Abstract
Background: The objective of this study is to investigate the effect of preoperative diabetes on all-cause mortality and major postoperative complications among patients with continuous-flow left ventricular assist device (LVAD) by using data from a national database.
Methods and Results: The 545 study patients who underwent primary HeartMateII implantation between 2013 and 2019 were divided into 2 groups according to their diabetes mellitus (DM) status; patients with DM (n=116) and patients without DM (n=429). First, the on-device survival and incidence of adverse events were evaluated. Second, after adjusting for patients’ backgrounds, the change of laboratory data in the 2 groups were compared. Overall, on-device survival at 1, 2, and 3 years was almost equivalent between the 2 groups; it was 95%, 94%, and 91% in patients without DM, and 93%, 91%m and 91% in patients with DM (P=0.468) The incidence of adverse events was similar between 2 groups of patients, except for driveline exit site infection in the adjusted cohort. Cox proportional hazards regression analysis revealed younger age (HR: 0.98 (95% confidence interval (CI): 0.97–0.99, P=0.001) and presence of DM (HR: 1.83 (95% CI: 1.14–2.88), P=0.016) as significant predictors of driveline infection. Laboratory findings revealed no differences between groups throughout the periods.
Conclusions: The clinical results after LVAD implantation in DM patients were comparable with those in non-DM patients, except for the driveline exit site infection.
Patients with diabetes mellitus (DM) are at an increased risk of developing heart failure,1 and many proceed to end-stage heart failure, which requires advanced therapies, such as left ventricular assist device (LVAD) support or heart transplantation. The treatment of end-stage heart failure by LVAD has become prevalent in Japan; the number of heart failure patients complicated with DM has also been increasing. However, less is known about the effect of DM on outcomes of patients supported with continuous flow LVAD (CF-LVAD); some small studies have shown inconsistent results.2–5 The International Society for Heart and Lung Transplantation recommendation to consider the presence of DM and poor glycemic control or severe DM-associated end-organ damage as a relative contraindication for LVAD implantation, is thus based on data generated from the general DM population with HF, as well as on limited data from studies on outcomes of small groups of patients with DM supported with LVAD (Class IIb; Level of Evidence C).6
Editorial p 1959
In this study, we evaluated the effect of preoperative DM on mortality and major adverse events during LVAD support by using data from a Japanese national database (J-MACS).
Methods
Patients
This study was a retrospective analysis of patients who had an implanted HeartMateII (HMII) LVAD and received bridge-to-transplant (BTT) therapy at 30 medical institutions in Japan. The data presented represents follow-up data for all patients who underwent HMII implantation between April 2013 and December 2019. During this period, 547 patients underwent 629 HeartMateII LVAD implantations. Of these, 2 patients whose DM status was unknown were excluded. After excluding these 2 patients, we divided the remaining 545 patients who had undergone primary HeartMateII implantation (including patients bridged from extracorporeal LVAD or transcatheter LVAD) into 2 groups according to their DM status; patients with DM (n=116) and patients without DM (n=429). Of the 116 patients with DM, 12 (10.3%) were receiving insulin treatment. Baseline characteristics, duration of LVAD support, clinical outcomes, survival, adverse events, and end-organ function measured at the mid-term follow up were compared between the 2 groups.
The rate of heart transplantations in Japan is one of the lowest in the world due to an extreme shortage of donor hearts, leading to prolonged waiting times and a limitation of the acceptable LVAD candidate age (≤64 years). In Japan, because all patients who underwent a continuous-flow implantable LVAD must be listed in the national heart transplantation registry until July 2021, all patients in this study underwent HeartMateII LVAD implantation as BTT therapy. There are some definitive DM-related complications that are contraindications for being listed in the national heart transplantation register, which are as follows: proliferative retinopathy, nephropathy with its creatinine clearance <30 mL/min/m2, or poor blood glycemic control.
