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BACKGROUND: Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities available for early AF detection in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long-term arrhythmia information via remote monitoring. METHODS AND RESULTS: Confirm-AF is a prospective randomized, nonblinded, two arm, multicenter clinical trial to be performed in the United States, enrolling 477 patients with a history of HF hospitalization and left ventricular ejection fraction >35% from 30 medical sites. Patients will be randomized in a 2:1 fashion to undergo ICM implant with remote monitoring and symptom-triggered mobile app transmissions versus (vs.) Non-ICM management and follow-up. The primary objective of this trial is to compare the time to first detection of AF lasting > 5 min using an Abbott ICM compared to non-ICM monitoring in symptomatic HF patients. This article describes the design and analytic plan for the Confirm-AF trial. CONCLUSIONS: The Confirm-AF trial seeks to accurately define the burden of AF in high-risk HF patients with LVEF > 35% using an Abbott ICM. A finding showing significantly higher incidence of AF along with improved clinical outcomes with ICM monitoring is expected to have substantial clinical implications and may change the method of monitoring high-risk HF patients.
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Fibrilação Atrial , Insuficiência Cardíaca , Humanos , Estados Unidos , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Estudos Prospectivos , Volume Sistólico , Eletrocardiografia , Eletrocardiografia Ambulatorial/métodos , Função Ventricular Esquerda , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/diagnósticoRESUMO
BACKGROUND: Clinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation. OBJECTIVES: The authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. METHODS: The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated. RESULTS: Age, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next. CONCLUSIONS: A practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955).
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Insuficiência Cardíaca , Coração Auxiliar , Humanos , Insuficiência Cardíaca/terapia , Fatores de Risco , Pressão Propulsora Pulmonar , Medição de RiscoRESUMO
Targeted blood pressure (BP) control is a goal of left ventricular assist device medical management, but the interpretation of values obtained from noninvasive instruments is challenging. In the MOMENTUM 3 Continued Access Protocol, paired BP values in HeartMate 3 (HM3) patients were compared from arterial (A)-line and Doppler opening pressure (DOP) (319 readings in 261 patients) and A-line and automated cuff (281 readings in 247 patients). Pearson (R) correlations between A-line mean arterial (MAP) and systolic blood pressures (SBP) were compared with DOP and cuff measures according to the presence (>1 pulse in 5 seconds) or absence of a palpable radial pulse. There were only moderate correlations between A-line and noninvasive measurements of SBP (DOP R = 0.58; cuff R = 0.47) and MAP (DOP R = 0.48; cuff R = 0.37). DOP accuracy for MAP estimation, defined as the % of readings within ± 10 mmHg of A-line MAP, decreased from 80% to 33% for DOP ≤ 90 vs. >90 mmHg, and precision also diminished (mean absolute difference [MAD] increased from 6.3 ± 5.6 to 16.1 ± 11.4 mmHg). Across pulse pressures, cuff MAPs were within ±10 mmHg of A-line 62.9%-68.8% of measures and MADs were negligible. The presence of a palpable pulse reduced the accuracy and precision of the DOP-MAP estimation but did not impact cuff-MAP accuracy or precision. In summary, DOP may overestimate MAP in some patients on HM3 support. Simultaneous use of DOP and automated cuff and radial pulse may be needed to guide antihypertensive medication titration in outpatients on HM3 support.
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Determinação da Pressão Arterial , Coração Auxiliar , Pressão Sanguínea/fisiologia , Frequência Cardíaca , Coração Auxiliar/efeitos adversos , Humanos , Ultrassonografia Doppler/métodosRESUMO
There are limited data on the association of smoking with the risk of stroke following left ventricular assist device (LVAD) implantation. We designed this study to analyze the impact of smoking status at the time of LVAD implantation on stroke. We hypothesized that current smokers are at increased risk of stroke when compared with patients who were former or never smokers. The study population comprised of 369 patients in the University of Rochester Medical Center LVAD database, implanted with an LVAD between 2008 and 2018. Patients were stratified as current smoker (smoking within 30 days before LVAD implantation), former smoker, and never smoker. Stroke was defined as a transient ischemic attack or cerebrovascular accident (hemorrhagic or ischemic). There were 45 current smokers, 198 former smokers, and 125 never smokers. Current smokers were younger (mean age 50 ± 11 years), as compared with former (58 ± 12 years) and never smokers (56 ± 13 years) p < 0.001. At 2 years following LVAD implantation, the cumulative incidence of stroke was significantly higher among current smokers (39%) as compared with former and never smokers (16% and 15%, respectively; p = 0.022 for the overall difference during follow-up). In a multivariate model adjusted for significant clinical variables, current smoking was associated with a significant 88% (p = 0.018) higher risk of stroke when compared with all noncurrent smokers. In conclusion, our data suggest that LVAD candidates who are current smokers experience a significantly higher risk of stroke following device implantation.
