Time Of Left Ventricular Assist Device Implantation Research Articles

Dysregulation of the Angiopoietin-2/Tie-2 Axis is Associated with Reduced Pulsatility and Increased Arteriovenous Malformation Related Gastrointestinal Bleeding Following Left Ventricular Assist Device Implantation

Recent studies have suggested arteriovenous malformation related gastrointestinal bleeding (AVM-GIB) after left ventricular assist device (LVAD) implantation is associated with reduced arterial pulsatility and right heart failure. Angiopoietin-2 (Ang-2) is elevated among patients on LVAD support, and in concert with abnormal expression of vascular endothelial growth factor (VEGF), binding of Ang-2 to the Tie-2 receptor contributes to abnormal angiogenesis and post-LVAD GIB. The purpose of this study was to evaluate the association between Ang-2, Tie-2, and VEGF with AVM-GIB and its clinical associates. We evaluated 65 patients who underwent LVAD implantation at Loyola University Medical Center. Blood samples were obtained at a median follow up of 13 (interquartile range 1.7-31.5) months following LVAD implantation. A total of 19 (29%) patients developed AVM-GIB. Patients with AVM-GIB were older at the time of LVAD implantation (63±10 vs. 53±15 years; p=0.048), but the groups were otherwise balanced in baseline characteristics. Patients with AVM-GIB had increased levels of Ang-2 (8169±4.471 vs. 6560±397 pg/mL; p=0.02) and Tie-2 (20.0±3.3 vs. 17.3±4.0 ng/mL; p=0.07) without a difference in VEGF (200.5±183.3 vs. 216.6±220 pg/mL; p=0.7). Patients whose aortic valve opened less than 80% of cardiac cycles had significantly higher levels of Ang-2 (7948±4226 vs 5566±3691 pg/mL; p=0.02) and Tie-2 (19.6±4.5 vs. 16.3±3.2 ng/mL; p=0.001). There was no association between the evaluated biomarkers and other demographic or clinical characteristics including invasive and noninvasive hemodynamics. Our study suggests that dysregulation of the Ang-2/Tie-2 axis among LVAD patients is associated with AVM-GIB. Further, we find that reduced pulsatility is associated with elevations of Ang-2 and Tie-2, providing a possible mechanism for the link between reduced pulsatility and GIB. Whether hemodynamic optimization with ramp studies could reduce Ang-2 and AVM-GIB is a subject of our ongoing research.

Post-Transplant Survival of Morbidly Obese LVAD Patients Undergoing Bariatric Surgery

Patients with left ventricular assist devices (LVADs) who are morbidly obese cannot be easily bridged to heart transplantation (HT). Reported UNOS data show that the survival rate of such patients was low after HT. Some patients are obese at the time of LVAD implantation, whereas others become morbidly obese following LVAD implantation. We applied laparoscopic sleeve gastrectomy (LSG) as a treatment strategy and our study looked to determine its efficacy and safety. We reviewed our experience of 29 patients who underwent LVAD implantation and had LSG from 2/2013 - 11/2017. Preoperative characteristics, postoperative mortality and morbidity following LVAD implantation were compared between 20 pts who had LSG performed concomitantly versus 9 who had LSG after LVAD implant. There were no significant differences in INTERMACS class, comorbidities, laboratory parameters, and demographic features, between the groups. Incidence of infectious complications was similar between groups: 7/20 (35%) vs 5/9 (56%) had driveline infection (p=0. 422); 2/20 vs 0/9 developed pocket infection (p=0.09), and 5/20 vs 1/9, (p=0.633) had sternal wound infections when LSG was performed concomitantly vs later after LVAD implant, respectively. All 29 patients were alive within 1 year of LVAD implantation; 13/29 underwent HT and 2 had LVAD successfully explanted. Currently, 27/29 patients are alive; 1 patient in the concomitant group died following an intracranial hemorrhage while listed for HT (3 years after LVAD implantation). Out of 13 pts who underwent HT 1 patient died 6 months after HT. Survival of HT patients is as follows: 4 pts>1yr; 3>2 yr, 3>3 yr; 1>5 years; 1 patient is alive over 3 months after HT. LSG can be applied as a weight loss strategy in morbidly obese LVAD recipients, either concomitantly or after LVAD implantation. Although, device-related complications occur with greater frequency in LVAD recipients who are considered morbidly obese, sufficient weight loss can be achieved and a sizable number of patients can be listed and successfully undergo HT with good posttransplant survival.

