Turning extra pulses into pluses

The r(evolution) of calcium in Bristol

Contents: 2-3 The r(evolution) of calcium in Bristol

4-5 Managing eccentric and nodular calcium

The r(evolution) of calcium in Bristol

CALCIUM IS EVERY interventionist’s foe. Sadly, its independent association with advancing age, hypertension, and ST-elevation myocardial infarction (STEMI) presentation1 increases our likelihood of encountering significant calcific disease during unplanned, emergency percutaneous coronary intervention (PCI). Consequently, devices to overcome calcium are needed in every interventionist’s toolbox.

Shockwave IVL disrupted the landscape of UK interventional cardiology early in 2018 with a live-case undertaken by Keith Oldroyd at Golden Jubilee, Glasgow. Undoubtedly, the arrival of Shockwave IVL provided renewed enthusiasm for the management of complex calcific coronary disease. Simplicity of use has resulted in IVL becoming the ‘go-to’ adjunctive tool for calcium modification. However, associated costs have required a thoughtful approach to technology adoption.

IVL arrived in Bristol in July 2018 and through our interest in intracoronary imaging we elected to combine IVL adoption with a more thorough assessment of coronary calcification. It has been well demonstrated that intravascular ultrasound (IVUS) and optical coherence tomography (OCT) reveal significantly more calcium than appreciated by coronary angiography alone.2 Furthermore, we now have quantitative thresholds that predict stent under-expansion and facilitate tailored decision making for adjunctive calcium modification.3 Consequently, our adoption of intracoronary imaging to guide the management of calcific coronary disease resulted in a 60.6% increase in modification with either rotational atherectomy (RA) or IVL, and a more than doubling of intracoronary imaging guidance in severe calcium cases (see Figure 1) Looking at the national adoption of IVL, using data available from the annual British

Cardiovascular Intervention Society (BCIS) audit results, there has been a steady rise in IVL use, with a reduction in RA, similar to our experience, but additionally an impressive rise in the use of cutting balloon technologies, corresponding with the arrival of IVL (Figure 2).

It is important to reflect that our realworld use of IVL differs significantly from the cohorts recruited to the DISRUPT-CAD series of studies,4‒6 where amongst others, recent acute coronary syndrome (ACS) presentation, left main stem (LMS) disease, chronic total occlusion (CTO), and significant left ventricular dysfunction (ejection fraction [EF] <40%) all were excluded.

As acknowledged earlier, significant calcium

6-7 More shocks for rocks

associates with STEMI, and consequently a device that is easy to use provides a novel solution during emergency intervention, 38.8% of our cases have been in the setting of ACS, similar to the experience of another highvolume UK centre.7 Additionally, the excellent safety profile demonstrated in the DISRUPTCAD series reassured us in extending the use of the device in higher risk patient/lesion subsets; in our first two years of IVL treatment, 9.2% of cases were unprotected LMS and 8.2% were CTO. With increasing lesion complexity and burden of disease, we have observed the need for extensive IVL treatment with 30% of cases utilising all 80 pulses and 5% of cases requiring multiple balloons. Consequently, the arrival of Shockwave C2+, providing 50% more shocks (120 pulses vs. 80 pulses), offers an advantage in cases of the highest burden calcification.

Our adoption of intracoronary imaging in calcific disease has led to an awareness of differing patterns of calcium and consequently generated significant debate regarding the optimal tools to achieve effective modification, thereby facilitating a durable stent result. Beyond quantifying high-burden disease including >180-degree

Tom Johnson (University Hospitals Bristol & Weston NHS Foundation Trust, Bristol, UK) outlines how the arrival of intravascular lithotripsy (IVL) has moved the dial for coronary calcium treatment within his centre in the last five years.

Tom Johnson

Figure 1: Impact of the introduction of intravascular lithotripsy on calcium modification and adjunctive intracoronary-imaging guidance at Bristol Heart Institute, UK (2016–2020).

Annual UK usage of calcium modification tools

operator, but the ease of use and excellent safety profile of IVL has resulted in Shockwave’s use for all but uncrossable lesions.

