First in human evaluation of a novel Sirolimus-eluting ultra-high molecular weight bioresorbable scaffold: 9-, 24-and 36-months imaging and clinical results from the multi-center RENASCENT study.

BACKGROUND: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-µm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions. METHODS: FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months. RESULTS: A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months. CONCLUSIONS: In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.

First-in-human evaluation of a novel sirolimus-eluting ultra-high molecular weight APTITUDE bioresorbable scaffold: 9- and 24-month imaging and clinical results of the RENASCENT II trial.

AIMS: The novel sirolimus-eluting ultra-high molecular weight APTITUDE bioreabsorbable vascular scaffold (BRS) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to other BRS technologies. RENASCENT II is a prospective, multicentre first-in-human clinical study evaluating the clinical performance of the APTITUDE BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: The APTITUDE BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR) at 9 and 24 months. A total of 60 patients were enrolled. All patients underwent lesion predilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100%, respectively. Angiographic late lumen loss was 0.19±0.26 mm at 9 months and 0.3±0.41 mm at 24 months. At 9 months, TVF occurred in 2/59 patients (3.4%) due to TV-MI but there was no TLR. No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up. CONCLUSIONS: In this multicentre prospective study, the APTITUDE BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-month clinical follow-up.

First in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous PLLA bioresorbable scaffold in the absence of anti-proliferative drugs: Two-year imaging results in humans.

OBJECTIVES: In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA bioresorbable scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND: The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS: A total of 10 patients undergoing single scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS: At 6 months, mean intra-scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION: At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

Three-month evaluation of strut healing using a novel optical coherence tomography analytical method following bioresorbable polymer everolimus-eluting stent implantation in humans: the TIMELESS study.

AIMS: Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear. PATIENTS AND METHODS: The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-D,L-lactide-co-glycolide polymer-eluting everolimus. RESULTS: A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5% and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1% of struts were definitely uncovered or covered with fibrin, 12.5% (5.0-18.5%) showed evidence of partial coverage, and the remaining (∼85%) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up. CONCLUSION: In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.

First clinical evaluation of a luminal self-expanding shield in patients with intermediate coronary lesions.

AIMS: Earlier generation self-expanding stents (SExS) showed high restenosis rates and long-term stent over-expansion. A novel SExS with reduced outward expansive force has been developed to overcome these limitations. This first-in-human study aimed to evaluate the safety and feasibility of the low pressure self-expanding nitinol-based vProtect™ luminal shield (LS) in the treatment of intermediate coronary lesions. METHODS AND RESULTS: A total of 29 patients with clinical evidence of myocardial ischaemia and intermediate de novo coronary lesions were included. The LS was deployed after low-pressure balloon pre-dilatation. Acute procedural and device success was achieved in all patients. Angiographic follow-up at nine months showed an in-stent lumen loss of 0.50±0.30 mm and a binary restenosis rate of 10.3%. There were no cases of late LS over-expansion or acute/late malapposition as evaluated by intravascular ultrasound (IVUS). The cumulative major adverse cardiac events (MACE) rate at nine months was 10.3%, consisting of three target lesion revascularisations, with no cases of death, myocardial infarction or stent thrombosis. CONCLUSIONS: Implantation of the LS in non-complex coronary lesions of intermediate severity was feasible, safe, and resulted in low rates of late loss and restenosis. IVUS analysis at nine months showed favourable mechanical properties of the LS without evidence of late device over-expansion.

Experiencia multicéntrica colombiana durante tres años en el cierre percutáneo de la comunicación interventricular con diferentes dispositivos oclusores: propuesta para la simplicación de la técnica en pacientes seleccionados / Colombian multicentric experience during three years for percutaneous closure of interventricular septal defect with different occluder devices: proposal for technique simplification in selected patients

Objetivos: se describe la experiencia del cierre endovascular de comunicación interventricular realizada durante tres años en diferentes centros de cardiología intervencionista, y se destaca el resultado en un grupo de pacientes seleccionados en quienes dicho procedimiento se efectuó mediante el uso de un dispositivo de última generación diseñado para el cierre de ductus arterioso. Pacientes: entre junio de 2006 hasta octubre de 2009 se sometió un total de 34 pacientes a la técnica de oclusión de comunicación interventricular por vía endovascular. La indicación del procedimiento incluyó sobrecarga de volumen, sobrecarga de presión y volumen, falla cardiaca crónica, prolapso de válvula aórtica con insuficiencia y lesión traumática. La edad promedio fue de 12,9 años y el peso fue de 36 kilos. Se evidenció un predominio del sexo masculino (53 porciento. El promedio de cálculo de flujos demostró Qp/Qs de 1,71 a 1 y el de resistencias vasculares pulmonares fue 1,18 U Wood/m2. Materiales y Métodos: el dispositivo PM VSD Occluder se implantó con la técnica clásica (62,5 porciento) mientras que el dispositivo Duct Occluder II (28,1 porciento) se utilizó con la técnica simplificada propuesta. Se usó anestesia general en 98 porciento de los casos, 60 porciento fueron guiados con fluoroscopia y ecocardiografía transesofágica y 40 porciento con transtorácica. Resultados: el tamaño del defecto varió entre 4 y 12 mm. El 91 porciento de los pacientes tenía un defecto septal aislado. La mediana del tiempo quirúrgico se cuantificó en 56 minutos, siendo mayor en el grupo en el cual se utilizó la técnica clásica (85 min) en comparación con aquel grupo en el que se empleó la técnica simplificada con un promedio de 36 minutos...

