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The 6-minute walking test (6mWT) is used to prescribe physical activity in cardiac surgery patients. The clinical value of a pre-discharge 6mWT and its association with outcome is not well defined.We retrospectively analyzed data from 313 patients (age 66 ± 11 years, 23% females, left ventricular ejection fraction (LVEF) 52 ± 11%, Hb 10.5 ± 1.3 g/dl, serum albumin 3.9 ± 0.4 mg/dl) who were admitted to our rehabilitation institute following cardiac surgery. A 6mWT was performed at entry and at discharge and expressed as % of theoretical predicted values calculated on the basis of individual age, height, weight and sex. The endpoint was represented by all-cause mortality. The predictive value of 6mWT was tested in univariate and multivariate analysis.A pre-discharge 6mWT was completed by 284 out of 313 patients. Two patients died in hospital. During a median of 23 months, mortality was 9% (26/284) and 44% (12/27) (p0.0001) in patients who did or did not perform the pre-discharge 6mWT. The distance covered at the pre-discharge 6mWT as a continuous variable of % predicted values was a significant predictor of subsequent mortality (Hazard Ratio (HR) 0.97 (95% CI 0.96-0.99), p = 0.0019). After adjustment for all preselected covariates, the pre-discharge 6mWT (HR 0.97 (95% CI 0.95-0.99), p = 0.0038) and LVEF (HR 0.93 (95% CI 0.90-0.96), p0.0001) remained significantly associated with the outcome.In recent cardiac surgery patients, the pre-discharge 6mWT is not only a valid measurement of the impact of cardiac rehabilitation but also provides outcome information offering the possibility to identify patients who may need more intensive follow-up.

within the chest. For example, patients who have undergone Fontan palliation have only 1 atrioventricular valve, and a capacitance chamber must be constructed to adequately connect the TAH-t. Virtual implantation offers the ability to test several surgical approaches for device placement before the patient even enters the operating room. This study was limited by a single-center experience in a small patient cohort. In addition, the assessment by virtual implantation was retrospective, and no 50cc TAH-t device was actually implanted to confirm the predicted results of the virtual implantation because it was not available during the study. However, two 70cc TAH-t devices were placed successfully as predicted by virtual implantation. In conclusion, virtual compatibility testing allows device consideration for fit to be individualized and represents a movement away from using generalized assumptions about heart size, chest wall anatomy, and spatial relationships of cardiothoracic structures to determine fit. Disclosure statement

The authors performed a comparative analysis of 60 whole blood samples containing cyclosporine (CsA) from heart transplant (HTx) recipients (n = 60) by the two "specific" monoclonal immunoassays, enzyme-multiplied immunoassay technique (EMIT) and fluorescence polarization immunoassay (S-FPIA), using the Altman-Bland approach based on graphical techniques and simple calculations. The CsA blood concentrations measured by S-FPIA [mean (SD): 268.1 (108.8) ng/mL] showed a statistically significant difference (P < 0.001) from the corresponding concentrations measured by EMIT [219.6 (118.7) ng/mL]. The CsA concentrations were 27% (median) higher when determined by monoclonal S-FPIA than by EMIT. The comparison between EMIT and S-FPIA showed a good correlation (S-FPIA conc. (ng/mL) = EMIT conc. (ng/mL) x 0.88 + 76.1, r = 0.96, P < 0.001). However, a high correlation does not mean that the two methods agree, and their use as interchangeable might be misleading. The authors summarized the degree of agreement by calculating the bias estimated by the mean difference (d) and the standard deviation of the difference (SD). For CsA concentration data, the mean difference (S-FPIA minus EMIT) is +49.9 ng/mL and SD is 31.2 ng/mL. Altman-Bland analysis indicates considerable lack of agreement between EMIT and S-FPIA, with discrepancies of more than 100 ng/mL. The present study's data clearly show that there is a considerable and clinically unacceptable lack of agreement between the S-FPIA and the EMIT techniques in HTx recipients for the whole range of concentrations evaluated (25-500 ng/mL), and this is caused by the variation in the overestimation of the CsA parent compound. Even though a similar CsA reference range was reported during maintenance therapy for both methods (150-250 ng/mL), which might encourage their interchangeability in the clinical setting, this approach should be avoided. Laboratory reports should always state both the concentration of CsA and the analytical method.