Impact of Continuous Flow Left Ventricular Assist Device on Molecular Genetic Changes in Aortic Tissue

A pulsatility decrement caused by implantation of continuous flow left ventricular assist device (LVAD) has been corroborated as an additive factor further compromising aortic wall morphology and function. MicroRNAs (miRNAs) are important post-transcriptional regulators of gene expression which could reflect individual biologic adaptation to exposure to the low pulsatile environment. We hypothesized that pulsatility deficit caused by CF-LVAD implantation may influence miRNAs expression in aortic wall and that the miRNA profiles may differ between devices with different pulsatility profiles, such as speed modulated artificial pulse wave in HeartMate3. Paired aortic samples obtained at the time of LVAD implantation and at the time of Heart transplantation from CF-LVAD patients were examined for miRNA profiling in ten patients (3 females; mean age 55±13.8 years, ischemic cardiomyopathy 40%; HeartMateII(n=4), HeartMate3 (n=6). Human miRNome profile (miRCURY LNA miRNA PCR panels) of 752 miRNAs using qPCR on QuantStudio6 RT-PCR instrument was performed in all samples. The mean support duration was 383.5±222.4 days (range 162 to 887 days). 25 differently expressed multifunctional miRNAs that contribute to the regulation of multiple signaling pathways were identified. The most significant differences in miRNAs expression between implant/explant samples were found in miR-99b-5p; -144-3p; -23b-3p; -30e-3p and let-7d-5p (all p<0.002) which all play important role in differentiation of endothelial cells, vascular smooth muscle cells, or inflammation. No differences were observed between different types of CF-LVAD. The study provides additional evidence on a negative effect of suppressed physiologic pulsatility amplitude in CF-LVAD patients. Negative changes predominantly in miRNAs participating in vascular tissue engineering in aortic wall and pro-inflammatory changes of miRNA profiles during LVAD duration were observed. Our observations suggest that a programmed artificial pulsatility in HeartMate3 does not provide mitigation of continuous flow effect on aortic wall. Moreover, the most up-expressed miR-99b which target ENO2 gene, a marker of neuronal injury, was detected after explant of LVAD. Larger scale adverse events matched clinical trials are warranted.

Gastrointestinal Bleeding After HeartMate II or HVAD Implantation: Incidence, Location, Etiology, and Effect on Survival.

The number of patients on destination therapy is increasing as long-term survival on continuous-flow left ventricular assist device (CF-LVAD) therapy has improved. Gastrointestinal bleeding (GIB) is a common complication after CF-LVAD implantation, and its risk correlates with longer support time, emphasizing the importance of GIB management. The lower pulsatility of CF-LVADs may promote arteriovenous malformations, which amplify the bleeding risk. Here, we retrospectively analyzed the location, incidence, and survival effect of GIB events in HeartMate II (HM-II) and HeartWare Ventricular Assist Device (HVAD) recipients to provide specific details regarding these complications. From November 2003 to March 2016, 526 patients with chronic heart failure underwent primary implantation of an HM-II (n = 403) or HVAD (n = 123) CF-LVAD at our center. Of the 526 patients, 140 (26.6%) had a GIB event (HM-II: n = 100; HVAD: n = 40), 92 (17.5%) had a single GIB event, and 48 (9.1%) had multiple GIB events (range: 2-9 events). HVAD recipients had a higher incidence of both upper and lower GIB events (p < 0.001 and P = 0.002, respectively) than HM-II recipients. Arteriovenous malformation was the most common etiology for GIB (50 patients/72 events); for this group, the average time-to-event was 300.4 days, the recurrence rate was 34%, and the 90-day and 1-year survival rates were 88.3% and 66.7%, respectively. Age at implantation was the only predictor of GIB. In conclusion, our study provides detailed information about GIB events associated with current CF-LVADs. Additional studies are required to evaluate strategies to reduce the incidence of GIB morbidity.

Emerging electromagnetic interferences between implantable cardioverter-defibrillators and left ventricular assist devices.

AimsTo investigate the prevalence of electromagnetic interference (EMI) between left ventricular assist devices (LVADs) and implantable cardioverter-defibrillators (ICDs)/pacemakers (PMs).Methods and resultsA retrospective single-centre study was conducted, including all patients undergoing HeartMate II (HMII) and HeartMate 3 (HM3) LVAD implantation (n = 106). Electromagnetic interference was determined by the inability to interrogate the ICD/PM. Overall, 85 (mean age 59 ± 8, 79% male) patients had an ICD/PM at the time of LVAD implantation; 46 patients with HMII and 40 patients with HM3. Among the 85 LVAD patients with an ICD’s/PM’s, 11 patients (13%) experienced EMI; 6 patients (15%) with an HMII and 5 patients (11%) with an HM3 (P = 0.59). Electromagnetic interference from the HMII LVADs was only present in patients with a St Jude/Abbott device; 6 of the 23 St Jude/Abbott devices. However, in the HM3 patients, EMI was mainly present in patients with Biotronik devices: 4 of the 18 with only one (1/25) patient with a Medtronic device. While initial interrogation of these devices was not successful, none of the 11 cases experienced pacing inhibition or inappropriate shocks.ConclusionIn summary, the prevalence of EMI between ICDs in the older and newer type of LVAD's remains rather high. While HMII patients experienced EMI with a St Jude/Abbott device (which was already known), HM3 LVAD patients experience EMI mainly with Biotronik devices. Prospective follow-up, preferably in large registries, is warranted to investigate the overall prevalence and impact of EMI in LVAD patients.

