Outcomes of HeartWare Ventricular Assist System support in 141 patients: a single-centre experience.

OBJECTIVES: A third-generation ventricular assist device, the HeartWare Ventricular Assist System, has demonstrated its reliability and durability in animal models and clinical experience. However, studies of a large series of applications are still lacking. We evaluate the safety and efficacy of the HeartWare pump in 141 patients with end-stage heart failure at a single centre. METHODS: A total of 141 patients (116 men and 25 women with a mean age of 52 years) in New York Heart Association (NYHA) Class IV received implantation of the HeartWare Ventricular Assist System between August 2009 and April 2011 at the Deutsches Herzzentrum Berlin. The outcomes were measured in terms of laboratory data, adverse events, NYHA functional class and survival during device support. RESULTS: The HeartWare system provided an adequate haemodynamic support for patients both inside and outside the hospital. NYHA class improved to I-II. Organ function and pulmonary vascular resistance improved significantly. In this cohort of patients, 14 patients underwent heart transplantation, one had had the device explanted following myocardial recovery, one had changed to another assist device, 81 were on ongoing support and 44 died. The overall actuarial survival rates at 6 and 12 months were 70 and 67%, respectively, and the 3-, 6- and 12-month survival rates on a left ventricular assist device (LVAD) support for bridge to transplantation patients were 82, 81 and 79%, respectively. Infection and bleeding were the main adverse events. Four patients underwent an LVAD exchange for pump thrombosis. CONCLUSIONS: The HeartWare system provides a safe and effective circulatory support in a population with a wide range of body surface areas, with a satisfactory actuarial survival time and an improved quality of life. It can be used for univentricular or biventricular support, being implanted into the pericardial space with simplified surgical techniques.

Factors associated with the need of biventricular mechanical circulatory support in children with advanced heart failure.

OBJECTIVES: Postimplantation right ventricular dysfunction is associated with increased morbidity and mortality in ventricular assist device (VAD) recipients. This study aimed to determine the preoperative risk factors for severe right heart failure needing biventricular mechanical circulatory support in children with end-stage heart failure. METHODS: We reviewed data from 84 children supported with long-term VADs at the German Heart Institute Berlin between January 1999 and October 2010. Right ventricular assist device (RVAD) support was needed for 24 (29%) patients, and the other 60 (71%) were implanted with left ventricular assist devices (LVADs). RESULTS: The median age at implantation was 7 years (12 days-18 years), and the median support time was 41 days (1-432 days). Of the 84 patients, the overall survival to transplantation or recovery of ventricular function was 69%. Compared with children implanted with LVAD, patients receiving biventricular support had significantly higher postoperative mortality (P = 0.04). The multivariate logistic regression indicated that decreased milrinone use was the only preoperative factor independently associated with increased requirement for biventricular support (odds ratio: 0.1, 95% confidence interval: 0.04-0.64, P = 0.01). Children treated with milrinone preoperatively showed improved survival after implantation (P = 0.04). CONCLUSIONS: Paediatric patients needing biventricular support had significantly higher postoperative mortality. Preoperative milrinone use might decrease the risk of severe right ventricular failure requiring additional RVAD insertion and improve postimplantation survival in children with advanced heart failure.

Predictors of in-hospital mortality in children after long-term ventricular assist device insertion.

OBJECTIVES: This study aimed to determine the pre-implantation predictors for in-hospital mortality in children with ventricular assist device (VAD) support. BACKGROUND: Candidate selection is of critical importance for improved outcomes in patients supported with VAD. However, risk factors for post-VAD survival in children are still not clearly understood. METHODS: From June 1996 to December 2009, 92 children underwent implantation of a long-term VAD at Germany Heart Institute Berlin. Data on all these patients were retrospectively analyzed, and pre-operative risk factors for in-hospital survival after VAD implantation were identified by multivariate logistic regression. RESULTS: Of the 92 subjects, the median age at implantation was 7 years (range 12 days to 18 years), and the median support time was 35 days (range 1 to 591 days). The overall survival rate to transplantation or recovery of ventricular function was 63%. Independent predictors of in-hospital mortality in children included congenital etiology (odds ratio [OR]: 11.2; 95% confidence interval [CI]: 2.6 to 47.5), norepinephrine requirement (OR: 6.9; 95% CI: 1.4 to 31), C-reactive protein level >6.3 mg/dl (OR: 4.9; 95% CI: 1.1 to 22.1), and central venous pressure >17 mm Hg (OR: 4.6; 95% CI: 1.1 to 20). CONCLUSIONS: Congenital etiology, pre-operative norepinephrine requirement, higher serum C-reactive protein, and central venous pressure were associated with increased in-hospital mortality in children with VAD support. Optimal candidate selection and timing of VAD insertion may be of great importance for improved outcomes in children with advanced heart failure.

