Patients Undergoing Balloon Aortic Valvuloplasty Research Articles

Use of Machine Learning to Develop Prediction Models for Mortality and Stroke in Patients Undergoing Balloon Aortic Valvuloplasty

ObjectiveTo develop an artificial intelligence, machine learning prediction model for estimating in-hospital mortality and stroke in patients undergoing balloon aortic valvuloplasty (BAV). MethodsThe National Inpatient Sample (NIS) database was used to identify patients who underwent BAV from 2005 to 2017. Outcomes analyzed were in-hospital all-cause mortality and stroke after BAV. Predictors of mortality and stroke were selected using LASSO regularization. A conventional logistic regression and a random forest machine learning algorithm were used to train the models for predicting outcomes. The performance of all the modeling algorithms for predicting in-hospital mortality and stroke was compared between models using c-statistic, F1 score, brier score loss, diagnostic accuracy, and Kolmogorov-Smirnov plots. ResultsA total of 6962 patients with severe aortic stenosis who underwent BAV were identified. The performance of random forest classifier was comparable with logistic regression for predicting in-hospital mortality for all measures of performance (F1 score 0.422 vs 0.409, ROC-AUC 0.822 [95 % CI 0.787–0.855] vs 0.815 [95 % CI 0.779–0.849], diagnostic accuracy 70.42 % vs 70.93 %, KS-statistic 0.513 vs 0.494 and brier score loss 0.295 vs 0.291). The random forest algorithm significantly outperformed logistic regression in predicting in-hospital stroke with respect to all performance metrics: F1 score 0.225 vs 0.095, AUC 0.767 [0.662–0.858] vs 0.637 [0.499–0.754], brier score loss [0.399 vs 0.407], and KS-statistic [0.465 vs 0.254]. ConclusionsThe good discrimination of machine learning models reveal the potential of artificial intelligence to improve patient risk stratification for BAV.

Balloon Aortic Valvuloplasty in the Era of Transcatheter Aortic Valve Implantation - A Review of Complications, Mortality and Destination Therapy

Aims: To review the complications, mortality and destination therapy of patients undergoing balloon aortic valvuloplasty (BAV) in the era of transcatheter aortic valve implantation (TAVI). Methods: A systematic literature search identified journal articles reporting the outcomes of adult patients undergoing BAV procedures. Cohorts of 50 or more patients undergoing BAV between January 2002 and May 2018 were included in the review. Patient baseline characteristics, surgical risk scores, complications, short- and long-term mortality and reported destination therapy were extracted and aggregated, with estimated mean and standard deviation weighted by cohort size. Results: A total of 29 papers were included, describing the outcomes of 9,602 patients. The mean age of the patient cohorts was 82.3 ± 1.3 years. 51.6% of the patients were female and the mean STS score was 12.3 ± 3.2. The rates of stroke, myocardial infarction, major vascular complications and greater than BARC 2 bleeding post-BAV were 1.2% ± 0.7, 1.2% ± 1.5, 2.4% ± 1.1 and 8.9% ± 2.2 respectively. Periprocedural and intrahospital mortality rates were 1.7% ± 2.8 and 7.0% ± 4.2. Mortality rates at 30 days and 12 months were 7.7% ± 6.0 and 34.4% ± 12.7. Reported rates of patients undergoing TAVI, surgical aortic valve replacement or medical management post-BAV were 17.2% ± 12.1, 4.9% ± 4.0 and 77.0% ± 14.0. Conclusions: Short and medium-term outcomes following BAV are similar to contemporary cohorts undergoing TAVI. The vast majority of patients do not proceed to further intervention, with BAV being their destination therapy. The clinical and economic impact of such practice in the era of TAVI requires further study.

Acute Success of Balloon Aortic Valvuloplasty in the Current Era: A National Cardiovascular Data Registry Study

