Repeat Percutaneous Mitral Valvuloplasty Research Articles

Pulmonary artery pressure response to percutaneous mitral valvuloplasty: Associated factors and clinical implications.

Pulmonary hypertension (PH) is a marker of poor outcome in mitral stenosis (MS), which improves after percutaneous mitral valvuloplasty (PMV). However, mechanical interventions for relief of valve obstruction often but not always reduce pulmonary pressures. This study aimed to assess the parameters associated with abnormal pulmonary artery pressure (PAP) response immediately after a successful PMV, and also its impact on long-term outcome. A total of 181 patients undergoing PMV for rheumatic MS were prospectively enrolled. Invasive hemodynamic and echocardiographic measures were examined in all patients. Abnormal PAP response was defined as the mean PAP (mPAP) values unchanged at the end of the procedure. Long-term outcome was a composite endpoint of death, mitral valve replacement, repeat PMV, new onset of atrial fibrillation (AF), or stroke. The mean age was 44.1 ± 12.6 years, and 157 patients were women (86.7%). In the overall population, mPAP decreased from 33.4 ± 13.1 mmHg pre to 27.6 ± 9.8 mmHg post (p < 0.001). Following PMV, 52 patients (28.7%) did not have any reduction of mPAP immediately after the PMV. Multivariable analysis adjusting for baseline values of PAP and mitral valve area revealed that AF (Odds ratio [OR] 2.7, 95% [confidence interval] CI 1.3 to 6.7), maximum mitral valve leaflets displacement (OR 0.8, 95% CI 0.7 to 0.9), and post-procedural left ventricular compliance (OR 0.7, 95% CI 0.5 to 0.9) were predictors of a lack of improvement in mPAP. During a median follow-up of 4.4 years, the endpoint was reached in 56 patients (31%). The pulmonary pressure response to PMV was not an independent predictor of long-term events. In patients with MS undergoing PMV, pulmonary pressures may not reduce immediately after the procedure, despite adequate opening of the valve. Abnormal PAP response can be predicted from baseline clinical and valvular characteristics as well as post-procedural left ventricular compliance. The lack of any immediate reduction in mPAP is not associated with long-term adverse outcomes.

P4718Inadequate response of pulmonary artery pressure after percutaneous mitral valvuloplasty: determinant factors and prognostic impact

Abstract Introduction Pulmonary hypertension (HP) has long been known to be a marker of poor outcome in patients with mitral stenosis (MS). Percutaneous mitral valvuloplasty (PMV) is currently the treatment of choice for MS, which results in improvement in HP. However, despite the successful valve opening, the regression of PH may be incomplete. This has been attributed to irreversible morphologic changes within the pulmonary vasculature. Purpose To assess the clinical, echocardiographic and hemodynamic parameters associated with an inadequate response of the pulmonary artery pressure (PAP) immediately after a successful PMV, and also the impact of residual PH on long-term outcome in these patients. Methods 181 patients undergoing PMV for rheumatic MS were enrolled. Invasive hemodynamic and echocardiographic measures were examined in all patients. Inadequate response of PAP was defined as the mean pulmonary artery pressure (mPAP) values unchanged at the end of the procedure. Long-term outcome was a composite endpoint of death, mitral valve replacement, repeat PMV, new onset of atrial fibrillation (AF), or stroke. Results The mean age was 44.1±12.6 years, and 157 patients were women (86.7%). In the overall population, mPAP decreased from 33.4±13.1 mmHg pre to 27.6±9.8 mmHg post (p&lt;0.001), as mitral valve increased from 0.96±0.2 cm2 pre to 1.68±0.2 cm2 post (p&lt;0.001) PMV. Following PMV, 10 patients developed severe mitral regurgitation and were excluded from the analysis. Of the 171 patients analyzed, 52 (30%) did not present reduction of mPAP immediately after the PMV. Transmitral pressure gradients were significantly greater and mitral valve area was smaller in those patients with unchanged mPAP after PMV than in those whose PAP had decreased. Systolic, diastolic and mPAP pressures as well as left atrial pressure were higher in those patients who had improvement in pulmonary pressures after PMV. Multivariate analysis revealed the following independent predictors of unchanged mPAP: AF (Odds ratio [OR] 2.7, 95% [confidence interval] CI 1.1 to 6.4), mitral valve area (OR 1.3, 95% CI 1.1 to 1.5), maximum mitral valve leaflets displacement (OR 0.8, 95% CI 0.7 to 0.9), and left ventricular compliance after PMV (OR 0.8, 95% CI 0.6 to 0.9). During a mean follow-up of 28 months, the endpoint was reached in 48 patients (26%). The pulmonary pressure response to PMV was not predictor of long-term events. Conclusions In a large cohort of patients with MS undergoing PMV, mean pulmonary artery pressure values do not reduce immediately after the procedure in 30% of the cases, despite adequate opening of the valve. The factors associated with inadequate PAP response following PMV were presence of AF, larger mitral valve area, reduced valve leaflets mobility and post procedural low left ventricular compliance. The early non-reduction of mPAP after PMV is not associated with adverse outcome.