The primary endpoint was successful bridge-to-heart transplantation, death on device support, LVAD removal for heart recovery, or LVAD exchange because of LVAD malfunction. The total follow-up period was 1313.5 patient-years in overall patients. The mean and median follow-up period was 2.42±1.44 and 2.30 (interquartile range (IQR): 1.29–3.35) years respectively.
All data including baseline characteristics, laboratory values, echocardiographic parameters, surgical parameters, adverse events and mortality were extracted from the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS) database. Before LVAD implantation, all patients provided informed consent for registration in the J-MACS database at each hospital. The utilization of the data from the J-MACS database was approved by the ethical committee at Osaka University (IRB: 14344-2), and this study was conducted in accordance with the Declaration of Helsinki.
Device Implantation and Postoperative Management
Details regarding device implantation have been detailed previously.7 Generally, because patients who undergo continuous-flow LVAD implantation must be listed in the national heart transplantation registry in Japan, patients who experience cardiogenic shock with unknown eligibility for heart transplantation are treated with an extracorporeal LVAD or a trans-catheter LVAD (Impella, Abiomed, MA, USA). These patients are initially hemodynamically stabilized with an extracorporeal or transcatheter VAD,8 before receiving a HeartMateII LVAD after confirmation and entry into the heart transplantation registry. The HeartMateII LVAD was mainly implanted via a median sternotomy. Standard cardiopulmonary bypass was established by aortic perfusion with bicaval or single atrial drainage, according to whether the patient required additional procedures to the institution policy. The majority of implantations were performed under beating-heart conditions. The driveline exit site was created at the lateral side of the left rectus abdominis. The decision for additional concomitant valve surgery was performed at the discretion of the treating surgeon in each hospital.
Postoperative anticoagulation treatment also was at the discretion of the treating cardiologist or cardiovascular surgeon at each hospital. Briefly, antiplatelet therapy with 100 mg of aspirin daily and anticoagulation with warfarin is managed with a target prothrombin time-international normalized ratio (PT-INR) range of 2.0–2.5, according to the manufacturer’s recommendation.
Data Collection
Patient data were obtained from the J-MACS database. Primary outcome variables included in-hospital mortality and overall survival. Preoperative variables that may affect the primary outcome were identified, including baseline demographics, medical histories, laboratory values, and hemodynamics. Information about intraoperative variables, such as cardiopulmonary bypass time, amount of blood products used, and concomitant cardiac procedures, were also collected. Early post-implantation data included complications that occurred between the operation and the hospital discharge. Major adverse events requiring readmission during LVAD support were also extracted; these included right heart failure, gastrointestinal tract bleeding, major cerebral events, driveline infections, and LVAD pocket infection. Basically, each adverse event was defined according to the International Society of Heart and Lung Transplantation (ISHLT) statement.9 Of these adverse events, those that required the patient to be re-admitted were registered in the database. In the present study, cerebrovascular accident (CVA) was defined as a cerebral infarction and/or intracranial hemorrhage. Transient ischemic attack and seizure without any corresponding lesions were excluded from CVA definition.
The Heart Mate II Risk Score (HMRS) was calculated as follows: HMRS = 0.0274 × age − 0.723 × serum albumin (mg/dL) + 0.74 × serum creatinine (mg/dL) + 1.136 × international normalized ratio (INR).10 Because we could not evaluate the number of LVAD implantation surgeries in each specific hospital in a specific year, the factor about the volume in each hospitals was excluded from the analysis. The estimated glomerular filtration rate (eGFR) was calculated using the following formula: eGFR = 186 × (serum creatinine (mg/dL))−1.154 × (age)−0.203 × (0.742 if female).
