Long-term Mechanical Circulatory Support Devices Research Articles

The Evolution and Complications of Long-Term Mechanical Circulatory Support Devices

Heart failure, a common clinical syndrome caused by functional and structural abnormalities of the heart, affects 64 million people worldwide. Long-term mechanical circulatory support can offer lifesaving treatment for end-stage systolic heart failure patients. However, this treatment is not without complications. This review covers the major complications associated with implantable mechanical circulatory support devices, including strokes, pump thrombosis and gastrointestinal bleeding. These complications were assessed in patients implanted with the following devices: Novacor, HeartMate XVE, CardioWest, Jarvik 2000, HeartMate II, EVAHEART, Incor, VentrAssist, HVAD and HeartMate 3. Complication rates vary among devices and remain despite the introduction of more advanced technology, highlighting the importance of device design and flow patterns. Beyond clinical implications, the cost of complications was explored, highlighting the difference in costs and the need for equitable healthcare, especially with the expected rise in the use of mechanical circulatory support. Future directions include continued improvement through advancements in design and technology to reduce blood stagnation and mitigate high levels of shear stress. Ultimately, these alterations can reduce complications and enhance cost-effectiveness, enhancing both the survival and quality of life for patients receiving mechanical circulatory support.

3D Virtual modelling, 3D printing and extended reality for planning of implant procedure of short-term and long-term mechanical circulatory support devices and heart transplantation.

The use of three-dimensional (3D) reconstruction and printing technology, together with extended reality applied to advanced heart failure adult patients with complex anatomy, is rapidly spreading in clinical practice. We report practical experience with application to acute and chronic heart failure: planning and performing mechanical circulatory device insertion or heart transplantation. From November 2019 until February 2022, 53 3D virtual biomodels were produced for intervention planning (using Virtual/Augmented Reality and/or 3D printing), following a specific segmentation and preprocessing workflow for biomodelling, in patients with advanced heart failure due to structural heart disease or cardiomyopathies. Four of those patients were complex cases requiring mechanical circulatory support implant procedures in our center. One short-term and three long-term ventricular assist device system were successfully clinically implanted after application of this technique. In other two cases with extremely high procedural risk, visualized after application of this multimodality imaging, heart transplantation was elected. 3D printing based planning and virtual procedure simulation, are of great importance to select appropriate candidates for mechanical circulatory support in case of complex patient anatomy and may help to diminish periprocedural complications. Extended reality represents a perspective tool in planification of complex surgical procedures or ventricular assist device insertion in this setting.

Durable ventricular assist device in Spain (2007-2020). First report of the REGALAD registry

Introduction and objectivesThis report presents the clinical characteristics, outcomes and complications of all consecutive patients implanted with a long-term mechanical circulatory support device in Spain between 2007 and 2020. MethodsAnalysis of the Spanish Registry of durable ventricular assist devices (REGALAD) including data form Spanish centers with a mechanical circulatory support program. ResultsDuring the study period, 263 ventricular assist devices were implanted in 22 hospitals. The implanted device was an isolated continuous-flow left ventricular assist device in 182 patients (69%), a pulsatile-flow device (58 isolated left ventricular and 21 biventricular) in 79 (30%), and a total artificial heart in 2 patients (1%). The strategy of the implant was as bridge to heart transplant in 78 patients (30%), bridge to candidacy in 110 (42%), bridge to recovery in 3 (1%) and destination therapy in 72 patients (27%). Overall survival at 6, 12 and 24 months was 79%, 74% and 69%, respectively, and was better in continuous-flow left ventricular assist devices (84%, 80%, and 75%). The main adverse events related to this therapy were infections (37% of patients), bleeding (35%), neurological (29%), and device malfunction (17%). ConclusionsDurable ventricular assist devices have emerged in Spain in the last few years as a useful therapy for patients with advanced heart failure. As in other international registries, the current trend is to use continuous-flow intracorporeal left ventricular devices, which are associated with better results. Adverse events continue to be frequent and severe.

