RESUMEN
BACKGROUND: Conduction disturbances have uncertain implications for long-term left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR). We aimed to examine LVEF changes in patients up to two years post-TAVR. METHODS: We examined patients who underwent TAVR between 2012 and 2020 and underwent echocardiography follow-up. Patients were categorized into four groups: 1) Those without a permanent pacemaker (PPM) or left bundle branch block (LBBB) pre- or post-TAVR; 2) Patients with pre- and post-TAVR LBBB; 3) Individuals with preexisting PPM; and 4) Patients requiring new PPM after TAVR. LVEF was assessed at the outset of TAVR, at 30 days, 1-year, and 2-years post-TAVR. RESULTS: The study included 730 patients: 421 (57.6 %) without conduction abnormalities, 151 (20.7 %) with post-TAVR LBBB (48 pre-existing, 103 new-onset), 63 (8.6 %) with pre-existing PPM, and 95 (13.1 %) requiring new PPM. At discharge, patients without conduction abnormalities exhibited the highest LVEF (57.4 ± 11.5 %), whereas those with pre-existing PPM had the lowest (48.1 ± 15.5 %). Over two years, LVEF remained constant in patients without conduction issues and in those with pre-existing PPM. However, patients with new LBBB experienced a 6.3 % decrease in LVEF, and those requiring new PPM showed a 4.1 % reduction. CONCLUSION: New conduction abnormalities, such as LBBB or the need for PPM, induce a decline in LVEF post-TAVR. It is imperative to focus on the long-term monitoring of left ventricular function in patients experiencing new conduction disturbances post-TAVR.
RESUMEN
BACKGROUND: PROTECT IV is a current enrolling randomized controlled trial evaluating high-risk percutaneous coronary intervention (HR-PCI) with prophylactic Impella versus no Impella to reduce the composite primary endpoint of all-cause death, stroke, myocardial infarction (MI), or cardiovascular hospitalization. In a PROTECT IV-like cohort of patients who underwent HR-PCI without Impella, we aimed to report the rate of major adverse events to determine whether the trial is adequately powered. METHODS AND RESULTS: A total of 700 patients meeting similar inclusion/exclusion criteria of PROTECT IV who underwent HR-PCI without Impella at a single tertiary center from 2008 to 2022 were included in the analysis. The composite rates of all-cause death, MI, target lesion revascularization, and target vessel revascularization at 1, 2, and 3 years were estimated using the Kaplan-Meier method, and the results were used to calculate the sample size under the constant hazard ratio assumption and expected number of events to be observed used in planning PROTECT IV. The primary endpoint occurred in 30.8 % of patients at 2 years. PROTECT IV assumes a hazard ratio of 0.75 using a multivariate Cox regression, which, under a 5 % level and 90 % power, yields 516 events. This implies a 2-year primary outcome rate of 50 % for the non-Impella arm. CONCLUSION: Therefore, PROTECT IV estimates that a sample size of 1252 patients is required for Impella to be declared superior to the non-Impella group. Using our observed 2-year outcome of 30.8 %, we estimate that PROTECT IV requires 1966 patients, demonstrating that PROTECT IV is probably underpowered.
RESUMEN
Bioprosthetic aortic valve thrombosis is frequently detected after transcatheter and surgical aortic valve replacement due to advances in cardiac computed tomography angiography technology and standardized surveillance protocols in low-surgical-risk transcatheter aortic valve replacement trials. However, evidence is limited concerning whether subclinical leaflet thrombosis leads to clinical adverse events or premature structural valve deterioration. Furthermore, there may be net harm in the form of bleeding from aggressive antithrombotic treatment in patients with subclinical leaflet thrombosis. This review will discuss the incidence, mechanisms, diagnosis, and optimal management of bioprosthetic aortic valve thrombosis after transcatheter aortic valve replacement and bioprosthetic surgical aortic valve replacement.