Impact of left atrial compliance improvement on functional status after percutaneous mitral valvuloplasty.

Conventional hemodynamic parameters may not accurately predict symptomatic improvement after percutaneous mitral valvuloplasty (PMV). Changes in left heart chamber compliance following adequate relief o0066 mitral stenosis (MS) may be useful in determining functional capacity after PMV. This study aims to determine the acute effects of PMV on compliance of the left heart and whether its changes relate to the patient's functional capacity. One-hundred thirty-seven patients with severe MS undergoing PMV were enrolled. Left atrial (Ca ) and left ventricular (Cv ) compliance were invasively estimated and net atrioventricular compliance (Cav ) was calculated before and immediately after the procedure. B-type natriuretic peptide (BNP) levels were obtained before and 24 hr after the procedure. The primary endpoint was functional status at 6-month follow-up, and the secondary endpoint was a composite of death, mitral valve (MV) replacement, repeat PMV, new onset of atrial fibrillation, or stroke in patients in whom PMV was successful. The mean age was 43 ± 12 years, and 119 patients were female (87%). After PMV, Ca and Cav improved significantly from 5.3 [IQR 3.2-8.2] mL/mmHg to 8.7 [5.3-19.2] mL/mmHg (P < 0.001) and 2.2 [1.6-3.4] to 2.8 [2.1-4.1] mL/mmHg (P < 0.001), respectively, whereas Cv did not change (4.6 [3.2-6.8] to 4.4 [3.1-5.6]; P = 0.637). Plasma BNP levels significantly decreased after PMV, with no correlation between its variation and changes in left chamber compliance. At 6-month follow-up, NYHA functional class remained unchanged in 32 patients (23%). By multivariable analyses, changes in Ca immediately after PMV (adjusted OR 1.42; 95% CI 95% 1.02 to 1.97; P = 0.037) and younger age (adjusted OR 0.95; CI 95% 0.92-0.98; P = 0.004), predicted improvement in functional capacity at 6-month follow-up, independent of postprocedural data. The secondary endpoint were predicted by post-PMV mean gradient (adjusted HR 1.363; 95% CI 95% 1.027-1.809; P = 0.032), and lack of functional improvement at 6-month follow-up (adjusted HR 4.959; 95% 1.708-14.403; P = 0.003). Ca and Cav increase significantly after PMV with no change in Cv . The improvement of Ca is an important predictor of functional status at 6-month follow up, independently of other hemodynamic data. Postprocedural mean gradient and lack of short-term symptomatic improvement were predictors of adverse outcome.

Complications of repeat percutaneous mitral valvuloplasty

Percutaneous mitral valvuloplasty (PMV) has emerged as the procedure of choice in treatment of mitral stenosis and has proved effectiveness in cases of mitral restenosis after surgical commissurotomy Compared with surgery, PMV is associated with shorter hospital stays, reduced patient discomfort, and significantly lower costs. However, it is unknown whether patients who developed symptomatic mitral restenosis after PMV may benefit from repeat PMV (re-PMV) with safety. This study was designed to evaluate the occurrence rate and the predictive factors for severe complications following re-PMV. Retrospective study from a series of 40 procedures of re-PMV with the Inoue balloon at 8 ± 4 years after prior procedure. A clinical and ultrasound follow-up was achieved in 31 patients with a mean follow-up period of 43 ± 26 months. The mean age of patients was 43 ± 11 years [23; 63], 87,5% of the population being female (5 men and 35 women). The immediate procedural success was achieved in 31 patients (77.5%). A severe mitral regurgitation (MR) was observed in 3 patients (7.5%). A cerebrovascular stroke occurred in 1 patient (2.5%). No procedure-related death or cardiac tamponade were noted. Only a left atrial area ≤ 25 cm 2 was linked to high risk of severe MR. At long-term, mitral restenosis was observed in 13 patients (42%) at 53 ± 30 months [9; 128] after re-PMV, 2 patients presented thromboembolic events (6%) and no death. Only the male had been identified as a predictor of restenosis. The feasibility of re-PMV with a relatively high procedural success rate and an acceptable complication profile makes it an appealing therapeutic strategy for patients with recurrent valve stenosis. The improved experience of our medical teams, and the systematic use of transoesophageal echocardiography to detect thrombi explain the low incidence of the complications of re-PMV in our study.

