ABSTRACT
Background
Left Ventricular Assist Device (LVAD) implantation is an important treatment option for patients with advanced CHF. Referral to an early, intensive cardiac rehabilitation (CR) program in these patients seems still underused. This observational descriptive study aimed to evaluate the feasibility and efficacy of an early intensive CR program in LVAD recipients, also comparing results with a matched group of advanced HFrEF patients.
Methods
The study involved patients with LVAD implantation due to HFrEF who were admitted to our intensive post‐acute CR program from several surgery wards from 2009 to 2023. They underwent a twice‐a‐day individualized exercise program and physiotherapeutic treatment, according to clinical stability and functional assessment. The study exclusively focused on the in‐hospital rehabilitation period and documented cardiac and non‐cardiac complications, including the Hemocompatibility‐Related Adverse Events (HRAEs). The Barthel index (BI) was used to assess functional recovery from admission to discharge. Results in a subgroup of 210 LVAD patients matched on a 1:1 basis with an HFrEF population were also analyzed.
Results
One patient died during the inward rehabilitation period (respiratory failure). The majority (70.0%) of patients improved their disability (BI 67 ± 24 to 84 ± 23, p < 0.001). HRAEs occurred in 25 patients (9.1%). Compared to the HFrEF group, LVAD patients showed similar improvement in disability (p = 0.54).
Conclusions
The study suggests that an early intensive post‐acute CR program can significantly improve functional capacity and disability in LVAD patients, similar to HFrEF patients admitted to the same program. Our data support scientific recommendations suggesting participation of LVAD to a CR.
Keywords: cardiac rehabilitation, circulation support, congestive heart failure, end‐stage heart failure, ventricular assist device
Early, intensive, post‐acute cardiac rehabilitation programs significantly improve functional capacity and disability in LVAD patients, similar to HFrEF patients admitted to the same program. Data support scientific recommendations suggesting implementation of early intensive cardiac rehabilitation in LVAD patients.
1. Introduction
Congestive heart failure (CHF) is the leading cause of hospitalization and the most common cause of death from cardiovascular disease in western countries, with the prevalence that is expected to rise further in the coming years due to the aging population and the increasing prevalence of risk factors. This poses a major challenge for healthcare systems: it is estimated that in Europe the cost of CHF is over €210 billion per year [1], including the cost of treatment, hospitalizations, and the lost productivity. In US, the prevalence of CHF is projected to increase by 46% from 2012 to 2030, affecting > 8 million adult people, and the total percentage of the population with CHF is projected to rise from 2.4% in 2012 to 3.0% in 2030 [2].
Left Ventricular Assist Device (LVAD) implantation became an important treatment option for patients with advanced CHF, with the number of devices implanted per year having been increasing steadily over the past decade. In 2013, there were approximately 2500 LVAD implants in the US, and by 2020 that number had risen to over 16 000 [2] and is expected to increase further. This growth is due to a number of factors, including an improvement in technology, an increased awareness of LVAD options, and expanding indications for device use, including patients with less severe heart failure.
Cardiac rehabilitation (CR) is a cornerstone component of the recovery of patients after cardiac surgery or acute cardiac events, including those with advanced CHF [3]; however, despite recommendations from scientific societies, referral of LVAD patients to CR seems still less than optimal, and evidence of an early post‐acute CR feasibility and efficacy in LVAD patients is still poor.
The aim of this observational descriptive study was twofold: (1) to provide a brief description of an early post‐acute comprehensive CR program in LVAD patients, including the incidence of complications and its effect on functional recovery, and (2) to compare the results obtained in patients with LVAD, considering exclusively the inpatient period of CR, with those of a matched group of patients with advanced CHF, where the role of CR is well established, also in the postacute inpatient CR stay.
2. Materials and Methods
In Italy, the team of rehabilitation cardiologists usually receives these patients from implant centers without knowing the details of their prior medical history, aside from what is summarized in the documentation accompanying the patient at the time of transfer. Similarly, after discharge from rehabilitation, the patient continues clinical follow‐up at the implant center, with the rehabilitation clinic neither involved nor updated on subsequent events. As such, all data were prospectively collected and then gathered from our hospital information system during the CR in‐hospital stay. Data included clinical, administrative, pharmacological therapy, laboratory tests data, and functional scales, and were at the end retrospectively analyzed.
