Transseptal transcatheter mitral valve replacement with dedicated prosthesis: current devices and early results

Abstract

Transcatheter mitral valve replacement (TMVR) has emerged as a transformative intervention for patients with severe mitral valve disease who are at high or prohibitive surgical risk. Among the various access routes, the transseptal approach has gained prominence due to its minimally invasive nature and favorable hemodynamic profile. The transseptal route offers direct access to the mitral valve while avoiding thoracotomy and cardiopulmonary bypass, making it particularly suitable for frail and comorbid patients. However, it poses unique technical challenges, including precise transseptal puncture, complex valve anchoring in the dynamic mitral annulus, and management of left ventricular outflow tract obstruction risk. Multimodal imaging, especially real-time 3D transesophageal echocardiography and cardiac computed tomography, plays a pivotal role in procedural planning and execution. This review underscores the transseptal TMVR approach as a rapidly advancing frontier in structural heart disease treatment, emphasizing the need for further randomized trials and long-term data to fully define its role in the therapeutic landscape of mitral valve disease.

Keywords

Mitral regurgitation / transcatheter treatment / mitral replacement / mitral valve disease

References

[1] Iung B,Delgado V,Rosenhek R.et al. ; EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart disease: The EUR observational research programme valvular heart disease II survey Circulation. 2019 140 1156 69

[2] Unger P,Tribouilloy C. Aortic stenosis with other concomitant valvular disease: aortic regurgitation, mitral regurgitation, mitral stenosis, or tricuspid regurgitation Cardiol Clin. 2020 38 33 46

[3] Badhwar V,Chikwe J,Gillinov AM.et al. Risk of surgical mitral valve repair for primary mitral regurgitation J Am Coll Cardiol. 2023 81 636 48

[4] Otto CM,Nishimura RA,Bonow RO.et al. 2020 ACC/AHA Guideline for the management of patients with valvular heart disease: executive summary: a report of the American college of cardiology/American heart association joint committee on clinical practice guidelines Circulation. 2021 143 e35 71

[5] Deja MA,Malinowski M,Widenka K.et al. Repair or replacement for secondary mitral regurgitation: results from polish national registry Ann Thorac Surg. 2022 113 146 56

[6] Vahanian A,Beyersdorf F,Praz F.et al. ; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease Eur Heart J. 2022 43 561 632

[7] Gavazzoni M,Taramasso M,Zuber M.et al. Conceiving MitraClip as a tool: percutaneous edge-to-edge repair in complex mitral valve anatomies Eur Heart J Cardiovasc Imaging. 2020 21 1059 67

[8] Elbadawi A,Dang AT,Hamed M.et al. Transcatheter edge-to-edge repair for mitral regurgitation using PASCAL or MitraClip Catheter Cardiovasc Interv. 2023 102 521 7

[9] Wang J,Liu X,Pu Z.et al. Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial EuroIntervention. 2024 20 e239 49 10870008

[10] Feldman T,Foster E,Glower DD.et al. ; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation N Engl J Med. 2011 364 1395 406

[11] von Bardeleben RS,Mahoney P,Morse MA.et al. 1-year outcomes with fourth-generation mitral valve transcatheter edge-to-edge repair from the EXPAND G4 Study JACC Cardiovasc Interv. 2023 16 2600 10

[12] Zahr F,Smith RL,Gillam LD.et al. 1-year outcomes from the CLASP IID randomized trial for degenerative mitral regurgitation. 2023;16:2803-16

[13] Stone GW,Lindenfeld J,Abraham WT.et al. ; COAPT Investigators. Transcatheter mitral-valve repair in patients with heart failure N Engl J Med. 2018 379 2307 18

[14] Anker SD,Friede T,von Bardeleben RS.et al. ; RESHAPE-HF2 Investigators. Transcatheter valve repair in heart failure with moderate to severe mitral regurgitation N Engl J Med. 2024 391 1799 809

[15] Stocker TJ,Stolz L,Karam N.et al. ; EuroSMR Investigators. Long-term outcomes after edge-to-edge repair of secondary mitral regurgitation: 5-year results from the EuroSMR registry JACC Cardiovasc Interv. 2024 17 2543 54

[16] Kar S,von Bardeleben RS,Rottbauer W.et al. Contemporary outcomes following transcatheter edge-to-edge repair: 1-year results from the EXPAND study JACC Cardiovasc Interv. 2023 16 589 602

[17] Webb JG,Hensey M,Szerlip M.et al. 1-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study JACC Cardiovasc Interv. 2020 13 2344 57

[18] Spargias K,Lim DS,Makkar R.et al. Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study Catheter Cardiovasc Interv. 2023 102 145 54

