RESUMEN
Our comprehension of atrial mechanics, atrial cardiomyopathy and their clinical implications across various cardiovascular conditions has advanced significantly. Atrial interventions can have differing effects on atrial mechanics. With the rapid increase in the use of atrial interventions, it is crucial for investigators and clinicians to acknowledge the potential adverse effects of these interventions on atrial mechanics that might not be clinically significant at the time of interventions. Recognizing the preclinical stage of atrial maladaptation might enable early interventions before the development of irreversible atrial remodeling and clinical manifestation. We review normal atrial function and mechanics, and atrial cardiomyopathy in select cardiovascular conditions. We also summarize and discuss the current evidence of the impact of various atrial interventions on atrial function and mechanics.
Asunto(s)
Cardiomiopatías , Atrios Cardíacos , Humanos , Atrios Cardíacos/fisiopatología , Cardiomiopatías/fisiopatología , Cardiomiopatías/etiología , Función Atrial/fisiología , Remodelación Atrial/fisiología , Ablación por Catéter/métodos , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/terapiaRESUMEN
Left ventricular assist device therapy for advanced heart failure is contraindicated if a patient lives in an unsafe environment and recent guidelines declare that "legal history is pertinent for determining personal constraints or financial responsibilities due to parole requirements, pending charges, and possible imprisonment," implying that incarceration would be a contraindication. International guidelines and precedent in the United States establish that medical care for incarcerated persons should match access in the community. We present a case example and practical considerations for advanced heart failure programs faced with the challenge of partnering with patients with heart failure who may be incarcerated and their correctional health systems in the care of their chronic condition. We encourage the heart failure community to not let incarceration be a contraindication to left ventricular assist device therapy.
Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Estados Unidos , Prisiones , Insuficiencia Cardíaca/terapiaRESUMEN
BACKGROUND: We sought to describe changes in demographic variables, process of care measures, and outcomes of patients treated in a regional ST-segment elevation myocardial infarction (STEMI) program over the last 15 years. METHODS: We describe demographic variables, process of care measures, and outcomes of patients treated in the program in various 5-year time periods: 2003-2007 (n = 1,821), 2008-2012 (n = 1,968), and 2013-2018 (n = 2,223). The primary outcome measures were in-hospital and 30-day mortality. RESULTS: Among 6,012 STEMI patients treated from 2003 to 2018 we observed a significant increase in mean age at presentation (62 ± 14 to 64 ± 13 years) and diabetes (14-22%, p < .01). The proportion of patients with cardiogenic shock (CS) and cardiac arrest (CA) pre-PCI increased significantly from 9.5% to 11.1% and 8.5% to 12.7% (p < .05), respectively. The median door-to-balloon (D2B) times decreased from 98 to 93 min and total ischemic time decreased from 202 to 185 min (all p < .05). Despite increased patient complexity, the proportion of nontransfer and transfer patients achieving D2B times consistent with guideline recommendations remained unchanged (for nontransfer patients 79-82%, p = .45 and for transfer patients 65-64%, p = .34). Among all STEMI patients, in-hospital mortality increased during the study period from 4.9 to 6.9% (p = .007) but remained stable (<2%) when CA and CS patients were excluded. CONCLUSIONS: Over the last 15 years, short-term STEMI mortality has increased despite improvements in care delivery metrics. Patients with CA and/or CS now represent 10% of STEMI patients and are responsible for 80% of deaths. Therefore, efforts to improve STEMI mortality, and metrics for assessing STEMI programs, should focus on these patients.
Asunto(s)
Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Intervención Coronaria Percutánea/efectos adversos , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/terapia , Choque Cardiogénico , Tiempo de Tratamiento , Resultado del TratamientoRESUMEN
BACKGROUND: Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. OBJECTIVE: We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. METHODS: In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. RESULTS: Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79-.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). CONCLUSION: Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed.