Worsening Renal Function in Cardiac Mechanical Support

Venous congestion in heart failure (HF) may lead to worsening renal failure (WRF). We hypothesised that WRF in patients hospitalised for left ventricular assist device (LVAD) implantation is associated with increased 1-year mortality. There is limited data regarding WRF in HF patients with mechanical support. The objective of this paper is to determine whether WRF in HF patients hospitalised for LVAD implantation is associated with increased 1-year mortality and to identify risk factors for WRF. We performed a single centre retrospective chart analysis of 162 patients who received an LVAD between August 2006 and December 2014 with pre-LVAD right heart catheterisation data. We stratified patients to those who demonstrated WRF and the use of haemodialysis (HD) or ultrafiltration (UF). Patients with a higher central venous pressure (CVP) >16 mmHg (17-24 mmHg range) developed WRF (29.7% vs. 14.1%, p=0.019). A CVP ≥16 and glomerular filtration rate (GFR) <30 ml/min/1.74m2 increased the odds of WRF. Worsening renal failure and HD/UF use were associated with increased 1-year mortality. Furthermore GFR <30, atherosclerosis, and right ventricular failure were independent predictors for increased 1-year mortality. A GFR <30 increased the odds of developing WRF five-fold (OR 4.14, CI [1.95-8.78], p<0.0001), and GFR <30 and central venous pressure (CVP) >16 increased the odds of requiring HD/UF. Worsening renal failure is associated with a higher CVP at the time of LVAD implantation and increases the risk of 1-year mortality and the odds of requiring HD/UF. Careful evaluation of renal function and comorbid conditions during LVAD implantation is critical to reduce mortality and for risk stratification.

Durability and Efficacy of Tricuspid Valve Repair in Patients Undergoing Left Ventricular Assist Device Implantation

ObjectivesThis study sought to determine the durability of tricuspid valve repair (TVr) performed concurrently with left ventricular assist device (LVAD) implantation and its association with the development of late right heart failure (RHF). BackgroundSurgical management of tricuspid regurgitation (TR) at the time of LVAD implantation is performed in an attempt to reduce the occurrence of postoperative RHF. Limited data exist regarding the durability of TVr in patients with LVAD as well as its impact on development of late RHF. MethodsA retrospective review was conducted of consecutive adult patients who underwent durable LVAD implantation and concurrent TVr at the authors’ institution between 2009 and 2017. Late RHF was defined as readmission for HF requiring inotropic or diuretic therapy. TVr failure was defined as moderate or severe TR at any follow-up echocardiographic examination after LVAD implantation. ResultsA total of 156 patients underwent LVAD and concurrent TVr during the study. Of the total, 59 patients (37.8%) had a failed TVr. The mean duration of echocardiographic follow-up was 23 ± 22 months. Of the 146 patients who were discharged after the index hospitalization, 53 patients (36.3%) developed late RHF. Multivariate Cox proportional hazard analysis demonstrated that TVr failure was an independent predictor of late RHF development (hazard ratio: 2.62; 95% confidence interval: 1.38 to 4.96; p = 0.003). ConclusionsFailure of TVr in this cohort occurred at a significant rate. Failure of TVr is an independent risk factor for development of late RHF. Future studies should investigate strategies to reduce recurrence of significant TR.

Impact of Change in Body Mass Index on Outcomes After Left Ventricular Assist Device Implantation in Obese Patients.

Obesity could be a risk factor portending a poor prognosis after left ventricular assist device (LVAD) implantation. We sought to determine the impact of change in body mass index (BMI) on outcomes in obese patients supported by LVAD. Fifty-nine patients, who received LVAD between January 2010 and June 2015, with BMI ≥30 kg/m at the time of LVAD implantation, were retrospectively analyzed. Patients were divided into two groups based upon whether BMI after 6 months of device support decreased when compared with before. Thirty-eight patients who experienced decrease in BMI (group D) were compared with 21 patients whose BMI increased (group I). Baseline characteristics were similar between the groups except for body weight and BMI, which were significantly higher in group D (BMI: 35.9 ± 4.0 kg/m vs. 33.4 ± 3.5 kg/m; p = 0.018). During mean follow-up of 560 ± 178 days, group I had significantly higher incidence of infection [events per patient-years (eppy): nondevice related: 0.18 vs. 0.35, p = 0.01; device related: 0.1 vs. 0.32, p < 0.01; sepsis: 0.1 vs. 0.32, p < 0.01], heart failure (eppy: 0.1 vs. 0.25, p < 0.01), and renal failure (eppy: 0.03 vs. 0.14, p < 0.01). Survival at 2 years was significantly lower in group I (84.8% vs. 57.1%, p = 0.025). Increase in BMI in obese patients on LVAD is associated with worse survival with a higher incidence of infection, heart failure, and renal failure. Weight control may be a modifiable factor to improve prognosis.

