Ventricular Assist Device Destination Therapy Research Articles

The Brink of the Ab The Brink of the Abyss: From Transcatheter A anscatheter Aortic Valve Implantation, to Impella, to Left Ventricular Assist Device Destination Therapy

Acute valvular emergencies are common causes of cardiogenic shock. Patients with critical aortic pathologies causing shock frequently undergo percutaneous interventions for valve replacement. However, in cases of persistent cardiogenic shock after valve replacement, there are limited options for further mechanical support. In this case study, we report a patient with a prior history of aortic valve replacement who presented in cardiogenic shock. After a transcatheter aortic valve-in-valve replacement, he remained in persistent shock with worsening clinical parameters requiring escalating inotropic and vasopressor support. With input from a multidisciplinary care team, an Impella 5.5 (Abiomed, Inc.) was placed through the valve for mechanical circulatory support, ultimately serving as a bridge to a durable left ventricular assist device as destination therapy. This technically challenging approach was successful, and the patient was discharged to acute rehabilitation with improved symptoms.

Heart failure in Poland: Left ventricular assist device destination therapy and other challenges of interventional cardiology and cardiac surgery.

Patients with severe heart failure (HF), who are not eligible for cardiac transplantation and receive optimal medical management, based mainly on the use of pharmacological treatment and devices such as resynchronization therapy (implantable cardioverter-defibrillator), achieve poor clinical outcomes and constitute a group with extremely poor prognosis. Currently, the technology used in the latest generation left ventricular assist devices (LVADs), such as the HeartMate 3, makes it possible to achieve patient survival at the level obtained by patients after heart transplantation, and they can be used not only in patients eligible for heart transplantation as a bridge to transplant, but also in those with significantly worse prognosis, who are ineligible for heart transplantation as destination therapy. The objective of this publication is to present recommendations from experts in cardiology and cardiac surgery, supported by clinical trial results, on the use of LVADs as a destination therapy in HF patients who are not eligible for cardiac transplantation. The paper also presents the issue of cardiac transplantation and extracorporeal membrane oxygenation therapy in Poland, as well as current challenges faced by interventional cardiology and cardiac surgery in Poland.

Abstract 17262: Outcomes following High Risk Surgery provided as an Alternative to Transplant in patients with End-stage Heart Disease

Background: Heart transplant (Tx) and ventricular assist device (VAD) have become established treatments for end stage heart failure; however, both treatments still have unsolved problems. Patients referred for Tx or VAD are often found to have cardiac lesions amenable to surgical intervention. We examined the results of conventional surgery in patients with severe left ventricular dysfunction to explore the possibility of high risk surgery as an alternative option. Methods: We reviewed our institutional database and identified all surgical patients referred to our senior author with severe LV dysfunction (EF<20%). We then selected patients who were initially referred for consideration of Tx or VAD, but were instead offered conventional surgery. All patients underwent evaluation for Tx candidacy and thus were prospectively stratified into Tx eligible (Tx-E) or Tx non-eligible (Tx-NE) groups. We compared outcomes stratified by Tx eligibility as well as by type of surgery. Results: A total of 133 patients were enrolled. 68 patients were Tx-E, and 65 were Tx-NE. Tx-E patients were younger than Tx-NE (57±8 vs 70±8 year-old, p<0.01). Isolated CABG was performed in 77 patients, while 56 had other procedures. In-hospital mortality was 8.8% in Tx-E, and 15.4% in Tx-NE (p=0.29). Kaplan-Meier analysis demonstrated that survival in Tx-E was comparable to ISHLT Tx data, while survival in Tx-NE was comparable to INTERMACS DT data (Figure1). When stratified by type of surgery, in-hospital mortality was lower for isolated CABG (6.5% vs 19.6%, p=0.03). Isolated CABG seemed to have comparable survival to ISHLT Tx and INTERMACS DT by Kaplan-Meier analysis (Figure2). Conclusion: The mortality and morbidity in patients undergoing alternative surgeries appears to be similar to the contemporary results of Tx and VAD destination therapy. Particularly if the pathology of heart failure is graftable coronary artery disease, isolated CABG may be a good option for highly selected patients.

