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1.
J Heart Lung Transplant ; 43(8): 1318-1325, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38744355

ABSTRACT

BACKGROUND: Previous studies have demonstrated an association between transplantation rate per center and postoperative mortality after heart transplantation. In 2011, Sweden centralized heart transplants and waiting lists, reducing the number of centers from 3 to 2. We aimed to assess the active waiting time and pre- and post-transplant mortality before and after centralization. METHODS: Heart transplantations performed in Sweden between January 1, 2001 and December 31, 2020 were included. Background and donor organ supply data were collected from Scandiatransplant, the Swedish Thoracic Transplant Registry, and the Swedish Cardiac Surgery Registry. The Fine and Gray methods were applied to visualize cumulative incidence curves and conduct competing risk regressions. A Cox model was used to adjust for factors influencing time to post-transplant death. RESULTS: When comparing the two eras, the median active waiting time increased from 54 to 71 days (p = 0.015). The risk of mortality on the waiting list decreased in the later era (subhazard ratio 0.43; [95% confidence interval {CI} 0.25-0.74]; p = 0.002). The number of heart transplantation procedures (including pediatric patients) increased by 53%. There was a significant difference in organ utilization between eras (p = 0.033; chi-square test). 30-day and 1-year survival post-transplant rates for adults increased from 90.8% to 97.8% (p < 0.001) and from 87.9% to 94.6% (p < 0.001), respectively. 1-year mortality was reduced by 63% (hazard ratio 0.37; 95% CI 0.22-0.61). CONCLUSIONS: This nationwide study examined patients listed for and undergoing heart transplantation before and after the centralization of waiting lists and surgeries in Sweden. Waiting list mortality decreased, and 1-year post-transplantation survival was improved.


Subject(s)
Heart Transplantation , Registries , Waiting Lists , Humans , Heart Transplantation/mortality , Waiting Lists/mortality , Sweden/epidemiology , Male , Female , Middle Aged , Adult , Adolescent , Survival Rate/trends , Retrospective Studies , Child , Young Adult , Time Factors , Follow-Up Studies , Child, Preschool , Tissue and Organ Procurement/statistics & numerical data
2.
Eur J Heart Fail ; 25(12): 2164-2173, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37795642

ABSTRACT

AIMS: Mineralocorticoid receptor antagonists (MRAs) improve outcomes in heart failure with reduced ejection fraction (HFrEF) but remain underused and are often discontinued especially in patients with chronic kidney disease (CKD) due to concerns on renal safety. Therefore, in a real-world HFrEF population we investigated the safety of MRA use, in terms of risk of renal events, any mortality and any hospitalization, across the estimated glomerular filtration rate (eGFR) spectrum including severe CKD. METHODS AND RESULTS: We analysed patients with HFrEF (ejection fraction <40%), not on dialysis, from the Swedish Heart Failure Registry. We performed multivariable logistic regression models to investigate patient characteristics independently associated with MRA use, and univariable and multivariable Cox regression models to assess the associations between MRA use and outcomes. Of 33 942 patients, 17 489 (51%) received MRA, 32%, 45%, 54%, 54% with eGFR <30, 30-44, 45-59 or ≥60 ml/min/1.73 m2 , respectively. An eGFR ≥60 ml/min/1.73 m2 and patient characteristics linked with more severe HF were independently associated with more likely MRA use. In multivariable analyses, MRA use was consistently not associated with a higher risk of renal events (i.e. composite of dialysis/renal death/hospitalization for renal failure or hyperkalaemia) (hazard ratio [HR] 1.04, 95% confidence interval [CI] 0.98-1.10), all-cause death (HR 1.02, 95% CI 0.97-1.08) as well as of all-cause hospitalization (HR 0.99, 95% CI 0.95-1.02) across the eGFR spectrum including also severe CKD. CONCLUSIONS: The use of MRAs in patients with HFrEF decreased with worse renal function; however their safety profile was demonstrated to be consistent across the entire eGFR spectrum.


