Prior Balloon Aortic Valvuloplasty Research Articles

30-Day and 1-Year Mortality after Transcatheter Aortic Valve Replacement: The Impact of Balloon Aortic Valvuloplasty as a Bridging Therapy in a Portuguese Tertiary Center

Introduction. Since the advent and development of transcatheter aortic valve replacement (TAVR) in the contemporary era, balloon aortic valvuloplasty (BAV) has seen renewed interest. We aimed to compare 30-day and 1-year all-cause mortality between patients submitted to BAV as a bridging therapy before definite TAVR and patients submitted directly to TAVR. Methods. This was an observational, retrospective study of patients who underwent TAVR between 2009 and 2022 in a tertiary center. Patients with severe aortic stenosis (SAS) who underwent TAVR without prior BAV (woBAV group) and patients who were performed TAVR with prior BAV (wBAV group) as a bridging therapy were included. Primary endpoint was all-cause mortality at 30 days and 1 year after TAVR between wBAV and woBAV groups. Results. 800 patients were included, of which 767 were in woBAV group and 33 were in wBAV group. 30-day all-cause mortality rate was 21% in wBAV group compared to 4.4% in woBAV (unadjusted hazard ratio [HR], 5.19; 95% confidence interval [CI], 2.3–11.7, p < 0.001). At 1-year, all-cause mortality rate was 27% in wBAV group compared to 12% in woBAV group (unadjusted HR, 2.55; 95% CI, 1.28–5.10, p = 0.007). After covariate adjustments, mortality remained significantly higher in wBAV group. Conclusion. This study provides valuable insights into the outcomes of patients undergoing TAVR with prior BAV as bridging therapy, as these patients had higher mortality at 30 days and 1 year compared to patients direct to TAVR.

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial

ObjectivesThe aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BackgroundRandomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. MethodsDIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. ResultsDevice success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. ConclusionsDirect TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519)

Balloon Aortic Valvuloplasty as a Bridge to Aortic Valve Replacement: A Contemporary Nationwide Perspective

ObjectivesThis study sought to use a national representative database to assess the incidence, predictors, and outcomes of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve replacement (TAVR) in contemporary practice. BackgroundNationwide data on the use and outcomes of BAV as a bridge to TAVR are limited. MethodsPatients who underwent BAV between January and June in 2015 and 2016 were identified in the National Readmission Database. We assessed rate of subsequent TAVR following BAV, and predictors and timing of subsequent TAVR. We then identified a group of patients who had direct TAVR (without prior BAV) in the original 2015 to 2016 National Readmission Database dataset. We compared in-hospital outcomes following TAVR between patients with prior bridging BAV and those undergoing direct TAVR. ResultsAmong the 3,691 included patients 1,426 (38.6%) had subsequent TAVR. Timing of TAVR was pre-discharge in 7.4%, within 30 days in 35%, between 31 and 90 days in 47%, between 91 and 180 days in 14%, and >180 days in 4%. Negative predictors of subsequent TAVR included prior defibrillator (odds ratio [OR]: 0.56; 95% confidence interval [CI]: 0.36 to 0.85), dementia (OR: 0.60; 95% CI: 0.46 to 0.79), malnutrition (OR: 0.64; 95% CI: 0.45 to 0.90), and malignancy (OR: 0.62; 95% CI: 0.47 to 0.82). In propensity-score matched cohorts of patients who underwent direct TAVR versus those with prior BAV, in-hospital mortality during TAVR admission was similar (3.7% vs. 3.5%; p = 0.91). Major complications, length of stay, and discharge disposition were also comparable. However, cost of the hospitalization was higher in the direct TAVR group. ConclusionsAbout 40% of BAV patients undergo subsequent TAVR mostly within 90 days. In-hospital outcomes of TAVR in these patients were comparable with propensity-score matched patients who underwent TAVR without prior BAV. Further investigations are needed to define the role of BAV in contemporary practice.

