Adverse Events With Intravascular Lithotripsy After Coronary Use: A Report From the FDA MAUDE Database

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Overview

Percutaneous coronary intervention (PCI) on heavily calcified lesions has been associated with more complications.¹ Intravascular lithotripsy (IVL) was recently approved for treating de novo calcified coronary lesions based on excellent safety and efficacy on several studies, but there are limited “real world” outcomes.

We conducted a comprehensive search of the MAUDE database between February 12, 2021, and February 28, 2023 using the manufacturer and brand name tabs with the keywords "Shockwave Medical" and "Shockwave," respectively. Given that a single IVL catheter can fail or cause multiple adverse events through different mechanisms, we considered all possible outcomes. The MAUDE database is freely accessible and de-identified, obviating the need for institutional review board approval.

Results. A total of 48 unique reports were identified, which contained adequate information and clarity regarding the incident under investigation. These reports were classified into 2 groups based on the probability of the incident being linked with the use of IVL: a "certainly caused by IVL" group (34 of the 48 reports) and an "unlikely to have been caused by IVL" group (14 of the 48 reports).

In the “certainly caused by IVL” adverse event group, the most reported modes of failure were balloon or catheter dislodgement (9/34), dissection (8/34), balloon rupture (8/34), death (6/34), arrhythmia (5/34), perforation (3/34), thrombus formation (2/34), balloon kinking (2/34), and “other” (6/34). The IVL catheter was used off-label for in-stent restenosis (ISR) lesions in 6/34 (18%) cases. Of the 8 instances of balloon or catheter dislodgement, surgery was required to remove the hardware in 4 cases, the dislodged hardware was successfully snared in 1 case, the dislodged hardware was removed using another wire in 1 case, the dislodged hardware was removed interventionally at a different center in 1 case, and the dislodged hardware was left in place without treatment in 2 cases.

A total of 6 deaths were reported in the MAUDE database related to IVL use. Among those, 2 cases were associated with balloon rupture, of which 1 led to a dissection and acute vessel closure, and 1 led to ventricular fibrillation in a patient described as “extremely sick.” Another case involved dissection after catheter removal, leading to electrical arrhythmias and death. In 1 case, IVL balloon inflation in the left main coronary artery caused reduced ejection fraction and patient distress, necessitating a balloon pump, which subsequently failed, leading to death. One case involved IVL site perforation, requiring pericardiocentesis, with the patient subsequently having a stroke and dying. In the last case, the IVL device was incorrectly prepared and there was difficulty crossing the lesion, with the patient developing cardiac arrest 10 minutes after use. The patient was stabilized using an Impella device but ultimately died 5 to 6 hours after the procedure.

“Other” modes of failure included 1 case where a balloon pump was “sensing” each energy delivery of the IVL catheter as an R wave and timing the balloon deflation from this, 1 case of post-cardiac injury syndrome, 1 case of balloon deflation failure, 2 cases of electric shocks being experienced by the IVL operator from the device hub, 1 case of chest pain during energy delivery, and 1 case of off-label usage of the IVL balloon for ISR, leading to temporary entrapment within the stent.

In the “unlikely to have been caused by IVL” adverse event group, the most reported modes of failure were death (10/14), perforation (7/14), coronary dissection (1/14), arrhythmia (1/14), aortic dissection (1/14), and stroke (1/14). The event descriptions of those reports indicate that IVL use was not likely the cause of the adverse event but were reported out of an abundance of caution.

A pooled study of 628 patients in the Disrupt Coronary Artery Disease (DISRUPT CAD) trial studies reported that cardiac death occurred in 0.2% of patients, flow-limiting dissection occurred immediately following IVL in 1.8% of patients, and post-stent perforation occurred in 0.2% of patients.²

Study limitations. Our study has limitations as MAUDE reports lack independent validation and may have missing or incomplete data. Moreover, it is not possible to compute the incidence of adverse events as the denominator is not known.

Conclusion

In conclusion, our study of the MAUDE reports showed few adverse events associated with coronary IVL. Six deaths were reported related to IVL use, and the IVL catheter was used off-label for in-stent lesions in 18% of cases. Further research is needed to determine the real-world effectiveness and safety of IVL for treatment of calcified coronary lesions.

Acknowledgements

The authors are grateful for the philanthropic support of our generous anonymous donors, and the philanthropic support of Drs. Mary Ann and Donald A. Sens; Mrs. Diane and Dr. Cline Hickok; Mrs. Wilma and Mr. Dale Johnson; Mrs. Charlotte and Mr. Jerry Golinvaux Family Fund; the Roehl Family Foundation; the Joseph Durda Foundation. The generous gifts of these donors to the Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease (CCAD) helped support this research project.

Affiliations and Disclosures

From the ¹Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.

Disclosure statement: Dr. Allana: consultant at Abiomed and Boston Scientific Corporation. Dr. Brilakis: consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Asahi Intecc, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), CSI, Elsevier, GE Healthcare, IMDS, Medicure, Medtronic, Siemens, Teleflex, and Terumo; research support: Boston Scientific, GE Healthcare; owner, Hippocrates LLC; shareholder: MHI Ventures, Cleerly Health, Stallion Medical.

Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Minneapolis Heart Institute, 920 E 28th Street #300, Minneapolis, Minnesota 55407. Email: esbrilakis@gmail.com

References 

1. Shah M, Najam O, Bhindi R, De Silva K. Calcium modification techniques in complex percutaneous coronary intervention. Circ Cardiovasc Interv. 2021;14(5):e009870. doi:10.1161/circinterventions.120.009870

2. Kereiakes DJ, Di Mario C, Riley RF, et al. Intravascular lithotripsy for treatment of calcified coronary lesions: patient-level pooled analysis of the disrupt CAD studies. JACC: Cardiovascular Interventions. 2021;14(12):1337-1348. doi:10.1016/j.jcin.2021.04.015