2. • Optimal coronary stent implantation is among the few successful strategies in
preventing stent failures, notably in-stent restenosis and stent thrombosis.
• Understanding the intravascular milieu is a prerequisite for optimization of PCI.
• Patients with obstructive coronary lesions with a high calcium content (LHCC)
have an exaggerated clinical risk, because the presence of calcification is a/w
More extensive coronary atheroma
Higher burden of comorbidities.
3. • Treatment of LHCC using percutaneous techniques is complex because
Increased risk of incomplete lesion preparation with suboptimal stent deployment
Higher rates of acute and chronic stent failure
• Calcified lesions limit stent expansion, the most robust predictor of target lesion
revascularization, and are thus associated with worst outcomes.
4. CLINICAL IMPLICATIONS OF CORONARY CALCIFICATIONS
• Age and sex dependent
more common in men older than 70 years of age
>90% in men vs. 67% in women
• The incidence varies on the used imaging modality
• A/w larger plaque burden and a greater degree of lesion complexity including
involvement of coronary bifurcation or chronic total occlusion
5. • Association between LHCC and adverse clinical outcome is independent of
clinical presentation and the implanted stent categories
• Bourantas et al. showed how patients with LHCC undergoing PCI are
less likely to receive complete revascularization (48% vs. 55.6%; p < 0.001)
more likely to die subsequently (10.8% vs. 4.4%; p < 0.001)
6. • In the pooled analysis of the ACUITY (Acute Catheterization and Urgent
Intervention Triage Strategy) and the HORIZON-AMI (Harmonizing Outcomes
with Revascularization and Stents in Acute Myocardial Infarction) trials, PCI
performed on moderately/severely calcified coronary lesions in patients with acute
coronary syndrome was a/w
62% higher risk of definite stent thrombosis
44% higher risk of ischemic target lesion failure
7. • Adverse clinical outcomes observed in patients treated with LHCC are related to
comorbidity
the increased technical complexity of PCI
• These lesions are challenging to cross with standard devices and are less likely to
respond to balloon dilatation
8. • Inadequate preparation of any LHCC lesion before stenting increases the risk of
Stent loss
Stent underexpansion/fracture
Rate of intraprocedural complications, such as
No reflow
Coronary dissection
Perforation
10. CORONARYANGIOGRAPHY
• LHCC is initially detected in emergency cardiac patients during coronary
angiography
• Before injecting angiographic contrast, LHCC typically appears as
linear areas of x-ray attenuation (black areas) following the silhouette of the
coronary artery, with a synchronous movement during cardiac contraction and
relaxation
11. • Angiographic CAC is often classified into 3 groups:
None/mild
Moderate
Severe
12. • Severe calcification : radiopacities seen without cardiac motion before contrast
injection, usually affecting both sides of the arterial lumen(rail track calcification)
• Moderate calcification : radiopacities noted only during the cardiac cycle before
contrast injection
• Mild calcification : other than severe and moderate
13. • A pivotal study by Mintz et al showed that coronary angiography
able to identify calcium only in 38% of cases
detection seemed to be dependent on the degree of the arch of calcification (60%
for moderate calcifications and 85% for severe calcifications)
14. • The overall diagnostic accuracy of coronary angiography was 59%
• Although angiography may be highly specific (89%) for the presence of lesion
calcium, it was fairly insensitive
In the presence of one or two quadrants
Short lengths of calcium
15. • Advanced intravascular imaging techniques enhance identification of LHCC, but
also allow a comprehensive assessment of calcium burden, distribution, and
eccentricity.
• Intravascular ultrasound (IVUS) and optical coherence tomography (OCT)
are the 2 principal intravascular imaging modalities.
16. IVUS ( INTRAVASCULAR ULTRASOUND)
• LHCC typically appears on an IVUS image as a hyperechogenic arch combined
with deeper acoustic shadowing
• In an initial postmortem study, IVUS reported a 90% sensitivity and 100%
specificity for identification of dense calcified plaque or of cluster of
microcalcifications, with a lower accuracy for identifying isolated
microcalcifications.
