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Thinking beyond resynchronization therapy in the failing heart

Kimberly A. Parks, DO,* Maria Rosa Costanzo, MD†
From the *Advanced Heart Failure Section, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, and †Center for Advanced Heart Failure, Edwards Heart Hospital, Midwest Heart Foundation, Lombard, Illinois.

Introduction
Heart failure (HF) is a chronic, progressive disease that leads to high morbidity and mortality. In 2010, approximately 5.8 million people in the United States were diagnosed with HF. Each year, approximately 670,000 people are diagnosed with HF, and more than 290,000 deaths are associated with the disease.1 Despite advances in medical therapy, the incidence of HF continues to rise, mainly due to the growth of the aging population2 and the increased risk of HF with advancing age.1 When treated with appropriate medical therapy, many patients with HF improve significantly and may even recover completely. Implantable cardioverter-defibrillators (ICDs) have added a significant survival benefit,3,4 however, as a result, more patients go on to experience end-stage disease. Some patients who have progressive disease may benefit from cardiac resynchronization therapy (CRT),5–7 but many still develop progressive HF symptoms and end-stage disease. This article reviews the advanced therapies available to patients with end-stage HF that is refractory to CRT and medical therapy. These options include cardiac transplantation, ventricular assist devices (VADs), and the total artificial heart (TAH).

Cardiac transplantation
Organ transplantation was first explored in the early 1900s with surgery performed on animals.8 The first human cardiac transplantation was performed in 1967 by Dr. Christiaan Barnard in Cape Town, South Africa (Table 1).9 The initial results were poor: the first cardiac transplant recipient died 18 days after surgery due to infectious complications. Increased understanding of immunomodulation and the development of newer immunosuppressive agents have led to improved survival, with a current 1-year survival rate of 83% and a 10-year survival rate of 50%.10 These rates far surpass the approximate 25% 1-year survival rate of patients with American College of Cardiology/American Heart Association (ACC/AHA) stage D HF (Table 2) who are inotrope-dependent.11 When HF progresses to end-stage disease, the only possibility of survival for many patients is a heart transplant. Cardiac transplantation should be considered for those patients who otherwise would have a very high 1-year mortality (Ͼ50%) and is the therapy of choice for patients with end-stage HF that is refractory to medical therapy.12 However, cardiac transplantation is not the answer for all patients with end-stage disease, and significant problems are associated with transplantation. First, many patients with HF may not meet selection criteria13 due to extracardiac factors such as concomitant systemic disease or lack of social support. Second, immunosuppressive therapy is a lifelong commitment, requiring frequent monitoring in the initial posttransplantation period, including weekly to monthly endomyocardial biopsies to assess for rejection.14 Finally, although cardiac function continues as long as the allograft remains viable, over time cardiac transplantation can lead to various iatrogenic conditions. Within 1 year, 73% of surviving recipients have hypertension, 27% have renal dysfunction, 58% have hyperlipidemia, and 27% have diabetes mellitus. At 5 years, these rates increase to 93% for hypertension, 31% for renal dysfunction, 87% for hyperlipidemia, and 37% for diabetes mellitus. The prevalence of malignancy among 5-year survivors is 14.3%, and 31% have allograft vasculopathy. The leading cause of death after transplantation is rejection, followed by infection and malignancy.10 Most importantly, cardiac transplantation is limited by donor organ availability and wait times, which can range
http://dx.doi.org/10.1016/j.hrthm.2012.04.025

KEYWORDS Artificial heart; Cardiac resynchronization therapy; Cardiac transplantation; End-stage heart failure; Ventricular assist device ABBREVIATIONS ACC ϭ American College of Cardiology; AHA ϭ American Heart Association; AF ϭ atrial fibrillation; CRT ϭ cardiac resynchronization therapy; EMI ϭ electromagnetic interference; FDA ϭ United Stated Federal Drug Administration; HF ϭ heart failure; HM II ϭ HeartMate II; HM XVE ϭ HeartMate XVE; ICD ϭ implantable cardioverter-defibrillator; INR ϭ international normalized ratio; LV ϭ left ventricle; LVAD ϭ left ventricular assist device; MMVT ϭ monomorphic ventricular tachycardia; NYHA ϭ New York Heart Association; PMVT ϭ polymorphic ventricular tachycardia; RV ϭ right ventricle; TAH ϭ total artificial heart; VA ϭ ventricular arrhythmia; VF ϭ ventricular fibrillation; VT ϭ ventricular tachycardia (Heart Rhythm 2012;9:S36 –S44) Dr. Parks has received consultancy fees from Thoratec. Dr. Costanzo has received research support from St. Jude Medical, Paracor Medical, and CardioMems; honoraria from CHF Solutions, St. Jude Medical, and Gilead; and consultancy fees form CHF Solutions, Medtronic, and St. Jude Medical. Address reprint requests and correspondence: Dr. Kimberly Parks, Harvard Medical School, Massachusetts General Hospital, 55 Fruit St/GB 800, Boston, MA 02114-2621. E-mail address: kaparks@partners. org.