Patent foramen ovale-related complications in left ventricular assist device patients: a reappraisal for cardiovascular professionals.

Left ventricular assist device (LVAD) implantation is an important treatment option for patients with advanced heart failure. The presence of a patent foramen ovale (PFO) may elicit undesired consequences in LVAD patients: hypoxemia and paradoxical embolization. The variable physiological status of the patient with heart failure can make pre-LVAD implant identification of a PFO elusive. When identified pre- or intraoperatively, PFO is closed at time of LVAD implantation. In the case of delayed diagnosis, percutaneous PFO closure has proven to be a feasible and safe solution. As mechanical circulatory support gains prevalence, it is important to raise awareness of physiological implications of right-to-left shunt during mechanical circulatory support. We reviewed the diagnostic and therapeutic management of PFO in LVAD patients.

Cardiac implantable electronic devices with a defibrillator component and all-cause mortality in left ventricular assist device carriers: results from the PCHF-VAD registry.

To compare characteristics of left ventricular assist device (LVAD) recipients receiving a cardiac implantable electronic device (CIED) with a defibrillator component (implantable cardioverter-defibrillator and cardiac resynchronization therapy with defibrillation, CIED-D) vs. those without one, and to assess whether carrying such a device contiguously with an LVAD is associated with outcomes. Overall, 448 patients were analysed (mean age 52 ± 13 years, 82% male) in the multicentre European PCHF-VAD registry. To account for all active CIED-Ds during ongoing LVAD treatment, outcome analyses were performed by a time-varying analysis with active CIED-D status post-LVAD as the time-varying covariate. At the time of LVAD implantation, 235 patients (52%) had an active CIED-D. Median time on LVAD support was 1.1 years (interquartile range 0.5-2.0years). A reduction of 36% in the risk of all-cause mortality was observed in patients with an active CIED-D [hazard ratio (HR) 0.64, 95% confidence interval (CI) 0.46-0.91; P=0.012), increasing to 41% after adjustment for baseline covariates (HR 0.59, 95% CI 0.40-0.87; P=0.008) and 39% after propensity score adjustment (HR 0.61, 95% CI 0.39-0.94; P=0.027). Other than CIED-D, age, LVAD implant as redo surgery, number of ventricular arrhythmia episodes and use of vasopressors pre-LVAD were remaining significant risk factors of all-cause mortality. Incident ventricular arrhythmias post-LVAD portended a 2.4-fold and 2.6-fold increased risk of all-cause and cardiovascular death, respectively; carrying an active CIED-D remained associated with a 47% and 43% reduction in these events, respectively. In an analysis accounting for all active CIED-Ds, including those implanted during LVAD support, carrying such a device was associated with significantly better survival during LVAD support.

Left Ventricular Assist Devices vs. Cardiac Transplantation: The Age Factor

Background Outcomes of patients bridged with a left ventricular assist device (LVAD) when compared to primary cardiac transplantation may vary by age group. Methods Single-center study of patients who underwent cardiac transplantation or LVAD implantation. The study population was categorized by age groups. Group 1 included patients under 50 years of age, while Group 2 included patients over 50 years of age. For each age group, separate analyses of baseline demographics and outcomes were compared between 3 subgroups: patients bridged with an LVAD (BTT-LVAD group), primary cardiac transplantation patients (TXP group), and destination therapy (DT-LVAD group). For the BTT-LVAD group, survival was assessed from time of LVAD implantation and included days alive after cardiac transplantation. For the TXP group, survival was defined as days alive since transplantation. Kaplan-Meier curves were used to analyze survival between groups. Results A total of 380 patients were analyzed in the study. 136 patients were included in Group 1 (35.8%). At baseline, no significant differences with regards to age, gender, ethnicity and BMI were noted among subgroups. During the study period, 76% of Group 1 BTT-LVAD patients underwent transplantation. A high survival rate was observed with no significant differences in 1-year survival noted between subgroups (Group 1 BTT-LVAD: 96%; Group 1 TXP: 97.3%; Group 1 DT-LVAD:91.8%, p=0.472). 3-year survival remained high in Group 1 BTT-LVAD patients, but a significant decrease in survival of both Group 1 TXP and DT-LVAD was noted (Fig. A). Group 2 patients comprised 244 patients (64.2% of total population; Group 2 BTT-LVAD: 36.1.%; Group 2 TXP: 25.4%; Group 2 DT-LVAD: 38.5%). At baseline, no significant differences with regards to age, gender, BMI were noted among subgroups. Group 2 DT-LVAD had a higher proportion of black patients. During the study period, 76% of Group 2 BTT-LVAD patients underwent transplantation. A high survival rate was observed in Group 2 with no significant differences in 1-year survival noted between subgroups (Group 2 BTT-LVAD: 95.5%; Group 2 TXP: 87.1%; Group 2 DT-LVAD: 88.3%, p=0.14). 3-year survival remained high in Group 2 BTT-LVAD and TXP, but a significant decrease in survival of Group 2 DT-LVAD was noted (Fig. B). Conclusions Our study showed exceptionally high mid- and long-term survival rates in patients bridged with a LVAD in both age groups. While a TXP strategy may be reasonable in older patients, younger patients who underwent TXP had a significant decline in survival at 3 and 5 years. Conversely, outcomes of DT-LVAD therapy in younger patients continues to improve.

