Thrombosis and cable damage in the HeartWare pump: clinical decisions and surgical technique.

Exchange of the HeartWare HVAD made necessary by thrombosis or cable damage is rare, but it is a complex procedure associated with morbidity. Less invasive exchange procedures may contribute to faster postoperative recovery and early mobilization. Between September 2009 and April 2012, 225 patients (median age 55.4 years, range 7-82 years, 40 of them women) were supported with the HeartWare HVAD at our institution. Cumulative follow-up in all 225 patients was 151.9 patient/years. In six patients, early pump thrombosis (<30 days) requiring pump exchange occurred after a median time of 7 (2-9) days. In six patients, late pump thrombosis requiring pump exchange occurred after a median of 380 (84-705) days. The overall incidence was 5.3% with 0.079 thromboses per year. In two instances of accidental cable damage as a result of massive external mechanical impact, pump exchange was necessary. We describe a safe and less invasive technique for the explantation and exchange of the HeartWare HVAD through a left thoracotomy. Pump thrombosis of the HeartWare HVAD is a very rare condition caused mostly by new onset of heparin-induced thrombocytopenia type II, mismanagement of anticoagulation, or hypercoagulability in the case of severe sepsis. Since the introduction of the sintered inflow cannula no early thrombosis has occurred. Pump exchange in the case of hemolysis should not be delayed. The cable of the HeartWare HVAD is very reliable and breaks only after excessive external impact. A minimally invasive approach for pump exchange on cardiopulmonary bypass for pump thrombosis and off-pump for cable damage or pump explantation is recommended.

Incidence rates and predictors of major and minor depression in patients with heart failure.

AIMS: Depression is common in heart failure (HF) and associated with adverse outcomes. This study aimed to investigate incidence rates and predictors of depression in patients sampled from four subprojects of the German Competence Network Heart Failure. METHODS: Eight hundred thirty nine symptomatic HF patients free of depression at baseline underwent repeat depression screening (Patient Health Questionnaire, PHQ-9) after 12 months. Ordered logistic regression analysis was employed to search for predictors of incident depression. RESULTS: Incident minor (major) depression was observed in 61 (7.3%) and 47 (5.6%) of the population. Depression was recurrent in 15 (25%) and 16 (34%), respectively. Multiple regression analysis revealed seven variables predicting minor or major depression: Previous depressive episode (odds ratio [OR] 4.04, 95% confidence interval [CI] 2.37-6.89, p ≤ 0.001), previous resuscitation (OR 2.44, CI 1.23-4.81, p=0.010), current smoking (OR 2.06, CI 1.08-3.50, p=0.008), >4 visits/year to general practitioner (OR 1.67, CI 1.06-2.63, p=0.026), New York Heart Association class (OR 1.54/class, 95% CI 1.05-2.25, p=0.027), PHQ-9 baseline sum-score (OR 1.18/point, CI 1.11-1.27, p<0.001), and SF-36 physical functioning (OR 1.08/-5 points, CI 1.03-1.13, p=0.002). CONCLUSIONS: In these HF patients initially free of depression annual incidence rates were high. Several independent predictors allowed identification of patients at particular risk. Although obtained in a selected cohort these findings call, in view of the grave prognosis of HF patients with comorbid depression, for regular depression screening and development of specific supportive strategies to improve patient care and outcomes in HF.

Pump exchange for cable damage in patients supported with HeartMate II left ventricular assist device.

Implantable continuous flow pumps are a routine treatment for end-stage heart failure. The waiting time for heart transplantation is increasing, and more and more patients receive the pump for permanent support. We retrospectively analyzed our database of patients supported with the HeartMate II left ventricular assist device to identify instances of cable damage. Between May 9, 2006 and May 9, 2012, 161 patients were supported with the HeartMate II. There were 187 cumulative years of HeartMate II support. The documented cable damage occurred in 12 patients (7.5%), requiring pump exchange in five patients after a mean time of 706 days on support. There was no perioperative mortality. The damage occurred typically at the "weak" place-the feedthrough of the driveline to the pump body. In some cases, the device alarm history and x-ray may allow diagnosis before pump stop occurs. However, since the most recent changes in the design of the connection and modifications made in the implantation technique, no instance of cable damage has been registered.