17. • These pathologic data are consistent with subsequent clinical data demonstrating
the enhanced sensitivity of IVUS in detecting coronary calcium compared with
angiography (73% of cases vs. 38%; p < 0.001).
• Because of the higher penetration of ultrasound, IVUS detects abluminal
calcified deposits within the deeper layers (media or adventitia) of the vessel
wall.
18. • However, because of acoustic shadowing, IVUS allows only definition of the
calcific arch, without offering insights into thickness of the calcium
• Consequently, dedicated strategies for LHCC preparation have historically been
based on measurement of the calcific arch circumference detected on IVUS, with
an arch >180 predicting possible stent underexpansion
19. OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Because of its higher spatial resolution OCT offers more accurate definition and
quantification of the calcific plaque
• On OCT imaging, LHCC appears as areas of low reflectivity, low attenuation with
clearly delineated luminal and abluminal borders.
• Calcium identification on OCT is challenging in
Nonhomogeneous plaque (fibro-lipidic-calcific)
Calcific deposit is nonsuperficial and deep or underneath a lipidic or necrotic core
20. • Despite these limitations, OCT seems to be more accurate than IVUS in defining
calcific burden, because it provides additional measurable parameters
calcium area
calcium thickness
calcium length
calcium 3-dimensional volume
21. A NEW OCT-BASED CALCIUM SCORING SYSTEM TO PREDICT
STENT UNDEREXPANSION : Akiko fujino et al
• Score based on
Calcium angle > 180°(2 points)
Maximum calcium thickness > 0.5 mm(1 point)
Calcium length > 5 mm (1 point)
• Lesions with calcium score of 0 to 3 : excellent stent expansion
• Score of 4 had poor stent expansion (96% versus 78%, p<0.01)
22. • Intravascular imaging can also be used to assess the final stent result and OCT
has better sensitivity than IVUS in detecting stent malapposition and
underexpansion and in evaluating the effects of post-dilation.
27. • BALLOON BASED TECHNIQUES
1. CUTTING BALLOON
2. SCORING BALLOON
3. SUPER HIGH PRESSURE BALLOON
4. LITHOPLASTY BALLOON
28. PERCUTANEOUS TRANSLUMINAL ROTATIONAL ATHERECTOMY
• Mechanism of Action
• PTRA removes tissue and reduces lesion rigidity by attacking calcified
atherosclerotic plaque
• Based on the theory of differential cutting
• Rotary ablation pulverizes rigid atherosclerotic plaque, which is not able to
deflect, and yet preserves the integrity of the flexible artery wall.
• The hard plaque is abraded into small particles that average 5 μm in diameter and
are taken up by the reticuloendothelial system.
29. EQUIPMENT
• The rotablator system contains:
• A preconnected burr with an advancing device that houses an air turbine and drive
shaft
• A console that regulates an air supply and monitors the rotation of the burr
• A dynaglide foot pedal to activate the device
30. • The burr has an abrasive tip that is welded to a long flexible drive shaft covered by
a plastic sheath
• Tracks over a central coaxial RotaWire (0.009-inch diameter, 3.3-m length) that
has a flexible radiopaque platinum distal part (20 mm-length) that does not rotate
during abrasion.
• The wire and the burr can be advanced independently.
31. • The elliptical nickel-coated brass burr has 2000 to 3000 microscopic diamond
crystals on its leading face
• The diamond crystals are 20 μm in size, with only 5 μm protruding from the
nickel coating
• Trailing edge of the burr is smooth
• Burrs are available in various diameters that range from 1.25 to 2.50 mm in 0.25-
mm increments.
32.
33. ROTAFLUSH SOLUTION
• Contains lubricant, verapamil 5 mg, 5000 units of heparin, and 1000 μg of
nitroglycerin per 500 mL saline
• Irrigates the catheter sheath to lubricate and cool the rotating parts
34. PROCEDURE
• Pretreated with aspirin and an anticoagulant
• A 6-Fr Guide accommodates a 1.25-mm burr, allowing conversion to PTRA if an
undilatable or uncrossable lesion is encountered during PTCA, even during
transradial PCI
• Rotary ablation is preceded by placing the RotaWire across the lesion and parking
the unfolded wire tip in a straight segment of the distal vessel
35. • Protection of side branches is unnecessary because a “snow plow” effect is rare
• Before advancing the burr into the guide catheter, the rotational speed of the burr
is checked outside the body at the Y-adaptor with flush running
• An outside-body speed of 155,000 rpm translates to an unimpeded speed of
140,000 rpm within the coronary artery
• A recent study has suggested no difference in clinical or angiographic outcomes at
speeds of 140,000 or 190,000 rpm
36. • The burr and drive shaft are manually advanced over the guidewire to a proximal
segment of the target vessel.