The study cohort includes adult ( ≥ 18 years) patients with LVAD implantation due to heart failure with reduced ejection fraction (HFrEF) who were consecutively admitted to an inpatient, intensive, post‐acute CR program early (i.e., directly from the surgical department) after implantation from February 2009 to the end of June 2023.
2.1. Ethics
The study protocol was approved by our Institutional Review Board. An informed consent to the treatment of anonymized clinical data was signed by all patients, according to our institutional policy. The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki.
2.2. Intervention
The majority of patients underwent an echocardiography, a chest x‐ray, and a blood sample for standard chemistry within 24 h of admission. Echocardiography was repeated at discharge and whenever clinically indicated.
The rehabilitation program included a twice‐a‐day (over 6 days), individualized exercise program (calisthenics, cycling, assisted walking, and stair climbing), either in the ward orin a dedicated fitness room, according to clinical stability and functional assessment. Individualized physiotherapeutic treatments, according to specific issues, were also included (e.g., diaphragmatic exercises, passive mobilizations).
Additional components included the optimization of pharmacological therapy and the surgical site surveillance; counseling and education on heart health and risk factor identification and management, aimed at promoting lifestyle changes, as well as relaxation techniques and stress management for both patients and caregivers were also provided. The patient's self‐perceived health was assessed by the EuroQol VAS on admission and at discharge.
Specific training for patients and caregivers was dedicated to the driveline exit point medication and to the battery change and management.
2.3. Outcome Assessment
Outcome measures were the rate of in‐hospital occurrence of cardiac and non‐cardiac complications, including the so‐called hemocompatibility‐related adverse events (HRAEs). These events were defined according to the MOMENTUM‐3 trial: nonsurgical bleeding, neurological events such as stroke (haemorrhagic or ischemic, disabling or nondisabling) or other neurological events (e.g., transient ischemic attack, seizures) at any time, and thromboembolic events such as suspected or confirmed pump thrombosis and arterial thromboembolism with or without organ involvement [4].
The Barthel index (BI) was used as a measure of disability and was assessed twice, as it has been demonstrated to be an useful tool for measuring functional improvement in rehabilitation patients. Furthermore, Barthel scores at discharge correlate with patient prognosis. It was applied on admission (i.e., the same day of discharge from the surgical department) to assess the residual disability post‐surgery and at discharge, to evaluate the functional recovery after rehabilitation [5, 6, 7]. According to BI, patients were classified as: < 60: severely disabled; 60–89: moderately disabled; 90–99: mildly disabled; 100: normal.
A 6mWT (6 Minute Walk Test) was performed within 48 h of admission and repeated at pre‐discharge, whenever possible, in clinically stable condition. The 6mWT was performed by trained personnel, according to procedure guidelines [8]: the variables reported were meters and heart rate/oxygen saturation at the start and at the end of the test. The predicted performance was determined according to Enright's formula [9], and functional capacity was classified in: < 200 m = very poor, 200–300 m = poor, 301–400 m = sufficient, 401–500 m = good, > 500 m = very good.
2.4. Statistical Analysis
Data normality was verified by the Kolmogorov–Smirnov test. Continuous variables are reported as mean ± SD, and categorical variables as percentages. The χ 2 test, Fisher's exact test, and the Student's t‐test were used as appropriate for group comparisons and admission‐to‐discharge changes.
Additionally, in order to carry on an unbiased evaluation of the results of CR in LVAD, the main study cohort was compared to a group of advanced HFrEF patients admitted in the same period for a CR program, selected after a propensity score matching (PSM, single nearest‐neighbor, 1‐to‐1 match without replacement). The following variables were used for matching: age, gender, risk factors, left ventricular ejection fraction (LVEF), comorbidity assessed via the Cumulative Illness Rating Scale (CIRS), and the BI on admission. A repeated measure ANOVA was also used to evaluate admission to‐discharge changes between LVAD and HFrEF patients when indicated.