1547-5271/$ -see front matter © 2012 Heart Rhythm Society. All rights reserved.

LVAD ϭleft ventricular assist device.16. a patient initially deemed to be an inappropriate candidate for transplant may become suitable. but less than ordinary physical activity results in fatigue. and Blood Institute began to sponsor the development of an artificial heart program.17 They can be placed percutaneously or can be fully implantable. from months to years. which are fully implantable pumps intended as long-term support for patients who have endstage LV failure. palpitation. Available devices can support the right ventricle (RV). or a total artificial heart TAH. Lung. left ventricle (LV). or long-term support.Parks and Costanzo Thinking Beyond Resynchronization Therapy in the Failing Heart S37 Table 1 Landmark events in the development of ventricular assist devices Year 1954 1964 1966 1967 1969 1970s 1974 Event Development of the cardiopulmonary bypass machine Chartering of the Artificial Heart Program by the National Heart. The program included development of mechanical devices for short. Of those patients listed for cardiac transplant.15 VADs The concept of mechanical circulatory support first gained attention in 1964. or both. The first-generation LVADs were used clinically in the mid-1980s. approximately 20% will die each year while awaiting a donor organ. LVADs may become a “bridge to decision”. that number has remained static over the past 10 years.19 In practice. and they can be used for acute. or anginal pain Unable to carry out any physical activity without discomfort Symptoms of cardiac insufficiency may be present even at rest HF ϭ heart failure. dyspnea. the most promising option is long-term mechanical circulatory support.10 As a result of limited donor organ availability and long wait times. In 2003. Long-term mechanical circulatory support devices include the left ventricular assist device (LVAD). and despite the growing population of patients with HF.and long-term circulatory support as well as development of a TAH. consideration has been given to therapeutic Table 2 Classifications of heart failure American College of Cardiology/American Heart Association Staging System Stage A High risk for developing HF Hypertension Coronary artery disease Diabetes mellitus Family history of cardiomyopathy Previous myocardial infarction Left ventricular systolic dysfunction Asymptomatic valvular disease Known structural heart disease Shortness of breath and fatigue Reduced exercise tolerance Marked symptoms at rest despite maximal medical therapy Stage B Asymptomatic HF Stage C Symptomatic HF Stage D Refractory end-stage HF New York Heart Association (NYHA) Functional Classification Class I Class II Class III Class IV No symptoms with ordinary activity Slight limitation of physical activity Comfortable at rest. The focus of this article is on LVADs. or a patient may develop myocardial recovery20 and potentially be weaned off the device. Birks et al17 demonstrated that a number of patients with dilated 1984 1985 1991 1993 1994 1994 FDA ϭ United States Food and Drug Administration. VAD ϭ ventricular assist device. Nearly 3300 transplants are completed in North America and Europe each year. VADs can reduce mortality in patients waiting for transplant and can serve as an alternative to cardiac transplantation. and Blood Institute First use of a pneumatic device as a bridge to recovery First human heart transplantation First successful use of a pneumatic total artificial heart as a bridge to transplantation Development of a variety of extracorporeal and implantable pneumatic VADs Redirection of the efforts of the Artificial Heart Program toward the development of implantable devices First implantation of a total artificial heart as a permanent device Multicenter evaluation of left ventricular assist devices as a bridge to transplantation Moratorium on the use of the total artificial heart FDA approval of a New Investigational Device exemption for a total artificial heart FDA approval of an LVAD as a bridge to transplantation First use of a wearable LVAD 1996–present alternatives to improve survival rates in patients with HF. but ordinary physical activity results in fatigue. or angina Marked limitation of physical activity Comfortable at rest. a biventricular assist device. dyspnea. LVADs were also approved by the FDA for destination therapy. . when the National Heart.18 and the devices were approved by the United States Federal Drug Administration (FDA) in 1994 for use as a bridge to transplantation. Currently. intermediate. palpitation. Lung.

