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Maspalomas, Octubre 2011
NOVEDADES QUIRÚRGICAS EN TERAPIA VALVULAR. 2011 José L. Pomar, MD, PhD Director Adjunto Instituto Clínico del Tórax Hospital Clinic Universidad de Barcelona
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PRIMERAS PRÓTESIS HETEROTÓPICAS
Maspalomas, Octubre 2011
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PRIMERAS PRÓTESIS ORTOTÓPICAS
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ULTIMOS DISEﾃ前S DE BIOPROTESIS
Maspalomas, Octubre 2011
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LO MAS NOVEDOSO, ES NOVEDOSO ?
Maspalomas, Octubre 2011
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Maspalomas, Octubre 2011
VALVULA AÓRTICA Homoinjertos: Presente y futuro de unos pocos privilegiados Bioprótesis: Crecimiento exponencial. Nuevos diseños. Nuevos accesos Procedimientos percutaneos. Prótesis mecánicas: la anticoagulación, será imprescindible? VALVULA MITRAL Reparar siempre mejor que cambiar? Algo nuevo en la reparación? Procedimientos percutaneos VALVULA TRICUSPIDE Reparaciones en VD muy dilatados Prótesis: Está ya todo dicho? LA IMAGEN Y LA CIRUGIA VALVULAR
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VÁLVULA AÓRTICA
Maspalomas, Octubre 2011
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Maspalomas, Octubre 2011
HOMOINJERTOS E INGENIERIA TISULAR
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HOMOINJERTOS Y SOLUCIONES
Maspalomas, Octubre 2011
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REPARACION VALVULAR AÓRTICA
Maspalomas, Octubre 2011
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Maspalomas, Octubre 2011
BIOPROTÉSIS
Form follows function
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BIOPROTÉSIS Del implante tradicional al simplificado
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BIOPROTÉSIS Del implante tradicional al simplificado
Perceval de Sorin Intuitive de Edwards
179 patients with symptomatic severe aortic stenosis
90% 69% P=0.01
Hospital Clinic University of Barcelona
CURSO PRACTICO DE ACTUALIZACIÓN CARDIOVASCULAR. Barcelona 2008
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Porcelain ascending aorta
Maspalomas, Octubre 2011
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2 parts composite graft
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INDICATIONS for TAVI
•Quantitative assessment
•Clinical judgment
•LOGISTIC EUROSCORE >20%
•Chest radiation
•STS >10%
•Previous CABG •Porcelain aorta •Liver cirrhosis •Etc…..
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Maspalomas, Octubre 2011
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≤ 30-Day Adverse Events (N = 948)
30‐Day All Mortality Rate
68 (7.2%)
Cardiac Deaths** Myocardial Infarction Major Arrhythmias Pacemaker
42 (4.4%) 6 (0.6%) 30 (3.2%) 84 (8.9%)
Renal Failure Stroke TIA Structural Valve Dysfunction Valve Migration
10 (1.1%) 14 (1.5%) 5 (0.5%) 0 (0.0%) 0 (0.0%)
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Maspalomas, Octubre 2011
CONGRESO ANNUAL DE LA SEC
Maspalomas, Octubre 2011
Interferencia con los orificios coronarios
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Maspalomas, Octubre 2011
Pseudoaneurisma post apical
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Symetis reports on its trans-apical ACURATE TATM first-in- man clinical study
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Paniagua
Enable PHV
Maspalomas, Octubre 2011
AorTx
Direct Flow
Heart Leaflet Technologies
Valvexchange
Sadra
Perceval
Jena
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Maspalomas, Octubre 2011
Unknowns by 2011 • Unknown durability in humans after 6 years
• Unknown effects on heart failure progression
• Unknown effects of remaining AoI on ventricular remodeling
• Unknown effect on the ability to do subsequent valve repair or replacement
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Maspalomas, Octubre 2011
PROACT: Early results show high-risk patients do well with low warfarin and carbon valve
MCRI's On-X Prosthetic Heart Valve in Aspirin Study; Clinical Study May Provide Evidence to Support Eliminating the Use of Warfarin As an Anticoagulant for On-X Mechanical Valve Recipients
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Maspalomas, Octubre 2011
Enrollment Objective Achieved for Aspirin and Clopidogrel Patient Group of the On-X Heart Valve Anticoagulation Clinical Study