Repair of anomalous origin of the left coronary artery from the pulmonary artery in infants and children.

OBJECTIVE: Although mortality after direct aortic reimplantation for anomalous origin of the left coronary artery from the pulmonary artery (ALCAPA) has significantly decreased, many questions remain unanswered. METHODS: Between 1986 and June 2010, we operated on 27 consecutive pediatric patients with anomalous origin of the left coronary artery from the pulmonary artery (ALCAPA). All patients underwent reestablishment of a dual coronary system with direct aortic reimplantation of the left coronary artery into the aorta. Postoperative extracorporeal mechanical circulatory support was necessary in 7 cases. In all 7 patients, hemodynamic stability was achieved after 4 to 10 days of support. Mitral valve repair was performed in 9 patients with severe mitral valve incompetence and resulted in stable mitral valve function during follow-up as long as 19 years. RESULTS: There were no early or late deaths. During follow-up (3 months-17.5 years), both early and late improvement of myocardial function was observed in all patients. Reduced left ventricular regional function late after successful surgical correction of ALCAPA was related to the presence of left ventricular myocardial scar tissue, as detected by magnetic resonance imaging. CONCLUSIONS: Despite the absence of early and late mortality, the long-term prognosis for patients after reimplantation of ALCAPA into the aorta is not clear. Scars and perfusion deficits of the left ventricle may not be detected by standard echocardiographic evaluation of global left ventricular function and therefore may be underestimated. We therefore recommend lifelong surveillance of these patients, including magnetic resonance imaging.

[Technical possibilities and limitations of mechanical circulatory support]. / Herzinsuffizienz - Technische Möglichkeiten und Grenzen der Mechanischen Kreislaufunterstützung.

Ventricular assist devices (VAD) to support the left (LVAD), the right (RVAD) or both ventricles (BVAD) have emerged as one standard of care for advanced heart failure patients. Initially used to bridge patients to transplantation (BTT) they are now more frequently implanted as permanent support (destination therapy, DT). Bridge to recovery (BTR) is a valid option for only a small number of patients. Although there are different devices available, patient selection, preoperative and intraoperative management, and the timing of VAD implantation are the elements critical to successful circulatory support.

Is bridge to recovery more likely with pulsatile left ventricular assist devices than with nonpulsatile-flow systems?

BACKGROUND: Weaning from left ventricular assist devices (LVADs) after myocardial recovery in patients with idiopathic dilated cardiomyopathy is a clinical option. With the broad application of continuous-flow pumps, we observed a decrease in the numbers of possible LVAD explanations due to myocardial recovery in these particular patients. We investigated this phenomenon and its causes. METHODS: Between July 1992 and December 2009, 387 patients (age, 0.1 to 82 years) with idiopathic dilated cardiomyopathy underwent LVAD implantation at our institution. Patients were divided into two groups depending on whether they were weaned from the LVAD (group A) or not (group B). Univariate and multivariate analyses were performed on 24 different factors with a possible influence on myocardial recovery. RESULTS: In 34 patients, LVAD removal due to myocardial recovery was performed with long-term stable cardiac function (weaning rate, 8.8%). Patients with a pulsatile-flow LVAD had an almost threefold chance for myocardial recovery (odds ratio, 2.719; 95% confidence interval, 1.182 to 6.254) than patients who received continuous-flow devices. Younger patients had significantly higher recovery rates than older patients (odds ratio, 1.036; 95% confidence interval, 1.016 to 1.057). CONCLUSIONS: Pulsatile-flow LVADs and young age were important factors for myocardial recovery in idiopathic dilated cardiomyopathy patients in our analysis. Further studies should investigate whether pulsatility in itself or the different degrees of left ventricular unloading by the two types of systems play a role in myocardial recovery.

