Interventional Cardiology

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Interventional Cardiology
Dr. Krisada Sastravaha M.D. 14 December 2012
Balloon Angioplasty Stent and New Devices Distal protection and Thrombectomy devices Vascular Closure Device
Cardiac Interventions Non-coronary Angiography 12/22/12
Charles Dotter 1920 - 1985
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Melvin P. Judkins 1922 - 1985

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Mason Sones 1919 - 1985
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Andreas Gruentzig 1939 - 1985 12/22/12
Mason Sones 1919 - 1985
Andreas Gruentzig 1939 - 1985
Charles Dotter 1920 - 1985
Melvin Judkins 1922 - 1985 12/22/12
Historic Time Line

Abele,Bentoff,and Myler developed a
prototype coronary artery dilator catheter in 1970. In 1976 Gruentzig miniaturized his peripheral balloon catheter to perform coronary angioplasty in a canine model and later human cadaver experiments. In May 1977, in San Francisco, Gruentzig,Myler and Hanna performed coronary angioplasty for the first time in living human.
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LAD Lesion
Pr e
Durin g
Post
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INDICATIONS FOR PTCA
INTERVENTIONAL CARDIOLOGY
ASYMPTOMATIC , MILD SYMPTOMS

SUDDEN CARDIAC DEATH SEVERE MYOCARDIAL ISCHEMIA FAILURE MEDICAL THERAPY INTOLERANT OF MEDICAL THERAPY PRIOR TO HIGH RISK SURGERY
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INDICATIONS FOR PTCA
SYMPTOMATIC
UNSTABLE ANGINA PECTORIS FAILED MEDICAL THERAPY LARGE AREA VIABLE MYOCARDIUM RESCUE PTCA PRIMARY PTCA IN ACUTE MI CARDIOGENIC SHOCK
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CONTRAINDICATIONS
ABSOLUTE
UNPROTECTED LEFT MAIN LESION LESS THEN 50% NO SURGICAL BACKUP
RELATIVE
DIFFUSELY DISEASED SVG DIFFUSELY DISEASED NATIVE VESSELS
WITH GOOD DISTAL TARGETS
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CONTRAINDICATIONS
RELATIVE (continued)
BLEEDING DIASTHESIS PTCA OF NON-INFARCT VESSEL DURING
PRIMARY PTCA HIGH RISK ANATOMY FOR ABRUPT CLOSURE SOLE VESSEL SUPPLYING HEART DIABETICS WITH MULTIVESSEL Dx
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In the beginning, there were balloons

1977 1990 Success rate approached 90% Failures resulting in emergency CABG
about 5% Compared to CABG, equivalent initial and 5 year outcome, except repeat procedures Restenosis 20- 25%
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Balloon Angioplasty (PTCA)

Catheter
threaded through artery usually femoral or radial to the aortic root Guide wire is then inserted into the coronary artery and advanced past the area of stenosis

Balloon tipped
catheter inserted over guide wire until balloon is in area of stenosis Balloon is inflated pushing plaque against the vessel wall
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Balloon inflation causes what has been
called a controlled injury to the coronary artery. On balloon deflation, there is some immediate recoil resulting in a loss of 15-30% of the inflated balloon diameter.
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Complications of PTCA
Plaque rupture, may lead to:
Thrombus formation Intimal flap
Arterial rupture Acute closure Sub-optimal result Restenosis

Requires further intervention to make vessel
patent
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MAJOR COMPLICATIONS
DEATH (0.5%-1%) Q-WAVE MYOCARDIAL
INFARCTION ( 1%-3%)
EMERGENT SURGERY (1%)
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PROCEDURAL COMPLICATIONS
ACUTE CLOSURE (4%-8%)

SPASM THROMBUS DISECTION EMBOLISM TREATABLE WITH STENTS
PERFORATION
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Limitation of Coronary Intervention.

