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Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis
International Journal of Cardiology 177 (2014) 881–885
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International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis☆ Fabrizio Tomai a,⁎, Achille Gaspardone b, Francesco Versaci c, Anna S. Ghini a, Luca Altamura a, Leonardo De Luca a, Gaetano Gioffrè b, Pier Agostino Gioffrè a,1 a b c
Department of Cardiovascular Sciences, European Hospital, Rome, Italy Department of Medicine, S. Eugenio Hospital, Rome, Italy Cardiology Unit, Cardarelli Hospital, Campobasso, Italy
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Article history: Received 12 June 2014 Received in revised form 24 September 2014 Accepted 18 October 2014 Available online 22 October 2014 Keywords: Mitral stenosis Percutaneous balloon mitral valvuloplasty Valvular heart disease
a b s t r a c t Background: Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV. Methods: Between 1991 and 2010, 482 consecutive patients underwent successful PMV in a single center. Procedural success was defined as post-procedural valve area ≥ 1.5 cm2 and regurgitation moderate or less, without in-hospital major adverse cardiac and cerebro-vascular events. The primary endpoint was 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery or repeat PMV. Results: Long-term follow-up (mean 11.6 ± 4.9 years; range 0.5 to 20) was completed in 441 (91.5%) patients. The incidence of the primary endpoint was 41.9% (95% confidence interval [CI]: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4), and 5.9% (95% CI: 3.9 to 8.5), respectively. Cumulative MACE-free survival at 20 years was 35.9 ± 4.7%. At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4–2.8, p b 0.001), echocardiographic score N 8 (HR: 2.19; 95% CI: 1.6–2.9, p b 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2–2.1, p = 0.003) and valve area ≤ 1.75 cm2 after PMV (HR: 3.1; 95% CI: 2.3–4.2, p b 0.001) were identified as independent predictors of the primary endpoint. Conclusions: Up to 20 years after successful PMV, a sizeable proportion of patients still exhibit a good clinical result. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction
2. Methods 2.1. Patients and assessments
Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis [1,2]. Some series have reported late results after PMV [3–8]. However, few studies with follow-up longer than a decade are available [9–11] and only one study reported data in a large population of patients undergoing PMV from 1986 to 1995 with a median follow-up period longer than 10 years [11]. Thus, the aim of the present study was to report very long-term results up to 20 years, in a more contemporary series of patients treated by PMV.
☆ The authors report no relationships that could be construed as a conflict of interest. ⁎ Corresponding author at: Department of Cardiovascular Sciences, Division of Cardiology, European Hospital, Via Portuense 700-00149 Rome, Italy. E-mail address: [email protected] (F. Tomai). 1 Professor Pier Agostino Gioffrè passed away on the 6th of November 2011.
http://dx.doi.org/10.1016/j.ijcard.2014.10.040 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
From January 1991 to December 2010, 527 consecutive patients with rheumatic mitral stenosis underwent a first PMV at our Institution. All data were collected prospectively and recorded electronically. Clinical status was determined by the New York Heart Association (NYHA) classification. An echo-Doppler study was performed before and 24 h after PMV in all patients. Evaluations included mitral valve area (using planimetry by two-dimensional echocardiography or, when planimetry was not feasible, the Doppler pressure half-time method), echocardiographic score [12] and mitral regurgitation (MR) estimation by color-Doppler semi-quantitative method, graded as: no or trivial (0), mild (1 +), moderate (2+), moderately severe (3 +), and severe (4+). All patients also underwent transesophageal echocardiography 1 day before the procedure in order to rule out left atrium or appendage thrombosis. Prior to study enrollment a written informed consent was required. The study protocol and related materials were approved by the Institutional Review Boards and Ethical Committees of our center.
2.2. Percutaneous mitral valvuloplasty technique PMV was performed by an antegrade trans-septal approach using the Inoue technique, as previously described [13]. Balloon size was determined by the formula: maximal
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balloon size (mm) = [patient's height (cm) / 10] + 10. Right and left heart catheterization was performed pre- and post-PMV, to determine cardiac output and pressures, including transmitral gradient. Contrast left ventriculography was performed before and after PMV. Angiographic MR severity was graded as: no (0), mild (1+), moderate (2+), moderately severe (3+), and severe (4+). 2.3. Study definitions Procedural success was defined as post-PMV valve area ≥ 1.5 cm2 and angiographic MR b 3+, in the absence of in-hospital major adverse cardiac and cerebrovascular events, including any death, stroke, mitral surgery and cardiac tamponade. Clinical improvement after PMV was defined as ≥1 NYHA class reduction compared to baseline with a postprocedural class ≤2 at one month. The primary endpoint was the 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery (repair or substitution) or repeat PMV. The secondary endpoint was the cumulative incidence of any death, need for mitral surgery or repeat PMV, and functional impairment (NYHA class N 2) at long-term follow-up. Any unexplained death was considered to be cardiovascular related. 2.4. Follow-up All patients were followed up by clinical visit at 1 month and every year after the index PMV. Adverse events were monitored throughout the entire study period. When the patient was lost to follow-up, the family, physician, or personal cardiologist was contacted. 2.5. Statistical analysis Continuous variables are reported as mean and standard deviation (or standard error for actuarial survival) and were compared using the Student's t test or Wilcoxon rank sum test as appropriate. Categorical variables are reported as percentages and compared using the chi-square or Fisher's exact test as appropriate. Univariate analysis to test the relation between the clinical and treatment variables and the occurrence of MACE at follow-up was performed by means of Cox proportional hazards regression, obtaining the hazard ratio (HR) and 95% confidence interval (CI) for each parameter. Significant covariates were then entered into a multivariate Cox proportional hazards regression model to assess the simultaneous effect of multiple variables on the occurrence of MACE at follow-up. Long-term freedom from MACE was calculated using the Kaplan–Meier method. For all analyses, the conventional p value of 0.05 or less was used to determine the level of statistical significance. All data were analyzed using the statistical software package IBM SPSS 20.
