Markers of Tissue Perfusion as Predictors of Adverse Outcomes in Patients with Left Ventricular Dysfunction Undergoing Coronary Artery Bypass Surgery. / Marcadores de Perfusão Tecidual como Preditores de Desfechos Adversos em Pacientes com Disfunção Ventricular Esquerda Submetidos à Revascularização Miocárdica (Bypass Coronário).

BACKGROUND: Cardiac surgery patients may be exposed to tissue hypoperfusion and anaerobic metabolism. OBJECTIVE: To verify whether the biomarkers of tissue hypoperfusion have predictive value for prolonged intensive care unit (ICU) stay in patients with left ventricular dysfunction who underwent coronary artery bypass surgery. METHODS: After approval by the institution's Ethics Committee and the signing of informed consent, 87 patients with left ventricular dysfunction (ejection fraction < 50%) undergoing coronary artery bypass surgery were enrolled. Hemodynamic and metabolic biomarkers were collected at five time points: after anesthesia, at the end of the surgery, at ICU admission, and at six and twelve hours after. An analysis of variance for repeated measures followed by a Bonferroni post hoc test was used for repeated, continuous variables (hemodynamic and metabolic variables) to determine differences between the two groups over the course of the study period. The level of statistical significance adopted was 5%. RESULTS: Thirty-eight patients (43.7%) who presented adverse outcomes were older, higher Euro score (p<0.001), and elevated ΔpCO2 as analyzed 12 hours after ICU admission (p<0.01), while increased arterial lactate concentration at 6 hours postoperatively was found to be a negative predictive factor (p<0.01). CONCLUSIONS: Euro SCORE, six-hour postoperative arterial lactate, 12-hour postoperative ΔPCO2, and eRQ are independent predictors of adverse outcomes in patients with left ventricular dysfunction after cardiac surgery.

FUNDAMENTO: Pacientes submetidos à cirurgia cardíaca podem estar expostos à hipoperfusão tecidual e metabolismo anaeróbico. OBJETIVO: Verificar se os biomarcadores de hipoperfusão tecidual têm valor preditivo para permanência prolongada na Unidade de Terapia Intensiva (UTI) em pacientes com disfunção ventricular esquerda submetidos à cirurgia de bypass da artéria coronária. MÉTODOS: Após aprovação pelo comitê de ética institucional e assinatura do termo de consentimento, 87 pacientes com disfunção ventricular esquerda (fração de ejeção <50%) submetidos à cirurgia de bypass coronário foram incluídos. Biomarcadores hemodinâmicos e metabólicos foram coletados em cinco momentos: após anestesia, ao final da cirurgia, na admissão na UTI, e a seis e 12 horas depois. Uma análise de variância para medidas repetidas seguida de um teste post-hoc de Bonferroni foi usado para variáveis contínuas repetidas (variáveis metabólicas e hemodinâmicas) para determinar diferenças entre os dois grupos ao longo do estudo. O nível de significância adotado foi de 5%. RESULTADOS: Trinta e oito pacientes (43,7%) que apresentaram desfechos adversos eram mais velhos, apresentaram um Euroscore mais alto (p<0,001), e gradiente venoarterial de CO2 (ΔPCO2) elevado, analisados 12 horas após a admissão na UTI (p<0,01), enquanto uma concentração de lactato arterial aumentada seis horas após a cirurgia foi um fator preditivo negativo (p<0,01). CONCLUSÕES: EuroSCORE, lactato arterial seis horas após a cirurgia, ΔPCO212 horas após a cirurgia e QRe são preditores independentes de desfechos adversos em pacientes com disfunção ventricular esquerda após cirurgia cardíaca.

Incidence, progression, and predictors of left atrial appendage sealing after Watchman FLX device implantation with computed tomographic assessment.

BACKGROUND: Limited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure. METHODS: This study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre- and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1-year follow-up CT. RESULTS: A total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre- and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency. CONCLUSION: Postprocedural CT at 45 days detected patent LAA in one-third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.

In-Stent Restenosis Overview: From Intravascular Imaging to Optimal Percutaneous Coronary Intervention Management.