• Decelerations of greater than 5000 rpm are avoided to reduce the risk of vessel
trauma, heat formation, and large particle generation.
• Ablation runs are limited to 15 to 20 seconds each.
• If the lesion cannot be crossed after five attempts, downsizing of the burr may be
required
37. CLINICAL RESULTS
• The study to determine rotablator and transluminal angioplasty strategy (STRATAS) trial
• Compared an aggressive debulking strategy (burr/artery ratio of 0.7 to 0.9 followed by balloon
inflation of less than 1 atm or no inflation) with a moderate debulking strategy (burr/artery ratio
of less than 0.7 followed by conventional balloon angioplasty)
• The clinical success was similar
• Aggressive strategy caused more myocardial infarctions (11% vs. 7%) and a higher rate of
restenosis (58% vs. 52%).
38. • The Coronary Angioplasty and Rotablator Atherectomy Trial (CARAT)
• Compared a large-burr strategy (burr/artery ratio >0.7) with a small-burr strategy
(burr/artery ratio <0.7).
• The large-burr strategy achieved similar immediate lumen enlargement and rate of
target-vessel revascularization (TVR) as the small-burr strategy but caused more
angiographic complications (12.7% vs. 5.2%, P < .05).
39. • These two trials are the basis for recommending
A single burr for each procedure
Selecting a burr/artery ratio of 0.5 to 0.6
Avoiding burr over-sizing
40. • In a series of multicenter randomized trials, rates of major adverse cardiac events
(MACEs) at 30 days and rates of angiographic restenosis were higher after PTRA
than after balloon PTCA alone
41.
42.
43. LESION SELECTION
• 1% to 3% of lesions that can be crossed with a guidewire are uncrossable with
balloon catheters or are undilatable at pressures higher than 20 atm.
• For long calcified lesions, small burrs are recommended to allow balloon
angioplasty and spot stenting of the segments with dissection
• Angulated lesions in bends of more than 60 degrees are a relative contraindication
• lesions in a bend greater than 90 degrees are an absolute contraindication because
dissection or perforation may occur
44. • Rotational atherectomy should be avoided in
Dissected segments after balloon angioplasty
Lesions with visible thrombus
Degenerated saphenous vein grafts
45. ORBITAL ATHERECTOMY
• Mechanism of action
• Based on the principle of elliptical burr movement
• Rotational speed determines the effective burr size
• The OA device uses an eccentrically mounted, diamond-coated crown that orbits
over an atherectomy wire at speeds of 80,000 to 120,000 rpm.
• Repeated passes of the crown across a calcified lesion “sands” away rigid plaque
but allows elastic tissue to flex away from the crown.
46. EQUIPMENT
• The Diamondback 360° OA System works on a 0.012-inch, 325-cm ViperWire.
• The system is composed of a handheld device and an atherectomy controller
47. PROCEDURE
• OA is performed with a 1.25-mm diamond-encrusted crown.
• The crown is eccentrically mounted
• device spins at 80,000 or 120,000 rpm
• The diamond-encrusted sanding surface will ablate hard material while deflecting
away from softer healthy tissue
48. • OA requires the use of the ViperWire guidewire, a unique 0.012-inch, 330-cm
tapered wire
• Also require pumping mechanism that is designed to push a lubricant, called
Viperglide, along with saline through the device
• Ablation runs are limited to 30 seconds each
49. LESION SELECTION
• OA is recommended for severely calcified coronary lesions
Severe calcification detected fluoroscopically in both sides of the arterial wall for
at least 15 mm when viewed longitudinally
The presence of at least a 270-degree arc of calcium viewed in cross section using
intravascular ultrasound (IVUS).