Specific lesion characteristics may pose
challenges for coronary intervention. Anatomic classification. High risk lesions : Diffuse,excessive vessel tortuosity, extremely angulated, total occlusion,degenerated vein grafts. High risk lesions are associated with lower initial success rate and high incidence of recurrent stenosis.
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DISSECTION
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ULCERATED PLAQUE
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ACC-AHA Coronary Artery Lesion Classification
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Types of Lesions
Type A lesions
Discrete (<10 mm length) Concentric Readily accessible Non-angulated segment <45o Smooth contour Little or no calcification
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Types of Lesions
Type A lesions: Less than totally occlusive Not ostial in location No major branch involvement Absence of thrombus
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Type A
DISCRETE
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Types of Lesions
Type B lesions
Tubular (10-20 mm length) Eccentric Moderate tortuosity of proximal segment Moderately angulated segment >45o
<90o Moderate to heavy calcification
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Types of Lesions
Type B lesions
Total occlusions < 3 months old Ostial in location Bifurcation lesions requiring double
guide wires Some thrombus present
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Type B1- B2 lesions

Type B1 lesions have a single
adverse B characteristic. Type B2 lesions have two or more adverse characteristics
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Type B1
ECCENTRIC THROMBUS
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Type B2 (2 Charastics)
ECCENTRIC TUBULAR
ECCENTRIC IRREGULAR 12/22/12
Types of Lesions
Type C lesions
Diffuse (>2 cm length) Excessive tortuosity of proximal
segment Extremely angulated segments >90o Total occlusions > 3 months old
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Types of Lesions
Type C lesions
Inability to protect major side branches Degenerated vein grafts with friable
lesions
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Type C
DIFFUSE FRIABLE
OLD OCCLUSION
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IMPLICATIONS
Type A
92% Success, 2% Complications
Type B1
Type B2
Type C
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Then came the new devices

1990 all were investigational Approval 1992 1994 Success approached 98% Stents are embraced Need for emergency CABG < 1% Restenosis 10-15%
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Directional Coronary Atherectomy
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Directional Atherectomy
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Directional Atherectomy
First alternative to angioplasty. Can be applied selectively to eccentric
disease in the vessel wall, which may be cut out and retrieved. The cutter rotates at about 2000rpm and as it is advanced it shaves material, which become embedded in the cutting chamber. Potential concern : Perforation/Dissection. No clear clinical benefit of DCA in controlled trials : CAVEAT I and II
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Laser Angioplasty
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Laser

Laser ablation Fluorescence guided laser angioplasty Directional laser atherectomy Laser assisted thrombolysis Laser directed myocardial revascularization
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Laser Angioplasty
Catheter employs buldle of optic fibers
delivering ultraviolet laser energy. Small vessels,thrombotic lesions. Trials : Increased restenosis.
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Rotational Atherectomy
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Diamond chip-covered burr, which rotates
at 150,00-200,000rpm. Calcified lesions especially related to ostia of the vessel. Lesions that resist balloon dilatation and bifurcation lesions. Coronary spasm and no reflow ocure with increased frequency. Trials : ARTIST and ERBAC
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Rotational Atherectomy (Rotoblator)

.009 Guidewire with . 017 spring tip
Elliptical burr coated with diamond chips
Rapidly spinning burr ablates plaque tissue Differential cutting Used to debulk lesions Followed with balloon dilatation
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Aspects of Technique by Location A. Body of LMS (N = 2/44) - simplest NB guidewire bias in eccentric lesion
PRE
POST
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Particulate Size Distribution

5 studies, 33 experiments
99.97% < 30 um (theoretically the um) < Capillary 99.3% smallest protection device) Diameter 98.2% < Red Blood Cell Diameter Average Particle Distribution
(Models= Carbon blocks; Thermal injury porcine coronary artery; Diseased cadaver peripheral arteries) particle size: 1.92 um ( .1 Mean
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Fall from favour/use late 1990s 1. unfavourable restenosis data (ERBAC, ARTIST) 2. regarded as timeconsuming to use
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Cutting Balloon
3 to 4 atherotomes mounted on balloon. Capable of protruding outside of the
inflated balloon. Approved for lesions not dilatable by standered balloon technique. Considerable interest in using for in-stent restenosis. Little data avialable to suggest superiorirty over alternative technology.
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Cutting Balloon
Atherotomes on balloon
Advantages
Controlled
dissection Non-compliant balloon
Disadvantages Crossability Flexibility
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Stent
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What is a Stent?
A small tubular mesh usually made of
either stainless steel or Nitinol. Inserted into stenotic arteries to keep the lumen patent often used after PTCA. Used at various sites including the coronary, renal, carotid and femoral arteries. Non-arterial uses e.g. in bronchus, trachea, ureter, bile duct.
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Palmaz Corinthian Iliac artery stent
Gianturco-Roubin II Stent 12/22/12
Second Generation Stent
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Deployed Stents
ACS Tetra Tubular Stent
Cordis Crown Tubular Stent
Medtronic S670 Ring Stent
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Stenting
Most PCI are
performed with the use of stents Wire mesh coil pushed against vessel wall to prevent closure of the vessel post procedure
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Bifurcation Lesions
JOSTENT Bifurcation
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XIENCE SBA
Full Deployment with Side Branch Preservation
Proximal
In Vivo Porcine Model
Side Branch Portal
Main Side Stent Branch Branch Length ID Access ID XIENCE SBA is designed 3.0 mm 2.5 mm 18 mm
Distal
to allow for easy crossing of additional stent into side branch Portal structure is well apposed to the side branch ostium Max post-dilatation diameters 12/22/12
XIENCE SBA Delivery System