Asunto(s)
Corazón Auxiliar , Calidad de Vida , Adulto , Anciano , Análisis Factorial , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Psicometría , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
Extracorporeal membrane oxygenation has evolved, from a therapy that was selectively applied in the pediatric population in tertiary centers, to more widespread use in diverse forms of cardiopulmonary failure in all ages. We provide a practical review for cardiovascular clinicians on the application of veno-arterial extracorporeal membrane oxygenation in adult patients with cardiogenic shock, including epidemiology of cardiogenic shock, indications, contraindications, and the extracorporeal membrane oxygenation circuit. We also summarize cannulation techniques, practical management and troubleshooting, prognosis, and weaning and exit strategies, with attention to end of life and ethical considerations.
Asunto(s)
Contraindicaciones , Cardiopatías/mortalidad , Choque Cardiogénico/epidemiología , Choque Cardiogénico/terapia , Cateterismo/métodos , Oxigenación por Membrana Extracorpórea/métodos , Humanos , Resultado del TratamientoRESUMEN
BACKGROUND: In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) versus enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice. METHODS: PROVIDE-HF was a prospective study within a national research network (Patient-Centered Outcomes Research Network) of HFrEF outpatients recently initiated on sacubitril/valsartan versus controls with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change. The primary end point was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12â¯weeks. Other end points included responder analyses: ≥5-point and ≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting. RESULTS: Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and N-terminal pro-brain natriuretic peptide 1083â¯pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; Pâ¯=â¯.027) and were more likely to have aâ¯≥5-point andâ¯≥20-point response (all Pâ¯<â¯.05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; Pâ¯=â¯.101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI: 0.84-2.86; Pâ¯=â¯.16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; Pâ¯=â¯.006). CONCLUSIONS: In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change, the between-group difference in the primary end point, mean KCCQ change at 12â¯weeks was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-point improvement in KCCQ at 12â¯weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.
Asunto(s)
Aminobutiratos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Medición de Resultados Informados por el Paciente , Datos Preliminares , Calidad de Vida , Tetrazoles/uso terapéutico , Anciano , Aminobutiratos/administración & dosificación , Antagonistas de Receptores de Angiotensina/administración & dosificación , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/administración & dosificación , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Compuestos de Bifenilo , Estudios de Casos y Controles , Combinación de Medicamentos , Femenino , Insuficiencia Cardíaca/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Péptido Natriurético Encefálico/sangre , Fragmentos de Péptidos/sangre , Puntaje de Propensión , Estudios Prospectivos , Tetrazoles/administración & dosificación , ValsartánRESUMEN
Cardiogenic shock in the setting of acute myocardial infarction (AMICS) carries high mortality. A systematic, protocol-driven, approach to AMICS may improve outcomes. The 5 key "ingredients" for the managements of AMICS are: (a) early diagnosis; (b) hemodynamic assessment; (c) culprit-only coronary revascularization; (d) judicious use of mechanic circulatory support; (e) expert in-hospital treatment.
Asunto(s)
Infarto del Miocardio , Choque Cardiogénico , HumanosRESUMEN
BACKGROUND: Published data on mechanical circulatory support for elderly patients in continuous flow devices are sparse and suggest relatively poor survival. This study investigated whether LVADs can be implanted in selected patients over the age of 65 years with acceptable survival compared with published outcomes. METHODS AND RESULTS: A single-center retrospective analysis was conducted in 64 consecutive patients ≥65 years of age implanted with a continuous-flow left ventricular assist device (CF-LVAD) as either bridge to transplantation or destination therapy from August 2005 to January 2012. Baseline laboratory and hemodynamic characteristics and follow-up data were obtained. Median survival was 1,090 days. Survival was 85%, 74%, 55%, and 45% at 6 months and 1, 2, and 3 years, respectively. Our cohort had a baseline mean Seattle Heart Failure Model (SHFM) score of 2.6 ± 0.9. Observed survival was significantly better than SHFM-predicted medical survival. Stratification by age subsets, renal function, SHFM, implantation intention, or etiology did not reveal significant differences in survival. The most common cause of death was sepsis and nonlethalcomplication was bleeding. CONCLUSIONS: Our experience with patients over the age of 65 receiving CF-LVADs suggests that this group demonstrates excellent survival. Further research is needed to discern the specific criteria for risk stratification for LVAD support in the elderly.