All calculations were performed using the STATA IC 13.1 system (StataCorp, College Station, Texas, USA); PSM was obtained using the Stata module PSMATCH2 version 4.0.12 [10].
3. Results
The study cohort included 274 patients (89% male, age 63 ± 8 y) with LVAD consecutively admitted to a post‐acute CR in the study period, on average 52 ± 12 days after intervention. Patients included in our study represent almost all patients discharged from surgery to our CR Center, without any kind of selection on the basis of clinical criteria. In Italy, to avoid prolonged stay in the acute phase post LVAD implantation, cardiac surgery wards send all patients as soon as the clinical conditions are stabilized to an intensive in‐hospital rehabilitation center. The number of patients accepted in each CR centre thus depends on the availability of free beds when the request is sent from the surgery centre and not on clinical or demographic selection.
Demographics, echocardiographic and clinical characteristics, as well as pharmacologic treatments, are reported in Tables 1 and 2.
TABLE 1.
Clinical and echocardiographic data on admission.
| Number | 274 |
| Age (years) | 63 ± 8 |
| Male | 244 (89.1) |
| BMI (kg/m2) | 24 ± 4 |
| Etiology: IHD | 160 (58.4) |
| ICD | 204 (74.5) |
| Atrial fibrillation | 33 (15.6) |
| NYHA class | 3.3 ± 0.8 |
| Risk factors | |
| Smoke | 113 (41.2) |
| Hypertension | 95 (34.7) |
| Diabetes | 65 (23.7) |
| Dyslipidemia | 64 (23.4) |
| Familiarity of CAD | 45 (16.4) |
| Device model | |
| Jarvik 2000 | 16 (5.8) |
| Incor | 8 (2.9) |
| Heart ware | 103 (37.6) |
| Heart mate 2 | 50 (18.2) |
| Heart mate 3 | 96 (35.0) |
| Echocardiographic data a | |
| LVEF (%), n = 216 | 25 ± 8 |
| Dec time (msec), n = 128 | 162 ± 35 |
| PAPs, (mmHg), n = 141 | 31.5 ± 7.5 |
| TAPSE, (mm), n = 143 | 12.2 ± 2.9 |
| Functional data | |
| Barthel index | 66 ± 25 |
| Normal | 21 (7.7) |
| Mild | 48 (17.5) |
| Moderate | 105 (38.3) |
| Severe | 100 (36.5) |
| 6mWT, n = 67 (24%), m | 274 ± 84 |
| EuroQoL VAS, mm (n = 195) | 58.8 ± 16.2 |
Note: Data are expressed as mean ± SD (numerical variables) or number and % of LVAD recipients (categorical variables).
Abbreviations: 6mWT, 6 min walk test; BMI, body mass index; CAD, coronary artery disease; Dec time, deceleration time of trans‐mitral flow; Euro QoL VAS, Euro quality of life assessment through visual analogue scale; ICD, implanted cardioverter defibrillator; IHD, ischemic heart disease; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction; NYHA, New York heart association; PAPs, systolic pulmonary arterial pressure; TAPSE, tricuspid annular plane systolic excursion.
Due to technical limitations, echographic parameters were not available in all patients.
TABLE 2.
LVAD patients medical therapy, echocardiographic, and functional data on admission and at discharge.
