Interventional procedure overview of intravascular lithotripsy to treat calcified coronary arteries during percutaneous coronary intervention

Corl JD, Frizzell JD, Bohrer CA, Kereiakes DJ (2022) Shock Buddy Technique for Intravascular Lithotripsy of Severe Eccentric Arterial Calcification

Case report N=1 patient

The "shock buddy" technique was used successfully to treat severe, eccentric arterial calcification in an 80-year-old man. The procedure involved the use of two balloons to optimize the positioning of the IVL balloon, resulting in successful plaque modification and improved vessel compliance without intraprocedural complications

Larger studies added to table 2

Costoya IR, Marcos HT, Montilla BV et al. (2019) Coronary lithoplasty: initial experience in coronary calcified lesions. Rev Est Cardio (article in press)

Case report N=3 patients with multivessel coronary artery disease had IVL.

The lithoplasty balloon was successfully used to treat 6 severely calcified lesions. There were no intraprocedural complications such as dissections or perforations

Larger studies added to table 2.

De Silva K, Roy J, Webb I et al. (2019) A calcific, undilatable stenosis; Lithoplasty – a new tool in the box? JACC: Cardiovascular Interventions 10(3): 304- 6

Case report A 69-year-old man with severe calcific disease in the right coronary artery had PCI after balloon dilation. He had PCI with adjunctive lithotripsy for calcium debulking.

OCT done pre and post lithoplasty showed the calcium 'cracking' effect of the technique. The segment of disease was then treated with a stent with good angiographic result.

Larger studies added to table 2.

Fedele M, (2021) Shockwave Intravascular Lithotripsy in the Treatment of Under-expanded Coronary Stents

2 patients with 12 month follow up

Both patients showed good angiographic results and uneventful follow ups after 12 months

Small sample size (N=2) limits the ability to generalise results.

Gonzalez IC, Ferreiro RG, Moreiras JV et al. (2019) Facilitated transfemoral access by shockwave lithoplasty for transcatheter aortic valve replacement. JACC: Cardiovascular Interventions 12(5): e35- 8

Case report N=1 patient with severe aortic stenosis, coronary artery disease (CAD) and severe peripheral artery disease had IVL to help transfemoral transcatheter aortic valve replacement.

Results showed a significant reduction in stenosis severity with high acute gain, no major adverse events.

Larger studies added to table 2

Kassimis G, Raina T, Kontogiannis N et al. (2019) How should we treat heavily calcified coronary artery disease in contemporary practice? From atherectomy to intravascular lithotripsy. Cardiovascular Revascularization Medicine. Available January 2019

Review

With the introduction of several adjunctive PCI tools, like cutting and scoring balloons, atherectomy devices, and intravascular lithotripsy technology, the treatment of calcified coronary lesions has become feasible, predictable and safe. This review highlights the techniques in the clinical setting and gives examples of how best to apply them through better patient and lesion selection, with the main objective being optimising drug eluting stent delivery and implantation, and subsequent improved outcomes

Review

Kereiakes et al. (2021) "Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions"

628 patients with 30-day follow-up.

The study demonstrated that IVL is safe and effective for facilitating stent implantation in severely calcified coronary lesions. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. The incidence of serious angiographic complications was low.

Focus on short term outcomes

Kereiakes et al. (2021) "Principles of Intravascular Lithotripsy for Calcific Plaque Modification" JACC Cardiovascular Interventions

Review – does not specify participant numbers of follow up details

IVL is a promising and effective technique for treating vascular calcification. It provides a comprehensive summary of the physics, preclinical, and clinical data supporting IVL's safety and efficacy in modifying calcified plaque to facilitate stent expansion and improve luminal gain.

Review article summarising existing data rather than presenting original clinical trial results with specific participant data and follow-up periods. Therefore, it does not provide the direct clinical evidence necessary for inclusion in a main evidence summary focused on clinical trial outcomes.

Khan S, Li B, Salata K, et al. (2019) The current status of lithoplasty in vascular calcifications: A systematic review. Surgical Innovation: 1- 11

Systematic review N=9 studies 211 patients with vascular calcification lesions had lithoplasty. Follow up: 5.5 months.