Based Upon MULTI-LINK FRONTIER Concept
Side Branch (OTW) Joining mandrel inserted through OTW inner member
Main Branch (RX)
Dual lumen tip
Design Features
Single Tip Delivery

Objectives
Ease of use Avoid wire wrap 7F guide catheter compatible Deploy stent quickly Minimize plaque shift Provide ostial scaffolding
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Simultaneous Balloon Deployment Side Branch Portal
Dedicated XIENCE
XIENCE Technology Dedicated to Side Branch Access
Side Branch
Access and Preservation XIENCE Technology
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Side Branch Access and Preservation

XIENCE SBA Deployment Sequence
1.
Advance system into the main branch, over a conventional RX wire Retract joining mandrel to release OTW side branch tip; insert exchange length guide wire Position guide wire in the side branch and advance system to the carina With a one inflation device, stent XIENCE SBA is currently a pipeline product at Abbott Vascular. Not available for sale. is deployed herein a single, Information contained withfor presentation outside of the U.S. and outside Japan. Not to be reproduced, distributed, or excerpted. simultaneous inflation
2.
3.
4.
Following deflation, the delivery system is retracted, preserving access in both branches.
All illustrations are artists rendition.
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XIENCE SBA is Designed to Treat Lesions at Bifurcations

XIENCE SBA shows complete lateral wall apposition and even stent coverage around the side branch
Standard workhorses may show a malapposed lateral wall and trainwrecking at and around the side branch after post-deployment balloon dilatation
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Wires maintained after system withdrawal for further treatment if needed
Side Branch Access Maintained Throughout the Procedure
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As a result of plaque shift, side branch occlusion can occur 5-26% of the time and is associated with adverse events
results showed higher rate of MI due to side branch occlusion SPIRIT III showed a higher rate of MI for side 1. S Garg et al. Interventional Cardiology 2006. 2. AJ Lansky et al. EuroIntervention. 2010;6 Suppl J:J44-J52. branch occlusion subset
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Simultaneous Balloon Inflation May Reduce Plaque Shift
NIRVANA study
XIENCE SBA
Deployment Sequence
3
System delivered to MB via RX wire 2.Joining mandrel removed, releasing SB tip; insert exchange length GW into the SB 3.Advance system to carina 4.Inflate both balloons with a single inflation device 5.After system removal, both guide wires remain for further treatment if desired
1.
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Coronary Perforation
JOSTENT Stent Graft
Ultra thin layer of expandable PTFE is placed between two stents, welded at its ends effectively seals off the vessel wall for perforations, aneurysms and can be beneficial in life saving situations
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STENTS
Currently over 70% of all interventions
on de novo lesions involve stent deployment. Address the two major limitations of angioplasty : acute occlusion and restenosis. Two major shortcoming of PTCA, elastic recoil and constrictive remodeling, are eliminated by stents. The superiority of stents over PTCA in reducing restenosis has been demonstrated in several clinical trials: STRESS - 29%Vs 43% 12/22/12
Restenosis
7 Days 90 Days
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The Problem
In-stent restenosis is a hyper-proliferative 12/22/12 disorder.
Restenosis
Recurrence of luminal narrowing after
angioplasty is termed restenosis. Mechanism involves elastic recoil, neointimal hyperplasia and arterial remodeling. Usually occurs within the first 2-6 months. Balloon angioplasty of native de novo coronary lesions was associated with restenosis rate of : - 32% in BENESTENT TRIAL - 42% in STRESS TRIAL 12/22/12 - 57% in CAVEAT TRIAL.
Stent Failure
Restenosis
20-30 %
7 Days
90 Days
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Mechanism of Restenosis
i shear stress Intimal Hyperplasia i lumen h shear stress If baseline shear stress not restored
continuing intimal hyperplasia and RESTENOSIS
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Factors Which Contribute to In-stent Restenosis