Subject(s)
Heart Failure , Renal Insufficiency, Chronic , Humans , Mineralocorticoid Receptor Antagonists/therapeutic use , Heart Failure/drug therapy , Heart Failure/epidemiology , Heart Failure/complications , Sweden/epidemiology , Stroke Volume/physiology , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/epidemiology , Registries
3.
ESC Heart Fail ; 10(2): 884-894, 2023 04.
Article in English | MEDLINE | ID: mdl-36460627

ABSTRACT

AIMS: Use of left ventricular assist devices (LVADs) in older patients has increased, and assessing outcomes in older LVAD recipients is important. Therefore, this study aimed to investigate associations between age and outcomes after continuous-flow LVAD (cf-LVAD) implantation. METHODS AND RESULTS: Cf-LVAD patients from the multicentre European PCHF-VAD registry were included and categorized into those <50, 50-64, and ≥65 years old. The primary endpoint was all-cause mortality. Among secondary outcomes were heart failure (HF) hospitalizations, right ventricular (RV) failure, haemocompatibility score, bleeding events, non-fatal thromboembolic events, and device-related infections. Of 562 patients, 184 (32.7%) were <50, 305 (54.3%) were aged 50-64, whereas 73 (13.0%) were ≥65 years old. Median follow-up was 1.1 years. Patients in the oldest age group were significantly more often designated as destination therapy (DT) candidates (61%). A 10 year increase in age was associated with a significantly higher risk of mortality (hazard ratio [HR] 1.34, 95% confidence interval [CI] [1.15-1.57]), intracranial bleeding (HR 1.49, 95% CI [1.10-2.02]), and non-intracranial bleeding (HR 1.30, 95% CI [1.09-1.56]), which was confirmed by a higher mean haemocompatibility score (1.37 vs. 0.77, oldest vs. youngest groups, respectively, P = 0.033). Older patients suffered from less device-related infections requiring systemic antibiotics. No age-related differences were observed in HF-related hospitalizations, ventricular arrhythmias, pump thrombosis, non-fatal thromboembolic events, or RV failure. CONCLUSIONS: In the PCHF-VAD registry, higher age was associated with increased risk of mortality, and especially with increased risk of major bleeding, which is particularly relevant for the DT population. The risks of HF hospitalizations, pump thrombosis, ventricular arrhythmia, or RV failure were comparable. Strikingly, older patients had less device-related infections.


Subject(s)
Heart Failure , Heart-Assist Devices , Thrombosis , Humans , Aged , Heart-Assist Devices/adverse effects , Treatment Outcome , Heart Failure/epidemiology , Heart Failure/therapy , Arrhythmias, Cardiac , Registries , Thrombosis/etiology
4.
ESC Heart Fail ; 10(2): 1054-1065, 2023 04.
Article in English | MEDLINE | ID: mdl-36547014

ABSTRACT

AIMS: Data on sex and left ventricular assist device (LVAD) utilization and outcomes have been conflicting and mostly confined to US studies incorporating older devices. This study aimed to investigate sex-related differences in LVAD utilization and outcomes in a contemporary European LVAD cohort. METHODS AND RESULTS: This analysis is part of the multicentre PCHF-VAD registry studying continuous-flow LVAD patients. The primary outcome was all-cause mortality. Secondary outcomes included ventricular arrhythmias, right ventricular failure, bleeding, thromboembolism, and the haemocompatibility score. Multivariable Cox regression models were used to assess associations between sex and outcomes. Overall, 457 men (81%) and 105 women (19%) were analysed. At LVAD implant, women were more often in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2 (55% vs. 41%, P = 0.009) and more often required temporary mechanical circulatory support (39% vs. 23%, P = 0.001). Mean age was comparable (52.1 vs. 53.4 years, P = 0.33), and median follow-up duration was 344 [range 147-823] days for women and 435 [range 190-816] days for men (P = 0.40). No significant sex-related differences were found in all-cause mortality (hazard ratio [HR] 0.79 for female vs. male sex, 95% confidence interval [CI] [0.50-1.27]). Female LVAD patients had a lower risk of ventricular arrhythmias (HR 0.56, 95% CI [0.33-0.95]) but more often experienced right ventricular failure. No significant sex-related differences were found in other outcomes. CONCLUSIONS: In this contemporary European cohort of LVAD patients, far fewer women than men underwent LVAD implantation despite similar clinical outcomes. This is important as the proportion of female LVAD patients (19%) was lower than the proportion of females with advanced HF as reported in previous studies, suggesting underutilization. Also, female patients were remarkably more often in INTERMACS profile 1 or 2, suggesting later referral for LVAD therapy. Additional research in female patients is warranted.


