Follow-up recatheterization after balloon aortic valvuloplasty. Mansfield Scientific Aortic Valvuloplasty Registry Investigators

The results of recatheterization were assessed in a select group of 95 patients enrolled in the Mansfield Scientific Aortic Valvuloplasty Registry to determine whether any procedural or patient-related variables at baseline predicted either initial immediate or follow-up (6.2 +/- 3.3 months) results. At the follow-up catheterization, 39 (41%) of the patients were in improved condition and 56 patients (59%) had recurrence of symptoms, allowing for analysis of the effect of the procedure in two symptomatic patient subsets. In the total group the aortic valve area increased initially from 0.56 +/- 0.16 to 0.87 +/- 0.27 cm2 but partial return to the baseline valve area was evident at follow-up (0.63 +/- 0.25 cm2). Similarly, the mean aortic gradient initially decreased from 72 +/- 30 to 35 +/- 16 mm Hg but then increased to 55 +/- 25 mm Hg at follow-up. Neither the initial nor the late hemodynamic results appeared affected by any definable procedural variable at the time of valvuloplasty, including the maximal diameter of balloons, number of balloons simultaneously used, mean inflation time or total number of inflations. Such technical concerns also did not seem to affect short- or long-term outcome. Similarly, no baseline hemodynamic variable clearly separated those who became increasingly symptomatic from those whose condition was improved at the 6 month interval. At recatheterization, a reduction in the aortic valve area toward baseline was observed in 24 (62%) of the 39 improved patients and in 45 (80%) of the 56 who were symptomatic.(ABSTRACT TRUNCATED AT 250 WORDS)     

Patient age and results of balloon aortic valvuloplasty: the Mansfield Scientific Registry experience. The Mansfield Scientific Aortic Valvuloplasty Registry Investigators

Patients enrolled in the Mansfield Scientific Aortic Valvuloplasty Registry were followed up a mean of 7 months after balloon aortic valvuloplasty. Results were compared for patients less than 70, 70 to 79 and greater than or equal to 80 years of age at time of valvuloplasty. As assessed by aortic valve area indexed to body surface area, stenosis was more severe in the older patients and the incidence of congestive heart failure was also greater in those aged greater than or equal to 80 years. The results of valvuloplasty were comparable in all three age groups, and indexed final valve area was not significantly different among the groups. In-hospital mortality ranged from 4.2% to 9.4%, but this and other complications were not significantly different among the groups. Total 7 month mortality was 23%. As performed in this registry study, balloon aortic valvuloplasty produced similar results in older and younger patients, despite initially more severe disease in the older patients.     

Acute catastrophic complications of balloon aortic valvuloplasty. The Mansfield Scientific Aortic Valvuloplasty Registry Investigators

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)     

Balloon aortic valvuloplasty: results of the Valvuloplasty and Angioplasty of Congenital Anomalies Registry

Data from 204 children and infants who underwent aortic balloon valvuloplasty between 1982 and 1986, reported to the Valvuloplasty and Angioplasty of Congenital Anomalies Registry, were reviewed. Valvuloplasty was successful in 192 of 204 children, reducing the peak systolic left ventricular ejection gradient from 77 +/- 2 to 30 +/- 1 mm Hg, p less than 0.001. The same degree of aortic stenosis gradients reduction was noted in both the 38 children under 1 year of age and in the 166 children over 1 year of age. Significant complications included death, aortic regurgitation and femoral artery thrombosis or damage. The incidence of these complications correlated with the age of the child, the ratio of valvuloplasty balloon size/anulus size, or both. The data suggest that percutaneous balloon valvuloplasty provides effective acute relief of valvar aortic stenosis in both infants and children. However, long-term follow-up data are necessary before balloon valvuloplasty can be established as a treatment of choice for congenital valvar aortic stenosis.     

