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Brave Decisions with premier stent
Yasser Ahmed Sadek, MD
NHI
CLINICAL HISTORY
• Male pt 46 ys old.
• Diabetic(IDDM) for more than 20 ys,ex-smoker and hyperlipidemic.
• He complained of exertional chest pain with effort 2 months ago with (CCS II).
• He started medical treatment and 2 weeks later he developed severe chest pain and diagnosed as NSTEMI.
LAB
• HB 13.2 gm/dl
• Urea 48 , cretinine 1.4mg/dl
• Troponin: 0.2 ng/dl
• ECG: ST segment depression at anterolateral leads
• ECHO:SWMA at the entire apex and inferolateral wall with preserved LV global systolic function
1st Coronary angiography
CA continued
Trial of PCI
Multiple Balloon Inflations(8 balloons)and failed to cross two different types of the stents
Tight proximal focal calcific lesion resistant to high pressure balloon inflation
Follow up
• The patient chest pain related procedure controlled on maximal medical treatment.
• The patient refused surgery and he insisted to do PCI again after recurrence of exertional chest pain.
• What we need……….
Equipment's needed
• High pressure balloon.
• Cutting balloon.
• Rotablator.
• IVUS.
• the exceptional pushability, trackability and flexibility stents.
EPU guiding catheter3.5/6f via transradialapproach
SION 0.014 guiding wire
The guiding wire changed by rota wire via microcatheter then Rotablator 1.5 burr
10 min to cross by Rota then Quantum balloon 2.75x20mm
Quantum NC 3.25x20mm and 3.5x20mm also failed to fully inflated at the same lesion
IVUS Catheter
IVUS
Finally Flextome cutting balloon 3.25x15mm fully inflated successfully
Premier stent 2.75x24mm distally overlapped by premier stent 2.75x32mm
Wiring of 1st OM by Sion wire
Body wire by PT(LS)wire and premier stent 2.75x38mm after the predilation
The ostial LAD showed significant lesion!!!!!!!
IVUS for LAD
Stenting ostial LAD by premier stent 3.5X12mm and postdilation by NC balloon 4x20mm
Just ostial
Final angio
Final angio, continued
• What is the Rotablator System?
• Rotational Atherectomy System• Diamond-tipped burr designed to preferentially ablate calcium and fibrous
plaque
• System includes both capital equipment and disposable components
• Capital Equipment• Console
• Foot Pedal
• Air Tank
• Disposables• Wires
• Advancer
• Burr
RotablatorTM
Rotational Atherectomy System
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
Clinical Application
• Why use Rotational Atherectomy?
• Calcium is out there.
• The prevalence of severe calcium, defined as superficial in nature with greater than 180° arc, is estimated to present itself in 12% of cases using angiographic imaging. When IVUS guidance is used, it’s seen in approximately 26% of cases.1
• Calcium can preclude optimal stenting.
• Asymmetrical stent expansion occurs in up to 50% of cases where calcium is not treated before stent deployment.2
• With DES, rotational atherectomy is an important tool for calcified lesions.
• Lesion preparation with compliance change for a calcified lesion can substantially facilitate stent delivery and symmetrical stent expansion for more homogeneous drug delivery.3
30 of 57
1. Mintz et al. Patterns of Calcification in Coronary Artery Disease. Circulation April 1995, Volume 91, No 7
2. Moussa, Moses, Columbo et al. Coronary Stenting After Rotational Atherectomy in Calcified and Complex Lesions. Circulation 1997; 96:128-136
3. Iakovou, I. et. al. J Am Coll Cardiol 2005;46:1446-55
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
• Porcine Model*
31 of 57
RotablatorTM System result with minimal vessel injuryAngioplasty result with vessel injury
Intended PTCRA benefits• Minimize vessel wall stretch and elastic recoil • Eliminate vessel barotrauma• Produce a smooth lumen/channel• Facilitate stent delivery and expansion
Mechanism of Action
*Porcine model results may not necessarily be indicative of clinical performance.
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
Key Procedural Steps
Important reminder on Burr movement
• The directions for use (DFU) for the RotablatorTM RotalinkTM Burr Catheters specify to always keep the burr advancing or retracting while it is rotating.
• Maintaining the burr in one location while it is rotating may lead to excessive tissue removal or damage to the Rotablator system.
• System damage could include wire damage or fracture.