References

1. Genereux P, Madhavan MV, Mintz GS, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol 2014;63:1845‒1854. doi: 10.1016/j.jacc.2014.01.034

2. Wang X, Matsumura M, Mintz GS et al. In Vivo Calcium Detection by Comparing Optical Coherence Tomography, Intravascular Ultrasound, and Angiography. JACC Cardiovascular imaging 2017;10:869‒879. doi: 10.1016/j.jcmg.2017.05.014

3. Fujino A, Mintz GS, Matsumura M et al. A new optical coherence tomography-based calcium scoring system to predict stent underexpansion. EuroIntervention 2018;13:e2182-e2189. doi: 10.4244/EIJ-D-17-00962

4. Hill JM, Kereiakes DJ, Shlofmitz RA et al. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020;76:2635‒2646. doi: 10.1016/j.jacc.2020.09.603

5. Ali ZA, Nef H, Escaned J et al. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019;12:e008434. doi: 10.1161/ CIRCINTERVENTIONS.119.008434

analysis, with or without calcified nodule, highlighted an association of calcified nodules with the right coronary artery (51.9%—promoting the connection with vessel mobility), higher burden calcium, and requirement for greater predilatation (48.1% vs. 27.3%, p=0.005).

6. Brinton TJ, Ali ZA, Hill JM et al. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019;139:834-836. doi: 10.1161/CIRCULATIONAHA.118.036531

7. Yeoh J, Kanyal R, Pareek N, et al. Intravascular lithotripsy in the treatment of coronary artery calcification in a high-risk real world population. Catheter Cardiovasc Interv. 2023. doi: 10.1002/ccd.30546

8. Torii S, Sato Y, Otsuka F, et al. Eruptive Calcified Nodules as a Potential Mechanism of Acute Coronary Thrombosis and Sudden Death. J Am Coll Cardiol. 2021;77:1599‒1611. doi: 10.1016/j.jacc.2021.02.016

arc, thickness >500 m and longitudinal extent >5mm3, the location and qualitative nature of calcium influences our choice of modification device.

Intracoronary imaging and post-mortem analysis of calcified coronary arteries have extended our knowledge of the characteristics of calcific plaques, with calcified sheet being the most commonly encountered but eruptive calcified nodule causing the greatest concern through association with plaque instability, coronary thrombosis and sudden cardiac death.8,9

Interestingly, calcified nodules have been observed most frequently in the proximal and mid portions of the major epicardial vessels and their eruptive nature has been attributed to highly mobile vessel segments, where the calcium is exposed to greater torsional stress.8 Regardless of eruptive potential, calcified nodules defined by IVUS have been associated with poorer clinical outcomes10 and consequently greater attention to their modification and treatment is needed. Recently, a pooled analysis of cases recruited to the DISRUPT-CAD study series4‒6,11 has facilitated an assessment of IVL’s impact on calcified nodules.12 This small OCT cohort

Despite greater calcium burden, IVL treatment of calcified nodules achieved comparable stent expansion (mean 104.9% vs. 99.4% for non-calcified nodule lesions, p=0.87) and minimal stent areas (6.3mm2 vs. 6.0mm2, p=0.41). Interestingly all eruptive nodules were deformable, whereas just over one third of non-eruptive nodules were nondeformable with persisting stent eccentricity/ asymmetry. Larger-scale studies are needed and at present, consensus has not been achieved with regard to device selection for differing patterns of calcium, with multiple algorithms available to consider.13,14

Selecting between ablative and balloon-based technologies is left to the discretion of the

9. Sugiyama T, Yamamoto E, Fracassi F, et al Calcified Plaques in Patients With Acute Coronary Syndromes. JACC Cardiovasc Interv. 2019;12:531-540. doi: 10.1016/j.jcin.2018.12.013

10. Morofuji T, Kuramitsu S, Shinozaki T, et al. Clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy. Catheter Cardiovasc Interv 2021;97:10‒19. doi: 10.1002/ccd.28896

11. Saito S, Yamazaki S, Takahashi A, et al, Disrupt CADIVI. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent PlacementPrimary Outcomes From the Japanese Disrupt CAD IV Study. Circulation Journal : official journal of the Japanese Circulation Society. 2021;85:826‒833. doi: 10.1253/circj.CJ-20-1174

