{ "id": "ep5dmwxh50", "slug": "transcatheter-mitral-valve-implantation", "title": "Transcatheter mitral valve implantation", "updated": "2026-10-15", "topic_path": [ { "id": "life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/topics/life" }, { "id": "life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health" }, { "id": "life.health.clinical", "label": "Clinical assessment and procedures", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.clinical" }, { "id": "life.health.clinical.clinical-surgery", "label": "Surgery and surgical specialties", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.clinical.clinical-surgery" }, { "id": "life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures", "label": "Cardiac and thoracic surgery procedures", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures" }, { "id": "life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures.cardiac-valve-procedures", "label": "Cardiac valve procedures", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures.cardiac-valve-procedures" } ], "geo": [ { "id": "geo.nongeo.t2001.life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures", "label": "Non-geographic · 2001 to 2020: Cardiac and thoracic surgery procedures", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures", "path": [ { "id": "geo.nongeo", "label": "Non-geographic", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo" }, { "id": "geo.nongeo.t2001", "label": "Non-geographic · 2001 to 2020", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001" }, { "id": "geo.nongeo.t2001.life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life" }, { "id": "geo.nongeo.t2001.life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health" }, { "id": "geo.nongeo.t2001.life.health.clinical", "label": "Clinical assessment and procedures", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.clinical" }, { "id": "geo.nongeo.t2001.life.health.clinical.clinical-surgery", "label": "Surgery and surgical specialties", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.clinical.clinical-surgery" }, { "id": "geo.nongeo.t2001.life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures", "label": "Cardiac and thoracic surgery procedures", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures" } ] } ], "excerpt": "Transcatheter mitral valve implantation (TMVI), also called transcatheter mitral valve replacement (TMVR), is a minimally invasive catheter procedure replacing the mitral valve, first performed in 2012, for patients unsuitable for surgery.", "snippet": "Transcatheter mitral valve implantation (TMVI), also called transcatheter mitral valve replacement (TMVR), is a minimally invasive catheter procedure replacing the mitral valve, first performed in 2012, for patients unsuitable for surgery.", "node": "life.health.clinical.clinical-surgery.cardiac-and-thoracic-surgery-procedures.cardiac-valve-procedures", "markdown": "# Transcatheter mitral valve implantation\n\nTranscatheter mitral valve implantation (TMVI), also called transcatheter mitral valve replacement (TMVR), is a minimally invasive procedure that replaces the mitral valve by delivering a prosthetic valve through a catheter, rather than through open-heart surgery. It treats severe mitral valve disease, chiefly symptomatic mitral regurgitation (MR), in patients judged unsuitable for surgery or for transcatheter edge-to-edge repair (TEER) by a multidisciplinary heart team.[1](https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250019B.pdf)\n\n| Key fact | Detail |\n|---|---|\n| First human implant | June 12, 2012, Rigshospitalet, Copenhagen, using the CardiAQ system via transfemoral transseptal delivery[2](https://eurointervention.pcronline.com/article/transcatheter-mitral-valve-implantation-a-brief-review) |\n| First approved native-valve device | Tendyne, CE mark January 2020, FDA approval May 2025[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/) |\n| Main access routes | Transapical mini-thoracotomy (Tendyne) and transfemoral transseptal (SAPIEN M3, Intrepid, Cephea)[4](https://eurointervention.pcronline.com/article/clinical-outcomes-and-predictors-of-transapical-transcatheter-mitral-valve-replacement-the-tendyne-expanded-clinical-study) • [5](https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2026.1682730/full) |\n| Tendyne registry outcomes | Technical success 95%; durable MR ≤1+ in 98%; all-cause mortality 