Asunto(s)
Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/terapia , Trasplante de Corazón/mortalidad , Trasplante de Corazón/tendencias , Corazón Auxiliar/tendencias , Factores de Edad , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Resultado del TratamientoRESUMEN
BACKGROUND: HAS-BLED and CHA2DS2-VASc scores predict bleeding in patients on anticoagulation and thromboembolic (TE) risk in patients with atrial fibrillation, respectively. We hypothesized that these scores would be predictive of bleeding and TE complications following continuous-flow ventricular assist device (CF-VAD) implantation. METHODS AND RESULTS: Baseline HAS-BLED and CHA2DS2-VASc scores were retrospectively determined for 173 consecutive patients who underwent HeartMate II CF-VAD implantation at a single center from 2005 to 2011. Forty-three patients had bleeding (24.9%) and 22 had TE (12.7%) events over a 290 patient-year follow-up period. The mean ± SD HAS-BLED scores were 2.7 ± 1.0 and 1.9 ± 1.1 (P < .0001) in patients with and without bleeding, respectively. The CHA2DS2-VASc scores were 3.6 ± 1.4 and 2.9 ± 1.5 (P = .03) in patients with and without TE events, respectively. A HAS-BLED score of ≥ 3 was associated with a significantly higher risk of bleeding events compared with a score of <3 (42% vs 15%, respectively; hazard ratio [HR] 3.40, 95% confidence interval [CI] 1.82-6.32; P < .001). A CHA2DS2-VASc score of ≥ 3 was associated with a higher risk of TE events compared with a score of <3 (18% vs 4%, respectively; HR 4.02, 95% CI 1.19-13.6; P = .025). CONCLUSIONS: Baseline HAS-BLED and CHA2DS2-VASc scores of ≥ 3 conferred significantly higher risks of bleeding and TE, respectively, following HeartMate II implantation.
Asunto(s)
Insuficiencia Cardíaca/cirugía , Corazón Auxiliar/efectos adversos , Hemorragia Posoperatoria/diagnóstico , Implantación de Prótesis/efectos adversos , Medición de Riesgo/métodos , Trombosis/diagnóstico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/mortalidad , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Minnesota/epidemiología , Hemorragia Posoperatoria/epidemiología , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Trombosis/epidemiología , Trombosis/etiología , Adulto JovenRESUMEN
Background: Infective endocarditis (IE) is a feared complication after surgical valve replacement accounting for 10% to 30% of all cases of IE. Our case is unique as we present a decompensated heart failure patient with IE who urgently needed mechanical circulatory support (MCS) to stabilize while IE was treated. We used Impella to bridge him to sterile state before heart transplant was done. This case highlights the importance of different strategies for bridge to heart transplant in decompensated heart failure patients with endocarditis. Case summary: We describe a case of 62-year-old male who initially presented with severe shortness of breath with minimal exertion, weight gain, and lower extremity oedema diagnosed with acute on chronic systolic heart failure (HF) exacerbation (ACC stage D, NYHA class IV). Initial blood cultures and extensive work-up for IE were negative. He continued to decompensate haemodynamically despite inotropic support and the decision was to proceed with durable left ventricular assist device (LVAD) as bridge to orthotopic heart transplantation (OHT). Immediately prior to LVAD implantation, patient's blood cultures became positive for Cutibacterium acnes. Echocardiogram revealed IE on bioprosthetic aortic valve. Patient therefore underwent urgent aortic valve replacement (AVR) and was stabilized with Impella 5.5. Discussion: We highlight a case where MCS with Impella was used as a bridge to transplant in a decompensated HF patient who was septic. Patient was listed for OHT but was found to be septic due to IE and had to undergo AVR to achieve infection source control prior to undergoing heart transplant. Impella was used effectively to stabilize ACC stage D/NYHA class IV patient while he recovered from AVR and endocarditis before his blood cultures cleared up and he was listed for OHT. He successfully underwent OHT after 3 weeks.
