The Carmat Bioprosthetic Total Artificial Heart Is Associated With Early Hemostatic Recovery and no Acquired von Willebrand Syndrome in Calves.

OBJECTIVES: To determine hemostasis perturbations, including von Willebrand factor (VWF) multimers, after implantation of a new bioprosthetic and pulsatile total artificial heart (TAH). DESIGN: Preclinical study SETTING: Single-center biosurgical research laboratory. PARTICIPANTS: Female Charolais calves, 2-to-6 months old, weighing 102-to-122 kg. INTERVENTIONS: Surgical implantation of TAH through a mid-sternotomy approach. MEASUREMENTS AND MAIN RESULTS: Four of 12 calves had a support duration of several days (4, 4, 8, and 10 days), allowing for the exploration of early steps of hemostasis parameters, including prothrombin time; coagulation factor levels (II, V, VII+X, and fibrinogen); and platelet count. Multimeric analysis of VWF was performed to detect a potential loss of high-molecular weight (HMW) multimers, as previously described for continuous flow rotary blood pumps. Despite the absence of anticoagulant treatment administered in the postoperative phase, no signs of coagulation activation were detected. Indeed, after an immediate postsurgery decrease of prothrombin time, platelet count, and coagulation factor levels, most parameters returned to baseline values. HMW multimers of VWF remained stable either after initiation or during days of support. CONCLUSIONS: Coagulation parameters and platelet count recovery in the postoperative phase of the Carmat TAH (Camat SA, Velizy Villacoublay Cedex, France) implantation in calves, in the absence of anticoagulant treatment and associated with the absence of decrease in HMW multimers of VWF, is in line with early hemocompatibility that is currently being validated in human clinical studies.

First clinical use of a bioprosthetic total artificial heart: report of two cases.

BACKGROUND: The development of artificial hearts in patients with end-stage heart disease have been confronted with the major issues of thromboembolism or haemorrhage. Since valvular bioprostheses are associated with a low incidence of these complications, we decided to use bioprosthetic materials in the construction of a novel artificial heart (C-TAH). We report here the device characteristics and its first clinical applications in two patients with end-stage dilated cardiomyopathy. The aim of the study was to evaluate safety and feasibility of the CARMAT TAH for patients at imminent risk of death from biventricular heart failure and not eligible for transplant. METHODS: The C-TAH is an implantable electro-hydraulically actuated pulsatile biventricular pump. All components, batteries excepted, are embodied in a single device positioned in the pericardial sac after excision of the native ventricles. We selected patients admitted to hospital who were at imminent risk of death, having irreversible biventricular failure, and not eligible for heart transplantation, from three cardiac surgery centres in France. FINDINGS: The C-TAH was implanted in two male patients. Patient 1, aged 76 years, had the C-TAH implantation on Dec 18, 2013; patient 2, aged 68 years, had the implantation on Aug 5, 2014. The cardiopulmonary bypass times for C-TAH implantation were 170 min for patient 1 and 157 min for patient 2. Both patients were extubated within the first 12 postoperative hours and had a rapid recovery of their respiratory and circulatory functions as well as a normal mental status. Patient 1 presented with a tamponade on day 23 requiring re-intervention. Postoperative bleeding disorders prompted anticoagulant discontinuation. The C-TAH functioned well with a cardiac output of 4·8-5·8 L/min. On day 74, the patient died due to a device failure. Autopsy did not detect any relevant thrombus formation within the bioprosthesis nor the different organs, despite a 50-day anticoagulant-free period. Patient 2 experienced a transient period of renal failure and a pericardial effusion requiring drainage, but otherwise uneventful postoperative course. He was discharged from the hospital on day 150 after surgery with a wearable system without technical assistance. After 4 months at home, the patient suffered low cardiac output. A change of C-TAH was attempted but the patient died of multiorgan failure. INTERPRETATION: This preliminary experience could represent an important contribution to the development of total artificial hearts using bioprosthetic materials. FUNDING: CARMAT SA.

Animal studies with the Carmat bioprosthetic total artificial heart.

