Best Practice & Research Clinical Anaesthesiology 29 (2015) 203e227
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Mechanical circulatory support Kathirvel Subramaniam, MD, MPH, Visiting Associate Professor Department of Anesthesiology, University of Pittsburgh, Pittsburgh, PA 15213, USA
Keywords: ventricular assist device mechanical circulatory support
Heart failure (HF) is a condition in which the heart is not able to pump enough blood and oxygen required for organ systems to function. According to recent statistics from the American Heart Association (AHA), about 5.1 million people in the nation suffer from HF; one in nine deaths in 2009 included HF as a contributing cause. About half of people who develop HF die within 5 years of diagnosis. HF costs the nation an estimated $32 billion each year. This total includes the cost of health-care services, medications to treat HF, and missed days of work [1]. Despite several recent promising developments in medical therapy for HF, many patients still progress to advanced stages of HF. The annual mortality rate for patients with advanced HF remains high [2]. Heart transplantation (HT) is the definitive therapy for advanced HF, but it is limited by the availability of donors and strict recipient criteria applied to avoid poor outcomes. Therefore, the alternate treatment of mechanically supporting the ventricles, ventricular assist device (VAD) therapy, has gained an important role in the management of advanced HF (stage D). This chapter discusses the indications, contraindications, and various classifications of mechanical circulatory support (MCS) and individual features of commonly used VADs. Perioperative management of patients undergoing MCS will also be described in detail. © 2015 Elsevier Ltd. All rights reserved.
Indications and categories of mechanical circulatory support Heart failure (HF) is a well-recognized costly public health problem with high patient mortality [1,2]. Patients with heart failure symptoms refractory to optimum medical treatment are referred for mechanical circulatory support therapy. According to Interagency Registry for Mechanically Assisted E-mail address: [email protected]. http://dx.doi.org/10.1016/j.bpa.2015.04.003 1521-6896/© 2015 Elsevier Ltd. All rights reserved.
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Table 1 Intermacs patient profiles for end-stage heart failure. Profile Clinical picture 1 2 3 4 5 6 7
Critical cardiogenic shock. Life-threatening hypotension, increasing requirement for inotropes with evidence of organ hypoperfusion (elevated lactate levels and acidosis). Patients need MCS in hours. Progressive decline on inotropes with evidence of volume overload, poor tolerance to increasing doses of inotropes and impaired organ perfusion. Patient will need VAD support in few days. Clinical stability on moderate dose of inotropes or temporary circulatory support, can be hospitalized or at home. VAD support indicated in weeks. Recurrent advanced heart failure e resting symptoms on home oral therapy. VAD support is indicated in weeks or months. Exertion intolerant e comfortable at rest, but ADL limited by symptoms. VAD support requirement is variable. Exertion limited e ADL not limited, but all meaningful exertion limited. VAD support requirement is variable. History of decompensation but currently stable at reasonable level of activity (advanced NYHA Class 3). VAD implantation has been shown to improve survival.
ADL, Activity of Daily Living. NYHA, New York Heart Association.
Circulatory Support (Intermacs) statistics, about 12,474 ventricular assist devices (VADs) were implanted across 149 participating programs in the United States between June 2006 and September 2014 [3]. Intermacs classified severe heart failure (HF) into seven subcategories to describe patient status before VAD implantation (Table 1). Potential modifiers for the clinical profiles include frequent shocks (>2 per week) by a defibrillator, requirement for any form of temporary circulatory support (TCS) (applies to profiles one, two, and three), and frequent hospitalizations (three visits in 14 days after LVAD implantation [45]. RVAD is required in 50% of patients undergoing VAD placement for acute shock and 4e10% of patients undergoing LVAD for chronic HF [46,47]. RV dysfunction after LVAD is associated with increased mortality and morbidity [45]. LVAD recipients with RV dysfunction also have higher reexplorations, longer hospital stay, and lower survival to HT. Several perioperative factors contribute to RVF after LVAD placement [48] (Table 8). Therefore, preoperative prediction of RV function using clinical, laboratory, hemodynamic, and echocardiographic parameters is of paramount importance in improving the prognosis of LVAD recipients (Table 9). RV function is assessed intraoperatively by the correlation of several parameters: MAP, central venous pressure (CVP), mean PA pressure, CI, SVO2, flows through the LVAD, direct visualization of the RV through surgical field, and TEE evaluation of RV function. Elevated CVP, lower PA pressure/MAP ratio, lower CI and SVO2, lower flows through the LVAD, RV dilatation, and worsening TR all indicate the need to support RV function. Maintenance of adequate preload to the LVAD without causing RV dysfunction can be challenging. Fluid infusion and transfusion are titrated to PA diastolic pressures between 15 and 18 mm Hg and CVP between 10 and 15 mm Hg while observing the interventricular septum (IVS) and ventricular filling via TEE. Midline IVS position should be maintained by adjusting LVAD speed (RPM). Higher speed and flows can cause excessive LV unloading and negative pressure around the inflow cannula, resulting in LV collapse with leftward shifting of the IVS. This shift will further worsen RV function, as the septal
Table 9 Preoperative predictors of post-LVAD RV dysfunction. Clinical
Laboratory
Hemodynamic
Female gender Old age Poor nutritional status Obesity Nonischemic cardiomyopathy Redocardiac surgery Preoperative inotropes Preoperative mechanical ventilation Preoperative IABP/ECMO Emergency surgery
Elevated liver enzymes Hyperbilirubinemia Hypoalbuminemia Elevated BUN and creatinine Elevated NT-proBNP, C-reactive protein Thrombocytopenia Elevated prothrombin time
CVP/PCWP ratio > 0.64 Increased RAP RVSWI < 250 mm Hg. Ml/m2 CI < 2.2 l/m2
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contribution to overall RV contractility is lost. Decreasing the speed will enable the situation to revert back to normal. Factors causing elevation of PVR (hypoxemia, hypercarbia, acidosis, hypothermia, inadequate anesthesia, and excessive positive end expiratory pressure) should be avoided. MAP should be normalized to optimize RV function, keeping in mind systemic hypertension; the resultant increased afterload can cause a decrease in LVAD flows. Maintenance of sinus rhythm is advised to optimize hemodynamics. Sinus rhythm is important to preserve RV function and prevent clot formation and ventricular recovery. Patients with ischemic cardiomyopathy and significant right CAD may benefit from coronary artery grafting. The effect of continuous flow on the native coronary and graft blood flows deserves further investigation. Management of RV dysfunction is initially pharmacological with inotropes, vasopressin, and pulmonary vasodilators. Among the pulmonary vasodilators, inhaled nitric oxide (iNO) is used in the operating room and ICU to improve LVAD flows. However, a multicenter, placebo controlled, doubleblinded and prospective study by Potapov et al. failed to show any significant effect of iNO on the incidence of RV dysfunction after LVAD placement. Secondary end points such as requirement for RVAD, mechanical ventilation, and length of ICU and hospital stay were not improved [49]. Few studies using inhaled prostaglandins have shown a decrease in PA pressures after LVAD placement, but definitive conclusions on benefits for RV function cannot be drawn from available studies [50,51]. The phosphodiesterase 5 inhibitor sildenafil has been shown to improve persistent pulmonary hypertension after LVAD placement and to prevent the