Double-balloon Valvuloplasty Research Articles

PMD6 - A Health Technology Assessment of Single Balloon Valvuplasty

This HTA aims to evaluate the clinical effectiveness of Single Balloon Valvoloplasty in comparison to the Double Ballon Valvuloplasty in order to assess its results in patients suffering from Mitral Stenosis. Health technology assessment was conducted by systematically reviewing the published literature . An electronic literature search was performed in Cochrane, PubMed, Journal of the American College of Cardiology databases for randomized controlled trials. RevMan 5.3 was used for data analysis and quantitative data synthesis. Out of 78 studies which were screened, 15 studies were included in the quantitative analysis (meta-analysis). In comparison to the Double Balloon Valvuloplasty Single Balloon Valvuloplasty significantly reduced mortality by 17 % which is indicated by Risk Ratio (RR) 0.83 (95%CI, 0.38- 1.84). Single Balloon Valvuloplasty is found to be 4% more effective in reducing Mitral regurgitation Risk Ratio (RR)is 0.96(95%CI, 0.74- 1.23).Procedure failure with single balloon Valvoloplasty is less indicated by Risk Ratio (RR)0.98 (95%Cl ,0.89-1.07). Single Balloon Valvuloplasty is clinically effective as far as the outcomes pertaining to the Mortality,Mitral regurgitation and Procedure failure are concerned . The burden of Rhuematic Heart Disease which thereby results in Mitral Stenosis being high therefore Single Balloon Valvuloplasty can be a potent intervention.

Subacute papillary muscle rupture following percutaneous mitral valvuloplasty

Mitral valve stenosis is becoming increasingly rare in industrialized countries thanks to the almost complete extinction of rheumatic valve disease. Nevertheless, every cardiologist will encounter a few cases, notably in elderly with degenerated calcified nnitral valves or in younger immigrants coming from parts of the world with endemic rheumatic valve disease. Patients usually present with progressive dyspnoea due to increased left atrial and pulmonary artery pressures and a decline in cardiac output secondary to preload reduction. Introduced by Inoue in 1984, percutaneous balloon mitral valvuloplasty constitutes an elegant treatment modality in patients with appropriate valvular anatomy, with excellent immediate results and long-term outcome. The original Inoue technique, based on the surgically closed commissurotomy, employs the eponymous balloon to crack the mitral commissures to separate the mitral leaflets along their natural plane thereby enlarging the mitral valve area. Similar but slightly different techniques have emerged throughout the years and have extensively been used in the clinic. One of them is the so-called double balloon valvuloplasty, first described in Saoudi Arabia by Al-Zaibag, during which two balloons are positioned side-by-side across the stenotic valve and inflated simultaneously. Mitral regurgitation is relatively common after balloon dilatation, but is mostly mild and caused by excessive commissural tearing or slight prolapse of the anterior leaflet(1). We present a rare case of severe mitral regurgitation following double balloon mitral valvuloplasty due to papillary muscle rupture.

Subacute papillary muscle rupture following percutaneous mitral valvuloplasty

Introduction Mitral valve stenosis is becoming increasingly rare in industrialized countries thanks to the almost complete extinction of rheumatic valve disease. Nevertheless, every cardiologist will encounter a few cases, notably in elderly with degenerated calcified mitral valves or in younger immigrants coming from parts of the world with endemic rheumatic valve disease. Patients usually present with progressive dyspnoea due to increased left atrial and pulmonary artery pressures and a decline in cardiac output secondary to preload reduction. Introduced by Inoue in 1984, percutaneous balloon mitral valvuloplasty constitutes an elegant treatment modality in patients with appropriate valvular anatomy, with excellent immediate results and longterm outcome. The original Inoue technique, based on the surgically closed commissurotomy, employs the eponymous balloon to crack the mitral commissures to separate the mitral leaflets along their natural plane thereby enlarging the mitral valve area. Similar but slightly different techniques have emerged throughout the years and have extensively been used in the clinic. One of them is the so-called double balloon valvuloplasty, first described in Saoudi Arabia by Al-Zaibag, during which two balloons are positioned side-by-side across the stenotic valve and inflated simultaneously. Mitral regurgitation is relatively common after balloon dilatation, but is mostly mild and caused by excessive commissural tearing or slight prolapse of the anterior leaflet1. We present a rare case of severe mitral regurgitation following double balloon mitral valvuloplasty due to papillary muscle rupture.