32 of 57
Illustration by Boston Scientific
Prior to use, please see the complete ‘Directions For Use’ for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
FlextomeTM Cutting BalloonTM Device in Complex Lesions
33*When treating lesions at a bifurcation, the Cutting Balloon Device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat theside branch of a lesion at a bifurcation.
*
FlextomeTM Cutting BalloonTM Device in Complex Lesions
In-Stent Restenosis Lesions - Avoid balloon slippage• Lesions with a high composition of neo-intimal hyperplasia which offer greater resistance to
dilatation and cause balloon slippage1,2
• The scoring mechanism of action of the Cutting BalloonTM device allows controlled dilatation while preventing balloon slippage3.
Ostial and Bifurcation* Lesions - Avoid Plaque shift• Challenging lesion subsets with a higher degree of recoil and potential of plaque shift effect
• The Cutting BalloonTM device successfully dilates while reducing elastic recoil4 and allowing more plaque compression with minimal plaque shift and less vessel stretching5,6,7
Fibrotic lesions - Change lesion compliance• Resistant lesions with a higher concentration of elastin and muscle fibers
• Cutting BalloonTM atherotomes gently score through fibrotic plaque providing a novel and simple strategy for coronary lesions resistant to conventional balloon dilatation15
34
The FlextomeTM Cutting BalloonTM device is a unique** and effective*** tool for the mechanical challenges of complex lesions that are often resistant to conventional
balloon angioplasty
*When treating lesions at a bifurcation, the Cutting Balloon Device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat the side branch of a lesion at a bifurcation.**As know to date on the market****Compared to Cutting Balloon Ultra²TMBench testing and cadaver testing conducted by Boston Scientific Corporation. N=3, 3.0mmx15mm balloons. Data on file. Bench test results may not necessarily be indicative of clinical performance.Please refer to Glossary for references
Flextome is better than Ultra 2
35
• 30% more Deliverable*
• 50% better Re-cross*
• Distal shaft PEBAX® - better tracking and flexibility
• Mid shaft nylon blend vs. braid -better flexibility
• Atherotome Flexpoints every 5 mm for more flexibility • Catheter shaft MaverickTM platform
• Rated Burst Pressure increased from 10ATM (1013kPa) to 12ATM (1216kPa)
• Non-compliant Nylon balloon material provides improved
flexibility, better re-wrap and puncture resistance*
Performance improvement*
Minor enhancements
Major enhancements
Based on bench testing
Differences from Cutting Balloon Ultra2™ Device
* Compared to Cutting Balloon Ultra²TMBench testing and cadaver testing conducted by Boston Scientific Corporation .N=3, 3.0mmx15mm balloons. Data on file. Bench test results may not necessarily be indicative of clinical performance.Pebax is a registered trademark of Arkema.
Deliverability
Flexibility
Cutting BalloonTM Device Clinical Benefits
• Precise dilatation
• Scoring the plaque by severing the elastic and fibrotic continuity of the vesselwall
• Lesion dilatation at lower pressures with less recoil compared to POBA
• Lumen gain through plaque compression instead of vessel wall expansion
• Successful vessel preparation prior to stent placement to avoid under expansion and malapposition
• Lower residual percent diameter stenosis with Cutting BalloonTM Device plus stent Versus POBA plus stent at post procedure and at 6 month follow-up.11
• High rate of delivery and deployment success
• Excellent acute outcomes when used as a primary therapy device
• No slippage on deployment – controlled vessel injury zone3
• Minimal plaque shift
• Low rates of acute complications, total dissections and severe dissection and perforations compared to POBA.
• Please refer to Glossary for references36
Technical ConsiderationsIndications/ Contraindications/Warnings
• Indications:
• The Flextome Cutting Balloon Device is indicated for use in patients with coronary vessel disease who are acceptable candidates for coronary artery bypass graft surgery, should it be urgently needed. In addition, the target lesion should possess the following characteristics:
• Discrete (<15 mm in length), or tubular (10 to 20 mm in length)
• Reference vessel diameter (RVD) of 2.00 mm - 4.00 mm
• Readily accessible to the device
• Light to moderate tortuosity of proximal vessel segment
• Nonangulated lesion segment (< 45°)
• Smooth angiographic contour
• Absence of angiographically visible thrombus
• Contraindications:• Use of the Cutting Balloon Device is contraindicated in situations where the Cutting Balloon Device would
be passed through the side cell of a previously placed stent as the deflated Cutting Balloon Device could become entangled in the stent.
