Predictive Value of Models for End-Stage Liver Disease Score in Patients With Pulsatile Flow POLVAD MEV Left Ventricular Assist Device Support.

BACKGROUND: Model for End-Stage Liver Disease (MELD) score predicts multisystem dysfunction and death in patients with heart failure (HF). Left ventricular assist devices (LVADs) have been used for the treatment of end-stage HF. AIM OF THE STUDY: We evaluated the prognostic values of MELD, MELD-XI, and MELD-Na scores in patients with POLVAD MEV LVAD. MATERIALS AND METHODS: We retrospectively analyzed data of 25 consecutive pulsatile flow POLVAD MEV LVAD patients (22 men and 3 women) divided in 2 groups: Group S (survivors), 20 patients (18 men and 2 women), and Group NS (nonsurvivors), 5 patients (4 men and 1 woman). Patients were qualified in INTERMACS class 1 (7 patients) and class 2 (18 patients). Clinical data and laboratory parameters for MELD, MELD-XI, and MELD-Na score calculation were obtained on postoperative days 1, 2, and 3. Study endpoints were mortality or 30 days survival. MELD scores and complications were compared between Groups S and NS. RESULTS: 20 patients survived, and 5 (4 men and 1 woman) died during observation. Demographics did not differ. MELD scores were insignificantly higher in patients who died (Group 2). Values were as follows: 1. MELD preoperatively (21.71 vs 15.28, P = .225) in day 1 (22.03 vs 17.14, P = .126), day 2 (20.52 vs 17.03, P = .296); 2. MELD-XI preoperatively (19.28 vs 16.39, P = .48), day 1 (21.55 vs 18.14, P = .2662), day 2 (20.45 vs 17.2, P = .461); and 3. MELD-Na preoperatively (20.78 vs 18.7, P = .46), day 1 23.68 vs 18.12, P = .083), day 2 (22.00 vs 19.19, P = .295) consecutively. CONCLUSIONS: The MELD scores do not identify patients with pulsatile LVAD at high risk for mortality in our series. Further investigation is needed.

Left Ventricular Assist Device Implantation in Patients With Optimal and Borderline Echocardiographic Assessment of Right Ventricle Function.

BACKGROUND: Left ventricular assist devices (LVADs) are used for treatment of end-stage heart failure. Outcomes are dependent on right ventricle (RV) function. Prediction of RV function after LVAD implantation is crucial for device selection and patient outcome. The aim of our study was to compare early LVAD course in patients with optimal and borderline echocardiographic parameters of RV function. MATERIAL AND METHODS: We retrospectively reviewed 24 male patients with LVAD implantation. The following echocardiographic data of RV function were collected: FAC (fractional area change) with optimal value > 20%, tricuspid annulus plane systolic excursion >15 mm, RV diameter < 50mm, and right-to-left ventricle ratio < 0.57 (RV/LV). Patients were divided into group 1 (12 patients) with transthoracic echocardiography parameters in optimal ranges and group 2 (12 patients) with suboptimal transthoracic echocardiography findings. Study endpoints were mortality, discharge from the intensive care unit, and RV dysfunction. Demographics, postoperative clinical outcomes, comorbidities, complications, and results in a 30-day period were analyzed between groups. RESULTS: Echocardiography parameters differed significantly between groups 1 and 2 according to FAC (31.8% vs 24.08%; P = .005), RV4 (45.08 mm vs 51.69 mm; P = .02), and RV/LV ratio (0.6 vs 0.7; P = .009). Patients did not differ according to course of disease, comorbidities before implantation, or complications. One patient from each group died. Patients in group 2 experienced more pulmonary hypertension, required increased doses of catecholamines, and stayed in the intensive care unit longer. No RV dysfunction was noted. CONCLUSIONS: Borderline FAC, tricuspid annulus plane systolic excursion, and RV4 add RV/LV ratio prolonged recovery after LVAD implantation even with no RV failure. Parameters chosen for qualification are in safe ranges.

Red Blood Cell Distribution Width in End-Stage Heart Failure Patients Is Independently Associated With All-Cause Mortality After Orthotopic Heart Transplantation.