Objective: To discuss informed consent to heart transplantation in the case of an intensive care unit (ICU) patient: relatives’ informed consent was refused by the patient himself whose cognitive ability appeared to be reasonable for the purpose. Setting: ICU of a university teaching hospital. Patient: a 62-year-old man who underwent myocardial revascularization had in the immediate post-operative hemodynamic instability, continuous serious arrhythmias, ventilatory support, fentanyl infusion. Heart transplantation could be the only chance for his survival. Intervention: heart transplantation. Results: despite patient’s refusal, we decided to hold the relative’s consent as valid, and transplantation was accordingly performed, to the subsequent satisfaction of the patient. Conclusions: Our decision was based on two beliefs: (1) the severity of the patient’s clinical condition may have impaired his cognitive abilities; (2) the very same conditions may mask impairment and certainly make reliable assessment of cognition and judgment impossible. This being so, the preservation of life assumes priority.

Proliferating cell nuclear antigen (PCNA) myocyte expression and histopathologic features related to its occurrence were investigated in normal and diseased hearts of adult humans using both immunohistochemical and Western blotting techniques. Ki67 Western blotting was also performed in the same samples used for PCNA blotting. Two hundred seventy-one endomyocardial biopsies, and 15 adult, 1 embryonic and 2 fetal hearts were studied. The biopsies were from normal donor hearts (n = 71), patients with cardiomyopathy and myocarditis (n = 64), and patients with transplantation with (n = 106) and without (n = 30) acute rejection of any grade. The 15 hearts were from 1 heart donor, and from patients with cardiomyopathy (n = 5), valvular heart disease (n = 2), ischemic heart disease (n = 4), amyloidosis (n = 1) and transplantation with acute rejection (n = 2). The PCNA labeling index was plotted against myocyte hypertrophy, inflammatory infiltrates and binucleation index. The PCNA labeling index ranged from 2 to 9% in embryonic and fetal hearts. PCNA was expressed by 1 to 2% of myocyte nuclei in 12% of normal heart biopsies, 1 to 5% of myocyte nuclei in 28% of cardiomyopathy and myocarditis biopsies, and by up to 8% of myocyte nuclei in 53% of biopsies of patients with transplantation, independently of the presence and degree of acute rejection. In the latter biopsies and in myocarditis, some inflammatory cells also showed PCNA expression. PCNA positive myocytes were both mono- and binucleated, and there was no correlation between binucleation and PCNA labeling indexes. Ki67 and PCNA blotting confirmed imiminohistochemical results. The results show that few myocytes express PCNA in normal hearts. This expression is only detectable by immunohistochemical stains. The percentage of PCNA expressing myocytes increases in diseased hearts of any origin, so that it becomes detectable by both immunohistochemical and Western blotting techniques. Data from transplanted heart biopsies confirm that as in myocarditis, immunologic-inflammatory stimuli are likely powerful triggers of PCNA expression. Therefore, cardiac myocytes of adult humans can express proliferating cell markers, and this expression increases in hearts with hypertrophy or inflammatory reaction.

Seven cases of Pneumocystis carinii pneumonia (PCP) (two in 1988, three in 1989, one in 1990 and one in 1991) have been observed in a group of 241 heart transplant recipients transplanted in Pavia, Italy, from November 1985 through December 1991. Median time to onset of symptoms was 100 days after transplantation (range 59-333 days). Diagnosis was achieved in all patients by cytological examination of bronchoalveolar lavage (BAL) fluid and/or transbronchial biopsy. Clinical and roentgenographic features were remarkably similar in all PCP-affected heart transplant recipients. A dry, persistent hacking cough associated with dyspnoea was consistently observed. Fever ranged from 37.6 to 39.4 degrees C, median leukocyte count and median arterial oxygen saturation (SaO2) values were 7,300/mm3 (range 3,000-16,000/mm3) and 61% (range 49.3-93%), respectively. Median CD4+ count at the onset of symptoms was 211/mm3 (range 28-739/mm3). The only patient experiencing a recurrence of PCP had a CD4+ cell count of 28/mm3 at the end of treatment with trimethoprim-sulfamethoxazole (TMP-SMX). In all patients human cytomegalovirus was isolated from BAL fluids; however, treatment with TMP-SMX alone (20 mg/kg/day of TMP) was consistently followed by a complete recovery.

