gastric Mapping Phenotypes for Gastroduodenal Disorders: ‘Auckland Classification’ v1.0
Varghese, Chris , Dachs, Nicky , Schamberg, Gabriel , Abell, Thomas, Al‐Haddad, Mohammad, Angeli, Timothy R. , Ayubi, Homira , Bashashati, Mohammad , Bulat, Robert, Calder, Stefan, Cederwall, Christopher Brian, Chang, Bianca W. , Cheng, Leo K. , Clarke, John, Daker, Charlotte , Du, Peng, Erickson, Jon, Eriksson, Sven, Fikree, Asma , Foong, Daphne , Fox, Mark, Goenka, Mahesh, Haidry, R, Holtman, Gerald, Hobson, Anthony , Koloski, Natasha, Kuo, Braden, Law, Mikaela, Levinthal, D., Liu, Joy , Mathur, Prateek , Moshiree, Baharak, Ngo, Catherine, Nguyen, Linda, Oblizajek, Nicholas R. , Parkman, Henry P., Podboy, Alexander, Rezaie, Ali, Simmonds, Sam , Sivakumar, Jonathan , Sirimongkolkasem, Jarongkorn , Sonu, Irene, Stocker, Abigail, Sujka, Joseph, Tack, Jan, Weinstein, Douglas, Windsor, John, Zarate‐Lopez, Natalia, Andrews, Christopher N., O'Grady, Greg, Clarke, John O. , Angeli-Gordon, Timothy R , Chang, Bianca , Cheng, Leo K , Daker, Charlotte , Ghoshal, Uday C , Hasler, W L , Ho, Vincent , Keszthelyi, Daniel , Khalsa, Sahib S , Liu, Joy J , Neshatian, Leila , Oblizajek, Nicholas R , Pandanaboyana, Sanjay , Sharma, Amol , Wang, Xiao Jing , Xu, William , Varghese, Chris , Clarke, J , Schamberg, Gabriel , Al‐Haddad, Mohammad , Ayazi, Shahin , Bulat, Robert, Calder, Stefan , Cederwall, Chris, Du, Peng , Erickson, Jonathan C. , Ghoshal, Uday C. , Hasler, William L. , Hayee, Bu , Ho, Vincent , Huang, I‐Hsuan , Khalsa, Sahib S. , Kuo, Braden , Kunkel, David C. , Law, Mikaela , Levinthal, David J. , Moshiree, Baharak , Neshatian, Leila , Parkman, Henry P. , Podboy, Alexander , Rezaie, Ali , Sonu, Irene S. , Stocker, Abigail, Sujka, Joseph , Tack, Jan , Verdonk, Charles , Wang, Xiao Jing , Wongjarupong, Nicha , Xu, William , Andrews, Christopher N. , Gharibans, Armen A.

Neurogastroenterology & Motility | July 1, 2026 | Volume: 38 | Issue: 7 | Pages: No page available

10.1111/nmo.70377 | PMID 42381563 Get It

ABSTRACT Introduction Chronic gastroduodenal disorders remain challenging to manage, and new diagnostic approaches are needed to better delineate underlying causes and guide therapeutic decisions. Body Surface Gastric Mapping (BSGM) technologies combine high‐resolution gastric myoelectrical activity measurements with symptom and psychological profiling to provide mechanistic insights into gastric motor and sensory dysfunction. An International Working Group convened to derive the first consensus classification of BSGM phenotypes (the “Auckland Classification”). Methods A Technical Group conducted a systematic literature and clinical database review to identify objective test biomarkers and candidate disease mechanisms. Evidence was synthesized across 50 studies (primarily in gastroparesis, chronic nausea and vomiting, and functional dyspepsia), and BSGM phenotypes were mapped to existing treatment guidelines. Subsequently, iterative review and development of consensus was performed by a Consensus Group composed of international clinical experts familiar with BSGM. Eleven statements underlying the classification were then derived and circulated as a final survey to establish agreement. Results Six BSGM phenotypes were endorsed: three defined by myoelectrical abnormalities (Dysrhythmic, High Frequency, and Low Meal Response) and three by characteristic symptom associations (Sensorimotor, Continuous, and Delayed Onset Symptoms). Published studies plausibly linked these phenotypes to mechanisms including interstitial cell of Cajal depletion, vagal impairment, hypomotility, visceral hypersensitivity, gut‐brain dysregulation, and small bowel dysfunction. Phenotypes were also mapped to existing mechanism‐based treatment guidelines. Ten out of the eleven statements had > 80% agreement. Conclusions The Auckland Classification, derived by international consensus, presents a structured framework for BSGM‐defined patient phenotypes. Evidence and mechanism‐based treatment options are suggested for each phenotype to provide a foundation for research, further validation, and a pathway for integrating BSGM into clinical care.
Robotic Assisted Bronchoscopy with Endobronchial Ultrasound for the Evaluation of Multiple Pulmonary Nodules: A Multi-Center Registry
Kapp, Christopher M. , Wahidi, Momen M, Rowell, J. M., Yong, Sylvia S, Seides, Benjamin, Smith, Sean B. , Balan, Bharat, DiBardino, David, Haas, K, White, Brian, Kim, Jeremy , Guiance, Irene Riestra , Bhargava, Rohan , Diaz, Natalia H, Trujillo, D. Abia, Silvestri, G, Liu, Yupeng, Pfister, Courtney, Thiboutot, Jeffrey, Lee-Mateus, Alejandra Y, Abia Trujillo, David, Wahidi, Momen M. , Rowell, Jamie H, YONG, SYLVIA S, DiBardino, David M. , Haas, Kevin P. , Diaz, Natalia, Lee‐Mateus, Alejandra Yu , Thiboutot, Jeffrey P.