Asunto(s)
Válvula Aórtica , Bioprótesis , Fibrinolíticos , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Trombosis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Prótesis Valvulares Cardíacas/efectos adversos , Bioprótesis/efectos adversos , Trombosis/diagnóstico por imagen , Trombosis/etiología , Trombosis/terapia , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Fibrinolíticos/efectos adversos , Fibrinolíticos/administración & dosificación , Incidencia , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Medición de Riesgo , Valor Predictivo de las PruebasRESUMEN
Spontaneous coronary artery dissection (SCAD) is a rare cause of ST-segment elevation myocardial infarction (STEMI), predominantly affecting women. Because primary percutaneous coronary intervention (PPCI) is reserved for a select group of patients, vulnerable and minority patients may experience delays in appropriate management and adverse outcomes. We examined the racial differences in the outcomes for patients with SCAD who underwent PPCI for STEMI. Records of patients aged ≥18 years who underwent PPCI for SCAD-related STEMI between 2016 and 2020 were identified from the National Inpatient Sample database. Clinical, socioeconomic, and hospital characteristics were compared between non-White and White patients. Weighted multivariate analysis assessed the association of race with inpatient mortality, length of stay (LOS), and hospitalization costs. The total weighted estimate of patients with SCAD-STEMI who underwent PPCI was 4,945, constituting 25% non-White patients. Non-White patients were younger (56 vs 60.7 years, p <0.001); had a higher prevalence of diabetes, acute renal failure, and obesity; and were more likely to be uninsured and be in the lowest income group. Inpatient mortality (7.7% vs 8.4%, p = 0.74) and hospitalization costs ($34,213 vs $31,858, p = 0.27) were similar for non-White and White patients, and the adjusted analysis did not show any association between the patients' race and inpatient mortality (odds ratio 0.60, 95% confidence interval [CI] 0.32 to 1.13, p = 0.11) or hospitalization costs (ß [ß coefficient]: 215, 95% CI -4,193 to 4,623, p >0.90). Similarly, there was no association between the patients' race and LOS (incident rate ratio 1.20, 95% CI 1.00 to 1.45, p = 0.054). The weighted multivariate analysis showed that age; clinical co-morbidities such as diabetes, acute renal failure, valvular dysfunction, and obesity; low-income status; and hospitalization in the western region were associated with adverse outcomes. In conclusion, our study does not show any differences in inpatient mortality, LOS, and hospitalization costs between non-White and White patients who underwent PPCI for SCAD-related STEMI.
Asunto(s)
Anomalías de los Vasos Coronarios , Mortalidad Hospitalaria , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Femenino , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/estadística & datos numéricos , Infarto del Miocardio con Elevación del ST/cirugía , Infarto del Miocardio con Elevación del ST/epidemiología , Anomalías de los Vasos Coronarios/complicaciones , Anomalías de los Vasos Coronarios/epidemiología , Anomalías de los Vasos Coronarios/cirugía , Estados Unidos/epidemiología , Enfermedades Vasculares/epidemiología , Enfermedades Vasculares/congénito , Enfermedades Vasculares/cirugía , Tiempo de Internación/estadística & datos numéricos , Anciano , Disparidades en Atención de Salud/estadística & datos numéricos , Costos de Hospital/estadística & datos numéricos , Estudios Retrospectivos , Lesión Renal Aguda/epidemiología , Lesión Renal Aguda/etiologíaAsunto(s)
Circulación Coronaria , Electrocardiografía , Microcirculación , Humanos , Circulación Coronaria/fisiología , Microcirculación/fisiología , Vasos Coronarios/fisiopatología , Vasos Coronarios/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/fisiopatología , Enfermedad de la Arteria Coronaria/diagnósticoRESUMEN
Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting.
