A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study.

BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. METHODS: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. RESULTS: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). CONCLUSIONS: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307).

New scoring system for predicting percutaneous coronary intervention of chronic total occlusion success: Impact of operator's experience.

BACKGROUND: Several scoring systems have been developed in order to predict percutaneous coronary intervention (PCI) result of chronic total occlusion (CTO). The scores principally include anatomic and clinical variables. Operator experience is a decisive factor for achieving successful result. We sought to assess the real impact of operator growing experience on CTO-PCI success. METHODS: The angiographic and clinical variables of CTO-PCIs performed in our center between May 2007 and April 2021 were collected, and variables with potential association with procedural result were thoroughly reviewed. The influence of operator experience based on the number of previous CTO-PCIs was statistically assessed. A scoring system with combination of anatomic variables and operator experience was devised. RESULTS: A total of 540 PCIs in 457 patients were performed in our institution. The scoring model was developed from the derivation set (2/3 of the cohort). The final variables in logistic regression model were CTO length ≥ 20 mm, blunt stump, vessel tortuosity > 45o and operator experience < 100 PCIs. The model showed good performance in the derivation set (area under curve [AUC]: 0.768; confidence interval [CI]: 0706-0.830; p < 0.001) with no significant shrinkage in the validation set (AUC: 0.704; CI: 0.613-0.796; p < 0.001). CONCLUSIONS: This new score (E-CTO score) adequately predict the probability of CTO-PCI failure. The model includes a variable representing operator experience along with other anatomic variables.

J-chronic total occlusion score predictive capacity for percutaneous coronary intervention success of chronic total occlusion: Results from a European single center cohort with progressive experience over time.

BACKGROUND: Several scoring systems have been described to assess the level of difficulty and to predict the probability of success of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). The J-CTO score was initially developed to correlate CTO complexity with guidewire time crossing through the lesion within 30 min. Moreover, almost all scoring systems represent procedures performed by seasoned operators. Herein, this study sought to evaluate the predictive capacity of J-CTO for PCI success in a European single-center cohort with growing experience in the approach of CTO. METHODS: Five hundred twenty-six procedures were performed between 2007 and 2020 mainly by a single operator. The predictive power of J-CTO score was assessed by area under the receiver-operator characteristic curve (ROC) in the entire cohort and additionally in two separate periods. The goodnessof- fit of the model was evaluated by the Hosmer and Lemeshow statistic. RESULTS: Successful procedure in first-attempt PCI was 79.5% and the overall success including 47 repeated procedures was achieved in 85.8%. The retrograde approach was attempted in 14.4%. The score was inversely associated with procedural success with lower success rate in more difficult CTOs (p < 0.001). ROC curve for the entire cohort, and first block (case 1-200) and second block (case 201-526) was 0.696, 0.661 and 0.748, respectively. The model showed good calibration for the entire cohort (X2 = 1.7; p = 0.43). CONCLUSIONS: J-CTO score showed an acceptable predictive power for procedural success in this cohort although its discriminatory power is better as the level of experience is improved.

Real-World Multicenter Coronary Lithotripsy Registry: Long-Term Clinical Follow-Up.

OBJECTIVES: Coronary lithotripsy (CL) works by fracturing the calcified plaque, allowing mean area gain, enhancing vessel compliance, and facilitating stent deployment. This study reports the safety, effectiveness, and durability of the clinical benefit of CL at long-term follow-up of a real-world multicenter registry. METHODS: This was a prospective, multicenter, single-arm study that included consecutive patients with calcified lesions undergoing CL from August, 2018 to October, 2020 with a clinical follow-up of 20 months (interquartile range, 14.5-25). Exclusion criteria were a target lesion located in a vessel <2.5 mm and/or the presence of dissection prior to CL. The primary endpoint was the rate of major adverse cardiovascular event (MACE, defined as death or target-lesion revascularization [TLR] or myocardial infarction [MI]) at follow-up. RESULTS: This registry included 109 patients (128 lesions). The population was elderly (mean age, 74 years old), with high rates of diabetic patients (58%), renal insufficiency (32%), and multivessel disease (76%). Most of the lesions were predilated with semicompliant/noncompliant balloons (25 with cutting balloon). Rotational atherectomy was used in 20 lesions. On average, CL required the use of 1 balloon delivering a mean of 60 pulses. Twelve patients presented with ST-segment-elevation MI and a culprit calcified coronary lesion undergoing CL. Successful CL was achieved in 99% of cases. There were few procedural complications, with 30-day freedom from MACE rate of 98%. The MACE rate at long-term follow-up was 5.6%. CONCLUSION: This is the first real-world, multicenter registry that confirms the safety and long-term efficacy of percutaneous coronary intervention for calcified lesions using CL in an unselected and high-risk population with a low long-term follow-up MACE rate.

