The effect of coenzyme Q10 on morbidity and mortality in chronic heart failure: results from Q-SYMBIO: a randomized double-blind trial.

OBJECTIVES: This randomized controlled multicenter trial evaluated coenzyme Q10 (CoQ10) as adjunctive treatment in chronic heart failure (HF). BACKGROUND: CoQ10 is an essential cofactor for energy production and is also a powerful antioxidant. A low level of myocardial CoQ10 is related to the severity of HF. Previous randomized controlled trials of CoQ10 in HF were underpowered to address major clinical endpoints. METHODS: Patients with moderate to severe HF were randomly assigned in a 2-year prospective trial to either CoQ10 100 mg 3 times daily or placebo, in addition to standard therapy. The primary short-term endpoints at 16 weeks were changes in New York Heart Association (NYHA) functional classification, 6-min walk test, and levels of N-terminal pro-B type natriuretic peptide. The primary long-term endpoint at 2 years was composite major adverse cardiovascular events as determined by a time to first event analysis. RESULTS: A total of 420 patients were enrolled. There were no significant changes in short-term endpoints. The primary long-term endpoint was reached by 15% of the patients in the CoQ10 group versus 26% in the placebo group (hazard ratio: 0.50; 95% confidence interval: 0.32 to 0.80; p = 0.003) by intention-to-treat analysis. The following secondary endpoints were significantly lower in the CoQ10 group compared with the placebo group: cardiovascular mortality (9% vs. 16%, p = 0.026), all-cause mortality (10% vs. 18%, p = 0.018), and incidence of hospital stays for HF (p = 0.033). In addition, a significant improvement of NYHA class was found in the CoQ10 group after 2 years (p = 0.028). CONCLUSIONS: Long-term CoQ10 treatment of patients with chronic HF is safe, improves symptoms, and reduces major adverse cardiovascular events. (Coenzyme Q10 as adjunctive treatment of chronic heart failure: a randomised, double-blind, multicentre trial with focus on SYMptoms, BIomarker status [Brain-Natriuretic Peptide (BNP)], and long-term Outcome [hospitalisations/mortality]; ISRCTN94506234).

Obstructive sleep apnea in a Danish population of men and women aged 60-80 years with nocturia.

INTRODUCTION AND HYPOTHESIS: The aim of the present study was in a case-control design to evaluate the association between nocturia and obstructive sleep apnea, in men and women who had nocturia ≥ 2 per night (nocturics) compared to those without nocturia (controls). METHODS: Participants were randomly selected among respondents in a population study of 4000 elderly individuals. Nocturia was assessed using the validated Nocturia, Nocturnal Enuresis, and Sleep-interruption Questionnaire (NNES-Q). Nocturia (≥ 2 voids/night) or control (< 1 void/night) status was assessed by a 3-day frequency volume chart (FVC). Furthermore, all participants completed an overnight ambulatory polygraphic recording to identify obstructive sleep apnea (OSA). RESULTS: Of 1111 eligible individuals, a total of 75 nocturics and 75 controls (13.5%) were included. Overall, the prevalence and severity of OSA among nocturics and controls was not significantly different. In a sub-analysis we found that 22 nocturics with OSA (69%) had nocturnal polyuria. This led to a significantly increased risk of having OSA (OR 2.8, 95% CI: 1.1-7.3, p < 0.05) when having nocturnal polyuria compared to other pathophysiological causes of nocturia (polyuria, low bladder capacity, a combination of nocturnal polyuria/low bladder capacity, and neither nocturnal polyuria/low bladder capacity). CONCLUSIONS: Nocturia twice or more was not significantly associated with OSA. However, nocturics with nocturnal polyuria had a significantly higher risk of having OSA than nocturics with other pathophysiologies.

Improvement in renal function after everolimus introduction and calcineurin inhibitor reduction in maintenance thoracic transplant recipients: the significance of baseline glomerular filtration rate.

