Development of ventricular assist devices in China: present status, opportunities and challenges.

The growing number of heart failure patients and the scarcity of organ donors account for the huge need for the development of mechanical circulatory systems, including ventricular assist devices (VADs) and artificial hearts, in China. Several research programmes on blood pumps have been under way for the last three decades. However, unlike in other countries, the development of VADs has been extremely slow, and no system is currently approved and available for clinical application. There are many reasons for this situation. This article provides an overview of the present development of experimental and clinical research on VADs in China. In addition, the challenges for the clinical development of mechanical circulatory support in China are discussed.

Colder is better during hypothermic circulatory arrest for acute type A aortic dissection.

OBJECTIVES: To evaluate the influence, on early postoperative outcomes, of temperature during hypothermic circulatory arrest in emergent surgery for acute type A aortic dissection. DESIGN: Hypothermic circulatory arrest (HCA) with antegrade cerebral perfusion was performed in 63 patients who underwent emergent surgery for acute type A aortic dissection between 2000 and 2009. Patients were retrospectively separated in two groups: ( 1 ) deep HCA, lowest nasopharyngeal temperature < 17 °C (n = 29; 46%) and ( 2 ) moderate HCA, lowest nasopharyngeal temperature ≥ 17 °C (n = 34; 54%). RESULTS: Hospital mortality reached 27%. The nasopharyngeal temperature did not influence postoperative mortality or neurological outcome. Patients with deep HCA had significantly lower rate of infection (33% vs. 69%; p = 0.009) and shorter median intensive care unit length of stay (4 days ( 17 ) vs. 15.5 days ( 26 ) p = 0.017). Multiple regression analysis revealed that the lowest nasopharyngeal temperature was the only significant variable associated with intensive care unit length of stay (p = 0.005). CONCLUSIONS: Patients suffering from acute type A aortic dissection might benefit from colder hypothermia during circulatory arrest.

[Evaluation of new implantable medical devices]. / L'évaluation des nouveaux dispositifs médicaux implantables.

Complex administrative procedures have gradually been established for the evaluation of implantable medical devices, resulting in improved patient safety. These procedures include in vitro testing, animal experimentation, clinical premarketing studies, and post-market surveillance. Further improvements are needed, however, including more independent experts and clinical studies, while ensuring that the approval process is neither to slow nor too hasty.

Risk factors for hospital death after surgery for type A aortic dissection.

This study was undertaken to identify perioperative risk factors for hospital death in patients undergoing surgery for acute type A aortic dissection. Between 2000 and 2009, 101 consecutive patients underwent emergency surgery for acute type A aortic dissection. Four patients died before institution of cardiopulmonary bypass or completion of the procedure. In the remaining 97 (68 men; mean age, 63.4±16.7 years), proximal repair was performed using ascending aortic replacement with valve re-suspension in 52 (53.6%) and composite valve graft replacement in 44 (45.4%). Distal repair required hemi- or total arch replacement in 42 (43.3%) patients. Overall hospital mortality reached 25.8% (25/97 patients). Logistic regression analysis revealed that advanced age, location of an intimal tear in the arch or more distally, and preoperative coronary malperfusion were significant independent risk factors for hospital death. No procedure-related variables were significant risk factors. Current hospital mortality in patients undergoing emergency surgery for acute type A aortic dissection remains high, but seems to be mainly determined by preoperative variables. More aggressive proximal or distal repairs were not associated with increased mortality.

Importance of monocyte deactivation in determining early outcome after ventricular assist device implantation.

