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Resumen Introduccion y objetivos El acceso transaxilar (ATx) se ha convertido en el acceso alternativo al transfemoral (ATF), mas utilizado en pacientes sometidos a implante percutaneo de valvula aortica (TAVI). El objetivo principal de este estudio es comparar la mortalidad total hospitalaria y a los 30 dias de los pacientes incluidos en el registro espanol de TAVI a los que se trato por acceso ATx frente a ATF. Metodos Se analizo a todos los pacientes incluidos en el registro espanol de TAVI tratados por ATx o ATF. Los eventos hospitalarios y a los 30 dias de seguimiento se definieron segun las recomendaciones de la Valve Academic Research Consortium. Se evaluo el impacto de la via de acceso mediante emparejamiento por puntuacion de propension segun las caracteristicas clinicas y ecograficas. Resultados Se incluyo a 6.603 pacientes, 191 (2,9%) tratados por ATx y 6.412 con ATF. Despues del ajuste (grupo de ATx, n = 113; grupo de ATF, n = 3.035), el exito del dispositivo fue similar entre ambos grupos (el 94% en el grupo de ATx frente al 95% en el de ATF; p = 0,95); sin embargo, se observo un incremento en la tasa de infarto agudo de miocardio (OR = 5,3; IC95%, 2,0-13,8; p = 0,001), complicaciones renales (OR = 2,3; IC95%, 1,3-4,1; p = 0,003) e implante de marcapasos (OR = 1,6; IC95%, 1,01-2,6; p = 0,03) en el grupo de ATx comparado con el de ATF. De mismo modo, la mortalidad hospitalaria y a los 30 dias fueron superiores en el grupo de ATx (respectivamente, OR = 2,2; IC95%, 1,04-4,6; p = 0,039; y OR = 2,3; IC95%, 1,2-4,5; p = 0,01). Conclusiones El ATx se asocia con un aumento en la mortalidad total tanto hospitalaria como a los 30 dias frente al ATF. Ante estos resultados, el ATx debe considerarse solo en caso de que el ATF no sea posible.

Introduction and objectives: Patients with left main coronary artery (LMCA) stenosis have been excluded from the trials that support the non-inferiority of the instantaneous wave-free ratio (iFR) compared to the fractional flow reserve (FFR) in the decision-making process of coronary revascularization. This study proposes to prospectively assess the concordance between the two indices in LMCA lesions and to validate the iFR cut-off value of 0.89 for clinical use. Methods: National, prospective, and observational multicenter registry of 300 consecutive patients with intermediate lesions in the LMCA (angiographic stenosis, 25% to 60%. A pressure gudiewire study and determination of the RFF and the iFR will be performed: in the event of a negative concordant result (FFR > 0.80/iFR > 0.89), no treatment will be performed; in case of a positive concordant result (FFR ≤ 0.80/iFR ≤ 0.89), revascularization will be performed; In the event of a discordant result (FFR> 0.80/iFR ≤ 0.89 or FFR ≤ 0.80/iFR> 0.89), an intravascular echocardiography will be performed and revascularization will be delayed if the minimum lumen area is > 6 mm2. The primary clinical endpoint will be a composite of cardiovascular death, LMCA lesion-related non-fatal infarction or need for revascularization of the LMCA lesion at 12 months. Conclusions: Confirm that an iFR-guided decision-making process in patients with intermediate LMCA stenosis is clinically safe and would have a significant clinical impact. Also, justify its systematic use when prescribing treatment in these potentially high-risk patients. Registered at ClinicalTrials.gov ( Identifier: NCT03767621).

BACKGROUND The aim of this study was to analyze the feasibility of a physiological coronary evaluation with the instantaneous wave-free ratio (iFR) of nonculprit lesions in patients with acute coronary syndrome (ACS) successfully revascularized. METHODS A multicenter registry including patients of four high-volume PCI centers with ACS and underwent successful revascularization of the culprit vessel and had other nonculprit lesions that were physiologically evaluated with the iFR between January 2017 and December 2019. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction, probable or definitive stent thrombosis and new revascularization (MACEs). RESULTS A total of 356 patients with 472 nonculprit lesions were included. The mean age was 66 ± 11 years. The clinical presentation was ACS without persistent ST-segment elevation (NSTE-ACS) in 235 patients (66%) and ST-segment elevation myocardial infarction (STEMI) in 121 patients (34%). After a median follow-up period of 21 (14-30) months, the primary endpoint occurred in 32 patients (9%). There were no differences in outcomes regarding clinical presentation (NSTEMI vs. NSTE-ACS, 9.1 vs. 8.9%, padj = 0.570) or iFR induced treatment strategy (patients with all lesions revascularized vs. patients with at least one lesion with an iFR > 0.89 deferred for revascularization, 10.5 vs. 8.4%, padj = 0.476). CONCLUSIONS The use of the iFR to guide percutaneous coronary intervention decision making in nonculprit lesions seems to be feasible, with an acceptable percentage of MACEs at the mid-term follow-up. Patients with deferred revascularization of lesions without physiological significance and patients undergoing complete revascularization had a similar risk of MACEs.

Last year’s Editor’s page discussed the emerging quality of our publication that celebrated its first anniversary at that time. Also, the fast and effective response of the journal at the early and confusing times of the COVID-19 crisis should be noted, publishing—in record time—consensus documents written by the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) in collaboration with other medical societies. A clear example of this was the article describing the effects of the COVID-19 pandemic on the healthcare situation in interventional cardiology in Spain that has been cited numerous times in some of today’s most prestigious medical journals.1 Over the last year, special articles elaborated by the ACI-SEC or by some of its working groups have been published such as “Update on requirements and equipment in interventional cardiology”,2 and the article on the assessment of endothelial function and spasm provocation test.3 Both documents are of great interest to the entire cardiovascular community, not only from the clinical but also from the administrative point of view. The main protagonists of such a satisfactory trajectory have been the authors, both those who have submitted their manuscripts in different formats as well as those invited by the editorial committee to write...

Background In developed countries, health care delivery in dermatology is hampered by the low availability of dermatologists. Objective To analyze the feasibility of a teledermatology-based action plan to provide initial dermatologic care in areas with low availability of dermatologists. Methods A cross-sectional study describing the feasibility and cost of a 12-month action plan based on a store-and-forward teledermatology (TD) connecting primary care centers and a TD center. Teleconsultations from patients complaining of any cutaneous condition were included. The primary outcome measure was the percentage of patients not referred to the local dermatologist. Results Among the total of 15,523 teleconsultations attended in the TD-based action plan, 3360 (21.65%) required a face-to-face visit with a local dermatologist. In 32.32% (n = 5017) of the cases, a therapeutic and follow-up plan report was issued. The most common conditions managed were melanocytic nevi (15.63%, n = 2426), followed by seborrheic keratosis (14.89%, n = 2312), and actinic keratosis (8.65%, n = 1342). The average response time was 14.52 days (95% CI 14.35-15.23). The additional total investment in this action plan was $142,681.01, with a unit cost of 9.20$/patient. Limitations Noncontrolled study. Conclusions Experienced dermatologists working with store-and-forward TD can deliver a fast and effective response in health care areas with access limitations.