Objectives: we describe the experience of the endovascular closure of interventricular communication performed for three years in different centers of interventional cardiology and highlight its result in a group of selected patients in whom such procedure was made by the use of a last generation device designed for the closure of ductus arteriosus. Methodology: between June 2006 and October 2009, a total of 34 patients underwent endovascular occlusion for interventricular septal defect. Indication of this procedure included volume overload, pressure and volume overload, chronic congestive heart failure, aortic valve prolapse with insufficiency and traumatic injury. Mean age was 12,9 years old and mean weight was 36 kg. A prevalence in male gender (53 porciento) was evidenced. Main blood flow calculation showed Qp / Qs of 1.71 to 1 and the pulmonary vascular resistance was 1.18 U Wood/m2. Materials and methods: PM VSD occluder device was implanted with the classic technique (62,5 porciento) while the Duct Occluder II (28,1 porciento) was used with the proposed simplified technique. General anesthesia was used in 98 porciento cases; 60 porciento were guided by fluoroscopy and transesophageal echocardiography and 40 porciento with transthoracic echocardiography. Results: size of the defect varied from 4 to 12 mm. 91 porciento of patients had an isolated septal defect. Mean surgical time was 56 min, being longer in the group in which the classic technique was used (85 min) compared with the group in which the technique used was the simplified one, with a mean duration of 36 min. Mean hospital stay was estimated in 36 hours. Follow up: complete closure was documented in 100 porciento of patients at 30 days. There were three adverse events due to minor complications related to transient rhythm disturbances...

Comportamiento arterial coronario ante el barotrauma en un modelo experimental de reestenosis en porcinos: Intervencion con octreotido de somatostatina / Coronary arterial manifestations for barotrauma in experimental model of re-stenosis in pigs

La angioplastia coronaria transluminal percutánea (ACTP) es la terapia de elección en más del 50 por ciento de los pacientes con enfermedad coronaria severa sintomática. Sin embargo, la reestenosis coronaria (RC) continua siendo la principal limitación. Diseño: Utilizamos un modelo de RC experimental en arterias coronarias de cerdos sanos, mediante barotrauma con un catéter-balón. Relación balón:arteria de 1.3:1. Los animales fueron divididos en dos grupos. Un grupo control sometido a placebo y un grupo sometido a la administración de octreótido de somatostatina por vía subcutánea durante 5 días iniciando dos días antes del barotrauma. Hicimos un seguimiento de 4 semanas, al cabo de las cuales se realizó sacrificio y análisis histomorfométrico de las arterias coronarias. Resultados: Ingresaron al estudio 32 cerdos sometidos a barotrauma en forma exitosa. En el grupo 1 (control) 11 cerdos con 24 arterias intervenidas y en el Grupo 2 (octreótido) 21 cerdos con 49 arterias intervenidas. No existió entre los dos grupos diferencias en cuanto a raza, peso, edad, glicemia, colesterol total, triglícéridos, c-HDL, c-LDL, fibrinógeno e insulina. Los análisis histomorfométricos teniendo en cuenta solamente segmentos con score 2 de trauma, demostraron el beneficio del octreótido de somatostatina en la reducción de la respuesta proliferatíva neointimal. En el Grupo 1 el grosor de la neoíntima fue de 0.84 ñ 0.29 mm, el área de neoíntima de 2.28 ñ 0.77 mm2, el área de adventicia fue de 7.85 ñ 1.10 mm2 y el área total de la pared del vaso fue de 3.17 ñ 0.77 mm2. En el Grupo 2 los resultados fueron de 0.61 ñ 0.27 mm (p = 0.0120), 1.89 ñ 1.04 mm2 (p = 0.2171), 6.77 ñ 1.48 mm2 (p = 0.0194) y 2.63 ñ 0.97 mm2 (p = 0.0756) respectivamente. Durante el tiempo de seguimiento no se encontraron diferencias en los índices de remodelación vascular entre los dos grupos. Conclusiones: El octreótido de somatostatina demostró beneficio, utilidad y seguridad en la reducción de la respuesta neointimal en un modelo de RC experimental en porcinos

Hipertrofia ventricular izquierda regresión con lisinopril vs. amlodipino

Objetivo: la hipertrofia ventricular izquierda secundaria a hipertensión conlleva enfermedad coronaria, arritmia, falla cardíaca y muerte súbita. Se ha reportado regresión con el tratamiento farmacológico. Nosotros cuantificamos la respuesta a inhibidores ECA y calcioantagonistas, comparando su eficacia. Diseño:experimento clínico controlado, aleatorizado, ciego. Marco de referencia: Hospital Universitario San Juan de Dios de Bogotá, servicio de consulta externa, programa riesgos cardiovasculares. Pacientes: se seleccionaron los pacientes teniendo como criterios; hipertensión arterial (HTA) de recientes diagnóstico y sin medicación, sin enfermedad cardiovascular concomitante, no obesos ni atletas, entre octubre 1994 y junio 1997. Intervención: asignación aleatoria a tratamiento con lisinopril y amlodipino. Medición: ecocardiografía bidimensional al inicio y seis meses despúes de tratamiento farmacológico. Resultados: de 35 pacientes seleccionados, 30 finalizaron el estudio, los grupos fueron homogéneos, en cuanto a edad, peso, talla y cifras de presión arterial. Encontramos una prevalencia de 30 por ciento para hipertrofia y una regresión de 15.64 gr/m² en el grupo de lisinopril (10.6 por ciento) y 4.6 gr.m²(3.65 por ciento) en el grupo de amlodipino, diferencias no significativas. Control de presión arterial adecuada en ambos grupos de 150/104 al inicio a 140/84 en el grupo A y 159/105 a 139/84 en el grupo B, eficacia comparable. Conclusión: aunque hubo control adecuado de la presión arterial y regresión de la hipertrofia en más de 60 por ciento de los pacientes en ambos grupos, las diferencias no fueron estadísticamente significativas