Basic principles of the procedure

Frijo Jose A

ComparisonDiagnostic v/s Guiding catheters Stiffer shaft Larger internal diameter (ID) Shorter & more angulated tip (110 vs. 90) Re-enforced construction (3vs.2 layers)

Guide catheter construction

Curves in guide catheter

Guiding catheter
For each given size of, its ID is either a standard, large or giant lumen Larger sizes
better opacification of the contrast better guide support allow pressure monitoring increased risk of ostial trauma, vascular complications and the possibility of kinking of catheter shaft

Judkins and Amplatz

Judkins Extremely useful as a diagnostic cath - 1: curve is fixed
Intubates small segment of ostium - risk of trauma

Limitation while performing PCI - 1: curve is fixed

May not be co-axial as cath makes an angle of ~90 with cor - may be difficult to pass balloons-esp LCX

JL- point of contact on asc Ao -very high & narrow- chance of prolapse & dislodgement JR- no point of contact on asc Ao - extremely poor support

Backup force
3 factors
Catheter size Area of contact made by cath on Ao Angle (theta) of cath on the reverse side of Ao

The angle (theta) determines the force that can dislodge the guiding catheter.

If this angle is 90:, it results in a greater backup force. Therefore a lower position is preferable as the point of contact on the reverse side of the aorta because the angle approaches 90

Other Guiding Catheters

Long tip cath like Xtra backup (XB) & Extra back up (EBU) modifications for JL- stiffer & free 1: curve more co-axial & support
XB distal tip - lies more horizontal within cor, sometimes pointing , & intubating more LMCA Longer segment of XB cath comes in contact with contralat wall of Ao- back-up support

XB cath- ~67% additional support v/s JR- at the cost of likelihood of trauma LMCA, esp - pre-existing plaque stiffer - chance of injury XBLAD - support for LAD interventions specifically

Xtra backup (XB) tip

Guide Catheter for RCA Interventions

JR or Hockey Stick (HS) is usually preferred Extra-support-(CTO/tortuous)- AL1 MP cath- esp abn take-off, esp inf Three dimensional right curve (3 DRC) cathtortuous, bent anatomy & postr/supr take off of RCA XBR & XBRCA -new caths specifically for inf & sup take off of RCA respectively

Guide Catheter for LCX Interventions

JL 4 may be gently rotated clockwise to achieve a stable co-axial alignment Ao root dialated / if JL 4 points anteriorly- JL 5 If additional support AL cath recommended
Unlike JL, a simple withdrawal can cause the tip to advance even furthe- best way to disengage an AL is to advance it slightlyprolapse tip out of cor & then rotate it out of the ostium

Voda cath- esp when a double PTCA of LAD & LCX in same sitting

The Voda catheter

Side Holes v/s No Side Holes

Side holes
where P gets freq damped (RCA) where prolonged intubation of cor mandated (CTO) to know P through out PCI (sole surviving art / LMCA)

P will not be damped allow additnl blood flow out the tip- perfuse cor may also avoid catastrophic dissections in the ostium of the artery if the guide catheter is not co-axial it can be a false sense of security Ao P, not cor P is being monitored suboptimal opacification back up support- weak cath shaft & kinking at side holes

Guide Techniques for PCI of Tortuous Arteries Deep Seating of Guide cath deeply intubated into cor- support RCA/LCX - clockwise rotation & gentle advancing of guide over the guide wire LAD - counterclockwise rotation

risk of dissection & embolization, esp degenerated SVG

Guide Techniques for PCI of Tortuous Arteries Child in Mother Technique 110cm long 5Fr guide (Child) in 100cm long 6Fr/7Fr guide catheter (Mother) May provide up-to 70% more support Trauma to vessel dissection Air embolism usually occurring during intubation of child catheter/during CAG performed via mother guide

Shepard's Crook RCA Dramatic upturn with a 180 switchback turn AL1/0.75 & 3DRC are best suited for this anatomy

Guide wire - construction

Most - calibre of 0.014 inch Multi-layer constructions:
1. Core element (usually stainless steel/or nitinol): tapers at variable points towards wire tip to impart differential stiffness along wire's length 2. Terminal coil segment (often 30mm length; usually radio-opaque material e.g. platinum/iridium alloys): gives flexibility and allows wire tip to be shaped per operator requirements 3. Coating: most wires silicone/Teflon outer coating to aid easy advancement. Some coated with a hydrophilic polymer coating that becomes a gel when wet to reduce surface friction and increase wire slipperiness

Guide wire - construction

Most - calibre of 0.014 inch 3 main components of guidewire design:
central core outer covering exible distal tip

The wire tip may be further subdivided into spring coil & short distal tip weld Also, all guidewires have a specic surface coating applied