3. Results 3.1. In-hospital outcome Baseline and peri-procedural characteristics of the whole population are reported in Table 1. Procedural success was obtained in 482 (91%) patients, with a clinical improvement in 478 (99.2%). The remaining 45 (8.5%) patients were excluded from the analysis because of procedural failure, including sub-optimal valve dilatation (post-PMV valve
area b 1.5 cm2) in 14 patients (2.7%), severe MR requiring surgery (repair or substitution) in 26 (4.9%), cardiac tamponade in 2 (0.4%), stroke in 1 (0.2%) and death in 2 (0.4%) (Fig. 1). A trend toward a higher success rate was observed for the procedures performed in the second (from 2001 to 2010, n = 210) than in the first (from 1991 to 2000, n = 317) decade (94.3% versus 89.6%, p = 0.053). 3.2. Long-term follow-up Follow-up was completed in 441 patients (91.5% of eligible) with a mean follow-up period of 11.7 ± 4.9 years (range 0.5 to 20 years), with 289 of the patients (65.5%) being followed up for at least 10 years. The incidence of the primary endpoint was 41.9% (95% CI: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4) and 5.9% (95% CI: 3.9 to 8.5), respectively. The incidence of the secondary endpoint was 51.9% (95% CI: 47.2 to 56.7). Details regarding the occurrence of clinical events at the 20-year follow-up are reported in Table 2. The cumulative MACE-free survival at 20 years in patients with successful PMV was 35.9 ± 4.7% (Fig. 2), while survival free of any death, any intervention and functional impairment was 21 ± 4.7%. In the overall population (including patients with unsuccessful PMV) the longterm cumulative MACE-free survival was 11.6 ± 8.6% (Fig. 3). At the univariate analysis the incidence of the primary endpoint was associated with age N 50 years (p = 0.002), male gender (p = 0.004), atrial fibrillation (p = 0.004), an echocardiographic score N8 (p b 0.001), pre-procedural MR ≥ 2 (p = 0.003), pre- (p = 0.012) and post- (p = 0.005) procedural high mean mitral gradient and postprocedural mitral valve area ≤ 1.75 cm2 (p b 0.001). Similar findings were obtained for the incidence of the secondary end-point (Table 3). At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4–2.8, p b 0.001), the echocardiographic score N 8 (HR: 2.19; 95% CI: 1.6–2.9, p b 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2–2.1, p = 0.003) and valve area ≤ 1.75 cm2 after PMV (HR: 3.1; 95% CI: 2.3–4.2, p b 0.001) were identified as independent predictors of the primary endpoint (Table 4). The same variables and age were identified as independent predictors of the secondary endpoints (Table 4). 4. Discussion The main findings of this study indicate that: i) a sizeable proportion of patients undergoing successful PMV still exhibit a good outcome after
Table 1 Baseline and peri-procedural characteristics. Characteristic
All patients
Patients with procedural success
Patients with procedural failure
Patients with procedural success and follow-up
Patients with procedural success lost at follow-up
N (%) Age, y Age N 50 years, N (%) Female gender, N (%) NYHA class N II, N (%) Previous CM or PMV, N (%) Atrial fibrillation, N (%) Echo score N 8, N (%) Echo score Mitral regurgitation ≥ 2, N (%) Mitral valve area, cm2 Mean mitral gradient, mm Hg
527 55.3 ± 11.6 337 (63.9) 439 (83.3) 386 (73.2) 38 (7.2) 238 (45.2) 195 (37%) 7.9 ± 2.3 58 (11) 0.99 ± 0.2 17 ± 6.6
482 (91.5) 55.4 ± 11.7 310 (64.3) 398 (82.6) 346 (71.8) 30 (6.2) 218 (45.2) 177 (36.7) 7.9 ± 2.3 47 (9.8) 0.99 ± 0.2 16.9 ± 6.7
45 (8.5) 54.6 ± 10.9 27 (60%) 41 (91.1) 40 (88.9)⁎ 8 (17.8)⁎ 20 (44.4) 18 (40%) 8.5 ± 2.2 11 (24.4)⁎
41 (8.7) 51.5 ± 8.9⁎⁎ 18 (43.9) 33 (80.5) 34 (82.9) 2 (4.9) 16 (39.0) 7 (17.1)⁎⁎
0.97 ± 0.2 17.8 ± 5.8
441 (91.5) 55.7 ± 11.8 292 (66.2) 365 (82.8) 312 (70.7) 28 (6.3) 202 (45.8) 170 (38.5) 7.9 ± 2.4 41 (9.3) 1.0 ± 0.2 16.8 ± 6.5
7.5 ± 1.9 6 (14.6) 0.88 ± 0.2 18 ± 8.4
After procedure Mitral valve area, cm2 Mitral valve area ≤ 1.75 cm2, N (%) Mean mitral gradient, mm Hg Mitral regurgitation ≥ 2, N (%)
1.9 ± 0.4 176 (33.4) 6.6 ± 4.1 114 (21.6)
1.9 ± 0.4 144 (29.9) 6.0 ± 3.0 88 (18.3)
1.4 ± 0.4⁎ 32 (71.1)⁎ 13.1 ± 7.9⁎ 26 (57.8)⁎
1.9 ± 0.4 122 (27.7) 5.9 ± 2.9 78 (17.7)
1.8 ± 0.3 12 (29.3) 6.1 ± 3.3 10 (24.4)
Values are mean ± SD or number (percent of total). CM: surgical commissurotomy; PMV: percutaneous balloon mitral valvuloplasty. ⁎ p b 0.05 versus patients with procedural success. ⁎⁎ p b 0.05 versus patients with procedural success and follow-up.
