The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), a joint effort among the National Heart, Lung, and Blood Institute, the Food and Drug Administration, the Centers ...for Medicare and Medicaid Services, and others, was established in 2005 at the University of Alabama at Birmingham. The registry examined clinical outcomes and quality-of-life metrics of patients who received an Food and Drug Administration-approved durable mechanical circulatory support (MCS) device to treat advanced heart failure. On January 1, 2018, the Intermacs Database became part of The Society of Thoracic Surgeons National Database, providing additional resources for quality assessment and improvement and scientific advancement.
The Intermacs Database Annual Report summarizes outcomes in patients (≥19 years of age) who underwent durable MCS implant between June 23, 2006, and December 31, 2017. Outcomes are presented for patients who underwent isolated continuous flow left ventricular assist device (CF LVAD) support, CF LVAD support with concomitant right ventricular assist device (RVAD) implant, or total artificial heart implant. Analyses of patients with CF LVADs are stratified by axial flow and centrifugal flow configurations. Because of the association of era with outcomes, the survival analyses are restricted to isolated CF LVADs implanted in the 2012 to 2016 era.
There were 25,145 adult patients with MCS reported to Intermacs, of whom 18,539 (74%) received CF LVADs, 667 (2.6%) had an RVAD with CF LVAD, 339 received a total artificial heart (1.3%), and 20 (0.07%) received an isolated RVAD. Of the CF LVADs, mean age was 57 ± 1 years, 26% were listed for transplantation, and 51% were in cardiogenic shock (profile 1 to 2) preoperatively. CF LVADs included 14,527 axial flow (78%) and 4,012 centrifugal flow (22%) devices. Intermacs patient phenotype has evolved over time to include more patients with profile 3 (26% in 2006 to 2011 versus 35% in 2012 to 2016) and fewer patients with profile 2 (40% versus 35%), patients with better markers of preoperative renal and hepatic function, and more patients who received implants for destination therapy (29% versus 48%) indication. In 2017, centrifugal flow implants (51%) approximated that of axial flow devices (49%). Mean CF LVAD support duration was 20 months (31,563 patient-years). One-year survival for isolated CF LVADs was 83% and 5-year survival was 46%. One-year survivals for centrifugal versus axial flow devices were 85% and 84%, respectively. Patients who required concomitant RVAD support had 1- and 5-year survivals of 58% and 28%, respectively. Freedom from all-cause readmission was 70% at 1 month and 20% at 1 year. At 1 year, stroke occurred in 20% of patients on centrifugal flow and 13% of patients on axial flow support (p < 0.001), gastrointestinal bleeding affected 20% of patients with centrifugal flow devices and 25% of patients with axial flow devices (p < 0.001), and pump-related infection occurred in 28% of patients with centrifugal flow devices versus 25% of patients with axial flow devices (p = 0.01). Neurologic dysfunction (19% of deaths) and multisystem organ dysfunction (15%) were the most common causes of death.
With the evolution of MCS, patient phenotype and outcomes are also changing over time. CF LVAD support is increasingly being used in the less ill patient phenotype and more patients are supported for destination therapy. Mean survival is now approaching 5 years, but adverse events, especially neurologic events, continue to have a detrimental impact on the success of CF LVAD support.
The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), a joint effort among the National Heart, Lung, and Blood Institute, the Food and Drug Administration, the Centers ...for Medicare and Medicaid Services, and others, was established in 2005 at the University of Alabama at Birmingham. The registry examined clinical outcomes and quality-of-life metrics of patients who received an Food and Drug Administration-approved durable mechanical circulatory support (MCS) device to treat advanced heart failure. On January 1, 2018, the Intermacs Database became part of The Society of Thoracic Surgeons National Database, providing additional resources for quality assessment and improvement and scientific advancement.
The Intermacs Database Annual Report summarizes outcomes in patients (≥19 years of age) who underwent durable MCS implant between June 23, 2006, and December 31, 2017. Outcomes are presented for patients who underwent isolated continuous flow left ventricular assist device (CF LVAD) support, CF LVAD support with concomitant right ventricular assist device (RVAD) implant, or total artificial heart implant. Analyses of patients with CF LVADs are stratified by axial flow and centrifugal flow configurations. Because of the association of era with outcomes, the survival analyses are restricted to isolated CF LVADs implanted in the 2012 to 2016 era.
