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1.
J Card Fail ; 30(10): 1265-1272, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39389736

RESUMEN

Novel transcatheter therapies for tricuspid regurgitation (TR) appear promising, yet their applicability to an all-comer TR population remains unclear. We aimed to assess the feasibility of emerging transcatheter tricuspid therapies in a real-world population with greater than or equal to moderate symptomatic TR. A total of 178 patients were referred to our center between January 2019 and December 2021 for greater than or equal to moderate symptomatic TR and were classified into 4 groups: Investigative (patients eligible for enrollment in the Triluminate, Clasp TR, and TRISCEND trials), off-label clipping, surgery, and medical treatment. A total of 10.7% of the population were deemed eligible for investigative therapies, 20.2% and 19.7% of patients were offered off-label clipping and surgery, respectively, and 49.4% received medical treatment. Common reasons for investigative therapy-related ineligibility were unsuitable anatomy (large tricuspid annulus or wide leaflet coaptation gap) and the presence of significant comorbidities. Compared with the other groups, the investigative group was less likely to harbor concomitant ≥moderate mitral regurgitation, greater than or equal to moderate right ventricular dysfunction or severe pulmonary hypertension (P < .05). At 1 year, there remained a significant reduction in TR severity in the investigative group (P < .001) in comparison with the medical treatment group. However, the results were comparable to off-label clipping (P = .60) and inferior to surgery (P =.04). Exploratory analyses failed to show evidence of differences in the rates of all-cause mortality (P =.40) and heart failure hospitalizations (P = .94) between all groups. Current real-world eligibility of TR patients for emerging transcatheter therapies remains limited, underscoring the need for continued innovative efforts to offer device therapies to a broader TR cohort.


Asunto(s)
Cateterismo Cardíaco , Estudios de Factibilidad , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/cirugía , Femenino , Masculino , Cateterismo Cardíaco/métodos , Anciano , Implantación de Prótesis de Válvulas Cardíacas/métodos , Estudios Retrospectivos , Determinación de la Elegibilidad/métodos , Selección de Paciente , Anciano de 80 o más Años , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Válvula Tricúspide/diagnóstico por imagen , Persona de Mediana Edad , Estudios de Seguimiento
2.
Heart Lung Circ ; 2024 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-39358130

RESUMEN

BACKGROUND & AIM: The extent and composition of coronary plaque, and its progression differ with patients' age. The interplay of patient's age with respect to risk factor control, upon atheroma progression has not been evaluated. We tested the hypothesis that risk factor control modulates the association between age and coronary atheroma progression. METHOD: We performed a posthoc pooled analysis of data from 10 prospective, randomised trials involving serial coronary intravascular ultrasonography (IVUS) (n=5,823). The percent atheroma volume (PAV) was calculated as the proportion of the entire vessel wall occupied by atherosclerotic plaque. RESULTS: Mean overall age was 58±9 years (28% women). In a fully adjusted multivariable analysis (following adjustment of sex, body mass index, systolic blood pressure [SBP], smoking, high-density lipoprotein and low-density lipoprotein [LDL]-cholesterol, triglyceride levels, peripheral vascular disease, diabetes mellitus, trial, region, and baseline PAV), an increase in age by one standard deviation was linked with PAV progression (ß-estimate 0.097; 95% confidence interval 0.048-0.15; p<0.001). In patients with good risk factor control (LDL-cholesterol <1.8 mmol/L and SBP <130 mmHg), increasing age remained associated with PAV progression (0.123; 0.014-0.23; p=0.027). Lower effect sizes for the association of age with PAV progression were observed for patients with partial control of LDL-cholesterol and SBP and were not significantly associated with PAV progression when both LDL-cholesterol and SBP were not controlled (0.099; 0.032-0.167; p=0.004 and 0.042; -0.056 to 0.14; p=0.40, respectively). CONCLUSIONS: Patient age is directly associated with coronary atheroma progression independently of traditional cardiovascular risk factors. In the setting of poor risk factor control, the influence of age on coronary artery disease progression is attenuated.