Gender differences during mechanical circulatory support.

Long-term mechanical circulatory support (MCS) with ventricular assist devices (VADs) is now an acceptable option for patients with end-stage heart failure (HF). There are growing numbers of reports identifying sex-related differences in the development and prognosis of HF and cardiac surgery. With the experience of 1,607 VAD implantations in our institution we are the first to analyze our data to determine gender distribution in our patient populations and the effect of gender on outcomes. Of the total 1,456 patients with MCS, 1,225 were male and 231 female. The patients were divided into three age groups-below 13 years (group 1, n = 100), between 13 and 50 years (group 2, n = 540) and older than 50 years (group 3, n = 824). Five-year survival, HF etiology, and procedural success, defined as 30-day and 5-year survival were analyzed retrospectively. In group 1 the gender distribution was equal; the leading HF etiology was dilated cardiomyopathy (DCMP) with 17% in male (n = 17) and 19% in female (n = 19) patients, followed by congenital diseases (13% in male versus 9% in female) and postcardiotomy failure (13% in male versus 8% in female). No differences were seen in 5-year survival and procedural success. In group 2, significantly more men (n = 451, p < 0.0001) were supported by VADs. DCMP was the major cause for VAD implantation (54%) and was significantly more frequent in men (57.6%, p = <0.0001). Male patients were older (mean age = 37.1 years, p < 0.0001), with a longer median support time (151.6 days, p < 0.0001) and a higher median weight (78.2 kg, p < 0.0001). No difference was seen in procedural success whereas 5-year survival was better in men than in women (53% vs. 42%, p = 0.02).Group 3 consisted of 723 male patients and 101 female patients (p < 0.0001). Ischemic cardiomyopathy was the main HF etiology (37.9 %) and it was significantly more often the reason for left ventricular assist device support in men (p = 0.009). No differences were seen in procedural success; 5-year survival showed a better outcome in men (49% vs. 25%, p = 0.026). In patients supported by a VAD, gender has a significant impact on the distribution of diagnoses in the adult population. Women were underrepresented in the age group 13-50 years, and 50 years and older, and women had a higher risk for mortality on VAD support in the adult age groups (groups 2 and 3).

Gender differences in health-related quality of life after coronary bypass surgery: results from a 1-year follow-up in propensity-matched men and women.

OBJECTIVE: To examine whether the predictive value of gender for health-related quality of life (HRQoL) is independent of clinical health status and depression. Women undergoing coronary bypass surgery generally report a poorer HRQoL than men. METHODS: A total of 990 (20% women) patients completed study questionnaires 1 day before coronary bypass surgery and 1 year after surgery. Physical aspects of HRQoL were assessed with the Short Form 36 Health Survey. Depression was measured with the self-reported Patient Health Questionnaire. Propensity score matching was applied to match men and women with respect to 65 clinical variables. Of 198 women, 157 (79.3%) could be matched to a partner, resulting in an excellent balance of clinical variables between the matched groups. RESULTS: At baseline, propensity-matched men and women differed in physical functioning (p < .001) and role functioning (p = .007), but not in bodily pain and general health perception. In both men and women, HRQoL outcomes improved over 1 year. Preoperative depression predicted worse physical HRQoL in all outcomes, except general health perception 1 year after surgery. After adjusting for depression, gender lost its predictive power with respect to physical functioning. However, compared with women, men still reported a better role functioning. CONCLUSION: Our data suggest that gender is a marker for role functioning, independent of the clinical health status and depression. Rehabilitation measures designed for the specific needs of women might help to improve their HRQoL.

Causal attributions among patients undergoing coronary artery bypass surgery: gender aspects and relation to depressive symptomatology.