development of RVF [52,53]. Any beneficial effect of pulmonary vasodilators on PVR and RV function is probably masked by the effective unloading of pulmonary circulation by LVAD [54]. Inotropes are the mainstay of RV dysfunction. Milrinone 0.25e0.75 mg/kg/min is initiated while the patient is on CPB for inotropy and pulmonary vasodilatation. A bolus of milrinone can be given before the termination of bypass if MAP is not low. Epinephrine of 0.05 mg/kg/min is added before the termination of bypass, and it is increased to 0.1 mg/kg/min as needed. Dobutamine and dopamine are not commonly used intraoperatively at our institution, but practices may vary. Preoperative optimization with levosimendan, a calcium-sensitizing inodilator, has also been investigated in two reports, and it was shown to improve hemodynamic performance and identify patients who will develop RVF after LVAD insertion [55,56]. This drug is not approved by the US FDA, and more controlled clinical trials are required before its routine use is adopted for patients who underwent cardiac surgery. Vasoplegic syndrome after LVAD implantation occurs in up to 40% of patients [57,58]. The mechanisms include excessive endogenous production of nitric oxide, the lack of vasopressin, systemic inflammatory response, and the use of pulmonary vasodilators (e.g., milrinone). Preoperative low LV ejection fraction, prolonged CPB, and preoperative ACEI intake are risk factors. Vasoplegic syndrome is best treated by the infusion of vasopressin, which increases MAP with negligible effects on PVR [59,60]. Severe vasoplegia may require the use of multiple vasopressors such as dopamine, norepinephrine, and methylene blue (in refractory vasoplegia). Failure to maintain adequate systemic blood pressure will lead to LV over-decompression, negative suction around the cannula on the LV, septal shift toward LV, and worsening RV dysfunction. If RV dysfunction persists despite maximum doses of inotropes (epinephrine of 0.1 mg/kg/min and milrinone of 0.75 mg/kg/min) and vasopressor support, RVAD should be inserted early to avoid venous congestion and end-organ dysfunction. Centrimag is the preferred RVAD device at our institution, although percutaneous RVAD devices are increasingly used for RV dysfunction nowadays [61,62]. The only long-term RVAD support device in use is paracorporeal Thoratec RVAD, which can provide support for up to 12e24 months as BTT [63]. HVAD has been used as BiVAD in a limited case series with good results [64]. Research is needed to pursue more options for long-term RV mechanical support after LVAD insertion, as a significant number of patients need continued RV support after failure to wean from temporary RVAD support [65].
Perfusion and surgical considerations Implantation of LVAD using the off-pump method is possible but hemodynamically can be very challenging, so most implantations are done with the use of normothermic or mild hypothermic CPB.
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Bicaval cannulation is recommended for tricuspid valve procedures and PFO closure. Aortic crossclamping and cardioplegic arrest are avoided, except when aortic or mitral valve procedures are necessary. CPB is utilized to remove excessive volume through ultrafiltration. CO2 in the field is used to decrease air embolism, and TEE-guided de-airing is performed before coming off CPB [33]. Ventricles are filled with volume, and Valsalva breaths are given to get the air out of the pulmonary circulation. Patients are placed in the Trendelenburg position, the outflow is clamped, and the needle inserted into the outflow graft proximal to the clamp to de-air the ventricles. Vigorous shaking of the atrium and ventricles may be needed to get the air out of the poorly contracting ventricles. Sometimes, air may appear in the ascending aorta even after thorough de-airing. If this happens or if RV function is poor, CPB should be reinitiated and de-airing maneuvers continued. The LVAD pump is started slowly at lower speeds, and MAP is maintained (afterload to LVAD) to avoid excessive LV decompression, septal shift, and consequent RV dysfunction. Pump speed can be increased slowly while monitoring TEE for septal midline position. Bleeding and transfusions Bleeding and transfusions are major concerns after LVAD insertion. Bleeding could be related to inadequate surgical hemostasis or medical coagulopathy. Common sites of surgical bleeding include the RA cannulation site, sternal wiring, pre-peritoneal pump pocket, and around the inflow cannula and outflow-aorta graft anastomotic site. Absolute surgical hemostasis should be ensured before closure of the chest. The chest can be kept open with packing if bleeding is significant or hemodynamic instability prevents closure. The sternum can be closed after removing clots when hemostasis is restored in 24 h. Delayed chest closure after LVAD insertion increases the ICU length of stay, but it does not increase infection rates [66]. Coagulopathy in VAD patients is multifactorial. Preexisting antiplatelet/anticoagulant therapy, liver dysfunction, hypothermia, prolonged CPB, platelet dysfunction, dilutional coagulopathy, and the effect of contact between mechanical device and blood all contribute to bleeding after LVAD insertion. Transfusion can be associated with three major problems in patients with VADs: transfusioninduced lung injury (TRALI), transfusion-induced circulatory overload (TACO), and transfusioninduced immunomodulation (TAIM) have implications for VAD patients [33]. TRALI may cause hypoxemia and increased PVR, thus necessitating venovenous ECMO support or RVAD support in some patients. TACO can cause RV dysfunction and increase morbidity. TAIM is associated with immunosuppression and increased infection rate. Transfusion-associated allosensitization and the formation of panel reactive antibodies can complicate a patient's listing for HT. Care to avoid transfusions in these patients is important. Normalizing coagulation preoperatively, the use of antifibrinolytics and retrograde autologous priming, the use of miniature circuits, and POC testing can reduce the need for transfusions. Transfusion cannot be avoided completely in all patients, and prompt treatment of coagulopathy with appropriate blood products is indicated. Desmopressin can be used in chronic renal insufficiency. The safety of factor concentrates in LVAD patients has not been established. Bruckner et al. have shown a high incidence of thromboembolic events (37%) with a high-dose factor VII (30e70 mg/kg) compared with a low-dose regimen (9.4% with 10e20 mg/kg) during LVAD procedures [67]. The successful use of prothrombin complex concentrate (PCC) has been reported in two patients with LVAD undergoing noncardiac surgery (NCS) without any thromboembolic sequelae [68]. Further research is required to establish the safety of factor concentrates in LVAD patients as they are given in smaller volumes than fresh-frozen plasma, thereby possibly avoiding RV dysfunction. Postoperative management Postoperative care of VAD patients is complex, and a multidisciplinary team approach involving intensivists, cardiac anesthesiologists, cardiac surgeons, HF cardiologists, perfusionists, VAD engineers, nutritionists, physical therapists, VAD nurses, and social workers is essential to improve outcomes. Teams should meet regularly to evaluate progress and future care. Patients who had MCS placed for ACS will need more intense care and experience longer ICU stays. These patients have a higher
