Tools
Left Ventricular Assist Devices
Introduction
Heart failure is a frequent cause of inpatient admissions. The Framingham study in 1993 described the risk factors for heart failure and showed unacceptably high 5-year mortality rates of 25% in men and 38% in women.[1] The American Heart Association reported a prevalence of 5.1 million heart failure cases in the United States in 2006.[2] The global prevalence has been estimated at 23 million.[3]
Heart failure can be categorized based on the left ventricular ejection fraction (LVEF) into systolic and diastolic heart failure. The former group includes patients with LVEF less than or equal to 40%, also termed heart failure with reduced ejection fraction (HFrEF). Heart failure with preserved ejection fraction (HFpEF) includes those with LVEF greater than or equal to 40%.
The multiple modalities available for treating heart failure include, but are not limited to, lifestyle modifications, pharmacologic agents, device therapies such as implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT). At times, failure to improve may necessitate short-term mechanical circulatory support with an intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO). However, a large population of patients continues to have advanced HF with worsening LVEF despite maximal therapy.
Circulatory support using a left ventricular assist device (LVAD) is an emerging field. The landmark REMATCH trial that compared LVADs with optimal medical therapy in those with class IV heart failure found a 48% reduction in mortality from any cause.[4] There was also a significant increase in survival rates at 1 year (52% vs 25%) and 2 years (23% vs 8%). The definitive treatment for advanced heart failure (class II and IV) is cardiac transplantation.[5] However, with the limited number of donor hearts available, LVADs are life-saving.
Anatomy and Physiology
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Anatomy and Physiology
The basic design of LVADs has remained essentially unchanged since their inception. The inlet cannula is placed in the apex of the left ventricle. The blood subsequently enters the pump, whose structure has changed significantly over time; the outflow graft then leads to the ascending (most common) or descending aorta.[6]
The first-generation LVADs were approved by the United States Food and Drug Administration for clinical use in 1994. These were pulsatile-flow LVADs used for circulatory support as a bridge to transplantation for patients awaiting donor hearts. However, second- and third-generation continuous-flow devices have undergone structural and functional modifications that improve durability, thereby expanding their use as destination therapy in patients ineligible for cardiac transplantation.[7][8] The eighth annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) in 2017 reported 1-year and 2-year survival rates with currently used continuous-flow devices of greater than 80% and greater than 70%, respectively.[9]
First-Generation Devices
The first-generation devices were pulsatile volume-displacement pumps. The Heartmate I was used in the REMATCH trial and underwent many modifications, but it is no longer manufactured. Another device from its generation, the Novacor, is now obsolete due to a high risk of stroke. The Thoratec paracorporeal ventricular assist device is still produced but rarely used. The first-generation devices required significant surgical dissection for placement and were designed for patients with large body habitus. They also had a high infection rate at the external lead. Additionally, the pump was audible and caused discomfort. These limitations led to the discontinuation of their use.
Second-Generation Devices
These are continuous-flow devices that use axial-flow pumps. The Heartmate II and Jarvik 2000 are the 2 most commonly used devices, with the latter characterized by outflow graft anastomosis to the descending aorta. The rotor is the only moving part of these devices, which increases their durability. These devices are smaller, easier to implant, quieter, and associated with lower rates of driveline infection compared to first-generation devices. The sixth INTERMACS annual report noted that, since 2010, all patients receiving destination therapy have had continuous-flow devices.
Third-Generation Devices
These are continuous-flow centrifugal pumps, with the HeartWare and HeartMate 3 being the most popular. They are designed for long-term durability (5–10 years), ease of surgical placement, and a low risk of hemolysis or thrombosis. Smaller devices are currently undergoing testing.
Biventricular Assist Device
This device is used for patients with either biventricular failure or right ventricular failure associated with left ventricular disease. The total artificial heart has been a revolution. The SynCardia total artificial heart is the most widely used, with more than 1600 patients benefiting.[10]
Indications
Bridge-to-Transplantation
The purpose of bridge-to-transplantation is to provide circulatory support to transplant-eligible patients with HFrEF until a donor's heart becomes available.
Destination Therapy
Destination therapy is used in patients with HFrEF who are ineligible for cardiac transplantation. Newer, more durable devices have demonstrated higher survival rates in this patient population.
Bridge-to-the-Decision
LVADs have been used as a temporary measure in patients with end-organ dysfunction due to heart failure (relative contraindication to transplantation). Stabilization of hemodynamics, improvement in renal function and nutritional status, and reduction in pulmonary hypertension can help make them transplant-eligible.
