Off-label use of intravascular lithotripsy in severely calcified carotid stenosis: a case series and literature review
Case Series

Off-label use of intravascular lithotripsy in severely calcified carotid stenosis: a case series and literature review

Yasser Almadani1, Indrani Sen1, Noora Jabeen1, Randall De Martino2, Thomas Carmody1, Tiziano Tallarita1

1Department of Cardiovascular Surgery, Mayo Clinic Health System, Eau Claire, WI, USA; 2Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN, USA

Contributions: (I) Conception and design: All authors; (II) Administrative support: All authors; (III) Provision of study materials or patients: All authors; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: None; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Tiziano Tallarita, MD. Department of Cardiovascular Surgery, Mayo Clinic Health System, 1221 Whipple St, Eau Claire, WI 54703, USA. Email: Tallarita.tiziano@mayo.edu.

Background: Severe extracranial carotid artery stenosis caused by heavily calcified coral reef plaque presents major limitations for endovascular therapy. The thickness and length of the calcification can increase the risk of technical failure, stent recoil, and restenosis. Intravascular lithotripsy (IVL) has been utilized to fragment calcium deposits in the intimal and medial layers of the vessel wall before stenting in the coronary and infra-inguinal arteries, resulting in a more pliable plaque and durable intraluminal gain. Our study is unique as it includes both internal and common carotid artery lesions, incorporates various clinical scenarios—including prior surgical interventions and complex ostial disease—and demonstrates technical success and short-term patency across all patients. It adds valuable data to the emerging body of evidence supporting IVL’s off-label use in this context and highlights the need for prospective studies to further assess long-term outcomes.

Case Description: In this report, we describe four patients treated with adjunct IVL of the internal or common carotid arteries before trans-carotid artery revascularization (TCAR). All four patients recovered without complications and showed excellent stent expansion and luminal gain.

Conclusions: IVL could be a valuable adjunct in the treatment of severely calcified carotid artery stenosis, potentially reducing the risk of technical failure, stent recoil, and restenosis. Additional research is needed to assess the long-term safety and efficacy of IVL in the treatment of severely calcified carotid artery stenosis.

Keywords: Carotid artery stenosis; carotid atherosclerotic disease; intravascular lithotripsy (IVL); shockwave balloon; case series

Received: 05 January 2025; Accepted: 30 May 2025; Published online: 28 October 2025.

doi: 10.21037/acr-25-7

Highlight box

Key findings

• Intravascular lithotripsy (IVL) was successfully used as an adjunct to trans-carotid artery revascularization in four patients with severely calcified carotid artery stenosis.

• All patients showed excellent stent expansion and luminal gain without complications.

• The study suggests that IVL can improve the outcomes of stenting in heavily calcified carotid arteries.

What is known and what is new?

• IVL is an established technique for treating calcified plaques in coronary and infra-inguinal arteries, improving vessel compliance and stent expansion.

• This manuscript provides evidence of the successful off-label use of IVL in the carotid arteries, demonstrating its potential to enhance stent expansion and luminal gain in cases of severe calcification.

What is the implication, and what should change now?

• The findings suggest that IVL could be a valuable adjunct in the treatment of severely calcified carotid artery stenosis, potentially reducing the risk of technical failure, stent recoil, and restenosis.

• Further research is required to assess the long-term safety and efficacy of IVL in this context. Clinicians should consider IVL as a treatment option for high-risk patients with severe carotid calcification when conventional methods are insufficient.

Introduction

Trans-carotid artery revascularization (TCAR) has been shown to have similar periprocedural stroke as carotid endarterectomy (CEA), and it has been recently approved for standard risk patients (1). Severely and circumferentially calcified carotid plaques represent a unique challenge, with increased risk for stent thrombosis, restenosis, and recoil (2,3). A calcific lesion greater than 3 cm in length and/or circumferential calcification and/or calcific plaque thickness greater than 3 millimeters are considered relative contraindications for carotid stenting/TCAR (4). However, off-label use of intravascular lithotripsy (IVL) has been reported as an adjunct to TCAR in patients with severe carotid calcification (4).

