Biventricular Assist Device Implantation Research Articles

Trasplante cardiaco con éxito tras asistencia biventricular tipo Berlin-Heart EXCOR en pacientes adultos

Ventricular assist devices provide mechanical circulatory support and are also capable of replacing cardiac function in situations of advanced heart failure. The use of these devices as a bridge to transplantation is growing in our country. Berlin Heart Excor (Berlin Heart AG, Berlin, Germany) is a paracorporeal, pneumatically driven pulsatile flow device, that is mainly used as a bridge to transplantation in adult patients when biventricular support is required, in the presence of significant right ventricular dysfunction. The experience with such patients in our country, given complexity and frequent complications, has been bad so far. We present the first three cases of adult patients successfully transplanted in Spain after Berlin-Heart EXCOR biventricular assist device implantation. All three patients were male, mean age 65 years, and mean time on support was 150 days. This support allowed hemodynamic stabilization in our first patient (previously on venoarterial-ECMO support due to refractory cardiogenic shock) and normalization of pulmonary vascular resistance in the other two (with severe pulmonary hypertension prior to implant) thus contributing to transplantation were carried out with success.

Early Biventricular Assist Device Use in Children: A Single-Center Review of 31 Patients.

Biventricular assist device (BiVAD) support is considered a risk factor for worse outcomes compared with left ventricular assist device (LVAD) alone for children with end-stage heart failure. It remains unclear whether this is because of the morbidity associated with a second device or the underlying disease severity. We aimed to show that early BiVAD support can result in good survival by analyzing our prospectively collected database for all pediatric patients who underwent BiVAD implantation. From 2005 to 2009, BiVADs were used exclusively. From 2010 to 2014, LVAD alone was considered, maintaining a low threshold for BiVAD support. All BiVADs were pulsatile devices. Thirty-one patients with median age of 3.5 years received BiVAD support. Diagnoses included dilated cardiomyopathy in 17 (55%), myocarditis in 6 (19%), and congenital heart disease in 3 (10%). Survival to transplant was achieved in 27 (87%) with a median duration of 41 days (interquartile range, 15-69). Adverse event rates (per 100 days of support) were bleeding at 0.52, infection at 1.17, and central nervous system dysfunction at 0.78. Of those who survived to transplant, 26 (96%) remain alive with a median follow-up of 55 months. These results show that BiVAD support can bridge patients to transplant with excellent long-term survival.

Clinical course and long-term outcome following venoarterial extracorporeal life support-facilitated interhospital transfer of patients with circulatory failure

BackgroundInterhospital transfer of patients experiencing circulatory failure and shock has a significant risk of cardiovascular deterioration and death. Extracorporeal life support (ECLS) is a rescue tool for hemodynamic stabilization that makes patient transportation much safer. MethodsDemographic data, clinical course, and outcome data were reviewed for patients who underwent placement of a venoarterial ECLS in a remote hospital and were transported to our tertiary care facility. Results68 patients were transported to our center with ECLS. The majority of these patients (79%) underwent cardiopulmonary resuscitation during or immediately prior to ECLS initiation. The mean patient age was 52 years, and 53 patients were male. The most common underlying diagnosis was acute coronary syndrome (60%). Overall, 23 patients underwent consecutive cardiosurgical procedures, including coronary artery bypass grafting in 12, and left ventricular assist device and biventricular assist device implantation in 11. The median duration of ECLS was 5 days. None of the patients died during transportation. Twelve of the surgically treated patients survived, as well as 21 patients with non-surgical treatment, which resulted in an overall survival of 33 patients (48.5%). ConclusionECLS-facilitated patient transfer enables safe interhospital transfer of critically ill patients. In this study, a relevant percentage of patients were in need of a cardiosurgical intervention. The long-term survival rate of these patients supports the further use of this time-, cost- and personnel-demanding strategy.