28 Social and psychological circumstances also should be considered. and third-generation pumps based on their engineering design (Table 3). Three long-term support LVADs have been approved for use by the FDA: Novacor (World Heart Corp. No 8S. repair may be indicated at the time of LVAD implantation. Patient selection is crucial. It can be programmed to offer partial or full support. the device risk exceeds benefit. Contraindications include consideration of recipient age. coagulation disorders. Second. after years of continued development.19 Many other devices have been manufactured and are available for use in clinical trials or in Europe. August Supplement 2012 First-generation devices Pulsatile pumps HeartMate XVE (Thoratec Corp) HeartMate IP1000 (Thoratec Corp) Thoratec PVAD (Thoratec Corp) Thoratec IVAD (Thoratec Corp) Novacor LVAS (World Heart Corp) Third-generation devices* Continuous-flow.21 HeartMate XVE. The recipient must demonstrate the ability to operate the device and maintain compliance with medications. With the newer-generation devices. and body size. RV function. infectious diseases. USA) Continuous-flow. allowing for much greater patient mobility. The goal of fully implantable systems has yet to be attained. and it can provide a maximum stroke volume of 83 mL. Timing of device placement is critical. feasibility of implanting the LVAD.18 and the HeartMate II (HM II. Third-generation devices are under clinical investigation and currently are not available for commercial use in the United States. The most widely used device in current clinical practice is the HM II.23 Risk models typically assess severity of HF. A hand pump can be used to operate the device in case of emergency. the mechanical pump itself. Multiple risk models have been developed to predict which patients will have a favorable outcome and to predict optimal timing for device placement. and a number of variables must be considered. If the patient has significant valvular pathology or septal defects. This device was large with bulky external components that limited the patient’s mobility. and if the device is placed in patients with advanced disease. Trials are ongoing in the United States to assess the use of LVADs as a bridge to recovery. usually via cardiopulmonary exercise testing. contraindications. no longer manufactured). Vol 9. in which the pump senses an increase in ventricular volume and activates the pusher plate to eject blood into the aorta. was the HeartMate XVE (HM XVE). if a device is placed too early. Technological advances in the design.27 The feasibility of device implantation takes into account an individual patient’s anatomic factors. and 74% of these patients survive to undergo transplantation.24 –26 Severity of HF is based on clinical and hemodynamic assessment as well as assessment of functional capacity. biomaterials. developed in 1991. Thoratec Corp). They are further divided into first-. but all consist of a power source and console.30 First-generation VADs were large pulsatile pumps with cumbersome external components. volume displacement pump. second-. rotary pumps with contact bearings HeartMate II (Thoratec Corp) Jarvik 2000 FlowMaker MicroMed-DeBakey (MicroMed) *In various stages of clinical development.and third-generation LVADs are nonpulsatile pumps. cardiomyopathy who were implanted with an LVAD and were given concomitant medical therapy had reverse remodeling and were able to have their LVADs successfully weaned and explanted. and hepatic function. The first to be used in a clinical trial was the HeartMate LVAD. pulmonary. largely due to problems with reliability.28 First-generation LVADs The initial implantable LVADs consisted of a pulsatile.S38 Table 3 Left ventricular assist devices grouped by engineering design Second-generation devices Heart Rhythm. 91% of patients with severe congestive HF can be discharged from the hospital. rotary pumps without contact bearings HeartWare HVAD (HeartWare Inc) HeartMate III (Thoratec Corp) VentrAssist (Ventracor) Levacor (World Heart Corp) Incor (Berlin Heart AG) DuraHeart (Terumo Somerset. Pulsatile flow is delivered using a pusher plate system.29. and individual operative risk.31 Currently available LVADs are composed of an inflow cannula that is placed at the apex of the LV. The external components vary in size and portability.32 . the operative risk exceeds the benefit.22 Classification and design of LVADs LVADs are classified into two categories: pulsatile pumps (volume displacement) and nonpulsatile (continuous-flow) pumps. an outflow conduit that is attached to the ascending aorta. not available for commercial use in United States. and a percutaneous drive line that is connected to various external components (Figure 1). and newer wearable systems have performed remarkably well in patients awaiting transplantation. Selection criteria Patients who should be considered for long-term mechanical circulatory support are those with NYHA functional class IIIb/IV and ACC/AHA stage D HF (Table 2). and some devices that previously were developed are no longer being manufactured for various reasons. renal. and miniaturization of LVADs have eliminated bulky external consoles.17. This system consists of portable battery units that can be carried. The final iteration. and other inflammatory disorders as well as malignancies and nutritional status. The patient must have a support network in place to help provide adequate postoperative wound care and assistance should a device malfunction occur.

Second-generation devices have largely replaced firstgeneration devices in clinical practice. nonpulsatile flow. first-generation devices had a high failure rate. Figure 2 HeartMate II LVAD in situ.36 The leading causes of death in patients with the HM II device were hemorrhagic stroke. are more durable. The HM II is the only second-generation LVAD approved for use by the FDA: for bridge to transplantation (in 2008) and as destination therapy in 2010 (Figure 2). these pumps are highly preload-dependent for optimum function. Clinical outcomes have proved to be superior to those seen with the firstgeneration devices. The rotor is capable of producing flow rates up to 10 L/min. which most often occurred as a result of inflow valve incompetence. thereby eliminating the need for the valves associated with the high device failure rate of first-generation LVADs. therefore. It is important to note that second-generation LVAD continuous-flow pumps have the capability of generating negative intraventricular pressure and ventricular collapse. they contain a rotary blood pump with an internal rotor suspended by contact bearings.5. Unfortunately. Additionally. fatal sepsis (25% of patients). with 1-year survival as high as 69% vs 26% in the medical therapy arm. or recovery of 79% at 18 months.37 with a more narrow range depending on individual patient characteristics such as presence of atrial fibrillation.33 This study demonstrated that patients with the HM XVE device had substantially better outcomes than did those in the medical treatment arm. Postapproval studies have demonstrated a 1-year survival rate of 85%.34 and have a lower risk of infection.5 and 2. More than 8000 HM Second-generation LVADs Second-generation LVADs use continuous.Parks and Costanzo Thinking Beyond Resynchronization Therapy in the Failing Heart S39 Figure 1 HeartMate XVE LVAD in situ. they are thrombogenic and require anticoagulation with a recommended international normalized ratio (INR) level between 1.35 The results of the pivotal trial assessing the HM II as a bridge to transplantation demonstrated excellent survival outcomes. with a 2-year survival rate of only 35%.32 A high rate of complications in patients implanted with the HM XVE included infection (28% of patients by 3 months). and long-term outcomes. Image courtesy of HeartMate. ongoing support. .5 m2). Durability was also poor due to bearing wear resulting from accumulation within the device filters of metal debris produced by the pusher plates. The HM XVE was used in the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial. In contrast to first-generation devices. and external power interruption. RV failure. Rather than having a volume displacement pump. The poor results were primarily attributed to a high rate of mechanical failure. which compared the use of a LVAD to conventional medical therapy in patients with end-stage HF. remained poor. Patient selection was limited because the large pump could be placed only in larger individuals (body surface area Ͼ1. and a high rate of bleeding events (42% of patients by 6 months). High failure rates and the bulky size of first-generation devices highlighted the necessity for development of smaller pumps with greater durability. although superior to those of medical therapy. with better actuarial survival at 2 years compared to outcomes seen with the HM XVE (58% vs 24%) and a 1-year survival rate of 68%. with survival to transplantation. sepsis. Image courtesy of HeartMate. these pumps are smaller to accommodate smaller patients.