12. Ali ZA, Kereiakes D, Hill J, et al. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules. JACC Cardiovasc Interv. 2023. doi: 10.1016/j. jcin.2023.02.015

13. De Maria GL, Scarsini R, Banning AP. Management of Calcific Coronary Artery Lesions: Is it Time to Change Our Interventional Therapeutic Approach? JACC Cardiovasc Interv. 2019;12:1465‒1478. doi: 10.1016/j.jcin.2019.03.038

14. Fan LM, Tong D, Mintz GS, et al. Breaking the deadlock of calcified coronary artery lesions: A contemporary review. Catheter Cardiovasc Interv. 2021;97:108‒120. doi: 10.1002/ ccd.29221

Devices to overcome calcium are needed in every interventionist’s toolbox.”

Figure 3: Optical coherence tomographic examples of eruptive calcified nodule, calcific sheet and protruding nodular calcium.

calcified nodule

Superficial calcific sheet Protruding nodular calcium

Figure 2: Annual usage of calcium modification tools in United Kingdom 2016–2022 (data adapted from BCIS Society Audit).

IVL in calcific nodules

Managing eccentric and nodular calcium with IVL

Calcified nodules are frequently identified among coronary artery lesions and are associated with poor percutaneous coronary intervention (PCI) results and adverse long-term results. The best strategy to adequately manage this situation remains debated, says Nicolas Amabile (Institut Mutualiste Montsouris, Paris, France), who reports a case in which intravascular lithotripsy (IVL) was successfully used to treat calcified nodules in a challenging location.

Case presentation

A 60-year-old man was referred to our cath lab for a coronary angiography. His medical history was significant for stable multivessel coronary artery disease: he benefited from coronary artery bypass grafting (CABG) (left internal mammary artery [LIMA] left anterior descending [LAD] & right obtuse mammary artery [RIMA] to obtuse marginal artery [OM1]) ten years prior, and subsequent ramus and circumflex PCIs three years before his admission. The patient had been suffering from recurrent angina for the previous two months and a stress echocardiography revealed ischaemia in the inferior left ventricular (LV) walls (three segments).

Coronary angiography depicted occluded LAD, occluded circumflex and patent ramus stents. Moreover, LIMA and RIMA grafts presented no abnormalities and downstream native vessels were correctly visualised. In addition, the ostial RCA presented a tight, calcified, severe stenosis creating pressuredamping when cannulated (Figure 1). Severe aortic wall calcifications were also observed. This angiographic aspect was compatible with a de novo calcified nodule.

In order to better characterise the right coronary RCA lesion and prepare further plaque modification before stent implantation, an HD-intravascular ultrasound

(IVUS) analysis (OptiCross catheter, Boston Scientific) was performed. This intracoronary imaging modality was chosen because of the excellent catheter profile and its ability to accurately assess coronary ostia morphology and dimensions. The initial IVUS run showed diffuse and severe calcifications on proximal RCA with some concentric and eccentric moderate stenoses (Figure 2,1). A massive eruptive calcified nodule, defined as a convex shape of luminal surface and luminal side of calcium with protrusion into the coronary artery lumen,1 was observed at the junction between the aorta and RCA (Figure 2, 2-4). The minimal residual luminal area was measured to 2.8mm2 at this site.

PCI was decided on the ostial and proximal RCA. According to the lesion characteristics, IVL was proposed. The stenosis was predilated with a 3x12mm non-compliant balloon that was inflated up to 12atm for 20 seconds. A Shockwave C2+ IVL catheter was subsequently advanced into the target vessel and 12 cycles of 10 pulses were delivered in the proximal and ostial RCA, leading to the progressive disappearance of the residual imprint on the balloon (Figure 3, A-C).