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Insuficiência Cardíaca , Coração Auxiliar , Acidente Vascular Cerebral , Adulto , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/etiologia , Coração Auxiliar/efeitos adversos , Humanos , Incidência , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Fumar/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologiaRESUMO
BACKGROUND: Studies of long-term inotrope use in advanced HF have previously provided limited and conflicting results. This study aimed to evaluate the safety and efficacy of long-term milrinone use and identify predictors of failure to bridge to orthotropic heart transplant (OHT) in a cohort of end-stage heart failure (HF) patients listed for heart transplantation and receiving inotrope therapy. METHODS: The study included 150 adults listed for OHT at a single center from 2001 to 2017 who received milrinone therapy for ≥30 days. Multivariate Cox proportional hazards models were used to identify factors associated with "failure" (left ventricular assist device, intra-aortic balloon pump, status downgrade due to instability, death) vs. "success" (OHT, recovery) during bridging to OHT. RESULTS: "Failure" occurred in 33 (22%) patients. Factors independently associated with failure included male sex (HR = 7.6; p = 0.004), no implantable cardioverter-defibrillator (HR = 3.8; p = 0.009), and lack of guideline-directed medical therapy (GDMT) with a beta-blocker (HR = 7.8; p = 0.002) or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (HR = 6.3; p < 0.001). Patients who received fewer guideline-directed medications had a higher cumulative probability of failure. Adverse events included central line-associated bloodstream infection (2.55 per 1000 line-days) and arrhythmia (1.59 per 1000 treatment-days). CONCLUSIONS: Our findings suggest that long-term milrinone therapy in selected patients is associated with a high rate of successful bridging to OHT and a low rate of adverse events. Patients intolerant of GDMT are more likely to fail to bridge to OHT without mechanical support. Sex differences in outcomes associated with milrinone therapy should be explored.
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Insuficiência Cardíaca , Transplante de Coração , Coração Auxiliar , Adulto , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Masculino , Milrinona/efeitos adversos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: History of prior cardiac surgery has traditionally been considered a risk factor for subsequent cardiac procedures. The aim of this study was to investigate the outcomes of patients implanted with a left ventricular assist device via redo sternotomy. METHODS: Prospectively collected data were reviewed for all patients implanted with a continuous-flow left ventricular assist device at a single institution from December 2006 through June 2018. Patients were separated into 2 cohorts: those with a history of prior cardiac surgery (redo sternotomy) and those undergoing primary sternotomy at the time of left ventricular assist device implantation. The primary outcome was overall survival. RESULTS: Of the 321 patients included in the study, 77 (24%) were implanted via redo sternotomy and 244 (76%) via primary sternotomy. The redo sternotomy cohort was generally older (59 ± 10 vs 57 ± 12 years, P = 0.050) and had a higher incidence of ischaemic disease (70% vs 49%, P = 0.002). The Kaplan-Meier survival analysis demonstrated that overall survival was not significantly different between the redo sternotomy and primary sternotomy groups (6-month survival: 86% vs 92%; 5-year survival: 53% vs 51%; log-rank P = 0.590 for overall difference during follow-up). The propensity score analysis consistently showed that redo sternotomy was not significantly associated with mortality risk (hazard ratio 1.19, 95% confidence interval 0.73-1.93; P = 0.488). Redo sternotomy patients were more likely to require rehospitalization during their first year postoperatively (P = 0.020) and spent less time out of the hospital during the first year (P = 0.046). CONCLUSIONS: The redo sternotomy cohort represents a more technically challenging patient population, but overall survival similar to that of primary sternotomy patients can be achieved.