RESUMEN
Right ventricular failure (RVF) is a significant cause of mortality in patients undergoing left ventricular assist device (LVAD) implantation. Although right ventricular assist devices (RVADs) can treat RVF in the perioperative LVAD period, liberal employment before RVF is not well established. We therefore compared the survival outcomes between proactive RVAD placement at the time of LVAD implantation with a bailout strategy in patients with RVF. Retrospectively, 75 adult patients who underwent durable LVAD implantation at our institution and had an RVAD placed proactively before LVAD implantation or as a bailout strategy postoperatively due to hemodynamically unstable RVF were evaluated. Patients treated with a proactive RVAD strategy had lower Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and a higher proportion of these required temporary mechanical circulatory support (MCS) preoperatively. Preoperative hemodynamic profiling showed a low pulmonary artery pulsatility index (PAPi) score of 1.8 ± 1.4 and 1.6 ± 0.94 ( p = 0.42) in the bailout RVAD and proactive RVAD groups, respectively. Survival at 3, 6, and 12 months post-LVAD implantation was statistically significantly higher in patients who received a proactive RVAD. Thus, proactive RVAD implantation is associated with short- and medium-term survival benefits compared to a bailout strategy in RVF patients undergoing LVAD placement.
Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Masculino , Persona de Mediana Edad , Femenino , Estudios Retrospectivos , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/mortalidad , Adulto , Disfunción Ventricular Derecha/etiología , Disfunción Ventricular Derecha/fisiopatología , Resultado del Tratamiento , Hemodinámica/fisiología , AncianoRESUMEN
Although current studies support the use of prophylactic distal perfusion catheters (DPCs) to decrease limb ischemia in patients on venoarterial extracorporeal membrane oxygenation (VA ECMO), methods for monitoring limb ischemia differ between studies. We evaluated the safety of a selective rather than prophylactic DPC strategy at a single center with a well-established protocol for limb ischemia monitoring. Distal perfusion catheters were placed selectively if there was evidence of hypoperfusion at any point until decannulation. All patients were followed daily by vascular surgery with continuous regional saturation monitoring. Of 188 patients supported with VA ECMO, there were no significant differences in baseline characteristics between patients with upfront, delayed, and no DPC. Thirty day mortality was highest in patients with an upfront DPC (56% in the upfront DPC group, 19% in the delayed DPC group, and 22% in the no-DPC group, p < 0.001). The incidence of major bleeding, fasciotomy, and amputation in the entire cohort was 3.7%, 3.7%, and 0%, respectively. With strict adherence to a protocol for limb ischemia monitoring, a selective rather than prophylactic DPC strategy is safe and may obviate the risks of an additional arterial catheter.
RESUMEN
Heart failure is a clinical syndrome characterized by the inability of the heart to meet the circulatory demands of the body without requiring an increase in intracardiac pressures at rest or with exertion. Hemodynamic parameters can be measured via right heart catheterization, which has an integral role in the full spectrum of heart failure: from ambulatory patients to those in cardiogenic shock, as well as patients being considered for left ventricular device therapy and heart transplantation. Hemodynamic data are critical for prompt recognition of clinical deterioration, assessment of prognosis, and guidance of treatment decisions. This review is a field guide for hemodynamic assessment, troubleshooting, and interpretation for clinicians treating patients with heart failure.
