Patient Selection


Profile

Description

1-year survival %

Time frame for intervention

Profile 1: Critical cardiogenic shock

Life-threatening hypotension despite rapidly increasing inotropic support. Critical organ hypoperfusion confirmed by worsening acidosis or high lactate levels

65

Within hours

Profile 2: Progressive decline

Declining function despite inotropic support. May see worsening renal or hepatic function

72

Within a few days

Profile 3: Stable but inotrope dependent

Stable hemodynamics and organ function while on inotropic support but unable to wean from support

82

Elective intervention over a period of weeks to months

Profile 4: Resting symptoms

Hemodynamically stable but with daily symptoms at rest or during activities of daily living. Usually require high doses of diuretics

75

Elective intervention over a period of weeks to months

Profile 5: Exertion intolerant

Comfortable at rest or during activities of daily living but unable to perform other activities

72

Variable, depends on maintenance of nutrition, organ function, symptoms and activity

Profile 6: Exertion limited

Comfortable at rest and is able to perform other activities outside the home but fatigues after a few minutes

72

Variable, depends on maintenance of nutrition, organ function, symptoms and activity

Profile 7: Advanced NYHA III

Stable without current or recent episodes of unstable fluid balance

73

LVAD may not be currently indicated



The Columbia University/Cleveland Clinic risk factor selection scale (RFSS) was the first scoring system to examine risk of mechanical circulatory support. This study examined 56 patients with the HeartMate (HM) implantable pneumatic (IP) and HM vented electric (VE) devices. While too small for a multivariate analysis, this study identified five risk factors for death: oliguria, ventilator dependence, elevated central venous pressure (CVP), elevated prothrombin time (PT), and reoperation status [40]. This scoring system was later revised based on data from 130 patients receiving the HM VE. A summary of the revised scoring system (RSS) is shown in Table 25.2. While mechanical ventilation, elevated CVP and PT remained a part of the risk scoring system, post-cardiotomy shock and pre-operative LVAD were also found to be important factors. A score greater than 5 was estimated to have an operative mortality risk of 46 % [41].


Table 25.2
Predicting overall outcomes [37, 4042]








































Scoring system

Number of patients

Device studied

Predictors of mortality (Points per risk factor)

Scoring

Columbia University/Cleveland Clinic Risk Factor Selection Scale (RFSS) [37]

56

HM XVE

HM IP

Urine output <30 cc/hr (1)

Elevated CVP (1)

Mechanical ventilation (1)

Elevated prothrombin time (1)

Redo sternotomy (1)

>5 points: operative mortality 67 %

Columbia University/Cleveland Clinic Revised Screening Scale (RSS) [40]

130

HM VE

Mechanical ventilation (3)

Cardiogenic shock (2)

Pre-operative LVAD (2)

Elevated CVP (2)

Elevated prothrombin time (1)

1 year survival:

≤5 points: 46 %

>5 points: 12 %

Lietz-Miller Destination Therapy Risk Score (DTRS) [41]

222

HM XVE

Platelet Count ≤148,000/uL (7)

Albumin ≤3.3 g/dL (5)

INR >1.1 (4)

Vasodilator therapy (4)

Mean pulmonary artery pressures ≤25 mmHg (3)

Aspartate aminotransferase >45 U/mL (2)

Hematocrit ≤34 % (2)

Blood urea nitrogen >51 U/dL (2)

No intravenous inotropes (2)

1 year survival:

0–8 points: 81 %

9–16 points: 62 %

17–19 points: 28 %

>19 points: 11 %

Muenster University Medical Center [42]

241

Variable

Pre-operative transfusion of >10 units RBC and/or 10 units FFP (6)

Inotropes (5)

Lactate >3 mg/dL (5)

LDH >500 and/or CK >200 and/or troponin I >20 ng/mL (5)

C-reactive protein >8 and/or WBC >13 (4)

Re-do sternotomy (4)

Pre-operative mechanical ventilation (3)

Creatinine >1.5 mg/dL and/or BUN >40 and/or CVVH(d) (3)

Emergency implant (3)

Pre-operative CPR (2)

Ischemic etiology (2)

Heart rate >100 (1)

Hemoglobin <12 g/dL and/or hematocrit <35 % (1)

Age >50

ICU mortality:

