February 14, 2019Cardiology JournalOpen Access

Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study

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Why the study?

To investigate the safety and performance of the New Valve Technology Allegra bioprosthesis in high-risk patients undergoing TAVI.

Population

Twenty seven high surgical risk patients with severe symptomatic AS

Comparison

Transfemoral TAVI with the self-expanding NVT Allegra bioprosthesis

Design

Pilot prospective study

Follow-up

30 days

Authors

DJDariusz JagielakCedars-Sinai Medical Center ASAleksandra StańskaGdańsk Medical University AKAndrzej KlapkowskiUniversity Clinical Centre

Discussion

Member takes

Implication

Supports short-term safety of NVT Allegra TAVI in high-risk patients; hypothesis-generating and leaves open confirmation in larger randomized trials.

Structured PICO

Population

27 elderly patients (mean age 83, 70.4% female) with severe, symptomatic aortic stenosis (NYHA class II-IV) at high surgical risk (mean logistic EuroSCORE 12.4%). Key inclusion: age ≥ 75 years, symptomatic severe degenerative native AS, high risk for surgical aortic valve replacement.

Intervention

Transfemoral transcatheter aortic valve implantation (TF-TAVI) using the self-expanding New Valve Technology (NVT) Allegra bioprosthesis.

Outcome

All-cause mortality at 30 dayshard clinical

The self-expanding NVT Allegra bioprosthesis demonstrated a favorable 30-day safety profile, excellent hemodynamic performance, and a low rate of pacemaker implantation in high-risk patients with severe aortic stenosis.

Limitations

Single-arm study
Relatively small sample size
Short-term follow-up (30 days)
No inferences can be drawn regarding long-term outcomes

Cite This Study

Jagielak et al. (2019) studied this question.

synapsesocial.com/papers/6a23f6429e1c90a91c097bcc https://doi.org/10.5603/cj.a2019.0019

Topics

Transcatheter aortic valve replacement TAVR in low-risk patients

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Implication

Supports short-term safety of NVT Allegra TAVI in high-risk patients; hypothesis-generating and leaves open confirmation in larger randomized trials.

Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study

Discussion

Member takes

Implication

Structured PICO

Limitations

Cite This Study

Topics

Transfermoral aortic valve implantation using self-expanding New Valve Technology (NVT) Allegra bioprosthesis: A pilot prospective study

Discussion

Member takes

Implication

Structured PICO

Limitations

Cite This Study

Also Consider

Topics

Also Consider