Thrombus/platelet/fibrin adherence to
stent struts. Metabolic disorder/smoking/atherogenic diet. Small lumen diameter. Stress concentration at end of stent. Flow disturbance within stented region.
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Brachytherapy
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Coronary Brachytherapy
Pre Diffuse lesion
Post Dilatation
Residual stenosis @ stent edge
Radiation Treatment or Placebo
Residual stenosis @ stent edge
Cardiac Angiography
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Cardiac Angiography
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Revolution in Percutaneous Coronary 1977 1988 2001 Today Intervention
197 7 Balloon Angiopla sty (PTCA)
Bare Metal Stents (BMS)
Coronar y Drug Eluting Stents (DES)
Absorb Bioresor bable Vascular Scaffold (BVS)

After impla nt. After resorp tion.
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Absorb BVS: Design Components

Bioresorbabl e Scaffold l Poly (Llactide) (PLLA) Based on proven MULTI-LINK pattern l Naturally resorbed, fully metabolize d* l Bioresorbabl e Coating Poly (D,Llactide) (PDLLA) Naturally resorbed, fully metabolize d l Everolimus XIENCE V
Delivery System
Similar dose density and release rate to XIENCE V
World-class deliverabilit y
*Except for platinum markers
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Description of the ABSORB Device
4. Description & usage of study device
ABSORB
Bioresorbable Vascular Scaffold
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BVS Design Optimization: Objectives
More uniform strut distribution More even support of arterial wall Lower late scaffold area loss
Cohort A
Maintain radial strength for at least 3 months
Unchanged:

Cohort B Photos taken by and on file at Abbott

Vascular.
Material, coating and backbone Strut thickness Drug release profile
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ABSORB BVS Cohort A, Cohort B and XIENCE V

ABSORB BVS Cohort A
Cohort A and B poly-L-
lactide (PLLA) covered with poly-D,L-lactide (PDLLA), containing and controlling release of everolimus
XIENCE V cobalt chromium

ABSORB BVS Cohort B
with fluoropolymer with controlled release of everolimus
XIENCE V 12/22/12
How Absorb Resorbs

lWater in surrounding vascular cells and blood penetrates polymer matrix lLong polymer chainsbecome shorter and shorter
Tie chai ns

Initially, hydrolysis preferentially cleaves amorphous tie chains, leading to a decrease in molecular weight without altering radial strength
When enough tie chains are broken, the device begins losing radial strength
Molecular Weight
Sup por t
Mass Loss 1 3 6 1 2 1 8
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24 Mont hs
Restoration of Vascular Integrity

Degrading polymer is first replaced by extracellular matrix, then by cells
6 mont hs
12 mont hs
18 mont hs
24 mont hs
36 mont hs
48 mont hs
Porcine coronary artery model
Based on preclinical histology evidence. Data and images on file at Abbott Vascular.
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Conformability Respects the Natural Contour of the Vessel

88 91
ABSORB BVS
Serruys, PW. , TCT 2009
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Are rigid permanent scaffolds the way of the past?

Fracture
I I
I I I
I V
I=single strut fracture, II=2 or more struts fracture without deformation, III=2 or in the CVPath registry, stent fracture was Among 200 DES lesionsmore struts fracture with deformation, IV=multiple fractures with acquired transection(29%). gap, documented in 51 (SES 32, PES 19) lesions without V=multiple fracturesidentified in 9 (SES 6, PES 3) lesions. Grade V fracture was with acquired transections with gap
Metal fatigue can result in strut fracture, triggering local inflammation, focal restenosis, and/or stent thrombosis 12/22/12 Nakazawa G, et al. J Am Coll Cardiol 2009; 54: 1924-
Periprocedural complications
In 1% to 3%, procedure is complicated
in hospital by a severe adverse event, while in the remainder, the procedure is unsuccessful either because a guidewire or device could not be delivered across the lesion or because the criteria for success are not met.
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Difficult angioplasty Scenarios

