Paravalvular leak closure after TAVI with plugs: A literature review with a specific focus on arterio-arterial loop.

More than mild paravalvular leak (PVL) following transcatheter aortic valve implantation (TAVI) is associated with a twofold increase in all-cause mortality, heart failure hospitalizations, and the need for reintervention. Successfully addressing PVL in TAVIs is more challenging than in surgical valves. The arterial-arterial (A-A) rail technique emerges as a valuable strategy for post-TAVI PVL closure, enhancing success rates by enabling the effective use of lower-profile vascular plug devices. When standard approach is ineffective, generating an A-A loop for post-TAVI PVL closure is probably the most recommended strategy to ensure procedural success.

The association of hematological markers with occurrence of thrombotic and bleeding events following left atrial appendage occlusion.

Introduction Patients undergoing left atrial appendage occlusion (LAAO) are at increased risk for bleeding or thromboembolic events. Concurrently, biomarkers are of growing importance in risk stratification for atrial fibrillation patients. We aimed to evaluate the association of hematological markers and clinical characteristics with the occurrence of thromboembolic and bleeding events following LAAO. Methods Seven implanting centers retrospectively gathered data on hematological markers (i.e. platelet count (PC), mean platelet volume (MPV), and fibrinogen) prior LAAO. Prespecified thromboembolic and major bleeding outcomes were collected and the association with pre-procedural hematological markers and clinical characteristics was evaluated using Cox regression analysis. Results In total, 1315 patients were included (74±9 years, 36% female, CHA2DS2-VASc 4.3±1.5, HAS-BLED 3.3±1.1). Over a total follow-up duration of 2682 patient years, 77 thromboembolic events and 107 major bleeding events occurred after LAAO. Baseline PC was the only biomarker showing a signal for a relation to thromboembolic events (HR 1.18, 95% CI: 1.00-1.39) per 50*109 increment, p=0.056). Thrombotic event rates, including device-related thrombus, increased within higher PC quartiles. Thromboembolism was associated with age (HR 1.05, 95% CI: 1.00-1.10, per year increase) and prior thromboembolism (HR 2.08, 95% CI: 1.07-4.03), but with none of the biomarkers in multivariate analysis. No association of any of the hematological markers with major bleeding was observed. Major bleeding following LAAO was associated with prior major bleeding (HR 5.27, 95% CI: 2.71-10.22), renal disease (HR 1.93, 95% CI: 1.17-3.18) and discharge on dual antiplatelet therapy (HR 1.71, 95% CI: 1.05-2.77). Conclusion Most thrombotic events occurred in the highest PC quartile, but no association of any of the hematological markers with thromboembolism or major bleeding was observed in our analysis. In multivariate analysis, older age and prior thromboembolism were associated with thromboembolism. Prior major bleeding, renal disease and discharge on DAPT were multivariate predictors of major bleeding after LAAO.

Usefulness of a novel sizing chart for left atrial appendage occlusion with the Amplatzer Amulet.

PURPOSE: The present article aims to compare a novel sizing chart based on both maximum and minimum diameters (novel MATRIX) with the current sizing recommendation instructions for use (IFU) based on the maximum diameter. BACKGROUND: Current IFU with the Amulet device are still based on the maximum left atrial appendage (LAA) diameter, which might lead to inappropriate oversizing, especially in elliptic appendages. METHODS: This was a retrospective analysis of patients undergoing LAA occlusion in two high-volume centers. Two hundred patients were included (100 patients with baseline cardiac computed tomography angiography [CCTA] and 100 with baseline 2D and 3D-transesophageal echocardiography [TEE]). The degree of concordance between the predicted device size recommendation and the actual device selection was the primary outcome. RESULTS: The novel MATRIX showed a higher level of concordance between the predicted and implanted device size, regardless of imaging modalities. CCTA showed the strongest, and 2D-TEE the weakest concordance between the predicted and implanted device for both MATRIX and IFU charts. The percentage of patients in whom the disagreement among the predicted and implanted device represented >1 size was higher when using the IFU chart. In elliptical LAA anatomies, the differences favoring the use of MATRIX compared to the IFU in terms of predicted/implanted agreement were higher. Finally, no significant differences in clinical or imaging endpoints were observed between the two different sizing charts. CONCLUSIONS: Incorporating both the LAA maximum and minimum diameters, as opposed to just maximum diameter, appears to improve sizing accuracy. The proposed MATRIX sizing chart offered a higher level of concordance between predicted and implanted device compared to the current IFU.