Sex-Specific Predictors of Mortality Following Balloon Aortic Valvuloplasty

BackgroundA differential impact of sex has been observed in balloon aortic valvuloplasty (BAV) outcomes from small observational studies. Accordingly, we sought to compare mortality in men and women undergoing BAV and identify sex-specific predictors of mortality.MethodsThe Nationwide Inpatient Sample was screened for hospitalizations involving adults who underwent BAV between 2006 and 2014. Demographic data and clinical history were recorded. In-hospital mortality and predictors of death after BAV were assessed in men and women.ResultsAmong an estimated national cohort of 18,415 adults undergoing BAV, 8871 (48.2%) were women and 9543 (51.8%) were men. Compared with male patients, women were older, with a lower prevalence of coronary artery disease, prior myocardial infarction, diabetes mellitus, chronic kidney disease, chronic obstructive lung disease, and peripheral arterial disease but a higher rate of hypertension and obesity. In-hospital mortality rates were 6.7% and 9.4% in women and men respectively (p = 0.004). In multivariable regression analysis, female sex was independently associated with lower mortality [odds ratio (OR) 0.73, 95% confidence interval (CI) 0.57–0.93) following BAV. Sex-specific risk-adjusted predictors of mortality included atrial fibrillation in women and younger age, congestive heart failure, chronic kidney disease, and absence of prior myocardial infarction, hypertension, and peripheral arterial disease in men.ConclusionsWomen undergoing BAV had a different risk profile compared to men. Risk-adjusted in-hospital mortality was lower in women, and disparate predictors of risk-adjusted mortality exist in men and women undergoing BAV. Further studies are warranted to determine whether preventive interventions can improve outcomes in both men and women in this high-risk population.     

Balloon pulmonary valvuloplasty: results of the Valvuloplasty and Angioplasty of Congenital Anomalies Registry

Eight hundred twenty-two balloon pulmonary valvuloplasties were reported to the Valvuloplasty and Angioplasty of Congenital Anomalies Registry. Before and after systolic outflow gradients were recorded in 784 valvuloplasties, and the gradient decreased from 71 +/- 33 to 28 +/- 21 mm Hg. The sites of residual obstructions could be ascertained in 196 patients. In these, the total systolic outflow gradients decreased from 85 +/- 41 mm Hg to 33 +/- 27 mm Hg. Of this total residual gradient, 16 +/- 15 mm Hg was transvalvar and 18 +/- 24 mm Hg was infundibular. The degree to which infundibular obstruction subsequently resolved was not determined in this study. The procedure was less effective in reducing outflow gradients in patients with dysplastic valves with or without Noonan's syndrome. There were 5 major complications (0.6%), including 2 deaths (0.2%), a cardiac perforation with tamponade (0.1%) and 2 tricuspid insufficiencies (0.2%). There were 11 minor complications (1.3%) and 21 incidents (2.6%). The incidence of major complications, minor complications and incidents was inversely related to age; it was substantially higher in infants and, in particular, neonates. Balloon pulmonary valvuloplasty is a safe and effective method of lowering pulmonary outflow gradients in infants, children and adults. Small transvalvar and varied infundibular gradients commonly are present at the end of the procedure. Assessing the full effect of the procedure requires intermediate-term follow-up and assessing the duration of relief requires long-term follow-up.     

Balloon angioplasty for aortic recoarctation: results of Valvuloplasty and Angioplasty of Congenital Anomalies Registry

Balloon angioplasty was performed in 200 patients with recoarctation of the aorta in a multicenter prospective study. The average age at the time of the procedure was 7.0 years (range 1 month to 26 years). Systolic pressure (mean +/- standard deviation) in the ascending aorta decreased from 134.5 +/- 23.4 to 127.4 +/- 22.0 mm Hg. The descending aortic systolic pressure rose from 92.7 +/- 18.2 to 114.1 +/- 21.6 mm Hg. Peak systolic pressure differences decreased from 41.9 +/- 19.6 to 13.3 +/- 12.1 mm Hg. The diameter of the recurrent coarctation site increased from 5.2 +/- 2.9 to 8.9 +/- 3.4 mm. After angioplasty residual pressure differences of less than or equal to 20 mm Hg were found in 79.4% of the patients. Five patients died of complications related to the procedure (2.5%). Two deaths were directly related to the technical aspects of the procedure and 3 patients died because of the severity of the underlying disease. One additional patient had a cerebrovascular accident. Femoral artery complications occurred in 17 patients (8.5%) and 8 patients required surgical thrombectomy. Balloon angioplasty offers a satisfactory alternative to surgery for recurrent coarctation; both results and complications compare favorably with surgical therapy.     