Central core
Longest & stiffest portion of guidewire Tapers distally to a variable extent
2-piece core- distal part of core does not reach distal tip of wire shaping ribbon, extends to distal tip 1-piece core- tapered core reaches distal tip weld

2-piece easy shaping & durable shape memory 1-piece better force transmission to tip & greater tactile response for operator

Central core
Stainless steel
superior torque characteristics, can deliver more push, provides good shapeability of tip in core-to-tip design wires more susceptible to kinking

Durasteel- better tip shape retention and durability Nitinol

pliable but supportive, less torquability than SS generally considered kink resistant & have a tendency to return to their original shape, making them potentially less susceptible to deformation during prolonged use

Distal tip
Flexible, radio-opaque part Consists of spring coil extending from distal untapered part of central core to distal tip weld Integrates tapered core barrel (as well as shaping ribbon in 2-piece wire) Spring coil-variable length (1-25cm)-radio-opaque section located at its terminal end Distal tip weld- short (2mm)compact cap forming the true distal end of the wire - to trauma while the wire is traversing vessels

Wire Coating-hydrophilic/hydrophobic
Hydrophobic Repels water - requires no actuation/wetting friction (to V/S no coating), trackability Preserves tactile feel, allows easier anchorability / parking - esp CTO Silicone, Teflon

Hydrophilic Attracts water - needs lubrication Thin, slippery, non-solid when dry becomes a gel when wet
friction( no coating) glide through tortuous trackability Thrombogenic tactile feel- risk of perforation Tendency to stick to angioplasty cath

Useful in negotiating tortuous lesions and in finding microchannels in total occlusions Lubricity is highest with hydrophilic wires, less with Silicone coating and least with PTFE or Teflon coating

Properties Of An Ideal Guidewire

Push transmission/steerability Torque transmission/torquability Body support/ trackability Tip support/mobility Flexibility Tip durability/elasticity Tip visibility and markers Tactile feedback Prolapse tendency

 Push transmission/steerability: ability of a guide wire tip to be delivered to the desired position in a vessel
Torque transmission: ability to transmit rotational forces from the operators hand to the tip Body support/ trackability: ability to advance balloon catheters/other devices on guidewire Tip support/mobility: Allows moving the distal tip to search for the true lumen Tip durability/elasticity: Permits shape memory retention of the distal tip throughout Tactile feedback: feel of the wire tips behavior, as perceived by the operator
better appreciated with non-coated / hydrophobic coated, coil tipped wires and it with hydrophilic coating

Shapeability and shaping memory

Shapeability - allows to modify its distal tip conformation Shaping memory - ability of tip to return back to its basal conformation after having been exposed to deformation & stress
Both do not necessarily go in parallel SS core wires -easier to shape (memory- nitinol core) 2-piece core + shaping ribbon - easier to shape & memory

General rule- when negotiating a vessel with J loop, distal bend ~ D of vesselmore bend wire tip prolapsing, less bend - steerability

Types Of Guidewires
Depending on tip load- Balanced, Extra support, Floppy Tip load- force needed to bend a wire when exerted on a straight guide wire tip, at 1 cm from the tip
Balanced 0.5-0.9g Extra support - >0.9g Floppy - <0.5g

 Workhorse wire: default choice - balance btw stiffness/support & flexible tip majority lesions Stiff wires: offer extra support for tortuous/calcified cor Floppy wires: when vessel trauma is a concern (e.g. re-crossing a dissected lesion)

Workhorse (frontline) Guidewires

ATW/ATW Marker Stabilizer BMW / BMW Universal Zinger Cougar XT Asahi Light / Medium Asahi Standard Asahi Prowater Flex Choice Floppy Luge IQ Forte Floppy Runthrough NS Galeo

Balance Middleweight Universal wire

(Abbott Vascular/Guidant, Santa Clara, CA)

Quite steerable - tip is suitable for bending in a J conguration for distal advancement into the distal vessel bed with minimal trauma while still maintaining some torque shape retention relatively poor -any J conguration tends to become magnied over time consequent loss in steerability moderately torquable- progression - minimal friction (light hydrophilic coating) - Dye injection may also be helpful to propagate distal advancement suitable for rapid, uncomplicated interventions low risk to cause dissections/distal perforations support - low to moderate

Balance Middleweight wires

from the generation previous to the Universal lack light hydrophilic coating at the tip more steerability but requires greater effort for distal advancement more direct tactile feedback (v/s more automatic progression Universal) Support-moderate -power steering-

Runthrough NS wire
unique dual core design
main shaft core of SS & a distal core of nitinol alloy, which extends into a nitinol shaping ribbon

distal tip is hydrophilic coated

Runthrough NS wire

Guidewire Strategies for Approaching CTO

A) Guidewires for Approaching Micro-channels
Crosswire NT Whisper / Pilot Rinato Shinobe / Shinobe Plus ChoICE PT / ChoICE PT ES PT Graphix PT2