[19] Taramasso M,Maisano F,Latib A.et al. Clinical outcomes of MitraClip for the treatment of functional mitral regurgitation EuroIntervention. 2014 10 746 52

[20] Higuchi S,Orban M,Stolz L.et al. Impact of residual mitral regurgitation on survival after transcatheter edge-to-edge repair for secondary mitral regurgitation JACC Cardiovasc Interv. 2021 14 1243 53

[21] Boekstegers P,Hausleiter J,Schmitz T.et al. ; MITRA-PRO Investigators. Intraprocedural residual mitral regurgitation and survival after transcatheter edge-to-edge repair: prospective German multicenter registry (MITRA-PRO) JACC Cardiovasc Interv. 2023 16 574 85

[22] Singh GD,Price MJ,Shuvy M.et al. Combined impact of residual mitral regurgitation and gradient after mitral valve transcatheter edge-to-edge repair JACC Cardiovasc Interv. 2024 17 2530 40

[23] Hausleiter J,Stocker TJ,Adamo M,Karam N,Swaans MJ,Praz F. Mitral valve transcatheter edge-to-edge repair EuroIntervention. 2023 18 957 76 9869401

[24] Sugiura A,Kavsur R,Spieker M.et al. Recurrent mitral regurgitation after MitraClip: predictive factors, morphology, and clinical implication Circ Cardiovasc Interv. 2022 15 e010895

[25] Sorajja P,Vemulapalli S,Feldman T.et al. Outcomes with transcatheter mitral valve repair in the United States: An STS/ACC TVT registry report J Am Coll Cardiol. 2017 70 2315 27

[26] Adamo M,Pagnesi M,Popolo Rubbio A.et al. Predictors of optimal procedural result after transcatheter edge-to-edge mitral valve repair in secondary mitral regurgitation Catheter Cardiovasc Interv. 2022 99 1626 35

[27] Orban M,Rottbauer W,Williams M.et al. Transcatheter edge-to-edge repair for secondary mitral regurgitation with third-generation devices in heart failure patients - results from the Global EXPAND Post-Market study Eur J Heart Fail. 2023 25 411 21

[28] Kubo S,Yamamoto M,Saji M.et al. ; OCEAN‐Mitral Investigators. One-year outcomes and their relationship to residual mitral regurgitation after transcatheter edge-to-edge repair with MitraClip device: insights from the OCEAN-mitral registry J Am Heart Assoc. 2023 12 e030747 PMC10757540

[29] Chhatriwalla AK,Vemulapalli S,Szerlip M.et al. Operator experience and outcomes of transcatheter mitral valve repair in the United States J Am Coll Cardiol. 2019 74 2955 65

[30] Taramasso M,Gavazzoni M,Nickenig G,Maisano F. Transcatheter mitral repair and replacement: which procedure for which patient? EuroIntervention. 2019;15:867-74

[31] Muller DWM,Farivar RS,Jansz P.et al. ; Tendyne global feasibility trial investigators. Transcatheter mitral valve replacement for patients with symptomatic mitral regurgitation: a global feasibility trial J Am Coll Cardiol. 2017 69 381 91

[32] Fukui M,Sorajja P,Gössl M.et al. Left ventricular remodeling after transcatheter mitral valve replacement with Tendyne: new insights from computed tomography JACC Cardiovasc Interv. 2020 13 2038 48

[33] Muller DWM,Sorajja P,Duncan A.et al. 2-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation J Am Coll Cardiol. 2021 78 1847 59

[34] Hell MM,Wild MG,Baldus S.et al. ; TENDER Investigators. Transapical mitral valve replacement: 1-year results of the real-world Tendyne European experience registry JACC Cardiovasc Interv. 2024 17 648 61

[35] Ben Ali W,Ludwig S,Duncan A.et al. ; CHOICE-MI Investigators. Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1-year results from the CHOICE-MI registry Eur J Heart Fail. 2022 24 887 98

[36] Al-Tawil M,Butt S,Reap S.et al. Transseptal vs transapical transcatheter mitral valve-in-valve and valve-in-ring implantation: a systematic review and meta-analysis Curr Probl Cardiol. 2023 48 101684

[37] Anselmi A,Leurent G,Donal E. Transcatheter mitral valve replacement: technology update. advances in cardiovascular technology. Elsevier; 2022. pp. 319-34

[38] Tartaglia F,Antonelli G,Gitto M.et al. TMVR for the treatment of mitral regurgitation: a state-of-the-art review Circ Cardiovasc Interv. 2025 18 e015298 12533778

[39] Zahr F,Song HK,Chadderdon S.et al. 1-year outcomes following transfemoral transseptal transcatheter mitral valve replacement: intrepid TMVR early feasibility study results JACC Cardiovasc Interv. 2023 16 2868 79