Despite ongoing progress in stent technology and deployment techniques, in-stent restenosis (ISR) still remains a major issue following percutaneous coronary intervention (PCI) and accounts for 10.6% of all interventions in the United States. With the continuous rise in ISR risk factors such as obesity and diabetes, along with an increase in the treatment of complex lesions with high-risk percutaneous coronary intervention (CHIP), a substantial growth in ISR burden is expected. This review aims to provide insight into the mechanisms, classification, and management of ISR, with a focus on exploring innovative approaches to tackle this complication comprehensively, along with a special section addressing the approach to complex calcified lesions.

Trends in tracheal, bronchial and lung cancer attributed to smoking in South America: Global Burden of Disease analysis 1990-2019

[ABSTRACT]. Objective. To investigate the burden of tracheal, bronchus, and lung (TBL) cancer due to tobacco exposure in the last 30 years in 12 South American countries. Methods. We used the Global Burden of Disease (GBD) 2019 exposure-response function to analyze the total tobacco, smoking, and secondhand smoke exposure-related TBL cancer deaths and disability-adjusted life years (DALYs), for 12 South American countries, between 1990 and 2019. Metrics were described as abso- lute numbers or rates per 100 000 individuals. The relative change in burden was assessed by comparing the 1990-1994 to 2015-2019 periods. Results. In 2019, the all-ages number of TBL cancer deaths and DALYs associated with tobacco expo- sure in South America was 29 348 and 658 204 in males and 14 106 and 318 277 in females, respectively. Age-adjusted death and DALYs rates for the region in 2019 were 182.8 and 4035 in males and 50.8 and 1162 in females, respectively. In males, 10/12 countries observed relative declines in TBL death rates attributed to tobacco exposure while only 4 countries reduced their mortality in females. Conclusion. While significant efforts on tobacco control are under place in South America, substantial bur- den of TBL cancer persists in the region with significant sex-specific disparities. Increased country-specific primary data on TBL cancer and tobacco exposure is needed to optimize healthcare strategies and improve comprehension of regional trends.

[RESUMEN]. Objetivo. Investigar la carga del cáncer de tráquea, bronquios y pulmón por exposición al tabaco en los últi- mos 30 años en 12 países de Sudamérica. Métodos. Se utilizó la función de relación entre exposición y respuesta de la carga mundial de morbilidad del 2019 para analizar las muertes por cáncer de tráquea, bronquios y pulmón asociadas a la exposición total al tabaco, al tabaquismo activo y al tabaquismo pasivo, así como los años de vida ajustados en función de la discapacidad (AVAD), en 12 países de Sudamérica, entre 1990 y el 2019. Los resultados se presentaron en forma de número absoluto o de tasa por 100 000 personas. Se evaluó el cambio relativo de la carga mediante la comparación de los períodos 1990-1994 y 2015-2019. Resultados. En el 2019, el número de muertes por cáncer de tráquea, bronquios y pulmón y los AVAD aso- ciados a la exposición al tabaco para todas las edades en Sudamérica fueron de 29 348 y 658 204 en los hombres y de 14 106 y 318 277 en las mujeres, respectivamente. La tasa de mortalidad y los AVAD ajustados por la edad correspondientes al 2019 en la región fueron de 182,8 y 4035 en los hombres y de 50,8 y 1162 en las mujeres, respectivamente. En el caso de los hombres, en 10 de los 12 países se observaron disminuciones relativas de la tasa de mortalidad por cáncer de tráquea, bronquios y pulmón atribuido a la exposición al tabaco, mientras que en el caso de las mujeres solo en 4 países hubo una reducción de la mortalidad. Conclusión. Aunque en Sudamérica se están llevando a cabo iniciativas importantes para el control del tabaco, en esta región persiste una carga considerable de cáncer de tráquea, bronquios y pulmón, con diferencias significativas en función del sexo. Es preciso contar con más datos primarios específicos de cada país sobre el cáncer de tráquea, bronquios y pulmón, así como sobre la exposición al tabaco, para optimizar las estrategias de atención de salud y mejorar la comprensión de las tendencias regionales.