BACKGROUND: Red blood cell markers (RBCM) have been found to be predictors of mortality in various populations. However, there is no information regarding the association between the values of RBCM and long-term outcomes after orthotopic heart transplantation (OHT). The aim of this study was to assess whether the values of inflammatory markers and RBCM obtained directly before OHT are associated with mortality in patients diagnosed as having end-stage heart failure undergoing OHT. METHODS: We retrospectively analyzed data of 173 nonanemic adult patients diagnosed as having end-stage heart failure undergoing primary OHT between 2007 and 2014. Clinical and laboratory data were obtained at the time of admission for the OHT. RBCM were analyzed using an automated blood counter (Sysmex XS-1000i and XE-2100, Sysmex Corporation, Kobe, Japan). RESULTS: Mean age of the patients was 54 (41-59) and 72% of them were male. During the observation period, the mortality rate was 32%. Multivariable analysis of Cox proportional hazard confirmed that elevated pretransplantation red blood cell distribution width value (hazard ratio [HR], 1.38 [1.25-1.48], P < .001) was the sole independent predictor of death during long-term follow-up. Other red blood cell distribution width such as mean corpuscular volume, mean corpuscular hemoglobin concentration, and mean corpuscular hemoglobin (HR, 0.88 [0.84-0.91]; P < .001; HR, 0.75 [0.53-1.05]; P < .05; HR, 0.78 [0.64-0.96]; P < .05, respectively) had predictive value in univariable analysis. CONCLUSIONS: In summary, we have demonstrated that elevated red blood cell distribution width immediately before OHT is an independent predictor of all-cause mortality in heart transplant recipients. Other factors associated with posttransplantation mortality include lower values of mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration.

Predictive Value of the Model for End-Stage Liver Disease Score Excluding International Normalized Ratio One Year After Orthotopic Heart Transplantation.

BACKGROUND: The Model for End-Stage Liver Disease (MELD) scoring system incorporating a combination of hepatic and renal laboratory parameters does not adequately reflect the degree of multi-organ dysfunction in patients with heart failure, who need oral anticoagulation. In order to exclude the impact of oral anticoagulation on the international normalized ratio (INR), we used the MELD excluding INR (MELD-XI) score. The aims of the study were to calculate the individual preoperative MELD-XI score and its ability to predict 1-year mortality after heart transplantation and to identify other preoperative laboratory prognostic parameters. METHODS: We retrospectively analysed data of 87 consecutive adults undergoing heart transplantation between 2011 and 2014. Clinical data and laboratory parameters for the calculation of the MELD-XI score were obtained at the time of admission for the heart transplantation. RESULTS: The average age of the patients was 48.8 ± 13.3 years and 68.9% of them were male. During the observation period, the mortality rate was 18.4%. Multivariate analysis of Cox proportional hazard confirmed that the pretransplantation MELD-XI score (hazard ratio [HR] = 1.625 [1.286-2.053]; P < .001), sodium serum concentration (HR = 0.824 [0.677-1.001]; P < .05) and highly sensitive C-reactive protein (hs-CRP) serum concentration (HR = 1.045 [1.008-1.083]; P < .02) were independent predictors of death during the first year after heart transplantation. Area under the receiver operating characteristic (ROC) curve (AUC) indicated a good discriminatory power of MELD-XI (AUC 0.997; P < .04) and plasma sodium concentration (AUC 0.901; P < .01) in death prediction. CONCLUSIONS: Our study confirms that the pretransplantation MELD-XI score, as well as serum sodium and hsCRP concentrations, may be used to estimate postoperative risk in heart transplant recipients during a 1-year follow-up.

Predictive Value of Hepatic and Renal Dysfunction Based on the Models for End-Stage Liver Disease in Patients With Heart Failure Evaluated for Heart Transplant.

