Transcatheter Aortic Valve Replacement With Different Valve Types in Elliptic Aortic Annuli

Maeno, Yoshio; Abramowitz, Yigal; Yoon, Sung‐Han; Jilaihawi, Hasan; Raul, Sharma; Israr, Sharjeel; Miyamoto, Masaki; Kawamori, Hiroyuki; Kazuno, Yoshio; Rami, Tanya; Takahashi, Nobuyuki; Mangat, Geeteshwar; Kashif, Mohammad; Chakravarty, Tarun; Nakamura, Mamoo; Cheng, Wen; Makkar, Raj

doi:10.1253/circj.cj-16-1240

Cited by 13 publications

(19 citation statements)

References 24 publications

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“…Although the incidence of moderate AR at 1 year increased to 6.4% in the Evolut R group, all cases had elliptical annuli. Previous studies reported that elliptical annuli had a higher incidence of more than moderate AR, 25 but there was no study comparing third‐generation THVs.…”

Section: Discussionmentioning

confidence: 98%

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Hase

Yoshijima

Yanagisawa

et al. 2020

Cathet Cardio Intervent

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Objectives To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. Background Few studies have directly compared TAVR outcomes using third‐generation THVs, focusing on patients with small aortic annuli. Methods In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third‐generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. Results The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0–11.9] vs. 12.0 [IQR: 9.9–16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01–1.46] vs. 1.08 [IQR: 0.90–1.28] cm2/m2, p < .001}. However, no significant differences were reported in the incidence of severe prosthesis‐patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all‐cause mortality (log‐lank test, p = .81). Conclusions TAVR for patients with a small annulus using third‐generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all‐cause mortality at 1 year was similar between both groups.

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Section: Discussionmentioning

confidence: 98%

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Hase

Yoshijima

Yanagisawa

et al. 2020

Cathet Cardio Intervent

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“…Residual mild leaks associated with higher mortalities at two years are reported in up to 61% of patients after TAVI [13], [14]. The main causes of regurgitation are malpositioning or undersizing of the prosthetic device [10]- [12], an elliptic shape of the aortic annulus or an irregular distribution of calcium depositions within the surrounding tissue [15], [16]. In such cases, the expansion of the prosthetic valve might be incomplete or uneven.…”

Section: Introductionmentioning

confidence: 99%

Sizing the aortic annulus with a robotised, commercially available soft balloon catheter: in vitro study on idealised phantoms

Palombi

Bosi

Giuseppe

et al. 2019

2019 International Conference on Robotics and Automation (ICRA)

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Transcatheter aortic valve implantation (TAVI) is a minimally invasive surgical technique to treat aortic heart valve diseases. According to current clinical guidelines, the implanted prosthetic valve replacing the native one is selected based on pre-operative size assessment of the aortic annulus through different imaging techniques. That very often leads to suboptimal device selection resulting in major complications, such as prosthetic valve leakage or interruption of the cardiac electrical signal. In this paper, we propose a new, intra-operative approach to determine the diameter of theaortic annulus exploiting intraballoon pressure and volume data, acquired from a robotised valvuloplasty balloon catheter. An inflation device, capable of collecting real-time intra-balloon pressure and volume data, was designed and interfaced with a commercially available valvuloplasty balloon catheter. A sizing algorithm allowing to precisely estimate the annular diameter was integrated. The algorithm relies on a characterised analytical model of the balloon free inflation and an iterative method based on linear regression. In vitro tests were performed on idealised aortic phantoms. Experimental results show that pressure-volume data can be used to determine annular diameters bigger than the unstretched diameter of the balloon catheter. For these cases, the proposed approach exhibited good precision (maximum average error 0.93%) and good repeatability (maximum standard deviation ±0.11 mm).

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“…This finding might be related to generally lower gradients measured during transthoracic echocardiography after implantation of larger THV devices; however, it has to be noted that the implantation of self‐expandable valves in patients with particularly large or elliptical annuli tends to demonstrate generally lower rates of device success compared to balloon‐expandable valves. 15 , 16 , 17 …”

Section: Discussionmentioning

confidence: 99%

The use of semi‐compliant versus non‐compliant balloon systems for predilatation during the implantation of self‐expandable transcatheter aortic valves

Mach¹,

Szalkiewicz²,

Poschner

et al. 2021

Eur J Clin Investigation

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Transcatheter Aortic Valve Replacement With Different Valve Types in Elliptic Aortic Annuli

Cited by 13 publications

References 24 publications

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

Sizing the aortic annulus with a robotised, commercially available soft balloon catheter: in vitro study on idealised phantoms

The use of semi‐compliant versus non‐compliant balloon systems for predilatation during the implantation of self‐expandable transcatheter aortic valves

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