elevated right atrial pressure (Ͼ20mm Hg). Warfarin goals in patients with an LVAD who also have AF should be adjusted to match the goals needed in patients with AF. Other considerations: RV failure. is also a miniaturized. Drugs that are contraindicated in the HF population should be avoided. In some cases with RV dysfunction. when they first came to clinical use. and ICDs RV failure LVADs provide total replacement therapy for the LV. and biventricular support should be considered. and Levacor. as is patient selection to ensure the ability of the heart to tolerate LV support alone. After LV support is placed.39 Thirdgeneration devices include HeartWare (Figure 3).31 The HeartMate III LVAD. No 8S. the success of the device is dependent on RV and pulmonary flow. Image courtesy of HeartMate. there is typically minimal compromise in hemodynamics because the atrial contribution to left-sided stroke volume is no longer needed.41 Risk models have been developed to help determine which patients are at highest risk for RV failure postoperatively. as well as increased pulmonary vascular resistance. Attempts should be made in the perioperative period to optimize RV function using inotropes. which may occur in the immediate postoperative setting. potentially leading to shorter postoperative recovery times. it is about the size of a golf ball and weighs about 6 oz. there is a potential for the thrombus to become lodged within the impeller. left-sided output increases.44 In the HF population. the atrial contribution to RV stroke volume may play a more important role. intrathoracically implantable blood pump and should be available for clinical trials in 2012. including formation of scar tissue. Management of AF in patients with a LVAD should follow the same treatment guidelines as in the general HF population and includes the use of beta-blockers for rate control and antiarrhythmic agents (dofetilide. Arrhythmias Both ventricular and atrial arrhythmias are common in patients with end-stage HF due to a number of various mechanisms. and restoration of sinus rhythm may be beneficial. and low mean pulmonary arterial pressures in the setting of elevated right atrial pressures.43 When a patient with an LVAD develops an atrial arrhythmia such as atrial fibrillation. It is placed in the intrapericardial space above the diaphragm.45 This risk is confounded with the increased risk of early postoperative AF that occurs after patients have undergone cardiac surgery. appropriate perioperative management is crucial. patients who have atrial fibrillation (AF) are at higher risk for thromboembolism than are those without HF. Figure 4 HeartMate III LVAD.42 Isolated LV support should not be offered to patients who are at high risk for postoperative RV failure. It embodies the design of a miniaturized LVAD. the LV cannot adequately fill. Vol 9.46 AF poses a unique threat in patients who have a LVAD because if thrombus were to form and subsequently propagate from the left atrium. VentriCor. . but in contrast with second-generation devices. and neurohormonal and electrolyte abnormalities. Therefore. therefore. amiodarone) and/or cardioversion when restoration of normal sinus rhythm is desired.40 Poor prognostic indicators of RV performance after LVAD placement include low RV stroke work index. Without adequate output from the right side of the heart. August Supplement 2012 Third-generation LVADs Third-generation LVADs have more efficient electronics and are designed for ultra-long life. They use continuousflow pumps. leading to mechanical failure of the pump. can lead to RV failure.38.S40 II LVADs have been implanted worldwide since late 2004. arrhythmias. leading to a rise in preload to the RV.37 Figure 3 HeartWare LVAD. Image courtesy of HeartWare.5. dilation and hypokinesis of the RV. the internal rotor uses magnetic levitation that eliminates contact with bearings and the resulting wear. hemodynamic derangements. The HeartWare LVAD has been used in clinical trials in the United States and has gained the most popularity to date. Heart Rhythm. The increased preload. currently under development. severe tricuspid regurgitation. and pulmonary vasodilators. HeartMate III (Figure 4). diuretics.5–2. as the INR goal for patients with an LVAD ranges from 1. and more than 350 patients have been supported for more than 5 years. centrifugal.

