Assist Device Implantation Research Articles

Preinterventional quantification of dense scar or borderline zone in patients undergoing ventricular tachycardia ablation

Abstract Funding Acknowledgements Type of funding sources: None. Introduction This study sought to examine the prognostic role of quantifying areas of interest in preinterventional cardiac magnetic resonance (CMR) in patients with structural heart disease (SHD) referred for ablation of ventricular tachycardia (VT). Background The role of preinterventional CMR for the identification of scar areas, borderline zones and reentry channels in the ventricles has been well established. Whether the burden of dense scar or borderline tissue has a prognostic impact on the acute and the long-term ablation outcome in SHD patients is disputed. Methods and results We investigated 185 patients with SHD undergoing preinterventional CMR prior to VT-ablation. 38 patients were excluded because of poor imaging quality, leaving a cohort of 147 patients with positive late enhancement (LGE) imaging (mean age 62 years, 47% non-ischemic cardiomyopathy, mean left ventricle ejection fraction 38%, 96% with implanted ICD). The cohort was divided in ischemic (ICM) and non-ischemic (NICM) cardiomyopathy group and the results regarding burden of overall scar tissue, dense scar, borderline zone, as well as clinical and procedural characteristics, acute and long-term results of the two groups were compared. The ICM patients had more advanced NYHA stadium (p = 0.046), reduced left ventricular ejection fraction (LV-EF, p <0.001) and higher left ventricular enddiastolic volume (LVEDV, p <0.001). The NICM patients were more often under antiarrhythmic therapy (p = 0.005) and underwent more frequently epicardial ablation (p <0.001). Although the overall scar burden war higher in ICM patients (p <0.001), the groups showed no significant difference in borderline zone burden (p = 0.580). Furthermore, the two groups had similar results in number of inducible VTs (p = 0.054) and VT inducibility at the end of the procedure (p = 0.121). Nevertheless, the NICM group underwent overall more ablation procedures during the 19-month follow up (p = 0.023). Both groups showed similar results regarding assist device implantation, heart transplantation or death until the end of the follow up (p = 0.192). Conclusion While quantification of the scar tissue and the borderline zone is feasible in ICD patients with SHD, the scar or the borderline zone burden were not predictive of the VT ablation outcome.

Severe Pulmonary Bleeding after Assist Device Implantation: Incidence, Risk Factors and Prognostic Impact.

Background: Continuous flow left ventricular assist devices (CF-LVAD) improve survival in patients with advanced heart failure but confer risk of bleeding complications. Whereas pathophysiology and risk factors for many bleeding complications are well investigated, the literature lacks reports about pulmonary bleeding. Therefore, it was the aim of the present study to assess incidence, risk factors, and clinical relevance of pulmonary bleeding episodes after LVAD implantation. Methods: We retrospectively analyzed our institutional database of 125 consecutive patients who underwent LVAD implantation between 2008 and 2017. Demographic and clinical variables related to bleeding were collected. The primary endpoint was incidence of severe pulmonary bleeding (SPB). Results: Nine out of 125 patients suffered from SPB during the postoperative course (7.2%) 11 days after surgery in the median. None of them had a known history of lung disease or bleeding disorder. History of prior myocardial infarction (0% vWD. 42.2%, p = 0.012) and ischemic cardiomyopathy (25.0% vs. 50.0%, p = 0.046) were less frequent in the SBP group. Concomitant aortic valve replacement was more common in the group with SPB (33.3% versus 7.0%, p = 0.034). Surgical (blood loss 9950 vs. 3800 mL, p = 0.012) as well as ear-nose-throat (ENT) bleedings (33% vs. 4.6%, p = 0.015) were observed more frequently in patients with SPB. SPB was associated with a complicated postoperative course with a higher incidence of acute kidney failure (100% versus 36.7%, p = 0.001) and delirium (44.4% versus 14.8%, p = 0.045); a higher need for red blood cell (26 packs versus 7, p < 0.001), fresh frozen plasma (18 units versus 6, p = 0.002), and platelet transfusion (8 pools versus 1, p = 0.001); longer ventilation time (1206 versus 171 h, p = 0.001); longer ICU-stay (58 versus 13 days, p = 0.002); and higher hospital mortality (66.7% vs. 29%, p = 0.029). Conclusion: SPB is a rare but serious complication after LVAD implantation and is significantly associated with higher morbidity and mortality. The pathophysiology and potential risk factors are unknown but may include coagulation disorders and frequent suctioning or empiric bronchoscopy causing airway irritation.

