Predictors of long-term event-free survival and of freedom from restenosis after percutaneous balloon mitral commissurotomy

doi:10.1067/mhj.2001.118470

American Heart Journal

Volume 142, Issue 6, December 2001, Pages 1072-1079

https://doi.org/10.1067/mhj.2001.118470 Get rights and content

Abstract

Background Most long-term studies after balloon mitral commissurotomy (BMC) were from industrialized countries. Less is known about the long-term results of BMC from developing countries where patients are younger with fewer mitral valve deformities. Methods Between December 1987 and December 1998, we performed BMC in 654 patients whose mean age was 33 ± 13 years. Baseline and postprocedural variables were evaluated to identify predictors of event-free survival (survival without repeat BMC or mitral valve replacement) and of freedom from restenosis defined as a mitral valve area (MVA) ≥1.5 cm² after BMC and <1.5 cm² at follow-up. Results The actuarial survival rates were 98%, 98%, and 97% at 5, 7, and 10 years, respectively. The 5-, 7-, and 10-year event-free survival rates were 85%, 81%, and 72%. Multivariate predictors of a higher 10-year event-free survival rate were lower echocardiographic score (79% for a score ≤8, 61% for a score of 9 to 11, 62% for a score ≥12, P < .001) and cardiac sinus rhythm (P = .04) before BMC, lower mean left atrial pressure (P < .001), lower mitral valve gradient (P < .001), and less than or equal to grade 2 mitral regurgitation (P = .036) after BMC. Restenosis occurred in 16% of patients. The restenosis-free rates were 88%, 80%, and 66% at 5, 7, and 10 years, respectively. A higher freedom from restenosis at 10 years was associated with a lower score (77% for a score ≤8, 45% for a score of 9-11 and 50% for a score ≥12, P = .03) and a larger MVA before BMC (P = .03), a larger MVA (P < .001), and a lower mitral valve gradient (P = .04) after BMC. Conclusions BMC produces excellent 10-year results in patients with pliable mitral stenosis and good results in patients with semipliable or calcified mitral stenosis. BMC is the procedure of choice in patients with pliable valves and it is a reasonable treatment option in young patients with unfavorable mitral valve anatomy. (Am Heart J 2001;142:1072-9.)

Section snippets

Study population

Between December 1987 and December 1998, BMC was performed in 654 consecutive patients with symptomatic rheumatic mitral stenosis (MS). The baseline clinical and echocardiographic characteristics of the 654 patients are summarized in Table I.

. Baseline characteristics of the 654 patients

Characteristic	Value
Age (y)	33.6 ± 13
≤20 (No. [%])	110 (17)
21-50 (No. [%])	462 (71)
>50 (No. [%])	82 (12)
Sex
Female	474
Male	180
Atrial fibrillation (No. [%])	195 (29)
New York Heart Association functional class (No. [%])
II	205

Immediate results

BMC was completed in 647 (99%) patients. There were 3 early deaths: 2 because of left ventricular perforation by straight, sharp-tip catheters and one because of stroke that occurred during the procedure. Overall, there were 10 systemic embolisms, 9 cerebral and 1 in the right coronary artery. After the procedure there was a substantial increase in MVA (Gorlin’s) from 1.0 ± 0.2 to 2.2 ± 0.4 cm² and in cardiac index from 2.9 ± 0.7 to 3.5 ± 0.8 L · min^–1 · m^–2 and a decrease in left atrial

Discussion

In our study, BMC was completed in 99% of the 654 patients in whom it was attempted.

Acknowledgements

We thank Jamila Rassas for her secretarial assistance.

References (28)