Causal attributions made by patients for their coronary heart disease may contribute to gender differences in emotional adjustment. The purpose of this study was to determine gender differences in causal attributions and to analyze the associations between causal attributions and depressive symptomatology in patients undergoing coronary artery bypass graft (CABG) surgery. Nine hundred and seventy-nine patients (mean age 66.8 years, 19.9% women) completed a modified version of the Illness Perception Questionnaire (IPQ) and the depression module of the Patient Health Questionnaire (PHQ-9) 1-3 days before CABG-surgery and 1 year after surgery. Men were more likely to name their health behavior (men: 40.2%, women: 26.9%, P < .001) as a cause of disease, whereas women were more likely to cite destiny (women: 34.7%, men: 25.7%, P = .012). Regression analyses showed cross-sectional and longitudinal associations of attributions with depressive symptomatology which were independent of gender, sociodemographic and clinical variables. Attribution to personality and stress were associated with an increase in depressive symptomatology. Causal attributions may present a valuable approach for identifying patients at risk for depression and the implementation of targeted interventions.

Predictive relationship between depression and physical functioning after coronary surgery.

BACKGROUND: Depression is a prevalent condition in patients undergoing coronary artery bypass graft surgery (CABG) and is often associated with a less favorable health status. The aim of this study was to investigate the relationship between depression and physical functioning in patients undergoing CABG. METHODS: The analyses were based on a sample of 883 consecutive subjects (aged 35-93 years; 19.8% women) undergoing CABG. Depression was assessed using the Patient Health Questionnaire (PHQ); the subscale "physical functioning" was taken from the 36-Item Short-Form Health Survey. Questionnaires were administered 1 to 3 days before surgery (T1) and 2 months (T2) and 1 year (T3) after surgery. RESULTS: A cross-lagged path analytic model showed that an increase in depressive symptoms predicted a decrease in physical functioning (ß(T)1₋(T)2 = -0.15 [P < .001]; ß(T)2₋(T)3= -0.17 [P < .001]), but not the other way around. Multigroup comparisons revealed one moderator effect: in patients with systolic heart failure (left ventricular ejection fraction [LVEF], ≤45%), the effect of depression on physical functioning from T2 to T3 was significantly stronger than in patients with preserved LVEF (ß(T)2₋(T)3= -0.30 [P < .001] vs ß(T)2₋(T)3= -0.14 [P < .001]; χ²(diff) = 3.885 [P = .049]). CONCLUSIONS: More attention should be paid to diagnosis and treatment of depression in patients undergoing CABG. After surgery, patients with systolic heart failure and depressive symptoms in particular seem at risk of a deterioration of their physical functioning.

Regression of myocardial hypertrophy after aortic valve replacement: faster in women?

BACKGROUND: In patients with aortic stenosis, pressure overload induces cardiac hypertrophy and fibrosis. Female sex and estrogens influence cardiac remodeling and fibrosis in animal models and in men. Sex differences and their molecular mechanisms in hypertrophy regression after aortic valve replacement have not yet been studied. METHODS AND RESULTS: We prospectively obtained preoperative and early postoperative echocardiography in 92 patients, 53 women and 39 men, undergoing aortic valve replacement for isolated aortic stenosis. We analyzed in a subgroup of 10 patients matrix gene expression in left ventricular (LV) biopsies. In addition, we determined the effect of 17ß-estradiol on collagen synthesis in isolated rat cardiac fibroblasts. Preoperatively, women and men had similar ejection fraction. Similar percentages of women and men had increased LV diameters (37% and 38%). Women more frequently exhibited LV hypertrophy than men (women: 86%; men: 56%; P<0.01). Postoperatively, increased LV diameters persisted in 34% of men but only in 12% of women (P<0.023). LV hypertrophy reversed more frequently in women than in men, leading to a similar prevalence of LV hypertrophy after surgery (women: 45%; men: 36%). In surgical biopsies, men had significantly higher collagen I and III and matrix metalloproteinase 2 gene expression than women. In isolated rat cardiac fibroblasts, 17ß-estradiol significantly increased collagen I and III gene expressions in male cells but decreased it in female cells. CONCLUSIONS: Women adapt to pressure overload differently from men. Less fibrosis before surgery may enable faster regression after surgery.