BACKGROUND: The NOCTET (NOrdic Certican Trial in HEart and lung Transplantation) trial demonstrated that everolimus improves renal function in maintenance thoracic transplant (TTx) recipients. Nevertheless, introduction of everolimus is not recommended for patients with advanced renal failure. We evaluated NOCTET data to assess everolimus introduction amongst TTx recipients with advanced renal failure. METHODS: This 12-month multicenter Scandinavian study randomized 282 maintenance TTx recipients to everolimus introduction with calcineurin inhibitor (CNI) reduction or standard CNI therapy. The measured glomerular filtration rate (mGFR) was noted at baseline and after 1-year using Cr-ethylenediaminetetraacetic acid clearance. RESULTS: In 21 patients with a baseline mGFR of 20 to 29 ml/min/1.73 m(2), renal function improved in the everolimus group compared with the control group ((ΔmGFR 6.7 ± 9.0 vs -1.6 ± 5.1 ml/min/1.73 m(2); p = 0.03). Amongst 173 patients with moderate renal impairment (mGFR 30-59 ml/min/1.73 m(2)), renal function improvement was also greater amongst everolimus patients than in controls (ΔmGFR 5.1 ± 11.1 vs -0.5 ± 8.7 ml/min/1.73 m(2); p < 0.01). In 55 patients with mGFR 60 to 89 ml/min/1.73 m(2), mGFR did not change significantly in either group. Improvement in mGFR was limited to patients with a median time since TTx of less than 4.6 years and was also influenced by CNI reduction during the study period. CONCLUSIONS: Everolimus introduction and reduced CNI significantly improved renal function amongst maintenance TTx patients with pre-existing advanced renal failure. This beneficial effect was limited to patients undergoing conversion in less than 5 years after TTx, indicating a window of opportunity that is appropriate for pharmacologic intervention with everolimus.

Good long-term survival after paediatric heart transplantation.

INTRODUCTION: The brain-death criterion was introduced in Denmark in 1990. The first Danish paediatric heart transplantation (HTx) was performed at Copenhagen University Hospital, Rigshospitalet, in Copenhagen in 1991. We describe our experiences during the first 20 years with paediatric HTx. MATERIAL AND METHODS: This was a retrospective study of 37 paediatric patients (<18 years) who were listed for HTx from 1991 to 2011. RESULTS: A total of 26 of the 37 children listed underwent HTx, nine due to congenital heart disease (CHD) and 17 due to cardiomyopathy (CM). Ten patients died while being on the waiting list. One patient was withdrawn from the list due to spontaneous improvement. A total of 21 patients remain alive. Survival was 92% after five years and 82% after ten years. We had two early (CHD) and three late (CM) deaths. Complications were few, but significant. Early acute rejection occurred in seven patients, whereas one patient with repeated late episodes of acute rejection died from graft failure 5.5 years after HTx. We found a time-related progressive deterioration in renal function. Two patients underwent renal Tx, two others died while being on dialysis. Cardiac allograft vasculopathy occurred in three patients, two of whom died. The third remains alive today, 19 years after HTx. CONCLUSION: Our paediatric HTx results are comparable with those of larger international centres and consistent with true long-term survival. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Pregnancy in heart- and heart/lung recipients can be problematic.

OBJECTIVE: The first successful pregnancy after heart transplantation was reported in 1988. Worldwide experience with heart and heart/lung transplanted (H-HLTx) pregnant women is limited. To expand this knowledge the collaborating Nordic thoracic transplant centers wanted to collect information on all such pregnancies from their centers. DESIGN: Information was retrospectively collected on all H-HLTx pregnancies in the Nordic countries. RESULTS: A total of 25 women have had 42 pregnancies and all survived the gestation. Minor complications were increasing incidence of proteinuria, hypertension and diabetes. Major problems were two rejections (early post partum), two severe renal failures, seven pre-eclampsias and 17 abortions. Five women died two to 12 years after delivery. Of 25 live born children, one was born with cancer and one died early after inheriting the mother's cardiomyopathy. CONCLUSION: Pregnancy after H-HLTx can be successful for both mother and child. There are, however, many obstacles which should be addressed. Respecting the couple's desire for children the attitude should be carefully, not too optimistic, after proper pre-pregnant information and counseling. Delivery should preferably take place at the transplant center.

