Prototype Development of an Implantable Compliance Chamber for a Total Artificial Heart.

At our institute a total artificial heart is being developed. It is directly actuated by a linear drive in between two ventricles, which comprise membranes to separate the drive and blood flow. A compliance chamber (CC) is needed to reduce pressure peaks in the ventricles and to increase the pump capacity. Therefore, the movement of the membrane is supported by applying a negative pressure to the air volume inside the drive unit. This study presents the development of the implantable CC which is connected to the drive unit of the total artificial hearts (TAH). The anatomical fit of the CC is optimized by analyzing CT data and adapting the outer shape to ensure a proper fit. The pressure peaks are reduced by the additional volume and the flexible membrane of the CC. The validation measurements of change in pressure peaks and flow are performed using the complete TAH system connected to a custom mock circulation loop. Using the CC, the pressure peaks could be damped below 5 mm Hg in the operational range. The flow output was increased by up to 14.8% on the systemic side and 18.2% on the pulmonary side. The described implantable device can be used for upcoming chronic animal trials.

Diagnosis of obstructive coronary artery disease by cardiogoniometry: a field test in a real-life setting.

Cardiogoniometry is an electrocardiographic and vectorcardiographic method utilizing computer-assisted analysis of cardiac potentials focusing on T-wave abnormalities resulting from myocardial malperfusion. We describe a case of diagnosis of obstructive coronary artery disease with this method and discuss the possible implications for the clinical setting.

Nocardiosis in Heart Transplant Recipients.

Nocardia has emerged as an important opportunistic pathogen, especially in organ transplant recipients. Heart transplant (HT) recipients initially had an especially high rate of Nocardia infection, but this could be reduced by the routine use of cyclosporine. Our objective was to clarify the prevalence and presentation of Nocardiosis in HT recipients in a retrospective cross-sectional analysis.

Normothermic ex vivo allograft blood perfusion in clinical heart transplantation.

BACKGROUND: Cold ischemia associated with cold static storage is an independent risk factor for primary allograft failure and survival of patients after orthotopic heart transplantation. The effects of normothermic ex vivo allograft blood perfusion on outcomes after orthotopic heart transplantation compared to cold static storage have been studied. METHODS: In this prospective, nonrandomized, single-institutional clinical study, normothermic ex vivo allograft blood perfusion has been performed using an organ care system (OCS) (TransMedics, Andover, MA, USA). Included were consecutive adult transplantation patients who received an orthotopic heart transplantation (oHTx) without a history of any organ transplantation, in the absence of a congenital heart disorder as an underlying disease and not being in need of a combined heart-lung transplantation. Furthermore, patients with fixed pulmonary hypertension, ventilator dependency, chronic renal failure, or panel reactive antibodies >20% and positive T-cell cross-matching were excluded. Inclusion criteria for donor hearts was age of <55 years, systolic blood pressure >85 mmHg at the time of final heart assessment under moderate inotropic support, heart rate of <120 bpm at the time of explantation, and left ventricular ejection fraction >40% assessed by an transcutaneous echo/Doppler study with the absence of gross wall motion abnormalities, absence of left ventricular hypertrophy, and absence of valve abnormalities. Donor hearts which were conventionally cold stored with histidine-tryptophan-ketoglutarate solution (Custodiol; Koehler Chemie, Ansbach, Germany) constituted the control group. The primary end point was the recipients' survival at 30 days and 1 and 2 years after their heart transplantation. Secondary end points were primary and chronic allograft failure, noncardiac complications, and length of hospital stay. RESULTS: Over a 2-year period (January 2006 to July 2008), 159 adult cardiac allografts were transplanted. Twenty-nine were assigned for normothermic ex vivo allograft blood perfusion and 130 for cold static storage with HTK solution. Cumulative survival rates at 30 days and 1 and 2 years were 96%, 89%, and 89%, respectively, whereas in the cold static storage group survival after oHTx was 95%, 81%, and 79%. Primary graft failure was less frequent in the recipients of an oHTx who received a donor heart which had been preserved with normothermic ex vivo allograft blood perfusion using an OCS (6.89% versus 15.3%; P = .20). Episodes of severe acute rejection (23% versus 17.2%; P = .73), as well as, cases of acute renal failure requiring haemodialysis (25.3% versus 10%; P = .05) were more frequent diagnosed among recipients of a donor heart which had been preserved using the cold static storage. The length of hospital stay did not differ (26 days versus 28 days; P = .80) in both groups. CONCLUSIONS: Normothermic ex vivo allograft blood perfusion in adult clinical orthotopic heart transplantation contributes to better outcomes after transplantation in regard to recipient survival, incidence of primary graft dysfunction, and incidence of acute rejection.