Statistical Analysis
All data were analyzed using JMP software version 14.0 (SAS, USA). Statistical significance was determined on the basis of a predetermined α=0.05. Categorical variables were summarized with frequencies and percentages and compared across groups using the chi-squared or Fisher’s exact tests. Continuous variables are summarized as mean±standard deviation or median (IQR). Two-sample t-tests, Mann-Whitney U-test or a paired t-test was used for comparisons across groups. Overall survival rate, and incidence of adverse events were estimated by using Kaplan-Meier curves and compared across groups using log-rank tests. Patients who underwent heart transplantation, HeartMateII removal for recovery, or LVAD exchange for another LVAD were censored at each event from the follow-up. Cox regression hazard models for survival outcomes were used to adjust for the effects of preoperative variables on incidence of driveline infection. The factors in univariate analysis with P<0.05 and DM were considered for Cox hazard model analysis to identify the risk factors for incidence of driveline infection.
To compare the incidence of major adverse events, we adjusted age and body mass index because they were significantly higher in DM patients. To compare change in laboratory data in the 2 groups, the backgrounds of the 2 groups were adjusted by using propensity score matching. The propensity score was obtained by multivariate logistic regression analysis. The factors (age, gender, body surface area, body mass index, preoperative laboratory parameters, left ventricular end-diastolic dimension) were adjusted for the analysis of DM effect on laboratory data. We performed a 1 : 1 nearest-available matching algorithm with a 0.1 caliper, before 100 patients without DM and 100 patients with DM were extracted from the database depending on the propensity score matching model.
Results
Baseline characteristics of 429 patients without DM and 116 patients with DM are compared in Table 1. Patients with DM was significantly older and had a larger body mass index. As for etiologies, in DM patients, 55% was idiopathic dilated cardiomyopathy, and 25% was ischemic cardiomyopathy. There were no significant differences in echocardiographic and hemodynamic parameters between the groups. Although renal function was preserved in both groups, estimated GFR was significantly lower in patients with DM. And although there was no statistical significance, the HeartMateII risk score was higher in patients with DM.
Table 1. Baseline Characteristics of Study Patients
| |
DM (−)
(n=429) |
DM(+)
(n=116) |
P value |
| Baseline characteristics |
| Age (years) |
44 (34–55) |
54 (47–60) |
<0.001 |
| Male, n (%) |
317 (74) |
96 (83) |
0.051 |
| Height (cm) |
167 (162–173) |
170 (162–174) |
0.373 |
| Weight (kg) |
56.4 (49.0–63.4) |
60.6 (54.1–68.2) |
<0.001 |
| Body surface area (m2) |
1.65 (1.53–1.75) |
1.71 (1.58–1.81) |
<0.001 |
| Body mass index (kg/m2) |
20.1 (18.4–22.6) |
21.7 (19.6–23.9) |
<0.001 |
| Etiologies, n (%) |
| Idiopathic DCM |
360 (71) |
72 (55) |
<0.001 |
| Ischemic |
47 (9) |
32 (25) |
<0.001 |
| HCM |
53 (11) |
12 (9) |
0.748 |
| Past cardiac surgery, n (%) |
213 (42) |
50 (38) |
0.485 |
| ICD |
264 (52) |
73 (56) |
0.490 |
| CRT-D |
214 (42) |
65 (50) |
0.137 |
| Echocardiographic parameters (mm) |
| LVDd |
68 (60–77) |
71 (62–78) |
0.265 |
| LVDs |
63 (55–71) |
64 (55–72) |
0.335 |
| Right heart catheterization |
