Clinical evaluation of the Hydra self‐expanding transcatheter aortic valve: 6 month results from the GENESIS trial

Chandra, Praveen; Jose, John; Mattummal, Shafeeq; Mahajan, Ajaykumar U; Govindan, Sajeev Chakanalil; Makhale, C.N.; Chandra, Sharad; Shetty, Ranjan; Mohanan, Sandeep; John, John F; Mehrotra, Sanjay; Søndergaard, Lars

doi:10.1002/ccd.29733

Cited by 7 publications

(25 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, RHD among TAVI candidates may increase in significance in the forthcoming years as a consequence of expansion of TAVI to younger patients and immigration from low-income and middle-income countries20; most importantly, however, RHD will come to the spotlight with dissemination of TAVI to middle-income countries 21. Affordable transcatheter heart valves (THV) developed in emerging countries22 23 may open the door to this technology for the rest of the world24 and catalyse the expansion of TAVI to patients with RHD.…”

Section: Discussionmentioning

confidence: 99%

Transcatheter aortic valve implantation in patients with rheumatic aortic stenosis

Okuno

Tomii

Buffle

et al. 2022

Heart

View full text Add to dashboard Cite

BackgroundRheumatic heart disease (RHD) accounts for the highest number of deaths from valvular heart disease globally. Yet, rheumatic aortic stenosis (AS) was excluded from landmark studies investigating the safety and efficacy of transcatheter aortic valve implantation (TAVI). We aimed to describe the clinical and anatomical characteristics of patients with rheumatic AS undergoing TAVI, and to compare procedural and clinical outcomes with patients undergoing TAVI for degenerative AS.MethodsIn a prospective TAVI registry, patients with rheumatic AS were identified based on International Classification of Diseases version 10 codes and/or a documented history of acute rheumatic fever and/or the World Heart Federation criteria for echocardiographic diagnosis of RHD, and were propensity score-matched in a 1:4 ratio to patients with degenerative AS.ResultsAmong 2329 patients undergoing TAVI, 105 (4.5%) had rheumatic AS. Compared with patients with degenerative AS, patients with rheumatic AS were more commonly female, older, had higher surgical risk and more commonly suffered from multivalvular heart disease. In the unmatched cohort, both technical success (85.7% vs 85.9%, p=0.887) and 1-year cardiovascular mortality (10.0% vs 8.6%; HR 1.16, 95% CI 0.61 to 2.18, p=0.656) were comparable between patients with rheumatic and degenerative AS. In contrast, patients with rheumatic AS had lower rates of 30-day and 1-year cardiovascular mortality compared with matched patients with degenerative AS (1.9% vs 8.9%, adjusted HR (HRadj) 0.18, 95% CI 0.04 to 0.80, p=0.024; and 10.0% vs 20.3%, HRadj 0.44, 95% CI 0.24 to 0.84, p=0.012, respectively).ConclusionTAVI may be a safe and effective treatment strategy for selected elderly patients with rheumatic AS.Trial registration numberNCT01368250.

show abstract

Section: Discussionmentioning

confidence: 99%

Transcatheter aortic valve implantation in patients with rheumatic aortic stenosis

Okuno

Tomii

Buffle

et al. 2022

Heart

View full text Add to dashboard Cite

show abstract

“…However, the lower radial strength may lead to less mechanical injury to the conduction system and explain the lower rate for a PPM implantation (from 8.3 to 12.3%9) [27][28][29] compared to the reported PPM following the implantation of other SE THVs (17.4% to 34.1%) [32,33]. On the other hand, the low radial force may translate into incomplete apposition of the device to the virtual basal ring, increasing the risk of PVL [19]. However, data from observational site-reported studies showed an incidence of moderate-to-severe PVL ranging from 1.4% to 4.8% [33][34][35].…”

Section: Acurate Neo™mentioning

confidence: 99%

“…Both the delivery and the loading system were the same for all three THV sizes. The GENESIS trial [19] assessed the performance of the SE Hydra THV system in patients with severe AS and high or extreme surgical risk. In this trial, VARC-2 defined device success was 92.5%.…”

