History and Future of Transcatheter Mitral Valve Interventions
-
Upload
drmaisano -
Category
Health & Medicine
-
view
5.350 -
download
3
description
Transcript of History and Future of Transcatheter Mitral Valve Interventions
History and Future of Transcatheter Mitral Valve Repair
Francesco MaisanoSan Raffaele Hospital
MilanoItaly
TAVI is moving rapidly into a clinical procedure widely available
• Replacement of the aortic valve is less demanding than MVR or repair
• Aortic stenosis is more prevalent in the elderly
• There is evidence of undertreatment of patients with aortic stenosis
Euro Heart Surveysurgery is often denied in the older patients
Isolated MRIsolated MR
(n=877)(n=877)
Severe MRSevere MR
(n=546)(n=546)
No Severe MRNo Severe MR
(n=331)(n=331)
No SymptomsNo Symptoms
(n=144)(n=144)
SymptomsSymptoms
(n=396)(n=396)
No InterventionNo Intervention
(n=193) 49%(n=193) 49%
InterventionIntervention
(n=203) 51%(n=203) 51%
Mirabel et al, European Heart J 2007;28:1358-1365
2/3 of symptomatic MR patients >70 are
denied surgery
Prevalence of valve disease in the population: MR is epidemic in the elderly
Nkomo et al , Lancet 2006
Transcatheter mitral interventionsTranscatheter mitral interventions• Balloon commissurotomyBalloon commissurotomy
• Annular repairAnnular repair– Sinoplasty (Monarc, Carillon, Sinoplasty (Monarc, Carillon,
PTMA)PTMA)– Direct reshaping (Mitralign, Direct reshaping (Mitralign,
GDS)GDS)
• Leaflet repairLeaflet repair– Edge-to-edge repair Edge-to-edge repair
(Mitraclip)(Mitraclip)– Others (plicating clips, chordal Others (plicating clips, chordal
repair)repair)
Cinching devicesCinching devices Internal (PS3)Internal (PS3) External (Coapsys)External (Coapsys)
OtherOther Hybrid devices (Mitral Hybrid devices (Mitral
Solutions, Micardia)Solutions, Micardia) Occluder (Cardiac Occluder (Cardiac
Solutions)Solutions) Transcatheter MVR Transcatheter MVR
(Endovalve)(Endovalve) Perivalvular leak closure Perivalvular leak closure
AJC 3:653,1959
1959
JAMA 1966
1984
1998-2001, Edwards suction and suture device (MILANO 1)
2002-2006 Edwards suction and suture device (MOBIUS / MILANO 2)
Clip repair in porcine heart (6 mos post repair)
Fann JI; St. Goar FG; Komtebedde J; Oz MC; Block PC; Foster E; Feldman T; Burdon TA Circulation 2003, 108:(Supp IV) 493.
2002-2003 Off-pump Edge-to-Edge Mitral Valve Technique Using a Mechanical Clip in a Chronic
Model – Initial clinical experience
FIM (2003)
Worldwide experience about 750 patients treated
Transcatheter mitral valve procedures
• Most devices are evolution of surgical devices
• Image-guided delivery vs surgical direct vision
• Therapy guided by function vs lesion
• On line effect or therapy
MONARC (Edwards Lifesciences LLC)
Two-anchor design with chronic reshaping (6weeks) by a foreshortening bridge
EVOLUTION trial (69 pts enrolled)
CARILLON (Cardiac Dimensions Inc)
Acute reshaping device acting in P2P3, repositionable, retrievable
AMADEUS trial(43 pts enrolled )
PTMA (Viacor Inc)
Tri-lumen catheter, reshapable, possibility of multiple long term adjustment
PTOLEMY(24 pts enrolled)
Devices in clinical trial
Device Positioning and Deployment
Device Positioning
Anchor Deployment
Final Confirmation
Percutaneous Mitral Valve RepairProsthetic Ring Coronary Sinus Annuloplasty
Monarch Carillon Viacor
n 69 43 26
Success implantation %
80 70 42
Death % 3 2 0
MI % 3 4 0
Tamponade % 3 4 4
Dissection CS % 0 2 8
Safety at 30 Days
Monarc Carillon Viacor
Pre 6 Mos Pre Post
(TEE no core lab)
n 21
Reduction MR>/=1+
57% 63% NA
ERO Cm² 0.31 0.20 0.33
0.19 NA
Rvol ml 42 27 40 24 NA
Efficacy
Percutaneous Mitral Valve RepairProsthetic Ring Coronary Sinus Annuloplasty
Ptolemy Trial - VIACOR implant is modifying annular geometry
• 3D ECHO annulus tracing end-diastole• Composite SL diameter reduction for 7 implants= 5.6±2.5mm
Improved quality of life / symptoms
Quality of life assessment 6-min-walking test
Coronary Sinus Devices: potential anatomical issues associated with efficacy / safety
• Anatomical relations with the mitral annulus• only posterior• atrialization
• Relation with the Cx artery– Potential risk of AMI
• Risk of lesions
• PREDICTABILITY OF RESULT
Predicting responders in EVOLUTION I and AMADEUS trials
• No differences in CS/GCV location relative to the annulus between patients with or without efficacy
• Neither MR reduction or lack of MR reduction is explained by relative position of vein to annulus
Courtesy of J Harnek, MD
Devices to reduce SL dimension
