Retrograde Balloon Aortic Valvuloplasty Research Articles

The safety and feasibility of retrograde balloon aortic valvuloplasty using the INOUE-BALLOON with severe aortic stenosis.

In the transcatheter aortic valve implantation (TAVI) era, the indications for balloon aortic valvuloplasty (BAV) are increasing. Previously, the INOUE-BALLOON® (IB) was used only for antegrade BAV, but recently, it has also been used for retrograde BAV. However, the safety and feasibility of retrograde BAV using an IB are not fully understood. In this study, we investigated the safety and feasibility of retrograde BAV using an IB in elderly Japanese patients with severe aortic stenosis (AS). We compared 39 cases of retrograde BAV using an IB performed from June 2018 to September 2020 and 34 cases of antegrade BAV using an IB performed from August 2013 to May 2018. The total number of complications was lower in retrograde BAV than in antegrade BAV (p = 0.020). The procedure time was significantly shorter in retrograde BAV than in antegrade BAV (p < 0.001), and the maximum balloon size and number of balloon inflations were smaller in retrograde BAV than in antegrade BAV (p = 0.002 and p < 0.001, respectively). There was no significant difference in the degree of improvement in the aortic valve area or ejection fraction between retrograde and antegrade BAV. In conclusion, the present study showed the safety and feasibility of retrograde BAV using an IB in elderly Japanese patients with severe AS compared with antegrade BAV using an IB.

Safety and feasibility of retrograde INOUE-BALLOON for balloon aortic valvuloplasty without rapid ventricular pacing during transcatheter aortic valve replacement

Rapid ventricular pacing (RVP) is commonly employed during transcatheter aortic valve replacement (TAVR); however, frequent TAVR is associated with worse prognoses. The retrograde INOUE-BALLOON® (IB) allows balloon aortic valvuloplasty (BAV) without RVP. The aim of this study was to evaluate the feasibility of retrograde IB for TAVR preparation. The study population included 178 consecutive patients (mean age, 84 ± 5 years; male, 47%) who underwent retrograde BAV before prosthetic valve replacement via the transfemoral approach. Patients were divided into a retrograde IB group without RVP (n = 74) and a conventional balloon (CB) group with RVP (n = 104). The primary endpoint was prolonged hypotension after BAV (reduced systolic pressure < 80 mmHg for over 1 min or vasopressor drug requirement). The incidence of prolonged hypotension after BAV was significantly lower in the IB group compared with the CB group (4% vs. 16%, p = 0.011). Balloons were able to penetrate and expand the aortic valve in both groups. RVP was used less for total TAVR in the IB group compared with the CB group. The aortic valve area-index after BAV was not significantly different between the two groups (0.72 ± 0.14 cm2/m2 vs. 0.71 ± 0.12 cm2/m2; p = 0.856). Multivariate analysis demonstrated that IB use was associated with avoidance of prolonged hypotension (OR, 0.27 [0.059–0.952]; p = 0.041). In conclusion, BAV using retrograde IB without RVP is both safe and feasible. More stable hemodynamics were achieved using retrograde IB by avoiding RVP during TAVR.

Safety and feasibility of retrograde inoue balloon for balloon aortic valvuloplasty without rapid ventricular pacing during transcatheter aortic valve implantation