Shockwave peripheral IVL system (Shockwave Medical Inc, California) works by fragmenting calcific plaque via sonic pressure waves, increasing vessel compliance, restoring vessel mobility, and improving the therapeutic effectiveness and lumen gain after balloon angioplasty with or without stent implantation (5). Although IVL received Food and Drug Administration (FDA) approval for severely calcified coronary artery disease (CAD) (6), aorto-iliac (7) and femoropopliteal vessels (8), it has been utilized off-label in mesenteric (9), renal (10), and carotid arteries (11).

Current literature lacks comprehensive data on the long-term safety and efficacy of IVL in treating calcified carotid artery stenosis, particularly in high-risk patients. This study aims to evaluate the safety and efficacy of adjunct use of IVL in patients with severely calcified carotid artery stenosis. We present this case series in accordance with the AME Case Series reporting checklist (available at https://acr.amegroups.com/article/view/10.21037/acr-25-7/rc).

Case presentation

In this case series, we retrospectively present four cases in which IVL was used to successfully treat severely calcified carotid artery lesions prior to stenting. These patients were deemed high-risk for open surgery. All patients’ risk values fall within the 4th quartile (75–100th percentile) of risk for CEA according to the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Cardiac Risk Index (VQI CRI).

All patients were informed of the intended off-label use of the IVL for their procedures and consented accordingly. All patients were treated with the Precise stent, consistent with prior TCAR trials that supported FDA approval. In our institution, this stent is also routinely reimbursed by insurance providers, which influences its selection. We intentionally did not use balloon predilation to minimize carotid clamping time and potential cerebral ischemia risk. All procedures were conducted under general anesthesia, and all patients were discharged the following day on aspirin (81 mg lifetime) and Plavix (75 mg for 28 days).

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from the patients for the publication of this case series and accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Patient 1

A 73-year-old female with asymptomatic, severe left internal carotid artery (ICA) stenosis diagnosed based on carotid duplex ultrasound (DUS) [ICA peak systolic velocity (PSV) 419 cm/sec, ICA/common carotid artery (CCA) ratio of 7.2] and confirmed on computed tomography angiography (CTA) (Figure 1A). The lesion was 21 mm long, and a circumferential calcification thickness of 4 mm was evaluated for possible intervention. The CCA was free from atherosclerotic disease. She also had asymptomatic, moderate right ICA stenosis. Cardiovascular risk factors included smoking (former), obesity [body mass index (BMI) =37 kg/m2], history of myocardial infarction, congestive heart failure (CHF) [ejection fraction (EF) 30%], chronic obstructive pulmonary disease (COPD) and chronic kidney disease stage (CKD 3a). Due to extensive comorbidities, the decision was made to treat her with minimally invasive left trans-carotid ICA IVL, followed by stenting. The procedure was conducted through a 3 cm left supraclavicular incision. Through the 8 Fr ENROUTE sheath (Silk Road Medical Inc., California), an intraoperative angiogram was obtained, demonstrating 85% stenosis of the ICA (Figure 1B). After the CCA was clamped, under roadmap assistance, a 0.014 wire was advanced beyond the lesion. The lesion was pre-dilated with a 5 mm shockwave balloon with good luminal gain (4 cycles, 30 seconds each), followed by the deployment of an 8 mm × 40 mm PRECISE stent (Cordis, Miami Lakes, Florida). Flow reversal was then allowed for 2 min. Completion angiography was performed after the removal of the proximal clamp, which revealed no dissection, contrast extravasation, or residual stenosis (Figure 1C). Total flow reversal time was 12 minutes. At six-month follow-up, the patient remained neurologically intact, and the carotid DUS showed widely patent stent (ICA PSV 127 cm/sec, ICA/CCA ratio of 2.3).

Figure 1 Imaging sequence demonstrating preprocedural CTA, intraoperative angiogram, and post-procedural resolution of ICA stenosis. (A) Preprocedural CTA confirming 85% stenosis of the ICA (black arrow indicates the severe stenosis site). (B) Intraoperative angiogram demonstrating 85% stenosis of the ICA (black arrow indicates the stenotic segment of the ICA). (C) Completion angiogram showing no residual stenosis (black arrow indicates the previously stenotic site, now widely patent). CCA, common carotid artery; CTA, computed tomography angiography; ICA, internal carotid artery.