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Procedimentos Cirúrgicos Cardíacos/métodos , Insuficiência Cardíaca/cirurgia , Ventrículos do Coração/fisiopatologia , Coração Auxiliar , Complicações Pós-Operatórias/epidemiologia , Pontuação de Propensão , Feminino , Ventrículos do Coração/cirurgia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
Background and study aims Left ventricular assist device (LVAD) placement is a therapeutic modality for patients with end-stage heart failure. Gastrointestinal bleeding is a common complication following LVADâimplantation. The aim of this study was to report our experience in management and outcomes of gastrointestinal bleeding in a large cohort of patients with LVADs. Patients and methods We performed a retrospective review of all patients who underwent LVAD implantation at the University of Rochester Medical Center from January 2008 to June 2017. Data were collected on patient characteristics, clinical aspects of gastrointestinal bleeding events, and procedural interventions. A Cox proportional hazard model was utilized to identify potential risk factors for a gastrointestinal bleeding event. Results During the study period, 345 patients underwent LVAD implantation. Of these, 125 patients (36.2â%) experienced 297 gastrointestinal bleeding events resulting in 533 endoscopic procedures. The diagnostic yield of endoscopy in determining a bleeding source was 49.5â%. If required, therapeutic interventions were successful in achieving homeostasis in 96.2â% of procedures. Our 30-day overall post-procedure adverse event (AE) rate was 6.6â%. Procedure-related (bleeding, infection, and perforation) AEs were very minimal (2.8â%). A Cox proportional hazard model indicated that older age at implant, female sex, African-American race, diabetes mellitus, and pulmonary hypertension were statistically significant predictors of a gastrointestinal bleeding event following LVADâimplantation. Conclusions LVADâpatients have a high risk of gastrointestinal bleeding. Endoscopy was able to safely locate a bleeding lesion in approximately half of our patients and was successful in treating bleeding lesions in a majority of the cases.
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OBJECTIVE: Early reports of less invasive techniques for left ventricular assist device (LVAD) implantation have demonstrated promising results. We sought to investigate the safety and feasibility of implementing the complete sternal-sparing (CSS) approach for LVAD implantation in patients with a history of prior cardiac operation. METHODS: This was a retrospective review of prospectively collected data for all patients implanted with a fully magnetically levitated LVAD from April 2017 through December 2018. Patients were dichotomized based on surgical approach: CSS or full median sternotomy (FS). Perioperative complications and overall survival were compared between cohorts. RESULTS: Of the 29 eligible patients, 15 (52%) were implanted via the CSS approach and 14 (48%) via FS. Preoperative characteristics were similar between cohorts. Overall survival to discharge was 93% for CSS compared to 71% for FS (P = 0.169). The CSS cohort demonstrated fewer postoperative complications, including fewer cases of severe right ventricular failure (P = 0.006) and less blood product utilization (P = 0.015). Median hospital length of stay was significantly shorter for the CSS cohort (median 13 vs 32.5 days, P = 0.016). Neither cohort had any 30-day readmissions. CONCLUSIONS: Early data suggest that the CSS technique is a safe and effective technique for patients with a history of prior sternotomy. Further studies are needed to validate this single-center experience.
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Procedimentos Cirúrgicos Cardíacos , Coração Auxiliar , Tratamentos com Preservação do Órgão , Esternotomia , Esterno/cirurgia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos , Complicações Pós-Operatórias , Implantação de Prótese/métodos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Donation after Circulatory Death (DCD) is an alternative to Donation after Brain death (DBD), and is a growing strategy for organ procurement in the United States(US). The purpose of this analysis was to review the number and quality of hearts in one United Network for Organ Sharing (UNOS) Region that were not utilized as a potential consequence of nonheart DCD donation. We retrospectively identified all successful US DCD solid organ donors from 1/2011 to 3/1/2017, defined an ideal heart donor by age and left ventricular ejection fraction (LVEF), and then reviewed the donor charts of unused hearts in New York and Vermont (UNOS Region 9). Of 8302 successful DCD donors across the United States, 5033 (61%) were between 18 and 49 years of age, and 872 had a screening echocardiogram, with 573 (66%) measuring an EF >50%. Of these 573 potential donors, 44 (7.7%) were from Region 9. Detailed donor chart review identified 36 ideal heart donors, 24 (66.7%) with anoxic brain injury. Trends in Region 9 DCD donation increased from 4 unused hearts in 2011, to 13 in 2016. In the context of severe organ scarcity, these data indicate that implementation of DCD heart transplantation in the United States would improve overall donation rates and provide a pathway to utilize these ideal donor hearts.