ObjectivesThe aim of this study was to evaluate practice patterns and outcomes of a contemporary group of patients undergoing balloon aortic valvuloplasty (BAV) for congenital aortic stenosis (AS). BackgroundBAV is the most common treatment for isolated congenital AS. MethodsWithin the IMPACT (Improving Pediatric and Adult Congenital Treatments) Registry, all BAV procedures performed between January 2011 and March 2015 were identified. Procedures were separated into those performed for critical versus noncritical AS. Outcomes were stratified into optimal, adequate, and inadequate, with optimal and adequate outcomes defining “successful” procedures. Multivariate logistic regression was used to identify patient and procedural characteristics associated with unsuccessful BAV. Mortality and adverse events rates were compared across patient cohorts. ResultsOf the 1,026 isolated BAV procedures captured in IMPACT, 718 (70%) were “successful.” Success rates were 70.9% for noncritical AS (n = 916) and 62.7% for critical AS (n = 110). Multivariate analysis revealed that prior cardiac catheterization, mixed valve disease, baseline aortic valve gradient >60 mm Hg, baseline aortic insufficiency greater than mild, presence of a trainee, and multiple balloon inflations were associated with unsuccessful BAV in the noncritical AS cohort. There were no factors associated with unsuccessful procedures in the critical AS group. No procedural deaths occurred, but 2.4% of patients did not survive to hospital discharge. Adverse events occurred in 15.8% of all cases and were more frequent in procedures performed for critical AS (30.0% vs. 14.1%; p < 0.001). ConclusionsBAV is an effective treatment for congenital AS with low rates of mortality and adverse events. Patients with critical AS have a higher risk for procedure-related adverse events.

Outcomes of hemodynamic support with Impella in very high-risk patients undergoing balloon aortic valvuloplasty: Results from the Global cVAD Registry

BackgroundReports on the role of hemodynamic support devices in patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction undergoing balloon aortic valvuloplasty (BAV) are limited. MethodsPatients were identified from the cVAD registry, an ongoing multicenter voluntary registry at selected sites in North America that have used Impella in >10 patients. ResultsA total of 116 patients with AS who underwent BAV with Impella support were identified. Mean age was 80.41±9.03years and most patients were male. Mean STS score was 18.77%±18.32, LVEF was 27.14%±16.07, and 42% underwent concomitant PCI. In most cases Impella was placed electively prior to BAV, whereas 26.7% were placed as an emergency. The two groups had similar baseline characteristics except for higher prevalence of CAD and lower LVEF in the elective group, and higher STS score in the emergency group. Elective strategy was associated higher 1-year survival compared to emergency placement (56% vs. 29.2%, p=0.003). One-year survival was higher when BAV was used as a bridge to definitive therapy as opposed to palliative treatment (90% vs. 28%, p<0.001). On multivariate analysis, STS score and aim of BAV (bridge to definitive therapy vs. palliative indication) were independent predictors of mortality. ConclusionIn this large cohort of patients with AS and severe LV dysfunction undergoing BAV, our results demonstrates feasibility and promising long-term outcomes using elective Impella support with the intention to bridge to a definitive therapy.

CRT-800.29 Impact of Atrial Fibrillation and Flutter on Clinical Outcomes in Patients Undergoing Balloon Aortic Valvuloplasty

Cardiovascular risk in patients with advanced aortic stenosis (AS) remains substantial following treatment with balloon aortic valvuloplasty (BAV). While concomitant atrial fibrillation or flutter (AF/AFL) is frequent among patients with AS, the impact of AF/AFL on outcomes following BAV remains

IMPACTS OF THE SYSTEMIC RIGHT VENTRICULAR TRABECULAE AND PAPILLARY MUSCLES ON VOLUMES AND FUNCTION ASSESSED BY NOVEL MAGNETIC RESONANCE ALGORITHM

BACKGROUND: Procedural rapid ventricular pacing (RVP) and transoesophageal echocardiography (TOE) guidance have been well established in the transcatheter aortic valve replacement field. However, scarce data exist on the use of these techniques for transcatheter treatment of congenital aortic stenosis. METHODS: Charts of all patients undergoing balloon aortic valvuloplasty from January 1995 to January 2015 at the Centre Hospitalier de l’Universite Laval in Quebec City were reviewed. Statistical analyses between groups were done by univariate studies. Cox regression analysis was used to evaluate factors influencing freedom from surgery. RESULTS: Sixty-one patients (37 males; 24 females) with a mean age of 7.2 11.5 years and a mean gradient of 58 21 mmhg underwent 71 balloon aortic valvuloplasty. The mean follow-up period is 4.9 4.9 years. Fourteen balloon valvuloplasty (19.7%) were done on patients <1 month and 22 (31%) on patients between 1 month and 1 year of age. Twenty-six procedures (37%) were on patients with associated left sided lesions, fibroelastosis or pulmonary stenosis (2 patients). Three patients had an aortic valve Z-score h -2. At last follow-up, 20 (32%) patients have required surgery: 8 for aortic insufficiency, 9 for residual stenosis and 2 for a mixed lesion. Since August 2006, rapid pacing has been used in 20 procedures, which represents 28% of the overall cohort and 82% of the procedures done after 08-2006. The use of rapid pacing was associated with a shorter procedure time (112 11 vs 79 5 min p1⁄40.008), and a tendency towards requiring less surgical intervention on follow-up (p1⁄40.08). Since January 2004, determination of balloon diameter has relied on valve annulus measurement done per procedure by TOE (40/51 procedures; 78%). The use of TOE was associated with less complications (7 vs 32% p1⁄40.01). Significant aortic insufficiency, on early follow up transthoracic echocardiogram, was the only predictor of the need of a surgical aortic procedure at median term follow-up (p1⁄40.002). CONCLUSION: The use of TOE guidance and RVP improved the results of balloon aortic valvuloplasty in congenital patients. This may have a major impact on the need for surgical procedures in these patients. Larger studies with a longer follow-up are needed to confirm these results. 059 IMPACTS OF THE SYSTEMIC RIGHT VENTRICULAR TRABECULAE AND PAPILLARY MUSCLES ON VOLUMES AND FUNCTION ASSESSED BY NOVEL MAGNETIC RESONANCE ALGORITHM

