Long-term effects of primary graft dysfunction after heart transplantation.

BACKGROUND: We studied the incidence of primary graft dysfunction (PGD), its impact on in-hospital and follow-up outcomes and searched for independent risk factors. METHODS: During an 18-year period, 508 individuals underwent heart transplantation at our institution. Patients were diagnosed with none, mild, moderate or severe PGD according to ISHLT criteria. RESULTS: Thirty-eight patients (7.5%) met the ISHLT criteria for mild PGD, 92 (18.1%) for moderate PGD and 23 (4.5%) for severe PGD. Patients were classified into none/mild PGD (77.4%) and moderate/severe PGD (22.6%) groups. In-hospital mortality was 12.4% (7.8% for none/mild PGD and 28.7% for moderate/severe PGD; p < .001). Survival at 1, 5, and 15 years was 85.5 ± 1.9% versus 67.2 ± 4.5%, 80 ± 2.2% versus 63.5 ± 4.7%, and 60.4 ± 3.6% versus 45.9 ± 8.4%, respectively (p < .001). Excluding the events occurring during the first month of follow-up, survival was comparable between the two groups (93.1 ± 1.4% vs. 94.7 ± 2.6 at 1 year and 65.6 ± 3.8% vs. 70.4 ± 10.4% at 15 years, respectively; p = .88). Upon multivariate logistic regression analysis preoperative mechanical circulatory support (odds ratio [OR] = 5.86) and preoperative intra-aortic balloon pump (IABP) (OR = 9.58) were independently associated with moderate/severe PGD. CONCLUSIONS: Our results confirm that PGD is associated with poor in-hospital outcome. The poor outcome does not extend beyond the first month of follow-up, with comparable survival between patients with none/mild PGD and moderate/severe PGD in the short and long-term. Mechanical circulatory support and preoperative IABP were found to be independent risk factors for moderate/severe PGD.

Organ Care System Heart™ in donors requiring high-risk excision of suspected neoplastic lesions.

Although Heart Transplant is still the gold standard treatment for end-stage heart failure patients, the limitation of this procedure is the discrepancy between the amount of waiting list patients and donors. Organ Care Systems, preventing the detrimental effects of cold ischemia, potentially increase donor pool. Herein we report three cases where high-risk excisions were required to clarify the nature of suspected lesions in donors. We decided to retrieve the organs and to place them in the devices before performing the excision. Our experience confirm the possibility to utilise this device as a time buffer in these peculiar scenarios.

Percutaneous RVAD with the Protek Duo for severe right ventricular primary graft dysfunction after heart transplant.

Right ventricular primary graft dysfunction after heart transplant is a serious life-threatening condition. The severe form, refractory to maximal medical therapy, has traditionally required temporary mechanical support through veno-arterial extracorporeal membrane oxygenation or central right ventricular support. The Protek Duo is a dual lumen cannula recently introduced in the market, which allows for the institution of a percutaneous right ventricular support. We present the first promising case series of the use of this novel support in patients with right ventricular primary graft dysfunction after heart transplant.

Veno-arterial extracorporeal membrane oxygenation using Levitronix centrifugal pump as bridge to decision for refractory cardiogenic shock.