Chronic total occlusion. Calcified lesion. Ostial lesion. Bifurcation lesion. Long lesion. Bypass conduit.
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Severe Adverse Events

Death (0.5% to 1%) Q wave myocardial infarction (1% to3%) Need for emergent CABG (less than 1%) Acute Occlusion . Dissection. Thrombosis, spasm, embolism. Perforation. Significant CPK elevation.
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No-Reflow Phenomenon
Distal embolization of thrombus and/or
atheromatous debris . Thrombotic lesions, degenerated vein grafts are high risk .
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Thrombectomy Devices
To treat thrombus containing lesion and prevent distal embolization
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What happens if you just stent thrombus
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The importance of clot to coronary intervention
The presence of
thrombus increases the risk of complication
i.c. thrombolytic (Urokinase) 100-250,000 U/hr for 6 - 12 hours ? i.v. Aciximab bolus Transluminal extraction catheter (TEC) X-Sizer, Export, etc. Possis AngioJet Acolysis device (ultrasound)
Dissolution
Aspiration
eliminated by: Auto-lysis, particularly if facilitated by

i.v. heparin x 1 week
Clot can be
Fragmentation
12/22/12 OmniSonics
Intra-coronary thrombolysis
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Transluminal Extraction Catheter
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TEC Device
Transluminal extraction catheter. 750rpm. Aspirate debris as it is advanced through
the vessel. The device appear most suitable thrombus laden vessels. Distal embolization, no reflow and CPK elevation. No significant long term benefit.
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Transluminal Extraction Catheter (TEC)
Large guide Low efficiency Low success High complic.
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Clot Extraction Catheter
Diver C.E.
ev3 Inc. 12/22/12
Diver CE in Action!!
1
AMI: RCA occluded
2
Thrombus removal with Diver CE
3
Fluoroscopy provided with permission from Burzotta, et al
Final Result
Restoration of flow
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AMI with RCA Thrombus
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AngioJet LF140
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Angiojet
Flexible catheter. Saline injected at high speed. Venturi effect is created. Fragments the thrombus and suck it
back up into the collecting bag. Used in situaltions in which there is large thrombus burden.
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ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM THREE COMPONENTS

Drive Unit
Generates 10,000 pounds per square inch (PSI) pressure Monitors system performance to assure patient safety Versatile platform accommodates all AngioJet catheters Set up ease through lighted prompt menu
Pump Set
Isovolumetric balance between fluid delivery and removal Effectively bridges non-sterile and sterile environment
Catheters
Disposable catheters approved for a variety of indications
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Angiojet of SVG Thrombus
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The ev3 (EndiCOR) X-Sizer

atherectom devic Thromb and 2.3 mm e 1.5, 2.0 y o cutters 7-9F guide compatible
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X-TRACT: 30 Day MACE
All p=NS
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X-TRACT: Impact of Thrombus

Thrombus pre (n=450) No thrombus pre (n=253)
60%
54%
30%
17%
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Distal Protection Devices
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Distal Protection Device Concepts
Filter Device
Balloon Occlusion Device 12/22/12
Distal Protection Devices

The AngioGuard Filter
The PercuSurge GuardWire and Export aspiration catheter
The EPI FilterWire EX
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Distal Protection The 2 Principles of Distal Protection:

You need distal embolization to benefit from distal protection The Most Frequent Complication of Distal Protection Devices is Distal Embolization
(Device-, Operator-/Technique-, Lesion-related) 12/22/12
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Limitations of Angiography
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Intravascular Ultra Sound (IVUS)
Ultrasound transducer mounted near tip of catheter Provides a 2-D image from insideout of artery Allows for 360 visualization of vessel wall
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IVUS: Method of Application
Courtesy of Steven E. Nissen, MD.
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Vessel
Ultrasound scan plane
Catheter
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High frequency sound waves echo off vessel walls and are sent back to system
System electronics process the signal
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IVUS A New Dimension in Imaging
Normal angiographic image of vessel
OLD GOLD STANDARD
IVUS image of vessel with eccentric plaque 12/22/12
NEW GOLD STANDARD
IVUS of native artery
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IVUS of Stent
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The IVUS technique can detect angiographically silent atheroma

