Transcatheter aortic valve replacement in pure native aortic regurgitation: when off-label indications match the patient's requirements / TAVI en IA pura de válvula nativa: cuando indicaciones fuera de guías cumplen los requerimientos del paciente

Abstract Objective: In recent years, transcatheter aortic valve replace (TAVR) has revolutionized the interventional treatment of aortic stenosis, however, only scarce evidence considers it as treatment for Aortic Regurgitation (AR). At present, the treatment of Pure AR of Native Valve with TAVR does not fall within the recommendations of international guidelines, as it poses multiple challenges with immediate and long-term variable and unpredictable results. The objective of this paper is to present the case of a patient with prohibitive operative risk that benefited of TAVR treatment for AR. Materials and methods: We present the case of a 79-year-old male patient who has severe Pure Native Aortic Valve Regurgitation, considered inoperable. Based on the heart team's decision, TAVR was planned with the use of an Edwards SAPIEN 3 valve. After TAVR, the patient developed complete heart block and a pacemaker was implanted. He improved to NYHA II functional class. At 15-month follow-up, he suffered intracranial hemorrhage and passed away. Results and Conclusions: Management of patients with severe symptomatic AR with high surgical risk continues to be a special challenge. They have high mortality if left untreated with valvular change, despite medical treatment. Even though it is strictly off-label, TAVR might be a reasonable solution for a select type of patients who are considered inoperable due to surgical high mortality risk.

Resumen Objetivo: En años recientes, el reemplazo valvular aórtico vía percutánea (TAVI) ha revolucionado el tratamiento de los pacientes con estenosis aórtica, sin embargo, poca evidencia la considera como opción de tratamiento en pacientes con insuficiencia aórtica (IA), especialmente en pacientes con Insuficiencia Aórtica Pura de Válvula Nativa (IAPVN), dado que esta patología confiere múltiples retos con resultados muy variables tanto a corto como a largo plazo. Dada su alta mortalidad en caso de permanecer sin tratamiento, la primera opción de tratamiento es la cirugía de cambio valvular. Material y Métodos: Presentamos el caso de un masculino de 79 años con IAPVN grave considerado inoperable dadas las comorbilidades. De acuerdo con la decisión del equipo de Cardiología, se decidió realizar TAVI con la colocación de una Válvula Edwards SAPIEN 3. El paciente desarrolló bloqueo AV completo como única complicación y se colocó marcapasos permanente. Permaneció en clase funcional NYHA II. A los 15 meses de seguimiento presentó hemorragia intracraneal y falleció. Resultados y Conclusiones: El manejo de los pacientes con IAPVN grave sintomática con riesgo quirúrgico alto sigue siendo un reto especial. Tienen alta mortalidad si no se realiza cambio valvular a pesar de tratamiento médico. A pesar de que no se recomienda en las guías actuales, la TAVI puede ser una opción razonable para un grupo muy selecto de pacientes que son considerados inoperables.

Outcomes of chronic total occlusion percutaneous coronary intervention in patients with prior coronary artery bypass graft surgery: Insights from the LATAM CTO registry.

OBJECTIVES: To evaluate the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in patients with and without prior coronary artery bypass graft (CABG) surgery. BACKGROUND: Data on the outcomes of CTO PCI in patients with versus without CABG remains limited and with scarce representation from developing regions like Latin America. METHODS: We evaluated patients undergoing CTO PCI in 42 centers participating in the LATAM CTO registry between 2008 and 2020. Statistical analyses were stratified according to CABG status. The outcomes of interest were technical and procedural success and in-hospital major adverse cardiac and cerebrovascular events (MACCE). RESULTS: A total of 1662 patients were included (n = 1411 [84.9%] no-CABG and n = 251 [15.1%] prior-CABG). Compared with no-CABG, those with prior-CABG were older (67 ± 11 vs. 64 ± 11 years; p < 0.001), had more comorbidities and lower left ventricular ejection fraction (52.8 ± 12.8% vs. 54.4 ± 11.7%; p = 0.042). Anatomic complexity was higher in the prior-CABG group (J-CTO score 2.46 ± 1.19 vs. 2.10 ± 1.22; p < 0.001; PROGRESS CTO score 1.28 ± 0.89 vs. 0.91 ± 0.85; p < 0.001). Absence of CABG was associated with lower risk of technical and procedural failure (OR: 0.60, 95% CI: 0.43-0.85 and OR: 0.58, 95% CI: 0.40-0.83, respectively). No significant differences in the incidence of in-hospital MACCE (3.8% no-CABG vs. 4.4% prior-CABG; p = 0.766) were observed between groups. CONCLUSION: In a contemporary multicenter CTO-PCI registry from Latin America, prior-CABG patients had more comorbidities, higher anatomical complexity, lower success, and similar in-hospital adverse event rates compared with no-CABG patients.