F. Tomai et al. / International Journal of Cardiology 177 (2014) 881–885
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Fig. 2. Kaplan–Meier analysis for cumulative MACE-free survival at long-term follow-up in patients with successful PMV.
Fig. 1. Study flow chart.
two decades; ii) predictors of long-term outcome are multiple and include male gender, anatomical impairment of mitral valve, the presence of atrial fibrillation and procedural results. Previous studies showed that the outcome of PMV is good and comparable with those of surgical commissurotomy [3–8]. Indeed, followup data beyond 20 years after the implantation of a tissue or mechanical mitral prosthesis showed survival rates equivalent to that observed with PMV [14]. Few studies with very long-term follow-up after PMV are currently available [9,10] and only in one study data at a median follow-up time of 12 years have been reported [11]. Specifically, Bouleti et al. [11] found in 912 patients undergoing successful PMV between 1986 and 1995, a 20-year rate of cardiovascular survival without re-intervention of 38%. Our findings, obtained in 482 patients successfully treated by PMV in a single Institution between 1991 and 2010, are in accordance with those of Bouleti et al., showing a 20-year rate of cardiovascular survival without re-intervention of 36%. Such good results, coming from a more contemporary series of patients undergoing PMV, suggest that although the number of procedures decreases over the time due to a less incidence of rheumatic mitral stenosis, a substantial number of patients are still treated in experienced centers with good immediate and long term outcomes, making an ‘old’ interventional procedure still valuable and effective in patients with mitral stenosis. In our study, similarly to previous investigations [5–10], prediction of long-term outcome after successful PMV appears to be multifactorial. In particular, we found that independent predictors of 20-year MACE Table 2 Hierarchical events at 20-year follow-up. Events
n = 441
MACE (primary endpoint) Cardiovascular death Non cardiovascular death Need for repeat PMV Need for mitral surgery Functional impairment (NYHA class N 2)a Any death, any intervention and functional impairment (secondary endpoint)
185 (41.9) 40 (9.1) 23 (5.2) 26 (5.9) 119 (27) 21 (4.8) 229 (51.9)
Values are number (percent of total). MACE: major adverse cardiovascular events, including cardiovascular death, need for mitral surgery (repair or substitution) or repeat PMV (percutaneous balloon mitral valvuloplasty). a Functional impairment refers to surviving patients not undergoing mitral surgery or repeat PMV.
are age, procedural result, echocardiographic score, the presence of atrial fibrillation and male gender. Of note, the strongest independent predictor was a valve area ≤ 1.75 cm2 after PMV. This cut-off value has been previously shown to be the best predictor of long-term outcome after successful PMV [15]. This implies that an optimal result of the procedure, which, in turn, depends on the extent of mitral valve disease and the correctness of the technique, will likely avoid further interventions for many years. The pivotal importance of final mitral valve area or mean transvalvular gradient reduction, in the prediction of a good long-term outcome has consistently been emphasized in several different investigations [5–10]. Another independent predictor of long-term MACE resulted in the echocardiographic score, which reflects valve anatomy and, as a consequence, the type and extent of mitral valve disease. Specifically, among patients successfully treated by PMV, those with an echocardiographic score N 8 exhibited a twofold risk of 20-year MACE rate than patients with a score ≤ 8. Also the presence of atrial fibrillation was independently related to long-term MACE, as previously reported after PMV and surgical commissurotomy [6,7]. An intriguing finding of our study was that also male gender resulted as an independent predictor of long-term outcome. Indeed, Bouleti et al. [10] found an interaction between sex and valve calcification showing that the impact of valve anatomy is stronger in men. However, Cruz-Gonzalez et al. [16], who specifically evaluated the relationship between sex and long-term clinical outcome in a series of 1015 patients (176 men), showed that women have a higher rate of mitral valve surgery, probably due to a smaller post-procedural mitral valve area. This latter finding is consistent with our results, as a final valve area ≤ 1.75 cm2 was more frequent in women than in men (30% versus 17%, respectively, p = 0.024). In our study, however, male but not female gender resulted as an independent predictor of poor long-term outcome. Thus, it remains unclear whether such a finding might be related to the fact that our study was limited to patients undergoing successful PMV, or to the small number of men (84, less than 20% of our population) and, therefore, to chance. In addition, this finding may reduce the generalizability of our results. The predictors of the primary endpoint resulted also independent predictors of the secondary endpoint, including any death, need for mitral surgery or repeat PMV and functional impairment at 20-year follow-up. 4.1. Limitations Because of the observational nature of the present study, no a priori sample size was calculated. Echocardiographic data at long-term follow-up were not systematically obtained and therefore not available in more than 50% of patients. Nonetheless, the inclusion in the secondary endpoint of functional impairment, likely prevented the
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Fig. 3. Kaplan–Meier analysis for cumulative MACE-free survival at long-term follow-up in the overall population (successful and unsuccessful PMV).