strong consideration should be made for implantation of a prophylactic ICD in patients who do not already have an implanted device. impedance decreased from 479 Ϯ 118 ⍀ to 418 Ϯ 94 ⍀ (P ϭ .7 Ϯ 3.2 Ϯ 3.1 mV to 5. RV lead revisions were recommended for 4 patients (13%). but new scar is formed at the area of cannula insertion. EpicϩHF V-350. RV output is decreased and cardiac output drops. particularly with the firstgeneration devices57.Parks and Costanzo Thinking Beyond Resynchronization Therapy in the Failing Heart S41 Ventricular arrhythmias (VAs) are common in patients with severe HF and include monomorphic ventricular tachycardia (MMVT). and ventricular tachycardia.58 Because the RV is not supported. the 1-year risk of appropriate ICD treatment in those with an indication for primary prophylaxis was 24%.63 Other observational studies have reported similar findings.” These occur when there is movement of the intraventricular septum toward the inflow cannula and the endocardium is “sucked” into the inflow cannula.47. but wall tension is decreased as the ventricle is decompressed with LVAD therapy.63 Electromagnetic interference EMI with the HM II LVAD has been demonstrated in several ICD models. One patient did not sense VF during defibrillation testing.53 and patients who experience VA after LVAD implant have been shown to have a higher mortality rate than those without VA.7 mJ to 11. As discussed in the previous section.64 In the cases in which loss of ICD-to-programmer telemetry occurred. sustained arrhythmias can lead to decreased pump flow. Jude Atlas VR V-193. and failure of sensing and capture was noted in 2 patients.50 Preexisting myocardial substrate is not altered during LVAD placement.6 mV (P Ͻ. and 6 patients (20%) required ICD testing. 9 patients (30%) required follow-up interventions. appropriate treatment of VA in patients supported by LVADs is an important aspect of optimal management and outcomes. leading to both arrhythmias and hemodynamic instability.62 Therefore.001). Because a fair number of patients do experience hemodynamic instability with VA after LVAD placement and because the incidence of VA increases after implantation of a LVAD. while the device was programmed to the most sensitive sensing level and the battery pack was plugged into a wall socket with 240-V AC. the SJM . provide a substrate for reentrant circuits around the inflow cannula. and amplitude after LVAD implantation.008). with decreased pump flow. in some cases. polymorphic ventricular tachycardia (PMVT). leading to VA. The presence of VAs can be tolerated in patients supported by an LVAD. and threshold increased from 4. but there are several proposed mechanisms. and EpicϩVR V-196 as well as the Sorin Ovatio DR. and the incidence of appropriate ICD treatment is high. inappropriate sensing.61 These changes occur early after LVAD implantation and persist over time. One patient experienced an inappropriate shock due to lead oversensing. Compared to preimplantation values. Therefore.3 Ϯ 6. including changes in lead parameters. This unusual case occurred during battery charging by the pump console. except in one observational case study in which oversensing occurred and an inappropriate shock was delivered.63 A retrospective review of 30 patients with an ICD who underwent LVAD placement with either an HM XVE or HM II device demonstrated changes in RV lead impedance. including the St. it is important to perform ICD lead threshold testing early after implantation and to inform the patient of the potential need for device revision after LVAD implantation. Finally.52 An increased incidence of VAs has been noted in continuous-flow VADs compared to the first-generation devices. In patients who had an ICD placed for secondary prevention.52. and electromagnetic interference (EMI).49 PMVT and VF usually are the result of repolarization abnormalities associated with progressive dysfunction of the failing ventricle. Changes in lead sensing could be due to the geometric distortion that occurs when the ventricle is decompressed and could result in changes in lead sensing. threshold. altered efficacy of high-voltage therapy.64 – 66 but device function has not been shown to be altered due to EMI.59 In a prospective study of 61 patients who underwent LVAD implantation. where the inflow cannula is placed. Additionally.60. several factors have been identified as contributing to the increase in VAs after LVAD placement. the 1-year risk of appropriate ICD treatment was 50%.51 As the LV is decompressed with LVAD therapy. Thus. with the highest risk