Immediate and long-term results of percutaneous balloon aortic valvuloplasty: a report of 33 procedures

The purpose of this study was to evaluate the immediate and long-term clinical and haemodynamic effects of Percutaneous Balloon Aortic Valvuloplasty (PBAV). Thirty-three procedures were performed in 27 patients, 11 males and 16 females with a mean age of 72 years. The peak to peak systolic gradient across the aortic valve decreased by 52%, from 67 ± 24 mmHg to 31 ± 15 mmHg (p< 0.0001) and the aortic valve area increased by 35%, from 0.48 ±0.16 to 0.67 ± 0.21 cm² (p <0.001) after PBAV. There were no procedural deaths. Minor complications occurred in seven patients. Eighty-one per cent of patients (27 procedures) showed immediate symptomatic improvement, five remained symptomatic and one died in hospital before discharge. In a mean follow-up of 17 ± 12 months (range six to 38 months), eight patients died due to congestive cardiac failure, six underwent repeat PBAV, three died due to noncardiac causes and three had recurrent symptoms controlled on medical therapy. Event free survival at 15 months was 43%. In conclusion PBAV produces a satisfactory immediate clinical and haemodynamic result, however, considering the high rate of symptom recurrence, this procedure has a beneficial role only in short-term palliation of severely symptomatic patients who are unable to undergo aortic valve replacement. (Aust NZ J Med 1992; 22: 647ndash;651.)     

Methodologic issues in clinical evaluation of stenosis severity in adults undergoing aortic or mitral balloon valvuloplasty. The NHLBI Balloon Valvuloplasty Registry.

Although both catheterization and Doppler measures of valvular stenosis severity have been validated, each has specific advantages and limitations, particularly in the setting of balloon valvuloplasty. Invasive valve area and mean pressure gradient recorded immediately before and after aortic (n = 589) or mitral (n = 608) catheter balloon valvuloplasty were compared with Doppler valve area and mean pressure gradient recorded less than 30 days before and 24 to 72 hours after the procedure. For aortic stenosis, Doppler valve area ranged from 0.1 to 1.4 cm2 before and 0.2 to 2.3 cm2 after catheter balloon valvuloplasty. Doppler and invasive aortic valve areas differed by less than or equal to 0.5 cm2 in 99% and by less than 0.2 cm2 in 92% of patients. Linear correlation was higher before versus after catheter balloon valvuloplasty, for both valve area (r = 0.49 vs r = 0.35, p = 0.01) and mean pressure gradient (r = 0.64 vs r = 0.50, p = 0.01). Group mean invasive valve area was slightly smaller before (0.50 vs 0.59 cm2, p less than 0.0001) but was not different after (0.80 vs 0.78 cm2, p = 0.16) catheter balloon valvuloplasty. Variables affecting the valve area differences were cardiac output, aortic regurgitation, heart rate and blood pressure. Mean pressure gradient differences were related to echo quality, blood pressure and mitral regurgitation. For mitral stenosis, 2-dimensional echocardiographic valve area ranged from 0.4 to 2.8 cm2 before and 0.7 to 3.8 cm2 after catheter balloon valvuloplasty. Two-dimensional echocardiography and invasive mitral valve areas differed by less than or equal to 0.5 cm2 in 96% and by less than 0.2 cm2 in 81% of cases. Linear correlation was not different before versus after catheter balloon valvuloplasty for two-dimensional echocardiographic valve area (r = 0.40 vs 0.36), pressure halftime valve area (r = 0.31 vs 0.32) or mean pressure gradient (r = 0.55 vs r = 0.46). Group mean 2-dimensional echocardiography and pressure halftime valve areas were larger than invasive valve areas before (1.09 vs 1.02 cm2, p = 0.001) and smaller after (1.71 vs 2.02 cm2, p less than 0.0001) catheter balloon valvuloplasty. Important variables affecting the differences were mitral regurgitation, interatrial shunt, cardiac output and heart rate. Nonsimultaneous studies, differing volume flow measurements, and the underlying accuracy of each technique largely account for discrepancies between these methods. The clinical use of each will depend on its ability to predict long-term patient outcome.     

