Evidence map›Paper›PMID 41819447›Full record

ArticleIndian heart journal

Safety and performance of the Hydra self-expanding THV: 6 months outcomes from the GENESIS-II study.

Anmol Sonawane, Praveen Chandra, John Jose, Sandeep Bansal, Rahul Gupta, Krishnankutty Sudhir, Nagendra Boopathy Senguttuvan

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07566624 (Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07566624 recruitingnot on this map

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

Typeobservational_patient_registrySponsorFundación EPICRan2026 to 2029Enrolled100ConditionsSevere Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve StenosisArmsHydra THV
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Anmol SonawaneDepartment of Cardiology, Breach Candy Hospital Trust, Mumbai, Maharashtra, India.
Praveen ChandraDepartment of Cardiology, Medanta - The Medicity Hospital, Gurgaon, Haryana, India.
John JoseDepartment of Cardiology, Christian Medical College, Vellore, Tamil Nadu, India.
Sandeep BansalDepartment of Cardiology, Safdarjung Hospital, New Delhi, Delhi, India.
Rahul GuptaDepartment of Cardiology, Apollo Hospitals Enterprise Limited, Thane, Maharashtra, India.
Krishnankutty SudhirSahajanand Medical Technologies, Surat, Gujarat, India.
Nagendra Boopathy SenguttuvanDepartment of Cardiology, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India. Electronic address: drsnboopathy@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe Hydra THV incorporates an active release mechanism designed to facilitate the deployment of the supra-annular valve. The aim of the GENESIS-II study was to assess the safety and performance of Hydra THV at 6 months follow-up after treating severe aortic stenosis in patients at high surgical risk.

methodsThis prospective, multicenter, non-randomized, investigational study was conducted between November 2021 and November 2023. The study enrolled 40 patients with high surgical risk and symptomatic severe aortic stenosis from 19 sites across India. The primary safety endpoint of the study was cardiovascular mortality at 30 days, while the primary performance endpoint was device success, as defined by VARC-2.

resultsAmong the 40 patients, the mean age was 74.4 ± 6.7 years, 65% were male, and the mean Society of Thoracic Surgeons (STS) risk score was 3.5 ± 1.6%. The device had a success rate of 95%. At 6 months, there was one cardiovascular death (2.5 %). All-cause death was observed in 5% patients. The incidence of new permanent pacemaker implantation was 7.9%. There was a progressive enhancement in effective orifice area, from 0.6 ± 0.2 cm

conclusionThe results of 6 months follow-up after implantation of the Hydra THV with an active release mechanism in the GENESIS-II study demonstrated a high device success rate with favorable safety and performance of the device.

Indexed as

Aortic ValveAortic Valve StenosisHeart Valve ProsthesisHeart Valve Prosthesis ImplantationAgedFemaleFollow-Up StudiesHumansIndiaMaleProspective StudiesProsthesis DesignTime FactorsTreatment OutcomeAortic valve stenosisSafety outcomesTranscatheter aortic valve replacement

Identifiers

PMID41819447
PMCPMC13522705

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