Two Antiplatelets No Better Than Aspirin Alone After TAVI
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VÁLVULA MITRAL
Maspalomas, Octubre 2011
The Master of Valve therapy
Bad Neustadt, October 2011
The echocardiographic assessment
Perforation of the leaflet observed under normal, colour doppler and at surgery
The Master of Valve therapy
Bad Neustadt, October 2011
Large defect on the Anterior Leaflet
The Master of Valve therapy
Bad Neustadt, October 2011
Flail leaflet after chordal rupture in BE Perforation on a previously rheumatic mitral
The Master of Valve therapy
Bad Neustadt, October 2011
The Master of Valve therapy
RD.Leiden MC
Bad Neustadt, October 2011
RD.Leiden MC
Repairing with a pericardial patch a Type I lesion of an acute endocarditis
The Master of Valve therapy
Bad Neustadt, October 2011
Reconstruction of anterior leaflet and posterior commissure
The Master of Valve therapy
Bad Neustadt, October 2011
The Master of Valve therapy
SURGICAL FINDINGS
Bad Neustadt, October 2011
SURGICAL REPAIR
The use of a prosthetic ring was unnecessary in this case
The Master of Valve therapy
Bad Neustadt, October 2011
Mitral abscesses and tissue destruction management Posterior annulus management radical excision direct reconstruction ? autologous pericardial patch with GA partial homograft Anterior annulus management mitro-aortic continuity radical excision multi-patch reconstruction Commissures radical excision plication and annuloplasty partial homograft
mitro-aortic management
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Maspalomas, Octubre 2011
Partial Homograft Mitral Valve Implantation
Mitral homograft
Mitral homograft implant in an IVDA patient and histopathology after 12 years
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Indirect MITRAL VALVE Annuloplasty CS - Reshaping
Bridge
MONARCH ELS Distal Anchor
Proximal Anchor
CARRILLON
CARDIAC DIMENSIONS
Carillon XE
PTMA Implant Device Shaft ( NiTi ) PTFE Unused Lumen Filler
PTMA
VIACOR
PTMA Implant Device Proximal Stops (Ti)
PTMA Implant Hub and Cap (Ti)
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Indirect MITRAL VALVE Annuloplasty CS – Reshaping NIH CERCLAGE of Lederman • Circumferential tension around mitral
annulus • CS – proximal septal branch of GCV –
image guided (MRI roadmapping coupled with fluoroscopy) traversal of myocardium to reenter right heart chambers • Circle is closed by snare retrieval than applying and fixing graded tension to reduce MR • Successful MR reduction in 14/16
swine with suitable anatomy
Maspalomas, Octubre 2011
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Direct Annuloplasty
MITRALIGN
• Retrograde access to post MV annulus - Direct annular reduction: • • • •
Suture-anchor plication Guiding catheter in CS with radio-opaque markers placed at P1, P2 and P3 Trident catheter delivers wires in P1, P2 and P3 FIM: Jan-2008 – Dr. Adrian Ebner – Paraguay CE Pilot study PI: Prof. E. Grube
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Maspalomas, Octubre 2011
Direct Annuloplasty Aortic Valve
ACCUCINCH GDS
Anterior Leaflet
Cinching implant below the posterior mitral annulus Trigone-to-Trigone
P3
P 1
Posterior Leaflet
P 2
Anchors
Anchors Therapeutic Area
49
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Maspalomas, Octubre 2011
Direct Adjustable Annuloplasty (Hybrid Techniques) MICARDIA • Ring implanted surgically during
conventional surgical repair • Direct mechanical adjustability • in OR or Cath Lab • 2 sizes • 24 to 30 • 30 to 38
Pre-implant
Post-implant
Post-adjustment
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Direct Adjustable Annuloplasty (Hybrid Techniques)
DYNAPLASTY MICARDIA
• Ring implanted surgically during conventional surgical repair • RF energy mediated reshaping • In OR by suture-electrodes • In Cath Lab with a catheterbasket and electrode mounted on the splines - docking confirmed by impedance • Completed FIM trials 2012
Maspalomas, Octubre 2011
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Maspalomas, Octubre 2011
Leaflet Plication MITRACLIP ABBOT • Over 300 cases - Everest I and Everest II (randomized+registry) in 36 sites • Freedom from death at 36 Mo: 97% • Freedom from Sx at 36 Mo: 85% • Freedom from death, surgery or MR>2+ at 36 Mo: 67%
•
Guide catheter 17-19 Fr
•
Stitch Catheter 11-12 Fr
•
Housing with a vacuum port, needles and suture
•
Fastener catheter 7 Fr.