OBJECTIVES: The Carmat bioprosthetic total artificial heart (TAH) contains bioprosthetic blood-contacting surfaces, and is designed for orthotopic cardiac replacement. In preparation for clinical studies, we evaluated the TAH performance and its effects on end-organ function in an animal model. METHODS: Twelve female Charolais calves, 2-3 months of age and weighing 102-122 kg, were implanted with the TAH through a mid-sternotomy to ensure an adequate anatomic fit. The intended support duration was 4-10 days. Haematological values, creatinine, bilirubin and lactate levels were measured and mean arterial and central venous pressure, central venous oxygen saturation and TAH parameters were monitored. RESULTS: The calves were placed in a cage immediately postoperatively, and extubated on postoperative day 1 in most cases. Average support duration was 3 days, with 4 of 12 calves supported for 4, 4, 8 and 10 days. The initial procedures were used to refine surgical techniques and postoperative care. Pump output ranged from 7.3 to 10 l/min. Haemodynamic parameters and blood analysis were within acceptable ranges. No device failures occurred. No anticoagulation was used in the postoperative phase. The calves were euthanized in case of discomfort compromising the animal well-being, such as respiratory dysfunction, severe blood loss and cerebral dysfunction. Device explant analysis showed no thrombus formation inside the blood cavities. Histological examination of kidneys showed isolated micro-infarction in 2/12 animals; brain histology revealed no thromboembolic depositions. CONCLUSION: The Carmat bioprosthetic TAH implanted in calves up to 10 days provided adequate blood flow to organs and tissues. Low levels of haemolysis and no visible evidence of thromboembolic depositions in major organs and device cavities, without the use of anticoagulation, may indicate early-phase haemocompatibility of the TAH.

Results with SynCardia total artificial heart beyond 1 year.

Mechanical circulatory support devices have been increasingly used for long-term support. We reviewed outcomes in all patients supported with a SynCardia total artificial heart (TAH) for more than 1 year to assess its safety in long-term support. As of December 2011, all 47 patients who received the TAH from 10 centers worldwide were included in this retrospective study. Clinical data were collected on survival, infections, thromboembolic and hemorrhagic events, device failures, and antithrombotic therapy. The mean age of patients was 50 ± 1.57 years, the median support time was 554 days (range 365-1373 days). The primary diagnosis was dilated cardiomiopathy in 23 patients, ischemic in 15, and "other" in 9. After a minimum of 1 year of support, 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) is still supported. Five patients (10%) had a device failure reported. Major complications were as follows: systemic infections in 25 patients (53%), driveline infections in 13 patients (27%), thromboembolic events in 9 patients (19%), and hemorrhagic events in 7 patients (14%). SynCardia TAH has proven to be a reliable and effective device in replacing the entire heart. In patients who reached a minimum of 1 year of support, device failure rate is acceptable and only in two cases was the leading cause of death. Infections and hemorrhagic events were the major causes of death. Patients who remain supported beyond 1 year are still likely to survive to transplantation.

A mock circulatory system to assess the performance of continuous-flow left ventricular assist devices (LVADs): does axial flow unload better than centrifugal LVAD?

Hemodynamic performances comparisons between different types of left ventricular assist devices (LVADs) remain difficult in a clinical context. The aim of this study was to create an experimental model to assess and compare two types of LVAD under hemodynamic conditions that simulated physical effort and pulmonary hypertension. An experimental mock circulatory system was created to simulate the systemic and pulmonary circulations and consisted of pulsatile left and right cardiac simulators (cardiowest pump), air/water tanks to model compliances, and tubes to model the venous and arterial resistances. Two types of continuous-flow ventricular assist devices were connected to this pulsated model: an axial flow pump, Heartmate II (HTM II), and a centrifugal pump, VentrAssist (VTA). The hemodynamic conditions at rest and during exercise were replicated. Mean aortic pressures were not significantly different at rest and during effort but mean flow under maximum pump speed was higher with HTM II (13 L vs. 10 L, p = 0.02). Left atrial pressure was lower at rest and during effort for the HTM II (11 mm Hg vs. 3 mm Hg, p = 0.02 and 9 mm Hg vs. 2 mm Hg, p = 0.008) than with the VTA, but with greater risk of left-ventricle suck-down for the axial flow. Power consumption for a similar flow was lower with the VTA during rest (4.7 W vs. 6.9 W, p = 0.002) and during effort (4.3 W vs. 6.6 W, p = 0.008). In case of high pulmonary vascular resistance with preserved right ventricular function, lower right ventricular pressure was obtained with HTM II (21 mm Hg vs. 28 mm Hg, p = 0.03). Observed results are in favor of a better discharge of the left and right cavities with the HTM II compared to the VTA yet with a higher risk of left cavity collapse occurrence.

