Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve

BackgroundThe balloon-expandable SAPIEN 3 (S3) is superior to the older-generation balloon-expandable SAPIEN XT (XT) in a lower incidence of paravalvular aortic regurgitation, lower complication rates and better survival in transcatheter aortic valve implantation (TAVI). However, prosthesis–patient mismatch (PPM) more frequently occurs in S3 than XT. Further, little information is available on PPM after TAVI using S3 in Asians. This study aims to determine the incidence and predictors of PPM in S3 by focusing on the difference between S3 and XT using data from a Japanese multicentre registry.MethodsFrom the Optimised transCathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry, 2134 patients undergoing TAVI using S3 or XT were included. PPM was defined as moderate if ≧0.65 but ≦0.85 cm2/m2 or severe if <0.65 cm2/m2 at the indexed effective orifice area by postprocedural echocardiography.ResultsThe incidence of moderate and severe PPM in S3 was 13.3% and 1.3%, respectively. The 20 mm transcatheter heart valve (THV) was more frequently used in S3 than XT (7.4% vs 2.4%, p<0.0001). PPM was more frequently observed in S3 than XT (14.7% vs 8.8%, p<0.0001). Multivariate logistic regression analysis revealed S3 predicted PPM (OR 1.92 (95% CI 1.35 to 2.74), p=0.0003). The mutual predictors for PPM between S3 and XT were younger age, larger body surface area, smaller aortic valve area, no balloon postdilatation and the use of 20 mm and 23 mm THV. When comparing 23 mm, 26 mm and 29 mm S3, the ORs of 20 mm S3 were 5.67 (95% CI 2.88 to 11.12), 19.24 (95% CI 8.13 to 46.86) and 51.03 (95% CI 12.28 to 280.77), respectively.ConclusionsThe incidence of PPM after TAVI using S3 was 14.6% overall in this Asian population. PPM was more frequently observed in S3 than XT. A considerable number of patients were treated by the 20 mm S3 in an Asian cohort. The 20 mm THV was identified as a strong predictor for PPM.

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Early Safety and Efficacy of Sapien 3 20 mm Transcatheter Heart Valve Implantation in Small Japanese Body Size

The Heart Surgery Forum ◽

10.1532/hsf.1918 ◽

2018 ◽

Vol 21 (5) ◽

pp. E341-E344

Author(s):

Kentaro Meguro ◽

Ryota Kakizaki ◽

Takuya Hashimoto ◽

Tomoyoshi Yanagisawa ◽

Toshimi Koitabashi ◽

...

Keyword(s):

Body Size ◽

Aortic Valve ◽

Heart Valve ◽

Small Body ◽

Japanese Patients ◽

Aortic Valve Area ◽

Small Body Size ◽

Transcatheter Heart Valve ◽

Sapien 3 ◽

Valve Implantation

Background: Transcatheter aortic valve implantation (TAVI) is effective in treating severe aortic stenosis in inoperable or high-risk surgical patients, however, the little is known about outcomes after Sapien 3 20 mm transcatheter heart valve (THV) implantation. The purpose of this study was to investigate the short term outcomes of Sapien 3 20 mm THV implantation in Japanese people with a small body size. Methods: We retrospectively collected the hospital records of consecutive patients who underwent TAVI using the Sapien 3 20 mm THV between October 2016 and March 2017. Clinical and echocardiographic data from before and one week after TAVI were collected. Results: Six Japanese patients (all female, mean age 89 ± 5 years, body surface area [BSA] 1.29 ± 0.16m2) received a Sapien 3 20 mm THV. All the procedures were feasible and successful, and the 30-day mortality rate was 0%. The functional class and the echocardiographic findings significantly improved (aortic valve area, 0.5 ± 0.1 cm2 to 0.8 ± 0.1cm2; mean pressure gradient, 55 ± 15 mmHg to 19 ± 7 mmHg; P = .043, respectively). However, the values of the indexed effective orifice area in all patients after Sapien 3 20 mm THV implantation were less than 0.85 cm2/m2, suggesting prosthesis-patient mismatch (PPM). Conclusions: The implantation of a Sapien 3 20 mm THV was safe and effective in high surgical risk elderly Japanese patients with a small body size. PPM after Sapien 3 20mm THV may be prevalent among Asians with small body sizes. Careful clinical follow-up will be necessary after Sapien 3 20 mm THV implantation.

