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BACKGROUND: Clonal hematopoiesis of indeterminate potential (CHIP) occurs due to acquired mutations in bone marrow progenitor cells. CHIP confers a 2-fold risk of atherosclerotic cardiovascular disease. However, there are limited data regarding specific cardiovascular phenotypes. The purpose of this study was to define the coronary artery disease phenotype of the CHIP population-based on coronary angiography. METHODS: We recruited 1142 patients from the Vanderbilt University Medical Center cardiac catheterization laboratory and performed DNA sequencing to determine CHIP status. Multivariable logistic regression models and proportional odds models were used to assess the association between CHIP status and angiography phenotypes. RESULTS: We found that 18.4% of patients undergoing coronary angiography had a CHIP mutation. Those with CHIP had a higher risk of having obstructive left main (odds ratio, 2.44 [95% CI, 1.40-4.27]; P=0.0018) and left anterior descending (odds ratio, 1.59 [1.12-2.24]; P=0.0092) coronary artery disease compared with non-CHIP carriers. We additionally found that a specific CHIP mutation, ten eleven translocase 2 (TET2), has a larger effect size on left main stenosis compared with other CHIP mutations. CONCLUSIONS: This is the first invasive assessment of coronary artery disease in CHIP and offers a description of a specific atherosclerotic phenotype in CHIP wherein there is an increased risk of obstructive left main and left anterior descending artery stenosis, especially among TET2 mutation carriers. This serves as a basis for understanding enhanced morbidity and mortality in CHIP.
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Cateterismo Cardíaco , Hemodinámica , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico , Hemodinámica/fisiología , Cateterismo Cardíaco/métodos , Masculino , Femenino , Anciano , Prueba de Esfuerzo/métodos , Válvula Mitral/cirugía , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/métodosRESUMEN
BACKGROUND: Real-world applicability of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized controlled trial (RCT) has been debated because of careful patient selection and the contrasting results of the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) RCT. OBJECTIVES: The COAPT-PAS (COAPT Post-Approval Study) was initiated to assess the safety and effectiveness of the MitraClip in patients with secondary mitral regurgitation (SMR). METHODS: COAPT-PAS is a prospective, single-arm, observational study of 5,000 consecutive patients with SMR treated with the MitraClip at 406 U.S. centers participating in the TVT (Transcatheter Valve Therapy) registry from 2019 to 2020. The 1-year outcomes from the COAPT-PAS full cohort and the COAPT-like and MITRA-FR-like subgroups who met RCT inclusion/exclusion criteria are reported. RESULTS: Patients in the COAPT-PAS had more comorbidities, more severe HF and functional limitations, and less guideline-directed medical therapy than those in the COAPT or MITRA-FR RCTs. Patients in the COAPT-PAS full cohort and the COAPT-like (n = 991) and MITRA-FR-like (n = 917) subgroups achieved a 97.7% MitraClip implant rate, a similar and durable reduction of mitral regurgitation to ≤2+ at 1 year (90.7%, 89.7%, and 86.6%, respectively), a large improvement in quality of life at 1 year (Kansas City Cardiomyopathy Questionnaire +29 COAPT-PAS, +27 COAPT-like, and +33 MITRA-FR-like), faster procedure times, similar or lower clinical event rates compared with the RCTs' MitraClip arms, and lower clinical event rates than the RCTs' guideline-directed medical therapy only arms. One-year heart failure hospitalizations was 18.9% in COAPT-PAS, 19.7% in COAPT-like compared with 24.9% in COAPT-RCT, and 28.7% in COAPT-PAS-MITRA-FR-like compared with 47.4% in MITRA-FR-RCT. CONCLUSIONS: This large, contemporary, real-world study reinforces the safety and effectiveness of the MitraClip System in patients with SMR, including those who met the COAPT or MITRA-FR RCT inclusion/exclusion criteria and patients excluded from the RCTs.
