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Introduction and Objectives: Thrombocytopenia frequently occurs after transcatheter aortic valve implantation (TAVI) but its impact is poorly understood. We aimed to analyze the incidence, clinical impact, and predictors of acquired thrombocytopenia after TAVI., Methods: This retrospective multicenter registry included 3913 patients undergoing TAVI with a baseline platelet count of ≥ 100 *10 9 /L. Acquired thrombocytopenia was defined as a decrease in baseline platelet count of ≥ 50% (early nadir ≤ 3 days and late nadir ≥ 4 days) post-TAVI. The primary endpoint was 30-day all-cause mortality and secondary endpoints were procedural safety and 2-year all-cause mortality., Results: The incidence of acquired thrombocytopenia was 14.8% (early nadir: 61.5%, late nadir: 38.5%). Thirty-day mortality occurred in 112 (3.0%) patients and was significantly higher in those with thrombocytopenia (8.5% vs 2.0%, adjusted OR, 2.3; 95%CI, 1.3-4.2). Procedural safety was lower and 2-year mortality was higher in patients with thrombocytopenia vs those without (52.1 vs 77.0%; P <.001, and 30.2% vs 16.8%; HR, 2.2, 95%IC, 1.3-2.7) and especially in those with late nadir thrombocytopenia (45.8% vs 54.5%; P=.056, and 38.6% vs 23.8%, HR, 2.1; 95%CI, 1.5-2.9). Independent predictors of thrombocytopenia comprised baseline and procedural factors such as body surface area, absence of diabetes, poorer renal function, peripheral vascular disease, nontransfemoral access, vascular complications, type of transcatheter heart valve, and earlier TAVI procedures., Conclusions: Acquired thrombocytopenia was common (15%) after TAVI and was associated with increased short- and mid-term mortality and decreased procedural safety. Moreover, late thrombocytopenia compared with early thrombocytopenia was associated with significantly worse clinical outcomes. Further investigations are needed to elucidate the etiologic mechanisms behind these findings., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Background: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly., Aims: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events., Methods: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted., Results: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF., Conclusions: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.

Multivalvular heart disease (MVHD) is present in one-third of patients with valvular heart disease (VHD). Compared to single VHD patients, these patients have a more significant hemodynamic impact and are often left under medical treatment. Most importantly, when undergoing multiple valve interventions, they show worse rates of heart failure and mortality. The guidelines-supported interventions in patients with MVHD in combined aortic regurgitation and mitral stenosis include percutaneous mitral balloon commissurotomy, open mitral commissurotomy, or surgical mitral valve replacement followed by transcatheter or surgical aortic valve replacement, trying to minimize the increased mortality risk of double-valve replacement. Simultaneous transcatheter valve replacement (STVR) for native MVHD is still off-label and not yet considered in clinical guidelines since the evidence of its results is limited to a few cases reported worldwide. However, fully percutaneous transfemoral STVR seems promising for MVHD patients thanks to its minimal invasiveness, the continuous improvement of the transcatheter heart valve devices, the likely shorter length of stay and the fastest recovery. To our knowledge, this is the first case ever reported of fully percutaneous STVR for native MVHD in aortic regurgitation and mitral stenosis. Deep understanding of both pathologies and their interactions, not only from a pathological point of view but from the procedural planning and procedural steps point of view is mandatory. Hereby we present the specific STVR procedural planning considerations, a step-by-step guide on how to perform an aortic and mitral STVR and its critical considerations, as well as the procedural and follow-up results., Competing Interests: The authors report no conflict of interest., (© 2024 The Author(s).)

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., Competing Interests: The study was supported by 10.13039/100016545Roche Diagnostics International. Dr Bernard is supported by a doctoral scholarship from 10.13039/501100000024Canadian Institutes of Health Research (CIHR). Dr Tastet was supported by a doctoral scholarship from Fonds de Recherche du Québec: Santé (10.13039/501100000156FRQS). Dr Arsenault is supported by a senior scholar award from the 10.13039/501100000156FRQS. Dr Rodés-Cabau holds the Famille Jacques Larivière Chair in Structural Heart Disease. Dr Pibarot holds the Canada Research Chair in Valvular Heart Diseases, Canadian Institutes of Health Research; has received funding from 10.13039/100016545Roche Diagnostics, Edwards Lifesciences, and Medtronic for echocardiography CoreLab analyses with no personal compensation; and has received a research grant from the Canadian Institutes of Health Research (grant #FDN-143225; Ottawa, Ontario, Canada). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

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., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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.