Triple‐balloon pulmonary valvuloplasty: An advantageous technique for percutaneous repair of pulmonary valve stenosis in the large pediatric and adult patients

This report describes a new valvuloplasty procedure for the treatment of pulmonary valve stenosis (PVS) and large pulmonary valve annulus (PVA) diameters using a triple-balloon valvuloplasty (TBV) technique. We sought to demonstrate the safety and efficacy of this new technique. Percutaneous balloon pulmonary valvuloplasty (BPV) is the preferred treatment for PVS. BPV in older patients with large PVA remains a challenge, even when the double-balloon valvuloplasty technique is performed. The technique was first attempted in a case where a large single balloon was unsuccessful and double-balloon valvuloplasty met with technical difficulties. Three subsequent patients underwent the procedure safely and successfully. An algorithm is presented to determine balloon size for TBV. The median PVA diameter was 23.9 mm. Balloon diameters ranged from 12 to 18 mm. The median peak right ventricular-to-pulmonary artery systolic pressure gradient was 43.5 mm Hg before valvuloplasty and was reduced to 12 mm Hg following intervention. No major complications were encountered. Percutaneous valvuloplasty using TBV can be performed safely and provides excellent clinical results. This technique offers advantages over single-balloon and double-balloon valvuloplasty techniques, especially in treatment of PVS in large pediatric or adult patients.

When, how and why to perform a double ballooning technique for dogs with valvular pulmonic stenosis

Pulmonic valvuloplasty is a well-established method for the treatment of valvular pulmonic stenosis in people and dogs. In dogs, pulmonic valvuloplasty has been restricted to a single balloon; however, the simultaneous use of two balloons is common in pediatric cardiology. The use of two balloons provides an alternative to the use of a single large balloon in small dogs with a pulmonic anulus size that requires a large dilation catheter and large diameter introducer. Moreover, double balloon valvuloplasty permits dilation in large dogs with large pulmonic anulus sizes for which standard dilation catheters are not available. This report outlines the materials required, describes the technique, gives the advantages and disadvantages encountered when performing percutaneous double balloon valvuloplasty and provides some ‘tips’ for a successful outcome.

Successful percutaneous double balloon valvuloplasty for congenital mitral stenosis

A 19-month-old infant had an isolated severe ‘typical’ congenital mitral stenosis with dysplastic valves and two symmetric papillary muscles. He underwent successful double balloon mitral valvuloplasty via the right femoral vein. Left atrium pressure decreased from 30 to 20 mmHg and end diastolic mitral gradient from 12 to 0 mmHg. Cardiac index increased from 4.4 to 6.3 l/min per m 2. Gorlin's mitral valve area increased from 1 to 1.7 cm 2/m 2 and Doppler mitral valve area from 0.9 to 2.2 cm 2/m 2. At 16 months follow-up, the infant showed sustained clinical improvement.