C) Guidewires for Penetrating Strategy

Cross IT Conquest Pro Liber 8

D) Guidewires for Retrograde Technique

Fielder/FielderFC X -treme Whisper ChoICE PT2 Runthrough / Runthrough Hypercoat

B) Guidewires for Drilling Strategy

Persuader Miracle Bros Cross-It

CTO
Start with the intermediate wire This provides 3g of distal force and moderate support Conventional stainless steel core wire with 30mm of tip radio-opacity and 0.014 in. diameter If this wire fails to cross, Miracle series

Intermediate Wire (Asahi Intecc)

Tip load ............................... 3.0 g Tip radiopacity .................... 3 cm PTFE coating over the shaft

Miracle series (Asahi Intecc)

0.014 in wires - specically designed for CTO 110mm of distal tip radio-opacity for optimal visualization Come in 4 versions of distal force: 3g, 4.5g, 6g, 12g

Tip load ............................... 3.0 g Tip radiopacity .................. 11 cm PTFE coating over the shaft

Tip load ............................... 4.5 g Tip radiopacity .................. 11 cm PTFE coating over the shaft

Tip load ............................... 6.0 g Tip radiopacity .................. 11 cm PTFE coating over the shaft

Tip load ............................. 12.0 g Tip radiopacity .................. 11 cm PTFE coating over the shaft

Conquest series (Asahi Intecc)

The next evolution- tapered tip Conquest wire (Conanza)
Has a distal tip diameter of only 0.009 in The distal tip is radio-opaque for 200mm Provides 9g of distal force

Conquest Pro (Conanza Pro)

Also tapered to 0.009 in Provides 9g of force Hydrophilic-coated for the distal 20 cm Tip tapering is proposed to help the wire nd and navigate microchannels in the occluded segment, while the hydrophilic coating of the Conquest Pro reduces the tip friction by about onethird

Tip load ............................... 9.0 g Tip radiopacity .................. 20 cm Tip outer diameter ...... 0.009 inch (0.23 mm) PTFE coating over the shaft

Tip load ............................... 9.0 g Tip radiopacity .................. 20 cm Tip outer diameter ...... 0.009 inch (0.23 mm) SLIP COAT coating over the spring coil PTFE coating over the shaft The distal tip is not coated to allow it to catch on the entry point of the lesions

Tip load ............................. 12.0 g Tip radiopacity .................. 20 cm Tip outer diameter ...... 0.009 inch SLIP COAT coating over the spring coil PTFE coating over the shaft For penetration of calcification and proximal or distal thick, fibrous caps

Tip load ............................. 22.0 g Tip radiopacity .................. 17 cm Tip outer diameter ...... 0.008 inch (0.20 mm) SLIP COAT coating over the spring coil PTFE coating over the shaft Designed for crossing complex lesions with heavy calcifications and tough fibrous tissues Finest and stiffest guidewire in the current Asahi series.

Fielder / Fielder FC (Asahi Intec Co.)

Special guidewire - distal coil coated with polymer sleeve & further coated with a hydrophilic coating Provides advanced slip performance & trackability for highly stenosed lesion & tortuous vessels Very good torque performance Combines both slide and torque performance Primary wire used in the retrograde technique of recanalization of CTO

Tip load ............................... 1.0 g Tip radiopacity .................... 3 cm Polymer sleeve length ..... 22 cm SLIP COAT coating over the spring coil PTFE coating over the shaft

Tip load ............................... 0.8 g Tip radiopacity .................... 3 cm Polymer sleeve length ..... 20 cm SLIP COAT coating over the spring coil PTFE coating over the shaft

Tip load ............................... 0.8 g Tip radiopacity .................. 16 cm Polymer sleeve length ..... 16 cm Tip outer diameter ...... 0.009 inch0.23 mm SLIP COAT coating over the spring coil PTFE coating over the shaft

Galeo guide wire

Optimum guide wire positioning

Should be placed as distally as possible in the target vessel Allows extra support when crossing with balloon/stent catheters chance of the wire becoming displaced backwards across the lesion and necessitating re-crossing Avoid vessel perforation when positioning wires with hydrophilic coatings very distally

Plain old balloon angioplasty

1977- Andreas Gruentzig 1st gen balloon cath - fixed to guidewire - difficult to cross tight/tortuous lesions Initially, over-the-wire systems new monorail systems
Short guidewires Facilitates performance of PTCA by a single operator

Progression in balloon technology

different type, better materials, better coatings, lower-profile systems, improved delivery, burst pressure, compliance

Balloon technology

Construction of the balloon catheter (monorail type)

Only the distal 1525 cm of the balloon catheter tracks over the guidewire 1. 2. 3. 4. less procedural time a single operator reduced fluoroscopy time no additional devices for the exchange

The catheter has a lumen through its entire length that tracks over a guidewire Guidewire and balloon catheter move independently of each other

1. two operators 2. can exchange balloon catheters only with a 300 cm exchange length wire or specific products (Trapper or Magnet) in order to maintain the wire position across the lesion 3. increased exposure to radiation because the fluoroscopy needs to be on during the placement of the balloon

The guidewire and balloon are on the system

1. 2. 3. 4. 5.