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Transplante de Coração/legislação & jurisprudência , Doadores de Tecidos , Obtenção de Tecidos e Órgãos/métodos , Adolescente , Adulto , Feminino , Transplante de Coração/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Obtenção de Tecidos e Órgãos/legislação & jurisprudência , Estados Unidos , Função Ventricular Esquerda/fisiologia , Adulto JovemRESUMO
Exercise and cardiac rehabilitation have been underused therapy options for patients with congestive heart failure despite being recommended in international guidelines and being covered by Medicare in the US. This article reviews the evidence behind this treatment strategy and details current trials that will contribute to the evidence base.
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The association of an implantable cardioverter defibrillator (ICD) with survival in patients with left ventricular assist devices (LVADs) is not well understood. We evaluated all-cause mortality by the presence of an ICD at the time of LVAD implantation, or by ICD implantation after LVAD placement in 191 patients, using Kaplan-Meier survival analyses and Cox models with multivariate adjustment. During the median follow-up of 23 months, 33 of 129 patients (26%) with an ICD and 17 of 62 patients (27%) without an ICD died. Patients had similar all-cause mortality with or without an ICD before LVAD, after censoring for post-LVAD ICD implantation (log-rank p = 0.889). Multivariate models after adjustments revealed no statistically significant survival benefit from an ICD before LVAD (hazard ratio [HR]: 0.65, 95% CI: 0.27-1.57, p = 0.340). Thirty-one of 62 (50%) patients without an ICD before LVAD implantation subsequently received an ICD after LVAD, although these patients did not have significantly better survival when compared with those with no ICD in a time-dependent analysis (HR: 0.70, 95% CI: 0.25-1.95, p = 0.497). Among LVAD patients, neither a previously implanted ICD nor a new ICD implantation after LVAD yielded statistically significant survival benefit. Further studies are warranted to investigate the role of ICD implantation in LVAD patients.
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Desfibriladores Implantáveis , Insuficiência Cardíaca/terapia , Coração Auxiliar , Adulto , Idoso , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos RetrospectivosRESUMO
BACKGROUND: Advancements in left ventricular assist device (LVAD) technology have improved long-term survival for properly selected patients with advanced heart failure. However, the subset of patients in critical cardiogenic shock remain difficult to treat with persistently high patient morbidity and mortality. The goal of this study is to describe our institutional experience utilizing extracorporeal membrane oxygenation (ECMO) as a bridge to LVAD for patients in cardiogenic shock comparing the less invasive complete sternal-sparing (CSS) surgical technique to median sternotomy. METHODS: Data was collected as a single center retrospective review of patients implanted with a continuous-flow LVAD directly off ECMO from 2012 to 2018. Patients were stratified by LVAD surgical technique. The primary outcome was survival to discharge. Secondary outcomes included postoperative complications, resource utilization and survival at 6-months. RESULTS: Of the 37 patients implanted directly off ECMO, 26 (70%) patients were implanted via median sternotomy and 11 (30%) patients by the CSS approach. Median time on ECMO support was 8 days (range, 2-29 days). Preoperative characteristics were similar between groups. Survival to discharge was 78% overall (73% vs. 91% CSS, P=0.391). The CSS cohort had fewer postoperative complications, including fewer transfusions (P=0.044) and trend towards less right ventricular (RV) failure (62% vs. 27% CSS, P=0.079). Both cohorts required similar median length of stay (LOS) in the intensive care unit (ICU) (11 vs. 12 days, P=0.695) and similar overall hospital LOS (34 vs. 22 days, P=0.242). Overall survival was 74% at six months (68% vs. 89% CSS, P=0.386). CONCLUSIONS: VA ECMO can be used effectively as a bridge-to-LVAD for patients in cardiogenic shock. The less invasive CSS approach demonstrates potential advantages to median sternotomy. Further study is needed to better understand the benefits of less invasive surgical techniques.