Prospective preoperative mediastinal lymph node staging by integrated positron emission tomography-computerised tomography in patients with non-small-cell lung cancer.

OBJECTIVE: Mediastinal lymph node staging determines the treatment strategy for non-small-cell lung cancer. This study aims to evaluate prospectively the accuracy of preoperative integrated 18-fluoro-2-deoxy-D-glucose positron emission tomography-computerised tomography ((18)FDG PET-CT) for mediastinal lymph node staging. METHODS: Preoperative integrated (18)FDG PET-CT was used to analyse mediastinal lymph nodes in patients with non-small-cell lung cancer. Nodal stations were identified according to the American Thoracic Society mapping system. Lymph nodes with a standardised uptake value (SUVmax) >3 were considered to be positive. The mediastinal lymph nodes were harvested during lung resection and the results of integrated (18)FDG PET-CT were compared to the mediastinal lymph node histology results. RESULTS: A total of 51 patients were enrolled in this study. The mean interval between integrated (18)FDG PET-CT and surgery was 31+/-15.8 days (range: 2-78 days). The mean mediastinal lymph node harvested and station number per patient during surgery were 11.8+/-5.6 (range: 2-27) and 3.8+/-1 (range: 2-6), respectively. The incidence of N2 pathological disease was 19.6%. The integrated (18)FDG PET-CT sensitivity and specificity were 40+/-30% and 85+/-11%, respectively. The positive and negative predictive values were 40+/-30% and 85+/-11%, respectively. False-positive results (six patients) were mainly due to inflammatory lymph nodes. False-negative results (six patients) were mainly due to infra-centimetrical, malignant lymph node invasion. CONCLUSION: The sensitivity of integrated (18)FDG PET-CT for mediastinal lymph node staging in patients selected for surgery is low. When positive mediastinal lymph nodes are detected, invasive mediastinal staging must be performed. On the other hand, the specificity is high: patients with negative integrated (18)FDG PET-CT can be operated upon without invasive mediastinal staging.

Risk factors for mortality in patients with mediastinitis after cardiac surgery.

BACKGROUND: Patients with mediastinitis after cardiac surgery have higher morbidity and mortality. AIMS: Describe the characteristics of patients with mediastinitis, determine the mortality within one month, and assess the risk factors associated with mortality. METHODS: Retrospective cohort study including all adult patients with mediastinitis during the 2002-2006 period at the Nantes University Hospital. Multivariate analysis by logistic regression and Kaplan-Meier curve of survey were done. RESULTS: Nearly 5574 patients were operated during the study period, with a mediastinitis incidence rate of 0.7%, 28 patients (72%) had coronary artery bypass graft. The mortality rate increased from de 12.8% during hospital stay to 20.5% within one year. Only two deaths were associated with mediastinitis. The occurrence of a co-infection was the only independent risk factor associated with mortality (OR 13, P<0.04). The instantaneous risk of death was increased by 7 in patient with co-infection, particularly mechanical ventilator-associated pneumonia (CR 1,97). CONCLUSION: Mortality varied according to the duration of surveillance, and mediastinitis was not the major cause of death. Mechanical ventilator-associated pneumonia after mediastinitis increases the mortality and needs specific prevention.

CardioWest (Jarvik) total artificial heart: a single-center experience with 42 patients.

