Assessment of left ventricular and aortic valve function after aortic balloon valvuloplasty in adult patients with critical aortic stenosis

Preliminary reports have documented the utility of balloon aortic valvuloplasty as a palliative treatment for high-risk patients with critical aortic stenosis, but the effect of this procedure on cardiac performance has not been studied in detail. Accordingly, 32 patients (mean age 79 years) with long-standing, calcific aortic stenosis were treated at the time of cardiac catheterization with balloon dilatation of the aortic valve, and serial changes in left ventricular and valvular function were followed before and after valvuloplasty by radionuclide ventriculography, determination of systolic time intervals, and Doppler echocardiography. Prevalvuloplasty examination revealed heavily calcified aortic valves in all patients, a mean peak-to-peak aortic valve gradient of 77 +/- 27 mm Hg, a mean Fick cardiac output of 4.6 +/- 1.4 liters/min, and a mean calculated aortic valve area of 0.6 +/- 0.2 cm2. Subsequent balloon dilatation with 12 to 23 mm valvuloplasty balloons resulted in a fall in aortic valve gradient to 39 +/- 15 mm Hg, an increase in cardiac output to 5.2 +/- 1.8 liters/min, and an increase in calculated aortic valve area to 0.9 +/- 0.3 cm2. Individual hemodynamic responses varied considerably, with some patients showing major increases in valve area, while others demonstrated only small increases. In no case was balloon dilatation accompanied by evidence of embolic phenomena. Supravalvular aortography obtained in 13 patients demonstrated no or a mild (less than or equal to 1+) increase in aortic insufficiency. Serial radionuclide ventriculography in patients with a depressed left ventricular ejection fraction (i.e., that less than or equal to 55%) revealed a small increase in ejection fraction from 40 +/- 13% to 46 +/- 12% (p less than .03). In addition, for the study group as a whole there was a decrease in left ventricular end-diastolic volume index (113 +/- 38 to 101 +/- 37 ml/m2, p less than .003), a fall in stroke-volume ratio (1.49 +/- 0.44 to 1.35 +/- 0.33, p less than .04), and no immediate change in left ventricular peak filling rate (2.05 +/- 0.77 to 2.21 +/- 0.65 end-diastolic counts/sec, p = NS). Serial M mode echocardiography and phonocardiography showed an increase in aortic valve excursion (0.5 +/- 0.2 to 0.8 +/- 0.2 cm, p less than .001), a decrease in time to one-half carotid upstroke (80 +/- 30 to 60 +/- 10 msec, p less than .001), and a small decrease in left ventricular ejection time (0.44 +/- 0.03 to 0.42 +/- 0.02 sec, p less than .001).(ABSTRACT TRUNCATED AT 400 WORDS)     

Treatment of acquired aortic stenosis in adults by percutaneous valvuloplasty with balloon catheterization. Experience of 245 cases

In our department, percutaneous balloon valvuloplasty has become the routine treatment of aortic valve stenosis in adults. We report here the results obtained in 245 consecutive patients. The patients' age varied between 30 and 98 years (mean 74 +/- 11 years), 77 of them (31 p. 100) being 80 years' old or older. The initial peak to peak ventriculo-aortic gradient was 72 +/- 25 mmHg and the aortic valve area was 0.53 +/- 0.17 cm2. After dilatation the gradient was reduced to 29 +/- 14 mmHg (p less than 0.001) and the aortic valve area was increased to 0.95 +/- 0.33 cm2 (p less than 0.0001). The aortic valve area was increased by 100 p. 100 or more in 83 patients (34 p. 100) and by less than 25 p. 100 in only 17 patients (7 p. 100). The ventricular ejection fraction rose slightly but significantly from 48 +/- 18 p. 100 to 51 +/- 17 p. 100 (p less than 0.01). One patient developed massive regurgitation and had to undergo semi-emergency surgery. The experience acquired and the use of better catheters enabled us to improve these results by almost doubling the number of patients whose aortic valve area became 1 cm2 or more and by reducing by half those whose aortic valve area remained 0.7 cm2 or less. Three patients aged 82, 91 and 98 respectively died, and there was one cerebral vascular accident in the catheterization room. Nine patients (4 p. 100) died in hospital during the following days.(ABSTRACT TRUNCATED AT 250 WORDS)     