Figure

Proximal RCA analysis by IVUS. Severe calcifications were observed in a non-severely stenosed part of RCA (panel 1) and a massive protruding nodule was identified in ostial part of the vessel (panels 2-4)

Post-IVL angiography showed a significantly improved angio aspect with mild residual stenosis (Figure 3, D). A 3.5x24mm everolimus-eluting stent (Synergy Megatron, Boston Scientific) was then implanted. The device diameter and length were determined according to the dimensions of the distal landing zone by IVUS. In order to prevent any geographical miss, a mild device protrusion in the aorta was applied (Figure 4, A-B). Finally, additional post-dilation was performed with a 3.5x12mm non-compliant balloon that was inflated up to 14atm (Figure 4, C). Final angio results depicted no residual stenosis (Figure 4, D). Post-PCI IVUS analysis confirmed adequate results: there was no edge dissection, nor strut significant malapposition. The device section was mostly symmetric and circular, suggesting that the initial calcium nodule did not affect stent expansion after the lesion was prepared by IVL (Figure 5). The minimal stent area was measured as 7.9mm2, which represented a significant increase compared to the baseline minimal lumen area. The subsequent clinical evolution was uneventful.

Nicolas Amabile

2:

Figure 1: Baseline angiographic aspects of the ostial calcified nodule. The embedded images show the presence of severe underlying vessel calcifications before contrast medium injection (white arrows)

Case discussion

This case illustrates the challenges in treating coronary artery calcified nodules. This pattern could be identified in up to 30% of patients2 and represents up to 12% of calcified stenoses.3 The presence of calcified nodules has been reported as risk factor for poor stent expansion and impaired outcomes, thus requiring adequate and dedicated plaque preparation.4,5 However, the optimal strategy remains debated in this situation.6 The use of conventional non-compliant balloons could appear as a simple first-line strategy, but is frequently inefficient for obtaining a correct pre-stent implantation result (as witnessed by a residual imprint on balloon <30%). The abrasive tools such as rotational or orbital atherectomy have an uncertain impact on this type of lesion, as they might not prepare/ debulk correctly the most eccentric portion of the calcified stenosis and could, in addition, damage the healthy portion of the vessel. This issue could be very relevant in case of tortuous vessel or ostial lesion, which represents per se an independent risk factor for increased major adverse cardiovascular events (MACE) over time in the case of rotational atherectomy use.5

Contrastingly, IVL therapy has been reported to be safe and equally efficient in calcified nodules and non-calcified nodule lesions (according to the post stenting minimal lumen area measurements) in the DISRUPT-CAD III pooled data analysis.3 Moreover, the most recent data from this cohort reported comparable two-year clinical outcomes in patients with or without initial calcified nodules.7 Hence, although the maximal benefits of IVL have been presumed to be observed in cases of concentric/calcified ring lesions,6 these results suggest that IVL could be considered in cases of heavily calcified

nodules. In our case, IVL also appeared as a safer approach than rotational atherectomy in this ostial lesion.5

Calcified nodules are frequently associated with diffuse vessel calcifications that can be easily identified by intracoronary imaging.2 Thus, calcified nodules represent the visible luminal “tip” of an underlying severe calcified atherosclerosis “iceberg”. This implies that the vessel preparation before stenting should be considered in a greater and longer portion (surrounding lesions) than just the most stenotic lesion. In this perspective, the introduction of the new Shockwave C2+ catheter represents a more appropriate option than the previous C2 device: as the number of delivered pulses is now 120 (compared to 80), it allows the treatment of a longer segment through a more intense focused therapy on the calcified nodule until the optimal result, the disappearance of any residual imprint, is achieved. Interestingly, previous experience of calcified nodule IVL therapy with the Shockwave C2 catheter revealed that the post-stenting minimal stent area was not measured on the site of the maximal calcification but rather on the surrounding zones, suggesting the need of an extensive preparation for these segments.3 This approach and the optimal balance in the required pulses number between the focal “culprit lesion” and “associated lesions” therapy might vary according to the morphology (thickness, eccentricity) and the location of the calcified stenosis. In our patient, we delivered 50 pulses on the RCA ostium because the radiographic continuity between aortic wall and coronary calcifications suggested a massive calcium burden at this precise site. Whether this tailored IVL with the C2+ catheter could improve the therapy efficiency has to be further investigated.

In conclusion, calcified nodules are frequently identified among calcified lesions and represent a challenge for optimal PCI. The use of C2+ IVL catheter represents a valuable option for preparing the lesion and obtaining an optimal result in this situation.