CRT-810 Contemporary Outcomes of Patients Undergoing Balloon Aortic Valvuloplasty who were Initially Excluded from Transcatheter Aortic Valve Replacement

The utilization of balloon aortic valvuloplasty (BAV) as a bridge therapy to transcatheter aortic valve replacement (TAVR) in addition to its well established use in palliative therapy for patients not eligible for TAVR has become widespread in recent years. We sought to understand the contemporary

CRT-710 Gender Differences in Clinical Presentation, and Outcomes of Patients Undergoing Balloon Aortic Valvuloplasty

Balloon aortic valvuloplasty (BAV) is being used more and more as a bridging procedure to more definitive surgery or TAVR. The present study aims at evaluating the gender differences in clinical characteristics and outcomes of patients undergoing BAV in TAVR era. From April 2009 to August 2012, the

Left ventricular end‐diastolic pressure as an independent predictor of outcome during balloon aortic valvuloplasty

In this study, we examined the predictive value of the left ventricular end-diastolic pressure (LVEDP) in patients undergoing balloon aortic valvuloplasty (BAV). The LVEDP is a useful indicator of hemodynamic status in patients with severe aortic stenosis. In BAV, decompensated heart failure is associated with worse outcomes. We identified all consecutive patients with severe symptomatic aortic stenosis who underwent retrograde BAV at the Massachusetts General Hospital from 2004 to 2008. Patients were stratified and compared according to their baseline LVEDP into ≤15 mm Hg, 16-20 mm Hg, 21-25 mm Hg, and ≥26 mm Hg. Procedural and in-hospital outcomes and adverse events were compared. Multivariate logistic regression was used for the adjusted analysis. A total of 111 patients with a mean age of 83±11 years underwent BAV. Of these, the LVEDP was ≤15 mm Hg in 29 (26%), 16-20 mm Hg in 41 (37%), 21-25 mm Hg in 16 (14%), and ≥26 mm Hg in 25 (23%) patients. Baseline characteristics were similar among the four groups. Noticeably, patients with high LVEDP levels had significantly higher rates of the combined endpoint of in-hospital death, myocardial infarction (MI), cardiopulmonary arrest, and tamponade was P = 0.02. Periprocedural MI was more common among those with higher LVEDP (16% vs. 2.3%; P = 0.04). Multivariate analysis revealed LVEDP (OR 1.08, for each mm Hg increase in pressure, 95 % CI 1.02-1.14), small LV chamber size, and New York Heart Association class as independent predictors of adverse outcomes. The LVEDP is an important independent predictor of poor in-hospital outcome during BAV. In these patients, the immediate hemodynamic status may be more important than the baseline left ventricular systolic function. Hemodynamic optimization before or during BAV should be considered and may be beneficial.

Abstract 18793: Impact of Chronic Kidney Disease on Outcomes in Patients Undergoing Balloon Aortic Valvuloplasty: Results from the BRAVO Study