Asunto(s)
Cateterismo Cardíaco , Aprobación de Recursos , Insuficiencia de la Válvula Tricúspide , Válvula Tricúspide , United States Food and Drug Administration , Humanos , Comités Consultivos , Cateterismo Cardíaco/métodos , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/métodos , Diseño de Prótesis , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/cirugía , Estados UnidosRESUMEN
BACKGROUND: The intricate relationship between mental health disorders, notably anxiety and depression, and chest pain associated with non-obstructive coronary artery disease has become a focus of investigation. METHODS: This study from the Coronary Microvascular Disease Registry (CMDR) evaluated the association of mental health disorders and coronary microvascular dysfunction (CMD) among patients with angina with no obstructive coronary artery disease (ANOCA) who had undergone comprehensive invasive physiological testing for CMD. Clinical data regarding baseline characteristics, comorbidities, and noninvasive cardiac testing were obtained from chart review. The primary outcome of interest was the potential relationship between mental health diagnoses and the presence of CMD. RESULTS: Of patients included in the CMDR, 27 % (41/152) had at least one documented mental health disorder diagnosis (International Classification of Diseases, Tenth Revision codes) and CMD. There was no difference in mental health diagnosis prevalence between CMD-positive and CMD-negative patients (21.1 % vs. 28.9 %, p = 0.34). The most common mental health diagnoses were depression (15.8 %) and anxiety (15.8 %). Furthermore, 46.3 % (19/41) of patients with mental health disorders were prescribed psychiatric medications, with the most common being benzodiazepines (26.8 %). CONCLUSION: Patients with chest pain not due to CMD did not have an increased prevalence of mental health disorders compared with patients with ANOCA due to CMD, challenging the notion of a psychosomatic component in the pathogenesis of ANOCA.
RESUMEN
BACKGROUND: Coronary microvascular dysfunction (CMD) is associated with various inflammatory conditions that worsen endothelial dysfunction. This study aimed to investigate the relationship between CMD and inflammation using common inflammatory markers derived from complete blood count (CBC) analysis. METHODS: Information was gathered from the Coronary Microvascular Disease Registry to examine the neutrophil-to-lymphocyte ratio (NLR), eosinophil-to-monocyte ratio (EMR), and monocyte-to-high-density lipoprotein ratio (MHR) in a cohort of patients with angina who showed non-obstructive coronary arteries and underwent invasive physiological assessments for CMD. RESULTS: Of the 171 patients studied, 126 were CMD-negative and 45 were CMD-positive, constituting two groups of interest. The average age of all patients was 61.7 ± 11.1 years, and 63.7 % were female. No significant differences were observed between the two groups in terms of baseline characteristics, cardiovascular risk factors, or potential anti-inflammatory medications. Furthermore, there were no statistically significant differences in NLR (2.54 ± 3.71 vs. 2.52 ± 2.28, p = 0.97), EMR (0.3 ± 0.21 vs. 0.34 ± 0.29, p = 0.31), or MHR (0.02 ± 0.01 vs. 0.01 ± 0.01, p = 0.54) between CMD-positive and CMD-negative patients. CONCLUSION: Our findings did not show a noteworthy connection between CMD and inflammation, as suggested by various simple CBC-based biomarkers.
RESUMEN
BACKGROUND: Coronary microvascular dysfunction (CMD) has been implicated as a potential mechanism in the pathophysiology of different clinical presentations, including ischemia and no obstructive coronary artery disease (INOCA), myocardial infarction and nonobstructive coronary arteries (MINOCA), stress cardiomyopathy, heart failure, and myocarditis. There are limited data about the role of CMD in cancer therapy-related cardiovascular toxicities. CASE PRESENTATIONS: Four women with a diagnosis of active cancer receiving treatment who developed subsequent MINOCA or INOCA presented for cardiac catheterization. Upon coronary angiography showing no obstructive coronary arteries, coronary function testing was performed to evaluate for CMD. METHODS: Coronary physiology was assessed measuring non-hyperemic (resting full-cycle ratio [RFR]) and hyperemic (fractional flow reserve [FFR]) indices using a physiologic pressure wire. The wire also measured coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and RFR using thermodilution technology. CMD was confirmed if the CFR was <2.5 and the IMR was >25. RESULTS: Among 4 patients with diagnosis of active cancer presenting with chest pain, there was no evidence of obstructive coronary artery disease, leading to separate diagnoses of INOCA, MINOCA, stress cardiomyopathy, and myocarditis. We found CMD in 2 patients (1 with INOCA and 1 with immune checkpoint inhibitor-related myocarditis). CONCLUSIONS: CMD may play a role in cardiovascular toxicities. Further coronary physiology studies are needed to understand the mechanisms of cancer therapy-related cardiovascular toxicity and CMD, as well as optimal preventive and treatment options.
RESUMEN
Hypertension continues to be a prominent, avoidable factor contributing to major vascular issues on a global scale. Even with lifestyle adjustments and more aggressive medical treatments, maintaining optimal blood pressure levels remains challenging. This challenge has driven the emergence of device-oriented approaches to address hypertension. To assess the safety and efficacy of the Recor Paradise Ultrasound Renal Denervation System, the Circulatory System Devices Panel was convened by the US Food and Drug Administration (FDA). This manuscript provides a condensed overview of the information put forth by the sponsor and the FDA, along with an account of the considerations and conversations that took place during the meeting.