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incidence of bleeding, reoperations, RVAD support, end-organ dysfunction, and mortality compared to those who had elective long-term VADs inserted for chronic HF. Postoperative hemodynamic management is a continuum of intraoperative intensive management. The usefulness of ImaCor hTEE has been shown in hemodynamic management after high-risk cardiac surgery and MCS [69,70]. Patients are extubated once the criteria are fulfilled, invasive monitors are removed, and they are taken off vasopressors/inotropes. Anticoagulation with heparin and Coumadin is started once bleeding is stable. Enteral nutrition is started as soon as possible, and renal replacement therapy may be required in patients with volume overload. Oral antihypertensives are restarted once the patients can orally take medication. Arrhythmias may indicate or may result in RV dysfunction. In one case series of 23 patients, ventricular arrhythmias occurred in 52% of patients. Eight patients received defibrillation and three of them became hemodynamically unstable [71]. AICD should be reactivated in the postoperative period or some VAD patients may require AICD insertion or ablation for intractable new onset arrhythmias. Reoperations are common, with bleeding and tamponade accounting for the majority of reoperations. Other reasons for reoperations include RV failure, pump failure, and infections [72]. Several other early and late complications are listed in Table 10 [73]. Among late complications, bleeding deserves special mention. Acquired VWF deficiency is reported with only CF-LVAD, which may result in bleeding episodes or excessive bleeding after HT [74e76]. Device explantation results in the resolution of this deficiency. Desmopressin and cryoprecipitate are recommended therapies. Another unique complication is the development of A-V malformations in the GI tract and bleeding in patients supported with CF devices [77,78]. Thrombotic complications are less common than bleeding. Altered blood flow in the chambers and cannulae and the activation of inflammatory/coagulation cascade are suggested mechanisms for VADrelated thrombosis. Development of thrombosis within the LVAD pump is the most devastating complication, and it has been increasing in frequency in the last 3 years. The diagnosis of VAD thrombosis requires symptoms and signs of HF, elevated lactate dehydrogenase from hemolysis, and echocardiography. VAD monitoring will show increasing power with a low PI. Thrombolysis, anticoagulation, and urgent surgical pump replacement are currently recommended therapies. More research is needed to understand this fatal complication [79]. Clinical heparin-induced thrombocytopenia (HIT) occurs in 10% of patients despite positive antibodies in 60% of patients [80]. Device malfunction and failure are uncommon with the third-generation CF devices nowadays. Infections are common, and they can be classified as device and nondevice related [73]. Infections are associated with significant morbidity, reoperations, and mortality. Device-related infections include driveline and pump-pocket infections, pump endocarditis, and sternal wound infections, and common systemic infections reported in LVAD recipients include respiratory, urinary tract, and catheter-related infections. CF devices with small parts produce fewer infections compared to pulsatile devices. The administration of prophylactic antibiotics is recommended before surgical incision and continued postoperatively for 48 h. Once an infection is diagnosed, it is treated with broad-spectrum antibiotics, surgical exploration/drainage, and, in refractory cases, VAD exchange or HT. Table 10 Early and late complications after VAD insertion. Early (60 days)
Bleeding requiring transfusion and reoperation (31e81%), Tamponade 28% Atrial and ventricular arrhythmias (30e60%) RV failure (10e30%)
Bleeding complications (17.5%)
Reoperations (50%) Respiratory failure (20e30%) Neurologic dysfunction stroke 15%, TIA 12%, seizures 4% Renal failure 3e28% Hepatic failure 2e8% Hemolysis Infections (42%)
GI bleeding 10e40% Thromboembolism 6% Pump thrombosis 2e9% Aortic valve degeneration (90% in long term) Cannula malposition/occlusion Infections (94% at 1 year) Hemolysis (0e3%) Psychiatric problems Device malfunction and failure (rare to 2%)
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Total artificial heart TAH devices can provide biventricular support for critically ill end-stage HF patients. They are useful in patients with severe biventricular failure, ventricular rupture, significant ventricular septal defect, and intractable arrhythmias. TAH offers an advantage in situations in which ventricular drainage may be inadequate (restrictive, hypertrophic cardiomyopathy). Currently, two TAH devices are available for human use: Cardiowest TAH and Abiocor implantable replacement heart. Cardiowest TAH is a pneumatically driven, pulsatile biventricular support device approved for use as BTT. It has two prosthetic ventricles that connect to the native atria (Fig. 10). The stroke volume is 70 cc, and it can deliver a maximum flow rate of 8 l/min. It has been implanted in 930 patients worldwide. Copeland et al. described its use in 101 patients between 1993 and 2009 [81]. Ninety-one percent belonged to Intermacs profile one patients and 63.8% survived to HT. Survival after transplantation at 1, 5, and 10 years was 76.8%, 60.5%, and 41.2%, respectively. Infection, bleeding, neurological events, and device malfunction are common complications. Copeland et al. reported a 7.9% incidence of stroke and reexploration for bleeding in 24% of patients in their series. Current versions of TAH are limited by their size, durability, and complications. Continuous flow TAH pumps are being developed and evaluated in preclinical research studies; these pumps may offer hope in the future [82].
VAD patients for noncardiac surgery Hessel II et al. recently reviewed the management of NCS in patients with VADs [83]. As patients with CF-VADs survive longer with good quality of life, they more often present for NCS. Several
Fig. 10. Total artificial heart support using Syncardia Systems. (Courtesy: SynCardia Systems, Inc. Reproduced with permission from Syncardia Systems Inc.)
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series and case reports on VAD patients undergoing NCS have been published [84e87]. Outcomes after NCS in patients with VAD are favorable [88,89]. Anesthesia care should be managed at specialized centers by cardiac anesthesiologists, and patients should recover in the ICU. A VAD engineer should be available to manage the system, and a cardiac surgeon who implanted the device should be contacted to discuss the management. In many centers, HF cardiologists take over the care of VAD patients once they are stable from surgical perspective, and they can also serve as a useful resource in perioperative management. RV dysfunction and the need for RVAD at the time of LVAD implantation should alert the anesthesiologist to monitor RV function closely. The status of anticoagulation (last dose of Coumadin, ASA physical status, prothrombin time, and INR) should be checked. Reversal of Coumadin's effect and holding anticoagulation during the perioperative period out of concern for bleeding are well tolerated in HM II patients. AICD can be inactivated depending on the procedure needs, and external defibrillator pads should be applied in these patients until AICD can be reactivated. Special attention should be paid to the administration of broad-spectrum antibiotics required for the particular NCS, as infectious complications may result in significant morbidity and mortality. It is not possible to obtain either reliable blood pressure with a noninvasive blood pressure cuff or oxygen saturation with pulse oximetry in patients with CF-LVADs. Invasive arterial access under ultrasound guidance is advised in surgeries with anticipated fluid shifts and blood loss. Minor surgical procedures can be performed using a blood pressure cuff and Doppler ultrasound of the radial artery. A cerebral oximeter can be used to get an idea about oxygenation, as this does not depend on pulsatility. Central line placement will aid in the administration of inotropes/vasoactive drugs, and it can be used to monitor CVP. Any elevation in CVP (>15 mm Hg) with lower flows and blood pressure may indicate RV dysfunction. Diagnosis should be confirmed by TEE and appropriate management initiated. The use of a PA catheter is not unreasonable in patients with pulmonary hypertension and borderline RV function who are undergoing major surgery. In the event of cardiac standstill, external cardiac massage is avoided. Epinephrine is administered, and ECMO is initiated for TCS.