OBJECTIVES: Cardiogenic shock still carries a very high mortality. We adopted veno-arterial extracorporeal membrane oxygenation using the Levitronix centrifugal pump (Levitronix LLC, Waltham, Massachusetts) as a first-line treatment of cardiogenic shock in a "bridge to decision" strategy. This article provides our experience of this clinical approach. METHODS: Since 1988, 160 ventricular assist devices have been implanted at our hospital for heart failure. Since 2005, 15 consecutive patients have been treated with veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock. Veno-arterial extracorporeal membrane oxygenation has been implanted either centrally or peripherally. RESULTS: Mean age was 44.7 ± 20.0 years (2-78 years). There were 5 women. Veno-arterial extracorporeal membrane oxygenation was implanted peripherally in 8 cases (53.4%) and centrally in the remaining 7 (46.6%). Mean veno-arterial extracorporeal membrane oxygenation duration was 11.5 ± 8.1 days (range, 1-30). No patient experienced any neurologic event or vascular complication at the cannulation site. Twelve patients (80%) were weaned from veno-arterial extracorporeal membrane oxygenation or bridged to either a long-term left ventricular assist device or heart transplantation. Three patients died during veno-arterial extracorporeal membrane oxygenation support secondary to multi-organ failure. Seven patients (46.6%) were discharged from the hospital, with a 100% survival at follow-up. The survivors include 2 patients affected by fulminant myocarditis, who were bridged to recovery, and 5 patients who were bridged to heart transplantation. Survivors were younger than nonsurvivors (mean age, 28.5 vs 58.8 years, respectively). CONCLUSIONS: In our experience, the use of veno-arterial extracorporeal membrane oxygenation as bridge to decision has been effective to promptly restore adequate systemic perfusion, allowing further time to evaluate myocardial recovery or candidacy for ventricular assist device or heart transplantation. Younger patients, with no or mild end-organ injury, had the best outcomes. Peripheral cannulation decreases the surgical trauma and makes emergency implantation possible, even in the intensive care unit.

Destruction of the tricuspid septal leaflet: correction by bicuspidization.

We describe a surgical technique to repair severe tricuspid valve regurgitation secondary to loss of the septal leaflet. Tricuspid valve competency is obtained by means of mobilization of the anterior and posterior leaflets.

Prevention of limb ischemia and edema during peripheral venoarterial extracorporeal membrane oxygenation in adults.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a mechanical circulatory support indicated for the advanced treatment of refractory heart failure. The cannulation of the femoral vessels may be complicated by distal limb ischemia by arterial hypoperfusion and severe edema by venous obstruction. We describe a modified cannulation technique in order to prevent ischemia and edema of the inferior limb during VA-ECMO.

Noncardiac surgical procedures in patient supported with long-term implantable left ventricular assist device.

BACKGROUND: Left ventricular assist devices (LVADs) are increasingly used as bridges to transplantation or as destination therapy. As sicker and older patients are more frequently considered for mechanical support, general surgical problems are expected to increase in these patients. METHODS: Anesthesia records and clinical charts were reviewed for 11 recipients of LVADs undergoing 12 general surgical procedures between January 1988 and March 2007. RESULTS: Eight patients underwent major surgical procedures: 1 intracranial hematoma drainage, 1 right hemicolectomy with ileocolostomy, 1 splenectomy, 1 surgical repair of an iliac-femoral artery pseudoaneurysm, 2 cholecystectomies, 1 pyelolithotomy, and 1 coil embolization of a femoral side-branch disruption. Four patients underwent minor surgical procedures. The mean duration of LVAD support before surgery was 58.7 +/- 45.6 days. All patients survived the procedures. CONCLUSION: Noncardiac surgery in LVAD recipients is feasible, without significant morbidity or mortality. Intraoperative coagulation management has a key role in safely performing these procedures.

Is aortic wall degeneration related to bicuspid aortic valve anatomy in patients with valvular disease?

OBJECTIVE: Patients with bicuspid aortic valve are at increased risk for aortic complications. METHODS: A total of 115 consecutive patients with bicuspid aortic valve disease underwent surgery of the ascending aorta. We classified the cusp configuration by 3 types: fusion of left coronary and right coronary cusps (type A), fusion of right coronary and noncoronary cusps (type B), and fusion of left coronary and noncoronary cusps (type C). Histopathologic changes in the ascending aortic wall were graded (aortic wall score). RESULTS: We observed type A fusion in 85 patients (73.9%), type B fusion in 28 patients (24.3%), and type C fusion in 2 patients (1.8%). Patients with type A fusion were younger at operation than patients with type B fusion (51.3 +/- 15.5 years vs 58.7 +/- 7.6 years, respectively; P = .034). The mean ascending aorta diameter was 48.9 +/- 5.0 mm and 48.7 +/- 5.7 mm in type A and type B fusion groups, respectively (P = .34). The mean aortic root diameter was significantly larger in type A fusion (4.9 +/- 6.7 mm vs 32.7 +/- 2.8 mm; P < .0001). The aortic wall score was significantly higher in type A fusion than in type B fusion (P = .02). The prevalence of aortic wall histopathologic changes was significantly higher in type A fusion. Moreover, there were no statistically significant differences between type A and type B fusion in terms of prevalence of bicuspid aortic valve stenosis, regurgitation, or mixed disease. CONCLUSION: In diseased bicuspid aortic valves, there was a statistically significant association between type A valve anatomy and a more severe degree of wall degeneration in the ascending aorta and dilatation of the aortic root at younger age compared with type B valve anatomy.