There were 25,145 adult patients with MCS reported to Intermacs, of whom 18,539 (74%) received CF LVADs, 667 (2.6%) had an RVAD with CF LVAD, 339 received a total artificial heart (1.3%), and 20 (0.07%) received an isolated RVAD. Of the CF LVADs, mean age was 57 ± 1 years, 26% were listed for transplantation, and 51% were in cardiogenic shock (profile 1 to 2) preoperatively. CF LVADs included 14,527 axial flow (78%) and 4,012 centrifugal flow (22%) devices.
Intermacs patient phenotype has evolved over time to include more patients with profile 3 (26% in 2006 to 2011 versus 35% in 2012 to 2016) and fewer patients with profile 2 (40% versus 35%), patients with better markers of preoperative renal and hepatic function, and more patients who received implants for destination therapy (29% versus 48%) indication. In 2017, centrifugal flow implants (51%) approximated that of axial flow devices (49%).
Mean CF LVAD support duration was 20 months (31,563 patient-years). One-year survival for isolated CF LVADs was 83% and 5-year survival was 46%. One-year survivals for centrifugal versus axial flow devices were 85% and 84%, respectively. Patients who required concomitant RVAD support had 1- and 5-year survivals of 58% and 28%, respectively. Freedom from all-cause readmission was 70% at 1 month and 20% at 1 year. At 1 year, stroke occurred in 20% of patients on centrifugal flow and 13% of patients on axial flow support (p < 0.001), gastrointestinal bleeding affected 20% of patients with centrifugal flow devices and 25% of patients with axial flow devices (p < 0.001), and pump-related infection occurred in 28% of patients with centrifugal flow devices versus 25% of patients with axial flow devices (p = 0.01). Neurologic dysfunction (19% of deaths) and multisystem organ dysfunction (15%) were the most common causes of death.
With the evolution of MCS, patient phenotype and outcomes are also changing over time. CF LVAD support is increasingly being used in the less ill patient phenotype and more patients are supported for destination therapy. Mean survival is now approaching 5 years, but adverse events, especially neurologic events, continue to have a detrimental impact on the success of CF LVAD support.
The mission of the American Heart Association/American Stroke Association includes increasing access to high-quality, evidence-based care that improves patient outcomes such as health-related quality ...of life and is consistent with the patients’ values, preferences, and goals. Awareness of and access to palliative care interventions align with the American Heart Association/American Stroke Association mission. The purposes of this policy statement are to provide background on the importance of palliative care as it pertains to patients with advanced cardiovascular disease and stroke and their families and to make recommendations for policy decisions. Palliative care, defined as patient- and family-centered care that optimizes health-related quality of life by anticipating, preventing, and treating suffering, should be integrated into the care of all patients with advanced cardiovascular disease and stroke early in the disease trajectory. Palliative care focuses on communication, shared decision making about treatment options, advance care planning, and attention to physical, emotional, spiritual, and psychological distress with inclusion of the patient’s family and care system. Our policy recommendations address the followingreimbursement for comprehensive delivery of palliative care services for patients with advanced cardiovascular disease and stroke; strong payer-provider relationships that involve data sharing to identify patients in need of palliative care, identification of better care and payment models, and establishment of quality standards and outcome measurements; healthcare system policies for the provision of comprehensive palliative care services during hospitalization, including goals of care, treatment decisions, needs of family caregivers, and transition to other care settings; and health professional education in palliative care as part of licensure requirements.
Table 4 Retired STEMI and NSTEMI Measures From the 2008 Set AMI indicates acute myocardial infarction; LDL, low-density lipoprotein; NSTEMI, non-ST-elevation myocardial infarction; PM, performance ...measure; QM, quality measure; and STEMI, ST-elevation myocardial infarction. # Care Setting Measure Title Rationale for Retiring the Measure PM-12 Inpatient Adult Smoking Cessation Advice/Counseling This measure is being retired because perfect scores are consistently achieved and the measure appears to have reached a ceiling effect. ...given absence of room for further improvement, the writing committee opted to omit this measure from the inpatient performance measure set for AMI (realizing also that a separate outpatient CAD measure set will likely address smoking cessation advice/counseling). ...the benefit of fibrinolytic therapy is most effective when provided promptly, and the ACCF/AHA guideline set a benchmark time goal from hospital arrival to drug administration, or DTN time, to be <=30 min (12). ...measuring troponin levels expeditiously help in the early diagnosis and risk stratification of these patients, which can lead to earlier triage and institution of appropriate medical and interventional treatments (11). Numerator Eligible∗ patients with AMI who are prescribed an aldosterone antagonist at hospital discharge Denominator All post-AMI patients who:a are receiving an ACE inhibitor and a beta blocker;ANDb have a LVEF <=40%;ANDc have either diabetes mellitus or HF Denominator Exclusions Patients age <18 y Patients who leave against medical advice Patients who die during hospitalization Patients who are on comfort care measures only or hospice Patients who are transferred to another hospital for inpatient acute care Denominator Exceptions Documentation of a medical reason for not prescribing an aldosterone antagonist at hospital discharge (e.g., allergy or intolerance to aldosterone antagonist, significant renal dysfunction Cr >2.5 mg/dL in men; >2.0 mg/dL in women, hyperkalemia K >5.0 mEq/L) Patient currently enrolled in a clinical trial related to AMI (e.g., trials involving renin-angiotensin-aldosterone system inhibitors) Measurement Period Encounter Sources of Data Medical record or other database (e.g., administrative, clinical, registry) Attribution Measure reportable at the facility or provider level Care Setting Inpatient Rationale The EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival) study demonstrated benefits from adding eplerenone, a selective aldosterone antagonist, to ACE inhibitors or ARBs (in 87% of patients) and beta blockers (75%), including a 15% and 17% reduction in overall and cardiovascular mortality, respectively. ...in the absence of contraindications, post-MI patients with HF may benefit from adding an aldosterone antagonist to an ACE inhibitor or ARB, and a beta blocker.