Background Balloon aortic valvuloplasty (BAV) is a palliative treatment for severe aortic stenosis that is increasingly performed as a bridge to transcatheter aortic valve replacement. While chronic kidney disease (CKD) is a frequent comorbidity in elderly patients with aortic stenosis undergoing BAV, its impact on in-hospital outcomes has not yet been determined. Methods We conducted a retrospective analysis of 421 consecutive patients who underwent non-emergent BAV at two high-volume centers. We analyzed baseline and procedural characteristics as well as in-hospital outcomes according to the presence or absence of CKD, defined as a glomerular filtration rate of &lt;60 mL/min/1.73m 2 . All adverse events were adjudicated by a blinded, independent clinical events committee. Results Of the 421 patients who underwent BAV, 251 (59.2%) had CKD. Patients with CKD had significantly higher rates of mortality (8.0% vs. 2.4%, p=0.02) and major bleeding (14.3% vs. 7.6%, p=0.04) as well as net adverse clinical events (18.7% vs. 11.2%, p=0.04) compared to patients without CKD. A secondary analysis stratifying the groups by type of antithrombotic used revealed an almost 3-fold decrease in major bleeding events in CKD patients treated with bivalirudin compared to those receiving heparin (5.8% vs. 14.9%, p=0.01). After multivariate analysis controlling for multiple confounders, CKD remained associated with an increased risk for bleeding (OR 1.99; 95%CI [0.83, 4.78]; p=0.12) and death (OR 2.12; 95%CI [0.61, 7.33]; p=0.24), without statistical significance. Conclusions CKD is associated with an increased risk of in-hospital mortality and bleeding complications post-BAV. Further research is warranted to determine whether adverse outcomes in CKD patients can be reduced through selective use of novel devices or alternative pharmacological approaches.

TCT-886 Predictors of Vascular complications in patients undergoing Balloon Aortic Valvuloplasty

TCT-886 Predictors of Vascular complications in patients undergoing Balloon Aortic Valvuloplasty

Efficacy and Safety of Bivalirudin Compared to Unfractionated Heparin Among Patients Undergoing Balloon Aortic Valvuloplasty: a Two-Center Registry

Efficacy and Safety of Bivalirudin Compared to Unfractionated Heparin Among Patients Undergoing Balloon Aortic Valvuloplasty: a Two-Center Registry

TCT-179: Efficacy and Safety of Bivalirudin Compared to Unfractionated Heparin in Relation to the Use of “Preclose” Technique Using the Perclose Vascular Closure Device Among Patients Undergoing Balloon Aortic Valvuloplasty

TCT-179: Efficacy and Safety of Bivalirudin Compared to Unfractionated Heparin in Relation to the Use of “Preclose” Technique Using the Perclose Vascular Closure Device Among Patients Undergoing Balloon Aortic Valvuloplasty

Severity of aortic stenosis, not STS score, predicts procedural mortality in elderly patients undergoing balloon aortic valvuloplasty

Severity of aortic stenosis, not STS score, predicts procedural mortality in elderly patients undergoing balloon aortic valvuloplasty

Characterization and outcome of patients with severe symptomatic aortic stenosis referred for percutaneous aortic valve replacement

Many high-risk patients with severe symptomatic aortic stenosis are not referred for surgical aortic valve replacement. Although this patient population remains ill-defined, many of these patients are now being referred for percutaneous aortic valve replacement. We sought to define the characteristics and outcomes of patients referred for percutaneous aortic valve replacement. Between February 2006 and March 2007, 92 patients were screened for percutaneous aortic valve replacement. Clinical and echocardiographic characteristics of patients undergoing surgical aortic valve replacement, percutaneous aortic valve replacement, balloon aortic valvuloplasty, or no intervention were compared. The primary end point was all-cause mortality. Nineteen patients underwent successful surgical aortic valve replacement, 18 patients underwent percutaneous aortic valve replacement, and 36 patients had no intervention. Thirty patients underwent balloon aortic valvuloplasty, and of these, 8 patients were bridged to percutaneous aortic valve replacement and 3 were bridged to surgical aortic valve replacement. Of the remaining 19 patients undergoing balloon aortic valvuloplasty, bridging to percutaneous aortic valve replacement could not be accomplished because of death (n = 9 [47%)], exclusion from the percutaneous aortic valve replacement protocol (n = 6 [32%]), and some patients improved after balloon aortic valvuloplasty and declined percutaneous aortic valve replacement (n = 4 [21%]). The most common reasons for no intervention included death while awaiting definitive treatment (n = 10 [28%]), patient uninterested in percutaneous aortic valve replacement (n = 10 [28%]), and questionable severity of symptoms or aortic stenosis (n = 9 [25%]). Patients not undergoing aortic valve replacement had higher mortality compared with those undergoing aortic valve replacement (44% vs 14%) over a mean duration of 220 days. Symptomatic patients with severe aortic stenosis have high mortality if timely aortic valve replacement is not feasible. Twenty percent of the patients referred for percutaneous aortic valve replacement underwent surgical aortic valve replacement with good outcome. Patients undergoing balloon aortic valvuloplasty alone or no intervention had unfavorable outcomes.

Use of a percutaneous arterial suture device (Perclose) in patients undergoing percutaneous balloon aortic valvuloplasty.