in the immediate postoperative period.54 With continuous-flow devices.48 Whereas MMVT typically arises in areas of scar. the frequency of VAs increases after LVAD placement. sensing amplitude decreased from 9. These models have demonstrated loss of ICD-to-programmer telemetry. Positioning can trigger arrhythmias.64 The exact mechanism of why these changes occur after LVAD placement is not known. VA is common after LVAD placement. As a result of alterations in lead parameters. surgical manipulation of the ventricular apex and microdislodgement of the RV lead is another plausible mechanism.55 Other factors contributing to increased arrhythmias include changes in ventricular repolarization56 and altered calcium handling gene expression. Mechanico-electric feedback has been noted to occur as a result of the VAD motor. there is a subsequent slight decrease in the incidence of PMVT and VF. The decrease in wall tension can reduce the incidence of PMVT and ventricular fibrillation (VF) after LVAD placement.53 Although the mechanisms are not well understood.60. arrhythmias can occur as a result of “suction events. the apical cannula must be surgically repositioned. the frequency of MMVT is increased due to creation of new scar tissue in addition to the existing substrate.0 Ϯ 16. alterations in lead sensing could be related to absence of a portion of LV myocardium that was involved in sensing and capture due to surgical removal of a core from the LV apex necessary for implantation of the LVAD. Mechanical irritations and scar tissue formation at the LV apex. and. however.60 LVADS and ICDs Clinically important interactions between LVADs and ICDs can occur. however.8 mJ (P ϭ .021).

stroke. The AbioCor device is FDA-approved under a Humanitarian Device Exception. and it is intended as a destination therapy for patients who are not eligible for transplant. there is no need for reoperation if a part fails.2-kHz operating frequency used by the HM II pulse width modulator. Images courtesy of SynCardia. with a rate of survival to transplantation of 79% compared to 49% of controls. It is fully implantable with no externalized parts. Ongoing trials are now assessing the safety of the device for home use. are not a candidate for an LVAD. progressive dis- . Medtronic 175 kHz. It has been implanted in approximately 14 patients to date and soon will be available for clinical trial use in the United States. It was intended to provide total circulatory support. Sorin devices that have demonstrated EMI use an operating frequency of 16 kHz. biventricular failure in patients who are not candidates for an LVAD due to RV failure. Because the driveline is externalized. ICD models mentioned use an operating frequency of 8 kHz.S42 Heart Rhythm. or are unable to wean from biventricular assist devices. The SynCardia TAH was approved as a bridge to transplantation in 2004 and is available only for in-hospital use in the United States. which is close to the 7. Smaller drivers have been devel- oped to ease this application because the current in-hospital driver weighs 418 lb. Newer-generation ICDs that are manufactured by SJM operate at a frequency of 64 kHz. The current indication for the TAH is severe. EMI has not been demonstrated with devices that operate at higher frequencies (Biotronik 32 kHz.69 Common adverse events associated with the SynCardia TAH include bleeding. and infection. The role of palliation cannot be underestimated in this population. Boston Scientific 100 kHz). Survival data are promising and comparable with those seen with LVADs as a bridge to transplantation.and 5-year survival rates after transplantation are 86% and 64%. the 1. No 8S. August Supplement 2012 Figure 5 The SynCardia total artificial heart and it’s accompanying ЉBig BlueЉ Driver which is used to power the device. Palliative care Current advances in technology have allowed patients with HF to survive longer with an improved quality of life. electronic parts can be repaired easily. respectively. but many will not be candidates for any of the advanced therapies discussed. The device is powered by a large pneumatic driver within which all electronic parts are contained.67. and early involvement of palliative care teams is essential. Vol 9. require multiple agents for inotropic support.70 HF is a chronic.68 The two FDA-approved TAHs are the SynCardia temporary TAH (Figure 5) and the AbioCor replacement heart (Figure 6).66 TAH The TAH had been conceptualized for years before it was first implanted in a human in 1984.

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