M Pan et al.
Factors determining late success after mitral balloon valvotomy
Am J Cardiol
(1993)
LS Dean et al.
For-year follow-up of patients undergoing percutaneous balloon mitral commissurotomy: a report from the National Heart, Lung, and Blood Institute Balloon Valvuloplasty Registry
J Am Coll Cardiol
(1996)
GS Pavlides et al.
Predictors of long-term event-free survival after percutaneous balloon mitral valvuloplasty
Am J Cardiol
(1997)
PC Block et al.
Late (two-year) follow-up after percutaneous balloon mitral valvotomy
Am J Cardiol
(1992)
A Desideri et al.
Long-term (9 to 33 months) echocardiographic follow-up after successful percutaneous mitral commissurotomy
Am J Cardiol
(1992)
PC Block et al.
Mechanism of percutaneous mitral valvotomy
Am J Cardiol
(1987)
JD Kaplan et al.
In vitro analysis of mechanisms of balloon valvuloplasty of stenotic mitral valves
Am J Cardiol
(1987)
PA Ribeiro et al.
Mechnism of mitral valve area increase by in vitro single and double balloon mitral valvotomy
Am J Cardiol
(1988)
Multicenter experience with balloon mitral commissurotomy: the NHLBI Balloon Valvuloplasty Registry report on immediate and 30-day follow-up results
Circulation
(1992)
HC Hermann et al.
Factors influencing immediate results, complications and short-term follow-up status after Inoue balloon mitral valvotomy: a North American multicenter study
Am Heart J
(1992)

CR Chen et al.

Percutaneous balloon mitral valvuloplasty by the Inoue technique: a multicenter study of 4832 patients in China

Am Heart J

(1995)

M Ben-Farhat et al.

Results of percutaneous double-balloon mitral commissurotomy in one medical center in Tunisia

Am J Cardiol

(1995)

B Iung et al.

Immediate results of percutaneous mitral commissurotomy: a predictive model on a series of 1514 patients

Circulation

(1996)

DJ Cohen et al.

Predictors of long-term outcome after percutaneous balloon mitral valvuloplasty

N Engl J Med

(1992)

Cited by (56)