Image based evaluation of mediastinal constraints for the development of a pulsatile total artificial heart.

BACKGROUND: Good anatomical compatibility is an important aspect in the development of cardiovascular implants. This work analyzes the interaction of the pump unit of an electrically driven pulsatile Total Artificial Heart (TAH) and the mediastinum. For an adequate compliance, both overall dimensions and alignment of inlets and outlets must be matched. METHODS: Cross-sectional medical image data of 27 individuals, including male and female patients suffering from end stage heart failure, was segmented and reconstructed to three dimensional (3D) surface models. Dimensions and orientations of relevant structures were identified and analyzed. The TAH surface model was virtually placed in orthotopic position and aligned with atrioventricular valves and big vessels. Additionally seven conventional cadaver studies were performed to validate different pump chamber designs based on virtual findings. Thereby 3D-coordinates were captured and introduced to the virtual environment to allow quantitative comparison between different individuals. RESULTS: Spatial parameters varied more in male patients with higher values if heart failure persists. Good correlation of the virtual analysis both to literature data and conventional cadaver studies could be shown. The full data of the 27 individuals as well as the summarized values found in literature are enclosed in the appendix. By superimposing the TAH-volume model to the anatomy, various misalignments were found and the TAH-design was adjusted. CONCLUSIONS: Virtual fitting allows implant design adjustments in realistic anatomy which has not been influenced by thoracotomy. Higher numbers of relevant individuals can be reasonably investigated in the virtual environment and quantitatively correlated. Using this approach, conventional cadaver studies can be significantly reduced but not obviated, due to the unavailable haptic feedback and immobility of potentially compressed structures.

Results of the European clinical trial of Arrow CorAide left ventricular assist system.

The aim of this study was to evaluate the safety and performance of the Arrow CorAide left ventricular assist system (LVAS) (Arrow International, Reading, PA, USA), a continuous-flow left ventricular assist device, as bridge to transplantation or recovery as well as destination therapy in patients with New York Heart Association (NYHA) class IV heart failure. Twenty-one patients were implanted with the CorAide LVAS between February 2005 and February 2006 in a prospective, multicenter, nonrandomized trial. Seventeen patients (81%) survived to >180 days or to transplantation. The cumulative time on device was 16.58 patient years (range 23-796 days, median 192 days). No intraoperative technical issues were observed at the time of implantation. Of the 21 implants, nine patients died on device, two were converted to other devices, and 10 were transplanted. Three patient deaths were attributed to pump polymer coating delamination. Postmortem device inspection determined delamination of the polymer coating on the pump's internal surface to be the cause of the late hemolysis and sudden fatal pump stops. No embolic or driveline infection event was recorded. The automatic flow control algorithm functioned reliably throughout the trial. Primary performance trial endpoint was achieved with 81% survival to 180 days or transplantation. Delamination of the polymer coating on the internal surface of the pump with resultant hemolysis and pump stops was the sole major device event in this trial. Elimination of the polymer coating and replacement with an amorphous carbon coating has resolved this in preclinical testing, prior to initiation of further clinical testing of this device.

EuroSCORE-predicted mortality and surgical judgment for interventional aortic valve replacement.