Subject(s)
Heart Failure , Heart-Assist Devices , Humans , Male , Female , Heart-Assist Devices/adverse effects , Treatment Outcome , Heart Failure/epidemiology , Heart Failure/therapy , Registries
5.
Heart Vessels ; 37(12): 1985-1994, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35737119

ABSTRACT

Aortic regurgitation (AR) following continuous flow left ventricular assist device implantation (cf-LVAD) may adversely impact outcomes. We aimed to assess the incidence and impact of progressive AR after cf-LVAD on prognosis, biomarkers, functional capacity and echocardiographic findings. In an analysis of the PCHF-VAD database encompassing 12 European heart failure centers, patients were dichotomized according to the progression of AR following LVAD implantation. Patients with de-novo AR or AR progression (AR_1) were compared to patients without worsening AR (AR_0). Among 396 patients (mean age 53 ± 12 years, 82% male), 153 (39%) experienced progression of AR over a median of 1.4 years on LVAD support. Before LVAD implantation, AR_1 patients were less frequently diabetic, had lower body mass indices and higher baseline NT-proBNP values. Progressive AR did not adversely impact mortality (26% in both groups, HR 0.91 [95% CI 0.61-1.36]; P = 0.65). No intergroup variability was observed in NT-proBNP values and 6-minute walk test results at index hospitalization discharge and at 6-month follow-up. However, AR_1 patients were more likely to remain in NYHA class III and had worse right ventricular function at 6-month follow-up. Lack of aortic valve opening was related to de-novo or worsening AR (P < 0.001), irrespective of systolic blood pressure (P = 0.67). Patients commonly experience de-novo or worsening AR when exposed to continuous flow of contemporary LVADs. While reducing effective forward flow, worsening AR did not influence survival. However, less complete functional recovery and worse RV performance among AR_1 patients were observed. Lack of aortic valve opening was associated with progressive AR.


Subject(s)
Aortic Valve Insufficiency , Heart Failure , Heart-Assist Devices , Humans , Male , Adult , Middle Aged , Aged , Female , Aortic Valve Insufficiency/diagnosis , Aortic Valve Insufficiency/epidemiology , Aortic Valve Insufficiency/etiology , Heart-Assist Devices/adverse effects , Heart Failure/diagnosis , Heart Failure/therapy , Heart Failure/complications , Echocardiography , Ventricular Function, Right , Retrospective Studies , Treatment Outcome
6.
Clin Transplant ; 36(9): e14756, 2022 09.
Article in English | MEDLINE | ID: mdl-35726189

ABSTRACT

BACKGROUND: Post heart-transplant survival has increased, but information is lacking on specific causes of death and life expectancy. We aimed to assess cause-specific loss of life-years compared to the general population, evaluate classification for cause of death after heart transplantation, and assess validity of cause of death data from the International Society of Heart and Lung Transplant (ISHLT) registry. METHODS: In this single center study, we included 239 heart recipients transplanted between 1988 and 2019 in Lund, Sweden (n = 239, 50% of the transplanted population where the cause of death was available). Two cardiologists retrospectively assigned causes of death according to a published classification (CLASS) in the 91 recipients who died during follow-up. Life expectancy was compared to data from the general population. RESULTS: Compared to the average Swedish population, life expectancy for heart transplant recipients was 20 years shorter (IQR 12.9-27.2). The largest number of life-years lost were for deaths due to acute (49 years) and chronic rejection (27 years). Primary graft dysfunction (24 years) accounted for 24% of deaths, followed by malignancy (20 years) and infection (17 years), each accounting for ∼20% of deaths. Use of CLASS revealed moderate inter-rater agreement (56%) and moderate agreement with the ISHLT registry (62%). CONCLUSIONS: Survival after heart transplantation was 20 years lower than in the general population. In the young, more life-years were lost due to acute graft rejection, whereas chronic graft rejection and primary graft failure were more important causes of death in older patients. Agreement was moderate between CLASS and the ISHLT registry classifications.