Background Restrictive transfusion strategies have been suggested for cardiac surgical patients, leading to various degrees of postoperative anemia. This study investigates the exercise tolerance during rehabilitation of cardiac surgical patients who did not receive transfusions, with respect to their level of postoperative anemia. Methods This observational study started in January 2010 and ended in May 2010 in 2 rehabilitation hospitals and 2 large-volume cardiac surgical hospitals. The study population was 172 patients who did not receive transfusions during cardiac surgical operations with cardiopulmonary bypass and subsequently followed a rehabilitation program in 1 of the 2 rehabilitation hospitals. No patient received a transfusion during the rehabilitation hospital stay. Exercise tolerance was measured using the 6-minute walk test at admission and discharge from the rehabilitation hospital. The level of anemia at admission to the rehabilitation hospital was tested as an independent predictor of exercise tolerance within a model inclusive of other possible confounders. Results Patients with values of hemoglobin less than 10 g/dL at admission to the rehabilitation institute had a significantly ( p = 0.007) worse performance on the 6-minute walk test than patients with higher values (258 ± 106 vs 306 ± 101 meters). This functional gap was completely recovered during a normal rehabilitation period. Other independent factors affecting exercise tolerance were age, sex, and albumin concentration. Conclusions Postoperative anemia with hemoglobin levels of 8 to 10 g/dL is well tolerated in patients who have not received a transfusion and induces only a transient impairment of exercise tolerance.

From November 1985 to December 1990, 2,552 endomyocardial biopsy specimens from 209 heart transplant patients were studied. Forty-four (21%) patients developed 45 episodes of major human cytomegalovirus infection (HCMV). Human cytomegalovirus infection was primary in 13 of 44 patients. Thirty-one patients developed episodes of recurrent major infection. One patient had both primary and recurrent infections. Conventional histopathologic and immunohistochemical study, in situ hybridization, and polymerase chain reaction were used to diagnose HCMV myocardial involvement on corresponding endomyocardial biopsy specimens performed during infection. Conventional morphologic study showed typical viral inclusion bodies in four biopsy specimens. Two cases had myocyte HCMV localization with necrotizing myocarditis, whereas two had endothelial cell involvement without any inflammatory reaction. In these four biopsy specimens, immunohistochemistry showed a higher number of infected cells than that recognized by conventional histopathologic study. In situ hybridization detected infected cells with no evidence of cytopathic effect. Polymerase chain reaction gave HCMV amplification products in two additional biopsy specimens otherwise interpreted as moderate and mild rejection, respectively. Therefore, 6 biopsies showed HCMV myocardial involvement (6 of 45; 13.3%): all were from patients with primary HCMV infection (6 of 13; 46%). None of 32 major recurrent infections showed any myocardial involvement. In conclusion, our study is the first to demonstrate that myocardial HCMV involvement preferentially occurs in primary infection and HCMV endothelial localization can be free from inflammatory reaction, whereas HCMV myocyte localization leads to necrotizing myocarditis. Polymerase chain reaction has a higher diagnostic sensitivity than in situ hybridization. However, polymerase chain reaction findings of HCMV DNA on otherwise negative endomyocardial biopsy specimens remains of questionable significance because polymerase chain reaction-positive biopsy samples do not necessarily indicate tissue infection. It is impossible to determine whether amplified sequences derive from circulating leukocytes or from tissue cells.

