Mitral stenosis transcatheter therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor-In-Chief: Sudarshan Srivats, M.D., M.P.H.[2]; Sara Zand, M.D.[3] Mohammed A. Sbeih, M.D. [4]; Joanna J. Wykrzykowska, M.D.

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Synonyms and keywords: Balloon mitral valvuloplasty, PMBC, percutaneous mitral balloon valvotomy, percutaneous mitral balloon valvuloplasty, PMBV, mitral valvuloplasty, percutaneous mitral valvuloplasty, PMC, percutaneous mitral commissurotomy

Overview

Percutaneous mitral balloon commissurotomy (PMBC) is the first-line intervention for symptomatic severe rheumatic mitral stenosis (MS) with favorable valve morphology, less than moderate (2+) mitral regurgitation, and no left atrial (LA) thrombus. Randomized trials show safety and efficacy comparable to surgical commissurotomy while avoiding thoracotomy at lower cost.[1][2] Long-term follow-up shows 70%–80% of patients free of recurrent symptoms at 10 years and 30%–40% at 20 years.[3] For patients who are not PMBC candidates, mitral valve surgery (commissurotomy or replacement) is indicated. Nonrheumatic calcific MS due to mitral annular calcification (MAC) is a fundamentally different disease: PMBC has no role, and transcatheter mitral valve replacement (TMVR) is an emerging option for inoperable or prohibitive-risk patients.[3][4]

Decision Algorithm: PMBC vs. Surgery

Selection of intervention type and timing depends on clinical characteristics, valve and subvalvular anatomy, and local expertise. The following framework integrates the 2020 ACC/AHA and 2021 ESC/EACTS recommendations.[3][5][6]

 
 
 
 
Severe MS
(MVA ≤1.5 cm²)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Determine etiology
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Rheumatic MS
(commissural fusion)
 
 
 
Calcific MS (MAC)
no commissural fusion
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assess symptoms
+ morphology
 
 
 
PMBC / surgical
commissurotomy:
no role
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Favorable morphology
(Wilkins ≤8, <2+ MR,
no LA thrombus)		Unfavorable morphology,
≥2+ MR, or LA thrombus
 
Severely symptomatic
(NYHA III–IV)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PMBC if symptomatic
(Class I); or asymptomatic
with PASP >50 mm Hg (IIa)
or new-onset AF (IIb)		MV surgery if acceptable
risk (Class I); PMBC as
palliation if high risk (IIb)
 
Valve intervention only
after risk discussion (IIb);
TMVR if inoperable /
prohibitive risk
 

Abbreviations: AF, atrial fibrillation; LA, left atrial; MAC, mitral annular calcification; MR, mitral regurgitation; MS, mitral stenosis; MVA, mitral valve area; NYHA, New York Heart Association; PASP, pulmonary artery systolic pressure; PMBC, percutaneous mitral balloon commissurotomy; TMVR, transcatheter mitral valve replacement. Adapted from the 2020 ACC/AHA VHD guideline.[3][4]

  1. Confirm severe rheumatic MS (MVA ≤1.5 cm²).
  2. Assess symptoms: symptomatic (NYHA II–IV) → proceed; asymptomatic → intervene only if PASP >50 mm Hg or new-onset AF, otherwise surveillance.
  3. Assess morphology: favorable (Wilkins ≤8, no commissural calcification, mobile/thin leaflets, minimal subvalvular disease), <2+ MR, and no LA thrombus → PMBC; unfavorable morphology, ≥2+ MR, or LA thrombus → surgical evaluation.
  4. Assess surgical candidacy: acceptable risk → MV surgery (commissurotomy if anatomy permits, otherwise MVR); high/prohibitive risk → PMBC may be considered as palliation despite suboptimal anatomy.
  5. Favor surgery over PMBC for: failed prior PMBC, concomitant moderate-to-severe tricuspid regurgitation requiring repair, need for other cardiac surgery, or no access to an experienced PMBC operator.