BACKGROUND AND AIM OF THE STUDY: Transcatheter aortic valve implantation (TAVI) is used as an alternative to conventional surgery in high-risk patients. The EuroSCORE quantifies the risk, and patients are selected for this procedure if their predicted mortality is high. The study aim was to evaluate the risk discrimination and calibration of the EuroSCORE, as well as the surgical judgment that is used when selecting the aortic valve replacement (AVR) approach. METHODS: Between 2003 and 2006, a total of 2757 patients underwent isolated, open AVR. The EuroSCORE was compared to the observed in-hospital mortality. A survey among surgeons assessed the relevance of patient-specific factors towards the approach of TAVI versus open AVR. RESULTS: Survivors of AVR had a lower additive EuroSCORE than non-survivors (7.2 +/- 3.34 versus 12.0 +/- 3.34; p < 0.001). The EuroSCORE demonstrated reasonable risk stratification (c-statistic 0.843, p < 0.001). However, none of the 67 non-survivors was correctly predicted (Hosmer-Lemeshow test; p < 0.001), and most patients with a high EuroSCORE survived AVR. The actual mortality was 2.8% as compared to a EuroSCORE-predicted mortality of 12.5 +/- 14.2% (p < 0.001). This poor calibration was worse with higher EuroSCOREs (Cusum test; p < 0.001). Surgeons identified a porcelain aorta as the only factor that warranted TAVI. Most EuroSCORE variables had either no relevance for treatment selection, or prompted open AVR. CONCLUSION: Patient selection for TAVI cannot be based on the EuroSCORE, because it lacks discrimination and center-specific calibration. Thus, individual, surgical judgment that weighs institutional expertise for high-risk patients against a possible reduction of mortality by using interventional techniques, is recommended.

Circulating calcitriol concentrations and total mortality.

BACKGROUND: Evidence is accumulating that vitamin D supplementation of patients with low 25-hydroxyvitamin D concentrations is associated with lower cardiovascular morbidity and total mortality during long-term follow-up. Little is known, however, about the effect of low concentrations of the vitamin D hormone calcitriol on total mortality. We therefore evaluated the predictive value of circulating calcitriol for midterm mortality in patients of a specialized heart center. METHODS: This prospective cohort study included 510 patients, 67.7% with heart failure (two-thirds in end stage), 64.3% hypertension, 33.7% coronary heart disease, 20.2% diabetes, and 17.3% renal failure. We followed the patients for up to 1 year after blood collection. For data analysis, the study cohort was stratified into quintiles of circulating calcitriol concentrations. RESULTS: Patients in the lowest calcitriol quintile were more likely to have coronary heart disease, heart failure, hypertension, diabetes, and renal failure compared to other patients. They also had low 25-hydroxyvitamin D concentrations and high concentrations of creatinine, C-reactive protein, and tumor necrosis factor alpha. Eighty-two patients (16.0%) died during follow-up. Probability of 1-year survival was 66.7% in the lowest calcitriol quintile, 82.2% in the second quintile, 86.7% in the intermediate quintile, 88.8% in the fourth quintile, and 96.1% in the highest quintile (P < 0.001). Discrimination between survivors and nonsurvivors was best when a cutoff value of 25 ng/L was applied (area under the ROC curve 0.72; 95% CI 0.66-0.78). CONCLUSIONS: Decreased calcitriol levels are linked to excess midterm mortality in patients of a specialized heart center.

International normalized ratio patient self-management for mechanical valves: is it safe enough?

PURPOSE OF REVIEW: People with mechanical heart valve replacement depend on lifelong anticoagulation. Since a few years, patients can control this themselves with the assistance of a portable anticoagulation monitor. If the patient performs the complete self-testing and self-adjustment by himself, the method is called self-management. Recently completed studies concerning international normalized ratio (INR) self-management in mechanical heart valve patients are reviewed in this article. RECENT FINDINGS: Large randomized prospective studies have demonstrated that the INR self-management concept results in well-trained patients with a high percentage of their measured INR values lying within the predetermined therapeutic range, thus resulting in a low rate of complications such as bleeding and thromboembolism. The reduced anticoagulation level resulted in fewer grade III bleeding complications (which means there is a need for surgery or endoscopy, in-hospital treatment or permanent damage) without increasing thromboembolic event rates. SUMMARY: The concept of INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. Data of the Early Self-Controlled Anticoagulation Trial (ESCAT II) study demonstrate that low-dose INR self-management does not increase the risk of thromboembolic events compared with conventional-dose INR self-management.