BACKGROUND: Patients undergoing mechanical circulatory support using ventricular assist devices (VADs) experience a postoperative mixed antagonistic (proinflammatory and antiinflammatory) response syndrome. This response can result in immunoparalysis, exposing VAD recipients to infection and interfering with patient recovery despite adequate hemodynamic support. We undertook the present study to evaluate whether postoperative monocytic human leukocyte antigen-DR (mHLA-DR) expression is of prognostic value for mortality or infection of VAD recipients during their initial intensive care unit (ICU) stay after implantation. METHODS: Since 2004, we have monitored postoperative mHLA-DR expression in 50 VAD recipients using flow cytometry. RESULTS: Thirty-seven patients (74%) developed infection, and 22 patients (44%) died during their initial ICU stay. mHLA-DR expression was lowest in the immediate postoperative period (postoperative days [PODs] 1-3) but increased progressively thereafter. Multiple regression analysis showed that preoperative aspartate aminotransferase level was the only significant and independent predictor of the percentage of HLA-DR-positive monocytes on PODs 1-3 (ß = -0.726, p = 0.0001). ICU death and infection were associated with significantly lower percentages of HLA-DR-positive monocytes on PODs 1-3. ROC curve analysis revealed that the percentage of HLA-DR-positive monocytes on PODs 1-3 had significant discriminative power for ICU death (area under the curve = 0.73, 95% confidence interval, 0.545-0.912, p = 0.037), but not for infection. CONCLUSIONS: Postoperative mHLA-DR expression was closely related to preoperative hepatic cytolysis. It appeared to be the only early postoperative biological parameter that had some predictive power for death of VAD recipients in the ICU.

[Basic surgical training in 2010]. / Reflexions sur la formation initiale du chirurgien en 2010: l'acquisition des fondamentaux.

Initial surgical training must take into account the major changes that have taken place in recent years. Training in surgical technique, clinical expertise, communication skills, clinical and experimental surgical research, team work and risk management is required to maintain the leadership position of future surgeons.

Integrated management of cardiac failure: the cardiac failure clinic.

The prevalence of the risk factors and the risk of cardiac failure are both increasing in China. This might be the consequence of the changes of the life conditions (emigration to the urban areas, changes in the diet and life style, lack of physical exercise, etc.). The wide range of clinical presentations of cardiac failure (acute or chronic) and of therapeutic approaches (medical or surgical) makes necessary the integration within the same structure of the various experts involved in the diagnosis and the treatment of cardiac diseases. Technologic and human resources required to offer all the options represent a multifaceted commitment which should be focused optimally in dedicated centers. In these centers, collaboration should replace competition between the medical and the surgical cardiac specialists. Development of team work should permit to optimize the cost efficacy of the treatments. Most of all, such a structure will facilitate the translation of innovative therapies between the research centers and clinical facilities.

[Cardiac surgery in China in 2010]. / La chirurgie cardiaque en Chine en 2010.

In China, cardiac surgery has been developing fast over the past 30 years, but it still cannot meet the huge demand created by the high prevalence of risk factors for cardiovascular disease, such as hypertension, diabetes and smoking, and the high frequency of congenital cardiopathies. In China, cardiac surgery is available in about 600 centers, but fewer than 10 centers account for the bulk of operations. Most of these high-volume centers are located in well-developed eastern cities, but cardiac surgery is growing at an extremely rapid pace in the western provinces too. Private structures are appearing alongside public and military hospitals. Huge efforts are being made to train medical staff and to develop basic and clinical research. The Chinese biomedical industry is also developing rapidly, providing local alternatives to imported products. Large university centers in major eastern cities are assisting the development of less experienced centers. The high cost of cardiac surgery remains an obstacle, but the improving economic situation and the expansion of insurance coverage is rapidly improving patient access to these treatments.

Single-centre experience with the Thoratec paracorporeal ventricular assist device for patients with primary cardiac failure.