9% at 30 days and 29% at 1 year[6](https://www.jacc.org/doi/10.1016/j.jcin.2023.12.027) |\n| SAPIEN M3 pivotal trial | Primary endpoint (death or heart failure rehospitalization at 1 year) 25.2%, below the 45% performance goal[7](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2825%2902073-2/abstract) |\n| Dominant complication risk | LVOT obstruction: 13.4% overall in one TMVR series, rising to 54.1% in valve-in-MAC[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/) |\n| Key screening tool | Contrast-enhanced cardiac CT for annular sizing and predicted neo-LVOT area[4](https://eurointervention.pcronline.com/article/clinical-outcomes-and-predictors-of-transapical-transcatheter-mitral-valve-replacement-the-tendyne-expanded-clinical-study) |\n\n## How it works\n\nProposed CT-based eligibility criteria, including mitral annulus area greater than 8.6 cm², mean annular systolic diameter of 38.3 mm or less, aorto-mitral angulation greater than 130°, and annulus-to-apex distance under 100 mm, predict eligibility with a positive predictive value of 75% and a negative predictive value of 85.5%.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC8863742/) [Experience](https://www.edgepedia.org/experience) in native mitral valves remains limited because of high patient-selection failure.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC8863742/)\n\n## How it is done\n\n**Screening and sizing.** Contrast-enhanced cardiac CT assesses mitral valve anatomy, determines prosthesis type and size, plans the access site, and predicts the post-deployment neo-LVOT area, integrating annular dimensions, anterior mitral leaflet length, and ventricular geometry.[4](https://eurointervention.pcronline.com/article/clinical-outcomes-and-predictors-of-transapical-transcatheter-mitral-valve-replacement-the-tendyne-expanded-clinical-study) • [5](https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2026.1682730/full) A critically reduced predicted neo-LVOT is a major contraindication or forces a change of access and technique.[5](https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2026.1682730/full)\n\n**Transapical delivery (Tendyne).** The procedure is performed under general anesthesia via a left-sided mini-thoracotomy, with a 34 Fr or 36 Fr sheath passed through or near the left ventricular apex, without rapid pacing or cardiopulmonary bypass.[4](https://eurointervention.pcronline.com/article/clinical-outcomes-and-predictors-of-transapical-transcatheter-mitral-valve-replacement-the-tendyne-expanded-clinical-study) Patients receive warfarin for at least 3 months after the procedure, targeting an INR of 2.5 to 3.5.[4](https://eurointervention.pcronline.com/article/clinical-outcomes-and-predictors-of-transapical-transcatheter-mitral-valve-replacement-the-tendyne-expanded-clinical-study)\n\n**Transfemoral transseptal delivery (SAPIEN M3).** The nitinol dock is introduced through right femoral venous access using a 23-Fr system and deployed around the subvalvular apparatus; a 29-mm balloon-expandable SAPIEN valve is then expanded within the dock.[9](https://recintervcardiol.org/images/pdf-files/RECIC-26-066-L-ENG-RECICEM26000607.pdf) The transfemoral transseptal route is the most widely adopted because it is percutaneous, but it can give poor coaxiality and limited stability in valve-in-MAC, prior rings, or horizontal mitral-aortic angulation; the transapical route offers better control at the cost of greater invasiveness.[5](https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2026.1682730/full)\n\n## Origin\n\nTMVI was performed on an inoperable 86-year-old patient using the first-generation CardiAQ valve system delivered transfemorally via the transseptal route; the patient died of multi-organ failure on postoperative day three.[2](https://eurointervention.pcronline.com/article/transcatheter-mitral-valve-implantation-a-brief-review) Five systems had been implanted in humans at the time of that review: CardiAQ, Tiara (Neovasc), FORTIS ([Edwards Lifesciences](https://www.edgepedia.org/edwards-lifesciences)), Tendyne (Tendyne Inc.), and Twelve (Twelve, Inc.).[2](https://eurointervention.pcronline.com/article/transcatheter-mitral-valve-implantation-a-brief-review) The first-in-human Tiara implant.[2](https://eurointervention.pcronline.com/article/transcatheter-mitral-valve-implantation-a-brief-review) Tendyne implants had successful delivery in all 12 patients and no 30-day deaths.