Table 3 Univariate regression analysis for the occurrence of 20-year events included in primary and secondary endpoints. Primary endpoint
Secondary endpoint
HR (95% CI)
p value
HR (95% CI)
p value
Age N 50 years Age Male gender NYHA class N 2 Previous CM-PMV Atrial fibrillation Echo-score N 8 Mean mitral gradient MVA Mitral regurgitation ≥ 2
1.68 (1.22–2.32) 1.03 (1.01–1.04) 1.65 (1.17–2.32) 1.00 (0.73–1.38) 0.90 (0.50–1.62) 1.52 (1.14–2.03) 2.40 (1.79–3.22) 0.97 (0.95–0.99) 0.72 (0.38–1.36) 1.90 (1.23–2.92)
0.002 0.001 0.004 0.98 0.72 0.004 0.001 0.012 0.31 0.003
1.88 (1.39–2.53) 1.03 (1.02–1.05) 1.47 (1.07–2.02) 1.17 (0.87–1.57) 1.03 (0.63–1.68) 1.46 (1.13–1.90) 2.44 (1.88–3.17) 0.97 (0.95–0.99) 0.68 (0.39–1.20) 1.92 (1.31–2.82)
0.001 0.001 0.019 0.31 0.91 0.004 0.001 0.001 0.18 0.001
After procedure Mean mitral gradient MVA MVA ≤ 1.75 cm2 Mitral regurgitation 2+
1.06 (1.02–1.11) 0.31 (0.20–0.48) 2.91 (2.15–3.93) 1.37 (0.95–1.98)
0.005 0.001 0.001 0.093
1.08 (1.04–1.12) 0.26 (0.17–0.38) 3.62 (2.76–4.74) 1.35 (0.97–1.88)
0.001 0.001 0.001 0.079
Numbers indicate the hazard ratios (HR), 95% confidence intervals (CI) and the significance level (p) for each parameter. The primary endpoint is the 20-year incidence of major adverse cardiac events, including cardiovascular death and need for mitral surgery (repair or substitution) or repeat PMV. The secondary endpoint is the cumulative incidence of any death, need for mitral surgery or repeat PMV, and functional impairment (NYHA class N 2) at long-term follow-up. CM: mitral commissurotomy; MVA: mitral valve area; NYHA: New York Heart Association; PMV: percutaneous balloon mitral valvuloplasty.
Table 4 Multivariate analysis of predictors for the occurrence of 20-year events included in primary and secondary endpoints. Primary endpoint
Age Male gender Echo-score N 8 Atrial fibrillation Final MVA ≤ 1.75 cm2
Secondary endpoint
HR (95% CI)
p value
HR (95% CI)
p value
1.01 (0.99–1.02) 1.97 (1.39–2.81) 2.11 (1.56–2.84) 1.49 (1.11–2.00) 2.95 (2.14–4.05)
0.198 0.001 0.001 0.008 0.001
1.02 (1.00–1.03) 1.84 (1.33–2.56) 2.08 (1.59–2.72) 1.42 (1.09–1.86) 3.51 (2.64–4.67)
0.015 0.001 0.001 0.009 0.001
Numbers indicate the hazard ratios (HR), 95% confidence intervals (CI) and the significance level (p) for each parameter. The primary endpoint is the 20-year incidence of major adverse cardiac events, including cardiovascular death and need for mitral surgery (repair or substitution) or repeat PMV. The secondary endpoint is the cumulative incidence of any death, need for mitral surgery or repeat PMV, and functional impairment (NYHA class N 2) at long-term follow-up. MVA: mitral valve area; PMV: percutaneous balloon mitral valvuloplasty.
underestimation of mitral valve restenosis with which clinical status is strictly correlated. In addition, 8.5% of patients undergoing successful PMV were lost at follow-up. Such a proportion of patients, however, is quite small and similar to that of the other study reporting results up to 20 years [10,11]. Furthermore, no significant difference could be detected in baseline characteristics and procedural results between patients with and those without follow-up, thus implying that patients lost at follow-up would have probably presented a similar outcome. Finally, as we excluded from the analysis patients with unsuccessful PMV, predictors of procedural success, such as the recently reported commissural mitral valve calcification [17], were not assessed.
5. Conclusions Twenty years after successful PMV, more than one third of patients still exhibit a good clinical status thus confirming that, after 30 years since its introduction, PMV represents a reasonable therapeutic option for the treatment of patients with rheumatic mitral stenosis.