Net atrioventricular compliance is an independent predictor of cardiovascular death in mitral stenosis

ObjectivesRheumatic mitral stenosis (MS) is a progressive disease, and risk of death may persist despite relief of the obstruction. Net atrioventricular compliance (Cn) modulates the overall haemodynamic burden of the...

Impact of percutaneous mitral valvuloplasty on left ventricular function in patients with mitral stenosis assessed by 3D echocardiography

BackgroundThe status of intrinsic left ventricular (LV) contractility in patients with isolated rheumatic mitral stenosis (MS) has been debated. The acute changes in loading conditions after percutaneous mitral valvuloplasty (PMV) may affect LV performance. We aimed to examine the acute effects of PMV on LV function and identify factors associated with LV ejection fraction (LVEF) changes, and determinants of long-term events following the procedure. MethodsOne hundred and forty-two patients who underwent PMV for symptomatic rheumatic MS (valve area of 0.99±0.3cm2) were prospectively enrolled. LV volumes and LVEF were measured by three-dimensional (3D) echocardiography. Long-term outcome was a composite endpoint of death, mitral valve (MV) replacement, repeat PMV, new onset of atrial fibrillation, and stroke. ResultsThe mean age was 42.3±12.1years, and 125 patients were women (88%). After PMV, LVEF increased significantly (51.4 vs 56.5%, p<0.001), primary due to a significant increase in LV end-diastolic volume (65.8mL vs 67.9mL, p=0.002), and resultant increase in the stroke volume (33.9mL vs 39.6mL, p<0.001). Changes in cardiac index and systolic pulmonary artery pressure were associated with LVEF changes after PMV. During a mean follow-up period of 30.8months, 28 adverse clinical events were observed. Postprocedural mitral regurgitation, MV area, and mean gradient were independent predictors of composite endpoints. ConclusionsIn patients with rheumatic MS, PMV resulted in a significant improvement in LV end-diastolic volume, stroke volume and consequently increased in LVEF. Changes in cardiac index and systolic pulmonary artery pressure were associated with LVEF changes after PMV. The predictors of long-term adverse events following PMV were post-procedural variables, including mitral regurgitation, valve area, and mean gradient.

0331: Predictors of outcome of repeated percutaneous mitral valvuloplasty

Percutaneous mitral valvuloplasty (PMV) has emerged as the procedure of choice in treatment of mitral stenosis and has proved effectiveness in cases of mitral restenosis after surgical commissurotomy Compared with surgery, PMV is associated with shorter hospital stays, reduced patient discomfort, and significantly lower costs. However, it is unknown whether patients who developed symptomatic mitral restenosis after PMV may benefit from repeat PMV (re-PMV) with safety. This study was designed to evaluate the occurrence rate and the predictive factors for severe complications following re-PMV. Retrospective study from a series of 40 procedures of re-PMV with the Inoue balloon at 8±4 years after prior procedure, performed between 1996 and 2011. A clinical and ultrasound follow-up was achieved in 31 patients with a mean follow-up period of 43±26 months. The mean age of patients was 43±11 years [23, 63]. 87.5% of the population being female (5 men and 35 women). The immediate procedural success was achieved in 31 patients (77.5%). A severe mitral regurgitation (MR) was observed in 3 patients (7.5%). A cerebrovascular stroke occurred in 1 patient (2.5%). No procedure-related death or cardiac tamponade were noted. Only a left atrial area ≤25cm 2 was linked to high risk of severe MR. At long-term, mitral restenosis was observed in 13 patients (42%) at 53±30 months [9; 128] after re-PMV, 2 patients presented thromboembolic events (6%) and no death. Only the male had been identified as a predictor of restenosis. The feasibility of re – PMV with a relatively high procedural success rate and an acceptable complication profile makes it an appealing therapeutic strategy for patients with recurrent valve stenosis.