| Central venous pressure (mmHg) |
8 (4–13) |
7 (4–12) |
0.057 |
| sPAP (mmHg) |
39 (28–50) |
43 (30–56) |
0.059 |
| dPAP (mmHg) |
21 (14–26) |
21 (14–28) |
0.476 |
| PCWP (mmHg) |
20 (12–27) |
20 (13–28) |
0.917 |
| Cardiac index (L/min/m2) |
2.11 (1.83–2.53) |
2.08 (1.73–2.49) |
0.921 |
| PVR (woods) |
1.67 (1.13–2.56) |
2.12 (1.11–3.41) |
0.080 |
| Laboratory valuables at diagnosis |
| White blood cell counts (×1,000/μL) |
6.1 (4.9–7.8) |
6.1 (4.9–7.4) |
0.273 |
| C-reactive protein (mg/dL) |
0.3 (0.1–1.4) |
0.4 (0.1–1.3) |
0.005 |
| Hemoglobin (g/dL) |
11.5 (10.2–12.8) |
11.5 (10.1–12.9) |
0.763 |
| Platelet counts (×1,000/μL) |
191 (154–235) |
176 (144–240) |
0.373 |
| Blood urea nitrogen (mg/dL) |
16 (11–22) |
17 (13–21) |
0.552 |
| Creatinine (mg/dL) |
0.90 (0.70–1.13) |
0.98 (0.80–1.22) |
0.054 |
| eGFR (mL/min/1.73 m2) |
91 (67–128) |
81 (64–107) |
0.018 |
| Total bilirubin (mg/dL) |
0.9 (0.6–1.3) |
0.9 (0.6–1.4) |
0.467 |
| Total protein (mg/dL) |
6.7 (6.1–7.1) |
6.6 (6.2–7.0) |
0.766 |
| Albumin (mg/dL) |
3.8 (3.4–4.1) |
3.7 (3.3–4.0) |
0.098 |
| Cholinesterase |
234 (184–296) |
211 (164–265) |
0.030 |
| Cholesterol |
159 (132–184) |
152 (108–191) |
0.266 |
Values are given as the median (interquartile range). CRT-D, cardiac resynchronization therapy-defibrillator; DCM, idiopathic dilated cardiomyopathy; DM, diabetes mellitus; dPAP, diastolic pulmonary pressure; eGFR, estimated glomerular filtration rate; HCM, hypertrophic cardiomyopathy; ICD, implantable cardioverter defibrillator; LVDd, left ventricular diastolic dimension; LVDs, left ventricular systolic dimension; PCWP, pulmonary capillary wedge pressure; PVR, pulmonary vascular resistance; sPAP, systolic pulmonary artery pressure.
The operative results of the patients are compared in Table 2. There were no significant differences in concomitant valve surgeries or right ventricular assist device requirement between patients with and without DM. Thirty-day mortality was 2% in patients without DM and 0% in patients with DM (P=0.588). The frequency of each adverse event is also shown in Table 2. CVA was seen in 0.068 and 0.088 events/patient-year in patients with and without DM respectively (P=0.271). Driveline infection was seen in 0.30 and 0.33 of patients with and without DM respectively (P=0.613).
Table 2. Operative Results and Frequency of Each Adverse Event for the Study Patients
| |
DM (−)
(n=429) |
DM (+)
(n=116) |
P value |
| Concomitant surgery, n (%) |
| Aortic valve procedure |
36 (7) |
10 (8) |
0.850 |
| Mitral valve procedure |
43 (9) |
11 (8) |
>0.999 |
| Tricuspid valve procedure |
357 (71) |
96 (74) |
0.516 |
| RVAD implantation |
3 (1) |
1 (1) |
>0.999 |
| Operative time and transfusion |
| Total operation time (min) |
452 (330–604) |
410 (309–560) |
0.090 |
| Cardiopulmonary bypass time (min) |
130 (89–170) |
124 (83–159) |
0.181 |
| Total amount of blood transfusion (L) |
2.40 (1.68–3.71) |
1.68 (0.84–3.71) |
0.950 |
| ICU stay (days) |
7 (4–12) |
6 (4–14) |
0.424 |
| 30-day mortality, n (%) |
5 (2) |
0 (0) |
0.588 |
| Adverse events during LVAD support (events/patient-year) |
| Cerebrovascular accident |
0.068 |
0.088 |
0.271 |
| Driveline infection |
0.30 |
0.33 |
0.613 |
| Right heart failure |
0.022 |
0.026 |
0.704 |
| GI bleeding |
0.12 |
0.14 |
0.255 |
Values are given as the median (interquartile range). DM, diabetes mellitus; GI, gastrointestinal; LVAD, left ventricular assist device; RVAD, right ventricular assist device.