Transcatheter Therapy for Mitral Valve Stenosis
2024, Interventional Cardiology Clinics
Difficulties to enter the left ventricle during percutaneous transvenous mitral commissurotomy (PTMC)- our experiences of 80 cases with modified techniques
2021, Indian Heart Journal
Citation Excerpt :
PTMC shows good immediate and long-term clinical results and carries a low risk when performed by experienced teams. The failure rate ranges from 1 % to 17 %.5–17 Failure is mostly caused by an inability to puncture the atrial septum or to position the balloon correctly across the mitral valve (MV).
Percutaneous transvenous mitral commissurotomy (PTMC) is the standard of treatment for symptomatic severe rheumatic mitral stenosis (MS). PTMC has the standard Inoue technique, but we have to modify the procedure in many technically challenging cases, especially to cross the mitral valve.
Two over-the-wire strategies to enter the LV were taken in 80 complex cases of PTMC. The first one was done by exchanging the J-shaped wire from the balloon, introducing the spring wire into it, and pushing it into LV. The second one-removal of balloon keeping the spring wire in LA and the Mullin's sheath was introduced, and the tip of the wire was pushed into LV, and the balloon was introduced over the wire. We also changed the left atrium (LA) graphy in the RAO view instead of the AP view to facilitating entry into LV.
We succeeded in 76 (95 %) cases. Strategy one was applied to all but successful in only 25 cases (31 %), and strategy 2 was applied in the remaining. Strategy 1 required less procedural time and fluoroscopic time in comparison to strategy 2 (40 ± 10 vs 60 ± 16 min, 25 ± 7 vs 35 ± 8 min). After modification of taking the LA graphy in RAO view, our rate of facing the difficulties decreased from 21 % to 9 %. Critical MS (31 %) and the giant LA (30 %) were the topmost causes of difficulties. No major complications were recorded.
Over-the-wire entry into LV is cost-effective, requiring no new equipment and is safe and can be used in complex cases.
Impact of moderate to severe mitral stenosis in patients undergoing transcatheter aortic valve replacement
2019, International Journal of Cardiology
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR), the impact of concomitant mitral stenosis (MS) remains unknown. The aim of this study was to determine the incidence and impact of moderate to severe MS in patients undergoing TAVR.
The study included 2113 consecutive patients (mean age: 80 ± 9 years, mean STS: 6.4 ± 5.2%) who underwent TAVR in 2 centers. The presence of MS was defined as a mean transmitral gradient ≥ 5 mm Hg on baseline echocardiography in the absence of severe mitral regurgitation. Clinical events were prospectively collected in a dedicated TAVR database.
A total of 157 patients (7.4%) had moderate to severe MS (mean gradient: 7.2 ± 2.8 mm Hg; degenerative origin in 88%). Patients with MS were younger, more frequently women, had a higher left ventricular ejection fraction and an increased rate of severe pulmonary hypertension (p < 0.02 for all). Thirty-day mortality was similar in both groups (MS: 3.8%; no MS: 5.5%, adjusted p = 0.34). At a mean follow-up of 3 ± 2 years, there were no differences between groups in mortality (MS: 35%, no MS: 36.2%, adjusted HR: 1.14, 95% CI: 0.86–1.51), or heart failure rehospitalization (MS: 21%, no MS: 21.7%; adjusted HR: 1.16, 95% CI: 0.81–1.67). Patients with MS exhibited a similar functional status at follow-up compared to those with no MS (NYHA I–II in 85% and 88% of patients, respectively, adjusted p = 0.20).
About 7% of patients undergoing TAVR had concomitant moderate to severe MS. The presence of MS had no negative impact on early and mid-term clinical outcomes post-TAVR. These results suggest that TAVR is a valid alternative for treating patients with aortic stenosis in the presence of moderate to severe MS.
Immediate and late clinical outcomes of balloon mitral valvotomy based on immediate postballoon mitral valvotomy mitral valve area & percentage gain in mitral valve area—A tertiary centre study
2018, Indian Heart Journal
The aim of the study was to compare the immediate and late clinical outcomes of balloon mitral valvotomy (BMV), based on the immediate post-BMV valve area and percentage gain in mitral valve area (MVA).
Clinical data of 818 consecutive patients who underwent BMV in our institute from 2000 to 2008 were analyzed retrospectively. They were categorized into three groups based on the postprocedural MVA and percentage gain in valve area—(1) 50% gain with final MVA <1.5 cm², group 1 (fair result); (2) final MVA of ≥1.5 cm², group 2 (good result); and (3) <50% gain with final MVA <1.5 cm², group 3 (suboptimal result).
The baseline characteristics of the three patient groups were clearly distinct. Those who had <50% gain with final MVA <1.5 cm² were older and had higher incidence of atrial fibrillation (17 [22.4%]), heart failure (32 [42.1%]), pulmonary artery hypertension (45 [59.2%]), and significantly deformed valves (39 [51.3%]) at baseline. At a mean follow-up period of 5.64 ± 3.84 years, incidence of redo BMV (23 [4.6%]) and mitral valve replacement (17 [3.4%]) was higher in them than those with immediate MVA ≥1.5 cm². Among those with MVA <1.5 cm², events on follow-up were similar irrespective of the percentage gain in MVA.
Immediate postprocedural MVA of ≥1.5 cm², and not percentage gain, predicts better long-term clinical outcomes after BMV. Patients who had less than 50% gain with final MVA <1.5 cm² represent high-risk population with advanced mitral valve disease and comorbidities.
Late outcome of percutaneous mitral commissurotomy: Randomized comparison of Inoue versus double-balloon technique
2017, American Heart Journal
Citation Excerpt :
These results were excellent, and might have been better than the previously reported clinical follow-up data that confirmed the late efficacy of PMC: event-free survival range from 30–70% after 10–20 years, depending on patient characteristics.4,9,20-22,25 A comparison of various results of PMC should include clinical characteristics of patients because younger patient age and favorable mitral valve morphology are known to be good predictive factors for outcomes of PMC.8,29-31 Despite the differences in procedure time and dilating shape,15,19 we previously demonstrated that PMC using either the Inoue or double-balloon technique showed similar excellent 7-year outcomes in terms of survival, cardiac events, and echocardiographic restenosis.14
Late prognosis after successful percutaneous mitral commissurotomy (PMC) is unclear. We compared late results of PMC using Inoue versus double-balloon techniques up to 25 years in a randomized trial.
Between 1989 and 1995, 302 patients (77 men, 41 ± 11 years) with severe mitral stenosis were randomly assigned to undergo PMC using Inoue (n = 152; group I) or double-balloon technique (n = 150; group D). The end points were the composite events of death, mitral surgery, repeat PMC, or deterioration of New York Heart Association (NYHA) class ≥3.
During median follow-up of 20.7 years (maximum, 25.6), clinical events occurred in 82 (53.9%) patients in group I (37 deaths, 44 mitral surgeries, 9 repeat PMCs, 3 NYHA class ≥3) and in 79 (52.7%) patients in group D (34 deaths, 51 mitral surgeries, 5 repeat PMCs, 4 NYHA class ≥3). Event-free survival rates at 24 years were not significantly different between group I and group D (40.8% and 42.6%, respectively; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.65–1.20; P = .423). On multivariate analysis, absence of post-PMC commissural mitral regurgitation (MR) (HR, 1.84; 95% CI, 1.28–2.63; P = .001) and immediate post-PMC mitral valve area (MVA) <1.8 cm² (HR, 1.53; 95% CI, 1.04–2.25; P = .031) were independently correlated with clinical events after successful PMC.
The Inoue and double-balloon methods showed similar good clinical outcomes up to 25 years, and the achievement of effective commissurotomy to develop post-PMC commissural MR or immediate post-PMC MVA ≥1.8 cm² is important in optimizing the late results of PMC.
Initial Results and Long-Term Follow-up of Percutaneous Mitral Valvuloplasty in Patients with Pulmonary Hypertension
2017, Heart Lung and Circulation
Percutaneous balloon mitral valvuloplasty (PMV) is an attractive therapeutic approach in patients with mitral stenosis. The aim of this study was to assess the immediate and long-term clinical, echocardiographic and haemodynamic outcomes of PMV in patients with severe pulmonary hypertension (PAH).
Percutaneous balloon mitral valvuloplasty was performed in 157 consecutive patients; 60 patients (38.2%) had significant PAH defined as baseline pulmonary artery mean pressure (PAMP) ≥ 30 mm Hg (Group 1) and 97 patients (61.8%) had PAMP ≤ 30 mmHg (Group 2).
Pulmonary artery systolic pressure (PASP), mortality, need for mitral valve replacement or new PMV, and valve restenosis were evaluated during follow-up.
Mean age was 44.2 years and 88.5% (139 patients) were women. Primary success was achieved in 79.6% of the patients (125 patients) without differences between the groups.
Mitral valve area increased from 0.90 cm² to 1.76 cm², PASP fell from 57 mmHg to 35 mmHg in Group 1 and from 38 mmHg to 30 mmHg in Group 2.
Median PASP in Group 1 was 35, 32, 36, 38 and 34 mmHg at 12, 24, 36, 48 and 60 months. There were no significant differences in mitral valve area, PASP and clinical status between the groups.
Percutaneous balloon mitral valvuloplasty is a safe and effective technique for the treatment of patients with mitral stenosis and PAH. A significant decrease in pulmonary pressure was observed after valvuloplasty. Although there was a gradual decrease of MVA at long-term follow-up, most patients remained asymptomatic and PASP was stable.