TCT-705 Immediate and long term outcomes after repeat percutaneous mitral valvuloplasty for patients with mitral valve restenosis

Only rare reports have been published about redo PMV and data regarding its long term safety and efficacy are scarce. So we decided to explore the immediate and long-term outcomes of repeat (redo) percutaneous mitral valvuloplasty (PMV) in a series of patients with mitral restenosis in comparison

0549: Complications of repeat percutaneous mitral valvuloplasty

Percutaneous mitral valvuloplasty (PMV) has emerged as the procedure of choice in treatment of mitral stenosis and has proved effectiveness in cases of mitral restenosis after surgical commissurotomy Compared with surgery, PMV is associated with shorter hospital stays, reduced patient discomfort, and significantly lower costs. However, it is unknown whether patients who developed symptomatic mitral restenosis after PMV may benefit from repeat PMV (re-PMV) with safety. This study was designed to evaluate the occurrence rate and the predictive factors for severe complications following re-PMV. Retrospective study from a series of 40 procedures of re-PMV with the Inoue balloon at 8±4 years after prior procedure, performed between 1996 and 2011. A clinical and ultrasound follow-up was achieved in 31 patients with a mean follow-up period of 43±26 months. The mean age of patients was 43±11 years [23, 63]. 87,5% of the population being female (5 men and 35 women). The immediate procedural success was achieved in 31 patients (77.5%). A severe mitral regurgitation (MR) was observed in 3 patients (7.5%). A cerebrovascular stroke occurred in 1 patient (2.5%). No procedure-related death or cardiac tamponade were noted. Only a left atrial area ≤25cm ² was linked to high risk of severe MR. At long-term, mitral restenosis was observed in 13 patients (42%) at 53±30 months [9; 128] after re-PMV, 2 patients presented thromboembolic events (6%) and no death. Only the male had been identified as a predictor of restenosis The feasibility of re – PMV with a relatively high procedural success rate and an acceptable complication profile makes it an appealing therapeutic strategy for patients with recurrent valve stenosis. The improved experience of our medical teams, and the systematic use of transoesophageal echocardiography to detect thrombi explain the low incidence of the complications of re-PMV in our study.

Abstract 19359: A Novel Parameter to Predict Long-term Cardiac Mortality in Mitral Stenosis

The prognosis of patients with mitral stenosis (MS) depends on the severity of obstruction and hemodynamic burden affecting the pulmonary vasculature. Net atrioventricular compliance (C n ) reflects the overall adverse hemodynamic consequence of MS and may be useful in predicting mortality. Methods: A total of 402 MS patients (mean age 51 ± 16 years, valve area of 1.04 ± 0.24 cm 2 , 84% female) undergoing percutaneous mitral valvuloplasty (PMV) between 2000 and 2013 at 2 centers were enrolled. Invasive hemodynamic and echocardiographic measures (pre and 24 hours post PMV) were examined and patients were followed for a median of 28 months post PMV. Endpoints were cardiovascular death (primary), and a composite of death from any cause, mitral valve replacement (MVR) or repeat PMV (secondary). Results: At baseline, 138 (34%) were in atrial fibrillation and 48% were NYHA functional class III or IV. PMV resulted in significant increase in valve area, decrease in transmitral pressure gradients, pulmonary pressures and an improvement in right ventricular (RV) function. A total of 47 (12%) died (39 cardiovascular deaths). In addition, 48 patients underwent MVR, and 12 required repeat PMV with an overall incidence of adverse events of 11.4 events per 100 patient-years. Baseline C n was a strong predictor of both cardiac death (adjusted hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.49 - 0.86, p = 0.008), and composite endpoint (adjusted HR 0.81, 95% CI 0.67 - 0.91, p = 0.016). Cardiac mortality was significantly higher in patients with C n ≤ 4 ml/mmHg than in patients with C n &gt; 4 ml/mmHg (adjusted HR 0.35, 95% CI 0.16 - 0.75, p=0.007), after adjusting for clinical factors, pulmonary artery pressure, tricuspid regurgitation (TR) severity, RV function and immediate procedural results. Survival rate at 1-, 3- and 5-years follow-up was 96%, 94% and 87% in patients with C n &gt; 4 ml/mmHg compared to 89%, 79% and 75% in patients with C n ≤ 4 ml/mmHg. Conclusions: Baseline C n is a strong predictor of cardiovascular-related mortality in patients with significant MS, after adjustment for other prognostic factors including postprocedural pulmonary artery pressure. C n assessment therefore has potential value in evaluation of mortality risk in the setting of MS.