| Admission | Discharge | p | |
|---|---|---|---|
| Medical therapy | |||
| Beta‐ blockers (yes) | 162 (59.1) | 232 (84.7) | < 0.001 |
| Loop‐diuretics (yes) | 213 (77.7) | 210 (76.6) | NS |
| ACE‐inhibitors (yes) | 123 (44.9) | 153 (55.8) | < 0.05 |
| Sildenafil (yes) | 80 (29.2) | 36 (13.1) | < 0.001 |
| Echocardiographic data | |||
| LVEF (%) | 25 ± 8 | 26.7 + 7 | < 0.05 |
| DecT (msec) | 162 ± 35 | 171 + 43 | < 0.05 |
| PAPs (mmHg) | 31.5 ± 7.5 | 31.4 + 7.6 | NS |
| TAPSE (mm) | 12.2 ± 2.9 | 12.8 + 2.8 | NS |
| Functional data | |||
| Barthel index | 66 ± 25 | 84 ± 24 | < 0.001 |
| No disability: 100 | 21 (7.7) | 91 (33.2) | < 0.001 |
| Mild disability: 90–99 | 48 (17.5) | 93 (33.9) | |
| Moderate disability: 60–89 | 105 (38.3) | 55 (20.1) | |
| Severe disability: < 60 | 100 (36.5) | 34 (12.4) | |
| 6mWT, n = 67 a /94 b (24%/34%), m | 274 ± 84 | 327 ± 78 | < 0.01 |
| % of Predicted 6mWT performance | 48.3 | 58.6 | < 0.01 |
| Functional capacity | |||
| < 200 m = very poor | 13 (4.7) | 6 (2.2) | < 0.001 |
| 200–300 m = poor | 32 (11.7) | 17 (6.2) | |
| 301–400 m = sufficient | 18 (6.6) | 55 (20.1) | |
| 401–500 m = good | 3 (1.1) | 16 (5.8) | |
| > 500 m = very good | 1 (0.4) | 0 (0) | |
| NYHA class | 3.3 ± 0.8 | 2.3 ± 0.5 | < 0.01 |
| EuroQoL VAS | 58.8 ± 16.2 | 79.1 ± 16.2 | < 0.001 |
Note: Data are expressed as mean ± SD (numerical variables) or number and % of LVAD recipients (categorical variables).
Abbreviations: 6mWT, 6 min walk test; DecT, deceleration time of mitral diastolic flow; Euro QoL VAS, Euro quality of life assessment through visual analogue scale; LVEF, left ventricular ejection fraction; NYHA class, New York heart association class; PAPs, systolic pulmonary arterial pressure; TAPSE, tricuspid annular plane systolic excursion.
LVAD patients with 6mWT both at admission and at discharge.
LVAD patients with 6mWT at admission or at discharge.
Ischemic heart disease was the prevalent etiology (58.4%), and hypertension was the most frequent risk factor after smoke (Table 1). Destination therapy was the prevalent clinical indication for LVAD implantation (45%), bridge to decision or bridge to transplantation were the indication in 29% and 25% of patients, respectively. Combined valvular surgery was performed in 44 patients (16%).
On admission, the average LVEF was 25% ± 8%, the NYHA class was 3.3 ± 0.8, and the BI was 66 ± 25, with 100 (36.5%) patients suffering from severe disability (Tables 1 and 2). The self‐rated health perception on EuroQol VAS was 58.8 ± 16.2.
3.1. Outcome Measures
During CR stay, only one patient died (0.4%) of multi‐organ failure, in particular with respiratory failure, having refused the proposed tracheotomy. Death occurred after 23 days from CR admission and a total of 57 days from LVAD implant.
The average length of stay of the whole LVAD population (LOS) was 33 ± 18 days, and the majority (87%) of patients were discharged at home; however, 13% were transferred to an acute setting, the majority (n = 18) urgently transported.
Major complications occurred in 82 patients (29.9%) (Table 3): arrhythmias, mainly ventricular premature beats (VPB) or sustained/non‐sustained ventricular tachycardia, occurred in 43 patients (15.7%); 28 patients (10.2%) had infections requiring antibiotics; a driveline infection or colonization was documented in only 9 patients (3.3%).
TABLE 3.
Major Complications and hemocompatibility‐related adverse events.
| Driveline infections | 9 (3.3) |
| Arrhythmias | 43 (15.7) |
| Hypotension, syncope | 8 (2.9) |
| Other infections | 19 (6.9) |
| Worsening heart failure | 3 (1.1) |
| Urgent transfer to acute setting | 18 (6.6) |
| Hemocompatibility related adverse events | |
|---|---|
| Cerebral bleeding | 11 (4.0) |
| Not disabling stroke | 5 (1.8) |
| Gastro‐Intestinal bleeding | 6 (2.2) |
| Neurological complications, excluded stroke | 1 (0.4) |
| Device thrombosis | 2 (0.8) |
Note: Data are expressed as number and % of LVAD patients.