Subject(s)
Heart Transplantation , Aged , Cause of Death , Graft Rejection/epidemiology , Graft Rejection/etiology , Heart Transplantation/adverse effects , Humans , Life Expectancy , Registries , Retrospective Studies , Survival Rate
7.
Eur J Heart Fail ; 24(7): 1305-1315, 2022 07.
Article in English | MEDLINE | ID: mdl-35508920

ABSTRACT

AIMS: Temporal changes in patient selection and major technological developments have occurred in the field of left ventricular assist devices (LVADs), yet analyses depicting this trend are lacking for Europe. We describe the advances of European LVAD programmes from the PCHF-VAD registry across device implantation eras. METHODS AND RESULTS: Of 583 patients from 13 European centres in the registry, 556 patients (mean age 53 ± 12 years, 82% male) were eligible for this analysis. Patients were divided into eras (E) by date of LVAD implantation: E1 from December 2006 to December 2012 (6 years), E2 from January 2013 to January 2020 (7 years). Patients implanted more recently were older with more comorbidities, but less acutely ill. Receiving an LVAD in E2 was associated with improved 1-year survival in adjusted analysis (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.35-0.98; p = 0.043). LVAD implantation in E2 was associated with a significantly lower chance of heart transplantation (adjusted HR 0.40, 95% CI 0.23-0.67; p = 0.001), and lower risk of LVAD-related infections (adjusted HR 0.64, 95% CI 0.43-0.95; p = 0.027), both in unadjusted and adjusted analyses. The adjusted risk of haemocompatibility-related events decreased (HR 0.60, 95% CI 0.39-0.91; p = 0.016), while heart failure-related events increased in E2 (HR 1.67, 95% CI 1.02-2.75; p = 0.043). CONCLUSION: In an analysis depicting the evolving landscape of continuous-flow LVAD carriers in Europe over 13 years, a trend towards better survival was seen in recent years, despite older recipients with more comorbidities, potentially attributable to increasing expertise of LVAD centres, improved patient selection and pump technology. However, a smaller chance of undergoing heart transplantation was noted in the second era, underscoring the relevance of improved outcomes on LVAD support.


Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Adult , Aged , Europe/epidemiology , Female , Heart Failure/epidemiology , Heart Failure/therapy , Humans , Male , Middle Aged , Registries , Retrospective Studies , Treatment Outcome
8.
ASAIO J ; 68(3): 363-368, 2022 03 01.
Article in English | MEDLINE | ID: mdl-34225278

ABSTRACT

Despite advances in therapy, bleeding and thromboembolic events are frequent complications in patients with left ventricular assist device (LVAD) support. Maintaining warfarin in therapeutic range has been shown to be more challenging in this patient population compared to other indications. Patients with LVADs on warfarin typically are within goal international normalized ratio (INR) range 36-57% of the time, compared to about 65% for other indications. The goal of this study was to evaluate if an INR remote monitoring system along with the implementation of a standardized warfarin management protocol improves warfarin time in therapeutic range (TTR) for patients with LVADs. This single-center, retrospective, observational study included 78 patients with LVADs that were followed at our academic center from January 2015 to October 2017. In October 2016, we updated our warfarin management protocol and implemented a remote monitoring system with patients' weekly INR results monitored. The primary objective of the study was to determine the difference between TTRs in remote monitoring versus standard monitoring. We found that the average TTR was significantly higher in the remote monitoring group compared to the standard monitoring cohort (61.1% vs. 40.0%, p < 0.005). However, bleeding, thrombotic incidence, and hospital readmission rates were similar between the two patient cohorts. Remote monitoring improved warfarin TTR significantly in this study and may have the potential to improve anticoagulation-related outcomes in patients with LVADs.