The guidewire cannot be advanced independently over the Balloon Fixed system- does not allow for guidewire exchange Has the lowest profile Inability to exchange for another balloon catheter without having to recross the lesion Need to remove the whole system if the wire tip becomes damaged

Either an over-the-wire or a monorail design Perfusion side holes proximal and distal to the actual balloon As the balloon is inflated, the perfusion side holes allow blood to enter the catheter through the proximal holes, flow within the inflated balloon, and exit the catheters distal side holes Balloon can be inflated for longer periods of time Specific situations- cor perforation & abrupt closure, that cannot be recovered by a stent Decreased trackability due to its larger diameter

Balloons
Distal tip -usually tapered- allows to cross lesion less traumatically Profile of the distal tip will determine how much push is needed to get across the lesion Coating also determinant for ability to cross
A hydrophilic coating- superior in crossabilty A slippery characteristic- not suitable for in-stent restenosis- balloon will easily slip out of the lesion when inflated

Performance Parameters
Low entry & crossing profile- for optimum tracking & crossing Short inflation & deflation time- to avoid ischemic complications Optimum refolding characteristics- to avoid traumatization or stent damage Predictable balloon compliance- to allow precise diameter sizing High balloon-burst strength- for high-pressure dilatations Low bending stiffness- for easy tracking of curved vessels

Profile
Largest diameter in the balloon region
To position balloon safely across tight lesions, possible profiles required To cross extremely tight & long lesions, both entry & crossing profiles must be profiles -to avoid luminal obstructions

Maximum Profile of PTCA Balloon Catheters

Distal profile (mm) Medtronic Sprinter 3.0/20 mm Proximal profile (mm)

0.85 0.85

1.00 1.00

Biotronik Elect 3.0/20 mm Guidant Voyager 3.0/20 mm

0.80
0.85

0.95
0.95

Boston Scientific Maverick 2 3.0/20 mm

Cordis Aqua T3 3.0/20 mm

0.80

0.95

Inflation & Deflation Time Inflation of a balloon within a narrowed, but not completely occluded, blood vessel results in ischemia of the dependent tissue To ischemic time - obstruction time Obstruction time =time required to transmit pressure in the hand pump to the balloon + time for balloon inflation + deflation time

 Resistance,R- determined by viscosity, inner radius r & length l of the hypotube Poiseuille's law
So r of the tubing- major determinant of resistance Low-caliber - long inflation/deflation timelimit on catheter shaft profiles Inflation & deflation times depend on volume of balloon- not useful in balloon comparisons

For balloon inflation, a clinically relevant mixture of saline & contrast agent (1:1) should be used

 Deflated balloon remains within lumen & obstructs blood flow To minimize residual obstruction & to avoid vessel damage by flaring unfolded balloon of parts on retraction, the geometric refolding characteristics of balloon after deploymentimportant cross-sectional area & smooth profile of refolded balloon - least blood-flow obstruction, avoids vessel traumatization, stent damage on withdrawal

Average deflation time of PTCA balloon catheters

Balloon Compliance
Change in balloon D for a given change in balloon P Can be either indicated as a %in D/bar, or listed as a table of P & corresponding balloon D- 1st useful for classification of balloons as noncompliant/semicompliant, latter is usually given by the manufacturer for each device as the compliance chart

High to moderate compliance balloons

Polyolefin copolymer (POC) Polyethylene (PE) [< than POC] Balloon sizing important oversizing can easily occur Tend not only to stretch in D but also to overexpand into the areas of least resistance, i.e. prox & distal to lesion (dog-boning)- dissection observed more commonly Crossability may be superior

Nylon
Thick material- compliant at pressures mean burst pressures

Non complaint balloons

Polyethylene terephthalate (PET) thicker-walled balloon Allow work at higher pressures hard calcified lesion or post-stent dilatation

(a) A compliant balloon tends to be oversized at the edges, with less dilatation at the obstructive segment of the lesion (dog-boning) (b) A noncompliant balloon gives a predictable amount of pressure at the lesion without uncontrolled radial and longitudinal growth

D Compliance of High-pressure PTCA Balloons

Diameter compliance (%/bar) Medtronic Sprinter 3.0/20 mm Biotronik Elect 3.0/20 mm Guidant Voyager 3.0/20 mm Boston Scientific