Clinical outcome and bridge to transplant rate of left ventricular assist device recipient patients: comparison between continuous-flow and pulsatile-flow devices.

BACKGROUND: Long-term implantable continuous axial-flow pumps are increasingly used in bridging heart failure patients to heart transplant. Compared to pulsatile left ventricular assist devices (LVADs), they offer smaller dimensions, less surgical trauma and less thromboembolisms. However concerns still remain about the long-term effects of continuous-flow on patients' outcome. The aim of this study was to review our mechanical bridge to transplant experience to compare pre- and post-transplant outcomes between pulsatile and continuous-flow LVAD recipients. METHODS: Thirty-six patients with a continuous-flow device (Micromed DeBakey, Houston, TX or InCor Berlin Heart, Berlin, Germany--group A) were compared with 41 patients supported with a pulsatile device (Novacor, WorldHeart, Oakland, CA--group B). RESULTS: Mean age (48.6+/-12.4 vs 47.2+/-12.5) and LVAD duration (119.3+/-115.4 vs 128.3+/-198.3) were similar in the two groups. Group A recipients were smaller compared to group B (mean body surface area=1.77+/-0.18 vs 1.93+/-0.16; p<0.001). Idiopathic dilated cardiomyopathy was not significantly greater between the two groups (78% vs 58.3%; p=0.085). Successful bridging to transplantation was similar in group A compared to group B (52.8% vs 63.4%; p=non significant). On-VAD mortality was similar between the two groups (A vs B=33.3% vs 36.6%; p=non significant). Thirty-day mortality after HTx in group A was 10.5% compared to 7.7% in group B (p=non significant). First year post-transplant incidence of treated rejections (36.8% vs 46%; p=non significant) as the mean number of rejection/patient (0.38+/-0.5 vs 0.53+/-0.83; p=non significant) were similar in group A compared to group B. CONCLUSIONS: In our experience, when compared to pulsatile LVAD, continuous-flow pumps are similarly effective in transplant rate and post-transplant outcome.

Influence of inflow cannula length in axial-flow pumps on neurologic adverse event rate: results from a multi-center analysis.

BACKGROUND: The application of axial-flow pumps in patients with end-stage heart failure reveals a significantly reduced infectious complication rate as compared with rates observed with pulsatile devices. The remaining adverse event rate relates mainly to thromboembolic complications with neurologic consequences. We investigated the dependence of the neurologic adverse event rate on the length of the inflow cannula. METHODS: A total of 216 consecutive patients with an axial-flow pump (INCOR; Berlin Heart GmbH, Berlin, Germany) were included in a retrospective multi-center analysis. In 138 patients, a short inflow cannula (24-mm tip length into the left ventricle), and in 78 patients a long inflow cannula (tip length 34 mm) was applied. RESULTS: Patients with a long inflow cannula (LC) demonstrated a better survival rate than those with a short inflow cannula (SC) at the end of the observation period (LC, 63.4%; SC, 52.9%; p = 0.05). The thromboembolic adverse event rate was also significantly lower. Only 3 of the 78 patients (3.8%) with an LC had a thromboembolic adverse event (thromboembolic events per patient-year = 0.11) as compared with 32 (23.2%) of SC patients (thromboembolic events per patient-year = 0.50, p < 0.001). CONCLUSIONS: Patients with a long inflow cannula had a better survival rate and a lower incidence of cerebrovascular adverse events than patients with a short inflow cannula.

Mechanical circulatory support for cardiogenic shock complicating acute myocardial infarction: an experimental and clinical review.