Survival benefit of revascularization versus optimal medical therapy alone for chronic total occlusion management in patients with diabetes.

BACKGROUND: Chronic total occlusion (CTO) is common in patients with diabetes mellitus. Data on the long-term outcomes after treatment of CTOs in this high-risk population are scarce. AIM: To compare the long-term clinical outcomes of CTO revascularization either by coronary artery bypass graft (CABG) or successful percutaneous coronary intervention (PCI) versus optimal medical treatment (MT) alone in patients with diabetes. METHODS AND RESULTS: A total of 538 consecutive patients with diabetes and at least one CTO were identified from 2010 to 2014 in our center. In the present analysis, patients were stratified according to the CTO treatment strategy that was selected. MT was selected in 61% of patients whereas revascularization in the remaining 39%. Patients undergoing revascularization were younger, had higher left ventricular ejection fraction (LVEF), lower ACEF score, and more positive myocardial ischemia detection results compared to the MT group (p < .001).Patients referred for CABG had higher rates of left main disease compared to the PCI and MT groups (32% vs. 3% and 11%, respectively; p < .001). Complete revascularization was more often achieved in the CABG group, compared to the PCI group (62% vs. 32% p < .001). Multivariable analysis showed that revascularization with CABG was associated with lower rates of all-cause and cardiac mortality rates compared to MT, [hazard ratio (HR) 0.41, 95% confidence interval (CI) 0.25-0.70, p < .001 and HR 0.40, 95% CI 0.20-81, p = .011, respectively]. Successful CTO-PCI showed a trend towards benefit in all-cause mortality (HR 0.58, 95% CI 0.33-1.04, p = .06). CONCLUSION: In our registry, CTO revascularization in diabetic patients, especially with CABG, was associated with lower long-term mortality rates as compared to MT alone.

Percutaneous left atrial appendage closure, a safe alternative to anticoagulation for patients with nonvalvular atrial fibrillation and end-stage renal disease on hemodialysis: A single center experience.

The evidence about the effectiveness and safety of oral anticoagulation in patients on hemodialysis is conflicting and scarce. Percutaneous left atrial appendage occlusion (LAAO) has demonstrated to be a valid alternative therapeutic option for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). The aim of this study is to present the outcomes of percutaneous LAAO in patients with end-stage renal disease (ESRD) on hemodialysis and NVAF in our center. We conducted a retrospective review of clinical records, demographics, LAAO procedure, complications, and outcomes of patients with NVAF and ESRD on hemodialysis who underwent a percutaneous LAAO in our center between January 2017 and January 2019. In the period of the study, eight patients with ESRD on hemodialysis underwent a percutaneous LAAO in our center. The overall mean age was 67.5 years (range 56-81; SD ± 7.2). All patients had permanent NVAF. The total mean dialysis duration was 8.49 years (range 0.83-14.8; SD ± 6.2). The mean CHA2DS2-VASc and HAS-BLED scores were high (4.75 [SD ± 1.16] and 4.62 [SD ± 0.91], respectively). All patients had history of a major hemorrhagic event (BARC Score ≥3). Most patients (n = 6) showed left ventricular hypertrophy, and the average LVEF was 54% (SD ± 6.5). All devices were implanted successfully. Postprocedural antithrombotic regimen prescribed was based on antiplatelet therapy. No deaths, cardioembolic events, or major bleeding (according to the BARC scale) were reported during a mean follow-up of 14.24 months (SD ± 9.44). Percutaneous LAAO could be of particular interest in patients with NVAF and CKD in hemodialysis. Further studies will be necessary to confirm this hypothesis.

Impact of revascularization versus medical therapy alone for chronic total occlusion management in older patients.