Effect of everolimus introduction on cardiac allograft vasculopathy--results of a randomized, multicenter trial.

BACKGROUND: Everolimus reduces the progression of cardiac allograft vasculopathy (CAV) in de novo heart transplant (HTx) recipients, but the influence on established CAV is unknown. METHODS: In this Nordic Certican Trial in Heart and lung Transplantation substudy, 111 maintenance HTx recipients (time post-HTx 5.8 ± 4.3 years) randomized to everolimus+reduced calcineurin inhibitor (CNI) or standard CNI had matching (intravascular ultrasound) examinations at baseline and 12 months allowing accurate assessment of CAV progression. RESULTS: No significant difference in CAV progression was evident between the treatment groups (P = 0.30). When considering patients receiving concomitant azathioprine (AZA) therapy (n = 39), CAV progression was attenuated with everolimus versus standard CNI (Δmaximal intimal thickness 0.00 ± 0.04 and 0.04 ± 0.04 mm, Δpercent atheroma volume 0.2% ± 3.0% and 2.6% ± 2.5%, and Δtotal atheroma volume 0.25 ± 14.1 and 19.8 ± 20.4 mm(3), respectively [P < 0.05]). When considering patients receiving mycophenolate mofetil (MMF), accelerated CAV progression occurred with everolimus versus standard CNI (Δmaximal intimal thickness 0.06 ± 0.12 vs. 0.02 ± 0.06 mm and Δpercent atheroma volume 4.0% ± 6.3% vs. 1.4% ± 3.1%, respectively; P < 0.05). The levels of C-reactive protein and vascular cell adhesion molecule-1 declined significantly with AZA+everolimus, whereas MMF+everolimus patients demonstrated a significant increase in levels of C-reactive protein, vascular cell adhesion molecule-1, and von Willebrand factor. CONCLUSIONS: Conversion to everolimus and reduced CNI does not influence CAV progression among maintenance HTx recipients. However, background immunosuppressive therapy is important as AZA+everolimus patients demonstrated attenuated CAV progression and a decline in inflammatory markers, whereas the opposite pattern was seen with everolimus+MMF. The different effect of everolimus when combined with AZA versus MMF could potentially reflect hitherto unknown interactions.

Driveline infections in patients supported with a HeartMate II: incidence, aetiology and outcome.

OBJECTIVES: To investigate the incidence and outcome of driveline infections in patients supported with a continuous flow left ventricular assist device (HeartMate II (HMII)) and to study the microbiological aetiology. DESIGN: Retrospective analysis of 31 patients who received an implantation of a HMII. Follow-up was from implantation to either device explantation, death or closure of the study. Clinical signs of infections were divided into superficial, deep or systemic and compared to culture and gram stain, the clinical course and infectious parameters. RESULTS: The incidence of driveline infections was 1.65 episodes per patient per year. Staphylococcus aureus and Escherichia coli were the most common bacterial aetiology. More than two weeks of treatment was required in 81% of the patients. In terms of detecting superficial driveline infections, leucocyte count demonstrated a sensitivity of 27% and C-reactive protein (CRP) a sensitivity of 28%. In 22 cases of driveline infections plasma pro-calcitonin was found to be normal. CONCLUSION: Driveline infections are common in HMII recipients but primarily remain superficial and are reasonably easy to manage. Infectious agents mostly originate from the skin and gastrointestinal tract. Blood biomarkers did not appear to be helpful in detecting driveline infections.

Factors associated with the development of cytomegalovirus infection following solid organ transplantation.