Design, manufacture and initial tests of a drug-eluting coronary stent / Diseño, fabricación y pruebas iniciales de una endoprótesis coronaria liberadora de fármaco

Abstract Introduction: A drug-eluting coronary stent is being developed at the National Institute of Cardiology of Mexico for the treatment of ischemic heart disease. Objective: To establish the best animal model for the tests, to show the advances in the drug-eluting stent prototype, to assess two drugs’ antiproliferative activity and histological results. Method: Smooth muscle cell culture tests were performed in order to assess sirolimus and paclitaxel antiproliferative properties. The drugs were encapsulated inside the polymeric matrix of the stents. Rabbits and pigs were used as animal models. Results: Sirolimus and paclitaxel showed an inhibitory effect, which was higher for the latter. Infrared spectroscopy and light and optical microscopy showed that the drug/polymer layer properly adhered to the stent. At a four-week follow-up, both animal models showed satisfactory clinical evolution and adequate histological response, although the porcine model was shown to be more suitable for future protocols. Conclusions: Preliminary tests of the drug-eluting stent provided bases for the development of a study protocol with an adequate number of pigs and with clinical angiographic and histopathological three-month follow-up.

Resumen Introducción: En el Instituto Nacional de Cardiología de México se desarrolla una endoprótesis (stent) coronaria liberadora de fármacos para el tratamiento de la cardiopatía isquémica. Objetivo: Establecer el mejor modelo animal para las pruebas, mostrar los avances en el prototipo del stent liberador de fármacos, evaluar la actividad antiproliferativa de dos fármacos y los resultados histológicos. Método: Se realizaron cultivos de células de músculo liso para evaluar las propiedades antiproliferativas de sirolimus y paclitaxel. Los fármacos fueron encapsulados en el interior de la matriz polimérica de los stents. Se emplearon conejos y cerdos como modelos animales. Resultados: Sirolimus y paclitaxel mostraron efecto inhibitorio, mayor en el segundo. La espectroscopia infrarroja y la microscopia óptica y electrónica mostraron que la capa del polímero con el fármaco se adhería adecuadamente al stent. A las cuatro semanas de seguimiento, ambos modelos animales mostraron evolución clínica satisfactoria y adecuada respuesta histológica, si bien el modelo porcino resultó más conveniente para protocolos futuros. Conclusiones: Las pruebas preliminares del stent liberador de fármaco brindó bases para desarrollar el protocolo con un número adecuado en cerdos y con seguimiento clínico angiográfico e histopatológico a tres meses.

Human pilot study of bare-metal stent: INC-01

ABSTRACT Background: The cost of performing a percutaneous coronary intervention is considerably high for the patient as well as for health systems, which have promoted the development of local technology to help meet the need for these devices. Methods: The INC-01 bare-metal stent was developed at the National Institute of Cardiology in Mexico City and was first implanted on porcine models with technical success in 100% of the evaluated parameters. Presentation of Cases: We present the first three cases of patients with ischemic heart disease, to whom the INC-01 bare-metal stent was implanted. Intracoronary ultrasonography was performed post-stent implantation, showing all the characteristics of implant success during evaluation and clinical follow-up. Conclusions: Angiography and intracoronary ultrasound were carried out demonstrating that the INC-01 bare-metal stent has physical, biological, and histological characteristics similar to those found in commercial metallic stents.

Guiding Principles for Chronic Total Occlusion Percutaneous Coronary Intervention.

Outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have improved because of advancements in equipment and techniques. With global collaboration and knowledge sharing, we have identified 7 common principles that are widely accepted as best practices for CTO-PCI. 1. Ischemic symptom improvement is the primary indication for CTO-PCI. 2. Dual coronary angiography and in-depth and structured review of the angiogram (and, if available, coronary computed tomography angiography) are key for planning and safely performing CTO-PCI. 3. Use of a microcatheter is essential for optimal guidewire manipulation and exchanges. 4. Antegrade wiring, antegrade dissection and reentry, and the retrograde approach are all complementary and necessary crossing strategies. Antegrade wiring is the most common initial technique, whereas retrograde and antegrade dissection and reentry are often required for more complex CTOs. 5. If the initially selected crossing strategy fails, efficient change to an alternative crossing technique increases the likelihood of eventual PCI success, shortens procedure time, and lowers radiation and contrast use. 6. Specific CTO-PCI expertise and volume and the availability of specialized equipment will increase the likelihood of crossing success and facilitate prevention and management of complications, such as perforation. 7. Meticulous attention to lesion preparation and stenting technique, often requiring intracoronary imaging, is required to ensure optimum stent expansion and minimize the risk of short- and long-term adverse events. These principles have been widely adopted by experienced CTO-PCI operators and centers currently achieving high success and acceptable complication rates. Outcomes are less optimal at less experienced centers, highlighting the need for broader adoption of the aforementioned 7 guiding principles along with the development of additional simple and safe CTO crossing and revascularization strategies through ongoing research, education, and training.