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Insuficiencia Cardíaca , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Hospitalización , Evaluación de Resultado en la Atención de Salud , Selección de PacienteRESUMEN
Tricuspid regurgitation (TR) etiologies include primary valve pathology or secondary (functional) regurgitation from increased hemodynamic pressure or volume on the right side of the heart. Patients with severe TR have a worse prognosis independent of all other variables. Surgical treatment for TR has mostly been limited to patients undergoing concomitant left-sided cardiac surgery. The results and durability of surgical repair or replacement are not well defined. For patients with significant and symptomatic TR, transcatheter techniques would be beneficial, but these techniques and devices have been slow to develop. Much of the delay is a result of neglect and challenges in defining the symptoms associated with TR. In addition, the anatomic and physiological aspects of the tricuspid valve apparatus present unique challenges. Several devices and techniques are in various phases of clinical investigation. This review highlights the current landscape of transcatheter tricuspid interventions and future opportunities. It is imminent that these therapies become commercially available and widely adopted to have a significant positive impact on millions of patients that have been neglected.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Humanos , Resultado del Tratamiento , Cateterismo Cardíaco , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugíaRESUMEN
BACKGROUND: The relationship between left ventricular (LV) remodeling and clinical outcomes after treatment of severe mitral regurgitation (MR) in heart failure (HF) has not been examined. OBJECTIVES: The aim of this study was to evaluate the association between LV reverse remodeling and subsequent outcomes and assess whether transcatheter edge-to-edge repair (TEER) and residual MR are associated with LV remodeling in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. METHODS: Patients with HF and severe MR who remained symptomatic on guideline-directed medical therapy (GDMT) were randomized to TEER plus GDMT or GDMT alone. Baseline and 6-month core laboratory measurements of LV end-diastolic volume index and LV end-systolic volume index were examined. Change in LV volumes from baseline to 6 months and clinical outcomes from 6 months to 2 years were evaluated using multivariable regression. RESULTS: The analytical cohort comprised 348 patients (190 treated with TEER, 158 treated with GDMT alone). A decrease in LV end-diastolic volume index at 6 months was associated with reduced cardiovascular death between 6 months and 2 years (adjusted HR: 0.90 per 10 mL/m2 decrease; 95% CI: 0.81-1.00; P = 0.04), with consistent results in both treatment groups (Pinteraction = 0.26). Directionally similar but nonsignificant relationships were present for all-cause death and HF hospitalization and between reduced LV end-systolic volume index and all outcomes. Neither treatment group nor MR severity at 30 days was associated with LV remodeling at 6 or 12 months. The treatment benefits of TEER were not significant regardless of the degree of LV remodeling at 6 months. CONCLUSIONS: In patients with HF and severe MR, LV reverse remodeling at 6 months was associated with subsequently improved 2-year outcomes but was not affected by TEER or the extent of residual MR. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]; NCT01626079).
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Insuficiencia Cardíaca , Insuficiencia de la Válvula Mitral , Humanos , Remodelación Ventricular , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Resultado del Tratamiento , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/terapia , Recolección de DatosRESUMEN
BACKGROUND: Most approaches to the creation of an interatrial shunt require placement of a permanent implant to maintain patency. OBJECTIVES: The goal of this study was to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF). METHODS: This was a multicenter, uncontrolled study of patients with HFpEF/HFmrEF and NYHA functional class ≥II, ejection fraction >40%, and pulmonary capillary wedge pressure (PCWP) during supine exercise ≥25 mm Hg with PCWP-to-right atrial gradient ≥5 mm Hg. Follow-up was through 6 months with imaging to assess shunt durability. RESULTS: A total of 28 patients were enrolled: mean age was 68 ± 9 years, and 68% were female. Baseline resting and peak exercise PCWP were 19 ± 7 mm Hg and 40 ± 11 mm Hg, respectively. All procedures displayed technical success with confirmation of left-to-right flow (shunt diameter 7.1 ± 0.9 mm). At 1 month, peak exercise PCWP decreased 5.4 ± 9.6 mm Hg (P = 0.011) with no change in right atrial pressure. There were no serious device or procedure-related adverse events through 6 months. Mean 6-minute walk distance increased 101 ± 71 meters (P < 0.001); Kansas City Cardiomyopathy Questionnaire Overall Summary Score increased 26 ± 19 points (P < 0.001); N-terminal pro-B-type natriuretic peptide decreased 372 ± 857 pg/mL (P = 0.018); and shunt patency was confirmed with unchanged diameter. CONCLUSIONS: In these feasibility studies of a no-implant interatrial shunt, HFpEF/HFmrEF shunts exhibited stability with favorable safety and early efficacy signals. The results show promise toward this new approach for treating patients with HFpEF/HFmrEF and an appropriate hemodynamic profile. (Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction [ALLEVIATE-HF-1]; NCT04583527; Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction [ALLEVIATE-HF-2]; NCT04838353).