Conflict of interest None.
Practice points
LVADs improve survival and quality of life compared to medical therapy alone in HF patients CF-LVADs offer durability, reliability, and better survival compared to pulsatile LVAD devices CF-LVAD devices also provide similar 2-year survival rates (80%) when compared to HT Patients with ACS should be stabilized on TCS before definite decisions can be made regarding long-term support, transplantation, and recovery. Several options are currently available for temporary support of both ventricles: Impella, TandemHeart, and ECMO. RV dysfunction occurs in 20% of patients after LVAD insertion. Preoperative prediction is possible using clinical, hemodynamic, and echocardiographic parameters so that early management with biventricular support can be initiated Intraoperative echocardiography plays an important role in the guidance of VAD procedures Early and late complication rates are quite significant, and they are the limiting factors in making mechanical support an alternative treatment to HT NCS is common in patients with VADs, and definitive guidelines and protocols should be established at each institution to improve outcomes after NCS
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Research points In the era of cost containment and the Affordable Care Act, the cost effectiveness of LVAD implantation and maintenance should be proven before strong recommendations can be made about their use, especially in NYHA class III patients. Pulsatile perfusion may have long-term advantages, including improved LV recovery, improved compliance of small arteries, and decreased gradients across the aortic valve. Therefore, the creation of pulsatility within CF-LVADs is being explored. Safe and effective RVADs are needed for patients who require long-term RV support Large prospective multicenter studies comparing the safety and effectiveness of various percutaneous temporary VADs are needed, as they are very promising in the management of ACS. TAHs with continuous flow technology are being developed; these will play a significant role in the management of severe biventricular failure in the future. Reliable, noninvasive blood pressure measurement devices, if developed, will be useful in the perioperative management of patients with CF-LVADs undergoing NCS.
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Serial echocardiography using tissue Doppler and speckle tracking imaging to monitor right ventricular failure before and after left ventricular assist device surgery. JACC Heart Fail 2013;1:216e22. [42] Kiernan MS, French AL, DeNofrio D, et al. Preoperative three dimensional echocardiography to assess risk of right ventricular failure following left ventricular assist device surgery. J Card Fail 2015;21:189e97. [43] Wang TS, Hernandez AF, Felker GM, et al. Valvular heart disease in patients supported with left ventricular assist devices. Circ Heart Fail 2014;7:215e22. [44] Chumnanvej S, Wood MJ, MacGillivray TE, et al. Perioperative echocardiographic examination for ventricular assist device implantation. Anesth Analg 2007;105:583e601. [45] Meineri M, Van Rensburg AE, Vegas A. Right ventricular failure after LVAD implantation: prevention and treatment. Best Pract Res Clin Anaesthesiol 2012;26:217e29. [46] Ziemba EA, John R. Mechanical circulatory support for bridge to decision: which device and when to decide. J Card Surg 2010;25:425e33. [47] Kormos RL, Teuteberg JJ, Pagani FD, et al., HeartMate II Clinical Investigators. Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes. J Thorac Cardiovasc Surg 2010;139:1316e24. [48] Marzec LN, Ambardekar AV. Preoperative evaluation and perioperative management of right ventricular failure after left ventricular assist device implantation. Semin Cardiothorac Vasc Anesth 2013;17:249e61. [49] Potapov E, Meyer D, Swaminathan M, et al. Inhaled nitric oxide after left ventricular assist device implantation: a prospective, randomized, double-blind, multicenter, placebo-controlled trial. J Heart Lung Transpl 2011;30:870e8. [50] Groves DS, Blum FE, Huffmyer JL, et al. Effects of early inhaled epoprostenol therapy on pulmonary artery pressure and blood loss during LVAD placement. J Cardiothorac Vasc Anesth 2014;28:652e60.
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[51] Antoniou T, Prokakis C, Athanasopoulos G, et al. Inhaled nitric oxide plus iloprost in the setting of post-left assist device right heart dysfunction. Ann Thorac Surg 2012;94:792e8. [52] Hamdan R, Mansour H, Nassar P, et al. Prevention of right heart failure after left ventricular assist device implantation by phosphodiesterase 5 inhibitor. Artif Organs 2014;38:963e7. [53] Tedford RJ, Hemnes AR, Russell SD, et al. PDE5A inhibitor treatment of persistent pulmonary hypertension after mechanical circulatory support. Circ Heart Fail 2008;1:213e9. [54] Kukucka M, Potapov E, Stepanenko A, et al. Acute impact of left ventricular unloading by left ventricular assist device on the right ventricle geometry and function: effect of nitric oxide inhalation. J Thorac Cardiovasc Surg 2011;141:1009e14. [55] Theiss HD, Grabmaier U, Kreissl N, et al. Preconditioning with levosimendan before implantation of left ventricular assist devices. Artif Organs 2014;38:231e4. [56] Sponga S, Ivanitskaia E, Potapov E, et al. Preoperative treatment with levosimendan in candidates for mechanical circulatory support. ASAIO J 2012;58:6e11. [57] Omar S, Zedan A, Nugent K. Cardiac vasoplegia syndrome: pathophysiology, risk factors and treatment. Am J Med Sci 2015;349:80e8. [58] Levin MA, Lin HM, Castillo JG, et al. Early on-cardiopulmonary bypass hypotension and other factors associated with vasoplegic syndrome. Circulation 2009;120:1664e71. [59] Gilbert M, Lema G. [Vasoplegic syndrome and its treatment with vasopressin during cardiac surgery with cardiopulmonary bypass]. Rev Med Chil 2011;139:368e72. [60] Currigan DA, Hughes RJ, Wright CE, et al. Vasoconstrictor responses to vasopressor agents in human pulmonary and radial arteries: an in vitro study. Anesthesiology 2014;121:930e6. [61] Shuhaiber JH, Jenkins D, Berman M, et al. The Papworth experience with the Levitronix CentriMag ventricular assist device. J Heart Lung Transpl 2008;27:158e64. [62] Haneya A, Philipp A, Puehler T, et al. Temporary percutaneous right ventricular support using a centrifugal pump in patients with postoperative acute refractory right ventricular failure after left ventricular assist device implantation. Eur J Cardiothorac Surg 2012;41:219e23. [63] Farrar DJ. The thoratec ventricular assist device: a paracorporeal pump for treating acute and chronic heart failure. Semin Thorac Cardiovasc Surg 2000;12:243e50. [64] Krabatsch T, Potapov E, Stepanenko A, et al. Biventricular circulatory support with two miniaturized implantable assist devices. Circulation 