Hemocompatibility‐related adverse events (HRAEs) occurred in 25 patients (9.1%), mainly cerebral bleeding (11 patients, 4.0%) (Table 3).
There was no case of LVAD replacement during the CR inward period.
Comparing HeartMate‐III (HM‐III) versus the other devices, HRAEs were significantly less frequent in HM‐III recipients: 1 (2.9%) vs. 24 (10%), p = < 0.001. In particular, no device thrombosis and only one cerebral bleeding were documented in HM‐III recipients.
From admission to discharge, medical therapy was optimized, particularly concerning the use of beta‐blockers that increased from 59.1% to 84.7% of patients (p < 0.001); a significant increase in the use of ACE inhibitors (44.9% vs. 55.8%, p < 0.05) and a significant reduction in the use of sildenafil (29.1% vs. 13.2%; p < 0.001) was also obtained (Table 2).
Concerning echocardiographic data, only marginal improvement in LVEF and DecT (deceleration time on diastolic mitral flow) was observed (both p < 0.05), while no changes occurred in systolic pulmonary arterial pressure (PAPs) or tricuspid annular plane systolic excursion (TAPSE) (Table 2).
A significant improvement in the disability, as documented by the BI (on average from 66 ± 25 to 84 ± 24, p < 0.001), was obtained, with 192 patients (70.0%) improving and only 34 patients (12.4%) vs. 100 (36.5%) on admission still having a severe disability (p < 0.001) (Table 2); 67.1% of patients obtained at discharge a BI ≥ 90.
Ninety‐four LVAD patients were able to perform a 6mWT (34%), and 67 patients collected both admission and discharge 6mWT (24%). A significant improvement in functional capacity was documented by the 6mWT, with the distance performed significantly increasing from 274 ± 84 m to 327 ± 78 m (p < 0.01), with 75.5% of patients able to perform at discharge more than 300 m (vs. 32.8% on admission) (Table 2).
At EuroQol VAS, a significantly better self‐perception of the health status was obtained at discharge (79.1) in respect to admission (58.8; p < 0.001).
3.2. Comparative Analysis Versus Severe Congestive Heart Failure Patients
To verify the efficacy of a CR program in LVAD recipients, after propensity score matching, a subgroup of 210 LVAD recipients was compared on a 1:1 basis with a subgroup selected from 1423 HFrEF patients admitted in the same period. The matching effect is reported in Table 4.
TABLE 4.
Matching results.
| LVAD | HFrEF | p | |
|---|---|---|---|
| Before matching | |||
| Number | 274 | 1423 | |
| Age (years) | 62.6 ± 8.2 | 69.5 ± 12.1 | < 0.0001 |
| LVEF (%) | 24.7 ± 7.9 | 34.2 ± 15 | < 0.0001 |
| Barthel index | 65.7 ± 24.8 | 70.9 ± 25.4 | 0.002 |
| CIRS | 3.6 ± 1.97 | 4.2 ± 2.2 | 0.0001 |
| After matching | |||
| Number | 210 | 210 | |
| Age (years) | 62.2 ± 8.6 | 62.2 ± 13.2 | 0.96 |
| LVEF (%) | 24.7 ± 7.8 | 24.5 ± 9.8 | 0.81 |
| Barthel index | 66.3 ± 24.4 | 66.6 ± 26.4 | 0.89 |
| CIRS | 3.5 ± 1.8 | 3.4 ± 2.0 | 0.80 |
Note: Data are expressed as mean ± SD.
Abbreviations: CIRS, cumulative illness rating scale; HFrEF, heart failure with reduced ejection fraction; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction.
BI and categories of disability were comparable between LVAD and advanced HFrEF patients, by matching effect (mild‐no disability: 25.7% and 30.5%, moderate: 39.5% and 33.8%, and severe disability: 34.8% and 35.7%, respectively; p = 0.61) (Table 5).