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International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Twenty year follow-up after successful percutaneous balloon mitral valvuloplasty in a large contemporary series of patients with mitral stenosis☆ Fabrizio Tomai a,⁎, Achille Gaspardone b, Francesco Versaci c, Anna S. Ghini a, Luca Altamura a, Leonardo De Luca a, Gaetano Gioffrè b, Pier Agostino Gioffrè a,1 a b c
Department of Cardiovascular Sciences, European Hospital, Rome, Italy Department of Medicine, S. Eugenio Hospital, Rome, Italy Cardiology Unit, Cardarelli Hospital, Campobasso, Italy
a r t i c l e
i n f o
Article history: Received 12 June 2014 Received in revised form 24 September 2014 Accepted 18 October 2014 Available online 22 October 2014 Keywords: Mitral stenosis Percutaneous balloon mitral valvuloplasty Valvular heart disease
a b s t r a c t Background: Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis. We sought to assess very long-term outcome after PMV. Methods: Between 1991 and 2010, 482 consecutive patients underwent successful PMV in a single center. Procedural success was defined as post-procedural valve area ≥ 1.5 cm2 and regurgitation moderate or less, without in-hospital major adverse cardiac and cerebro-vascular events. The primary endpoint was 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery or repeat PMV. Results: Long-term follow-up (mean 11.6 ± 4.9 years; range 0.5 to 20) was completed in 441 (91.5%) patients. The incidence of the primary endpoint was 41.9% (95% confidence interval [CI]: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4), and 5.9% (95% CI: 3.9 to 8.5), respectively. Cumulative MACE-free survival at 20 years was 35.9 ± 4.7%. At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4–2.8, p b 0.001), echocardiographic score N 8 (HR: 2.19; 95% CI: 1.6–2.9, p b 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2–2.1, p = 0.003) and valve area ≤ 1.75 cm2 after PMV (HR: 3.1; 95% CI: 2.3–4.2, p b 0.001) were identified as independent predictors of the primary endpoint. Conclusions: Up to 20 years after successful PMV, a sizeable proportion of patients still exhibit a good clinical result. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction
2. Methods 2.1. Patients and assessments
Percutaneous balloon mitral valvuloplasty (PMV) is currently considered the standard of care for suitable patients with rheumatic mitral stenosis [1,2]. Some series have reported late results after PMV [3–8]. However, few studies with follow-up longer than a decade are available [9–11] and only one study reported data in a large population of patients undergoing PMV from 1986 to 1995 with a median follow-up period longer than 10 years [11]. Thus, the aim of the present study was to report very long-term results up to 20 years, in a more contemporary series of patients treated by PMV.
☆ The authors report no relationships that could be construed as a conflict of interest. ⁎ Corresponding author at: Department of Cardiovascular Sciences, Division of Cardiology, European Hospital, Via Portuense 700-00149 Rome, Italy. E-mail address: [email protected] (F. Tomai). 1 Professor Pier Agostino Gioffrè passed away on the 6th of November 2011.
http://dx.doi.org/10.1016/j.ijcard.2014.10.040 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
From January 1991 to December 2010, 527 consecutive patients with rheumatic mitral stenosis underwent a first PMV at our Institution. All data were collected prospectively and recorded electronically. Clinical status was determined by the New York Heart Association (NYHA) classification. An echo-Doppler study was performed before and 24 h after PMV in all patients. Evaluations included mitral valve area (using planimetry by two-dimensional echocardiography or, when planimetry was not feasible, the Doppler pressure half-time method), echocardiographic score [12] and mitral regurgitation (MR) estimation by color-Doppler semi-quantitative method, graded as: no or trivial (0), mild (1 +), moderate (2+), moderately severe (3 +), and severe (4+). All patients also underwent transesophageal echocardiography 1 day before the procedure in order to rule out left atrium or appendage thrombosis. Prior to study enrollment a written informed consent was required. The study protocol and related materials were approved by the Institutional Review Boards and Ethical Committees of our center.
2.2. Percutaneous mitral valvuloplasty technique PMV was performed by an antegrade trans-septal approach using the Inoue technique, as previously described [13]. Balloon size was determined by the formula: maximal
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balloon size (mm) = [patient's height (cm) / 10] + 10. Right and left heart catheterization was performed pre- and post-PMV, to determine cardiac output and pressures, including transmitral gradient. Contrast left ventriculography was performed before and after PMV. Angiographic MR severity was graded as: no (0), mild (1+), moderate (2+), moderately severe (3+), and severe (4+). 2.3. Study definitions Procedural success was defined as post-PMV valve area ≥ 1.5 cm2 and angiographic MR b 3+, in the absence of in-hospital major adverse cardiac and cerebrovascular events, including any death, stroke, mitral surgery and cardiac tamponade. Clinical improvement after PMV was defined as ≥1 NYHA class reduction compared to baseline with a postprocedural class ≤2 at one month. The primary endpoint was the 20-year incidence of major adverse cardiac events (MACE), including cardiovascular death and need for mitral surgery (repair or substitution) or repeat PMV. The secondary endpoint was the cumulative incidence of any death, need for mitral surgery or repeat PMV, and functional impairment (NYHA class N 2) at long-term follow-up. Any unexplained death was considered to be cardiovascular related. 2.4. Follow-up All patients were followed up by clinical visit at 1 month and every year after the index PMV. Adverse events were monitored throughout the entire study period. When the patient was lost to follow-up, the family, physician, or personal cardiologist was contacted. 2.5. Statistical analysis Continuous variables are reported as mean and standard deviation (or standard error for actuarial survival) and were compared using the Student's t test or Wilcoxon rank sum test as appropriate. Categorical variables are reported as percentages and compared using the chi-square or Fisher's exact test as appropriate. Univariate analysis to test the relation between the clinical and treatment variables and the occurrence of MACE at follow-up was performed by means of Cox proportional hazards regression, obtaining the hazard ratio (HR) and 95% confidence interval (CI) for each parameter. Significant covariates were then entered into a multivariate Cox proportional hazards regression model to assess the simultaneous effect of multiple variables on the occurrence of MACE at follow-up. Long-term freedom from MACE was calculated using the Kaplan–Meier method. For all analyses, the conventional p value of 0.05 or less was used to determine the level of statistical significance. All data were analyzed using the statistical software package IBM SPSS 20.