Angiogram IVUS
No evidence of disease
Little evidence of disease
Atheroma
IVUS=intravascular ultrasound Nissen S, Yock P. Circulation 2001; 103: 604616
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IVUS Imaging of Intimal Plaque
Courtesy of Steven E. Nissen, MD.
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Intravascular Ultra Sound (IVUS)
Measurements can be made on the crosssectional image to give luminal diameter IVUS shows plaque deposits much greater than angiography alone
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Incomplete Stent Apposition
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LIMITATIONS OF ANGIOGRAPHY
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Virtual 12/22/12 Histology
Interventional Technique
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Kissing Balloon (or Stent)
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Anchor Balloon for CTO
12/22/12 Fujita et al Catheterization and Cardiovascular Interventions 59:482488 (2003)
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Retrograde Technique for CTO
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CTO device
TORNUS
Vascular)
Braided
(Abbott
stainless steel flexible catheter able to enlarge the vessel by screwing through it Tapered tip Rotate counter-clockwise to advance Clockwise to withdraw No more than 10-20 rotations in the same
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CTO device
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CTO device
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(Vascular Perspectives)
Tapered soft tip Hydrophilic coating ASAHI brand braiding pattern, consisting of 8
Corsair
thinner wires wound with 2 larger ones Advancement:
hold a torque device at all times to avoid ASAHI Corsair
and the guide wire to be rotated together Image the Corsair tip under fluoroscopy to make sure that the tip is not trapped by the lesion avoid torque accumulation - limit the rotation to 10 times in one direction. To continue advancing ASAHI Corsair, rotate the opposite direction
Rotate the Corsair during removal into the
guide
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Non-coronary interventions
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CAROTID STENOSIS
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CAROTID STENOSIS AFTER STENTING
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SUBCLAVIAN STENOSIS
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SUBCLAVIAN STENOSIS POST PTA
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Balloon Angioplasty SUMMARY

RAPIDLY GROWING FIELD PTCA IDEAL FOR SINGLE VESSEL AND 2-
VESSEL DISEASE WITHOUT PROXIMAL LAD INVOLVEMENT STENTS USED IN 90% PTCA CASES
Drug-eluting stents in 80%
RESTENOSIS LESS OF A LIMITING
FACTOR NON-CORONARY PTA EXPANDING

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Percutaneous Valvuloplasty
Mitral Valvuloplasty
Aortic Valvuloplasty 12/22/12
MITRAL VALVULOPLASTY
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Mitral stenosis
Normal Mild MS
4-6 cm2 2 cm2 1.0-1.5 cm2 cm2
Moderate MS
Severe MS < 1.0
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MS :PTMC
Wilkin Score -Leaflet mobility -Valvular thickening -Subvalvular thickening -Valvular calcification
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Aortic Stenosis:
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Aortic Stenosis
Recommendations for Aortic Balloon Valvotomy in Adults With Aortic Stenosis
Indication Class
I A bridge to surgery in hemodynamically IIa unstable patients who are at high risk for AVR Palliation in patients with serious IIb comorbid conditions Patients who require urgent noncardiac IIb surgery 12/22/12 III As an alternative to AVR Bonow et al. 1998 ACC/AHA Task
Balloon Aortic Valvuloplasty?

Benefits
Yes, but transient
Risks
Yes
Alternatives
AVR
Alters
natural history but also carries risk
Percutaneous AVR ?
The
future? The only role for BAV ?
BAV in autopsied heart. Note cracks in Ca++ nodules
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AS :Percutaneous AV replacement
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Percutaneous Aortic Valve Replacement
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Percutaneous Aortic Valve Replacement
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New TAVI valves are coming to the market in a few years time
Toda y Tomorro w

Next Gen. Medtronic CoreValve
Boston Sci. Lotus
HL T
Edwards Sapien XT Medtronic CoreValve Medtronic Engager Saint Jude Portico Direct Flow
Edwards Sapien JenaValve Symetis ACCURATE
Edwards Sapien XT
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PS :Percutaneous Balloon pulmonic Valvuloplasty (PBPV)
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Transcatheter Pulmonary Valve Replacement
Bonhoeffer Lancet 2000;356:1403-5
Melody Valve
SapienTM Valve
IDE Trial Began 1/2007 HDE Approval 1/2010
IDE Trial Began 1/08 COMPASSION -Recruiting 12/22/12
Atrial Septal Defect Closure