[2](https://eurointervention.pcronline.com/article/transcatheter-mitral-valve-implantation-a-brief-review) Among 12 reported cases, 30-day mortality was 25%, and Edwards suspended the FORTIS program in May 2015 to investigate valve thrombosis.[2](https://eurointervention.pcronline.com/article/transcatheter-mitral-valve-implantation-a-brief-review) • [10](https://www.annalscts.com/article/view/16556/html)\n\n## Variants\n\n**Tendyne** is a self-expanding, fully retrievable, and repositionable porcine valve with an inner circular stent frame and an outer D-shaped nickel-titanium frame, anchored to the left ventricular apex by a tethered locking pad, delivered transapically through a left mini-thoracotomy.[11](https://link.springer.com/article/10.1186/s13019-023-02446-4) It is the only self-expanding TMVR system with both CE mark (January 2020) and FDA approval (May 2025), and the first approved device for implantation in the native mitral valve.[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/) • [12](https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.010628)\n\n**SAPIEN M3** uses a nitinol dock covered with ePTFE tubing and PET braid, with a self-expanding PET-covered paravalvular-leak guard that encircles the native leaflets, pulling leaflets and chordae toward the dock center to create a landing zone for a balloon-expandable valve.[1](https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250019B.pdf) The dock is fully retrievable while connected to the delivery catheter.[13](https://www.jacc.org/doi/10.1016/j.jacc.2018.12.065) It received CE mark in April 2025 and FDA approval on December 22, 2025, for symptomatic moderate-to-severe or severe MR in patients unsuitable for surgery or TEER, and for symptomatic mitral valve dysfunction associated with mitral annular calcification in the same population.[1](https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250019B.pdf)\n\n**Intrepid** ([Medtronic](https://www.edgepedia.org/medtronic)) is a self-expanding nitinol valve with a circular outer fixation frame of 43, 46, or 50 mm diameter and a 27 mm inner stent frame; it evolved from transapical delivery to 35 Fr and now 29 Fr transfemoral transseptal delivery.[14](https://www.sciencedirect.com/science/article/pii/S0735109717413623) • [3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/) A first-in-human implant of the **Cephea** percutaneous transvenous transseptal system has been reported, and AltaValve is another transfemoral transseptal system under investigation.[15](https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.008003) • [3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/)\n\n## Applications\n\nTMVI is performed in the native valve and in three secondary scenarios: valve-in-valve (failed bioprosthesis), valve-in-ring, and valve-in-MAC; the MITRAL trial is evaluating transvenous transseptal mitral valve-in-valve implantation.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC8863742/) • [16](https://onlinelibrary.wiley.com/doi/10.1002/ccd.27128)\n\nIn the real-world Tendyne European registry of 195 patients (median age 77 years, 94% with MR 3+/4+), technical success was 95% and durable MR reduction to ≤1+ was achieved in 98%. All-cause mortality was 9% at 30 days and 29% at 1 year, and 83% of patients were in NYHA class I or II at 1 year.[6](https://www.jacc.org/doi/10.1016/j.jcin.2023.12.027) In the SAPIEN M3 pivotal trial, 299 patients were treated at 56 centers in six countries. The primary endpoint, a composite of all-cause mortality and heart failure rehospitalization at 1 year, was 25.2% (95% CI 20.6–30.6), significantly below the prespecified performance goal of 45% (p<0.0001).[7](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2825%2902073-2/abstract) Outcomes depend strongly on the substrate: in a multicenter registry of 521 high-risk TMVI patients, valve-in-valve showed 94% technical success with 30-day and 1-year mortality of 6.2% and 14%, while valve-in-MAC had 62% technical success and 30-day and 1-year mortality of 34.5% and 62.8%.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC8863742/) Long-term data show an 8-year cumulative incidence of death or mitral reintervention of 80%, with valve-in-valve patients faring best.