Both ACC/AHA and ESC/EACTS recommend PMBC for symptomatic severe MS with favorable anatomy (Class I) and consider PMBC in asymptomatic patients with favorable anatomy and PASP >50 mm Hg (Class IIa). The 2021 ESC/EACTS guideline additionally gives a Class IIa recommendation for PMC in asymptomatic patients with suboptimal anatomy but favorable clinical characteristics and high thromboembolic or hemodynamic decompensation risk.[5][6] A randomized trial (Kang et al., 2021; 167 patients, median follow-up 6.4 years) comparing early PMC with conventional management in asymptomatic severe MS found no significant reduction in the composite of cardiovascular events (HR 0.77; 95% CI 0.29–2.07; P=0.61), supporting current guideline conservatism for asymptomatic patients without elevated PASP or new-onset AF.[7]

2020 ACC/AHA Guideline Recommendations for Intervention

COR LOE Recommendation
I A Symptomatic patients (NYHA II–IV) with severe rheumatic MS (MVA ≤1.5 cm², Stage D), favorable morphology, <2+ MR, and no LA thrombus → PMBC at a Comprehensive Valve Center.
I B-NR Severely symptomatic patients (NYHA III–IV) with severe rheumatic MS who are not PMBC candidates, have failed PMBC, require other cardiac procedures, or lack PMBC access → MV surgery (repair, commissurotomy, or replacement).
IIa B-NR Asymptomatic patients with severe rheumatic MS (Stage C), favorable morphology, <2+ MR, no LA thrombus, and PASP >50 mm Hg → PMBC reasonable at a Comprehensive Valve Center.
IIb C-LD Asymptomatic patients with severe rheumatic MS (Stage C), favorable morphology, <2+ MR, no LA thrombus, and new-onset AF → PMBC may be considered.
IIb C-LD Symptomatic patients with MVA >1.5 cm² but hemodynamically significant MS on exercise (PAWP >25 mm Hg or mean gradient >15 mm Hg) → PMBC may be considered.
IIb B-NR Severely symptomatic patients (NYHA III–IV) with severe rheumatic MS and suboptimal anatomy who are not surgical candidates or at high surgical risk → PMBC may be considered (palliative).

All recommendations from the 2020 ACC/AHA VHD guideline.[3]

Patient Selection and Morphology Scoring

Wilkins Score

The Wilkins score grades leaflet mobility, leaflet thickening, subvalvular thickening, and calcification (each 1–4; total range 4–16). A score ≤8 predicts favorable PMBC outcomes, though a score >8 does not preclude PMBC — approximately 42% of patients with scores >8 still achieve optimal results (≥25% increase in MVA to >1.5 cm²).[3] Key limitations are that it does not account for pre-procedural MR (the most important contraindication) and does not specifically assess commissural morphology.[8]

Nunes Score

The Nunes score incorporates MVA ≤1 cm² (2 points), maximum leaflet displacement ≤12 mm (3 points), commissural area ratio ≥1.25 (3 points), and subvalvular involvement (3 points), stratifying into low (0–3), intermediate (5), and high (6–11) risk with suboptimal PMBC results of 17%, 56%, and 74%, respectively. It provided a net reclassification improvement of 45.2% over the Wilkins score.[9]

Commissural Calcification

In a cohort of 876 patients, commissural calcification was an independent predictor of significant post-PMBC MR (OR 1.69 early; OR 3.90 at 24 months), independent of Wilkins score. Combined Wilkins score and commissural calcification assessment is recommended for patient selection.[10]

CT-Based Scoring

A 2025 multicenter study (96 patients) found CT-derived Wilkins scores higher than echo scores (8.0 vs. 7.3). Among patients with intermediate echo scores (7–9), 90% had high CT scores (≥9), which were associated with higher rates of unsuccessful PMBC (61% vs. 19%). CT scoring is promising but not yet prospectively validated.[11]

3D Echocardiography

Three-dimensional transthoracic and transesophageal echocardiography improves pre-PMBC planning by enabling en face visualization of the mitral orifice for direct planimetry of MVA and detailed assessment of commissural fusion and calcification, complementing 2D scoring systems.[12]

Predictors of PMBC Outcome

Favorable predictors Unfavorable predictors
Wilkins score ≤8 Wilkins score >8
Sinus rhythm Atrial fibrillation
Good leaflet mobility Commissural calcification
No/minimal subvalvular involvement Severe subvalvular disease
Larger pre-procedural MVA Smaller pre-procedural MVA
Age ≤65 years Age >65 years
Complete commissural opening; post-PMBC MVA ≥1.8 cm² Post-procedural MR ≥3+; prior surgical commissurotomy

