Stroke and death risk in ventricular assist device patients varies by ISHLT infection category: An INTERMACS analysis

doi:10.1016/j.healun.2019.02.006

The Journal of Heart and Lung Transplantation

Volume 38, Issue 7, July 2019, Pages 721-730

https://doi.org/10.1016/j.healun.2019.02.006 Get rights and content

BACKGROUND

Ventricular assist device (VAD) patients often experience infections, which increase the risk of stroke and mortality. Using the definitions of the International Society for Heart and Lung Transplantation (ISHLT), we have characterized differences in clinical outcomes for categories of infection: VAD-specific (e.g., pump component related); VAD-related (e.g., bloodstream infection, BSI); and non-VAD infections (e.g., pneumonia).

METHODS

Querying of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) identified 16,597 continuous-flow VAD recipients. Categories of infection were tested in multivariate models to determine the risk of stroke and death.

RESULTS

After implant, 7,046 patients (42%) developed an infection at a median of 69 (interquartile range 12 to 272) days. A majority were non-VAD infections (49%), followed by VAD-related (26%) and VAD-specific infections (25%). BSIs were the most common form of VAD-related infection (92%), and the majority (59%) had no associated infection, that is, idiopathic bacteremia. Internal pump component infections were rare (0.003 event per patient-year [EPPY]). Infected VAD patients had a higher prevalence of stroke compared to patients without an infection (18% vs 11%, p < 0.001). The lowest stroke rate occurred after a VAD-specific infection (0.11 EPPY) compared with VAD-related (0.17 EPPY) and non-VAD infections (0.15 EPPY, p < 0.001). Hemorrhagic strokes were more common than ischemic strokes in all infection groups and highest after a VAD-related infection (0.13 EPPY). One-year survival after an infection was 87% in VAD-specific infections, as compared with VAD-related (71%) and non-VAD infections (72%, p < 0.001).

CONCLUSIONS

The ISHLT categorization of VAD infections unveils notable differences in associated risk of stroke and mortality. A re-assessment of transplant prioritization for eligible infected VAD patients may be useful to increase transplant-related survival benefit.

Section snippets

Methods

INTERMACS is funded by the National Heart, Lung and Blood Institute (NHLBI, Contract No. HHSN268201100025C). The INTERMACS Data Access, Analysis and Publications Committee approved the analysis described in this report, and the analysis was conducted at the Inova Heart and Vascular Institute. The INTERMACS Data and Clinical Coordinating Center and each participating institution received international review board/ethics review board approval for active informed consent or a waiver of consent to

Patients’ characteristics for those with and without an infection

The analysis included 16,597 continuous-flow VAD recipients (Figure 1). Of this cohort, 9,551 patients were free of any post-implant infection, whereas 7,046 patients (42%) developed an infection after implant. The median time to development of any infection was 69 (interquartile range [IQR] 12 to 272) days. Characteristics of patients with and without an infection are compared in Table S1 (refer to Supplementary Material available online at www.jhltonline.org/). Patients with a

Discussion

We performed an analysis of continuous-flow LVAD patients within INTERMACS to characterize the epidemiology of infections in VAD recipients and to determine the risk of stroke and death. Infections in VAD recipients are a significant cause of morbidity and mortality and we discovered distinct differences in clinical outcomes based on the 2011 ISHLT categorization of infections.⁴ Our principal findings are as follows: (1) the incidence rate of infection was highest in the early post-implant

Limitations

We used INTERMACS for our analysis and, as with all registry data sets, not all data points are available for all patients and not all individual data points can be reviewed by the data coordinating center. Specific reporting standards are mandated by INTERMACS for each center with regard to data quality and completeness. Because many DLIs are managed in the ambulatory setting or by outlying providers, it is possible that milder infections are underreported in the registry compared with BSIs,

Disclosure statement

P.S. has received an American Heart Association Scientist Development Award, co-funded by the Enduring Hearts Foundation, and has done consulting work for NuPulse and Ortho Clinical Diagnostics. L.B.C. reports grant support from Abbott. J.A.C. is a member of the Medtronic steering committee and receives travel-related financial support and compensation for speaking from Abbott, Inc. The remaining authors have no conflicts of interest to disclose.

The authors thank the INTERMACS investigators,

Supplementary data

Supplementary data associated with this article can be found in the online version at www.jhltonline.org/.

