CF LVAD Research Articles

Pulmonary Capillary Recruitment Is Attenuated Post Left Ventricular Assist Device Implantation

Intoduction There is limited knowledge of pulmonary physiology and pulmonary function following continuous flow-left ventricular assist device (CF-LVAD) implantation. Therefore, the present study investigated if CF-LVAD influenced the pulmonary circulation by assessing pulmonary capillary blood volume and alveolar- capillary conductance as well as pulmonary function in heart failure patients. Methods 17 patients with severe HF who were scheduled for CF-LVAD (Heart Mate II® or Heart Ware®) implantation participated in the study. They underwent pulmonary function testing (measures of lung volumes and flow rates) and more unique measures of pulmonary physiology using a rebreathe-technique that quantified the diffusing capacity of the lungs for carbon monoxide and nitric oxide (DLCO and DLNO, respectively) pre and 3 months post CF-LVAD implantation. Results After CF-LVAD, pulmonary function was not significantly changed (p>0.05). For lung diffusing capacity, DLCO was significantly reduced (p=0.04), however, alveolar volume (VA) was not changed (p=0.47). After DLCO was corrected by VA, DLCO/VA demonstrated a trend towards reduction (p=0.08). For the alveolar-capillary component, capillary blood volume (Vc) and alveolar membrane conductance (Dm) were significantly or trended towards a reduction (p<0.04, p=0.06, respectively). However, Dm/Vc was not altered (p=0.92). Conclusions Early post CF LVAD implantation, Vc is reduced likely as a result of pulmonary capillary de-recruitment which contributes to the fall in lung diffusing capacity. There is limited knowledge of pulmonary physiology and pulmonary function following continuous flow-left ventricular assist device (CF-LVAD) implantation. Therefore, the present study investigated if CF-LVAD influenced the pulmonary circulation by assessing pulmonary capillary blood volume and alveolar- capillary conductance as well as pulmonary function in heart failure patients. 17 patients with severe HF who were scheduled for CF-LVAD (Heart Mate II® or Heart Ware®) implantation participated in the study. They underwent pulmonary function testing (measures of lung volumes and flow rates) and more unique measures of pulmonary physiology using a rebreathe-technique that quantified the diffusing capacity of the lungs for carbon monoxide and nitric oxide (DLCO and DLNO, respectively) pre and 3 months post CF-LVAD implantation. After CF-LVAD, pulmonary function was not significantly changed (p>0.05). For lung diffusing capacity, DLCO was significantly reduced (p=0.04), however, alveolar volume (VA) was not changed (p=0.47). After DLCO was corrected by VA, DLCO/VA demonstrated a trend towards reduction (p=0.08). For the alveolar-capillary component, capillary blood volume (Vc) and alveolar membrane conductance (Dm) were significantly or trended towards a reduction (p<0.04, p=0.06, respectively). However, Dm/Vc was not altered (p=0.92). Early post CF LVAD implantation, Vc is reduced likely as a result of pulmonary capillary de-recruitment which contributes to the fall in lung diffusing capacity.

Incidence of Blood Stream Infection and Impact on Survival in Patients on Left Ventricular Assist Device Support

<h3>Purpose</h3> Bloodstream infection (BSI) is a severe complication in patients with continuous flow left ventricular assist devices (CF-LVADs). In this study, we aimed to describe the incidence of BSI on contemporary LVAD support and its impact on subsequent survival. <h3>Methods</h3> This analysis included adult patients with first time CF LVAD implantation at a single center (June 2005-June 2020). BSI was defined as ≥1 positive blood culture with a likely pathogen (e.g. Staphylococcus aureus) or >1 positive blood culture with a low virulence skin organism (e.g. Staphylococcus epidermidis). Time to BSI was recorded for each patient. Survival-free of BSI was estimated using Kaplan-Meier method and compared among device types. Survival among patients who did and did not develop BSI by 9 months post implant was compared using Cox regression adjusting for medical and social factors. <h3>Results</h3> 502 patients were included in the analysis. Over a median follow up period of 1,468 days (IQR 454-3,081 days), 73 (14.5%) developed a BSI. Patients who developed BSI were more likely to have diabetes, implanted cardiac defibrillators, and to have a designation of destination therapy. Median time to BSI was 389 days (IQR 94-997). The most common organisms were enterococci (23%) and streptococci (23%). At the time of BSI, 53% of patients had a WBC count above 11 × 10⁹/L. Compared to the HeartMate 2, patients implanted with the HeartMate 3 had a lower rate of 1-year survival free of BSI (87% vs. 95 %, p=0.007). When comparing survival after 9 months among those with and without BSI, mortality was significantly higher in patients with BSI in both unadjusted (HR =1.96, 95% CI; 1.02 - 3.76) and adjusted models (2.00, 95% CI; 1.03 - 3.88). <h3>Conclusion</h3> BSI continues to occur in the contemporary era of LVAD therapy and is associated with significantly worse survival. The absence of elevated WBC count in LVAD patients with severe infections such as bacteremia raises the question of whether leukocytosis should be infection criteria for UNOS status increase.