3.
Curr Cardiol Rep ; 2024 Oct 07.
Artículo en Inglés | MEDLINE | ID: mdl-39373959

RESUMEN

PURPOSE OF REVIEW: This review aims to highlight the current evidence on the use of cerebral embolic protection devices (CEPD) in left atrial and transcatheter mitral valve procedures. It also aims to summarize the antithrombotic management of patients undergoing such procedures. RECENT FINDINGS: Ischemic stroke is one of the most devastating complications of structural heart procedures. The manifestation of periprocedural stroke can range from asymptomatic and detectable only through brain imaging to major stroke with neurological deficits. CEP devices were initially developed to mitigate the risk of stroke associated with transcatheter aortic valve replacement (TAVR). However, the efficacy of such devices during different cardiac interventions is yet to be fully demonstrated, especially in left atrial appendage closure (LAAO), and mitral valve interventions. Few studies demonstrated that the risk of periprocedural strokes after LAAO and mitral valve interventions is not negligible and is highest during the periprocedural period and then falls. The majority of patients undergoing those procedures have cerebral ischemic injuries detected on diffusion-weighted magnetic resonance imaging (DW-MRI). Moreover, a reasonable number of those patients had debris embolization on the filters of the CEPD. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is crucial and should be tailored to each patient's risk of bleeding and ischemia. Close monitoring that includes a full neurological assessment and frequent follow-up visits with cardiac echocardiography are important. The risk of periprocedural stroke in left atrial and transcatheter mitral valve procedures is not negligible. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is important to mitigate the risk of stroke, especially the long-term risk. More prospective studies are needed to assess the efficacy of CEPD in such procedures.

5.
J Card Fail ; 2024 Sep 10.
Artículo en Inglés | MEDLINE | ID: mdl-39261158

RESUMEN

Heart failure (HF) is 1 of the major challenges of our time, given its increase in prevalence and related mortality rates. Foundational pharmacological therapies, including angiotensin receptor neprilysin inhibitors (ARNIs), beta-blockers, mineralocorticoid receptor antagonists (MRAs), and sodium-glucose co-transporter inhibitors (SGLTis), have been established for HF with reduced ejection fraction (HFrEF). Moreover, recent trials have established the role of SGLTis in patients with HF with preserved ejection fraction (HFpEF). However, even with these therapies, a substantial residual risk persists in both HFrEF and HFpEF. Alongside pharmacological advancements, device-based therapies have shown efficacy in HF management, including implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT). More recently, devices such as cardiac contractility modulation (CCM) and baroreflex activation therapy (BAT) have been approved by the FDA, although they lack comprehensive guideline recommendations. This scientific statement outlines the unmet needs in chronic HF, reviews contemporary data and provides a framework for integrating novel device-based therapies into current clinical workflows. It emphasizes the importance of early diagnosis and phenotyping, proper patient stratification and a personalized approach to combining pharmacological and device therapies. The document also highlights the need for further research into device interactions and patient selection to optimize outcomes, while recognizing the need for a more integrated approach to treatment so as to address the unmet needs and residual risks in HF management.

6.
Am J Cardiol ; 2024 Sep 05.
Artículo en Inglés | MEDLINE | ID: mdl-39243877

RESUMEN

In modern clinical practice, less than half of patients with new-onset heart failure (HF) undergo ischemic evaluation and only a minority undergo revascularization. We aimed to assess the proportion of the effect of hypertension (antihypertensive treatment) on incident HF to be eliminated by prevention of coronary heart disease (CHD) event treated with or without revascularization, considering possible treatment-mediator interaction. The causal mediation analysis of Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) included 42,418 participants (age 66.9 ± 7.7, 35.6% black, 53.2% men). A new CHD event (myocardial infarction or angina) that occurred after randomization but before the incident HF outcome was the mediator. Incident symptomatic congestive HF (CHF) and hospitalized/fatal HF (HHF) were the primary and secondary outcomes, respectively. Logistic regression (for mediator) and Cox proportional hazards regression (for outcome) were adjusted for demographics, cardiovascular disease history, and risk factors. During a median 4.5-year follow-up, 2,785 patients developed CHF, including 2,216 HHF events. Participants who developed CHD events had twice the higher incidence rate of CHF than CHD-free (28.5 vs 13.9 events/1,000 person-years). The proportion of reference interaction indicating direct harm because of a CHD event for lisinopril (234% for CHF, 355% for HHF) and amlodipine (244% for CHF, 468% for HHF) was greater than for chlortalidone (143% for CHF, 269% for HHF). In patients with revascularized CHD events, chlortalidone and amlodipine eliminated 21% to 24% and lisinopril eliminated -45% of HHF. Antihypertensive treatment could not eliminate harm from CHD events treated without revascularization. In conclusion, the antihypertensive drugs (chlortalidone, lisinopril, and amlodipine) prevent HF not principally by preventing CHD events but by way of other pathways. HF is moderated but not mediated by CHD events. Revascularization of CHD events is paramount for HF prevention.