BACKGROUND: When implanted in patients with biventricular failure, the CardioWest total artificial heart has asserted itself over time as a reliable bridge-to-transplant device that as yet is used by only a few international teams. The aim of this single-center retrospective study is to assess both the comorbidity and survival of patients awaiting heart transplants while receiving circulatory support with a CardioWest total artificial heart. METHODS: From 1990 to December 2006, 42 patients received a CardioWest total artificial heart at our center. Mean age at the time of implantation was 45.7 +/- 9.5 years, and 40 patients (95%) were men. Idiopathic or dilated cardiomyopathy was diagnosed in 45.2% (n = 19) of the patients and ischemic cardiomyopathy in 42.8% (n = 18). Average body surface area was 1.9 +/- 0.22 m(2). RESULTS: Duration of support was 1 to 292 days (mean, 101 +/- 86 days). Twelve patients died (28.5%) while receiving device support, and 30 patients (71.5%) underwent transplantation. Actuarial survival rates for the transplanted patients were 90% (n = 25), 81% (n = 14), and 76% (n = 10) at 1, 5, and 10 years, respectively. Causes of death during device support included multiorgan failure in 6 (50%), sepsis in 2, acute respiratory distress syndrome in 2, alveolar hemorrhage in 1, and other cause in 1. There were no device malfunctions that led to patient death. Adverse events included stroke in 3 patients (7%) and infections in 35 patients (85%) during support. CONCLUSIONS: The CardioWest total artificial heart is an excellent bridge-to-transplant device for patients with biventricular failure. Our study demonstrates excellent safety, reliability, and efficiency. Exceptional outcome after transplantation underlines its capacity to aid in end-organ recovery.

Outcome of heart transplants 15 to 20 years ago: graft survival, post-transplant morbidity, and risk factors for mortality.

OBJECTIVES: The study was conducted to determine the long-term outcome of patients who underwent heart transplantation 15 to 20 years ago, in the cyclosporine era, and identify risk factors for death. METHODS: A retrospective analysis was done of 148 patients who had undergone heart transplantation between 1985 and 1991 at a single center. Operative technique and immunosuppressive treatment were comparable in all patients. RESULTS: Actuarial survival rates were 75% (n = 111), 58% (n = 86), and 42% (n = 62) at 5, 10, and 15 years, respectively. The mean follow-up period was 12.1 +/- 5.6 years for patients who survived more than 3 months after transplantation (n = 131). The major causes of death were malignancy (35.8%) and cardiac allograft vasculopathy (24.7%). No death related to acute rejection was reported after the first month of transplantation. Graft coronary artery disease was detected on angiography in 66 (50.3%), and 7 (5.3%) had retransplantation. Malignancies developed in 131 patients (48.1%), including skin cancers in 31 (23.6%), solid tumors in 26 (19.8%), and hematologic malignancies in 14 (10.6%). Severe renal function requiring dialysis or renal transplantation developed in 27 patients (20.6%). By multivariable analysis, the only pre-transplant risk factor found to affect long-term survival was a history of cigarette use (p < 0.0004). CONCLUSIONS: Long-term survival at 15 years after cardiac transplantation remains excellent in the cyclosporine era. Controlling acute allograft rejection can be achieved but seems to carry a high rate of cancers and renal dysfunction. History of cigarette use affects significantly long-term survival in our study.

Pseudocoarctation as cause of a refractory hypertension.

Pseudocoarctation of the aorta is an abnormality of the descending portion of the aortic arch at the level of the isthmus without a real pressure gradient. We report a case of a stenotic pseudocoarctation causing severe refractory hypertension.

Surgical-site infection after cardiac surgery: incidence, microbiology, and risk factors.

OBJECTIVE: To identify risk factors associated with surgical-site infection according to the depth of infection, the cardiac procedure, and the National Nosocomial Infections Surveillance System risk index. DESIGN: Prospective survey conducted during a 12-month period. SETTING: A 48-bed cardiac surgical department in a teaching hospital. PATIENTS: Patients admitted for cardiac surgery between February 2002 and January 2003. RESULTS: Surgical-site infections were diagnosed in 3% of the patients (38 of 1,268). Of the 38 surgical-site infections, 20 were superficial incisional infections and 18 were mediastinitis for incidence rates of 1.6% and 1.4%, respectively. Cultures were positive in 28 cases and the most commonly isolated pathogen was Staphylococcus. A National Nosocomial Infections Surveillance System risk index score of 2 or greater was associated with a risk of surgical-site infection (relative risk, 2.4; P < .004). Heart transplantation, mechanical circulatory assistance, coronary artery bypass graft with the use of internal mammary artery, and reoperation for cardiac tamponade or pericard effusion were independent risk factors associated with surgical-site infection. CONCLUSIONS: Data surveillance using incidence rates stratified by cardiac procedure and type of infection is relevant to improving infection control efforts. Risk factors in patients who developed superficial infection were different from those in patients who developed mediastinitis. Coronary artery bypass graft using internal mammary artery was associated with a high risk of surgical-site infection, and independent factors such as reoperation for cardiac tamponade or pericard effusion increased the risk of infection.