BACKGROUND: Chronic total occlusions (CTOs) are present in more than one third of older patients with myocardial ischemia, but controversy remains about the best therapeutic approach. AIMS: To compare long-term survival after CTO revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) versus medical treatment (MT) alone in patients aged 75 and older. METHODS AND RESULTS: A total of 1,252 consecutive patients with at least one CTO were identified from 2010 to 2014 in our center. Patients were stratified by age (<75 years vs. ≥75 years) in the present analysis. All-cause and cardiac mortality were assessed at a median follow-up of 3.5 years. In the older subgroup (26%), patients were more likely to be treated with MT alone (71% vs. 43% of younger patients; p < 0.001). Patients undergoing revascularization were younger and had higher left ventricular ejection fraction (LVEF) and lower age, creatinine, ejection fraction (ACEF) score (age/LVEF +1 if creatinine >2.0 mg/dL), compared to the MT group (p < 0.05). As compared to MT, revascularization predicted lower rates of cardiac mortality and all-cause mortality in older patients, both in the subgroups treated with CABG (hazard ratio [HR] 0.35, 95% confidence interval [CI] 0.17-0.71; HR 0.39, 95%CI 0.18-0.81) and PCI (HR 0.57, 95%CI 0.33-0.98; HR 0.59, 95%CI 0.28-1.2). No differences in mortality were observed according to type of revascularization procedure. CONCLUSIONS: Among patients aged at least 75 years with a CTO, revascularization (PCI or CABG) rather than MT alone may portend a better outcome in terms of all-cause and cardiac mortality.

Predictors of renal replacement therapy after heart transplantation and its impact on long-term survival.

BACKGROUND: Renal replacement therapy (RRT) after heart transplant (HT) is associated with worse prognosis. We aimed to identify predictors of RRT and the impact of this complication on long-term survival. METHODS: Cohort study of HT patients. Univariate and multivariate competing-risk regression was performed to identify independent predictors of RRT. The cumulative incidence function was plotted for RRT. The Kaplan-Meier method was used to compare long-term survival. RESULTS: We included 103 patients. At multivariate analysis, only the emergency status of HT (short-term mechanical circulatory support as a bridge to transplant), chronic kidney disease, and low oxygen delivery were independent predictors of RRT (subhazard ratio [SHR] 4.11, 95% CI 1.84-9.14; SHR 3.17, 95% CI 1.29-7.77; SHR 2.86, 95% CI 1.14-7.19, respectively). Elective HT patients that required RRT showed a significantly reduced survival comparable to patients with emergency HT and RRT (75% ± 13% vs. 67% ± 16%). The absence of RRT implied an excellent survival in patients with an emergency status of HT and elective HT (100% vs. 93% ± 4%). CONCLUSION: The emergency status of HT, chronic kidney disease, and low oxygen delivery were independent predictors of RRT. The occurrence of RRT increases the risk of death in elective HT as much as in patients with an emergency status.

The Impact of Geriatric Conditions in Elderly Patients with Coronary Heart Disease: A State-of-the-Art Review.

The growing geriatric population presenting with coronary artery disease poses a primary challenge for healthcare services. This is a highly heterogeneous population, often underrepresented in studies and clinical trials, with distinctive characteristics that render them particularly vulnerable to standard management/approaches. In this review, we aim to summarize the available evidence on the treatment of acute coronary syndrome in the elderly. Additionally, we contextualize frailty, comorbidity, sarcopenia, and cognitive impairment, common in these patients, within the realm of coronary artery disease, proposing strategies for each case that may assist in therapeutic approaches.

Inflammation as a New Therapeutic Target among Older Patients with Ischemic Heart Disease.

Cardiovascular (CV) diseases remain a global health challenge, with ischemic heart disease (IHD) being the primary cause of both morbidity and mortality. Despite optimal pharmacological therapy, older patients with IHD exhibit an increased susceptibility to recurrent ischemic events, significantly impacting their prognosis. Inflammation is intricately linked with the aging process and plays a pivotal role in the evolution of atherosclerosis. Emerging anti-inflammatory therapies have shown promise in reducing ischemic events among high-risk populations. This review aims to explore the potential of targeted anti-inflammatory interventions in improving clinical outcomes and the quality of life for older patients with IHD.

5-Year Outcomes of Trans Carotid Transcatheter Aortic Valve Replacement.

BACKGROUND: Trans-carotid Transcatheter Aortic Valve Replacement (TC-TAVR) has emerged as an alternative TAVR access. However, scarce data on long-term outcomes following TC-TAVR exist. This study aimed to evaluate 5-year clinical outcomes post-TC-TAVR. METHODS: One hundred ten consecutive patients who underwent TC-TAVR and completed the 5-year after the procedure were included. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database. The primary endpoint was the incidence of a composite of all-cause mortality, stroke, and repeat hospitalization. Echocardiography results, New York Heart Association (NYHA) class, and quality of life (QOL) assessed with the EuroQol visual analogue scale (EQ-VAS) were examined over the 5-year follow-up. RESULTS: The median age was 77 (72-82.2) years, 42.3% were women, and the median STS risk score was 5.02% (3.4-7.5%). The incidence of the composite endpoint was 54.5%. Death from any cause occurred in 45.6% of cases (11.9 per 100 patients-years), stroke in 8.2% (1.9 per 100 patient-years), disabling stroke in 2.7% (0.7 per 100 patient-years), and rehospitalization in 27.2%. The improvements in valve hemodynamics, NYHA class, and EQ-VAS following the procedure persisted at the 5-year follow-up (p<.001). Bioprosthetic valve failure occurred in 0.9%. CONCLUSIONS: About half of the moderate-to-high-risk patients undergoing TC-TAVR survived with no major cardiovascular events at 5-year follow-up. The yearly incidence of strokes was low, and early improvements in valve hemodynamics, functional status and QOL persisted at 5 years. These results suggest the long-term safety and efficacy of TC-TAVR, and would support this approach as an alternative to surgery in non-transfemoral candidates.

Early Nonprocedural Bleeding After Left Atrial Appendage Occlusion.

BACKGROUND: Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. OBJECTIVES: This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. METHODS: This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. RESULTS: A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. CONCLUSIONS: Early nonprocedural bleeding after LAAO occurred in ∼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO.

Long-term survival after cardiac arrest in patients undergoing emergent coronary angiography.

AIM: To determine long-term survival of patients after cardiac arrest undergoing emergent coronary angiography and therapeutic hypothermia. METHODS: We analysed data from patients treated within the regional STEMI Network from January 2015 to December 2020. The primary endpoint was all-cause mortality at median follow-up. Secondary endpoints were periprocedural complications (arrhythmias, pulmonary edema, cardiogenic shock, mechanical complication, stent thrombosis, reinfarction, bleeding) and 6-month all-cause death. A landmark analysis was performed, studying two time periods; 0-6 months and beyond 6 months. RESULTS: From a total of 24,125 patients in the regional STEMI network, 494 patients who suffered from cardiac arrest were included and divided into two groups: treated with (n = 119) and without therapeutic hypothermia (n = 375). At median follow-up (16.0 [0.2-33.3] months), there was no difference in the adjusted mortality rate between groups (51.3 % with hypothermia vs 48.0 % without hypothermia; HRadj1.08 95%CI [0.77-1.53]; p = 0.659). There was a higher frequency of bleeding in the hypothermia group (6.7 % vs 1.1 %; ORadj 7.99 95%CI [2.05-31.2]; p = 0.002), without difference for the rest of periprocedural complications. At 6-month follow-up, adjusted all-cause mortality rate was similar between groups (46.2 % with hypothermia vs 44.5 % without hypothermia; HRadj1.02 95%CI [0.71-1.47]; p = 0.900). Also, no differences were observed in the adjusted mortality rate between 6 months and median follow-up (9.4 % with hypothermia vs 6.3 % without hypothermia; HRadj2.02 95%CI [0.69-5.92]; p = 0.200). CONCLUSIONS: In a large cohort of patients with cardiac arrest within a regional STEMI network, those treated with therapeutic hypothermia did not improve long-term survival compared to those without hypothermia.

Impact of coronary calcium morphology on intravascular lithotripsy.

BACKGROUND: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique. AIMS: We aimed to assess the impact of different calcium morphologies on IVL efficacy. METHODS: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions. RESULTS: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm2 vs 6.2±2.1 mm2; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm2; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%. CONCLUSIONS: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Timing of coronary angiography and use of antiplatelet pretreatment in patients with NSTEACS in Spain.

INTRODUCTION AND OBJECTIVES: The optimal timing of coronary angiography in patients admitted with non-ST-segment elevation acute coronary syndrome (NSTEACS) as well as the need for pretreatment are controversial. The main objective of the IMPACT-TIMING-GO registry was to assess the proportion of patients undergoing an early invasive strategy (0-24hours) without dual antiplatelet therapy (no pretreatment strategy) in Spain. METHODS: This observational, prospective, and multicenter study included consecutive patients with NSTEACS who underwent coronary angiography that identified a culprit lesion. RESULTS: Between April and May 2022, we included 1021 patients diagnosed with NSTEACS, with a mean age of 67±12 years (23.6% women). A total of 87% of the patients were deemed at high risk (elevated troponin; electrocardiogram changes; GRACE score>140) but only 37.8% underwent an early invasive strategy, and 30.3% did not receive pretreatment. Overall, 13.6% of the patients underwent an early invasive strategy without pretreatment, while the most frequent strategy was a deferred angiography under antiplatelet pretreatment (46%). During admission, 9 patients (0.9%) died, while major bleeding occurred in 34 (3.3%). CONCLUSIONS: In Spain, only 13.6% of patients with NSTEACS undergoing coronary angiography received an early invasive strategy without pretreatment. The incidence of cardiovascular and severe bleeding events during admission was low.

Influence of sex on the timing of coronary angiography and the prescription of antiplatelet therapy in patients with nonST-segment elevation myocardial infarction. / Impacto del sexo en los tiempos de cateterismo y en el uso de pretratamiento antiagregante plaquetario en pacientes con síndrome coronario agudo sin elevación del segmento ST (SCASEST).

OBJECTIVES: To assess differences in the clinical management of nonST-segment elevation myocardial infarction (NSTEMI), including in-hospital events, according to biological sex. MATERIAL AND METHODS: Prospective observational multicenter study of patients diagnosed with NSTEMI and atherosclerosis who underwent coronary angiography. RESULTS: We enrolled 1020 patients in April and May 2022; 240 (23.5%) were women. Women were older than men on average (72.6 vs 66.5 years, P .001), and more women were frail (17.1% vs 5.6%, P .001). No difference was observed in pretreatment with any P2Y12 inhibitor (prescribed in 68.8% of women vs 70.2% of men, P = .67); however, more women than men were prescribed clopidogrel (56% vs 44%, P = .009). Women prescribed clopidogrel were more often under the age of 75 years and not frail. Coronary angiography was performed within 24 hours less corooften in women (29.8% vs 36.9%, P = .03) even when high risk was recognized. Frailty was independently associated with deferring coronary angiography in the adjusted analysis; biological sex by itself was not related. The frequency and type of revascularization were the same in both sexes, and there were no differences in in-hospital cardiovascular events. CONCLUSION: Women were more often prescribed less potent antithrombotic therapy than men. Frailty, but not sex, correlated independently with deferral of coronary angiography. However, we detected no differences in the frequency of coronary revascularization or in-hospital events according to sex.

OBJETIVO: Evaluar las diferencias en el manejo clínico y eventos intrahospitalarios en una cohorte de pacientes con síndrome coronario agudo sin elevación del segmento ST (SCASEST) en función del sexo. METODO: Estudio observacional, prospectivo y multicéntrico que incluyó pacientes consecutivos con diagnóstico de SCASEST sometidos a coronariografía con enfermedad ateroesclerótica responsable. RESULTADOS: Entre abril y mayo de 2022 se incluyeron 1.020 pacientes; de ellos, 240 eran mujeres (23,5%). En comparación con los hombres, las mujeres fueron mayores (72,6 años vs 66,5 años; p 0,001) y más frágiles (17,1% vs 5,6%; p 0,001). No hubo diferencias en el pretratamiento con un inhibidor del receptor P2Y12 (68,8% vs 70,2%, p = 0,67), aunque las mujeres recibieron más pretratamiento con clopidogrel (56% vs 44%, p = 0,009), principalmente aquellas de edad 75 años y sin fragilidad. En las mujeres se realizaron menos coronariografías precoces (# 24 h) (29,8% vs 36,9%; p = 0,03) a pesar de presentar la misma indicación (criterios de alto riesgo). En el análisis ajustado, la fragilidad, pero no el sexo, se asoció de forma independiente con la realización de una coronariografía diferida. La tasa y el tipo de revascularización fue igual en ambos sexos, y no hubo diferencias en los eventos cardiovasculares intrahospitalarios. CONCLUSIONES: Las mujeres recibieron con mayor frecuencia un tratamiento antitrombótico menos potente. La fragilidad y no el sexo se asoció con la realización de coronariografía diferida. Sin embargo, no hubo diferencias en la tasa de revascularización coronaria ni en los eventos intrahospitalarios en función del sexo.

Functional rehabilitation based on therapeutic exercise training in patients with postacute COVID syndrome (RECOVER).

INTRODUCTION AND OBJECTIVES: Postacute COVID syndrome (PACS) is common after acute SARS-CoV-2 infection. One of the most frequent and disabling symptoms is exercise intolerance (EI). Recent evidence suggests that EI in PACS has a peripheral (metabolic-neuromuscular) origin, suggesting that exercise training may be an effective treatment. The aim of this study was to assess the role a therapeutic physical exercise program (TPEP) in PACS with EI. METHODS: This single-center, open-label, randomized clinical trial compared an exercise training program (intervention group) with regular physical activity recommendations (control group) in patients with PACS and EI. The intervention group underwent an 8-week TPEP. The primary endpoint was improvement in functional capacity, assessed as the change in peak VO2. RESULTS: We included 50 participants with PACS (73% women, mean age 47±7.1 years). The intervention group showed a 15% improvement in peak VO2 (peak VO2 pre- and postintervention: 25.5±7.7mL/kg/min and 29.3±4.7 mL/kg/min; P <.001) and a 13.2% improvement in predicted values (92.1±14.3% and 108.4±13.4%; P <.001). No significant changes in VO2 values were observed in the control group. Unlike the control group, the intervention group also showed improvements in all secondary outcomes: quality of life scales, muscle power, maximum inspiratory power, metabolic flexibility, and body fat percentage. CONCLUSIONS: The program improved functional capacity in patients with PACS and EI.

Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication.

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

A systematic review of contrast-enhanced computed tomography calcium scoring methodologies and impact of aortic valve calcium burden on TAVI clinical outcomes.

Different methodologies have been used to assess the role of AV calcification (AVC) on TAVI outcomes. This systematic review aims to describe the burden of AVC, synthesize the different methods of calcium score quantification, and evaluate the impact of AVC on outcomes after TAVI. We included studies of TAVI patients who had reported AV calcium scoring by contrast-enhanced multidetector CT and the Agatston method. The impact of calcification on TAVI outcomes without restrictions on follow-up time or outcome type was evaluated. Results were reported descriptively, and a meta-analysis was conducted when feasible. Sixty-eight articles were included, with sample sizes ranging from 23 to 1425 patients. Contrast-enhanced calcium scoring was reported in 30 studies, calcium volume score in 28 studies, and unique scoring methods in two. All studies with calcium volume scores had variable protocols, but most utilized a modified Agatston method with variable attenuation threshold values of 300-850 HU. Eight studies used the Agatston method, with the overall mean AV calcium score in studies published from 2010 to 2012 of 3342.9 AU [95%CI: 3150.4; 3535.4, I2 â€‹= â€‹0%]. The overall mean score was lower and heterogenous in studies published from 2014 to 2020 (2658.9 AU [95% CI: 2517.3; 2800.5, I2 â€‹= â€‹79%]. Most studies reported a positive association between calcium burden and increased risk of adverse outcomes, including implantation of permanent pacemaker (7/8 studies), paravalvular leak (13/13 studies), and risk of aortic rupture (2/2 studies). AVC quantification methodology with contrast-enhanced CT is still variable. AVC negatively impacts TAVI outcomes independently of the quantification method.