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This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I²) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with ¹⁸F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense ¹⁸F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.
18F-FDG PET/CT and radiolabeled leukocyte SPECT/CT imaging for the evaluation of cardiovascular infection in the multimodality context: ASNC Imaging Indications (ASNC I2) Series Expert Consensus Recommendations from ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS
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This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I²) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with ¹⁸F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense ¹⁸F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.
18F-FDG PET/CT and Radiolabeled Leukocyte SPECT/CT Imaging for the Evaluation of Cardiovascular Infection in the Multimodality Context: ASNC Imaging Indications (ASNC I2) Series Expert Consensus Recommendations From ASNC, AATS, ACC, AHA, ASE, EANM, HRS, IDSA, SCCT, SNMMI, and STS
2024, JACC: Cardiovascular Imaging
This document on cardiovascular infection, including infective endocarditis, is the first in the American Society of Nuclear Cardiology Imaging Indications (ASNC I²) series to assess the role of radionuclide imaging in the multimodality context for the evaluation of complex systemic diseases with multi-societal involvement including pertinent disciplines. A rigorous modified Delphi approach was used to determine consensus clinical indications, diagnostic criteria, and an algorithmic approach to diagnosis of cardiovascular infection including infective endocarditis. Cardiovascular infection incidence is increasing and is associated with high morbidity and mortality. Current strategies based on clinical criteria and an initial echocardiographic imaging approach are effective but often insufficient in complicated cardiovascular infection. Radionuclide imaging with fluorine-18 fluorodeoxyglucose (¹⁸F-FDG) positron emission tomography/computed tomography (CT) and single photon emission computed tomography/CT leukocyte scintigraphy can enhance the evaluation of suspected cardiovascular infection by increasing diagnostic accuracy, identifying extracardiac involvement, and assessing cardiac implanted device pockets, leads, and all portions of ventricular assist devices. This advanced imaging can aid in key medical and surgical considerations. Consensus diagnostic features include focal/multi-focal or diffuse heterogenous intense ¹⁸F-FDG uptake on valvular and prosthetic material, perivalvular areas, device pockets and leads, and ventricular assist device hardware persisting on non-attenuation corrected images. There are numerous clinical indications with a larger role in prosthetic valves, and cardiac devices particularly with possible infective endocarditis or in the setting of prior equivocal or non-diagnostic imaging. Illustrative cases incorporating these consensus recommendations provide additional clarification. Future research is necessary to refine application of these advanced imaging tools for surgical planning, to identify treatment response, and more.
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The medical management of patients supported with durable continuous flow left ventricular assist device (LVAD) support encompasses pharmacological therapies administered in the preoperative, intraoperative, postoperative, and chronic LVAD support stages. As patients live longer on LVAD support, the risks of LVAD-related complications and progression of cardiovascular and other diseases increase. Using existing data from cohort studies, registries, randomized trials, and expert opinion, this Heart Failure Society of America Consensus Document on the Medical Management of Patients on Durable Mechanical Circulatory Support offers best practices on the management of patients on durable mechanical circulatory support, focusing on pharmacological therapies administered to patients on continuous flow LVADs. Although quality data in the LVAD population are few, the use of guideline-directed heart failure medical therapies and the importance of blood pressure management, right ventricular preload and afterload optimization, and antiplatelet and anticoagulation regimens are discussed. Recommended pharmacological regimens used to mitigate or treat common complications encountered during LVAD support, including arrhythmias, vasoplegia, mucocutaneous bleeding, and infectious complications, are addressed. Finally, this document touches on important potential pharmacological interactions from antidepressants and herbal and nutritional supplements of relevance to providers of patients on LVAD support.
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Citation Excerpt :
In our study the median age was 57 years old and only 2 patients were 70. According to the latest studies, patients aged ≥70 years have reduced survival after DT LVAD, in part because of increased gastrointestinal bleeding, whereas the incidence of other adverse events like bleeding, stroke, or infection is similar to that of patients aged 50 to 69 years [2,7]. The authors suggest that appropriate selection of candidates and timing of LVAD implantation are critical for improved outcomes of DT.
Heart transplantation is the treatment of choice for selected patients with end-stage heart failure. Persistent donor organ shortage has resulted in a growing interest in mechanical circulatory support not only as a bridge to transplantation but also as a destination therapy.
The aim of the study was to analyze the indications, comorbidities, operative technique, complications, and follow-up of all patients undergoing left ventricular assist device implantation in one of the most experienced clinics in Poland between 2015 and 2020 and state the best timing of the procedure.
This study included 78 individuals (72 males, 92%; 6 females, 8%) with a median age of 57 years (range, 50-62 years). The median body mass index was 27.12 (range, 25.2-29.5). The etiology of cardiomyopathy was ischemic (n = 31, 39%), dilated cardiomyopathy (n = 47, 60%), and others. Sixty-four patients presented with New York Heart Association class IV (82%). Leading heart rhythm was sinus (n = 31, 40%) and pacemaker rhythm (n = 47, 60%). Sixty-four patients had implantable cardioverter defibrillator implantation (82%). Preoperative echocardiography revealed a median left ventricle ejection fraction of 14.5% (range, 10%-15%) and LV dimension 7.55 cm (range, 6.9-8.275 cm). In 51 patients (65%), imaging confirmed pulmonary hypertension. The intensive care unit stay was 6 days (range, 4.25-11.75 days). Median time to extubation was 25 hours (range, 23.75-70 hours). The median time to discharge was 31.5 days (range, 25-31.85 days). In-hospital mortality was 12 patients (15%). Median follow-up time was 19.5 months (range, 11.25-31 months) months, with the longest follow-up of about 53 months.
Appropriate selection of candidates and timing of left ventricular assist device implantation are critical for improved outcomes of destination therapy.

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¹: These authors have contributed equally to this work.

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ORIGINAL CLINICAL SCIENCEStroke and death risk in ventricular assist device patients varies by ISHLT infection category: An INTERMACS analysis

BACKGROUND

METHODS

RESULTS

CONCLUSIONS

Section snippets

Methods

Patients’ characteristics for those with and without an infection

Discussion

Limitations

Disclosure statement

Supplementary data

J Heart Lung Transplant

Ann Thorac Surg

J Heart Lung Transplant

J Am Coll Cardiol

J Heart Lung Transplant

J Heart Lung Transplant

J Heart Lung Transplant

J Heart Lung Transplant

JACC Heart Fail

J Heart Lung Transplant

Am J Infect Control

Am J Infect Control

JACC Heart Fail

J Heart Lung Transplant

ORIGINAL CLINICAL SCIENCE
Stroke and death risk in ventricular assist device patients varies by ISHLT infection category: An INTERMACS analysis