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Aortic valve function post-replacement of severe aortic stenosis by transcatheter procedure versus surgery: a systematic review and metanalysis

Scientific Reports ◽

10.1038/s41598-021-91548-x ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Charbel Abi Khalil ◽

Barbara Ignatiuk ◽

Guliz Erdem ◽

Hiam Chemaitelly ◽

Fabio Barilli ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Stenosis ◽

Aortic Valve Replacement ◽

Valve Replacement ◽

Randomized Clinical Trials ◽

Severe Aortic Stenosis ◽

Paravalvular Leak ◽

Effective Orifice Area ◽

Surgical Aortic Valve Replacement ◽

Transcatheter Heart Valve

AbstractTranscatheter aortic valve replacement (TAVR) has shown to reduce mortality compared to surgical aortic valve replacement (sAVR). However, it is unknown which procedure is associated with better post-procedural valvular function. We conducted a meta-analysis of randomized clinical trials that compared TAVR to sAVR for at least 2 years. The primary outcome was post-procedural patient-prosthesis-mismatch (PPM). Secondary outcomes were post-procedural and 2-year: effective orifice area (EOA), paravalvular gradient (PVG) and moderate/severe paravalvular leak (PVL). We identified 6 trials with a total of 7022 participants with severe aortic stenosis. TAVR was associated with 37% (95% CI [0.51–0.78) mean RR reduction of post-procedural PPM, a decrease that was not affected by the surgical risk at inclusion, neither by the transcatheter heart valve system. Postprocedural changes in gradient and EOA were also in favor of TAVR as there was a pooled mean difference decrease of 0.56 (95% CI [0.73–0.38]) in gradient and an increase of 0.47 (95% CI [0.38–0.56]) in EOA. Additionally, self-expandable valves were associated with a higher decrease in gradient than balloon ones (beta = 0.38; 95% CI [0.12–0.64]). However, TAVR was associated with a higher risk of moderate/severe PVL (pooled RR: 9.54, 95% CI [5.53–16.46]). All results were sustainable at 2 years.

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Impact of the Trifecta bioprosthetic valve in patients with low-flow severe aortic stenosis

Heart and Vessels ◽

10.1007/s00380-021-01802-5 ◽

2021 ◽

Author(s):

Tohru Takaseya ◽

Atsunobu Oryoji ◽

Kazuyoshi Takagi ◽

Tomofumi Fukuda ◽

Koichi Arinaga ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Stenosis ◽

Severe Aortic Stenosis ◽

Stroke Volume Index ◽

Low Flow ◽

Volume Index ◽

Effective Orifice Area ◽

Aortic Valve Area ◽

Hemodynamic Performance ◽

Mid Term Results

AbstractAortic stenosis (AS) is the most common valve disorder in advanced age. Previous reports have shown that low-flow status of the left ventricle is an independent predictor of cardiovascular mortality after surgery. The Trifecta bioprosthesis has recently shown favorable hemodynamic performance. This study aimed to evaluate the effect of the Trifecta bioprosthesis, which has a large effective orifice area, in patients with low-flow severe AS who have a poor prognosis. We retrospectively evaluated 94 consecutive patients with severe AS who underwent aortic valve replacement (AVR). Patients were divided into two groups according to the stroke volume index (SVI): low-flow (LF) group (SVI < 35 ml/m2, n = 22) and normal-flow (NF) group (SVI ≥ 35 ml/m2, n = 72). Patients’ characteristics and early and mid-term results were compared between the two groups. There were no differences in patients’ characteristics, except for systolic blood pressure (LF:NF = 120:138 mmHg, p < 0.01) and the rate of atrial fibrillation between the groups. A preoperative echocardiogram showed that the pressure gradient was higher in the NF group than in the LF group, but aortic valve area was similar. The Trifecta bioprosthesis size was similar in both groups. The operative outcomes were not different between the groups. Severe patient–prosthesis mismatch (PPM) (< 0.65 cm2/m2) was not observed in either of the groups. There were no significant differences in mid-term results between the two groups. The favorable hemodynamic performance of the Trifecta bioprosthesis appears to have the similar outcomes in the LF and NF groups. AVR with the Trifecta bioprosthesis should be considered for avoidance of PPM, particularly in AS patients with LV dysfunction.

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Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.121.010543 ◽

2021 ◽

Vol 14 (9) ◽

Author(s):

Tamim M. Nazif ◽

Thomas J. Cahill ◽

David Daniels ◽

James M. McCabe ◽

Mark Reisman ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Clinical Outcomes ◽

Valve Replacement ◽

Heart Valve ◽

Transcatheter Aortic Valve Replacement ◽

Transcatheter Aortic Valve ◽

Transcatheter Heart Valve ◽

Sapien 3 ◽

Transcatheter Valve

Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry. Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days. Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score–matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P =0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P <0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P =0.10), major vascular complications (1.1% versus 1.0%, P =0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P =0.81). Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.

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