Introducción: El tratamiento del valgo severo es complejo. El abordaje externo descrito por Keblish es ventajoso para tratar estas deformidades. Evaluamos nuestros resultados utilizando un abordaje externo en artroplastias de rodilla con genu valgo severo. Materiales y Métodos: De 795 artroplastias primarias realizadas entre enero de 2012 y marzo de 2020, analizamos 40 que tenían un abordaje externo. Todos los pacientes tenían una deformidad en valgo >20° y un ligamento colateral medial suficiente. Se incluyó a 33 mujeres (3 bilaterales) y 4 hombres, el promedio de edad era de 71 años. La causa fue fundamentalmente osteoartrosis (82%). La deformidad prequirúrgica era de 27°. Las mediciones preoperatorias eran: KSS 15 (rango 5-42) y KFS 17 (rango 0-40). El tiempo promedio de cirugía fue de 91 minutos y el seguimiento, de 37 meses. Resultados: El ángulo femorotibial posoperatorio fue de 6,2° (rango 4-40), el KSS posoperatorio fue de 79 (rango 46-95) y el KFS, de 82 (rango 60-100). Hubo tres complicaciones (7%): una infección, un mal posicionamiento de componentes y uno de neuropraxia peronea. Conclusiones: En la artroplastia de rodilla por genu valgo, este abordaje permite restituir el eje femorotibial, lograr una adecuada estabilidad de la prótesis, aun con implantes sin mayor grado de constreñimiento, con una tasa de complicaciones equiparable a la de otras técnicas.

Introduction and objectives The pocket sized KardiaMobile (KM) is a monitoring device for ECG recording through a smartphone-based application. This system is generally aimed as screening tool to detect alterations in cardiac rhythm but its diagnostic potential for detection of ST changes remains largely unknown. This study sought to assess the diagnostic sensitivity of the KM system for detection of ST changes in patients with ST elevated myocardial infarction (STEMI). Methods Patients admitted with diagnosis of STEMI were consecutively included. Recordings with KM were obtained in leads I, II and anterior precordial. KM recordings were obtained as well from healthy individuals. All recordings were submitted for blinded assessment. Results A total of 112 patients with STEMI and 25 healthy individuals were included. Among those showing ST changes, these consisted mostly in depression (75%). Sensitivity was modest for individual leads (57-58%). The combination of 2-leads, when including the precordial, and the combination of 3-leads markedly increased sensitivity (88-98% and 100% respectively) for both inferior and anterior STEMI. Specificity was very high (96-100%) and the Youden's J statistic was excellent for the 2-leads combinations that included the precordial lead (0.84-0.94) and for the 3-leads combination (0.96). Conclusions The Kardia Mobile system with the combination of 2-leads (I + precordial or II + precordial) or 3-leads shows a very high sensitivity for both anterior and inferior STEMI.

The impact of nutritional status at diagnosis of childhood acute lymphoblastic leukemia (ALL) on survival rates was assessed in a Hispanic cohort. Children

Artificial intelligence (AI) offers great promise in cardiology, and medicine broadly, for its ability to tirelessly integrate vast amounts of data. Applications in medical imaging are particularly attractive, as images are a powerful means to convey rich information and are extensively utilized in cardiology practice. Departing from other AI approaches in cardiology focused on task automation and pattern recognition, we describe a digital health platform to synthesize enhanced, yet familiar, clinical images to augment the cardiologist’s visual clinical workflow. In this article, we present the framework, technical fundamentals, and functional applications of the methodology, especially as it pertains to intravascular imaging. A conditional generative adversarial network was trained with annotated images of atherosclerotic diseased arteries to generate synthetic optical coherence tomography and intravascular ultrasound images on the basis of specified plaque morphology. Systems leveraging this unique and flexible construct, whereby a pair of neural networks is competitively trained in tandem, can rapidly generate useful images. These synthetic images replicate the style, and in several ways exceed the content and function, of normally acquired images. By using this technique and employing AI in such applications, one can ameliorate challenges in image quality, interpretability, coherence, completeness, and granularity, thereby enhancing medical education and clinical decision-making.

Central aortic blood pressure could be helpful in the evaluation of patients with aortic stenosis (AS). The SphygmoCor XCEL device estimates central blood pressure (BP) measurement with its easy-to-use, operator-independent procedure. However, this device has not been properly validated against invasive measurement in patients with severe AS. We evaluated the relationship between cuff-brachial BP, transfer function- estimated and invasively measured central aortic pressure in patients with severe AS before and after transcatheter aortic valve replacement (TAVR). Agreement between techniques was analyzed and, according to the ARTERY Society recommendations, the minimum acceptable error was a mean difference ± SD ≤5 ± ≤8 mm Hg. A total of 94 patients with AS undergoing TAVR had simultaneous non-invasive and invasive measurements of central BP before and after the procedure. Before TAVR central systolic BP was in average slightly underestimated, though with wide variability, when using the default calibration of brachial-cuff SBP (mean difference ± SD, −3 ± 15 mm Hg), and after TAVR the degree of underestimation increased (mean difference ± SD, −9 ± 13 mm Hg). The agreement tended to improve for those patients with low aor- tic gradient stenosis compared to those with high gradient at baseline (mean dif- ference ± SD, −2 ± 11 mm Hg vs. −4 ± 17, respectively, p = .3). The cuff-brachial systolic BP yielded numerically lower degree of agreement and weaker correlation with invasive measurements than SphygmoCor XCEL. In patients with severe AS the SphygmoCor XCEL cuff device, despite showing strong correlation, does not meet the ARTERY Society accuracy criteria for non-invasive measurement of central SBP.

[EN] Trial Design: An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. Inclusion Criteria: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)- classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. Results: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix , administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first dose of Fendrix. 57.14% (12 out 21) had a positive response to second dose of Fendrix . 22.22% (2 out 9) had a positive response to third dose of Fendrix and 42.96% (3 out 7) had a positive response to last dose of Fendrix. Overall, 94.02% (64 out 67) of participants had a positive response to Fendrix . No serious adverse event occurred. Conclusions: The use of Fendrix , is a viable vaccine alternative for NHS workers classified as ‘‘nonresponders”. Revaccination of healthy non-responders with Fendrix, resulted in very high proportions of responders without adverse events. Trial registration: The trial was registered in the Spanish National Trial Register (REEC), ClinicalTrials.gov and inclusion has been stopped (identifier NCT03410953; EudraCT-number 2016-004991-23). Funding: GRS 1360/A/16: Call for aid for the financing of research projects in biomedicine, health management and socio-health care to be developed in the centres of the Regional Health Management of Autonomous Community of Castile-Leon. In addition, this work has been supported by the Spanish Platform for Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), funded by the Subdirectorate General for Research Evaluation and Promotion of the Carlos III Health Institute (ISCIII), through the project PT13/0002/0039 and project PT17/0017/0023 integrated in the State Plan for R&D&I 2013–2016 and co-financed by and the European Regional Development Fund (ERDF).