BACKGROUND: The evaluation of prognosis and determination of a long-term treatment strategy is an important element of management in patients with heart failure (HF). METHODS: The aim of the study was to determine the prognostic value of the Model for End-Stage Liver Disease (MELD) and its modifications, MELD and serum sodium (MELD-Na) and MELD excluding the international normalized ratio (MELD-XI), as well as other independent risk factors for death during a 4-year follow-up. We analyzed retrospectively 143 patients with advanced HF, evaluated for heart transplant between 2009 and 2011. Patients using warfarin were excluded from the study. The long-term follow-up data were obtained during follow-up visits and/or phone contact with the patients or their families. RESULTS: The age of the patients was 54 (48-59) years and 88.1% of patients were male. Mortality rate during the follow-up period was 49%. The MELD scores (hazard ratio [HR], 1.12; P < .001), as well as serum high-sensitivity C-reactive protein (hs-CRP; HR, 1.01; P < .01) and N-terminal pro-brain natriuretic peptide (NT-proBNP; HR, 1.01; P < .05) levels, were independent risk factors for death. Receiver operator characteristic analysis indicated that a MELD cutoff of 10 (area under the curve [AUC], 0.756; P < .0001], MELD-XI cutoff of 13.0 (AUC, 0.720; P < .0001), MELD-Na cutoff of 13.0 (AUC, 0.813; P < .0001), hs-CRP cutoff of 4.02 (AUC, 0.686; P < .001), and NT-proBNP cutoff of 1055 (AUC, 0.722; P < .001) were the best predictive values as predictors of death. CONCLUSIONS: MELD, MELD-Na, and MELD-XI scores are prognostic factors for death during a 4-year follow-up. A high MELD score is an independent prognostic factor for death. NT-proBNP and hs-CRP serum concentrations are other independent factors influencing death.

Comparison of Mechanical Circulatory Support by the Use of Pulsatile Left Ventricular Assist Devices Polvad MEV and Continuous Flow Heart Ware and Heart Mate II in a Single-Center Experience.

BACKGROUND: Mechanical circulatory support is increasingly used in patients with heart failure as a bridge to transplant or recovery. Results of use the Polish POLVAD MEV pulsatile circulatory support system and its comparison with novel devices never was done. We compared the course of patients with left ventricular circulatory support (left ventricular assist device [LVAD]) supported by POLVAD MEV or continuous flow devices Heart Mate II (HM II) and Heart Ware (HW) in single-center cohort. METHODS: We retrospectively reviewed 44 patients who underwent Polvad Mev (group P; n = 24 [21M/3F]) or HW or HM II (group C; n = 20 [20M/0F]) implantation between April 2007 and February 2014. Patients were in INTERMACS 1 (6 in group P and 1 in group C) or 2. Preimplant demographics, and perioperative and postoperative clinical outcomes were reviewed between groups. We analyzed baseline signs of heart failure, comorbidities, complications, and the 30- and 90-day results. RESULTS: Among the groups, age, gender, weight, and cause of heart failure were comparable. Patients in group C suffered more frequently from hypercholesterolemia preoperatively. Patients in group P had more pulmonary complications (7 vs 0) after LVAD implantation and stay longer on intensive care unit than patients in group C (17.61 ± 16.96 vs 9.56 ± 9.42; P = .047). After exclusion, INTERMACS 1 patients it was not significant (14.8 ± 10.8 vs 9.8 ± 9.6 days; P = .065), the 30- and 90-day mortality was comparable. CONCLUSIONS: Implantation of pulsatile POLVAD MEV and continuous flow devices as LVAD support provides comparable results. A greater number of complications in group P can cause increased mortality over a longer observation period.

Effects of Left Ventricular Assist Device Support on End-Organ Function in Patients With Heart Failure: Comparison of Pulsatile- and Continuous-Flow Support in a Single-Center Experience.

BACKGROUND: Limited data exist about the effects of continuous-flow versus pulsatile-flow left ventricular assist devices (LVADs) on end-organ function. We hypothesized that a pulsatile Polvad MEV (PM) would result in outcomes similar to those of similarly ill patients implanted with a continuous-flow LVAD (Heartware [HW] or Heartmate II [HMII]). We aimed to compare renal, hepatic, and hematologic functions in the 1st 30 days of support. METHODS: We retrospectively reviewed patients with 24 PM (21 M, 3 F; group P) and 15 HW and 5 HMII (20 M, 0 F); group C LVAD implantations from April 2007 to February 2014. Creatinine, bilirubin, aspartate (AST) and alanine (ALT) transaminases, hematocrit, platelet count, international normalized ratio (INR), and activated partial thromboplastin time (APTT) parameters were analyzed before implantation and during 30 days of support. Demographic parameters were similar. RESULTS: No significant differences were found between the groups regarding baseline renal, hepatic, or hematologic function. Baseline INR and APTT were significantly higher in group P. Levels of creatinine were similar between groups. They increased from baseline to postoperative day (POD) 1 and then decreased. Bilirubin levels were insignificantly higher in group P. Transaminases were significantly higher in group P (AST in PODs 3-6, ALT in PODs 3-7). INR values were significantly higher at baseline and in POD 0. APTT values were insignificantly higher in group P. CONCLUSIONS: The use of LVAD improved renal and hepatic function in our series. Patients in group P had more decreased hepatic function and presented slower regeneration.