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Insuficiencia Cardíaca , Disfunción Ventricular Izquierda , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Volumen Sistólico , Función Ventricular Izquierda , Estudios de Factibilidad , Cateterismo Cardíaco , Disfunción Ventricular Izquierda/etiologíaRESUMEN
BACKGROUND: The impact of transcatheter edge-to-edge repair (TEER) on national surgical mitral valve repair (MVr) volume and outcomes is unknown. OBJECTIVES: This study aims to assess the impact of TEER availability on MVr volumes and outcomes for degenerative mitral regurgitation. METHODS: MVr volume, 30-day and 5-year outcomes, including mortality, heart failure rehospitalization and mitral valve reintervention, were obtained from the Society of Thoracic Surgeons database linked with Medicare administrative claims and were compared within TEER centers before and after the first institutional TEER procedure. A difference-in-difference approach comparing parallel trends in coronary artery bypass grafting outcomes was used to account for temporal improvements in perioperative care. RESULTS: From July 2011 through December 2018, 13,959 patients underwent MVr at 278 institutions, which became TEER-capable during the study period. There was no significant change in median annualized institutional MVr volume before (32 [IQR: 17-54]) vs after (29 [IQR: 16-54]) the first TEER (P = 0.06). However, higher-risk (Society of Thoracic Surgeons predicted risk of mortality ≥2%) MVr procedures declined over the study period (P < 0.001 for trend). The introduction of TEER was associated with reduced risk-adjusted odds of mortality after MVr at 30 days (adjusted OR: 0.73; 95% CI: 0.54-0.99) and over 5 years (adjusted HR: 0.75; 95% CI: 0.66-0.86). These improvements in 30-day and 5-year mortality were significantly greater than equivalent trends in coronary artery bypass grafting. CONCLUSIONS: The introduction of TEER has not significantly changed overall MVr case volumes for degenerative mitral regurgitation but is associated with a decrease in higher-risk surgical operations and improved 30-day and 5-year outcomes within institutions adopting the technology.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Anciano , Estados Unidos/epidemiología , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Resultado del Tratamiento , MedicareRESUMEN
Importance: In the setting of uncertain efficacy and additional, unreimbursed cost, use of an embolic protection device (EPD) during transcatheter aortic valve replacement (TAVR) has had variable uptake. The Centers for Medicare & Medicaid Services (CMS) instituted a new technology add-on payment to cover EPD use in October 2018. Objective: To evaluate the association between CMS TAVR reimbursement rates and EPD use. Design, Setting, and Participants: This cohort study used the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry to identify patients who underwent TAVR between January 2018 and September 2019. Analysis took place between July 2020 and February 2022. Main Outcomes and Measures: The association between EPD use and CMS reimbursement was assessed using multivariable logistic regression models adjusted for patient characteristics (model 1) and patient/hospital (annualized TAVR volume and teaching status) characteristics (model 2). Results: Among 511 institutions, CMS reimbursement for TAVR ranged from $28â¯062 to $111â¯280 with a median (IQR) of $45â¯884 ($40â¯331-$53â¯627). Among 84â¯353 patients (median [IQR] age, 81.0 [75.0-86.0] years; 46â¯247 male individuals [54.8%]; 3958 [4.7%] of Hispanic or Latino ethnicity; 78â¯170 White individuals [92.7%]) treated at the sites, 6012 (7.1%) underwent TAVR with EPD. Patient characteristics associated with EPD use included prior stroke (adjusted odds ratio [aOR], 1.13 [95% CI, 1.00-1.27]; P = .048), female sex (aOR, 0.85 [95% CI, 0.78-0.93]; P < .001), hemodialysis (aOR, 0.52 [95% CI, 0.40-0.68]; P < .001), and shock (aOR, 0.62 [95% CI, 0.41-0.94]; P = .03). Higher CMS reimbursement up to $50â¯000 per TAVR was associated with greater likelihood of EPD use in model 1 (per $1000; aOR, 1.08 [95% CI, 1.01-1.16]; P = .02). However, this association was no longer apparent after adjusting for site characteristics (model 2; aOR, 1.03 [95% CI, 0.96-1.11]; P = .38). Higher TAVR volume was associated with increased EPD use (per 25 TAVRs; aOR, 1.15 [95% CI, 1.09-1.21]; P < .001). There was no significant change in the odds of EPD uptake before vs after institution of the CMS new technology add-on payment across tertiles of CMS TAVR reimbursement (Wald χ2 = 3.59; P = .17). Conclusions and Relevance: EPD use during TAVR remains infrequent and is associated with multiple patient and site characteristics. While CMS reimbursement varies significantly across institutions, TAVR case volume, rather than CMS TAVR reimbursement or the CMS new technology add-on payment, appears to be the predominant factor associated with EPD use. Ongoing work is needed to understand the economic drivers that contribute to the association between procedural volume and EPD use.
