Ziad A Ali1,2,3, Holger Nef4, Javier Escaned5, Nikos Werner6, Adrian P Banning7, Jonathan M Hill8, Bernard De Bruyne9, Matteo Montorfano10, Thierry Lefevre11, Gregg W Stone3,12, Aaron Crowley3, Mitsuaki Matsumura3, Akiko Maehara2,3, Alexandra J Lansky13, Jean Fajadet14, Carlo Di Mario15. 1. St. Francis Hospital, Roslyn, NY (Z.A.A.). 2. NewYork-Presbyterian Hospital, Columbia University (Z.A.A., A.M.). 3. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S., A.C., M. Matsumura, A.M.). 4. Department of Cardiology, University of Giessen, Frankfurt, Germany (H.N.). 5. Hospital Clínico San Carlos IDISSC, Complutense University of Madrid, Spain (J.E.). 6. Krankenhaus der Barmherzigen Brüder Trier, Germany (N.W.). 7. Department of Cardiology, Oxford University Hospitals, United Kingdom (A.P.B.). 8. King's College Hospital, London, United Kingdom (J.M.H.). 9. Department of Cardiology, Cardiovascular Research Centre, OLV Hospital, Aalst, Belgium (B.D.B.). 10. San Raffaele Hospital, Milan, Italy (M. Montorfano). 11. Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Générale de Santé, Massy, France (T.L.). 12. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.W.S.). 13. Yale University Medical Center, New Haven, CT (A.J.L.). 14. Clinique Pasteur, Toulouse, France (J.F.). 15. Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy (C.D.M.).
Abstract
BACKGROUND: The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions. METHODS: The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events. RESULTS: Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length. CONCLUSIONS: In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.
BACKGROUND: The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions. METHODS: The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events. RESULTS: Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calciumfracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length. CONCLUSIONS: In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.
Authors: Thomas Baudinet; Benjamin Seguy; Laura Cetran; Muhammad Khaled Luttoo; Pierre Coste; Edouard Gerbaud Journal: J Cardiol Cases Date: 2021-01-09
Authors: Dmitriy N Feldman; Ehrin J Armstrong; Herbert D Aronow; Subhash Banerjee; Larry J Díaz-Sandoval; Michael R Jaff; Sasanka Jayasuriya; Safi U Khan; Andrew J Klein; Sahil A Parikh; Kenneth Rosenfield; Mehdi H Shishehbor; Rajesh V Swaminathan; Christopher J White Journal: Catheter Cardiovasc Interv Date: 2020-05-14 Impact factor: 2.692
Authors: Ata Doost; James Marangou; Thato Mabote; Gerald Yong; Sharad Shetty; Alan Whelan; Matthew Erickson; Michael Nguyen; Christopher Judkins; Anthony Putrino; Abdul Rahman Ihdayhid; Richard Clugston; James Rankin Journal: AsiaIntervention Date: 2022-03-15
Authors: Himanshu Rai; Fiona Harzer; Tatsuhiko Otsuka; Youssef S Abdelwahed; Paula Antuña; Florian Blachutzik; Tobias Koppara; Lorenz Räber; David M Leistner; Fernando Alfonso; Holger Nef; Masaru Seguchi; Alp Aytekin; Erion Xhepa; Sebastian Kufner; Salvatore Cassese; Karl-Ludwig Laugwitz; Robert A Byrne; Adnan Kastrati; Michael Joner Journal: J Am Heart Assoc Date: 2022-04-26 Impact factor: 6.106