Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve

Zaid, Syed; George, Isaac; Khalique, Omar; Abramowitz, Yigal; Maeno, Yoshio; Makkar, Raj; Jilaihawi, Hasan; Kamioka, Norihiko; Thourani, Vinod H.; Babaliaros, Vasilis; Webb, John G.; Htun, N.; Attinger‐Toller, Adrian; Ahmad, Hasan; Kaple, Ryan; Sharma, Kapil; Kozina, Joseph; Kaneko, Tsuyoshi; Shah, Pinak; Hirji, Sameer; Desai, Nimesh D.; Anwaruddin, Saif; Jagasia, Dinesh; Herrmann, Howard C.; Basra, Sukhdeep S.; Mathur, Moses; Tan, Christina; Don, Creighton W.; Sharma, Rahul; Gafoor, Sameer; Zhang, Ming; Kapadia, Samir; Mick, Stephanie; Krishnaswamy, Amar; Amoroso, Nicholas; Salemi, Arash; Wong, S. Chiu; Kini, Annapoorna; Rodés‐Cabau, Josep; Leon, Martin B.; Kodali, Susheel

doi:10.1016/j.jcin.2018.03.034

Cited by 40 publications

(33 citation statements)

References 23 publications

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“…9 The incidence of moderate paravalvular regurgitation reported in this study (7.2%) was similar to a recent series of large annuli patients treated with the SAPIEN 3 valve (6.9%) (Edwards Lifesciences, Irvine, California), but incidence of permanent pacemaker was higher with the self-expanding prosthesis (15.7% vs. 6.3%). 18…”

Section: Discussionmentioning

confidence: 99%

Initial experience of a large, self‐expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters’ registry

Dowling

Firoozi

Doyle

et al. 2018

Cathet Cardio Intervent

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Objectives: The UK & Ireland Implanters’ registry is a multicenter registry which reports on real‐world experience with novel transcatheter heart valves. Background: The 34 mm Evolut R transcatheter aortic valve is a self‐expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. Methods: Between January 2017 and April 2018, clinical, procedural and 30‐day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium‐2(VARC‐2)‐defined endpoint of device success. The primary safety outcome was the VARC‐2‐defined composite endpoint of early safety at 30 days. Results: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2. Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all‐cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. Conclusions: Real‐world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

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Section: Discussionmentioning

confidence: 99%

Initial experience of a large, self‐expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters’ registry

Dowling

Firoozi

Doyle

et al. 2018

Cathet Cardio Intervent

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“…5 While we have previously reported acceptable short-and midterm outcomes in 29 mm S3 TAVR with extreme annular undersizing (EAU), there have thus far been no reports on EAU with the S3U TAV and associated outcomes. 6,7 With the expanded sealing skirt, we hypothesize that the S3U TAV may not incur worse PVL even in extremely undersized compared to nominally sized annular anatomy. In addition, implanting a smaller TAV with a shorter stent frame may have the potential advantage of enabling redo-TAVR due to the reduced risk of coronary obstruction, by reducing sinus sequestration risk from sealing off the sinotubular junction.…”

Section: Introductionmentioning

confidence: 99%

Outcomes and feasibility of redo‐TAVR after Sapien 3 Ultra TAVR in extremely‐undersized versus nominally‐sized annuli

Hooda

Zaid

Chuang

et al. 2022

Cathet Cardio Intervent

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Objectives: To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS). Background:The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo-TAVR but risk compromising hemodynamics.Methods: From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm 2 for 23 mm or >546 mm 2 for 26 mm) were compared to NAS (338-430 mm 2 for 23 mm or 430-546 mm 2 for 26 mm). In-hospital and 30-day outcomes, and redo-TAVR feasibility were determined.Results: There were 79 (21.6%) EAU patients, with more bicuspid (p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification (p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: −8.2 ± 2.6% vs. 4.0 ± 7.0%, p < 0.001; 26 mm: −8.9 ± 2.2% vs. 6.7 ± 6.9%, p < 0.001), more balloon overfilling (71.3% vs. 11.6%, p < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in-hospital or 30-day mortality and stroke (p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%-60.9% (vs. 4.3%-23.2%) would not be feasible for redo-TAVR due to high risk of coronary obstruction.

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“…Other study showed that while the rate of PVL of moderate or greater degree among patients with small aortic annulus (<18mm) was <6%, in the large aortic annulus (≥20mm) group was >11% (P = 0.009) [29]. Moreover, Tang et al [31] demonstrated that larger LVOT was associated with higher PVL. They hypothesized that the mechanism of PVL is due to a reduced LVOT seal zone.…”

Section: Discussionmentioning

confidence: 93%

Computed tomography assessment of the aortic root morphology in predicting the development of paravalvular leak following transcatheter aortic valve implantation

Nieznańska¹,

Zatorska²,

Stokłosa³

et al. 2021

Polish Archives of Internal Medicine

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Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve

Abstract: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

Cited by 40 publications

References 23 publications

Initial experience of a large, self‐expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters’ registry

Initial experience of a large, self‐expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters’ registry

Outcomes and feasibility of redo‐TAVR after Sapien 3 Ultra TAVR in extremely‐undersized versus nominally‐sized annuli

Computed tomography assessment of the aortic root morphology in predicting the development of paravalvular leak following transcatheter aortic valve implantation

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