9.92 5.50
8.99 9.88

Maverick 2 3.0/20 mm Cordis Aqua T3 3.0/20

mm

5.88

Balloon Burst Strength

The radial & axial stresses (rad, ax) depend on balloon pressure p, balloon diameter d, & thickness s of balloon wall
Balloon will burst if stresses exceed rupture stress of the material Stress- linear correlation with P & D, and inverse relationship to balloon thickness Given the same material, a larger balloon diameter & thin balloon material burst P Also within the balloon axial stress is as big as radial stress

 RBP the maximum recommended P for safe use - 99.9% of the tested balloons will not fail at RBP with 95% confidence Nominal P the P at which balloon will have expanded to the manufacturer-specified size
e.g. a 2.5mm D balloon expanded to nominal P should have an external diameter of 2.5mm

The dilating force

Pressure (hydrostatic force) put in the balloon Tension determined by
balloon diameter, balloon material/compliancy, and vector force (the amount of constriction)

Therefore, balloon size and balloon compliance are the major determinants for successful mechanical dilatation

In IVUS , dissection is observed in up to 6070% of dilated segments Dissection may be necessary for optimal results after POBA

 Long lesions(>20mm)- may be treated with long balloon to avoid dissection at edges Soft lesions(recent)-lipid conc-inflation P Calcified lesions(cholesterol, conn tissue,& muscle cells)-dissection/perforation chance -NC balloon-allows inflation P to crack lesion Calcified lesions & post stent dilatationrated burst P & shorter balloons better Size of balloon- based on ref vessel D balloon/artery ratio of ~ 1.1 currently recom

 Trackability
ability of a system to be advanced to a target lesion affected by several technical parameters such as friction, bending stiffness etc

Crossability
ability to pass stenoses

Pushability
load transfer from interventionists end to the distal tip of catheter High load transfer allows finer & more direct tactile control of the instrumentation
Even small obstructions that cause only a minor in reaction forces at the catheter tip can be felt by the operator, allowing him to tune and finely adjust the pushing force to overcome the obstacle while utilizing the least injurious maneuver

Crossing Difficult Lesions

Following techniques use of stronger back-up catheters deep insertion of guide adding vibration Pushing balloon while pulling guidewire use of a stiff guidewire Buddy wire technique

Elect: Fast-exchange Balloon Catheter

Low shaft profile- compatible with smaller guide (5F compatibility for all balloon sizes) Hydrophilic coating improves gliding Soft Tapered Tip(Laser-rounded)-safety & crossability Embedded Platinum-Iridium Markersoptimized visibility, crossing profile

Elect: Fast-exchange Balloon Catheter

Lesion entry profile Shaft diameter 0.017" Proximal: 2.0F; Distal: 2.4F (1.25-1.5mm) , 2.6F ( 2.0-3.5mm), 2.7F ( 3.754.0 mm)

Recommended guide catheter Nominal Pressure

5F (min. I.D. 0.056") 7 bar

Rated burst pressure (RBP)

18 bar ( 1.25mm), 16 bar ( 1.52.25 mm), 14 bar ( 2.5-4.0mm)

Pleon
Superb pushability & crossability- esp suitable for reaching difficult target lesions laser-rounded soft tip hydrophilic coating

Jocath Mercury PTCA Catheter

Jocath Mercury PTCA Catheter

Balloon Compliance:
Shaft Diameter:

Semi-compliant
2.0F proximal 2.7F distal 140-145 cm 0.017" 8 bar

Shaft length: Lesion Entry Profile: Nominal Pressure:

Rated Burst Pressure:

Average Burst Pressure: Coating: Min. Guiding Catheter:

16 bar
22 bar HYDREX Coating System 5F (0.058")

NC Mercury PTCA Catheter

Maximized wall apposition due to NC balloon behavior Minimal balloon overhang- to limit vessel injury during high P dilatation Minimal tip flaring Fast deflation time Efficient access- low entry profile

Coronary stents

 Ulrich Sigwart & Joel Puel in 1987 implanted the first stent in a human coronary artery in Toulouse, France

TYPES OF STENTS
Metal composition Open v/s closed cell designs Thickness of struts Eluting drugs Stent design may be specific -small (<2.5 mm diameter) vessels / bifurcation lesions

Metal composition
Cobalt-chromium - more deliverable for challenging lesions Stainless steel designs - greater radial strength for bulky lesions or those involving more muscular aorto-ostial locations Co-Cr - stronger & more radiopaque than SS thinner struts, lower profiles (<0.40), better flexibility & similar radial strength

Stent structure
Slotted tube stents Modular stents Multicellular stents Modular-multicellular stent (hybrid stents)

Slotted tube stents

Slotted tube stents are made just by cutting longitudinal slashes in tubes

Modular stents
Consist of several crown-shaped modules, which may be manufactured from metal wires that are punctually connected to form a tube
ie, based on repeating identically designed units, again laser-cut, linked together by welded struts