≥15 points: 15.8 %

16–30 points: 48.2 %

>30 points: 65.2

Lietz et al. examined 45 baseline laboratory, hemodynamic, and clinical parameters and outcomes in destination therapy (DT) patients. The authors devised a score that stratified patients in low-, medium-, and high-risk categories. Estimated 1 year survival for patients in the low-, medium-, high, and very high-risk categories was 81.2, 62.4, 27.8 and 10.7 %. It is important to note that this study did not include patients requiring mechanical ventilation or intra-aortic balloon pump (IABP). Furthermore, when this risk assessment score was tested in continuous flow LVADs, it was shown to be a poor predictor of mortality in bridge to transplant (BTT) patients and only of modest use in DR patients [37]. Klotz et al. at Muenster University Medical Center identified several pre-operative risk factors for mortality in an analysis of 241 patients with variable devices. Using a weighted risk score, this study divided patients into low-, medium, and high-risk groups [42]. A summary of risk factors predicting death in LVAD patients for this study is shown in Table 25.2.

Holman et al. used the INTERMACS database to determine predictors of mortality for patients on mechanical circulatory support [43]. Predictors of death included older patient age, cardiogenic shock with hemodynamic compromise described by assignment of INTERMACS level 1, and clinical indicators of right ventricular failure such as ascites and hyperbilirubinemia.



Assessment of Right Ventricular Function


Right ventricular (RV) dysfunction is common in congestive heart failure [44]. Implantation of LVAD results in increased cardiac output and venous return, which can exacerbate severe RV failure [45]. In addition, unloading of the left ventricle can shift the interventricular septum to the left, decreasing the septal contribution to RV output [46, 47]. As many as 20–35 % of LVAD patients will develop severe RV failure and this directly increases mortality [48]. RV dysfunction after institution of MCS leads to longer lengths of stay, higher morbidity and mortality, and worse post-transplant outcomes [28, 4951]. For this reason, assessment of RV function prior to LVAD implantation is essential.

An assessment of RV function should include an echocardiogram and invasive hemodynamics [19]. A low RV systolic pressure with elevated right atrial pressure and low RV stroke volume is a marker of severe RV impairment with decreased potential for reversibility [52]. Echocardiographic parameters that may be helpful in predicting post-LVAD RV failure include tricuspid annular plane systolic excursion (TAPSE) less than 1.5 cm, right to left ventricular end-diastolic diameter greater than 0.72, and RV stroke volume index [53]. It must be kept in mind that an RV that appears dysfunctional on echocardiogram may still be capable of generating high pulmonary pressures, therefore, invasive hemodynamics are a critical component of RV assessment. A pulmonary artery systolic pressure of less than 50 mmHg is thought to be associated with a high RV failure risk [48]. In addition, a RV stroke work index (RVSWI) of less than 450 mmHG × ml/m2 is predictive of RV failure [48]. For patients with borderline RV function, an extended assessment period using a Swan-Ganz catheter in an ICU setting may be beneficial in determining if the patient can be managed with LVAD implantation alone [48].

Risk factor scores have been devised to help quantify the risk of RV failure as seen in Table 25.3. Fitzpatrick et al. from the University of Pennsylvania identified several risk factors for needing right ventricular assist device (RVAD) support. Independent predictors of RVAD support included cardiac index less than 2.2 L/m2, RVSWI less than 250 mmHG × ml/m2, severe RV dysfunction, serum creatinine greater than 1.9 mg/dL, previous cardiac surgery, and systolic blood pressure less than or equal to 96 mmHg. An important limitation of this study was that a small minority of the patients (less than 4 %) had continuous flow LVAD [54]. The University of Michigan risk score also identified several risk factors for RV failure. However, only 15 % of the devices in this study were continuous flow devices. Risk factors for RV failure in this study included vasopressor requirement, AST greater than 80 IH/L, bilirubin over 2.0 mg/dL, and serum creatinine greater than 2.3 mg/dL [48].


