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BACKGROUND: Patients have substantial variability in perioperative outcomes after left ventricular assist device (LVAD) implant. A perioperative multidimensional tool integrating mortality, adverse events (AEs), and patient-reported outcomes to assist in quality improvement initiatives is needed. METHODS: Patients undergoing HeartMate 3 LVAD implant (1/1/2017 and 1/31/2024) in the Society of Thoracic Surgeons' Intermacs registry were studied. A Cox proportional hazard multivariable analysis incorporating AEs as time-varying covariates for mortality out to 180 days was used to generate the Intermacs Short-Term Composite Quality (INSITE) score, reflecting the adjusted hazard ratio (HR) for mortality contributed by each AE, applying global ranking methodology. In those alive and on support at 6 months, multivariable logistic regression (odds ratio, OR) was used to examine the impact of AEs on health-related quality of life (QOL) at 180 days, captured through the INSITE-QOL score. Failure to achieve ≥1 point increase in visual analog scale (VAS) from baseline was the event in the QOL analysis. RESULTS: Of 13,148 patients, 4,389 (33.4%) suffered at least one AE or death through 180 days. Stroke (survival: HR 13.1; QOL: HR 1.7), dialysis (survival: HR 31.4; QOL: HR 4.2), prolonged respiratory failure (survival: HR 5.7; QOL: HR 2.3), reoperation (Survival: HR 3.4; QOL: HR 1.6) and right heart failure (survival: 5.0; QOL: HR 1.4), contributed to both mortality and failure to improve QOL at 180 days (all p<0.05). The median INSITE and INSITE-QOL scores were 0.0 [0.0,1.6] and 0.0 [0.0,0.0], respectively. At 9.4% (n=17) of centers, a high INSITE score (≥13) was present in 15% of patients while the top 25% of centers had perfect INSITE-QOL scores in at least 75% of patients. CONCLUSIONS: AEs after LVAD confer differential impact on mortality and QOL, enabling development of global rank outcome scores. Given the high mortality hazard conferred by 180-day AEs, center-specific quality interventions aimed at reducing early complications provide the greatest opportunity to improve long-term survival and QOL.
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While notable improvements in survival, the incidence of hemocompatibility-related adverse events, hospitalizations, and cost have been demonstrated with the only commercially available durable left ventricular assist device, a category of pump malfunctions characterized by outflow graft obstruction has been noted with broader use and clinical follow-up of recipients of this technology. Of particular concern is the accumulation of acellular biodebris between the outflow graft and bend relief covering the outflow graft at its origin with the pump (which we term extrinsic outflow graft obstruction at the bend relief). This process tends to be insidious, occurs late in the postoperative course, can be challenging to diagnose, and can result in significant morbidity and mortality. Herein, we provide a review of this complication and outline diagnostic, treatment, and preventive strategies.
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Infections remain a significant concern in patients receiving mechanical circulatory support (MCS), encompassing both durable and acute devices. This consensus manuscript provides updated definitions for infections associated with durable MCS devices and new definitions for infections in acute MCS, integrating a comprehensive review of existing literature and collaborative discussions among multidisciplinary specialists. By establishing consensus definitions, we seek to enhance clinical care, facilitate consistent reporting in research studies, and ultimately improve outcomes for patients receiving MCS.
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Corazón Auxiliar , Infecciones Relacionadas con Prótesis , Sociedades Médicas , Humanos , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/terapia , Trasplante de Corazón-Pulmón , ConsensoRESUMEN
BACKGROUND: In critically ill patients, delirium is a prognostic indicator of morbidity and mortality. OBJECTIVE: This study investigates the impact of a delirium diagnosis on outcomes after left ventricular assist device (LVAD) implantation. METHODS: This retrospective study included all adult patients who received LVADs at our institution between January 2016 and December 2020. We compared preimplantation characteristics between the two groups, with and without a diagnosis of delirium, and compared their outcomes, including 1-month, 6-month, and in-hospital mortality, as well as reintubation rate, length of stay, discharge disposition, and readmission rates. RESULTS: In total, 361 patients (26.7% women and 75.8% African American) received durable LVADs. Ninety-four patients (26.1%) were diagnosed with delirium during the index admission. Preimplantation demographic characteristics, past medical and psychiatric conditions, Interagency Registry for Mechanically Assisted Circulatory Support Profile, and laboratory values did not differ between the two groups with and without a diagnosis of delirium; older age (59 vs 56; P = 0.03) was associated with delirium. Delirium diagnosis was associated with higher 1-month (P = 0.007), 6-month (P = 0.004), and in-hospital mortality (P < 0.001), unplanned reintubations (P < 0.001), and a lower likelihood of discharge home (P = 0.03). Total hospital and intensive care unit length of stay were higher in patients with a diagnosis of delirium, though these results were not statistically significant. Readmission to the hospital after index admission was quicker in patients with a diagnosis of delirium, but this result was not statistically significant. CONCLUSIONS: In this study, a diagnosis of delirium during the LVAD implantation admission was associated with higher mortality, adverse postsurgical outcomes, and unfavorable discharge dispositions. Future prospective research is needed to validate the prognostic implications of delirium in both the short and long term. Additionally, there is a need to identify modifiable risk factors associated with delirium to promote early diagnosis and implement evidence-based management strategies to enhance outcomes within this population.