Overall on-device survival is shown in Figure 1. Overall on-device survival at 1, 2, and 3 years was almost equivalent between the 2 groups, because it was 95%, 94%, and 91% respectively in patients without DM, and 93%, 91% and 91% respectively in patients with DM (P=0.468).
The incidence of major adverse events (stroke, gastrointestinal bleedings, right heart failure, and driveline infection) were evaluated, as shown in Figure 2. The incidence of major cerebrovascular events at 1, 2, and 3 years was 11%, 13%, and 18% respectively in patients without DM, and 14%, 14%, and 18% respectively in patients with DM (P=0.530; Figure 2A). The incidence of gastrointestinal bleeding was 3%, 3%, and 5% respectively in patients without DM, 9%, 11%, and 11% respectively in patients with DM (P=0.012, Figure 2B) The incidence of right heart failure was 4%, 5%, and 6% respectively in patients without DM, 3%, 6%, and 8% respectively in patients with DM (P=0.501, Figure 2C). The incidence of driveline infection was 16%, 23%, and 25% respectively in patients without DM, and 21%, 28%, and 30% respectively in patients with DM (P=0.236, Figure 2D), and these differences were not significant. The incidence of pump pocket infection at 1, 2, and 3 years was 2%, 3%, and 5% respectively in patients without DM, and 1%, 2% and 3% respectively in patients with DM (P=0.740).
As patients with DM were significantly older, and had higher body mass index, we adjusted for age and body mass index using a propensity score matching method. After adjustment, there were no significant differences in all preoperative parameters between the groups, except in terms of etiologies (Supplementary Table). The median age was 52 (IQR: 46–60) years in patients without DM and 52 (IQR: 45–58) years in patients with DM. The incidence of major adverse events (stroke, gastrointestinal bleeding, right heart failure, and driveline infection) in the adjusted cohort was evaluated, as shown in Figure 3A–D. The incidence of major cerebrovascular events at 1, 2, and 3 years was 8%, 11%, and 11% respectively in patients without DM, and 13%, 17%, and 17% respectively in patients with DM (P=0.320; Figure 3A). Although the incidence of gastrointestinal bleeding was significantly higher in patients with DM in the overall cohort, there was no differences in the adjusted cohort (Figure 3B). There were no differences in the incidence of right heart failure both in the overall cohort and the propensity-matched cohort (Figure 3C). Importantly, the incidence of driveline site infection at 1, 2, and 3 years respectively was 9%, 16%, and 16% in patients without DM, and 23%, 28%, and 30% respectively in patients with DM (P=0.023, Figure 3D). The incidence of pump pocket infection at 1, 2, and 3 years respectively was 2%, 2%, and 2% in patients without DM, and 1%, 2% and 4% respectively in patients with DM in the propensity-matched cohort (P=0.236).
We analyzed the risk factors and the effect of DM on the driveline exit site infection by using Cox hazard analysis (Table 3). Univariate analysis shows younger age and being male, but not ischemic cardiomyopathy, as being risk factors for driveline exit site infection. Because patients with DM were significantly older than patients without DM, the univariate analysis did not show that DM had a significant effect on driveline exit site infection. However, the multivariate analysis revealed younger age (HR: 0.98 (95% confidence interval (CI): 0.97–0.99), P=0.001) and presence of DM (HR: 1.83 (95% CI: 1.14–2.88), P=0.016) as significant predictors of driveline exit site infection. Furthermore, we stratified patients according to age (>50 years or not) and DM status, and evaluated the incidence of driveline exit site infection within 2 years (Figure 4). In patients aged >50 years, the incidence of driveline infection was almost similar between patients with DM and without DM (Figure 4A). However, if patients were aged <50 years, the incidence of driveline infection was significantly higher in patients with DM (Figure 4B).