Invited Commentary

The decision to use a biventricular assist device (BIVAD) versus a left ventricular assist device (LVAD) for a child awaiting transplantation remains difficult. This investigation by Zafar and colleagues [1Zafar F. Jefferies J.L. Tjossem C.J. et al.Biventricular Berlin Heart EXCOR pediatric use across the United States.Ann Thorac Surg. 2015; 99: 1328-1334Google Scholar] from the Berlin Heart EXCOR Pediatric EXCOR study reveals sobering conclusions regarding mechanical assistance in children. In essence, one-third of the patients in this study required BIVAD assistance. The demographic and clinical variables of white race, abnormal glomerular filtration rate, sites with fewer than five implants, and use of the 10-mL pump were identified as predictors of mortality in BIVAD patients. BIVAD support was not associated with improved survival in any identified subset of patients, and survival in BIVAD patients was 60% versus 80% in LVAD patients at 100 days. Although pediatric patients differ from adult patients, a similar inferior survival for BIVAD patients compared with LVAD patients exists for adults [2Cleveland Jr., J.C. Naftel D.C. Reece T.B. et al.Survival after biventricular assist device implantation: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database.J Heart Lung Transplant. 2011; 30: 862-869Abstract Full Text Full Text PDF PubMed Scopus (123) Google Scholar]. Although one is tempted to conclude that perhaps BIVAD support should be avoided at all costs, this message is not the appropriate conclusion. As mechanical circulatory support evolves, we must continue to define which patients require BIVAD support and how we can then improve BIVAD outcomes. Clearly, the current study challenges us to question how the current pediatric BIVAD technology might change to improve BIVAD survival. Biventricular Berlin Heart EXCOR Pediatric Use Across the United StatesThe Annals of Thoracic SurgeryVol. 99Issue 4PreviewBiventricular assist device (BiVAD) support was a strong predictor of early mortality in the Berlin Heart EXCOR Pediatric investigational device exemption (IDE) study (Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device [VAD]). In adults, it has been identified that 5% to 10% of the VAD population is benefited by BiVAD support over left ventricular assist device (LVAD) support. An analysis of the Berlin Heart study cohort was performed to characterize patients supported with BiVAD, examine risk factors of mortality in this group, and identify subsets of patients in whom BiVAD is associated with survival. Full-Text PDF

Minimally Invasive Implantation of Biventricular Assist Devices

Background: Minimally invasive left ventricular assist device (LVAD) implantation is increasingly used as the preferred technique and supposedly reduces perioperative right ventricular failure. However bailout strategies for postoperative right ventricular failure (RVF) become necessary.

(90) - Left Ventricular vs. Bi-Ventricular Assist Device Implantation: Improvement of Preoperative Decision Making by Assessing Right Ventricular Adaptation to Loading Conditions

Load sensitivity of right ventricular (RV) performance, related to the impact of pre- and afterload on its size, geometry, contractile function, and tricuspid regurgitation (TR), explains RV ability to improve its function after left ventricular assist device (LVAD) insertion but it also can be misleading for preoperative prediction of RV function during LVAD support. We investigate the usefulness of preoperative assessment of RV adaptability to loading conditions for decision making before VAD implantation.

(139) - Comparison of Survival between Pediatric and Adult Patients after Biventricular Assist Device Implantation: Analysis of the UNOS Database

(139) - Comparison of Survival between Pediatric and Adult Patients after Biventricular Assist Device Implantation: Analysis of the UNOS Database

Minimally Invasive Implantation of Biventricular Assist Devices

As minimally invasive left ventricular assist device implantation is being advocated and more widely performed, bailout strategies for postoperative right ventricular failure (RVF) become necessary. We describe our surgical technique for additional right ventricular assist device implantation through a third mini-thoracotomy incision. This new technique allows avoidance of sternotomy even if RVF occurs.

Biventricular amputation for biventricular pulsatile assist device implantation in patients with severe ventricular septal perforation

Complete ischaemic destruction of the cardiac apex as well as the majority of the ventricular septum is usually a lethal condition with no alternatives except mechanical circulation support and highly urgent heart transplantation. Depending on the mass of the necrotic and destructed myocardium, implantation of a ventricular assist device can be challenging due to insufficient tissue quality. We describe here a new approach to pulsatile Thoratec (Thoratec Corporation, Pleasanton, CA, USA) extracorporeal biventricular assist device implantation.

Left ventricular assist device recipients at risk of right ventricular failure: the role of a planned temporary biventricular support

When patients at high risk for failure of isolated left ventricular assist device (LVAD) support are identified, biventricular assist device implantation is suggested as a primary option. Results of a planned temporary right ventricular mechanical support (RVAD) placement in high-risk LVAD recipients have been reported and analyzed. Between 2009 and 2011, 10 consecutive adult patients (9 men; age range 31-69 years), with preoperative evidence of moderate to severe biventricular failure, were supported simultaneously with an axial flow HeartMate II (Thoratec Corp., Pleasanton, California) LVAD and a temporary CentriMag (Levitronix LCC, Waltham, Massachusetts) RVAD as a primary option at our institution. Indications for support at implantation were ischemic dilated cardiomyopathy in 6 cases and idiopathic dilated cardiomyopathy in 4. Planned temporary RVAD insertion was defined as RVAD support placement at the same time as LVAD placement. Nine patients were successfully weaned from temporary RVAD support after an average time of 18.6 days (range 3-43 days) and discharged from hospital. One patient died due to respiratory failure. RVAD removal was performed through a minimally invasive approach without repeat sternotomy in 6 patients. None of the patients required a permanent RVAD support. When patients at high risk for failure of isolated LVAD support are identified, temporary biventricular assist device implantation is advised to improve the outcome of such a vulnerable patient population.