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.

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, I 2  = 53%) and myocardial infarction (MI) (OR 0.74 95% CI 0.59-0.93, I 2  = 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, I 2  = 72.3%) and repeat revascularization (OR 1 95% CI 0.82-1.20, I 2  = 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., Competing Interests: Hector Garcia-Garcia reports the following institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips, and Corflow. Jorge Sanz Sánchez has received minor speaking honoraria from Terumo, Cordis, Biotronik, and Medtronic. The rest of authors have no disclosures to declare., (© 2023 The Authors.)

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., Competing Interests: Funding Support and Author Disclosures Dr Nuche has received a research grant from the “Fundación Alfonso Martín Escudero” (Madrid, Spain). Dr Rodés-Cabau has received institutional research grants and speaker/consultant fees from Edwards Lifesciences and Medtronic. Dr Rodés-Cabau holds the research chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Interventions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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&lt;.001), and prior myocardial infarction (24.3% vs 1.8%; P&lt;.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 (&lt;1%) in both groups. NCPE patients were more frequently treated with anticoagulation following PFO closure (63% vs 13%; P&lt;.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.

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.

Background: The evaluation of long-term inflammatory response and function in postoperative patients with aortic valve replacement (AVR) deserves special analysis because it is important to try to prevent reoperation and improve durability and functionality of the prostheses. It is our objective METHODS: In this study, we included a cohort of patients with aortic valve damage treated by AVR with mechanical prosthesis, bio prosthesis and we included a control group., Results: We found that IL-4 and osteopontin levels were higher in patients with mechanical vs biological prostheses (p=0.01 and p=0.04, respectively), osteoprotegerin (OPG) levels were decreased (p=0.01), women had lower levels of ET-1 and IL-6, (p=0.02) (p=0.04), respectively. Patients older than 60 years had decreased levels of IL-1ß p<0.001) and a higher concentration of IL-4 p<0.05). IL-1ß, OPG and TNFα were higher in patients with less than 5 years of evolution vs more than 10 years (p=0.004, p=0.02 and p=0.03, respectively). Factors such as age, gender, prosthetic and elevated IL-1B and ET-1 levels are associated with valve dysfunction prosthetic. These results indicate that the inflammatory involvement present prior to valve replacement may be perpetuated by various factors in the long term., Conclusions: The findings provide us with the opportunity to effectively treat patients with AVR in the postoperative period, which could prolong the functionality of the bio prostheses., Trial Registration Number: NCT04557345., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

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., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

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., (Copyright: © 2022 Permanyer.)

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., (Copyright: © 2022 Permanyer.)

Competing Interests: Funding Support and Author Disclosures Dr. Damas de los Santos has been a proctor for Boston Scientific; and has been a speaker for Boston Scientific and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The COVID-19 was first described in late 2019 that quickly became a pandemic affecting every health system as we know it. The high transmissibility among humans represents a well-known high burden of morbidity and mortality not only for cardiovascular patients but also for a higher risk between health care professionals that must deliver high-quality care to them in any scenario, and cardiac catheterization rooms are no exception. This creates a new dilemma, minimize exposure to patients and health care professionals to COVID-19 while maintaining high quality in cardiovascular therapeutics. In order to achieve this, several international recommendations on treatment algorithms modifications and in safety measures in the catheterization room have been published, always aiming to solve this dilemma in the best possible way. Hereby, we present a summary of the most recent treatment algorithms in the most important cardiovascular interventions (acute coronary syndromes, structural and congenital heart diseases) as well as specific safety measures with a step-by-step preparedness before and after any interventional procedure during COVID-19 outbreak. The objective of this document is to inform and to train health care professionals that works in cardiac catheterization rooms on the risks as well on the plan for containment, mitigation, and response to the global situation of COVID-19 infection in order to apply this in their own local work environments., (© 2020 Wiley Periodicals LLC.)

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., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Treatment of ascending aorta disease is surgical; however, some series have evaluated the effectiveness of endovascular treatment. We report the case of a patient with a ruptured pseudoaneurysm who underwent endovascular repair via the left common carotid artery. The clinical and neurological evolution was satisfactory during the in-hospital follow-up. ( Level of Difficulty: Intermediate. )., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2020 The Authors.)

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., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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., (Copyright: © 2020 Permanyer.)

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., (Copyright: © 2020 Permanyer.)

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., (Copyright: © 2020 Permanyer.)

Competing Interests: Competing interests: None declared.