Asunto(s)
Presión Sanguínea , Aprobación de Recursos , Hipertensión , Arteria Renal , Simpatectomía , United States Food and Drug Administration , Humanos , Estados Unidos , Simpatectomía/efectos adversos , Simpatectomía/instrumentación , Hipertensión/fisiopatología , Hipertensión/cirugía , Arteria Renal/inervación , Arteria Renal/diagnóstico por imagen , Resultado del Tratamiento , Riñón/irrigación sanguínea , Comités Consultivos , Diseño de Equipo , Factores de RiesgoRESUMEN
BACKGROUND: Coronary functional testing to formally diagnose coronary microvascular dysfunction (CMD) reduces cardiovascular events and alleviates angina. This study aims to investigate the extensive and complex journey that patients with CMD undergo, from the onset of chest pain to eventual diagnosis. METHODS: Data from the Coronary Microvascular Disease Registry (CMDR) were analyzed, including information on the date of first documentation of chest pain, number of non-invasive and invasive tests the patient underwent, emergency department visits, and hospitalizations. In addition, we estimated the total cost per patient. A total of 61 patients with CMD diagnosis were included in this analysis. RESULTS: Most patients in our cohort were older than 50 years of age. The median time from initial chest pain symptoms to diagnosis was 0.62 (interquartile range [IQR]: 0.06-2.96) years. During this period, patients visited the emergency department a median of 1.0 (IQR: 0.0-2.0) times. Diagnostic tests included 3.0 (IQR: 2.0-6.0) electrocardiograms, 3.0 (IQR: 0.0-6.0) high-sensitivity troponin tests, and 1.0 (IQR: 1.0-2.0) echocardiograms. Prior to diagnosis of CMD, 13 (21.3 %) patients had left heart catheterization without coronary functional testing. Non-invasive testing for ischemia was conducted in 43 (70.5 %) patients. Alternative non-cardiac diagnoses were given to 11 (18.0 %) patients during the diagnostic process, with referrals made to gastroenterology for 16 (26.2 %) and pulmonology for 10 (16.4 %) patients. The cost was almost $2000/patient. CONCLUSION: Timely identification of CMD offers promising opportunities for prompt symptom alleviation, accompanied by reduced visits to the emergency department, cardiovascular testing, invasive medical procedures, and consequently reduced healthcare expenses.
Asunto(s)
Circulación Coronaria , Servicio de Urgencia en Hospital , Microcirculación , Valor Predictivo de las Pruebas , Sistema de Registros , Humanos , Persona de Mediana Edad , Masculino , Femenino , Factores de Tiempo , Anciano , Servicio de Urgencia en Hospital/economía , Enfermedad de la Arteria Coronaria/economía , Enfermedad de la Arteria Coronaria/fisiopatología , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/terapia , Costos de Hospital , Angina de Pecho/economía , Angina de Pecho/diagnóstico , Angina de Pecho/fisiopatología , Angina de Pecho/terapia , Análisis Costo-Beneficio , Electrocardiografía/economía , Adulto , Pruebas de Función Cardíaca/economía , Biomarcadores/sangre , Cateterismo Cardíaco/economía , Pronóstico , Costos de la Atención en Salud , Dolor en el Pecho/diagnóstico , Dolor en el Pecho/etiología , Dolor en el Pecho/economíaRESUMEN
Transcatheter heart valve (THV) procedures require careful planning and consideration to prevent coronary artery obstruction (CAO), which poses a significant and potentially life-threatening condition, especially in patients undergoing valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR). Despite identifying predictors of CAO and utilization of computed tomography and inputting THV features, a significant uncertainty remains in predicting CAO. The ShortCut™ device (Pi-Cardia, Rehovot, Israel) was purposefully designed to modify the leaflets in patients undergoing TAVR, especially prior to ViV procedures, to overcome the risk for CAO. This review aims to detail the device's objectives, structure, procedural steps, the available clinical data, and future directions for its intended utilization in the structural arena for the prevention of CAO.
Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Oclusión Coronaria , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Resultado del Tratamiento , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/prevención & control , Oclusión Coronaria/etiología , Oclusión Coronaria/terapia , Factores de Riesgo , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatologíaRESUMEN
Hypertension remains a leading preventable cause of myocardial infarction, stroke, kidney disease, and cardiovascular death worldwide. Despite lifestyle modifications and intensification of medical therapy, suboptimal blood pressure control is common, spurring the development of device-based therapies for hypertension. The US Food and Drug Administration (FDA) assembled the Circulatory System Devices Panel on August 22-23, 2023, to discuss the safety and effectiveness of renal denervation devices manufactured by Recor Medical and Medtronic. After reviewing the ultrasound-based Recor Paradise renal denervation system the day prior, the panel reconvened to discuss the radiofrequency-based Medtronic Symplicity Spyral Renal Denervation System. In this manuscript, we summarize the data presented by the sponsor and FDA and detail the deliberation and discussion during the meeting.
Asunto(s)
Sistema Cardiovascular , Hipertensión , Estados Unidos , Humanos , United States Food and Drug Administration , Riñón/cirugía , Presión Sanguínea , Simpatectomía , Resultado del Tratamiento , Antihipertensivos/uso terapéuticoRESUMEN
BACKGROUND: How to implement robotic-assisted PCI safely and when to escalate to more complex cases has not been previously described. We sought to evaluate clinical outcomes in patients undergoing robotic-assisted PCI in the first year of a newly established robotic-assisted PCI program. METHODS: All patients who underwent robotic-assisted PCI in the first 12 months at a single academic center were included in the study. Lesion complexity was characterized as "PRECISE-like", "CORA-PCI-like", or "CORA-PCI excluded" based on established criteria. The primary outcome was clinical success, defined as <30% residual stenosis after stenting with a final TIMI flow grade 2-3 and no procedural complications. Secondary outcomes included robotic success, defined as clinical success with robotic completion, unintentional manual conversion rate, procedure time, and procedural complications. RESULTS: Of the 57 consecutive lesions treated, 12 (22.6%) had a PRECISE-like lesion complexity while 32 (56.1%) had a CORA- PCI-like, and 13 (22.8%) a CORA-PCI excluded lesion complexity. There was no significant difference in clinical success (100.0% vs. 96.7% vs. 100.0%, p = 1.00) among the groups but robotic success was numerically lower as complexity increased (100.0% vs. 80.0% vs. 72.7%, p = 0.15), with an increased frequency of manual conversion. There was no significant difference in procedural complication rates among the groups. The robotic completion rate improved during the study period. CONCLUSION: Robotic-assisted PCI, can be safely implemented in a moderate-sized academic center, with a rapid escalation in patient and lesion complexity.
Asunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Procedimientos Quirúrgicos Robotizados , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/terapia , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Factores de Riesgo , Procedimientos Quirúrgicos Robotizados/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: This study aimed to evaluate whether baseline tricuspid regurgitation (TR) impacted clinical outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) for severe secondary mitral regurgitation (MR). BACKGROUND: Baseline TR is common among patients undergoing M-TEER for secondary MR, although its impact on clinical outcomes is unclear. METHODS: The Cochrane Library, PubMed/MEDLINE, and Google Scholar were searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines from January 1, 2011 through January 31, 2021. Randomized controlled trials and nonrandomized prospective studies that evaluated baseline TR by echocardiography before M-TEER for MR were included. The primary outcome was a composite of mortality and heart failure hospitalization (HFH) at 1-year. RESULTS: A total of 5 studies (n = 1395 patients) were included in the primary analysis. Concurrent moderate/severe TR was associated with a worse 1 year composite of all-cause mortality and HFH (OR: 2.13; 95% CI: 1.12-4.05; p = 0.02) after M-TEER for severe MR. In studies that reported TR grade pre- and post-M-TEER for severe MR, 32% of patients with moderate-to-severe baseline TR had a reduction in TR severity after the intervention. CONCLUSIONS: Baseline moderate-to-severe TR was associated with increased 1-year mortality and heart failure hospitalizations among patients undergoing M-TEER. Further randomized studies are needed to assess the interaction of TR among patients undergoing M-TEER.