[17](https://www.sciencedirect.com/science/article/abs/pii/S1936879825032881)\n\n## Limitations and alternatives\n\n**LVOT obstruction** is the characteristic serious complication. In a study of 194 TMVR patients it occurred in 13.4% overall, but in 54.1% of valve-in-MAC versus 8.0% of valve-in-ring and 1.9% of valve-in-valve cases; a neo-LVOT area of 1.7 cm² or less on CT predicted obstruction with 96.2% sensitivity and 92.3% specificity.[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/) Another review suggests a neo-LVOT above 200 mm² and an anterior mitral leaflet length under 22 mm may substantially reduce or abolish the risk; the two thresholds differ, and no single cutoff is settled.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC8863742/) The LAMPOON and BATMAN techniques have been developed to mitigate the risk of fatal LVOT obstruction.[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/)\n\n**Paravalvular leak** is the most common postoperative complication after Tendyne implantation and can often be resolved by valve re-tensioning.[11](https://link.springer.com/article/10.1186/s13019-023-02446-4) In the Tendyne Expanded Clinical Study, no structural valve degeneration was observed through 5 years, but infective endocarditis occurred in 7.3% of patients and device thrombosis in 5.8% by 5 years.[18](https://academic.oup.com/eschf/article-pdf/13/4/xvag175/68631624/xvag175.pdf) In the ENCIRCLE trial of SAPIEN M3 (299 patients), device implantation was completed in 96%, with 1-year all-cause mortality 13.9% and no clinically significant TMVR-related LVOT obstruction.[3](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/) The transapical route carries risks of apical tear, life-threatening apical bleeding, myocardial damage, coronary damage, and infection.[8](https://pmc.ncbi.nlm.nih.gov/articles/PMC8863742/)\n\nTMVI is reserved for patients ineligible for mitral surgery or TEER because of prohibitive operative risk, challenging anatomy, or comorbid conditions.[18](https://academic.oup.com/eschf/article-pdf/13/4/xvag175/68631624/xvag175.pdf) The SUMMIT trial evaluates Tendyne against the MitraClip System in patients with symptomatic moderate-to-severe or severe MR within approved [MitraClip](https://www.edgepedia.org/mitraclip) indications.[19](https://clinicaltrials.gov/ct2/show/NCT03433274) • [20](https://www.accessdata.fda.gov/cdrh_docs/pdf24/P240042B.pdf) A systematic review notes that although Tendyne shows high technical success and low residual MR, TMVR devices may have higher all-cause mortality and heart failure rehospitalization than MitraClip.[11](https://link.springer.com/article/10.1186/s13019-023-02446-4) The SAPIEN M3 system is contraindicated in patients who cannot tolerate anticoagulation or antiplatelet therapy or intraprocedural heparin, and in those with active bacterial endocarditis or other infections.[1](https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250019B.pdf) Valve-in-valve TMVI has the best documented outcomes, with MR of moderate degree or worse at 1 year or beyond in under 6% of patients versus under 20% for valve-in-ring, and 4-year survival of 62.5% versus 49.5%.[12](https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.010628) Open questions include pacemaker implantation rates, which published studies have not quantified, and randomized comparison of TMVI with surgical mitral valve replacement, which has not been published; there is also no consensus on anticoagulation management for TMVI with respect to valve thrombosis.[10](https://www.annalscts.com/article/view/16556/html)\n\n## References\n\n1. [SUMMARY OF SAFETY AND EFFECTIVENESS DATA, SAPIEN M3 transcatheter mitral valve replacement system (P250019)](https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250019B.pdf)\n2. [Transcatheter mitral valve implantation: a brief review | EuroIntervention](https://eurointervention.pcronline.com/article/transcatheter-mitral-valve-implantation-a-brief-review)\n3. [Transcatheter mitral valve options for severe mitral annular calcification](https://pmc.ncbi.nlm.nih.gov/articles/PMC12690499/)\n4. [Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study](https://eurointervention.pcronline.com/article/clinical-outcomes-and-predictors-of-transapical-transcatheter-mitral-valve-replacement-the-tendyne-expanded-clinical-study)\n5. [Case Report: The hybrid cable technique in transcatheter mitral valve implantation with Myval THV, Technical insights from three high-risk cases (Frontiers in Cardiovascular