Outcomes of ventricular assist device support in young patients with small body surface area.

OBJECTIVE: Although the ventricular assist device (VAD) has been a well-established therapy for larger adolescents and adult patients with advanced heart failure, current experience with the use of VAD for mechanical circulatory support in infants and young children with small body surface area is still limited. METHODS: Between January 1999 and December 2009, 56 small children with body surface area<1.2 m² were implanted with Berlin Heart EXCOR pediatric VAD in Germany Heart Institute Berlin. The etiology of end-stage myocardial failure included non-congenital (75%) and congenital heart disease (25%); the median age at implant was 1 year (12 days to 14 years), and the median support time was 55 days (1-432 days). RESULTS: Of the 56 pediatric patients, 24 were bridged to heart transplantation, 12 were explanted following myocardial recovery, two continued to receive support, and the other 18 died on support. The accurate rate of survival on VAD support was 81.1% ± 5.8% and 51.4% ± 9.3% at 30 days and 1 year after EXCOR implantation. Patients receiving biventricular support had a trend towards higher post-implantation mortality as compared with children implanted with left ventricular assist device (LVAD) (P = 0.09). Lower post-implantation survival was also observed in patients with congenital cardiac disease compared with children with a non-congenital etiology (P < 0.001). CONCLUSIONS: Berlin Heart EXCOR pediatric VAD could provide satisfactory and safe circulatory support for small children with end-stage heart disease.

Glucose-insulin-potassium therapy in adult patients undergoing cardiac surgery: a meta-analysis.

Glucose-insulin-potassium (GIK) has long been used as adjuvant treatment for patients with serious cardiovascular disease. Although many studies have reported their results based on GIK therapy in the setting of heart surgery, the outcomes remain controversial and inconclusive. The aim of this meta-analysis of randomized controlled trials (RCTs) was to determine the clinical effects of GIK in adult cardiac surgery patients. Electronic databases and manual bibliographical searches were conducted. A meta-analysis of all RCTs comparing GIK with control in heart surgery was performed. Data for all-causes mortality (within 2 months after surgery), perioperative myocardial infarction, postoperative inotropic support, atrial fibrillation, cardiac index, durations of intensive unit care stay and total hospital stay were extracted, and we summarized the combined results of the data of the RCTs as relative risk (RR), with 95% confidence intervals (CIs). A total of 33 RCTs including 2113 patients were assessed in this study. GIK infusion was associated with significantly fewer perioperative myocardial infarctions (RR = 0.63, 95% CI 0.42-0.95), less inotropic support requirement (RR = 0.66, 95% CI 0.45-0.96), better postoperative cardiac index (weighted mean difference (WMD) = 0.43, 95% CI 0.31-0.55), and reduced length of stay in the intensive care unit (WMD = -7.96, 95% CI -13.36 to -2.55). Further analysis showed that diabetic patients were benefited from GIK with glycemic control, but not GIK infusion without glucose control. GIK significantly reduced myocardial injury and improved hemodynamic performance in patients undergoing cardiac surgery. Glycemic control with GIK might be required for cardiac surgery patients with diabetes.

Predictors for the use of left ventricular assist devices in infants with anomalous left coronary artery from the pulmonary artery.