Table 3. Cox Hazard Analysis of the Risk Factors and the Effect of DM on the Driveline Exit Site Infection
| |
Univariate |
P value |
Multivariate |
P value |
| Baseline characteristics |
| Age (years) |
0.98 (0.97–0.99) |
0.003 |
0.98 (0.97–0.99) |
0.001 |
| Male, n (%) |
1.60 (1.01–2.66) |
0.045 |
1.54 (0.97–2.57) |
0.080 |
| Body surface area (m2) |
1.31 (0.45–3.76) |
0.617 |
|
|
| Body mass index |
1.66 (0.54–4.83) |
0.362 |
|
|
| DM |
1.29 (0.83–1.93) |
0.248 |
1.83 (1.14–2.88) |
0.016 |
| Episode of smoke |
1.02 (0.71–1.47) |
0.907 |
|
|
| Past cardiac surgery |
1.08 (0.73–1.58) |
0.689 |
|
|
| Etiologies, n (%) |
| Idiopathic DCM |
1.47 (0.98–2.26) |
0.068 |
0.51 (0.22–1.01) |
0.075 |
| Ischemic |
0.52 (0.23–0.99) |
0.047 |
|
|
| Past cardiac surgery, n (%) |
0.92 (0.63–1.37) |
0.689 |
|
|
| LVDd (mm) |
1.14 (0.97–1.35) |
0.119 |
|
|
| Laboratory valuables at diagnosis |
| C-reactive protein (mg/dL) |
0.96 (0.85–1.03) |
0.278 |
|
|
| Hemoglobin (g/dL) |
1.01 (0.91–1.13) |
0.843 |
|
|
| Creatinine (mg/dL) |
0.66 (0.35–1.19) |
0.178 |
|
|
| Total bilirubin (mg/dL) |
1.04 (0.91–1.13) |
0.454 |
|
|
| Total protein (mg/dL) |
1.08 (0.78–1.50) |
0.649 |
|
|
| Albumin (mg/dL) |
0.79 (0.55–1.16) |
0.233 |
|
|
| Cholinesterase |
0.99 (0.99–1.00) |
0.351 |
|
|
Abbreviations as in Table 1.
We also analyzed the change of estimated GFR, serum albumin level, and serum C-reactive protein (CRP) level after LVAD implantation (Figure 5A–F). Although estimated GFR was significantly lower in patients with DM in the overall cohort, except at 1 and 24 months after implantation in the overall cohort, there was no significant difference between the 2 groups in the propensity-matched cohort throughout the study period (Figure 5A,B). There was no significant difference in the serum albumin level between the 2 groups, both in the overall cohort and the propensity-matched cohorts (Figure 5C,D). As for inflammation level, although patients with DM had a higher preoperative CRP level in the overall cohort, there were no differences in both the overall and propensity-matched cohorts postoperatively (Figure 5E,F).
Discussion
The findings of the present study are as follows: (1) the overall on-device survival was similar among patients with and without DM; (2) incidence of adverse events were also similar among patients with and without DM, except in terms of driveline infection in young patients after adjusting background characteristics; and (3) the effect of DM on end-organ function, especially renal function, was limited during LVAD support.