Balloon Aortic Valvuloplasty in the First Year of Life

Between February 1988 and September 1993 balloon aortic valvuloplasty was attempted in 33 consecutive patients in the first year of life: 20 patients (61%) were younger than J month. Major associated anomalies such as mitral stenosis, coarctation, and hypoplastic left ventricle were found in 11 cases (33%). The balloon dilation of the aortic valve was accomplished through the right carotid cut-down approach in neonates and patients with body weight < 5 kg, through a percutaneous femoral approach in the others; the procedure was completed in all. The peak systolic gradient across the aortic valve measured at catheterization fell from 80 ± 33 mmHg (range 25–165) before the dilation to 27 ± 17 mmHg (range 0–65), afterwards (P < 0.0001). The left ventricular ejection fraction increased from 44%± 26% to 61%± 17%, 24–48 hours after the procedure (P < 0.0001). Aortic insufficiency developed in 17 cases, being moderate in 2, mild in 6, and trivial in 9. Seven patients (21%), all in the first month of life, died within 30 days from the valvuloplasty; major associated anomalies were present in six; the death was due to a procedure related complication in one. No mortality was observed among the patients undergoing valvuloplasty beyond the first month of life. On follow-up (6 months to 6 years) aortic restenosis occurred in 3 cases; 1 was treated by surgical valvotomy, 2 by repeat balloon valvotomy; in another 2 cases, a subvalvular aortic obstruction developed and was relieved by surgical resection. There was no late mortality. Thus, balloon valvuloplasty appears to be an effective palliation for critical aortic stenosis in infancy. Early mortality is mainly related to associated anomalies.     

Balloon aortic valvuloplasty: the Texas Heart Institute experience

Between October 1986 and January 1989, 73 percutaneous catheter balloon aortic valvuloplasty procedures were performed in 68 adult patients (32 men and 36 women; mean age, 77 +/- 9 years) with severe symptomatic aortic stenosis. Following the procedures, significant improvements were documented in aortic valve area, mean transvalvular pressure gradient, peak-to-peak pressure gradient, left ventricular systolic pressure, radionuclide ejection fraction, and left ventricular end-systolic volume index. There were no procedure-related deaths, but 2 patients (3%) required emergency surgery for acute aortic regurgitation. During hospitalization, 4 patients had persistent symptoms (3 died; 1 subsequently underwent repeat valvuloplasty and later, valve replacement). Short-term clinical improvement was noted in 59 of 65 patients (91%). During the follow-up period (mean, 11.6 +/- 8.4 months), 22 patients died (including the 3 who died during hospitalization). Sixteen underwent aortic valve replacement (including the 2 who underwent emergency aortic valve replacement); all 16 are alive. A total of 6 patients (1 with an initial balloon aortic valvuloplasty at an outside institution) underwent repeat valvuloplasty; of those, 4 subsequently underwent aortic valve replacement, and 2 died. Of the remaining 30 patients, 27 continue to experience relief of symptoms, and 3 have clinical symptoms that have not improved or have worsened since the valvuloplasty procedure. Multivariate predictors of clinical outcome (p<0.05) included post-valvuloplasty aortic valve area, pre- and post-valvuloplasty ejection fraction, absence of coronary artery disease, and absolute change in valve area. Overall actuarial and event-free survivals were 83% and 49%, respectively, at 1 year. Although clinical improvement is frequently noted after balloon aortic valvuloplasty, the procedure is associated with a high recurrence of symptoms and restenosis. Balloon aortic valvuloplasty is at best a palliative procedure; when feasible, surgical valve replacement is the more definitive therapy.     

Aortic annular tear after valvuloplasty: the role of aortic annulus echocardiographic measurement

Following percutaneous transluminal aortic valvuloplasty, 2/100 patients (2%) developed significant aortic insufficiency as a result of an aortic annular tear. Both patients underwent emergency aortic valve replacement and survived the operation. One patient died 4 weeks postoperatively from sepsis and multiorgan failure, and the other patient had a benign postoperative course. In both cases, the balloon area significantly exceeded the aortic annular area and caused the complication. Review of the balloon area-aortic annular area ratio in our series showed that a value of less than 1.2 was not associated with this complication.     