Atrial natriuretic peptide (ANP) was immunohistochemically investigated in (1) right ventricular endomyocardial biopsy specimens from 87 apparently healthy donor hearts taken from victims of cerebral accidents; (2) 1 normal heart not suitable for transplantation (HBsAg carrier); (3) right ventricular endomyocardial biopsy specimens from 151 patients with dilated cardiomyopathy (DC); and (4) 57 explanted hearts, 26 with DC and 31 with ischemic heart disease. No ANP immunoreactivity was found in normal ventricles. Failing hearts showed ventricular positivity in 31% of the DC biopsy series, in 61% of the left ventricles, and in 30% of the right ventricles of the explanted heart series. An endoepicardial gradient was observed, because ANP positivity was greater and more extensive in the subendocardial layers. Ultrastructural studies were performed on biopsy specimens from 10 normal hearts and 132 DC biopsy samples. No ANP-storing granules were found in biopsy samples of normal ventricles, whereas ANP granules were seen in 15 of 132 (11.4%) DC cases. In parallel immunoblotting, investigation showed the same 13 kDa band protein in 1 normal atrium as well as in 8 failing atria and ventricles. ANP immunoreactivity was positively correlated with higher New York Heart Association functional classes as well as with higher left ventricular end-diastolic pressure (p less than 0.005), end-diastolic volume (p less than 0.005) and end-diastolic volume index (p less than 0.005). In conclusion, apparently healthy ventricles do not show ANP immunoreactivity, whereas failing ventricles do. ANP expression seems to be independent of the underlying disease, but positively related to the clinical status and the degree of left ventricular impairment and dilatation.

Purpose: To evaluate the rate of return to work after transplantation and its determinants in a clinically-stable population of patients transplanted and followed-up at a single institution in Italy. Methods: 151 thoracic organ transplant recipients (72 lung, 79 heart) were examined. Patients were asked about daily activities, level of education, employment and clinical condition. A six-minute walking test was performed with measurement of dyspnoea using the Borg scale. Quality of Life was evaluated with the SF-36 and GHQ questionnaires. Results: Before transplantation 131 patients (87%), (70 heart and 61 lung) worked. After transplantation, 51 patients (39%) went back to work and 3 more started working. We found that younger age, a better quality of life (mainly in the mental domain), having had an occupation previously (particularly as an entrepreneur/freelancer), and having been off work for less than 24 months, were independent predictors of return to work. Conclusions: Considering their good, objective and subjective, functional status, some patients who could have returned to work, chose not to. Identifying factors which affect return to work might help health professionals to adopt the best course of treatment and psychological support in order to fulfil this goal; however, return to work should not be considered as the only expression of a patient's real psychophysical condition.

Introduction Orthotopic heart transplantation (OHTx) represents the therapy of choice for end-stage heart disease not treatable with medical or conservative surgical approach. Heterotopic heart transplantation (HHTx) is a surgical procedure in which the graft is connected to the native heart in a parallel fashion and it was especially employed in precyclosporine era. The aim of this paper is to present our experience with HHTx. Methods From November 1985 till May 2003, 713 heart transplanted patients included 12 (1.7%) received HHTx. Eleven were male, mean age was 50.7 ± 5.8 years. Five patients suffered from dilated cardiomyopathy and seven from ischemic cardiomyopathy. Indication for HHTx was: a body size mismatch in 11 cases and availability of a marginal organ in one case. Results Mean ischemic time was 149 ± 48 minutes and mean cross-clamp time was 82.3 ± 19.1 minutes. In four cases left ventricle aneurysm resection was associated with HHTx. Hospital mortality was 8.3% (one patient due to multiorgan failure). The actuarial survival rates were 92% and 64% at 1 and 5 years, respectively. The causes of death were: liver cancer, liver cirrosis, aortic dissection, cerebrovascular accident, and chronic rejection. Conclusions In our experience, HHTx survival rate is comparable to OHTx. Because of the scarcity of donors, use of an undersized or marginal graft is a valid option to increase the number of transplanted patients. The major disadvantages of HHTx are the need for anticoagulant therapy, the more difficult hemodynamic and immunologic follow-up, and the presence of the diseased native heart.

