TY - JOUR
T1 - Adverse Events With Intravascular Lithotripsy After Peripheral and Off-Label Coronary Use
T2 - A Report From the FDA MAUDE Database
AU - Chugh, Yashasvi
AU - Khatri, Jaikirshan J.
AU - Shishehbor, Mehdi H.
AU - Banerjee, Subhash
AU - Croce, Kevin
AU - Alaswad, Khaldoon
AU - Murad, Bilal
AU - Garcia, Santiago
AU - Burke, M. Nicholas
AU - Brilakis, Emmanouil S.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - BACKGROUND: Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.
AB - BACKGROUND: Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.
KW - intravascular lithotripsy
KW - peripheral artery disease
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M3 - Article
C2 - 34866049
AN - SCOPUS:85122484878
SN - 1042-3931
VL - 33
SP - E974-E977
JO - The Journal of invasive cardiology
JF - The Journal of invasive cardiology
IS - 12
ER -