[RESUMO]. Objetivo. Investigar a carga de câncer de traqueia, brônquios e pulmão (TBP) decorrente da exposição ao tabaco nos últimos 30 anos em 12 países da América do Sul. Métodos. A função de exposição-resposta do estudo Carga Global de Doença (GBD, na sigla em inglês) 2019 foi usada para analisar o número de mortes e de anos de vida ajustados por incapacidade (AVAI) por câncer de TBP relacionado à exposição total ao tabaco e ao tabagismo e ao fumo passivo em 12 países da América do Sul entre 1990 e 2019. Os índices foram descritos em números absolutos ou taxas por 100 mil pessoas. A variação relativa da carga foi avaliada comparando-se os períodos de 1990 a 1994 e de 2015 a 2019. Resultados. Em 2019, os números de mortes e de AVAI por câncer de TBP associado à exposição ao tabaco na América do Sul, em todas as idades, foram, respectivamente, 29.348 e 658.204 em homens e 14.106 e 318.277 em mulheres. As taxas de mortalidade e os AVAI ajustados por idade na região foram, respecti- vamente, 182,8 e 4.035 em homens e 50,8 e 1.162 em mulheres em 2019. Em homens, 10 dos 12 países registraram uma diminuição relativa das taxas de mortalidade por câncer de TBP atribuído à exposição ao tabaco, mas somente 4 países obtiveram uma redução da mortalidade em mulheres. Conclusão. Apesar dos consideráveis esforços atuais para o controle do tabaco na América do Sul, ainda há uma expressiva carga de câncer de TBP na região, com disparidades significativas entre os sexos. É necessário dispor de mais dados primários sobre câncer de TBP e exposição ao tabaco específicos para cada país para aprimorar as estratégias de atenção à saúde e melhorar a compreensão das tendências regionais.

Trends in tracheal, bronchial and lung cancer attributed to smoking in South America: Global Burden of Disease analysis 1990-2019.

Objective: To investigate the burden of tracheal, bronchus, and lung (TBL) cancer due to tobacco exposure in the last 30 years in 12 South American countries. Methods: We used the Global Burden of Disease (GBD) 2019 exposure-response function to analyze the total tobacco, smoking, and secondhand smoke exposure-related TBL cancer deaths and disability-adjusted life years (DALYs), for 12 South American countries, between 1990 and 2019. Metrics were described as absolute numbers or rates per 100 000 individuals. The relative change in burden was assessed by comparing the 1990-1994 to 2015-2019 periods. Results: In 2019, the all-ages number of TBL cancer deaths and DALYs associated with tobacco exposure in South America was 29 348 and 658 204 in males and 14 106 and 318 277 in females, respectively. Age-adjusted death and DALYs rates for the region in 2019 were 182.8 and 4035 in males and 50.8 and 1162 in females, respectively. In males, 10/12 countries observed relative declines in TBL death rates attributed to tobacco exposure while only 4 countries reduced their mortality in females. Conclusion: While significant efforts on tobacco control are under place in South America, substantial burden of TBL cancer persists in the region with significant sex-specific disparities. Increased country-specific primary data on TBL cancer and tobacco exposure is needed to optimize healthcare strategies and improve comprehension of regional trends.

Difference Between Cardiopulmonary Bypass Time and Aortic Cross-Clamping Time as a Predictor of Complications After Coronary Artery Bypass Grafting.