A single solution for multiple organ procurement and preservation.

Two or three different solutions may be used to preserve thoracic and abdominal organs during a single procurement. The aim of this prospective, multi-center, noncomparative study was to evaluate the safety and efficacy of Celsior (study solution, solution S) as a flushing and cold storage solution for both thoracic and abdominal organs. Between August 1999 and July 2000, 72 consecutive multiple-organ procurements were performed using solution S as the sole solution for flushing out and cold-storing thoracic and abdominal grafts. Two hundred and sixty-four grafts were implanted into 245 recipients (131 kidneys, 9 kidney-pancreases, 69 livers, 34 hearts and 6 heart-lungs). The mean cold ischemia time was 21 h for kidneys (26%>24 h); 11 h 26 min for pancreases, 9 h 16 min for livers (23%>12 h), and 2 h 58 min for hearts and lungs. No cardiac failure or arrhythmia occurred on graft reperfusion. Fourteen percent of kidney recipients had delayed graft function. The mean serum creatinine level at 3 months was 123 +/- 41 micromol/l. All pancreas recipients were insulin-free at 3 months. Primary graft nonfunction occurred in one liver recipient. Complete hepatic artery thrombosis occurred in six liver recipients during the first month; four of these patients had a risk factor for thrombosis. All but three of the heart recipients were in sinus rhythm on day 1, and 65% were extubated on day 1. Inotropic drugs were necessary during the first 72 h in 25% of heart recipients. Twelve-month patient and graft survival rates were, respectively, 100% and 96% (kidney), 100% and 89% (pancreas), 88% and 83% (liver), 77.5% (heart) and 67% (heart-lung). These results suggest that Celsior, a ready-to-use solution, is safe and effective for multiple organ procurement and preservation.

Pneumothorax after left pneumonectomy: implantation of an intrapleural prosthesis.

Postpneumonectomy syndrome is defined as an airway obstruction due to mediastinal shift and rotation after pneumonectomy. A patient who had undergone a left pneumonectomy for bronchial carcinoma 13 years before presented with tension pneumothorax of her remaining lung. Although all factors relevant to the development of postpneumonectomy syndrome were ascertained, the patient had a pneumothorax rather than an airway obstruction. This pneumothorax was treated surgically. The goal of this operation was to reduce the right pleural cavity volume by implanting an intrapleural prosthesis in the pneumonectomy cavity. This treatment is identical to that used for postpneumonectomy syndrome, which allows the right lung to be rejoined with the thoracic wall.

Prospective clinical and biological comparison of three blood cardioplegia techniques in low-risk CABG patients: better is worse than good enough.

OBJECTIVE: Three myocardial protection techniques were evaluated in a prospective, randomised trial during coronary artery bypass grafts in 69 patients. MATERIAL AND METHOD: Twenty seven patients received intermittent hyperkalaemic undiluted warm blood anterograde cardioplegia (AC), 21 received continuous hyperkalaemic undiluted warm blood retrograde cardioplegia (RC) and 21 received intermittent, hyperkalaemic, diluted cold blood (15 degrees C), anterograde cardioplegia (CC). Assessment criteria were clinical, laboratory and haemodynamic. RESULTS: Groups were homogeneous in terms of age, sex, cardiovascular risk factors, severity of coronary disease, preoperative ejection fraction, and number of bypass grafts performed. The oxygen extraction coefficient, and lactate and troponin production in the coronary sinus on aortic unclamping was not significantly different between the three groups. The base excess was -0.19+/-0.13 in the RC group, -0.18+/-0.52 in the AC group and -2.67+/-0.59 in the CC group (P<0.01 CC vs. AC and CC vs. RC). The priming volume was 1485+/-64 ml (CC), 1317+/-44 ml (RC) and 1318+/-30 ml (AC) (P<0.05 CC vs. AC and CC vs. RC). The haematocrit during CPB was 28.9+/-0.9 (CC), 32.5+/-0.8 (RC) and 32+/-0.7 (AC) (P<0.05 CC vs. AC and CC vs. RC). The volume of crystalloid delivered was 735+/-85 ml (CC), 362+/-67 ml (RC) and 357+/-105 ml (AC) (P<0.05 CC vs. AC and CC vs. RC). The incidence of ventricular fibrillation on aortic unclamping was 61.9% (CC), 9.5% (RC) and 0% (AC) (P<0.01 CC vs. AC and CC vs. RC). The transfusion rate, duration of intubation, postoperative troponin level, complication rate and mortality were not significantly different between the three groups. Haemodynamic parameters at H2, H4, H8 did not vary significantly between the three groups. CONCLUSION: These three techniques appear to be comparable in terms of myocardial protection. Anterograde cardioplegia ensures an identical degree of security to retrograde cardioplegia regardless of the coronary lesions, apart from redo lesions. CC requires greater haemodilution of the patients during CPB.