• Coronary artery spasm in the absence of significant stenosis
• Warnings:• Exercise extreme care when treating a lesion distal to a stent. If the guidewire has passed through the
stent cell rather than down the axis of the stent, the deflated Cutting Balloon Device could become entangled in the stent. When treating lesions at a bifurcation, the Cutting Balloon Device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat the side branch of a lesion at a bifurcation
NEW Contraindication and Warning will also included in Cutting Balloon Ultra²TM DFU37
1. See Directions for Use for clinical outcomes – PLATINUM Clinical Trial Program.
2. Deliverability bench testing performed by Boston Scientific Corporation on 2.50 mm stents (n = 3). Data on file at Boston Scientific.
stent architecture for strength & flexibility
clinical outcomes1
deliverability2
Promus PREMIER™ Stent SystemCustomized for Premier Outcomes
CUSTOMIZED
OUTSTANDING
UNMATCHED
Procedural and Clinical ImpactAlloy and Design
Stent Platform
(BMS / DES)Alloy Deliverability
Radial
StrengthAxial Strength Radiopacity Conformability
Fracture
Resistance
Post-Dilatation
CapabilityRecoil
Velocity / Cypher
Platform
Stainless
Steel
(316L)
Vision / Xience
MultiLink / Xience
Xpedition™
Platform
Cobalt
Chromium
(L605)
Driver / Endeavor
Integrity / Resolute
Platform
Cobalt
Nickel
(MP35N®)
PREMIER
Platform
Platinum
Chromium
(PtCr)
Least Capable Capable Most Capable
1. Based on scientific properties of alloy and stent design. Data on file at Boston Scientific.
Promus PREMIER™ Stent System has several performance advantages1
Visibility ComparisonPlatinum has over 2x the density of Iron or Cobalt1
1. Data on file at Boston Scientific. Based on 2.50 mm stents. Copper phantom to simulate body mass. Photographs taken by Boston Scientific. Bench test results may not necessarily be indicative of clinical performance.
PtCr
Promus
PREMIER™
Stent
0.081 mm
(0.0032”)
CoCr
Xience V™
Stent
0.081 mm
(0.0032”)
CoCr
Xience
Xpedition™
Stent
0.081 mm
(0.0032”)
CoNi
Resolute
Integrity™
Stent
0.089 mm
(0.0035”)
PtCr
PROMUS
Element™
Stent
0.081 mm
(0.0032”)
CoCr
Orsiro™
Stent
0.060 mm
(0.0024”)
SS
Nobori™
Stent
0.112 mm
(0.0044”)
SS
BioMatrix
Flex™
Stent
0.112 mm
(0.0044”)
(Post Expansion - Percentage a stent diameter decreases after balloon deflation)
Exceptionally Low Recoil
Rec
oil (
%)
Less R
eco
il
Promus PREMIER™ Stent has up to 40% Less Recoil
than Cobalt Alloy Stents tested1
1. Bench testing performed by Boston Scientific Corporation. Data on file at Boston Scientific. All stents 2.50 mm; Promus PREMIER Stent n = 15, PROMUS Element Stent n = 15, Orsiro Stent n = 3, Xience Xpedition Stent n = 3,
Xience V Stent n = 10, Resolute Integrity Stent n = 3, Nobori Stent n = 3, BioMatrix Flex Stent n = 3.
Bench test results may not necessarily be indicative of clinical performance.
Exceptionally Low Acute Lumen Loss
Exceptionally Low Acute Lumen Loss
Exceptionally Low Acute Lumen Loss
Enhanced Design for Easier Deliverability
Pro
mu
s P
RE
MIE
R™
Ste
nt
Syste
m
Strong outer layer (72D)
Flexible inner layer (63D)
Features Advantages
Shorter Tip Improves tip flexibility
Red Tip Colorant Improves tip visibility when loading on a guidewire
PTFE Coating vs.
Nylon on Proximal
Shaft Hypotube
Reduced friction
Kink resistance
Proximal shaft profile and lubricity
Bi-Segment™ Inner
Lumen Catheter
Pushable proximal segment
Flexible distal segment
Dual-layer
PEBAX™ Balloon
Optimal compliance
Minimal balloon growth
1. Deliverability bench testing performed by Boston Scientific Corporation on 2.50 mm stents (n = 3). Data on file at Boston Scientific. Illustrations are not indicative of clinical performance.