An open-cell design Highly flexible Offer better side-branch access

Boston Scientific Express stent

 Open-cell/modular stent design Multiple repeating modules are linked at certain points of the design, giving flexibility but less metal : artery coverage

Medtronic DriverTM stent

 The Palmaz-Schatz stent Based on repeating modules

Multicellular stents
Completely closed cell design Less flexible Uniform vessel wall coverage preventing tissue prolapse
Guidant Multi-Link

 Closed-cell stent design Modern closed-cell stents have relatively large cells

Boston LiberteTM stent

Modular-multicellular stent
Also called hybrid stents Try to combine the advantages of multicellular and modular stents
Lekton Motion, Pro Kinetic

Cell design
Closed cell (in which each ring is interconnected) more support less flexible Open cell improves flexibility improves sidebranch access reduce radial support

 Strut- single element that forms larger structural entities such as cells, rings, or crowns Cell - small but regularly repetitive structure of a stent
Open cells have a more complicated structure than closed cells Cells represent the elementary geometrical figure of the stent- will deform during stent expansion

Rings and crowns- comprise a cluster of cells forming a higher-order geometrical pattern of the stent, which may form complete stent segments usually coupled by longitudinal bridges or links

Strut thickness
Thinner struts - vessel injury Strut thickness <100 microns - thin strut stents

Stent coating
The eluted drug is linked by a degradable/permanent polymer coating only a few micrometers in thickness
not expected to change mechanical strength may affect surface friction

 Provides local delivery of a drug Methods for the storage and controlled release
Nondegradable or biodegradable polymer Cavities on the stent struts- drug depots Small amounts of drugs applied directly to stent surface

Nondegradable polymers- polyurethane, silicone, polyorganophosphazene, polymethacrylate, poly(ethylene terephthalate), & phosphorylcholine Biodegradable polymer- poly(l-lactide), poly(3hydroxybutyrate), polycaprolactone, polyorthoester, fibrin

DES- mechanism of benefit

Late lumen loss and restenosis after nonstent interv combination of acute recoil, negative remodeling (arterial contraction), and local neointimal hyperplasia Late lumen loss after stenting - solely to in-stent neointimal hyperplasia The restenosis benefit of DES compared to BMS results from inhibition of in-stent neointimal hyperplasia , which is reflected as a lesser degree of late in-stent lumen loss at 6-9/12 (0.2 to 0.4 versus 0.9 to 1.0 mm with BMS) -Neointimal suppression is still sustained at 2years

 In the Ontario registry the benefit was limited to those patients with two or three risk factors for restenosis (diabetes, vessels <3 mm in diameter, and lesions 20 mm in length) In the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), the benefit with DES compared with BMS was most apparent when any one of these high risk features was present

Sirolimus
aka Rapamycin- immunosuppressant drug - macrolide First discovered from Streptomyces hygroscopicus in Easter island soil sample island aka "Rapa Nui", hence named Originally developed as an anti-fungal agent Sirolimus is lipophilic - crosses cell membranes binds FK binding protein-12 (FKBP-12)an active complex Sirolimus:FKBP-12 complexbinds & inhibits mammalian Target Of Rapamycin (TOR) Inhibition of this enzymecytokine-dependent cellular proliferation at G1 to S phase of cell cycle The mechanism of inhibition is cytostatic rather than cytotoxic as the affected cells remain viable

Paclitaxel
Mitotic inhibitor isolated it from bark of the Pacific yew tree, Taxus brevifolia, hence named taxol Stabilizes microtubules interferes with the N breakdown of microtubules during cell divisionprevents DNA synth Paclitaxel-inhibited cells remain at the G0/G1 and G2/M interfaces of the cell cycle Cells exposed to paclitaxel undergo apoptosis/cell death- cytotoxic

Everolimus
A rapamycin analogue Novel macrolide with potent immunosuppressive & antiproliferative effect Arrests cell cycle at the G1 to S phase

Biodegradable stents
Intended to support a vessel for just as long as is necessary to complete the healing process and to then disappear after a specified time period Complications resulting from long-term intravascular presence of a FB- thrombogenicity, permanent mechanical irritation, prevention of positive remodeling, are eliminated Poly(L-lactic acid) (PLLA), poly(D-lactic acid) (PDLA), poly(e-caprolactone) (PCL), poly(glycolic acid) (PGA)

Scanning electron micrograph of a PLLA stent prototype

NexgenTM Cobalt Chromium Coronary Stent System

Hybrid cell design Ultra-low strut thickness of 65m The balloon overhang is 0.3mm ensuring that balloon related injury is marginalized

Stent Material

: Cobalt Chromium L605

: 65 m (0.065mm or 0.0026") : 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 : 8, 13, 16, 19, 24, 29, 32, 37, 40 : 0.29%

