Outcomes on Continuous Flow Left Ventricular Assist Devices: A Single Institutional 9-Year Experience

doi:10.1016/j.athoracsur.2016.03.026

The Annals of Thoracic Surgery

Volume 102, Issue 4, October 2016, Pages 1266-1273

https://doi.org/10.1016/j.athoracsur.2016.03.026 Get rights and content

Background

Continuous-flow left ventricular assist devices (LVADs) have become the standard of care for patients with advanced heart failure. The goal of this study was to review our 9-year institutional experience.

Methods

From March 2006 through May 2015, 231 patients underwent implantation of 240 CF LVADs, HeartMate II LVAD (Thoratec Corp., Pleasanton, CA; n = 205) or HVAD (HeartWare Inc., Framingham, MA; n = 35). Of these, 127 devices (52.9%) were implanted as bridge to transplantation (BTT) and 113 (47.1%) as destination therapy (DT).

Results

Mean age was 51.2 ± 11.9 years for BTT patients and 58.2 ± 11.4 years for DT patients (p < 0.001). There was a higher incidence of preoperative diabetes, renal insufficiency, peripheral vascular disease, and previous cardiac operation in DT patients (p < 0.05). Survival was higher for BTT patients, with 1-, 6-, 12-, and 24-month survivals of 91.0%, 90.0%, 88.5%, and 72.1%, respectively, versus 85.3%, 81.1%, 75.6%, and 59.0%, respectively, for DT patients (p = 0.038). Gastrointestinal bleeding was the most common complication (29.6%), followed by right ventricular failure (22.5%) and stroke (15.0%), with a similar incidence for BTT and DT patients. Preoperative liver biopsy (hazard ratio [HR] 2.27, p = 0.036), mechanical support (HR 1.82, p = 0.025), aspartate transaminase (HR 1.07, p = 0.001), and alanine aminotransferase (HR 0.95, p = 0.024) were severe independent predictors of survival in multivariate analysis.

Conclusions

These data indicate excellent survival for BTT and DT patients on long-term LVAD support. However, for LVAD therapy to become a plausible alternative to heart transplantation, we need to further decrease the incidence of postoperative complications.

Section snippets

Material and Methods

Our health system’s institutional review board approved this retrospective study. We reviewed our institution’s LVAD data set and analyzed patients who underwent CF LVAD implantation as a BTT or DT from March 2006 through May 2015. Two hundred thirty-one patients who underwent 240 device implants (9 were device exchanges) were identified and formed the cohort of this study. Patients received either HeartMate II LVADs (n = 205) or HeartWare HVADs (n = 35).

Demographic and Operative Characteristics of LVAD Recipients

Mean age of our overall patient cohort was 54.5 ± 12.1 years (range, 17 to 81 years), 25.4% were women, and the indication for LVAD implantation was 52.9% in the BTT cohort and 47.1% in the DT cohort. Patients who received LVAD therapy as a BTT were significantly younger (51.2 ± 11.9 versus 58.2 ± 11.4 years, p < 0.001). Additional demographic characteristics and comorbidities are summarized in Table 1. Patients in the BTT cohort were more likely to have nonischemic dilated cardiomyopathy as

Comment

Continuous flow LVADs have substantially altered the expected survival for patients with end-stage heart failure refractory to optimal medical therapy 11, 12, 13. Patients implanted as a BTT or DT have substantially increased survival compared with patients implanted with the older generation HeartMate XVE device [11]. However, both the HM II and HVAD devices are associated with a relatively high incidence of device-related complications, such as GIB, RV failure, stroke, and DL infections 14, 15

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Cited by (16)