Low Stent and Tip Profile
1.13 mm
(0.044”)
0.457 mm
(0.018”)
Xience Xpedition™
Stent System
1 mm
1.03 mm
(0.041”)
0.457 mm
(0.018”)
PROMUS Element™ Plus Stent System
1 mm
1.09 mm
(0.043”)
0.452 mm
(0.018”)
Xience V™
Stent System
1 mm
Crossing Profile Tip ProfileMarker Bands
1.02 mm
(0.040”)
0.455 mm
(0.018”)
Promus PREMIER™
Stent System
1 mm
1.10 mm
(0.043”)
0.500 mm
(0.020”)
Resolute Integrity™
Stent System
1 mm
1.17 mm
(0.046”)
0.465 mm
(0.018”)
Biomatrix Flex™
Stent System
1 mm
1. Data on file at Boston Scientific. All 2.50 mm stent systems, n = 3. Images by Boston Scientific. Cognex Test Method (crimped: distal, mid, proximal).
1.12 mm
(0.044”)
0.450 mm
(0.018”)
Nobori™
Stent System
1 mm
0.98 mm
(0.038”)
0.465 mm
(0.018”)
Orsiro™
Stent System
1 mm
PRESSURES 11
1115
15
1517
10
1013
9
912
8
811
16
1620
18
1827
17
1724
12
1213
13
1317
14
1420
6
608
2.50 – 2.75 mm
3.00 – 2.75 mm
ATM
kPa
2.25 – 2.75 mm
3.00 – 4.00 mm
4.00 mm
2.25 – 3.50 mm
2.25 – 2.50 mm
3.00 – 4.00 mm
Nominal and Rated Burst Pressures
Promus PREMIER™ Stent has exceptional compliance and low balloon growth
Promus PREMIER
Stent System
Xience V™
Stent System
Xience Xpedition™
Stent System
Resolute Integrity™
Stent System
2.25 – 2.75 mm
3.00 – 4.00 mm
2.25 – 3.00 mm
3.50 – 4.00 mm
2.25 – 3.00 mm
3.50 – 4.00 mm
Orsiro™
Stent System
Biomatrix Flex™
Stent System
Nobori™
Stent System
1. Promus PREMIER Stent System, Xience V Stent System, Xience Xpedition Stent System, Resolute Integrity Stent System, Orsiro Stent System, Biomatrix Flex Stent System and Nobori Stent System Directions for Use.
Total: 1.12 mm
0.53 mm
Total: 0.93 mm
0.44 mm
Total: 1.38 mm
0.55 mm
Inflated to 1114.575 kPa (11 ATM)
Total: 1.63 mm
0.65 mm
Inflated to 1823.25 kPa (18 ATM)
Minimal balloon overhang to help minimize vessel trauma or damage outside the stent
Low Balloon Overhang
Total: 1.14 mm
0.53 mm
Total: 1.01 mm
0.45 mm
Total: 1.24 mm
0.72 mm
Total: 1.43 mm
0.82 mm
Promus PREMIER™
Stent System
PROMUS Element™
Plus Stent System
Xience V™
Stent System
Xience Xpedition™
Stent System
Promus PREMIER
Stent System
PROMUS Element
Plus Stent System
Xience V
Stent System
Xience Xpedition
Stent System
Total: 1.32 mm
1.17 mm
Total: 1.48 mm
1.75 mmResolute Integrity™
Stent System
Resolute Integrity
Stent System
Total: 2.60 mm
1.47 mm
Total: 2.01 mm
0.79 mm
Total: 2.92 mm
1.69 mm
Total: 2.94 mm
1.31 mm
Biomatrix Flex™
Stent System
Nobori™
Stent System
Biomatrix Flex
Stent System
Nobori
Stent System
1. Data on file at Boston Scientific. Images taken by Boston Scientific. All 2.50 mm stent systems; n = 3. Bench test results may not necessarily be indicative of clinical performance..
Take Home Message
• Complex PCI needs all tools to be there.• The rotablator is a very helpful tool in heavily calcific
stentic arteries.• Oversized burr in diffuse calcium and too much pressure
can jam.• Cutting balloon providing a novel and simple strategy for
coronary lesions resistant to conventional balloon dilatation to prepare the vessel prior to stent placement.
• Premier stent has improved the tip flexibility ,the exceptional
pushability and also has outstanding trackability.
Thank You