3. Results 3.1. In-hospital outcome Baseline and peri-procedural characteristics of the whole population are reported in Table 1. Procedural success was obtained in 482 (91%) patients, with a clinical improvement in 478 (99.2%). The remaining 45 (8.5%) patients were excluded from the analysis because of procedural failure, including sub-optimal valve dilatation (post-PMV valve
area b 1.5 cm2) in 14 patients (2.7%), severe MR requiring surgery (repair or substitution) in 26 (4.9%), cardiac tamponade in 2 (0.4%), stroke in 1 (0.2%) and death in 2 (0.4%) (Fig. 1). A trend toward a higher success rate was observed for the procedures performed in the second (from 2001 to 2010, n = 210) than in the first (from 1991 to 2000, n = 317) decade (94.3% versus 89.6%, p = 0.053). 3.2. Long-term follow-up Follow-up was completed in 441 patients (91.5% of eligible) with a mean follow-up period of 11.7 ± 4.9 years (range 0.5 to 20 years), with 289 of the patients (65.5%) being followed up for at least 10 years. The incidence of the primary endpoint was 41.9% (95% CI: 37.3 to 46.7%). The rate of cardiovascular death, need for mitral surgery or repeat PMV was 9.1% (95% CI: 6.6 to 12.1), 27% (95% CI: 22.9 to 31.4) and 5.9% (95% CI: 3.9 to 8.5), respectively. The incidence of the secondary endpoint was 51.9% (95% CI: 47.2 to 56.7). Details regarding the occurrence of clinical events at the 20-year follow-up are reported in Table 2. The cumulative MACE-free survival at 20 years in patients with successful PMV was 35.9 ± 4.7% (Fig. 2), while survival free of any death, any intervention and functional impairment was 21 ± 4.7%. In the overall population (including patients with unsuccessful PMV) the longterm cumulative MACE-free survival was 11.6 ± 8.6% (Fig. 3). At the univariate analysis the incidence of the primary endpoint was associated with age N 50 years (p = 0.002), male gender (p = 0.004), atrial fibrillation (p = 0.004), an echocardiographic score N8 (p b 0.001), pre-procedural MR ≥ 2 (p = 0.003), pre- (p = 0.012) and post- (p = 0.005) procedural high mean mitral gradient and postprocedural mitral valve area ≤ 1.75 cm2 (p b 0.001). Similar findings were obtained for the incidence of the secondary end-point (Table 3). At multivariate analysis, male gender (hazard ratio [HR]: 1.99; 95% CI: 1.4–2.8, p b 0.001), the echocardiographic score N 8 (HR: 2.19; 95% CI: 1.6–2.9, p b 0.001), atrial fibrillation (HR: 1.54; 95% CI: 1.2–2.1, p = 0.003) and valve area ≤ 1.75 cm2 after PMV (HR: 3.1; 95% CI: 2.3–4.2, p b 0.001) were identified as independent predictors of the primary endpoint (Table 4). The same variables and age were identified as independent predictors of the secondary endpoints (Table 4). 4. Discussion The main findings of this study indicate that: i) a sizeable proportion of patients undergoing successful PMV still exhibit a good outcome after
Table 1 Baseline and peri-procedural characteristics. Characteristic
All patients
Patients with procedural success
Patients with procedural failure
Patients with procedural success and follow-up
Patients with procedural success lost at follow-up
N (%) Age, y Age N 50 years, N (%) Female gender, N (%) NYHA class N II, N (%) Previous CM or PMV, N (%) Atrial fibrillation, N (%) Echo score N 8, N (%) Echo score Mitral regurgitation ≥ 2, N (%) Mitral valve area, cm2 Mean mitral gradient, mm Hg
527 55.3 ± 11.6 337 (63.9) 439 (83.3) 386 (73.2) 38 (7.2) 238 (45.2) 195 (37%) 7.9 ± 2.3 58 (11) 0.99 ± 0.2 17 ± 6.6
482 (91.5) 55.4 ± 11.7 310 (64.3) 398 (82.6) 346 (71.8) 30 (6.2) 218 (45.2) 177 (36.7) 7.9 ± 2.3 47 (9.8) 0.99 ± 0.2 16.9 ± 6.7
45 (8.5) 54.6 ± 10.9 27 (60%) 41 (91.1) 40 (88.9)⁎ 8 (17.8)⁎ 20 (44.4) 18 (40%) 8.5 ± 2.2 11 (24.4)⁎
41 (8.7) 51.5 ± 8.9⁎⁎ 18 (43.9) 33 (80.5) 34 (82.9) 2 (4.9) 16 (39.0) 7 (17.1)⁎⁎
0.97 ± 0.2 17.8 ± 5.8
441 (91.5) 55.7 ± 11.8 292 (66.2) 365 (82.8) 312 (70.7) 28 (6.3) 202 (45.8) 170 (38.5) 7.9 ± 2.4 41 (9.3) 1.0 ± 0.2 16.8 ± 6.5
7.5 ± 1.9 6 (14.6) 0.88 ± 0.2 18 ± 8.4
After procedure Mitral valve area, cm2 Mitral valve area ≤ 1.75 cm2, N (%) Mean mitral gradient, mm Hg Mitral regurgitation ≥ 2, N (%)
1.9 ± 0.4 176 (33.4) 6.6 ± 4.1 114 (21.6)
1.9 ± 0.4 144 (29.9) 6.0 ± 3.0 88 (18.3)
1.4 ± 0.4⁎ 32 (71.1)⁎ 13.1 ± 7.9⁎ 26 (57.8)⁎
1.9 ± 0.4 122 (27.7) 5.9 ± 2.9 78 (17.7)
1.8 ± 0.3 12 (29.3) 6.1 ± 3.3 10 (24.4)
Values are mean ± SD or number (percent of total). CM: surgical commissurotomy; PMV: percutaneous balloon mitral valvuloplasty. ⁎ p b 0.05 versus patients with procedural success. ⁎⁎ p b 0.05 versus patients with procedural success and follow-up.
