Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial

Waksman, Ron; Torguson, Rebecca; Medranda, Giorgio A.; Shea, Corey; Zhang, Cheng; Gordon, Paul; Ehsan, Afshin; Wilson, Sean R.; Levitt, Robert G.; Hahn, C; Parikh, Puja B.; Bilfinger, Thomas V.; Butzel, David; Buchanan, Scott; Hanna, Nicholas; Buchbinder, Maurice; Asch, Federico M.; Weissman, Gaby; Ben‐Dor, Itsik; Shults, Christian; García‐García, Héctor M.; Satler, Lowell F.; Rogers, Toby

doi:10.1016/j.ahj.2021.03.006

Cited by 16 publications

(14 citation statements)

References 13 publications

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“…Although previous reports, include 1 from our center, have been less certain of such associations, the present study is an expansion and was conducted with analyses for prosthesis deformation and HALT performed in a CT core laboratory. 1,3,4,36,37 Differences in the association with clinical outcomes in our study might be explained through differences in the patient population, the large size of our cohort, and the prospective acquisition of the CT examinations. Nevertheless, our findings for the association of HALT with clinical outcomes need further validation.…”

Section: Discussionmentioning

confidence: 89%

Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes

et al. 2022

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Background: Although transcatheter aortic valve replacement (TAVR) therapy continues to grow, there have been concerns about the occurrence of hypoattenuating leaflet thickening (HALT), which may affect prosthesis function or durability. This study aimed to examine prosthesis frame factors and correlate their extent to the frequency of HALT and clinical outcomes. Methods: We prospectively examined 565 patients with cardiac computed tomography screening for HALT at 30 days after balloon-expandable SAPIEN3 and self-expanding EVOLUT TAVR. Deformation of the TAVR prostheses, asymmetric prosthesis leaflet expansion, prosthesis sinus volumes, and commissural alignment were analyzed on the postprocedural computed tomography. For descriptive purposes, an index of prosthesis deformation was calculated, with values >1.00 representing relative midsegment underexpansion. A time-to-event model was performed to evaluate the association of HALT with the clinical outcome. Results: Overall, HALT was present in 21% of SAPIEN3 patients and in 16% of EVOLUT patients at 30 days after TAVR. The occurrence of HALT was directly associated with greater prosthesis frame deformation ( P <0.001), worse asymmetry of the leaflets ( P <0.001), and smaller TAVR neosinus volumes ( P <0.001). These relations were present in both prosthetic types and in all of their size ranges (all P <0.05). In multivariable analyses that include clinical variables previously associated with HALT (eg, anticoagulant therapy), variables of TAVR prosthesis deformation remained predictive of HALT. Although HALT was not associated with changes in prosthetic hemodynamics, its presence was associated with the risk of mortality at 1 year, with respect to greater incidences of all-cause mortality (hazard ratio, 2.98 [95% CI, 1.57–5.63]; P =0.001), cardiac death (hazard ratio, 4.58 [95% CI, 1.81–11.6]; P =0.001), and a composite outcome of all-cause mortality and heart failure hospitalization (hazard ratio, 1.94 [95% CI, 1.14–3.30]; P =0.02) with adjustment for age, sex, and comorbidities. Conclusions: Nonuniform expansion of TAVR prostheses resulting in frame deformation, asymmetric leaflet, and smaller neosinus volume is related to occurrence of HALT in patients who undergo TAVR. These data may have implications for both prosthesis valve design and deployment techniques to improve clinical outcomes for these patients.

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Section: Discussionmentioning

confidence: 89%

Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes

et al. 2022

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“…The risk profile of TAVI is a highly relevant topic, as there is currently a discussion on whether the indication should be extended to include patients at lower risk 2 . The main risks associated with TAVI deterioration can be divided into those related to structural valve degeneration and to those unrelated to the state of the valve, such as endocarditis and thrombosis 15 .…”

Section: Discussionmentioning

confidence: 99%

“…Transcatheter aortic valve implantation (TAVI), has become the default treatment approach for severe aortic tricuspid valve stenosis in patients who are inoperable or at high or intermediate surgical risk with encouraging results also in patients considered at low procedural risk 1,2 . Long‐term follow‐up indicates transcatheter heart valve (THV) thrombosis as a relevant complication.…”

Section: Introductionmentioning

confidence: 99%

Transcatheter aortic valve thrombosis: Data from a French multicenter cohort analysis