BACKGROUND: Infection with cytomegalovirus (CMV) remains a potentially serious complication in transplant patients. In this study we explored the risk factors for CMV infection in the 12 months following a solid organ transplantation (n = 242) in patients monitored for CMV infection from 2004 to 2007. METHODS: CMV infection was defined as 2 consecutive quantifiable CMV-polymerase chain reaction (PCR) values or 1 measurement of >3000 copies/ml. Data describing pre- and post-transplantation variables were extracted from electronic health records. Time to CMV infection was investigated using Cox proportional hazards analysis. RESULTS: Overall, 31% (75/242) of solid organ transplant patients developed CMV infection: 4/8 (50.0%) heart, 15/43 (34.9%) liver, 30/89 (33.7%) lung and 26/102 (25.5%) kidney transplant patients. The risk of CMV infection according to donor (D)/recipient (R) CMV serostatus (positive + or negative-) was highest for D+/R-(adjusted hazard ratio 2.6, 95% confidence interval 1.6-4.2) vs D+/R+, and was reduced for D-/R+(adjusted hazard ratio 0.2, 95% confidence interval 0.2-0.8) vs D+/R+. CONCLUSION: Positive donor CMV-serostatus is a major risk factor for CMV-infection in CMV-na ve recipients, but also in recipients with positive CMV-serostatus. Conversely, if donor is CMV serostatus is negative, the risk of CMV infection is low, irrespective of recipients CMV-serostatus. These findings suggest poorer immune function towards donor-induced strains of CMV versus recipient own latent strains.

Primary cardiac tumors: a clinicopathologic evaluation of four cases.

INTRODUCTION: We report the clinical, pathological, and immunohistochemical features of four primary malignant cardiac tumors identified at the Department of Pathology, Rigshospitalet, Denmark. A panel of immunohistochemical markers for classification is proposed. METHODS: Between 2000 and 2008, four patients with malignant cardiac tumors were treated at our hospital. We retrospectively reviewed the medical records and evaluated the patient characteristics and treatment. RESULTS: Three patients presented with severe dyspnea; one patient presented with chest pain. Transthoracic echocardiography demonstrated, in all four cases, abnormal masses in the atria. The cases were, based on morphological features and immunoprofile, classified as myogenic sarcoma (two cases), undifferentiated pleomorphic sarcoma, and leiomyosarcoma. Three of the patients received orthotopic heart transplantation. One patient survived 6.5 years after the diagnosis, and two patients are still alive 2 and 3 years after being diagnosed, respectively. CONCLUSIONS: All four cases were sarcomas. A limited number of immunohistochemical markers can be used in order to define a specific line of differentiation. In this small study, three of the patients were offered orthotopic heart transplantation, and the survival times were generally longer than in most series.

Two-year outcomes in thoracic transplant recipients after conversion to everolimus with reduced calcineurin inhibitor within a multicenter, open-label, randomized trial.

BACKGROUND: Use of the mammalian target of rapamycin inhibitor everolimus with an accompanying reduction in calcineurin inhibitor (CNI) exposure has shown promise in preserving renal function in maintenance thoracic transplant patients, but robust, long-term data are required. METHODS: In a prospective, open-label, multicenter study, thoracic transplant recipients more than or equal to 1 year posttransplant with mild-to-moderate renal insufficiency were randomized to continue their current CNI-based immunosuppression or convert to everolimus with predefined CNI exposure reduction. After a 12-month core trial, patients were followed up to month 24 after randomization. RESULTS: Of 245 patients who completed the month 12 visit, 235 patients (108 everolimus and 127 controls) entered the 12-month extension phase. At month 24, mean measured glomerular filtration rate had increased by 3.2±12.3 mL/min from the point of randomization in everolimus-treated patients and decreased by 2.4±9.0 mL/min in controls (P<0.001), a difference that was significant within both the heart and lung transplant subpopulations. During months 12 to 24, 5.6% of everolimus patients and 3.1% of controls experienced biopsy-proven acute rejection (P=0.76). There were no significant differences in the rate of adverse events or serious adverse events (including pneumonia) between groups during months 12 to 24. CONCLUSIONS: Converting maintenance thoracic transplant recipients to everolimus with low-exposure CNI results in a renal benefit that is sustained to 2 years postconversion, with significantly improved measured glomerular filtration rate in both heart and lung transplant patients. Despite reductions of more than 50% in CNI exposure, there was no marked loss of efficacy. The safety profile of the everolimus-based regimen was acceptable.