Annals of the American Thoracic Society | June 29, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1093/annalsats/aaoag142 | PMID 42366642 Get It

Abstract Introduction Multiple pulmonary nodules (MPNs) are commonly encountered in patients at elevated risk for thoracic malignancy and represent a spectrum of disease states and stages. We evaluated the safety, and procedural outcomes of a combined robotic assisted bronchoscopy (RaB) and linear endobronchial ultrasound (EBUS) approach to patients with MPNs during a single bronchoscopic procedure. Methods This multicenter observational registry included patients who underwent RaB for evaluation of MPNs. Data were prospectively collected from six centers between 2019 and 2025. Demographics, imaging characteristics, safety events, and procedural outcomes were analyzed and associated with final diagnosis. Results A total of 191 patients underwent RaB with biopsy of MPN during a single procedure; 167 patients also underwent linear EBUS lymph node sampling. The strict per nodule diagnostic yield was 71.5% overall (first nodule 70.7%, second 74.3%, third 71.4%). At least one malignant nodule was identified in 127 patients (66.8%), and 85 patients (44.5%) had two or more malignant nodules; 15 patients (17.6%) demonstrated heterogeneous histopathology between malignant nodules. Among patients with non–small cell lung cancer, adequate cellularity for next generation sequencing was achieved in 82.6% of nodules. Malignant lymph nodes were identified in 10.8% (18/167). No patients with two pure ground glass nodules (0/8) had malignant nodal involvement. Pneumothorax occurred in 7.3% of cases, with 2.1% requiring chest tube placement; unplanned admissions occurred in 3.7%. Conclusion This study provides a large multisite registry evaluation of performance of simultaneous bronchoscopic sampling of multiple pulmonary nodules with EBUS staging during a single anesthesia event demonstrating an acceptable safety profile and adequacy for molecular profiling.
Do Multimodal Vision-Language Models Enhance the Medical Diagnostic Process? A Systematic Review
Eauchai, Lattawat , González, Laura Otálora , Shi, Yifan , McGinnis, Michele , Yovchev, Alexander, Herasevich, Svetlana , Pickering, Brian W., Otálora González, Laura , McGinnis, Michele T , Herasevich, Vitaly , Shi, Yifan , Pickering, Brian W. , Herasevich, Vitaly

Healthcare | June 29, 2026 | Volume: 14 | Issue: 13 | Pages: 1877

10.3390/healthcare14131877 | PMID 42450887 Get It

Background/Objectives: Novel vision-language models (VLMs) can integrate patient textual data with image data to support medical diagnosis. Recent studies reported conflicting results regarding the performance of multimodal VLMs compared to other models and physician performance. This systematic review aims to assess the diagnostic performance of multimodal VLMs integrating both patient textual and image data across diverse real-world hospital settings. Methods: We performed comprehensive searches of eight resources, including Embase, MEDLINE, and SCOPUS, on 17 December 2025. Eligible studies reporting diagnostic performance of VLMs integrating both image and patient history textual data from real-world adult patients compared to that of other models and physicians were included. The review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The Prediction model study Risk Of Bias Assessment Tool + AI (PROBAST + AI) was used to assess the quality and risk of bias. The study protocol was registered in the PROSPERO database (CRD420251244054). This review received no external funding. Results: We screened 11,026 records, of which 18 studies met the inclusion criteria. Six studies comparing multimodal and unimodal models demonstrated the consistent superiority of the multimodal models. Four studies evaluating VLM accuracy as standalone agents compared with physician performance reported conflicting evidence. One study assessing VLMs as a clinical copilot demonstrated higher accuracy from the group of physicians using VLM assistance. A meta-analysis could not be performed due to the heterogeneity across study populations and outcomes. The majority of the studies were assessed as having a high risk of bias due to dataset quality. Primary limitations identified across studies include small sample size, a lack of external validation, and the need for prospective clinical deployment studies. No study provided documented considerations regarding model safety or data security. Conclusions: This systematic review suggests that multimodal VLMs consistently outperform unimodal models with access to only image or text. While model performance as standalone agents compared to humans remains inconclusive, a copilot model has demonstrated high diagnostic accuracy. Given substantial methodological concerns across studies, cautious interpretation is required, No firm clinical recommendation can be made regarding the use of standalone VLMs. Further research employing high-quality datasets is needed to ensure the reliability and clinical applicability of future VLMs.
Dispelling myths and misconceptions of constipation with a focus on stimulant laxatives
Lacy, Brian E. , Brenner, Darren M, Serra, Jordi , Pohl, Daniel, Andresen, Viola, Aran, Alèxia, Lacy, Brian , Lacy, Brian E. , Brenner, Darren M. , Pohl, Daniel , Andresen, Viola, Aran, Alexia