Section: Self-expanding Transcatheter Heart Valvesmentioning

confidence: 99%

An Update on New Generation Transcatheter Aortic Valves and Delivery Systems

Santangelo

Ielasi

Pellicano

et al. 2022

JCM

View full text Add to dashboard Cite

Over the last 15 years, the management of aortic valve disease has been changed by transcatheter aortic valve replacement, which has become the standard of care across the entire spectrum of surgical risk. As a result of continuous evolution of this technique, several next-generation transcatheter heart valves (THVs) have been developed to minimize procedural complications and improve patient outcomes. This review aims to provide an update on the new generation THVs and delivery systems.

show abstract

“…Fifteen registries and studies reported procedural success [16][17][18][19][21][22][23][24][25][26]28,29,[32][33][34]. The mean success rate was 95.40% with a weighted standard deviation (SD) of 1.5% [16][17][18][19][21][22][23][24][25][26]28,29,[32][33][34].…”

Section: Procedural Successmentioning

confidence: 99%

“…Eighteen studies reported that a total of 224 out of 13,509 patients died by 30 days after TAVI, giving a weighted mean for 30-day mortality rate of 1.66%, with a weighted standard deviation of 1.2% [8,[17][18][19][20][21][22][23][24][25][26][28][29][30][31][32][33].…”

Section: -Day Mortalitymentioning

confidence: 99%

Transcatheter Aortic Valve Implantation Outcomes and Challenges in Asia: A Systematic Review and Meta-Analysis

Rivera¹,

Luna²,

Ansay³

et al. 2023

Rev. Cardiovasc. Med.

View full text Add to dashboard Cite

Background: Aortic stenosis (AS) is the world's most prevalent heart valve disease. Transcatheter aortic valve replacement (TAVR) or Implantation (TAVI) is widely available yet adopting this procedure in Asia has been slow due to high device cost, the need for specific training programs, and the lack of specialized heart teams and dedicated infrastructures. The limited number of randomized controlled trials describing TAVI outcomes among the Asian population hampered the approval for medical reimbursements as well as acceptance among surgeons and operators in some Asian countries. Methods: A comprehensive medical literature search on TAVI and/or TAVR performed in Asian countries published between January 2015 and June 2022 was done through MEDLINE and manual searches of bibliographies. The full text of eligible articles was obtained and evaluated for final analysis. The event rates for key efficacy and safety outcomes were calculated using the data from the registries and randomized controlled trials. Results: A total of 15,297 patients were included from 20 eligible studies. The mean patient age was 82.88 ± 9.94 years, with over half being females (62.01%). All but one study reported Society of Thoracic Surgeons (STS) scores averaging an intermediate risk score of 6.28 ± 1.06%. The mean logistic European Systems for Cardiac Operations Risk Evaluation (EuroSCORE) was 14.85. The mean baseline transaortic gradient and mean aortic valve area were 50.93 ± 3.70 mmHg and 0.64 ± 0.07 cm 2 , respectively. The mean procedural success rate was 95.28 ± 1.51%. The weighted mean 30-day and 1-year all-cause mortality rate was 1.66 ± 1.21% and 8.79 ± 2.3%, respectively. The mean average for stroke was 1.98 ± 1.49%. The acute kidney injury (AKI) rate was 6.88 ± 5.71%. The overall major vascular complication rate was 2.58 ± 2.54%; the overall major bleeding rate was 3.88 ± 3.74%. Paravalvular aortic regurgitation rate was 15.07 ± 9.58%. The overall rate of pacemaker insertion was 7.76 ± 4.6%. Conclusions: Compared to Americans and Europeans, Asian patients who underwent TAVI had lower all-cause mortality, bleeding, and vascular complications, however, had a higher rate of postprocedural aortic regurgitation. More studies with greater sample sizes are needed among Asian patients for a more robust comparison.

show abstract

Clinical evaluation of the Hydra self‐expanding transcatheter aortic valve: 6 month results from the GENESIS trial

Cited by 7 publications

References 29 publications

Transcatheter aortic valve implantation in patients with rheumatic aortic stenosis

Transcatheter aortic valve implantation in patients with rheumatic aortic stenosis

An Update on New Generation Transcatheter Aortic Valves and Delivery Systems

Transcatheter Aortic Valve Implantation Outcomes and Challenges in Asia: A Systematic Review and Meta-Analysis

Contact Info

Product

Resources

About