Abstract 16322: Safety and Efficacy of Transapical Transcatheter Aortic Valve Replacement in the Treatment of Pure Non-calcified Native Aortic Regurgitation

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Can Shen ◽  
Ying Peng ◽  
Lulu Liu ◽  
Jun Shi ◽  
Yingqiang Guo ◽  
...  

Background: Transcatheter aortic valve replacement (TAVR) in patients with pure aortic regurgitation (AR) is still “off-label” use due to the lack of suitable transcatheter heart valve. This study aimed to evaluate the safety and efficacy of TAVR with J-Valve TM (JieCheng Medical Technology Co., Ltd., Suzhou, China) transcatheter heart valve for the treatment of patients with pure non-calcified native AR. Methods: The clinical and follow-up data of patients with pure non-calcified native AR treated by TAVR with J-Valve TM between April 2014 and November 2019 in the West China Hospital were summarized. Procedural results and clinical outcomes were analyzed using Valve Academic Research Consortium-2 criteria. Results: A total of 123 patients were enrolled with a mean age of 72.1±6.4 years. There were 28 cases with bicuspid aortic valve and 95 cases with trilobal aortic valve. The median follow-up period was 18 months. Transapical implantation with J-Valve TM was successful in all patients (100%). By the end of the follow up, the rate of all-cause mortality was 5.7%, among which 5 cases died during the perioperative period. Other results include stroke (1.6%), new permanent pacemaker implantation (8.9%), major bleeding (6.5%), acute kidney injury (2.4%) and aortic valve-related re-intervention (3.3%, they were given surgical aortic valve replacement for thrombosis of artificial valve (2 cases) or severe post-procedural paravalvular leakage (2 cases)). Among the 112 survival cases without re-intervention, Echocardiography revealed that none of them had moderate or severe paravalvular leakage; mild and mild-moderate paravalvular leakage occurred in 9.8% and 8.0% cases, respectively. Mean transvalvular gradient after valve implantation was 9.2±3.5 mmHg. At 6 months of follow up, left ventricular end diastolic diameter was remarkably smaller compared to that before procedure (53.5±8.2 mm vs 64.3±8.9 mm, P<0.001) and left ventricular ejection fraction was significantly increased (56.3±11.8 % vs 54.2±12.4 %, P=0.031). Conclusions: TAVR with J-Valve TM transcatheter heart valve system for treatment of patients with pure non-calcified native AR is safe and effective which may be a reasonable option in the future treatment.

2021 ◽  
Vol 3 (4) ◽  
pp. 633-635
Author(s):  
Abdul Rahman Ihdayhid ◽  
Janarthanan Sathananthan ◽  
Richard Brown ◽  
Philipp Blanke ◽  
John G. Webb

Author(s):  
Tamim M. Nazif ◽  
Thomas J. Cahill ◽  
David Daniels ◽  
James M. McCabe ◽  
Mark Reisman ◽  
...  

Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry. Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days. Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score–matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P =0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P <0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P =0.10), major vascular complications (1.1% versus 1.0%, P =0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P =0.81). Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Heger ◽  
B Marchandot ◽  
M Kibler ◽  
M Peillex ◽  
A Trimaille ◽  
...  

Abstract Background Electrocardiographic (ECG) strain pattern has recently been associated with increased adverse outcome in aortic stenosis (AS) and after surgical aortic valve replacement (AVR). However, the relation linking ECG strain and cardiovascular MACE in patients with transcatheter aortic valve replacement (TAVR) has not been yet described. Objectives The aim of our study was to determine the impact and incremental value of ECG Strain pattern in predicting adverse outcome after TAVR. Methods 585 patients with severe AS (mean age: 83±7 male 39.8%) were enrolled from November 2012 to May 2018. ECG strain pattern was defined as ≥1 mm concave down-sloping ST-segment depression and asymmetrical T-wave inversion in the lateral leads. Patients with baseline left bundle branch block (LBBB), right bundle branch block (RBBB) or ventricular paced rhythm were excluded. All patients underwent transthoracic echocardiography (TTE) before TAVR and at 30 days follow up. The primary endpoints of the study were the overall all-cause mortality after TAVR, rehospitalization for Hearth failure (HF), myocardial infarction and stroke. Results 178 (30.4%) patients were excluded from analyses owing to the presence of either LBBB (n=103) or RBBB (n=75). Among the 407 remaining patients, 106 had ECG strain pattern (26.04%). Patients with ECG strain were significantly younger (81.6±8 years vs 83.5±6.8 years; p=0.022), had lower BMI (23±4.5 kg.m2 vs 27.9±6.8 kg.m2; p=0.02) more severe AS (mean gradient 52.3±15.2 mmHg vs 47.9±11.8 mmHg; p=0.003), significant lower LVEF (51.8±15% vs 58.4±10.7%; p<0.001). Left ventricular hypertrophy (LVH) was more frequent in patients with ECG Strain (indexed left ventricular mass (135.9±33.4 g.m2 vs 123.6±31.9 g.m2; p=0.002)). Death from any cause (22 (20.8%) vs 61 (20.3%); p=0.508) did not differ significantly between groups. Major adverse cardiovascular events (MACE) including death, stroke and heart failure at 1 month showed similar incidence (7 (6.6%) vs 17 (5.6%), p=0.439). Rehospitalization for hearth failure (HF) was significantly higher (33 (31.1%) vs 33 (11%); p<0.001) in patients with ECG strain pattern. In univariate model, ECG Strain was a strong predictor of rehospitalization for HF (HR 2.621 95% CI (1.607–4.277), p=0.001), independently of LVH assessed either by ECG criteria (HR 1.181 95% CI (0.698–1.997; p=0.536) or TTE (HR 1.557 95% (CI 0.701–3.458; p=0.277). ECG Strain remained associated with a higher risk of rehospitalization for hearth failure in multivariate analyses (HR 2.747 95% (CI 1.614- 4.674); p<0.001) Conclusion In patients with AS eligible for TAVR, ECG Strain Pattern is frequent and associated with an increased risk of post interventional heart failure regardless of preoperative LVH. ECG Strain pattern represents an easy, objective, reliable and low-cost tool to identify patients who may benefit from an extend and intensified post-interventional follow-up.