Unusual Presentation of Cardiac Tamponade after Biventricular Assist Device Implantation: Diastolic Collapse of the Outflow Graft

(Echocardiography 2012;29:E20‐E21)

Delayed intracardial shunting and hypoxemia after massive pulmonary embolism in a patient with a biventricular assist device

We describe the interdisciplinary management of a 34-year-old woman with dilated cardiomyopathy three months postpartum on a cardiac biventricular assist device (BVAD) as bridge to heart transplantation with delayed onset of intracardial shunting and subsequent hypoxemia due to massive pulmonary embolism. After emergency surgical embolectomy pulmonary function was highly compromised (PaO2/FiO2 54) requiring bifemoral veno-venous extracorporeal membrane oxygenation. Transesophageal echocardiography detected atrial level hypoxemic right-to-left shunting through a patent foramen ovale (PFO). Percutaneous closure of the PFO was achieved with a PFO occluder device. After placing the PFO occluder device oxygenation increased significantly (Δ paO2 119 Torr). The patient received heart transplantation 20 weeks after BVAD implantation and was discharged from ICU 3 weeks after transplantation.An increase in pulmonary vascular resistance in patients on BVAD can reopen a PFO resulting in atrial right-to-left shunting and subsequent hypoxemia. The case demonstrates the usefulness of transesophageal echocardiography examinations in the detection of this unexpected event. Percutaneous placement of a PFO occluder device is an appropriate strategy to stop intracardiac shunting through PFO in fixed elevation of pulmonary vascular resistance.

455 Long-term follow up of left ventricular size and function in patients successfully bridged to recovery after left ventricular assist device support

Ventricular assist devices (VADs) have traditionally been viewed as a bridge to transplant (BTT) for patients in decompensated heart failure. A subset of patients implanted with VADs will develop enough myocardial recovery to allow weaning and explantation of their devices. However, it is unclear what happens to left ventricular size and function in patients successfully bridged to recovery post LVAD explant. From 2002 to 2011, 70 patients have undergone VAD implantation at our institution. A retrospective review including all implanted patients was performed. Of these, 10 patients (14%) have recovered myocardial function enough to allow explantation. Of the explanted patients, 7 underwent isolated left ventricular assist device (LVAD) implantation, 2 underwent right ventricular assist device implantation, and one underwent biventricular assist device implantation. Only the patients who underwent isolated LVAD implantation and subsequent explantation were included in this analysis. The majority of these patients (86%) were implanted with a continuous flow rather than pulsatile flow device. Eighty-six percent of patients had non-ischemic heart failure and the most common etiology of heart failure amongst successfully weaned patients was acute myocarditis (43%) and dilated cardiomyopathy (43%). Mean and median duration of symptoms prior to implantation were 78 and 30 days, respectively, with the majority of patients presenting with new onset heart failure (71%). Mean duration of support prior to explantation was 180 days. At mean follow-up of 697 days, all 7 patients were alive and had NYHA I functional class. The table provides baseline and post-explant characteristics of all explanted patients. All patients had severe left ventricular (LV) dysfunction with mean LV ejection fraction (EF) 16% prior to implantation. LVEF significantly improved at the time of explantation (52%) and remained stable at last follow-up (50%). LV end-diastolic dimension (LVEDD), however, increased from 42 mm at explantation to 52mm at last follow-up (Table).Tabled 1 We show that VADs may facilitate myocardial recovery and be used as a bridge to recovery in a subset of patients who require mechanical circulatory support for decompensated heart failure. Despite LV dilation post LVAD explant, the improvement in left ventricular function achieved by VAD support appears to remain stable over time with sustained symptomatic improvement.

Surgical Strategy for Biventricular Assist Device Implantation after Previous Coronary Artery Bypass Grafting

In an aging population, numerous patients who underwent previous coronary artery bypass grafting (CABG) are presenting with end-stage ischemic cardiomyopathy. Although redo CABG and cardiological interventions are possible treatment options, orthotopic heart transplantation remains an ultimate option for these patients. However, there is high morbidity and mortality on the waiting list, and mechanical circulatory support is a life-saving concept [Hetzer 2006; Taylor 2009].We developed a simplified and safe technique for implantation of a biventricular assist device as a redo in complex patients after previous CABG and end-stage heart failure.

