Safety and efficacy of the INC bioprosthetic heart valve in humans.

INTRODUCTION: Heart valve bioprostheses are the gold standard for aortic valve surgical replacement in selected patients. OBJECTIVE: To evaluate the safety and efficacy of the National Institute of Cardiology (INC) bioprosthetic heart valve in humans. METHODS: Single-center study that included 341 patients who underwent single surgical aortic valve replacement with INC heart valve. RESULTS: 318 implants were performed de novo (93%) and 23 as redo surgery (7%); STS scores were 1.4 and 1.8%, and follow-up was for 42 and 46 months, respectively. There were no differences in clinical complications or pacemaker implantation rate. Both groups maintained a normal LVEF. Overall improvement in functional class was observed, with worsening only in two patients of the de novo group. INC prosthesis dysfunction requiring surgical reintervention was observed in eight patients (4.65%) of the de novo group vs. one patient in the redo group. CONCLUSIONS: The INC heart valve is efficacious and safe, and is associated with a low rate of complications and functional class improvement during long-term follow-up. Prospective, comparative studies of this valve are required.

INTRODUCCIÓN: Las bioprótesis de válvulas cardiacas son el estándar de oro para el reemplazo quirúrgico de la válvula aórtica en pacientes seleccionados. OBJETIVO: Evaluar la seguridad y eficacia de la válvula cardiaca bioprotésica del Instituto Nacional de Cardiología (INC) en humanos. MÉTODOS: Estudio unicéntrico que incluyó 341 pacientes que se sometieron a reemplazo valvular quirúrgico único de válvula aórtica con válvula INC. RESULTADOS: Se realizaron 318 implantes de novo (93 %) y 23 como segunda cirugía (7 %); las puntuaciones STS fueron de 1.4 y 1.8 % y el seguimiento de 42 y 46 meses, respectivamente. No existieron diferencias en las complicaciones ni en la tasa de implantación de marcapasos. Ambos grupos mantuvieron una FEVI normal. Se observó mejoría global en la clase funcional con empeoramiento solo en dos pacientes del grupo de novo. La disfunción de la prótesis INC que ameritó reintervención quirúrgica se observó en ocho pacientes (4.65 %) del grupo de novo versus un paciente (7.69 %) con segunda cirugía. CONCLUSIONES: La válvula cardiaca INC es eficaz y segura, se asocia a baja tasa de complicaciones y mejoría de la clase funcional durante el seguimiento a largo plazo. Se necesitan estudios prospectivos comparativos de esta válvula.

Design, manufacture and initial tests of a drug-eluting coronary stent.

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.

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.

Multimarker Approach to Improve Risk Stratification of Patients Undergoing Transcatheter Aortic Valve Implantation.

Background: A blood multimarker approach may be useful to enhance risk stratification in patients undergoing TAVI. Objectives: The objective of this study was to determine the prognostic value of multiple blood biomarkers in transcatheter aortic valve implantation (TAVI) patients. Methods: In this prospective study, several blood biomarkers of cardiovascular function, inflammation, and renal function were measured in 362 patients who underwent TAVI. The cohort was divided into 3 groups according to the number of elevated blood biomarkers (ie, ≥ median value for the whole cohort) for each patient before the procedure. Survival analyses were conducted to evaluate the association between blood biomarkers and risk of adverse event following TAVI. Results: During a median follow-up of 2.5 (IQR: 1.9-3.2) years, 34 (9.4%) patients were rehospitalized for heart failure, 99 (27%) patients died, and 113 (31.2%) met the composite endpoint of all-cause mortality or heart failure rehospitalization. Compared to patients with 0 to 3 elevated biomarkers (referent group), those with 4 to 7 and 8 to 9 elevated biomarkers had a higher risk of all-cause mortality (HR: 1.54 [95% CI: 0.84-2.80], P = 0.16, and HR: 2.81 [95% CI: 1.53-5.15], P < 0.001, respectively) and of the composite endpoint (HR: 1.65 [95% CI: 0.95-2.84], P = 0.07, and HR: 2.67 [95% CI: 1.52-4.70] P < 0.001, respectively). Moreover, adding the number of elevated blood biomarkers into the clinical multivariable model provided significant incremental predictive value for all-cause mortality (Net Reclassification Index = 0.71, P < 0.001). Conclusions: An increasing number of elevated blood biomarkers is associated with higher risks of adverse clinical outcomes following TAVI. The blood multimarker approach may be helpful to enhance risk stratification in TAVI patients.

