What is the clinical evidence from this study?

Study design: Observational. Population: Aortic stenosis (n=1976). Intervention: New-generation TAVI devices (Acurate, Evolut, Lotus, Portico, Sapien3) vs. Cross-comparison among devices. Primary outcome: Major adverse events (composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure) at 1 month (p=<0.001).

November 19, 2019Scientific ReportsOpen Access

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Q: What are the key findings of this study?

At 1 month, new-generation TAVI devices demonstrated significantly different rates of major adverse events, ranging from 11.5% with Portico to 25.6% with Acurate (p<0.001).

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Key result

At 1 month, new-generation TAVI devices demonstrated significantly different rates of major adverse events, ranging from 11.5% with Portico to 25.6% with Acurate (p<0.001).

Why the study?

Several new-generation TAVI devices have been introduced, but comparative analyses of their outcomes are lacking.

Does the choice of new-generation TAVI device (Acurate, Evolut, Lotus, Portico, Sapien3) affect 1-month safety and effectiveness in patients undergoing TAVI?

Population

1976 patients undergoing TAVI

Comparison

Acurate vs Evolut vs Lotus vs Portico vs Sapien3

Design

Prospective observational registry study

Follow-up

1-month

Authors

AGArturo GiordanoUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro”NCNicola CorcioneInterventional Cardiology PFPaolo FerraroCentro Clinico Nemo

Discussion

Member takes

Implication

Device-specific differences in 1-month TAVI outcomes are hypothesis-generating; randomized trials needed before guiding selection.

Study Design

Type

Observational (n=1,976)

Multicenter

Yes

Structured PICO

Does the choice of new-generation TAVI device (Acurate, Evolut, Lotus, Portico, Sapien3) affect 1-month safety and effectiveness in patients undergoing TAVI?

Population

1,976 patients with aortic stenosis undergoing transcatheter aortic valve implantation with one of five new-generation devices, followed for 1 month.

Exposure

Transcatheter aortic valve implantation (TAVI) using one of five new-generation devices: Acurate (n=234), Evolut (n=703), Lotus (n=151), Portico (n=347), or Sapien3 (n=541).

Comparator

Comparative analysis among the five different new-generation TAVI devices (Acurate, Evolut, Lotus, Portico, Sapien3).

Outcome

1-month major adverse events (composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure) and procedural success.composite

Main Result

p-value: p=<0.001

New-generation TAVI devices demonstrate high procedural success but exhibit distinct profiles of early comparative safety and efficacy, highlighting the importance of individualized device selection.

Limitations

Non-randomized design and reliance on propensity score adjustment
Short-term follow-up of only 1 month
Incomplete data collection for ancillary baseline features such as frailty
Absence of an imaging core lab and lack of systematic endpoint adjudication
Residual confounding cannot be excluded
Operator volume and experience were not collected
Mainly descriptive and hypothesis-generating scope
Multiplicity issues in sensitivity analyses
Observational design subject to selection bias based on operator preference and patient features

Cite This Study

Giordano et al. (2019) conducted an observational in Aortic stenosis (n=1,976). New-generation TAVI devices (Acurate, Evolut, Lotus, Portico, Sapien3) vs. Cross-comparison among devices was evaluated on Major adverse events (composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure) at 1 month (p=<0.001). At 1 month, new-generation TAVI devices demonstrated significantly different rates of major adverse events, ranging from 11.5% with Portico to 25.6% with Acurate (p<0.001).

synapsesocial.com/papers/6a9a92de9ded1192d2016ca2 https://doi.org/10.1038/s41598-019-53081-w

Topics

Valvular heart disease Transcatheter aortic valve replacement TAVR in low-risk patients

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Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider