Dual balloon technique for valvuloplasty of aortic stenosis in adults.
ABSTRACT A dual balloon technique was studied in 16 patients with aortic stenosis in whom results with a single balloon (up to 20 mm, 5.5 cm or 25 mm, 3.0 cm in diameter and length, respectively) were judged to be suboptimal. Dual balloon valvuloplasty was performed using 2 balloons advanced and inflated simultaneously across the stenotic aortic valve orifice. For the group as a whole, the average peak transvalvular gradient was reduced from 79 +/- 8 to 57 +/- 7 mm Hg (mean +/- standard error) using a single balloon (p less than 0.0005), and reduced further to 36 +/- 4 mm Hg using dual balloons (p less than 0.0005 compared with single balloon results). Similarly, calculated aortic valve orifice area was increased from 0.45 +/- 0.04 to 0.57 +/- 0.05 cm2 using a single balloon (p less than 0.0005), and further increased to 0.77 +/- 0.06 cm2 using dual balloons (p less than 0.0005). Dual balloon dilation caused no complications directly attributable to the use of 2 balloons, including no exacerbation of aortic regurgitation. These results suggest that dual balloon valvuloplasty is safe and efficacious in selected patients with aortic stenosis.
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ABSTRACT: Among the initial 492 patients who underwent balloon aortic valvuloplasty as part of the Mansfield Investigational Device Exemption Protocol, 31 (6.3%) had acute catastrophic complications. These included ventricular perforation in nine (1.8%), seven women and two men; six cases (67%) involved serial balloon inflations and seven (78%) also involved dual balloon inflations. In six (67%) of the nine patients perforation was fatal. In four patients studied at necropsy, the perforation involved the base of the lateral left ventricular free wall. Pericardiocentesis was performed in five patients, three of whom survived with (one patient) or without (two patients) operative repair. Acute, severe aortic regurgitation developed in four patients (0.8%), all women. None had significant regurgitation before valvuloplasty; dual balloons were used in two of the four. All three patients who underwent emergency valve replacement survived. A fourth patient died 2 days after valvuloplasty without operative intervention. Fatal cardiac arrest complicated balloon aortic valvuloplasty in 13 patients (2.6%), including 7 with cardiogenic shock and 4 with refractory ventricular arrhythmias. Of the seven with shock, four had been treated with serial balloon inflations; dual balloons were used in three. In two of three patients studied at necropsy, the aortic valve was observed to be congenitally bicuspid. A fatal cerebrovascular accident occurred in two patients (0.4%); it was hemorrhagic in one, embolic in another. Both patients were treated with serial (including one dual) balloon inflations. Limb amputation was required in three patients (0.6%), two women and one man; in two patients amputation was above the knee, in the third patient it was limited to two toes.(ABSTRACT TRUNCATED AT 250 WORDS)Journal of the American College of Cardiology 06/1991; 17(6):1436-44. · 14.09 Impact Factor
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ABSTRACT: Balloon aortic valvuloplasty was developed as an alternative to aortic-valve replacement in selected elderly patients with aortic stenosis. The use of this procedure is limited, however, by a high incidence of restenosis. Between December 1985 and April 1989, valvuloplasty was performed in 205 patients. We evaluated 40 demographic and hemodynamic variables as univariate predictors of event-free survival by Cox regression analysis and identified independent predictors of event-free survival by stepwise multivariate analysis. Early hemodynamic results indicated a decrease in the peak transaortic-valve pressure gradient from 67 +/- 28 to 33 +/- 15 mm Hg after valvuloplasty and an increase in aortic-valve area from 0.6 +/- 0.2 to 0.9 +/- 0.3 cm2 (P less than 0.001 for both comparisons). The rate of event-free survival (defined as survival without recurrent symptoms, repeated valvuloplasty, or aortic-valve replacement) was 18 percent over the mean (+/- SD) follow-up period of 24 +/- 12 months (range, 1 to 47). Significant predictors of event-free survival included the left ventricular ejection fraction and the left ventricular and aortic systolic pressure before valvuloplasty, and the percent reduction in the aortic-valve pressure gradient; the pulmonary-capillary wedge pressure was inversely associated with event-free survival. Although the predicted event-free survival rate for the entire patient group was 50 percent at one year (95 percent confidence interval, 43 to 57 percent) and 25 percent at two years (95 percent confidence interval, 19 to 31 percent), the probability of event-free survival at one year varied between 23 and 65 percent when patients were stratified according to three independent predictors: the aortic systolic pressure, the pulmonary-capillary wedge pressure, and the percent reduction in the peak aortic-valve gradient. The most important predictors of event-free survival after balloon aortic valvuloplasty were related to base-line left ventricular performance. The best long-term results after valvuloplasty were observed among patients who would also have been expected to have excellent long-term results after aortic-valve replacement.New England Journal of Medicine 08/1991; 325(1):17-23. · 54.42 Impact Factor
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ABSTRACT: Catheter balloon valvuloplasty of stenotic aortic valves has met with generally poor short- and long-term clinical results. Part of this problem resides with the lack of recognition of various etiologies of aortic stenosis. Part I of this review discusses the various etiologies of aortic stenosis and provides an anatomic basis for successful valve dilation. Results of an in vitro study indicate stenotic aortic valves are dilated by various mechanisms (cracking, stretching) based in part upon the etiology of the aortic valve stenosis.Clinical Cardiology 02/2009; 14(10):836 - 846. · 1.83 Impact Factor