0019: Immediate and long-term results of repeat percutaneous mitral valvuloplasty

It is unknown whether patients who developed symptomatic mitral restenosis after percutaneous mitral valvuloplasty (PMV) may benefit from repeat PMV (re-PMV).The purpose of this study is to assess the immediate and long-term results of the re-PMV in patients with mitral restenosis following to previous PMV. Retrospective study from a series of 40 procedures of re-PMV with the Inoue balloon at 8±4 years after prior procedure, performed between 1996 and 2012. A clinical and ultrasound follow-up was achieved in 31 patients with a mean follow-up period of 43±26 months. The mean age of patients was 43±11 years [23; 63]. 87,5% of the population being female (5 men and 35 women). The immediate procedural success was achieved in 31 patients (77.5%). A severe mitral regurgitation (MR) was observed in 3 patients (7.5%). A cerebrovascular stroke occurred in 1 patient (2.5%). No death or cardiac tamponade were noted. Class III or IV of NYHA, a pre-procedural MR, pulmonary hypertension and a Padial score >10 were identified as predictors of failure. More the score of Wilkins is high (>8), more it is predictive of failure. Only a left atrial area ≤ 25 cm 2 was linked to high risk of severe MR. At long-term, most patients (84%) had no functional impairment, the mean mitral valve area was 1,5±0,33 cm 2 [0,9;2,2], mitral restenosis was observed in 13 patients (42%) at 53±30 months [9;128] after re-PMV. 9 patients had mitral valve replacement (32%), 4 patients underwent a re-PMV (13%), 2 patients presented thromboembolic events (6%) and no death. Only the male had been identified as a predictor of restenosis. Re-PMV in patients with restenosis after a prior PMV is feasible, effective and achieves interesting immediate and long-term results.

High success rate of repeat percutaneous mitral valvuloplasty (PMV) in patients with recurrent mitral valve stenosis following previous PMV

Correlation between fractional flow reserve and intravascular ultrasound lumen area in intermediate coronary artery stenosis Itsik Ben-Dor, Michael Mahmoudi, Teshome Deksissa, Anh B. Bui, Michael A. Gaglia Jr., Manuel A. Gonzalez, Gabriel Maluenda, Gabriel Sardi, Rafael Romaguera, Ana Laynez, Rebecca Torguson, Zhenyi Xue, Lowell F. Satler, William O. Suddath, Joseph Lindsay, Augusto D. Pichard, Ron Waksman Washington Hospital Center, Washington, DC, USA

144 Is redo percutaneous mitral balloon valvuloplasty indicated in patients with mitral restenosis?

It is unknown if patients who developed symptomatic mitral restenosis after PMV may benefit from repeat percutaneous mitral balloon valvuloplasty (PMV). Our purpose is to assess the immediate and long-term outcomes of repeat PMV for post-PMV mitral restenosis. We report the immediate outcomes and long-term clinical follow-up results of 73 patients (mean age 29,95 years, 80,6% women) with symptomatic mitral restenosis after prior PMV, who were treated with a repeat PMV at 51,73 ± 29,4 months after the initial PMV. The mean follow-up period was 58, 85 months. There was a significant increase in the mitral valve area (1,08 ± 0,21 to 1,76 ± 0,32; p < 0,001), and decrease in the mean transmitral gradient (15,28 ± 6,84 to 8,67 ± 4,07 mm Hg; p < 0.001) and the mean left atrial pressure (25,01 ± 7,33 to 14,75 ± 5,88 mm Hg; p < 0,001). Mean pulmonary artery pressure decreases significantly with redo PMV (47,5 ± 14,73 to 34,38 ± 9,57; p < 0,001). The onset of new mitral regurgitation had occurred in 15 patients (21, 7%) Successful procedural outcome was achieved in 79, 6% of patients. No patient developed severe mitral regurgitation after redo PMV. There were no in-hospital complications. Early symptomatic improvement after redo PMV of 1 NYHA functional class was obtained in 96.7% of the patients. During the follow-up period, there were no deaths, and 10 (13, 69%) patients required mitral valve replacement. Overall, 44 patients (60, 27%) were alive without further valvular intervention at follow up after redo PVM. All of these patients were in NYHA class I or II at follow-up. The probability of event-free survival (alive and free of mitral valve replacement and/or NYHA class >III) at follow up was 91.2%. By univariate analysis age, history of previous surgical commissurotomy, pre-PMV NYHA functional class, lower echocardiographic score, post-PMV pulmonary artery pressure and atrial fibrillation were identified as univariate predictors of long-term event-free survival in the redo PMV group. Repeat percutaneous mitral valvuloplasty in patients with restenosis after a prior percutaneous valvuloplasty is feasible and can be accomplished with acceptable morbidity and mortality.