Right Ventricular Function in Patients With Left Ventricular Assist Device Support by Pulsatile Polvad MEV and Continuous-Flow Pumps Heartware and Heartmate II.

BACKGROUND: Left ventricular assist device (LVAD) support is increasingly used in patients with heart failure. The right ventricle (RV) plays a main role in LVAD support. Little is known about the effects of pulsatile Polvad MEV devices or continuouseconds flow pumps on RV function. We compared hemodynamic parameters of RV in patients after implantation of Polvad MEV (PM) and Heartware (HW) or Heartmate II (HMII) LVADs. METHODS: Forty-four patients were retrospectively reviewed after implantation of PM (group P; n = 24 [21 M, 3 F]) or HW or HMII (group C; n = 20 [20 M, 0 F]) LVADs from April 2007 to February 2014. Hemodynamic data-mean pulmonary pressure (mPAP), central venous pressure (CVP), cardiac output (CO), and cardiac index (CI)-were collected before surgery, after surgery, and every 2 hours in the intensive care unit, with the time points numbered from 1 to 120. Right ventricular work (RVW) was calculated according to the equation: RCW = CO × (mPAP - CVP) × 0.0144 (g·m). RESULTS: Baseline characteristic of the patients were similar. mPAP values were similar between groups. CVP values were higher in group P, significantly at time points 5 and 7-33. CO values were higher in group C, significantly from point 3 and almost all the time to point 43. CI reached significance at point 9, 12-14, 16-19, and 30-41. RCW was higher in group P before implantation. Post-implantation RCW values were higher in group C, significantly at time points 19, 20, 32-34, 51-53, and 55-57. CONCLUSIONS: Continuous-flow pumps more effectively optimize RV function than pulsatile LVADs, which can result in more effective prevention of RV failure or insuffiency in that group.

Effectiveness and safety of treatment with sildenafil for secondary pulmonary hypertension in heart transplant candidates.

BACKGROUND: Pulmonary hypertension (PH) is a predictor of early death risk owing to right heart insufficiency after orthotopic heart transplantation (OHT). The aim of this study was to evaluate the effectiveness and safety of sildenafil therapy to decrease pulmonary vascular resistance (PVR) in patients with heart failure requiring transplantation, who may otherwise have been excluded because of PH. MATERIAL AND METHODS: We analyzed the hemodynamic results of six men (aged 47 to 61) with well-grounded OHT indications and PH diagnosed by a transpulmonary gradient (TPG) > 12 mmHg and/or PVR > 2.5 Wood units. Patients underwent a PH reversibility test with sodium nitroprusside (NPS) to achieve normal TPG and PVR results without a drop in systolic arterial pressure <85 mmHg. Unresponsiveness to NPS was shown in all subjects, who were subsequently qualified for sildenafil therapy (50 mg bid). RESULTS: After 1 month of sildenafil, three subjects achieved normal TPG and PVR, and acceptable responsiveness of PH to NPS in two other patients, all of whom qualified for OHT. Therapy was unsuccessful in one patient, which was confirmed also by right heart catheterization after 3 months of sildenafil use. Therapy was well tolerated in all patients, namely, no significant drop in arterial pressure on angiotensin-converting enzyme inhibitors. CONCLUSIONS: Sildenafil may be effectively used for treatment of secondary, irreversible PH in potential heart transplant recipients.

Comparison of long-term results of drug-eluting stent and bare metal stent implantation in heart transplant recipients with coronary artery disease.