Cardiogenic shock (CS) occurs in 7% to 10% of cases after acute myocardial infarction and remains the most common cause of death in these patients. Despite aggressive treatment regimens such as fibrinolysis and percutaneous transluminal coronary angioplasty, mortality rates from CS remain extremely high. It has been shown that intra-aortic balloon pumping can result in initial hemodynamic stabilization. However, in the majority of studies, death was merely delayed. In recent years, efforts have been made to develop ventricular devices (LVAD) capable of providing complete short-term hemodynamic support. Seventeen major studies of LVAD support for CS complicating acute myocardial infarction are reported in the literature, with a mean weaning and survival rate of 58.5% and 40%, respectively. Patients considered in these studies are difficult to compare in terms of demographic and anatomic data, but taking these considerations into account, LVAD support seems to give no survival improvement in these patients compared with early reperfusion alone or associated with intra-aortic balloon pumping. Data emerging from experimental studies of acute myocardial infarction supported with LVAD are intriguing. In this review, we report the LVAD experience in the CS setting, starting from percutaneous extracorporeal support up to bridge therapy with implantable devices.

Left ventricular mechanical support with the Impella Recover left direct microaxial blood pump: a single-center experience.

The Impella Recover left direct (LD) is a new intravascular microaxial blood pump, intended as a short-term mechanical support especially in case of acutely reduced left ventricular function. From September 2002 to October 2004, Impella was used to support 12 patients: six patients were supported as bridge-to-heart transplant (HTx); three patients were treated for fulminant acute myocarditis, and three patients for postcardiotomy low-output syndrome. Mean support time was 8.8 +/- 2.3 days. Overall mortality was 50%. Four patients were successfully HTxed; two patients supported as bridge-to-HTx died on left ventricular assist device. Two patients with myocarditis died of septic shock; two patients in the group of postcardiotomy died of multiorgan failure. The latter two patients were slowly weaned from the device, and at 3-months follow-up showed good improvement of the left ventricular function. Our initial experience with Impella Recover LD as mechanical support for patients in cardiogenic shock of various etiology is promising, yielding a good survival in a population of particularly compromised patients.

Bridge to transplantation with the MicroMed DeBakey ventricular assist device axial pump: a single centre report.

OBJECTIVE: Left ventricular assist devices (VADs) are an accepted therapy to bridge patients with end-stage heart failure to heart transplantation. The DeBakey VAD, a continuous axial flow pump weighing 93 g, has been introduced into clinical practice as a bridge to transplant. METHODS: Starting from April 2000,17 patients (12 males, five females, mean age 44.3 +/- 12.8 years; 11 dilated idiopathic cardiomyopathy, five ischaemic cardiomyopathy, one pulsatile device failure) with end-stage heart failure were implanted with a DeBakey VAD as a bridge to transplantation at our institution. Before implant, all patients suffered from severe heart failure (New York Heart Association functional class IV) despite optimal medical therapy and were put on the waiting list for heart transplantation. Mean cardiac index was 1.59 +/- 0.51 l/min/m2. RESULTS: Fourteen patients were successfully transplanted after 99 +/- 117 days of assistance (range 11-443 days). Two patients died during assistance of multiorgan failure, one patient is still on VAD. No patient needed additional right ventricular mechanical support. Left ventricular/left VAD thrombosis occurred in one patient who was successfully treated conservatively. No clinical elevation of plasma free haemoglobin was detected. Neither device, driveline, abdominal pocket infection nor device failure occurred. CONCLUSIONS: In our experience with the continuous axial flow DeBakey VAD, a high success rate was obtained associated with a low risk of complications. All the patients tolerated continuous blood flow for extended periods that makes this device a valuable alternative to pulsatile VADs as a bridge to transplantation.

[Mechanical assist devices in advanced heart failure. Indications and perspectives]. / Assistenza ventricolare meccanica nell'insufficienza cardiaca avanzata. Indicazioni e prospettive.