BACKGROUND: Left ventricular (LV) mechanical circulatory support (MCS) may be necessary after repair of anomalous left coronary artery from the pulmonary artery. We evaluated LV function parameters for their ability to predict postoperative need for MCS. METHODS: Fourteen infants (median age, 3.6; range, 2.3 to 12 months) underwent direct aortic reimplantation of the left coronary artery. We compared preoperative LV end-diastolic diameter, end-diastolic pressure, ejection fraction, and fraction of shortening of 8 patients with successful weaning from cardiopulmonary bypass (group 1) and 6 patients with unsuccessful weaning from cardiopulmonary bypass and temporary MCS support (group 2). RESULTS: No perioperative or late deaths occurred. All patients at follow-up were free of reoperation (median follow-up, 10.4 years [range, 1.4 to 17 years]). Median preoperative LV end-diastolic diameter (47 [range, 41 to 60 mm] vs 32 mm [range, 21 to 36 mm]) and LV end-diastolic pressure (20 [range, 18 to 25 mm Hg] vs 12 mm Hg [range, 7 to 20 mm Hg]) were significantly higher in group 2 than in group 1 (p = 0.002 and p = 0.048). LV ejection fraction (0.28 [range, 0.19 to 0.37] vs 0.43 [range, 0.23 to 0.76]) and LV fraction of shortening (9% [range, 7% to 15%] vs 22% [range 13% to 30%]) were significantly lower in group 2 than in group 1 (p = 0.035 and p = 0.002). MCS support duration ranged from 4 to 12 days. There were no significant differences in LV function parameters at discharge or during follow-up between the groups. CONCLUSIONS: A preoperative LV end-diastolic diameter above 40 mm is the strongest predictor for postoperative temporary MCS after anomalous left coronary artery from the pulmonary artery repair in infancy. However, even with temporary MCS, direct aortic reimplantation for anomalous left coronary artery from the pulmonary artery can be performed with no mortality and excellent LV recovery.

Warm versus cold cardioplegia for heart surgery: a meta-analysis.

Much controversy persists regarding the optimal techniques for myocardial protection during heart surgery. Numerous studies have compared warm cardioplegia with cold cardioplegia for myocardial preservation, but the outcomes were inconclusive. The aim of this meta-analysis of randomised controlled trials (RCTs) was to compare the beneficial and harmful effects of warm and cold cardioplegia during heart surgery. Electronic databases and manual bibliographical searches were conducted. A meta-analysis of all RCTs comparing warm cardioplegia to cold cardioplegia perfusion during cardiac surgery was performed. Data for clinical events (in-hospital death, myocardial infarction (MI), low output syndrome, postoperative use of intra-aortic balloon pump, stroke and atrial fibrillation), postoperative cardiac index, postoperative creatine kinase-MB (CK-MB) and cardiac troponin release were extracted, and we summarised the combined results of the data of the RCTs as relative risk (RR), with 95% confidence intervals. A total of 41 RCTs including 5,879 patients were assessed in this study. We found that there was no statistical difference between patients receiving warm cardioplegia and cold cardioplegia in the incidences of clinical events. Warm cardioplegia was associated with improved postoperative cardiac index. CK-MB and cardiac troponin concentrations after surgery were significantly lower in the warm group as compared with the cold group. Using warm cardioplegia for myocardial protection during heart surgery resulted in similar incidences of clinical events, significant improvement in postoperative cardiac index and reduction in postoperative enzyme release as compared with cold cardioplegia.

A right-sided aortic arch with Kommerell's diverticulum of the aberrant left subclavian artery presenting with syncope.

A right-sided aortic arch with an aneurysm of the aberrant subclavian artery is a rare disease. We report a case of Kommerell's diverticulum of an aberrant left subclavian artery in a patient with a right-sided aortic arch. Fewer than 50 cases have been reported in the literature. A number of operative strategies are described. Right thoracotomy provides good exposure and avoids the morbidity associated with bilateral thoracotomy or sternotomy and thoracotomy. In our patient with symptoms of dysphagia, syncope, and left subclavian steal syndrome, a left thoracotomy was used. The repair was accomplished by division of a left ligamentum arteriosum, obliteration of the Kommerell's aneurysm, and an aorto-subclavian bypass. Postoperative complications included left vocal cord palsy and Horner's syndrome. Hoarseness and left ptosis recovered spontaneously 3 months after surgery, and the patient remained symptom-free at the 1-year follow-up. We believe a left thoracotomy for direct repair of Kommerell's diverticulum is a simple and safe method without the increased morbidity found in other procedures.

Coronary atherosclerosis of the donor heart--impact on early graft failure.