Successful Use of Temporary Right Ventricular Support to Avoid Implantation of Biventricular Long-Term Assist Device: A Transcutaneous Approach

Severe right ventricular (RV) failure after left ventricular assist device (LVAD) implantation is a serious complication with a poor prognosis. The most effective therapy for these patients is an upgrade to biventricular mechanical support. However, it is well recognized that primary and secondary biventricular ventricular assist device implantation is associated with higher mortality rates. We report on three patients with cardiogenic shock, who were provided on an emergency basis with a percutaneous extracorporeal life support (ECLS) system by the femoral vessels. After stabilization, a LVAD was implanted. To avoid secondary RV failure, the ECLS was switched to a transcutaneous RV assist device (RVAD) as a temporary RV support. The arterial cannula was removed from the femoral artery, and a prosthesis-supported cannula was sutured to the pulmonary artery and passed through a subxiphoid exit. The femoral vein cannula was left in situ. Both cannulae were connected to a centrifugal pump. Two patients could be weaned from the RVAD; the system was explanted under local anesthesia. One patient died due to internal bleeding. In conclusion, the ease of device implantation, weaning, and explantation justifies a liberal use of temporary RV support to avoid implantation of the problematic long-term biventricular assist devices.

Thoratec paracorporeal biventricular assist device therapy: the Freiburg experience

The treatment of severe biventricular (BV) contractile failure using mechanical circulatory support is challenging. We analyzed our center's results following implantation of a biventricular assist device (BVAD). We implanted 39 BVADs between September 2001 and January 2009. All patients were qualified candidates for heart transplantation, without an organ available at time of BVAD implantation. Fifteen patients without a history of chronic cardiomyopathy suffered from acute BV failure (group 1), whereas the other 24 suffered from severe chronic cardiomyopathy (group 2). The indication for BVAD implantation was determined in reference to echocardiography, the degree of end-organ damage, and whether the patient qualified for a heart transplant or was a candidate for bridge to recovery. Both groups were similar regarding their preoperative hemodynamics, intraoperative and early postoperative findings, and adverse events. Patients in group 1 were younger (mean age 37±17 years) than those in group 2 (51±12 years). Mean duration of support in group 1 was 137±109 days, and 65±61 days in group 2. In group 1, 33% (5/15) were weaned off the device and 53% (8/15) underwent heart transplantation, whereas 8/24 patients (42%) in the chronic group were transplanted. Group 1's mortality on the device was lower than that of group 2 (13% vs 67%). Furthermore, 11 patients of group 1 survived for 1 year compared with four in group 2 (73% vs 17%). Implantation of a BVAD in patients with chronic heart failure and acute decompensation is associated with a high mortality and morbidity rate. By contrast, BVAD implantation can achieve excellent results in patients with acute BV failure without a history of chronic cardiomyopathy, even if they are in cardiogenic shock upon admission.

Survival after biventricular assist device implantation: An analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database

Patients requiring biventricular assist device (BiVAD) for mechanical circulatory support (MCS) have substantially worse outcomes than patients requiring left VAD (LVAD) support only. Patient-specific risk factors have yet to be consistently identified in a large, multicenter registry, which may underlie the poorer outcomes for BiVAD patients. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a registry of U.S. Food and Drug Administration-approved durable MCS devices used for bridge-to-transplantation, destination therapy, or recovery. The purposes of this study were to 1) identify the underlying pre-implant characteristics of the population requiring BiVAD support that contribute to reduced survival, and 2) identify differences in postoperative outcomes with respect to adverse events compared with patients supported with LVAD alone. From June 2006 to September 2009, 1,646 patients were entered into the INTERMACS database in which adverse events and outcomes were recorded for primary implants with LVAD or BiVAD. Competing outcomes methodology was used to estimate the time-related probability of death, transplant, or recovery. Overall survival for all groups was analyzed with Kaplan-Meier methods and Cox proportional regression analysis. The distribution of primary device implants included 1,440 LVADs and 206 BiVADs. BiVAD patients presented with a lower INTERMACS profile 93% in INTERMACS 1 or 2, compared with 73% for LVAD patients (p < 0.001). Survival at 6 months was 86% for LVADs and 56% for BiVADs (p < .0001). Adverse event rates, expressed as episodes/100 patient-months for the BiVAD group compared with LVAD, were significantly higher for infection (33.2 vs 14.3), bleeding (71.6 vs 15.5), neurologic events (7.9 vs 2.6), and for device failure (4.9 vs 2.0). Patients requiring BiVAD support at the time of durable MCS implant are more critically ill at the time of MCS implant. BiVAD patients experience worse survival than patients supported with LVAD alone and higher rates of serious adverse events. Characteristics of the population present at the time of BiVAD implant likely influence post-implant MCS outcomes.