Stent diferido versus inmediato en pacientes con infarto de miocardio ST elevado y alta carga de trombo residual reclasificado en la lesión culpable / Deferred versus immediate stenting in patients with ST - segment elevation myocardial infarction and residual large thrombus burden reclassified in the culprit lesion

Resumen Introducción: Un trombo intracorononario largo reclasificado es un predictor independiente de resultados adversos y no reflujo en el infarto agudo de miocardio con elevación del ST. Pacientes con mayor carga de trombo residual tienen peor disfunción microvascular y mayor daño miocárdico. Métodos: Evaluamos retrospectivamente a 833 pacientes que fueron a angioplastia primaria entre enero del 2011 y junio del 2016. La carga de trombo residual final fue reclasificada tras realizar el cruce de la guía, predilatación con balón o tromboaspiración, para restaurar y estabilizar un flujo TIMI 2-3. Las estrategias de stent diferido vs. stent inmediato fueron comparadas, siendo el objetivo primario la incidencia de no reflujo (TIMI ≤ 2, o TIMI 3 con TMP < 2). Resultados: Cuarenta y siete pacientes (6.8%) presentaron una alta carga trombo residual reclasificado. La coronaria derecha fue la arteria culpable en 34 casos. Hubo mayor frecuencia de ectasia coronaria en el grupo de stent diferido (p = 0.005). Se encontraron menores tasas de no reflujo en el stent diferido (36% vs. 58%), con una mayor frecuencia de un TMP 3 (p = 0.005). Tras la nueva cateterización un 56% quedó libre de stent en el grupo diferido y la anticoagulación oral les fue más frecuentemente indicada (p = 0.031). La tasa de eventos cardiacos adversos mayores fue similar entre los grupos. Hubo una tendencia a una mejor función ventricular izquierda en el grupo diferido (p = 0.056). Conclusiones: El stent diferido puede ser una alternativa eficiente en pacientes con IAM CEST y alta carga de trombo residual reclasificado, después de conseguir un flujo TIMI 2-3 estable.

Abstract Background: Reclassification of a large thrombus burden is an independent predictor of major adverse cardiac events and no-reflow in patients with ST- segment elevation myocardial infarction (STEMI). Patients with a greater residual thrombus burden have worse microvascular dysfunction and greater myocardial damage. Methods: A retrospective analysis was performed on 833 STEMI patients who underwent primary percutaneous coronary intervention. The final residual thrombus burden was reclassified after the lesion was wired, and a thrombus aspiration or balloon dilatation was performed to restore and stabilise a thrombolysis in myocardial infarction (TIMI) 2-3 flow. Deferred stenting (DEI) was compared with immediate stenting (ISI) group, and the primary outcome was the incidence of no-/slow-reflow (TIMI ≤ 2, or TIMI 3 with myocardial blush grade < 2). Results: Overall, 47 patients (6.8%) had a residual large thrombus burden reclassified. The right coronary artery was the culprit vessel in 34 cases. More patients had coronary ectasia in the DSI group (P=.005). Fewer patients in the DSI had no-/slow-reflow (36% vs. 58%), and the myocardial blush grade 3 was more frequent in the DSI group (P=.005). After repeat coronary angiography in the DSI group, stenting was not performed in 56%, and oral anticoagulation was more frequent in the follow-up (P=.031). Major cardiac adverse events were similar between groups. There was a tendency to better left ventricular function in the DSI group (P=.056). Conclusions: Deferred stenting may be an efficient option in STEMI patients with a residual large thrombus burden reclassified after achieving a stable TIMI 2-3 flow.

[Vertebral-subclavian bifurcation treatment. "The wedding ring technique" for a vertebral in-stent restenosis associated with stent fracture].

This report describes a solution for a restenosis and for the fracture of a stent in the vertebral artery in a patient suffering from vertebrobasilar symptoms. Angiography demonstrates restenosis of a vertebral stent as well as its fracture and migration into the subclavian artery. This complication was managed percutaneously by passing a guide wire through the fractured stent. Pre-dilatation and kissing balloon techniques were applied in both the vertebral and subclavian arteries to modify the stent's dimensions and shape it into the form of a "ring." Postprocedural angiography demonstrated an excellent final result with the assistance of StentBoost visualization. Control angiography at six months also utilized StentBoost imaging and confirmed the patency of the bifurcation and that the stent was not displaced.

