Dynamic Mitral Valve Ring Annuloplasty Micardia Concept Maurice

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Dynamic Mitral Valve Ring Annuloplasty: Micardia Concept Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Dynamic Mitral Valve Ring Annuloplasty: Micardia Concept Maurice Buchbinder, MD Foundation for Cardiovascular Medicine La Jolla, CA Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

DISCLOSURES Maurice Buchbinder, MD Honoraria – Boston Scientific Corporation, Cordis, a Johnson & Johnson

DISCLOSURES Maurice Buchbinder, MD Honoraria – Boston Scientific Corporation, Cordis, a Johnson & Johnson company, Abbott Vascular

Disclosure. Stents? Why Degradable Speaker’s name: Maurice Buchbinder, MD I have the following potential

Disclosure. Stents? Why Degradable Speaker’s name: Maurice Buchbinder, MD I have the following potential conflicts of interest to report: Micardia Inc Consulting Employment in industry Stockholder of a healthcare company Scientific Advisory, Board Member I do not have any potential conflict of interest Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Ischemic MR • Ischemic Mitral Regurgitation (IMR) is seen in up to 20% of

Ischemic MR • Ischemic Mitral Regurgitation (IMR) is seen in up to 20% of patients following acute myocardial infraction. (Hickey; Circulation 1988; 78: 151 -159, Lamas; Circulation 1997; 96: 827 -833) • Treatment of IMR includes medical therapy and in severe cases surgical repair with an undersized annuloplasty ring to reduce the size of the mitral annulus and improve leaflet coaptation. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Ischemic MR • Following isolated annuloplasty surgery recurrent (>2+) MR is seen in 10

Ischemic MR • Following isolated annuloplasty surgery recurrent (>2+) MR is seen in 10 -30% of patients (Mc. Gee; J. Thorac Cardiovasc Surg 2004; 128: 916 -24) • Recurrent MR appears to be commonly seen within the first year following surgery and remains relatively stable thereafter (Mc. Gee; J. Thorac Cardiovasc Surg 2004; 128: 916 -24) • Unlike in dilated cardiomyopathy IMR is associated with asymmetric deformation of the annulus (Kwan; Circulation. 2003; 107: 1135. ) Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Current technology does not cope with dynamic ischemic disease • Residual post-op occurrence 6

Current technology does not cope with dynamic ischemic disease • Residual post-op occurrence 6 -10% Edwards Physio • 6 month, recurrence 15%-25% Medtronic Duran • 3 Years, recurrence 30% to 50% SJM Tailor ATS Simulus Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Mi. Cardia Semi-Rigid Dynamic Annuloplasty “C” Ring (Degenerative) Baseline Shape (Implanted) Transparent = Baseline

Mi. Cardia Semi-Rigid Dynamic Annuloplasty “C” Ring (Degenerative) Baseline Shape (Implanted) Transparent = Baseline Red = Post Activation Shape Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Mi. Cardia Rigid Dynamic Annuloplasty “D” Ring (Ischemic) Baseline Mi. Cardia Dynamic Ring Transparent

Mi. Cardia Rigid Dynamic Annuloplasty “D” Ring (Ischemic) Baseline Mi. Cardia Dynamic Ring Transparent = Baseline Red = Activated Shape Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

The Mi. Cardia Dynamic Ring • Available in “C” and “D” shape sizes 28

The Mi. Cardia Dynamic Ring • Available in “C” and “D” shape sizes 28 mm through 36 mm • Without activation functions as a “standard” ring • Pre-attached electrodes used for activation make the ring Dynamic Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Intra-Operative Re-shaping • Each RF wire is connected to the propriatary Mi. Cardia RF

Intra-Operative Re-shaping • Each RF wire is connected to the propriatary Mi. Cardia RF generator. • Following implantation, Wires are activated as needed to reshape the ring in vivo • Echocardiography confirms effectiveness of activation during and post re-shaping Maurice Buchbinder, MD Foundation for Cardiovascular Medicine P 1 P 3 P 2

Dynamic Ring - Features • Implants identical to existing technology • Semi-rigid metal core