Bleeding Events After Transcatheter Aortic Valve Replacement: JACC State-of-the-Art Review.

Transcatheter aortic valve replacement (TAVR) has gained over time a major reduction in procedural complications. Despite this, clinically relevant bleeding still occurs in a non-negligible proportion of patients and adversely affects prognosis. Patients with severe aortic stenosis are at heightened risk for spontaneous bleeding due to advanced age and a high comorbidity burden. Also, procedural factors and antithrombotic management contribute to define individual bleeding susceptibility. Bleeding prevention represents an emerging area for improving patient care. Because of the tight hemorrhagic/ischemic balance, a tailored approach based on individual bleeding-risk profile, such as a less invasive antithrombotic regimen or appropriate diagnostic preprocedural evaluation, should be pursued to avoid bleeding events. This review aims to provide an in-depth overview of bleeding events in the TAVR field, including definitions, timing and the extent of risk, and clinical impact, as well as updates on antithrombotic management and its potential influence on bleeding complications.

Transcatheter Patent Foramen Ovale Closure in Patients With Transient Ischemic Attack.

Limited data exist on patients with a transient ischemic attack (TIA) who underwent patent foramen ovale (PFO) closure. The objectives of this study were to determine the clinical and procedural characteristics and long-term outcomes of patients with TIA who underwent transcatheter PFO closure. This was a multicenter study including 1,012 consecutive patients who underwent PFO closure after a cerebrovascular event. Patients were divided into 2 groups according to their index event leading to PFO closure: TIA (n = 183 [18%]), and stroke (n = 829 [82%]). The median follow-up was 3 (2 to 8) years (complete in 98% of patients). There were no significant differences between patients with TIA and stroke, except for a lower Risk of Paradoxical Embolism score in the TIA group (6.1 vs 6.9 in the stroke group, p <0.001). PFO closure was successful in all patients with a low rate of complications (<1%) in both groups. There were no differences in the incidence of neurologic events during long-term follow-up. There was 1 stroke event in the TIA group and 6 in the stroke group (0.08 vs 0.17 per 100 patients-years, p = 0.584). There were 2 TIA events in the TIA group and 10 in the stroke group (0.17 vs 0.28 per 100 patients-years, p = 0.557). In conclusion, our study showed that patients with TIA who underwent PFO closure have similar clinical characteristics as patients with stroke including a high Risk of Paradoxical Embolism score. Furthermore, these results suggest that PFO closure procedural results and long-term clinical outcomes are similar to their stroke counterparts, with a very low incidence of recurrent neurologic events. Further prospective randomized clinical trials are needed on this population.

Sex Differences in Patients With Cryptogenic Cerebrovascular Events Undergoing Transcatheter Closure of Patent Foramen Ovale.