Endovascular treatment of type B dissection in patients with Marfan syndrome: mid-term outcomes and aortic remodeling.

OBJECTIVES: To evaluate the mid-term outcomes, and the aortic remodeling in Marfan syndrome (MFS) patients with type B dissection that were treated with endovascular repair. BACKGROUND: MFS is a relative contraindication to thoracic endovascular aortic repair (TEVAR). Mid-term aortic outcomes data in MFS after TEVAR are limited, and the occurrence of late events remains unclear. METHODS: Of 89 patients that underwent TEVAR between September 2002 and February 2011, 10 patients with mid-term follow-up fulfilled the Ghent criteria for MFS and complicated type B dissection. High risk for open surgery was documented in 90%. RESULTS: The mean age was 35.1 ± 9.4 years and all patients presented with acute aortic syndrome complicating a chronic type B dissection (DeBakey type IIIb). Five patients underwent a Bentall surgical procedure previous to endovascular repair, and in four patients initial TEVAR was followed by surgery of the ascending aorta. Treatment was limited to endovascular repair in only one patient. In-hospital mortality was 10%. At a mean follow-up of 59.6 ± 38.9 months, the cumulated mortality was of 20% and late mortality 11.1%. The rate of secondary endoleak was 44.4%, and late reintervention of 33.3%. Survival freedom from cardiovascular death at 8 years was 80.0%, and positive remodeling was documented in 37.5% of patients. CONCLUSIONS: Our results suggest that TEVAR is feasible, safe, and associated with a high reintervention rate and reduced rate of positive aortic remodeling in patients with Marfan syndrome. Survival at 8 years was comparable to contemporary series of open repair.

Ensayo clínico de asignación aleatoria, para evaluar la eficacia de dos técnicas de compresión en la disminución de complicaciones en el sitio de acceso vascular femoral, posterior a cateterismo diagnóstico y terapéutico / Randomized, controlled trial, to assess the efficacy of two vascular compression techniques in reducing complications at vascular access sites after therapeutic or diagnostic catheterization

Objetivo: Comparar la incidencia de falla en la hemostasia y frecuencia de eventos vasculares, durante y después de la compresión con dos maniobras diferentes. Métodos: Se realizó un ensayo clínico de asignación aleatoria a compresión mecánica o compresión manual, para el retiro de introductor en arteria femoral posterior a cateterismo diagnóstico o terapéutico. Resultados: Se incluyeron 100 pacientes en el grupo de compresión con compresor (grupo uno) y 112 de forma manual (grupo dos). La falla para lograr hemostasia se presentó en 48% del grupo uno vs 19.7% en el grupo dos (p<0.001). Existió una tendencia a presentar con más frecuencia hematomas >4 cm durante el seguimiento con ultrasonido, en el grupo con compresor 11.4% vs el grupo manual 4.6% (p=0.062). En el análisis de regresión logística sólo se encontró que los factores independientes para falla en la hemostasia fueron: uso de compresor con OR 4.34 (IC 95%, 2.24-8.43, p<0.001) y edad mayor a 61 años con OR 2.44 (IC 95%, 1.3-4.7, p=0.008), el índice de masa corporal < 26 disminuyó el riesgo con OR 0.86 (IC 95%, 0.78-0.94, p=0.001). Conclusiones: Para el retiro de introductores, la compresión manual es superior al empleo del compresor mecánico para evitar la falla de hemostasia en el sitio de punción. Una limitación es que no se puede asegurar cuál de los dos métodos es superior para disminuir complicaciones vasculares, dado que no se completó el tamaño de muestra calculado.

Objective: To compare the incidence of hemostatic failure and rate of vascular events during and after vascular compression using two different techniques. Methods: Patients were randomized to mechanical or manual compression after a therapeutic or diagnostic catheterization procedure. Results: One hundred patients were enrolled in the mechanical compression group (group one) and 112 patients in the manual compression group (group two). Failed hemostasis was observed in 48% of patients in group 1 and 19.7% in group two (p<0.001). A tendency towards a greater incidence for hematoma (>4cm) formation was found on ultrasound follow-up in group 1 (11.4% vs 4.6%, p=0.062). Logistic regression analysis found that the only independent factors for hemostatic failure were: use of mechanical compression device (OR 4.34, 95% CI 2.24-8.43, p<0.001) and age greater than 61 years (OR 2.44, 95% CI 1.3-4.7, p=0.008). A body mass index <26 was found to reduce the risk for hemostatic failure (OR 0.84, 95% CI 0.78-0.94, p=0.001). Conclusion: After introducer sheath removal, manual compression is superior to mechanically-assisted hemostasis in avoiding hemostatic failure at vascular access site. This study was not able, however, to show the superiority of either method to reduce the rate of vascular complications due to the small sample size of patients enrolled at the time of early study termination for safety reasons.

