SEVs Perform Better Than BEVs in East Asians With SAA Undergoing TAVR
Self-expanding valves (SEVs) are associated with less prosthesis-patient mismatch (PPM) in East Asian patients with small aortic annuli (SAA) undergoing TAVR, compared with balloon-expandable valves (BEVs), and provide superior hemodynamic performance, according to a study published Jan. 14 in JACC: Asia.
Most East Asians have lower BMI, smaller body surface area (BSA) and smaller aortic valve annular size compared with non-Asian populations, thus require smaller TAVR prostheses. Patients with SAA (annular diameter ≤23 mm, area ≤400-415 mm2 or perimeter ≤72 mm on CT) are at higher risk for residual gradients and PPM, which can lead to adverse cardiovascular events.
Ying-Hwa Chen, MD, PhD, and Howard C. Herrmann, MD, FACC, looked at the incidence of PPM in East Asian patients treated with small or large prostheses (26-/29-mm Sapien XT/Sapien 3 or 29-/31-/34-mm CoreValve/Evolut platform) using data from seven registries or studies conducted in East Asia, a population they note is heterogenous.
The OCEAN-TAVI registry of patients in Japan was used across three time periods. The average BSA in this population was 1.4 m2, which the authors noted contributed to reducing the incidence of PPM. The initial study included 1,546 patients (71% women) with 90% receiving BEVs, mainly Sapien XT. Small prostheses were used in 61.7%. Moderate and severe PPM occurred in 8.9% and 0.7% of patients, respectively, with Sapien 3 independently linked to PPM (odds ratio [OR], 2.73; p=0.0002). In a subsequent registry with 2,134 patients treated with BEV (69% women), 62.7% received smaller prostheses. Moderate and severe PPM occurred in 10% and 1%, respectively. Multivariate analysis identified Sapien 3 over Sapien XT (OR, 1.92; p=0.0003) and use of small prostheses as independent predictors of PPM.
A study with 8,750 patients treated with Sapien 3 (61% women) of whom 58% received small prostheses, the incidence of moderate and severe PPM was 12.8% and 2.0%, respectively. For patients with small prostheses, moderate and severe PPM occurred in 27.6% and 6.6% with 20-mm Sapien 3, and 14.6% and 2.4% with 23-mm Sapien 3, respectively. For larger prostheses, moderate and severe PPM were observed in 9.9% and 1.1% with 26-mm Sapien 3, and 5.2% and 0.9% with 29-mm Sapien 3, respectively.
The Multiracial Transpacific TAVR Registry included 562 Asian patients (mainly Korean; 49% women) with average BSA of 1.6 m2. Sapien 3 BEVs were used in 83%; 37% received small prostheses. PPM was significantly lower in Asians (33.6%; moderate 26.5%; severe 7.1%) compared with non-Asians (54.5%; moderate 29.8%; severe 24.7%). In a Korean TAVR registry, 660 patients were treated with BEV or SEV; 10.6% had a small annulus diameter (≤20 mm). PPM was significantly higher (33.3%) for those with smaller (33.3%) compared with larger annuli (19.2%) at 30 days but this difference was not significant at one year.
In a prospective single-center study of 201 Taiwanese TAVR patients treated with SEV, 56% women, average BSA was 1.6 m2. Small prostheses were used in 47%. Moderate and severe PPM were seen in 18.4% and 1.5%, respectively, with no significant link to valve size.
Overall, in East Asians, 47% to 59% have SAA, leading to insertion of smaller TAVR prostheses in 37% to 70% of patients. Among Japanese patients, PPM rates vary, depending on valve type and size. Of note, Sapien 3 and 20-/23-mm BEVs are significant predictors of PPM. In contrast, Korean patients have a 33.6% PPM rate with Sapien 3, while Taiwanese patients with SEVs have lower PPM rates.
The authors conclude that PPM incidence is significantly higher among patients receiving 20-/23-mm BEV, while consistent among various SEV sizes. They write that "SEVs demonstrate superior hemodynamic performance in East Asian patients with [SAA], underscoring the need for customized device selection and procedural planning to mitigate PPM risks in this population."
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery
Keywords: Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement, Aortic Valve, Asia, Southeastern, Far East