Contemporary Use of Balloon Aortic Valvuloplasty in the Era of Transcatheter Aortic Valve Implantation

The development of transcatheter aortic valve implantation (TAVI) has increased the use of balloon aortic valvuloplasty (BAV) in treating aortic stenosis. We evaluated our use of BAV in an academic tertiary referral center with a developing TAVI program.We reviewed 69 consecutive stand-alone BAV procedures that were performed in 62 patients (mean age, 77 ± 10 yr; 62% men; baseline mean New York Heart Association functional class, 3 ± 1) from January 2009 through December 2012. Enrollment for the CoreValve^® clinical trial began in January 2011. We divided the study cohort into 2 distinct periods, defined as pre-TAVI (2009–2010) and TAVI (2011–2012). We reviewed clinical, hemodynamic, and follow-up data, calculating each BAV procedure as a separate case.Stand-alone BAV use increased 145% from the pre-TAVI period to the TAVI period. The mean aortic gradient reduction was 13 ± 10 mmHg. Patients were successfully bridged as intended to cardiac or noncardiac surgery in 100% of instances and to TAVI in 60%. Five patients stabilized with BAV subsequently underwent surgical aortic valve replacement with no operative deaths. The overall in-hospital mortality rate (17.4%) was highest in emergent patients (61%).The implementation of a TAVI program was associated with a significant change in BAV volumes and indications. Balloon aortic valvuloplasty can successfully bridge patients to surgery or TAVI, although least successfully in patients nearer death. As TAVI expands to more centers and higher-risk patient groups, BAV might become integral to collaborative treatment decisions by surgeons and interventional cardiologists.     

Serial evaluation of ventricular function after percutaneous aortic balloon valvuloplasty

To evaluate the serial changes in right and left ventricular performance after percutaneous aortic balloon valvuloplasty, 15 patients, mean age 75 +/- 18 years, and in New York Heart Association (NYHA) class III, were studied with first-pass radionuclide angiocardiography (RNA) immediately before, then 5 minutes, 2 hours, 4 hours, 6 hours, and 3 days after valvuloplasty. No change was observed in heart rate, aortic root systolic pressure, Fick, or RNA cardiac output, amount of aortic insufficiency measured either angiographically or with the regurgitant fraction determination immediately after valvuloplasty. However, significant changes were observed in the peak-to-peak aortic valve gradient (63 to 35 mm Hg; p less than 0.001), mean aortic valve gradient (54 to 33 mm Hg; p less than 0.001), aortic valve area (0.60 to 0.90 cm2; p less than 0.001), and meridional wall stress (79 to 50 10(3) dynes/cm2; p less than 0.01) immediately following valvuloplasty. In addition, left ventricular end-diastolic volume decreased from 186 to 153 ml (p less than 0.001), end-systolic volume decreased from 114 to 86 ml (p less than 0.001), micromanometric left ventricular end-diastolic pressure decreased from 20 to 14 mm Hg (p less than 0.02), and left ventricular ejection fraction increased from 0.39 to 0.45 (p less than 0.001). Peak positive left ventricular dP/dt and end-systolic pressure-volume ratio did not change after valvuloplasty (1700 to 1550 mm Hg/sec, 2.1 to 2.5 mm Hg/ml, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)     

Usefulness of noninvasive assessment of aortic stenosis before and after percutaneous aortic valvuloplasty

Noninvasive and catheterization studies were performed in 40 patients (mean age 76 +/- 12 years) before and after percutaneous aortic valvuloplasty. Measurements included time to 1/2 carotid upstroke, left ventricular ejection time, aortic valve excursion, mean aortic valve gradient and aortic valve area assessed using the continuity equation: aortic valve area = A X V/V1, where A = left ventricular outflow tract area, V = maximal left ventricular outflow tract velocity assessed by pulsed Doppler echocardiography and V1 = peak velocity in the aortic stenotic jet assessed using continuous-wave echocardiography. In addition, mitral regurgitation was assessed by pulsed Doppler mapping techniques. Mean aortic valve gradient, cardiac output and aortic valve area, calculated using the Gorlin formula, were determined at cardiac catheterization. There were significant correlations between Doppler and catheterization measurements of aortic valve area both before (r = 0.71, p less than 0.001) and after (r = 0.85, p less than 0.0001) valvuloplasty. The relations were demonstrated to be linear by F test and met criteria for identity. There were significant increases (all p less than 0.0005) after valvuloplasty in catheterization valve area (0.60 +/- 0.21 to 0.95 +/- 0.39 cm2), Doppler valve area (0.64 +/- 0.22 to 0.91 +/- 0.37 cm2), valve excursion (0.5 +/- 0.3 to 0.8 +/- 0.3 cm) and cardiac output (4.5 +/- 1.6 to 4.9 +/- 1.7 liter/min).(ABSTRACT TRUNCATED AT 250 WORDS)