Heart transplantation in women with dilated cardiomyopathy.

BACKGROUND: Dilated cardiomyopathy (DCM) is responsible for over half of all heart transplants. Fewer women with DCM undergo heart transplants than men with DCM; the reasons for this state of affairs are unclear. METHODS AND RESULTS: We analyzed prospectively a cohort of 698 DCM patients who were referred to our heart transplant center. Only 15.5% of them were women. Women and men did not differ in age or ejection fraction (24%). Women were more frequently in New York Heart Association class III-IV, had lower exercise tolerance, worse pulmonary function, and poorer kidney function (all P<0.05) than men. Women were less commonly diabetic (14% vs. 23%; P<0.05). Similar percentages of women and men who were referred were transplanted; the women spent less time on the waiting list (153+/-37 days for women and 314+/-29 days for men; P<0.05). The 10-year survival rate of women and men after transplantation was similar (57% and 45%, respectively; P<0.203). We compared our current data to our overall experience from 1985 till date (n=972), and also with the Eurotransplant heart dataset. Similar to our current findings, far lower percentages of DCM patients in both cohorts were women, although the 10-year survival of female and male DCM patients after transplantation was not different. CONCLUSIONS: Because women were referred with more severe heart failure but fewer relative contraindications, it seems that the option of transplantation is less intensely considered for women, particularly for those with comorbidities, by the referring physicians. Because women with DCM do as well as men after transplantation, efforts should be undertaken to improve referral of women.

Screening for depression: Rasch analysis of the dimensional structure of the PHQ-9 and the HADS-D.

BACKGROUND: Both the depression modules of the Hospital Anxiety and Depression Scale (HADS-D) and the Patient Health Questionnaire (PHQ-9) are widely used for the screening of depression. We analyzed the dimensionality and the item fit of both scales individually and across the scales. Moreover, we sought to identify items which evidenced item response bias associated with age and gender. METHODS: The depression subscales HADS-D and the PHQ-9 were administered to 1271 patients (mean age 67.2; 22.5% women) undergoing coronary artery bypass graft surgery (CABG). Rasch analyses were performed to assess the overall fit of the model, individual item fit and differential item functioning (DIF). RESULTS: Rasch analysis revealed that the HADS-D and the PHQ-9 feature a common core construct containing six items of the HADS-D and three items of the PHQ-9. Two of these items are identical with the 2-item short form of the PHQ-9. In addition, fatigability was the only somatic item that fitted the model. No substantial DIF was observed. LIMITATIONS: The generalizability of these results might be restricted to patients awaiting CABG. CONCLUSIONS: The short form of the PHQ-9 seems to be an economic and valid instrument for the screening of depression, which indicates the same latent construct that is captured by six items of the HADS-D. Further studies are needed to evaluate whether the addition of fatigability might enhance the validity of the PHQ-2 in this patient population.

A network against failing hearts--introducing the German "Competence Network Heart Failure".

Heart failure (HF) has been identified as one of the most threatening diseases for the western civilisation, posing a risk to health for a rising number of patients. Acknowledging the medical problem of HF to be both economically and socially threatening the German Federal Ministry of Research and Education (BMBF) initiated a nationwide research network aiming to find new ways in prevention, alleviation and treatment of the widespread disease. The "Competence Network Heart Failure" (CNHF), initiated in 2003, bundles the scientific expertise in a large-scale research network; its aims are the coordination of basic and applied clinical research as well as dissemination of findings into clinical practice in order to consolidate and perpetuate the achieved improvements. The scope of this paper is to introduce the CNHF and to provide an overview of the tasks and hitherto attained achievements to a broad spectrum of health care providers.

Predictors of preoperative depressive risk in patients undergoing coronary artery bypass graft surgery.