TCT-182 Outlook of patients undergoing transcatheter aortic valve implantation after prior balloon aortic valvuloplasty: insights from the multicenter RISPEVA trial

Transcatheter aortic valve implantation (TAVI) represents an effective treatment for high or intermediate risk patients with severe aortic stenosis. Yet, balloon aortic valvuloplasty (BAV) is still occasionally offered to apparently inoperable patients as bridge or destination therapy, with some

First experience with transfemoral transcatheter aortic valve implantation without prior balloon pre-dilatation using a latest generation repositionable and retrievable transcatheter heart valve†.

: The aim of this study was to prove technical feasibility and document haemodynamic and clinical outcomes of transcatheter aortic valve implantation (TAVI) with the latest generation repositionable and retrievable Lotus™ transcatheter heart valve (THV) without prior balloon-aortic valvuloplasty (BAV). It has been demonstrated for self-expandable and balloon-expandable THV that implantation without prior BAV is not only feasible and safe but also results in lower fluoroscopy times and amounts of contrast agent while yielding non-inferior haemodynamic and clinical outcome. To date no reports exist for TAVI without BAV for the Lotus™ THV. : A consecutive patient series received direct transfemoral (TF)-TAVI without prior BAV using the Lotus™ valve system. Baseline, intraprocedural and acute follow-up data up to 30 days were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized Valve Academic Research Consortium (VARC)-2 definitions. : A total of 9 patients received direct TF-TAVI using the Lotus THV (77.7% female, 82.5 ± 5.3 years, logistic European System for Cardiac Operative Risk Evaluation I 14.2 ± 13.7%). Device success according to VARC-2 definitions was achieved in 100% (9/9) of the patients. Peak and mean transvalvular gradients as determined by transthoracic echocardiography prior to discharge decreased from 51.5 ± 17.3 to 24.4 ± 10.4 mmHg and 29.5 ± 9.6 to 13.2 ± 5.2 mmHg (both P < 0.01). Effective orifice area increased from 0.9 ± 0.2 to 1.9 ± 0.3 cm 2 ( P < 0.01). No paravalvular leakage (PVL) ≥ moderate was detected. All-cause 30-day mortality was 11.1% (1/9), with one death due to ischaemic enteritis. : In our series, TF-TAVI without prior BAV using this particular THV technical feasibility, no increased incidence of significant paravalvular leakage, and good haemodynamic and clinical outcome in selected patients. These results will have to be confirmed in larger patient numbers for further clinical evaluation and before general recommendations regarding patient selection can be made.

Trends over the past 4 years in population characteristics, 30-day outcomes and 1-year survival in patients treated with transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) is recommended in patients with severe aortic stenosis that is either inoperable or at high-risk for surgical valve replacement. To evaluate trends in the feasibility and safety of transfemoral TAVI over the past 4 years. Between 2010 and 2013, all consecutive patients undergoing TAVI in our institution were included in a prospective registry. Population characteristics and 30-day and 1-year outcomes were analysed. Outcomes were classified according to the Valve Academic Research Consortium-2. Overall, 429 patients underwent TAVI; transfemoral access was used in 368 (85.7%). The proportion of patients treated via a transfemoral approach increased (70.1% to 89.9%; P<0.0001) and the use of prior balloon aortic valvuloplasty decreased (44.7% to 11.2%; P<0.0001). The mean logistic EuroSCORE decreased significantly from 19.4±10.9% to 15.8±8.7% (P=0.01). The 30-day mortality rate did not change significantly (6.4% vs. 5.6%; P=0.99). Similarly, rates of major vascular complications (12.8% vs. 15.4%; P=0.87) and stroke (2.1% vs. 1.4%; P=0.75) remained unchanged. Mean length of stay after TAVI decreased significantly from 8.9±11.3 days to 4.8±4.7 days (P=0.002) and 72 (50.3%) patients were discharged early in 2013. One-year survival increased significantly from 81.0% to 94.4% (P=0.03). Over the past 4 years, TAVI has been increasingly performed using a transfemoral approach. Treated patients are at lower-risk with less co-morbidity. Thirty-day mortality and complications remained unchanged, but length of stay after TAVI and 1-year mortality decreased dramatically.