Asistencia ventricular de larga duración en España (2007-2020). I informe del registro REGALAD

Introduction and objectivesThis report presents the clinical characteristics, outcomes and complications of all consecutive patients implanted with a long-term mechanical circulatory support device in Spain between 2007 and 2020. MethodsAnalysis of the Spanish Registry of durable ventricular assist devices (REGALAD) including data form Spanish centers with a mechanical circulatory support program. ResultsDuring the study period, 263 ventricular assist devices were implanted in 22 hospitals. The implanted device was an isolated continuous-flow left ventricular assist device in 182 patients (69%), a pulsatile-flow device (58 isolated left ventricular and 21 biventricular) in 79 (30%), and a total artificial heart in 2 patients (1%). The strategy of the implant was as bridge to heart transplant in 78 patients (30%), bridge to candidacy in 110 (42%), bridge to recovery in 3 (1%) and destination therapy in 72 patients (27%). Overall survival at 6, 12 and 24 months was 79%, 74% and 69%, respectively, and was better in continuous-flow left ventricular assist devices (84%, 80%, and 75%). The main adverse events related to this therapy were infections (37% of patients), bleeding (35%), neurological (29%), and device malfunction (17%). ConclusionsDurable ventricular assist devices have emerged in Spain in the last few years as a useful therapy for patients with advanced heart failure. As in other international registries, the current trend is to use continuous-flow intracorporeal left ventricular devices, which are associated with better results. Adverse events continue to be frequent and severe.Full English text available from:www.revespcardiol.org/en

Unusual Vascular Access for Extracorporeal Membrane Oxygenation Implantation a Case Report

The venoarterial extracorporeal membrane oxygenation (V-A ECMO) has emerged as a life-saving measure for patients in cardiac-respiratory failure in order to provide a mechanical support when conventional strategies have failed, allowing time for recovery, decision-making, or bridging to implantation of a long-term mechanical circulatory support device and occasionally heart transplantation.

Successful venoplasty of superior vena cava stenosis in a patient with a total artificial heart after orthotopic heart transplantation due to primary graft failure

With the limited number of available suitable donor hearts resulting in plateaued numbers of heart transplantations, short- and long-term mechanical circulatory support devices, including the implantation of total artificial hearts (TAHs) are modalities that are increasingly being used as treatment options for patients with end-stage heart failure. The superior vena cava syndrome has been described in this context in various disease processes. We report successful venoplasty for superior vena cava syndrome in a patient with a TAH. A 65-year-old man with a history of nonischemic cardiomyopathy had received a left ventricular assist device, and then 2 years later, underwent orthotopic heart transplantation using the bicaval anastomosis technique. The postprocedural course was complicated by primary graft failure, resulting in the need for implantation of a TAH. About 5 months after TAH implantation, he started to develop complications such as volume retention, swelling of the upper extremities, and was diagnosed to have a superior vena cava syndrome. The patient underwent a successful venoplasty of his superior vena cava by interventional radiology with resolution of upper body edema, normalization of renal, and liver function. Potential fatal complications caused by catheter or wire entrapment in the right-sided mechanical valve of a TAH have been reported. We describe a safe method for the treatment of superior vena cava syndrome in patients with TAH.

Do Stable Patients Supported with Long-Term Mechanical Circulatory Support Device Have Equitable Access to Donor Hearts in the New French Allocation System?