Adapted from the 2020 ACC/AHA guideline.[3] Older patients with low transmitral gradients (<10 mm Hg) may derive less symptomatic benefit from PMBC, as reduced net atrioventricular compliance, LA noncompliance, and LV diastolic dysfunction can contribute to symptoms independent of valve area.[3]

Contraindications to PMBC

  • Persistent LA or LA appendage thrombus (TEE mandatory before the procedure).[3]
  • MR ≥2+ (moderate or greater).[8]
  • Massive or bicommissural calcification.[13]
  • Absence of commissural fusion (non-rheumatic etiology).[13][3]
  • Severe concomitant aortic valve disease, organic tricuspid stenosis, or severe functional TR with annular dilation requiring surgery.
  • Severe concomitant coronary artery disease requiring CABG, or need for other cardiac surgery.[3]

Procedural Technique

PMBC is performed via a transvenous transseptal approach, most commonly with the Inoue balloon system.[3]

  • Transseptal puncture at the fossa ovalis under fluoroscopic and echocardiographic guidance; the interatrial septum may be more horizontal and lower in MS.
  • Advancement of the Inoue balloon (24–30 mm, sized to patient height) across the mitral valve into the LV.
  • Stepwise inflation in three stages (distal, then proximal, then full) for self-positioning and commissural splitting.
  • Hemodynamic assessment after each inflation: transmitral gradient, MVA, and MR severity.
  • Endpoint: adequate MVA (typically ≥1.5 cm²) achieved, or any increase in MR severity → stop.

A randomized comparison with 24-year follow-up (302 patients) showed no significant difference in event-free survival between Inoue and double-balloon techniques (40.8% vs. 42.6%).[14] PMBC should be performed only by experienced operators at Comprehensive Valve Centers with surgical backup; declining US procedural volumes have been accompanied by rising complication rates.[3]

Outcomes

  • Typical MVA increase from ~1.0 cm² to ~2.0 cm², with rapid reduction in LA pressure, increased cardiac output, and reduced pulmonary artery pressure.[3]
  • Event-free survival at 20 years is approximately 40%–55% in patients with initial good results; the pre-procedural Wilkins score is the strongest independent predictor of long-term events.[14][15]
  • Post-procedural MVA ≥1.8 cm² and absence of commissural MR are independently associated with better long-term outcomes.[14]

PMBC vs. Surgical Commissurotomy

A meta-analysis of 7 RCTs (553 patients) found no convincing difference in restenosis or re-intervention between PMBC and surgical commissurotomy, with lower periprocedural morbidity for PMBC.[1] One large observational study (402 PMBC vs. 159 surgery, 9-year follow-up) found open surgery associated with higher adjusted event-free survival (HR 3.73 for PMBC vs. surgery), particularly with Wilkins score ≥8 or AF.[16] For comparison of open surgical commissurotomy with mitral valve replacement, see the Surgical Therapy microchapter.

Complications of PMBC

Complication Incidence
Procedural mortality 0–0.5% (up to 3% in high-risk)
Severe MR requiring surgery 1.6–3%
Any increase in MR (≥1 grade) ~25%
Hemopericardium/tamponade 0.5–2%
Stroke/systemic embolism 0.5–1%
Residual iatrogenic ASD (usually small; rarely hemodynamically significant) Common on imaging; clinically significant in a minority

Catastrophic complications (tamponade, stroke, acute severe MR) occur in 2%–5% of procedures; a ruptured leaflet requires urgent surgery.[3][1] Residual iatrogenic atrial septal defect from transseptal access is frequently detectable but only occasionally hemodynamically significant.[3]

PMBC in Pregnancy

PMBC is the preferred intervention for pregnant women with severe symptomatic MS refractory to medical therapy.[3]

  • A meta-analysis of 21 studies (745 pregnancies) found a procedural success rate of 94.3%; MR was the most common complication (12.7%), preterm delivery occurred in 3.9%, and stillbirth in 0.9%. Maternal deaths occurred almost exclusively with severe subvalvular disease (Wilkins subvalve score ≥3).[17]
  • Timing is preferably after 20 weeks' gestation and ideally between 26–30 weeks; abdominal shielding and minimized fluoroscopy are essential.[18]
  • MV surgery during pregnancy carries a 20%–30% fetal mortality risk from cardiopulmonary bypass and should be reserved for non-PMBC candidates.[19]