Gastrointestinal angiodysplasia in heart failure and during CF LVAD support

Angiodysplasias (AGD) are common sites of bleeding in the gastrointestinal (GI) tract after Continuous Flow Left Ventricular Assist Device (CF-LVAD) implantation. We sought to investigate whether AGDs are formed as a result of LVAD physiology or preexist as a consequence of heart failure. Thirty-six subjects with HF reduced EF (HFrEF) underwent video capsule endoscopy (VCE) to assess for the presence of AGD. Fifty-three subjects without HF who underwent VCE for a nonbleeding indication formed a control group. The prevalence of AGD was significantly higher in the HFrEF compared to the non-HF controls (50% vs 13%, p=0.0002). This association persisted after controlling for age and comorbidities. Within the HFrEF cohort, higher Ang2, NT-proBNP and BUN were associated with the presence of AGD. AGD in the GI tract are associated with HFrEF. This is the first description of a new pathology associated with HFrEF and adds to our understanding of CF LVAD associated GI bleeding.

Gender differences in psychosocial and clinical characteristics in the European Registry for Patients with Mechanical Circulatory Support

BackgroundNot much is known about psychosocial characteristics of men and women receiving continuous flow left ventricular assist devices (CF LVAD). ObjectiveTo investigate gender differences in clinical and psychosocial (demographic, behavioral, psychological) characteristics in CF LVAD recipients. MethodsWe analyzed European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data (N=2395, 16.8% women; 2011 to 2017) and compared pre-implant characteristics in men and women intended for bridge-to-transplant (BTT) or destination therapy (DT). ResultsWomen were underrepresented [DT (n=61): 13.4%; BTT (n=341): 17.6%]. They were more likely to be divorced/separated, widowed, in unstable clinical condition, and non-working (DT only), but less likely to be smokers, to have ischemic cardiomyopathy or diabetes, and younger (BTT only) than men. Missing data were abundant, especially those that reflect psychological characteristics (>87%). ConclusionGender differences were noted, some specific to device strategy. Improved collection of psychosocial characteristics is warranted to elucidate their relationship to future prognosis.

Chances of Prolonged 5- and 10-year Survival after Continuous-Flow LVAD Implantation?

<h3>Purpose</h3> Continuous-flow LVADs (CF-LVADs) have been implanted for both bridge-to-transplant and for destination therapy. Extended survival with CF-LVADs has not been completely examined. We examined the likelihood of surviving more than 5 to 10 years with a CF-LVAD <h3>Methods</h3> We reviewed the 198 patients alive and currently being followed at our institution after CF-LVAD implantation. Patients were stratified as to type of pump implanted (HeartMate 2, HeartWare, or HeartMate 3), reason for implantation (Bridge-to-transplant or destination therapy), and length of survival (<5 years, 5-10 years, or >10 years). <h3>Results</h3> Seven (7) of the 198 patients being followed had a CF-LVAD in place and functioning for more than 10 years. 4 of these 7 patients surviving more than 10 years had not required pump exchange. There were 18 patients being followed with a CF-LVAD in place for 5-10 years. There were 173 being followed with a CF-LVAD in place for < 5 years. Of the 7 patients with a CF-LVAD in place >10 years, 6 were HeartMate 2 (HM2) CF-LVADs and one was a HeartWare (HW). Five (5) of the 7 patients with a CF-LVAD in place >10 years had the LVAD implanted as a bridge-to-transplant. Of the 18 patients with a CF-LVAD in place for 5-10 years, 9 had a HM2, 8 had a HW, and 1 had a HeartMate3 (HM3). The CF LVAD was implanted as a bridge-to-transplant in 5 of the 18 patients <h3>Conclusion</h3> Prolonged survival after CF-LVAD implantation is increasingly likely. A substantial number of patients with a CF-LVAD in place for more than 5 years originally had the device implanted as a bridge-to-transplant.