The new French allocation system grants priority to patients on long-term mechanical circulatory support (MCS) with device complications but does not prioritize stable long-term MCS candidates. Some experts expressed concerns regarding waiting time of long-term MCS candidates without complication. The aim of this study was to evaluate the access to transplantation of long-term MCS candidates. The study included all candidates on long-term MCS without complication registered on the French heart transplant waiting list between January 2018 and March 2019 (group 1, n=65) and those ambulatory without circulatory support(group 2, n=220). The main outcomes were 6-month cumulative incidence (CI) of transplantation, and, of waitlist mortality or delisting for worsening medical condition. The CI were estimated using the competing risk analyses and compared using Gray's test. In addition, the restricted mean survival was used to estimate the difference in access to transplantation between the 2 groups. Among the 65 stable long-term MCS candidates, 37 were on support at listing and 28 were implanted while listed. The 6-month CI of transplantation was significantly lower in patients on long-term MCS than in ambulatory candidates (25% vs 49%; p<0.01). The difference of restricted mean survival between the groups was 37 days. The 6-month CI of waitlist mortality was higher in long-term MCS candidates implanted while listed (19%) than in patients on MCS at listing (8 %) and in ambulatory patients (1%). Access to transplantation was lower in stable long-term MCS patients than in ambulatory candidates. The increased waitlist mortality was only observed in candidates implanted while listed. The French allocation system is being revised with a new version granting a provision in stable long-term MCS candidates.

An ambulatory counterpulsation system-a potential option for extended mechanical support.

As the incidence of heart failure increases, an organ shortage for cardiac transplant worsens. There has been development of both short and long-term mechanical circulatory devices for this population, each with unique advantages and different adverse event profiles. The long-term devices provide excellent mechanical circulatory support but are associated with significant morbidity. The intravascular ventricular assist system (iVAS) is a minimally invasive, ambulatory, counterpulsation heart assist system developed to provide long-term support for patients with advanced heart failure while avoiding the surgical trauma of a left ventricular assist device and minimizing the risks of infection and hemocompatibility-related adverse events. Initial experience with the iVAS shows promising evidence for its use as a long-term mechanical circulatory support device.

(1054) - Impact of Preoperative Glycemic Control on Long-Term Mechanical Circulatory Support Device Implantation

(1054) - Impact of Preoperative Glycemic Control on Long-Term Mechanical Circulatory Support Device Implantation

Ten-year survival and prognostic markers in one thousand patients with advanced heart failure. A single-centre analysis.

Patients with advanced heart failure (HF) represent a pool of candidates for heart transplantation and long-term mechanical circulatory support devices. The aim of our study was to determine simple and reliable markers of one-year mortality for selection of the most suitable patients for heart replacement therapy. One thousand consecutive patients with HF (mean age 49 ± 10.9 years; 86.8% males) referred to a single tertiary centre from January 1998 to January 2010 in order to assess the indication for heart transplantation were enrolled. Kaplan-Meier survival analysis was performed. Independent mortality predictors were established using logistic regression analysis. The mean follow-up was 4.3 ± 2.7 years (range 1-12 years). Cumulative survival was as follows: 1-year survival 83%, 3-year 63%, 5-year 50%, 7-year 39%, and 10-year 23%. Independent predictors of 1-year mortality included coronary artery disease, left ventricular diastolic diameter >79 mm, plasma sodium <135 mmol/L, the need for intravenous treatment at hospital admission (diuretics and/or inotropes), and furosemide dose at discharge >240 mg/day. Short-term prognosis of HF patient can be estimated based on simple parameters. Patients with signs of poor prognosis should be referred to tertiary centres to be considered for heart replacement therapy.

Short-term mechanical circulatory support by veno-arterial extracorporeal membrane oxygenation in the management of cardiogenic shock and end-stage heart failure

Despite modern treatment modalities, cardiogenic shock is associated with a very high risk of mortality and morbidity. The short- and long-term survival in patients with cardiogenic shock or end-stage heart failure has improved considerably by recent technological advances in short and long-term mechanical circulatory support devices. For short-term mechanical support, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been increasingly used as bridge-to-decision and bridge-to-recovery in cardiogenic shock patients. Long-term mechanical circulatory support devices such as left ventricular assist devices (LVADs) are widely available and play a central role in bridge-to-transplantation in those eligible for heart transplantation (HTX) and as destination therapy (DT) in those not eligible for heart transplantation. Nevertheless, patients with critical cardiogenic shock show a deleterious outcome after LVAD-implantation or HTX with higher mortality, more complications and higher burden on financial resources. These considerations underscore the importance of optimal timing and appropriate patient selection for eventual LVAD therapy. The current report will focus on the immediate management of patients with cardiogenic shock with inotropes, discuss the use of IABP and focus mainly on pivotal choices to be made in the period spanned by short term mechanical circulatory support in patients with refractory cardiogenic shock.

