IVL- new era in interventional cardiology

1. Intravascular Lithotripsy
Dr Maliha Islam Poorna
MD Resident
Phase B
Dept of Cardiology
NHFH&RI

2. Coronary artery calcification
• The amount of coronary artery calcification increases with age, and
the presence of cardiovascular risk factors and comorbidities.
• Up to 20% of PCIs are challenged by severe calcifications ( Forero and
Daemen, 2019).
• Coronary calcifications have been shown to be an independent
predictor of PCI failure and future adverse cardiac events.
• Lesion calcification increases procedural complexity and time.

3. • Coronary artery calcification hinders percutaneous coronary
intervention by-
Impairment of device crossing
Delamination of drug and polymer from stents
Alteration of elution kinetics and drug delivery, and
Impairment of stent apposition and expansion.

4. • Several techniques to treat calcified lesions in native coronary arteries
are available, including-
High pressure non compliant balloon dilatation
Speciality balloons ( scoring, cutting, ultra high pressure)
Atherectomy ( both rotational and orbital)
• However, all of these techniques have significant limitations.

5. Intravascular lithotripsy (IVL)...
Intravascular lithotripsy is a novel technique based on an established
treatment strategy for renal calculi, in which multiple lithotripsy
emitters mounted on a traditional catheter platform deliver localized
pulsatile sonic pressure waves to circumferentially modify vascular
calcium ( Ali et al, 2019).

6. IVL device
• The coronary IVL catheter is a single-use, sterile, disposable catheter
that contains multiple lithotripsy emitters enclosed in an integrated
balloon.
• The emitters generate sonic pressure waves in the shape of a sphere
creating a field effect to treat vascular calcium.
• The generated sonic pressure waves selectively disrupt and fracture
calcium in situ, altering vessel compliance while minimizing injury and
maintaining integrity of the vessel wall.

7. • The IVL catheter is available in 2.5 to 4 mm in diameters & 12 mm in
length.
• The IVL catheter is connected via a connector cable to the generator
that is preprogrammed to deliver 10 pulses in sequence at a
frequency of 1 pulse/s for a maximum of 80 pulses per catheter.

9. Advantages of IVL over Atherectomy or specialty
balloons:
• Unlike atherectomy, IVL requires no specific training as the
IVL device is delivered similar to standard catheter-based
PCI.
• IVL therapy is balloon based,and,therefore the risk of
atheromatous embolization may be lower than free
debulking devices.

10. Advantages of IVL over Atherectomy or specialty
balloons:
• Plaque modification using IVL is not subject to guideware
bias, instead, energy is distributed uniformly across the
lithotripsy emitter addressing calcium irrespective of its
circumferential location.
• Unlike traditional balloon technology, which is dependant on
static barometric pressure, IVL delivers circumferential
ultrashort pulses of high-intensity acoustic energy results in
effective circumferential modification of calcific atheroma.

11. Advantages of IVL over Atherectomy or specialty
balloons:
• IVL is typically performed at low atmospheric pressure
balloon inflation & thus minimizing mechanical vascular
trauma, in contrast to standard & specialty balloons which
are inflated at high atmospheric pressure to modify calcium.
• Side-branch protection using a guidewire may be easily
performed using IVL, without risk of wire entrapment or
severing as may occur with rotational or orbital atherectomy.

12. Studies on coronary intravascular lithotripsy
Disrupt CAD I study- it was a prospective, multicenter, single arm
study, which demonstrated the feasibility of IVL for modification of
severe coronary artery calcification.
Disrupt CAD II study- it was also a prospective, multicenter, single
arm study, conducted at 15 hospitals in 9 countries, on 120 patients,
carried out between May 2018 and March 2019. It concluded that, in
patients with severe coronary artery calcification who require
revascularization, IVL was safely performed, with high procedural
success and minimal complications and resulted in substantial calcific
plaque fracture in most lesions.

13. IVL at NHF...

14. **References:
Forero MN, Daemen J. The coronary intravascular lithotripsy system.
Interventional Cardiology Review 2019; 14(3):174-81
Brinton TJ, Ali ZA, Hill JM et al. Feasibility of shockwave coronary
intravascular lithotripsy for the treatment of calcified coronary
stenoses. Circulation 2019; 139: 834-36
Ali ZA, Nef H, Escaned J. Safety and effectiveness of coronary
intravascular lithotripsy for treatment of severely calcified coronary
stenoses. Circ Cardiovasc Interv. 2019; 12:e008434