Short- and long-term outcomes of continuous-flow left ventricular assist device therapy in 79 patients with end-stage heart failure.

An increasing number of patients with end‑stage heart failure, along with a shortage of heart donors, necessitates the use of mechanical circulatory support. This single‑center retrospective study evaluated short- and long term outcomes of continuous‑flow left ventricular assist device (CF LVAD) therapy in patients with end stage heart failure. We collected and assessed data of 79 patients (77 men, 2 women; mean age, 50.3 years; mean INTERMACS profile, 3.1) implanted with a CF‑LVAD between 2009 and 2017 (HeartMate 3 in 19 patients [24%]; HeartMate 2 in 9 [11.4%]; and HeartWare in 51 [64.6%]). The mean time on CF-LVAD support was 604 days (range, 1–1758 days). There were 2 device exchanges due to pump thrombosis and 1 explantation due to heart regeneration; 9 patients (11.4%) underwent heart transplant. Stroke (nondisabling, 48%) occurred in 27.8% of patients (ischemic in 9 patients; hemorrhagic, in 14; both types, in 1) despite the standardized anticoagulation regimen. Major gastrointestinal bleeding and pump thrombosis were reported in 13 patients (16.5%), while 18 patients (22.8%) developed driveline infections (recurrent in 15 patients [19%]). Hemorrhagic stroke and bacteremia had a negative impact on survival. Hemorrhagic stroke was the main cause of death. Survival probability was 0.9 at 1 month and 0.81, 0.71, 0.61, and 0.53 at 1, 2, 3, and 4 years, respectively. Although CF‑LVAD support is associated with substantial adverse events, they do not significantly affect mortality (except hemorrhagic stroke and bacteremia). Novel devices seem to overcome these limitations, but larger studies are needed to support these findings.

Waitlist Outcomes in Patients with Blood Group O during Continuous Flow Left Ventricular Assist Device Support

Continuous flow left ventricular assist device (CF LVAD) supported patients with blood group O may wait longer for heart transplantation (HT), but it remains uncertain if during this waiting period such patients have greater morbidity and mortality from major adverse events (AEs). We conducted a UNOS database analysis of all patients that were waitlisted for HT after CF LVAD implantation from January 2006 to March 2019. Major demographics, waitlist times, waitlist mortality and occurrence of major AEs were retrieved. Patients were categorized as blood group O and non-blood group O. Post-transplant survival was also retrieved. Waitlist and post HT survival were assessed by Kaplan Meier analysis and Cox proportional hazard ratios were calculated. AEs during device support were compared by logistic regression. Overall, 8,578 patients with CF LVADs were placed on the UNOS waitlist during the study period. As expected, Blood group O (n=4,115) had longer waitlist times (412 days, IQR: 102-576; non-O 250 days, IQR 39-323 days, p<0.0001) than non-blood group O (n=4,461) patients. There were no significant differences between groups in age and gender. Blood group O had a higher likelihood of driveline infections (OR: 1.40, 95% CI 1.19-1.64, p<0.001) and life-threatening ventricular arrhythmias (OR: 2.22, 95% CI 1.44-3.42, <p=0.001, figure1A). Interestingly, waitlist mortality was similar in both groups (HR: 1.01, 95% CI 0.84-1.21, p=0.95, figure1B), as well as post HT survival (HR 0.96, 95% CI 0.85-1.09, p=0.58, figure1C). Despite more major AEs during CF LVAD support, patients with blood group O experience similar wait list and post HT survival.

Physiologically Significant Pulsatility Key to Reducing Adverse Events in CF LVADS

Hypertension is common in continuous flow LVAD (CFLVAD) patients and is linked to major adverse events like stroke and aortic incompetence. The human circulation was modelled with wave propagation and reflections using physiologic data from ADAN 86, with a set of 86 arteries including the cerebral vessels. 1. Blood pressure was compared for a flow of 5 litres/minute for a normal pulsatile flow and CF LVAD with varying degrees of pulsatility RESULTS: CONCLUSION: Restoring physiologically significant pulsatility is likely to restore normal blood pressure with significant reduction in adverse events like stroke, aortic incompetence and gastric bleeds. The degree of pulsatility needed to achieve this needs further study.