Orifice variability of the stenotic aortic valve: evaluation before and after balloon aortic valvuloplasty

The effects of balloon aortic valvuloplasty on orifice variability of the stenotic sclerocalcific aortic valve were evaluated by hemodynamic measurements of aortic valve function in 14 patients before balloon aortic valvuloplasty, during nitroprusside infusion before valvuloplasty, 48 h after valvuloplasty and during nitroprusside infusion 48 h after valvuloplasty. Aortic valve function was assessed by aortic valve area calculations with use of the Gorlin and Cannon formulas. Nitroprusside infusion before balloon aortic valvuloplasty caused no change in mean aortic valve gradient but a significant increase in mean aortic transvalvular flow from 186 +/- 46 to 202 +/- 61 ml/s (p less than 0.05), in Gorlin aortic valve area from 0.49 +/- 0.17 to 0.53 +/- 0.21 cm2 (p less than 0.05) and in Cannon aortic valve area from 0.45 +/- 0.18 to 0.49 +/- 0.22 cm2 (p less than 0.05). Nitroprusside infusion 48 h after valvuloplasty induced no change in mean aortic valve gradient but a significant increase in mean aortic transvalvular flow from 214 +/- 61 to 254 +/- 78 ml/s (p less than 0.005), in Gorlin aortic valve area from 0.71 +/- 0.25 to 0.83 +/- 0.32 cm2 (p less than 0.01) and in Cannon aortic valve area from 0.78 +/- 0.33 to 0.88 +/- 0.40 cm2 (p less than 0.05). Forty-eight hours after valvuloplasty, nitroprusside infusion induced a larger increase (40 +/- 40 ml/s) in mean transvalvular flow than before valvuloplasty (16 +/- 27 ml/s; p less than 0.05) and a larger increase (0.12 +/- 0.14 cm2) in Gorlin aortic valve area than before valvuloplasty (0.05 +/- 0.07 cm2; p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)     

Percutaneous valvuloplasty of aortic stenosis in adults. Immediate and mid-term results: apropos of 78 attempts

Between February, 1986 and October, 1987 percutaneous aortic valvuloplasty was attempted in 78 patients: 25 men (32 p. 100) and 53 women aged from 61 to 89 years (mean 79.5 years). All patients were symptomatic; 9 were in class II, 49 in class III and 20 in class IV of the NYHA classification. The decision to try percutaneous valvuloplasty was determined by the high surgical risk associated with age (over 75 in 87 p. 100 of the patients), poor physiological condition or concurrent pathology, or by refusal of surgery. 70 dilatations could actually be made (90 p. 100) either by the brachial route (n = 39) or the femoral route (n = 18) or the transseptal route (n = 7) or by a combined brachial and femoral route which enabled the double balloon technique to be used (n = 6). The procedure comprised 5.6 +/- 3 inflations and lasted for 58 +/- 29 min. The diameter of the largest balloon utilized was greater than 20 mm in 75 p. 100 of the cases. Dilatation reduced the aortic gradient from 62 to 28 mmHg (p less than 0.001) without altering the cardiac index (2.36 to 2.32 l/min/m2) and significantly increased the aortic valve area from 0.49 to 0.76 cm2 (p less than 0.001). At the end of the procedure the aortic valve area was greater than 0.7 cm2 in 63 p. 100 and greater than 1 cm2 in 14 p. 100 of the patients. Five patients had to be operated upon within the month following dilatation (3 after technical failure, 2 for poor functional results).(ABSTRACT TRUNCATED AT 250 WORDS)     

Medium-term follow-up after percutaneous aortic valvuloplasty in the elderly. Clinical study apropos of 102 cases