Extracorporeal life support devices and strategies for management of acute cardiorespiratory failure in adult patients: a comprehensive review.

Evolution of extracorporeal life support (ECLS) technology has added a new dimension to the intensive care management of acute cardiac and/or respiratory failure in adult patients who fail conventional treatment. ECLS also complements cardiac surgical and cardiology procedures, implantation of long-term mechanical cardiac assist devices, heart and lung transplantation and cardiopulmonary resuscitation. Available ECLS therapies provide a range of options to the multidisciplinary teams who are involved in the time-critical care of these complex patients. While venovenous extracorporeal membrane oxygenation (ECMO) can provide complete respiratory support, extracorporeal carbon dioxide removal facilitates protective lung ventilation and provides only partial respiratory support. Mechanical circulatory support with venoarterial (VA) ECMO employed in a traditional central/peripheral fashion or in a temporary ventricular assist device configuration may stabilise patients with decompensated cardiac failure who have evidence of end-organ dysfunction, allowing time for recovery, decision-making, and bridging to implantation of a long-term mechanical circulatory support device and occasionally heart transplantation. In highly selected patients with combined severe cardiac and respiratory failure, advanced ECLS can be provided with central VA ECMO, peripheral VA ECMO with timely transition to venovenous ECMO or VA-venous ECMO upon myocardial recovery to avoid upper body hypoxia or by addition of an oxygenator to the temporary ventricular assist device circuit. This article summarises the available ECLS options and provides insights into the principles and practice of these techniques. One should emphasise that, as is common with many emerging therapies, their optimal use is currently not backed by quality evidence. This deficiency needs to be addressed to ensure that the full potential of ECLS can be achieved.

General surgical complications associated with the use of long-term mechanical circulatory support devices: are we ‘under-reporting’ problems?

Multiple complications are associated with use of ventricular assist devices (VADs). Cardiac-related complications and infections are most frequently reported. VADs, however, can also lead to a number of general surgical complications equally significant in terms of morbidity and mortality. The authors performed a systematic literature search to review current data that specifically relate general surgical complications to patients who undergo left VAD implantation. The review provides a relatively clear understanding of the spectrum of general surgical complications and shows that they contribute significantly to morbidity and mortality in these patients.

Mechanical circulatory support for the visually impaired: is it appropriate?

Long-term mechanical circulatory support devices, especially left ventricular assist devices, are being increasingly utilized in the management of end-stage heart failure either as bridge to heart transplantation, recovery or as destination therapy. However, current technology for controllers and alarm systems for left ventricular assist devices does not permit their implantation in eligible patients with visual impairment. We report two patients in whom the decrease in visual acuity was a significant factor in determining eligibility for long-term mechanical circulatory support.