Objectives This study sought to evaluate the incidence and causes of percutaneous coronary intervention (PCI) at different time periods following transcatheter aortic valve replacement (TAVR). Background Coronary artery disease (CAD) and aortic stenosis frequently coexist, but the optimal management of CAD following TAVR remains incompletely elucidated. Methods Patients undergoing unplanned PCI after TAVR were retrospectively included in an international multicenter registry. Results Between July 2008 and March 2019, a total of 133 patients (0.9%; from a total cohort of 15,325) underwent unplanned PCI after TAVR (36.1% after balloon-expandable bioprosthesis, 63.9% after self-expandable bioprosthesis). The median time to PCI was 191 days (interquartile range: 59 to 480 days). The daily incidence of PCI was highest during the first week after TAVR and then declined over time. Overall, the majority of patients underwent PCI due to an acute coronary syndrome, and specifically 32.3% had non–ST-segment elevation myocardial infarction, 15.4% had unstable angina, 9.8% had ST-segment elevation myocardial infarction, and 2.2% had cardiac arrest. However, chronic coronary syndromes are the main indication beyond 2 years. PCI success was reported in almost all cases (96.6%), with no significant differences between patients treated with balloon-expandable and self-expandable bioprostheses (100% vs. 94.9%; p = 0.150). Conclusions Unplanned PCI after TAVR is rare, with an incidence declining over time after TAVR. The main indication to PCI is acute coronary syndrome in the first 2 years after TAVR, and thereafter chronic coronary syndromes become prevalent. Unplanned PCIs are frequently successfully performed after TAVR, with no apparent differences between balloon-expandable and self-expandable bioprostheses. (Revascularization After Transcatheter Aortic Valve Implantation [REVIVAL]; NCT03283501 )

Back in May 2019 at the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC), we presented the first issue of REC: Interventional Cardiology (figure 1). A dream we had been dreaming for years was finally coming true. And it was coming to life the way we thought was the most suitable one, as a free of charge, open-access, bilingual (Spanish and English) publication with an optimal digital and print presentation. Figure 1. Presentation of the journal in 2019. A: at the editorial office; from left to right: Iria del Río, María González Nogal, Helena Gómez-Lobo, Belén Juan, and Eva M. Cardenal. B: Official Congress of the Spanish Society of Cardiology (2019); from left to right: José M. de la Torre-Hernández, Raúl Moreno, Fernando Alfonso, and Juan Sanchis. Since then, 7 issues have been published including original articles, clinical cases, letters, review articles, clinical trial reviews, editorials, debates, and news that have covered all aspects of interventional cardiology both coronary and structural. The...

Introduction and objectives: Chronic total coronary occlusion (CTO) is often a complex entity to deal with through a percutaneous coronary intervention, and the clinical benefits of successful recanalization still remain uncertain. Most registries feature data in limited time periods and do not reflect the impact that specific dedicated programs have on recanalization. Our study evaluates the results of a CTO program on a long-term period of time. Methods: All patients’ CTOs treated with percutaneous coronary interventions at our center from 2002 through 2017 were prospectively included in the registry. The clinical, angiographic and procedural data were collected, and clinical follow-up was conducted. Three consecutive periods of time were considered for the analysis of temporal trends. Results: Atotal of 424 CTOs (408 patients) were included. In 339 patients (80%) the procedure was successful. The rate of success increased over time, from 57% in 2002-2006 to 87% in 2012-2017 (P = .001). The most important independent predictor of procedural failure was lesion tortuosity. After a median follow-up of 39.7 months, the rates of major adverse cardiovascular events and cardiovascular mortality in success vs failed groups were 13.9% vs 24.7% (P = .015) and 3.6% vs 14.1% (P = .001), respectively. These were the independent predictors of cardiovascular mortality: chronic kidney disease, left anterior descending artery occlusion, and procedural failure. Conclusions: Our series shows a high rate of success in CTO recanalization, which has increased over the last few years due to greater expertise and improved program-specific technical advances. Several angiographic and procedural variables have been identified as predictors of failure. Successful procedures, especially on the left anterior descendent coronary artery, were associated with lower rates of cardiovascular mortality.

Introduction and objectives: This study primary endpoint was to present the in-hospital all-cause mortality of the Spanish TAVI registry from its inception until 2018. Secondary endpoints included other in-hospital clinical events, 30-day all-cause mortality, and an assessment of the time trend of this registry. Methods: All consecutive patients included in the Spanish TAVI registry were analyzed. In this time-based analysis, the population was been divided into patients treated before 2014 (cohort A: 2009-2013) and patients treated between 2014 and 2018 (cohort B). Results: From August 2007 to June 2018, 7180 patients were included. The mean age was 81.2 ± 6.5 years and 53% were women. The logistic EuroSCORE was 12% (8-20). Transfemoral access was used in 89%. In-hospital and 30-day all-cause mortality was 4.7% and 5.7%, respectively. On the time-based analyses during the hospital stay, the rate of myocardial infarction, stroke, need for pacemakers, tamponade, coronary obstruction, and vascular complications was similar between both groups. However, cohort B showed less need for conversion to surgery and malapposition of the valve. Also, the implant success rate increased from 93% to 96% (P< .001). In-hospital and 30-day all-cause mortality was significantly lower in cohort B, ([OR, 0.65; IC95%, 0.48-0.86; P= .003] and [OR, 0.71; IC95%, 0.54-0.92; P= .002], respectively). Conclusions: The time trend analysis of the Spanish TAVI registry showed a change in the patients’ clinical profile and an improvement in the in-hospital clinical outcomes and 30-day all-cause mortality in patients treated more recently.

Objectives This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR). Background DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies. Methods This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization . Results A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4–59.5). In the DES-ISR subgroup, these parameters were 52.6 ± 10% and 55.2% (IQR 49.3–58.5), respectively. In-segment LLL was 0.25 ± 0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months. Conclusions In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR. Summary We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4–59.5). In the DES-ISR subgroup, corresponding values were 52.6 ± 10% and 55.2% (IQR 49.3–58.5), respectively. The observed in-segment LLL was 0.25 ± 0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.

This study sought to determine, in patients with new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI), the incidence and factors associated with (i) LBBB recovery and (ii) permanent pacemaker implantation (PPI) at 1-year follow-up. This was a multicenter study including 153 patients (mean age: 81 ± 5 years, 56% of women) with NOP-LBBB post-TAVI (balloon-expandable valve in 112 patients). Delta PR (ΔPR) and delta QRS (ΔQRS) were defined as the difference in PR and QRS length between baseline and hospital discharge ECG, and the relative ΔPR and ΔQRS as absolute ΔPR and ΔQRS divided by baseline PR and QRS length, respectively. The patients had a clinical visit and 12-lead ECG at 1-year follow-up. LBBB recovery was observed in 50 patients (33%), and 14 patients (9%) had advanced conduction disturbances requiring PPI during the follow-up period. No clinical or ECG variables were associated with LBBB recovery, including prosthesis type (self- or balloon-expandable valve, p = 0.563), QRS width at baseline/discharge or absolute/relative ΔQRS (p >0.10 for all). The presence of atrial fibrillation at baseline (0.026), a longer PR interval at discharge (0.009), and a longer absolute and relative ΔPR (p = 0.002 and p = 0.004, respectively) were associated with an increased risk of PPI at 1-year follow-up. In conclusion, NOP-LBBB post-TAVI resolved in one-third of patients at 1-year follow-up, but no clinical or ECG variables were associated with LBBB recovery. Conversely, a nonsinus rhythm at baseline and a longer ΔPR were associated with an increased risk of PPI within the year after TAVI.

Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44–0.96; P non-inferiority < 0.001; P superiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46–0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032.

Background New‐generation drug‐eluting stents (DES) reduce target‐vessel revascularization compared with bare‐metal stents (BMS), and recent data suggest that DES have the potential to decrease the risk of myocardial infarction and cardiovascular mortality. We evaluated the treatment effect of DES versus BMS according to the target artery (left anterior descending [LAD] and/or left main [LM] versus other territories [no‐LAD/LM]). Methods and Results The Coronary Stent Trialist (CST) Collaboration gathered individual patient data of randomized trials of DES versus BMS for the treatment of coronary artery disease. The primary outcome was the composite of cardiac death or myocardial infarction. Hazard ratios (HRs) with 95% CIs were derived from a 1‐stage individual patient data meta‐analysis. We included 26 024 patients across 19 trials: 13 650 (52.4%) in the LAD/LM and 12 373 (47.6%) in the no‐LAD/LM group. At 6‐year follow‐up, there was strong evidence that the treatment effect of DES versus BMS depended on the target vessel ( P ‐interaction=0.024). Compared with BMS, DES reduced the risk of cardiac death or myocardial infarction to a greater extent in the LAD/LM (HR, 0.76; 95% CI, 0.68–0.85) than in the no‐LAD/LM territories (HR, 0.93; 95% CI, 0.83–1.05). This benefit was driven by a lower risk of cardiac death (HR, 0.83; 95% CI, 0.70–0.98) and myocardial infarction (HR, 0.74; 95% CI, 0.65–0.85) in patients with LAD/LM disease randomized to DES. An interaction ( P =0.004) was also found for all‐cause mortality with patients with LAD/LM disease deriving benefit from DES (HR, 0.86; 95% CI, 0.76–0.97). Conclusions As compared with BMS, new‐generation DES were associated with sustained reduction in the composite of cardiac death or myocardial infarction if used for the treatment of LAD or left main coronary stenoses. Registration URL: https://www.crd.york.ac.uk/PROSPERO ; Unique identifier: CRD42017060520.

Background Elderly patients show a higher incidence of ischemic and bleeding events after PCI. Purpose We sought to investigate clinical outcomes in elderly patients revascularized with last generation everolimus-eluting stent (EES) treated with antithrombotic strategies guided by bleeding and ischemic risks. Methods Prospective multicenter registry including patients over 75 years revascularized with EES and subsequent antithrombotic therapy guided according to a protocol based on clinical presentation, PCI complexity and the PRECISE DAPT score. The primary safety endpoint was a composite of cardiac death, myocardial infarction and definitive/probable stent thrombosis and the primary efficacy endpoint was TLR. An historical matched group of patients treated with current drug eluting stents other than EES was used as control. Results Finally, 1,064 patients were included, 80.8±4.2 years, 36.6% women, 72% ACS and 53.6% complex PCI. Primary safety endpoint was met in 6.2% and primary efficacy endpoint in 1.5%. Bleeding BARC 2–5 was reported in 7.8% and definite or probable stent thrombosis in 1.3%. The multivariable adjusted model showed no significant association of the prescribed short/long therapies with any endpoint. No stent thrombosis were reported in the subgroup with shorter DAPT duration. As compared to control group, bleeding BARC 2–5 was significantly lower in SIERRA-75 group (7.4% vs 10.2%, p=0.04) as well as the composite of MACE and bleeding (14.3% vs 18.5%, p=0.02). Conclusions In elderly population the use of last generation EES along with a predefined risks-adjusted antithrombotic regimen seems to be associated with an improved prognosis in terms of ischemic and bleeding outcomes. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Abbott Laboratories

Aims Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus (DM), reduced left ventricular ejection fraction (LVEF) and chronic kidney disease (CKD). However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI. Methods DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded end-point, multi-center trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing a TAVI. Candidate patients should have prior history of HF admission plus ≥1 of the following criteria: 1) DM, 2) LVEF ≤40%, or 3) estimated glomerular filtrate rate between 25 and 75 mL/min/1.73 m2. A total of 1020 patients will be randomized (1:1) to dapagliflozin versus no dapagliflozin. Key secondary outcomes include: (i) Incidence rate of individual components of the primary outcome; (ii) Cardiovascular mortality; (iii) The composite of HF hospitalization or CV death; (iv) Total number of recurrent HF hospitalizations. Conclusion DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI. This article is protected by copyright. All rights reserved.

Resumen Introduccion y objetivos Los pacientes mayores de 75 anos con infarto agudo de miocardio con elevacion del segmento ST sometidos a angioplastia primaria en situacion de shock cardiogenico sufren una gran mortalidad. La identificacion previa al procedimento de variables predictoras de la posterior mortalidad seria muy util para guiar la toma de decisiones. Metodos Analisis del registro multicentrico de angioplastia primaria en pacientes mayores de 75 anos (ESTROFA MI + 75), que incluye a 3.576 pacientes. Se analizaron las caracteristicas y la evolucion clinica del subgrupo con shock cardiogenico para identificar predictores de supervivencia a 1 ano tras la angioplastia y elaborar un indice pronostico. Se valido el indice en una cohorte independiente. Resultados Se incluyo a 332 pacientes. Los predictores basales independientes fueron: la localizacion anterior (HR = 2,8; IC95%, 1,4-6,0; p = 0,005), una fraccion de eyeccion 6 h (HR = 3,2; IC95%, 1,6-7,5; p = 0,001). Se diseno un indice basado en estas variables (indice «6-ANT-40»). La supervivencia a 1 ano fue del 54,5% de aquellos con indice 0, el 32,3% con indice 1, el 27,4% con indice 2 y el 17% con indice 3 (p = 0,004, estadistico C = 0,70). En una cohorte independiente de 124 pacientes, las supervivencias a 1 ano fueron del 64,5, el 40,0, el 28,9 y el 22,2% respectivamente (p = 0,008; estadistico C = 0,68). Conclusiones Un indice basado en simples variables clinicas previas al procedimiento (localizacion anterior, fraccion de eyeccion 6 h) permite estimar la supervivencia tras una angioplastia primaria de los pacientes mayores con shock cardiogenico, y asi ayudar en la toma de decisiones.