Atrial septal defect Devices
Amplatzer
Helex
Atrial Septal Defects Advantages of Transcatheter Closure
Fewer Complications Avoidance of Cardioplegia and
C-P bypass Shorter Hospitalization Reduce Need for Blood Productions Less Patients Discomfort
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Lock Clamshell
CardioSEAL
STARFlex
Das Angel Wings
Amplatzer
ASDOS Umbrella 12/22/12
Amplatzer ASD Closure Device
12/22/12

Amplatzer Septal Occluder Self-expandable, double disc Nitinol wire mesh, short connecting
waist Discs and waist filled with polyester fabric
ASD Closure Device

Cera
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Amplatzer Septal Occluder Advantages

Easy deployment Retrievability prior to complete
deployment
Self-centering defect stenting
mechanism
Single unit construction Lack of sharp edges
(reduces cardiac 12/22/12

Atrial septal defect Cribriform
device
Transcatheter Closure of ASDs Potential Complications

Device embolization
device) (part or whole
Device migration TIAs, CVAs

emboln) (air, thrombus, or device
Perforation of atrium Atrial arrhythmias Device encroachment on adjacent
structures
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Leaflet mal-coaptation resulting in MR

Central MR Primary Jet in A2-P2
Anatomic Eligibility
Non-rheumatic/endocarditic valve morphology; LVIDs 55mm; MVA 4cm2

Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D Percutaneous Mitral Repair with the MitraClip System: Safety and Midterm Durability in the Initial EVEREST Cohort J Am Coll Cardiol 54:686-694, 2009
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Percutaneous Mitral Valve Repair Clinical evidence demonstrates*: System

-
Superior safety when compared to surgery Reduction in mitral regurgitation Favorable left ventricular remodeling Improvement in patient symptoms
Reduction in hospitalizations for heart failure
l The MitraClip:
-
Establishes vertical coaptation while capturing the leaflets and drawing them together Repositionable to allow real-time MR assessment prior to deployment Safety and effectiveness are supported by data from the EVEREST clinical trial program and numerous real-world studies
*N ENGL J MED 2011; 364:1395-1406. MitraClip is subject to prior training requirement as per the Instruction for Use.
12/22/12
Mitral Valve Clip
12/22/12
Clip repair in porcine heart (6 months post repair)
Suture (4 years post repair)
Privatera et al: Circulation. 2002;106:e173 repair in human heart
Fann JI, , et al. Beating heart catheter-based-edge-to-edge mitral valve procedure in a porcine model; efficacy and healing response. Circulation 110:988-993, 2004
12/22/12
Mitral Regurgitation Grade

EVEREST II High Surgical Risk Cohort
FMR
N = 100 Matched Cases
DMR
N = 37 Matched Cases
p < 0.0001
p = 0.006
82%
78%
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WaveCrest: device design
Small 14-20mm Medium 18-25mm Large 23-30mm

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WaveCrest device design
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Left atrial appendage closure: WaveCrest
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Closure Devices
12/22/12
Femoral Haemostasis
Potential advantages of closure devices:
prolonged bed rest increased comfort reduced cost (LOS) pain and associated vagal reactions Improve use of physician / nurse time complications
12/22/12
Closure devices
Primary Intention Clips and Sutures Collagen / thrombin / pads
Angiolink Onux
Perclose X-site Sutura
Angioseal
Vasoseal
Duett
Quick seal Sub Q (gel foam) BioIntervention Clo sure PAD Syvek Flo seal Biodisc Therus (Ultrasound)
Closure devices
Primary Intention Clips and Sutures Collagen / thrombin / pads
Angiolink Onux
Perclose X-site Sutura
Angioseal
Vasoseal
Duett
Quick seal Sub Q (gel foam) BioIntervention Clo sure PAD Syvek Flo seal Biodisc Therus (ultrasound) 12/22/12
Perclose
Redwood City, CA, USA
TechStar
7F - 1 suture
ProStar XL
8F and 10F 2 sutures
The Closer
6F 1 suture Knot making tool 3-0 braided polyester (non-absorbable)
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Perclose - Closer
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Perclose - Closer
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Perclose - Closer
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Perclose - Closer
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Perclose - Closer
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6F and 8F devices Components
St Jude Medical, St. Paul, Minnesota, USA
Angioseal
Biodegradable anchor (intra-arterial) collagen plug (extra-arterial) 3-0 Vycril suture (with clinch knot)
12/22/12
Angioseal
Modifications
improved collagen weave pattern mono-fold sheath tip enhanced suture delivery and release
mechanisms re-designed anchor anti-rotation sheath cap Improved indication markings
12/22/12
Angioseal
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Angioseal
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Duett
Vascular Solutions Inc., Minneapolis, Minnesota, USA
Collagen and thrombin

Intra arterial balloon during thrombin
delivery Seals artery and tissue tract Balloon then removed Delivery followed by short period of manual compression
5F to 9F
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Duett
3F Duett catheter
Existing sheath
Insert the Duett catheter into the artery via the existing introducer sheath.

