Héctor Cubero-Gallego1, Raúl Millán2, Mónica Fuertes3, Ignacio Amat-Santos4, Xavier Quiroga2, Josep Gómez-Lara5, Neus Salvatella2, Helena Tizón-Marcos6, Alejandro Negrete7, Sandra Santos-Martínez4, Mohsen Mohandes3, Joan A Gómez-Hospital5, César Morís1, Beatriz Vaquerizo8. 1. Área del Corazón, Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias-ISPA, Universidad de Oviedo, Oviedo, Asturias, Spain. 2. Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital del Mar, Universidad Autónoma de Barcelona, Barcelona, Spain. 3. Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital Universitario Joan XXIII, Universidad Rovira y Virgili, Tarragona, Spain. 4. Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares-CIBERCV, Instituto de Ciencias del Corazón-ICICOR, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 5. Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital Universitario de Bellvitge, Instituto de Investigación Biomédica de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain. 6. Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital del Mar, Universidad Autónoma de Barcelona, Barcelona, Spain; Instituto Hospital del Mar de Investigaciones Médicas-IMIM, Barcelona, Spain. 7. Instituto Hospital del Mar de Investigaciones Médicas-IMIM, Barcelona, Spain. 8. Unidad de Cardiología Intervencionista, Servicio de Cardiología, Hospital del Mar, Universidad Autónoma de Barcelona, Barcelona, Spain; Instituto Hospital del Mar de Investigaciones Médicas-IMIM, Barcelona, Spain. Electronic address: beavaquerizo@yahoo.es.
Abstract
INTRODUCTION AND OBJECTIVES: Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population. METHODS: This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory. RESULTS: This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization. CONCLUSIONS: This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.
INTRODUCTION AND OBJECTIVES: Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population. METHODS: This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory. RESULTS: This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization. CONCLUSIONS: This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.