Restenosis and adverse clinical events after successful percutaneous mitral valvuloplasty: immediate post-procedural mitral valve area as an important prognosticator

We sought to investigate the factors associated with restenosis and its potential association with late clinical deterioration after successful percutaneous mitral valvuloplasty (PMV). We analysed echocardiographic (median 74 months) and clinical (median 109 months) follow-up data of 329 patients who achieved procedural success, defined as mitral valve area (MVA) > or =1.5 cm(2) and mitral regurgitation (MR) < or =2/4, between 1995 and 2000. Clinical events included cardiovascular death, mitral valve surgery, and repeat PMV. The 1, 3, 5, 7, and 9 year rates of restenosis-free survival were 99 +/- 1%, 97 +/- 1%, 95 +/- 1%, 86 +/- 3%, and 72 +/- 4%, respectively. The 1, 3, 5, 7, and 9 year rates of event-free survival were 99.7 +/- 0.3%, 96.4 +/- 1.0%, 94.5 +/- 1.3%, 90.8 +/- 1.6%, and 90.0 +/- 1.7%, respectively. Immediate post-PMV MVA and commissural MR or splitting, indicators of procedural adequacy, were independent predictors of both restenosis and clinical events. The best immediate post-PMV MVA cut-off value for predicting both restenosis and clinical events within 5 years after successful PMV were 1.8 cm(2) [95% confidence interval (CI) = 1.7-1.9] and 1.9 cm(2) (95% CI = 1.7-2.0), respectively. Patients with immediate post-PMV MVA <1.8 cm(2) showed significantly lower event-free survival rate than those with post-PMV MVA > or =1.8 cm(2) (P < 0.001). Immediate post-PMV MVA> or =1.8 cm(2) was an important predictor of both restenosis- and clinical event-free survival and this value should be considered as a component of optimal result.

Randomized comparison between Inoue balloon and metallic commissurotome in the treatment of rheumatic mitral stenosis: Immediate results and 6‐month and 3‐year follow‐up

The metallic commissurotome (MC) technique is a cheaper alternative to the Inoue balloon (IB) technique for percutaneous mitral valvuloplasty (PMV). There are no randomized trials comparing these techniques with longer follow-up of the patients. The objective of this study was to compare the immediate results and short- and medium-term follow-up of PMV using either the IB or the MC technique. Fifty patients with rheumatic mitral stenosis were randomly assigned to PMV using the IB (n = 27) or the MC (n = 23) technique. There were no significant differences between the groups regarding baseline clinical, echocardiographic, and hemodynamic data. Clinical and echocardiographic follow-up were done 6 months and 3 years after the procedure. The success rate was 100% in the IB group and 91.3% in the MC group (P = 0.15); two patients in the latter group developed mitral regurgitation grade 3/4, requiring elective surgery. The mean final mitral valve area was bigger in the MC group (2.17 +/- 0.13 vs. 2.00 +/- 0.36 cm2; P = 0.04), but after 6-month and 3-year follow-up, this difference was no longer significant (2.06 +/- 0.27 vs. 1.98 +/- 0.38 cm2, P = 0.22, and 1.86 +/- 0.32 vs. 1.87 +/- 0.34 cm2, P = 0.89, respectively). This finding suggests valve stretching as an important mechanism of valve dilation with the MC. Three patients in the MC group and two patients in the IB group (P = 0.65) developed mitral valve restenosis; one of them underwent repeat PMV and the other four, all asymptomatic, were clinically followed. PMV performed either with the IB or the MC technique is effective and provides excellent short- and medium-term outcomes regardless of the technique employed.