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Estenosis de la Válvula Aórtica , Dispositivos de Protección Embólica , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Estudios de Cohortes , Femenino , Humanos , Masculino , Medicare , Tecnología , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estados UnidosRESUMEN
Background: Worsening aortic insufficiency (AI) is a known sequela of prolonged continuous-flow left ventricular assist device (LVAD) support with a significant impact on patient outcomes. While medical treatment may relieve symptoms, it is unlikely to halt progression. Surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) are among non-medical interventions available to address post-LVAD AI. Limited data are available on outcomes with either SAVR or TAVR for the management of post-LVAD AI. Methods: The National Inpatient Sample data collected for hospital admissions between the years 2015 and 2018 for patients with pre-existing continuous-flow LVAD undergoing TAVR or SAVR for AI were queried. The primary outcome of interest was a composite of in-hospital mortality, stroke, transient ischaemic attack, MI, pacemaker implantation, need for open aortic valve surgery, vascular complications and cardiac tamponade. Results: Patients undergoing TAVR were more likely to receive their procedure during an elective admission (57.1 versus 30%, p=0.002), and a significantly higher prevalence of comorbidities, as assessed by the Elixhauser Comorbidity Index, was observed in the SAVR group (29 versus 18; p=0.0001). We observed a significantly higher prevalence of the primary composite outcome in patients undergoing SAVR (30%) compared with TAVR (14.3%; p=0.001). Upon multivariable analysis adjusting for the type of admission and Elixhauser Comorbidity Index, TAVR was associated with significantly lower odds of the composite outcome (odds ratio 0.243; 95% CI [0.06-0.97]; p=0.045). Conclusion: In this nationally representative cohort of LVAD patients with post-implant AI, it was observed that TAVR was associated with a lower risk of adverse short-term outcomes compared with SAVR.
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Background: Heart failure with preserved ejection fraction represents a major unmet clinical need with limited treatment options. Recent device therapies under investigation have focused on decompression of the left atrium through an implantable interatrial shunt. Although these devices have shown favorable safety and efficacy signals, an implant is required to maintain shunt patency, which may increase the patient risk profile and complicate subsequent interventions requiring transseptal access. Methods: The Alleviant System is a no-implant approach to creating an interatrial shunt using radiofrequency energy to securely capture, excise, and extract a precise disk of tissue from the interatrial septum. Acute preclinical studies in healthy swine (n = 5) demonstrated the feasibility of the Alleviant System to repeatably create a 7 mm interatrial orifice with minimal collateral thermal effect and minimal platelet and fibrin deposition observed histologically. Results: Chronic animal studies (n = 9) were carried out to 30- and 60-day time points and exhibited sustained shunt patency with histology demonstrating completely healed margins, endothelialization, and no trauma to adjacent atrial tissue. Preliminary clinical safety and feasibility were validated in a first-in-human study in patients with heart failure with preserved ejection fraction (n = 15). All patients demonstrated shunt patency by transesophageal echocardiographic imaging at 1, 3, and 6 months, as well as cardiac computed tomography imaging at 6-month follow-up timepoints. Conclusions: Combined, these data support the safety and feasibility of a novel no-implant approach to creating an interatrial shunt using the Alleviant System. Continued follow-up and subsequent clinical studies are currently ongoing.