References

1. Lee JB, Mintz GS, Lisauskas JB, et al Histopathologic Validation of the Intravascular Ultrasound Diagnosis of Calcified Coronary Artery Nodules. American Journal of Cardiology, 2011. 108(11): p. 1547-1551.

2. Xu Y, Mintz GS, Tam A, et al. Prevalence, Distribution, Predictors, and Outcomes of Patients With Calcified Nodules in Native Coronary Arteries. Circulation, 2012. 126(5): p. 537-545.

3. Ali ZA, Kereiakes D, Hill J, et al. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules. JACC Cardiovasc Interv, 2023.

4. Zhang M, Matsumura M, Usui E, et al. Intravascular Ultrasound Derived Calcium Score to Predict Stent Expansion in Severely Calcified Lesions. Circulation: Cardiovascular Interventions, 2021. 14(10): p. e010296.

5. Morofuji T, Kuramitsu S, Shinozaki T, et al. Clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy. Catheter Cardiovasc Interv, 2021. 97(1): p. 10-19.

6. Shah M, Najam O, Bhindi R, et al. Calcium Modification Techniques in Complex Percutaneous Coronary Intervention. Circulation: Cardiovascular Interventions, 2021. 14(5): p. e009870.

7. Shlofmitz RA, Saito S, Honton B, et al. CRT-100.36 Impact of Calcified Nodules on 2-Year Clinical Outcomes After IVL-Assisted Coronary Stenting: Pooled Analysis From the DISRUPT CAD OCT Sub-Studies. JACC: Cardiovascular Interventions, 2023. 16(4_Supplement): p. S1-S1.

Figure 3: Calcified nodule preparation with non-compliant balloon and 3.0 x 12 mm Shockwave C2+ IVL catheter

Figure 4: Stent implantation, post dilation and final angiographic result

Figure 5: Final IVUS analysis

More shocks for rocks

How has the new Shockwave C2+ catheter changed the treatment of calcified coronary lesions at Herzzentrum Lahr/Baden (Lahr, Germany)? Kambis Mashayekhi, Emmanouil Chourdakis and team detail their intravascular lithotripsy (IVL) journey, including a case study involving a diffuse calcified left main bifurcation.

INTERVENTION

IN CALCIFIED

coronary lesions remains a challenging field. Proper lesion preparation is associated with better lumen gain, stent expansion, and arterial compliance, as well as easier stent delivery, with lower rates of stent thrombosis and periprocedural complications.1

IVL is a well-established and safe plaque modification technique for the treatment of severely calcified coronary stenosis, regardless of plaque morphology (superficial or deep, concentric or eccentric).2,3 The Shockwave device is a single-use semicompliant balloon catheter with a very short learning curve and fast preparation compared to atherectomy devices, without wire bias or device entrapment.

At the 2023 Cardiovascular Research Technologies (CRT) conference (25–28 February, Washington DC, USA),4 new research demonstrated that IVL is histologically superior in cracking coronary calcium compared with conventional balloon angioplasty treatment. However, we should not rely on evidence of fracture to confirm IVL effectiveness, as optical coherence tomography (OCT) has the potential to fail to identify the presence of calcium fractures and underestimate the depth of fracture compared to microcompted tomography (micro-CT).4

Our intracoronary journey with IVL began five years ago with de novo short calcified lesions. Over time, we have increasingly been confronted with severely calcified longer stenosis, including the off-label use of IVL for in-stent failure.5,6

One issue that has been raised in the past has been pulse delivery, which, at 80 pulses, limited the device to shorter segments. The new Shockwave C2+ catheter is now suitable for treating longer calcified lesions with an increased number of pulses from 80 to 120 (10 pulses per cycle). The additional 40 pulses allow the preparation of longer calcified lesions with different distribution patterns within the same patient. Thus, not only can superficial and concentric lesions

be treated with a single catheter, but also nodular and eccentric lesions— which usually require more extensive modification with a higher pulse rate.