7.
Eur Heart J Digit Health ; 5(5): 611-621, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39318685

RESUMEN

Aims: Despite the highest prevalence of stroke, obesity, and diabetes across races/ethnicities, paradoxically, Hispanic/Latino populations have the lowest prevalence of atrial fibrillation and major Minnesota code-defined ECG abnormalities. We aimed to use Latent Profile Analysis in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) population to obtain insight into epidemiological discrepancies. Methods and results: We conducted a cross-sectional analysis of baseline HCHS/SOL visit. Global electrical heterogeneity (GEH) was measured as spatial QRS-T angle (QRSTa), spatial ventricular gradient azimuth (SVGaz), elevation (SVGel), magnitude (SVGmag), and sum absolute QRST integral (SAIQRST). Statistical analysis accounted for the stratified two-stage area probability sample design. We fitted a multivariate latent profile generalized structural equation model adjusted for age, sex, ethnic background, education, hypertension, diabetes, smoking, dyslipidaemia, obesity, chronic kidney disease, physical activity, diet quality, average RR' interval, median beat type, and cardiovascular disease (CVD) to gain insight into the GEH profiles. Among 15 684 participants (age 41 years; 53% females; 6% known CVD), 17% had an increased probability of likely abnormal GEH profile (QRSTa 80 ± 27°, SVGaz -4 ± 21°, SVGel 72 ± 12°, SVGmag 45 ± 12 mVms, and SAIQRST 120 ± 23 mVms). There was a 23% probability for a participant of being in Class 1 with a narrow QRSTa (40.0 ± 10.2°) and large SVG (SVGmag 108.3 ± 22.6 mVms; SAIQRST 203.4 ± 39.1 mVms) and a 60% probability of being in intermediate Class 2. Conclusion: A substantial proportion (17%) in the Hispanic/Latino population had an increased probability of altered, likely abnormal GEH profile, whereas 83% of the population was resilient to harmful risk factors exposures.

8.
Artículo en Inglés | MEDLINE | ID: mdl-39181443

RESUMEN

OBJECTIVE: Valve-sparing aortic root replacement for proximal aortic dilation with aortic regurgitation is associated with excellent outcomes. Modified aortic reimplantation entails reducing the anulus size to the expected size for sex and body surface area and creating neosinuses to preserve the aortic valve. We present our mid- and late-term outcomes with the modified technique, including a single-surgeon's experience over the past 2 decades. METHODS: From January 2002 to January 2024, 528 patients underwent modified aortic reimplantation for aortic aneurysm or dilation; 491 were included in this study. End points included time-related mortality and postoperative morbidities, including aortic valve reintervention and longitudinal aortic regurgitation grade. RESULTS: There were no operative deaths. Survival at 30 days, 1 year, and 15 years were 100%, 99.6%, and 87%, respectively. Postoperative stroke occurred in 4 patients (0.81%) and reoperation for bleeding in 7 (1.4%). Moderate or severe aortic valve regurgitation was seen in 6.2% and 10% of patients at 1 and 10 years, respectively. Aortic valve mean gradients were 7.0 and 7.5 mm Hg at 1 and 10 years, respectively. Freedom from reintervention on the aortic valve was 99.9%, 99%, and 95% at 30 days, 1 year, and 15 years, respectively. CONCLUSIONS: Modified aortic reimplantation technique is a reliable and reproducible technique with excellent mid- and long-term outcomes in survival and freedom from reintervention. The results advocate for modified reimplantation in patients with enlarged aortic roots, especially in younger patients with connective tissue disorder.

9.
J Am Coll Cardiol ; 84(10): 889-900, 2024 Sep 03.
Artículo en Inglés | MEDLINE | ID: mdl-39197978

RESUMEN

BACKGROUND: The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described. OBJECTIVES: This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens. METHODS: The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression. RESULTS: Among 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus. CONCLUSIONS: In real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin.