Successful percutaneous double balloon valvuloplasty for congenital mitral stenosis

Successful percutaneous double balloon valvuloplasty for congenital mitral stenosis

Percutaneous double balloon valvuloplasty for stenosis of porcine bioprostheses in the tricuspid valve position: A report of 2 cases

The feasibility and results of percutaneous double balloon valvuloplasty were evaluated in 2 patients with stenosis of porcine bioprostheses in the tricuspid valve position. The procedures were performed with a Trefoil 3 x 10 and a 15 mm balloon. Long inflations (4 and 3 minutes) were well tolerated. A significant immediate increase in the valve area, without significant valvular regurgitation, was achieved in both cases, from 0.65 to 1.15 cm2 in case 1 and from 0.9 to 1.65 cm2 in case 2. Both patients required valve replacement during the follow-up, at 14 and 21 months. There was no restenosis, but echocardiography showed right atrial thrombosis in case 1. Progressive restenosis with peripheral edema and increase of the mean doppler gradient occurred in case 2. The procedure is feasible, safe, and well tolerated. It provides significant immediate hemodynamic improvement, but it should be considered as a palliative technique since a normal valve area can not usually be obtained and a restenosis is likely to occur at midterm follow-up.

Intraoperative percutaneous double-balloon valvuloplasty versus surgical commissurotomy for mitral valve stenosis

I n patients with pure mitral stenosis, a significant inThe study population consisted of 10 patients (4 men crease in valvular area can be obtained by a percutaneand 6 women, mean age 46 f 8 years) with severe pure ous approach with balloon valvuloplasty, by surgical mitral stenosis (mitral valve regurgitation <grade 1 closed commissurotomy, and by a selective eye-guided of Sellers classification), no or mild leafret calcium reparative procedure during cardiopulmonary bypass. and Block echocardiographic score 18. Patients with The surgical closed mitral commissurotomy for treatmarked dysfunction of the subvalvular apparatus were ment of mitral stenosis was first described by Cutler in excludedfrom the study. Allpatients underwent double1924 and is still the most common surgical procedure in balloon dilatation of the mitral valve and subsequently most countries. The open surgical commissurotomy, surgical open commissurotomy during cardiopulmonary more recently introduced, together with the mitral valve bypass. replacement represent a more appropriate choice in paDuring cardiopulmonary bypass the left atrium was tients with leaflet calcification, subvalvular disease or left opened, the mitral valve inspected and its area measured atria1 thrombus. Percutaneous balloon mitral valvuloby a Hegar calibrator. Two balloons (20 and 15 mm in plasty was first described by Inoue et all in 1984 as a diameter) were advanced across the mitral valve and nonsurgical therapeutic approach to surgical commissursimultaneously inflated with saline solution at 5 atm, otomy in patients with pure mitral stenosis. Al Zaibag et After the procedure the surgeon performed a complete al* subsequently developed the double-balloon technique reparative procedure opening the commissures not yet to obviate the noncommercial availability of the Inoue split and mobilizing tendinous cords and papillary muscatheter. Under similar anatomic conditions, open-chest cles. Measurements of valve area were obtained after commissurotomy should be more effective in terms of balloon valvuloplasty and after surgical commissurfinal valvular area than techniques such as closed cornotomy. missurotomy or percutaneous balloon valvuloplasty that A 2-tailed Student’s t test was used to test the dtfferinduce a rude mechanical stress to the mitral commisences between interventions. Ap value <0.05 was considsures and leaflets. It has been recently suggested, howered significant. Results are expressed as mean f I ever, that balloon valvuloplasty provides hemodynamic standard deviation. results comparable to those obtained by either surgical Double-balloon valvuloplasty caused splitting of open or closed commissurotomy.3 The present study comboth commissures in Spatients, whereas only the anteropares intraoperative effects on final mitral valve area, as lateral commissures were opened in the remaining 5 paassessed by a Hegar calibrator, of percutaneous doubletients. The valve area increasedfrom I Sl f 0.24 to 3.28 balloon mitral valvuloplasty and open-chest commissurf 0.48 cm2 Cp <O.OOl) after double-balloon valvulootomy. plasty and to 5.2 f 0.56 cm2 after the surgicalprocedure From the Department of Cardiology and Cardiovascular Surgery, Uni@ <O.OOl compared with valvuloplasty) (Figure 1). No versity “La Sapienza” Rome, Italy. Manuscript received December 12, damage of the valvular apparatus was evident after dou1991; revised manuscript received April 2,1992, and accepted April 4. ble-balloon dilatation in any patient.