Bridge-to-Recovery
Bridge-to-recovery provides temporary ventricular support in some patients with heart failure and has been shown to improve myocardial function and promote recovery.[11] Strong indications for either bridge-to-transplantation, destination therapy, or bridge-to-recovery are as follows (all must be applicable):
- New York Heart Association class IV for 60 to 90 days
- Maximal tolerated medical therapy and certified respiratory therapy/implantable cardioverter-defibrillator if indicated
- Chronic dependence on inotropic agents
- LVEF less than 25%
- Pulmonary capillary wedge pressure greater than or equal to 20 mm Hg
- Systolic blood pressure less than or equal to 80 to 90 mm Hg or cardiac index less than or equal to 2 L/min/m2, evidence of declining renal or right ventricular function [12]
Contraindications
Various contraindications have been well summarized in a review based on entry criteria across several studies.[12] They include:
- Right ventricular dysfunction
- Either primary or right heart failure, not secondary to left heart failure. Impaired right ventricular function results in insufficient left ventricular filling, which may cause inadequate inflow to the device and, ultimately, device malfunction.
- Acute cardiogenic shock with a neurological compromise
- Without adequate higher functions, LVAD placement is not recommended, as it would only increase morbidity and decrease the quality of life.
- Coexisting severe terminal comorbidity
- Severe renal, pulmonary, liver, or neurological disease or evidence of advanced metastatic cancer are considered contraindications.
- Bleeding
- Active bleeding or thrombocytopenia (platelet count less than 50000 x 10 per L) or confirmed heparin-induced thrombocytopenia
- Not only the bleeding but also the inability to be placed on anticoagulation constitute contraindications.
- Anatomical factors
- Hypertrophic cardiomyopathy or a significant ventricular septal defect hinders device placement and function.
- Technical limitations
- Body surface area less than 1.2 to 1.5 m2 or any other factor
- Social considerations
- LVAD management requires a high degree of patient compliance, which necessitates adequate psychological functioning to adhere to medication regimens and device maintenance. Management also involves family education in interpreting basic functions and alarms. Thus, any difficulty attributable to such factors could constitute a contraindication to LVAD placement.
Technique or Treatment
The operation is performed using either a median sternotomy or left thoracotomy. Cardiopulmonary bypass is established. The apex of the heart is elevated, and an area approximately 1 cm lateral to it is selected; this is ideally confirmed with echocardiographic guidance. The device's sewing ring is sutured to the apex. The left ventricle apex is then cored out, and all muscle bands are cleared to prevent inflow obstruction. The LVAD inflow cannula is secured to the sewing ring.
The outflow graft, with a fenestrated bend relief, is sized to the ascending aorta. The graft is anastomosed to the ascending aorta, and de-airing is performed. The driveline is tunneled and exits the abdominal wall at the planned site. The LVAD pump is started with sequential speed increases. Ensuring adequate right ventricular function is essential; if not, right ventricular assist device support may be necessary. Cardiopulmonary bypass is then weaned off; closure is performed in the standard manner. Minimally invasive approaches to implantation have been described and widely adopted.[13]
Complications
Hematologic
Bleeding is the most common complication, occurring in both the perioperative period as well as later due to the need for anticoagulation with warfarin.[14] Cardiopulmonary bypass perioperatively alters the coagulation cascades and impairs the normal clotting mechanism, leading to bleeding. Also, bleeding has been attributed to the association of acquired von Willebrand disease in patients with LVAD, typically more than a week after the procedure.[15] This is usually reversible upon LVAD removal.[16] Bleeding may occur due to a leak at the pump site from polyester grafts in the conduits, the gastrointestinal mucosal surfaces, and intracranial vessels. The target international normalized ratio in outpatients is usually 1.5 to 2.5.[17]
Thrombosis is another significant hematological complication. Patients may develop pump thrombosis, embolic events, or stroke. These thrombotic events are usually due to subtherapeutic anticoagulation, atrial fibrillation, or infection that predisposes to a hypercoagulative state. Hemolysis is another possibility due to technical complications such as pump design issues, malpositioned cannulae, or the development of heparin-induced thrombocytopenia and pump thrombosis.[18]
Right Heart Failure
Anatomic changes following LVAD placement cause right ventricular geometric alterations. With left ventricular unloading, the septum shifts leftward. Increased cardiac output from the LVAD increases venous return to the right ventricle, which now has improved compliance. However, in patients with chronic heart failure, there is preexisting pulmonary hypertension; this can result in right ventricular failure, which may necessitate the use of milrinone to reduce pulmonary vascular resistance or epoprostenol as a selective pulmonary vasodilator.[19][20][21][22] In some circumstances, right ventricular mechanical support or extracorporeal membrane oxygenation (ECMO) may be required.[23][24]
Infection
The International Society of Heart and Lung Transplantation has classified infections based on their relationship to LVAD.[25][26] These infections typically occur at the pump site, pump pocket, or driveline. They usually present with localized warmth and erythema at the pump site, along with fever and leukocytosis. Ultrasound of the affected area can help diagnose collections and guide aspiration. Swabs are useful for directing treatment.