Nonrheumatic Calcific (MAC-Related) MS

Calcific MS due to severe MAC is fundamentally different from rheumatic MS: there is no commissural fusion, so PMBC and surgical commissurotomy have no role.[3]

  • 2020 ACC/AHA (Class IIb, LOE C-LD): In severely symptomatic (NYHA III–IV) patients with severe MS (MVA ≤1.5 cm²) from extensive MAC, valve intervention may be considered only after discussion of high procedural risk and patient preferences.[3]
  • 2025 AATS Expert Consensus: Symptomatic MAC-related MS in patients who are inoperable or at prohibitive surgical risk should be considered for TMVR; LVOT obstruction risk can be mitigated with anterior mitral leaflet laceration (LAMPOON).[4]

TMVR for MAC (Emerging Evidence)

The SUMMIT-MAC study (2026), the first prospective trial of a dedicated TMVR device (Tendyne) for severe MAC, enrolled 103 patients (mean age 78) with significant mitral valve dysfunction — predominantly MR (97% with ≥2+ MR at baseline), with or without concomitant MS. Technical success was 94.2% and 30-day mortality 6.8%; the primary endpoint (freedom from all-cause mortality and HF hospitalization at 12 months) was met at 60.4% (vs. performance goal 43%), with substantial NYHA and KCCQ improvement. These results should be interpreted cautiously for isolated calcific MS, as the trial population was predominantly MR.[20] Durability data are limited, and roughly two-thirds of patients are excluded from current TMVR trials due to anatomic unsuitability.[21]


