History and Future of Transcatheter Mitral Valve Interventions
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History and Future of Transcatheter Mitral Valve Interventions

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Invited lecture at the Scandinavian Society of Cardiothoracic Surgeons on transcathter mitral valve interventions (2009)

Invited lecture at the Scandinavian Society of Cardiothoracic Surgeons on transcathter mitral valve interventions (2009)

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  • Ross J Jr, Braunwald E, Morrow AG AJC 3:653-655,1959 In 1958, while working at National Institutes of Health, Eugene Braunwald was director of a cath lab, and 1st Yr Fellow was John Ross. Ross was using sizing balloons to measure atrial septal defects in the cath lab. A visiting physician from Argentina observed this procedure and asked whether Ross had considered using a needle to puncture the intact septum. Ross discussed at doiner with EB, then requested time off from the cath lab, and developed a needle device in the dog lab. This was introduced into patients via femoral cutdown. A couple of years later when the Seldinger technique was introduced, a surgical resident working with Breaunwald designed a catheter, the Brockenbrough, through which the Ross needle could be placed. Related by EB March 09, 2004
  • JAMA 196:991-992, 1966
  • Here is a schematic movie the progressive shortening of the annulus and the theoretical changes of the geometry of the heart
  • The third step is the implantation, the distal anchor is first deployed , than the proximal At the end of the procedure a coronary angiography is again performed to insure that there is no immediate coronary artery complication
  • Removed “Remained Improved by 12 months” and put “improved by 12-months”. Remained improved implies the patients who improved at 30-days that were still improved at 12-months. 85% of the 82% 30-day successes were improved at 12-months. – this is 70% of the 30-day success patients. 79% of the total pop improved at 12months
  • Paired T-Test

History and Future of Transcatheter Mitral Valve Interventions History and Future of Transcatheter Mitral Valve Interventions Presentation Transcript

  • History and Future of Transcatheter Mitral Valve Repair
    • Francesco Maisano
    • San Raffaele Hospital
    • Milano
    • Italy
  • 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 Survey surgery is often denied in the older patients Isolated MR (n=877) Severe MR (n=546) No Severe MR (n=331) No Symptoms (n=144) Symptoms (n=396) No Intervention (n=193) 49% Intervention (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 interventions
    • Balloon commissurotomy
    • Annular repair
      • Sinoplasty (Monarc, Carillon, PTMA)
      • Direct reshaping (Mitralign, GDS)
    • Leaflet repair
      • Edge-to-edge repair (Mitraclip)
      • Others (plicating clips, chordal repair)
    • Cinching devices
      • Internal (PS3)
      • External (Coapsys)
    • Other
      • Hybrid devices (Mitral Solutions, Micardia)
      • Occluder (Cardiac Solutions)
      • Transcatheter MVR (Endovalve)
      • 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
  •  
  • Devices in clinical trial 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)
  • Device Positioning and Deployment
      • Device Positioning
      • Anchor Deployment
      • Final Confirmation
  • Percutaneous Mitral Valve Repair Prosthetic Ring Coronary Sinus Annuloplasty Safety at 30 Days 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
  • Percutaneous Mitral Valve Repair Prosthetic Ring Coronary Sinus Annuloplasty Efficacy 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
  • 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 Eligibility Leaflet 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 Cohort Enrollment with 30 day Core Lab Follow-Up
    • Preliminary Cohort analysis per EVEREST II definitions
    • 30 North American sites
    • 70% are 1 st , 2 nd , or 3 rd procedure at a site
  • EVEREST Preliminary Cohort Patients with 30 Day Major Adverse Events ( N = 107 )
  • EVEREST Preliminary Cohort Efficacy 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 procedures are 1 st , 2 nd or 3 rd at Site
  • CASE EXAMPLE, Functional MR HSR; October 23 rd 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
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  • 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) MitraClip therapy results in sustained MR reduction Mild-Moderate MR (Grade 1+/2+) Moderate-Severe or Severe MR (Grade 3+/4+) 52% of patients had MR grade 0 or 1+ at 12 months n=34, Matched Data 97% 3% 26% 18% 82% 74%
  • HRR FMR: LV Function (ITT) 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 192 153 103 87 Systolic Diastolic
  • 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 di 22
  • TC orientation and capture
  • Chordal implant dynamic adjustment and post-mortem
  •  
  • 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 today Tailored approach – the best option for the patient