Bridging patients in cardiogenic shock with a paracorporeal pulsatile biventricular assist device to heart transplantation-a single-centre experience.

We evaluated the outcome of patients in cardiogenic shock receiving a paracorporeal pulsatile biventricular assist device as a bridge to transplantation. We performed a retrospective single-centre analysis of all patients who received a Berlin Heart Excor® at our institution between 2004 and 2019. A total of 97 patients (90 adults, 7 paediatric) were analysed. Eighty-four patients were in Interagency Registry for Mechanically Assisted Circulatory Support level 1 (80 adults, 4 paediatric). Diagnoses were dilated cardiomyopathy (n = 41), ischaemic cardiomyopathy (n = 17) or myocardial infarction (n = 4), myocarditis (n = 15), restrictive cardiomyopathy (n = 2), graft failure after heart transplant (n = 7), postcardiotomy heart failure (n = 5), postpartum cardiomyopathy (n = 3), congenital heart disease (n = 1), valvular cardiomyopathy (n = 1) and toxic cardiomyopathy (n = 1). All patients were in biventricular heart failure and had secondary organ dysfunction. The mean duration of support was 63 days (0-487 days). There was a significant decrease in creatinine values after assist device implantation (from 1.83 ± 0.79 to 1.12 ± 0.67 mg/dl, P = 0.001) as well as a decrease in bilirubin values (from 3.94 ± 4.58 to 2.65 ± 3.61 mg/dl, P = 0.084). Cerebral stroke occurred in 16 patients, bleeding in 15 and infection in 13 patients. Forty-eight patients died on support, while 49 patients could be successfully bridged to transplantation. Thirty-day survival and 1-year survival were 70.1% and 41.2%, respectively. A pulsatile biventricular assist device is a reasonable therapeutic option in cardiogenic shock, when immediate high cardiac output is necessary to rescue the already impaired kidney and liver function of the patient.

332 Clinical and prognostic significance of junctional late gadolinium enhancement in patients with non-ischaemic cardiomyopathy

Abstract Aims Pulmonary hypertension (PH) carries a poor prognosis in patients with non-ischaemic dilated cardiomyopathy (NIDC). Cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE) evaluation can identify myocardial abnormalities. In particular, junctional LGE is already an established marker of adverse right ventricular (RV) remodelling in patients with pre-capillary PH. This study sought to assess the prevalence of junctional LGE by CMR in NIDC, its relationship with hemodynamic parameters and, moreover, its prognostic significance. Methods and results Patients with NIDC who underwent right heart catheterization (RHC) and CMR within 3 months in a tertiary hospital were enrolled. Patients with acute heart failure were excluded. Among others, RV and left ventricular (LV) volumes, junctional LGE at CMR, pulmonary artery pressure (PAP) and pulmonary capillary wedge pressure (PCWP) at RHC were tabulated. Pulmonary hypertension was defined accordingly to current Guidelines (median PAP at RHC ≥ 25 mmHg). The primary endpoint consisted of heart failure (HF) hospitalization during follow-up. A total of 188 patients [median age 49 (SD 15), 71% males] were evaluated. At morpho-functional CMR evaluation, most subjects (76%) had important systolic dysfunction (LV EF ≤ 35%). Junctional LGE was observed in 83 (44%) patients. Among patients with junctional LGE, 21 had LGE confined only to the junctional region, while 61 had also mid-wall interventricular septal stria and 21 a mid-wall stria in the lateral free LV wall. Patients with junctional LGE had lower RV EF (49% vs. 56%, P &amp;lt; 0.001) and LV EF (27% vs. 30%, P = 0.012) when compared to those without junctional LGE although no differences in LV and RV dimensions were found. RHC showed PH in 83 patients (44%). Patients with junctional LGE showed a worse hemodynamic profile in terms of PH (55% vs. 36%; P = 0.011) and increase in PCWP (PCWP &amp;gt; 15 mmHg in 60% vs. 42%; P = 0.015) compared to subjects without junctional LGE. Among 79 patients with PH and PCWP &amp;gt; 15 mmHg, 75 (95%) had a combined post capillary and pre-capillary PH (diastolic pressure gradient ≥7 mmHg). Univariate analysis showed that junctional LGE was associated with a worse hemodynamic profile; on multivariable model, RV EF was significantly associated with the presence of junctional LGE (OR: 0.91; 95% CI: 0.87–0.96, P &amp;lt; 0.001). During a median follow-up of 58 months, 33 patients (18%) died or underwent heart transplantation/ventricular assist device implantation, 17% in the junctional LGE group vs. 18% among those without junctional LGE. Thirty-eight patients (20%) had at least one episode of HF, 22 among junctional LGE group and 16 in control group (27% vs. 15%, P = 0.056). When adjusted for age, junctional LGE resulted a significant determinant of HF hospitalization (OR: 2.13, 95% CI: 1.02–4.44, P = 0.044). Conclusions Junctional LGE is detectable in almost half of NIDC patients and it is related to a worse haemodynamic profile, characterized by PH and elevated PCWP. Moreover, after adjustment for age, it was a significant determinant of HF hospitalization during follow-up in our population. Junctional LGE can therefore represent a useful prognostic tool, as marker of adverse ventricular remodelling likely related to ventricular interdependence.