Background Scarce data exist on sex differences in patients with cryptogenic cerebrovascular events undergoing patent foramen ovale (PFO) closure. This study aimed to determine the sex differences in clinical profile, procedural characteristics, and long-term outcomes of patients with cryptogenic cerebrovascular events undergoing PFO closure. Methods and Results A retrospective cohort was used, including 1076 consecutive patients undergoing PFO closure because of a cryptogenic cerebrovascular event. Patients were divided into 2 groups: 469 (43.6%) women and 607 (56.4%) men. The median follow-up was 3 years (interquartile range, 2-8 years). Women were younger (46±13 versus 50±12 years; P<0.01) and had a higher risk of paradoxical embolism score (6.9±1.7 versus 6.6±1.6; P<0.01). Procedural characteristics and postprocedural antithrombotic therapy were similar. At follow-up, there were no differences in atrial fibrillation (women versus men: 0.47 versus 0.97 per 100 patient-years; incidence rate ratio [IRR], 0.55 [95% CI, 0.27-1.11]; P=0.095; adjusted P=0.901), stroke (0.17 versus 0.07 per 100 patient-years; IRR, 2.58 [95% CI, 0.47-14.1]; P=0.274; adjusted P=0.201), or transient ischemic attack (0.43 versus 0.18 per 100 patient-years; IRR, 2.58 [95% CI, 0.88-7.54]; P=0.084; adjusted P=0.121); nevertheless, women exhibited a higher incidence of combined ischemic cerebrovascular events (0.61 versus 0.26 per 100 patient-years; IRR, 2.58 [95% CI, 1.04-6.39]; P=0.041; adjusted P=0.028) and bleeding events (1.04 versus 0.45 per 100 patient-years; IRR, 2.82 [95% CI, 1.41-5.65]; P=0.003; adjusted P=0.004). Conclusions Compared with men, women with cryptogenic cerebrovascular events undergoing PFO closure were younger and had a higher risk of paradoxical embolism score. After a median follow-up of 3 years, there were no differences in stroke events, but women exhibited a higher rate of combined (stroke and transient ischemic attack) cerebrovascular events and bleeding complications. Additional studies are warranted to clarify sex-related outcomes after PFO closure further.

Cerebrovascular Events in Older Patients With Patent Foramen Ovale: Current Status and Future Perspectives.

Patent foramen ovale (PFO) closure, along with medical therapy, has emerged as the therapeutic gold standard in younger (<60-year-old) patients with a PFO-related stroke for preventing recurrent events. However, PFO management guidelines lack definite recommendations for older (>60 years) patients with a PFO-related cerebrovascular event, a complex group of patients who were mostly excluded from PFO closure clinical trials. Nevertheless, several studies have shown a higher prevalence of PFO among older patients with cryptogenic stroke, and its presence has been associated with an increased risk of recurrent events. Furthermore, older patients exhibit a higher prevalence of high-risk PFO anatomical features, present inherent age-related risk factors that might increase the risk of paradoxical embolism through a PFO, and have a higher incidence of ischemic events after a PFO-related event. Additionally, observational studies have shown the safety and preliminary efficacy of PFO closure in older PFO-related stroke patients. Yet, higher rates of recurrent cerebrovascular events and new-onset atrial fibrillation were observed in some studies among older patients compared to their younger counterparts. After careful case-by-case evaluation, including the assessment of hidden potential cardioembolic sources of a cryptogenic stroke other than PFO, transcatheter PFO closure might be a safe and effective therapeutic option for preventing recurrent thromboembolic events in patients >60 years with a high-risk PFO-associated stroke. Ongoing trials will provide important insights into the role of PFO closure in the elderly population.

Impact of the antiplatelet strategy following patent foramen ovale percutaneous closure.

AIMS: Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge. METHODS AND RESULTS: The ambispective AIR-FORCE cohort included consecutive patients from seven centres in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centres were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. A total of 1532 patients (42.2% female, median age: 49 [40-57] years) were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases. After a median follow-up of 2.4 [1.1-4.4] years, a total of 58 events were observed. In the weighted analysis, the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83). CONCLUSION: The antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.

Fractional flow reserve use in coronary artery revascularization: A systematic review and meta-analysis.