Percutaneous transluminal balloon aortic valvuloplasty was introduced in 1985 and, owing to its sometimes dramatic short-term results, it has rapidly become a useful procedure in the management of aortic stenosis in elderly subjects. The purpose of this study was to determine its clinical results at medium-term and to identify possible prognostic factors in order to improve the selection of patients suitable for this technique. Between January 1986 and December 1987, 78 patients (30 men, 48 women, aged from 60 to 93 years, mean 80 +/- 6.7 years) totalling 85 procedures were selected among 102 dilatations on the basis of a primary success without complications. Dilatation was performed by a technique similar to that described by Cribier et al. The follow-up period was 10 +/- 5.7 months (range: 1 to 27 months). The aortic valve area increased from 0.47 +/- 0.15 cm2 to 0.77 +/- 0.23 cm2, i.e. from 0.29 +/- 0.09 cm2/m2 to 0.48 +/- 0.13 cm2/m2 as regards the indexed area. The hospital mortality rate was 3.3 p. 100. At the end of the follow-up period 55 p. 100 of the patients were in NYHA class I or II; 29 p. 100 had died, 10 p. 100 had undergone a second dilatation and 13 p. 100 had had aortic valve replacement. This distribution into functional classes and major cardiac events was not significantly different in the subgroup of patients with an aortic valve area greater than 0.9 cm2 or in the subgroup of primary failure. The patients who died for cardiac reasons were older (p less than 0.01), had a lower cardiac output before and after dilatation (p less than 0.001) and a lower ejection fraction after dilatation (p less than 0.05) or even before in case of early death (p less than 0.05). Mortality and morbidity therefore were high at medium-term and unrelated to the haemodynamic effect of dilatation. On the other hand, the left ventricular systolic function was determinant, mainly because it could improve or remain stable when initially altered. These results suggest that only patients for whom aortic valve replacement is truly contra-indicated and who have a limited alteration of left ventricular function should be selected for aortic valvuloplasty.     

Serial assessment of mitral regurgitation by pulsed Doppler echocardiography in patients undergoing balloon aortic valvuloplasty

Mitral regurgitation was serially assessed by pulsed Doppler echocardiography in 144 patients undergoing balloon aortic valvuloplasty for symptomatic aortic stenosis. Regurgitant scores of 0, 1, 2 and 3 were assigned to pulsed Doppler patterns corresponding to no, mild, moderate and severe mitral regurgitation, respectively. Before balloon aortic valvuloplasty, mitral regurgitant score correlated significantly (p less than 0.005) but weakly with aortic valve area (r = -0.24), left ventricular ejection fraction (r = -0.34) and left ventricular systolic pressure (r = 0.23). There was no significant correlation between mitral regurgitation and either mean catheterization or mean Doppler aortic valve gradient. Balloon aortic valvuloplasty produced significant decreases in both catheterization and Doppler mean transvalvular aortic valve gradients (56 +/- 19 to 31 +/- 12 and 60 +/- 19 to 48 +/- 16 mm Hg, respectively; both p less than 0.0001) and a significant increase (p less than 0.0001) in aortic valve area assessed by catheterization (0.6 +/- 0.2 to 0.9 +/- 0.3 cm2). Left ventricular ejection fraction did not change, but cardiac output increased (p less than 0.001) and pulmonary capillary wedge pressure decreased (p less than 0.0001). Pulsed Doppler findings of mitral regurgitation were present in 102 of the 144 patients. Eighty-eight patients had a score compatible with mild or more severe degrees of mitral regurgitation, and 49 had a score indicative of moderate or severe valvular insufficiency. In the entire group of 144 patients, mitral regurgitant score decreased significantly from 1.1 +/- 1.0 to 1.0 +/- 1.0 (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

The long-term evolution of patients with senile aortic stenosis undergoing percutaneous valve dilatation]

