Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses

Brinton, Todd J.; Ali, Ziad A.; Hill, Jonathan; Meredith, Ian T.; Maehara, Akiko; Illindala, Uday; Lansky, Alexandra J.; Götberg, Matthias; Mieghem, Nicolás M. Van; Whitbourn, Robert; Fajadet, Jean; Mario, Carlo Di

doi:10.1161/circulationaha.118.036531

Cited by 261 publications

(225 citation statements)

References 5 publications

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“…As opposed to other techniques, using calcified plaque debulking as a strategy, the risk of plaque displacement or embolizaton of calcium debris is lower when using the Shockwave™ technology. In the Disrupt CAD I trial, no cases of thrombosis or slow flow/no‐reflow were described . Similar results were reported in the Disrupt PAD II trial, where no cases of thrombus or distal embolization where described …”

Section: Discussionsupporting

confidence: 79%

“…In the Disrupt CAD I trial, no cases of thrombosis or slow flow/no-reflow were described. 7 Similar results were reported in the Disrupt PAD II trial, where no cases of thrombus or distal embolization where described. 9 The process of intravascular lithotripsy is not sensed by the patient and, hence, entirely free of pain.…”

Section: Discussionsupporting

confidence: 79%

“…6 Intravascular lithotripsy, based on the principle of calcium disruption by sonic pressure waves first used in urology, has been introduced as a new method for calcified plaque modification in coronary and peripheral arteries. [7][8][9] In this case report, we report as the first the use of intravascular lithotripsy to enable transfemoral TEVAR in a patient with small caliber iliac arteries and circumferential calcified plaques.…”

Section: Introductionmentioning

confidence: 99%

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Intravascular iliac artery lithotripsy to enable transfemoral thoracic endovascular aortic repair

Rosseel

Søndergaard

Bieliauskas

2019

Cathet Cardio Intervent

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Thoracic endovascular aortic repair (TEVAR) is performed with large‐bore delivery systems. Small‐size access vessels may be a contraindication for TEVAR, particularly in case of severe calcifications. In this case report, we describe the first‐in‐man use of intravascular lithotripsy to enable transfemoral delivery of TEVAR stent grafts in a patient with severely calcified iliac arteries. A 69‐year‐old female with multiple sclerosis and thoracic aortic aneurysm (TAA) was referred for percutaneous TEVAR. Both common iliac arteries were severely calcified with circumferential calcifications and a minimum diameter below 5.5 mm. In order to enable percutaneous delivery of 20 French Valiant Navion stent grafts (Medtronic), the circumferential calcified plaques were treated by use of a Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.). Subsequently, the aortic stent grafts were safely and successfully passed through the iliofemoral artery and the TAA was excluded by TEVAR. Final angiography showed normal flow in the iliofemoral artery without any signs of perforation or overt dissection. This case report demonstrates successful application of intravascular lithotripsy in calcified iliofemoral arteries enabling percutaneous transfemoral TEVAR. If confirmed in future cases and trials, indications for transfemoral TEVAR may further expand toward patients with severely calcified peripheral arterial disease.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

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Intravascular iliac artery lithotripsy to enable transfemoral thoracic endovascular aortic repair

Rosseel

Søndergaard

Bieliauskas

2019

Cathet Cardio Intervent

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“…Between December 2015 and March 2019, 180 patients were enrolled in the Disrupt CAD I and Disrupt CAD II studies across 19 sites in 10 countries. Disrupt CAD I (n = 60) was a pre-market, prospective, single-arm, multi-center study designed to evaluate the safety and performance of the Shockwave (Shockwave Medical Inc., Santa Clara, CA, USA) coronary intravascular lithotripsy (IVL) system in the treatment of calcified coronary lesions for the purpose of optimizing the placement of stents and reducing the ultimate residual stenosis [12].…”

Section: Study Design and Populationmentioning

confidence: 99%

Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies

et al. 2020

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Background The aim of this study was to assess the safety and effectiveness of intravascular lithotripsy (IVL) in treating eccentric calcified coronary lesions. Methods Between December 2015 and March 2019, 180 patients were enrolled in the Disrupt CAD I and CAD II studies across 19 sites in 10 countries. Patient-level data were pooled from these two studies (n = 180), within which 47 eccentric lesions (26%) and 133 concentric lesions were identified. Results Clinical success, defined as residual stenosis < 50% after stenting and no in-hospital MACE, was similar between the eccentric and concentric cohorts (93.6% vs. 93.2%, p = 1.0). There were no perforations, abrupt closure, slow flow or no reflow events observed in either group, and there were low rates of flow-limiting dissections (Grade D–F: 0% eccentric, 1.7% concentric; p = 0.54). Final acute gain and percent residual stenosis were similar between the two groups. Final residual stenosis of 8.6 ± 9.8% in eccentric and 10.0 ± 9.0% (p = 0.56) in concentric stenosis confirms the significant effect of IVL in calcified coronary lesions. Conclusion In this first report from a pooled patient-level analysis of coronary IVL from the Disrupt CAD I and CAD II studies, IVL use was associated with consistent improvement in procedural and clinical outcomes in both eccentric and concentric calcified lesions.

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“…This technology has been assessed in the multicenter, prospective, single‐arm DISRUPT CAD study showing clinical success defined as the ability of coronary lithotripsy to produce a residual diameter stenosis <50% after stenting with no evidence of in‐hospital major adverse cardiac event in 57 of 60 patients with severe coronary calcification enrolled in the trial. Notably, there were no slow‐flow/no‐flow phenomena, embolization, or perforations . Moreover, in an imaging sub‐study, optical coherence tomography demonstrated efficacy in the achievement of significant acute area gain and favorable stent expansion …”

Section: Discussionmentioning

confidence: 96%

Slender distal radial five French coronary shockwave lithotripsy

Sgueglia

Gioffrè

Piccioni

et al. 2019

Cathet Cardio Intervent

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Despite technological evolution, percutaneous coronary interventions targeting coronary calcifications remain challenging and associated with high rates of complications and adverse outcomes. Over the years, rotational atherectomy has emerged as the reference treatment of calcified coronary artery lesions despite some inherent limitations. Also, rotational atherectomy typically requires relatively large guiding catheters which may unfavorably impact on the decision for transradial access, especially when radial artery is small, and consequently offset the relevant clinical benefits associated to transradial access. Recently, a new technology has been introduced in interventional practice to implement coronary lithotripsy. The device implements multiple small emitters enclosed in a coronary balloon creating sonic pressure waves to selectively fracture calcium within the plaque and favorably modify vessel compliance. Owing to its specific design, coronary shockwave lithotripsy could be used with small bore guiding catheters which may allow for straightforward transradial percutaneous treatment of calcified coronary lesions even in patients with a small radial artery. To illustrate this concept, we report the first experience of slender transradial coronary shockwave lithotripsy with a five French sheathless guiding catheter.

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Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses

Cited by 261 publications

References 5 publications

Intravascular iliac artery lithotripsy to enable transfemoral thoracic endovascular aortic repair

Intravascular iliac artery lithotripsy to enable transfemoral thoracic endovascular aortic repair

Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies

Slender distal radial five French coronary shockwave lithotripsy

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