Abstract 11735: Periprocedural Cerebral Ischemic Events With TAVI Performed Without Prior Balloon Dilatation of the Aortic Valve: A Randomized Prospective Study

Introduction: Balloon aortic valvuloplasty (BAV) is considered as an essential part of Transcatheter Aortic Valve Implantation (TAVI) procedure, but cerebral embolization may occur during this step. Hypothesis: We assessed the hypothesis that TAVI performed without prior BAV may be associated with decrease of risk of periprocedural cerebral ischemia assessed using diffusion-weighted (DW) magnetic resonance imaging (MRI). Methods: In this prospective monocentric study we randomized consecutive patients who underwent TAVI with the new generation balloon expandable SAPIEN 3 prosthesis. Group 1 (n=14) included patients with BAV performed prior implantation of the prosthesis and group 2 (n=14) patients with direct implantation of the valve. Periprocedural cerebral ischemia was assessed blindly by neurological testing and serial cerebral DW MRI at baseline and within 3 days after TAVI. Results: On the 28 patients included, mean age was 83 years (78-86),18 were of female gender (64.3%) and mean logistic Euroscore II was 8.4 (6.3-10.6) without significant differences between the 2 groups. Implantation of the valve was successful in all patients. Considering the total population, preexisting silent ischemic brain abnormalities were observed in 11 patients (39.3%) and microbleeds in 14 patients (50 %). New foci of restricted diffusion, mainly lacunar, and new microbleeds were found on cerebral DW MRI in respectively 13 (46.4%) and 6 (21%) patients after the procedure without significant difference between the 2 groups (table 1). There were neither apparent impairments of neurocognitive function or neurological events during the in-hospital stay in the 2 groups. In conclusion: Direct implantation of new generation balloon expandable prosthesis appears feasible but is not associated with reduction of periprocedural ischemic cerebral events . These results argue for embolization occurring during positioning of the valve rather than during balloon valvuloplasty.

Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon Valvuloplasty.

The purpose of this study was to analyze the effect of transcatheter aortic valve replacement (TAVR) without versus with prior balloon aortic valvuloplasty (BAV) on the risk of cerebral embolization in patients who receive a balloon-expandable valve. Avoiding BAV prior to TAVR may simplify the procedure, but the risk of cerebral embolization is currently unknown. A total of 87 consecutive high surgical-risk patients with no contraindications for diffusion-weighted magnetic resonance imaging (DW-MRI) were enrolled. Thirty-two patients received a balloon-expandable aortic valve with and 55 patients without BAV. The incidence, number, and volume of new ischemic lesions in DW-MRI performed 2to7 days after TAVI were evaluated. Mean age (83.8 ± 5.2 years vs. 82.9 ± 6.8 years) and sex (43.8% vs. 52.7% male) of the patients with versus without BAV, respectively, as well as other demographic and hemodynamic data were not significantly different between both groups. The procedural success rate was 93.5% with and 98.2% without BAV, and procedure duration and contrast volume were significantly lower without BAV. The incidence of new cerebral ischemic lesions in the total cohort was 66.7%. Compared with patients with BAV, those without BAV had a significantly higher total volume of cerebral ischemic lesions (235.4 ± 331.4 mm(3) vs. 89.5 ± 128.2 mm(3); p= 0.01). The implantation of a balloon-expandable aortic valve without versus with prior BAV, although performed with a shorter procedure time and lower contrast volume, is associated with a significantly higher volume ofcerebral ischemic lesions.

Long-term outcome of congenital aortic valve stenosis: predictors of reintervention.

