Palliative Balloon Valvuloplasty for Late Stenosis of a Degenerated Transcatheter Heart Valve: Proof of Concept.
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SUBMITTER: Vinayak M
PROVIDER: S-EPMC11308799 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Palliative Balloon Valvuloplasty for Late Stenosis of a Degenerated Transcatheter Heart Valve: Proof of Concept.
Vinayak Manish M Tang Gilbert H L GHL Anastasius Malcolm M Moreno Pedro P Dangas George D GD Kini Annapoorna S AS Sharma Samin K SK Khera Sahil S
Journal of the Society for Cardiovascular Angiography & Interventions 20231010 1
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Project description:BackgroundPercutaneous balloon pulmonary valvuloplasty is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. The present study describes our experience in balloon pulmonary valvuloplasty using the Inoue balloon catheter in adolescent and adult patients.AimsTo assess the immediate and mid-term outcomes of percutaneous balloon valvuloplasty with Inoue balloon catheter in adolescent and adult patients.Methods and resultsBetween June 2010 and July 2015, we performed percutaneous balloon pulmonary valvuloplasty with Inoue balloon catheter in 32 patients (59.37% females) aged 8 to 54 years (mean 23.6±11.5). Following the procedure, the mean right ventricular systolic pressure and the pulmonary valvular peak-to-peak systolic gradient decreased from (121.6±42.4 to 61.19±24.5mmHg, p=0.001) and (100.9±43.3 to 36.4±22.5mmHg, p=0.001), respectively. Twenty patients (Group A) showed immediate optimal results with post-procedure peak systolic gradient <36mmHg while 12 patients (Group B) had suboptimal results. An increase in pulmonary regurgitation by one grade was detected in 17 patients (53.2%). Twenty-three patients available for follow-up (mean duration, 2.75 years [range 0.25-5 years]) had a mean residual peak gradient of 23.6±2.51mmHg on Doppler echocardiography with attenuation of reactive RVOT stenosis in all Group B patients. There was no further increase in grade of pulmonary regurgitation or restenosis on mid-term follow-up.ConclusionPercutaneous Inoue balloon technique is an attractive alternative with excellent mid-term results for adolescents and adults with isolated pulmonary stenosis.
| S-EPMC5415049 | biostudies-literature
Project description:Balloon aortic valvuloplasty (BAV) has historically been recommended prior to transcatheter aortic valve implantation (TAVI). Pre-implantation BAV (pBAV) creates fractures at the level of calcified leaflets, thereby facilitating delivery of the transcatheter valve system across the diseased aortic valve and, enhances prosthesis implantation and expansion within the calcified aortic valve annulus. New device designs, lower profile delivery systems and increasing operator experience have enabled direct-TAVI (without pBAV), and its appeal amongst TAVI operators enhanced the dissemination of a direct TAVI approach across many centres. In this review, we discuss contemporary evidence that inform the debate on the need for routine pBAV for TAVI candidates and present a framework that may assist operators in selecting patients for pBAV.
| S-EPMC6242918 | biostudies-literature
Project description: Not available
| S-EPMC5523791 | biostudies-literature
Project description: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.