Medicine, 2026)](https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2026.1682730/full)\n6. [Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry](https://www.jacc.org/doi/10.1016/j.jcin.2023.12.027)\n7. [abstract (thelancet.com)](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2825%2902073-2/abstract)\n8. [Challenges and Open Issues in Transcatheter Mitral Valve Implantation: Smooth Seas Do Not Make Skillful Sailors](https://pmc.ncbi.nlm.nih.gov/articles/PMC8863742/)\n9. [Early experience with transcatheter mitral valve replacement using the Edwards SAPIEN M3 prosthesis: a case series (REC: Interventional Cardiology)](https://recintervcardiol.org/images/pdf-files/RECIC-26-066-L-ENG-RECICEM26000607.pdf)\n10. [Novel mitral valve technologies, transcatheter mitral valve implantation: a systematic review](https://www.annalscts.com/article/view/16556/html)\n11. [Transcatheter mitral valve implantation with Tendyne System Ten Years since the First In-Human Implant: A systematic review](https://link.springer.com/article/10.1186/s13019-023-02446-4)\n12. [Transcatheter Mitral Valve Implantation: Current Status and Future Perspectives](https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.010628)\n13. [Percutaneous Transcatheter Mitral Valve Replacement: First-in-Human Experience With a New Transseptal System | JACC](https://www.jacc.org/doi/10.1016/j.jacc.2018.12.065)\n14. [Early Experience With New Transcatheter Mitral Valve Replacement (Original Investigation)](https://www.sciencedirect.com/science/article/pii/S0735109717413623)\n15. [First-in-Human Implant of the Cephea Transseptal Mitral Valve Replacement System](https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.008003)\n16. [Transseptal transcatheter mitral valve-in-valve: A step by step guide from preprocedural planning to postprocedural care](https://onlinelibrary.wiley.com/doi/10.1002/ccd.27128)\n17. [Long-Term Clinical and Hemodynamic Outcomes of Transcatheter Mitral Valve Replacement (JACC: Cardiovascular Interventions, 2025)](https://www.sciencedirect.com/science/article/abs/pii/S1936879825032881)\n18. [Five-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation: results from the Tendyne Expanded Clinical Study (ESC Heart Failure)](https://academic.oup.com/eschf/article-pdf/13/4/xvag175/68631624/xvag175.pdf)\n19. [Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System (SUMMIT)](https://clinicaltrials.gov/ct2/show/NCT03433274)\n20. [SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED), Tendyne (P240042)](https://www.accessdata.fda.gov/cdrh_docs/pdf24/P240042B.pdf)\n\n---\n*Topic: Encyclopedia › Life and health › Human health and medicine › Clinical assessment and procedures › Surgery and surgical specialties › Cardiac and thoracic surgery procedures › Cardiac valve procedures*\n\n*Initially written Sep 29, 2026 · Edited: Oct 15, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n", "same_as": [], "url": "https://www.edgepedia.org/transcatheter-mitral-valve-implantation", "markdown_url": "https://www.edgepedia.org/transcatheter-mitral-valve-implantation.md", "license": { "name": "Edgepedia Community License 1.0", "url": "https://www.edgepedia.org/edgepedia/license", "summary": "Free with credit, commercial use included. AI training is open to everyone. For other uses, organizations over USD 100M in revenue or 100M monthly users license separately.", "spdx": "LicenseRef-Edgepedia-Community-1.0" }, "credit": "\"Transcatheter mitral valve implantation\", Edgepedia (EdgeChat), https://www.edgepedia.org/transcatheter-mitral-valve-implantation. Edgepedia Community License 1.0.", "credit_md": "\"[Transcatheter mitral valve implantation](https://www.edgepedia.org/transcatheter-mitral-valve-implantation)\", Edgepedia (EdgeChat), [https://www.edgepedia.org/transcatheter-mitral-valve-implantation](https://www.edgepedia.org/transcatheter-mitral-valve-implantation). [Edgepedia Community License 1.0](https://www.edgepedia.org/edgepedia/license).", "credit_html": "\"Transcatheter mitral valve implantation\", Edgepedia (EdgeChat), https://www.edgepedia.org/transcatheter-mitral-valve-implantation. Edgepedia Community License 1.0.", "speakable": "Transcatheter mitral valve implantation, also called transcatheter mitral valve replacement, is a minimally invasive catheter procedure replacing the mitral valve, first performed in 2012, for patients unsuitable for surgery." }