Table 25.3
Scoring scales to predict RV failure after LVAD implantation [48, 54, 55]


































Scoring system

Number of patients

Device studied

Predictors of mortality (Points per risk factor)

Scoring

University of Pennsylvania RV Failure Risk Score [54]

266

Variable

Cardiac index ≤2.2 L/min/m2 (18)

RVSWI ≤250 mmHG × ml/m2 (18)

Severe RV dysfunction (17)

Previous cardiac surgery (16)

Systolic BP <96 mmHG (13)

Need for RV support:

<30 points: 4 %

≥65 points: 89 %

University of Michigan Risk Score [48]

197

Variable

Vasopressor requirement (4)

AST ≥80 IU/L (2)

Bilirubin ≥2 mg/dL (2.5)

Serum creatinine ≥2.3 mg/dL (3)

Likelihood of RV failure:

≤3 points: 0.49

4–5 points: 2.8

≥7.6

Kormos et al. [55]

484

Heartmate II

CVP/PCWP >0.63 (RR: 2.3)

Mechanical ventilation (RR: 5.5)

BUN >39 mg/dL (RR: 2.1)

Relative risk for RV failure

Kormos et al. carried out the largest study to date examining RV failure after implantation of a continuous-flow LVAD. In this study, numerous clinical, echocardiographic, and hemodynamic parameters were assessed. The University of Michigan RV failure score was also examined. Of the 484 patients in this study to receive the Heartmate-2 (HM-2) as a bridge to transplantation, 6 % required RVAD, 7 % required prolonged inotropic support, and 7 % required late initiation of inotropic support. The parameters found to predict RV failure on multivariate analysis included the need for mechanical ventilation, a central venous pressure/wedge pressure ratio greater than 0.63, and a blood urea nitrogen (BUN) over 39 mg/dL [55].


Timing of Implantation


While mechanical circulatory support was once reserved for patients in New York Heart Association class IV heart failure in impending cardiogenic shock [29, 56], the benefits of implanting less critically ill patients is coming to light. Earlier device implantation, before end organ damage and right ventricular failure, leads to improved outcomes. Yet the estimated 5–10 % perioperative mortality [11, 57] for device implantation must be considered when implanting less severely ill patients. For example, a patient with a short estimated waiting time for cardiac transplantation in good clinical state might benefit from awaiting transplantation. However, for DT patients who reach inotrope dependence, LVAD implementation should not be delayed [58].

The two most common indications for LVAD placement are cardiogenic shock (INTERMACS level 1) and worsening symptoms in inotropic dependent patients (INTERMACS level 2). These two classes of patients account for 60 % of all MCS patients [10]. For stable, but inotropic-dependent patients (INTERMACS level 3), true dependence should be verified with a trial to withdraw inotropes. Once dependence has been verified, the patient should be considered for LVAD implantation as these patients have been shown to obtain the most benefit from institution of LVAD [58, 59].

For patients meeting INTERMACS levels 4–6 criterion, the timing of LVAD implantation remains controversial. Subgroup analysis of the REMATCH trial showed no survival benefit with implantation of LVAD in non-inotropic dependent patients. However, all clinical factors should be considered as up to 40 % of ambulatory heart transplantation candidates will deteriorate and require upgrade to high-urgency status or require emergency MCS [60]. For these non-inotrope dependent patients, cardiopulmonary testing is considered to be the best indicator of long-term outcomes [61, 62] and may be a useful tool in determining if patients will have a desirable outcome without LVAD support. Other risk scores such as the Heart Failure Survival Score [63] or the Seattle Heart Failure Risk Score [64] may also be useful adjuncts.


Total Artificial Heart


The total artificial heart (TAH) provides biventricular support and replaces the patient’s native ventricles and all four valves orthotopically. A large proportion of patients with LVAD will go on to develop right heart failure. The TAH can maintain these patients and provide complete replacement of the failing heart. The TAH has other additional advantages. It can be useful in patients whom LVAD and BIVAD is contraindicated, such as those with aortic regurgitation, cardiac arrhythmias, left ventricular thrombus, an aortic prosthesis, or an acquired ventricular septal defect [65, 66].

The largest study to date examining the use of the TAH demonstrated that in patients with irreversible biventricular failure, TAH implantation results in improved survival. Implantation of the TAH improved outcomes by providing immediate hemodynamic restoration and recovery of end-organ damage. This allowed a greater number of patients to reach cardiac transplantation [65, 66]. As experience with the TAH has increased, outcomes have improved [66]. Continued research and device improvement will lead to better results and decreased adverse events.

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Sep 30, 2017 | Posted by in CARDIOLOGY | Comments Off on Patient Selection

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