Angiographic Characteristics and Outcomes of Percutaneous Coronary Intervention of Reattempted Chronic Total Occlusion: Potential Contributing Factors to Procedural Success.

This study aimed to analyze angiographic characteristics of new attempted percutaneous coronary intervention (PCI) on chronic total occlusion (CTO) compared to first attempt group. The cohort of 527 CTO-PCIs was divided into first-attempt and re-attempt groups, and angiographic characteristics, level of complexity, and contributing factors to failure were analyzed. Between-group success rate difference and potential angiographic and technical aspects contributing to the success in new attempts were scrutinized. A total of 47 new PCIs in 39 patients were performed. The reattempt group showed higher J-CTO score compared to the first-attempt group (2.4 ± 1.06 vs. 1.2 ± 1.06; p < 0.001). The use of more complex techniques and devices such as retrograde approach (29.8% vs. 12.9%) and IVUS (48.9 vs. 27.3%; p: 0.002) were more frequent in the reattempt group. Both procedural and fluoroscopy time were higher in the reattempt group (197 ± 83.9 vs. 150.1 ± 72.3 and 97.7 ± 55.4 vs. 68.7 ± 43, respectively; p < 0.001). There was no between-group difference in terms of technical success (79.8 vs. 76.6% for first attempt vs. reattempt group, respectively; p: 0.6). The overall success rate increased by 6.1%, achieving 85.9% in the entire cohort. Reattempted CTO-PCIs required more complex techniques and had comparable technical success rate with regard to the first-attempt group.

Effect of COMBinAtion therapy with remote ischemic conditioning and exenatide on the Myocardial Infarct size: a two-by-two factorial randomized trial (COMBAT-MI).

Remote ischemic conditioning (RIC) and the GLP-1 analog exenatide activate different cardioprotective pathways and may have additive effects on infarct size (IS). Here, we aimed to assess the efficacy of RIC as compared with sham procedure, and of exenatide, as compared with placebo, and the interaction between both, to reduce IS in humans. We designed a two-by-two factorial, randomized controlled, blinded, multicenter, clinical trial. Patients with ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention (PPCI) within 6 h of symptoms were randomized to RIC or sham procedure and exenatide or matching placebo. The primary outcome was IS measured by late gadolinium enhancement in cardiac magnetic resonance performed 3-7 days after PPCI. The secondary outcomes were myocardial salvage index, transmurality index, left ventricular ejection fraction and relative microvascular obstruction volume. A total of 378 patients were randomly allocated, and after applying exclusion criteria, 222 patients were available for analysis. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. IS was similar between groups for the RIC (24 ± 11.8% in the RIC group vs 23.7 ± 10.9% in the sham group, P = 0.827) and the exenatide hypotheses (25.1 ± 11.5% in the exenatide group vs 22.5 ± 10.9% in the placebo group, P = 0.092). There were no effects with either RIC or exenatide on the secondary outcomes. Unexpected adverse events or side effects of RIC and exenatide were not observed. In conclusion, neither RIC nor exenatide, or its combination, were able to reduce IS in STEMI patients when administered as an adjunct to PPCI.

Safety and efficacy of coronary laser ablation as an adjunctive therapy in percutaneous coronary intervention: a single-centre experience.