Management of Biventricular Assist Device Implantation in Patients with Necrotic Pancreatitis

This report describes the management of biventricular assist device (BIVAD) implantation in a patient with necrotic pancreatitis. BIVADs provide mechanical support for ventricular ejection in the failing heart and have become an accepted treatment for end-stage heart failure. They also have proved to be a successful bridge to heart transplantation. As their popularity has grown, the number of patients with BIVADs presenting for noncardiac surgery is increasing. We report the successful management of an implanted extracorporeal BIVAD in a patient with end-stage heart failure and with pancreatic stents in a case of necrotic pancreatitis. Historical, physical, laboratory, and imaging data allowed conservative management leading to a favorable outcome.

Early planned institution of biventricular mechanical circulatory support results in improved outcomes compared with delayed conversion of a left ventricular assist device to a biventricular assist device

It is generally accepted that patients who require biventricular assist device support have poorer outcomes than those requiring isolated left ventricular assist device support. However, it is unknown how the timing of biventricular assist device insertion affects outcomes. We hypothesized that planned biventricular assist device insertion improves survival compared with delayed conversion of left ventricular assist device support to biventricular assist device support. We reviewed and compared outcomes of 266 patients undergoing left ventricular assist device or biventricular assist device placement at the University of Pennsylvania from April 1995 to June 2007. We subdivided patients receiving biventricular assist devices into planned biventricular assist device (P-BiVAD) and delayed biventricular assist device (D-BiVAD) groups based on the timing of right ventricular assist device insertion. We defined the D-BiVAD group as any failure of isolated left ventricular assist device support. Of 266 patients who received left ventricular assist devices, 99 (37%) required biventricular assist device support. We compared preoperative characteristics, successful bridging to transplantation, survival to hospital discharge, and Kaplan-Meier 1-year survival between the P-BiVAD (n = 71) and D-BiVAD (n = 28) groups. Preoperative comparison showed that patients who ultimately require biventricular support have similar preoperative status. Left ventricular assist device (n = 167) outcomes in all categories exceeded both P-BiVAD and D-BiVAD group outcomes. Furthermore, patients in the P-BiVAD group had superior survival to discharge than patients in the D-BiVAD group (51% vs 29%, P < .05). One-year and long-term Kaplan-Meier survival distribution confirmed this finding. There was also a trend toward improved bridging to transplantation in the P-BiVAD (n = 55) versus D-BiVAD (n = 22) groups (65% vs 45%, P = .10). When patients at high risk for failure of isolated left ventricular assist device support are identified, proceeding directly to biventricular assist device implantation is advised because early institution of biventricular support results in dramatic improvement in survival.

Paracorporeal pulsatile biventricular assist device versus extracorporal membrane oxygenation–extracorporal life support in adult fulminant myocarditis

Biventricular assist device support with a paracorporeal pulsatile device is known to be an efficient bridge to recovery for patients with fulminant myocarditis-related cardiogenic shock. Whether these patients can be as efficiently supported with femorofemoral extracorporeal membrane oxygenation remains unclear. From 2001 to 2006, 11 patients were referred to our cardiac surgery department for fulminant myocarditis-related cardiogenic shock. The first 5 patients (mean age, 32 +/- 2 years) were supported with a biventricular assist device (Thoratec, Pleasanton, Calif; group I), whereas the remaining patients (40 +/- 4 years) were supported with femorofemoral extracorporeal membrane oxygenation (group II). Preimplantation probability of death was calculated by using the APACHE II score, which was 11 +/- 9 in group I versus 24 +/- 18 in group II. One patient in each group died while receiving support. In group I the death occurred after 18 days of support in a patient who had 45 minutes of external resuscitation before biventricular assist device implantation. In group II a patient who remained unstable during extracorporeal membrane oxygenation was switched to a biventricular assist device 13 days later and eventually died of tamponade after 45 days. All other patients were weaned from the device after a mean duration of support of 21 +/- 5 days in group I versus 13 +/- 4 days in group II. At hospital discharge, the mean ejection fraction was 45% +/- 5% in both groups, and at 6 months' follow-up, it was 65% and 75%, respectively, in groups I and II. In our experience extracorporeal membrane oxygenation is as efficient as use of a biventricular assist device as a bridge to recovery for patients with fulminant myocarditis-related cardiogenic shock and facilitates renal and hepatic recovery on support.