Bivalvular mechanical mitral-aortic valve replacement in 254 patients: long-term results--a 22-year follow-up.

BACKGROUND: We have retrospectively studied 254 patients who underwent a bivalvular mechanical mitral-aortic replacement in the cardiovascular and thoracic surgery unit of Nantes from 1979 to 1989. The follow-up was 22 years (1979 to 2001). The last patient was operated on 12 years before the end of the follow-up. METHODS: All mitral prostheses were St. Jude Medical (SJM) bileaflet valves, and the aortic prostheses were 124 monodisc Björk-Shiley valves, 3 Sorin prostheses, and 127 St. Jude Medical bileaflet prostheses. The mean age was 56.8 +/- 8.5 years with a sex ratio equal to 1. Rheumatism as the etiology predominated with 79.5%. Ninety-seven percent of the patients were followed for a total of 2,779 patient-years and a mean of 11.7 years. RESULTS: Operative mortality was 7.08%. Freedom from overall mortality and valve-related mortality at 22 years were 45.7% +/- 3.6% and 73.1% +/- 3%, respectively. The linearized rates of thromboembolic and hemorrhagic events were 1.07% and 0.9% per patient-year, respectively. Multivariate analysis showed age (p < 0.002), sex (p < 0.01), and degenerative etiology (p = 0.04) as independent factors of late mortality, and age, sex, degenerative disease, and tricuspid pathology were related to valve-related mortality. CONCLUSIONS: This study shows good results after mechanical mitral-aortic replacement in terms of survival rate and quality of life in surviving patients, and outlines the factors influencing long-term results as compared with isolated mitral valve replacement.

Does the pretransplant UNOS status modify the short- and long-term cardiac transplant prognosis?

BACKGROUND: We compared the morbidity and mortality rates of patients who had urgent heart transplantation or transplantation after bridging with a ventricular assist device, with the rates of patients whose clinical stability allowed them to wait at home. METHODS: From March 1985 to December 2000, 404 patients underwent heart transplantation in a single center. There were 273 patients with UNOS status 2 (US 2), 103 patients with UNOS Status 1A (US 1A), and 28 patients with UNOS Status 1B (US 1B). We compared the groups retrospectively with respect to pretransplantation status and operative results. RESULTS: Despite more severely impaired hemodynamics and a significantly higher preoperative infection rate in US 1A and 1B patients, there were no statistically significant differences in survival rates among the three groups. Donor sex and age, cytomegalovirus and toxoplasmosis, mismatch rate, ischemic time, method of myocardial protection, and operative technique did not differ statistically among the three groups. Length of intensive care unit stay, postoperative morbidity, first year postoperative rejection rate, and graft occlusive vascular disease rate were statistically similar among the three groups. Although pretransplantation cancer assessment was less complete in US 1A and 1B than in US 2 patients, the late-cancer rate was not statistically different among the three groups. CONCLUSIONS: These data suggest that urgently transplanted patients have both early and long term morbidity and mortality similar to those of patients waiting for transplantation at home or with a ventricular assist device.

Surgical treatment of nonaneurysmal aortic arch lesions in patients with systemic embolization.