The long-term follow-up of 35 patients with mean age of 74.3 +/- 8 years (64-86) who underwent percutaneous aortic valvuloplasty (PAV) is presented. The mean duration of the follow-up study was 33 months (range 1-48). Global mortality was 42% (14 patients) and was related to post-PAV aortic valvular area (47% mortality in less than 0.7 cm2 area group vs 28% in greater than or equal to 0.7 cm2 group) and left ventricular ejection fraction (67% in EF less than 35% group vs 35% in EF greater than or equal to 35% group). The actuarial probability of remaining alive and free of symptoms and of cardiac surgery or new PAV was 57, 41, 33, and 20% at 1, 2, 3 and 4 years. After PAV clinical improvement was obtained in most of the patients (68%), but only 42% of those with successful dilatation remain asymptomatic after a 24 months period (85 +/- 28 mmHg, p = NS). Transvalvular gradient studied by Doppler decreased immediately after PAV (92.8 +/- 26 mmHg vs 51 +/- 16 mmHg, p less than 0.001), but returned to baseline values after 12 months. These results show that PAV yields a clinical improvement in most of the patients, but this improvement is transitory, does not modify the natural history of the disease and has a high degree of restenosis. Thus, its use must be limited to a reduced group of patients who are not candidates for cardiac surgery.     

Results of percutaneous transluminal valvuloplasty in 218 adults with valvular aortic stenosis

The results of balloon aortic valvuloplasty (BAV) in 218 adult patients with valvular aortic stenosis (AS) are reported. In most cases, 3 transcutaneously introduced balloons of successively increasing size were used. Tolerance was excellent in 64%, whereas a decrease in blood pressure below 60 mm Hg during inflation was observed in 36%. The left ventricular-aortic peak to peak gradient decreased from 72 +/- 25 to 29 +/- 14 mm Hg (p less than 0.001) and the aortic valve area increased from 0.52 +/- 0.18 to 0.93 +/- 0.33 cm2 (p less than 0.001). The final aortic valve area was greater than or equal to 1 cm2 in 69 patients (32%). In only 6 cases (3%) the aortic valve area did not change or increased by less than 10%. A clear improvement in the results was observed with gained experience and better catheters. There was 1 death and 1 stroke in the procedure room, and 3 strokes after BAV. Nine patients died shortly after the procedure. There were local complications (hematoma or thrombosis) at the femoral puncture site in 28 (13%) patients. Clinical follow-up was obtained for 144 patients (mean 8 months). There were 24 deaths. In the 120 remaining cases, symptomatic improvement was good in 84%, with decrease or disappearance of dyspnea, angina or both. This study demonstrates that BAV is feasible in adult AS at a low risk and is able to produce marked clinical improvement in most cases.     

Echocardiographic assessment of aortic valve area in elderly patients with aortic stenosis and of changes in valve area after percutaneous balloon valvuloplasty

Echocardiographic studies, adequate for analysis of aortic valve area using the continuity equation, were obtained in 31 patients aged greater than or equal to 60 years who were undergoing catheterization for assessment of suspected aortic stenosis. Catheterization-determined aortic valve area was 0.74 +/- 0.30 cm2 (mean +/- SD) and Doppler-determined aortic valve areas were 0.68 +/- 0.27 and 0.65 +/- 0.27 cm2, depending on whether peak or mean velocities, respectively, were entered into the continuity equation. There were significant correlations between both of the Doppler-derived and the catheterization-determined aortic valve areas (r = 0.86, p less than 0.001 for both the continuity equation employing peak velocities and the continuity equation employing mean velocities) which were demonstrated to be linear by F test (catheterization area = -0.03 + 1.13 X Doppler area determined using peak velocities, SEE = 0.163 cm2, p less than 0.001; and catheterization area = -0.02 + 1.16 X Doppler area determined using mean velocities, SEE = 0.165 cm2, p less than 0.001). Both sets of correlations had linear regression parameters meeting the conditions for identity. Significant linear correlations were also noted between the non-invasive measurements of aortic valve excursion, ventricular ejection time, time to one-half carotid upstroke, maximal Doppler velocity and maximal Doppler gradient and catheterization aortic valve area, but the correlations were less tight than those between valve areas determined by catheterization and by Doppler continuity equation. Ten of the patients underwent percutaneous balloon aortic valvuloplasty. There were significant linear correlations between aortic valve areas determined by Doppler and catheterization methods both before valvuloplasty (r = 0.77, p = 0.01; p less than 0.001 by F test, SEE = 0.134 cm2) and after valvuloplasty (r = 0.85, p less than 0.01; p = 0.0001 by F test, SEE = 0.161 cm2). Linear regression parameters met the conditions for identity. There was also a significant linear correlation between catheterization and Doppler measurements of absolute change in aortic valve area (r = 0.79, p less than 0.01; p less than 0.001 by F test, SEE = 0.11 cm2). Aortic valve area can be determined reliably by continuity equation in elderly patients. In addition, results of balloon valvuloplasty, measured by changes in catheterization-determined aortic valve area, are accurately reflected by changes in aortic valve area determined using the continuity equation.     