2011;13(124):S179e86. [65] Takeda K, Naka Y, Yang JA, et al. Outcome of unplanned right ventricular assist device support for severe right heart failure after implantable left ventricular assist device insertion. J Heart Lung Transpl 2014;33:141e8. [66] Stulak JM, Romans T, Cowger J, et al. Delayed sternal closure does not increase late infection risk in patients undergoing left ventricular assist device implantation. J Heart Lung Transpl 2012;31:1115e9. [67] Bruckner BA, DiBardino DJ, Ning Q, et al. High incidence of thromboembolic events in left ventricular assist device patients treated with recombinant activated factor VII. J Heart Lung Transpl 2009;28:785e90. [68] Hurlburt L, Roscoe A, van Rensburg A. The use of prothrombin complex concentrates in two patients with non-pulsatile left ventricular assist devices. J Cardiothorac Vasc Anesth 2014;28:345e6. [69] Sarosiek K, Kang CY, Johnson CM, et al. Perioperative use of the imacor hemodynamic transesophageal echocardiography probe in cardiac surgery patients: initial experience. ASAIO J 2014;60:553e8. [70] Cavarocchi NC, Pitcher HT, Yang Q, et al. Weaning of extracorporeal membrane oxygenation using continuous hemodynamic transesophageal echocardiography. J Thorac Cardiovasc Surg 2013;146:1474e9. [71] Andersen M, Videbaek R, Boesgaard S, et al. Incidence of ventricular arrhythmias in patients on long-term support with a continuous-flow assist device (HeartMate II). J Heart Lung Transpl 2009;28:733e5. [72] Genovese EA, Dew MA, Teuteberg JJ, et al. Incidence and patterns of adverse event onset during the first 60 days after ventricular assist device implantation. Ann Thorac Surg 2009;88:1162e70. [73] Allen SJ, Sidebotham D. Postoperative care and complications after ventricular assist device implantation. Best Pract Res Clin Anaesthesiol 2012;26:231e46. [74] Meyer AL, Malehsa D, Budde U, et al. Acquired von Willebrand syndrome in patients with a centrifugal or axial continuous flow left ventricular assist device. JACC Heart Fail 2014;2:141e5. [75] Crow S, Chen D, Milano C, et al. Acquired von Willebrand syndrome in continuous-flow ventricular assist device recipients. Ann Thorac Surg 2010;90:1263e9. [76] Uriel N, Pak SW, Jorde UP, et al. Acquired von Willebrand syndrome after continuous-flow mechanical device support contributes to a high prevalence of bleeding during long-term support and at the time of transplantation. J Am Coll Cardiol 2010;56:1207e13. [77] Demirozu ZT, Radovancevic R, Hochman LF, et al. Arteriovenous malformation and gastrointestinal bleeding in patients with the HeartMate II left ventricular assist device. J Heart Lung Transpl 2011;30:849e53. [78] Stern DR, Kazam J, Edwards P, et al. Increased incidence of gastrointestinal bleeding following implantation of the HeartMate II LVAD. J Card Surg 2010;25:352e6. [79] Birati EY, Rame JE. Diagnosis and management of LVAD. Thromb Curr Treat Options Cardiovasc Med 2015;17:361. [80] Warkentin TE, Greinacher A, Koster A. Heparin-induced thrombocytopenia in patients with ventricular assist devices: are new prevention strategies required? Ann Thorac Surg 2009;87:1633e40. [81] Copeland JG, Copeland H, Gustafson M, et al. Experience with more than 100 total artificial heart implants. J Thorac Cardiovasc Surg 2012;143:727e34. [82] Sale SM, Smedira NG. Total artificial heart. Best Pract Res Clin Anaesthesiol 2012;26:147e65. *[83] Hessel 2nd EA. Management of patients with implanted ventricular assistdevices for noncardiac surgery: a clinical review. Semin Cardiothorac Vasc Anesth 2014;18:57e70. [84] Chacon MM, Hattrup EA, Shillcutt SK. Perioperative management of two patients with left ventricular assist devices presenting for noncardiac surgery in the prone position. A A Case Rep 2014;2:70e3. [85] Chestovich PJ, Kwon MH, Cryer HG, et al. Surgical procedures for patients receiving mechanical cardiac support. Am Surg 2011;77:1314e7.
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[86] Riha H, Netuka I, Kotulak T, et al. Anesthesia management of a patient with a ventricular assist device for noncardiac surgery. Semin Cardiothorac Vasc Anesth 2010;14:29e31. [87] Stone ME, Soong W, Krol M, et al. The anesthetic considerations in patients with ventricular assist devices presenting for noncardiac surgery: a review of eight cases. Anesth Analg 2002;95:42e9. [88] Brown JB, Hallinan WM, Massey HT, et al. Does the need for noncardiac surgery during ventricular assist device therapy impact clinical outcome? Surgery 2009;146:627e33. [89] Stehlik J, Nelson DM, Kfoury AG, et al. Outcome of noncardiac surgery in patients with ventricular assist devices. Am J Cardiol 2009;103:709e12.
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9
Mechanical circulatory support Kathirvel Subramaniam, MD, MPH, Visiting Associate Professor Department of Anesthesiology, University of Pittsburgh, Pittsburgh, PA 15213, USA
Keywords: ventricular assist device mechanical circulatory support
Heart failure (HF) is a condition in which the heart is not able to pump enough blood and oxygen required for organ systems to function. According to recent statistics from the American Heart Association (AHA), about 5.1 million people in the nation suffer from HF; one in nine deaths in 2009 included HF as a contributing cause. About half of people who develop HF die within 5 years of diagnosis. HF costs the nation an estimated $32 billion each year. This total includes the cost of health-care services, medications to treat HF, and missed days of work [1]. Despite several recent promising developments in medical therapy for HF, many patients still progress to advanced stages of HF. The annual mortality rate for patients with advanced HF remains high [2]. Heart transplantation (HT) is the definitive therapy for advanced HF, but it is limited by the availability of donors and strict recipient criteria applied to avoid poor outcomes. Therefore, the alternate treatment of mechanically supporting the ventricles, ventricular assist device (VAD) therapy, has gained an important role in the management of advanced HF (stage D). This chapter discusses the indications, contraindications, and various classifications of mechanical circulatory support (MCS) and individual features of commonly used VADs. Perioperative management of patients undergoing MCS will also be described in detail. © 2015 Elsevier Ltd. All rights reserved.
Indications and categories of mechanical circulatory support Heart failure (HF) is a well-recognized costly public health problem with high patient mortality [1,2]. Patients with heart failure symptoms refractory to optimum medical treatment are referred for mechanical circulatory support therapy. According to Interagency Registry for Mechanically Assisted E-mail address: [email protected]. http://dx.doi.org/10.1016/j.bpa.2015.04.003 1521-6896/© 2015 Elsevier Ltd. All rights reserved.