BACKGROUND: Temporary mechanical circulatory support may be indicated in some patients with cardiac failure refractory to conventional therapy, as a bridge to myocardial recovery or transplantation. AIMS: To evaluate outcomes in cardiogenic shock patients managed by the primary use of a paracorporeal ventricular assist device (p-VAD). METHODS: We did a retrospective analysis of demographics, clinical characteristics and survival of patients assisted with a Thoratec p-VAD. RESULTS: p-VADs were used in 84 patients with cardiogenic shock secondary to acute myocardial infarction (35%), idiopathic (31%) or ischaemic (12%) cardiomyopathy, myocarditis or other causes (23%). Before implantation, 23% had cardiac arrest, 38% were on a ventilator and 31% were on an intra-aortic balloon pump. Cardiac index was 1.6+/-0.5 L/min/m(2) and total bilirubin levels were 39+/-59 micromol/L. During support, 29 patients (35%) died in the intensive care unit and seven (10%) died after leaving. Forty-seven patients (56%) were weaned or transplanted, with one still under support. Despite significantly more advanced preoperative end-organ dysfunction, survival rates were similar in patients with biventricular devices (74%) and those undergoing isolated left ventricular support (24%) (63% versus 45%, respectively; p=0.2). Actuarial survival estimates after transplantation were 78.7+/-6.3%, 73.4+/-6.9% and 62.6+/-8.3% at 1, 3 and 5 years, respectively. CONCLUSIONS: Our experience validates the use of p-VAD as a primary device to support patients with cardiogenic shock. In contrast to short-term devices, p-VADs provide immediate ventricular unloading and pulsatile perfusion in a single procedure. Biventricular support should be used liberally in patients with end-organ dysfunction.

Temporary right ventricular support with Impella Recover RD axial flow pump.

Post-cardiotomy right ventricular failure is a serious complication that frequently results in adverse outcomes. We reviewed our experience with the Impella Recover RD (Impella Cardiosystems GMbH, Aachen, Germany). From January 2007 to December 2007, 7 patients (5 males, 54 +7 years old) had this device implanted for temporary support after heart transplantation in 4, after repeat mitral valve replacement in 2, and with a left ventricular assist device in 1. Devices were implanted during initial operation (n =5) or shortly thereafter (n =2). Six patients underwent implantation without cardiopulmonary bypass. Effective support with pump flows of 4.0-4.5 L x min(-1) and adequate unloading (central venous pressure decreased from 15.3 +/- 1.4 to 9.4 +/- 1.2 mm Hg) was achieved in all patients. Patients were assisted for a mean duration of 4.9 +/- 4.5 days. Three patients could be weaned after 7.0 +/- 5.6 days of support and underwent device explantation without cardiopulmonary bypass. One of these patients died of recurrent right ventricular failure, 2 remained stable but died later of sepsis. The patient with a left ventricular assist device was switched to an alternative device for prolonged support. Two patients experienced pump dysfunction. Our preliminary experience shows that the Impella Recover RD is an effective device that can be easily implanted and explanted. However, its mechanical reliability needs to be improved.

Long-term results of combined heart and kidney transplantation: a French multicenter study.

BACKGROUND: Outcomes in recipients who have undergone combined heart and kidney transplantation have mainly been addressed in small, single-center studies. We studied long-term results of combined heart and kidney transplantation in a large multicenter cohort. METHODS: Between 1984 and 2007, 67 consecutive patients (61 men and 6 women) from 3 French centers underwent combined heart and kidney transplantation. At transplantation, 38 (57%) were receiving dialysis. All patients received immediate triple immunosuppression therapy (anti-calcineurin, steroids, azathioprine, or mycophenolate). RESULTS: Overall actuarial survival rates were 62.0%, 60.3%, 53.3%, and 46.5% at 1, 3, 5, and 10 years, respectively. These rates were similar to those observed in 2981 isolated heart recipients at the 3 participating centers during the same period (respectively, 71.0%, 65.2%, 60.1%, and 47.2%, p = 0.6). Survival tended to improve during the last decade (1996 to 2007) and reached 71.1%, 67.5%, and 60% at 1, 3, and 5 years. Cardiac allograft rejection requiring treatment occurred in 12 (17.9%). Coronary artery vasculopathy developed in 3 (9.3%). Kidney allograft rejection occurred in 9 (13.4%). Kidney graft survival was 95.9% at 1, 3, 5, and 10 years. CONCLUSIONS: Long-term survival rates in a large cohort of combined heart and kidney recipients are similar to those of isolated heart recipients in France. The rates of acute heart and kidney rejection and angiographic coronary artery vasculopathy were low in this patient population.