Just in Time from JACC: Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease - The Disrupt CAD III Study

Educational Objectives

After completing the activity, the clinician will be better able to evaluate the safety of intravascular lithotripsy therapy in patients with severe coronary calcification.

Summary

Correspondent: Matthew A. Cavender, MD, MPH, FACC, Chapel Hill, NC

Take-home Messages:

• Intravascular lithotripsy (IVL) shock wave therapy utilizes a technology that has been used to treat kidney stones for 30 years. The intervention involves using a fluid-filled balloon that integrates emitters that transmit up to 50 atmospheres of sonic pressure waves in an instantaneous, circumferential fashion.
• DISRUPT CAD III is a single-arm study that looked at IVL in ischemic patients from 47 international centers with heavily calcified vessels (eg, presence of an arc of calcium of ≥270 degrees). Performance goals of the trial were based on the ORBIT II investigational device exemption trial. DISRUPT CAD III investigators looked at the primary safety end point of freedom from 30-day major adverse cardiovascular events (MACE; cardiac death, myocardial infarction, target vessel revascularization), the primary effectiveness end point of successful stent delivery, and in-hospital MACE.
• Performance goals for both the primary safety end point and primary effectiveness end point were far exceeded. The rates of in-hospital MACE and 30-day MACE were 7.0% and 7.8%, respectively. There were no perforations, abrupt closures, or reflow events following IVL alone. IVL was found to be safe and predictable, with an average stent expansion of 102% in these patients who had severe calcification (average arc of calcium of 293 degrees) and average calcium thickness of 0.96 mm.
• Decreased systolic blood pressure (BP) was seen in 41% of patients with IVL-induced ventricular capture and was more common in patients with resting bradycardia. Drop in systolic BP did occur more commonly in patients with IVL-induced capture than in those without, but the magnitude of the BP drop was similar in both groups. Ventricular capture was not associated with clinical sequelae.
• Rotational atherectomy, orbital atherectomy, and IVL are complementary technologies. Because the larger burr sizes of the devices used in ablative interventions are related to higher complication rates, IVL allows for safer and easier modification of calcium without the application of wire-based ablative techniques.

References:

1. Hill JM, Kereiakes DJ, Shlofmitz RA, et al. Intravascular lithotripsy for treatment of severely calcified coronary artery disease. J Am Coll Cardiol. 2020;76(22):2635-2646. doi:10.1016/j.jacc.2020.09.603
2. Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014;7(5):510-518. doi:10.1016/j.jcin.2014.01.158

Readings

Disclosures

Dean J. Kereiakes, MD, Cincinnati, OH

Consultant Fees/Honoraria: Boston Scientific, Caliber Therapeutics/Orchestra Biomed, Elixir Medical Corporation, Shockwave, Sino Medical Sciences Technology Inc, Svelte Medical Systems Inc; Other: Ablative Solutions Inc

Roxana Mehran, MD, New York, NY

Consultant Fees/Honoraria: Boston Scientific, Cine-Med Research Institute, Janssen Scientific Affairs; Other: Elixir Medical, WebMD; Ownership Interest/Partnership/Principal: Applied Therapeutics, Caret (bought by Boston Scientific), ControlRad, STEL; Research/Research Grants: Abbott Laboratories, AstraZeneca Pharmaceuticals, Bayer Healthcare Pharmaceuticals, Beth Israel Deaconess Medical Center, Bristol-Myers Squibb Company, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Corporation, OrbusNeich

Acknowledgements

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 0 CE contact hours.

Lecture ID:

AC530204

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.

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