Ziad A Ali1, Todd J Brinton2, Jonathan M Hill3, Akiko Maehara4, Mitsuaki Matsumura4, Keyvan Karimi Galougahi5, Uday Illindala6, Matthias Götberg7, Robert Whitbourn8, Nicolas Van Mieghem9, Ian T Meredith10, Carlo Di Mario11, Jean Fajadet12. 1. Center for Interventional Vascular Therapy, Division of Cardiology, New York Presbyterian Hospital and Columbia University, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: zaa2112@columbia.edu. 2. Stanford University Hospital and Clinics, Stanford, California. 3. King's College Hospital NHS Trust, London, United Kingdom. 4. Center for Interventional Vascular Therapy, Division of Cardiology, New York Presbyterian Hospital and Columbia University, New York, New York; Cardiovascular Research Foundation, New York, New York. 5. Center for Interventional Vascular Therapy, Division of Cardiology, New York Presbyterian Hospital and Columbia University, New York, New York. 6. Shockwave Medical, Fremont, California. 7. Institute of Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden. 8. Department of Cardiology, St Vincent's Hospital, Melbourne, Fitzroy, Australia. 9. VU University Medical Center, Amsterdam, the Netherlands. 10. Cardiovascular Research Centre, Monash Medical Centre, Clayton, Australia. 11. Royal Brompton Hospital, London, United Kingdom. 12. Clinique Pasteur, Toulouse, France.
Abstract
OBJECTIVES: This study sought to determine the mechanistic effects of a novel balloon-based lithoplasty system on heavily calcified coronary lesions and subsequent stent placement using optical coherence tomography (OCT). BACKGROUND: The Shockwave Coronary Rx Lithoplasty System (Shockwave Medical, Fremont, California) delivers localized, lithotripsy-enhanced disruption of calcium within the target lesion (i.e., lithoplasty) for vessel preparation before stent implantation. METHODS: We analyzed OCT findings in 31 patients in whom lithoplasty was used to treat severely calcified stenotic coronary lesions. RESULTS: After lithoplasty, intraplaque calcium fracture was identified in 43% of lesions, with circumferential multiple fractures noted in >25%. The frequency of calcium fractures per lesion increased in the most severely calcified plaques (highest tertile vs. lowest tertile; p = 0.009), with a trend toward greater incidence of calcium fracture (77.8% vs. 22.2%; p = 0.057). Post-lithoplasty, mean acute area gain was 2.1 mm2, which further increased with stent implantation, achieving a minimal stent area of 5.94 ± 1.98 mm2 and mean stent expansion of 112.0 ± 37.2%. Deep dissections, as part of the angioplasty effect, occurred in 13% of cases and were successfully treated with stent implantation without incidence of acute closure, slow flow/no reflow, or perforation. CONCLUSIONS: High-resolution imaging by OCT delineated calcium modification with fracture as a major mechanism of action of lithoplasty in vivo and demonstrated efficacy in the achievement of significant acute area gain and favorable stent expansion.
OBJECTIVES: This study sought to determine the mechanistic effects of a novel balloon-based lithoplasty system on heavily calcified coronary lesions and subsequent stent placement using optical coherence tomography (OCT). BACKGROUND: The Shockwave Coronary Rx Lithoplasty System (Shockwave Medical, Fremont, California) delivers localized, lithotripsy-enhanced disruption of calcium within the target lesion (i.e., lithoplasty) for vessel preparation before stent implantation. METHODS: We analyzed OCT findings in 31 patients in whom lithoplasty was used to treat severely calcified stenotic coronary lesions. RESULTS: After lithoplasty, intraplaque calciumfracture was identified in 43% of lesions, with circumferential multiple fractures noted in >25%. The frequency of calciumfractures per lesion increased in the most severely calcified plaques (highest tertile vs. lowest tertile; p = 0.009), with a trend toward greater incidence of calciumfracture (77.8% vs. 22.2%; p = 0.057). Post-lithoplasty, mean acute area gain was 2.1 mm2, which further increased with stent implantation, achieving a minimal stent area of 5.94 ± 1.98 mm2 and mean stent expansion of 112.0 ± 37.2%. Deep dissections, as part of the angioplasty effect, occurred in 13% of cases and were successfully treated with stent implantation without incidence of acute closure, slow flow/no reflow, or perforation. CONCLUSIONS: High-resolution imaging by OCT delineated calcium modification with fracture as a major mechanism of action of lithoplasty in vivo and demonstrated efficacy in the achievement of significant acute area gain and favorable stent expansion.
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