Mouyen

Manigold

Collet

et al. 2021

Cathet Cardio Intervent

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Objectives To evaluate the effectiveness of anticoagulant therapies in patients with clinical transcatheter heart valve (THV) thrombosis, to describe complications, and to assess their risk profile was the objectives. Background Little research has been conducted on clinical THV thrombosis. Methods Patients with clinical THV thrombosis were identified based on greater than 50% increased transvalvular gradient on transthoracic echocardiogram confirmed by 4‐dimensional computed tomography, transesophageal echocardiogram, or regression with anticoagulant therapy. A cohort free from thrombosis for more than 1,100 days postprocedure was used for comparison. Results Fifty‐four patients with clinical THV thrombosis were identified. Most subjects (98.1%) received anticoagulant therapy which was effective (≥50% reduction in transvalvular gradient or return to postprocedure value) in 96%. The rate of serious hemodynamic or embolic complications in the thrombosis population was 31.5%. A multivariate analysis of subjects with and without thrombosis indicated a significantly increased risk of thrombosis from preexisting thrombocytopenia (odds ratio [OR] 9.96), absence of predilatation (OR = 5.67), renal insufficiency (OR = 4.84), and >10 mmHg mean transvalvular gradient postprocedure (OR = 3.36). No recurrence of thrombosis was identified during on average 685 days follow‐up. Conclusions These data, from one of the largest cohorts with clinical THV thrombosis confirm anticoagulants appear effective. The rate of serious associated complications was high. The findings underline the importance of recognizing risk factors for thrombosis.

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“…Since the first successful TAVR was performed in France in 2002, the technology has been widely developed worldwide, and the indications for this operation have expanded from middleand high-risk surgical patients to low-risk patients with aortic stenosis (Waksman et al, 2019;Coylewright et al, 2020). With the popularization of this technique, more and more patients are expected to undergo TAVR in the future.…”

Section: Discussionmentioning

confidence: 99%

Effect of Eccentric Calcification of an Aortic Valve on the Implant Depth of a Venus-A Prosthesis During Transcatheter Aortic Valve Replacement: A Retrospective Study

Liu

Park

et al. 2021

Front. Physiol.

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ObjectOur goal was to assess the implant depth of a Venus-A prosthesis during transcatheter aortic valve replacement (TAVR) when the areas of eccentric calcification were distributed in different sections of the aortic valve.MethodsA total of 53 patients with eccentric calcification of the aortic valve who underwent TAVR with a Venus-A prosthesis from January 2018 to November 2019 were retrospectively analyzed. The patients were divided into three groups (A, B, and C) according to the location of the eccentric calcification, which was determined by preprocedural computerized tomography angiography (CTA) images. The prosthesis release process and position were evaluated by contrast aortography during TAVR, and the differences in valve implant depths were compared among the three groups. The effects of different aortic root structures and procedural strategies on prosthesis implant depth were analyzed.ResultsEleven patients had eccentric calcification in region A; 19 patients, in region B; and 23 patients, in region C. The patients with eccentric calcification in region B had a higher risk of prosthesis migration (10.5% upward and 21.1% downward), and the position of the prosthesis after TAVR in group B was the deepest among the three groups. When eccentric calcification was located in region A or C, the prosthesis was released at the standard position with more stability, and the location of the prosthesis was less deep after TAVR (region A: 4.12 ± 3.4 mm; region B: 10.2 ± 5.3 mm; region C: 8.4 ± 4.0 mm; region A vs. region B, P = 0.0004; region C vs. region B; and P = 0.0360). In addition, the left ventricular outflow tract (LVOT) (P = 0.0213) and aortic root angulation (P = 0.0263) also had a significant effect on implant depth in the aortic root structure of the patients. The prosthesis size was 28.3 ± 2.4 in the deep implant group and 26.4 ± 2.0 in the appropriate implant group (P = 0.0068).ConclusionThe implant depth of the Venus-A prosthesis is closely related to the distribution of eccentric calcification in the aortic valve during TAVR. Surgeons should adjust the surgical strategy according to aortic root morphology to prevent prosthesis migration.

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Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial

Cited by 16 publications

References 13 publications

Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes

Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes

Transcatheter aortic valve thrombosis: Data from a French multicenter cohort analysis

Effect of Eccentric Calcification of an Aortic Valve on the Implant Depth of a Venus-A Prosthesis During Transcatheter Aortic Valve Replacement: A Retrospective Study

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