Most often, the gram-positive Staphylococcus aureus is isolated, though Enterococcus and other staphylococcal species may also be present. The most common gram-negative organism is Pseudomonas aeruginosa.[27] Effective treatment involves using appropriate antibiotics to target the pathogen. Surgical revision of the driveline away from the infection site may be necessary, and the pump generally needs to be replaced.
For deeper infections, surgical debridement with omental or muscle flaps or vacuum-assisted closure techniques, as described, may be required.[25][28][29] Infection significantly increases mortality rates. Therefore, severe infections may require device explantation, potentially accompanied by ECMO or cardiac transplantation as definitive treatments.
Neurological
Stroke is one of the most dreaded complications of LVAD placement. Both ischemic and hemorrhagic strokes are known to occur, either immediately postoperatively or after several months.[30] Strokes are more commonly located in the right hemisphere, indicating a cardioembolic source.[31] Ischemic events have been attributed to partial obstruction of the inflow cannula, blood deformation within the pump apparatus, outflow graft obstruction, and subtherapeutic anticoagulation or infection. The risk of hemorrhagic stroke is due to anticoagulation. Hence, a delicate balance is necessary to achieve optimum anticoagulation.
Arrhythmias
Ventricular arrhythmias are common after the procedure. Placement of the cannula can cause reentrant circuits.[32] Suction can cause the cannula to contact the ventricular septum, thereby triggering an arrhythmia. Also, significant weight changes or the development of scar tissue can cause malpositioning of the cannula, leading to arrhythmias.[33] Typically, the development of such arrhythmias can be managed by adjusting device settings, such as reducing LVAD speed to allow adequate ventricular filling. Management with a variety of medications is usually successful; however, refractory cases require catheter ablation or device exchange.
Clinical Significance
LVADs have become a critical therapy in the management of advanced heart failure, particularly in patients with class IV disease who remain symptomatic despite maximal guideline-directed medical therapy. These devices provide mechanical circulatory support by unloading the failing left ventricle and maintaining systemic perfusion, thereby improving cardiac output and end-organ blood flow. LVADs are most commonly used as bridge-to-transplant therapy in patients awaiting heart transplantation.
Still, they are also increasingly used as destination therapy for patients who are not transplant candidates. In selected cases, LVADs may serve as a bridge-to-recovery, allowing temporary ventricular support while myocardial function improves. The introduction of continuous-flow LVADs has significantly improved survival, functional status, and quality of life in patients with severe heart failure who previously had limited therapeutic options.
The clinical significance of LVAD therapy extends beyond hemodynamic support. By reducing left ventricle filling pressures and improving forward flow, LVADs can reverse some of the pathophysiologic consequences of chronic heart failure, including pulmonary hypertension, renal dysfunction, and hepatic congestion. However, LVAD implantation also introduces complex management considerations, including risks of bleeding, pump thrombosis, stroke, right ventricular failure, and device-related infection. As a result, successful outcomes require careful patient selection, perioperative optimization, and long-term multidisciplinary management involving cardiologists, cardiothoracic surgeons, intensivists, advanced practice providers, nurses, pharmacists, and rehabilitation specialists.[34] LVAD therapy has therefore become a cornerstone of modern advanced heart failure management, offering a life-prolonging option for patients who previously faced extremely limited survival.[35]
Enhancing Healthcare Team Outcomes
Caring for patients with an LVAD requires specialized clinical skills and coordinated strategies across multiple disciplines to ensure safe and effective care.[36] Physicians and advanced practitioners must be proficient in patient selection, perioperative optimization, and long-term management of LVAD physiology, including interpretation of device parameters such as pump speed, flow, pulsatility index, and power consumption. Early recognition and management of complications, such as right ventricular failure, pump thrombosis, bleeding, infection, and arrhythmias, are critical to improving outcomes. Nurses play a central role in continuous monitoring of hemodynamics, driveline care, and patient education regarding device maintenance, alarm management, and lifestyle adjustments. Pharmacists contribute by optimizing anticoagulation and antiplatelet therapy, managing heart failure medications, and monitoring for drug interactions or bleeding risks associated with long-term antithrombotic therapy.
Effective interprofessional communication and care coordination are essential throughout the continuum of LVAD care, from evaluation and implantation to outpatient management and potential heart transplantation. Collaboration among cardiologists, cardiothoracic surgeons, intensivists, advanced practitioners, nurses, pharmacists, physical therapists, and social workers helps ensure comprehensive patient-centered care. A retrospective review on the impact of a standardized interdisciplinary outpatient LVAD clinic demonstrated an important role of regimented follow-up in reducing morbidity and mortality.[36]
Clear communication regarding device status, hemodynamic changes, and potential complications enables rapid intervention and improves patient safety. Coordinated discharge planning, structured outpatient follow-up, and rehabilitation programs support functional recovery and quality of life. This team-based approach enhances clinical decision-making, reduces complications, and promotes optimal long-term outcomes for patients living with LVAD support.
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