Milano II Feasibility Trial Early Experiences Edwards MOBIUS … · Maurice Buchbinder, MD...
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Milano II Feasibility TrialEarly Experiences
Edwards MOBIUS Leaflet Repair System
Milano II Feasibility TrialEarly Experiences
Edwards MOBIUS Leaflet Repair System
Maurice Buchbinder , MDFoundation for Cardiovascular Medicine
La Jolla, CA
Maurice Buchbinder , MDMaurice Buchbinder , MDFoundation for Cardiovascular MedicineFoundation for Cardiovascular Medicine
La Jolla, CALa Jolla, CA
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
MOBIUS: Leaflet Repair SystemEdwards LifeSciencesMOBIUS: Leaflet Repair SystemEdwards LifeSciences
PurposeRepair degenerative/Organic Mitral valve disease
Basic ConceptPerform an edge to edge (Alfieri) repair using Percutaneous approach
Working PrincipleDeliver suture(s) across Mitral valveSecure suture with Nitinol clip(s)
GuidanceAngiographyEchocardiography (ICE or TEE )
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
MOBIUS system:MOBIUS system:
Guide catheter – 17F single plane deflecting tip device
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
MOBIUS system:MOBIUS system:
Therapy catheter – 11F “Housing” includes vacuum port, needles,
suture
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
MOBIUS system:MOBIUS system:
Fastener catheter – 7FLow profile FlexibleBuilt-in nitinol clip
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Clinical ExperienceClinical Experience
Phase I Feasibility – Europe & CanadaNon-randomized, multi-center studyPurpose: To demonstrate the safety and feasibility of the Edwards MOBIUS Leaflet Repair System for the treatment of organic MRCurrent Status: Study is in re-activated phase of enrollment
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
MR grade 2 - 4 Degenerative etiology with no significantannular enlargement
Inclusion criteria
MILANO II StudyMILANO II Study
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
MILANO II StudyMILANO II StudyEndpoints
MR reduction ≥ 1 grade @ 3-months
Death / AMI/ pulmonaryedema/ Worsening MR / Persistent ASD /embolisation at3-months
Secondary
Proceduralsuccess: MR reduction ≥ 1 grade, w/o complication
Death / pericardial effusion / embolisation / AMI at30 days
Primary
EfficacySafety
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Milano II Study TeamMilano II Study Team
Study PI:Maurice Buchbinder, Scripps Memorial, La Jolla
Echo PI:Maurice Sarano, Mayo Clinic; Rochester
Echo Core Lab:Neil Weissman, Cardiovascular Research Institute; Washington, DC
Protocors:Maurice Buchbinder, Scripps Memorial, La JollaFrancesco Maisano, San Rafaelle; MilanTasneem Naqvi, Cedars-Sinai; Los Angeles
G. LaCannaFrancesco MaisanoSan Rafaelle HospitalBrad MuntJohn WebbSt. Paul’s HospitalArsenè BasmadjianRaoul BonanMontreal Heart InstituteEric BrochetAlec VahanianHospital BichatEcho PIInterventional PISite
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Case Reviews of MOBIUS System PatientsCase Reviews of MOBIUS System Patients
Case # 1: P2 prolapse
Case # 2: P2 flail
Case # 3: P2 flail with ischemic MR
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Clinical caseClinical case
72 year maleActive Smoldering Lymphoma
(1995),chemotherapy,thrombopeniaPacemaker 2004History
MR dg. 1995. Pulmonary edemaSurgery was contraindicatedCurrently: Dyspnea NYHA class IIIMed Rx: ACE inhib, Furosemide
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
EchocardiographyEchocardiography
LV ESD: 43 mm
LVEF: 40 %
Severe MR: ERO =68mm²; R Vol =57ml
SPAPs: 45 mmhg
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
PRE
ERO : 48 mm² RV : 57 ml
POST
ERO : 8 mm² RV : 12 ml
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Case # 2 – Flail P2 scallop with severe, anteriorly directed jet Case # 2 – Flail P2 scallop with severe, anteriorly directed jet
Male, 61 years old
Presented with 4+ MR, active tuberculosis
Mild/Moderate annular dilatation
Moderately thickened leaflets with flail P2
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Pre-procedure: Short Axis ViewPre-procedure: Short Axis View
4+ MR
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Pre-procedure: Long Axis View Pre-procedure: Long Axis View
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Discharge: Echo ViewsDischarge: Echo Views
2+ MR (2 grade reduction)Double suture repair
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Case # 2: SummaryCase # 2: Summary
Anatomy: Flail P2 scallop with severe, anteriorly directed jet
Repair: Double suture
MR Reduction: 2 grades at discharge
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Case # 3 – Flail P2 with dilated left atrium, ventricle, and annulusCase # 3 – Flail P2 with dilated left atrium, ventricle, and annulus
Male, 77 years oldPresented with 4+ MR, CAD, old inferior infarct, CABG x3 (1991), PADHigh risk surgical patientCentral jetThick leafletsGlobally hypokinetic, inferior akinesia, dystrophic valves
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Pre-Procedure: Long Axis ViewsPre-Procedure: Long Axis Views
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Discharge: Echo ViewsDischarge: Echo Views
3+ MR (1 grade reduction)3+ MR (1 grade reduction)MR from flail is eliminated, but MR from flail is eliminated, but ischemic MR remainsischemic MR remainsDouble suture repairDouble suture repair
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Discharge vs. Pre-Procedure: Echo Views
Discharge vs. Pre-Procedure: Echo Views
Pre-ProcedureDischargeJet direction alteredJet direction altered
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Case # 3: SummaryCase # 3: Summary
Anatomy: Flail P2 with dilated atrium, ventricle and annulus
Repair: Double suture
MR Reduction: 1 grade at discharge (flail MR), ischemic MR remains
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Clinical Results : 30 DAY outcome F.I.M.Clinical Results : 30 DAY outcome F.I.M.
15 patients enrolled
Acute procedural success (9)
# Stitch- 3 single, 5 double, 1 triple
Acute reduction MR 2 grade
Figure of “8” at 30days Present- 5 Absent- 4
Procedural failure (6)
Surgical Repair (6)
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
Safety Results: 30 daysSafety Results: 30 days
MIMI 00CVACVA 00DeathDeath 00Worsening MRWorsening MR 00Pericardial effusionPericardial effusion 11Clip Embolism Clip Embolism 11
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Maurice Buchbinder, MDFoundation for Cardiovascular Medicine
ConclusionConclusion
Experience to date has confirmed a reproducible procedure with a reliable rate of primary success and no acute complications.
Echo visualization and guidance remains a significant challenge…From this very early experience careful selection of patients with specific Valvular pathologies seems criticalExtent of MR reduction and long term durability of the repair remains the primary goal of our ongoing investigation.