Background Proper scaling of cardiac dimensions is of paramount importance in making correct decisions in clinical cardiology. The usual normalization of cardiac dimensions to overall body size assumes an isometric relationship. We sought to investigate these relationships to obtain the best allometric coefficient (AC) for scaling. Methods Ninety-seven healthy volunteers were included. The dimensions to be scaled were the left atrial volume, the end-diastolic and end-systolic left ventricular volumes, and the diameter of the tricuspid annulus. A Bayesian statistical analysis was applied with isometric coefficients as priors. Results The linear correlations between cardiac dimensions and body size were modest, ranging from 0.12 (-0.10-0.32) for the left atrial volume and height to 0.70 (0.58-0.80) for the end-diastolic volume and height. The ACs varied across the different cardiac dimensions and body size measurements. For the best linear relationships, the isometric coefficients were outside the 95% highest density interval of the posterior distribution for the left atrial volume-weight (AC: 0.7; 0.4-0.9) and end-diastolic volume-height (AC: 2.3; 1.7-2.9), whereas they were different from 1 for the left atrial volume-weight, end-diastolic volume, and diameter of the tricuspid annulus-body surface area (AC: 0.6; 0.3-0.8). Not scaling the cardiac dimensions to their corresponding ACs can lead to important errors in size estimations of cardiac structure. Conclusions The ACs found in this study are somewhat different from the corresponding isometric coefficients and often different from 1. This finding should be considered when normalizing cardiac structures to body size when making clinical decisions.

Background Triple antithrombotic therapy (TT) is recommended for patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, there is a lack of comparative data in a real-world clinical setting between non-vitamin K antagonist oral anticoagulants (NOAC) and vitamin K antagonists (VKA). The aim of this study was to compare the safety and efficacy of TT with NOAC or VKA after PCI in patients with AF at 1-year of follow-up. Materials and Methods This was an observational retrospective study in 2 tertiary care hospitals during 2013-2016. Patients with indication for anticoagulation due to AF from an initial registry of 5,269 patients undergoing PCI were identified. Safety primary endpoint was the occurrence of major bleeding events as defined by Bleeding Academic Consortium (BARC ≥ 3). The primary efficacy endpoint was defined as major adverse cardiovascular events (MACE). Results A total of 187 consecutive patients on TT were identified: 45.4% of were discharged on NOAC and 54.6% on VKA. Patients who received VKA presented more comorbidities and had a higher bleeding risk than those who received NOACs. Major bleeding events occurred in 17 patients (9%), with a higher rate in the VKA group (3.5% vs. 13% confidence interval, 0.19-0.86, P = 0.02). There were no differences in the rates of major adverse cardiovascular events, stroke or net clinical benefit. Conclusions In this real-world study, patients with AF undergoing PCI treated on NOAC-based TT showed lower bleeding rates than those on VKA, with a lower rate of major bleeding events, while efficacy was similar between groups.

OBJECTIVES We investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS). BACKGROUND A number of clinical trials support the overall efficacy and safety of the SYNERGY stent. However, a recent trial (TIDES-ACS) in the context of ACS reported worrying figures of infarction and definite/probable stent thrombosis in the SYNERGY control arm. METHODS This is a multicenter registry (10 centers) including consecutive patients with ACS (unstable angina, non-ST elevated myocardial infarction, ST elevated myocardial infarction) who underwent percutaneous revascularization with the implantation of SYNERGY stent. The primary endpoint was the composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months. RESULTS A total of 1008 patients were included with age 65.4 ± 14.8 years, 23.8% females and a 24.5% diabetics. Regarding presentation, a 15.2% with unstable angina, 43% with non-ST elevated myocardial infarction and 41.8% with ST elevated myocardial infarction. Primary outcome was met in 3% (7% in SYNERGY TIDES-ACS arm, P superiority

This consensus document is the second of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS)-IVUS. Beyond guidance of stent selection and optimization of deployment, invasive imaging facilitates angiographic interpretation and may guide treatment in acute coronary syndrome. Intravascular imaging can provide additional important diagnostic information when confronted with angiographically ambiguous lesions and allows assessment of plaque morphology enabling identification of vulnerability characteristics. This second document focuses on useful imaging features to identify culprit and vulnerable coronary plaque, which offers the interventional cardiologist guidance on when to adopt an intracoronary imaging-guided approach to the treatment of coronary artery disease and provides an appraisal of intravascular imaging-derived metrics to define the haemodynamic significance of coronary lesions.

Resumen Introduccion y objetivos El impacto de la intervencion coronaria percutanea (ICP) sobre oclusiones coronarias cronicas totales (OCT) presenta controversias. Se analizan los resultados agudos y al seguimiento en nuestro entorno. Metodos Registro prospectivo de ICP sobre OCT en 24 centros durante 2 anos. Resultados Se realizaron 1.000 ICP sobre OCT en 952 pacientes. La mayoria tenia sintomas (81,5%) y cardiopatia isquemica previa (59,2%), y hubo intentos de desobstruccion previos en un 15%. El SYNTAX anatomico fue 19,5 ± 10,6 y tenia J-score > 2 el 17,3%. El procedimiento fue retrogrado en 92 pacientes (9,2%). La tasa de exito fue del 74,9%, mayor en aquellos sin ICP previa (el 82,2 frente al 75,2%; p = 0,001), con J-score ≤ 2 (el 80,5 frente al 69,5%; p = 0,002) y con el uso de ecografia intravascular (el 89,9 frente al 76,2%; p = 0,001), que fue predictor independiente del exito. Por el contrario, lesiones calcificadas, > 20 mm o con munon proximal romo lo fueron de fracaso. El 7,1% tuvo complicaciones, como perforacion (3%), infarto (1,3%) o muerte (0,5%). Al ano de seguimiento, el 88,2% mejoro clinicamente en caso de ICP exitosa (frente al 34,8%; p Conclusiones Los pacientes del Registro Iberico con OCT tratados con ICP presentan complejidad clinico-anatomica, tasas de exito y complicaciones similares a los de otros registros nacionales e importante impacto de la recanalizacion exitosa en la mejoria funcional, que a su vez se asocio con menor mortalidad.

AIM: To investigate key aspects of the problem of myocardial revascularization failure (MRF) and repeat or secondary myocardial revascularization (SR) in contemporary practice.; METHODS: The registry of secondary revascularization (REVASEC) is an investigator-initiated, multicenter, prospective registry enhanced with data monitoring and independent event adjudication (ClinicalTrials.govNCT03349385). It includes patients with prior revascularization referred to coronary angiography for suspected MRF with broad inclusion criteria. The main objectives are to describe the characteristics of patients with prior revascularization referred for repeat angiography, to describe and the rate and mechanisms of MRF (stent or graft failure, coronary artery disease progression or residual coronary artery disease); to evaluate the management including medical treatment and SR of these patients; and to assess the prognosis according to the outlined causative mechanisms. The registry has one year follow up for the primary endpoint (Patient-oriented composite endpoint including all-cause death, any myocardial infarction or any new unplanned revascularization according to subsets of MRF), but extended follow-up will be carried out up to 5years.; CONCLUSION: The REVASEC Registry will provide updated data on the characteristics, patterns of treatment, and 1-year outcomes of patients with MRF and SR in contemporary clinical practice. Copyright © 2021. Published by Elsevier Inc.