TABLE 5.
Baseline clinical and disability data on admission in LVAD patients and in those with HFrEF.
| LVAD | HFrEF | p | |
|---|---|---|---|
| Number | 210 | 210 | |
| Age (years) | 62.2 ± 8.6 | 62.2 ± 13.2 | |
| Male, n (%) | 185 | 183 | |
| LVEF (%) | 24.7 ± 7.8 | 24.5 ± 9.8 | |
| EuroQoL VAS | 58.2 ± 18.0 | 64.2 ± 21.7 | < 0.05 |
| CIRS | 3.5 ± 1.8 | 3.4 ± 2.0 |
| Functional data | |||
|---|---|---|---|
| Barthel index | 66.3 ± 24.4 | 66.6 ± 26.4 | |
| Mild‐no disability: 100 | 54 (25.7) | 64 (30.5) | 0.61 |
| Moderate disability: 60–89 | 83 (39.5) | 71 (33.8) | |
| Severe disability: < 60 | 73 (34.8) | 75 (35.7) |
Note: Data are expressed as mean ± SD (numerical variables) or number and % of LVAD recipients (categorical variables).
Abbreviations: CIRS, cumulative illness rating scale; HFrEF, heart failure with reduced ejection fraction; Euro QoL VAS, Euro quality of life assessment through visual analogue scale; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction.
The LOS was significantly longer in LVAD (33.3 + 19.7days) than in HFrEF patients (25.8 + 14.1 days; p < 0.001). During CR, 13 patients in the HFrEF group and only one in the LVAD group died (p < 0.01 for death) (Table 6).
TABLE 6.
Major complications in 210 LVAD patients and 210 matched HFrEF patients.
| LVAD | HFrEF | p | |
|---|---|---|---|
| Arrhythmias | 37 (17.6) | 3 (1.4) | < 0.0001 |
| Hypotension, syncope | 6 (2.8) | 0 | = 0.05 |
| Infections | 19 a (9.0) | 17 (8.1) | NS |
| Worsening heart failure | 3 (1.4) | 26 (12.4) | < 0.0001 |
| Urgent transfer to acute setting | 16 (7.6) | 39 (18.6) | < 0.001 |
| Hemocompatibility related adverse events | 22 (10.5) | NA | — |
| Death | 1 (0.5) | 13 (6.2) | < 0.0001 |
Note: Data are expressed as number and % of LVAD recipients. Device‐specific complications in LVAD patients (e.g., failure of the device) were excluded.
Abbreviations: HFrEF, heart failure with reduced ejection fraction; LVAD, left ventricular assist device; NA, not applicable.
Including driveline infections.
Comparing the pure rehabilitation intervention, LVAD patients performed significantly more time in cycling or calisthenic exercise (28 min/day/pts) than the HFrEF group (20 min/day/pts; p < 0.0001).
At repeated measure ANOVA, between admission and discharge, the BI significantly increased in both LVAD and HFrEF patients (within groups p < 0.001), by a comparable trend (between groups p = 0.54; Table 7).
TABLE 7.
Comparison in admission‐discharge variations between LVAD and HFrEF patients in disability categories, assessed by the Barthel index, and the self‐perceived quality of life, assessed by the EuroQoL.
| LVAD | HFrEF | Repeated measure ANOVA | ||||
|---|---|---|---|---|---|---|
| Admission | Discharge | Admission | Discharge | Within group | Between groups | |
| Barthel index | 66.3 ± 24.5 | 84.3 ± 23.7 | 66.6 ± 26.5 | 84.9 ± 24.1 | p < 0.001 | p = 0.54 |
| EuroQoL VAS | 58.2 ± 18.0 | 80.2 ± 14.8 | 64.2 ± 21.7 | 77.6 ± 18.3 | p < 0.001 | p = 0.68 |
| Barthel index | Admission | Discharge | ||||
|---|---|---|---|---|---|---|
| Mild‐no disability: 90–100 | 54 (25.7) | 145 (69.0) | 64 (30.5) | 136 (68.3) | p = 0.61 | p = 0.40 |
| Moderate disability: 60–89 | 83 (39.5) | 38 (18.1) | 71 (33.8) | 32 (16.1) | ||
| Severe disability: < 60 | 73 (34.8) | 27 (12.9) | 75 (35.7) | 31 (15.6) |
Note: Data are expressed as mean ± SD (numerical variables) or number and % of LVAD recipients (categorical variables).