Percutaneous treatment of idiopathic chylopericardium.

Chylopericardium is a rare disease that may result from a variety of causes, such as cardiac surgery, trauma, obstruction of the thoracic duct near its drainage into the subclavian vein, or have no identifiable underlying cause. The present report describes a case of idiopathic chylopericardium in which percutaneous transabdominal occlusion of the thoracic duct was performed as an alternative to surgical duct ligation. The procedure was successful, resulting in a decrease in pericardial fluid accumulation. However, it failed to cure the patient, as constrictive pericarditis developed 2 months later, requiring surgical pericardectomy. Whether this could have been avoided by early (percutaneous) pericardial fenestration is unknown.

First clinical application of the DuraHeart centrifugal ventricular assist device for a Japanese patient.

The DuraHeart ventricular assist device (VAD) is a third-generation implantable centrifugal pump with a magnetically levitated impeller. Since February 2007, the device has been clinically applied with excellent results as a bridge to heart transplantation in Europe. As of this writing, however, the device has yet to be approved by the Ministry of Health, Labour and Welfare for clinical use in Japan. We herein report the first clinical application of this device for a Japanese patient. A 31-year-old man with dilated cardiomyopathy was transferred to the Heart and Diabetes Center NRW (HDZ-NRW) in Bad Oeynhausen, Germany, where he was to await heart transplantation. The transfer was safely completed under management with low-dose dopamine. His condition gradually deteriorated at HDZ-NRW, and the DuraHeart left ventricular assist device was implanted for the left ventricle at 7 weeks after admission. Shortly thereafter, however, on POD 7, a Thoratec VAD had to be inserted on the right side due to refractory right heart failure. The right ventricular assist device could be explanted after a 3-month assist, and the patient is now waiting for heart transplantation at home in Germany.

Initial results of clinical trial with a new left ventricular assist device (LVAD) providing synchronous pulsatile flow.

OBJECTIVES: A multicentric European Clinical Study is ongoing to evaluate safety and efficacy of a new pulsatile implantable LVAD (BestBeat), smaller and lighter than similar devices, capable of providing synchronous and counterpulsating flow with respect to the LV of end-stage heart failure patients. Preliminary clinical results are reported. METHODS: The new BestBeat LVAD was used, consisting of an implantable pulsatile blood pump, electromechanically driven by a ball screw mechanism, and a wearable electronic controller and power sources. The clinical trial was conducted at 5 european centers. Adult patients affected by CHF in NYHA Class IV despite optimized medical treatment were enrolled. The primary study endpoint was survival at 90 days. Further study endpoints were maintenance of adequate LVAD pump flow and a minimum rate of adverse events during support. RESULTS: As of June 2008, 6 patients received the implant. Cumulative support time was 3.7 years, median support time 176 days. All patients who completed the study survived except for one, who died after 48 days, due to combined infection and cerebrovascular accident. Another two patients died: one from intracranial bleeding 113 days after implant, and one from septic shock after 123 days. Hemodynamic improvement with CI>2.0 l/min/m2 and recovery of end-organ function expressed by consistent improvement of BUN, creatinine and bilirubin were reached in all patients. No device failure was observed. There was no bleeding requiring re-exploration, no hemolysis and only two device-related infections (both in one patient). Neurologic events were reported, the most serious ones occurring in patients with pre-implant respiratory and kidney failure. Three patients were discharged home. Two patients were successfully transplanted, one after 6 months and one after 13 months on device. CONCLUSIONS: Good performance and efficacy of the device were observed; the endpoints of the study were achieved, and its safety was consistent with expectations. The ongoing study will allow further conclusions to be drawn.

Protective and toxic effects of vitamin D on vascular calcification: clinical implications.