Subject(s)
Heart-Assist Devices , Anticoagulants/adverse effects , Blood Coagulation , Heart-Assist Devices/adverse effects , Humans , International Normalized Ratio/methods , Retrospective Studies , Warfarin/therapeutic use
9.
Int J Cardiol ; 340: 26-33, 2021 10 01.
Article in English | MEDLINE | ID: mdl-34437934

ABSTRACT

BACKGROUND: There is conflicting observational data on the survival benefit cardiac implantable electronic devices (CIED) in patients with LVADs. METHODS: Patients in whom an LVAD was implanted between January 2008 and April 2017 in the multinational Trans-Atlantic Registry on VAD and Transplant (TRAViATA) registry were separated into four groups based on the presence of CIED prior to LVAD implantation: none (n = 146), implantable cardiac defibrillator (ICD) (n = 239), cardiac resynchronization without defibrillator (CRT-P) (n = 28), and CRT with defibrillator (CRT-D) (n = 111). RESULTS: A total of 524 patients (age 52 years ±12, 84.4% male) were followed for 354 (interquartile range: 166-701) days. After multivariable adjustment, there were no differences in survival across the groups. In comparison to no device, only CRT-D was associated with late right ventricular failure (RVF) (hazard ratio 2.85, 95% confidence interval [CI] 1.42-5.72, p = 0.003). There was no difference in risk of early RVF across the groups or risk of ICD shocks between those with ICD and CRT-D. CONCLUSION: In a multinational registry of patients with LVADs, there were no differences in survival with respect to CIED subtype. However, patients with a pre-existing CRT-D had a higher likelihood of late RVF suggesting significant long-term morbidity in those with devices capable of LV­lead pacing post LVAD implantation.


Subject(s)
Cardiac Resynchronization Therapy , Defibrillators, Implantable , Heart Failure , Heart-Assist Devices , Electronics , Female , Heart Failure/diagnosis , Heart Failure/therapy , Humans , Male , Middle Aged , Treatment Outcome
10.
Int J Cardiol ; 324: 122-130, 2021 02 01.
Article in English | MEDLINE | ID: mdl-32950592

ABSTRACT

BACKGROUND: Geographic variations in management and outcomes of individuals supported by continuous-flow left ventricular assist devices (CF-LVAD) between the United States (US) and Europe (EU) is largely unknown. METHODS: We created a retrospective, multinational registry of 524 patients who received a CF-LVAD (either HVAD or Heartmate II) between January 2008 and April 2017. Follow up spanned from date of CF-LVAD implant to post-HTx period with a median follow up of 44.8 months. RESULTS: The cohort included 299 (57.1%) EU and 225 (42.9%) US patients. Although the US cohort was significantly older with a higher prevalence of comorbidities, survival was similar between the cohorts (US 63.1%, EU 68.4% at 5 years, unadjusted log-rank test p = 0.43).Multivariate analyses suggested that older age, higher body mass index, elevated creatinine, use of temporary mechanical circulatory support prior CF-LVAD, and implantation of HVAD were associated with increased mortality. Among CF-LVAD patients undergoing HTx, the median time on CF-LVAD support was shorter in the US, meanwhile US donors were younger. Finally, the pattern of adverse events (stroke, gastrointestinal bleedings, late right ventricular failure, and driveline infection) during support differed significantly between US and EU. CONCLUSIONS: Although waitlisted patients in the US on CF-LVAD have higher risk comorbid conditions, the overall outcome is similar in US and EU. Geographic variations with regards to donor characteristics, duration of CF-LVAD support prior to transplant, and adverse events on support can explain the disparity in the utilization of mechanical bridge to transplant strategy between US and EU.


Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Aged , Europe/epidemiology , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/surgery , Heart-Assist Devices/adverse effects , Humans , Registries , Retrospective Studies , Treatment Outcome , United States/epidemiology
11.
ASAIO J ; 67(1): 74-83, 2021 01 01.
Article in English | MEDLINE | ID: mdl-33346993

ABSTRACT

The success of left ventricular assist device (LVAD) therapy is hampered by complications such as thrombosis and bleeding. Understanding blood flow interactions between the heart and the LVAD might help optimize treatment and decrease complication rates. We hypothesized that LVADs modify shear stresses and blood transit in the left ventricle (LV) by changing flow patterns and that these changes can be characterized using 2D echo color Doppler velocimetry (echo-CDV). We used echo-CDV and custom postprocessing methods to map blood flow inside the LV in patients with ongoing LVAD support (Heartmate II, N = 7). We compared it to healthy controls (N = 20) and patients with dilated cardiomyopathy (DCM, N = 20). We also analyzed intraventricular flow changes during LVAD ramp tests (baseline ± 400 rpm). LVAD support reversed the increase in blood stasis associated with DCM, but it did not reduce intraventricular shear exposure. Within the narrow range studied, the ventricular flow was mostly insensitive to changes in pump speed. Patients with significant aortic insufficiency showed abnormalities in blood stasis and shear indices. Overall, this study suggests that noninvasive flow imaging could potentially be used in combination with standard clinical methods for adjusting LVAD settings to optimize flow transport and minimize stasis on an individual basis.


Subject(s)
Coronary Circulation/physiology , Heart Ventricles/diagnostic imaging , Heart-Assist Devices , Hemodynamics/physiology , Adult , Echocardiography/methods , Female , Heart Failure/therapy , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Stress, Mechanical , Ultrasonography, Doppler/methods
13.
Eur J Heart Fail ; 22(1): 139-147, 2020 01.
Article in English | MEDLINE | ID: mdl-31721391

ABSTRACT

BACKGROUND: Predicting mortality is important in patients with heart failure (HF). However, current strategies for predicting risk are only modestly successful, likely because they are derived from statistical analysis methods that fail to capture prognostic information in large data sets containing multi-dimensional interactions. METHODS AND RESULTS: We used a machine learning algorithm to capture correlations between patient characteristics and mortality. A model was built by training a boosted decision tree algorithm to relate a subset of the patient data with a very high or very low mortality risk in a cohort of 5822 hospitalized and ambulatory patients with HF. From this model we derived a risk score that accurately discriminated between low and high-risk of death by identifying eight variables (diastolic blood pressure, creatinine, blood urea nitrogen, haemoglobin, white blood cell count, platelets, albumin, and red blood cell distribution width). This risk score had an area under the curve (AUC) of 0.88 and was predictive across the full spectrum of risk. External validation in two separate HF populations gave AUCs of 0.84 and 0.81, which were superior to those obtained with two available risk scores in these same populations. CONCLUSIONS: Using machine learning and readily available variables, we generated and validated a mortality risk score in patients with HF that was more accurate than other risk scores to which it was compared. These results support the use of this machine learning approach for the evaluation of patients with HF and in other settings where predicting risk has been challenging.


Subject(s)
Heart Failure , Cohort Studies , Heart Failure/diagnosis , Humans , Machine Learning , Risk Assessment , Risk Factors
14.
ASAIO J ; 66(4): 409-414, 2020 04.
Article in English | MEDLINE | ID: mdl-31192845

ABSTRACT

Left ventricular assist devices (LVADs) have dramatically improved short-term outcomes among patients with advanced heart failure. While neurohormonal blockade (NHB) is the cornerstone of treatment for patients with heart failure with reduced ejection fraction, its effect after LVAD placement has not been established. We reviewed medical records of 307 patients who underwent primary LVAD implantation from January 2006 to September 2015 at two institutions in the United States. Patients were followed for at least 2 years post-LVAD implantation or until explantation, heart transplantation, or death. Cox regression analysis stratifying on center was used to assess associations with mortality. Neurohormonal blockade use was treated as a time-dependent predictor. Stepwise selection indicated treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEIs/ARBs) (hazard ratio [HR] = 0.53 [0.30-0.95], p = 0.03), age at the time of implantation (HR = 1.28 [1.05-1.56] per decade, p = 0.02), length of stay postimplantation (HR = 1.16 [1.11-1.21] per week, p < 0.01) and INTERMACS profile of 1 or 2 (HR = 1.86 [1.17-2.97], p < 0.01) were independent predictors of mortality. In this large, retrospective study, treatment with ACEIs or ARBs was an independent factor associated with decreased mortality post-LVAD placement.