OBJECTIVE: Due to the shortage of donor hearts, the criteria for organ acceptability have been considerably extended and donor grafts with coronary atherosclerosis are among those offered. This study evaluated whether and to what degree pre-existing coronary atherosclerosis may be acceptable. METHODS: A total of 1253 consecutive HTx recipients were investigated retrospectively for donor-transmitted coronary atherosclerosis (DCAS). Donor-transmitted coronary atherosclerosis was defined as focal atherosclerosis with stenosis of at least 50%. Inclusion criteria were absence of pre-HTx angiogram but performance of angiogram or autopsy within 6 months after heart transplantation. Kaplan-Meier analysis and log-rank test were used. RESULTS: Eighty-five out of 1253 (6.8%) cases were excluded, since coronary evaluation was not performed within 6 months (n=45) or hearts had undergone pre-transplant angiography (n=40). In 1086 patients no donor-transmitted coronary atherosclerosis was found (NDCAS group) and in 82 patients (7%) donor-transmitted coronary atherosclerosis was diagnosed by angiography (n=49) or autopsy (n=33). Single-vessel donor-transmitted coronary atherosclerosis was found in 53/82 patients (DCAS1 group) and double- or triple-vessel donor-transmitted coronary atherosclerosis in 26/82 patients (DCAS2/3 group). Three of the 82 patients with donor-transmitted coronary atherosclerosis were excluded since the autopsy report was unclear regarding degree of atherosclerosis. Early after heart transplantation the 30-day mortality in the NDCAS and DCAS1 groups was 12.2% versus 13.2% whereas in the DCAS2/3 group it was 61.5%. Beyond the first year the annual decrease with and without donor-transmitted coronary atherosclerosis (single-vessel disease) is comparable. CONCLUSIONS: Donor screening without coronary angiogram overlooks significant atherosclerotic lesions in a considerable number of cases (7.0%). Therefore, angiographic donor screening should be performed. Donor grafts with single-vessel coronary atherosclerosis may be accepted as marginal hearts; however, in our opinion, revascularisation (CABG, PTCA) should be considered. Grafts with two- or even three-vessel coronary atherosclerosis seem to have a serious risk for early graft failure. Beyond the first year the outcome of healthy grafts and grafts with donor-transmitted coronary atherosclerosis seems to be comparable.

Orthotopic heart transplantation in patients with Marfan syndrome.

BACKGROUND: Due to the risk of vascular complications, the indication for heart transplantation (HTx) in patients with Marfan syndrome and end-stage heart disease remains controversial. We analyzed the results of such patients who underwent HTx at our institution. METHODS: Ten patients with Marfan syndrome (median age 36, range 19 to 56 years) underwent HTx between March 1986 and December 2005. The primary vascular manifestation of Marfan syndrome was type-A aortic dissection in three patients and ascending aortic aneurysm in seven patients. All patients had undergone cardiovascular operations prior to transplantation. All had refractory heart failure (New York Heart Association class IV) before transplantation. Three patients underwent transplantation after ventricular assist device (VAD) support (left VAD, n = 2; biventricular assist device, n = 1). RESULTS: There were no perioperative deaths. Two patients died of causes unrelated to Marfan disease (pneumonia on day 27, n = 1; stroke on day 102, n = 1). One patient died due to type-B dissection 3.8 years posttransplantation and one due to rupture of an aortic arch aneurysm after 12.1 years. Two patients underwent thoracoabdominal aortic replacement for chronic dissection 14 and 20 months posttransplantation, respectively. Kaplan-Meier survival rate was 80% at 1 year and 64% at 10 years. The Kaplan-Meier freedom from reoperation was 100% at 1 year and 62.5% at 10 years. CONCLUSIONS: Heart transplantation in patients with Marfan syndrome results in good long-term survival, similar to that of patients without Marfan syndrome. Close follow-up and timely operation of aortic pathologies is mandatory. Reluctance to place these patients on a heart transplant waiting list appears not to be justified.

Changes in myocardial collagen content before and after left ventricular assist device application in dilated cardiomyopathy.