Everolimus with reduced calcineurin inhibitor in thoracic transplant recipients with renal dysfunction: a multicenter, randomized trial.

BACKGROUND: The proliferation signal inhibitor everolimus offers the potential to reduce calcineurin inhibitor (CNI) exposure and alleviate CNI-related nephrotoxicity. Randomized trials in maintenance thoracic transplant patients are lacking. METHODS: In a 12-month, open-labeled, multicenter study, maintenance thoracic transplant patients (glomerular filtration rate > or =20 mL/min/1.73m and <90 mL/min/1.73 m) >1 year posttransplant were randomized to continue their current CNI-based immunosuppression or start everolimus with predefined CNI exposure reduction. RESULTS: Two hundred eighty-two patients were randomized (140 everolimus, 142 controls; 190 heart, 92 lung transplants). From baseline to month 12, mean cyclosporine and tacrolimus trough levels in the everolimus cohort decreased by 57% and 56%, respectively. The primary endpoint, mean change in measured glomerular filtration rate from baseline to month 12, was 4.6 mL/min with everolimus and -0.5 mL/min in controls (P<0.0001). Everolimus-treated heart and lung transplant patients in the lowest tertile for time posttransplant exhibited mean increases of 7.8 mL/min and 4.9 mL/min, respectively. Biopsy-proven treated acute rejection occurred in six everolimus and four control heart transplant patients (P=0.54). In total, 138 everolimus patients (98.6%) and 127 control patients (89.4%) experienced one or more adverse event (P=0.002). Serious adverse events occurred in 66 everolimus patients (46.8%) and 44 controls (31.0%) (P=0.02). CONCLUSION: Introduction of everolimus with CNI reduction offers a significant improvement in renal function in maintenance heart and lung transplant recipients. The greatest benefit is observed in patients with a shorter time since transplantation.

Bladder pain syndrome/interstitial cystitis in a Danish population: a study using the 2008 criteria of the European Society for the Study of Interstitial Cystitis.

OBJECTIVE: To characterize and evaluate a Danish patient population with bladder pain syndrome/interstitial cystitis (BPS/IC), using a working definition for BPS/IC incorporating six variables, and a set of criteria defined by the European Society for the Study of Interstitial Cystitis (ESSIC); to describe the clinical course and treatment intensity in relation to these variables. PATIENTS AND METHODS: Clinical data were obtained retrospectively from medical records for 349 consecutive patients with IC referred to the Department of Urology, Copenhagen University Hospital Herlev, Denmark between 1966 and 2008. The median (range) age at diagnosis was 53 (16-88) years; 64% were followed for at least 2 years. The outcome was expressed in terms of treatment intensity and was correlated with clinical data (pain, nocturnal frequency, bladder capacity, mucosal glomerulations, detrusor mastocytosis, detrusor intrafascicular fibrosis, IFF). RESULTS: All patients had pain and 75% had nocturia at least twice. The bladder capacity estimated under general anaesthesia was <500 mL in 42%; 53% presented with detrusor mastocytosis (> or =28 mast cells/mm(2)) and 50% with IFF. The detrusor mast cell count (P < 0.001), IFF (P = 0.004) and nocturnal frequency (P = 0.043) had statistically significant prognostic value for treatment intensity, whereas bladder capacity and glomerulations were not significant. CONCLUSION: Nocturia, detrusor mastocytosis and IFF are associated with multiple treatments and presumed failure of standard urological therapy in patients with BPS/IC, while bladder capacity and glomerulations are not. Valid conclusions cannot be drawn because of numerous limitations to the study.