Double-transseptal, double-balloon valvuloplasty for congenital mitral stenosis.

Eight patients with severe congenital mitral stenosis underwent double transseptal, double-balloon valvuloplasty; two had isolated congenital mitral stenosis, six had additional cardiac defects, and one had previous surgical valvotomy. Ages ranged from 0.6 to 36 years (median, 9 years). All procedures were tolerated well. After valvuloplasty, the left atrial a wave minus the left ventricular end-diastolic pressure (LVEDP) gradient was reduced from 25 +/- 6 mm Hg to 9 +/- 3 mm Hg (p less than 0.001), the mitral valve mean gradient was reduced from 18 +/- 7 mm Hg to 8 +/- 3 mm Hg (p = 0.003), and the LVEDP was unchanged. All patients had marked clinical improvement. Only one patient developed significant mitral regurgitation. Two of the first four patients underwent repeat balloon valvuloplasty 7 months later. Follow-up evaluation on six patients from 4 to 54 months revealed no recurrence of symptoms or increased mitral regurgitation. Double transseptal, double-balloon valvuloplasty is an effective treatment for many forms of congenital mitral stenosis. Mitral regurgitation is uncommon after this procedure. The double transseptal approach results in less trauma to the atrial septum and femoral veins and allows easy assessment of any residual postvalvuloplasty gradient.

Balloon valvuloplasty for fungal endocarditis induced stenosis of a bioprosthetic tricuspid valve

Palliative treatment was provided without complications by double balloon valvuloplasty of a stenotic porcine tricuspid valve in a patient with fungal endocarditis. With two 15 mm diameter valvulotomy balloons the peak tricuspid gradient decreased from 21 to 7 mm Hg and valve area increased from 0.3 to 1.2 cm2. After the procedure the patient clinically improved; however, valve replacement was not performed as planned because the patient developed an intracranial hemorrhage. She subsequently died of complications of fungemia. The present report demonstrates the possible use of valvuloplasty as a palliative procedure in selected patients with valvular stenosis involved with endocarditis.

Percutaneous double‐balloon valvuloplasty of porcine bioprosthetic valves in the tricuspid position

This is a description of the first two reported cases of double-balloon valvuloplasty in the treatment of porcine bioprosthetic valve stenosis in the tricuspid position. In both cases, the double-balloon technique resulted in a better hemodynamic improvement than single-balloon valvuloplasty and was well tolerated. Double-balloon valvuloplasty is a reasonable alternative to surgical replacement of a stenotic bioprosthesis in the tricuspid position.

Experimental balloon valvuloplasty of fibrotic and calcific mitral valves.

This study evaluated the mechanism of valvular area expansion during single- and double-balloon valvuloplasty in fibrotic and calcific mitral valves. Special interest was focused on the morphological features of the valves treated. Mitral valves that appeared unsuitable for commissurotomy were excised in toto at the time of mitral valve replacement in 15 patients. The excised valves were mounted in a fluid-filled chamber with a window for photographic evaluation. The chamber was perfused continuously to ensure maximal valvular opening. The valve was photographed, and the orifice area was measured before and after balloon expansion. In addition, the specimens were examined macroscopically and radiographically with regard to calcium content and degree and localization of fibrosis. These data were correlated with splitting of commissures and with rupture of leaflets. Nine valves were fibrotic, and six were calcific. Dilatation was performed first with a single-balloon catheter (diameter, 2 cm) and then with a double-balloon catheter (diameter, 2 and 1.5 cm). After dilatation with one balloon, the average mitral valve area increased from 0.79 to 1.09 cm2, and with two balloons, average area increased to 1.59 cm2. The single-balloon technique caused commissural splitting in nine valves, stretching in three, partial leaflet rupture in one, and no change in two. After the double-balloon technique, commissural splitting occurred in 12 valves and three leaflets were ruptured where severe fibrosis and calcification were mainly located within the commissures. As a rule, after dilatation with the single-balloon technique, the remaining stenosis was still severe, and after dilatation with the double-balloon technique, the remaining stenosis was moderate.(ABSTRACT TRUNCATED AT 250 WORDS)