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Cardiac allograft vasculopathy (CAV) is a significant determinant of long-term survival in heart transplant recipients. Standard CAV screening typically utilizes invasive coronary angiography (ICA). Quantitative flow ratio (QFR) is a computational method for functional testing of coronary stenosis, and may add diagnostic value to ICA in assessing CAV. Consecutive subjects who received heart transplantation and underwent two separate routine coronary angiograms between January 2013 and April 2016 were enrolled. Coronary angiograms and IVUS were performed per local protocol at 1, 2, 3 and 5 years post-transplant. QFR was calculated offline. CAV was assessed semi-quantitively based on coronary angiogram results. Twenty-two patients were enrolled. Mean time from transplant to first included ICA was 2.1 years. QFR in at least 1 coronary vessel was interpretable in 19/22 (86%) of initial ICA (QFR1). QFR1 correlated well with the CAV score derived from the second ICA (CAV2) with a clustering of CAV at lower QFR values. In a receiver-operating characteristic (ROC) analysis, an optimal QFR threshold of 0.88 yielded 0.94 sensitivity and 0.67 specificity (AUC of 0.79) for at least non-obstructive subsequent CAV. Initial angiographically and intravascular ultrasound derived CAV severity poorly predicted subsequent CAV severity. QFR derived from invasive coronary angiography predicts subsequent development of CAV more accurately than angiography and intravascular ultrasound. This novel method of coronary flow assessment in recipients of heart transplantation may be useful to diagnose and predict subsequent CAV development.
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Enfermedad de la Arteria Coronaria , Trasplante de Corazón , Humanos , Angiografía Coronaria/métodos , Valor Predictivo de las Pruebas , Trasplante de Corazón/efectos adversos , Corazón , Aloinjertos/irrigación sanguínea , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/terapiaRESUMEN
Traditional ice storage has been the historic standard for preserving donor's hearts. However, this approach provides variability in cooling, increasing risks of freezing injury. To date, no preservation technology has been reported to improve survival after transplantation. The Paragonix SherpaPak Cardiac Transport System (SCTS) is a controlled hypothermic technology clinically used since 2018. Real-world evidence on clinical benefits of SCTS compared to conventional ice cold storage (ICS) was evaluated. Between October 2015 and January 2022, 569 US adults receiving donor hearts preserved and transported either in SCTS (n = 255) or ICS (n = 314) were analyzed from the Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN-Heart) registry. Propensity matching and a subgroup analysis of >240 minutes ischemic time were performed to evaluate comparative outcomes. Overall, the SCTS cohort had significantly lower rates of severe primary graft dysfunction (PGD) ( p = 0.03). When propensity matched, SCTS had improving 1-year survival ( p = 0.10), significantly lower rates of severe PGD ( p = 0.011), and lower overall post-transplant MCS utilization ( p = 0.098). For patients with ischemic times >4 hours, the SCTS cohort had reduced post-transplant MCS utilization ( p = 0.01), reduced incidence of severe PGD ( p = 0.005), and improved 30-day survival ( p = 0.02). A multivariate analysis of independent risk factors revealed that compared to SCTS, use of ice results in a 3.4-fold greater chance of severe PGD ( p = 0.014). Utilization of SCTS is associated with a trend toward increased post-transplant survival and significantly lower severe PGD and MCS utilization. These findings fundamentally challenge the decades-long status quo of transporting donor hearts using ice.