Patient 2

A 75-year-old male with a prior history of symptomatic right ICA and right subclavian stenosis, status post aorto-to-right carotid and right subclavian bypass, presented with left ocular ischemic syndrome from near occlusion of the left ICA, confirmed by CTA (Figure 2A). He also had a concomitant calcific, coral reef plaque causing severe stenosis at the left CCA origin. Cardiovascular risk factors included CHF (EF 63%), hypertension, diabetes mellitus type 2 with diabetic kidney disease stage 4, prior smoking, obesity, and hyperlipidemia. The decision was made to perform a left CEA with retrograde shock wave angioplasty and stenting of the origin of the CCA under EEG monitoring. Through a 7 cm cervical incision on the anterior border of the sternocleidomastoid muscle, the common carotid and its bifurcation were dissected free and controlled with vessel loops. Retrograde access was obtained in the left CCA. Intraoperative angiogram showed a cauliflower-like calcific lesion causing severe stenosis of the origin of the left CCA (Figure 2B). The lesion was crossed intraluminally and angioplastied with 8 cycles of 9 mm shockwave balloon (Figure 2C), followed by stenting with VBX 9 mm × 29 mm stent (Gore & Associates, Inc). The sheaths and wires were removed, and conventional CEA and patch angioplasty were performed. Completion angiogram showed complete expansion of the stent with no residual stenosis, dissection, or contrast extravasation (Figure 2D). At 7-month follow-up, the patient remained neurologically intact, and the stent was patent based on magnetic resonance angiography (MRA).

Figure 2 Imaging sequence showing preprocedural CTA, intraoperative angiogram, balloon angioplasty with intraluminal shockwave, and successful stent expansion. (A) Preprocedural CTA confirming near occlusion of the left ICA (black arrow points to near occlusion of the left ICA). (B) Intraoperative angiogram showing severe stenosis of the origin of the left CCA (black arrow indicates the critical stenosis at the CCA origin). (C) Intraluminal shockwave balloon (black arrow highlights the position of the balloon within the stenotic segment). (D) Completion angiogram showed full expansion of the stent (black arrow indicates the fully expanded stent at the site of previous stenosis). CCA, common carotid artery; CTA, computed tomography angiography; ICA, internal carotid artery.

Patient 3

A 66-year-old female with symptomatic, severe right ICA stenosis diagnosed based on carotid DUS (PSV 150 cm/sec, ICA/CCA ratio of 3.6) and confirmed by CTA, causing multiple episodes of right eye amaurosis fugax. Comorbidities included moderate-severe CHF, CAD status post coronary stenting, prior smoking, obesity, hyperlipidemia, diabetes mellitus type 2 and CKD stage 3b. The lesion was circumferentially calcified, and the patient underwent trans-carotid stenting with shockwave lithotripsy and angioplasty balloon. The TCAR was conducted in a standard fashion under general anesthesia. Once the 8Fr sheath was in place, an intraoperative angiogram confirmed good placement of the delivery sheath and demonstrated a 30 mm long, severely calcified, 95% stenosis of the ICA (Figure 3A). Under roadmap assistance, a 0.014 wire was advanced beyond the lesion. The lesion was pre-dilated with a 5.5 mm × 60 mm shockwave angioplasty balloon (unknown number of cycles; Figure 3B), followed by stenting with an 8 mm × 40 mm Precise stent. The stent was post-ballooned with a 6 mm balloon. Flow reversal was then allowed for 2 min. Completion angiogram showed complete expansion of the stent with no residual stenosis, dissection, or contrast extravasation (Figure 3C). Total flow reversal time was 25 minutes. At 10-month follow-up, the patient remained neurologically intact, and the right ICA stent was widely patent on US (PSV 75 cm/sec, ICA/CCA ratio of 1.7).

Figure 3 Imaging sequence demonstrating intraoperative angiogram of severe ICA stenosis, intraluminal shockwave balloon angioplasty, and post-procedural luminal restoration. (A) Intraoperative angiogram showing 95% stenosis of the ICA (black arrow marks the critical stenosis of the ICA). (B) Intraluminal shockwave balloon (black arrow shows the positioning of the balloon within the stenosis). (C) Completion angiogram showing excellent luminal gain (black arrow highlights the previously stenotic area, now with restored lumen diameter). ICA, internal carotid artery.