Congestive heart failure is recognized as a major public health issue and is the leading cause of death in western countries. Heart transplantation currently remains the gold standard option for end-stage heart failure patients. Heart transplantation is also one of the most limited therapies, not only with regard to the lack of donor hearts but also because of the surgical limitations inherent to the clinical aspects of this severely ill patient population. Mechanical circulatory support systems have been developed as effective adjuvant therapeutic options in these terminally ill patients. Over the past two decades, mechanical circulatory support devices have steadily evolved in the clinical management of end-stage heart failure, and have emerged as a standard of care for the treatment of acute and chronic heart failure refractory to conventional medical therapy. Future blood pumps should be smaller and totally implantable, as well as more efficient, biocompatible, and reliable.

Surgical ablation of arrhythmias.

The surgical approach was the earliest therapeutic ablation of hyperkinetic arrhythmias. Following the progressive improvements in electrophysiological mapping and operative techniques, new surgical approaches have been developed for the treatment of those arrhythmias related to ectopic phenomena or reentry mechanisms. These procedures have been proven to be highly effective but the associated morbidity and mortality were unacceptably high. More recent and advanced techniques of transcatheter ablation have revolutionized the treatment of these arrhythmias and now represent the treatment of choice in the majority of cases. However, the significant reduction in the operative risk and the improvement in patient outcome with respect to the past, thanks to a better patient selection and to advances in the surgical and myocardial protection techniques, make do that the surgical approach to some forms of arrhythmias is still valid, especially in those cases requiring associated surgery: atrial tachyarrhythmias in patients with congenital heart disease, post-ischemic ventricular tachycardias in patients who necessitate myocardial revascularization, and/or ventricular remodeling and chronic or paroxysmal atrial fibrillation in patients who require cardiac surgery. New techniques such as radiofrequency, microwaves and cryoablation guarantee the creation of linear and transmural lesions with minimum damage to the cardiac structures and appear very interesting as they are surgically simple and associated with shorter procedure times and less complications. The possibility of performing the ablative procedure completely on the epicardial surface may open the way for atrial fibrillation surgery on a totally beating heart and for procedures that are ever less invasive thus enabling treatment of patients without associated surgical indications.

Different applications for left ventricular mechanical support with the Impella Recover 100 microaxial blood pump.

The "Impella Recover 100" (IR100) is a new intravascular microaxial blood pump for use as short-term mechanical support for cases of acutely reduced left ventricular function. From September 2002 to April 2003, we used the IR100 to support 5 patients: 2 patients were bridged to heart transplant; 2 were being treated for fulminant acute myocarditis; and 1 for post-cardiotomy low-output syndrome. Only 1 patient with myocarditis died of septic shock, 2 had successful heart transplants; and the latter 2 were slowly weaned from the device and, at 3-month follow-up, showed moderate improvement of left ventricular (LV) function. Our initial experience with the IR100 as mechanical support for patients in cardiogenic shock of varying etiology has been positive, yielding good survival in a population of particularly compromised patients.

Different clinical scenarios for circulatory mechanical support in acute and chronic heart failure.

Chronic heart failure (HF) is a leading cause of death in developed countries. Over the last 2 decades, mechanical circulatory support (MCS) devices have steadily evolved in the clinical management of end-stage HF and have emerged as a standard of care for the treatment of acute and chronic HF refractory to conventional medical therapy. Possible indications for using MCS are acute cardiogenic shock, as a bridge to transplantation, as a bridge to recovery, and more recently, as destination therapy in dilated cardiomyopathy, of either ischemic or idiopathic etiology. We reviewed the different clinical scenarios in which we think there are currently indications to implant different kinds of MCS systems.

First successful bridge to recovery with the Impella Recover 100 left ventricular assist device for fulminant acute myocarditis.

A patient with septic and cardiogenic shock secondary to acute fulminant myocarditis was successfully treated by mechanical offloading of the left ventricle using the Impella Recover 100, a new implantable micro-axial blood pump designed for short-term circulatory support (for a maximum of 7 days). The possibility of implanting this device without using cardiopulmonary bypass allowed as to manage the septic shock, to reverse cardiac and hepatorenal failure and to wean the patient off treatment after 18 days of support. At 3 months the left and right ventricular function was satisfactory. The widespread application of this kind of support depends on the availability of an inexpensive "mini-invasive" blood pump, appropriate weaning protocols and emerging strategies to promote sustainable myocardial recovery.