In the present study, the on-device survival rate was excellent, with ~90% at 3 years in both patients with and without DM. In terms of the effect of DM on survival after LVAD implantation, it is still controversial because there have been some conflicting results about the effect of DM on survival after continuous-flow LVAD implantation.2,11–14 Asleh et al reported that among patients with median age of 62 years and in 63% of the destination therapy (DT) population, DM patients had worse survival after LVAD implantation.2 Usoh et al also reported DM was associated with a higher risk of death at 3 years (42% vs. 21%; P=0.013).13 Meanwhile, Vest et al reported the outcomes of 300 consecutive patients who underwent implantation of continuous-flow LVADs (62% BTT), of whom 43% had DM.5 In accordance with our findings, there were no differences in overall mortality (adjusted HR: 0.88 [0.57–1.37]; P=0.58). The overall survival rate in the present study was superior both in patients with and without DM compared to these previous reports. This is probably because the median age of 52 years in our DM patients was younger than that of previous reports, whereby the median age was ~60 years. In addition, our patients comprised only BTT patients because DT has only just been approved in Japan. Patients with severe DM-related complications could not be enrolled in the study cohort. After DT is approved, further investigation into the effect of DM on overall survival is required because of the increasing number of aging patients who undergo LVAD implantation.
For extensive long-term support regarding LVAD for heart transplantation or DT, prevention of LVAD-related infection is critically important.15,16 In our study, DM, as well as younger age, was one of the risk factors of driveline infection, although no significant differences were found in terms of pump pocket infection. In particular, DM had a significant effect on driveline infection only in the younger patients. Although it is well known that DM predisposes patients to infection, there has still been controversy about the effect of DM on LVAD-related infectious complications. Vest et al reported that DM was not associated with LVAD-related infections.5 In contrast, Asleh et al reported that patients with DM had a significantly higher incidence of device infection after adjusting for background characteristics.2 Various functions of the immune system are altered in patients with DM, including impairment in leukocyte adherence, bacterial phagocytosis, or oxygen-dependent killing of micro-organisms.17,18 Long-standing DM can adversely affect the inflammatory response to pathogens through activation of adhesion molecules on endothelial cells, and DM is involved in impairment of defense mechanisms against micro-organism penetration.19 Because the driveline exit site is always exposed to micro-organisms, this site is extremely vulnerable to infection, and a high incidence of infection can be explained by impaired immune responses to pathogens in patients with DM. It is suspected that younger patients are more ambulant than elderly patients; therefore, the driveline exit fixation is worse and vulnerable for infection, especially in young DM patients.
It is well known that renal function usually declines gradually after LVAD implantation.20 Diabetic kidney disease is a typical complication of type 2 DM and is an important cause of end-stage renal disease that requires renal replacement therapy.21 Yalcin et al reported that patients with DM showed less improvement of renal function after LVAD implantation.22 Fortunately, in the present study, renal function was maintained throughout the first 2 years after LVAD implantation in patients with DM. This is probably because, in the present study, preoperative renal function was preserved even in patients with DM because only BTT patients were included. One of the reasons for these controversial results might be explained by glycemic control after LVAD implantation. There have been several studies that reported LVAD implantation improved glycemic control in heart failure patients.2,23,24 Asleh et al reported that LVAD implantation resulted in a remarkable decrease in hemoglobin A1c levels and a significant reduction in requirements of DM medications.2 Therefore, glycemic control is important after LVAD implantation to maintain renal function.
This study has several limitations. First, because this is a multicenter study, which is based on national database data, the details of each adverse event were limited. The management of LVAD patients, especially driveline management and treatment of infection, could be different in different hospitals. Second, this study only enrolled BTT patients, and renal function and/or DM were well controlled in all patients before LVAD implantation; therefore, information about the effect of DM on outcomes might be limited. Third, severity and change in DM status was unknown because the hemoglobin A1c level was not followed up and recorded in the database; therefore, we could not evaluate the effect of DM control on clinical outcomes.
In conclusion, the clinical results after LAVD implantation in DM patients were compatible with those in non-DM patients, except in terms of the driveline exit site infection.
Disclosures
M.O., Y. Sawa, and A.U. are members of Circulation Journal’s Editorial Team.
IRB Information
The present study was approved by the ethics committee of Osaka University (reference number: 14344-2).
Supplementary Files
Please find supplementary file(s);
https://doi.org/10.1253/circj.CJ-21-1056
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