Analysis of Outcomes in Heart Transplantation
2020, Journal of Cardiothoracic and Vascular Anesthesia
Citation Excerpt :
Increased CF-LVAD utilization as BTT necessitates examination of the effects of LVAD implantation and duration on post-transplantation outcomes, particularly given the risks of repeat sternotomy, allosensitization from more frequent blood transfusions, and device-related complications including infection. Interestingly, despite the potential complications of heart transplantation after LVAD implantation, most studies indicate excellent short- and long-term post-transplant outcomes in patients bridged with CF-VADs, comparable to those of medically managed patients, and no effect of CF-VAD duration on post-transplant survival.55-63 Additionally, unadjusted ISHLT data show that post-heart transplant survival is similar between CF-LVAD patients and medically managed patients, but slightly worse for pulsatile LVAD recipients.
Clinical Nutrition in Critical Care Medicine – Guideline of the German Society for Nutritional Medicine (DGEM)
2019, Clinical Nutrition ESPEN
Citation Excerpt :
Patients after VAD implantation need a therapeutic anticoagulation. This therapy increases (i) the risk of local bleeding complications when establishing an enteral (or parenteral) access site, and (ii) the risk of spontaneous gastrointestinal bleeding which interferes with volitional intake/enteral nutrition; these risks make it more difficult to reach recommended calorie and protein intake/targets [497,498]. According to several case reports, however, endoscopic PEG tube placement is feasible and safe in patients after VAD implantation, if specific indications/contraindications are strictly respected [499,500].
Enteral and parenteral nutrition of adult critically ill patients varies in terms of the route of nutrient delivery, the amount and composition of macro- and micronutrients, and the choice of specific, immune-modulating substrates. Variations of clinical nutrition may affect clinical outcomes. The present guideline provides clinicians with updated consensus-based recommendations for clinical nutrition in adult critically ill patients who suffer from at least one acute organ dysfunction requiring specific drug therapy and/or a mechanical support device (e.g., mechanical ventilation) to maintain organ function.
The former guidelines of the German Society for Nutritional Medicine (DGEM) were updated according to the current instructions of the Association of the Scientific Medical Societies in Germany (AWMF) valid for a S2k-guideline. According to the S2k-guideline classification, no systematic review of the available evidence was required to make recommendations, which, therefore, do not state evidence- or recommendation grades. Nevertheless, we considered and commented the evidence from randomized-controlled trials, meta-analyses and observational studies with adequate sample size and high methodological quality (until May 2018) as well as from currently valid guidelines of other societies. The liability of each recommendation was described linguistically. Each recommendation was finally validated and consented through a Delphi process.
In the introduction the guideline describes a) the pathophysiological consequences of critical illness possibly affecting metabolism and nutrition of critically ill patients, b) potential definitions for different disease phases during the course of illness, and c) methodological shortcomings of clinical trials on nutrition. Then, we make 69 consented recommendations for essential, practice-relevant elements of clinical nutrition in critically ill patients. Among others, recommendations include the assessment of nutrition status, the indication for clinical nutrition, the timing and route of nutrient delivery, and the amount and composition of substrates (macro- and micronutrients); furthermore, we discuss distinctive aspects of nutrition therapy in obese critically ill patients and those treated with extracorporeal support devices.
The current guideline provides clinicians with up-to-date recommendations for enteral and parenteral nutrition of adult critically ill patients who suffer from at least one acute organ dysfunction requiring specific drug therapy and/or a mechanical support device (e.g., mechanical ventilation) to maintain organ function. The period of validity of the guideline is approximately fixed at five years (2018–2023).
Fatal Neurologic Dysfunction During Continuous-Flow Left Ventricular Assist Device Support
2019, Annals of Thoracic Surgery
Citation Excerpt :
Willey and colleagues [12] showed an association between diabetes mellitus and ND. Morgan and colleagues [16] showed that preoperative liver biopsy, mechanical support, aspartate transaminase, and alanine aminotransferase were strong independent predictors of overall mortality. Although both Willey and associates [12] and Coffin and associates [11] showed an association between the HVAD and incidence of ND, our data show no significant difference in the incidence of ND in patients with the HM-II and those with the HVAD (p = 0.95).