Most lesions (72%, 152/212) were in peripheral artery beds, with the remainder occurring in coronary vessels. Lesioned vessels typically had severe calcium burden 62.6% (131/210), with an average initial stenosis of 76.6% (range, 68.1% to 77.8%). After treatment, the average residual stenosis was 21.0% (range, 13.3% to 26.2%), with a mean acute gain of vessel diameter of 2.5 mm. A limited number of type D dissections occurred, with a total of 2.4% (5/211) of patients needing stent implantation. Recent studies suggest that lithoplasty is a promising intervention to decrease vessel stenosis in both peripheral artery disease and coronary artery disease, with minimal occurrence of major adverse events. Further research studies, with more rigorous study designs, are needed to determine the effectiveness of lithoplasty in vascular calcifications.

The review included both peripheral and coronary circulation studies. Evidence is from limited quality case series, case reports, and conference abstracts. Peripheral artery disease is out of the remit of this guidance.

Legutko J, Niewiera L, Tomala M et al. (2019) Successful shockwave intravascular lithotripsy for severely calcified undilatable lesion of the left anterior descending coronary artery in patient with recurrent myocardial infarction. Kardiologia Poloska (published online June 6)

Case report N=1 patient with severely calcified, critical narrowing of left anterior descending coronary artery associated with a history of recurrent myocardial infarction had IVL

Angiography, intravascular ultrasound and OCT confirmed optimal PCI result with perfect stent expansion and apposition. No complications occurred during hospitalisation and patient was discharged home 48 hours after the procedure free of angina and ventricular arrhythmia

Larger studies included in table 2.

Mathias B, Federico M, Stefan T et al. (2019) The effect of lithoplasty on coronary arteries. Cardiovascular medicine 22:02013

Case report 79-year-old man with non-ST-elevation myocardial infarction and a heavily calcified bifurcation stenosis of the left anterior descending artery (LAD) had IVL

The subsequent OCT showed calcium containing cracks in the intima and the media of the LAD. The bifurcation lesion was treated with 2 stents. The final OCT showed good stent expansion and apposition.

Larger studies included in table 2.

Riley R et al. (2023) SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions

The study provides expert consensus rather than individual patient data

Consensus outlines strategies for managing calcified coronary lesions using various calcium modification tools. It emphasises the importance of intravascular imaging and provides guidelines for using balloons, atherectomy, and IVL.

This study provides expert consensus and guidelines rather than empirical data from patient trials, making it more suitable for clinical guidance rather than direct comparison in the main evidence summary.

Sattar Y, Ullah W, Ul Hasan Virk H et al. (2021) Coronary intravascular lithotripsy for coronary artery calcifications

Review

Shockwave intravascular lithotripsy (S-IVL) may be used in cases of the calcifieddisease to gain vessel lumen in order to deploy drug-eluting stents with PCI. The success ofthe DES implantation of IVL can be 100% with a minimal complication rate

Review

Sgueglia GA, Gioffre G, Piccioni F et al. (2019) Slender distal radial five French coronary shockwave lithotripsy. Catheter cardiovascular Interventions 1-4

Case report 72-year-old man with calcific atherosclerosis of the left anterior descending artery with stenosis had IVL PCI using a 5 French guiding catheter.

Procedure was successful with optimal stenting results and reported no complications at 6 months follow up.

Larger studies added to table 2

Shavadia JS, Minh NV, Kevi B. 2018 Challenges with severe coronary artery calcification in percutaneous coronary intervention: A Narrative Review of Therapeutic Options. Canadian Journal of Cardiology, 3 (12): 156-72

Review

Summary of the principles, technique, and contemporary evidence for the currently approved devices designed to treat severe coronary calcific lesions.

Review

Salazar C, Escaned J, Tirado G et al. (2019) Undilatable calcific coronary stenosis causing stent under expansion and late stent thrombosis. A complex scenario successfully managed with intravascular lithotripsy. JACC: Cardiovascular Interventions. 12(15): 1510-3

Case report N=71-year-old man with repeat STEMI had PCI. A suboptimal under expansion was achieved by coronary calcification. A new PCI using IVL was done to modify calcific plaques.

A good final angiography result was achieved. The case showed effectiveness of IVL to modify calcific plaques and act through a previously implanted stent.