Gender Differences in Early Mortality after LVAD: An IMACS Analysis

Prior studies have observed higher mortality in women after LVAD; however a paucity of data exists on mediators of observed disparities. We used the International Registry for Mechanically Assisted Circulatory Support (IMACS) database to examine what clinical factors might mediate observed gender differences in mortality after LVAD. We analyzed 15,498 adults (>18 years) who received a CF LVAD from Jan 2013 - Sep 2017 (age: 56.0 ± 13.2 yrs, 20.8% female, 35.9% centrifugal pumps, median follow-up:13.4 [IQR 5.6, 25.9] months). Inverse probability weighted Cox proportional hazards model was used to estimate the association of female gender with all-cause mortality. Covariates included age, BSA, pump type, sodium, BUN, bilirubin, INR, hemoglobin, eGFR, MELD score, modified HeartMate II Risk Score (without center volume), INTERMACS profile, PADP and CI. Restricted cubic spline regression analysis was used to examine hazard ratio (HR) variation with time. Causal mediation analysis was performed to test plausible pre-implant mediators that were significantly different between genders (p<0.05). Women were younger, less likely to have ischemic HF, and more likely to have a centrifugal pump (all p<0.001). Women had higher mortality after LVAD (adjusted HR: 1.38, 95% CI: 1.20 - 1.57, p<0.001). Gender*time interaction was significant (p<0.001), with women experiencing increased mortality during the first 3 months after implant (adj HR: 1.76, 95% CI: 1.42 - 2.19, p<0.001), but not after (adj HR: 1.17, 95% CI: 0.98-1.39, p=0.08). Increased tricuspid regurgitation (TR), and smaller LV end-diastolic diameter (LVEDD) at baseline mediated ∼20.6% of the increased early hazard of death in females; however most of the mechanisms underlying the increased hazard remained unexplained. Women have higher post-LVAD mortality during the first 3 months after implant, that is partly mediated by increased TR and smaller LVEDD at baseline. Further studies are needed to explore additional underlying mechanisms.

Peak Left Atrial Appendage Emptying Velocity Remains Reduced in Atrial Fibrillation during Continuous Flow Left Ventricular Assist Device Support

Purpose Although regions of stasis such as the left atrial appendage (LAA) may be potential sites of thrombus formation during atrial fibrillation (AF), its thrombotic contribution during high flow mechanical unloading is unknown. Moreover, registry studies only show a mixed association of AF and stroke during continuous flow left ventricular assist device (CF LVAD) support. Since a lower peak Left Atrial Appendage Emptying Velocity (LAAEV) of less than 40 cm/s during AF, mechanistically contributes to thrombosis and stroke in non-CF LVAD populations, we sought to evaluate the LAAEV in CF LVAD patients with and without AF. Methods We conducted a single center review of patients who had a measurement of the LAAEV by pulsed-waved Doppler by transesophageal echocardiography (TEE). To evaluate at the steady state CF LVAD speed, operating room studies were excluded. CF LVAD patients were categorized into groups with and without AF during TEE and LAAEVs were compared. Matched non-heart failure (HF) and HF patients with and without AF were included as controls. Results Thirty eight patients with a CF LVAD had a peak LAAEV measurement by TEE, of whom 15 were in AF. There were no differences in age (AF: 58±11 vs. no AF: 59±13 years, p=0.8) and gender (AF: 20% vs. no AF: 9% female, p=0.6). The peak LAAEV was significantly lower for CF LVAD patients in AF (33±18 cm/s) in comparison to those in sinus rhythm (SR) (60±20 cm/s, p Conclusion Despite mechanical unloading, the LAAEV remains reduced in patients with AF. Further studies are warranted to investigate the relation between reduced LAAEV and thromboembolism during CF LVAD support.

Risk Factors and Early Outcomes of Vasoplegia Syndrome (VS) after Heart Transplantation in CF-LVAD Patients

Purpose VS in heart transplantation has been associated with adverse survival outcomes. We evaluated risk factors for and early outcomes of VS amongst CF-LVAD patients undergoing OHT. Methods Single center, retrospective cohort of all adult CF-LVAD BTT patients between 5/2013 to 5/2018. VS was defined as profound vasodilatory shock (SVR ≤ 800 dynes/s/cm−5) with a preserved cardiac index (CI ≥2.2 L/min/m2) requiring vasopressor support (vasopressor score ≥ 4) within 48hrs post OHT. Vasopressor score = (epinephrine dose x 100 μg/kg/min) + (norepinephrine dose x 100 μg/kg/min) + (vasopressin dose x 10000 units/kg/min) + (phenylephrine dose x 100 μg/kg/min). Pulsatility Index (PI) of HM II CF-LVAD at index admission was obtained as a surrogate marker of pulsatility. Results Eighty-four CF-LVAD patients underwent OHT during the study period. Median age was 56 years, 22 (26.2%) females, and 29 (34.5%) ischemic etiology. Eighteen (21.4%) patients developed VS after OHT. VS was associated with a higher median BMI (31.0 vs 27.3; p = 0.01) as compared to patients absent VS. Median duration of CF-LVAD support was longer in VS patients; 13.4 months vs 9.2 months, p=0.27. In 69 HMII patients, the mean PI at admission was lower in those who subsequently developed VS; 5.9 vs 6.4; p= 0.04. The rest of the recipient, donor and intraoperative characteristics were similar between groups. Multivariate logistic regression analysis revealed BMI (OR 1.34; 95% CI 1.11-1.63; p Conclusion VS after transplant in CF LVAD subjects is associated with low pulsatility and high BMI. In this single center experience, VS was not associated with worse outcomes.

