Circulation, Vol 84, 2383-2397, Copyright © 1991 by American Heart Association
BACKGROUND. Percutaneous balloon aortic valvuloplasty has been used as a
therapeutic option for relief of valvular stenosis. This study describes
patients undergoing initial percutaneous aortic balloon valvuloplasty
enrolled in the National Heart, Lung, and Blood Institute (NHLBI) Balloon
Valvuloplasty Registry. METHODS AND RESULTS. Extensive baseline procedural
and postprocedural data were tabulated in 674 patients during a 24-month
period. Functional status was captured using standard methods and an
overall functional scoring system. Complications were defined and divided
into procedural, acute (within 24 hours), in-hospital, and within 30 days
of the procedure. The patient population was elderly and symptomatic, with
83% greater than 70 years of age. New York Heart Association functional
class (FC) III or IV congestive heart failure (CHF) was present in 76%,
syncope or presyncope was present in 34%, and Canadian Heart Association
class III or IV angina was present in 23%. Using an overall functional
scoring system (0-100), 54% exhibited scores less than 50. Comorbid disease
was common. Forty-five percent possessed at least one serious noncardiac
disability as a reason for valvuloplasty. Eighty percent of those seen by a
cardiothoracic surgeon were believed inappropriate for aortic valve
replacement. Hemodynamically, the aortic valve area increased from 0.5 +/-
0.2 cm2 to 0.8 +/- 0.3 cm2 (p less than 0.0001), accompanied by a fall in
mean and peak aortic valve gradient from 55 +/- 21 and 65 +/- 28 mm Hg to
29 +/- 13 and 31 +/- 18 mm Hg, respectively (both p less than 0.0001).
Small but significant increases were observed in cardiac output, heart
rate, and mean aortic pressure with minor declines in the pulmonary artery
(PA) systolic and left ventricular (LV) end-diastolic pressure. One hundred
sixty-seven (25%) experienced at least one significant complication within
24 hours, and 211 (31%) experienced a significant complication before
discharge. Complications before hospital discharge included the need for
transfusion (23%), vascular surgery (7%), cerebrovascular accident (3%),
other systemic embolus (2%), myocardial infarction (2%), acute tubular
necrosis (1%), or cardiac surgery (1%). Seventeen (3%) patients died during
the procedure; 16 of those were due to cardiac causes. By hospital
discharge, there was an additional 52 total deaths; 37 were due to
cardiovascular causes. Between hospital discharge and 30 days, 23
additional deaths occurred; 18 were due to cardiac disease. At 30 days,
therefore, there was a grand total of 92 (14%) deaths; 71 (11%) were due to
cardiovascular-related causes. Univariate and logistic regression analysis
of mortality revealed that death was most frequent in patients suffering
multiorgan failure and poor LV systolic function. Thirty-day mortality was
associated with a predefined high-risk subset of hypotension and NYHA class
IV CHF (risk ratio, 4.4), blood urea nitrogen (BUN) greater than 30 mg/dl
(risk ratio, 3.7), use of an antiarrhythmic (risk ratio, 2.9), and cardiac
output less than 3.0 l/min (risk ratio, 2.4). Of the survivors (86%) at 30
days, symptomatic improvement was generally present. Seventy-five percent
experienced at least one functional class improvement in CHF, and 53%
experienced at least a quartile improvement in overall functional status
score. CONCLUSIONS. These data reveal that percutaneous aortic balloon
valvuloplasty in an elderly and debilitated population can be done with low
mortality but substantial morbidity. Mortality is greatest in patients with
multiorgan failure resulting from poor cardiac output. In patients with
reasonably preserved LV function who are otherwise inappropriate surgical
candidates because of comorbid factors, survival and early improvement in
symptomatic status are frequently observed after percutaneous aortic
valvuloplasty.
ARTICLES
Percutaneous balloon aortic valvuloplasty. Acute and 30-day follow-up results in 674 patients from the NHLBI Balloon Valvuloplasty Registry
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