Incidence and Severity of Paravalvular Aortic Regurgitation With Multidetector Computed Tomography Nominal Area Oversizing or Undersizing After Transcatheter Heart Valve Replacement With the Sapien 3

Yang, Tae–Hyun; Webb, John G.; Blanke, Philipp; Dvir, Danny; Hansson, Nicolaj C.; Nørgaard, Bjarne Linde; Thompson, Christopher R.; Thomas, Martyn; Wendler, Olaf; Vahanian, Alec; Himbert, Dominique; Kodali, Susheel; Hahn, Rebecca T.; Thourani, Vinod H.; Schymik, Gerhard; Precious, Bruce; Berger, Adam; Wood, David; Pîbarot, Philippe; Rodés‐Cabau, Josep; Jaber, Wael A.; Leon, Martin B.; Walther, Thomas; Leipsic, Jonathon

doi:10.1016/j.jcin.2014.10.014

Cited by 123 publications

(65 citation statements)

References 20 publications

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“…However, it is generally accepted that before introducing TAVR on a more routine basis into younger and lower-risk patients, the extent of paravalvular leakage needs to be comparable with that occurring with surgical prostheses. New data are encouraging because annulus measurement by CT scan, [19][20][21][22] optimization of the TAVR procedure, and improvements in prosthesis design have helped to mitigate paravalvular leakage 24 as well as conduction abnormalities. Subgroup analyses of all-cause mortality at 2 years were conducted for several baseline characteristics.…”

Section: Discussionmentioning

confidence: 99%

Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement

Søndergaard

Steinbrüchel

Ihlemann

et al. 2016

Circ: Cardiovascular Interventions

171

114

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Background— The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomize all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) with the CoreValve self-expanding bioprosthesis or surgical aortic valve replacement (SAVR), including a lower-risk patient population than previous trials. This article reports 2-year clinical and echocardiographic outcomes from the NOTION trial. Methods and Results— Two-hundred eighty patients from 3 centers in Denmark and Sweden were randomized to either TAVR (n=145) or SAVR (n=135) with follow-up planned for 5 years. There was no difference in all-cause mortality at 2 years between TAVR and SAVR (8.0% versus 9.8%, respectively; P =0.54) or cardiovascular mortality (6.5% versus 9.1%; P =0.40). The composite outcome of all-cause mortality, stroke, or myocardial infarction was also similar (15.8% versus 18.8%, P =0.43). Forward-flow hemodynamics were improved following both procedures, with effective orifice area significantly more improved after TAVR than SAVR (effective orifice area, 1.7 versus 1.4 cm 2 at 3 months). Mean valve gradients were similar after TAVR and SAVR. When patients were categorized according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) (<4% versus ≥4%), there was no statistically significant difference for TAVR and SAVR groups in the composite outcome for low-risk (14.7%, 95% confidence interval, 8.3–21.2 versus 16.8%; 95% confidence interval, 9.7–23.8; P =0.58) or intermediate-risk patients (21.1% versus 27.1%; P =0.59). Conclusions— Two-year results from the NOTION trial demonstrate the continuing safety and effectiveness of TAVR in lower-risk patients. Longer-term data are needed to verify the durability of this procedure in this patient population. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01057173.

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Section: Discussionmentioning

confidence: 99%

Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement

Søndergaard

Steinbrüchel

Ihlemann

et al. 2016

Circ: Cardiovascular Interventions

171

114

View full text Add to dashboard Cite

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“…We chose an arc length of 5 mm to avoid an artificial increase in perimeter by contour irregularities as described previously. 21 The presence, distribution and extent of annular and subannular calcification was semi-quantitatively graded on a four point scale 11,22 : grade 0: no calcification; grade 1 (mild): one nodule of calcium extending <5 mm in any dimension and covering <10% of the perimeter of the LVOT; grade 2 (moderate): 2 nodules of calcification or 1 extending >5 mm in any direction or covering >10% of the perimeter of the LVOT; and grade 3 (severe): multiple nodules of calcification or single focus extending >1 cm in length or covering >20% of the perimeter of the LVOT.…”

Section: Annular Analysismentioning

confidence: 99%

Dynamism of the aortic annulus: Effect of diastolic versus systolic CT annular measurements on device selection in transcatheter aortic valve replacement (TAVR)

Murphy

Blanke

Alaamri

et al. 2016

Journal of Cardiovascular Computed Tomography

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“…81 Important reductions of moderate-to-severe AR could be achieved using multislice computed tomographic-based valve sizing. 82,83 Newer devices-some are repositionable and totally retrievable-are provided with effective paravalvular sealing mechanisms, and their use is associated with a very low rate of moderate-tosevere AR.…”

Section: Aortic Regurgitationmentioning

confidence: 99%

Transcatheter Aortic Valve Implantation in Lower-Risk Patients With Aortic Stenosis

Abdelghani

Serruys

2016

Circ: Cardiovascular Interventions

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Abstract-Transcatheter aortic valve implantation underwent progressive improvements until it became the default therapy for inoperable patients, and a recommended therapy in high-risk operable patients with symptomatic severe aortic stenosis. In the lower-risk patient strata, a currently costly therapy that still has important complications with questionable durability is competing with the established effective and still-improving surgical replacement. This report tries to weigh the clinical evidence, the recent technical improvements, the durability, and the cost-effectiveness claims supporting the adoption of transcatheter aortic valve implantation in intermediate-low risk patients. The importance of appropriate patients' risk stratification and a more comprehensive approach to estimate that risk are also emphasized in the present report. (Circ Cardiovasc Interv. 2016;9:e002944.

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Incidence and Severity of Paravalvular Aortic Regurgitation With Multidetector Computed Tomography Nominal Area Oversizing or Undersizing After Transcatheter Heart Valve Replacement With the Sapien 3

Abstract: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.

Cited by 123 publications

References 20 publications

Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement

Two-Year Outcomes in Patients With Severe Aortic Valve Stenosis Randomized to Transcatheter Versus Surgical Aortic Valve Replacement

Dynamism of the aortic annulus: Effect of diastolic versus systolic CT annular measurements on device selection in transcatheter aortic valve replacement (TAVR)

Transcatheter Aortic Valve Implantation in Lower-Risk Patients With Aortic Stenosis

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