LVAD as Bridge to Transplant Leads to Better Outcomes When Compared to Transplant-Only Strategy

Background Patient who are bridged to transplantation with a left ventricular assist device (LVAD) when compared to primary heart transplantation have had mixed outcomes. Methods Single-center study of patients who underwent cardiac transplantation or LVAD implantation. Baseline demographics and outcomes were compared between 3 groups: patients bridged with a LVAD (BTT-LVAD group), patients who underwent primary cardiac transplantation (TXP group), and patients who underwent LVAD as destination therapy (DT-LVAD group). For the TXP group, survival was defined as days alive since cardiac transplantation. For the BTT-LVAD group, survival was defined from time of LVAD implantation and included days alive after cardiac transplantation. In the DT-LVAD group, survival was defined as days alive since LVAD implantation. Kaplan-Meier curves were used to analyze survival between the groups. Results A total of 380 patients were included (BTT-LVAD group: 36.3.%; TXP group: 26%; DT-LVAD group: 37.6%). At baseline, no significant differences with regards to age and BMI were noted. Male gender and blood type O were more common in the BTT-LVAD group. The DT-LVAD group had a higher proportion of black patients. During the study period, 76% of LVAD-BTT group underwent cardiac transplantation. A high survival rate was observed is the study population at 1-year (92.1%). Non-statistically significant differences in 1-year survival were noted between groups with higher trends of survival observed in the BTT-LVAD group (BTT-LVAD group: 95.7%; TXP group: 90.9%; DT-LVAD group: 89.5%, p=0.14). By 2 years, survival rates remained high in all groups with statistically significant differences noted among the groups (BTT-LVAD group: 94.6%; TXP group: 85.9%; DT-LVAD group: 81.4%, p=0.01). 3-year survival remained high for both the BTT-LVAD and TXP groups however, a decline in survival was noted in the DT-LVAD group (BTT-LVAD group: 93.5%; TXP group: 81.6%; DT-LVAD group: 60.8%, p=0.00). While 5-year survival remained high for the LVAD-BTT group (figure), a further survival decrease was observed in both the TXP and DT-LVAD groups (BTT-LVAD group:8 4.2%; TXP group: 63%; DT-LVAD group: 29.8%, p=0.00). Conclusions Our study showed an exceptionally high survival rate in patients bridged to cardiac transplantation with LVAD implantation. These findings also suggest that the use of a LVAD as a BTT may be a better strategy than primary cardiac transplantation as it may add an additional survival benefit (total support time).

Functional Assessment of Decellularized Extracellular Matrix in Patients Undergoing LVAD Implantation

Purpose While changes in the extracellular matrix (ECM) have been demonstrated in the failing heart, changes in mechanical ECM properties are unknown. We aimed to determine the biomechanical properties of ECM obtained from myocardial tissue samples at the time of left ventricular assist device (LVAD) implantation. Methods Myocardial tissue samples obtained at the time of LVAD implantation underwent decellularization and determination of the stress-strain relationship. Storage modulus (G’, an assessment of elastic properties) and loss modulus (G’’, an assessment of viscous properties) were compared against the likelihood of clinical recovery as computed using an established predictive model, the INTERMACS Cardiac Recovery Score (I-CARS). Results 14 myocardial samples were obtained and analyzed at the time of LVAD implantation. Mean age was 48.8 years (range: 17-74). 11 subjects were male (79%) with ischemic etiology in 3 (21%). Mean ejection fraction was 19.2% ± 7.2%. Storage and loss modulus of the ECM samples were grouped into tertiles based on the likelihood of myocardial recovery as predicted by I-CARS score. The group with the lowest recovery likelihood (0.0%, I-CARS score of 0-3) had the highest average value of storage modulus (1312 ±1553 Pa at 1 rad/s). The group with intermediate recovery likelihood (6.3%, I-CARS score of 4-6) had intermediate average value (781 ±517 Pa at 1 rad/s). The group with the highest recovery likelihood (38.9%, I-CARS score of 7-9) had the lowest average value (450 ±308 Pa at 1 rad/s). Similar trends were seen with loss modulus (figure). Conclusion Analysis of ECM in myocardial tissue samples obtained at the time of LVAD implantation showed a trend toward lower storage modulus and loss modulus in those with a higher predicted likelihood of myocardial recovery based on the I-CARS recovery score. The functional properties of decellularized ECM can be assessed ex vivo and may represent an independent parameter for myocardial recoverability.