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Trasplante de Corazón , Donantes de Tejidos , Adulto , Humanos , Trasplante de Corazón/efectos adversos , Trasplante de Corazón/métodos , Hielo , Corazón , Incidencia , Estudios RetrospectivosRESUMEN
BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.
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Desfibriladores Implantables , Insuficiencia Cardíaca , Corazón Auxiliar , Taquicardia Ventricular , Humanos , Corazón Auxiliar/efectos adversos , Estudios Prospectivos , Calidad de Vida , Factores de Riesgo , Electrocardiografía , Arritmias Cardíacas , Taquicardia Ventricular/etiología , Resultado del TratamientoRESUMEN
Surgical aortic valve replacement (SAVR) remains the standard of care for patients with chronic severe aortic regurgitation (AR). The introduction of a dedicated transcatheter heart valve for AR has fueled interest in using transcatheter aortic valve replacement to treat patients with isolated AR. We aimed to characterize the profile and outcomes of patients with symptomatic severe AR who underwent isolated SAVR. We conducted a retrospective, observational study of patients who underwent isolated SAVR for symptomatic severe AR at our institution. The primary outcome was in-hospital all-cause mortality. Patients were followed up with 30-day clinical and echocardiographic assessment. A total of 979 patients who underwent SAVR for severe AR between January 2015 and June 2021 were screened for eligibility, of whom 112 patients (11.4%) underwent isolated SAVR for symptomatic severe AR and were included in this analysis. Approximately 25% of patients were deemed to be at intermediate or high risk (n = 26 of 112). The primary outcome occurred in 2.7% of patients (n = 3 of 112). In-hospital stroke occurred in 2.7% of patients (n = 3 of 112), and new-onset atrial fibrillation occurred in 32.1% (n = 36 of 112). At 30-day follow-up, all-cause mortality occurred in 3.6% of patients (n = 4 of 112), and 0.8% (1 of 112) had >mild AR. In conclusion, in a tertiary referral center, the number of patients who underwent isolated SAVR for pure AR represented a small fraction of the overall SAVR patients. The vast majority were low risk and younger when compared with patients with severe aortic stenosis. SAVR yielded excellent short-term mortality and echocardiographic improvements.
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Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Insuficiencia de la Válvula Aórtica/cirugía , Estudios Retrospectivos , Estenosis de la Válvula Aórtica/cirugía , Factores de Riesgo , Resultado del Tratamiento , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversosRESUMEN
PURPOSE OF REVIEW: Cardiogenic shock (CS) is a complex clinical entity that continues to carry a high risk of mortality. The landscape of CS management has changed with the advent of several temporary mechanical circulatory support (MCS) devices designed to provide hemodynamic support. It remains challenging to understand the role of different temporary MCS devices in patients with CS, as many of these patients are critically ill, requiring complex care with multiple MCS device options. Each temporary MCS device can provide different types and levels of hemodynamic support. It is important to understand the risk/benefit profile of each one of them for appropriate device selection in patients with CS. RECENT FINDINGS: MCS may be beneficial in CS patients through augmentation of cardiac output with subsequent improvement of systemic perfusion. Selecting the optimal MCS device depends on several variables including the underlying etiology of CS, clinical strategy of MCS use (bridge to recovery, bridge to transplant or durable MCS, or abridge to decision), amount of hemodynamic support needed, associated respiratory failure, and institutional preference. Furthermore, it is even more challenging to determine the appropriate time to escalate from one MCS device to another or combine different MCS devices. In this review, we discuss the current available data published in the literature on the management of CS and propose a standardized approach for escalation of MCS devices in patients with CS. Shock teams can play an important role to help in hemodynamic-guided management and algorithm-based step-by-step approach in early initiation and escalation of temporary MCS devices at different stages of CS. It is important to define the etiology of CS, and stage of shock and recognize univentricular vs biventricular shock for appropriate device selection and escalation of therapy.