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Table 1 Intermacs patient profiles for end-stage heart failure. Profile Clinical picture 1 2 3 4 5 6 7
Critical cardiogenic shock. Life-threatening hypotension, increasing requirement for inotropes with evidence of organ hypoperfusion (elevated lactate levels and acidosis). Patients need MCS in hours. Progressive decline on inotropes with evidence of volume overload, poor tolerance to increasing doses of inotropes and impaired organ perfusion. Patient will need VAD support in few days. Clinical stability on moderate dose of inotropes or temporary circulatory support, can be hospitalized or at home. VAD support indicated in weeks. Recurrent advanced heart failure e resting symptoms on home oral therapy. VAD support is indicated in weeks or months. Exertion intolerant e comfortable at rest, but ADL limited by symptoms. VAD support requirement is variable. Exertion limited e ADL not limited, but all meaningful exertion limited. VAD support requirement is variable. History of decompensation but currently stable at reasonable level of activity (advanced NYHA Class 3). VAD implantation has been shown to improve survival.
ADL, Activity of Daily Living. NYHA, New York Heart Association.
Circulatory Support (Intermacs) statistics, about 12,474 ventricular assist devices (VADs) were implanted across 149 participating programs in the United States between June 2006 and September 2014 [3]. Intermacs classified severe heart failure (HF) into seven subcategories to describe patient status before VAD implantation (Table 1). Potential modifiers for the clinical profiles include frequent shocks (>2 per week) by a defibrillator, requirement for any form of temporary circulatory support (TCS) (applies to profiles one, two, and three), and frequent hospitalizations (three visits in 14 days after LVAD implantation [45]. RVAD is required in 50% of patients undergoing VAD placement for acute shock and 4e10% of patients undergoing LVAD for chronic HF [46,47]. RV dysfunction after LVAD is associated with increased mortality and morbidity [45]. LVAD recipients with RV dysfunction also have higher reexplorations, longer hospital stay, and lower survival to HT. Several perioperative factors contribute to RVF after LVAD placement [48] (Table 8). Therefore, preoperative prediction of RV function using clinical, laboratory, hemodynamic, and echocardiographic parameters is of paramount importance in improving the prognosis of LVAD recipients (Table 9). RV function is assessed intraoperatively by the correlation of several parameters: MAP, central venous pressure (CVP), mean PA pressure, CI, SVO2, flows through the LVAD, direct visualization of the RV through surgical field, and TEE evaluation of RV function. Elevated CVP, lower PA pressure/MAP ratio, lower CI and SVO2, lower flows through the LVAD, RV dilatation, and worsening TR all indicate the need to support RV function. Maintenance of adequate preload to the LVAD without causing RV dysfunction can be challenging. Fluid infusion and transfusion are titrated to PA diastolic pressures between 15 and 18 mm Hg and CVP between 10 and 15 mm Hg while observing the interventricular septum (IVS) and ventricular filling via TEE. Midline IVS position should be maintained by adjusting LVAD speed (RPM). Higher speed and flows can cause excessive LV unloading and negative pressure around the inflow cannula, resulting in LV collapse with leftward shifting of the IVS. This shift will further worsen RV function, as the septal
Table 9 Preoperative predictors of post-LVAD RV dysfunction. Clinical
Laboratory
Hemodynamic
Female gender Old age Poor nutritional status Obesity Nonischemic cardiomyopathy Redocardiac surgery Preoperative inotropes Preoperative mechanical ventilation Preoperative IABP/ECMO Emergency surgery
Elevated liver enzymes Hyperbilirubinemia Hypoalbuminemia Elevated BUN and creatinine Elevated NT-proBNP, C-reactive protein Thrombocytopenia Elevated prothrombin time
CVP/PCWP ratio > 0.64 Increased RAP RVSWI < 250 mm Hg. Ml/m2 CI < 2.2 l/m2
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contribution to overall RV contractility is lost. Decreasing the speed will enable the situation to revert back to normal. Factors causing elevation of PVR (hypoxemia, hypercarbia, acidosis, hypothermia, inadequate anesthesia, and excessive positive end expiratory pressure) should be avoided. MAP should be normalized to optimize RV function, keeping in mind systemic hypertension; the resultant increased afterload can cause a decrease in LVAD flows. Maintenance of sinus rhythm is advised to optimize hemodynamics. Sinus rhythm is important to preserve RV function and prevent clot formation and ventricular recovery. Patients with ischemic cardiomyopathy and significant right CAD may benefit from coronary artery grafting. The effect of continuous flow on the native coronary and graft blood flows deserves further investigation. Management of RV dysfunction is initially pharmacological with inotropes, vasopressin, and pulmonary vasodilators. Among the pulmonary vasodilators, inhaled nitric oxide (iNO) is used in the operating room and ICU to improve LVAD flows. However, a multicenter, placebo controlled, doubleblinded and prospective study by Potapov et al. failed to show any significant effect of iNO on the incidence of RV dysfunction after LVAD placement. Secondary end points such as requirement for RVAD, mechanical ventilation, and length of ICU and hospital stay were not improved [49]. Few studies using inhaled prostaglandins have shown a decrease in PA pressures after LVAD placement, but definitive conclusions on benefits for RV function cannot be drawn from available studies [50,51]. The phosphodiesterase 5 inhibitor sildenafil has been shown to improve persistent pulmonary hypertension after LVAD placement and to prevent the development of RVF [52,53]. Any beneficial effect of pulmonary vasodilators on PVR and RV function is probably masked by the effective unloading of pulmonary circulation by LVAD [54]. Inotropes are the mainstay of RV dysfunction. Milrinone 0.25e0.75 mg/kg/min is initiated while the patient is on CPB for inotropy and pulmonary vasodilatation. A bolus of milrinone can be given before the termination of bypass if MAP is not low. Epinephrine of 0.05 mg/kg/min is added before the termination of bypass, and it is increased to 0.1 mg/kg/min as needed. Dobutamine and dopamine are not commonly used intraoperatively at our institution, but practices may vary. Preoperative optimization with levosimendan, a calcium-sensitizing inodilator, has also been investigated in two reports, and it was shown to improve hemodynamic performance and identify patients who will develop RVF after LVAD insertion [55,56]. This drug is not approved by the US FDA, and more controlled clinical trials are required before its routine use is adopted for patients who underwent cardiac surgery. Vasoplegic syndrome after LVAD implantation occurs in up to 40% of patients [57,58]. The mechanisms include excessive endogenous production of nitric oxide, the lack of vasopressin, systemic inflammatory response, and the use of pulmonary vasodilators (e.g., milrinone). Preoperative low LV ejection fraction, prolonged CPB, and preoperative ACEI intake are risk factors. Vasoplegic syndrome is best treated by the infusion of vasopressin, which increases MAP with negligible effects on PVR [59,60]. Severe vasoplegia may require the use of multiple vasopressors such as dopamine, norepinephrine, and methylene blue (in refractory vasoplegia). Failure to maintain adequate systemic blood pressure will lead to LV over-decompression, negative suction around the cannula on the LV, septal shift toward LV, and worsening RV dysfunction. If RV dysfunction persists despite maximum doses of inotropes (epinephrine of 0.1 mg/kg/min and milrinone of 0.75 mg/kg/min) and vasopressor support, RVAD should be inserted early to avoid venous congestion and end-organ dysfunction. Centrimag is the preferred RVAD device at our institution, although percutaneous RVAD devices are increasingly used for RV dysfunction nowadays [61,62]. The only long-term RVAD support device in use is paracorporeal Thoratec RVAD, which can provide support for up to 12e24 months as BTT [63]. HVAD has been used as BiVAD in a limited case series with good results [64]. Research is needed to pursue more options for long-term RV mechanical support after LVAD insertion, as a significant number of patients need continued RV support after failure to wean from temporary RVAD support [65].