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BACKGROUND: Immunosuppressant medications are essential for long-term survival following transplantation but increase the risk of developing skin cancer. Prevention and early detection of skin cancer requires screening and sun protection behaviors that can be achieved with patient education. PROBLEM STATEMENT: Our method for educating post heart transplant patients regarding skin cancer was inconsistent and was not effective. The aim of this project was to develop and integrate a multimodal skin cancer education program to increase knowledge and protective behaviors for heart transplant recipients. METHODS: Twenty-five post heart transplant patients who were scheduled to be seen for routine posttransplant care at a single-center transplant center between October 26, 2016, and November 15, 2016, took part in a multimodal skin cancer education program. RESULTS: There was a significant increase in knowledge between pretest and posttest 1 ( P <.01) and pretest and posttest 2 ( P <.01). A significant increase in sun protective behavior was noted. The project noted that knowledge and behavior was retained, knowledge score posttest 1 to posttest 2 ( P = .085), all had seen a dermatologist or had an appointment scheduled, and self skin exam retention was noted between posttest 1 and posttest 2 ( P = .25). Process Addressed: The feasibility of and findings from this intervention have led the clinic team to implement this protocol as part of the standard care for all patients. CONCLUSIONS: These data suggests that a multimodal intensive skin cancer education program may be effective at increasing knowledge and protective behavior with heart transplant recipients.
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Educação em Saúde/métodos , Transplante de Coração/efeitos adversos , Educação de Pacientes como Assunto/métodos , Neoplasias Cutâneas/etiologia , Neoplasias Cutâneas/prevenção & controle , Transplantados/educação , Transplantados/psicologia , Idoso , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Hospedeiro Imunocomprometido , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Fatores de Risco , Inquéritos e QuestionáriosRESUMO
Cardiac transplantation is the gold standard treatment for patients with advanced congestive heart failure that is refractory to maximal medical therapy. However, donor heart availability remains the major limiting factor, resulting in a large number of patients waiting long periods of time before transplantation. As a result, mechanical circulatory support devices have been increasingly used as a 'bridge' in order to sustain organ function and stabilise haemodynamics while patients remain on the transplant waiting list or undergo left ventricular assist device surgery. Intra aortic balloon pumps (IABP) are commonly used for temporary circulatory support in patients with advanced heart failure. IABP is traditionally placed percutaneously through the transfemoral artery approach. The major limitation with this approach is ambulatory restriction that can promote deconditioning, particularly in situations of prolonged circulatory support. A subclavian/axillary artery approach IABP insertion allows patients to be ambulatory during the pre-transplant period. In this review, we aim to summarise the physiology of IABP, the evidence for its use in advanced CHF and the efficacy and safety of subclavian artery IABP insertion.
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Limited data assessing the clinical significance of post-left ventricular assist device (LVAD) in renal function are available. We aimed to investigate the impact of changes in renal function after LVAD implantation on subsequent long-term outcomes. We followed 184 patients with HeartMate II LVADs implanted between May 2008 and November 2014. Serial assessment of renal function, was performed at baseline and at day 1, day 7, 1 month, 3 months, 6 months, 1 year, and 2 years after implantation. Effects of 1-month GFR and changes in GFR from baseline to 1 month on long-term mortality and hospital re-admission were evaluated. There were 30 patients with GFR <45 (low), 44 with GFR 45 to 59 (intermediate), and 110 with GFR ≥60 (normal) at baseline. Only patients with baseline GFR <45 experienced significant improvement in GFR after 2 years of follow-up (p = 0.012). At 1 month, a higher GFR category was significantly associated with a 31% reduction in mortality (hazard ratio [HR] 0.69, CI 0.49 to 0.98, p = 0.036), but not re-admission. Patients with baseline low and intermediate GFR who had no improvement in renal function category at 1 month experienced significantly greater risk of mortality (HR 1.95, CI 1.10 to 3.43, p = 0.022) and re-admission (HR 1.75, CI 1.07 to 2.84, p = 0.025), relative to patients whose GFR was normal at baseline and 1 month. In conclusion, renal function after LVAD implantation improves in patients with GFR <45. Change in renal function from baseline to 1 month after implantation is a powerful marker of long-term outcomes.