Aortic Root Thrombus after LVAD Implantation and Aortic Valve Replacement

Purpose The risk of developing thromboembolic events is elevated in the first 3 months after an aortic valve replacement (AoVR). Therefore, the current guidelines recommends very early (at day 1) introduction of low dose aspirin or therapeutic warfarin therapy after AoV replacement. Following Left Ventricular Assist Device (LVAD) implantation, AoVR with a bioprothesis is advised in patients with a moderate to severe aortic regurgitation (AR). Aim of this study was to evaluate the clinical outcome of bioprothesis post-LVAD, especially in relation to thromboembolic events. Methods We revised all LVAD implantations in our center (64 HeartMate II and 40 HeartMate 3 LVAD patients) starting from 2006 for AoVR and thromboembolic events diagnosed on CT-angiography (CT-a). Results Nine patients (8.7%; median age 53 years, 89% male) had concomitant AoVR at the time of LVAD implantation, one patient (1.0%; 56 years of age, male) had AoVR 520 days post-LVAD, one patient (1.0%; 59 years of age, female) had a Transcatheter Aortic Valve Implantation (TAVI) after 337 days post-LVAD. An overview of the clinical data is shown in the Table. Median follow-up time on LVAD support was 750 days [range: 86-2065]. Median time to therapeutic heparin/warfarin therapy was 4 days [range: 1-7] and median time to start of aspirin was 11.5 days [range: 5-39] after implantation. Three patients developed an aortic root thrombus within the first month after implantation, all primarily diagnosed with CT-a, and subsequently confirmed by transthoracic echocardiography. Furthermore, two patients suffered from a stroke, one ischemic and one hemorrhagic. Conclusion In our cohort, consisting of eleven patients with LVAD and AoVR, almost one third had LVOT/AoV thrombosis at CT-a, one of them developed an ischemic stroke. We hypothesize that concomitant AoVR at the time of LVAD implantation in selected patients may be associated with less risk for thrombus formation on LVOT/AoV as compared to a later intervention on the aortic valve.

Concurrent Mitral Valve Repair during Placement of Continuous-Flow Left Ventricular Assist Device

Purpose Pre-existing mitral valve pathology is common in patients undergoing continuous-flow left ventricular assist device (LVAD) implantation. Best management of pre-existingmitral valve disease remains controversial. Methods Between March 2004 and December 2017, a total of 594 patients received a continuous-flow left ventricular assist device. Of these, a total of 93 patients (16%) underwent a concurrent mitral valve repair, either with an Alfieri stitch via the left ventricular (LV) apex coring site (n =30, 32%) or with an annuloplasty ring via a left atriotomy (n = 63, 68%). Outcomes were compared between patients who received an Alfieri stitch and those who received an annuloplasty ring repair. Results All patients had moderate or greater mitral regurgitation at the time of LVAD implantation. Median age was 54 years (interquartile range [IQR], 43-74) in the annuloplasty cohort, and 56 years (interquartile range [IQR], 44-79) in the Alfieri stitch group. A proportionately greater number of women underwent Alfieri stitch repair (n = 6, 20%) compared to ring annuloplasty (n = 5, 8%; p = 0.01). Additionally, a greater number of patients in the Alfieri group underwent a concomitant valve intervention such as a Park stitch or tricuspid repair (n = 15, or 50%) compared to those patients undergoing a ring annuloplasty (n = 28, 44%; p = 0.04). Cardiopulmonary bypass times were shorter on average in the Alfieri patients, independent of concomitant valve procedure (111 minutes versus 134 minutes, p = .02). Thirty-day survival in the Alfieri group (n = 27, 90%) was similar to that of the ring annuloplasty group (n = 57, 91%); p > 0.05. However, in the 84 patients for whom data was available, 1-year survival was higher in the Alfieri group compared to the ring annuloplasty group (26.3% versus 18.6%, p = 0.032). Conclusion Concomitant mitral valve intervention is fairly common in patients undergoing continuous-flow LVAD placement. Our findings suggest that short-term outcomes are not impacted by type of mitral valve repair technique, but mitral valve repair via the LV apex coring site may be a favorable approach.