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Oxigenación por Membrana Extracorpórea , Corazón Auxiliar , Humanos , Choque Cardiogénico/terapia , Medición de Riesgo , HemodinámicaRESUMEN
OBJECTIVE: The use of del Nido cardioplegia (DNC) was initially adopted in the field of pediatric cardiac surgery. Several studies in adult patients suggested there were no differences in early postoperative outcomes as compared to blood-based cardioplegia. We sought to evaluate the impact of DNC as compared to modified Buckberg cardioplegia (BC) on early postoperative outcomes in patients undergoing surgical aortic valve replacement with and without coronary artery bypass grafting (SAVR ± CABG). METHODS: All SAVR ± CABG procedures were switched from BC to DNC at our institute in 2012. We compared outcomes of BC (November 2007-October 2012; n = 1037) with DNC (November 2012-December 2017; n = 1067). Significant baseline differences were observed between the two groups and such differences were adjusted via inverse propensity treatment weighting. RESULTS: After adjustment, SAVR ± CABG patients who received DNC required longer aortic cross-clamp times, while postoperative peak troponin I and creatinine kinase-MB isotype were significantly lower in the BC group. Length of hospital and intensive care unit stay were significantly shorter in the DNC group. The incidence of postoperative complications was lower in the DNC cohort. Thirty-day mortality rate was significantly lower in the DNC group (3.0% vs 4.9%, p = 0.002). CONCLUSIONS: The use of DNC cardioplegia in our cohort of adult patients who underwent SAVR ± CABG was safe and associated with improved postoperative outcomes. However, the use of DNC may be associated with higher degrees of myocardial injury.
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Válvula Aórtica , Soluciones Cardiopléjicas , Adulto , Humanos , Niño , Válvula Aórtica/cirugía , Soluciones Cardiopléjicas/efectos adversos , Paro Cardíaco Inducido/efectos adversos , Puente de Arteria Coronaria/efectos adversos , Periodo Posoperatorio , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
The standard method for cardiac allograft preservation for the past 50 years has been static storage using crushed ice. A heart transplant transportation system designed to improve preservation quality with temperature monitoring, the Paragonix SherpaPak Cardiac Transport System (SCTS), was evaluated for its impact on postoperative costs relative to conventional ice storage. Observational US multicenter registry data collected during the August 2015 to November 2021 timeframe from 12 transplant hospitals were analyzed using logistic regression analysis and propensity matching to balance measured baseline covariates and to reduce selection bias. Hospital cost and outcome data post-transplant were then evaluated using various statistical methods. One hundred seventy-four (174) patients were identified resulting in 87 matches. Baseline characteristics were similar between groups. The SCTS group had a significantly lower proportion of ICU days on post-transplant mechanical circulatory support ( p < 0.0001); significantly fewer patients on extracorporeal membrane oxygenation ( p = 0.017); and significantly fewer patients experiencing severe primary graft dysfunction (PGD) ( p = 0.03). Overall hospital plus mechanical circulatory support post-transplant costs were significantly lower by $26.7K in the CTS cohort ( p = 0.03). Use of the SCTS is associated with improved clinical outcomes resulting in significantly lower overall hospital care costs.
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Trasplante de Corazón , Hielo , Humanos , Puntaje de Propensión , Trasplante de Corazón/efectos adversos , Hospitales , Sistema de Registros , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: Bleeding and thrombosis are common complications during Extracorporeal Membrane Oxygenation (ECMO) support for COVID-19 patients. We sought to examine the relationship between inflammatory status, coagulation effects, and observed bleeding and thrombosis in patients receiving venovenous (VV) ECMO for COVID-19 respiratory failure. STUDY DESIGN: Cross-sectional cohort study. SETTINGS: Quaternary care institution. PATIENTS: The study period from April 1, 2020, to January 1, 2021, we included all patients with confirmed COVID-19 who received VV ECMO support. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: Thirty-two patients were supported with VV ECMO during the study period, and 17 patients (53%) survived to hospital discharge. The ECMO nonsurvivors mean lactate dehydrogenase (LDH) levels were markedly elevated in comparison to survivors (1046 u/L [IQR = 509, 1305] vs 489 u/L [385 658], p = 0.003). Platelet/fibrinogen dysfunction, as reflected by the low Maximum Amplitude (MA) on viscoelastic testing, was worse in nonsurvivors (65.25 mm [60.68, 67.67] vs 74.80 mm [73.10, 78.40], p = 0.01). Time-group interaction for the first seven days of ECMO support, showed significantly lower platelet count in the nonsurvivors (140 k/ul [103, 170] vs 189.5 k/ul [ 146, 315], p < 0.001) and higher D-dimer in (21 µg/mL [13, 21] vs 14 µg/mL [3, 21], p < 0.001) in comparison to the survivors. Finally, we found profound statistically significant correlations between the clinical markers of inflammation and markers of coagulation in the nonsurvivors group. The ECMO nonsurvivors experienced higher rate of bleeding (73.3% vs 35.3%, p = 0.03), digital ischemia (46.7% vs 11.8%, p = 0.02), acute renal failure (60% vs 11.8%, p = 0.01) and bloodstream infection (60% vs 23.5%, p = 0.03). CONCLUSION: The correlation between inflammation and coagulation in the nonsurvivors supported with VV ECMO could indicate dysregulated inflammatory response and worse clinical outcomes.