F. Tomai et al. / International Journal of Cardiology 177 (2014) 881–885
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Fig. 2. Kaplan–Meier analysis for cumulative MACE-free survival at long-term follow-up in patients with successful PMV.
Fig. 1. Study flow chart.
two decades; ii) predictors of long-term outcome are multiple and include male gender, anatomical impairment of mitral valve, the presence of atrial fibrillation and procedural results. Previous studies showed that the outcome of PMV is good and comparable with those of surgical commissurotomy [3–8]. Indeed, followup data beyond 20 years after the implantation of a tissue or mechanical mitral prosthesis showed survival rates equivalent to that observed with PMV [14]. Few studies with very long-term follow-up after PMV are currently available [9,10] and only in one study data at a median follow-up time of 12 years have been reported [11]. Specifically, Bouleti et al. [11] found in 912 patients undergoing successful PMV between 1986 and 1995, a 20-year rate of cardiovascular survival without re-intervention of 38%. Our findings, obtained in 482 patients successfully treated by PMV in a single Institution between 1991 and 2010, are in accordance with those of Bouleti et al., showing a 20-year rate of cardiovascular survival without re-intervention of 36%. Such good results, coming from a more contemporary series of patients undergoing PMV, suggest that although the number of procedures decreases over the time due to a less incidence of rheumatic mitral stenosis, a substantial number of patients are still treated in experienced centers with good immediate and long term outcomes, making an ‘old’ interventional procedure still valuable and effective in patients with mitral stenosis. In our study, similarly to previous investigations [5–10], prediction of long-term outcome after successful PMV appears to be multifactorial. In particular, we found that independent predictors of 20-year MACE Table 2 Hierarchical events at 20-year follow-up. Events
n = 441
MACE (primary endpoint) Cardiovascular death Non cardiovascular death Need for repeat PMV Need for mitral surgery Functional impairment (NYHA class N 2)a Any death, any intervention and functional impairment (secondary endpoint)
185 (41.9) 40 (9.1) 23 (5.2) 26 (5.9) 119 (27) 21 (4.8) 229 (51.9)
Values are number (percent of total). MACE: major adverse cardiovascular events, including cardiovascular death, need for mitral surgery (repair or substitution) or repeat PMV (percutaneous balloon mitral valvuloplasty). a Functional impairment refers to surviving patients not undergoing mitral surgery or repeat PMV.
are age, procedural result, echocardiographic score, the presence of atrial fibrillation and male gender. Of note, the strongest independent predictor was a valve area ≤ 1.75 cm2 after PMV. This cut-off value has been previously shown to be the best predictor of long-term outcome after successful PMV [15]. This implies that an optimal result of the procedure, which, in turn, depends on the extent of mitral valve disease and the correctness of the technique, will likely avoid further interventions for many years. The pivotal importance of final mitral valve area or mean transvalvular gradient reduction, in the prediction of a good long-term outcome has consistently been emphasized in several different investigations [5–10]. Another independent predictor of long-term MACE resulted in the echocardiographic score, which reflects valve anatomy and, as a consequence, the type and extent of mitral valve disease. Specifically, among patients successfully treated by PMV, those with an echocardiographic score N 8 exhibited a twofold risk of 20-year MACE rate than patients with a score ≤ 8. Also the presence of atrial fibrillation was independently related to long-term MACE, as previously reported after PMV and surgical commissurotomy [6,7]. An intriguing finding of our study was that also male gender resulted as an independent predictor of long-term outcome. Indeed, Bouleti et al. [10] found an interaction between sex and valve calcification showing that the impact of valve anatomy is stronger in men. However, Cruz-Gonzalez et al. [16], who specifically evaluated the relationship between sex and long-term clinical outcome in a series of 1015 patients (176 men), showed that women have a higher rate of mitral valve surgery, probably due to a smaller post-procedural mitral valve area. This latter finding is consistent with our results, as a final valve area ≤ 1.75 cm2 was more frequent in women than in men (30% versus 17%, respectively, p = 0.024). In our study, however, male but not female gender resulted as an independent predictor of poor long-term outcome. Thus, it remains unclear whether such a finding might be related to the fact that our study was limited to patients undergoing successful PMV, or to the small number of men (84, less than 20% of our population) and, therefore, to chance. In addition, this finding may reduce the generalizability of our results. The predictors of the primary endpoint resulted also independent predictors of the secondary endpoint, including any death, need for mitral surgery or repeat PMV and functional impairment at 20-year follow-up. 4.1. Limitations Because of the observational nature of the present study, no a priori sample size was calculated. Echocardiographic data at long-term follow-up were not systematically obtained and therefore not available in more than 50% of patients. Nonetheless, the inclusion in the secondary endpoint of functional impairment, likely prevented the
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Fig. 3. Kaplan–Meier analysis for cumulative MACE-free survival at long-term follow-up in the overall population (successful and unsuccessful PMV).