Asunto(s)
Anticoagulantes , Aspirina , Apéndice Atrial , Fibrilación Atrial , Inhibidores de Agregación Plaquetaria , Humanos , Apéndice Atrial/cirugía , Masculino , Femenino , Aspirina/administración & dosificación , Aspirina/efectos adversos , Aspirina/uso terapéutico , Anciano , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Sistema de Registros , Anciano de 80 o más Años , Terapia Antiplaquetaria Doble/métodos , Quimioterapia Combinada , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/epidemiología , Persona de Mediana Edad
10.
JACC Cardiovasc Interv ; 17(16): 1905-1915, 2024 Aug 26.
Artículo en Inglés | MEDLINE | ID: mdl-39197989

RESUMEN

BACKGROUND: Tricuspid regurgitation (TR) is associated with worse clinical outcomes after transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (M-TEER), but little is known about its association with health status outcomes. OBJECTIVES: The aims of this study were to explore, using the Society of Thoracic Surgeons and American College of Cardiology TVT (Transcatheter Valve Therapy) Registry, the association between baseline TR and health status after TAVR and M-TEER and to determine if baseline TR was associated with clinical endpoints. METHODS: Health status was assessed using Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score in patients enrolled in the TVT Registry who underwent isolated TAVR or M-TEER between January 2019 and June 2021. The association among baseline TR and KCCQ-OS score, being alive and well, and clinical outcomes was examined. RESULTS: In total, 130,097 TAVR patients (13.1% with moderate TR, 2.3% with severe TR) and 19,593 M-TEER patients (33.2% with moderate TR, 14.7% with severe TR) were included. Mean KCCQ-OS scores were lower with severe vs moderate vs none to mild TR at baseline prior to TAVR (39.4 ± 24.2 vs 45.2 ± 24.7 vs 51.3 ± 25.3; P < 0.01) or M-TEER (38.1 ± 23.9 vs 41.9 ± 24.7 vs 45.4 ± 25.2; P < 0.01) and similarly at 30 days and 1 year. The odds of being alive and well at 1 year were lower with moderate or severe TR before TAVR (adjusted OR: 0.79 [95% CI: 0.74-0.85] and adjusted OR: 0.81 [95% CI: 0.70-0.94], respectively) and severe TR before M-TEER (adjusted OR: 0.53; 95% CI: 0.40-0.71). Furthermore, moderate or severe TR before TAVR was associated with higher 1-year mortality and readmission, whereas moderate or severe TR before M-TEER was associated with higher 1-year mortality. CONCLUSIONS: In a large cohort of U.S. patients who underwent TAVR or M-TEER, greater baseline TR was associated with worse health status and clinical outcomes. Understanding adverse outcomes of TR in patients with coexisting valvular abnormalities is important, especially with rapidly evolving transcatheter tricuspid valve interventions.


Asunto(s)
Estenosis de la Válvula Aórtica , Válvula Aórtica , Estado de Salud , Válvula Mitral , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Insuficiencia de la Válvula Tricúspide , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Femenino , Masculino , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/mortalidad , Insuficiencia de la Válvula Tricúspide/cirugía , Anciano , Factores de Tiempo , Anciano de 80 o más Años , Factores de Riesgo , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Válvula Mitral/cirugía , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Estados Unidos , Medición de Riesgo , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/mortalidad , Índice de Severidad de la Enfermedad , Recuperación de la Función , Válvula Tricúspide/fisiopatología , Válvula Tricúspide/cirugía , Válvula Tricúspide/diagnóstico por imagen , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad
11.
J Am Heart Assoc ; 13(17): e031461, 2024 Sep 03.
Artículo en Inglés | MEDLINE | ID: mdl-39189613

RESUMEN

BACKGROUND: The treatment of severe aortic stenosis has evolved considerably since the introduction of transcatheter aortic valve replacement (TAVR), yet trends in complications for patients undergoing TAVR or surgical aortic valve replacement (SAVR) at a national level have yet to be evaluated. METHODS AND RESULTS: We performed a retrospective cohort study using Medicare data to evaluate temporal trends in complications among beneficiaries, aged ≥65 years, treated with elective isolated transfemoral TAVR or SAVR between 2012 and 2019. The study end point was the occurrence of a major complication (composite outcome) during index and up to 30 days after. Multivariable logistic regression was used to assess odds of complications for TAVR and SAVR, individually over time, and for TAVR versus SAVR, over time. The cohort included 211 212 patients (mean±SD age, 78.6±7.3 years; 45.0% women). Complication rates during index following elective isolated aortic valve replacement decreased from 49% in 2012 to 22% in 2019. These reductions were more pronounced for TAVR (41% to >19%, Δ=22%) than SAVR (51% to >47%, Δ=4%). After risk adjustment, the risk of any complication with TAVR was 47% (P<0.0001) lower compared with SAVR in 2012, and 78% (P<0.0001) lower in 2019. TAVR was independently associated with reduced odds of complications each year compared with 2012, with the magnitude of benefit increasing over time (2013 versus 2012: odds ratio [OR], 0.89 [95% CI, 0.81-0.97]; 2019 versus 2012: OR, 0.35 [95% CI, 0.33-0.38]). These findings are consistent for complications up to 30 days from index. CONCLUSIONS: Between 2012 and 2019, the risk of complications after aortic valve replacement among Medicare beneficiaries decreased significantly, with larger absolute and relative changes among patients treated with TAVR than SAVR.