Comparison of Unfractionated Heparin and Bivalirudin for Treatment of Suspected Device Thrombosis during Heart Mate II Support

Purpose Although intravenous anticoagulation is the mainstay medical therapy employed during CF LVAD thrombosis, the comparative impact of indirect thrombin inhibition with unfractionated heparin (UH) and direct thrombin inhibition with bivalirudin (BV) is unknown. Methods We conducted a single center review of all patients with a Heart Mate(HM) II who were admitted for suspected device thrombosis (SDT) from September 2011 to September 2018. Device thrombosis was suspected due to elevated outpatient lactate dehydrogenase (LDH), evidence of systemic emboli, or device alarms. After admission, patients were categorized into those receiving UH or BV. Crossovers were excluded. Freedom from device exchange was calculated with Kaplan Meier analysis. Results Twenty-three patients were admitted for SDT, of whom 13 received UH and 10 received BV. There were no differences in age (UH: 49.2 vs. BV: 46.9 years, p=0.60) and time from implant to SDT (UH: 10.3 vs. BV: 10.4 months, p=0.98). LDH remained elevated after UH (879, IQR: 755-1049 to 1028, IQR: 550-1438 U/L, p=0.34) but dropped with BV (839, IQR: 733-914 to 453, IQR: 352-465 U/L, p=0.002). During the follow up period, there was a lower likelihood of a device exchange in patients treated with BV (HR: 0.28, 95% CI: 0.09-0.89, p=0.04, figure 1). Conclusion In this sample of HM II patients, intravenous direct thrombin inhibition was more effective in treating device thrombosis.

Baseline ECHO a Suitable Screening Tool for LV Recovery during CF LVAD Support

Purpose A lack of standardized protocols looking for cardiac recovery during CF LVAD support is partially responsible for low rates of device explant. LVAD wean assessments are time consuming and therefore often not performed. We sought to determine whether a baseline (full-support) echo could serve as a screening assessment to identify those individuals with explant potential who should undergo wean assessment. Methods A retrospective review of all LVAD weaning studies performed at Montefiore between 2007 and 2018 was conducted. LVAD weaning studies were performed with HMII at 6000 rpms and HVAD at 1800rpms which are the generally accepted “net-zero” flows for each device. For individuals who had multiple weaning assessments, only the most recent was analyzed. Only those studies with adequate windows as defined by clear endocardial definition in both apical 4 and 2 chamber views were included. LV diameters, volumes by Simpson's biplane method, LVEF and RV fractional area changes (FAC) were measured at the baseline LVAD speed and at weaned speed after 15minutes. Results Of the 57 patients who had weaning studies, 41 met the inclusion criteria with a mean age of 46 yrs, 41.5% ischemic etiology, 24% female, and a median duration of 222 days of LVAD support. During wean assessments, there was an increase in all measures of LV size: LVIDd - 5.83cms to 6.15cm, LVEDV - 191mL to 207mL (p=0.0001) and LVESV - 141mL to 148mL. There was a corresponding modest increase in LVEF from 31 to 34% (p=0.07). Fourteen (34%) had a LVEF >40% on baseline echo; 5 of these went on to normal LVEF (>50%) on wean study. Conversely, no patient with a LVEF Conclusion During LVAD wean there was evidence of LV re-loading as shown by an increase in LV volumes and a modest increase in LVEF. An LVEF >40% on baseline echo identified all patients with a normal LVEF during wean assessment and therefore may serve as an appropriate screening tool.

The Society of Thoracic Surgeons Intermacs Database Annual Report: Evolving Indications, Outcomes, and Scientific Partnerships

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 flowimplants (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 Society of Thoracic Surgeons Intermacs database annual report: Evolving indications, outcomes, and scientific partnerships.