OUTCOMES FOLLOWING HIGH RISK SURGERY PROVIDED AS AN ALTERNATIVE TO TRANSPLANT IN PATIENTS WITH END-STAGE HEART DISEASE

minutes, p1⁄40.39) prior to IR. Coronary blood flow (6.41⁄4910 21, 6.91⁄4871 31, 7.41⁄4868 34 mL/min, p1⁄40.60) and coronary sinus lactate concentration (6.41⁄41.6 0.5, 6.91⁄41.3 0.1, 7.41⁄41.9 0.1 umol/L, p1⁄40.25) were comparable among treatment groups during IR. The pH of the cardioplegic solution delivered during the 3-minute IR period significantly impacted the development of myocardial edema (6.41⁄415.2 2.9, 6.91⁄48.5 1.2, 7.41⁄410.1 0.9 grams/hour weight gain, p1⁄40.03) and the recovery of indexed cardiac output (6.41⁄43.1 0.8, 6.91⁄48.4 1.8, 7.41⁄46.1 0.9 mL/minute/gram, p1⁄40.04) during subsequent EVHP. CONCLUSION: IR of DCD hearts with a profoundly acidic (pH1⁄46.4) cardioplegic solution is associated with the development of myocardial edema and impaired functional recovery during EVHP, while IR under moderately acidic (pH1⁄46.9) conditions appears to be protective.

Cost of 1-year left ventricular assist device destination therapy in chronic heart failure: a comparison with heart transplantation

Objective:To analyse overall cost involved with destination therapy (DT) in comparison to transplantation (HTX) and bridging to transplantation.Methods:Three groups of patients at one hospital were considered for this cost analysis: (1) patients included in the BENEMACS study starting May 2009 (n = 6); (2) all patients from May 2009 till May 2010 undergoing heart transplantation (n = 19); or (iii) undergoing Heartmate II implantation as a bridge to transplant (n = 13). Patients undergoing bridging were more sick (lower Intermacs class). DT patients were older (64±8 years). Cost was derived from actual hospital invoices, device, organ procurement and medical cost, and follow-up care during 1 year from implantation. Costs are presented in euro, by their mean values and standard deviation.Results:One-year survivals were 83, 84, and 77%, respectively, for DT, HTX, and bridging. Costs for initial and re-hospitalizations were not different between groups. Costs for medical follow-up and medication were significantly higher for transplanted patients. The 1-year total cost was €85 531±19 823 for HTX, €125 108±32 399 for bridging, and €137 068±29 007 for DT. As 42% of the transplanted patients were bridged, the cost of the medical pathway HTX was €138 076±19 823. Assuming a 5-year survival and a similar yearly follow-up cost, the average cost per year is €42 153 for HTX, €53 637 for transplantation including the bridging cost, and €47 487 for DT.Conclusion:Direct transplantation without bridging is the most cost-efficient treatment. The cost per patient per year for DT is similar to HTX considering its bridging activity.

Salvage of Infected Left Ventricular Assist Device with Antibiotic Beads

The use of left ventricular assist devices has become common for the treatment of end-stage heart failure, both as a bridge to transplantation and as destination therapy. The nature of these devices and the comorbid conditions of the patients in whom the devices are implanted lead to high rates of device infection that are related directly to mortality. Over 2 years, the senior author (S.A.I.) treated 26 patients with left ventricular assist device infections, ranging from superficial driveline infections to deeper pocket infections and device infections. An algorithm involving the use of repeated débridement and placement of antibiotic beads was used in treatment of these infections. Once cleared of infection, patients were treated with definitive closure or flap coverage of the formerly infected device component. Seventeen of 26 patients with left ventricular assist device-related infections were cleared of their infection using this method. Ten of these patients underwent flap coverage of the device after their infection was cleared. In patients that were cleared of infection, mortality was 29 percent, whereas patients with recalcitrant infections had a mortality of 67 percent over the course of the study. A systematic approach to treating left ventricular assist device-related infections has the potential to treat and clear these infections, with promising overall survival rates. This proposed algorithm led to high infection clearance rates compared with previously published literature. Infection clearance in patients on left ventricular assist device destination therapy may result in mortality rates approaching those of their uninfected peers.

Left Ventricular Assist Device–Destination Therapy for Symptom Management in Heart Failure

The left ventricular assist device originated as a means to provide temporary circulatory support for patients suffering from end-stage heart failure. The device was originally intended to serve as a bridge to cardiac transplantation. Increasingly, however, the left ventricular assist device is being utilized as a destination therapy for those patients who are not candidates for heart transplantation. It is this utilization as a destination therapy that raises additional significant ethical concern related to the risks and benefits of the devices, factors influencing quality of life, and consequences pertaining to end-of-life care.

