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Intravascular Lithotripsy Outcomes in Contemporary PCI
Quick Takes
- Since its introduction in early 2021, the use of coronary intravascular lithotripsy (IVL) has steadily increased, exceeding the rate of atherectomy use in Michigan by February 2022, becoming the most commonly used calcium modification device.
- Furthermore, both IVL and atherectomy were associated with similarly high rates of procedural success and low rates of adverse outcomes in an unadjusted analysis.
- Since IVL and atherectomy are frequently used in patients who would have been ineligible for the trials that led to their FDA approval, continued post-market surveillance to ensure the safe use of these devices is indicated.
Study Questions:
What are the trends and outcomes of coronary intravascular lithotripsy (IVL), rotational/orbital atherectomy, or both among patients who underwent percutaneous coronary intervention (PCI) in Michigan?
Methods:
The investigators included all PCIs between January 1, 2021, and June 30, 2022, performed at 48 Michigan hospitals. Outcomes included in-hospital major adverse cardiac events (MACE) and procedural success. Unadjusted outcome comparisons between IVL and atherectomy were performed for the MACE and procedural success outcomes, and two-sided 95% confidence intervals for these outcomes were estimated using the Clopper-Pearson (exact) method.
Results:
IVL was used in 1,090 patients (2.57%) and atherectomy was used in 1,743 (4.10%) patients, and both were used in 240 patients (0.57% of all PCIs). IVL use increased from 0.04% of PCI cases in January 2021 to 4.28% of cases in June 2022, ultimately exceeding the rate of atherectomy use. The rate of MACE (4.3% vs. 5.4%; p = 0.23) and procedural success (89.4% vs. 89.1%; p = 0.88) were similar among patients treated with IVL compared with atherectomy, respectively. Only 15.6% of patients treated with IVL in contemporary practice were similar to the population enrolled in the pivotal IVL trials. Among such patients (n = 169), the rates of MACE (0.0%) and procedural success (94.7%) were similar to the outcomes reported in the pivotal IVL trials.
Conclusions:
The authors report that coronary IVL use has steadily increased, exceeding atherectomy use in Michigan by February 2022 and generally associated with high rates of procedural success and low rates of complications.
Perspective:
This registry study reports that since its introduction in early 2021, the use of coronary IVL has steadily increased, exceeding the rate of atherectomy use in Michigan by February 2022, becoming the most commonly used calcium modification device. Furthermore, both IVL and atherectomy were associated with similarly high rates of procedural success and low rates of adverse outcomes in an unadjusted analysis. This early adoption of IVL is likely related to the ease of use of this device given that every IC is familiar with delivering and inflating an angioplasty balloon. Of note, these findings should be interpreted in the context that this analysis comparing IVL with atherectomy was unadjusted. Since IVL and atherectomy are frequently used in patients who would have been ineligible for the trials that led to their Food and Drug Administration (FDA) approval, continued post-market surveillance to ensure the safe use of these devices is indicated.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery
Keywords: Atherectomy, Lithotripsy, Percutaneous Coronary Intervention
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