Purpose
Adults living with mechanical circulatory support (MCS) present with unique challenges (e.g., left ventricular assist device LVAD-related self-care, adverse events) to research study ...enrollment, engagement, and completion. The purpose of this study was to understand the experiences of adults with MCS who were eligible for and enrolled in a study of health-related quality of life (HRQOL).
Methods
In a secondary analysis of data from the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life study, we used a mixed-methods approach to evaluate research engagement and experiences among adults preparing to undergo or currently living with MCS implant. First, we assessed the cascade of study engagement. Second, we assessed research experiences using a structured interview developed for this study.
Results
Of 1011 participants approached for the study, 86.7% enrolled, 12.7% declined, and 0.6% were ineligible. Of 877 participants enrolled, 272 were pre-implant (of whom 88% completed assessments; “respondents”) and 605 were post-implant (of whom 74% completed assessments). Only 14% of respondents reported difficulty completing the questionnaires, 54% had previously used an iPad to complete questionnaires, and 62% reported that their experience was “as expected.” Respondents qualitatively described both positive (e.g., value of research) and negative (e.g., too much time) research experiences, difficulties completing questionnaires (e.g., online platform, health literacy issues), and provided recommendations for the questionnaires and delivery.
Conclusions
Participants enjoyed participating in HRQOL research focused on MCS and had unique perspectives for improving the questionnaires. It is important to minimize the burden of participation and critical to be flexible to meet participant preferences for research engagement.
Trial registration
NCT03044535 (accessible at
https://clinicaltrials.gov/ct2/show/NCT03044535
), registered February 7, 2017.
Gaps in the literature exist regarding health-related quality of life (HRQOL) early after left ventricular assist device (LVAD) surgery. The purposes of our study were to describe HRQOL over time, by ...age and gender, and identify risk factors for poor HRQOL early after LVAD implant.
Patients (n = 7,353) from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database received a continuous-flow LVAD as a primary implant at 133 United States hospitals. Of these, 5,640 patients had pre-LVAD HRQOL data, 3,353 patients had 6-month post-LVAD HRQOL data, and 2,748 patients had data at both times. HRQOL was measured using the EQ-5D-3L (Euro-Qol) instrument. Data were collected pre-implant and 3 and 6 months post-operatively. Statistical analyses included chi-square test, t-test, Pearson correlation coefficients, and multiple regression analysis.
Overall HRQOL and dimensions of HRQOL improved from before to 6 months after device implant when examined by age and gender. However, younger patients and women reported significantly more problems regarding all dimensions before implant and significantly more problems regarding pain/discomfort and anxiety/depression at 3 and 6 months after implant. An increase in overall HRQOL from before to 6 months after implant was related to pre-implant INTERMACS Level 1. Factors related to a decrease in HRQOL from before to 6 months after implant were listed for heart transplant before surgery, comorbidities, better preoperative HRQOL, adverse events within 6 months after implant, bridge to transplant moderately likely and unlikely, and New York Heart Association Functional Classification IV at 6 months after LVAD (R(2) = 41%).
Overall HRQOL and dimensions of HRQOL improve in sub-groups of patients from before to 6 months after surgery, although differences in improvement exist. Adverse events are risk factors for decreased HRQOL across time and support the ongoing need to improve device technology with the aim of reducing adverse events.
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