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COVID-19 , Oxigenación por Membrana Extracorpórea , Trombosis , Humanos , COVID-19/complicaciones , COVID-19/terapia , Oxigenación por Membrana Extracorpórea/efectos adversos , Estudios Transversales , Estudios Retrospectivos , Inflamación/complicaciones , Hemorragia/etiología , Trombosis/etiologíaRESUMEN
The coronavirus disease 2019 (COVID-19) pandemic continues to pose a significant threat to patients receiving advanced heart failure therapies. The current study was undertaken to better understand the relationship between obesity and outcomes of SARS-CoV-2 infection in patients with a left ventricular assist device (LVAD) or heart transplant. We performed a retrospective review of patients with a heart transplant or LVAD who presented to one of the participating 11 institutions between April 1 and November 30, 2020. Patients were grouped by body mass index (BMI) into obese (BMI ≥ 30 k/m2) and nonobese cohorts (BMI < 30 kg/m2). Multivariable logistic regression models were used to estimate effects of obesity on outcomes of interest. Across all centers, 162 heart transplant and 81 LVAD patients were identified; 54 (33%) and 38 (47%) were obese, respectively. Obese patients tended to have more symptoms at presentation. No differences in rates of hospitalization or ICU admission were noted. Obese patients with LVADs were more likely to require mechanical ventilation (39% vs. 8%, p < 0.05). No differences in renal failure or secondary infection were noted. Mortality was similar among heart transplant patients (11% [obese] vs. 16% [nonobese], p = 0.628) and LVAD patients (12% vs. 15%, p = 1.0). BMI was not associated with increased adjusted odds of mortality, ICU admission, or mechanical ventilation (all p > 0.10). In summary, acute presentations of SARS-CoV-2 among heart transplant and LVAD recipients carry a significantly higher mortality than the general population, although BMI does not appear to impact this. Further studies on the longer-term effects of COVID-19 on this population are warranted.
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COVID-19 , Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Auxiliar , Humanos , Corazón Auxiliar/efectos adversos , Índice de Masa Corporal , COVID-19/complicaciones , SARS-CoV-2 , Trasplante de Corazón/efectos adversos , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/cirugía , Obesidad/complicaciones , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Best practices for left ventricular assist devices (LVADs) deactivation at end-of-life (EOL) have yet to be elucidated. We conducted a single-institution retrospective review of patients who died following LVAD deactivation between January 2017 and March 2020. Data were obtained from institutional databases and electronic health record and were analyzed using descriptive statistics. Fifty-eight patients (70% male, 70% African American, median age 62 years) were categorized by implant strategy: bridge therapy (BT, N = 22, 38%) or destination therapy (DT, N = 36, 62%). Clinical events leading to deactivation were categorized either acute ( e.g. , stroke [ N = 31, 53%]), gradual decline ( N = 12, 21%), or complications during index hospitalization ( N = 15, 26%). Implant strategy was not associated with clinical trajectory leading to EOL ( p = 0.67), hospital unit of death ( p = 0.13), or use of mechanical ventilation ( p = 0.69) or renal replacement therapy ( p = 0.81) during terminal hospitalization. Overall time from admission to code status change was mean 27.0 days (SD 30.3 days). Compared with BT patients, DT experienced earlier do-not-resuscitate (DNR) orders ( p ≤ 0.01) and shorter survival post-deactivation ( p ≤ 0.01). Deactivations after gradual decline tended to occur outside ICUs, compared with acute events or index implant-related complications ( p = 0.04). Implant strategy was not associated with differences in EOL experience except regarding timing of DNR order and survival post-deactivation.