AIMS: Depression is highly prevalent among patients undergoing coronary artery bypass graft (CABG) surgery and represents a significant risk factor for longer hospitalization, increasing health costs and worse outcomes. Nonetheless, preoperative depression is rarely assessed in clinical practice, limiting the possibilities for effective prevention and care. Thus, we sought to develop risk models to determine the depressive risk before CABG based on sociodemographic, clinical and treatment variables. METHODS AND RESULTS: One thousand two hundred and thirty-eight CABG-patients completed the 9-item Patient Health Questionnaire (PHQ-9) prior to surgery. Clinical and sociodemographic data were collected by trained study investigators. Overall 21.6% of patients displayed elevated depression scores, which were twice as common in women than in men (34.7 versus 17.9%, P < 0.001). Following bivariate analysis, multiple regression revealed that both dyspnea at rest (OR 1.69, 95% CI 1.11-2.57, P = 0.015) and dyspnea on exertion (OR 2.48, 95% CI 1.61-3.81, P < 0.001), previous myocardial infarction (OR 1.53, 95% CI 1.12-2.08, P = 0.007), comorbidities and medication with tranquillizers; in addition to younger age, female gender, lower school education, and living alone are significantly and independently associated with preoperative depressive symptoms. CONCLUSIONS: Knowledge of these risk factors will allow for better identification of patients at high depressive risk and thereby facilitate optimal treatment in order to improve postoperative outcomes.

The Biomaterialbank of the German Competence Network of Heart Failure (CNHF) is a valuable resource for biomedical and genetic research.

Genetic research on heart failure (HF) requires large cohorts of well-phenotyped patients. The German Competence Network of Heart Failure (CNHF) organized a biobank in 2004 to supply the necessary infrastructure and standard operating procedures (SOPs) for a centralized collection of blood specimen. We centralized data and collected serum, plasma and DNA of well characterized HF subjects all over Germany. Different pseudonyms were created automatically to address data safety and other concerns about privacy. Thus far, we have collected 85,000 sample specimen from 9,500 prospectively evaluated patients with HF. Detailed medical data were prospectively acquired together with corresponding blood samples. In 2008 clinician-scientists can apply for access to the material. Our biobank represents a major facet of the CNHF and has already documented research and clinical utility.

Does time spent on household activities or housework stress complicate recovery following coronary artery bypass surgery?

OBJECTIVES: The purpose of the present study was to examine the role of household activities and housework stress as factors contributing to gender differences in recovery following coronary artery bypass graft (CABG) surgery. Therefore, the impact of time spent on household activities and housework stress on physical functioning (PF) was explored. METHODS: Psychosocial data were measured two months and again one year after CABG in a sample of 351 patients (23% women) recruited within one week before surgery. Self-report questionnaires included assessment of household responsibilities, depression (PHQ-9), and PF (SF-36 subscale). RESULTS: The results revealed that, following CABG, women spent more time on household activities and experienced markedly more stress due to these activities than men. Surprisingly, only housework stress was associated with poorer PF, whereas the time spent on household activities did not explain differences in PF in men and women. Finally, household responsibilities were not associated with the poorer recovery of the female CABG patient. DISCUSSION: In conclusion, our results do not support the advice that women should not resume household activities two months after surgery. More research is needed to establish valid guidelines.

Gender aspects of the role of the metabolic syndrome as a risk factor for cardiovascular disease.