Asunto(s)
Estenosis de la Válvula Aórtica , Complicaciones Posoperatorias , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Femenino , Masculino , Anciano , Estados Unidos/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/epidemiología , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/tendencias , Anciano de 80 o más Años , Factores de Riesgo , Medicare , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/tendencias , Medición de Riesgo , Resultado del Tratamiento , Válvula Aórtica/cirugía , Factores de Tiempo
12.
J Soc Cardiovasc Angiogr Interv ; 3(5): 101345, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-39132458

RESUMEN

Background: Transcatheter edge-to-edge repair (TEER) improved outcomes in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) compared with guideline-directed medical therapy (GDMT) alone regardless of the severity of baseline left ventricular ejection fraction (LVEF). The study aimed to evaluate the effect of early changes in LVEF after TEER and GDMT alone in patients with HF and severe SMR. Methods: Within the COAPT trial, we evaluated outcomes according to changes in LVEF from baseline to 30 days. The primary outcome was all-cause death or HF hospitalization (HFH) between 30 days and 2 years. Results: Among 432 patients with paired echocardiographic data, 182 (42.1%) had increased LVEF (LVEF change 6.0% ± 4.9%) and 250 (57.9%) had a decrease or no change in LVEF (LVEF change -6.6% ± 5.6%) from baseline to 30 days. LVEF at 30 days increased more frequently with GDMT alone compared with TEER plus GDMT (51.4% vs 33.0%; P = .0001). Between 30 days and 2 years, there were no significant differences in death or HFH in the increase LVEF and the decrease LVEF groups (58.8% vs 51.4%; multivariable-adjusted HR, 0.97; 95% CI, 0.87-1.08; P = .59). TEER plus GDMT reduced the 30-day to 2-year rate of death or HFH compared with GDMT alone consistently in patients with increase LVEF and decrease LVEF (Pint = 0.75). Conclusions: Among patients with HF and severe SMR, early improvements in LVEF were more frequent with GDMT alone compared with TEER plus GDMT but were not associated with subsequent outcomes at 2 years. TEER reduced death or HFH during 2-year follow-up irrespective of early LVEF changes.

14.
Circ Cardiovasc Interv ; 17(9): e013750, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39056187

RESUMEN

BACKGROUND: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States. METHODS: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year. RESULTS: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients. CONCLUSIONS: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.


Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Sistema de Registros , Humanos , Apéndice Atrial/fisiopatología , Femenino , Masculino , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/terapia , Fibrilación Atrial/mortalidad , Fibrilación Atrial/fisiopatología , Anciano , Resultado del Tratamiento , Estados Unidos , Factores de Tiempo , Factores de Riesgo , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Cateterismo Cardíaco/mortalidad , Medición de Riesgo , Vigilancia de Productos Comercializados , Dispositivos de Protección Embólica , Accidente Cerebrovascular Isquémico/prevención & control , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/etiología , Diseño de Prótesis , Persona de Mediana Edad
16.
AsiaIntervention ; 10(2): 96-97, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-39070973
18.
Circ Cardiovasc Interv ; 17(9): e013697, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38837174

RESUMEN

BACKGROUND: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. METHODS: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. RESULTS: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (Pinteraction<0.05 for both instrumental variable and propensity-weighted analyses). CONCLUSIONS: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.


Asunto(s)
Estenosis de la Válvula Aórtica , Dispositivos de Protección Embólica , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Masculino , Femenino , Anciano de 80 o más Años , Anciano , Factores de Riesgo , Resultado del Tratamiento , Medición de Riesgo , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Factores de Tiempo , Estados Unidos/epidemiología , Mortalidad Hospitalaria , Embolia Intracraneal/prevención & control , Embolia Intracraneal/etiología , Embolia Intracraneal/mortalidad , Evaluación de la Discapacidad , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/diagnóstico , Factores Protectores , Estudios Retrospectivos
19.
JACC Adv ; 3(5): 100959, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38939639