•
After FIM, device is being redesigned
Stitch + Nitinol Anchor
5 2
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Leaflet Plication MitraFlex – TransCardiac Therapeutics TransCardiac Port™ •
Allow access into the chambers of a beating heart
TransCardiac Navigator™ •
Enables maneuverability within a beating heart
Clip advanced to hold the leaflets at midpoint
Maspalomas, Octubre 2011
CONGRESO ANNUAL DE LA SEC
Leaflet Plication MitraFlex – TransCardiac Therapeutics
Reach the Mitral Valve Percutaneously
Leaflet Stabilizer ™ deployed to hold leaflets in place Clip or Stitch to hold the leaflets at midpoint
Maspalomas, Octubre 2011
CONGRESO ANNUAL DE LA SEC
Percutaneous Artificial Chordae Implantation NEO CHORDS
Fiber optics
Maspalomas, Octubre 2011
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Percutaneous Artificial Chordae Implantation BABIC DEVICE
Artificial
Cordae Implanted
Maspalomas, Octubre 2011
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MitraClip
Maspalomas, Octubre 2011
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Space Occupier Mitra-Spacer and Percu-Pro by Cardiosolutions
• • • • • • •
Femoral Access I.C.E visualization Trans-septal approach Anchor in apex Mitra-Spacer™ positioned mid-valve Self-centering Currently finishing chronic animal studies – Pre Clinical • Acute animal n=40 • Chronic animal n=10 (30,90 and 180 days)
Maspalomas, Octubre 2011
CONGRESO ANNUAL DE LA SEC
Percutaneous Mitral Valve Implantation Endovalve-Herrmann Prosthesis
• Active anchoring • Rigidity and structure is
not stent based • Re-deployable • Fully valve-sparing • In-vivo ovine testing is ongoing
Maspalomas, Octubre 2011
CONGRESO ANNUAL DE LA SEC
Maspalomas, Octubre 2011
Percutaneous Mitral Valve Implantation Georg Lutter Mitral Valve Prosthesis Figure 1. Transesophageal echocardiographic views of the mitral valved stent. Figure 1A shows the valved stent along LV long axis view at 0 degree angle. Note the visible valve leaflets inside the body of the stent. Figure 1B represents the color frame showing the unobstructed LVOT and its relationship with the new mitral valved stent. Figure 2. TEE Doppler examination of the mitral valved stent and LVOT flows. Figure 2A illustrates the amount of regurgitation (trace) on Continuous Wave Doppler exam to assess the forward flow through the mitral valved stent. Figure 2B shows the Pulse Doppler exam through the LVOT showing unobstructed flow by the neighboring mitral valved stent.
(Lozonschi L and Lutter G: University of Kiel and University of Wisconsin)
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Minithoracotomy
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VÁLVULA TRICUSPIDE
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VÁLVULA TRICUSPIDE
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Is it to repair, replace by a bioprosthesis or a mechanical device?
Callahan et al.Am Heart J.1982;50:762
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LA IMAGEN REVOLUCIONA EL DIAGNOSTICO Y EL TRATAMIENTO
CONGRESO ANNUAL DE LA SEC
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LA IMAGEN REVOLUCIONA EL DIAGNOSTICO Y EL TRATAMIENTO
CONGRESO ANNUAL DE LA SEC
Maspalomas, Octubre 2011
LA IMAGEN REVOLUCIONA EL DIAGNOSTICO Y EL TRATAMIENTO
Allied Health Care Professionals
The Roland Hetzer Society, Lisbon 2011
But training and caring of all our allied personnel is also crucial
Allied Health Care Professionals
The Roland Hetzer Society, Lisbon 2011
The obesity network
Christakis NA, Fowler JH. NEJM 357 (4):370‐379, 2007
Allied Health Care Professionals
The Roland Hetzer Society, Lisbon 2011
Hubs in biological interaction networks Experimental asthma in a mouse model
Allied Health Care Professionals
The Roland Hetzer Society, Lisbon 2011
Systems Collection of linked individual elements with emerging properties that can not be attributed to each element considered separately.