Aortic valve area evolution after percutaneous aortic valvuloplasty. A prospective trial using a combined Doppler echocardiographic and haemodynamic method

The aortic valve area was serially evaluated in 45 patients, mean age 78 years, suffering from severe aortic stenosis who underwent percutaneous aortic valvuloplasty. The aortic valve area was calculated from haemodynamic data prior to and immediately after the procedure using the mean gradient. Serial determinations of the aortic valve area were also obtained 1 day before, 1 day after and 2 months after valvuloplasty from the thermodilution cardiac output and Doppler echocardiography mean left ventricle-to-aorta gradient. The mean gradient significantly decreased from 75 +/- 24 to 42 +/- 16 mmHg (P less than 0.01) when measured from haemodynamic data and from 63 +/- 20 to 41 +/- 13 mmHg (P less than 0.01) when estimated from Doppler-derived data. It rose to 48 +/- 15 mmHg at 2 months (NS). The aortic valve area increased significantly from 0.48 +/- 0.13 to 0.67 +/- 0.29 cm2 (P less than 0.01) when calculated from haemodynamic data, and from 0.53 +/- 0.18 to 0.74 +/- 0.23 cm2 (P less than 0.01) when estimated from Doppler-derived data. It declined to 0.69 +/- 0.27 cm2 at 2 months (NS). Aortic valve area values determined from haemodynamic data and from Doppler-derived data correlated well before valvuloplasty (r = 0.80, P less than 0.01) but poorly afterwards (r = 0.57, P less than 0.01). The aortic valve area was not influenced by valvuloplasty in eight patients. At 2 months, restenosis was apparent in eight patients out of 32 that were re-evaluated. Three patients died within 5 days of the procedure. After an average 12 months' follow-up, eight more patients died. Symptoms were not influenced or recurred in 17 patients, while 17 others remained improved by at least one NYHA functional class. Seven patients were operated on, and there was one operative death. The calculated aortic valve area was significantly greater at the end of the procedure in the patients with persistent improvement compared with those with a poor result (0.83 +/- 0.29 cm2 vs 0.65 +/- 0.14 cm2, P less than 0.05). In conclusion, in this study one third of the patients submitted to percutaneous aortic valvuloplasty had no objective improvement in calculated valve area or early restenosis after 2 months. Functional improvement was observed in one third of the patients. Immediate re-estimation of the aortic valve area from haemodynamic data at the end of the procedure may not reflect the actual effect of valvuloplasty on the aortic orifice.     

Dilatation of the aortic valve portion in aortitis syndrome. Angiographic evaluation of 70 patients

The dilatation of the aortic valve portion was evaluated by angiography in 70 patients with aortitis syndrome (Takayasu's arteritis). The diameter at aortic valve commissure was 20 +/- 2.8 min/M2 (NS, vs control) in 46 patients without aortic insufficiency (AI), 23 +/- 2.0 (p less than 0.02, vs without AI) in 11 patients with AI (I or II in grade), 27 +/- 2.0 (p less than 0.01, vs I or II in grade) in 13 patients with AI (III or IV in grade). The diameter was 20 +/- 2.0 in 13 normal control cases and 20 +/- 4.0 in 6 patients with rheumatic AI. The diameters at the levels of aortic valve annulus, sinus of Valsalva and ascending aorta increased also significantly in the patients with AI secondary to aortitis syndrome. The diameter at aortic valve commissure in 24 patients with AI was correlated (r = -0.48, p less than 0.05) to the diastolic blood pressure. Any diameter at the aortic valve portion was not different significantly by the complication of systolic hypertension (greater than or equal to 180 mmHg) in both groups of cases with and without AI. These results indicated that the dilatation of the aortic valve portion was observed in the patient with AI secondary to aortitis syndrome and might be the primary and common cause of AI in all grades, and that the dilatation might not be accelerated by the associated hypertension.     

Analysis of the early rise in aortic transvalvular gradient after aortic valvuloplasty

The relationship between dynamic changes in aortic valve gradient and left ventricular ejection performance in the early period after successful percutaneous aortic valvuloplasty has not been described in detail. Accordingly 20 adult patients with severe symptomatic calcific aortic stenosis underwent first-pass radionuclide angiography and Doppler echocardiography before, immediately after, and 2 to 4 days after the valvuloplasty procedure. A significant (p less than 0.001) reduction in peak-to-peak (72 +/- 24 mm Hg to 36 +/- 11 mmHg) and mean (60 +/- 20 mm Hg to 34 +/- 9 mm Hg) transaortic gradient and an increase in aortic valve area (0.5 +/- 0.2 cm2 to 0.8 +/- 0.2 cm2) were measured by high-fidelity micromanometer catheters immediately after aortic valvuloplasty. Results of Doppler echocardiography showed a significant (p less than 0.001) immediate decrease in peak instantaneous (81 +/- 22 mm Hg to 53 +/- 15 mm Hg) and mean (48 +/- 14 mm Hg to 31 +/- 9 mm Hg) aortic gradients. However, 2 to 4 days later a significant (p less than 0.001) return of peak (56 +/- 15 mm Hg to 65 +/- 20 mm Hg) and mean (31 +/- 9 mm Hg to 39 +/- 12 mm Hg) transvalvular gradient occurred. Aortic valve area as determined by the continuity equation also increased from 0.4 +/- 0.2 cm2 to 0.6 +/- 0.2 cm2 immediately after the procedure (p less than 0.001), then partially returned to baseline (0.5 +/- 0.2 cm2; p less than 0.005) at 2 to 4 days.(ABSTRACT TRUNCATED AT 250 WORDS)     

Gradient reduction, aortic valve regurgitation and prolapse after balloon aortic valvuloplasty in 32 consecutive patients with congenital aortic stenosis

From 1986 to 1988, balloon aortic valvuloplasty was performed in 32 patients with congenital valvular aortic stenosis. The patients ranged in age from 2 days to 28 years (mean +/- SD 8.3 +/- 5.9). One balloon was used in 17 patients and two balloons were used in 15 patients. Immediately after valvuloplasty, peak systolic pressure gradient across the aortic valve decreased significantly from 77 +/- 27 to 23 +/- 16 mm Hg (p less than 0.01), a 70% reduction in gradient. At early follow-up study (4.1 +/- 3.3 months after valvuloplasty), there was a 48 +/- 20.5% reduction in gradient compared with that before valvuloplasty, and at late follow-up evaluation (19.2 +/- 5.6 months), a reduction in gradient of 40 +/- 29% persisted. Echocardiography showed evidence of significantly increased aortic regurgitation in 10 patients (31%) and aortic valve prolapse in 7 patients (22%). There was no correlation between the balloon/anulus ratio and the subsequent development of aortic regurgitation or prolapse. In fact, no patient who showed a significant increase in aortic regurgitation had had a balloon/anulus ratio greater than 100%. It is concluded that balloon aortic valvuloplasty effectively reduces peak systolic pressure gradient across the aortic valve in patients with congenital aortic stenosis. However, subsequent aortic regurgitation and prolapse occur in a significant number of patients, even if appropriate technique and a balloon size no greater than that of the aortic anulus are used.     

Percutaneous balloon valvuloplasty for aortic stenosis: improved quality of life for elderly patients

From September 1986 to September 1987 percutaneous balloon valvuloplasty was performed in 20 patients with critical aortic stenosis. The mean age was 74, range 54 to 90 years. Two patients were NYHA class II, 10 patients were functional class III and eight were class IV. After percutaneous balloon valvuloplasty, using 15, 18 or 20 mm diameter balloon catheters via a 14F vascular sheath from the femoral artery, one patient was class I, 11 class II and seven were class III. One patient, who had only minimal reduction of aortic valve gradient from 120 to 100 mmHg, remained in class IV. The systolic gradient was reduced by 50% from 70 +/- 26 (+/- SD) to 35 +/- 22 mmHg (P less than 0.001) after valvuloplasty and the aortic valve area increased by 43% from 0.51 +/- 0.12 to 0.73 +/- 0.25 cm2 (P less than 0.001). There were no procedural or 30 day deaths nor any embolic events. Percutaneous balloon valvuloplasty is a relatively safe and effective treatment for the older adult with symptomatic aortic stenosis.     