The presence of vascular calcification (VC) is a predictor of poor survival in the general population. The development of VC is an active process that requires a pre-existing injury as an inducer and promoting factors such as hyperphosphatemia and hypercalcemia, as well as a deficiency in calcification repressor factors. Vascular smooth muscle cells possess an endogenous enzyme system for the biosynthesis of the vitamin D hormone calcitriol from its precursor 25-hydroxyvitamin D and also a cytosolic calcitriol receptor, indicating that the vasculature is an important target tissue for vitamin D. The toxic effects of supra-physiological vitamin D dosages on the vasculature have been known for several decades. Recent experimental data also demonstrate important physiological effects of vitamin D on factors that are protective for vascular health. This review article summarises the molecular basis of protective and toxic vitamin D actions on the vasculature. Chronic kidney disease can be considered as a human model of severe VC and poor survival. The disease is associated with calcitriol deficiency, hyperparathyroidism, and hyperphosphatemia. Evidence is increasing that phosphate overload plays a key role in the process of VC in chronic kidney disease. The first clinical studies indicate that vitamin D receptor activation can improve survival in these patients. Although less severe than in chronic kidney disease, vitamin D deficiency and secondary hyperparathyroidism are also frequent in the general population, especially in elderly and obese subjects. Future studies should focus on the impact of vitamin D deficiency on VC and clinical outcome in these groups.

Poor outcome in end-stage heart failure patients with low circulating calcitriol levels.

BACKGROUND: Vitamin D receptor knockout mice develop typical signs of congestive heart failure (CHF). In approximately 20% of stable CHF patients, frankly low concentrations of the vitamin D hormone calcitriol are found. AIMS: We investigated whether serum calcitriol concentrations predict clinical outcome in end-stage CHF. METHODS AND RESULTS: We collected blood samples in 383 end-stage CHF patients who were on a waiting list for cardiac transplantation. We assessed associations of calcitriol with disease severity and freedom from event (death or cardiac transplantation) during 1-year follow-up. In electively listed patients (n=325), 31% had deficient calcitriol levels (<43 pmol/l) compared to 47% in urgently/high urgently listed patients (n=58; P<0.001). As determined by multivariable logistic regression, calcitriol was an independent predictor of the listing status 'urgent/high urgent' (P<0.001). Calcitriol concentrations were also significantly lower in patients with an event (n=233) compared to those who survived on the waiting list (P<0.001). Cox regression analysis revealed that patients in the highest calcitriol tertile had a hazard ratio (95% CI) for an event of 0.506 (0.334-0.767) compared with patients in the lowest calcitriol tertile (P=0.005), after adjustment for potential confounders. CONCLUSION: Data indicate that low serum calcitriol concentrations are independently associated with poor clinical outcome in end-stage CHF.

Safety of low-dose aprotinin in coronary artery bypass graft surgery: a single-centre investigation in 2,436 patients in Germany.

BACKGROUND: The antifibrinolytic agent aprotinin is used to limit blood loss in cardiac surgery. In a recently performed multicentre observational study, the use of aprotinin was dose-dependently associated with a higher risk of renal failure and cardiovascular events. OBJECTIVE: Therefore, the aim of this study was to evaluate the impact of low-dose aprotinin (2 million kallikrein-inhibitor units) on safety variables in a large single-centre investigation in patients who underwent coronary artery bypass graft (CABG) surgery. METHODS: Clinical outcome variables such as renal failure, myocardial infarction, gastrointestinal failure, neurological complications and in-hospital mortality were assessed in 2,436 CABG surgery patients, whereof 1,162 patients received low-dose aprotinin perioperatively and 1,274 patients did not receive aprotinin. Statistical analysis was performed using multivariable logistic regression. RESULTS: In patients receiving aprotinin, the odds ratios of experiencing one of the aforementioned adverse events were not significantly different from the patients who did not receive aprotinin (p = 0.136-0.288). Moreover, the need for rethoracotomy did not differ between the two groups (p = 0.129). However, the use of low-dose aprotinin reduced the risk of peri- and postoperative use of packed red blood cells by 39% and was associated with a mean reduction in postoperative blood loss of 201 mL compared with patients who did not receive aprotinin (p < 0.001). Mean total blood loss in the aprotinin group and the control group was 875 mL (standard deviation [SD]: 757 mL) and 1,105 mL (SD: 867 mL), respectively (p < 0.001). In a sub-analysis in 2,049 patients undergoing their first cardiac surgery and undergoing CABG using the internal mammary artery, efficacy and safety data of aprotinin were similar to the results of the entire study cohort of 2,436 patients. CONCLUSIONS: Our data indicate that low-dose aprotinin efficiently reduces blood loss and does not adversely affect relevant safety variables in CABG surgery.