Severely impaired von Willebrand factor-dependent platelet aggregation in patients with a continuous-flow left ventricular assist device (HeartMate II).

OBJECTIVES: This study investigated the influence of the mechanical blood pump HeartMate II (HMII) (Thoratec Corporation, Pleasanton, California) on blood coagulation and platelet function. BACKGROUND: HMII is an implantable left ventricular assist device used for the treatment of heart failure. Patients treated with HMII have increased bleeding tendencies. METHODS: We measured agonist-induced platelet aggregation in 16 patients on HMII support. RESULTS: The von Willebrand factor (vWF)-dependent ristocetin-induced platelet aggregation was impaired in 11 of the 16 patients, of which 12 had experienced at least 1 minor or major bleeding episode. The impaired ristocetin-induced platelet aggregation was associated both with decreased specific activity of plasma vWF, presumably due to lack of high molecular weight vWF multimers, as well as with attenuated function of the platelets themselves. CONCLUSIONS: The results imply that HMII treatment is associated with impaired platelet aggregation, which may contribute to an increased tendency to bleed.

Nocturia and associated morbidity in a Danish population of men and women aged 60-80 years.

OBJECTIVE: To evaluate the association between nocturia and medical diseases, medication, urinary incontinence (UI), recurrent cystitis, smoking, alcohol, parity, hysterectomy, pelvic organ prolapse surgery, UI surgery, and prostate surgery. SUBJECTS AND METHODS: The previously validated questionnaire the Nocturia, Nocturnal Enuresis and Sleep-interruption Questionnaire was sent to 2000 women and 2000 men aged 60, 65, 70, 75, and 80 years. The population was selected at random from The Danish Civil Registration System. RESULTS: Using multiple logistic regressions UI and age were significantly associated with nocturia irrespective of severity. Nocturia of > or =1 voids was significantly associated with body mass index (BMI), hypertension, and smoking; and nocturia of > or =2 voids with gender, BMI, diabetes and recurrent cystitis, as well as between nocturia of > or =3 voids and gender, lung disease, diabetes, use of diuretics and recurrent cystitis. Summarising the associations in an ordinal regression analysis UI (odds ratio (OR) 2.17, 95% CI 1.76-2.68), recurrent cystitis (OR 1.97, 95% CI 1.30-2.97) and diabetes (OR 1.89, 95% CI 1.32-1.65) had the strongest associations with nocturia. CONCLUSIONS: Our results show that various disorders are associated with nocturia. However, the associations are strongly dependent on the severity of the nocturia.

Quantifying mast cells in bladder pain syndrome by immunohistochemical analysis.

OBJECTIVES: To evaluate a simple method for counting mast cells, thought to have a role in the pathophysiology of bladder pain syndrome (BPS, formerly interstitial cystitis, a syndrome of pelvic pain perceived to be related to the urinary bladder and accompanied by other urinary symptoms, e.g. frequency and nocturia), as >28 mast cells/mm(2) is defined as mastocytosis and correlated with clinical outcome. PATIENTS AND METHODS: The current enzymatic staining method (naphtolesterase) on 10 microm sections for quantifying mast cells is complicated. In the present study, 61 patients had detrusor biopsies taken between 2002 and 2005; the patients were given a clinical score, and sections of the biopsy stained with (i) naphtolesterase on 10 microm sections, staining every third section, or (ii) immunohistochemically with antitryptase on both 10 microm and 3 microm sections, with two and six unstained sections between, respectively. Mast cells were counted according to a well-defined procedure. RESULTS: The old and the new methods, on 10 and 3 microm sections, showed a good correlation between mast cell counts. When using tryptase staining and 3 microm sections, the mast cell number correlated well with the clinical score (Spearman's rho 0.576; 95% confidence interval 0.155-0.820) and 27 mast cells/mm(2) was the threshold suggesting mastocytosis. CONCLUSIONS: We recommend taking biopsies from the detrusor of patients with suspected BPS and examining them with tryptase-stained 3 microm thick sections, with every seventh section used for quantification; 27 mast cells/mm(2) is considered indicative of mastocytosis.

Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal.

OBJECTIVES: Because the term "interstitial cystitis" (IC) has different meanings in different centers and different parts of the world, the European Society for the Study of Interstitial Cystitis (ESSIC) has worked to create a consensus on definitions, diagnosis, and classification in an attempt to overcome the lack of international agreement on various aspects of IC. METHODS: ESSIC has discussed definitions, diagnostic criteria, and disease classification in four meetings and extended e-mail correspondence. RESULTS: It was agreed to name the disease bladder pain syndrome (BPS). BPS would be diagnosed on the basis of chronic pelvic pain, pressure, or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or urinary frequency. Confusable diseases as the cause of the symptoms must be excluded. Classification of BPS types might be performed according to findings at cystoscopy with hydrodistention and morphologic findings in bladder biopsies. The presence of other organ symptoms as well as cognitive, behavioral, emotional, and sexual symptoms, should be addressed. CONCLUSIONS: The name IC has become misleading and is replaced by BPS. This name is in line with recent nomenclature recommendations by the European Association of Urology and is based on the axial structure of the International Association for the Study of Pain classification. To facilitate the change of the name, ESSIC agreed to include IC in the overall term (BPS/IC) during this transition period.

[The Mechanical Heart--HeartMate 1--Danish results]. / Det mekaniske hjerte--HeartMate 1--de danske resultater.

INTRODUCTION: In 1998 the Heart Centre at the Danish National University Hospital implemented a new programme with long-term mechanical circulatory assist to patients with terminal heart failure who could not wait for a donor heart. A so-called Mechanical Heart, HeartMate 1, was to replace a failing left ventricle so that the patient could be resuscitated and await heart transplantation. The aim of the present study is to describe the results of this new treatment in Denmark. MATERIALS AND METHODS: A total of 28 patients with a mean age of 41 years were treated with the HeartMate 1 system in the period 1998 to 2006. Two patients had the system changed to a new HeartMate 1 due to mechanical problems. Both patients were later successfully heart transplanted. A third patient had the system successfully changed to a HeartMate 2 and he is waiting for a donor heart. RESULTS: Hemodynamic observations reveal fast improvement after implantation of the HeartMate system. Patients who were later heart transplanted had the HeartMate system implanted for a mean of 220 days. About 90% of those that were transplanted later improved due to the system from New York Heart Associations class IV to class I-II and they could often be discharged to a normal social life with a well-functioning HeartMate. Calculated 1-year survival with the HeartMate system was 82%. CONCLUSION: Patients with terminal heart failure can be treated and improved by implantation of the HeartMate system and await successful heart transplantation. Permanent advanced assist systems do exist today and these can be applied as a final treatment in selected patients--so-called destination therapy with mechanical circulatory support. The present study shows that it is very likely that the Heart Centre at the Danish National University Hospital will be able to establish a well-functioning programme for destination therapy.

[Destination therapy in end-stage heart failure. A possible alternative to heart transplantation?]. / Destinationsterapi ved terminalt hjertesvigt. Et muligt alternativ til hjertetransplantation?

The incidence of heart failure continues to increase but the number of available heart donors is limited. Implantation of circulatory assist devices as a permanent alternative to heart transplantation has become a promising new alternative in patients not eligible for heart transplantation (destination therapy). New technical advances have increased the durability of the devices and reduced complications.New generations of rotator pumps are smaller and more durable and will expand the use of these devices for destination therapy. This review discusses the current state of knowledge and indications for destination therapy in end-stage heart failure.