Abbreviations: ANOVA, analysis of variance; Euro QoL VAS, Euro quality of life assessment through visual analogue scale; HFrEF, heart failure with reduced ejection fraction; LVAD, left ventricular assist device.
Disability categories were also similar at discharge in LVAD and HFrEF patients (no‐mild disability: 69.0% and 68.3%, moderate: 18.1% and 16.1%., and severe: 12.9% and 15.6%, respectively, p = 0.40).
4. Discussion
Our results indicate that an early, comprehensive, post‐acute rehabilitation program is feasible also in the peculiar population of patients with a recent LVAD implantation. To the best of our knowledge, the present report includes one of the largest populations of LVAD patients referred to a rehabilitation program and directly transferred from the surgical department. In Italy, patients usually don't experience structured rehabilitation before being transferred to the CR ward. Very often these patients did not get out of bed since the implantation. Possible delays of transfer (few to several days) are usually due to infective complications or hemodynamic or hemorragic complications during the postoperative period in the surgery ward, thus the patient experiences the beginning of CR sometimes a long time after implantation, without ever getting out of bed. Thus, in the majority of cases, CR begins with disengagement for everybody.
We obtained a very significant improvement in patients' functional status, as documented by the BI improvement and by the increase in the 6mWT performance. Interestingly, 67.1% of patients reached at discharge a BI ≥ 90, a value that after a CR program in a large population of cardiac surgery patients was previously documented to be associated to a 5‐year mortality comparable to that of an age‐ and sex‐matched normative population [11].
Worth noting, the functional results obtained in LVAD patients were comparable to those obtained in a matched group of patients with advanced HFrEF, a population in whom the benefits of CR are well known.
4.1. Comparison With Other Reports
A relatively old report described a 77% referral to CR of LVAD patients in Italy in the period 2012–2014 [12].
Although in the general cardio‐surgical population some physiotherapeutic interventions (e.g., respiratory and mobilization exercise) are initiated as soon as 24–48 h [13], an intensive, comprehensive CR program usually starts thereafter, 8–14 days after acute ward discharge [14, 15].
In LVAD recipients, a recent report including a small group of 29 patients involved in a long‐term exercise‐based CR program documented a significant improvement in the 6mWT; in this group, the CR was initiated at a median of 159 days after device implantation [16]. We documented, in the present study, that even an earlier approach is feasible and able to induce a significant improvement in functional capacity. Our time frame is comparable to that of a previous report that started the CR program on average 48 days after implantation [17].
Another recent report documented, in a large group of patients comparable to that of the present experience, that those patients that completed a CR after LVAD implantation showed a lower readmission rates and higher survival [18], thus confirming the benefit of a CR program, already demonstrated in the general population of patients after an acute cardiac event or cardiac surgery [11], also in LVAD recipients.
According to the different health‐care systems, the post‐implantation management can be done either in an acute care, post‐acute care, or an inpatient early intensive rehabilitation facility. In the Italian reality, post‐implantation LVAD patients remain in the acute care environment until clinical stability is achieved and surgical observation is completed, then move to an early, intensive, inpatient rehabilitation setting as soon as possible. For our healthcare system, this way reduces the occupation in the cardiac surgical ward, and LVAD patients, not yet dischargeable at home, can perform a complete CR program in a protected environment and at a much lower cost than in the acute setting.
4.2. Complication Rate
In the present study population, the overall major complication rate (30.6%) was comparable to that of a general population admitted to CR after cardiac surgery or advanced CHF [11].