| S-EPMC8927037 | biostudies-literature
Project description:IntroductionThe role of balloon aortic valvuloplasty (BAV) in the era of transcatheter aortic valve replacement remains a topic of debate. We sought to study the safety and feasibility of combined BAV and percutaneous coronary intervention (BAV-PCI).MethodsBetween November 2009 and July 2020, all patients undergoing BAV were identified and divided into three groups: combined BAV-PCI (group A), BAV with significant unrevascularised CAD (group B), and BAV without significant CAD (group C). Procedural outcomes and 30-day and one-year mortality were compared.ResultsA total of 264 patients were studied (n = 84, 93, and 87 patients in groups A, B, and C, respectively). The STS score was 10.2 ± 8, 13.3 ± 19, and 8.1 ± 7, p = 0.026, in groups A, B, and C, respectively. VARC-3 adjudicated complications were similar among groups (11%, 13%, and 5%, respectively, p = 0.168, respectively). Thirty-day and one-year mortality were 9.8% (n = 26) and 32% (n = 86) of the entire cohort. The differences among groups did not reach statistical significance. Using univariate Cox regression analysis, group B patients were at higher risk of dying compared to group A patients (HR 1.58, 95% CI: 1.11-2.25, p = 0.010). With multivariate Cox regression analysis, the predictors of mortality were STS score, cardiogenic shock, mode of presentation, and lack of subsequent definitive valve intervention.ConclusionIn high-risk patients with aortic valve stenosis, combined BAV-PCI is safe and feasible with comparable outcomes to BAV with and without significant CAD.
| S-EPMC11449180 | biostudies-literature
Project description:Optimal initial treatment for congenital aortic valve stenosis in children remains unclear between balloon aortic valvuloplasty (BAV) and surgical aortic valvotomy (SAV). We performed a contemporary systematic review and meta-analysis to compare survival in children with congenital aortic valve stenosis. Secondary outcomes included frequency of at least moderate regurgitation at hospital discharge as well as rates of aortic valve replacement and reintervention. Single- and dual-arm studies were identified by a search of PubMed (Medline), Embase, and the Cochrane database. Overall 2368 patients from 20 studies were included in the analysis, including 1835 (77%) in the BAV group and 533 (23%) in the SAV group. There was no difference between SAV and BAV in hospital mortality (OR=0.98, 95% CI 0.5-2.0, P=0.27, I(2)=22%) or frequency of at least moderate aortic regurgitation at discharge (OR=0.58, 95% CI 0.3-1.3, P=0.09, I(2)=54%). Kaplan-Meier analysis showed no difference in long-term survival or freedom from aortic valve replacement but significantly more reintervention in the BAV group (10-year freedom from reintervention of 46% [95% CI 40-52] for BAV versus 73% [95% CI 68-77] for SAV, P<0.001). Results were unchanged in a sensitivity analysis restricted to infants (<1 year of age). Although higher rates of reintervention suggest improved outcomes with SAV, indications for reintervention may vary depending on initial intervention. When considering the benefits of a less-invasive approach, and clinical equipoise with respect to more clinically relevant outcomes, these findings support the need for a randomized controlled trial.
| S-EPMC5015309 | biostudies-literature
Project description:ObjectivesThis study aims to analyse the risks associated with valve-in-valve procedures for treating structural valve deterioration in Mitroflow bioprostheses, as well as to determine the impact of the original Mitroflow size on the patients' long-term outcomes.MethodsBetween January 2012 and September 2019, 21 patients (61.9% males; mean age 82.4 ± 5.4 years) were treated for Mitroflow deterioration with valve-in-valve procedures (12 transapical and 9 transfemoral).ResultsMean EuroSCORE I and EuroSCORE II were 28.2% ± 13.6% and 10.5% ± 6.1%, respectively. Six patients presented an indexed aortic root diameter <14 mm/m2 and 7 patients a diameter of sinus of Valsalva <30 mm. Implanted transcatheter valve sizes were 20 mm in 6 cases, 23 mm in 14 cases and 26 mm in 1 patient. A Valve Academic Research Consortium-2 complication occurred in 23.8% of cases, including 3 coronary occlusions. In-hospital mortality was 9.5%. The 20 mm transcatheter valves presented significantly higher postoperative peak and mean aortic gradients than other sizes (54.1 ± 11.3 mmHg vs 29.9 ± 9.6 mmHg, P = 0.003; and 29.3 ± 7.7 mmHg vs 17.4 ± 5.9 mmHg, P = 0.015, respectively). There were 12 cases of patient-prosthesis mismatch (57.1%) and 3 cases (14.3%) of severe patient-prosthesis mismatch. Cumulative survival was 85.7% ± 7.6% at 1 year, 74.3% ± 10% at 2 years and 37.1% ± 14.1% at 5 years.ConclusionsValve-in-valve procedures with balloon-expandable transcatheter valves associate a high risk of coronary occlusion in patients with indexed aortic root diameter <14 mm/m2 and low coronary ostia <12 mm. Valve-in valve procedures with 20 mm balloon-expandable transcatheter valves in ≤21 mm Mitroflow bioprosthesis leave significant residual transvalvular gradients that might obscure patients' long-term outcomes.