PURPOSE: Atherosclerotic lesions of the aortic arch are potential sources of arterial embolism. Here we investigate whether surgery, with the necessary circulatory supports, can be proposed as a good option for treatment of this problem. Study of these lesions on a national scale in France has made possible the assessment for future indications of techniques and results of the surgical management of aortic arch lesions, which retrospectively proved to be embolic. METHODS: Thirty-eight patients, (19 men and 19 women) underwent surgery between 1976 and 1996 in 17 French cardiovascular surgical centers. The average age at the time of surgery was 49 +/- 12 years (range, 31 to 82 years). Atherosclerotic lesions were detected with transesophagial echocardiography (n = 19), angiography of the aortic arch (n = 16), computed tomography (n = 9), and magnetic resonance imaging (n = 10). Surgery consisted of thrombectomy and endarterectomy (n = 22), aortic resection and graft replacement (n = 10), and patch aortoplasty (n = 5; one thrombus disappeared spontaneously before surgery was performed). RESULTS: The average postoperative period was 30 months (range, 3 to 82 months). Contact was lost with four patients after a follow-up period of 12 months. On pathologic specimens obtained at surgery, an atherosclerotic plaque was found in 73% of the cases (n = 28). In 15% of the cases, the aorta appeared normal (n = 6) and four other types of lesion were identified: angiosarcoma (n = 1), ectasia at the insertion of the remains of the ductus arteriosus (n = 1), rupture of tunica intima (n = 1), and a fibroblastic plaque (n = 1). A thrombus was identified in 26 cases, attached to the arterial wall in 18 cases. When transesophagial echocardiographic results showed mobile lesions (n = 22), histopathologic examination of specimens allowed the detection of a thrombus in 18 cases and an atherosclerotic plaque with a mobile projection in four cases. The postoperative mortality rate was 2.6%. The morbidity rate (28.9%; n = 11) was related to neurologic complications (n = 6), vascular complications (n = 4), and infection (n = 1). Four cases (12%) were reoperated. CONCLUSION: Nonaneurysmal aortic arch lesions are a frequent and still underestimated source of stroke and peripheral embolization. Surgery with circulatory support can be recommended in good operative candidates with recurrent critical events despite medical management and with high embolic potential (young patients with no calcified plaques).

Myocardial preservation using Celsior solution in cardiac transplantation: early results and 5-year follow-up of a multicenter prospective study of 70 cardiac transplantations.

BACKGROUND: Several storage methods using a wide variety of extracellular or intracellular solutions applied either as continuous perfusion, intermittent perfusion, or simple immersion of the heart have been commonly used. We have performed a prospective randomized multicenter study of 70 cardiac transplantation recipients to evaluate the Celsior solution for cardiac preservation. METHODS: Seventy consecutive patients were included in this trial and received a cardiac graft arrested and preserved with Celsior. The first follow-up period was 1 month. The mean age of the recipients was 49 years (range, 28 to 66 years), and 81.7% were male. The main disease was nonobstructive cardiomyopathy (64.3%). The age range of donors was between 14 and 56 years with a mean of 33 years. The majority of grafts (73%) were stored in 1 L of Celsior. A midterm follow-up at 5 years was performed and was 100% complete. RESULTS: The operative mortality (<30-day) rate was 6 of 70 (8.6%). Sixty-three patients (90%) had at least satisfactory hemodynamic measurements on day 2. The first postoperative echocardiograms showed good myocardial performance for 90% of the grafts. Actuarial survival rate at 5 years was 75% +/- 5.1%. CONCLUSIONS: The use of Celsior in cardiac transplantation was safe and very effective. This solution proved very valuable in at-risk patients.

Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT.

BACKGROUND: The Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare endocarditis rates in Silzone versus conventional valves. Recruitment ended January 21, 2000, because of higher rates of paravalvular leakage in patients receiving the Silzone prosthesis. The present analysis determined late event rates that might be used in the management of approximately 36,000 patients who have received the Silzone prosthesis. METHODS: A total of 807 patients in 19 centers in North America and Europe were randomized. Mean age was 61+/-11 years; 41% were women. Operations included aortic valve replacement in 59%, mitral valve replacement in 32%, and aortic and mitral valve replacements in 9%; 41% had concomitant operations (26% coronary artery bypass grafting). RESULTS: Major paravalvular leakage (followed by repair, explant, or mortality) occurred in 18 of 403 patients receiving Silzone valves and 4 of 404 patients without Silzone valves (2-year event-free rates: 91.1% versus 98.9% conventional, p < 0.003). Similarly, 2-year freedom from any explant was lower in the Silzone arm (19 versus 2 events; 90.1% versus 99.4%, p = 0.0002). Rates of mortality and stroke were similar during follow-up. CONCLUSIONS: Continued follow-up of AVERT supports the conclusion that the Silzone prosthesis has increased risk of paravalvular leakage requiring reoperation. Overall survival is similar in the two groups.