Combined percutaneous balloonvalvuloplasty of mitral and tricuspid valves

Combined mitral and t r icuspid stenosis are rarely encountered in pat ients with rheumat ic hear t disease. 1 In spite of being a recently introduced technique, balloon valvuloplasty in noncalcified mitral stenosis has been found to be consistently effective in the t rea tment of this condition. 2 Successful double balloon valvuloplasty in t r icuspid stenosis 3, 4 has recently been reported. We repor t a case in which balloon valvuloplasty was performed on both the mitral and tr icuspid valves during the same procedure, with good immediate and midte rm results, A 48-year-old woman pat ien t with New York Hear t Association (NYHA) functional class I I I was admi t t ed to the hospital for the evaluation of rheumatic mitral and tr icuspid stenosis. Physical examinat ion showed a typical mitral facies with p inkish-purple patches on the cheeks, elevated jugular venous pressure, and mild hepatomegaly. A loud first hear t sound and an opening snap were heard at the apex, with a low-pitched diastolic murmur. There was also a diastolic rumble along the lower left sternal border combined with a systolic murmur , both increasing on inspiration. The electrocardiogram (ECG) showed atr ial fibrillat ion and right-axis deviation. The chest x-ray film showed left and right atr ial enlargement with increased upper lobe vascular markings and enlargement of the pulmonary arteries. Echo-Doppler technique showed pure mi t ra l stenosis. The valve was flexible, with no evidence of calcification. Mit ra t valve area, calculated from the mitral flow using the pressure halft ime method as described by Hatle et al., 5 was 1 cm 2. Direct p lanimetry of the mitral orifice gave a valve area of 1.1 cm. 2 The left a t r ium was moderately enlarged and the left ventricle was normal. The tr icuspid valve showed a combinat ion of stenosis and mild incompetence. Tricuspid pressure halft ime was 366 msec. In the light of these findings, we decided to a t t empt percutaneous balloon valvuloplasty on both valves if the assessment was corroborated by diagnostic catheterization. Wri t ten consent was obtained from the pat ient . The catheterizat ion included the measurement of the mitral valve gradient, cardiac outpu t ( thermodilution), and calculation of the area using Gorlin's formula. A left ventriculogram was performed in the right anterior oblique view. Simultaneous recordings of

Double Balloon Technique for Percutaneous Balloon Pulmonary Valvuloplasty: Comparison with Single Balloon Technique

This study was designed to document our results of double balloon pulmonary valvuloplasty and to evaluate if the double balloon technique is preferable to single balloon valvuloplasty in the relief of isolated valvar pulmonic stenosis. Double balloon valvuloplasty in twelve patients reduced the pulmonary valvar gradient from 100.5 ± 28.0 (mean ± SD) to 26.6 ± 12.5 mm Hg (P &lt; 0.001) which remained improved, 17.5 ± 10.2 mm Hg (P &lt; 0.001) at 6 to 14 month follow‐up. Single balloon valvuloplasty with equivalent balloon/pulmonary valve annulus ratios (1.19 ± 0.14 vs 1.19 ± 0.15, P &gt; 0.1) in another 12 patients also reduced (P &lt; 0.001) the gradient from 96.3 ± 40.1 to 28.3 ± 17.3 mm Hg immediately following the procedure which at 6 to 13 month follow‐up was 12.8 ± 9.9 mm Hg. The right ventricular peak systolic pressures (116.6 ± 24.5 vs 113.8 ± 41.5 mm Hg) and pulmonary valvar gradients (100.5 ± 28.0 vs 96.3 ± 40.1 mm Hg) prior to valvuloplasty, residual right ventricular pressures (47.4 ± 12.2 vs 54.3 ± 14.2 mm Hg) and pulmonary valve gradients (26.6 ± 12.5 vs 28.3 ± 17.3 mm Hg) immediately after valvuloplasty, and residual right ventricular pressures (43.1 ± 10.9 vs 41.1 + 12.5 mm Hg) and pulmonary valvar gradients (17.5 ± 10.2 vs 12.8 ± 9.9 mm Hg) on follow‐up were similar (P ± 0.1) in both groups.These data indicate that results of double balloon valvuloplasty are excellent but not superior to single balloon valvuloplasty. It is suggested that the double balloon valvuloplasty should be used if the pulmonary valve annulus is too large to dilate with a single balloon. There is no need for double balloon valvuloplasty if the pulmonary valve can be dilated with a commercially available single balloon.