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Taxa de Filtração Glomerular/fisiologia , Coração Auxiliar , Rim/fisiopatologia , Disfunção Ventricular Esquerda/terapia , Função Ventricular Esquerda/fisiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , New York/epidemiologia , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Disfunção Ventricular Esquerda/mortalidadeRESUMO
This study was performed to determine if organ selection practices for heart utilization by Region 9 transplant programs were optimal, and to identify opportunities to increase local organ recovery. A retrospective review of de-identified region-wide donor data January 1, 2010 through December 31, 2013 was performed. Over the study period 537 heart donors were identified, of which 321 (60%) were transplanted. Two hundred-sixteen consented hearts were not used; 190 of these were not recovered, and 26 were recovered but not transplanted. Of these, 245/321 (76%) hearts were transplanted at one of 5 regional programs, 15 (5%) were transplanted out of region as primary offers, and 61 (19%) were turned down in region and exported. Of the 61 exported hearts, 43 were turned down in region for donor-related "quality" codes (UNOS 830, 833-837) by at least one program, the remaining 18 hearts were turned down for non-"quality" reasons, primarily histocompatibility and size. Only 5/43 exported were turned down for "quality" reasons by all regional programs offered the organ. A review of consented, not recovered donor offers suggested an additional 28 organs were possibly appropriate for transplant. Our review of regional turn-downs suggests transplant centers could potentially identify additional usable organs without compromising short-term outcomes.
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Seleção do Doador , Alocação de Recursos para a Atenção à Saúde/normas , Transplante de Coração , Alocação de Recursos/normas , Doadores de Tecidos/provisão & distribuição , Obtenção de Tecidos e Órgãos/métodos , Obtenção de Tecidos e Órgãos/normas , Adulto , Feminino , Seguimentos , Humanos , Masculino , Prognóstico , Estudos RetrospectivosRESUMO
INTRODUCTION: The wearable cardioverter defibrillator (WCD) may allow stabilization until reassessment for an implantable cardioverter defibrillator (ICD) among high-risk heart failure (HF) patients. However, there are limited data on the WCD benefit in the acute decompensated HF setting. METHODS AND RESULTS: The Study of the Wearable Cardioverter Defibrillator in Advanced Heart Failure Patients (SWIFT) was a prospective clinical trial carried out at two medical centers. Patients hospitalized with advanced HF symptoms and reduced left ventricular ejection function (LVEF) were enrolled and prescribed a WCD prior to discharge for a total of 3 months. Outcome measures included arrhythmic events, WCD discharge, and death. Study patients (n = 75, mean age 51 ± 14 years, 31% women) had a mean LVEF of 21.5 ± 10.4%. Non-ischemic cardiomyopathy was present in 66% of patients. The median WCD wearing time was 59 (interquartile range 17-97) days, and 80% of patients wore the device >50% of daily hours. WCD interrogations showed a total of 8 arrhythmic events in 5 patients, including 3 nonsustained or self-terminating ventricular tachycardia (VT) events, and one polymorphic VT successfully terminated by the WCD. None of the patients died while wearing the device and no inappropriate device therapies occurred. Upon termination of treatment with the WCD, 21 patients (28%) received an ICD. At 3 years, the cumulative death rate was 20% in the ischemic and 21% in non-ischemic cardiomyopathy patients. CONCLUSION: A management strategy incorporating the WCD can be safely used to bridge the decision regarding the need for ICD implantation in high-risk patients with advanced HF.
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Desfibriladores/tendências , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/tendências , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Adulto , Idoso , Estudos de Coortes , Desfibriladores Implantáveis/tendências , Feminino , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
OBJECTIVES: There are various strategies in the use of temporary mechanical circulatory support following orthotopic heart transplant (OHT). We sought to examine the outcomes following different temporary mechanical circulatory support strategies for acute graft failure. METHODS: Patients who received an OHT between 2001 and 2015 at a single institution were retrospectively reviewed. Patients were divided into 2 groups based on the need for temporary mechanical circulatory support (TMCS). RESULTS: A total of 9.9% (19 of 192) of patients required TMCS following OHT. There were no significant differences in the preoperative demographics between groups. Six patients (32%) required a biventricular assist device, 9 patients (47%) required a right ventricular assist device and 4 patients (21%) required a veno-arterial extracorporeal membrane oxygenator. Perioperative morbidity was comparable between all groups. Our entire TMCS cohort had 94.7% 30-day and 61.1% 1-year survival. When compared with the OHT patients with no TMCS (97.1% at 30 days and 92.8% at 1 year), survival was inferior in TMCS patients ( P = 0.01 at 30 days, P < 0.001 at 1 year, P < 0.001 overall). CONCLUSIONS: Acute graft failure requiring TMCS has inferior overall survival. Larger, multi-institutional studies are needed to further elucidate these differences and identify the best TMCS mode.