RESPOND EDGE Registry

LOTUS Edge Aortic Valve System image

RESPOND EDGE Study

An open-label, single-arm, post-market surveillance registry of 200 TAVR patients at up to 20 European centers. This registry collects clinical and device performance outcomes data following TAVR with LOTUS Edge as used in ‘routine’ clinical practice. This is a pre-specified interim analysis of the first 50 patients enrolled.

 

Baseline characteristics (first 50 patients)

Age (years) 

81.1 ± 6.4

Female  

48.0% 

BMI (kg/m2)

28.1 ± 5.8

STS score 

3.6% ± 3.1

EuroSCORE (%)

3.0 ± 2.2

Diabetes (medically treated)

24.0%

Hyperlipidemia (req. medication)

38.0%

Hypertension

52.0%

CAD

50.0%

Prior MI

12.0%

CHF

42.0%

AF

40.0%

Prior pacemaker 

20.0% 

Prior cerebrovascular accident

8.0%

Severe aortic valve calcification (site-reported) 

64.0% 

 

 

Discharge Clinical Results (N = 50)

discharge clinical results

Event

% Patients

All-cause mortality 

0.0%

All stroke 

4.0% (n = 2) 

Life-threatening or disabling bleeding 

0.0%

Acute kidney injury, Stage 2 or 3 

2.0% (n = 1) 

Coronary obstruction (periprocedural) 

0.0%

Major vascular complication 

2.0% (n = 1)

Repeat procedure for valve-related dysfunction 

0.0%  

Periprocedural MI (≤72 hours post-TAVR) 

0.0%  

Hospitalization for valve-related symptoms 

0.0%  

Permanent pacemaker implantation (all patients) 

18.0% (n = 9) 

         New pacemaker among pacemaker-naïve patients 

22.5% (n = 9) 

New onset of Afib or atrial flutter 

4.0% (n = 2) 

Valve embolization 

0.0%  

TAV-in-TAV 

0.0%  

Valve thrombosis or endocarditis 

0.0%  

 

 

Aortic Valve Hemodynamics

Aortic Valve Hemodynamics

 

 

PVL at Discharge

PVL at Discharge
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