Background. Bone loss has been reported as a complication after heart transplantation (HTx), and the increase in bone fractures is an effective problem. Treatment of osteoporosis has obtained mixed results. In this study we evaluate the effect of treatment with an oral bisphosphonate. Methods. Sixty-four patients with low mineral density 6 months after HTx were randomized as follows: Group A received oral clodronate (1600 mg/day in two divided doses), and Group B received placebo. Every patient was also treated with 2000 mg/day of oral calcium carbonate. Bone mineral density (BMD) was measured by dual energy x-ray absorptiometry at the lumbar spine, 1/3 and 1/10 of the distal nondominant forearm before and after 12 months of treatment. Laboratory tests were performed at 3, 6, and 12 months of treatment. Results. All patients demonstrated manifest bone loss 6 months after HTx compared with normal non-HTx controls (P=0.0001). After 1 year of clodronate therapy, BMD at the lumbar spine increased from 0.77±1.4 g/cm 2 to 0.86 g/cm 2 (P=0.02). Laboratory tests did not show any significant variation, except for the bone isoenzyme of alkaline phosphatase, which showed a significant decrease after 1 year of treatment. The incidence of new fractures was 9.3% in the placebo group and 0% in the clodronate group. Therapy was well tolerated without impact on graft function. Conclusions. One year of clodronate therapy induced a significant increase in BMD at the lumbar spine in our HTx patients. Treatment was well tolerated without onset of new bone fractures.

Respiratory sinus arrhythmia has been described in heart transplanted subjects. In order to investigate the mecha nisms involved in the generation of this condition in the transplanted heart and its evolution after surgery, graded exercise was performed (0–75 W in 25 W steps) on a cycle ergometer by 41 subjects (mean age 44 years) who had undergone heart transplantation 28 months (range 3–60) earlier and by six age matched-control subjects. R-R interval, respiratory signal, O2 consumption (VO2 and CO2 production (VCO were measured. Respiratory sinus arrhythmia was assessed by the autoregressive power spectrum of the R-R interval and respiration. All subjects reached the anaerobic threshold (heart transplants: 60% at 50 W, 40% at 75W Controls: 150 W). In control subjects, the respiratory sinus arrhythmia was higher than in heart transplanted subjects (5·80 ± 0·30 vs 1·45 ± 0·16 ln ms2) and it decreased significantly (4·66 ± 0·30 In ms2 P

Introduction. Amyloidosis is a systemic disease. Heart transplantation in this subset of patients is contraindicated by the majority of authors. In our center, patients with heart failure due to amyloidosis have been evaluated for cardiac transplantation since 1991. The aim of this study was to analyze the outcome of these patients waiting for transplant and the effectiveness of this therapy. Materials and Methods. Since 1991, eight patients affected by amyloidosis have been evaluated and enrolled on the waiting list for transplant: five affected by AL lambda type; two by APO A1; and one by TTR. Four were transplanted, three died waiting for a donor (two from cardiac failure, one from sudden death), and one has been recently transplanted after 17 months on waiting list. Results. Since 1985, 713 patients underwent heart transplantation in our center, five of whom were affected by amyloidosis (0.7%). Two are still alive (60 and 41 months) without evidence of cardiac amyloidotic infiltration. One patient recently underwent a combined heart-liver transplantation. Two patients died after the intervention: one sudden death after 23 months with amyloidotic infiltration of transplanted heart, and one multiple organ failure (MOF) due to progression of the systemic disease. Conclusions. Despite the small size of the group preventing us from drawing definitive conclusion, heart transplantation may prevent therapy to arrest organ damage in patients with isolated cardiac involvement. Cardiac events are the main cause of death. Patients must be followed-up for evolution of systemic disease. The midterm survival is encouraging.

We retrospectively analyzed 275 consecutive transplanted patients, dividing them into group A (128 patients) affected by ischemic cardiomyopathy and group B (147 patients) affected by dilated cardiomyopathy. The difference in demographic, clinical and hemodynamic preoperative and postoperative data between the groups was studied; group A patients presented at transplantation with a less compromised hemodynamic picture, requiring inotrope infusion and mechanical assistance less frequently. The influence of etiology on early postoperative complications was also analyzed: group A patients needed postoperative mechanical assistance, inotrope, infusion and prolonged mechanical ventilation more often, therefore requiring a longer stay in the intensive care unit (ICU). Hospital mortality was twice as high in group A. The older age of group A patients per se did not influence these results significantly. The long-term follow-up was then studied with particular attention to parenchymal functions, hemodynamics, coronary artery disease, metabolic and surgical complications, and survival. The complication rate was higher in group A, with more severe hypertension and higher cholesterol levels at 1 year, a higher prevalence of accelerated coronary artery disease (CAD) and a more frequent onset of insulin-dependent diabetes. Surgical and vascular complications were also more frequent. The final result was a better 5-year actuarial survival rate for group B patients. Donor and recipient ages at the time of transplant did not influence this result. We conclude that ischemic patients, even if they are transplanted in better condition and operated more electively, have a more critical early and long-term postoperative course and a worse survival rate. These findings are not explained by advanced age, but could be due to the impact of atherosclerosis and metabolic impairments associated with ischemic disease.