Inflate the balloon.
Withdraw the Duett catheter and sheath as a unit until the balloon is positioned firmly against the inner arterial wall.
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Duett
Deliver the procoagulant directly to the puncture site through the sidearm of the introducer sheath.
Continue procoagulant delivery until the entire tissue tract is filled.
12/22/12
Duett
Tissue track also Rx
Deflate balloon.
Remove the Duett catheter and introducer sheath from the patient.
Maintain direct pressure over the puncture site for 2-5 minutes.
12/22/12
Puncture site
External Iliac retroperitoneal haemorrhage
Optimal
A-V fistula pseudoaneurysm thrombosis vessel laceration Profunda femoris Superficial femoral 12/22/12
Puncture location
Schnyder G Cathet and Cardiovasc Int 2001;53:289
% where puncture will be above bifurcation
54.5%
81.5%
94.5%
98.5%
12/22/12
New complications
Skin tract ooze Failed closure Device Infection Arterial obstruction
12/22/12

Interventional Cardiology

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Interventional Cardiology

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Charles Dotter 1920 - 1985

Melvin P. Judkins 1922 - 1985

Mason Sones 1919 - 1985

Andreas Gruentzig 1939 - 1985 12/22/12

Mason Sones 1919 - 1985

Andreas Gruentzig 1939 - 1985

Charles Dotter 1920 - 1985

Melvin Judkins 1922 - 1985 12/22/12

Historic Time Line

INDICATIONS FOR PTCA

ASYMPTOMATIC , MILD SYMPTOMS

INDICATIONS FOR PTCA

WITH GOOD DISTAL TARGETS

In the beginning, there were balloons

Balloon Angioplasty (PTCA)

Balloon Angioplasty (PTCA)

Balloon Angioplasty (PTCA)

Arterial rupture Acute closure Sub-optimal result Restenosis

DEATH (0.5%-1%) Q-WAVE MYOCARDIAL

ACUTE CLOSURE (4%-8%)

Limitation of Coronary Intervention.

Click to edit Master subtitle style

ACC-AHA Coronary Artery Lesion Classification

<90o Moderate to heavy calcification

guide wires Some thrombus present

Type B1- B2 lesions

adverse B characteristic. Type B2 lesions have two or more adverse characteristics

ECCENTRIC IRREGULAR 12/22/12

Then came the new devices

Directional Coronary Atherectomy

Rotational Atherectomy (Rotoblator)

Elliptical burr coated with diamond chips

Particulate Size Distribution

dissection Non-compliant balloon

Disadvantages Crossability Flexibility

Palmaz Corinthian Iliac artery stent

Gianturco-Roubin II Stent 12/22/12

Second Generation Stent

Cordis Crown Tubular Stent

Medtronic S670 Ring Stent

In Vivo Porcine Model

Side Branch Portal

XIENCE SBA Delivery System

Main Branch (RX)

Dual lumen tip

Simultaneous Balloon Deployment Side Branch Portal

Side Branch Access and Preservation

XIENCE SBA is Designed to Treat Lesions at Bifurcations

Side Branch Access and Preservation

Side Branch Access and Preservation

Side Branch Access and Preservation

In-stent restenosis is a hyper-proliferative 12/22/12 disorder.

continuing intimal hyperplasia and RESTENOSIS

Factors Which Contribute to In-stent Restenosis

Residual stenosis @ stent edge

Radiation Treatment or Placebo

Residual stenosis @ stent edge

Revolution in Percutaneous Coronary 1977 1988 2001 Today Intervention

197 7 Balloon Angiopla sty (PTCA)

Bare Metal Stents (BMS)

Coronar y Drug Eluting Stents (DES)

Absorb Bioresor bable Vascular Scaffold (BVS)