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is recommended in revascularization guidelines for intermediate lesions. However, recent studies comparing FFR-guided PCI with non-physiology-guided revascularization have reported conflicting results. PubMed and Embase were searched for studies comparing FFR-guided PCI with non-physiology-guided revascularization strategies (angiography-guided, intracoronary imaging-guided, coronary artery bypass grafting). Data were pooled by meta-analysis using random-effects model. 26 studies enrolling 78,897 patients were included. FFR-guided PCI as compared to non-physiology-guided coronary revascularization had lower risk of all-cause mortality (odds ratio [OR] 0.79 95% confidence interval [CI] 0.64-0.99, I2 = 53%) and myocardial infarction (MI) (OR 0.74 95% CI 0.59-0.93, I2 = 44.7%). However, no differences between groups were found in terms of major adverse cardiac events (MACEs) (OR 0.86 95% CI 0.72-1.03, I2 = 72.3%) and repeat revascularization (OR 1 95% CI 0.82-1.20, I2 = 43.2%). Among patients with coronary artery disease (CAD), FFR-guided PCI as compared to non-physiology-guided revascularization was associated with a lower risk of all-cause mortality and MI.

Transcatheter Patent Foramen Ovale Closure in Stroke Patients with Thrombophilia: Current Status and Future Perspectives.

Transcatheter patent foramen ovale (PFO) closure is a safe and effective treatment for secondary prevention after a PFO-associated stroke as demonstrated in multiple large randomized clinical trials. However, these trials excluded a significant proportion of patients who could have benefited from percutaneous PFO closure due to coexisting potential confounders such as additional thromboembolic risk factors, namely thrombophilia. Since scarce and conflicting data existed on such patients, current clinical management guidelines on patients with PFO mainly recommended against PFO closure in patients with thrombophilia and failed to provide any recommendation on the type and duration of antithrombotic treatment after transcatheter PFO closure. In the past 2 years, there has been new evidence supporting transcatheter PFO closure as a clinically meaningful alternative (vs. medical treatment) in this high-risk group of patients, along with additional data supporting the important role of systematic screening for thrombophilia in PFO-associated cerebrovascular events. This review article provides an updated overview of the incidence, clinical characteristics and outcomes of PFO closure in patients with thrombophilia, also commenting on the most appropriate medical treatment after PFO closure and future perspectives in the field.

Vieussens' ring fistula to pulmonary artery: embolization with grandmother-mother-child technique.

A 53-year-old man with an asymptomatic fistula from the Vieussens ring to the pulmonary artery presented with progressive respiratory distress. Coil embolization of this type of fistula has been described by femoral access. The advanced transradial "grandmother-mother-son" technique for high active support safely allows successful embolization of this type of coronary fistulae.

Un hombre de 53 años con una fístula asintomática del anillo de Vieussens a la arteria pulmonar comenzó con dificultad respiratoria progresiva. La embolización con coils de este tipo de fístulas ha sido descrita por acceso femoral. La técnica transradial avanzada "abuela-madre-hijo" para un alto soporte activo permite de manera segura la embolización exitosa de este tipo fístulas coronarias.

Transcatheter Closure of Patent Foramen Ovale in Patients With Peripheral (Noncerebrovascular) Embolism.

OBJECTIVES: Scarce data exist on noncerebrovascular peripheral embolism (NCPE) patients undergoing transcatheter patent foramen ovale (PFO) closure. The objectives of this study were to determine the clinical and procedural characteristics, and long-term outcomes of patients with NCPE undergoing transcatheter PFO closure. METHODS: This was a multicenter study including 1136 consecutive patients who underwent PFO closure after a thromboembolic event. Patients were divided into 2 groups according to the type of event leading to PFO closure, ie, cerebrovascular event (CVE, n = 1099 [96.7%]) and NCPE (n = 37 [3.3%]). The median follow-up was 3 years (interquartile range, 1-8), with follow-up complete in 98%. RESULTS: Patients in the NCPE group exhibited higher rates of prior or concomitant pulmonary embolism (29.7% vs 3.4%; P<.001), and prior myocardial infarction (24.3% vs 1.8%; P<.001). Most NCPE events were located in the limbs (41%), followed by coronary (27%) and renal/splenic/mesenteric arteries (12%). PFO closure was successful in all patients, with a low complication rate (<1%) in both groups. NCPE patients were more frequently treated with anticoagulation following PFO closure (63% vs 13%; P<.001). There were no differences between NCPE and CVE groups in death (0 per 100 patient years vs 0.4 per 100 patient-years; P=.53) or cerebrovascular events (1.3 per 100 patient-years vs 0.4 per 100 patient-years; P=.15) at follow-up. CONCLUSIONS: Patients with NCPE events undergoing PFO closure exhibited differential baseline characteristics compared with patients with CVEs; limbs and coronary arteries were the most frequent NCPE location. PFO closure results and long-term outcomes were similar to their CVE counterparts, with a very low rate of recurrent thromboembolic events. Further studies are needed in this population.

Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography.

OBJECTIVES: The main objective of this study was to compare the efficacy of 3 hemostatic methods for the prevention of early radial artery occlusion (RAO): standard patent hemostasis, patent hemostasis with ulnar compression or the ulnar artery transient compression facilitating radial artery patent hemostasis (ULTRA) method, and facilitated hemostasis with a hemostatic disc. BACKGROUND: There are no prospective randomized studies that compare early RAO rates with the 3 most used nonocclusive hemostatic methods. METHODS: This was a prospective, longitudinal, comparative, and randomized study. The final population analyzed was 1,469, and they were randomized into 3 groups: 491 patients in group 1 with standard patent hemostasis, 490 patients in group 2 with the ULTRA method, and 488 patients in group 3 with facilitated hemostasis with a hemostatic disc. RESULTS: The RAO rate at 24 hours of the total population analyzed was 4.6%. By hemostasis groups, it was 3.6% for patent hemostasis, 5.5% for the ULTRA method, and 4.7% for facilitated hemostasis with a hemostatic disc, with no statistical difference among the 3 groups (P = 0.387). At 30 days, the overall rate of RAO was 1.8%, and by groups, it was 1.4% for the patent hemostasis group, 1.8% for the ULTRA method group, and 2.2% for the facilitated hemostasis with a hemostatic disc group, respectively (P = 0.185). CONCLUSIONS: The rates of RAO at 24 hours evaluated by plethysmography oximetry and confirmed by ultrasound among 3 current radial hemostasis methods (ie, patent hemostasis, the ULTRA method, and facilitated hemostasis with a hemostatic disc) are not different.

Bioprosthetic valve failure. Comparative trial of two balloon-expandable transcatheter heart valve systems in intermediate-risk patients: a propensity score analysis.

BACKGROUND: The comparative mid and long-term durability, including the rates of bioprosthetic valve failure (BVF) of the Sapien XT® and Sapien 3® transcatheter heart valve (THV) in patients with intermediate surgical risk has not been reported. METHODS: Consecutive intermediate-risk patients with severe aortic stenosis from the Mexican registry of transcatheter aortic valve replacement (TAVR) with Sapien® THVs were included. The primary endpoint was to compare the BVF rate between THVs at 2 years of follow-up. Secondary endpoints were comparisons of the composite of global mortality, cardiovascular mortality, and neurological events at 30 d and 24 months of follow-up. RESULTS: During 2014-2019, 115 (60 Sapien XT® and 55 Sapien 3®) patients met the inclusion criteria in five medical centres. The mean age was 77.3 ± 8.4 years. The average Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) was 5.6 ± 2.9. There was no statistically significant difference between the groups in BVF rate. At 30 d, overall, cardiovascular and non-cardiovascular mortality was 4.3%, 2.6%, and 1.7%, respectively. Neurological events rate was 1.73%. The mean long-term follow-up was 25.3 ± 14.2 months with an overall mortality of 9.56% but lower for the Sapien 3® group (15% vs. 3.6%, p=.037). The only independent predictor of composite mortality and neurological events that occurred in the long term was using a Sapien XT® [OR 1.6, CI 95%, 1.0-24.9; p=.049]. CONCLUSIONS: The BVF rate at 25 months of follow-up was similar with the XT and S3 systems. During this follow-up period, the major composite events of death from any cause and neurological events were significantly lower with the S3 system.

Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial.

OBJECTIVES: The aim of this study was to compare the rate of proximal radial artery occlusion (RAO) with Doppler ultrasound between distal and conventional radial access 24 h and 30 days after a transradial coronary procedure. BACKGROUND: The use of distal radial access to prevent proximal RAO (PRAO) in the proximal segment at 24 h and 30 days after a procedure, compared with conventional radial access, is unknown. METHODS: This was a prospective, comparative, longitudinal, randomized study. A total of 282 patients were randomized to either proximal radial access (n = 142) or distal radial access (n = 140) to evaluate the superiority of the distal approach in the prevention of PRAO with Doppler ultrasound 24 h and 30 days after a transradial coronary procedure. RESULTS: In the per protocol analysis, the rates of PRAO at 24 h and 30 days were 8.4% and 5.6% in the proximal group and 0.7% and 0.7% in the distal group, respectively (24 h: odds ratio [OR]: 12.8; 95% confidence interval [CI]: 1.6 to 100.0; p = 0.002; 30 days: OR: 8.2; 95% CI: 1.0 to 67.2; p = 0.019). In an intention-to-treat analysis, the 24-h and 30-day rates of PRAO were 8.8% and 6.4% for proximal radial access and 1.2% and 0.6% in the distal radial access group (24 h: OR: 7.4; 95% CI: 1.6 to 34.3; p = 0.003; 30 days: OR: 10.6; 95% CI: 1.3 to 86.4; p = 0.007). CONCLUSIONS: Distal radial access prevents RAO in the proximal segment at 24 h and 30 days after the procedure compared with conventional radial access.

Left main-like bifurcation primary percutaneous coronary intervention case report: anomalous right coronary artery ostium from the left anterior descending.

BACKGROUND: A single coronary artery ostium (SCAO) is estimated to be present in 0.066% of the general population. The proximal coronary course and the relationship with surrounding structures are related to malignant vs. benign prognoses. We present a case of SCAO with the right coronary artery (RCA) arising from the mid-left anterior descending (LAD), complicated by anterior and inferior STEMI because of acute thrombotic occlusion at the bifurcation and its percutaneous management. CASE SUMMARY: A 56-year-old male was admitted with sudden onset of resting chest pain. His ECG showed an anterior, inferior, and right ventricular STEMI. Via trans-radial access, coronary angiography showed significant stenoses at the left main and the circumflex but also a thrombotic occlusion at the proximal segment of the LAD while no RCA was seen. After crossing the LAD occlusion, the dominant RCA appeared from the mid-LAD. A provisional stent technique was performed achieving good results. Coronary computed tomography angiography showed an SCAO congenital anomaly with a patent stent in the bifurcation accompanied by diffuse coronary artery disease causing mild stenosis of the left main, proximal, and distal circumflex. DISCUSSION: The RCA arising from the mid-LAD with pre-pulmonic course has been described in only 37 cases. One reported an LAD/RCA bifurcation treatment with two stents technique in a stable scenario. The present is the first case reported of an acute thrombotic occlusion of an LAD/RCA bifurcation clinically resulting in a left main equivalent STEMI treated successfully with primary percutaneous coronary intervention using a bifurcation technique.

Design and manufacture of a coronary stent INC-1 and initial tests in experimental animal model.

In this paper, we describe our coronary stent (INC-1) design and development, the way that we found the specific characteristics needed for our device including biophysics aspects, design, finite element testing, manufacturing, and mechanic trials, we submitted and animal models experiences. The stent platform was cobalt-chromium L605 (Co-Cr), with struts thickness of 80 µm, balloon expandable. We placed the coronary stent INC-1 on a rabbit and dog models so we can evaluate efficacy and security of the device in relationship to its biomechanical properties including navigation capacity, traceability, symmetric expansion, and safety, as well as endothelial attachment, thrombogenicity, and lack of involvement of secondary branches in these models. We succeeded in efficacy and safety of the device after fluoroscopy-guided implant proving excellent capacity of release system, traceability, fluoroscopic visualization, symmetric expansion, and complete endothelial attach. Furthermore, we obtained a good post-implant balloon withdrawal, functional integrity, and no vascular complications. We observed adequate clinical evolution 3 weeks after the stent implantation.