[40] Schneider LM,Worthley S,Nickenig G.et al. 1-year outcomes following transfemoral transseptal transcatheter mitral valve replacement: The HighLife TSMVR feasibility study JACC Cardiovasc Interv. 2023 16 2854 65

[41] Maisano F. Cardiovalve device attributes, implant procedure and early results. Presented at EuroPCR 2019; May 22, 2019; Paris, France. https://www.tctmd.com/slide/cardiovalve-device-attributes-implant-procedure-and-early-results. (accessed 7 January 2026)

[42] Kaneko et al. AltaValve Early Feasibility Study Results. Presented at: PCR Tokyo Valves 2025. T. AltaValve System Early Feasibility Study Results. AltaValve Early Feasibility Study Results Presented at: PCR Tokyo Valves 2025. https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2025/PCR-Tokyo-Valves/Late-Breaking-Trial-session. (accessed 7 January 2026)

[43] Granada JF. Cephea TMVR Program Technology and Clinical Update. Presented at: New York Valves; June 26, 2025; New York, USA. Available from: https://d14d5nk8lue86f.cloudfront.net/public/2025-06/5dba363c-2b20-470c-b9e0-79974d7a5983.pdf. (accessed 30 December 2025)

[44] Makkar R,O'neill W,Whisenant B.et al. TCT-8 updated 30-day outcomes for the U.S. early feasibility study of the SAPIEN M3 transcatheter mitral valve replacement system J Am Coll Cardiol. 2019 74 B8

[45] Meerkin D,Guetta V,Shaburishvili T.et al. Early experience with the innovalve transcatheter mitral valve replacement system JACC Cardiovasc Interv. 2024 17 712 4

[46] Meredith I,Bapat V,Morriss J,McLean M,Prendergast B. Intrepid transcatheter mitral valve replacement system: technical and product description EuroIntervention 2016 12 Y78 80

[47] Zahr F,Song HK,Chadderdon SM.et al. 30-day outcomes following transfemoral transseptal transcatheter mitral valve replacement: intrepid TMVR early feasibility study results JACC Cardiovasc Interv 2022 15 80 9

[48] Lange R,Piazza N. The HighLife transcatheter mitral valve implantation system EuroIntervention 2015 11 Suppl W W82 3

[49] Maisano F,Benetis R,Rumbinaite E.et al. 2-year follow-up after transseptal transcatheter mitral valve replacement with the cardiovalve JACC Cardiovasc Interv 2020 13 e163 4

[50] Sherif M,Sündermann SH,Maisano F.et al. Cardiovalve in mitral valve position-additional solution for valve replacement Front Cardiovasc Med 2022 9 960849 9485574

[51] Généreux P,Wróbel K,Rinaldi MJ.et al. AltaValve atrial fixation system for the treatment of severe mitral regurgitation and mitral annular calcification Struct Heart 2024 8 100294 PMC11121746

[52] Généreux P,Wróbel K,Ninios V.et al. 6-month outcomes of a supra-annular transcatheter mitral valve replacement: an early feasibility study JACC Cardiovasc Interv 2025 18 2584 92

[53] Coisne A,Rodés-Cabau J,Ludwig S.et al. Impact of a dedicated transseptal transcatheter mitral valve replacement system on cardiac remodeling and hemodynamics JACC Cardiovasc Interv 2023 16 1310 2

[54] Modine T,Vahl TP,Khalique OK.et al. First-in-human implant of the Cephea transseptal mitral valve replacement system Circ Cardiovasc Interv 2019 12 e008003

[55] Alperi A,Dagenais F,Del Val D.et al. Early experience with a novel transfemoral mitral valve implantation system in complex degenerative mitral regurgitation JACC Cardiovasc Interv 2020 13 2427 37

[56] Penteris M,Lampropoulos K. The SAPIEN M3 system for transcatheter mitral valve replacement: a new era begins Cardiovasc Revasc Med 2025 79 120 5

[57] Webb JG,Murdoch DJ,Boone RH.et al. Percutaneous transcatheter mitral valve replacement: first-in-human experience with a new transseptal system J Am Coll Cardiol 2019 73 1239 46

[58] Husain A,Meier D,Dundas J.et al. Transcatheter mitral valve replacement: 5 years later JACC Cardiovasc Interv 2023 16 2920 2

[59] Niikura H,Gössl M,Kshettry V.et al. Causes and clinical outcomes of patients who are ineligible for transcatheter mitral valve replacement JACC Cardiovasc Interv 2019 12 196 204

[60] Demir OM,Conradi L,Prendergast B.et al. Clinical characteristics and outcomes of patients screened for but deemed clinically not suitable for transcatheter mitral valve replacement: DECLINE-TMVR registry Can J Cardiol 2023 39 581 9