50. CLINICAL RESULTS
• Safety and Feasibility of OA for the Treatment of Calcified Coronary Lesions
(ORBIT I) study (prospective nonrandomized study)
• 50 patients with severely calcified lesions treated with OA followed by stent
placement, procedural success was achieved in 47 patients (94%), and MACEs
were reported in 2 patients (4%) inhospital and 6 % at 30 days
• Angiographic complications included dissections in six patients (12%) and a
coronary perforation in one patient (2%)
51. PIVOTAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE OA SYSTEM
IN TREATING DE NOVO, SEVERELY CALCIFIED CORONARY LESIONS (ORBIT II)
• 443 patients with severely calcified coronary lesions
• The primary safety end point of freedom from 30-day MACE was achieved in 89.6% of patients.
• Stent delivery was successful in 97.7% of cases, with less than 50% diameter stenosis (DS)
achieved in 98.6% of subjects
• Low rates of in-hospital Q wave myocardial infarction (0.7%), cardiac death (0.2%), and TVR
(0.7%) were reported
• Angiographic complications included severe dissections in 15 patients (3.4%) and perforations in 8
patients (1.8%)
52. DIRECTIONAL CORONARY ATHERECTOMY
• Directional atherectomy consists of a circular cutting blade that excises plaque when
pressed against the diseased side of the arterial wall with an inflated balloon on the
backside of the catheter
• After approval of a DCA device by the U.S. FDA in 1990 using registry data, several
RCTs comparing DCA with PTCA with and without stenting failed to demonstrate a
clinical benefit of DCA
• At the current time, no DCA devices are marketed in the United States for coronary
indication
53.
54.
55. LASER ANGIOPLASTY
• Predominant mechanism : thermomechanical process
• In excimer laser, protein and nucleic acid chromophores absorb laser light at 308 nm and
transfer heat to water.
• Intracellular water vaporizes and generates bubbles twice the diameter of the laser catheter
• The explosive increase in volume lyses cells and generates stress waves within the irradiated
tissue
• The resulting barotrauma can be exploited to prepare rigid and undilatable lesions for stent
implantation.
56. TECHNIQUE
• The size of laser catheters used for angioplasty should be no more than two-thirds
the reference diameter of the target vessel.
• For severe stenoses, the smallest laser catheters are recommended to increase the
likelihood of successful crossing
• The elimination of blood and contrast from the coronary artery during ELCA
reduces collateral damage and dissection
57. • Achieved by flushing all lines with saline and by injecting saline through the
guide catheter at a rate of 2 to 3 mL per second during laser activation
• If lesions are found to be undilatable or uncrossable, using ELCA in a blood field
without saline flush will enhance the thermomechanical effects and may increase
successful crossing.
58. CLINICAL RESULTS
• Several randomized studies have compared pulsed wave lasers with other
treatment modalities but none have shown a benefit over conventional PTCA
59.
60. LESION SELECTION
• ELCA has been approved for seven lesion types—
1. Long lesions
2. Moderately calcified lesions
3. ISR before brachytherapy
4. SVG lesions
5. Ostial lesions
6. Total occlusions
7. Undilatable lesions
61. CUTTING BALLOON ANGIOPLASTY OR ATHEROTOMY
• Is a variation of conventional PTCA
• Three or four sharp metal microtomes mounted on a noncompliant
balloon incise and score coronary atheroma during balloon inflation
62. MECHANISM OF ACTION
• The aim is to reduce the appearance of uncontrolled longitudinal tears in the
vessel wall induced during conventional balloon dilation
• Compared with conventional PTCA, CBA makes controlled microincisions in the
atheromatous plaque at lower pressures.
• Small mechanistic studies have confirmed that lesions can be dilated at lower
pressure with cutting balloons than with conventional balloons.
63. EQUIPMENT
• The Cutting Balloon Ultra-2 is a monorail device
• Flextome Cutting Balloon : contains a flex point every 5 mm along the length of
the atherotomes for greater flexibility and deliverability.
• It is available in over-the-wire and monorail configurations.
• Cutting balloons are available in balloon lengths of 6, 10, and 15 mm.