During continuous-flow left ventricular assist device (CF-LVAD) support, neurologic dysfunction (ND) is a common complication and can be fatal. Few reports provide detailed data on neurologic mortality in such patients. Therefore, we examined ND-related mortality during CF-LVAD support.
Between November 2003 and March 2016, 526 patients underwent implantation of a CF-LVAD (403 HeartMate II [Thoratec, Pleasanton, CA] and 123 HVAD [HeartWare International, Framingham, MA]) at our center. We categorized ND as hemorrhagic or ischemic and recorded resulting deaths. Records were reviewed to determine preoperative demographics, perioperative variables, prevalence and causes of postimplantation ND, duration of support until ND, time from ND to death, laboratory data and medications at the time of ND, post-ND treatment procedures, and causes of hemorrhagic ND. We also performed Cox multivariable logistic regression analysis to identify predictors of ND-related mortality by calculating odds ratios and confidence intervals.
Neurologic dysfunction occurred in 141 patients (26.8%), 48 (9.1%) of whom subsequently died. Median duration of left ventricular assist device support before ND was 230 days (range, 3 to 2,422), and median time from ND to death was 3.5 days (range, 0 to 55). Parenchymal hemorrhage was the most frequent cause of early conversion (76.7%). In the Cox multivariable regression analysis, predictors of fatal ND were age, ischemic cause of heart failure, history of stroke, and longer intraoperative aortic cross-clamp time.
Our study elucidates the characteristics and risk factors of patients who died of ND during CF-LVAD support. Further studies are required to find ways to decrease the incidence of fatal ND during CF-LVAD support.
Hospital Complications and Causes of 90-Day Readmissions After Implantation of Left Ventricular Assist Devices
2018, American Journal of Cardiology
Citation Excerpt :
Acute HF, particularly right ventricular failure (RVF), has long been recognized as a frequent complication associated with high mortality, LOS, worsening coagulopathy, and morbidity among LVAD recipients.20,21 HF contributed to 12% of the readmissions and 18.5% of in-hospital complications, which was slightly lower compared with previously published results.6,22 Proposed mechanism for RVF includes RV myocardial dysfunction, leftward shifting of the interventricular septum, and suboptimal RV after load reduction.23–25
Left ventricular assist devices (LVADs) have emerged as an attractive option in patients with advance heart failure. Nationwide readmission database 2013 to 2014 was utilized to identify LVAD recipients using ICD-9 procedure code 37.66. The primary outcome was 90-day readmission. Readmission causes were identified using ICD-9 codes in primary diagnosis field. The secondary outcomes were LVAD associated with hospital complications. Hierarchic 2-level logistic models were used to evaluate study outcomes. We identified 4,693 LVAD recipients (mean age 57 years, 76.2% males). Of which 53.9% were readmitted in first 90 days of discharge. Cardiac causes (33.3%), bleeding (21.3%), and infections (12.4%) were leading etiologies of 90-day readmissions. Significant predictors (odds ratio, 95% confidence interval, p value) of readmission were disposition to nursing facilities (1.33, 1.09 to 1.63, p = 0.01) and longer length of stay (1.01, 1.00 to 1.01, p <0.01). Although private insurance (0.75, 0.66 to 0.86, p <0.01), and self-pay (0.58, 0.42 to 0.81, p <0.01) predicted lower readmissions. Cardiac complications (36.3%), major bleeding (29.8%), and postoperative infections (10.4%) were most common LVAD-related complications. In conclusion, high early readmission rate was observed among LVAD recipients with Cardiac complications, bleeding complications, and infections were driving force for major complications and most of readmissions.
Chemokine receptor patterns and right heart failure in mechanical circulatory support
2017, Journal of Heart and Lung Transplantation
Citation Excerpt :
As our purpose was to determine whether CCR expression as measured from peripheral blood cells before LVAD implant is associated with a failing RV in need of additional support, we included both planned (n = 17) and unplanned (n = 18) biventricular support in our RV MCS outcome group. This doubled our reported rate of RVF requiring MCS and should be kept in mind when interpreting the results; the overall rate of post-operative RVF excluding planned biventricular support for this cohort was 27.9%, which is in keeping with recent reports.29,30 Interestingly, there was no significant difference in CCR expression between planned and unplanned RV MCS, indicating a potential role for inflammatory signaling data in the comprehensive evaluation of pre-LVAD patients.