References

  1. ↑ 1.0 1.1 1.2 Singh AD, Mian A, Devasenapathy N, Guyatt G, Karthikeyan G (2020). "Percutaneous mitral commissurotomy versus surgical commissurotomy for rheumatic mitral stenosis: a systematic review and meta-analysis of randomised controlled trials". Heart. 106 (14): 1094–1101. doi:10.1136/heartjnl-2019-315906. PMID 31969438.
  2. ↑ Reyes VP, Raju BS, Wynne J, Stephenson LW, Raju R, Fromm BS; et al. (1994). "Percutaneous balloon valvuloplasty compared with open surgical commissurotomy for mitral stenosis". N Engl J Med. 331 (15): 961–7. doi:10.1056/NEJM199410133311501. PMID 8084355.
  3. ↑ 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18 Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, Gentile F; et al. (2021). "2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines". Circulation. 143 (5): e72–e227. doi:10.1161/CIR.0000000000000923. PMID 33332150 Check |pmid= value (help).
  4. ↑ 4.0 4.1 4.2 El-Eshmawi A, Halas M, Bethea BT; et al. (2025). "The American Association for Thoracic Surgery (AATS) 2025 Expert Consensus Document: Surgical Management of Mitral Annular Calcification". J Thorac Cardiovasc Surg. 170 (2): 502–522. doi:10.1016/j.jtcvs.2025.04.003. PMID 40324748 Check |pmid= value (help).
  5. ↑ 5.0 5.1 Vahanian A, Beyersdorf F, Praz F; et al. (2022). "2021 ESC/EACTS Guidelines for the management of valvular heart disease". Eur Heart J. 43 (7): 561–632. doi:10.1093/eurheartj/ehab395. PMID 34453165 Check |pmid= value (help).
  6. ↑ 6.0 6.1 Coisne A, Lancellotti P, Habib G; et al. (2023). "ACC/AHA and ESC/EACTS Guidelines For the Management of Valvular Heart Diseases: JACC Guideline Comparison". J Am Coll Cardiol. 82 (8): 721–734. doi:10.1016/j.jacc.2023.05.061. PMID 37587695 Check |pmid= value (help).
  7. ↑ Kang DH, Park SJ, Lee SA; et al. (2021). "Early percutaneous mitral commissurotomy or conventional management for asymptomatic mitral stenosis: a randomised clinical trial". Heart. 107 (24): 1980–1986. doi:10.1136/heartjnl-2021-319857. PMID 34526318 Check |pmid= value (help).
  8. ↑ 8.0 8.1 Wunderlich NC, Beigel R, Ho SY; et al. (2018). "Imaging for Mitral Interventions: Methods and Efficacy". JACC Cardiovasc Imaging. 11 (6): 872–901. doi:10.1016/j.jcmg.2018.02.024. PMID 29778854.
  9. ↑ Nunes MC, Tan TC, Elmariah S; et al. (2014). "The echo score revisited: Impact of incorporating commissural morphology and leaflet displacement to the prediction of outcome for patients undergoing percutaneous mitral valvuloplasty". Circulation. 129 (8): 886–95. doi:10.1161/CIRCULATIONAHA.113.001252. PMID 24398956.
  10. ↑ Rostambeigi S, Mazaherinia H, Hamidabad NM; et al. (2024). "Impact of commissural calcification on clinical outcome of percutaneous balloon mitral valvuloplasty; a retrospective cohort study of 876 patients". BMC Cardiovasc Disord. 24 (1): 309. doi:10.1186/s12872-024-03932-w. PMID 38762715 Check |pmid= value (help).
  11. ↑ Lee HJ, Kim NY, Kim DY; et al. (2025). "Selecting the optimal candidates for percutaneous mitral valvuloplasty using multi-modality imaging". Eur Heart J Cardiovasc Imaging. 26 (4): 705–711. doi:10.1093/ehjci/jeae334. PMID 39737766 Check |pmid= value (help).
  12. ↑ Pandian NG, Kim JK, Arias-Godinez JA; et al. (2023). "Recommendations for the Use of Echocardiography in the Evaluation of Rheumatic Heart Disease: A Report From the American Society of Echocardiography". J Am Soc Echocardiogr. 36 (1): 3–28. doi:10.1016/j.echo.2022.10.009. PMID 36495951 Check |pmid= value (help).
  13. ↑ 13.0 13.1 Chandrashekhar Y, Westaby S, Narula J (2009). "Mitral stenosis". Lancet. 374 (9697): 1271–83. doi:10.1016/S0140-6736(09)60994-6. PMID 19752328.
  14. ↑ 14.0 14.1 14.2 Lee S, Kang DH, Kim DH; et al. (2017). "Late outcome of percutaneous mitral commissurotomy: Randomized comparison of Inoue versus double-balloon technique". Am Heart J. 194: 1–8. doi:10.1016/j.ahj.2017.04.004. PMID 28407940.
  15. ↑ Meneguz-Moreno RA, Costa JR, Gomes NL; et al. (2018). "Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty". JACC Cardiovasc Interv. 11 (19): 1945–1952. doi:10.1016/j.jcin.2018.05.039. PMID 30190066.
  16. ↑ Song JK, Kim MJ, Yun SC; et al. (2010). "Long-term outcomes of percutaneous mitral balloon valvuloplasty versus open cardiac surgery". J Thorac Cardiovasc Surg. 139 (1): 103–10. doi:10.1016/j.jtcvs.2009.04.022. PMID 19660277.
  17. ↑ Sreerama D, Surana M, Moolchandani K; et al. (2021). "Percutaneous balloon mitral valvotomy during pregnancy: A systematic review and meta-analysis". Acta Obstet Gynecol Scand. 100 (4): 666–675. doi:10.1111/aogs.14029. PMID 33230814 Check |pmid= value (help).
  18. ↑ Elkayam U, Bansal P, Mehra A (2022). "Catheter-Based Interventions for the Management of Valvular Heart Disease During Pregnancy". JACC Adv. 1 (2): 100022. doi:10.1016/j.jacadv.2022.100022.
  19. ↑ Elkayam U, Goland S, Pieper PG, Silverside CK (2016). "High-Risk Cardiac Disease in Pregnancy: Part I.". J Am Coll Cardiol. 68 (4): 396–410. doi:10.1016/j.jacc.2016.05.048. PMID 27443879.
  20. ↑ Sorajja P, Thourani VH, Rogers JH; et al. (2026). "Transcatheter Mitral Valve Replacement for Severe Mitral Annular Calcification: Primary Outcomes From the SUMMIT-MAC Study". J Am Coll Cardiol. 87 (23): 3243–3256. doi:10.1016/j.jacc.2025.10.025. PMID 41194751 Check |pmid= value (help).
  21. ↑ Chehab O, Roberts-Thomson R, Bivona A; et al. (2022). "Management of Patients With Severe Mitral Annular Calcification: JACC State-of-the-Art Review". J Am Coll Cardiol. 80 (7): 722–738. doi:10.1016/j.jacc.2022.06.009. PMID 35953136 Check |pmid= value (help).

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