To evaluate long-term outcome of initial aortic valve intervention in a paediatric population with congenital aortic stenosis, and to determine risk factors associated with reintervention. From 1985 to 2009, 77 patients with congenital aortic stenosis and a mean age of 5.8±5.6 years at diagnosis were followed up in our institution for 14.8±9.1 years. First intervention was successful with 86% of patients having a residual peak aortic gradient 1 regurgitation increased by 7%. Long-term survival after the first procedure was excellent, with 91% survival at 25 years. At a mean interval of 7.6±5.3 years, 30 patients required a reintervention (39%), mainly because of a recurrent aortic stenosis. Freedom from reintervention was 97, 89, 75, 53, and 42% at 1, 10, 15, 20, and 25 years, respectively. Predictors of reintervention were residual peak aortic gradient (p=0.0001), aortic regurgitation post-intervention >1 (p=0.02), prior balloon aortic valvuloplasty (p=0.04), and increased left ventricular posterior wall thickness (p=0.1). Aortic valve intervention is a safe and effective procedure for congenital aortic stenosis with excellent survival results. However, rate of reintervention is high and influenced by increased left ventricular posterior wall thickness pre-intervention, prior balloon valvuloplasty, higher residual peak systolic valve gradient, and more than mild regurgitation post-intervention. The study highlights that long-term follow-up is recommended for these patients.

Balloon aortic valvuloplasty of severe aortic stenosis in the era of TAVR

Introduction. Balloon aortic valvuloplasty (BAV) is a percutaneous treatment option for aortic stenosis (AS). Because of early restenosis and poor long-term survival, it is used as a bridge to surgery (SAVR) or transcatheter aortic valve replacement (TAVR), in hemodinamically unstable patients or patients that require urgent non-cardiac surgery. Aim. The aim of this study was to evaluate all the BAV procedures performed in our centre in 2010 and to report our experience with BAV as a potential bridge to definitive therapy or as a palliative treatment. Methods. We retrospectively analyzed all the patients who underwent percutaneous treatment of aortic stenosis in our institution between January and December 2010. We stratified our cohort into 3 groups: BAV as a bridge to TAVR or SAVR, BAV as a final therapy and TAVR without prior BAV. We evaluated patient characteristics, echocardiographic data and peri-procedural complications in each cohort. Survival was evaluated using Kaplan-Meier analysis. Results. We included 86 high risk symptomatic patients with mean age of 82.2 ± 5.0 years and mean logistic EuroSCORE of 19.2 ± 11.8 %. After BAV we observed a significant decrease in mean transvalvular gradient (from 43.8 ± 14.4 to 33.5 ± 12.3 mmHg; p < 0.01) and a significant increase in aortic valve area after BAV (from 0.6 ± 0.2 to 0.8 ± 0.3 cm2; p < 0.01). Systolic pulmonary artery pressure, left ventricular ejection fraction and mitral regurgitation did not change significantly. Major intrahospital complications occurred in 5 patients (6.5 %), without any death related to the procedure. BAV as a bridge to TAVR had a better outcome compared with BAV alone. Conclusion. BAV is a feasible and reasonably safe approach for temporary relief of symptoms, improvement of quality of life, decrease of surgical risk prior major non-cardiac surgery or as a bridge to surgical or transcatheter aortic valve implantation in severe aortic stenosis.

Transapical transcatheter aortic valve implantation without prior balloon aortic valvuloplasty: feasible and safe