Frontline Gastroenterology | June 25, 2026 | Volume: No volume available | Issue: No issue available | Pages: flgastro-2025-103547

10.1136/flgastro-2025-103547 Get It

Myths and misconceptions about the evaluation and treatment of constipation persist. Many widely prevalent misconceptions about laxatives, specifically stimulant laxatives, interfere with the effective management of constipation. Although some of these myths and misconceptions have been dispelled in recent years, there is additional room for improving the awareness and understanding of the pathophysiology of constipation, the mechanisms of action and the efficacy and safety of available therapies. An evolution in our understanding of pathophysiology and the availability of new treatments requires that primary care practitioners be better positioned to treat this common disorder that reduces patients’ quality of life and negatively impacts the healthcare system. This review defines constipation and elucidates various factors that contribute to its aetiology, including lifestyle, dietary habits, medications and underlying medical conditions. This review addresses and refutes common myths and misconceptions about constipation, such as the belief that regular bowel movements must occur daily or the use of laxatives leads to dependence. This review also highlights the importance of distinguishing between normal and abnormal bowel habits and emphasises the need for individualised management approaches to address constipation effectively. Finally, the review discusses different classes of laxatives, dispelling misconceptions about their safety, efficacy and potential for misuse, with a specific focus on stimulant laxatives. In summary, this review enhances awareness and knowledge of this prevalent disorder, provides evidence-based insights into common myths and misconceptions surrounding constipation and promotes more informed decision-making regarding constipation and the use of laxatives.
Five-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation: results from the Tendyne Expanded Clinical Study
Muller, David W. , Duncan, AM, Sorajja, Paul, Dahle, Gry , Babaliaros, Vasilis, Lubos, Edith, Badhwar, Vinay , Denti, Paolo, Eng, Marvin H. , Grayburn, Paul, Bethea, Brian, Walters, Darren, Nickenig, Georg, As, Petronio, Thourani, Vinod H, Mumtaz, Mubashir, Dumonteil, Nicolas, Jf, Obadia, Kapadia, S R, Guerrero, Mayra E, Medeiros, Ricardo de, McNutt, Robert, Nie, Hong , Chuang, Michael, Blanke, Philipp, Conradi, Lenard, Duncan, Alison , Muller, David W M , Donal, Erwan , Modine, Thomas , Sorajja, Paul , Babaliaros, Vasilis , Denti, Paolo , Grayburn, Paul , Bethea, Brian, Walters, Darren, Donal, Erwan , Thourani, Vinod H. , Mumtaz, Mubashir , Modine, Thomas , Dumonteil, Nicolas, Guerrero, Mayra , Blanke, Philipp , Conradi, Lenard

ESC Heart Failure | June 25, 2026 | Volume: 13 | Issue: 4 | Pages: No page available

10.1093/eschf/xvag175 | PMID 42363737 Get It

Abstract Aims Transcatheter mitral valve replacement (TMVR) with the Tendyne Mitral Valve System is a treatment option for patients with severe symptomatic mitral regurgitation (MR) unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER). This study sought to evaluate the safety and effectiveness of TMVR through 5-year follow-up. Methods and Results The Tendyne Expanded Clinical Study is a prospective, single-arm, multicentre study that enrolled patients between November 2014 and June 2020. The study enrolled 191 patients (mean age 74.1 ± 8.0 years, 62.8% male, 70.2% New York Heart Association Class (NYHA) class III/IV, 88.5% secondary MR), of whom 186 (97.4%) underwent TMVR with Tendyne. MR grade decreased from ≥3+ in 99.5% patients at baseline to grade ≤1+ in 95.3% at 5 years. In those patients surviving to 5 years (n = 49), durable symptomatic improvement was evidenced by 73.5% patients being in NYHA class I/II at 5 years. The Kansas City Cardiomyopathy Questionnaire overall summary score increased from 48.5 ± 22.5 points at baseline to 67.6 ± 21.5 points at 5 years. Serious adverse events that occurred through 5 years included life-threatening bleeding (11.5%), fatal bleeding (2.6%), renal insufficiency/failure (28.8%), endocarditis (7.3%), device thrombosis (5.8%), and new onset atrial fibrillation (13.1%). No structural device degeneration or device embolism occurred through 5 years. Conclusions The Tendyne TMVR was effective at achieving immediate and sustainable elimination of MR, which was associated with symptomatic improvement and absence of structural valve degeneration in a high-risk cohort over 5 years. These findings support TMVR with the Tendyne System as an alternative for patients with appropriate mitral valve anatomy and symptomatic secondary MR unsuitable for mitral surgery or TEER.