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BACKGROUND: There is a paucity of real-world data regarding the temporal trends and outcomes of trans-septal transcatheter mitral valve replacement (TS-TMVR) in the United States (US). METHODS: We queried the Nationwide Readmissions Database (October 2015 to December 2018) for patients undergoing TS-TMVR procedures. We reported the temporal trends in the utilization, in-hospital outcomes and 30-day readmissions after TS-TMVR. The main study outcome was in-hospital mortality. RESULTS: There was an increase in the number of TS-TMVR procedures over time (48 in 2015 vs. 978 in 2018, Ptrend < 0.001), with a notable increase in the proportion of women (Ptrend = 0.04) and the prevalence of diabetes (Ptrend = 0.03). There was an increase in the number of centers performing TS-TMVR (21 in 2015 vs. 164 in 2018, Ptrend < 0.001). The overall in-hospital mortality was 7.2% with no change over time (6.3% in 2015 vs. to 5.2% in 2018, Ptrend = 0.67). There was no change in the frequency of in-hospital complications after TS-TMVR; however, the median length of stay has decreased over time. The overall 30-day readmission rate was 17.8%, with no change during the study years. The most frequent cause for 30-day readmission after TS-TMVR was acute heart failure followed by bleeding and infection-related complications. Prior coagulopathy and small-sized hospitals were independently associated with higher in-hospital mortality and 30-day readmissions. CONCLUSION: This nationwide observational analysis of real-world data showed an increase in the number of TS-TMVR procedures over time, which is now performed at a greater number of centers. There was no change in the rate of in-hospital mortality, complications or 30-day readmissions; but a significant reduction in the length of hospital stay over time was noted. As the number of TS-TMVR continue to expand, these data provide a perspective on the early experience with this procedure.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Cateterismo Cardíaco/efectos adversos , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Readmisión del Paciente , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
Ischaemic mitral regurgitation is a complex process with debate in the literature as to the optimal treatment pathway. Multiple therapies are available to alleviate mitral regurgitation including medical management, transcatheter edge-to-edge repair, mitral valve repair and mitral valve replacement. Medical management with goal-directed therapy should be utilised in patients with heart failure and mild-to-moderate regurgitation. Transcatheter approaches are typically used in patients with prohibitive operative risk, although their use is expanding, especially in those with functional mitral regurgitation who are not responding to goal-directed medical therapy. It is generally accepted that patients with mild-to-moderate disease can avoid valve intervention if successful revascularisation is performed. A higher consideration should be given to valve replacement over repair in patients with severe mitral regurgitation in the setting of myocardial ischaemia. Operative course must be personalised to each patient, and continues to develop with improving technologies and ongoing research into optimal treatment.
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Most transcatheter aortic valve replacement procedures are currently performed using a percutaneous transfemoral arterial retrograde approach. Complication rates can be minimized with thorough preprocedure planning, pristine technique, and increased team experience. Vascular complications will continue to happen and require early recognition and treatment.
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Reemplazo de la Válvula Aórtica Transcatéter , Arteria Femoral/cirugía , Hemostasis , Humanos , Punciones , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVE: To estimate the prevalence of guideline-directed medical therapy (GDMT) in commercially insured US patients with heart failure with reduced ejection fraction (HFrEF) and examine the effect of GDMT on all-cause mortality. GDMT for HFrEF includes pharmacologic therapies such as ß-blockers (BB), angiotensin-converting enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin receptor-neprilysin (ARNI), mineralocorticoid receptor antagonists (MRA), and sodium-glucose cotransporter inhibitors to reduce morbidity and mortality. METHODS: Patients in the Optum Integrated File from 2007 to 2019Q3, ≥18 years, with history of HFrEF, were identified. Patients prescribed both a BB and either an ACE-I, ARB, or ARNI during 6-month post-diagnosis were assigned to the GDMT cohort. All others were assigned to the not on GDMT cohort. The GDMT cohort was further classified by those patients with a record of prescription fills for both classes of medications concurrently (GDMT concurrent medication fills). Mortality at 2 years was assessed with a Cox regression model accounting for baseline demographics, comorbidities, and diuretic use. RESULTS: This study identified 14 880 HFrEF patients, of which 70% had a record of GDMT, and 57% had a record of concurrent prescriptions. Patients in the not on GDMT cohort had 29% increased risk of mortality versus GDMT (hazard ratio 1.29; 95% CI (1.19-1.40); p < .0001). As a sensitivity analysis, the effect of patients not on GDMT compared to GDMT with concurrent medication fills was more pronounced, with a 37% increased mortality risk. CONCLUSION: In a real-world population of HFrEF patients, inadequate GDMT confers a 29% excess mortality risk over the 2-year follow-up.