Experience with Long-Term Contiunous Flow Ventricular Assist Deviceas Bridge to Recovery Concept

Purpose In the era of continuous flow ventricular assist devices (VAD) only minority of patients can be considered for cardiac recovery and device explantation. The purpose of this study is to report our experience with several techniques of VAD deactivation/explantation. Methods This is a single center, observational study based on a prospectively collected data. Inclusion criteria were patients supported with Left VAD (LVAD) between 01.2010 and 09.2018. Routine echocardiography examinations were performed after VAD implantation. Once cardiac recovery was observed, the patients were admitted to hospital for right heart catheterization and exercise tests. The decision to wean and explant the LVAD was taken when satisfactory results were observed in excercise tests, including LVEF of >40% andleft ventricular end diastolic diameter of Results A total of 201 patients were supported with long term LVAD. Device deactivation was conducted in 11 (5 %) patients after a median LVAD support duration of 320 days (29-1587days). Patients characteristics includes: mean age 47 ± 15 years; male 82%; Ischemic Cardiomyopathy 55%; pre-LVAD INTERMACS level 2 ± 1; pre-LVAD short term circulatory support in 77%. Two patients underwent aortic valve replacement at the time of LVAD implantation. Different techniques were used for device deactivation. The majority of patients (54%) underwent device explantation through left thoracotomy approach (6 Off pump with insertion of left ventricularTitanium Plug and 1 Dor Platstik) . Pump deactivation und interventional outflow graft closure using a 12 mm Ductus-Occluder was performed in 2 patients, device deactivation and surgical outflow graft ligation through second intercostal space was performed in 1 patient and median sternotomy in 1 patient. None of the patients, except for one, developed heart failure symptoms after device explantation/deactivation. Conclusion Bridge to recovery option should be considered in every patient supported withLVAD. Cardiac recovery can take up to 4 years as in one of our patients, which is to our knowledge the longest reported time required for cardiac recovery after LVAD implantation. Various approaches are available for device deactivation/explantation. The ideal approach need to be tailored to the individual patient.

Long-Term Outcome of Patients after Successful LVAD Explant: A EUROMACS Study

Purpose In patients supported by a left ventricular assist device (LVAD) myocardial recovery resulting in explant occurs in approximately 1-2%. However, the long-term outcome of these patients is unknown. We studied the clinical management and long-term outcomes in patients after LVAD explant. Methods An analysis of the European Registry for Patients Assisted with Mechanical Circulatory Support (EUROMACS) was performed identifying patients > 18 years old with successful LVAD explant. Baseline characteristics were retrieved and follow-up (FU) of patients after explant was collected. A Kaplan-Meier analysis was performed for the event-free survival (EFS), events being LVAD reimplantation or heart transplantation. Results A total of 49 (1.4%) patients with successful LVAD explant were identified in EUROMACS. FU was acquired of 28 (57%) of the patients: median age 43y (range 18-64), 23 (82%) males, median LVEF was 18% (IQR 13-23%) at the time of LVAD implantation, 60.7% were INTERMACS class 1 or 2. Etiologies of heart failure (HF) were: dilated cardiomyopathy (DCMP) due to myocarditis (9), idiopathic DCMP (6), ischemic (3) or others (10). Devices implanted: 14 HeartMate II (50%), 11 HeartWare VAD (39%), 2 HeartMate 3 (7%), 1 unknown, with a mean duration of support of 13.5 months (range 1 - 42). Mean FU after explant was 27 months (±23). Use of HF medication was: ACE inhibitor 71%, β-blockers 85% and loop diuretics 50%. New York Heart Association (NYHA) class is I to II in 82% and III in 11% of these patients. Aspirin was used by 43% of the patients, 39% used warfarin, with 29% using neither of them. The inflow cannula was in situ in 3 (11%) patients, while no cerebrovascular accident was seen. EFS was 92.9% after 4 years. One patient required reimplantation after 32 days, and 1 died of sepsis 10 months after LVAD explant. Conclusion This EUROMACS FU study is, to our knowledge the first in the literature, and shows that long-term EFS after LVAD explant is excellent, with the majority of the patients having only mild to moderate HF symptoms.

Comparison of Amiodarone and Beta Blockers to Suppress Tachyarrhythmias in Patients with Left Ventricular Assist Devices