Currently, preimplant balloon aortic valvuloplasty (BAV) is considered a prerequisite for successful subsequent transapical transcatheter aortic valve implantation (TA-TAVI) using balloon-expandable devices. However, cerebral embolization has been shown to originate at least in part from BAV procedures. Omitting BAV may therefore reduce neurological events after TAVI and facilitate the procedure while yielding non-inferior haemodynamic and clinical outcomes. From May 2011 through December 2012, a total of 50 consecutive patients were treated by TA-TAVI without preimplant BAV (TA-TAVI(-BAV), study group) using the Edwards Sapien XT device (54% male, age 78 ± 8 years, logistic European System for Cardiac Operative Risk Evaluation I 21 ± 14%). Data were prospectively entered into a dedicated database, retrospectively analysed and compared with a consecutive series of conventional TA-TAVI using the same device (control group, n = 50). Reporting of data followed Valve Academic Research Consortium definitions. Overall device success rate was 94% (47/50) and 86% (43/50) in study and control groups, respectively (P = 0.32). Procedure time was similar in the study group compared with the control group (88 ± 31 vs 91 ± 25 min, P = 0.60), while significantly less contrast was used (138 ± 68 vs 183 ± 78 ml, P < 0.001). Post-procedural peak and mean transvalvular gradients were 16 ± 7 and 8 ± 3 mmHg, respectively, in the study group with similar values in the control group (19 ± 9 and 9 ± 5 mmHg, P = 0.08 and P = 0.09, respectively). Residual paravalvular leakage (PVL) grade 2 was present in 2 and 8% in study and control groups, respectively (P = 0.36), with no PVL >grade 2 in any patient. Rates of 30-day mortality and periprocedural stroke were 4 and 10% (P = 0.44) and 2 and 6% (P = 0.62), respectively. TA-TAVI(-BAV) is feasible and safe and has become ur default technique for patients allocated to TA-TAVI with balloon-expandable devices. This approach resulted in less contrast agent used and facilitated the procedure without compromising valve performance. Possible beneficial effects of this approach on the incidence of cerebrovascular events, other periprocedural complications or haemodynamic valve performance need to be verified in larger patient numbers before general recommendations can be made.

The use of vascular closure devices and impact on major bleeding and net adverse clinical events (NACEs) in balloon aortic valvuloplasty: A sub‐analysis of the BRAVO study

To determine the impact of suture-mediated vascular closure devices (VCDs) on net adverse clinical events (NACEs) after balloon aortic valvuloplasty (BAV). Ischemic and bleeding complications are common following transfemoral BAV; however, previous studies have been single center and limited by varying definitions of major bleeding. The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVOs) study was a retrospective observational study conducted at two high-volume academic centers over a 6-year period designed to compare the effect of bivalirudin versus unfractionated heparin. This is a subanalysis of 428 consecutive patients who underwent BAV (with 10-13 French sheaths) to compare the effect of hemostasis with VCDs versus manual compression utilizing standardized definitions. NACE was defined as the composite of major bleeding and major adverse clinical events (MACEs). All events were adjudicated by an independent clinical events committee who were blinded to antithrombin use. Preclosure was performed in 269 (62.8%) of patients. While bivalirudin was used more frequently in those with pre-closure (60.6% vs. 37.7%, P < 0.001), a history of prior BAV (11.1% vs. 3.6%, P = 0.04) and peripheral vascular disease (30.7% vs. 19.7%, P = 0.01) was more common in those not undergoing preclosure (n = 159, 37%). Other clinical and demographic features were well balanced between groups. Vascular closure was associated with a significant reduction in NACE (24.5% vs. 10.0% P < 0.001). Results remained significant after adjusting for baseline differences and bivalirudin use (OR 0.38, 95% CI: 0.21-0.68; P = 0.001). Our study suggests that suture-mediated vascular closure is associated with a substantial reduction in NACE after transfemoral BAV. Large randomized clinical trials should be conducted to confirm our results.

Transfemoral Aortic Valve Implantation in a Patient with Prior Mechanical Mitral Valve Replacement

Transfemoral aortic valve implantation has emerged as a promising alternative to surgical aortic valve replacement for high-risk patients with severe symptomatic aortic stenosis. In the setting of previous mechanical mitral valve replacement, the procedure represents a challenge due to the risk of interference and subsequent functional impairment of the mechanical prosthesis. The authors report a case of successful transfemoral implantation of a selfexpandable aortic bioprosthesis in a patient with a Björk-Shiley tilting-disk valve in mitral position demonstrating that the implantation is also feasible in this setting but requires careful preinterventional evaluation. Prior balloon aortic valvuloplasty with thorough observation of the mitral prosthesis during balloon inflation may be a helpful tool for indicating feasibility of this approach.