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Insuficiencia Cardíaca , Antagonistas Adrenérgicos beta/uso terapéutico , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/epidemiología , Humanos , Antagonistas de Receptores de Mineralocorticoides/efectos adversos , Volumen SistólicoRESUMEN
Aim: This study examines the effect of guideline-directed medical therapy (GDMT) on healthcare utilization in patients with heart failure with reduced ejection fraction from Optum® Integrated File from 1 January 2007 to 30 June 2020. Materials & methods: Patients with both a beta blocker and either an ACE inhibitor (ACE-I), angiotensin receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor were assigned to the GDMT cohort. All others were not on GDMT. Results: Estimated annual all cause hospitalizations and emergency department visits per 100 patients was 29% (80 vs 62 patients) and 26% higher (54 vs 43 patients; p < 0.0001) and annualized hospital days were longer (1.88 vs 1.64; p = 0.0020) for patients not on GDMT. Conclusion: In a real-world population, heart failure with reduced ejection fraction, patients not optimally managed on GDMT had higher annualized healthcare utilization when compared with patients on GDMT.
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Antagonistas de Receptores de Angiotensina , Insuficiencia Cardíaca , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Humanos , Aceptación de la Atención de Salud , Volumen SistólicoRESUMEN
There are limited data to support proposed increases to the minimum institutional mitral valve (MV) surgery volume required to begin a transcatheter mitral valve repair (TMVr) program. The current study examined the association between institutional MV procedure volumes and outcomes. All 2017 Medicare fee-for-service patients who received a TMVr or MV surgery procedure were included and analyzed separately. The exposure was institutional MV surgery volume: low (1 to 24), medium (25 to 39) or high (40+). Outcomes were in-hospital mortality and 1-year postdischarge mortality and cardiovascular rehospitalization. For MV surgery patients, in-hospital mortality rates were 6.4% at low-volume, 8.7% at medium-volume and 9.8% at high-volume facilities. Rates were significantly higher for low-volume [ORâ¯=â¯1.50, 95% CI (1.23 to 1.84)] and medium-volume [ORâ¯=â¯1.33, 95% CI (1.06 to 1.67)] compared with high-volume facilities. There was no statistically significant relationship between institutional MV surgery volume and in-hospital mortality for TMVr patients, either at low-volume [ORâ¯=â¯1.52, 95% CI (0.56, 4.13)] or medium-volume [ORâ¯=â¯1.58, 95% CI (0.82, 3.02)] facilities, compared with high-volume facilities. Across all volume categories, in-hospital mortality rates for TMVr patients were relatively low (2.3% on average). For both cohorts, the rates of 1-year mortality and cardiovascular rehospitalizations were not significantly higher at low- or medium-volume MV surgery facilities, as compared with high-volume. In conclusion, among Medicare patients, there was a relation between institutional MV surgery volume and in-hospital mortality for MV surgery patients, but not for TMVr patients.
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Cateterismo Cardíaco/estadística & datos numéricos , Implantación de Prótesis de Válvulas Cardíacas/estadística & datos numéricos , Medicare , Insuficiencia de la Válvula Mitral/cirugía , Anciano , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Insuficiencia de la Válvula Mitral/mortalidad , Readmisión del Paciente , Utilización de Procedimientos y Técnicas , Tasa de Supervivencia , Resultado del Tratamiento , Estados UnidosRESUMEN
This study aimed to quantify survival rates for patients with tricuspid regurgitation (TR) using real-world data. Several clinical conditions are associated with TR, including heart failure (HF), other valve disease (OVD), right-sided heart disease (RSHD), and others that impact mortality. Optum data from January 1, 2007, through December 31, 2018 included patients age ≥18 years with TR and 12 months of continuous health plan enrollment before TR. Exclusion criteria were end-stage renal disease or known/primary organ pathology. Cohorts were created hierarchically: (1) TR with HF; (2) TR with OVD (no HF); (3) TR with RSHD only (no OVD or HF); (4) TR only. Survival was estimated using a Cox hazard model with an interaction term for TR severity and adjusted for patient demographics and Elixhauser co-morbidities. A total of 33,686 met study inclusion (1) TR with HF (26.6%); (2) TR with OVD (36.7%); (3) TR with RSHD only (17.1%); (4) TR only (19.6%). TR patients (regardless of severity) with HF, OVD or RSHD had an increased risk of mortality compared with patients with TR alone. TR severity was also significantly associated (hazard ratioâ¯=â¯1.33; pâ¯=â¯0.0002) with an increased risk of all-cause mortality. In conclusion, TR severity is significantly associated with an increased risk of all-cause mortality, independent of associated conditions including HF, OVD, or RSHD. In patients with severe TR, the mortality risk is most pronounced for patients who had RSHD without HF or OVD before their TR diagnosis.