UNLABELLED: The aim of the study was to compare long-term results of intracoronary implantation of drug-eluting stents (DES) and bare metal stents (BMS) in patients suffering from transplant coronary artery disease (TxCAD). MATERIAL AND METHODS: We performed a retrospective analysis of all intracoronary stent implantations for TxCAD among subjects with at least one follow-up coronary angiography. We identified 28 sirolimus-eluting DES (n = 17) patients, 24 BMS (n = 13 patients), and both DES and BMS (n = 7 patients) implantations among 23 recipients. Mean follow-up after DES was 14 months and after BMS implantation, 20 months. We compared the occurrence of in-stent restenosis (ISR), and patient survival in the context of risk factors that were identified separately for each stent type. Significance was assessed using the log-rank, chi(2) and Mann-Whitney U test. RESULTS: There were 2 (7%) ISR among DES versus 14 (58%) ISR among BMS (P = .0002) patients, with a longer time of freedom from IRS after DES implantation (P = .022). There were three deaths (18%) among DES, four (31%) with BMS, and one (14%) with DES and BMS (P = NS). Left anterior descending artery was the place of DES implantation in 17 (61%) versus 10 (42%) of BMS cases (P = NS). Risk factor profile was comparable except for a higher age at the time of transplantation (46 +/- 7 vs 41 +/- 6 years; P = .011) and stent implantation (54 +/- 7 vs 49 +/- 6 years; P = .0002) for DES. CONCLUSION: Favorable long-term results of sirolimus-eluting stents over BMS implanted for TxCAD suggested their preferential use in heart transplant recipients.

The effect of Epstein-Barr virus infection on medium-term survival after orthotopic heart transplantation.

UNLABELLED: Our aim was to assess the medium-time results after orthotopic heart transplantation (OHT) depending on the serostatus of heart transplant recipients at the time of transplantation. MATERIALS AND METHODS: We enrolled 120 patients in this retrospective study including 107 males and an overall mean age of 49.1 +/- 8.6 years ischemic heart disease (IHD) was the diagnosis before OHT in 46%. The mean follow-up was 48 months. The first diagnostic coronary angiography was routinely preformed at 1 year after OHT, and then every second year. We evaluated every incidence of a change in the coronary arteries, the presence of significant stenosis (requiring percutaneous coronary intervention), acute myocardial infarction, death, or retransplantation. Using indirect immunofluorescence assays we detected Epstein-Barr virus (EBV) antigenemia by identification of antibodies against early antigens of EBV (EA) of IgM and IgG classes as well as IgG antibodies against nuclear antigen of EBV (EBNA). Since April 2001 all three types of antibodies were routinely investigated on admission to the hospital for OHT. RESULTS: At the time of transplantation, IgM-EA antibodies were detected in 17 (14%) patients, IgG-EA in 35 (29%), and IgG-EBNA in 113 (94%). Survival rate, incidence of cardiac allograft vasculopathy and death, as a function of the serostatus of the heart recipient at the time of transplantation were estimated by Kaplan-Meier curves; the results were compared by log-rank tests. The findings among IgM EA, IgG EA, and IgG EBNA-positive and -negative groups were statistically comparable. CONCLUSION: Infection with EBV before OHT did not worsen the prognosis over the first 4 years after transplantation.

The influence of cytomegalovirus infection, confirmed by pp65 antigen presence, on the development of cardiac allograft vasculopathy.

AIM: We sought to determine the impact of cytomegalovirus (CMV) infection on cardiac allograft vasculopathy (CAV) development in the long term after orthotopic heart transplantation (OHT). MATERIALS AND METHODS: We enrolled 144 patients in this retrospective study including 128 men with an overall age at transplantation of 48.4 +/- 9.3 years. Before OHT, 45% exhibited ischemic heart disease (IHD). The mean follow-up was 62 months. Detection of CMV antigenemia was performed by identification of pp65-antigen on peripheral blood leukocytes. The first diagnostic coronary angiography was routinely performed at 1 year after heart transplantation and thence every second year. We evaluated every incidence of change in the coronary arteries, of significant stenosis (requiring percutaneous coronary intervention), acute myocardial infarction, of death or of transplantation. All patients were followed to the incidence of a cardiovascular event, death, or the end of observation. RESULTS: Of 144 patients, 33 were pp65 positive, namely 29 men with overall mean age at transplantation of 48 +/- 10.3 years. Before OHT, 52% had IHD. The incidence of CAV during follow-up was 24% (n = 8) in the pp65(+) and 22% (n = 24) in the pp65(-) group. It was significant in 3 (9%) versus 8 (24%) patients. There were 4 (12%) deaths in pp65(+) and 9 (8%) deaths in the pp65(-) groups. Kaplan-Meier survival curves to estimate the time for CAV development and death showed no significant differences by log-rank tests. CONCLUSION: No impact of CMV infection on CAV development was observed in first 5 years after OHT.