Abstract Background Although rapid ventricular pacing (RVP) is commonly performed for preparation of transcatheter aortic valve implantation (TAVI). It has been reported that multiple and / or prolonged RVP is associated with adverse clinical outcomes of TAVI. Retrograde Inoue-Balloon was designed for balloon aortic valvuloplasty (BAV) without RVP to prevent slip of balloon by way of central waist during biphasic inflation. Purpose The purpose of this study was to evaluate safety and feasibility of Retrograde Inoue-Balloon for TAVI preparation. Methods From December 2013 to December 2019, 427 consecutive patients who performed TAVI for severe aortic valve stenosis, were retrospectively enrolled in Iwate Medical University. Of them, 227 (53%) patients (mean age 83±5 years, male 41%), underwent retrograde BAV before prosthetic valve implantation, comprised this study population. Retrograde BAV procedures were divided into two groups; patients used Inoue-Balloon without RVP and those did conventional balloon with RVP. The primary endpoint was defined as combined adverse events of 30-day mortality, cerebral infarction, and critical complications after BAV (aortic dissection, aortic rupture and cardiopulmonary arrest). The secondary endpoint was set as prolonged hypotension after BAV. Result Inoue-Balloon (IB) and conventional balloon (CB) were used for 73 patients (32%) and 154 (68%) patients, respectively. Both balloons were succeeded to through and expand of aortic valve in all cases. In the CB group, cardiopulmonary arrest occurred in 2.0% after BAV, cerebral infarction was observed in 3.9%, and 30-day death in 3.3%. On the other hand, no major complications were observed except one aortic dissection in the IB group. In logistic regression analysis adjusted by sex and age, the incidence of combined adverse events was significantly lower in the IB group (OR 0.17, 95% CI 0.009–0.917, P=0.037). Furthermore, the IB group had significantly a lower incidence of prolonged hypotension following BAV compared with CB group (4.1% vs 19.5%, p=0.002). Conclusion Balloon aortic valvuloplasty using retrograde Inoue-balloon without rapid ventricular pacing is safe and feasible, and may improve clinical outcomes of TAVI. Funding Acknowledgement Type of funding source: None

Predictors of early restenosis after intracardiac echocardiography guided antegrade balloon aortic valvuloplasty in high-risk or inoperable patients.

Antegrade balloon aortic valvuloplasty (BAV) may be more effective than retrograde BAV. However, early restenosis is found inconstantly within three months after BAV. To evaluate the factor of ER after intracardiac echocardiogram (ICE) guided Antegrade BAV, fifty patients with severe aortic stenosis (AS) underwent BAV procedures with ICE. ER was defined as mean aortic valve pressure gradient (PG) >40mmHg. During one-year follow-up period, 6 patients died and 2 patients underwent aortic valve replacement. ER was present in 13 patients (26%) at three months after BAV. Procedural, clinical, and hemodynamic data were collected. The mean age of the patient population was 85.4±7.6years; the mean STS score and EuroSCORE were 7.8±1.1 and 14.6±4.1, respectively. The mean aortic valve PG decreased from 63.4±19.8 to 28.5±10.1mmHg (p<0.0001). Baseline characteristics were similar between the two groups. There is no significant difference of mean aortic valve PG immediate after BAV(ER; 29±8.8mmHg, nonER; 21±6.1mmHg, p=ns). Univariate analysis showed patients with ER group had significantly higher rate of left ventricular hypertrophy, pulmonary hypertension, and high mean aortic valve PG at admission. Multivariate analysis revealed high mean aortic valve PG at admission as independent predictors of ER. Antegrade BAV may be effective for severe AS. Left ventricular hypertrophy, pulmonary hypertension and high mean PG were predictor of early restenosis. Early intervention should be considered for these patients.

Safety and Efficacy of Simultaneous Biplane Mode of 3-Dimensional Transesophageal Echocardiography-Guided Antegrade Multiple-Inflation Balloon Aortic Valvuloplasty in Patients With Severe Aortic Stenosis.

Balloon aortic valvuloplasty (BAV) is resurging as a bridge treatment in patients with severe aortic stenosis (AS) with a dissemination of transcatheter aortic valve implantation. However, the significantly high periprocedural mortality and complication rates still limit the indications of BAV. Further efforts are needed to improve the safety and efficacy of BAV.Methods and Results:We retrospectively investigated the safety and efficacy of simultaneous biplane mode of 3-dimensional transesophageal echocardiography (biplane-TEE) guided antegrade transseptal multiple-inflation BAV, with gradual upsizing of the balloon, by enrolling 20 consecutive AS patients who underwent BAV. The median age was 83 years, and there were 6 male patients (30.0%). The clinical frailty scale was 4, and the Society of Thoracic Surgeon score was 14.5%. The balloon was inflated at a median of 18 times, which improved the mean aortic valve pressure gradient from 43.0 to 15.2 mmHg (P<0.001). We safely performed BAV in all patients, without periprocedural death or symptomatic stroke, although asymptomatic stroke was detected in 8 patients (42.1%) on diffusion-weighted magnetic resonance imaging. Kaplan-Meier estimates showed that the survival rate was 84.0% and cardiovascular death-free survival was 88.9% at 1-year. Biplane-TEE guided antegrade multiple-inflation BAV might have the potential to improve periprocedural survival without increasing complications, compared with conventional retrograde BAV in patients with severe AS.