Calcified lesions that cannot be crossed with the Shockwave catheter may require prior plaque modification with atherectomy, colloquially referred to as “rotashock” therapy. This modifies superficial calcification, and facilitates balloon delivery for further modification of deep calcification by IVL, particularly in larger lumina.7

IVL has been adopted in our routine clinical practice for the treatment of calcified left main disease as it provides safe plaque modification with less perceived haemodynamic instability, less carina shift, and protection of the side branches by the guidewire during pulse delivery.8,9 IVL 3.5 or 4mm catheters provide good balloon apposition to the vessel wall, resulting in a greater effect of therapy with more lumen gain, tackling both superficial and deep calcification.8,9

Intracoronary imaging with intravascular ultrasound (IVUS) or OCT is key to understanding plaque morphology, proper IVL balloon sizing, management, planning and optimisation of percutaneous coronary intervention (PCI).10

The new Shockwave C2+ catheter can be used in all conventional guiding catheters (5, 6 or 7Fr) in combination with extra supportive guidewires, balloon anchoring techniques and “mother-inchild” catheters to significantly improve support for balloon delivery.

Case study

This case study demonstrates the possibilities of the new Shockwave C2+ balloon, detailing the treatement of a 67-year-old male patient with IVL for a diffuse calcified left main bifurcation.

A transradial approach with a 7Fr sheath from the right radial artery was chosen. A 7Fr XB 3.5 guide catheter (Cordis) was engaged into the left main ostium, placing a Sion blue extra supportive guide wire (Asahi Intecc) into the peripheral left anterior descending (LAD) artery and a Runthrough (Terumo) guidewire in the left circumflex (LCX) artery. For IVUS imaging, the HD 60MHz imaging catheter (Boston Scientific) was used to assess the calcium and lesion characteristics. (Figure 1) Due to significant calcium burden of the left main bifurcation with deep calcification, as well as a calcified nodule on the medial LCX, we decided to use a 3.5mm Sockwave C2+ IVL catheter,

Figure 1: Severe calcified distal left main stenosis involving both LAD and LCX ostia (red circle) and significant LCX lesion at the medial segment (red arrow) (left panel, 1A). Narrowing of ostial left main with pressure damping after cannulation with 7Fr XB 3.5 guide catheter (red circle, 1B) and relevant distal left main disease and LAD stenosis at LAD/D1 bifurcation level (black arrows 1B). IVUS assessment before IVL (right panel): Ostial left main without signs of severe calcium burden, but only small isolated deposit of calcium

(1C). Distal left main with a 180 degree arc of superficial calcium and deep calcium (1D). Ostial LAD with a 270 degree arc of superficial calcium and deep calcium (1E). Mild to moderate superficial calcification (around a 180 degree arc) was at the stenosis of medial LAD at the bifurcation level (1F). Significant narrowing with relevant circumferential deep calcification at the ostial RCX (1G). A calcified nodule protruding intraluminal at medial LCX was identified, located at 6 to 10 o‘clock (1H).

1A 1C 1D 1E

1B 1F 1G 1H

Kambis Mashayekhi Emmanouil Chourdakis

Figure 2: Left panel: Inflation of 3.5mm Shockwave C2+ at 4atm at ostial LAD. The balloon remained not fully expanded (red arrow, 2A). Improved balloon expansion after delivery of 20 pulses (red arrow, 2B). Further plaque modification with the same Shockwave balloon at medial LCX with balloon underexpansion exactly at the segment, where the calcified nodule is located (2C

sized 1:1 based on IVUS in order to achieve optimal plaque preparation.

Pulses were delivered at low pressure (4atm) and the pulse management strategy involved 20 pulses at the ostial proximal/ ostial LAD, 40 pulses at the ostial LAD/left coronary artery (LCA), 30 pulses at the ostial LCX/LCA and 30 pulses at the medial LCX.

Afterwards, IVL outcomes were assessed by imaging (Figure 2), and a 1:1 noncompliant balloon used to check the need for additional IVL or other plaque modification techniques. The non-compliant balloon was fully expanded with no need for further plaque modification after IVL. Based on the left main morphology (Medina 1-1-1), we decided to go for a two-stent strategy. IVUS-guided inverted culotte stenting was performed to treat this unprotected distal left main stem bifurcation disease.