Patient 4

An 81-year-old male with a history of previous right CEA with Dacron patch, who developed 90% restenosis distal to the patch diagnosed based on carotid DUS (ICA PSV 230 cm/sec, ICA/CCA ratio of 1.7) and confirmed by a CTA of the head and neck. The stenosis has been progressing despite optimal medical treatment and was circumferentially calcified with a 4 mm thickness (Figure 4A). The patient’s cardiovascular risk factors included prior smoking, CAD, deep vein thrombosis, hypertension, and CKD stage 3a. The patient was counseled on the off-label use and was elected to proceed with a TCAR with shockwave lithotripsy angioplasty balloon. After the intraoperative angiogram demonstrated 90% stenosis of the right ICA (Figure 4A), the lesion was pre-dilated with a 7 mm × 6 cm shockwave lithotripsy angioplasty balloon (6 cycles; Figure 4B) with excellent luminal gain, followed by stenting with a 10 mm × 40 mm Precise stent (Figure 4C). Total flow reversal time was 22 minutes. At one-year follow-up, the patient remained neurologically intact, and the right ICA stent was widely patent on US (ICA/CCA Ratio of 1.7, ICA PSV 126 cm/sec).

Figure 4 Imaging sequence showing intraoperative angiogram of ICA stenosis, shockwave balloon predilation, and post-procedural luminal gain. (A) Intraoperative angiogram demonstrated 90% stenosis of the right ICA (black arrow indicates the stenotic area). (B) Predilation with a 7 mm × 6 cm shockwave lithotripsy angioplasty balloon (black arrow indicates the balloon positioned within the stenosis). (C) Completion angiogram showing excellent luminal gain (black arrow indicates the site of prior stenosis, now well-dilated). ICA, internal carotid artery.

Discussion

This study confirms that IVL can be safely and effectively utilized in bulky, calcific carotid stenosis by microfracturing the plaque, allowing full expansion of the stent without increasing the risk of intraprocedural stroke. In all four cases, the stent was fully expanded and there was no early stent recoil or occlusion. Our patients were deemed high risk for surgery due to their comorbidities, lesion characteristics and history of prior surgery. At median follow-up of 8 months (6–12 months), all stents remained patent. Circumferentially, bulky calcified carotid stenoses pose a challenge and can prevent adequate stent expansion or cause early recoil, increasing the risk of acute stent occlusion. IVL may be a safe adjunct to allow stent expansion (4).

We used DUS for preoperative and postoperative carotid artery evaluation (except for one patient with a stent in the CCA who was evaluated with an MRA), as it is the primary imaging method of surveillance. We used the ICA/CCA PSV ratio in adjunct with PSV, as it is reported by the panel that a ratio of >2 is consistent with 50% to 69% stenosis, and a ratio of >4 is consistent with 70–99% stenosis (12).

Our findings corroborate prior case reports describing the utilization of IVL as an adjunct in carotid stenting (Table 1). Mehta and Wooster (15) described 3 symptomatic cases in which IVL was utilized before stenting in TCAR, transfemoral stenting, and post-stenting (angioplasty of an under-expanded stent). Other authors (14,16-19) reported in a total of ten patients, adequate stent expansion without intraoperative complications after IVL treatment of severely calcific coral reef lesions in patients deemed high-risk for surgical approach. Kang et al. (20) also described using IVL to successfully dilate an under-expanded stent, without recoil in the mid-term follow-up.