Larger studies added to table 2

Tassone EJ, Tripolino C, Morabito G et al. (2018) When calcium gets tough, the tough cardiologist starts to play. Cardiology, 141: 167-71

Case report N=60-year-old man with calcific restenosis of a previously stented or treated lesion (left coronary artery) had coronary shockwave lithotripsy.

IVUS after 3 cycles showed a significant area gain more than 6 mm2 . There was an excellent postprocedure angiographic result and a minimal lumen area on final IVUS. The patient was discharged after 48 hours in good condition and without symptoms.

Larger studies added to table 2.

Tovar Forero, MN, Wilschut J, Van Mieghem NM et al. (2019) Coronary lithoplasty: a novel treatment for stent under expansion. European Heart Journal. 40, 2: 221

Case report N= 74-year-old man with a heavily calcified stenotic lesion in the proximal left anterior descending coronary artery and under expanded stent resistant to conventional noncompliant balloons had coronary shockwave lithotripsy.

Full expansion was achieved after 2 lithoplasty therapies. OCT imaging showed multiple calcium fractures. The procedure completed without any complications.

Larger studies added to table 2.

Vainer J, Lux A, Ilhan M et al. (2019) Smart solution for hard times: successful lithoplasty of an undilatable lesion. Neth Heart J 27:216-7

Case report N=70-year-old woman with unsuccessful PCI with high-pressure balloons and rotational atherectomy had lithoplasty-assisted PCI.

Lithoplasty effectively resulted in plaque modification and a significant increase in diameter. OCT showed typical calcium tears and a large dissection. To cover the lesion, a drug-eluting stent was implanted. Proper stent expansion and apposition were confirmed with OCT.

Larger studies added to table 2.

Venuti G, D'Agosta G, Tamburino C et al. (2019). Coronary lithotripsy for failed rotational atherectomy, cutting balloon, scoring balloon and ultra-highpressure non-compliant balloon. Catheter Cardiovascular Interventions 1-5

Case report N= 67-year-old man having planned PCI of the right coronary artery targeting an undilatable lesion already resistant to multiple specialised balloons and rotational atherectomy had coronary lithotripsy and new PCI on the RCA.

Calcium modification at the target segment was seen and 3 stents were deployed with a good final result. No intra hospital complications reported. Patient was free from angina at 3 months follow up.

Larger studies added to table 2.

Wong B, El -Jack S et al. (2019) Shockwave intravascular lithotripsy of calcified coronary lesions in ST-elevation myocardial infarction: first in-man experience. Journal of invasive cardiology 31 (5), e73-5

Case series N=3 patients having PCI for ST-elevation myocardial infarction (STEMI) using IVL as an adjunct procedure.

The 3 presented cases include an upfront use of S-IVL in a right coronary artery, an instent restenosis, and a community cardiac arrest/ST-elevated myocardial infarction equivalent when S-IVL was used as a bailout technique to help stent delivery in a tortuous calcified vessel. Early experience has been favourable

Larger studies added to table 2. (cases also reported in study 3 in table 2)

Wong B, El -Jack S, Khan S et al. (2019) Treatment of heavily calcified unprotected left main disease with lithotripsy-the first case series. The journal of invasive cardiology, 31 (6): E143-7

Case series N=3 the use of S-IVL in a patient with left main-coronary artery disease (LM-CAD) with multivessel disease who declined surgery, a patient with an isolated LM-CAD and severe cardiomyopathy, and a late nonagenarian patient when surgical revascularisation was not an option reported.

No patients had procedural complications or major adverse events (stroke, myocardial infraction, death) during the index admission or within the first 30 days post discharge

Larger studies included in table 2

Yeoh J, Hill J, Spratt JC et al. (2019) Intravascular lithotripsy assisted chronic total occlusion revascularization with reverse controlled antegrade retrograde tracking. Catheter Cardiovasc Interv, 93:1295-7

Case report 81-year-old female with heavily calcified right coronary artery chronic total occlusion (CTO) had PCI via reverse controlled antegrade/retrograde tracking (RCART).Standard balloon inflation failed to create communication by modifying plaque and guidewire failed. So IVL was used in controlled antegrade/retrograde tracking.

IVL was used to help connection in R-CART to complete the CTO PCI when heavy calcification was present at the site of chronic occlusion. Multiple fractures helped connection between intimal and subintimal tissue planes.

Larger studies added to table 2