Are sounds from mechanical heart valves equal for different valve types?

BACKGROUND AND AIM OF THE STUDY: The closing 'click' sounds from mechanical heart valve prostheses are often clearly audible for patients and their relatives. These sounds have been recognized as a disturbing factor causing sleeping disturbances or social embarrassment, which patients must endure for the rest of their lives. The study aim was to determine whether the intensity of the transmitted sounds varies according to the type of valve implanted. METHODS: Closing sounds were measured from 15 patients with ATS valves, 29 with Medtronic-Hall valves, and 40 with St. Jude Medical (SJM) valve prostheses; all prostheses were implanted in the aortic position. The sounds were recorded by a microphone placed 5 cm above the chest of the patient when placed in a supine position in a bioacoustical laboratory. The mean sound pressure levels (SPLs) from the valves were measured in dB(A). RESULTS: The mean SPL values were 43 +/- 5 dB(A) for ATS valves, 41 +/- 4 dB(A) for Medtronic-Hall valves and 40 +/- 4 dB(A) for SJM valves (p < 0.05, ATS versus SJM). CONCLUSION: The study results showed a statistically significant difference in SPLs among the three investigated mechanical heart valve prostheses. The highest levels were in the ATS valves, and the lowest in the SJM valves. These objectively measured SPLs must be correlated with the sound as perceived by the patient in order to determine the annoyance that they cause.

Patient self-monitoring of prosthetic heart valve function.

BACKGROUND AND AIM OF THE STUDY: Prosthetic heart valve dysfunction impacts on morbidity and quality of life. Although the diagnosis can be made by imaging studies, clinical symptoms commonly precede the diagnostic work-up. The ThromboCheck device analyzes the sound frequency spectra of valve motion, and alterations due to valve dysfunction are observed before overt clinical symptoms develop. The study aim was to determine if the ThromboCheck can be used to monitor the prosthetic valve function of patients at home. METHODS: Between 2003 and 2007, a total of 541 prosthetic heart valve recipients was prospectively enrolled into a double-blind, multi-center study. ThromboCheck devices were used to evaluate the sound frequency phenomena of valve motion. If the sound frequency spectra deviated from baseline, alarm signals were returned to the medical center via telephone, and these prompted evaluation by fluoroscopy and echocardiography. The clinical follow up included questionnaires at regular intervals. RESULTS: The cumulative observation period exceeded 748 patient-years, with a median follow up of 25.2 months per patient (range: 1 to 36 months). Almost all patients used the device at least two to three times per week to evaluate valve function, and the vast majority found it easy to operate. About 135,000 codes were returned to the study centers for further analysis; of these codes, 30 (0.0002%) were alarm signals. On 29 of the 30 occasions, prosthetic valve dysfunction was confirmed by fluoroscopy and echocardiography, yielding positive predictive values and specificities of 97% and 100%, respectively. There was no clinical event in the absence of a ThromboCheck alarm signal. Thrombolysis or increased warfarin-based anticoagulation quickly restored the initial sound frequency spectrum of the prosthetic valve in 16 patients. Another 13 patients were surgically revised; their prosthetic valves revealed significant thrombi upon replacement. By using the ThromboCheck device as part of a surveillance system, 79% of the patients felt safer with regards to prosthetic valve dysfunction. CONCLUSION: Analysis of sound frequency spectra by the ThromboCheck identified prosthetic heart valve dysfunction before clinical symptoms developed, and promoted early therapy. The restoration of valve function normalized the frequency spectra, which may be utilized to guide treatment. These results justify further efforts to introduce the analysis of sound phenomena into routine clinical care after prosthetic valve implantation.