Strut Thickness

Stent Diameters (mm) Stent Lenghts (mm) Mean Foreshortening

genXCrCo coronary stent

Stent material L605 Co-Cr alloy

Design

10 Crown , variable geometry

Strut thickness

65 micro meters

Strut Width

Large 70 micro meters Small 60 micro meters

Guiding catheter Crossing profile

5 Fr compatible < 1 mm

genX coronary stent

Stent material SS316L Stainless Steel 10 Crown , variable geometry 105 micro meters Large 85 micro meters Small 75 micro meters 5 Fr compatible < 1 mm

Design

Strut thickness

Strut Width

Guiding catheter Crossing profile

Lekton Motion
Combines cell pattern & Z-shaped connections Strut thickness of 90m Ultra low profile (<1.00mm) permits excellent tracking & crossing Also available in 2 versions: Petite (vessels <2.5mm) & Mega (vessels >4mm)

 Petite
80 m struts Small vessel design with lowest crossing profile Shaft with Enhanced Force Transmission technology permits exellent positionning in distal anatomy

Mega
Compatible with 5F guide catheters in all sizes Special design for optimal flexibility and support of large vessels (>4mm) Maximum expansion: 5.5 mm

PRO-Kinetic
Cobalt Chromium Stents Struts- 60 m (0.0024) 3 Different Design
Specific designs for small, medium and large arteries

Low Profile
Low profile (0.95 mm) permits easy track & cross

Double Enhanced Force Transmission Shaft (EFT)

shaft flexibility & kink resistance

Hydroglide coating Shaft Profile- all sizes compatible with 5F space stents

Angstrom
Material- 316LVM Stainless Steel Non-Ferromagnetic Strut Width 0.09 mm Closed-cell design Profile before Delivery < 1mm

genXsync
Uniform sinus design Alternate S link offers excellent flexibility Biodegradable polymer in single layerinitial burst of sirolimus followed by sustained elution up to 40 days Polymer degrades by hydrolysis & enzymatic excreted in form of CO2 & H20 PTFE hypotubing shaft- improved pushability Super thin alloy (65m) with ultra thin coating (3m) Low crossing profile drug eluting stent (< 0.85 mm)

Stent material

L 605 Chromium Cobalt

Design

Uniform sinusoidal cell design

Bioresorbable and biodegradable polymers Sirolimus 65 m 85 m Nearly zero < 4.0% 5 Fr Compatible < 0.85 mm

Coating

Drug Strut thickness Strut width Nominal foreshortening Recoil Guiding Catheter Crossing Profile

CYPHER Stent
Stent Geometry Material Strut Thickness Crimped Profile Available Sizes Closed-cell FLEXSEGMENT Technology 316L Stainless Steel .0055" .044" Diameters: 2.25, 2.50, 2.75, 3.00, 3.50 mm Lengths: 8, 13, 18,23, 28, 33 mm Sirolimus

Drug Delivered Mechanism of Action

Inhibits m TOR to block growth factor induce proliferation Cytostatic

Drug Delivery Vehicle

Controlled-release, nonresorbable, elastomeric polymer coating 80% of sirolimus released in 30 days

Drug Release Kinetics

Approval Status

Approved by FDA

Biomime

Angstrom lll
Closed-cell design Stainless steel Paclitaxel eluting

XIENCE V
0.0032 strut thickness Clinically proven MULTI-LINK VISION CoCr stent

Endeavor Sprint Zotarolimus-Eluting Coronary Stent System

 Attempts to the amount of balloon protrusion outside the stent vessel trauma in adjacent cor segs A perfect match not yet achieved Diffuse disease- Minimal balloon overhand Significant vessel tapering- Minimal balloon overhand

A = plaque compression B = superficial tear/fissure (intimal) C = deeper sub-intimal tear D = subintimal tear with localized dissection E = deep subintimal tear with extensive dissection reaching media F = circular sub-intimal dissection

In eccentric lesions, stretching of vessel wall (without plaque) and sub-medial dissection can occur

Vessel size
In the beginning - elective stent deployment limited to large cor ( 3 mm) STRESS trial elective stenting provided superior angiographic & clinical outcomes in vessels <3 mm (stented using 3 mm stents)

Optimal stenting
Deployment with only minimal residual luminal stenosis -risk of both ST & ISR Suboptimal luminal dilation
inadequate balloon expansion (related in part to plaque characteristics) & elastic recoil ( asso with stent design & resistance)

 STARS 265 (13.5%) of 1,965 pts enrolled met prespecified criteria for suboptimal stenting (defined as residual stenosis >10 percent, evidence of stent thrombosis, dissection or abrupt closure, absence of TIMI III flow, or need for three or more stents)

Acute and nine-month clinical outcomes after "suboptimal" coronary stenting: results from the STent Anti-thrombotic Regimen Study (STARS) registry J Am Coll Cardiol 1999 Sep;34(3):698-706.