2015 ◽  
Vol 8 (14) ◽  
pp. 1809-1816 ◽  
Author(s):  
Oliver Husser ◽  
Costanza Pellegrini ◽  
Thorsten Kessler ◽  
Christof Burgdorf ◽  
Hannah Thaller ◽  
...  

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Islas ◽  
A De Agustin ◽  
P Jimenez ◽  
L Nombela ◽  
P Marcos Alberca ◽  
...  

Abstract Background Aortic stenosis causes several changes in left ventricular (LV) geometry and function; cardiac remodeling after transcatheter aortic valve replacement (TAVR) is variable among patients and it is not clearly defined. The aim of this study is to identify factors associated with LV functional and structural recovery. Methods 428 patients were retrospectively studied; all patients underwent transthoracic echocardiography prior to TAVR; specific measurements such as maximum internal diameter of the prosthetic valve, nominal loss and percentage of nominal loss regarding to valve size, as well as the discongruence index (Prosthesis size/BSA) were evaluated at discharge and 1-year follow up. Positive cardiac remodeling (PCR) was considered if patients had a reduction of ≥20% of left ventricle mass index (LVMi) and ≥10% of end-diastolic volume index (LVEDVi). Results Mean age of the cohort was 83±5.6 years, 55% were female (n=236), mean aortic valve area was 0.7±0.2cm2; mean LVMi and LVEDVi were 129.4±35.4gr/m2 and 54.5±22ml/m2 respectively. LVMi reduction ≥20% was observed in 30% (n=128) of patients; LVEDVi reduction ≥10% was observed in 44% (n=188) of patients. A total of 107 patients (25%) showed PCR. Female patients showed more PCR (p=0.04). Discongruence index was significantly higher in patients with PCR (15.5±1.9 vs 14.5±1.8, p=0.01) and was significantly associated to LVMi (121.5±28.9 vs 150.8±41.1g/m2) and LVEDVi individually (55.1±17.2 vs 42.7±16.7ml/m2; p&lt;0.01). Left ventricular ejection fraction (LVEF) had a statistically significant increase among patients with PCR (53.2±14.9 vs 56.7±11.5, p=0.04) global longitudinal strain showed improvement at 1-year follow-up as well, although not statistically significant (−17.3±3.7 vs −18.3±3.4 p=0.53). Conclusions The discongruence index is a simple and feasible parameter that can predict positive cardiac remodeling after TAVR which can have a significant impact in clinical outcome of patients. FUNDunding Acknowledgement Type of funding sources: None.


Author(s):  
Luca Nai Fovino ◽  
Alberto Cipriani ◽  
Tommaso Fabris ◽  
Mauro Massussi ◽  
Andrea Scotti ◽  
...  

Background - Conduction disturbances after transcatheter aortic valve replacement (TAVR) are often transient. Limited data exist on anatomic factors predisposing to PM dependency after TAVR. We sought to assess the rate and the possible predictors of pacemaker (PM) dependency after transcatheter aortic valve replacement (TAVR). Methods - Consecutive patients undergoing PM implantation up to 30-day after TAVR between May 2014 and September 2019 were included. Baseline electrocardiographic, computed tomography and procedural characteristics were collected, including valve implantation depth (ID) and membranous septum (MS) length, an anatomic surrogate of the distance between the aortic annulus and the His bundle. PM dependency at 30-day and 1-year and all-cause mortality during follow up were evaluated. Results - Of 728 TAVR patients, 112 (53.5% males, median age 81) underwent PM implantation after TAVR. Of these, 44.6% (50/112) were PM-dependent at 30-day, 46.7% (36/77) at 1-year. By multivariate analysis, independent predictors of 30-day PM dependency included left ventricular outflow tract (LVOT) calcifications under the left coronary cusp (LCC) (OR: 5.69, 95%CI: 1.45-22.31, p=0.013) and a difference between MS length and ID (ΔMSID) ≥3 mm (OR: 7.58, 95%CI: 2.07-27.78, p=0.002). Conversely, MS length and ID alone were not associated with PM dependency (OR: 0.79, 95%CI: 0.60-1.05, p=0.11 and OR: 1.11, 95%CI: 0.99-1.24, p=0.08). At a median follow-up of 28.1 [11.7-48.6] months, PM-dependent patients did not show a worse survival (p=0.26). Conclusions - Less than half of the patients undergoing PM implantation after TAVR are PM-dependent at mid-term follow-up. ΔMSID ≥3mm and presence of LVOT calcifications under the LCC, but not MS length nor ID alone, are predictive of long-term PM dependency after TAVR, thus influencing device selection and programming.


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