Asunto(s)
Cateterismo Cardíaco , Insuficiencia Cardíaca , Hemodinámica , Humanos , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/diagnóstico , Cateterismo Cardíaco/métodos , Hemodinámica/fisiologíaRESUMEN
AIMS: Despite increased temporary mechanical circulatory support (tMCS) utilization for acute myocardial infarction complicated by cardiogenic shock (AMI-CS), data regarding efficacy and optimal timing for tMCS support are limited. This study aimed to describe outcomes based on tMCS timing in AMI-CS and to identify predictors of 30-day mortality and readmission. METHODS AND RESULTS: Patients with AMI-CS identified in the National Readmissions Database were grouped according to the use of tMCS and early (<24â h) vs. delayed (≥24â h) tMCS. The correlation between tMCS timing and inpatient outcomes was evaluated using linear regression. Multivariate logistic regression was used to identify variables associated with 30-day mortality and readmission. Of 294 839 patients with AMI-CS, 109 148 patients were supported with tMCS (8067 veno-arterial extracorporeal membrane oxygenation, 33 577 Impella, and 79 161 intra-aortic balloon pump). Of patients requiring tMCS, patients who received early tMCS (n = 79 906) had shorter lengths of stay (7 vs. 15 days, P < 0.001) and lower rates of ischaemic and bleeding complications than those with delayed tMCS (n = 32 241). Patients requiring tMCS had higher in-hospital mortality [odds ratio (95% confidence interval)] [1.7 (1.7-1.8), P < 0.001]. Among patients requiring tMCS, early support was associated with fewer complications, lower mortality [0.90 (0.85-0.94), P < 0.001], and fewer 30-day readmissions [0.91 (0.85-0.97), P = 0.005] compared with patients with delayed tMCS. CONCLUSION: Among patients receiving tMCS for AMI-CS, early tMCS was associated with fewer complications, shorter lengths of stay, lower hospital costs, and fewer deaths and readmissions at 30 days.
Asunto(s)
Oxigenación por Membrana Extracorpórea , Corazón Auxiliar , Mortalidad Hospitalaria , Contrapulsador Intraaórtico , Infarto del Miocardio , Choque Cardiogénico , Humanos , Choque Cardiogénico/terapia , Choque Cardiogénico/mortalidad , Masculino , Femenino , Infarto del Miocardio/complicaciones , Infarto del Miocardio/mortalidad , Oxigenación por Membrana Extracorpórea/métodos , Persona de Mediana Edad , Mortalidad Hospitalaria/tendencias , Anciano , Contrapulsador Intraaórtico/métodos , Contrapulsador Intraaórtico/estadística & datos numéricos , Estudios Retrospectivos , Factores de Tiempo , Readmisión del Paciente/estadística & datos numéricos , Readmisión del Paciente/tendencias , Estados Unidos/epidemiología , Resultado del Tratamiento , Tasa de Supervivencia/tendencias , Tiempo de Internación/estadística & datos numéricos , Estudios de SeguimientoRESUMEN
AIMS: Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. METHODS AND RESULTS: Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population. CONCLUSIONS: In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.
Asunto(s)
Seno Coronario , Estudios de Factibilidad , Atrios Cardíacos , Insuficiencia Cardíaca , Volumen Sistólico , Humanos , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/terapia , Femenino , Masculino , Volumen Sistólico/fisiología , Anciano , Atrios Cardíacos/fisiopatología , Atrios Cardíacos/diagnóstico por imagen , Seno Coronario/fisiopatología , Resultado del Tratamiento , Persona de Mediana Edad , Ecocardiografía/métodos , Calidad de Vida , Cateterismo Cardíaco/métodos , Estudios Prospectivos , Función Ventricular Izquierda/fisiología , Estudios de Seguimiento , Hemodinámica/fisiologíaRESUMEN
Despite substantial improvements in treatment for chronic heart failure, morbidity and mortality for acute decompensated heart failure (ADHF) remain high. Treatment of ADHF is focused on controlling symptoms rather than improving long-term outcomes. The vasodilators nitroglycerin (NTG) and sodium nitroprusside (SNP) have been used in ADHF for decades, but, since the development of nesiritide 10 years ago, interest in new vasodilators has grown. Therapies that improve not only hemodynamics and symptoms but also long-term outcomes are in high demand, and numerous new vasodilatory agents have been investigated, including various natriuretic peptides, soluble guanylyl cyclase agents, renin-angiotensin-aldosterone system-modifying agents, and others. A review of the literature shows that few of them rise to the challenge set by NTG and SNP.
Asunto(s)
Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/tratamiento farmacológico , Vasodilatadores/uso terapéutico , Enfermedad Aguda , Animales , Insuficiencia Cardíaca/epidemiología , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodosRESUMEN
BACKGROUND: Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option. OBJECTIVES: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF. METHODS: A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise. RESULTS: Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices. CONCLUSIONS: In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.