Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry

Modolo, Rodrigo; Chang, Chun-Chin; Tateishi, Hiroki; Miyazaki, Yosuke; Pighi, Michele; Abdelghani, Mohammad; Roos, Martin; Wolff, Quinten; Wykrzykowska, Joanna J.; Winter, Robbert J. de; Piazza, Nicolò; Richardt, Gert; Abdel‐Wahab, Mohamed; Soliman, Osama; Onuma, Yoshinobu; Mieghem, Nicolas Van; Serruys, Patrick W.

doi:10.4244/eij-d-19-00362

Cited by 17 publications

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References 24 publications

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“…Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI [5][6][7][8]. The aim of the present analysis is to compare the quantitative angiographic AR after TAVI among the three BEVs (i.e., Myval THV, Sapien 3 THV, and Sapien XT THV).…”

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confidence: 99%

“…The CAAS A-valve 2.0.2 (Pie Medical Imaging BV, Maastricht, the Netherlands) was used for assessment of quantitative angiographic AR. This method relies on the angiographic radiopaque density changes after contrast injection in the ascending aorta and its regurgitation (and subsequently density increase) in the left ventricular outflow tract (LVOT) [5][6][7][8]. The ratio between the areas under the two-time density curves of these regions is the AR in percentage.…”

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confidence: 99%

“…Comparison of LVOT-AR was performed using one-way analysis of variance and 2-by-2 comparisons using the post-hoc Bonferroni test. Stratification of continuous variable regurgitation into categorical variables was performed according to the following pre-determined threshold criteria: 1) none or trace regurgitation (LVOT-AR <6%); 2) mild (6% to ≤17%); and 3) moderate or severe(>17%) [7,8]. The proportion of patients with moderate or severe AR (LVOT-AR >17%) was compared using a chi-square test.…”

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confidence: 99%

“…Second, the gold standard for AR assessment is still echocardiography. However, the quantitative videodensitometric aortographic assessment of AR following TAVI by the CAAS A-Valve software has been extensively vetted and validated in-vitro, in-vivo, and in the clinical setting [5][6][7][8] and is progressively adopted in TAVI centers with the advent of an online software [9]. Finally, the durability of the three BEVs was not investigated.…”

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confidence: 99%

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Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

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Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloonexpandable valves. Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI. Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database. Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246). Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

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Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

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“…This quantitative assessment of the AR from the aorta into the left ventricle outflow tract is reported as the LVOT-AR parameter; the results are expressed in percentages and quantify the fraction of AR defined as the ratio between the area under the time-density curves assessed by video densitometry in the LVOT (region of interest, ROI) and in the aortic root (reference area) during a conventional aortography. Technical details of video densitometry analysis and validation in silico, in vivo, in animal models as well as in clinical correlations with magnetic resonance imaging, transthoracic and transesophageal echocardiography have been extensively reported in literature [10][11][12][13][14]. Postimplantation balloon dilatation improvement in AR has also been quantitatively documented in a series of 61 patients [15].…”

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Quantitative Angiographic Assessment of Aortic Regurgitation After Transcatheter Implantation of the Venus A-valve: Comparison with Other Self-Expanding Valves and Impact of a Learning Curve in a Single Chinese Center

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Objectives:We aimed to compare the quantitative angiographic aortic regurgitation (AR) into the left ventricular out flow tract (LVOT-AR) of five different types of transcatheter selfexpanding valves and to investigate the impact of the learning curve on post-TAVR AR. Background: Quantitative video densitometric aortography is an objective, accurate, and reproducible tool for assessment of AR following TAVR. Methods and results: This retrospective academic core-lab analysis, analyzed 1150 consecutive cine aortograms performed immediately post-TAVR. Quantitative angiographic AR of postprocedural aortography in 181 consecutive patients, who underwent TAVR with the Venus A-valve in a single Chinese center, were compared to the results of Evolut Pro, Evolut R, CoreValve, (Medtronic, Dublin, Ireland) and Acurate Neo (Boston Scientific, Massachusetts, US) transcatheter heart valves (THVs), from a previously published pooled database. Among the 181 aortograms of patients treated with the Venus A-Valve, 113 (62.4%) were analyzable for quantitative assessment of AR. The mean LVOT-AR was 8.9% ± 10.0% with 14.2% of patients having moderate or severe AR in the Venus A-valve group. No significant difference in mean LVOT-AR was observed between Evolut Pro, Evolut R, Acurate Neo, and Venus A-valve. The incidence of LVOT-AR >17%, which correlates with echocardiographic derived ≥ moderate AR, with the Evolut Pro was lower than with the Venus A-valve (5.3% vs. 14.2%, p = 0.034), but was not different from the Evolut R (5.3% vs. 8.8%, p = 0.612), or the Acurate Neo (5.3% vs. 11.3% p = 0.16) systems. A landmark analysis after recruitment of the first half of patients treated with the Venus A valve (N = 56), showed a significantly lower mean LVOT-AR in the second half of the series (11.3% ± 11.9% vs. 6.5% ± 7.1%, p = 0.011). The incidence of LVOT-AR >17% in the latest 57 cases was also numerically lower (7.0% vs. 21.4%, p = 0.857) and compared favorably with the best in class of the self-expanding valves. Conclusion:The Venus A-valve has comparable mean LVOT-AR to other self-expanding valves but has a higher rate of moderate or severe AR than the Evolut Pro THV. However, after completion of a learning phase, results improved and compared favorably with the best in class of the Wang et al: Quantitative Angiographic Assessment of Aortic Regurgitation After Transcatheter Implantation of the Venus A-valve Art. 54, page 2 of 8commercially available self-expanding valves. These findings should be confirmed in prospective randomized comparisons of AR between different THVs.

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Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease

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Aims To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). Methods The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. Results Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08–1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83–1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p-interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11–4.23, p < 0.001) compared to those without CVD. Conclusions The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. Trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract

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Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry

Cited by 17 publications

References 24 publications

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

Quantitative Angiographic Assessment of Aortic Regurgitation After Transcatheter Implantation of the Venus A-valve: Comparison with Other Self-Expanding Valves and Impact of a Learning Curve in a Single Chinese Center

Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease

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