Objectives to test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid-term outcome accordingly. Background Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited. Methods ROCK II is a multicenter, investigator-driven, retrospective European study to compare the performance of IVUS and OCT versus angiography in patients undergoing distal-LM stenting. The primary study endpoint was target-lesion failure (TLF) including cardiac death, target-vessel myocardial infarction and target-lesion revascularization. We designed this study hypothesizing the superiority of intravascular imaging over angiographic guidance alone, and the non-inferiority of OCT versus IVUS. Results A total of 730 patients, 377 with intravascular-imaging guidance (162 OCT, 215 IVUS) and 353 with angiographic guidance, were analyzed. The one-year rate of TLF was 21.2% with angiography and 12.7% with intravascular-imaging (p = 0.039), with no difference between OCT and IVUS (p = 0.26). Intravascular-imaging was predictor of freedom from TLF (HR 0.46; 95% CI 0.23-0.93: p = 0.03). Propensity-score matching identified three groups of 100 patients each with no significant differences in baseline characteristics. The one-year rate of TLF was 16% in the angiographic, 7% in the OCT and 6% in the IVUS group, respectively (p = 0.03 for IVUS or OCT vs. angiography). No between-group significant differences in the rate of individual components of TLF were found. Conclusions Intravascular imaging was superior to angiography for distal LM stenting, with no difference between OCT and IVUS.

espanolIntroduccion y objetivos: El objetivo primario de este estudio fue presentar la mortalidad total intrahospitalaria del registro espanol de implante percutaneo de valvula aortica (TAVI) desde su inicio hasta el ano 2018, y como objetivos secundarios otros eventos clinicos intrahospitalarios, la mortalidad total a los 30 dias y la evaluacion de cual ha sido la evolucion temporal de este registro. Metodos: Fueron analizados todos los pacientes consecutivos incluidos en el registro espanol de TAVI. En este analisis temporal se dividio la poblacion en pacientes tratados antes de 2014 (cohorte A: 2009-2013) y pacientes tratados entre los anos 2014 y 2018 (cohorte B). Resultados: Desde agosto de 2007 hasta junio de 2018 se incluyeron 7.180 pacientes. La edad media fue de 81,2 ± 6,5 anos y el 53% eran mujeres. El EuroSCORE logistico fue del 12% (8-20). Se utilizo un acceso transfemoral en el 89%. La mortalidad total intrahospitalaria fue del 4,7% y a los 30 dias fue del 5,7%. En el analisis temporal durante la fase hospitalaria, las tasas de infarto, accidente cerebrovascular, necesidad de marcapasos, taponamiento, obstruccion coronaria y complicaciones vasculares fueron similares en ambos grupos. Sin embargo, en la cohorte B se observo una reduccion de la necesidad de conversion a cirugia y de mala posicion de la valvula, y ademas la tasa de exito del implante fue mayor (93 frente a 96%; p Conclusiones: En el analisis temporal del registro espanol de TAVI se observan un cambio en el perfil clinico de los pacientes y una mejora en la evolucion clinica tanto intrahospitalaria como a los 30 dias en los pacientes tratados en los ultimos anos. EnglishIntroduction and objectives: This study primary endpoint was to present the in-hospital all-cause mortality of the Spanish TAVI registry from its inception until 2018. Secondary endpoints included other in-hospital clinical events, 30-day all-cause mortality, and an assessment of the time trend of this registry. Methods: All consecutive patients included in the Spanish TAVI registry were analyzed. In this time-based analysis, the population was been divided into patients treated before 2014 (cohort A: 2009-2013) and patients treated between 2014 and 2018 (cohort B). Results: From August 2007 to June 2018, 7180 patients were included. The mean age was 81.2 ± 6.5 years and 53% were women. The logistic EuroSCORE was 12% (8-20). Transfemoral access was used in 89%. In-hospital and 30-day all-cause mortality was 4.7% and 5.7%, respectively. On the time-based analyses during the hospital stay, the rate of myocardial infarction, stroke, need for pacemakers, tamponade, coronary obstruction, and vascular complications was similar between both groups. However, cohort B showed less need for conversion to surgery and malapposition of the valve. Also, the implant success rate increased from 93% to 96% (P Conclusions: The time trend analysis of the Spanish TAVI registry showed a change in the patients’ clinical profile and an improvement in the in-hospital clinical outcomes and 30-day all-cause mortality in patients treated more recently.

espanolIntroduccion y objetivos: Una proporcion significativa de pacientes sometidos a implante percutaneo de valvula aortica (TAVI) presenta indicacion de anticoagulacion oral por fibrilacion auricular. En estos pacientes, con frecuencia el riesgo hemorragico es alto. El objetivo del estudio fue comparar los resultados clinicos en pacientes tratados con dosis baja de apixaban o con acenocumarol, un antagonista de la vitamina K (AVK). Metodos: Registro observacional multicentrico que incluyo pacientes sometidos a TAVI tratados con dosis baja de apixaban (2,5 mg/12 h) o AVK, en ambos casos sin tratamiento antiplaquetario asociado. Se llevo a cabo un emparejamiento por puntuacion de propension para seleccionar dos cohortes comparables. Se recabo la informacion de los 12 meses posteriores al procedimiento. Se consideraron objetivos coprimarios de eficacia (muerte, infarto de miocardio e ictus) y de seguridad (hemorragias BARC ≥ 2). Resultados: Se incluyeron 236 pacientes y se obtuvieron 2 grupos de 64 pacientes comparables en cuanto a caracteristicas basales. Solo 19 (30%) cumplieron estrictamente los criterios de ajuste a la baja de la dosis de apixaban. A los 12 meses, la incidencia de muerte, infarto de miocardio e ictus fue comparable (12,5% con AVK frente a 9,3% con apixaban; p = 0,5), pero la incidencia de hemorragia BARC ≥ 2 fue significativamente mayor en el grupo de AVK (7,8 frente a 0%; p = 0,02). La mayoria de los eventos tromboticos en el grupo de apixaban se observaron en pacientes con reduccion de dosis no ajustada a criterios. Conclusiones: En este registro de pacientes con TAVI y fibrilacion auricular, el uso de la dosis baja de apixaban en comparacion con el uso de AVK, sin antiagregantes concomitantes, se asocio a una menor incidencia de hemorragias mayores con una incidencia similar de eventos tromboembolicos. EnglishIntroduction and objectives: A significant amount of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for oral anticoagulation due to atrial fibrillation. In these patients the bleeding risk is often high. The purpose of this study was to compare the clinical outcomes of patients treated with low doses of apixaban or the vitamin K antagonist (VKA) acenocumarol in this setting. Methods: Multicenter observational registry including patients treated after TAVI with low doses of apixaban (2.5 mg/12 hours) or VKA both without associated antiplatelet therapy. Propensity score matching was conducted to select 2 comparable cohorts. Data were gathered for 12 months following the procedure. Coprimary endpoints of efficacy (death, myocardial infarction, and stroke) and safety (bleeding BARC ≥ 2) were considered. Results: A total of 236 patients were included. They were divided into 2 comparable groups of 64 patients each. Only 19 patients (30%) strictly met the dose adjustment criteria for apixaban. The rate of death, myocardial infarction, and stroke was similar at the 12-month follow-up (12.5% with VKA vs 9.3% with apixaban, P = .5), but the rate of bleeding BARC ≥ 2 was significantly higher in the VKA group (7.8% vs 0%; P = .02). Most of the events seen in the apixaban group occurred in patients with incorrect dose titration. Conclusions: In this registry of patients treated with TAVI and atrial fibrillation the use of low-dose apixaban compared to VKA—both without antiplatelet agents—was associated to a lower rate of actionable bleeding and a similar rate of thrombotic events.