Long-term outcomes of saphenous vein graft stenting compared with native coronary artery stenting in patients with previous coronary artery bypass graft surgery.

OBJECTIVE: Our main objective was to compare the in-hospital and long-term outcomes of saphenous vein graft stenting and native coronary artery stenting in patients with previous coronary artery bypass grafting. METHODS: We studied 127 patients who had prior coronary artery bypass; they were divided in two groups, according to the kind of percutaneous coronary intervention performed. The first group included 49 patients with saphenous vein graft stenting and the second group included 78 patients who underwent native coronary artery stenting. RESULTS: There was no significant difference in age, incidence of diabetes, smoking, arterial hypertension, dyslipidemia, left ventricular ejection fraction or in the New York Heart Association functional class between both groups. The incidence of no reflow phenomenon was higher in group 1 (10.2% vs. 1.2%, p = 0.0001). The cumulative incidence of major adverse cardiac events was different between groups at 1 month (10.2% vs. 2.5%, p = 0.041). There was a lower MACE (major adverse cardiovascular events) free survival at 36 months in the saphenous vein graft stenting group (65.0% vs. 89.1%, p = 0.024). CONCLUSIONS: Major in-hospital complications occurred more frequently in the saphenous vein graft stented group. MACE-free survival at 3 years was higher in the native coronary artery stent patients.

Long-term outcomes of saphenous vein graft stenting compared with native coronary artery stenting in patients with previous coronary artery bypass graft surgery / Stents en vasos coronarios nativos comparados con endoprótesis en injertos de vena safena en pacientes con cirugía de revascularización coronaria previa. Evolución a largo plazo

Propósito del estudio: el objetivo primario del estudio fue valorar la tasa de eventos cardiacos mayores después de cirugía de revascularización coronaria por angioplastia con stent en el injerto de vena safena, comparados con los de angioplastia con stent en la arteria coronaria nativa, tanto en el periodo de hospitalización como a largo plazo. Métodos: estudiamos a 127 pacientes, 49 con stent en injerto de vena safena (grupo 1) y a 78 con stent en arterias coronarias innatas (grupo 2). Resultados: no hubo diferencias significativas en la edad, ni en frecuencia de diabetes, tabaquismo, hipertensión arterial, dyslipidemia, fracción de expulsión del ventrículo izquierdo o clase funcional entre los grupos. La incidencia del fenómeno de no reflujo persistente fue mayor en el grupo 1 (10.2% contra 1.2%, p = 0.0001) y la suma de eventos cardiacos sólo fue distinta durante el primer mes (10.2% contra 2.5%, p = 0.041). La supervivencia sin eventos cardiacos a 36 meses fue menor en los pacientes del grupo 1 (65.0% contra 89.1%, p = 0.024). Conclusiones: La suma de eventos cardiacos mayores fue mayor en el grupo 1 y la supervivencia sin dichos eventos a 3 años fue superior en los pacientes con endoprótesis en arteria coronaria natural.

Objective: Our main objective was to compare the in-hospital and long-term outcomes of saphenous vein graft stenting and native coronary artery stenting in patients with previous coronary artery bypass grafting. Methods: We studied 127 patients who had prior coronary artery bypass; they were divided in two groups, according to the kind of percutaneous coronary intervention performed. The first group included 49 patients with saphenous vein graft stenting and the second group included 78 patients who underwent native coronary artery stenting. Results: There was no significant difference in age, incidence of diabetes, smoking, arterial hypertension, dyslipidemia, left ventricular ejection fraction or in the New York Heart Association functional class between both groups. The incidence of no reflow phenomenon was higher in group 1 (10.2% vs. 1.2%, p = 0.0001). The cumulative incidence of major adverse cardiac events was different between groups at 1 month (10.2% vs. 2.5%, p = 0.041). There was a lower MACE (major adverse cardiovascular events) free survival at 36 months in the saphenous vein graft stenting group (65.0% vs. 89.1%, p = 0.024). Conclusions: Major in-hospital complications occurred more frequently in the saphenous vein graft stented group. MACE-free survival at 3 years was higher in the native coronary artery stent patients.