Table 1

Review of the literature of patients treated with IVL Shockwave lithotripsy balloon in carotid arteries

Author Patients (n) Stenosis† Symptomatic (Y/N) Location (ICA vs. CCA) Complications Follow-up (months) Patency (Y/N) Number of patients with >70% restenosis Re-intervention (Y/N)
DiLosa et al. (11) 58 86% 22 Y (38%) – 3 TIA; 1 stroke ~4 Y 3 patients N
Giannopoulos et al. (13) 21 82.3% – ICA in 12; Bulb in 6; CCA/ICA in 3 1 ischemic stroke on day 17 ~6 Y 1 patient N
Dadashzadeh et al. (14) 4 ~90% 2 Y; 1 N L ICA in 2; R ICA in 2 None 12 Y None N
Mehta and Wooster (15) 3 ~70–95% Y R Carotid + R Bulb None 2 Y 1 patient N
Vadalà et al. (16) 2 70–79% Y L ICA; R ICA Temporary hypotensive status 1 Y None N
Henry et al. (17) 2 90% N R ICA None 1 Y None N
Misztal et al. (18) 1 ~70–89% Y L ICA TIA on day 5 1 Y None N
Grillo et al. (19) 1 ~90–99% N R ICA None 6 Y None N
Kang et al. (20) 1 90–95% N/A R CCA + R ICA None 4 Y None N

†, data are presented as exact percentages or ranges of stenosis. The symbol “~” indicates approximately. CCA, common carotid artery; ICA, internal carotid artery; IVL, intravascular lithotripsy; L, left; R, right; TIA, transient ischemic attack; Y/N, yes/no.

Other authors report cases complicated by post-operative transient ischemic attack (TIA)/stroke or midterm restenosis. Giannopoulos et al. (13) reported one patient who experienced an ischemic stroke on post-operative day 17 and one with significant restenosis (>70%) at 12-month follow-up out of 21 patients treated with IVL before carotid stenting. A recent multi-center study done by DiLosa et al. (11) described outcomes of 58 patients, of whom 22 were symptomatic, who were treated with adjunct IVL before ICA stenting. There were three TIA and one nonfatal stroke (30-day overall stroke rate of 6.8%), but the technical cause of stent failure is not reported. After a mean follow-up of four months, three stents developed recurrent stenosis (6%) on DUS, but no stent thrombosis or fracture was observed in the cohort among 47 patients (81%) with postoperative imaging available for review.

IVL has several disadvantages. First, lithotripsy requires 30-second-long inflations per cycle and may require multiple cycles to achieve low-pressure expansion of the calcium (15), prolonging the overall carotid occlusion time of the procedure. This can be a significant issue in patients with contralateral severe carotid stenosis/occlusion or when the circle of Willis is interrupted. More recently, the new IVL balloons have faster emitters and reduced cycle time to only 15 seconds. Secondly, the length of the shockwave IVL balloon is 40 mm for Shockwave S4 and 60 mm for Shockwave M5 (21,22), which can result in angioplasty of a normal segment of the carotid artery. Yet since each balloon has four emitters of sonic pressure waves, it is possible to stop every cycle after the first two emitters have fired to deliver the pressure wave towards the lesion only, circumventing the obstacle of not having a variety of balloon lengths.

For ostial lesions, such as the CCA treated in the second patient of our series, we recommend balloon expandable (versus a self-expandable) stents for the more precise deployment, which is required when treating ostial lesions. In the same scenario, we also prefer using covered over bare metal stents, based on an increasing body of literature that supports a longer primary patency rate with covered stents (11-13).

Conclusions

In our initial experience, adding IVL to TCAR in patients with calcific, coral reef lesions did not increase the risk of periprocedural stroke and was associated with excellent short-term primary patency. However, due to the lack of large prospective studies and long-term data on primary patency, restenosis and ipsilateral stroke rate, off-label use of IVL should be considered only for a very selective subgroup of patients, when no other options are available.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the AME Case Series reporting checklist. Available at https://acr.amegroups.com/article/view/10.21037/acr-25-7/rc

Peer Review File: Available at https://acr.amegroups.com/article/view/10.21037/acr-25-7/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://acr.amegroups.com/article/view/10.21037/acr-25-7/coif). T.T. serves as an unpaid editorial board member of AME Case Reports from October 2024 to September 2026. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from the patients for the publication of this case series and accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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doi: 10.21037/acr-25-7
Cite this article as: Almadani Y, Sen I, Jabeen N, Martino RD, Carmody T, Tallarita T. Off-label use of intravascular lithotripsy in severely calcified carotid stenosis: a case series and literature review. AME Case Rep 2025;9:167.

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