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.

Continuous-flow LVADs in the Nordic countries: complications and mortality and its predictors

Objectives: The purpose of this study was to assess complications and mortality and its predictors, with continuous-flow left ventricular assist devices (CF-LVADs) in the Nordic Countries. Design: This was a retrospective, international, multicenter cohort study. Results: Between 1993 and 2013, 442 surgically implanted long-term mechanical assist devices were used among 8 centers in the Nordic countries. Of those, 238 were CF-LVADs (HVAD or HeartMate II) implanted in patients >18 years with complete data. Postoperative complications and survival were compared and Cox proportion hazard regression analysis was used to identify predictors of mortality. The overall Kaplan–Meier survival rate was 75% at 1 year, 69% at 2 years and 63% at 3 years. A planned strategy of destination therapy had poorer survival compared to a strategy of bridge to transplantation or decision (2-year survival of 41% vs. 76%, p < .001). The most common complications were non-driveline infections (excluding sepsis) (44%), driveline infection (27%), need for continuous renal replacement therapy (25%) and right heart failure (24%). In a multivariate model age and left ventricular diastolic dimension was left as independent risk factors for mortality with a hazard ratio of 1.35 (95% confidence interval (CI) [1.01–1.80], p = .046) per 10 years and 0.88 (95% CI [0.72–0.99], p = .044) per 5 mm, respectively. Conclusion: Outcome with CF LVAD in the Nordic countries was comparable to other cohorts. Higher age and destination therapy require particularly stringent selection.

Durable Biventricular Support Using Right Atrial Placement of the HeartWare HVAD.

Patients with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) levels 1-2 who either have or are at risk for right ventricular failure face significant morbidity and mortality after continuous flow left ventricular assist device (CF-LVAD) implantation. Currently, the options for biventricular support are limited the Total Artificial Heart (TAH; CardioWest, Syncardia, Tuscon, AZ) or biventricular assist device (BiVAD), which uses bulky extracorporeal or implantable displacement pumps. We describe a successful series based on an innovative approach for biventricular support in consecutive INTERMACS levels 1-2 patients utilizing a HeartWare Ventricular Assist Device (HVAD; HeartWare, Framingham, MA) in a left ventricular (LV-HVAD) and a right atrial (RA-HVAD) configuration. From June 2014 through May 2016, 11 consecutive INTERMACS levels 1-2 patients with evidence of biventricular failure underwent implantation of a CF LVAD (10 LV-HVAD and 1 HeartMate II LVAD, Thoratec, Pleasanton, CA) and RA-HVAD pumps. A total of 4,314 BiVAD support days were accumulated in our case series. Seven patients have undergone orthotopic heart transplant, whereas 3 are ambulatory and are either waiting transplant or reconsideration for transplantation. There is one mortality in this case series, which was due to an intracranial bleed from supratherapeutic anticoagulation. Two other patients experienced hemorrhagic strokes, but without neurologic sequelae, whereas no patients have experienced ischemic strokes. There were two episodes of gastrointestinal bleeding. This is the largest series to date involving this approach with outcomes superior to those previously described in patients receiving biventricular support. We conclude this novel therapy is a viable alternative to current practices in the management of biventricular failure.

Systolic Blood Pressure and Outcomes in Patients on Continuous Flow LVAD Support: An INTERMACS Analysis

High mean arterial pressures in continuous flow (cf) LVAD patients are associated with increased stroke and pump thrombosis risks. Optimal thresholds for systolic blood pressure are unknown.

Longer Waitlist Time Places Blood Group O Patients at Greater Risk of Experiencing a Major CF LVAD Related Complication

Longer Waitlist Time Places Blood Group O Patients at Greater Risk of Experiencing a Major CF LVAD Related Complication

Angiodysplastic Lesions in the Gastrointestinal Tract of Heart Failure Patients Predates Post LVAD Bleeding

Gastrointestinal (GI) bleeding, primarily manifesting as angiodsyplasia (AGD) is one of the most common and challenging complications post CF LVAD. The possible mechanisms underlying LVAD induced AGD formation are the subject of intense research efforts and have focused on an association with low or absent pulsatility and acquired type 2A von Willebrand factor deficiency (vWD). We have previously reported a high prevalence of nasal mucosal vascular malformations, a possible surrogate marker for AGD, in patients with heart failure (HF) prior to LVAD implant. We have now extended our investigation to directly study the prevalence of GI AGD in HF patients prior to LVAD implant.