Comparison of single and double balloon valvuloplasty in children with aortic stenosis

To compare the effectiveness of the single and double balloon techniques, the short-term results of percutaneous balloon valvuloplasty were assessed in two consecutive groups of children with valvular aortic stenosis. In 16 children (aged 3 months to 17 years) the single balloon technique was utilized; the ratio of balloon diameter to valve anulus diameter was 0.96 ± 0.03 (mean ± SEM). In 11 children (aged 3 months to 21 years) the double balloon technique was utilized in which two balloons are positioned across the valve and inflated simultaneously; the ratio of the balloon diameter sum to valve anulus diameter was 1.32 ± 0.05. The groups were similar in age, weight, cardiac output, prevalvuloplasty gradient and valve anulus diameter.Overall, valvuloplasty reduced the peak systolic gradient by 53% from 80 ± 4 to 38 ± 3 mm Hg (p < 0.0001). In the single balloon group the gradient decreased from 82 ± 6 to 46 ± 4 mm Hg (p < 0.0001), whereas in the double balloon group the gradient decreased from 76 ± 5 to 26 ± 4 mm Hg (p < 0.0001). The peak systolic gradient after valvuloplasty was 43% lower in the double balloon group (p < 0.01). Furthermore, the single balloon technique reduced the gradient by an average of 43% compared with a 67% reduction with the double balloon technique (p < 0.001). The short-term complications of valvuloplasty were similar, with an increase in aortic insufficiency occurring in three children in each group. Although not a randomized trial, the present study suggests that the double balloon approach may be superior to single balloon valvuloplasty for children with aortic stenosis.

Mechanisms of Increase in Mitral Valve Area and Influence of Anatomic Features in Doubleballoon, Catheter Balloon Valvuloplasty in Adults with Rheumatic Mitral Stenosis: A Doppler and Two-Dimensional Echocardiographic Study

To study the mechanism of increase in the mitral valve area (MVA) and the anatomic features of the mitral valve that may affect the results of catheter double-balloon valvuloplasty (CBV) in adult patients with mitral stenosis, Doppler and two-dimensional echocardiography was performed in 12 patients before and immediately after CBV. Immediately after CBV, there was an increase in the transverse diameter of the mitral valve orifice from 18 +/- 1.6 to 25 +/- 2.8 mm (mean +/- SD, p less than .001). The anterior angles at the commissure increased from 33 +/- 6 to 57 +/- 20 degrees (p less than .05) and the posterior angles from 36 +/- 9 to 54 +/- 14 degrees (p less than .05). The MVA was greater after CBV in patients with pliable mitral valves (2.6 +/- 0.7 cm2) compared with those with rigid mitral valves (1.9 +/- 0.8 cm2; p = .08). After CBV, MVA was smaller in patients with calcification (2.1 +/- 0.2 cm2) compared with those without (2.7 +/- 0.5 cm2; p = .10) and in those with subvalvular disease (2.0 +/- 0...