| S-EPMC8759469 | biostudies-literature
Project description:Percutaneous balloon aortic valvuloplasty (PBAV), which is used to treat symptomatic aortic stenosis, requires ionizing radiation and contrast agent for imaging guidance. The aim of the study is to evaluate the feasibility and effectiveness of ultrasound-guided PBAV in patients with aortic stenosis. This case series included 30 patients (14 males; mean age, 61.5?±?4.5 years) with moderate/severe aortic stenosis treated with ultrasound-guided PBAV at the Ultrasound Department, Fuwai Hospital, Beijing, China, between January 2016 and July 2019. Cardiac function (New York Heart Association grade) was assessed before PBAV and 1 month after the procedure. Aortic peak jet velocity, aortic valve orifice area (AVA), mean transvalvular pressure gradient (MTPG), left ventricular end-diastolic diameter (LVDD), left ventricular ejection fraction (LVEF), and left ventricular end-systolic diameter (LVESD) were determined before and immediately after PBAV using Doppler echocardiography. Preprocedural cardiac function was grade I in 3 cases, grade II in 9 cases, grade III in 10 cases, and grade IV in 8 cases. Postprocedural cardiac function was grade I in 22 cases, grade II in 4 cases, and grade III in 4 cases, suggesting that cardiac function was improved by PBAV. Ultrasound-guided PBAV resulted in significant improvements (P < 0.05) in aortic peak jet velocity (3.68?±?0.811?m/s vs. 4.79?±?0.63?m/s), MTPG (33.77?±?13.85?mmHg vs. 54.54?±?13.81?mmHg), AVA (1.96?±?0.25?cm2 vs. 0.98?±?0.12?cm2), LVEDD (51.90?±?3.21?mm vs. 65.60?±?6.81?mm), LVEF (63.46?±?11.29% vs. 56.31?±?11.04%), and LVESD (35.50 2.62?mm vs. 45.20?±?2.42?mm). Ultrasound-guided PBAV is feasible and achieves good short-term effects in patients with aortic stenosis.
| S-EPMC7102489 | biostudies-literature
Project description:BackgroundBalloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation.Methods/designThe transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure.DiscussionThis prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice.Trial registrationClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.
| S-EPMC5496363 | biostudies-literature
Project description:We present the case of an 82-year-old man whose left coronary ostium became obstructed 15 months after transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve. The patient underwent TAVR for symptomatic severe aortic stenosis with no complications. Fifteen months after the initial TAVR, the patient complained of chest pain while exercising, and the exercise stress myocardial perfusion scintigraphy demonstrated the development of regional myocardial ischemia in the region of the left coronary artery. Coronary angiography implied severe stenosis in the ostium of the left coronary artery. Computed tomography angiography and intravascular ultrasonography indicated a soft tissue component along with stent struts, which was considered to cause delayed coronary obstruction. Our report emphasizes the importance of having a low threshold for clinically suspecting delayed coronary obstruction in patients who have undergone TAVR, even after several years of the procedure. <Learning objective:Delayed coronary obstruction (DCO) should be suspected in patients presenting with new ischemic symptoms after transcatheter aortic valve replacement (TAVR). DCO may occur even in the case of TAVR with a balloon-expandable prosthetic valve, on antithrombotic regimens, and several years after the initial procedure.>.
| S-EPMC8766574 | biostudies-literature