View all citing articles on Scopus

^☆: Reprint requests: Mohamed Ben-Farhat, MD, Division of Cardiology, Fattouma Bourguiba University Hospital, 5000, Monastir, Tunisia. E-mail: [email protected]

View full text

Valvular and Congenital Heart DiseasePredictors of long-term event-free survival and of freedom from restenosis after percutaneous balloon mitral commissurotomy☆

Abstract

Section snippets

Study population

Immediate results

Discussion

Acknowledgements

Am J Cardiol

J Am Coll Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

Am J Cardiol

Multicenter experience with balloon mitral commissurotomy: the NHLBI Balloon Valvuloplasty Registry report on immediate and 30-day follow-up results

Circulation

Factors influencing immediate results, complications and short-term follow-up status after Inoue balloon mitral valvotomy: a North American multicenter study

Am Heart J

Percutaneous balloon mitral valvuloplasty by the Inoue technique: a multicenter study of 4832 patients in China

Am Heart J

Results of percutaneous double-balloon mitral commissurotomy in one medical center in Tunisia

Am J Cardiol

Immediate results of percutaneous mitral commissurotomy: a predictive model on a series of 1514 patients

Circulation

Predictors of long-term outcome after percutaneous balloon mitral valvuloplasty

N Engl J Med

Valvular and Congenital Heart Disease
Predictors of long-term event-free survival and of freedom from restenosis after percutaneous balloon mitral commissurotomy☆