Percutaneous mitral annuloplasty Francesco Maisano MD, FESC San Raffaele Hospital Milano, Italy
Disclosure Consultant for Abbott, Medtronic, St Jude, Edwards, ValtechCardio Founder of 4Tech
Surgical techniques for MR Leaflet repair Annular remodeling
Annuloplasty Annuloplasty is routinely performed during MV repair to reduce and reshape the annulus Annuloplasty reduces stresses on the suture and on the valve structures and stabilizes annular diameter Lack of annuloplasty is associated to accelerated failure in the overall surgical population SI (kpa) - 647-520 - 394-267 - 140-134 + 113 + 240 + 367 + 493 + 620 + 747 +873 +100 0 Maisano F, et al Eur J Cardiothorac Surg. 1999;15:419-25 Gillinov et al J Thorac Cardiovasc Surg 1998;116:734-43
AV node Mitro aortic continuity Cx artery
CARILLON Mitral Contour System Advanced Delivery System 9F Curved Delivery Catheter Carillon XE2 Implant Handle Assembly 60, 70, 80 mm DA: 7-14 mm PA: 12-20 mm 7
TITAN Trial Baseline Characteristics Hoppe UC, Siminiak T, Haude M, et.al., European Heart J 2010:31;160-1. 8
TITAN Trial Major Adverse Event Rate Mortality Implanted: All Cause: 22% Cardiac: 11% Non-Implanted: All Cause: 24% Cardiac: 24% * Contrast-related acute renal failure in non-implanted patient. ** MAE s reviewed with DSMB; No relation to device identified Hoppe UC, Siminiak T, Haude M, et.al., European Heart J 2010:31;160-1. 9
TITAN Trial Reduction in Mitral Regurgitation Between groups comparison of paired absolute differences from baseline Hoppe UC, Siminiak T, Haude M, et.al., European Heart J 2010:31;160-1. 10
TITAN Trial Reverse Remodeling Between groups comparison of paired absolute differences from baseline Hoppe UC, Siminiak T, Haude M, et.al., European Heart J 2010:31;160-1. 11
Customized therapy Mitral disease is complex, lending itself to some customization Potential to use 1, 2 or 3 implants Customize the location of the implant to match the MR jet Customize the amount of plication to match the heart size, extent of MR 13 13
steerable guide catheter is brought to the mitral annulus 15 15
Drive a wire through the selected location on the annulus 17 17
Deliver pledget over the wire 19 19
Plicate and Lock 21 21
Atrium View Ventricle View Two Implants (~17mm Plication) 22 22
GDS Accucinch System Percutaneous Basal Ventriculoplasty 2
GSS Accucinch IMPLANT Surgically Placed GUIDE CATHETER Percutaneous GUIDE CATHETER + IMPLANT Percutaneous System Anchors Anchors Dr. J.G. Webb, St. Paul s Hospital, Vancouver Prof. J. Schofer, Medizinisches Versorgungszentrum, Hamburg
Subvalvar cinching
Valtech Cardioband Transcatheter mitral sutureless and adjustable posterior annuloplasty system Fully percutaneous direct annuloplasty the only approach with a proven surgical background
The transfemoral percutaneous Cardioband annuloplasty system Antigrade approach (transeptal) Annular fixation in supraannular position Annular dimensions are tuned using the adjustment tool
Cardioband delivery system Implant Transeptal Guide Catheter Implant Delivery System Anchor Drive Stand Cardioband Implant
Transseptal guide insertion
Therapy catheter insertion
First anchor implant Anchors are implanted individually by clockwise rotation of torquable catheter A clutch limiter prevents overrotation All anchors are repositionable and retrievable
AL to PM commissure
Contraction catheter insertion and automatic docking
Annular dimension adjustment by Cardioband contraction/relaxation Annular area change Transmitral gradient change
LA wall Circumflex artery Coronary sinus mitralign Fibrous annulus Posterior LV wall
Cardinal Ring Adjustment optimization of coaptation, in all cases * p=0.001 The Cardinal adjustable ring is implanted on the arrested heart, under direct vision, and adjusted onthe beating heart, under physiologic conditions Base line No adjustment Post adjustment Better coaptation and no residual MR = less recurrent surgery Cardinal multicenter EU trial
Pre-Clinical Experience Chronic Animals 10 Chronic Animals 90-day study Full Tissue Integration Acute Animals >90 acute animals
Transcatheter Heart Valve Repair 100% Solution When chord replacement is used in surgery 70% of mitral repairs can be done by Annuloplasty and Chords only* Percutaneous Annuloplasty Percutaneous Chordae Replacement Fully Percutaneous Mitral Repair *Seeburger et al. Minimal invasive mitral valve repair for mitral regurgitation: results of 1339 consecutive patients; Eur J Cardiothorac Surg 2008;34:760-765
Percutaneous annuloplasty Annular dilatation and remodeling is an important feature contributing to MR Several percutaneous technologies are developing Expand indcations Improve early outcomes Improve durability Challenge surgical outcomes