Suboptimal stenting periprocedural NSTEMI (8.7 v/s 4.2 %) overall 30 day mortality (1.1 v/s 0.06 %) clinical restenosis (27 v/s 16 %) 9/12 MACE(death,MI,TVR), esp due to NSTEMI(9 v/s 4.6 %) & TVR(15.5 v/s 10.2 %)

Acute and nine-month clinical outcomes after "suboptimal" coronary stenting: results from the STent Anti-thrombotic Regimen Study (STARS) registry J Am Coll Cardiol 1999 Sep;34(3):698-706.

Role of predilation
classic approach Predilation stent deployment high-P postdilation
procedure time radiation exposure contrast use cost

 Tight/heavily calcified lesions, esp in tortuous vessels risk of stent dislodgement from delivery balloon & potential embolization of the stent Predilatation also preferred when precise positioning of distal end of the stent is mandatory- potentially poor visualization of the vessel distal to the stent may occur, particularly in critical stenoses

Direct stenting
Theoretically less traumatic to vessel wall May be esp beneficial in the presence of thrombus/when treating degenerated SVG Direct stenting procedure time, contrast Prox anat landmark- side branch/Ca spot, to guide stent positioning - helpful during direct stenting Use of extra support guidewires & optimal cath support recommended

 Settings in which direct stenting might be considered

Vessel 2.5 mm Absence of severe cor Ca Absence of signi angulation (>45) Absence of occlusions & bifurcations

Direct stenting
Potential Advantages Avoidance of multiple exchanges Less trauma Failure of precise positioning, incomplete deployment Lower rate of noreflow Shorter procedural time Lower procedural costs Incomplete apposition Traumatization of the target vessel Stent damage or loss Potential Drawbacks Failure to track

(BET, SWIBAP, PREDICT, CONVERTIBLE, and TRENDS)

Major outcomes similar (proc success, adv events, MACE) Direct stenting for CSA- asso with periprocedural microcirculatory injury v/s pre-dilation -50 pts - J Am Coll Cardiol. 2008 Mar 18;51(11):1060-5

STEMI undergoing PPCI embolization of plaque constituents, no-reflow myo perfusion & salvage A randomized comparison DS v/s Conv-( J Am Coll Cardiol 2002 Jan 2;39(1):15-21) - 206 pts- 102/104 Composite end point of slow & noreflow/embolization- (DS-11.7% vs. 26.9%, p = 0.01) No ST resolution in 20.2% (DS) vs. 38.1%, p = 0.01

STEMI-Angio & clinical outcomes asso with direct v/s conv in pts treated with lytic therapy ( Am J Cardiol 2005 Feb 1;95(3):383-6) - Direct stenting -death, MI, or CCF during hosp & at 30 days independently asso with in-hospital outcomes

Spot stenting
Using the shortest possible stent only in the particular segments of a lesion - proposed by Colombo & colleagues
Attractive strategy, given the poor outcomes of long lesions treated with very long (>32 mm) stents

Clinical events & TLR in spot stenting gp than in conven (22% v/s 38% & 19% v/s 34%, resp)- Colombo A, De
Gregorio J, Moussa I, et al: J Am Coll Cardiol 2001; 38:142733.

Use of long stents to treat vessels >3.5 mm in diameter provides acceptable restenosis rates, whereas minimizing stent length is important in small vessels

Role of high pressure balloon dilation

High (16 to 20 atm) & low (8 to 10 atm) Stents usually deployed with a high P technique utilizing 12 to 16 atm Lower P deployment (8 to 14 atm) -signi vessel tapering/when prox edge injury is a concern, as is the case with use of drug-eluting stents Most cases- high-pressure postdilation with an appropriately sized NC balloon at 12 to 16 atm to achieve full stent expansion

Hospital discharge
Patients undergoing elective stenting are generally discharged within 24 hours after stent implantation following overnight observation and monitoring

EPOS trial
800 pts elective PCI Same-day discharge (after 4hrs of bed rest & 4hrs of ambulation) V/S overnight stay Femoral approach with 5F or 6F guiding catheters, pretreatment with 100mg of asa, single 5000 IU hep, 300mg clopi post procedure in pts who were stented 80%- eligible for same-day discharge in both gps Suitability criteria for early discharge -freedom from sympts & absence of ECG changes & puncture site abn Same-day discharge after elective PCI is feasible and safe in the majority (80%) of patients selected for day-case PCI. Same-day discharge does not lead to additional complications compared with overnight stay Limitations- postprocedural rather than preprocedural clopi; no use of bivalirudin or glycoprotein IIb/IIIa inhibitors; small catheter sizes and elective admission for PCI rather than PCI directly following angiography

Heyde GS; Koch KT et al. Circulation. 2007 May 1;115(17):2299-306

SAFETY OF MRI
Based upon available evidence, it appears to be safe to perform an MRI at any time after placement of coronary artery stents of any type