Risk stratification and survival in patients with HFmrEF: the role of cardiopulmonary exercise testing

Abstract Background The prognostic value of cardiopulmonary exercise testing (CPET) is established for risk stratification in patients with heart failure (HF) and reduced ejection fraction (HFrEF). Since the introduction of HF with mid-range ejection fraction (HFmrEF) as an additional category in 2016, optimal management strategy and risk stratification for these patients is a field of ongoing research. Purpose Left ventricular ejection fraction (LVEF) is only one part of the picture when planning treatment and estimating long time risk for patients with HF. We planned to investigate the predictive long-term value of exercise intolerance as measured by CPET in patients with HFmrEF in comparison to HFrEF. Methods We performed a single-center retrospective cohort study of ambulatory consecutive patients that showed signs of heart failure (NYHA functional class II or III) and had a LVEF of 49% or below as measured by echocardiography at the time of CPET. All patients underwent CPET evaluation with an upright bicycle between 2015–2017. The primary endpoint of all-cause mortality as well as the secondary composite endpoint of all-cause mortality or heart transplant/ventricular assist device implantation (transplant/VAD free survival) were assessed. Results For the primary analysis, 253 patients (mean age 61.2±13.0 years, 82.6% male) were included. 68 patients showed an LVEF between 40 and 49% (HFmrEF) whereas 185 patients had an LVEF of below 40% (HFrEF). HF etiology was in 31.3% ischemic. Mean BNP values were 788±1061 pg/ml while HFmrEF patients had on average lower values than HFrEF (322±676 vs. 945±1121, p&amp;lt;0.001). Patients were followed up for a median of 4.2 years (IQR: 3.5–5.0 years). Over this period, the primary and secondary end-point occurred in 22.5%/30.8% of patients. Patients in the HFmrEF group showed a higher mean peak oxygen uptake compared to HFrEF (pVO2; 17.3±4.6 vs 14.2±3.7 ml/min/kg, p&amp;lt;0.001), peak exercise power (Pmax; 111±49 vs 91±38 Watt, p=0.02) and peak oxygen pulse (pO2/HR; 12.6±4.2 vs 10.4±4.1 ml/min/kg, p&amp;lt;0.001). The Kaplan-Meier-Estimate showed a significant difference in survival for both HFmrEF and HFrEF who had pVO2 below 14 ml/min/kg (Log Rank: Chi2: 4.45, p=0.035 and Chi2: 10.05, p=0.02). In univariate Cox regression, pVO2 was predictive of the primary endpoint (HR per +1 mL/kg/min: 0.81; CI: 0.71–0.93; p=0.002 and HR per +1 mL/kg/min: 0.84; CI: 0.77–0.92; p&amp;lt;0.001) in both groups as was Pmax and pO2/HR (p&amp;lt;0.05 for both variables in both groups). Conclusion As in HFrEF, CPET is a useful tool to stratify risk in HFmrEF as well. Our findings support the prognostic role of pVO2 as well as pO2/HR and Pmax in HF with mid-range LVEF. Using a cut off of pVO2 14 ml/min/kg selected patients at risk with similar long-term prognosis as in the HFrEF cohort. Further research to identify subgroups at risk within the heterogeneous group of HFmrEF is warranted for optimal risk stratification. Funding Acknowledgement Type of funding sources: None.