Perfusion and surgical considerations Implantation of LVAD using the off-pump method is possible but hemodynamically can be very challenging, so most implantations are done with the use of normothermic or mild hypothermic CPB.
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Bicaval cannulation is recommended for tricuspid valve procedures and PFO closure. Aortic crossclamping and cardioplegic arrest are avoided, except when aortic or mitral valve procedures are necessary. CPB is utilized to remove excessive volume through ultrafiltration. CO2 in the field is used to decrease air embolism, and TEE-guided de-airing is performed before coming off CPB [33]. Ventricles are filled with volume, and Valsalva breaths are given to get the air out of the pulmonary circulation. Patients are placed in the Trendelenburg position, the outflow is clamped, and the needle inserted into the outflow graft proximal to the clamp to de-air the ventricles. Vigorous shaking of the atrium and ventricles may be needed to get the air out of the poorly contracting ventricles. Sometimes, air may appear in the ascending aorta even after thorough de-airing. If this happens or if RV function is poor, CPB should be reinitiated and de-airing maneuvers continued. The LVAD pump is started slowly at lower speeds, and MAP is maintained (afterload to LVAD) to avoid excessive LV decompression, septal shift, and consequent RV dysfunction. Pump speed can be increased slowly while monitoring TEE for septal midline position. Bleeding and transfusions Bleeding and transfusions are major concerns after LVAD insertion. Bleeding could be related to inadequate surgical hemostasis or medical coagulopathy. Common sites of surgical bleeding include the RA cannulation site, sternal wiring, pre-peritoneal pump pocket, and around the inflow cannula and outflow-aorta graft anastomotic site. Absolute surgical hemostasis should be ensured before closure of the chest. The chest can be kept open with packing if bleeding is significant or hemodynamic instability prevents closure. The sternum can be closed after removing clots when hemostasis is restored in 24 h. Delayed chest closure after LVAD insertion increases the ICU length of stay, but it does not increase infection rates [66]. Coagulopathy in VAD patients is multifactorial. Preexisting antiplatelet/anticoagulant therapy, liver dysfunction, hypothermia, prolonged CPB, platelet dysfunction, dilutional coagulopathy, and the effect of contact between mechanical device and blood all contribute to bleeding after LVAD insertion. Transfusion can be associated with three major problems in patients with VADs: transfusioninduced lung injury (TRALI), transfusion-induced circulatory overload (TACO), and transfusioninduced immunomodulation (TAIM) have implications for VAD patients [33]. TRALI may cause hypoxemia and increased PVR, thus necessitating venovenous ECMO support or RVAD support in some patients. TACO can cause RV dysfunction and increase morbidity. TAIM is associated with immunosuppression and increased infection rate. Transfusion-associated allosensitization and the formation of panel reactive antibodies can complicate a patient's listing for HT. Care to avoid transfusions in these patients is important. Normalizing coagulation preoperatively, the use of antifibrinolytics and retrograde autologous priming, the use of miniature circuits, and POC testing can reduce the need for transfusions. Transfusion cannot be avoided completely in all patients, and prompt treatment of coagulopathy with appropriate blood products is indicated. Desmopressin can be used in chronic renal insufficiency. The safety of factor concentrates in LVAD patients has not been established. Bruckner et al. have shown a high incidence of thromboembolic events (37%) with a high-dose factor VII (30e70 mg/kg) compared with a low-dose regimen (9.4% with 10e20 mg/kg) during LVAD procedures [67]. The successful use of prothrombin complex concentrate (PCC) has been reported in two patients with LVAD undergoing noncardiac surgery (NCS) without any thromboembolic sequelae [68]. Further research is required to establish the safety of factor concentrates in LVAD patients as they are given in smaller volumes than fresh-frozen plasma, thereby possibly avoiding RV dysfunction. Postoperative management Postoperative care of VAD patients is complex, and a multidisciplinary team approach involving intensivists, cardiac anesthesiologists, cardiac surgeons, HF cardiologists, perfusionists, VAD engineers, nutritionists, physical therapists, VAD nurses, and social workers is essential to improve outcomes. Teams should meet regularly to evaluate progress and future care. Patients who had MCS placed for ACS will need more intense care and experience longer ICU stays. These patients have a higher
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incidence of bleeding, reoperations, RVAD support, end-organ dysfunction, and mortality compared to those who had elective long-term VADs inserted for chronic HF. Postoperative hemodynamic management is a continuum of intraoperative intensive management. The usefulness of ImaCor hTEE has been shown in hemodynamic management after high-risk cardiac surgery and MCS [69,70]. Patients are extubated once the criteria are fulfilled, invasive monitors are removed, and they are taken off vasopressors/inotropes. Anticoagulation with heparin and Coumadin is started once bleeding is stable. Enteral nutrition is started as soon as possible, and renal replacement therapy may be required in patients with volume overload. Oral antihypertensives are restarted once the patients can orally take medication. Arrhythmias may indicate or may result in RV dysfunction. In one case series of 23 patients, ventricular arrhythmias occurred in 52% of patients. Eight patients received defibrillation and three of them became hemodynamically unstable [71]. AICD should be reactivated in the postoperative period or some VAD patients may require AICD insertion or ablation for intractable new onset arrhythmias. Reoperations are common, with bleeding and tamponade accounting for the majority of reoperations. Other reasons for reoperations include RV failure, pump failure, and infections [72]. Several other early and late complications are listed in Table 10 [73]. Among late complications, bleeding deserves special mention. Acquired VWF deficiency is reported with only CF-LVAD, which may result in bleeding episodes or excessive bleeding after HT [74e76]. Device explantation results in the resolution of this deficiency. Desmopressin and cryoprecipitate are recommended therapies. Another unique complication is the development of A-V malformations in the GI tract and bleeding in patients supported with CF devices [77,78]. Thrombotic complications are less common than bleeding. Altered blood flow in the chambers and cannulae and the activation of inflammatory/coagulation cascade are suggested mechanisms for VADrelated thrombosis. Development of thrombosis within the LVAD pump is the most devastating complication, and it has been increasing in frequency in the last 3 years. The diagnosis of VAD thrombosis requires symptoms and signs of HF, elevated lactate dehydrogenase from hemolysis, and echocardiography. VAD monitoring will show increasing power with a low PI. Thrombolysis, anticoagulation, and urgent surgical pump replacement are currently recommended therapies. More research is needed to understand this fatal complication [79]. Clinical heparin-induced thrombocytopenia (HIT) occurs in 10% of patients despite positive antibodies in 60% of patients [80]. Device malfunction and failure are uncommon with the third-generation CF devices nowadays. Infections are common, and they can be classified as device and nondevice related [73]. Infections are associated with significant morbidity, reoperations, and mortality. Device-related infections include driveline and pump-pocket infections, pump endocarditis, and sternal wound infections, and common systemic infections reported in LVAD recipients include respiratory, urinary tract, and catheter-related infections. CF devices with small parts produce fewer infections compared to pulsatile devices. The administration of prophylactic antibiotics is recommended before surgical incision and continued postoperatively for 48 h. Once an infection is diagnosed, it is treated with broad-spectrum antibiotics, surgical exploration/drainage, and, in refractory cases, VAD exchange or HT. Table 10 Early and late complications after VAD insertion. Early (60 days)