Aortic percutaneous transluminal valvuloplasty in elderly patients by balloon larger than aortic anulus

Twenty-four elderly patients (79 +/- 7 years) with long-standing calcified aortic stenosis have been divided in two comparable groups of 12. The first group was treated with 19 mm balloon percutaneous transluminal valvuloplasty, where the balloon diameter was always smaller than the aortic anulus diameter. Peak-to-peak aortic valve gradient decreased from 76 +/- 32 mmHg to 30 +/- 19 (P less than .05), and the aortic valve area, calculated by Gorlin formula, increased from 0.40 +/- 0.17 cm2 to 0.57 +/- 0.17 (P less than .05). The second group was treated with a trefoil 25 mm balloon, always larger than the aortic anulus diameter. In this second group, peak-to-peak aortic valve gradient decreased from 73 +/- 34 mmHg to 23 +/- 15 (P less than .05), and aortic valve area increased from 0.47 +/- 0.14 cm2 to 0.88 +/- 0.36 (P less than .05), increasing thus more than in group I (P less than .05). Clinical tolerance to balloon inflation was not the same according to individual patients but was similar between the two groups; complications were comparable in the two groups. These results suggest that aortic valvuloplasty by trefoil balloon larger than aortic anulus can provide wider aortic valve area without increasing complication rate.     

Doppler evaluation of results of percutaneous aortic balloon valvuloplasty in calcific aortic stenosis

To evaluate the short-term results of percutaneous aortic balloon valvuloplasty, 55 consecutive elderly patients with symptomatic, severe aortic stenosis who were at high risk for surgical intervention underwent the procedure, with follow-up by clinical evaluation and Doppler echocardiography. Over a mean follow-up of 6.2 months, there were three early deaths (less than 30 days) and eight late deaths. Nine patients underwent subsequent aortic valve surgery, and four had repeat balloon valvuloplasty. Doppler echocardiography revealed a reduction in aortic valve mean gradient from 48 +/- 18 to 33 +/- 12 mm Hg after the procedure (p less than 0.0001) but a return to 46 +/- 16 mm Hg at follow-up (p less than 0.05). The aortic valve area increased from 0.54 +/- 0.15 to 0.85 +/- 0.23 cm2 after the procedure (p less than 0.0001), but there was a significant decrease to 0.67 +/- 0.19 cm2 at follow-up (p less than 0.05). Of patients free of aortic valve operation or death after 30 days after the procedure, 76% were severely symptomatic before the procedure as compared with 38% at follow-up. In patients undergoing percutaneous aortic balloon valvuloplasty, there is a continued high short-term mortality and a significant incidence of restenosis over short-term follow-up. Nonetheless, a subset of patients do experience sustained clinical improvement from this procedure.     

Percutaneous balloon aortic valvuloplasty: results in 23 patients

Percutaneous balloon aortic valvuloplasty (BAV) was performed in 23 consecutive patients with valvular aortic stenosis with no associated cardiac defects. The patients were 2 to 17 years old and were referred from 12 hospitals in 4 states. The balloon was positioned across the aortic valve and inflated to pressures of 80, 100, then 120 psi. Each inflation lasted 5 to 10 seconds. The arterial and venous catheters were connected together outside the groin to avoid excessive increase in left ventricular pressure during total aortic valve occlusion with the inflated balloon. Peak systolic aortic valve pressure gradient and cardiac output were measured before and 15 minutes after BAV. There was no significant change in cardiac output, but all patients had a lessened gradient. The gradient before BAV was 113 +/- 48 mm Hg, decreasing to 32 +/- 15 mm Hg after BAV (p less than 0.01). The left ventricular peak systolic pressure decreased from 221 +/- 54 to 149 +/- 21 mm Hg (p less than 0.01). No aortic regurgitation was noted in 13 patients and very mild aortic regurgitation was noted in 10 patients after BAV. The balloons were 10 to 20 mm in diameter, chosen at least 1 mm smaller than the diameter of the aortic valve anulus. Pressures of 100 to 120 psi were required to achieve full inflation of the balloons. Six patients had repeat cardiac catheterization studies 3 to 9 months after BAV. In none was there a significant change in peak systolic aortic valve pressure gradient or cardiac output compared with the study immediately after valvuloplasty.     