Left Ventricular Assist Device–Destination Therapy for Symptom Management in Heart Failure

Left Ventricular Assist Device–Destination Therapy for Symptom Management in Heart Failure

Impact of Chronic Right Ventricular Failure on Outcomes in Left Ventricular Assist Device Destination Therapy Patients

Purpose: Acute right ventricular failure (RVF) at the time of left ventricular assist device (LVAD) implantation increases perioperative morbidity and mortality. We recently showed that chronic RVF in bridge-to-transplant patients is not associated with survival to transplantation. However, the effect of chronic RVF in destination therapy (DT) patients remains unclear. We sought to evaluate the impact of chronic RVF after DT LVAD implantation on outcomes. Methods & Materials: We retrospectively reviewed our implantable LVAD experience (HeartMate I and II) from 3/2005 to 2/2009 for evidence of chronic RV failure in patients who were implanted with an LVAD for DT and survived to hospital discharge.

Palliative Care in Patients Treated with Left Ventricular Assist Device Destination Therapy (LVAD-DT) (330)

Palliative Care in Patients Treated with Left Ventricular Assist Device Destination Therapy (LVAD-DT) (330) Keith Swetz, MD, Mayo Clinic, Rochester, MN, Monica Freeman, MSW LICSW, Mayo Clinic, Rochester, MN. Winifried Teuteberg, MD, University of Pittsburgh Medical Center, Pittsburgh, PA. Paul Mueller, MD MPH, Mayo Clinic, Rochester, MN. (All speakers have disclosed no relevant financial relationships.)

The beneficial role of left ventricular assist device destination therapy in the reversal of contraindications to cardiac transplantation

Clinical Summary Between January 2000 and September 2004, 15 patients received destination LVAD therapy in our institution. Nine patients had received the Novacor device as part of the INTrEPID (Investigation of Non-Transplant-Eligible Patients who are Inotrope Dependent) trial, and 6 had received the HeartMate XVE device (Thoratec Corporation) after US Food and Drug Administration approval was granted for destination therapy. From this group, 6 patients were reevaluated and listed for transplantation. The mean age was 52 years (range, 31-66 years). The cause of the underlying cardiomyopathy was ischemic in 4 patients, idiopathic in 1 patient, and adriamycin-induced heart failure in 1 patient. Contraindications for cardiac transplantation before LVAD destination therapy were irreversible severe pulmonary hypertension in 5 patients, 2 of whom also had concomitant renal insufficiency and 1 of whom had a recent history of treated endometrial cancer (Table 1). After LVAD implantations, significant reduction in pulmonary arterial pressure, pulmonary vascular resistance, and renal function was seen in these patients (Table 2). Heart transplantation was initially contraindicated in another patient because of psychosocial history and poor compliance. The mean duration of LVAD support until listing among the 6 patients was 243 days (range, 88-684 days). Four patients have undergone transplantation and are alive at a mean duration of 33 months (range, 8-55 months; Table 1). One patient is still on the waiting list, and 1 died from a hemorrhagic cerebrovascular accident before undergoing transplantation. In the one patient with cancer, there has been no evidence of recurrence. None of the patients who underwent transplantation with previous pulmonary hypertension had significant perioperative right ventricular dysfunction. The remaining 9 patients with LVAD destination therapy were not offered heart transplantation because of either the presence of ongoing contraindications to heart transplantation or perioperative death after LVAD implantation. The contraindications to heart transplantation in these 9 patients were significant comorbidity in 3 patients, advanced age in combination with significant comorbidity in 3 patients, and malignancy in 2 patients. At a mean follow-up of 200 days (range, 1-1095 days), 5 patients were deceased, whereas the remaining patients were still alive. The causes of death in the 5 patients were multiorgan failure in 3 patients, traumatic hemorrhagic cerebrovascular accident after a motor vehicle accident in 1 patient, and intraoperative death in 1 patient.

Nursing education and implications for left ventricular assist device destination therapy.

The HeartMate VE Left Ventricular Assist Device (vented electric abdominally positioned pulsatile blood pump; Thoratec Corp., Pleasanton, CA), approved as a permanent support, or destination therapy, by the US Food and Drug Administration in 2002 and Medicare in 2003, is now a potential therapy for numerous patients. Postimplantation nursing care is crucial to the success of left ventricular support device therapy and long-term recipient outcome. Nurses also contribute to cost containment, making this a viable treatment for the facility and the patient. Consequently, nurses must be educated about left ventricular assist device concepts and challenges, the benefits of device placement, intensive care unit and postintensive care unit daily care requirements, and outpatient preparation. This knowledge will enable nurses to provide necessary care and to educate recipients, families, and community health care providers on how to give appropriate posthospital care.