Table 3 Univariate regression analysis for the occurrence of 20-year events included in primary and secondary endpoints. Primary endpoint
Secondary endpoint
HR (95% CI)
p value
HR (95% CI)
p value
Age N 50 years Age Male gender NYHA class N 2 Previous CM-PMV Atrial fibrillation Echo-score N 8 Mean mitral gradient MVA Mitral regurgitation ≥ 2
1.68 (1.22–2.32) 1.03 (1.01–1.04) 1.65 (1.17–2.32) 1.00 (0.73–1.38) 0.90 (0.50–1.62) 1.52 (1.14–2.03) 2.40 (1.79–3.22) 0.97 (0.95–0.99) 0.72 (0.38–1.36) 1.90 (1.23–2.92)
0.002 0.001 0.004 0.98 0.72 0.004 0.001 0.012 0.31 0.003
1.88 (1.39–2.53) 1.03 (1.02–1.05) 1.47 (1.07–2.02) 1.17 (0.87–1.57) 1.03 (0.63–1.68) 1.46 (1.13–1.90) 2.44 (1.88–3.17) 0.97 (0.95–0.99) 0.68 (0.39–1.20) 1.92 (1.31–2.82)
0.001 0.001 0.019 0.31 0.91 0.004 0.001 0.001 0.18 0.001
After procedure Mean mitral gradient MVA MVA ≤ 1.75 cm2 Mitral regurgitation 2+
1.06 (1.02–1.11) 0.31 (0.20–0.48) 2.91 (2.15–3.93) 1.37 (0.95–1.98)
0.005 0.001 0.001 0.093
1.08 (1.04–1.12) 0.26 (0.17–0.38) 3.62 (2.76–4.74) 1.35 (0.97–1.88)
0.001 0.001 0.001 0.079
Numbers indicate the hazard ratios (HR), 95% confidence intervals (CI) and the significance level (p) for each parameter. The primary endpoint is the 20-year incidence of major adverse cardiac events, including cardiovascular death and need for mitral surgery (repair or substitution) or repeat PMV. The secondary endpoint is the cumulative incidence of any death, need for mitral surgery or repeat PMV, and functional impairment (NYHA class N 2) at long-term follow-up. CM: mitral commissurotomy; MVA: mitral valve area; NYHA: New York Heart Association; PMV: percutaneous balloon mitral valvuloplasty.
Table 4 Multivariate analysis of predictors for the occurrence of 20-year events included in primary and secondary endpoints. Primary endpoint
Age Male gender Echo-score N 8 Atrial fibrillation Final MVA ≤ 1.75 cm2
Secondary endpoint
HR (95% CI)
p value
HR (95% CI)
p value
1.01 (0.99–1.02) 1.97 (1.39–2.81) 2.11 (1.56–2.84) 1.49 (1.11–2.00) 2.95 (2.14–4.05)
0.198 0.001 0.001 0.008 0.001
1.02 (1.00–1.03) 1.84 (1.33–2.56) 2.08 (1.59–2.72) 1.42 (1.09–1.86) 3.51 (2.64–4.67)
0.015 0.001 0.001 0.009 0.001
Numbers indicate the hazard ratios (HR), 95% confidence intervals (CI) and the significance level (p) for each parameter. The primary endpoint is the 20-year incidence of major adverse cardiac events, including cardiovascular death and need for mitral surgery (repair or substitution) or repeat PMV. The secondary endpoint is the cumulative incidence of any death, need for mitral surgery or repeat PMV, and functional impairment (NYHA class N 2) at long-term follow-up. MVA: mitral valve area; PMV: percutaneous balloon mitral valvuloplasty.
underestimation of mitral valve restenosis with which clinical status is strictly correlated. In addition, 8.5% of patients undergoing successful PMV were lost at follow-up. Such a proportion of patients, however, is quite small and similar to that of the other study reporting results up to 20 years [10,11]. Furthermore, no significant difference could be detected in baseline characteristics and procedural results between patients with and those without follow-up, thus implying that patients lost at follow-up would have probably presented a similar outcome. Finally, as we excluded from the analysis patients with unsuccessful PMV, predictors of procedural success, such as the recently reported commissural mitral valve calcification [17], were not assessed.
5. Conclusions Twenty years after successful PMV, more than one third of patients still exhibit a good clinical status thus confirming that, after 30 years since its introduction, PMV represents a reasonable therapeutic option for the treatment of patients with rheumatic mitral stenosis.
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