INTRODUCTION: Along with cardiopulmonary bypass time, aortic cross-clamping time is directly related to the risk of complications after heart surgery. The influence of the time difference between cardiopulmonary bypass and cross-clamping times (TDC-C) remains poorly understood. OBJECTIVE: To assess the impact of cardiopulmonary bypass time in relation to cross-clamping time on immediate results after coronary artery bypass grafting in the Registro Paulista de Cirurgia Cardiovascular (REPLICCAR) II. METHODS: Analysis of 3,090 patients included in REPLICCAR II database was performed. The Society of Thoracic Surgeons outcomes were evaluated (mortality, kidney failure, deep wound infection, reoperation, cerebrovascular accident, and prolonged ventilation time). A cutoff point was adopted, from which the increase of this difference would affect each outcome. RESULTS: After a cutoff point determination, all patients were divided into Group 1 (cardiopulmonary bypass time < 140 min., TDC-C < 30 min.), Group 2 (cardiopulmonary bypass time < 140 min., TDC-C > 30 min.), Group 3 (cardiopulmonary bypass time > 140 min., TDC-C < 30 min.), and Group 4 (cardiopulmonary bypass time > 140 min., TDC-C > 30 min.). After univariate logistic regression, Group 2 showed significant association with reoperation (odds ratio: 1.64, 95% confidence interval: 1.01-2.66), stroke (odds ratio: 3.85, 95% confidence interval: 1.99-7.63), kidney failure (odds ratio: 1.90, 95% confidence interval: 1.32-2.74), and in-hospital mortality (odds ratio: 2.17, 95% confidence interval: 1.30-3.60). CONCLUSION: TDC-C serves as a predictive factor for complications following coronary artery bypass grafting. We strongly recommend that future studies incorporate this metric to improve the prediction of complications.

Deep learning segmentation of fibrous cap in intravascular optical coherence tomography images.

Thin-cap fibroatheroma (TCFA) is a prominent risk factor for plaque rupture. Intravascular optical coherence tomography (IVOCT) enables identification of fibrous cap (FC), measurement of FC thicknesses, and assessment of plaque vulnerability. We developed a fully-automated deep learning method for FC segmentation. This study included 32,531 images across 227 pullbacks from two registries (TRANSFORM-OCT and UHCMC). Images were semi-automatically labeled using our OCTOPUS with expert editing using established guidelines. We employed preprocessing including guidewire shadow detection, lumen segmentation, pixel-shifting, and Gaussian filtering on raw IVOCT (r,θ) images. Data were augmented in a natural way by changing θ in spiral acquisitions and by changing intensity and noise values. We used a modified SegResNet and comparison networks to segment FCs. We employed transfer learning from our existing much larger, fully-labeled calcification IVOCT dataset to reduce deep-learning training. Postprocessing with a morphological operation enhanced segmentation performance. Overall, our method consistently delivered better FC segmentation results (Dice: 0.837 ± 0.012) than other deep-learning methods. Transfer learning reduced training time by 84% and reduced the need for more training samples. Our method showed a high level of generalizability, evidenced by highly-consistent segmentations across five-fold cross-validation (sensitivity: 85.0 ± 0.3%, Dice: 0.846 ± 0.011) and the held-out test (sensitivity: 84.9%, Dice: 0.816) sets. In addition, we found excellent agreement of FC thickness with ground truth (2.95 ± 20.73 µm), giving clinically insignificant bias. There was excellent reproducibility in pre- and post-stenting pullbacks (average FC angle: 200.9 ± 128.0°/202.0 ± 121.1°). Our fully automated, deep-learning FC segmentation method demonstrated excellent performance, generalizability, and reproducibility on multi-center datasets. It will be useful for multiple research purposes and potentially for planning stent deployments that avoid placing a stent edge over an FC.

Percutaneous left atrial appendage occlusion in mitral valve disease: A Nationwide Readmission Database analysis.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) has emerged as a non-pharmacologic alternative to oral anticoagulation in reducing stroke risk in AF patients. However, patients with mitral valve disease (MVD), who are expected to have a significantly greater risk of left atrium (LA) thrombus formation and embolic stroke were excluded from randomized trials examining percutaneous LAAO. To address this gap, we present a national registry analysis of the use of LAAO among patients with MVD. METHODS: Using the National Readmissions Database, we performed a retrospective review of all hospitalizations for LAAO identified between September 2015 and November 2019. Of these, patients with ICD-10 codes for MVD were identified. Propensity matched (PSM) analysis was used to compare patients with MVD with a matched sample of patients undergoing LAAO with non-valvular AF. Outcomes examined included all-cause mortality, stroke, major bleeding, pericardial effusion (PE), and tamponade. RESULTS: 51,540 patients who underwent LAAO without a history of MVD and 3777 with a history of MVD were identified. Crude analysis demonstrated the odds of mortality, PE, and cardiac tamponade during index hospitalization to be higher in the MVD group. The length of stay and cost of index hospitalization were also slightly greater for the MVD group. A sample of 7649 patients (MVD: 3777 MVD and no MVD: 3872) were selected for PSM analysis with similar comorbidities across the two groups. In the PSM comparison, MVD was associated with higher risk of PE. The MVD group had a slightly higher rate of readmissions the association with PE remained at 30-day readmission (OR: 2.099 [1.360-3.238], p-value: <0.001). CONCLUSION: To our knowledge, this is the first study examining the use of LAAO among MVD patients. Our findings suggest that patients with MVD who underwent LAAO had a higher risk of post-procedural PE without an increase in mortality, stroke, or major bleeding. These results provide a rationale for considering LAAO as part of the stroke prevention strategy among patients with valvular AF.

