Citations 2
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
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.
Abstract 12681: GWAS Meta-Analysis in SCAD, a Women Predominant Ischemic Heart Disease, Reveals Common Variants and Genes Related to Artery Integrity and Tissue-Mediated Coagulation
Adlam, David , Ma, Lijiang , Blencowe, Montgomory, Turley, Tamiel N. , Yang, Min‐Lee , Junday, Keerat , CARDIoGRAMPlusC4D, investigators, DISCO register, Saw, Jacqueline , Xia, Yang, Samani, Nilesh J. , Berrandou, Takiy-Eddine , Georges, Adrien , Nelson, Christopher P. , Giannoulatou, Eleni , Iismaa, Siiri E. , Tarr, Ingrid S. , Muller, David W. , Hesselson, Stephanie , Fatkin, Diane , CARDIoGRAMPlusC4D, Combaret, Nicolas , investigators, DISCO register, Webb, Tom R. , Tweet, Marysia S. , Hayes, Sharonne N. , Yang, Xia , Ganesh, Santhi K. , Olson, Timothy M. , Kovacic, Jason C. , Graham, Robert M. , Bouatia‐Naji, Nabila
Circulation | June 15, 2023 | Volume: 146 | Issue: Suppl_1 | Pages: No page available
10.1161/circ.146.suppl_1.12681
Introduction: Spontaneous coronary artery dissection (SCAD) is an understudied cause of acute myocardial infarction due to hematoma formation in coronary arteries primarily affecting women. It is not known to what extent SCAD is genetically distinct from other cardiovascular diseases, including atherosclerotic coronary artery disease (CAD). Methods and Results: Through a meta-analysis of 8 GWAS (1917 cases, 9292 controls of European ancestry), we identified 17 risk loci, including 12 new. Functional annotations pointed at enrichment in enhancer marks of arteries, specifically smooth muscle cells, and strong candidate genes, such as tissue factor gene ( F3 ) on Chr1 near rs1146473 (OR=1.32, P=5.8 х10 -9 ). F3 is novel for SCAD or any cardiovascular disease. The risk allele correlated with F3 lower expression in arteries, supporting a mechanism consistent with hematoma formation. Bayesian gene regulatory networks constructed from expression and genetics data indicated the extracellular matrix organization in arteries as the biological function where most prioritized genes clustered (e.g. COL4A1/A2, HTRA1, and TIMP3 ). Overall, we report substantial polygenicity for SCAD (LDSC: h 2 SNP = 0.71 ± 0.11) and shared genetics with several neurovascular diseases (e.g intracranial aneurysm). Intriguingly, for 6 loci, colocalization analyses showed that SCAD and CAD are likely to share the same causal variants but involve opposite risk alleles (e.g COL4A1/A2 ). In addition, a negative genetic correlation was found between SCAD and CAD (rg=-0.12; P=3.7х10 -3 ), including after conditioning on BP (mt-COJO: rg CAD/SBP =-0.19, P=4.6х10 -6 ). Mendelian randomization analyses indicated higher BP to associate with increased risk for SCAD (beta IVW-SBP =0.05, P=7.6х10 -6 , beta IVW-DBP =0.10, P=1.9х10 -6 ) and CAD (beta IVW-SBP =0.04, P=8.6х10 -49 ; DBP: beta IVW-DBP =0.06, P=1.6х10 -44 ) but not BMI, lipids, or type 2 diabetes, which we confirmed as genetic risk factors for CAD Conclusions: Our results set the stage for future investigation of novel biological pathways relevant to both SCAD and CAD and potential therapeutic and preventive strategies specifically targeting this ischemic disease predominantly affecting women.