En esta publicación se describen el diseño y el desarrollo de un stent coronario (INC-1), la forma en que se determinaron las características biofísicas deseadas, el diseño y las pruebas computacionales por elemento finito, su fabricación, así como las pruebas mecánicas a las que se sometió el prototipo y por último las primeras experiencias en modelos animales. La plataforma del stent desarrollado fue de cobalto y cromo L605 (Co-Cr), con struts de 80 µm de grosor, expandido por balón. La colocación del stent coronario INC-1 se realizó en un modelo de conejo y uno canino con el objetivo de evaluar el éxito técnico y de seguridad del stent en relación con las propiedades biomecánicas (capacidad de navegación, maniobrabilidad, expansión simétrica del stent) y de seguridad (fijación a la pared vascular y ausencia de compromiso de ramas secundarias y formación de trombos en el momento de la colocación del stent en el modelo animal). Se obtuvo éxito técnico y de seguridad del stent después del implante guiado por fluoroscopia, lo que demostró adecuada capacidad del sistema liberador, excelente maniobrabilidad, adecuada visualización fluoroscópica, expansión simétrica y fijación completa a la pared vascular, capacidad para retirar el balón desinflado después del implante, e integridad funcional y sin complicaciones vasculares. La evolución clínica fue favorable a tres semanas del seguimiento planeado.

Design and manufacture of a coronary stent INC-1 and initial tests in experimental animal model.

In this paper we describe our coronary stent (INC-1) design and development, the way that we found the specific characteristics needed for our device including biophysics aspects, design, finite element testing, manufacturing and mechanic trials we submitted and animal models experiences. The stent platform was cobalt-chromium L605 (Co-Cr), with struts thickness of 80 µm, balloon expandable. We placed the coronary stent INC-1 on a rabbit and dog models so we can evaluate efficacy and security of the device in relationship to its biomechanical properties including navigation capacity, traceability, symmetric expansion and safety. As well as endothelial attachment, thrombogenicity and lack of involvement of secondary branches in these models. We succeeded in efficacy and safety of the device after fluoroscopy-guided implant proving excellent capacity of release system, traceability, fluoroscopic visualization, symmetric expansion and complete endothelial attach. Also, we obtained a good post-implant balloon withdrawal, functional integrity and no vascular complications. We observed adequate clinical evolution 3 weeks after the stent implantation.

En esta publicación se describen el diseño y el desarrollo de un stent coronario (INC-1), la forma en que se determinaron las características biofísicas deseadas, el diseño y las pruebas computacionales por elemento finito, su fabricación, así como las pruebas mecánicas a las que se sometió el prototipo y por último las primeras experiencias en modelos animales. La plataforma del stent desarrollado fue de cobalto y cromo L605 (Co-Cr), con struts de 80 µm de grosor, expandido por balón. La colocación del stent coronario INC-1 se realizó en un modelo de conejo y uno canino con el objetivo de evaluar el éxito técnico y de seguridad del stent en relación con las propiedades biomecánicas (capacidad de navegación, maniobrabilidad, expansión simétrica del stent) y de seguridad (fijación a la pared vascular y ausencia de compromiso de ramas secundarias y formación de trombos en el momento de la colocación del stent en el modelo animal). Se obtuvo éxito técnico y de seguridad del stent después del implante guiado por fluoroscopia, lo que demostró adecuada capacidad del sistema liberador, excelente maniobrabilidad, adecuada visualización fluoroscópica, expansión simétrica y fijación completa a la pared vascular, capacidad para retirar el balón desinflado después del implante, e integridad funcional y sin complicaciones vasculares. La evolución clínica fue favorable a tres semanas del seguimiento planeado.