Coronary sinus dissection during left ventricular pacing electrode implantation.

Coronary sinus (CS) dissection during biventricular pacing electrode implantation is a complication that rarely develops. A 71-year-old female with recurrent ventricular tachycardia, heart decompensation, and poor left ventricular function because of dilated cardiomyopathy was admitted for the implantation of a cardioverter-defibrillator for biventricular pacing. During the operation, we experienced a CS dissection with hematoma in the left ventricle wall while introducing the guidance catheter into the CS. However, the pacing lead was successfully implanted into the posterolateral vein using the "over-the-wire" technique. The postoperative electrocardiogram showed a decreased QRS; meanwhile, the echocardiography revealed dimensional reduction and functional improvement of the left ventricle.

Patients with congestive heart failure and healthy controls differ in vitamin D-associated lifestyle factors.

We have recently hypothesized that low vitamin D status may contribute to the pathogenesis of congestive heart failure (CHF). This study was aimed at evaluating, in a pilot study, whether CHF patients have indications for a low vitamin D status during earlier periods of their lives. We performed a case-controlled study in 150 CHF patients and 150 controls. Study participants had to answer a questionnaire that included several items concerning vitamin D-associated lifestyle factors during childhood, adolescence, and adulthood. A vitamin D score was constructed. This score takes into consideration that ultraviolet-B (UVB) exposure is the major vitamin D source for humans and that those lifestyle factors, which are associated with regular UVB exposure, can guarantee an adequate vitamin D status at best. The vitamin D score was significantly higher in controls than in patients (p < 0.001). Compared with the controls, more patients lived in large cities (p < 0.001), fewer patients were members of a sport club (p < 0.001), and fewer patients had summer holidays every year (p < 0.01). Patients also reported significantly less alcohol consumption during adulthood than controls (p < 0.001). Our results demonstrate that CHF patients and controls differed in several vitamin D-associated lifestyle factors and in alcohol consumption during earlier periods of their lives.

Vitamin D supplementation improves cytokine profiles in patients with congestive heart failure: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Elevated circulating concentrations of proinflammatory cytokines may contribute to the pathogenesis of congestive heart failure (CHF). In vitro studies suggest that vitamin D suppresses proinflammatory cytokines and increases antiinflammatory cytokines. OBJECTIVE: We evaluated the effect of vitamin D supplementation on the survival rate and different biochemical variables in patients with CHF. DESIGN: One hundred twenty-three patients randomly received either 50 mug vitamin D(3)/d plus 500 mg Ca/d [D(+) group] or placebo plus 500 mg Ca/d [D(-) group] for 9 mo. Biochemical variables were assessed at baseline and after 9 mo. The survival rate was calculated for a follow-up period of 15 mo. RESULTS: Ninety-three patients completed the study. Significant treatment effects were observed on logarithmic-transformed serum concentrations of 25-hydroxyvitamin D (P = 0.001), parathyroid hormone (P = 0.007), tumor necrosis factor alpha (P = 0.006), and interleukin 10 (P = 0.042). 25-Hydroxyvitamin D increased by 26.8 ng/mL in the D(+) group but increased only by 3.6 ng/mL in the D(-) group. Compared with baseline, parathyroid hormone was significantly lower and the antiinflammatory cytokine interleukin 10 was significantly higher in the D(+) group after 9 mo. The proinflammatory cytokine tumor necrosis factor alpha increased in the D(-) group but remained constant in the D(+) group. The survival rate did not differ significantly between the study groups during the follow-up period. CONCLUSIONS: Vitamin D(3) reduces the inflammatory milieu in CHF patients and might serve as a new antiinflammatory agent for the future treatment of the disease. Our data provide evidence for the involvement of an impaired vitamin D-parathyroid hormone axis in the progression of CHF.