Purpose We evaluated the role of amiodarone (AMI) and beta blockers (BB) in reducing the number of tachyarrhythmia events or related readmissions in patients with left ventricular assist devices (LVAD). Methods All patients that received a continuous-flow LVAD at a single center between 2011-2017 were retrospectively reviewed. Patients were separated into 4 groups including AMI only, BB only, both, or neither at time of LVAD implantation and 1 month, 6 months, or 12 months post-LVAD. Primary outcomes included number of tachyarrhythmia events (greater than 30 seconds or requiring cardioversion) between intervals 0-1 month, 1-6 months, and 6-12 months and readmissions due to arrhythmia at 12 months. Analysis involved ANOVA to compare the mean number of arrhythmia events between these time intervals with the 4 groups being determined by type of therapy at the beginning of each interval. Results A total of 111 patients were included in this study, including 27 (24.3%) females. The mean age was 60.5 (SD ± 12.3) years and mean BMI was 30.4 (SD ± 7.4) kg/m2. The BB only group included 0 (0%) patients at time of LVAD, 18 (16.3%) at 1 month, 31 (37.5%) at 6 months, and 27 (38.2%) at 12 months. The AMI only group included 53 (47.7%) at time of LVAD, 33 (33.6%) at 1 month, 10 (12.5%) at 6 months, and 8 (11.8%) at 12 months. The BB + AMI group included 1 (0.9%) at time of LVAD, 33 (33.7%) at 1 month, 33 (41.3%) at 6 months, and 27 (39.7%) at 12 months. Neither BB or AMI was used in 57 (51.3%) at time of LVAD, 14 (14.3%) at 1 month, 6 (7.5%) at 6 months, and 6 (8.8%) at 12 months. At 1 month, mean number of arrhythmia events was 1.7 with AMI only, 6.0 with BB + AMI, and 1.0 with neither (P = 0.02). Between 1 - 6 months post-LVAD, mean number of events was 7.7 with BB only, 0.5 with AMI only, 0.7 in BB + AMI, and 0.4 with neither (P = 0.27). Between 6 - 12 months, mean number of events was 0.1 with BB only, 0 with AMI only, 1.4 AMI + BB, and 0 with neither (P = 0.60). Mean number of readmissions at 12 months was greatest in group with BB + AMI at 6 months (BB only, 0.03; AMI only, 0; BB + AMI, 0.36; neither, 0; P = 0.04). Conclusion In this retrospective analysis, the use of AMI and/or BB did not appear to reduce the burden of tachyarrhythmias in patients with LVAD, and the use of both was associated with the highest number of readmissions. Prospective studies are needed to evaluate the efficacy of anti-arrhythmic therapies in these patients.

The Effects of Echo-Optimization of Left Ventricular Assist Devices on Functional Capacity: A RAndomized Controlled Trial (VAFRACT)

Purpose After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance . LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an improvement on functional capacity (FC). VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by cardiopulmonary exercise test (CPET) in LVAD optimization free population. Methods Patients were randomized in a 1:1 ratio to EO (EO group) versus standard setting (CONTROL group) after at least 3 months from LVAD implant. Optimal device speed is defined as the one that allows intermittent aortic valve opening and neutral position of the interventricular septum without increasing aortic or tricuspidal regurgitation and preserving right ventricular (RV) function. The primary end point is peak oxygen uptake (VO2 peak) change at 3 months after the EO. The secondary end points are: RV function (fractional area change - FAC); hospital admissions device related; NT pro BNP levels; CPET exercise time (ET); changes in quality of life (QoL) perceived by EuroQoL Scale. At the interim analysis 15 patients have been enrolled and 10 have completed the study. Assuming α = 0.05 and an 80% power, the sample size estimation is 18 patients per group. Results No statistically significant differences have been found in basal characteristics of the two groups. Time of LVAD implantation was about 2.5 years and the most common indication to implant was Bridge to Transplant. Preliminary analysis of data concerning patients who have already completed the study shows a tendential positive impact of EO on VO2 peak, ventilatory anaerobic threshold (VAT), ET and on the QoL (Table 1). Conclusion This is the first prospective randomized trial to evaluate the additional benefit of EO on FC; final results could demonstrate that this approach could lead to improvements in exercise capacity in LVAD supported patients.

Predicting Bleeding and Thrombosis Complications in Patients with Continuous Flow Left Ventricular Assist Devices

Background: Left ventricular assist device (LVAD) therapy has been proven to relieve heart failure symptoms and improve survival, but is not devoid of bleeding and/or thrombotic complications. Risk stratification tools have been utilized in other cardiovascular disease populations to estimate the risk of bleeding and thrombosis with and without anticoagulation, including the HAS-BLED, HEMORR2HAGES, CHADS2 and CHA2DS2-VASc models. The study objective was to evaluate the predictive value of available risk models for bleeding and thrombotic complications in patients with an LVAD within one year of implantation. Methods: This was a retrospective, single-center analysis of patients implanted with the HeartMate II continuous-flow LVAD from July 2011 to June 2016. All patients who received an LVAD within the study period were eligible for inclusion. The primary endpoint was the first occurrence of bleeding or thrombosis within one year from implantation. Baseline risk model scores were calculated at the time of LVAD implantation. Chi-square and student’s t-test were used to measure baseline differences and compare mean risk model scores between patients who had an event. A receiver operator characteristic (ROC) curve analysis was performed to evaluate the accuracy of the risk models to predict an event. Results: A total of 129 patients underwent LVAD implantation within the study time period. Mean CHADS2, CHA2DS2-VASc, and HAS-BLED scores were not significantly different in patients with and without an event. The mean HEMORR2HAGES score was 3.09 and 2.51 in those with and without a bleeding event, respectively (p = 0.008). The ROC curve area for the HEMORR2HAGES model was the highest at 0.620. Conclusion: The HAS-BLED, HEMORR2HAGES, CHADS2and CHA2DS2-VASc risk stratification models did not accurately predict bleeding or thrombosis events in our population. The mean HEMORR2HAGES model score was higher in patients who experienced a bleeding event. However, this model did not have strong positive predictive value. Better risk models are needed to predict bleeding and thrombotic events in this patient population.