• The cutting blades, or atherotomes, are mounted longitudinally along the balloon
surface.
64. • The number of atherotomes depends on balloon diameter
Three atherotomes are on 2.0- and 3.25-mm balloons
Four are on 3.5- and 4.0-mm balloons
65.
66. TECHNIQUE
• The guidewires, catheters, and techniques used for CBA are like the equipment
traditionally used for PTCA
• Cutting balloons are less compliant and may not track as well as conventional
balloon catheters
• During CBA, the risk of blade fracture or retention is reduced by
Slowly inflating and deflating the balloon
Avoiding balloon pressures at or above rated burst pressures
67. CLINICAL RESULTS
• Several small trials, all enrolling fewer than 200 patients, compared CBA with
PTCA and reported that CBA reduced restenosis by 41% to 69%
• Small studies that compared CBA with PTRA or balloon PTCA as pretreatment
before brachytherapy for ISR found no difference in restenosis
• Several large trials that compared CBA with PTCA generally found no difference
in restenosis
68. TRIALS
• The Global Randomized Trial (GRT)
• The restenosis cutting balloon evaluation trial (RESCUT)
• Restenosis Reduction by Cutting Balloon Evaluation (REDUCE 1)
• REDUCE 2 study
• REDUCE 3 study
69. • The Global Randomized Trial (GRT)
• randomized 1238 patients
• no difference in angiographic restenosis between CBA and balloon PTCA (31.4%
vs. 30.4%).
70. • The restenosis cutting balloon evaluation trial (RESCUT)
• Enrolled 428 patients with ISR
• No difference in restenosis between CBA and balloon PTCA (29.8% vs. 31.4%)
71. • The Restenosis Reduction by Cutting Balloon Evaluation (REDUCE 1) study
• Enrolled 802 patients
• Result : Slightly higher restenosis rates with CBA than with PTCA (32.7% vs.
25.5%).
72. • The REDUCE 2 study
• Enrolled 416 patients
• Observed a trend toward higher restenosis rates after CBA than after PTCA
(52.1% vs. 44.2%)
73. • REDUCE 3 study
• Randomized 453 patients undergoing coronary stenting
• Observed lower restenosis rates after the use of CBA than after PTCA (11.8% vs.
19.6%).
74. SYSTEMATIC OVERVIEW OF RANDOMIZED TRIALS OF CUTTING BALLOON ANGIOPLASTY (CBA) VERSUS
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA
75.
76. • Lesion Selection : Many interventional cardiologists consider using CBA for
ostial lesions or for ISR because cutting balloons appear to slip less often than
conventional balloons
• Complications: The risk of coronary perforation is slightly higher after the use of
CBA than after conventional PTCA (GRT (0.8% vs. 0.0%))
77. SCORING BALLOON ANGIOPLASTY
• The angiosculpt scoring balloon catheter is an alternative to the cutting balloon
• Contains a flexible nitinol scoring ribbon with three rectangular spiral struts to
incise the atheromatous plaque at pressures up to 18 atm.
• The system, which has a low crossing profile (2.7 fr), is promoted as a more
flexible alternative to the cutting balloon.
78. INTRACORONARY STENTING AND ANGIOGRAPHIC RESULTS: OPTIMIZING TREATMENT OF
DRUG ELUTING STENT IN-STENT RESTENOSIS 4 - ISAR-DESIRE 4 TRIAL
• A small randomized trial
• 252 patients with restenosis within drug-eluting stents
• Suggested that use of the scoring balloon compared with standard therapy resulted
in lower in-segment percentage diameter stenosis at follow-up(6-8months (35%
± 17% vs. 40% ± 21%) but no difference in clinical outcomes
79. SUPER HIGH-PRESSURE BALLOON
• Consists of a rapid-exchange noncompliant balloon with a twin-layer structure
allowing inflation pressure up to 35 to 40 atm without bursting of the balloon.
