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Tough Balloon With a Vulnerable Shaft: An Unexpected Device Failure
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A 73-year-old man, with a previous long drug-eluting stent (DES) from the mid-portion of the left main stem artery (LMS) to proximal left anterior descending artery (LAD), underwent elective coronary angiogram due to worsening anginal symptoms and an abnormal myocardial perfusion single photon emission computed tomography (SPECT) showing ischemia in the LAD territory. The angiogram showed 50% stenosis in the mid-portion of the LMS, just before the previous implanted stent, and stent underexpansion in proximal LAD (Figure, A).
Following confirmation of these findings with intravascular ultrasound (IVUS), we decided to treat both the LMS stenosis and the underexpanded stent. High pressure (up to 22 atm) dilatations of the underexpanded stent with a 3.5 x 12-mm non-compliant (NC) balloon failed; thus, we proceeded to intravascular lithotripsy (IVL) with a 4.0 x 12-mm integrated balloon performing 6 cycles (of 10 pulses each) with the Shockwave Medical IVL System (Shockwave Medical). Despite performing post-IVL dilatations with a 4.0 x 12-mm NC balloon, the angiographic and IVUS appearance of the underexpanded stent was not optimal; therefore, we attempted to further dilate it with a 3.5 x 10-mm OPN NC Super High-Pressure Balloon (SIS Medical AG) (Figure, B).
During the second dilatation and while the OPN NC balloon was inflated in 35 atm, there was an abrupt fall of the pressure on the analog readout of the indeflator and a surge of contrast in the aortic root, compatible with balloon rupture. Following prompt withdrawal of the device and exclusion of vessel perforation, we completed the procedure with implantation of a new DES in the proximal LMS (Figure, C).
Meticulous examination of the OPN NC balloon device on the catheterization laboratory table showed that the balloon itself was intact. When we attempted to inflate it, there was a leakage jet of the 50/50 saline-to-contrast mixture perpendicular to the shaft, suggesting a shaft tear (Figure, D; Video).
The OPN NC Super High-Pressure Balloon is a rapid exchange balloon catheter compatible with 0.014-inch coronary wires and a unique dual layer balloon technology (TWIN-Wall Balloon design), allowing inflations to very high atmospheric pressures (rated burst pressure of 35 atm) and thus ensuring uniform expansion over a wide range of pressures and reducing the risk of vessel damage. It was approved by the FDA in 2022 and was recently launched in the US market in 2023. It can be used in complex percutaneous coronary interventions to dilate resistant calcified lesions or to optimize inadequate stent expansion. To our knowledge, this is the first report of OPN NC balloon shaft failure during high pressure inflation.
Affiliations and Disclosures
From the 1st Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Disclosures: The authors report no financial relationships or conflicts of interest regarding the content herein.
Address for correspondence: Konstantinos C. Theodoropoulos, MD, MSc, PhD, 1st Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. Email: ktheod2005@hotmail.com