BACKGROUND: The interaction of the risk factors of abdominal obesity, disturbed glucose homeostasis, dyslipidemia, and hypertension is believed to represent a distinct entity, termed the metabolic syndrome (MetS), that leads to a greater increase in cardiovascular risk than does the sum of its components. OBJECTIVE: We reviewed currently available information regarding gender differences in the role of the MetS as a risk factor for cardiovascular disease (CVD). METHODS: Using the search terms women, men, sex, gender, sex differences, and gender differences in combination with the metabolic syndrome, we conducted a systematic review of the available literature on sex differences in the MetS. The National Institutes of Health, PubMed, and MEDLINE databases were searched retrospectively from 2007 to 1987. Reference lists of identified articles were also used as a source, and articles were not restricted to the English language. RESULTS: In recent years, the MetS has been more prevalent in men than in women but has risen particularly in young women, where it is mainly driven by obesity. Diagnostic criteria for the MetS vary for the cutoff points and definition of its components in a gender-specific manner. Based on the definition of impaired glucose homeostasis and pathologic abdominal circumference or waist/hip ratio, more or fewer women are included. Glucose and lipid metabolism are directly modulated by estrogen and testosterone, with a lack of estrogen or a relative increase in testosterone inducing insulin resistance and a proatherogenic lipid profile. Hypertension is a strong risk factor in both sexes, but the prevalence of hypertension increases more rapidly in aging women than in men. Menopause and polycystic ovary syndrome contribute to the development of MetS by the direct effects of sex hormones. Some components of the MetS (eg, diabetes and hypertension) carry a greater risk for CVD in women. CONCLUSIONS: Future gender-related clinical and research activities should focus on the identification of sex- and gender-specific criteria for risk management in patients with the MetS. We propose small, focused, mechanistic studies on sex-specific surrogate end points and sex-specific studies in animal models for diabetes and aging.

[Impact of gender and age on in-hospital mortality after coronary artery bypass graft].

OBJECTIVE: The purpose of this study was to explore the association of gender and age on in-hospital mortality after coronary artery bypass graft (CABG) among the Chinese population. METHODS: A total of 2682 patients (male: 2316, female: 366) who underwent CABG surgery were retrospectively investigated between January 1st, 1997 and December 31st, 2001 for perioperative risk factors and in-hospital mortality rate after CABG. RESULTS: Preoperative comorbidity rate and postoperative complication rate were higher in women than that in men, although left ventricular ejection fraction was higher and the number of diseased vessels fewer in women than in men. The in-hospital mortality rate was three times higher in women than that in men (3.01% vs. 1.12%, P = 0.001), especially in the younger age group (2.6% vs. 0.5%, P = 0.001, risk-adjusted odds ratio 4.844, 95% CI: 1.549 - 15.142). In older patients, there was no notable difference in in-hospital mortality between the genders (3.7% for women vs. 2.4% for men, P = 0.383). CONCLUSIONS: Chinese woman, especially in younger age, had a higher in-hospital mortality rate post CABG than that in men, suggesting that younger female gender is an independent risk factor for in-hospital mortality after CABG. Future studies are warranted to clarify the underlying mechanisms.

Heart failure and its treatment in women. Role of hypertension, diabetes, and estrogen.

Large differences exist between women and men in the syndrome of heart failure (HF). In contrast to men, hypertension and diabetes represent the major risk factors for development of HF in women and hypertension is also the major cause of left ventricular hypertrophy and stroke. Left ventricular hypertrophy in women increases the risk for mortality to a higher degree than it does in men. The clinical course of HF is generally more benign and more frequently characterized by HF with preserved systolic function. Estrogen receptors are present in the human heart. Based on data from rodent models, they are believed to modulate hypertrophy and the progression of HF. Some of the signaling pathways have been described and involve phosphorylation of intracellular kinases and production of nitric oxide. Interestingly, estrogen receptors are upregulated in human hypertrophy and HF. The clinical course of HF in women is characterized by the more frequent occurrence of diastolic HF. Myocardial remodeling with age and, as a consequence, of mechanical load is different in both genders. Adherence to guidelines in the diagnosis and treatment of HF is less strict in women than in men, leading to undertreatment with inhibitors of the renin-angiotensin system. Women are generally underrepresented in clinical trials in HF and gender-specific analyses have been neglected in most older large survival trials. In some of the large survival studies angiotensin-converting enzyme inhibitors or beta-receptor blockers did not reach significant endpoints in women. However, meta-analyses show overall positive effects for these groups of substances. Angiotensin receptor blockers were effective in large studies including high percentages of women.