BACKGROUND: Coronary laser is a long-established coadjuvant therapy in interventional cardiology. This study aimed to present our experience regarding the safety and efficacy of laser assistance to percutaneous coronary intervention (PCI) in different scenarios of coronary artery disease. METHODS: We used coronary laser as an adjunctive therapy for PCI between May 2014 and March 2020. The safety of laser ablation was evaluated by studying any complication associated with the laser application. Besides, the laser contribution to PCI and 1 year of follow-up for adverse cardiac events was studied. RESULTS: Coronary laser was performed in 81 lesions and 75 patients in different scenarios to assist PCI. The average age was 66 ± 11.7 years and 72 (88.9%) were men. Coronary laser was used in 30 (37%) cases for in-stent-material debulking; 26 (32.1%) in primary angioplasty, 19 (23.4%) in chronic total occlusion and 5 (6.2%) in saphenous vein grafts. Procedural success was achieved in 77 (95.1%) with 1 (1.2%) type III coronary perforation. One year of follow-up for combined adverse cardiac events consisting of death due to any cause, myocardial infarction or target vessel failure showed an event-free rate of 0.82 (95% confidence interval, 0.72-0.91). CONCLUSIONS: Our preliminary experience reveals the safety and efficacy of the current modality of coronary laser as a coadjuvant therapy in PCI with a low rate of adverse cardiac events in 1-year of follow-up. Further studies are needed to establish more precisely the contribution of laser application in different contexts of coronary artery disease.

Litoplastia coronaria en lesiones calcificadas: registro multicéntrico de la práctica clínica / Coronary lithoplasty for calcified lesions: real-world multicenter registry

INTRODUCCIÓN Y OBJETIVOS: La litoplastia coronaria (LC) es una técnica con balón que se utiliza para tratar lesiones calcificadas graves. Este estudio describe la experiencia inicial del tratamiento de lesiones calcificadas con LC en una población no seleccionada y de alto riesgo. MÉTODOS: Registro prospectivo, multicéntrico, que incluyó consecutivamente todos los casos con lesiones coronarias calcificadas que se trataron con LC entre agosto de 2018 y agosto de 2019. Los criterios de exclusión fueron lesiones localizadas en vaso pequeño (< 2,5mm) y la presencia de disección previa a la LC. Un laboratorio central independiente realizó la angiografía coronaria cuantitativa y el análisis de la ecocardiografía intravascular/tomografía de coherencia óptica. RESULTADOS: Este registro incluyó a 57 pacientes (66 lesiones). Una población de edad avanzada (72,6±9,4 años) con alta proporción de pacientes diabéticos (56%), enfermedad renal crónica (35%) y enfermedad multivaso (84%). Todas las lesiones eran de tipo B/C. Se predilataron más del 75% de las lesiones con balones semidistensibles/no distensibles o cutting-balloon. Se utilizó rotablación antes de la litoplastia en 5 lesiones (7,6%). En promedio, la LC necesitó 1,17 balones de litoplastia y una media de 60 pulsos. El éxito de la LC se logró en el 98%. En el 13% de los casos, el balón de litoplastia se rompió durante el procedimiento. Hubo pocas complicaciones durante el procedimiento: 2 casos de disección significativa (ninguna relacionada con ruptura del balón de litoplastia), que se trataron con éxito mediante implante de stent farmacoactivo; 1 paciente presentó trombosis del stent 2 días después de someterse con éxito a la revascularización de la lesión objetivo. CONCLUSIONES: Este es un registro multicéntrico de la práctica clínica que respalda la factibilidad, la seguridad y la eficacia a corto plazo de la intervención coronaria percutánea para lesiones coronarias calcificadas utilizando la LC con resultados prometedores en una población no seleccionada y de alto riesgo

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

Coronary lithoplasty for calcified lesions: real-world multicenter registry.

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.

Excimer Laser in Percutaneous Coronary Intervention of Device Uncrossable Chronic Total and Functional Occlusions.

Device uncrossable lesions are a challenge in interventional cardiology and despite improvements in balloon and microcatheter profile, rotational atherectomy is necessary in some circumstances in order to ablate and traverse the lesion. Nevertheless, the application of rotational atherectomy requires utilization of a specific wire, Rotawire, which is not always so easily navigable. Debulking of device uncrossable lesions can be performed by coronary laser over any kind of angioplasty guidewire. We present a series of six patients with chronic total (100%) and functional occlusions (99% stenosis) in whom after successful wire crossing, microcatheter failed to traverse the lesion. After coronary laser performance, 5 out of 6 lesions were successfully dilated, achieving a successful final angiographic result of 83.3%.

WITHDRAWN: Use of Repositionable Transcatheter Aortic Valve Systems in Past Mechanical Prosthetic Mitral Valve Recipients.

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