BACKGROUND: The purposes of this study were to confirm the changes in myocardial collagen level after left ventricular assist device (LVAD) support in dilated cardiomyopathy (DCM), find the relation between these changes and prognosis, and test a practical method to assess the level of myocardial collagen. METHODS: Left ventricular samples were collected from DCM patients with different prognosis (transplanted group n = 8, weaning group n = 10) at the time when the LVADs were implanted and again during cardiac transplantation (n = 8). The level of neutral salt soluble collagen (NSC) and acid soluble collagen (ASC) was measured by Sircol collagen assay, and that of total collagen and insoluble collagen (ISC) by quantification of hydroxyproline (Hyp). Serum samples were collected from a portion of these patients (transplanted group, n = 6; weaning group n = 7) at the time the LVADs were implanted, 1 month after implantation and on explantation. Circulating concentration of carboxy-terminal propeptide of type I procollagen (P I CP), amino-terminal propeptide of type I procollagen (P I NP), amino-terminal propeptide of type III procollagen (P III NP) and type I collagen telopeptide (I CTP) were measured by the equilibrium type radioimmunoassay. RESULTS: Before LVAD implantation the level of NSC and ISC in the weaning group was higher but ASC in the transplanted group was lower than in the controls (P < 0.05). After LVAD support, the level of total collagen was higher, but ASC was also lower in the transplanted group than in the controls (P < 0.05). In comparison of the pre- and post-LVAD subgroups of the transplanted and weaning groups, all collagen fraction levels before LVAD implantation were lower in the transplanted group than in the weaning group (P < 0.05); but this difference disappeared after LVAD support. Comparison of the pre- and post-LVAD subgroups of the transplanted group showed increased level of NSC and total collagen after LVAD support. The changes of serum peptide concentration showed that P III NP increased constantly in the transplanted group, but P I CP and P I NP increased in the weaning group after LVAD implantation. CONCLUSIONS: The changes in myocardial collagen level as a sign of myocardial interstitial remodeling in DCM are not involved with total collagen but involved with collagen fractions, and they are related to prognosis. The changes of myocardial collagen content and serum procollagen peptide after LVAD support can be regarded as an expression of the reverse of maladaptive myocardial interstitial remodeling.

Cannulation of the right axillary artery for surgery of acute type A aortic dissection.

OBJECTIVE: The optimal choice of the arterial inflow site during operations for type A aortic dissection is not clearly defined. The aim of the prospective study was to identify whether cannulation of the right axillary artery instead of the femoral artery may improve the results of surgery for acute type A aortic dissection. METHODS: Seventy consecutive patients were operated on because of acute type A aortic dissection from January 2000 to February 2002. The only difference in surgical strategy was the site of arterial cannulation: the right axillary artery was used in 20 patients [axillary group] and the left femoral artery in 50 patients [femoral group]. All patients had aortic surgery with open distal anastomosis during deep hypothermic arrest and retrograde cerebral perfusion. The mean age was 58.7 +/- 12 years with a range from 28 to 88 years (axillary group, 56.6 +/- 13 years; femoral group, 59.4 +/- 12 years; P = 0.435). Preoperatively evident organ malperfusion was identified in five (25%) patients of the axillary group and in seven (14%) of the femoral group. RESULTS: There was no perioperative death. The hospital mortality rate was 5.0% for the axillary group and 22% for the femoral group (all patients, 17%). Major neurological complications occurred postoperatively in 5% of patients from the axillary group (one out of 20 patients) and in 8% of patients from the femoral group (four out of 50 patients) (all patients, 7%). CONCLUSION: Cannulation of the right axillary artery improved the outcome of surgery for acute type A aortic dissection. However, postoperative complications occurred after both axillary and femoral artery cannulation.

Floating nonocclusive thrombus in the ascending aorta.

We report the case of a 55-year-old woman seen with signs of angina pectoris and dyspnea. Transesophageal echocardiography showed a floating thrombus distal to the right coronary ostium. At operation, we found a highly mobile thrombus attached to an atherosclerotic plaque distal to the right coronary ostium. The atherosclerotic lesion and the pedunculated thrombotic mass were removed without resection of the adjacent aortic wall. In our judgment, a floating mass in the ascending aorta represents an emergency and should be removed before major thromboembolic complications occur.