Right ventricular failure (RVF) complicates 9% to 44% of left ventricular assist device (LVAD) implants post-operatively. Current prediction scores perform only modestly in validation studies, and do not include immune markers. Chemokines are inflammatory signaling molecules with a fundamental role in cardiac physiology and stress adaptation. In this study we investigated chemokine receptor regulation in LVAD recipients who develop RVF.
Expression of chemokine receptor (CCR) genes 3 to 8 were examined in the peripheral blood of 111 LVAD patients, collected 24 hours before implant. RNA was isolated using a PAXgene protocol. Gene expression was assessed using a targeted microarray (RT2 Profiler PCR Array; Qiagen). Results were expressed as polymerase chain reaction (PCR) cycles to threshold and normalized to the average of 3 control genes, glyceraldehyde phosphate dehydrogenase (GAPDH), hypoxanthine phosphoribosyltransferase 1 (HPRT1) and β₂-microglobulin (B2M). Secondary outcomes studied were 1-year mortality and long-term RV failure (RVF-LT).
CCR3, CCR4, CCR6, CCR7 and CCR8 were downregulated in LVAD recipients with RVF. Within this cohort of patients, CCR4, CCR7 and CCR8 were further downregulated in those who required RV mechanical support. In addition, under-expression of CCR3 to CCR8 was independently associated with an increased risk of mortality at 1 year, even after adjusting for RVF. CCR expression did not predict RVF-LT in our patient cohort.
Pre-LVAD CCR downregulation is associated with RVF and increased mortality after implant. Inflammatory signatures may play a major role in prognostication in this patient population.
Heart failure therapies: new strategies for old treatments and new treatments for old strategies
2016, Cardiovascular Pathology
Citation Excerpt :
On the flip side of this coin, increasing the level of anticoagulation increases the risk of bleeding. Hemorrhage, especially of the brain and gastrointestinal tract, continues to be a significant problem in device recipients; gastrointestinal bleeding was seen in 29.6% of continuous flow LVAD patients (with an event rate of 0.18 per patient year) in a recent 9-year single-institution study [18]. Interestingly, patients with continuous flow devices can also develop acquired von Willebrand factor deficiency, thought to be secondary to high shear forces within the devices; this further limits the effectiveness of the platelet arm of the clotting cascade and predisposes to hemorrhage.
Heart failure, whether acute or chronic, remains a major health care crisis affecting almost 6 million Americans and over 23 million people worldwide. Roughly half of those affected will die within 5 years, and the annual cost exceeds $30 billion in the US alone. Although medical therapy has made some modest inroads in partially stemming the heart failure tsunami, there remains a significant population for whom medication is unsuccessful or has ceased being effective; such patients can benefit from heart transplantation or mechanical circulatory support. Indeed, in the past quarter century (and as covered in Cardiovascular Pathology over those years), significant improvements in pathologic understanding and in engineering design have materially enhanced the toolkit of options for such refractory patients. Mechanical devices, whether total artificial hearts or ventricular assist devices, have been reengineered to reduce complications and basic wear and tear. Transplant survival has also been extended through a better comprehension of and improved therapies for transplant vasculopathy and antibody-mediated rejection. Here we review the ideas and treatments from the last 25 years and highlight some of the new directions in nonpharmacologic heart failure therapy.

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Original articleAdult cardiacOutcomes on Continuous Flow Left Ventricular Assist Devices: A Single Institutional 9-Year Experience

Background

Methods

Results

Conclusions

Section snippets

Material and Methods

Demographic and Operative Characteristics of LVAD Recipients

Comment

J Thorac Cardiovasc Surg

J Am Coll Cardiol

Ann Thorac Surg

J Heart Lung Transplant

Ann Thorac Surg

J Heart Lung Transplant

Ann Thorac Surg

J Heart Lung Transplant

Ann Thorac Surg

J Am Coll Cardiol

Long-term use of a left ventricular assist device for end-stage heart failure

N Engl J Med

Advanced heart failure treated with continuous-flow left ventricular assist device

N Engl J Med

Use of a continuous-flow device in patients awaiting heart transplantation

N Engl J Med

Original article
Adult cardiac
Outcomes on Continuous Flow Left Ventricular Assist Devices: A Single Institutional 9-Year Experience