Among 265 patients transplanted at our Institution, 7 underwent cardiac retransplantation. There were five emergency retransplantations, the indication being graft failure in one case and acute rejection in four cases. Two patients, retransplanted because of acute rejection, had a positive panel reactivity antibody and a negative donor crossmatch. In the rejection cases immunosuppression was enhanced by perioperative plasmapheresis and a postoperative 1-month course of cyclophosphamide. In two cases emergency retransplantations were successfully performed despite a highly positive prospective crossmatch. Two patients underwent elective retransplantations for chronic rejection 12 and 41 months, respectively, after the primary transplants. The overall early and late survival rates are 71% and 57%, respectively, with a mean follow-up of 48.5 months. The early and late mortality for elective retransplantation is zero. Our experience confirms both the high operative risk for emergency retransplantation and the excellent results for elective retransplantation. The use of plasmapheresis and cyclophosphamide allowed us to undertake retransplantation successfully in 2 cases with positive donor crossmatch. Both hyperimmunized patients in our series were retransplanted because of irreversible acute rejection despite a negative crossmatch with the primary donor. The meaning of negative crossmatch in patients with preformed cytotoxic antibodies is therefore questionable.

Alternative surgical solutions have been proposed for some years in the face of the difficulties presented by medical treatment of ventricular tachycardia (VT) following myocardial infarction. Deeper knowledge of the electrophysiological mechanisms [2–5] of this type of tachycardia and above all the improvement of endo- and epicardial mapping techniques [6] in man have recently permitted the introduction of rational surgical techniques directed to the interruption of the reentry mechanism implicated in the pathogenesis of postinfarction VT.

Left main coronary artery disease (LMCAD) is a particularly severe form of coronary artery disease (CAD); its frequency ranges from 5% of 7% in patients with CAD [4, 6, 7] and virtually all published reports show a grim natural history: the survival rate of medically treated patients with LMCAD ranges from 65% to 57% at 2 years [9, 16], from 49% to 46% at 5 years [3, 13], and from 13% to 31% after 10 years [19]. Coronary artery bypass grafting (CABG) is generally accepted as the treatment of choice in these patients and randomized studies of large series have shown a significantly better prognosis for the operated patients, with 88% or 86% survival at 4 years [5, 7]. The data obtained from our experience with 155 consecutive cases of LMCAD treated by CABG form the basis of this report.

From July 1981 to June 1987 160 consecutive patients underwent left ventricular (LV) septoplasty for LV aneurysm involving the septum. LV septoplasty affords reconstruction of LV septum by means of a series of stitches passed from the free edge of the aneurysm through the border of the septal scar and pulled out through the adjacent right ventricular free wall. Associated procedures included 163 (coronary artery bypass grafts) and 49 antiarrhythmic treatments. Hospital and late mortalities were 6.2% and 10% respectively: 92% of the discharged patients were followed up. Actuarial survival rates were 89.9% and 83.7% at 1 and 5 years respectively. Clinical results showed functional improvement from a mean NYHA class 2.7 to 1.5 for dyspnea and from 2.1 to 1.1 for angina. The factors that seem to affect early and late prognosis are ejection fraction and preoperative congestive heart failure alone or associated with ventricular tachycardia. Ventricular septoplasty permits an optimal reconstruction of LV shape and function by excluding akinetic or dyskinetic septum. LV septoplasty can correct a postinfarction ventricular septal defect, if present, by excluding the involved portion of the septum.