Bleeding requiring transfusion and reoperation (31e81%), Tamponade 28% Atrial and ventricular arrhythmias (30e60%) RV failure (10e30%)
Bleeding complications (17.5%)
Reoperations (50%) Respiratory failure (20e30%) Neurologic dysfunction stroke 15%, TIA 12%, seizures 4% Renal failure 3e28% Hepatic failure 2e8% Hemolysis Infections (42%)
GI bleeding 10e40% Thromboembolism 6% Pump thrombosis 2e9% Aortic valve degeneration (90% in long term) Cannula malposition/occlusion Infections (94% at 1 year) Hemolysis (0e3%) Psychiatric problems Device malfunction and failure (rare to 2%)
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Total artificial heart TAH devices can provide biventricular support for critically ill end-stage HF patients. They are useful in patients with severe biventricular failure, ventricular rupture, significant ventricular septal defect, and intractable arrhythmias. TAH offers an advantage in situations in which ventricular drainage may be inadequate (restrictive, hypertrophic cardiomyopathy). Currently, two TAH devices are available for human use: Cardiowest TAH and Abiocor implantable replacement heart. Cardiowest TAH is a pneumatically driven, pulsatile biventricular support device approved for use as BTT. It has two prosthetic ventricles that connect to the native atria (Fig. 10). The stroke volume is 70 cc, and it can deliver a maximum flow rate of 8 l/min. It has been implanted in 930 patients worldwide. Copeland et al. described its use in 101 patients between 1993 and 2009 [81]. Ninety-one percent belonged to Intermacs profile one patients and 63.8% survived to HT. Survival after transplantation at 1, 5, and 10 years was 76.8%, 60.5%, and 41.2%, respectively. Infection, bleeding, neurological events, and device malfunction are common complications. Copeland et al. reported a 7.9% incidence of stroke and reexploration for bleeding in 24% of patients in their series. Current versions of TAH are limited by their size, durability, and complications. Continuous flow TAH pumps are being developed and evaluated in preclinical research studies; these pumps may offer hope in the future [82].
VAD patients for noncardiac surgery Hessel II et al. recently reviewed the management of NCS in patients with VADs [83]. As patients with CF-VADs survive longer with good quality of life, they more often present for NCS. Several
Fig. 10. Total artificial heart support using Syncardia Systems. (Courtesy: SynCardia Systems, Inc. Reproduced with permission from Syncardia Systems Inc.)
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series and case reports on VAD patients undergoing NCS have been published [84e87]. Outcomes after NCS in patients with VAD are favorable [88,89]. Anesthesia care should be managed at specialized centers by cardiac anesthesiologists, and patients should recover in the ICU. A VAD engineer should be available to manage the system, and a cardiac surgeon who implanted the device should be contacted to discuss the management. In many centers, HF cardiologists take over the care of VAD patients once they are stable from surgical perspective, and they can also serve as a useful resource in perioperative management. RV dysfunction and the need for RVAD at the time of LVAD implantation should alert the anesthesiologist to monitor RV function closely. The status of anticoagulation (last dose of Coumadin, ASA physical status, prothrombin time, and INR) should be checked. Reversal of Coumadin's effect and holding anticoagulation during the perioperative period out of concern for bleeding are well tolerated in HM II patients. AICD can be inactivated depending on the procedure needs, and external defibrillator pads should be applied in these patients until AICD can be reactivated. Special attention should be paid to the administration of broad-spectrum antibiotics required for the particular NCS, as infectious complications may result in significant morbidity and mortality. It is not possible to obtain either reliable blood pressure with a noninvasive blood pressure cuff or oxygen saturation with pulse oximetry in patients with CF-LVADs. Invasive arterial access under ultrasound guidance is advised in surgeries with anticipated fluid shifts and blood loss. Minor surgical procedures can be performed using a blood pressure cuff and Doppler ultrasound of the radial artery. A cerebral oximeter can be used to get an idea about oxygenation, as this does not depend on pulsatility. Central line placement will aid in the administration of inotropes/vasoactive drugs, and it can be used to monitor CVP. Any elevation in CVP (>15 mm Hg) with lower flows and blood pressure may indicate RV dysfunction. Diagnosis should be confirmed by TEE and appropriate management initiated. The use of a PA catheter is not unreasonable in patients with pulmonary hypertension and borderline RV function who are undergoing major surgery. In the event of cardiac standstill, external cardiac massage is avoided. Epinephrine is administered, and ECMO is initiated for TCS.
Conflict of interest None.
Practice points
LVADs improve survival and quality of life compared to medical therapy alone in HF patients CF-LVADs offer durability, reliability, and better survival compared to pulsatile LVAD devices CF-LVAD devices also provide similar 2-year survival rates (80%) when compared to HT Patients with ACS should be stabilized on TCS before definite decisions can be made regarding long-term support, transplantation, and recovery. Several options are currently available for temporary support of both ventricles: Impella, TandemHeart, and ECMO. RV dysfunction occurs in 20% of patients after LVAD insertion. Preoperative prediction is possible using clinical, hemodynamic, and echocardiographic parameters so that early management with biventricular support can be initiated Intraoperative echocardiography plays an important role in the guidance of VAD procedures Early and late complication rates are quite significant, and they are the limiting factors in making mechanical support an alternative treatment to HT NCS is common in patients with VADs, and definitive guidelines and protocols should be established at each institution to improve outcomes after NCS
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Research points In the era of cost containment and the Affordable Care Act, the cost effectiveness of LVAD implantation and maintenance should be proven before strong recommendations can be made about their use, especially in NYHA class III patients. Pulsatile perfusion may have long-term advantages, including improved LV recovery, improved compliance of small arteries, and decreased gradients across the aortic valve. Therefore, the creation of pulsatility within CF-LVADs is being explored. Safe and effective RVADs are needed for patients who require long-term RV support Large prospective multicenter studies comparing the safety and effectiveness of various percutaneous temporary VADs are needed, as they are very promising in the management of ACS. TAHs with continuous flow technology are being developed; these will play a significant role in the management of severe biventricular failure in the future. Reliable, noninvasive blood pressure measurement devices, if developed, will be useful in the perioperative management of patients with CF-LVADs undergoing NCS.
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