Dynamic Ring - Features • Implants identical to existing technology • Semi-rigid metal core maintains its shape. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Dynamic Ring - Activation • Can be reshaped intraoperatively by the operating Surgeon •

Dynamic Ring - Activation • Can be reshaped intraoperatively by the operating Surgeon • Or at a later date upon recurrence of MR using percutaneous techniques. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Intra-Operative Reshaping Pre-clinical “In-Vivo” experience Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Intra-Operative Reshaping Pre-clinical “In-Vivo” experience Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Intra-Operative Reshaping Pre-clinical “In-Vivo” experience • A-P distance shortening by 0. 5 -3. 0

Intra-Operative Reshaping Pre-clinical “In-Vivo” experience • A-P distance shortening by 0. 5 -3. 0 mm • Inter-Commissural distance contracted by 1. 0 -3. 5 mm • No heat damage to the surrounding tissue Postero-Medial commissure activation Courtesy Dr. Alex Marmureanu Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Ring Activation Pre-Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Intra-Op Activation

Ring Activation Pre-Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Intra-Op Activation

Ultimate Valve Repair Modality Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Ultimate Valve Repair Modality Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Reshaping: Q Device Platform Sub- • Single lead, atrial exit • No flow

Percutaneous Reshaping: Q Device Platform Sub- • Single lead, atrial exit • No flow interference • Subcutaneous “pocket“ deployment of lead • Simple outpatient activation • Activate days, weeks or months after the initial procedure to correct recurrence Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular

Percutaneous Reshaping: Sub. Q Device Platform @140 days Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Post-Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine PRE-Activation

Post-Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine PRE-Activation

Percutaneous Reshaping: Sub. Q Device Platform @140 days • Full activation within 60 seconds

Percutaneous Reshaping: Sub. Q Device Platform @140 days • Full activation within 60 seconds Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

140 days post implant Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

140 days post implant Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Percutaneous Reshaping: Sub. Q Device Platform @140 days • No infection • No dehiscence

Percutaneous Reshaping: Sub. Q Device Platform @140 days • No infection • No dehiscence • Full activation @ 140 days, despite 100% ingrowth Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Human Experience Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Human Experience Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

39 Human Implants Completed 34 DYANA study patients treated in Europe and 5 in

39 Human Implants Completed 34 DYANA study patients treated in Europe and 5 in the US Site Implants Activations University Hospital of Homburg 7 4 Leipzig University Heart Center 11 1 Sana Herzchirurgie, Stuttgart 8 2 University Hospital, Keil 4 0 William Beaumont Hospital 5 N/A Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE 2 D pre-procedure Bi-leaflet Prolapse Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE 2 D pre-procedure Bi-leaflet Prolapse Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE 4 -chamber Pre-procedure Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE 4 -chamber Pre-procedure Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE 4 -chamber post ring implant prior to activation Maurice Buchbinder, MD Foundation for

TTE 4 -chamber post ring implant prior to activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE 2 -chamber post ring implant prior to activation Maurice Buchbinder, MD Foundation for

TTE 2 -chamber post ring implant prior to activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

RF connecting cable in place Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

RF connecting cable in place Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TEE 3 -chamber Post-activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TEE 3 -chamber Post-activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE apical 4 -chamber prior to discharge Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

TTE apical 4 -chamber prior to discharge Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

PRE- Procedure TTE Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Post-Procedure TTE

PRE- Procedure TTE Maurice Buchbinder, MD Foundation for Cardiovascular Medicine Post-Procedure TTE

6 -Month F/U, TTE 4 -chamber Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

6 -Month F/U, TTE 4 -chamber Maurice Buchbinder, MD Foundation for Cardiovascular Medicine

Conclusion • From this early clinical experience the Mi. Cardia Dynamic Annuloplasty Ring appears

Conclusion • From this early clinical experience the Mi. Cardia Dynamic Annuloplasty Ring appears to be a promising device for the surgical treatment of Mitral regurgitation. • The In-Vivo adjustable feature may be an extremely valuable tool for optimization of surgical results • Further minimally invasive adjustments in ring geometry in the healing phase could be a compelling advantage for its use. • Clinical studies are ongoing. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine