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Ann Thorac Surg 2003;75:S29-S35
© 2003 The Society of Thoracic Surgeons

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Supplement

Patient selection for left ventricular assist device therapy

^a Division of Cardiology, University of Michigan, Ann Arbor, Michigan, USA
^b Section of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA

^* Address reprint requests to Dr Pagani, Heart Transplant and Circulatory Assist Program, Section of Cardiac Surgery, 2120 Taubman Center, Box 0348, 1500 East Medical Center Dr, Ann Arbor, MI 48109, USA
e-mail: fpagani{at}umich.edu

Presented at the Heart Failure & Circulatory Support Summit, Cleveland, OH, Aug 22–25, 2002.

Abstract

Patient selection for left ventricular assist device (LVAD) therapy is the most important process in obtaining a successful outcome. Evaluation requires assessing the appropriateness for device implantation based on need and risk of LVAD implant to the patient. Appropriate patients can be selected without the need for invasive hemodynamic measurements and selection can be based on symptoms, appropriateness of medical therapy, and on the need for inotropic therapy. Assessing the risk of LVAD therapy to the patient requires evaluating the degree of organ dysfunction and technical factors. Patients should be offered the option of LVAD therapy if they meet criteria for need, possess the potential for organ recovery, and have appropriate operative risk.

Patient selection for left ventricular assist device (LVAD) therapy involves two major areas of assessment: (1) evaluation of the appropriateness for device implant based on patient condition, degree of symptoms, and indication; and (2) determining the operative risk of LVAD implant to the patient. The process of successful patient selection first involves identifying patients with refractory congestive heart failure or cardiogenic shock who are at high risk of death and who would be expected to obtain a survival and symptomatic benefit with LVAD therapy. This assessment is based on symptoms, clinical examination, and traditionally by invasive hemodynamic criteria and need for inotropic or intraaortic balloon pump (IABP) support or both. Utilizing invasive hemodynamic criteria along with the need for inotropic or IABP support identifies a very ill cohort of patients [1, 2]. Although this group of patients derives benefit from LVAD therapy, disease progression is generally advanced and considerable comorbidities (ie, organ dysfunction) likely exist in these patients. In the multicenter clinical evaluation of the HeartMate vented-electric left ventricular assist system (VE LVAS) (Thoratec, Pleasanton, CA), inclusion criteria for consideration for LVAD therapy were based both on the requirement for inotrope therapy (IABP if possible) and meeting invasive hemodynamic criteria (Table 1). [2] Utilizing these criteria death in the historical control arm of the study was considerable with 32 of 48 patients (67%) dying before receiving a heart transplant. Twenty-two of these deaths occurred within 7 days of entering the study. Survival to transplant in the LVAD arm was 67% and was significantly better compared with the historical control arm.

Timing of LVAD intervention

The timing of LVAD operation relies heavily on clinical judgment but is influenced by institutional and personal experience and additionally by referral patterns. When patients with refractory heart failure or cardiogenic shock are identified and can not be weaned from intravenous inotrope therapy, implantation of an LVAD should be considered. Time should be taken to optimize the patient’s condition (ie, diuresis to improve systemic oxygenation and reduce secondary pulmonary hypertension, administration of vitamin K and fresh frozen plasma to correct elevated international normalized ratio (INR), or IABP to improve peripheral perfusion and protect against right ventricular ischemia) before proceeding to the operating room. Unnecessary interventions that delay the implantation should be avoided however. Signs of failure of inotrope therapy including the need for multiple inotropic agents, nausea, decreased level of alertness, significant tachycardia, difficult fluid management, progressive liver or renal dysfunction, requirement for supplemental oxygen, and ventricular arrhythmias or implanted cardiac defibrillator (ICD) discharge should be sought to identify inotrope-dependent patients who would benefit by LVAD therapy [7].

Assessing risk of LVAD therapy to the patient

Despite demonstrating a significant benefit for LVAD therapy in the REMATCH trial, morbidity and mortality in the LVAD arm of the trial was considerable. Patients in the device group were more than twofold as likely as patients in the medical arm to have a serious adverse event (rate ratio, 2.35; 95% confidence interval, 1.86 to 2.95) [4]. The probability of device infection was 28% by 3 months and sepsis was the largest single cause for death in the LVAD arm. The incidence of bleeding adverse events in the LVAD arm was 42% by 6 months. The incidence of major device malfunction was 35% by 2 years and 10 patients required reoperations for device failure. Thus LVAD therapy poses a significant risk to the patient and thorough preoperative evaluation is necessary to determine whether significant comorbitities exist that pose unreasonable perioperative risk. In general patients should be offered the option of LVAD therapy if they meet criteria for need and possess the potential for organ recovery.

Numerous studies have evaluated the impact of specific preoperative comorbid conditions on LVAD outcomes. Pennington and associates [8] reported on 44 patients undergoing circulatory support as a bridge to heart transplantation. Only white blood cell count, platelet count, and investigator experience proved to be preoperative variables that influenced outcome. More recently Oz and associates [9] developed a screening scale based on preoperative risk factors to predict operative mortality in a cohort of 56 patients undergoing LVAD operation. Urine output less than 30 mL/h, central venous pressure greater than 16 mm Hg, mechanical ventilation, prothrombin time greater than 16 seconds, reoperation, and leukocyte count greater than 15,000/mm³ were demonstrated to be significant comorbid conditions that influenced LVAD survival (Table 3). Patients with a risk score greater than or equal to 5 had a 67% operative mortality rate compared with a 10% operative mortality rate for patients with a risk score less than 5. However McCarthy and associates [10] reporting on a more recent series of 100 patients undergoing LVAD implant were unable to identify mechanical ventilation and low urine output as preoperative risk factors. The risk score reported by Oz and associates was not applicable in the most recent 64 patients in their series.

Based on these observations and those from other studies there is significant evidence to support that age, sepsis, and advancing degrees of organ dysfunction particularly renal and hepatic dysfunction contribute to poor outcome after LVAD survival. However these studies do not encompass all the factors that need to be considered in evaluating potential LVAD candidates.

Additional issues in evaluating patients for LVAD therapy

Neurologic and psychiatric considerations
Additional areas of focus and assessment that can impact adversely on LVAD outcomes include the degree of family and psychosocial support and preoperative neurologic function. Patients considered for LVAD therapy should have no major irreversible cognitive defects that would limit their understanding of LVAD maintenance and ability to troubleshoot LVAD alarms. Stroke with motor impairment only should not necessarily be a contraindication to LVAD implant. We have performed LVAD implant and subsequent heart transplantation on 2 patients who experienced strokes with significant motor deficits but no cognitive defects 2 weeks before LVAD implant with successful long-term outcomes in both instances.

Pulmonary function
Patients with significant chronic obstructive or restrictive lung disease are probably at increased risk for death after LVAD implantation. Significant pulmonary vascular disease may accompany chronic lung disease and result in pulmonary hypertension and an elevation in pulmonary vascular resistance that is not amenable to treatment with vasodilator therapy. Left ventricular assist device therapy reduces right ventricular afterload by reducing left ventricular filling pressures. In situations where pulmonary vascular resistance is fixed, unloading of the left ventricular by LVAD therapy may not achieve a significant reduction in right ventricular afterload and obtain a corresponding increase in pulmonary blood flow (restrictive pulmonary blood flow). In such cases LVAD device filling may be impaired and right-sided circulatory failure may develop. In selecting patients for LVAD therapy as a bridge to transplantation we have generally tried to establish reversibility of the pulmonary vascular resistance to less than 3 Wood units before committing patients to LVAD therapy and subsequently to heart transplantation. However in carefully selected patients prolonged LVAD therapy may lower pulmonary vascular resistance in those thought to have elevated pulmonary vascular resistance not responsive to vasodilator therapy. "Irreversible" patients likely to "reverse" with LVAD therapy include patients with a low pulmonary vascular resistance without vasodilator therapy documented within the prior 6 months, patients with prior documentation within 6 months of easily reversible pulmonary vascular resistance, and patients presenting with acute onset of cardiogenic shock. In all such cases however the possibility of pulmonary thromboembolic disease as the cause of fixed pulmonary vascular resistance should be strongly considered and eliminated.

There are no absolute criteria for pulmonary function testing that is utilized to select patients for LVAD therapy. In patients in cardiogenic shock or significant pulmonary edema, pulmonary function testing may not yield reliable estimates of true pulmonary function and reserve. Generally when pulmonary function testing is feasible we have utilized forced expiratory volume at 1 second of 50% of predicted, forced vital capacity of 50% of predicted, and diffusing capacity of the lung for carbon monoxide of 50% of predicted as guidelines for accepting patients for consideration for LVAD therapy and heart transplantation. In patients with markedly impaired pulmonary function testing we obtain a high-resolution computed tomography scan to identify the extent of parenchymal lung disease when feasible.

Hepatic function
Significant preoperative hepatic dysfunction assessed by total serum bilirubin or INR or both is an important marker of adverse outcome after LVAD implantation. The importance of adequate liver function cannot be overestimated and indicators of liver function (INR > 1.5; aspartate aminotransferase, alanine aminotransferase, or total bilirubin > 5 times normal) have been utilized as exclusion criteria for the REMATCH trial [12]. In addition evidence of hepatic fibrosis and cirrhosis is a contraindication to LVAD therapy. Liver biopsy, hepatic wedge pressure, or upper endoscopy may be necessary to exclude cirrhosis or manifestations of portal hypertension. Evidence of significant preoperative hepatic dysfunction predicts a higher need for biventricular as opposed to left ventricular support [13]. This observation becomes much more relevant when considering patients for destination therapy.

Renal function
Although numerous studies indicate that renal insufficiency or failure represents a significant risk factor for adverse LVAD outcome, careful evaluation must be performed in order not to exclude patients with the potential for organ recovery. In a review of 108 patients undergoing HeartMate LVAD implantation at our institution (October 1, 1996, through December 31, 2002) 17 patients were identified preoperatively with significant renal dysfunction or failure (creatinine > 3 mg/dL, n = 4 patients; or on renal support with continuous venovenous hemofiltration [CVVH], n = 13 patients; Fig 1). Three of 4 of patients with renal dysfunction only (creatinine ≥ 3 mg/dL) recovered renal function (defined by creatinine < 1.7 mg/dL at transplant or alive with LVAD). Of the 13 patients on preoperative CVVH more than 60% recovered renal function. Only 2 of the cohort of 17 patients experienced permanent renal failure requiring dialysis. Overall of the 17 patients with preoperative renal dysfunction or failure, 77% were long-term survivors (alive at 6 months with transplant or LVAD).

View larger version (28K): [in this window] [in a new window]   Fig 1. Incidence of death and permanent renal failure in 108 patients undergoing left ventricular assist device (LVAD) implant with preoperative (Preop) renal dysfunction (serum creatinine ≥ 3 mg/dL) or renal failure (need for continuous venovenous hemofiltration [CVVH]). Recovery of renal function defined by a serum creatinine less than 1.7 mg/dL at transplantation or alive with LVAD support.

Thus in both series patients with serious renal dysfunction have a significant probability of recovering renal function. However the duration of preoperative cardiogenic shock and renal failure along with base line renal function before the episode of shock or acute decompensation of heart failure must be considered in the decision process. Moreover underlying "nonreversible" etiologies for renal insufficiency or failure including diabetic nephropathy or hypertensive renal disease must be considered.

Right ventricular function
Evidence of preoperative right-sided circulatory failure presents a challenging problem in patients undergoing LVAD implantation (Table 4). For patients being considered for bridge to heart transplantation there are suitable alternatives (eg, Thoratec VAD; Thoratec, Pleasanton, CA) to implantable LVAD to provide circulatory support. In situations where implantable LVAD therapy is being considered as destination therapy there is currently no comparable systems to provide permanent biventricular support. Thus evidence of significant right-sided circulatory failure may become a significant obstacle to providing destination therapy. However not all patients requiring postoperative right ventricular assist device (RVAD) support after LVAD implantation need permanent RVAD support.

View larger version (19K): [in this window] [in a new window]   Fig 2. Incidence of successful right ventricular assist device (RVAD) removal in patients requiring early biventricular support. (ECMO = extracorporeal membrane oxygenation.)

Patients with a mechanical valve prosthesis in the aortic valve position should have the mechanical valve replaced with a bioprosthetic valve before institution of left ventricular assistance. However bioprosthetic valves in the aortic position are also prone to thrombosis or fusion as a result of complete unloading of the left ventricle with LVAD therapy that eliminates prosthetic valve opening and closing during support. Fusion of native aortic valve leaflets has been reported with LVAD support [20]. Some surgeons have advocated pericardial patch closure of the aortic valve annulus to prevent thromboembolism from mechanical or bioprosthetic valves [20].

Patients with significant preexisting mitral stenosis at the time of initiation LVAD support require correction of the valvular problem before implantation of the device owing to the impairment of left ventricular filling. Mitral regurgitation does not have an impact on LVAD function; however elevations in pulmonary pressures may persist with severe regurgitation and remodeling of the left ventricle may be adversely effected [21]. In situations where weaning from LVAD support is feasible correction of the mitral pathology is necessary in order to optimize ventricular function.

Adequate right heart function is extremely important to maintain LVAD flow in the early postoperative period. Severe tricuspid regurgitation can significantly impair the forward flow of blood on the right side particularly in situations of high pulmonary vascular resistance. Furthermore severe tricuspid regurgitation contributes to elevated central venous pressure, hepatic congestion, and renal dysfunction. Severe tricuspid regurgitation may be present preoperatively in the setting of volume overload and biventricular failure or may develop after institution of LVAD support as a consequence of right ventricular dilation from leftward shift of the interventricular septum [22–24]. If severe tricuspid regurgitation is present during the initiation of LVAD support tricuspid valve repair should be performed to improve right-sided circulatory function.

Intracardiac shunts
Patients with a patent foramen ovale or atrial septal defect should have closure of the defect performed at the time of LVAD implant to prevent right to left shunting across the defect and subsequent systemic hypoxia.

Arrhythmias
Atrial and ventricular arrhythmias are common in patients with cardiogenic shock and underlying ischemic heart disease or idiopathic cardiomyopathies. These arrhythmias generally persist in the immediate postoperative period and subsequently resolve with time as the hemodynamic condition of the patient improves and inotropic therapy is weaned. Some patients will have persistence of their arrhythmia due to their underlying pathology (eg, giant cell myocarditis). Severe ventricular arrhythmias have traditionally been thought to be a contraindication to univentricular support. However recent experience has revealed that the hemodynamic consequences in patients in whom these arrhythmias develop in the late postoperative period are generally not life threatening [25]. In the absence of pulmonary hypertension and elevated pulmonary vascular resistance in the postoperative period patients maintain adequate LVAD flows during ventricular fibrillation. This situation is similar to a Fontan (systemic vein to pulmonary artery) circulation. Some patients with refractory ventricular arrhythmias may require biventricular support indefinitely or until the pulmonary vasculature resistance drops and a Fontan circulation is tolerated [26]. The addition of right ventricular support for hemodynamic compromise due to refractory ventricular arrhythmia is unusual.

Atrial fibrillation and flutter hinders right ventricular filling but is reasonably well tolerated in recipients of ventricular assist devices. Early electrical or pharmacologic cardioversion is indicated to avoid thrombus formation and improve exercise tolerance. Anticoagulation is indicated in patients with persistent atrial or ventricular arrhythmias to prevent thrombus formation (even for those devices for which anticoagulation is otherwise unnecessary).

Influence of destination versus bridge indication for LVAD therapy on patient selection

As of November 2002 the Food and Drug Administration has approved two indications for implantable LVAD therapy that include both bridge to heart transplantation and destination therapy. The populations of patients being considered for bridge to transplant versus destination therapy are obviously different and these differences have important influences on timing of operation and assessment of risk to the patient. In a review of 108 patients undergoing LVAD implant as bridge to transplant therapy at the University of Michigan (October 1, 1996, through December 31, 2002) the median age of the cohort of patients was 50.7 years Of the 108 patients, 51 (47%) received at least one form of life support: mechanical ventilation (n = 34), hemodialysis or hemofiltration (n = 13), ECMO or extracorporeal ventricular assist device support (n = 24), or IABP (n = 28). Thus the bridge to transplant cohort in general is a younger population of patients than that studied in the REMATCH trial (mean age of the LVAD arm, 66 ± 9.1 years) with a larger number of patients presenting with an acute catastrophic illness accompanied by manifestations of severe organ injury [4]. This acuity of illness contributes significantly to the high incidence of nondevice- and device-related adverse outcomes associated with LVAD therapy in the bridge to transplant cohort. Fortunately many of these adverse outcomes are successfully treated by heart transplantation (eg, device infection and device malfunction) or can be successfully temporized until transplant (eg, right-sided circulatory failure requiring prolonged inotrope support or biventricular assistance). Treatment of major device infections was accomplished with the aid of heart transplantation in 9 of 13 infections (69%). The remaining 4 patients with device infection were treated with antibiotic therapy or device exchange or both—3 patients survived and 1 died, for an overall device infection survival of 92% (12 of 13 patients). Treatment of 14 major device malfunctions was successful in 12 cases (86%) and was accomplished by heart transplantation in 6 patients and by device exchange in 6 patients.

It is important to emphasize that patients studied in REMATCH had chronic heart failure and not an acute catastrophic illness. The high morbidity and mortality observed in the REMATCH sample was a reflection of the chronicity and severity of their heart failure, their significant burden of comorbid illness, and their advanced age. A number of patients acceptable for bridge to transplant therapy are inappropriate to consider for destination therapy. The exclusion criteria (INR < 1.5; serum creatinine < 3.5 mg/dL) in the REMATCH trial were obviously more restrictive than suitable for or currently utilized in a bridge to transplant population [12]. More restrictive criteria are obviously important to limit the potential for adverse outcomes such as right-sided circulatory failure and chronic renal failure that are less easily managed in the cohort of patients considered for destination therapy. Additionally the thoughtful concept of abandoning requirements for hemodynamic criteria in the REMATCH trial reflects an important understanding of the need to move intervention with LVAD therapy to a cohort with less catastrophic illness. Although earlier intervention will be an important contributor to improved outcomes for both destination and bridge to transplant patients the opportunities for earlier intervention with LVAD therapy in those patients being considered for destination therapy are probably more readily available than with the bridge to transplant patient.

Conclusion

Left ventricular assist device therapy offers a substantial improvement in survival for patients with refractory heart failure or cardiogenic shock as a bridge to heart transplantation or destination therapy. The process of evaluating and selecting patients for LVAD therapy directly effects outcome. Identifying appropriate patients before the onset of significant organ dysfunction improves survival, and reduces the degree of postoperative morbidity. However the presence of significant organ dysfunction should not immediately exclude patients from consideration and further assessment is warranted. The option of LVAD therapy should be offered if patients meet the criteria and the potential for organ recovery is present.

References

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