Extra-plaque rotational atherectomy for treating a balloon uncrossable ostial right coronary artery chronic total occlusion.

Performing atherectomy in the subintimal space remains controversial. We describe a case of successful ostial right coronary artery CTO recanalization using rotational atherectomy in subintimal space.

Midterm follow-up after computed tomography angiography planned left atrial appendage closure.

BACKGROUND: While studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™ legacy and FLX devices, there has been no reported long-term data for this approach. OBJECTIVES: We sought to evaluate long-term outcomes using CTA-based preprocedural planning for LAAC using the WATCHMAN™ device. METHODS: A prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5-year period. CTA-guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2-Vasc and HAS-BLED scores, respectively. RESULTS: From January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS-BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri-procedural complication rate was 2.2%. 6 patients were lost to follow-up. Mean follow-up was 608.94 days with a total of 377.04 patient years. Median follow-up period of 368 days (interquartile range: 209-1067 days). There were 51 deaths from all causes (13.52 per 100 patient-years), 10 cases of cerebral embolism (2.65 per 100 patient-years), 2 cases of systemic embolism (0.53 per 100 patient-years), 17 cases of major bleeding (4.50 per 100 patient-years), and 31 cases of minor bleeding (8.2 per 100 patient-years). All-cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively. CONCLUSIONS: CTA-based preprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

Amulet device implantation following incomplete left atrial appendage closure with Watchman legacy device.

Peri-device leak after left atrial appendage closure (LAAC) is often treated with endovascular coils, plugs, or second occluders. This is the first study reporting the Amulet device used for peri-device leak. An 80-year-old male with paroxysmal atrial fibrillation and recurrent falls with head trauma who underwent LAAC with a 24 mm Watchman 2.5 device 3 years ago at another institution was referred to our clinic for management of the peri-device leak. Transesophageal echocardiogram showed persistent residual peri-device leak with 5 mm width along the Coumadin ridge aspect of the device. Computed tomography (CT) also showed the peri-device leak with width of 6 mm and complete opacification of left atrial appendage (LAA). Importantly, CT demonstrated that the Watchman 2.5 device was deployed at distal LAA, leaving the proximal part of LAA with length of 10 mm from ostium. Under general anesthesia, a 22 mm Amulet device was deployed successfully with complete sealing of LAA. Procedure planning is the key to minimize the risk of peri-device leak or device-related thrombosis. Careful assessment of LAA anatomy using multimodality images for peri-device leak after LAAC helped optimal treatment strategy including second LAAC with different type of devices.

Difference Between Cardiopulmonary Bypass Time and Aortic Cross-Clamping Time as a Predictor of Complications After Coronary Artery Bypass Grafting

ABSTRACT Introduction: Along with cardiopulmonary bypass time, aortic cross-clamping time is directly related to the risk of complications after heart surgery. The influence of the time difference between cardiopulmonary bypass and cross-clamping times (TDC-C) remains poorly understood. Objective: To assess the impact of cardiopulmonary bypass time in relation to cross-clamping time on immediate results after coronary artery bypass grafting in the Registro Paulista de Cirurgia Cardiovascular (REPLICCAR) II. Methods: Analysis of 3,090 patients included in REPLICCAR II database was performed. The Society of Thoracic Surgeons outcomes were evaluated (mortality, kidney failure, deep wound infection, reoperation, cerebrovascular accident, and prolonged ventilation time). A cutoff point was adopted, from which the increase of this difference would affect each outcome. Results: After a cutoff point determination, all patients were divided into Group 1 (cardiopulmonary bypass time < 140 min., TDC-C < 30 min.), Group 2 (cardiopulmonary bypass time < 140 min., TDC-C > 30 min.), Group 3 (cardiopulmonary bypass time > 140 min., TDC-C < 30 min.), and Group 4 (cardiopulmonary bypass time > 140 min., TDC-C > 30 min.). After univariate logistic regression, Group 2 showed significant association with reoperation (odds ratio: 1.64, 95% confidence interval: 1.01-2.66), stroke (odds ratio: 3.85, 95% confidence interval: 1.99-7.63), kidney failure (odds ratio: 1.90, 95% confidence interval: 1.32-2.74), and in-hospital mortality (odds ratio: 2.17, 95% confidence interval: 1.30-3.60). Conclusion: TDC-C serves as a predictive factor for complications following coronary artery bypass grafting. We strongly recommend that future studies incorporate this metric to improve the prediction of complications.

Prediction of stent under-expansion in calcified coronary arteries using machine learning on intravascular optical coherence tomography images.

It can be difficult/impossible to fully expand a coronary artery stent in a heavily calcified coronary artery lesion. Under-expanded stents are linked to later complications. Here we used machine/deep learning to analyze calcifications in pre-stent intravascular optical coherence tomography (IVOCT) images and predicted the success of vessel expansion. Pre- and post-stent IVOCT image data were obtained from 110 coronary lesions. Lumen and calcifications in pre-stent images were segmented using deep learning, and lesion features were extracted. We analyzed stent expansion along the lesion, enabling frame, segmental, and whole-lesion analyses. We trained regression models to predict the post-stent lumen area and then computed the stent expansion index (SEI). Best performance (root-mean-square-error = 0.04 ± 0.02 mm2, r = 0.94 ± 0.04, p < 0.0001) was achieved when we used features from both lumen and calcification to train a Gaussian regression model for segmental analysis of 31 frames in length. Stents with minimum SEI > 80% were classified as "well-expanded;" others were "under-expanded." Under-expansion classification results (e.g., AUC = 0.85 ± 0.02) were significantly improved over a previous, simple calculation, as well as other machine learning solutions. Promising results suggest that such methods can identify lesions at risk of under-expansion that would be candidates for intervention lesion preparation (e.g., atherectomy).

Efficacy of 3D-multidetector computed tomography and fluoroscopy fusion for percutaneous left atrial appendage occlusion procedures.

INTRODUCTION: We studied the impact of the use of three-dimensional multidetector computed tomography (3D-MDCT) and fluoroscopy fusion on percutaneous left atrial appendage occlusion (LAAO) procedures in relation to procedure time, contrast volume, fluoroscopy time, and total radiation. METHODS: This was a single-center, prospective, single-blinded, randomized control trial. Patients meeting criteria for LAAO were randomized to undergo LAAO with the WATCHMAN FLXTM device with and without 3D-MDCT-fluoroscopy fusion guidance using a prespecified protocol using computed tomography angiography for WATCHMAN FLXTM sizing, moderate sedation, and intracardiac echocardiography for procedural guidance. RESULTS: Overall, 59 participants were randomly assigned to the fusion (n = 33) or no fusion (n = 26) groups. The median (interquartile range) age was 79 (75-83) years, 24 (41%) were female, and 55 (93%) were Caucasian. The median CHA2 DS2 VASc and HASBLED scores were 5 (4-6) and 3 (3-4), respectively. At the time of the study, 51 (53%) patients were on a direct acting oral anticoagulant. There were no significant differences between the fusion and no fusion groups in procedure time (52.4 ± 15.4 vs. 56.8 ± 19.5 min, p = .36), mean contrast volume used (33.8 ± 12.0 vs. 29.6 ± 11.5 mls, p = .19), mean fluoroscopy time (31.3 ± 9.9 vs. 28.9 ± 8.7 min, p = .32), mean radiation dose (1177 ± 969 vs. 1091 ± 692 mGy, p = .70), and radiation dose product curve (23.9 ± 20.5 vs. 35.0 ± 49.1 Gy cm2 , p = .29). There was no periprosthetic leak in the two groups in the immediate 1-month postprocedure follow-up periods. CONCLUSIONS: There was no significant difference with and without 3D-MDCT-fluoroscopy fusion in procedure time, contrast volume use, radiation dose, and radiation dose product.

First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System.

BACKGROUND: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited. OBJECTIVES: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience. METHODS: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported. RESULTS: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001). CONCLUSIONS: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.

Left Atrial Appendage Closure Outcomes in Patients With Cancer at a Single Tertiary Center.

Atrial fibrillation is the most common arrhythmia in patients with underlying malignancy. Patients with cancer have a higher risk of bleeding, and at the same time, carry an elevated risk of thromboembolism related to the hypercoagulable state, type of cancer, and anticancer treatment, rendering safe anticoagulation challenging in this population. Left atrial appendage closure is an alternative treatment option in patients with atrial fibrillation and high bleeding risk; however, the data on patients with cancer are limited. Our study aimed to compare the long-term outcomes in patients with cancer receiving left atrial appendage closure using the WATCHMAN device. This is a prospective, single-center study comparing outcomes in 389 patients who underwent percutaneous left atrial appendage closure using the WATCHMAN device over 5 years in a single, large academic hospital in the United States. The postprocedural outcomes of mortality, stroke, and major bleeding were evaluated in patients with and without cancer. Our study included 57 patients with cancer and 332 without cancer. The baseline characteristics were similar between the 2 groups. Metastatic disease was present in 16.4% of patients, and 25% were receiving active treatment at the time of the procedure. The median follow-up time was 354 (interquartile range 85 to 790) days. There was no difference in mortality (hazard ratio [HR] 1.3, 95% confidence interval [CI] 0.72 to 2.35, p = 0.38), major bleeding episodes (HR 1.2, 95% CI 0.45 to 3.33, p = 0.68), and stroke (HR 0.64, 95% CI 0.19 to 2.21, p = 0.49) at 3 years after the procedure in patients with and without cancer. There was no difference in the composite outcome (postprocedural mortality, stroke, and major bleeding) between the 2 groups (HR 1.25, CI 0.75 to 2.07, p = 0.38). Percutaneous left atrial appendage closure in patients with cancer appears to be safe and has a similar long-term risk compared with patients without cancer.

Human Saphenous Vein Endothelial Cell Isolation and Exposure to Controlled Levels of Shear Stress and Stretch.

Coronary artery bypass graft (CABG) surgery is a procedure to revascularize ischemic myocardium. Saphenous vein remains used as a CABG conduit despite the reduced long-term patency compared to arterial conduits. The abrupt increase of hemodynamic stress associated with the graft arterialization results in vascular damage, especially the endothelium, that may influence the low patency of the saphenous vein graft (SVG). Here, we describe the isolation, characterization, and expansion of human saphenous vein endothelial cells (hSVECs). Cells isolated by collagenase digestion display the typical cobblestone morphology and express endothelial cell markers CD31 and VE-cadherin. To assess the mechanical stress influence, protocols were used in this study to investigate the two main physical stimuli, shear stress and stretch, on arterialized SVGs. hSVECs are cultured in a parallel plate flow chamber to produce shear stress, showing alignment in the direction of the flow and increased expression of KLF2, KLF4, and NOS3. hSVECs can also be cultured in a silicon membrane that allows controlled cellular stretch mimicking venous (low) and arterial (high) stretch. Endothelial cells' F-actin pattern and nitric oxide (NO) secretion are modulated accordingly by the arterial stretch. In summary, we present a detailed method to isolate hSVECs to study the influence of hemodynamic mechanical stress on an endothelial phenotype.