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Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Masculino , Persona de Mediana Edad , Femenino , Corazón Auxiliar/efectos adversos , Estudios Retrospectivos , Insuficiencia Cardíaca/cirugía , Hospitalización , HospitalesRESUMEN
Percutaneous mechanical circulatory support (pMCS) devices are increasingly used in patients with cardiogenic shock as a bridge to recovery or bridge to decision to advanced heart failure therapies. Gastrointestinal bleeding (GIB) is a common complication that can be catastrophic. Because of the paucity of data describing the association of GIB with pMCS, we analyzed this population using the United States National Inpatient Sample database. We performed a retrospective study in patients with pMCS devices who had GIB during the index hospitalization using the National Inpatient Sample. Multivariate logistic regression analysis was performed to determine independent predictors of GIB in these patients. A total of 466,627 patients were included. We observed an overall increase in the incidence of adjusted GIB from 2.9% to 3.5% (p = 0.0025) from 2005 to 2014. In comparison to patients without GIB, those with GIB had significantly higher in-hospital mortality, length of stay, and hospitalization cost. In addition to the usual co-morbid conditions, the presence of small bowel and colonic ischemia, colon cancer, diverticulosis, chronic liver disease, and peptic ulcer disease were noted to be significant predictors of GIB for all (p <0.001). In conclusion, patients with pMCS and GIB have higher in-hospital mortality, longer length of stay, and higher cost of hospitalization. Awareness of patient risk factors for bleeding and gastrointestinal disorders are important before the use of mechanical circulatory support devices because they are associated with a substantially higher risk for bleeding.
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Hemorragia Gastrointestinal , Corazón Auxiliar , Hemorragia Gastrointestinal/etiología , Corazón Auxiliar/efectos adversos , Mortalidad Hospitalaria , Hospitalización , Humanos , Incidencia , Estudios Retrospectivos , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Outcomes in patients with smaller body size after HeartMate 3 left ventricular assist device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs larger body surface area (BSA) patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort. METHODS: The analysis cohort included 1015 HM3 patients divided into 2 groups: BSA ≤1.70 m2 (small patients, n = 82) and BSA >1.70 m2 (large patients, n = 933). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or to remove a malfunctioning device. Adverse events were compared between groups. RESULTS: Smaller patients were more frequently women (56.1% vs 17.7%; P < .001) and had lower prevalence of diabetes (28.1% vs 43.9%; P = .005) and hypertension (51.2% vs 71.9%; P < .001), larger median indexed LVEDD (normalized by BSA, 40 vs 33 mm/m2; P < .001), and lower median serum creatinine concentration (1.1 vs 1.3 mg/dL; P < .001). The proportion of patients achieving the composite end point at 2 years was 77% in both groups (adjusted hazard ratio, 1.14; 95% CI, 0.68-1.91; P = .62). Two-year adverse event rates were also similar between groups except for sepsis (6.1% vs 14.9%; P = .029) and cardiac arrhythmias (24.4% vs 35.3%; P = .005), which were higher in the larger patients. CONCLUSIONS: Outcomes after HM3 implantation were comparable between small and large patients. Smaller body size should not be used to deny HM3 implantation in patients who are otherwise suitable candidates for durable mechanical circulatory support.
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Insuficiencia Cardíaca , Corazón Auxiliar , Adulto , Femenino , Humanos , Tamaño Corporal , Insuficiencia Cardíaca/etiología , Corazón Auxiliar/efectos adversos , Estudios Prospectivos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Continuous infusion of ambulatory inotropic therapy (AIT) is increasingly used in patients with end-stage heart failure (HF). There is a paucity of data concerning the concomitant use of beta-blockers (BB) in these patients. METHODS: We retrospectively reviewed all patients discharged from our institution on AIT. The cohort was stratified into 2 groups based on BB use. The 2 groups were compared for differences in hospitalizations due to HF, ventricular arrhythmias and ICD therapies (shock or antitachycardia pacing). RESULTS: Between 2010 and 2017, 349 patients were discharged on AIT (95% on milrinone); 74% were males with a mean age of 61 ± 14 years. BB were used in 195 (56%) patients, whereas 154 (44%) did not receive these medications. Patients in the BB group had longer duration of AIT support compared to those in the non-BB group (141 [1-2114] vs 68 [1-690] days). After adjusting for differences in baseline characteristics and indication for AIT, patients in the BB group had significantly lower rates of hospitalizations due to HF (hazard ratio [HR] 0.61 (0.43-0.86); Pâ¯=â¯0.005), ventricular arrhythmias (HR 0.34 [0.15-0.74]; Pâ¯=â¯0.007) and ICD therapies (HR 0.24 [0.07-0.79]; Pâ¯=â¯0.02). CONCLUSION: In patients with end-stage HF on AIT, the use of BB with inotropes was associated with fewer hospitalizations due to HF and fewer ventricular arrhythmias.