Percutaneous balloon aortic valvuloplasty has been used as a therapeutic option for patients with severe aortic stenosis who are not candidates for aortic valve replacement. This procedure has been limited by both the high rate of aortic valve restenosis and high procedural morbidity related chiefly to the large femoral arteriotomies required. The purpose of this study was to assess the feasibility and vascular complication rate using the "Preclose" technique in patients undergoing balloon aortic valvuloplasty. We evaluated the immediate and 30-day results in 18 consecutive patients undergoing this procedure. Angiographically significant peripheral vascular disease was present in 39% of cases. Aortic balloon dilation produced significant decreases in the mean aortic valve pressure gradient from 55 +/- 20 mmHg to 30 +/- 22 mmHg (P < 0.001). Closure of the arteriotomy with an 8F (10F in 1 case) Perclose device led to immediate hemostasis in all patients. Perclose of the contralateral femoral arterial site with a 6F device was attempted in 50%, all of which were successful. The mean length of bed rest was 4.5 +/- 0.9 hr. No procedural was observed. No patient had a local vascular complication, and no patient required blood product transfusion after the procedure. The use of the "Preclose" technique for closure of femoral arteriotomies after balloon aortic valvuloplasty is feasible and associated with a low rate of periprocedural and short-term vascular complications.

Balloon aortic valvuloplasty in adults: Failure of procedure to improve long-term survival

This study sought to determine the long-term outcome of adult patients undergoing percutaneous balloon aortic valvuloplasty. Percutaneous balloon aortic valvuloplasty has been offered as an alternative to aortic valve replacement for selected patients with valvular aortic stenosis. Although balloon aortic valvuloplasty produces an immediate reduction in the transvalvular aortic gradient, a high incidence of restenosis frequently leads to recurrent symptoms. Therefore, it is unclear whether balloon aortic valvuloplasty impacts on the long-term outcome of these patients. Clinical, hemodynamic and echocardiographic data were collected at baseline in 165 patients undergoing balloon aortic valvuloplasty and examined for their ability to predict long-term outcome. The median duration follow-up was 3.9 years (range 1 to 6). Ninety-nine percent follow-up was achieved. During this 6-year period, 152 patients (93%) died or underwent aortic valve replacement, and 99 (60%) died of cardiac-related causes. The probability of event-free survival (freedom from death, aortic valve replacement or repeat balloon aortic valvuloplasty) 1, 2 and 3 years after valvuloplasty was 40%, 19% and 6%, respectively. In contrast, the probability of survival 3 years after balloon aortic valvuloplasty in a subset of 42 patients who underwent subsequent aortic valve replacement was 84%. Survival after aortic valvuloplasty was poor regardless of the presenting symptom, but patients with New York Heart Association functional class IV congestive heart failure had events earliest. Univariable predictors of decreased event-free survival were younger age, advanced congestive heart failure symptoms, lower ejection fraction, elevated left ventricular end-diastolic pressure, presence of coronary artery disease and increased left ventricular internal diastolic diameter. Stepwise multivariable logistic regression analysis found that only younger age and a lower left ventricular ejection fraction contributed independent adverse prognostic information (chi-square 14.89, p = 0.0006). Long-term event-free and actuarial survival after balloon aortic valvuloplasty is dismal and resembles the natural history of untreated aortic stenosis. Aortic valve replacement may be performed in selected subjects with good results. However, the prognosis for the remainder of patients who are not candidates for aortic valve replacement is particularly poor.

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 < 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 < 0.0001) and a significant increase (p < 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 < 0.0001) and pulmonary capillary wedge pressure decreased (p < 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 < 0.001). When the 88 patients with findings compatible with mild or more severe degrees of mitral regurgitation were considered separately, mitral regurgitant score decreased from 1.8 ± 0.7 to 1.5 ± 0.8 (p < 0.0001). Of the 49 patients with Doppler patterns of moderate or severe mitral regurgitation before dilation, regurgitant score decreased in 38, remained unchanged in 8 and increased (by only 0.5 grade) in 3. In these patients, mean pulmonary capillary wedge pressure decreased from 22 to 19 mm Hg (p < 0.001).This study shows that mitral regurgitation is common in adult patients undergoing balloon aortic valvuloplasty, that it is weakly and inversely correlated with left ventricular ejection fraction, aortic valve area and left ventricular systolic pressure and that its severity decreases after balloon aortic valvuloplasty. A decrease in the severity of mitral regurgitation may be an important mechanism for symptomatic improvement after aortic valvuloplasty.