Serial left ventricular performance evaluated by cardiac catheterization before, immediately after and at 6 months after balloon aortic valvuloplasty

Although impaired ventricular function has been shown to improve after aortic valve replacement, there are few data on hemodynamic changes after balloon aortic valvuloplasty based on follow-up catheterization. Of 71 patients surviving 6 months after balloon aortic valvuloplasty, 41 agreed to late recatheterization. All patients had pre- and postvalvuloplasty and 6 month catheterization data measured with high fidelity micromanometer pressure recordings and simultaneous digital subtraction left ventriculography. The hemodynamic result immediately after valvuloplasty included a reduction in the aortic valve gradient and a moderate increase in aortic valve area (0.51 +/- 0.14 to 0.81 +/- 0.19 cm2, p less than 0.0001). Ejection fraction increased slightly (52 +/- 18 to 55 +/- 17%, p less than 0.0001) despite a decrease in peak positive rate of rise of left ventricular pressure (dP/dt 1,650 +/- 460 to 1,500 +/- 490 mm Hg/s, p less than 0.05). There was also a decrease in left ventricular afterload and a small decrease in preload. At 6 month recatheterization, the mean aortic valve gradient and area were similar to baseline values, with 31 (76%) of 41 patients demonstrating valvular restenosis. At 6 months many left ventricular hemodynamic variables, including peak positive dP/dt and stroke work, also resembled prevalvuloplasty values. However, left ventricular end-diastolic volume was reduced (111 +/- 40 ml at 6 months versus 136 +/- 52 ml before valvuloplasty, p less than 0.01). The mean left ventricular ejection fraction was unchanged from prevalvuloplasty values in the study group of 41 patients, but was significantly improved in 9 of 15 patients with a baseline ejection fraction less than 50%.(ABSTRACT TRUNCATED AT 250 WORDS)     

Percutaneous transluminal balloon valvuloplasty of adult aortic stenosis: report of 92 cases

Percutaneous transluminal balloon valvuloplasty was attempted in 92 adult patients with severe calcific aortic stenosis. The mean age was 75 +/- 11 years (range 38 to 91) and 35 patients were more than 80 years old. Most of the patients were severely disabled; 66 were in New York Heart Association functional class III or IV, 27 had syncopal attacks and 21 had severe angina pectoris. Because of unacceptably high surgical risk or contraindication to thoracic surgery, 42 patients could not be considered for valve replacement. Other patients either were in a category of high operative risk or refused the surgical intervention. Valvuloplasty was performed by way of the femoral route (82 patients) or the brachial route (10 patients). Catheters of size 15, 18 and 20 mm were successively placed across the aortic valve and three inflations were usually done with each of them, lasting 80 seconds on average, until a decrease in peak to peak systolic pressure gradient to 40 mm Hg or less was attained, a result considered satisfactory. The inflated balloons were not totally occlusive in most cases and clinical tolerance of inflation was good. Valvuloplasty resulted in a reduction of mean systolic gradient from 75 +/- 26 to 30 +/- 13 mm Hg (p less than 0.001); the final gradient was less than 40 mm Hg in 78 patients. Mean calculated aortic valve area increased from 0.49 +/- 0.17 to 0.93 +/- 0.36 cm2 (p less than 0.001). Immediately after the procedure, ejection fraction increased from 48 +/- 16 to 51 +/- 16% (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)     

Dual balloon technique for valvuloplasty of aortic stenosis in adults

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.