Elevated Transvalvular Gradients Research Articles

ACURATE neo2 versus SAPIEN 3 Ultra for transcatheter aortic valve implantation.

No comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV). We aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV. A total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra (n=748). The primary endpoint was device success according to the latest Valve Academic Research Consortium definitions. The association of the THV used and the primary endpoint was assessed using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified 472 matched pairs. Results: After PSM, there were no relevant differences between the groups. While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001). Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio [OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were comparable between the 2 groups. Short-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall, comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates of device success. Rates of mild PVL were significantly lower with the Ultra THV.

Coagulation derangement and risk factors for valve thrombosis following transcatheter aortic valve implantation

AimsDurability of transcatheter aortic valve implantation (TAVI) is key to its expansion. We sought to identify incidence of valve thrombosis and predictors of valve thrombosis in our single centre with...

TCT-647 Hemodynamic valve deterioration following transcatheter aortic valve implantation: prevalence and predictors of elevated transvalvular gradients

TCT-647 Hemodynamic valve deterioration following transcatheter aortic valve implantation: prevalence and predictors of elevated transvalvular gradients

Mitral valve replacement with the novel TRIBIO and an established stented bioprosthesis in a sheep model

Heart valve replacement with a bioprosthesis is one of the most frequently performed procedures in cardiac surgery and represents a highly effective therapy to relieve diseased heart valves. Nevertheless, as postoperatively elevated transvalvular gradients and prosthesis-patient mismatch are reported as shortcomings of the procedure or of the currently used devices, there is a need for novel bioprostheses with improved haemodynamics. This study presents preclinical haemodynamic results after mitral valve replacement with the novel TRIBIO bioprosthesis (TRIBIO) compared with an established bioprosthesis in a sheep model. Six female sheep had their mitral valves replaced with the TRIBIO and 3 with the Carpentier-Edwards Perimount, both sized 19 mm. The TRIBIO consists of a flexible valve-bearing crown, a force-decoupled interface and an intra-annular base ring. Mean and peak transvalvular gradients as well as an effective orifice area were monitored in both groups using transthoracic echocardiography over the course of the 90-day study. In both groups, haemodynamic performance diminished over time. The TRIBIO demonstrated overall superior haemodynamics, i.e. lower transvalvular gradients and a larger effective orifice area, although the results were not statistically significant. On Day 90, the mean values for the mean and peak transvalvular gradients and the effective orifice area were 6 mmHg, 10.2 mmHg and 1.2 cm2 for the TRIBIO and 10 mmHg, 15.8 mmHg and 0.8 cm2 for the Carpentier-Edwards Perimount, respectively. This study demonstrates a trend towards improved preclinical haemodynamic performance following mitral valve replacement with the TRIBIO compared to that with an established bioprosthesis in a sheep model.

Leaflet motion abnormality after TAVI: genuine threat or much ado about nothing?

Symptomatic transcatheter heart valve (THV) thrombosis is noted in up to 1% of patients after transcatheter aortic valve replacement. Recently, hypoattenuated leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves associated with normal transvalvular gradients (and possibly related to subclinical leaflet thrombosis) have been reported. While trans-thoracic echocardiography is a useful initial screening imaging modality for the detection of symptomatic THV thrombosis associated with elevated transvalvular gradients, it has limited utility in the detection of subclinical THV thrombosis. In the present article, we describe the incidence, clinical presentation and strategies for the prevention and treatment of THV thrombosis, as well as the role of imaging modalities in the diagnosis and management of this phenomenon.

1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial

BackgroundThe use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve. ObjectivesThe aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up. MethodsThe investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function. ResultsAt 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval [CI]: 0.73 to 2.50; p = 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p = 0.54) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p = 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p = 0.19) did not statistically significantly differ between the 2 groups. Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%; p = 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p = 0.005). ConclusionsDespite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon- and self-expandable prostheses that were not statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial; NCT01645202)

Falsely Elevated Valve Gradients by Echocardiography in the 3f Aortic Bioprosthesis

The 3f Aortic Bioprosthesis (Medtronic, Inc, Minneapolis, MN) is a stentless aortic valve with a novel design that resembles a "tube within a tube." Although it has the potential for improved durability and hemodynamic performance, long-term data on this valve remain elusive. We present here 3 patients in whom postoperative echocardiography revealed significantly elevated transvalvular gradients of the 3f valve while transcatheter gradients proved to be negligible. By virtue of the unique design of the 3f bioprosthesis, great caution should be taken when interpreting echocardiographically derived gradients.