RESUMEN

Background: The prognostic value of cardiac damage staging classification based on the extent of extravalvular damage has been proposed in moderate/severe aortic stenosis (AS). Objectives: The purpose of this study was to assess the association of cardiac damage staging with mortality across the spectrum of patients with AS following aortic surgical or transcatheter aortic valve replacement (AVR). Methods: We conducted a pooled meta-analysis of Kaplan-Meier-derived reconstructed time-to-event data from studies published through February 2023. Results: In total, 16 studies (n = 14,499) met our eligibility criteria and included 12,282 patients with symptomatic severe AS and 2,217 patients with asymptomatic severe/moderate AS. For patients with symptomatic severe AS, all-cause mortality was 24.0%, 27.7%, 38.0%, 56.3%, and 57.3% at 5 years in patients with cardiac damage stage 0, 1, 2, 3, and 4, respectively (stage 0 as reference; HR in stage 1: 1.30 [95% CI: 1.03-1.64]; P = 0.029; stage 2: 1.74 [95% CI: 1.41-2.16]; P < 0.001; stage 3: 2.92 [95% CI: 2.35-3.64]; P < 0.001, and stage 4: 3.51 [95% CI: 2.79-4.41]; P < 0.001). For patients with asymptomatic moderate/severe AS, all-cause mortality was 19.3%, 36.9%, 51.7%, and 67.8% at 8 years in patients with cardiac damage stage 0, 1, 2, and 3 to 4, respectively (HR in stage 1: 1.70 [95% CI: 1.21-2.38]; P = 0.002; stage 2: 2.20 [95% CI: 1.60-3.02]; P < 0.001; and stage 3 to 4: 3.90 [95% CI: 2.79-5.47]; P < 0.001). Conclusions: In patients undergoing AVR across the symptomatic and severity spectrum of AS, cardiac damage staging at baseline has important prognostic implications. This pooled meta-analysis in patients undergoing AVR suggests that staging of baseline cardiac damage could be considered for timing and selection of therapy in patients with moderate or severe AS to determine the need for earlier AVR or adjunctive pharmacotherapy to prevent irreversible cardiac damage and improve the long-term prognosis.

20.
JACC Cardiovasc Imaging ; 17(9): 1015-1027, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38795108

RESUMEN

BACKGROUND: Functional mitral regurgitation induces adverse effects on the left ventricle and the left atrium. Left atrial (LA) dilatation and reduced LA strain are associated with poor outcomes in heart failure (HF). Transcatheter edge-to-edge repair (TEER) of the mitral valve reduces heart failure hospitalization (HFH) and all-cause death in selected HF patients. OBJECTIVES: The aim of this study was to evaluate the impact of LA strain improvement 6 months after TEER on the outcomes of patients enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. METHODS: The difference in LA strain between baseline and the 6-month follow-up was calculated. Patients with at least a 15% improvement in LA strain were labeled as "LA strain improvers." All-cause death and HFH were assessed between the 6- and 24-month follow-up. RESULTS: Among 347 patients (mean age 71 ± 12 years, 63% male), 106 (30.5%) showed improvement of LA strain at the 6-month follow-up (64 [60.4%] from the TEER + guideline-directed medical therapy [GDMT] group and 42 [39.6%] from the GDMT alone group). An improvement in LA strain was significantly associated with a reduction in the composite of death or HFH between the 6-month and 24-month follow-up, with a similar risk reduction in both treatment arms (Pinteraction = 0.27). In multivariable analyses, LA strain improvement remained independently associated with a lower risk of the primary composite endpoint both as a continuous variable (adjusted HR: 0.94 [95% CI: 0.89-1.00]; P = 0.03) and as a dichotomous variable (adjusted HR: 0.49 [95% CI: 0.27-0.89]; P = 0.02). The best outcomes were observed in patients treated with TEER in whom LA strain improved. CONCLUSIONS: In symptomatic HF patients with severe mitral regurgitation, improved LA strain at the 6-month follow-up is associated with subsequently lower rates of the composite endpoint of all-cause mortality or HFH, both after TEER and GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).


Asunto(s)
Función del Atrio Izquierdo , Cateterismo Cardíaco , Insuficiencia Cardíaca , Insuficiencia de la Válvula Mitral , Válvula Mitral , Recuperación de la Función , Humanos , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/etiología , Masculino , Femenino , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/diagnóstico por imagen , Anciano , Resultado del Tratamiento , Factores de Tiempo , Anciano de 80 o más Años , Persona de Mediana Edad , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Factores de Riesgo , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Atrios Cardíacos/fisiopatología , Atrios Cardíacos/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad
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