highlife...2017/09/25 · shares: highlife royalties: medtronic + transfemoral artery = transapical...
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HighLife
Rüdiger Lange
Department of Cardiovascular Surgery
German Heart Center Munich
Technische Universität München
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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
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+Transfemoral artery
=Transapical or transseptal
“Valve-in-Ring Concept”
Ring Valve2-step procedure
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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
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• 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)
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Posterior basal chords Submitral apparatus (chords)
Case 1 Case 7
Potential areas of entanglement – verification tests
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Case 2 Case 3
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Case 4 Case 5
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Case 6 Case 8
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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
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European Study (planned n=20)
France Germany
Inclusion Criteria
Annulus Range 35 – 50 mm
EF > 30%
Functional MR
Degenerative MR
Heart Team Decision
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• 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
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Mitral annulus diameter – 52 mm
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Virtual implantation of a 28 mm HighLife
Mitral annulus diameter – 52 mm
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Virtually no risk for LVOT obstruction
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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