Long-term clinical and echocardiographic outcome of percutaneous mitral valvuloplasty: Randomized comparison of Inoue and double-balloon techniques

OBJECTIVESThe purpose of the present study was to compare the long-term clinical and echocardiographic results of the Inoue and the double-balloon techniques.BACKGROUNDThe large randomized trial comparing the extent of commissurotomy and the long-term results between the double-balloon and Inoue balloon techniques has not been reported.METHODSWe conducted a prospective, randomized trial comparing two procedures in 302 consecutive patients who underwent percutaneous mitral valvuloplasty (PMV) using Inoue (n = 152; group I) or double-balloon technique (n = 150, group D) between 1989 and 1995. The sample size was planned to provide the study with approximately 80% power for the detection of a 10% difference between the two groups.RESULTSThere were no significant differences in baseline characteristics between the two groups. Immediately after PMV, mitral valve area (MVA) increased from 0.9 ± 0.2 to 1.8 ± 0.3 cm2in group I and from 0.9 ± 0.2 to 1.9 ± 0.3 cm2in group D. No significant differences existed between the two groups in terms of development of commissural splitting, commissural mitral regurgitation (CMR), moderate to severe mitral regurgitation (MR) and MVA after PMV. The successful immediate results (MVA ≥1.5 cm2and MR ≤2) were achieved in 127 (84%) patients of group I and 122 (81%) patients of group D (p = NS). Annual clinical and echocardiographic evaluation was completed for 290 (96%) patients with mean follow-up of 51 ± 27 months. Adverse events occurred in 19 (13%) patients of group I (3 deaths, 7 mitral valve replacements, 5 repeat PMV, 2 NYHA class ≥3, 2 technical failures) and 16 (11%) patients of group D (2 deaths, 10 mitral valve replacements, 3 repeat PMV, 1 NYHA class ≥3). Estimated actuarial seven-year event-free survival was 75 ± 7% in group I and 82 ± 6% in group D (p = NS). Estimated actuarial seven-year restenosis-free survival was 67 ± 7% in group I and 76 ± 6% in group D (p = NS). On multivariate analysis, unsuccessful immediate result (p < 0.001) and absence of CMR (p < 0.01) were independently related with events. Absence of CMR and smaller mitral valve area after PMV were independently related with restenosis (p < 0.001).CONCLUSIONSThe Inoue and double-balloon techniques were equally effective in commissurotomy and produced similar, excellent long-term results. The achievement of complete commissurotomy with development of CMR or larger post-PMV mitral valve area is important to optimize the long-term results of PMV.

Long-Term Clinical and Echocardiographic Follow-Up After Percutaneous Mitral Valvuloplasty With the Inoue Balloon

The objective of this study was to assess the long-term clinical outcome and valvular changes (area and regurgitation) after percutaneous mitral valvuloplasty (PMV). After PMV, 561 patients were followed up for 39 (+/-23) months and clinical/echocardiographic data obtained yearly. Kaplan-Meier and Cox regression analyses were performed to estimate event-free survival, its predictors, and the relative risks of several patient subgroups. There were several nonexclusive events: 19 (3.3%) cardiac deaths, 55 (9.8%) mitral replacements, 6 (1%) repeated PMVs, 56 (10%) cases of restenosis, and 108 (19%) cases of clinical impairment. Survival free of major events (cardiac death, mitral surgery, repeat PMV, or functional impairment) was 69% at 7 years, ranging from 88% to 40% in different subgroups of patients. Wilkins score was the best preprocedural predictor of mitral opening, but the procedural result (mitral area and regurgitation) was the only independent predictor of major event-free survival. Mitral area loss, though mild [0.13 (+/-0.21)cm2], increased with time and was >/=0.3 cm2 in 12%, 22%, and 27% of patients at 3, 5, and 7 years, respectively. Regurgitation did not progress in 81% of patients, and when it occurred it was usually by 1 grade. Seven years after PMV, more than two thirds of patients were in good clinical condition and free of any major event. The procedural result was the main determinant of long-term outcome, although a high score had also negative implications. Mitral area decreased progressively over time, whereas regurgitation did not tend to progress.