SINGLE CENTER EXPERIENCE WITH THE TANDEM HEART PVAD FOR TEMPORARY LEFT VENTRICULAR SUPPORT

OBJECTIVE: The TandemHeart (CardiacAssist, Inc.) percutaneous left ventricular assist device (pVAD) represents a significant advance in less invasive approaches to LVAD support. We report our institution’s experience with the TandemHeart pVAD. METHODS: From August 2002 through December 2004, 13 patients (mean age=63 +/- 17.9 years) were implanted with the TandemHeart pVAD for temporary left ventricular support. Six patients (46%) were implanted as a preventative measure while undergoing high-risk percutaneous coronary intervention (PCI). Seven patients (54%) were implanted to treat cardiogenic shock (CS), five after acute myocardial infarction and two as a result of decompensation from congestive heart failure. RESULTS: Mean support duration for high-risk PCI patients was 8 +/-10.4 hours. Mean support duration for CS patients was 6 +/- 3.7 days. Five of the six high-risk PCI patients (83%) and six of the seven CS patients (85%) survived to discharge after device removal. Two of the surviving CS patients (33%) were eventually bridged to long-term mechanical circulatory support devices. CONCLUSION: As a less invasive procedure than other temporary LVADs, the TandemHeart pVAD is an effective temporary therapy for the treatment of a variety of acute heart failure conditions. Further, this device can be successfully used as a short-term bridge to a long-term mechanical circulatory support device.

Mechanical Circulatory Support Sources of Emboli and Neurological Outcome

Long-term mechanical circulatory support devices are currently used as bridges to transplantation or myocar dial recovery and represent a major step forward in the treatment of end-stage heart failure. Examples of left ventricular assist devices/systems are Thoratec Labora tories (Berkley, CA), Baxter Novacor (Oakland, CA), and Thermo Cardiosystems Inc Heartmate (Woburn, MA). The CardioWest (Tucson, AZ) is the current total artifi cial heart device under clinical evaluation. These de vices are associated with neurological complications usually resulting from thromboembolic events to the cerebrum, cerebellum, or brainstem. The device itself is the commonest source of these emboli. Thrombus formation within the device occurs as a result of the interaction between the blood contacting surfaces of the device, the flow of blood through the device, and thrombotic tendency of the blood. There is a wide range of clinical presentation, from asymptomatic emboli detected by transcranial Doppler to devastating strokes. Strategies aimed to reduce the tendency to form throm bus are based on aggressive prevention with anticoagu lation and antiplatelet therapy and/or by design modifi cation. In particular, the use of a textured inner surface that encourages the formation of a pseudoneointima seems successful in reducing anticoagulation require ments and neurological complications.

Novacor left ventricular assist system versus heartmate vented electric left ventricular assist system as a long-term mechanical circulatory support device in bridging patients: A prospective study

Objective: Long-term mechanical circulatory support as a bridge-to-transplantation procedure and bridge to recovery is of increasing importance. The implantable left ventricular assist devices, Novacor N100 left ventricular assist system (Baxter Healthcare Corporation, Berkeley, Calif) and TCI HeartMate vented electric left ventricular assist system (Thermo Cardiosystems Inc, Woburn, Mass), have proved to be efficient devices in bridge-to-transplantation settings and for prolonged support. The two systems were compared with regard to reliability and morbidity. Methods: Between October 1996 and March 1998, a prospective, single-center study was done that included 40 patients, 20 of whom were treated with the Novacor system and 20 of whom were treated with the HeartMate device. The diseases were mainly dilated cardiomyopathy (13/9) and ischemic cardiomyopathy (6/10). There were no statistically significant differences between the two groups regarding age, sex, preoperative clinical blood chemistry values, hemodynamic data, or risk factors. Results: There were no statistically significant differences between the two groups with regard to postoperative hemodynamics, organ recovery, out-of-hospital support, and survival to heart transplantation. Mean duration of support was 235.3 ± 210 days for the Novacor group and 174.6 ± 175 days for the HeartMate group and mean out-of-hospital support was 241 ± 179 days and 166 ± 152 days for the two groups, respectively. Neurologic complications occurred significantly more often among the Novacor group, whereas the HeartMate group had a higher prevalence of infections and technical problems, which was statistically significant. Survival to transplantation was 65% for the Novacor group and 60% for the HeartMate group. Conclusions: Most patients had organ recovery with left ventricular assist system support, and a considerable number of patients in both groups underwent transplantation. However, both devices need revision to address the current problems, that is, thromboembolism for the Novacor device and infection and reliability for the HeartMate device. (J Thorac Cardiovasc Surg 2000;119:581-7)