Exhaled nitric oxide concentration in patients after heart transplantation.

Nitric oxide (NO) is present in exhaled air in humans and its level may decrease in heart diseases. In the present study we prospectively investigated how heart transplantation treated with oral immunosuppresive drugs based on ciclosporine A influences the exhaled NO concentration (exNO). The study was performed in 17 patients after heart transplantation in various time after procedure and 15 nonsmoking healthy volunteers as a control group. Patients after heart transplantation were free of clinical signs of rejection. End-tidal concentration of exNO was measured by the use of a chemiluminescence method. We found no statistically significant differences in the exNO level between patients after heart transplantation and healthy controls (6.81+/-2.70 part per billion (ppb) in the transplant group vs. 6.01+/-3.43 ppb in the control group). We conclude that heart transplantation and immunosuppresive therapy do not influence the exhaled NO concentration.

Potential confounding factors in measurement of exhaled nitric oxide.

Nitric oxide is present in the exhaled air. Factors affecting the level of exhaled nitric oxide (exNO), except for smoking, are not well defined. In this study we seek to determine whether age, gender, body mass index (BMI), part of the day, or time after a meal could modulate exNO levels. exNO was examined by the use of a chemiluminescence method in 100 subjects - 31 women (19 nonsmokers and 12 smokers) and 69 males (55 nonsmokers and 14 smokers). Forty four subjects took medications due to stable coronary disease, 22 were after heart transplantation, and 34 did not take any drugs. We found that exNO levels did not differ either between the whole groups of women and men or between smokers and nonsmokers of either respective group (4.91 +/-2.38 vs. 6.27 +/-4.23 ppb; 3.21 +/-1.16 vs. 3.71 +/-1.55 ppb; 5.98 +/-2.35 vs. 6.92 +/-4.45 ppb). The correlation of exNO with age in the whole population was weak (r=0.23; P=0.02) and insignificant in the smoking and nonsmoking subgroups. Likewise, correlations of exNO with BMI, part of the day, or time after a meal were insignificant in whole population as well as the subgroups. We conclude that the aforementioned factors are not able to confound the measurement of exNO in the population studied.

Moderate exercise decreases nitric oxide exhalation in patients with stable coronary artery disease.

Nitric oxide (NO) is present in exhaled air in humans and its level may decrease in heart diseases. Nitrates are metabolised to NO. In the present study we prospectively investigated how coronary disease treated with oral nitrates and physical exercise influence the exhaled NO concentration (exNO). The study was performed in 44 patients with stable coronary artery disease (CAD) treated with oral nitrates (31 nonsmokers and 13 smokers). End-tidal concentration of exhaled NO was measured by the use of a chemiluminescence method. The Bruce protocol of an exercise test was performed in 21 coronary patients and 11 volunteers. NO was measured before and 2-5 min after the test. We found no significant differences in the exNO level between healthy controls and CAD patients as analyzed either for the whole groups or non-smoker and smoker subgroups (6.01 parts per billion (ppb) vs. 4.91 ppb; 7.02 ppb vs. 5,89 ppb; 3.62 ppb vs. 3.33 ppb, respectively). However, the coronary patients group, as a whole, had lower exNO after exercise (4.22 ppb vs. 3,84 ppb, P<0.01). The difference persisted after division of this group into non-smokers and smokers; 5.19 ppb vs. 4,79 ppb, P<0.05 and 3.63 ppb vs. 3.27 ppb, P<0.05, respectively). The level of exNO changed inappreciably after exercise in control subjects. We conclude that coronary disease and oral nitrates, in themselves, do not influence the exhaled NO concentration. Physical exercise, on the other side, lowers the exhaled NO level in coronary patients.