Introduction and objectives: A significant amount of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for oral anticoagulation due to atrial fibrillation. In these patients the bleeding risk is often high. The purpose of this study was to compare the clinical outcomes of patients treated with low doses of apixaban or the vitamin K antagonist (VKA) acenocumarol in this setting. Methods: Multicenter observational registry including patients treated after TAVI with low doses of apixaban (2.5 mg/12 hours) or VKA both without associated antiplatelet therapy. Propensity score matching was conducted to select 2 comparable cohorts. Data were gathered for 12 months following the procedure. Coprimary endpoints of efficacy (death, myocardial infarction, and stroke) and safety (bleeding BARC ≥ 2) were considered. Results: A total of 236 patients were included. They were divided into 2 comparable groups of 64 patients each. Only 19 patients (30%) strictly met the dose adjustment criteria for apixaban. The rate of death, myocardial infarction, and stroke was similar at the 12-month follow-up (12.5% with VKA vs 9.3% with apixaban, P = .5), but the rate of bleeding BARC ≥ 2 was significantly higher in the VKA group (7.8% vs 0%; P = .02). Most of the events seen in the apixaban group occurred in patients with incorrect dose titration. Conclusions: In this registry of patients treated with TAVI and atrial fibrillation the use of low-dose apixaban compared to VKA—both without antiplatelet agents—was associated to a lower rate of actionable bleeding and a similar rate of thrombotic events.

Due to the high individual differences in the anatomy and pathophysiology of patients, planning individualized treatment requires patient-specific diagnosis. Indeed, hemodynamic quantification can be immensely valuable for accurate diagnosis, however, we still lack precise diagnostic methods for numerous cardiovascular diseases including complex (and mixed) valvular, vascular, and ventricular interactions (C3VI) which is a complicated situation made even more challenging in the face of other cardiovascular pathologies. Transcatheter aortic valve replacement (TAVR) is a new less invasive intervention and is a growing alternative for patients with aortic stenosis. In a recent paper, we developed a non-invasive and Doppler-based diagnostic and monitoring computational mechanics framework for C3VI, called C3VI-DE that uses input parameters measured reliably using Doppler echocardiography. In the present work, we have developed another computational-mechanics framework for C3VI (called C3VI-CT). C3VI-CT uses the same lumped-parameter model core as C3VI-DE but its input parameters are measured using computed tomography and a sphygmomanometer. Both frameworks can quantify: (1) global hemodynamics (metrics of cardiac function); (2) local hemodynamics (metrics of circulatory function). We compared accuracy of the results obtained using C3VI-DE and C3VI-CT against catheterization data (gold standard) using a C3VI dataset (N = 49) for patients with C3VI who undergo TAVR in both pre and post-TAVR with a high variability. Because of the dataset variability and the broad range of diseases that it covers, it enables determining which framework can yield the most accurate results. In contrast with C3VI-CT, C3VI-DE tracks both the cardiac and vascular status and is in great agreement with cardiac catheter data.

Background There is a paucity of outcome data on patients who are morbidly obese (MO) undergoing transcatheter aortic valve replacement. We aimed to determine their periprocedural and midterm outcomes and investigate the impact of obesity phenotype. Methods and Results Consecutive patients who are MO (body mass index, ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity‐related comorbidities; n=910) with severe aortic stenosis who underwent transcatheter aortic valve replacement in 18 tertiary hospitals were compared with a nonobese cohort (body mass index, 18.5–29.9 kg/m 2 , n=2264). Propensity‐score matching resulted in 770 pairs. Pre–transcatheter aortic valve replacement computed tomography scans were centrally analyzed to assess adipose tissue distribution; epicardial, abdominal visceral and subcutaneous fat. Major vascular complications were more common (6.6% versus 4.3%; P =0.043) and device success was less frequent (84.4% versus 88.1%; P =0.038) in the MO group. Freedom from all‐cause and cardiovascular mortality were similar at 2 years (79.4 versus 80.6%, P =0.731; and 88.7 versus 87.4%, P =0.699; MO and nonobese, respectively). Multivariable analysis identified baseline glomerular filtration rate and nontransfemoral access as independent predictors of 2‐year mortality in the MO group. An adverse MO phenotype with an abdominal visceral adipose tissue:subcutaneous adipose tissue ratio ≥1 (VAT:SAT) was associated with increased 2‐year all‐cause (hazard ratio [HR], 3.06; 95% CI, 1.20–7.77; P =0.019) and cardiovascular (hazard ratio, 4.11; 95% CI, 1.06–15.90; P =0.041) mortality, and readmissions (HR, 1.81; 95% CI, 1.07–3.07; P =0.027). After multivariable analysis, a (VAT:SAT) ratio ≥1 remained a strong predictor of 2‐year mortality (hazard ratio, 2.78; P =0.035). Conclusions Transcatheter aortic valve replacement in patients who are MO has similar short‐ and midterm outcomes to nonobese patients, despite higher major vascular complications and lower device success. An abdominal VAT:SAT ratio ≥1 identifies an obesity phenotype at higher risk of adverse clinical outcomes.

This is the case of a 77-year-old woman with hypertension, dyslipidemia, and stage V chronic kidney disease. While on hemodialysis she experiences precordial pain due to paroxysmal atrial fibrillation with rapid ventricular response. The electrocardiogram shows widespread ST-segment depression. The blood tests confirm the presence of slightly elevated ultrasensitive troponin I levels later showing an ascending and descending curve suggestive of acute coronary syndrome. A coronary angiography is indicated after these findings. The coronary angiography shows a single right coronary artery (figure 1) running through the atrioventricular sulcus and generating branches with perfusion to all myocardial territories of the left and right ventricles (figure 2 and video of the supplementary data). Figure 1. Figure 2. The prevalence of single right coronary artery is between 0.024% and 0.066%; the single right coronary artery is, actually, one of the rarest variants. In these patients, flow runs through a system with a large sequence of serial resistances. Based on these findings, we could argue that the perfusion of medioapical segments would be in a situation of «relative» ischemia compared to the rest. This would exacerbate in situations of greater myocardial demand as in tachyarrhythmias. Although cases of...