Complete atrioventricular block improved by balloon aortic valvuloplasty for severe aortic stenosis: Usefulness of sheathless technique in the retrograde approach

An 86-year-old man was admitted to our hospital for treatment of congestive heart failure with severe aortic stenosis and advanced atrioventricular (AV) block. Despite pharmacological therapy, he developed complete AV block and resultant acute pulmonary edema requiring temporary pacing and tracheal intubation. We urgently performed retrograde balloon aortic valvuloplasty (BAV) with a sheathless technique. The AV block disappeared soon after the procedure; this was probably attributable to the correction of relative myocardial ischemia, obtained by BAV. Thus, he successfully recovered from a critical condition.<Learning objective: It is widely accepted that balloon aortic valvuloplasty (BAV) dramatically reduces the systolic pressure gradient across the stenotic aortic valve, but the other important hemodynamic point is that it increases the coronary perfusion pressure by raising the diastolic blood pressure, both of which contribute to improving the imbalance between myocardial oxygen demand and supply. And the sheathless technique in retrograde BAV, although not yet popular, is less invasive and may be promising in urgent clinical situations.>

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.

Impact of rapid ventricular pacing during percutaneous balloon aortic valvuloplasty in patients with critical aortic stenosis: Should we be using it?

Rapid ventricular pacing (RP) during percutaneous balloon aortic valvuloplasty (BAV) facilitates balloon positioning by preventing the "watermelon seeding" effect during balloon inflation. The clinical consequences of RP BAV have never been compared with standard BAV in which rapid pacing in not used. We evaluated the immediate results and in-hospital adverse events of patients with severe aortic stenosis (AS) undergoing BAV with and without RP. This is a retrospective study of patients with severe AS undergoing retrograde BAV. Patients who underwent BAV with RP were compared to those who did not receive RP during BAV. Procedural outcomes, complications, and in-hospital adverse events were compared between both groups. Stratified analyses were performed to evaluate RP in pre-specified subsets for confounding and effect modification. Between January 2005 and December 2008, 111 consecutive patients underwent retrograde BAV at Massachusetts General Hospital. Sixty-seven patients underwent BAV with RP. Nearly 90% of patients were NYHA class III or IV and the mean AVA was 0.64 cm(2). Baseline characteristics and balloon sizes were similar in the two groups. The average post-BAV AVA was smaller in the RP group compared to the no-RP group (0.87 v. 1.02 cm(2), p = 0.02). Pre and post-cardiac output, in-hospital mortality, myocardial infarction, stroke, frequency of cardiopulmonary arrest, vasopressor use, and major complications were similar in the two groups. 1) RP allows precise balloon placement during BAV. 2) RP BAV is associated with lower post-BAV AVA. 3) RP BAV may be safely performed in patients with high-risk cardiac features.

Feasibility of transcatheter intervention for severe aortic stenosis in patients ≥90 years of age: Aortic valvuloplasty revisited

The goals of this study were to determine the feasibility, safety, and early outcomes of balloon aortic valvuloplasty (BAV) for severe aortic stenosis in a nonagenarian population. This very elderly population is expanding rapidly, has a high incidence of aortic stenosis, and uncommonly undergoes surgical aortic valve replacement. These patients may best be treated with a transcatheter approach due to comorbidities, surgical risk, and personal preference. We reviewed 31 consecutive patients >or=90 years of age who underwent BAV at our institution from July 2003 to August 2006 for data pertinent to patient characteristics, procedural techniques, and 30-day outcomes. Our patients had a mean age of 93 +/- 3.0 years (90-101). The society of thoracic surgery risk score was 18.5 (+/-10.2) and logistic Euroscore was 35.8 (+/-19.3). Twenty-five patients (81%) underwent retrograde BAV and 6 (19%) antegrade BAV. Five patients (16%) underwent combined BAV and coronary stenting. Overall mean aortic valve area increased from 0.52 cm2 (+/-0.17) to 0.92 cm2 (+/-0.22) and mean New York Heart Association (NYHA) functional class improved from 3.4 to 1.8. Intraprocedural mortality occurred in one patient (3.2%) and 30-day mortality in three patients (9.7%). BAV can be carried out in high risk nonagenarian patients with an acceptable complication rate, low perioperative mortality, and early improvement in NYHA functional class.