Concerning the specific HRAEs, during the CR period we observed 25 events, mainly cerebral hemorrhagic bleeding; the event rate was significantly lower in HM‐III recipients (2.9%) when compared to the other device models (10%; p < 0.001).
Our findings are in line with those reported by the MOMENTUM‐3 trial, which reported a survival free of any HRAEs at 6 months significantly higher for the HM‐II than for the HM‐III (p = 0.012) [4]. The HM‐III technology, based on fully electromagnetic levitation pumps, reduces the friction between the rotor components, thus resulting in better hemocompatibility and lowering the rate of device thrombosis [19].
4.3. End‐Of‐Life Passage
The only death that occurred was a patient with respiratory failure and subsequent multi‐organ failure refractory to therapy, who refused tracheostomy. After collegial discussion, in agreement with the patient and family members, palliative care was administered.
As often happens in ventricular‐assisted patients, they are not accepted into long‐term care wards nor palliative care unit, and end‐of‐life management at home is not smooth. The palliative pathway in heart failure is by no means as prepared and efficient as for the terminal neoplastic patient. Although many efforts are being made in recent years, a long way still remains to be done. Proper palliation in the cardiology patient cannot disregard cardiology expertise in order to integrate analgesia and sedation into cardiology care aimed at reducing the symptoms of refractory decompensation. If it is difficult to obtain a hospice place for a patient with terminal heart failure, it is even more so to manage the end of the life of a patient with a ventricular assistance device. In selected cases, due to absolute territorial shortage, we have supported implant centers in accompanying patients and caregivers along their end‐of‐life journey [20, 21]. Indeed, a rehabilitation facility with the specific expertise can efficiently support the end‐of‐life pathway.
4.4. Comparison With HFrEF Patients
In order to provide better evidence of the feasibility and the positive effect of an early CR program in LVAD patients, their results were compared to those obtained in a matched group of patients with HFrEF. Our study indicates that the reduction in disability (as assessed by the BI) in LVAD recipients was comparable to those obtained in HFrEF patients, confirming the beneficial effect of an early inpatient CR program also in this group of patients.
5. Study Limitations
This is a single‐center experience, and the results do not necessarily apply to other populations or centers; thus our findings have limited generalizability. The female group is significantly underrepresented, thus precluding a gender analysis. Only a small group of patients underwent a 6mWT, and the results, although highly significant, do not necessarily reflect the whole group, although a highly significant improvement in disability class, as determined by BI, has been documented. Moreover, we lack information on the event rate after discharge, so we are not able to verify the long‐term prognostic impact of an early CR program in LVAD patients. Finally, this is a retrospective analysis, although all data were prospectively and consecutively recorded.
6. Conclusions
Results from our study, involving a large number of LVAD patients, indicate that a comprehensive post‐acute inpatient CR program is feasible early after intervention also in this group. A significant improvement in functional capacity and disability was obtained, comparable to that achieved in a matched group of HFrEF patients admitted to the same CR program. Therefore, in agreement with scientific recommendations, participation of LVADs in a CR program should be strongly encouraged.
Author Contributions
Concept and design of the study, data analysis and interpretation, critical revision of the article, approval of the article, data collection, second revision of the manuscript: Massimo Pistono. Data analysis, statistics, data collection: Andrea Giordano. Data interpretation, critical revision of article, data collection, approval of article: Marco Gnemmi. Data interpretation, critical revision of article, approval of article, data collection, complete second revision of the manuscript: Fabiana Isabella Gambarin. Data collection: Mario Granata. Data collection, critical revision of article, approval of article: Alessandro Imparato. Data collection, critical revision of article, approval of article: Pierluigi Temporelli. Data collection, approval of article: Letizia Mannucci. Data collection, approval of article: Silvia Prolo. Concept and design of the study, data analysis and interpretation, drafting the article, approval of the article, data collection: Ugo Corrà.
Conflicts of Interest
The authors declare no conflicts of interest.
Acknowledgments
Deep thanks to Dr. Marcassa, because without his help we would not have materialized the work, and a thought to Dr. Bosimini, thanks to whom this adventure began in 2009. Open access funding provided by BIBLIOSAN.
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