HighLife

Rüdiger Lange

Department of Cardiovascular Surgery

German Heart Center Munich

Technische Universität München

Potential conflicts of interest

Speaker's name: Rüdiger Lange

☑ I have the following potential conflicts of interest to report:

Speaker fees: Abbott, Boston Scientific, Highlife, Medtronic

Shares: Highlife

Royalties: Medtronic

+Transfemoral artery

=Transapical or transseptal

“Valve-in-Ring Concept”

Ring Valve2-step procedure

Early transapical experience (n=8)

Safety & feasibility study (n=4)

Compassionate or Special access

(n=4)

Demographics

Age (years), avg. (range) 68 (50-79)

Male (%) 75

Functional MR (%) 75

Previous cardiac surgery (%) 38

LVEF (%), avg. (range) 33 (25-50)

Annular diameter (mm), range 32-48

First-in-man transapical experience

• 100% success

• 1 patients with > 1 year follow-up

• 3 patients with 6 month follow-up

• n= 1 successful implant(poor LV function 25%, in-hospital death)

• n = 1 successful implant (> 6 months follow-up)

• n= 1 conversion to surgery (for chordal entanglement, in-hospital death)

• n = 1 conversion to surgery (chordal entanglement, > 3 months follow-up)6/8 with successful implants

Early transapical experience

Early transapical experience (n=8)

Safety & feasibility study (n=4)

Compassionate or Special access

(n=4)

Posterior basal chords Submitral apparatus (chords)

Case 1 Case 7

Potential areas of entanglement – verification tests

Case 2 Case 3

Case 4 Case 5

Case 6 Case 8

Echocardiography is instrumental to verify loop positioning

Transapical design can accommodate a large annular range (32-48)

No paravalvular leaks, mean transmitral gradients < 5 mmHG, low left ventricular outflow tract gradients < 8 mmHg

First patient from the safety and feasibility trial with > 1 year follow-up

Conclusions from early TRANSAPICAL experience

European Study (planned n=20)

France Germany

Inclusion Criteria

Annulus Range 35 – 50 mm

EF > 30%

Functional MR

Degenerative MR

Heart Team Decision

• 79 year old male

• Severe functional mitral regurgitation

• Severe left ventricular dysfunction 25-30%

• Multiple recent admissions for CHF

• Moderate COPD

• Mild renal dysfunction

First-in-Human Transseptal Highlife

Mitral annulus diameter – 52 mm

Virtual implantation of a 28 mm HighLife

Mitral annulus diameter – 52 mm

Virtually no risk for LVOT obstruction

Can be delivered via transapical

and transseptal route

May not require arterial-venous guidewire loop

for delivery

Fixation is not based on radial

force

Does not require rotational

positioning

Does not require coaxial

positioning

Valve is self-centering upon

release

Features of the HighLife system