Subject(s)
Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Heart Failure/therapy , Heart-Assist Devices , Aged , Female , Heart Failure/mortality , Heart-Assist Devices/adverse effects , Humans , Male , Middle Aged , Proportional Hazards Models , Time Factors
15.
Scand Cardiovasc J ; 53(1): 14-20, 2019 02.
Article in English | MEDLINE | ID: mdl-30776923

ABSTRACT

OBJECTIVES: The purpose of this study was to assess complications and mortality and its predictors, with continuous-flow left ventricular assist devices (CF-LVADs) in the Nordic Countries. DESIGN: This was a retrospective, international, multicenter cohort study. RESULTS: Between 1993 and 2013, 442 surgically implanted long-term mechanical assist devices were used among 8 centers in the Nordic countries. Of those, 238 were CF-LVADs (HVAD or HeartMate II) implanted in patients >18 years with complete data. Postoperative complications and survival were compared and Cox proportion hazard regression analysis was used to identify predictors of mortality. The overall Kaplan-Meier survival rate was 75% at 1 year, 69% at 2 years and 63% at 3 years. A planned strategy of destination therapy had poorer survival compared to a strategy of bridge to transplantation or decision (2-year survival of 41% vs. 76%, p < .001). The most common complications were non-driveline infections (excluding sepsis) (44%), driveline infection (27%), need for continuous renal replacement therapy (25%) and right heart failure (24%). In a multivariate model age and left ventricular diastolic dimension was left as independent risk factors for mortality with a hazard ratio of 1.35 (95% confidence interval (CI) [1.01-1.80], p = .046) per 10 years and 0.88 (95% CI [0.72-0.99], p = .044) per 5 mm, respectively. CONCLUSION: Outcome with CF LVAD in the Nordic countries was comparable to other cohorts. Higher age and destination therapy require particularly stringent selection.


Subject(s)
Heart Failure/mortality , Heart Failure/therapy , Heart-Assist Devices , Ventricular Function, Left , Aged , Disease Progression , Female , Heart Failure/diagnosis , Heart Failure/physiopathology , Heart Transplantation , Heart-Assist Devices/adverse effects , Humans , Male , Middle Aged , Prosthesis Design , Recovery of Function , Retrospective Studies , Risk Assessment , Risk Factors , Scandinavian and Nordic Countries/epidemiology , Time Factors , Treatment Outcome
16.
J Cardiovasc Surg (Torino) ; 60(2): 251-258, 2019 Apr.
Article in English | MEDLINE | ID: mdl-30168306

ABSTRACT

BACKGROUND: The optimal advanced heart failure (HF) therapy strategy for patients aged 60 or older with end-stage HF refractory to optimal medical therapy remains uncertain. This study compares outcomes of three advanced HF therapy strategies in this patient population. METHODS: A single-center retrospective study was conducted in 95 patients aged 60-73 years who had undergone isolated heart transplantation (HTx) or continuous flow left ventricular assist device (LVAD) implantation from 2010 to 2017. Patients were stratified into three cohorts by strategy; HTx-only (N.=25), LVAD-to-HTx (N.=29), and LVAD-only (N.=41). Primary end point was 2-year overall survival. Secondary end points included incidence of post-operative adverse events, freedom from first readmission at 1 year, and percentage of days spent in hospital following advanced HF therapy. RESULTS: Two-year survival was 91% in HTx-only patients, 88% in LVAD-to-HTx patients, and 49% in LVAD-only patients (P=0.0008). No significant difference in post-transplant survival was found between patients with or without LVAD-related adverse events preceding transplantation (P=0.42). One-year freedom from first readmission was 38.3% in HTx-only patients, 17.2% in LVAD-to-HTx patients and 7.3% in LVAD-only patients (P=0.0028). Patients in LVAD-to-HTx cohort had higher incidences of gastrointestinal bleeding (38% vs. 3%; P<0.01), major bleeding (28% vs. 3%; P=0.02), and right heart failure (69% vs. 31%; P<0.01) during post-LVAD period compared with post-HTx period. Their percentage of days spent in hospital during post-LVAD period was significantly higher than post-HTx period (7.9% vs. 1.2%; P<0.001). CONCLUSIONS: Our experience with patients over 60 years old undergoing advanced therapy suggests that HTx-only and LVAD-to-HTx strategies had superior medium-term survival than LVAD-only strategy. LVAD-to-HTx strategy is effective in reducing incidence of adverse events and percentage of hospitalized days in this specific patient population.


