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).

Long-term survival after cardiac arrest in patients undergoing emergent coronary angiography.

AIM: To determine long-term survival of patients after cardiac arrest undergoing emergent coronary angiography and therapeutic hypothermia. METHODS: We analysed data from patients treated within the regional STEMI Network from January 2015 to December 2020. The primary endpoint was all-cause mortality at median follow-up. Secondary endpoints were periprocedural complications (arrhythmias, pulmonary edema, cardiogenic shock, mechanical complication, stent thrombosis, reinfarction, bleeding) and 6-month all-cause death. A landmark analysis was performed, studying two time periods; 0-6 months and beyond 6 months. RESULTS: From a total of 24,125 patients in the regional STEMI network, 494 patients who suffered from cardiac arrest were included and divided into two groups: treated with (n = 119) and without therapeutic hypothermia (n = 375). At median follow-up (16.0 [0.2-33.3] months), there was no difference in the adjusted mortality rate between groups (51.3 % with hypothermia vs 48.0 % without hypothermia; HRadj1.08 95%CI [0.77-1.53]; p = 0.659). There was a higher frequency of bleeding in the hypothermia group (6.7 % vs 1.1 %; ORadj 7.99 95%CI [2.05-31.2]; p = 0.002), without difference for the rest of periprocedural complications. At 6-month follow-up, adjusted all-cause mortality rate was similar between groups (46.2 % with hypothermia vs 44.5 % without hypothermia; HRadj1.02 95%CI [0.71-1.47]; p = 0.900). Also, no differences were observed in the adjusted mortality rate between 6 months and median follow-up (9.4 % with hypothermia vs 6.3 % without hypothermia; HRadj2.02 95%CI [0.69-5.92]; p = 0.200). CONCLUSIONS: In a large cohort of patients with cardiac arrest within a regional STEMI network, those treated with therapeutic hypothermia did not improve long-term survival compared to those without hypothermia.

Predictors of primary percutaneous coronary intervention delay in cases of myocardial infarction diagnosed in hospitals without hemodynamic support systems / Predictores de demora en el intervencionismo coronario percutáneo primario en el infarto de miocardio diagnosticado en hospitales sin hemodinámica.

OBJECTIVES: The need for primary percutaneous coronary intervention in hospitals without hemodynamic support capability is associated with delays between first medical contact (FMC) and reperfusion. It is important to identify factors involved in delays, particularly if they are relevant to the organization of emergency services. MATERIAL AND METHODS: Analysis of a registry of patients treated in hospitals without advanced hemodynamic support systems in a catchment area with an established care network for acute ST-segment elevation myocardial infarction (STEMI). The registry included care times. RESULTS: The network served 2542 patients with a mean (SD) age of 63 (13) years. FMC-to-reperfusion time was within 120 minutes in 42% of the cases. Nine of the hospitals had a chest-pain unit in the emergency department, and this factor was an independent predictor of FMC-to-reperfusion times of 120 minutes or less (odds ratio, 0.64; 95% CI, 0.54­0.77; P < .0001); the time was shortened by 11 minutes in such hospitals. FMC-to-reperfusion was delayed beyond 120 minutes in relation to the following factors: shock and need for intubation at start of care, age, gender, FMC at night, left bundle branch block, and Killip class. One-month and 1-year mortality rates increased in hospitals without hemodynamic support systems in proportion to reperfusion delay, by 1.7% and 3.5% if the delay was 106 minutes or less and by 7.3% and 12.4% if the delay was 176 minutes or longer (P < .0001). CONCLUSION: FMC-to-reperfusion time in STEMI exceeds recommendations in 58% of the hospitals without hemodynamic support systems and delay is inversely proportional to the availability of an emergency department chest pain unit. One-month and 1-year mortality is proportional to the degree of delay.

OBJETIVO: La indicación de intervencionismo coronario percutáneo primario (ICPP) en hospitales sin hemodinámica (HSH) se asocia con tiempos primera asistencia-apertura de la arteria (TPA) prolongados. Es pertinente identificar los factores implicados, especialmente aquellos relacionados con la organización de los servicios de urgencias. METODO: Análisis de un registro de pacientes atendidos en HSH en una región sanitaria con una red asistencial para infarto agudo de miocardio con elevación del segmento ST (IAMEST) establecida y de sus tiempos de actuación. RESULTADOS: En 2.542 pacientes, de edad 63 ± 13 años, se alcanzó un TPA 120 minutos en un 42% de casos. En 9 de los 16 HSH analizados existía un box de dolor torácico en el área de urgencias, que se comportó como factor predictor independiente de un TPA 120 minutos [OR 0,64 (IC 95% 0,54-0,77), p 0,001], con una reducción de 11 minutos de este. Se asociaron de forma independiente con un TPA superior a 120 minutos la intubación y shock durante la primera asistencia, edad, sexo, atención en horario nocturno, bloqueo de rama izquierda y la clase Killip. La mortalidad al mes y al año aumentó en los HSH proporcionalmente al TPA (1,7% y 3,5% si TPA 106 minutos y del 7,3% y 12,4% si TPA 176 minutos, p 0,001). CONCLUSIONES: El TPA alcanzado en activaciones procedentes de HSH supera las recomendaciones en el 58% de casos y se relaciona inversamente con la disponibilidad de un box de dolor torácico en urgencias. La mortalidad al mes y al año es proporcional al grado de retraso en la reperfusión.