Background We aimed to compare the performance of the recent CASTLE score to J-CTO, CL and PROGRESS CTO scores in a comprehensive database of percutaneous coronary intervention of chronic total occlusion procedures. Methods Scores were calculated using raw data from 1,342 chronic total occlusion procedures included in REBECO Registry that includes learning and expert operators. Calibration, discrimination and reclassification were evaluated and compared. Results Mean score values were: CASTLE 1.60±1.10, J-CTO 2.15±1.24, PROGRESS 1.68±0.94 and CL 2.52±1.52 points. The overall percutaneous coronary intervention success rate was 77.8%. Calibration was good for CASTLE and CL, but not for J-CTO or PROGRESS scores. Discrimination: the area under the curve (AUC) of CASTLE (0.633) was significantly higher than PROGRESS (0.557) and similar to J-CTO (0.628) and CL (0.652). Reclassification: CASTLE, as assessed by integrated discrimination improvement, was superior to PROGRESS (integrated discrimination improvement +0.036, p Conclusion Procedural percutaneous coronary intervention difficulty is not consistently depicted by available chronic total occlusion scores and is influenced by the characteristics of each chronic total occlusion cohort. In our study population, including expert and learning operators, the CASTLE score had slightly better overall performance along with CL score. However, we found only intermediate performance in the c-statistic predicting chronic total occlusion success among all scores.

Background During COVID-19 pandemic, elective invasive cardiac procedures (ICP) have been frequently cancelled or postponed. Consequences may be more evident in patients with diabetes. Objectives The objective was to identify the peculiarities of patients with DM among those in whom ICP were cancelled or postponed due to the COVID-19 pandemic, as well as to identify subgroups in which the influence of DM has higher impact on the clinical outcome. Methods We included 2,158 patients in whom an elective ICP was cancelled or postponed during COVID-19 pandemic in 37 hospitals in Spain. Among them, 700 (32.4%) were diabetics. Patients with and without diabetes were compared. Results Patients with diabetes were older and had a higher prevalence of other cardiovascular risk factors, previous cardiovascular history and co-morbidities. Diabetics had a higher mortality (3.0% vs. 1.0%; p = 0.001) and cardiovascular mortality (1.9% vs. 0.4%; p = 0.001). Differences were especially important in patients with valvular heart disease (mortality 6.9% vs 1.7% [p Conclusion Among patients in whom an elective invasive cardiac procedure is cancelled or postponed during COVID-19 pandemic, mortality and cardiovascular mortality is higher in patients with diabetes, irrespectively on other clinical conditions. These procedures should not be cancelled in patients with diabetes.

BACKGROUND The arrhythmic burden after discharge in patients with new-onset left bundle branch block (LBBB) undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN 3 (S3) valve remains largely unknown. OBJECTIVE The purpose of this study was to determine the incidence of late arrhythmias in patients with new-onset LBBB undergoing TAVR with the balloon-expandable S3 valve. METHODS This was a multicenter, prospective study that included 104 consecutive TAVR patients with new-onset persistent LBBB following TAVR with the S3 valve. An implantable cardiac monitor (Reveal XT, Reveal LINQ) was implanted before discharge. The primary endpoint was the incidence of high-degree atrioventricular block or complete heart block (HAVB/CHB). RESULTS A total of 40 patients (38.5%) had at least 1 significant arrhythmic event, leading to a treatment change in 17 (42.5%). Significant bradyarrhythmias occurred in 20 of 104 patients (19.2%) (34 HAVB/CHB episodes, 252 severe bradycardia episodes), with 10 of 20 patients (50%) exhibiting at least 1 episode of HAVB/ CHB. Most HAVB/CHB episodes ( 60%) occurred within 4 weeks after discharge. Nine patients ( 8.7%) underwent permanent pacemaker implantation at 12 months based on the Reveal findings (6 HAVB/CHB, 3 severe bradycardia). CONCLUSION S3 valve recipients with new-onset LBBB have a high arrhythmic burden, with more than one-third of patients exhibiting at least 1 significant arrhythmic episode within 12 months (HAVB/ CHB in 10% of patients). About one-half of bradyarrhythmic events occurred within 4 weeks after discharge. These results should inform future strategies on the use of continuous electrocardiographic monitoring in TAVR S3 patients with new conduction disturbances following the procedure.

OBJECTIVES The aim of this study was to compare, in a cohort of patients with complex coronary artery disease (CAD) and severe aortic stenosis (AS), the clinical outcomes associated with transfemoral transcatheter aortic valve replacement (TAVR) (plus percutaneous coronary intervention [PCI]) versus surgical aortic valve replacement (SAVR) (plus coronary artery bypass grafting [CABG]). BACKGROUND Patients with complex CAD were excluded from the main randomized trials comparing TAVR with SAVR, and no data exist comparing TAVR + PCI vs SAVR + CABG in such patients. METHODS A multicenter study was conducted including consecutive patients with severe AS and complex CAD (SYN-TAX [Synergy Between PCI with Taxus and Cardiac Surgery] score >22 or unprotected left main disease). A 1:1 propensity-matched analysis was performed to account for unbalanced covariates. The rates of major adverse cardiac and cere-brovascular events (MACCE), including all-cause mortality, nonprocedural myocardial infarction, need for new coronary revascularization, and stroke, were evaluated. RESULTS A total of 800 patients (598 undergoing SAVR + CABG and 202 undergoing transfemoral TAVR + PCI) were included, and after propensity matching, a total of 156 pairs of patients were generated. After a median follow-up period of 3 years (interquartile range: 1-6 years), there were no significant differences between groups for MACCE (HR for transfemoral TAVR vs SAVR: 1.33; 95% CI: 0.89-1.98), all-cause mortality (HR: 1.25; 95% CI: 0.81-1.94), myocardial infarction (HR: 1.16; 95% CI: 0.41-3.27), and stroke (HR: 0.42; 95% CI: 0.13-1.32), but there was a higher rate of new coronary revascularization in the TAVR + PCI group (HR: 5.38; 95% CI: 1.73-16.7). CONCLUSIONS In patients with severe AS and complex CAD, TAVR + PCI and SAVR + CABG were associated with similar rates of MACCE after a median follow-up period of 3 years, but TAVR + PCI recipients exhibited a higher risk for repeat coronary revascularization. Future trials are warranted. (J Am Coll Cardiol Intv 2021;14:2490-2499) (c) 2021 by the American College of Cardiology Foundation.

Aims There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). Methods and results The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle. Conclusion The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.

Objectives To asses mid‐term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large‐scale all‐comers population. Background Several clinical settings are underrepresented in randomized studies investigating BVS against drug‐eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. Methods The European ABSORB Consortium comprises the following European registries: GABI‐R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient‐level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target‐vessel myocardial infarction (TVMI) and target‐lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. Results A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12‐month follow‐up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. Conclusions The EAC demonstrates reasonable real‐world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

Aims We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Methods and results Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or implantable cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year. Conclusion Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307)

BACKGROUND The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown. OBJECTIVES The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug eluting stent implantation. METHODS The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI. RESULTS A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3 month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference-0.2%; 95% CI:-2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference-2.5%; 95% CI:-4.6% to-0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference-1.1%; 95% CI:-2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015). CONCLUSIONS Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742) (J Am Coll Cardiol 2021;78:2060-2072) (c) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Introduction and objectives: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. Methods: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. Results: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n = 113 TXA group and n = 3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P = .95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P= .001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P = .003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P = .03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P= .039 and OR, 2.3; 95%CI, 1.2-4.5; P = .01, respectively). Conclusions: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA. (C) 2021 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.