Subject(s)
Heart Failure/therapy , Heart Transplantation , Heart-Assist Devices , Ventricular Function, Left , Age Factors , Aged , Female , Heart Failure/diagnosis , Heart Failure/mortality , Heart Failure/physiopathology , Heart Transplantation/adverse effects , Heart Transplantation/mortality , Heart-Assist Devices/adverse effects , Humans , Length of Stay , Male , Middle Aged , Patient Readmission , Postoperative Complications/etiology , Prosthesis Design , Recovery of Function , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
17.
Heart Lung ; 48(2): 85-89, 2019.
Article in English | MEDLINE | ID: mdl-30227993

ABSTRACT

BACKGROUND: The Stanford integrated psychosocial assessment for transplantation (SIPAT) is a validated psychosocial evaluation tool in the transplant population. OBJECTIVE: We evaluated SIPAT in predicting post-left ventricular assist device (LVAD) outcomes, including cumulative re-admissions, driveline infections, pump malfunction, pump thrombosis, gastrointestinal bleeding, major bleeding, stroke and right ventricular failure. METHODS: This retrospective study included 50 LVAD patients at an academic institution in the United States who had a pre-implant SIPAT score during the years 2015-2017. Patients were split into two groups based on SIPAT score, separating a "excellent"/"good" from a "minimally acceptable"/"poor" candidate. Poisson regression, using SIPAT as both a categorical and continuous variable, was used to compare the incidence rates of the primary outcome of cumulative re-admissions and secondary outcomes of LVAD complications. RESULTS: The patient cohort was predominantly male 93.5% vs 89.4% (p = 0.629) with a median age of 67.0 vs 58.0 years (p = 0.037), planned destination therapy 48.4% vs 68.4% (p = 0.242) and median LVAD follow-up time of 241 vs 379 days (p = 0.10) in the low- and high- SIPAT groups, respectively. SIPAT was not a significant predictor for cumulative re-admissions, but there was an association between higher SIPAT scores and major bleeding. CONCLUSION: In this single-center retrospective study, SIPAT did not predict cumulative re-admissions. Further study is required to validate SIPAT before clinical implementation.


Subject(s)
Heart Failure/surgery , Heart Transplantation/psychology , Heart-Assist Devices , Aged , Female , Heart Failure/psychology , Humans , Male , Middle Aged , Patient Readmission/trends , Predictive Value of Tests , Prognosis , Retrospective Studies
18.
ASAIO J ; 65(4): e36-e41, 2019.
Article in English | MEDLINE | ID: mdl-30299301

ABSTRACT

Patients with biventricular assist devices (BIVAD) are severely critically ill compared with patients who receive left ventricular assist device (LVAD) support alone and portend a significant risk for greater adverse events including pump thrombosis (PT). Current approaches to treat PT are limited to LVAD with variable outcomes depending on the management strategy implemented. Moreover the management of PT in patients with BIVAD support, specifically to the right ventricular assist device (RVAD), is unknown. We describe the first care series to date on the management of PT in patients with durable right ventricular assist device and their outcomes.


Subject(s)
Heart-Assist Devices/adverse effects , Thrombosis/etiology , Thrombosis/therapy , Adult , Heart Failure/therapy , Humans , Male , Middle Aged , Retrospective Studies , Ventricular Dysfunction, Right/therapy , Young Adult
19.
JACC Clin Electrophysiol ; 4(7): 847-859, 2018 07.
Article in English | MEDLINE | ID: mdl-30025683

ABSTRACT

For patients with end-stage heart failure, the use of mechanical circulatory support has increased in the last decade due to improved outcomes with durable left ventricular assist devices. The management of these complex patients requires coordinated care by a multidisciplinary team including cardiac electrophysiologists because atrial and ventricular arrhythmias are prevalent in this population. There have been an increasing number of studies that attempt to address issues regarding arrhythmia management in patients with left ventricular assist devices. The purpose of this review is to provide electrophysiologists with an evidence-based approach to manage a broad spectrum of arrhythmia issues in these patients.


Subject(s)
Arrhythmias, Cardiac/therapy , Defibrillators, Implantable , Heart-Assist Devices , Electrocardiography , Heart Failure/therapy , Heart Ventricles/physiopathology , Humans
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