The first stent was implanted (Onyx TruStar, Medtronic 3.5x33mm) from LCX to LCA, and the second from LAD to LCA (Onyx TruStar 3.5x33mm), followed by kissing balloon dilatation with a 3.75mm non-compliant balloon in each branch. A final post optimisation technique was performed with a 5mm non-compliant balloon at the carina level. A third stent was placed into the medial LAD (Onyx TruStar 3x26mm), followed by 3.5mm n on-compliant balloon dilatation, finished with the implantation of a fourth stent at the ostial left main (Onyx TruStar 5x12mm). A proper stent apposition and stent expansion was achieved without signs of major

red arrow). After 30 pulses delivered at the medial and proximal LCX, followed by cracking the ostial LCX lesion with 30 pulses (2D). IVUS shows a calcium fracture at 11 o’clock, with a dissection plan at 3 o’clock in the distal LCA (red arrows, 2E). IVUS demonstrated sufficient plaque modification of the LAD ostium (red arrows, 2F) and of nodule surface at medial LCX (red arrow, 2G)

dissection on IVUS (Figure 3).

An excellent primary angiographic result with Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow and sufficient stent expansion was achieved. The patient remained haemodynamically stable during the procedure and was discharged the next day.

IVL treatment with the new Shockwave C2+ catheter offers several advantages in the treatment of heavily calcified coronary lesions, demonstrated in our left main intervention. The ability to deliver more

pulses contributes to a more effective and efficient procedure. Overall, IVL therapy has a low rate of major flow-limiting dissections and subsequently a lower rate of haemodynamic instability, providing a safe technique for plaque modification in bifurcation lesions, with the capability to continuously protect the side branch, making the Shockwave C2+ IVL catheter one of the most important protagonists in calcified complex coronary lesions.

References

1. Généreux P, Madhavan MV, Mintz GS, et al. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54.

2. Brinton TJ, Ali ZA, Hill JM, et al. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836.

3. Kereiakes DJ, Virmani R, Hokama JY et al. Principles of intravascular lithotripsy for calcific plaque modification. J Am Coll Cardiol Interv. 2021;14:1275–92.

4. Kawai K, Sato Y, Hakoma JY. Histology, OCT, and micro in Atherosclerotic Cadaver Arteries treated with Intravascular Lithotripsy. Cardiovascular Research Technologies. 2023 Feb 25–28 February; Washington DC, USA.

5. Tovar Forero MN, Sardella G, Salvi N, et al. Coronary lithotripsy for the treatment of underexpanded stents: the international & multicentre CRUNCH registry. EuroIntervention. 2022 Sep 20;18(7):574-581. doi: 10.4244/ EIJ-D-21-00545.

6. Dwivedi P, Dhulipala V, Kumar KR, et al. Efficacy and Safety of an Upfront RotaTripsy Strategy in the Treatment of De Novo and In-Stent Restenosis Cases. J Invasive Cardiol. 2023 Feb;35(2):E70-E74

7. Cosgrove CS, Wilson SJ, Bogle R, et al. Intravascular lithotripsy for lesion preparation in patients with calcific distal left main disease. EuroIntervention. 2020 May 20;16(1):76-79

8. Salazar CH, Gonzalo N, Aksoy A, et al, Ocaranza Sanchez R, Werner N, Escaned J. Feasibility, Safety, and Efficacy of Intravascular Lithotripsy in Severely Calcified Left Main Coronary Stenosis. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1727-1729.

9. Mintz GS. Intravascular imaging of coronary calcification and its clinical implications. JACC Cardiovasc Imaging. 2015 Apr;8(4):461-471.

10. Hill JM, Kereiakes DJ, Shlofmitz RA et al. Intravascular lithotripsy for treatment of severely calcified coronary artery disease. J Am Coll Cardiol. 2020;76:2635–46.

Figure 3: Excellent angiographic result after IVUS-guided culotte stenting technique of distal left main and medial LAD using the new Shockwave C2+

catheter (left panel 3A-C). Excellent stent expansion and without malapposition at left main bifurcation (right panel 3D-3G)