• This unique property offers application for undilatable lesions and undilatable
underexpanded stents when other options have failed
• Can be used both before and after stent implantation
• Most evidence confirms safety and efficacy during stent post-dilation
80. LITHOPLASTY BALLOON
• Latest technology available for the treatment of LHCC
• Lithoplasty consists of pulsatile mechanical energy delivered via miniaturized
emitters placed along the length of a semicompliant rapid-exchange balloon
• The balloon is inflated at a pressure of 4 atm initially and then impulses of
mechanical energy are delivered to the LHCC at a frequency of 1 Hz
81. • This energy interacts with the atherosclerotic plaque, causing vibration that cracks
and fractures calcific components in the superficial and deeper layers.
• Preferential effect on deep calcium is a major benefit of lithoplasty compared with
other ablation techniques.
• Being a balloon-based technique, it is user-friendly and combined with early
evidence of efficacy, suggests it will become a standard approach for many
LHCC.
82. • Ali et al have demonstrated, using OCT in 31 patients, that lithoplasty can fracture
calcified arch in 43% of cases with multiple fractures produced in >25% of cases.
• Efficacy is proportional with the calcium burden, with a higher rate of calcium
fractures (77%) in cases with higher degree of coronary calcifications.
• No serious safety issues or technique complications (coronary perforations, major
dissections, slow/no reflow) have been reported in the studies.
83. THE DISRUPT CAD I STUDY (SHOCKWAVE CORONARY RX LITHOPLASTY STUDY)
• 60 patients
• IVL was feasible, facilitating the delivery of stents in all patients, reducing stenosis to 12.2%
with an acute gain of 1.7 mm
• achieved 95% clinical success (residual diameter stenosis <50% without in-hospital MACE).
• IVL had 3 periprocedural MIs, resulting in 95% freedom from MACE at 30 days.
• There were no unresolved dissections, slow-flow/ no-flow, embolization, or perforations.
• At 6 months, MACE was 8.3%
84. SAFETY AND EFFECTIVENESS OF CORONARY INTRAVASCULAR LITHOTRIPSY
FOR TREATMENT OF SEVERELY CALCIFIED CORONARY STENOSES: DISRUPT
CAD II STUDY
• 120 patients were enrolled
• Successful delivery and use of the IVL catheter was achieved in all patients.
• residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent
implantation
• The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial
infarctions
• There was no procedural abrupt closure, slow or no reflow, or perforations.
• In 47 patients with post-PCI OCT, calcium fracture was identified in 78.7% of lesions
85. INTRAVASCULAR LITHOTRIPSY FOR TREATMENT OF SEVERELY CALCIFIED
CORONARY LESIONS: 1-YEAR RESULTS FROM THE DISRUPT CAD III STUDY
• 384 patients
• At 1 year, MACE occurred in 13.8% of patients (cardiac death: 1.1%, MI: 10.5%,
ischemia-driven target vessel revascularization: 6.0%)
• Stent thrombosis (definite or probable) occurred in 1.1% of patients
86. INTRAVASCULAR LITHOTRIPSY FOR VESSEL PREPARATION IN SEVERELY CALCIFIED CORONARY
ARTERIES PRIOR TO STENT PLACEMENT - PRIMARY OUTCOMES FROM THE JAPANESE
DISRUPT CAD IV STUDY
• 64 patients
• Primary endpoints were achieved with non-inferiority demonstrated for freedom
from 30-day MACE (CAD IV: 93.8% vs. Control: 91.2%, P=0.008), and
procedural success (CAD IV: 93.8% vs. Control: 91.6%, P=0.007)
• No perforations, abrupt closures, or slow/no-reflow events occurred at any time
during the procedures
87. • DISRUPT CAD I-IV TRIALS have shown that intravascular lithotripsy safely
and effectively facilitates stent delivery and optimizes stent expansion in patients
with severely calcified coronary lesions.
88. ADVANTAGES OF IVL
• IVL requires no specific training in comparison with traditional atherectomy
• Being balloon based, IVL may reduce the risk of atheromatous embolization in comparison with
atherectomy devices
• sonic pressure waves are distributed uniformly across the inflated balloon, addressing calcium
irrespective of its circumferential location leading to fracture
• unlike traditional balloon-based high-static barometric pressure vessel preparation, IVL creates
peak dynamic sonic mechanical energy lasting <2 µs in a balloon inflated at low pressures,
minimizing vascular injury