Ample- PS3 Myocor (Edwards) i-Coapsys
Rogers et al, Circulation 2006;113:2329
Direct annular remodeling
• Mitralign• GDS
• The closest devices to conventional suture annuloplasty
• Initial clinical trials
Other devices• Quantumcor• Percupro –
Cardiacsolutions
Transcatheter MVR
• Larger device• Anchoring• Asymmetric anatomy• Interaction with the aortic
valve• LVOT obstruction• PVL more problematic• At least 10 companies are
working on t-MVR
Evalve MitraClip® Device
Mitraclip
Description of Valve Repair System
Guide
Steerable sleeve
Clip delivery handle
Stabilizer
Atrial Septum
versatility
Functional MR Degenerative MR
Anatomic EligibilityLeaflet mal-coaptation resulting in MR
• Sufficient leaflet tissue for mechanical coaptation
• Non-rheumatic/endocarditic valve morphology
• Protocol anatomic exclusions– Flail gap >10mm – Flail width >15mm– LVIDs > 55mm– Coaptation depth >11mm – Coaptation length < 2mm
EVEREST Preliminary CohortEnrollment with 30 day Core Lab Follow-Up
• Preliminary Cohort analysis per EVEREST II definitions • 30 North American sites• 70% are 1st, 2nd, or 3rd procedure at a site
EVEREST Preliminary CohortPatients with 30 Day Major Adverse Events (N = 107)
Acute Procedural Success*MR < 2+
n=81/96 (84%)
Clip Implantedn=96 (90%)
No APSMR > 2+
n=15/96 (16%)
No ClipImplanted
n=11 (10%)
Clip Procedure AttemptedN = 107 (100%)
MR = 2+n=21/81(26%)
MR = 1-2+n=10/81(12%)
MR = 1+n=50/81(62%)
EVEREST Preliminary CohortEfficacy Results through Discharge
N = 107
* Acute Procedural Success (APS): Defined as placement of one or more Clips resulting in discharge MR severity of 2+ or less, as determined by Core Lab.
70% of proceduresare 1st, 2nd or 3rd at Site
CASE EXAMPLE, Functional MR HSR; October 23rd 2008
• 66 yo, male, 64 Kg, 164 cm, BSA 1.7 m2, BMI 24
• Post-ischemic Cardiomyopathy, CCS II, NYHA III
• Comorbidities
– Infrarenal abdominal aneurysm
– 2006 stenting of right common carotid artery and right internal carotid artery
– 2005 Bone Marrow Tx for AML
• 1994 anterior AMI; 2001 PCI followed by CABG (LIMA—LAD), followed by
multiple PTCA with DES
• 1/2008: AMI for intrastent thrombosis -> POBA on LAD
• 4/2008 Acute Pulmonary Edema CRT with Biventricular Pacing and ICD
Final result (2 hrs after, skin to skin)• Before treatment • After mitraclip
• The patient was transferred from ICU to the general ward in day 1 and discharged home 4 days after the procedure
• At 3 months the MR reduction is stable with mild residual MR, reduction of LV volumes, and the patient is in NYHA class II
HRR FMR:Mitral Regurgitation (ITT)
0%10%20%
30%40%50%60%70%
80%90%
100%
Baseline 30 day 12 month
MitraClip therapy results in sustained MR reduction
Mild-Moderate MR (Grade 1+/2+)
Moderate-Severe or Severe MR (Grade 3+/4+)
n=34, Matched Data
97%
3%
26%18%
82% 74%
52% of patients had MR grade 0 or 1+ at 12 months
HRR FMR: LV Function (ITT)
LV End Diastolic & Systolic Volumes
0
25
50
75
100
125
150
175
200
Volu
me
(ml)
MitraClip therapy results in reverse LV remodeling
n=34, Matched Data
P=0.001
P=0.0002
LVEDV Baseline
LVEDV 12 Months
LVESV Baseline
LVESV 12 Months
192
153103
87
SystolicDiastolic
European adoption of Mitraclip
• Mitraclip obtained CE mark late 2008
• 100 cases performed• Most patients treated are elderly
and high risk prolapse patients and patients with CHF
Mitraclip vs Surgery a preliminary comparison
• Safety is probably superior compared to surgery• Efficacy is probably inferior compared to surgery
– High rate of pts with residual MR– clinical benefit yet to be demonstrated
• Results will be influenced by improvements in:– Learning curve– Indications– imaging– Addition of annuloplasty
The future of endovascular mitral repair
Early treatment
Anatomical reconstruction
Neochordae Implantation
Edwards Mobius
49 di 22
TC orientation and capture
50
Chordal implant dynamic adjustment and post-mortem
51
The future of mitral valve surgery• Minimally invasive and
transcatheter approach• Image guidance and computer aided
decision making• Devices will be
– ethiology-specific– Adjustableoff pump– Implantable with no or minimal
conventional suturing
• Early treatment• Stepwise and combined strategies
Surgeons should prepare for the FUTURE
• Because transcatheter procedures are the natural evolution of surgery
• Because patients deserve an unbiased choice of the best approach
• Because surgeons own most of the core skills needed to run the procedures
Treating valve disease in the future
Tailored approach – the best option for the patient
today