Small left ventricular size predicts implantable cardioverter defibrillator therapy in long-term observation of patients with left ventricular assist device for non-ischemic cardiomyopathy

Abstract Funding Acknowledgements Type of funding sources: None. Background The number of patients who received left ventricular assisted device (LVAD) implantation because of end-stage heart failure has been increasing. In those patients, ventricular arrhythmias (VAs) occur commonly, and electrical storm (ES) and shock therapies by implantable cardioverter-defibrillator (ICD) are considered to increase mortality. Although it is important to identify patients with higher risk of VA events, there have been limited data reporting the risk of VAs in LVAD patients during long-term follow up, especially in non-ischemic cardiomyopathy (NICM). Purpose We sought to clarify the predictors of ICD therapies in LVAD patients diagnosed as NICM during long-term follow up. Methods We retrospectively analyzed non-ischemic heart failure patients whom a continuous flow LVAD was implanted as a bridge to transplantation therapy from July 2011 to February 2019. ICD programming was generally set as follows; one zone setting (VF zone with maximum shocks) for primary prevention or two zone setting (VF with maximum shocks and VT with ATPs and shocks) for secondary prevention. ICD settings were generally unchanged after LVAD implantation. Clinical and echocardiographic data were collected before and 3 months after LVAD implantation. Device interrogation was performed every 4 - 6 months at out-patient clinic. Patients were followed until May 2019. Results A total of 25 patients were included in the study. The mean age was 49 years, 88% were men. They majority of patients (52%) were diagnosed as idiopathic dilated cardiomyopathy. During the median follow up duration of 889 days (IQR 546 – 2070), 27 appropriate shock events occurred in 7 patients and 154 appropriate ATP-only events in 10 patients. The group with appropriate ICD event (11 patients, 44%) had significantly smaller LVDd (65.2 ± 4.0 vs. 79.4 ± 3.5 mm; p = 0.01) and higher LVEF (26.2 ± 1.6 vs. 20.5 ± 1.4 %; p = 0.02) before LVAD implantation. When patients were divided into 2 groups based on the median value (70.0 mm) of LVDd before LVAD implantation (pre LVDd), patients with smaller pre LVDd (≤ 70mm) had significantly higher rate of appropriate ICD treatment than those with larger pre LVDd (&amp;gt; 70 mm) (Log-rank p &amp;lt; 0.01). In univariate cox regression analysis, pre LVDd was negatively associated with appropriate ICD therapy (hazard ratio 0.94, 95% confidence interval 0.88 - 0.99; p = 0.02). Conclusion Smaller LVDd before LVAD implantation might be a possible predictor of appropriate ICD treatment in patients with NICM. Abstract Figure.

Reduction in the QRS area after cardiac resynchronization therapy is associated with survival and echocardiographic response.

IntroductionRecent studies have shown that the baseline QRS area is associated with the clinical response after cardiac resynchronization therapy (CRT). In this study, we investigated the association of QRS area reduction (∆QRS area) after CRT with the outcome. We hypothesize that a larger ∆QRS area is associated with a better survival and echocardiographic response.Methods and ResultsElectrocardiograms (ECG) obtained before and 2–12 months after CRT from 1299 patients in a multi‐center CRT‐registry were analyzed. The QRS area was calculated from vectorcardiograms that were synthesized from 12‐lead ECGs. The primary endpoint was a combination of all‐cause mortality, heart transplantation, and left ventricular (LV) assist device implantation. The secondary endpoint was the echocardiographic response, defined as LV end‐systolic volume reduction ≥ of 15%. Patients with ∆QRS area above the optimal cut‐off value (62 µVs) had a lower risk of reaching the primary endpoint (hazard ratio: 0.43; confidence interval [CI] 0.33–0.56, p < .001), and a higher chance of echocardiographic response (odds ratio [OR] 3.3;CI 2.4–4.6, p < .0001). In multivariable analysis, ∆QRS area was independently associated with both endpoints. In patients with baseline QRS area ≥109 µVs, survival, and echocardiographic response were better when the ∆QRS area was ≥62 µVs (p < .0001). Logistic regression showed that in patients with baseline QRS area ≥109 µVs, ∆QRS area was the only significant predictor of survival (OR: 0.981; CI: 0.967–0.994, p = .006).Conclusion∆QRS area is an independent determinant of CRT response, especially in patients with a large baseline QRS area. Failure to achieve a large QRS area reduction with CRT is associated with a poor clinical outcome.

Progression of Myocardial Fibrosis in Nonischemic DCM and Association With Mortality and Heart Failure Outcomes

ObjectivesThe purpose of this study was to assess whether the presence and extent of fibrosis changes over time in patients with nonischemic, dilated cardiomyopathy (DCM) receiving optimal medical therapy and the implications of any such changes on left ventricular ejection fraction (LVEF) and clinical outcomes. BackgroundMyocardial fibrosis on cardiovascular magnetic resonance (CMR) imaging has emerged as important risk marker in patients with DCM. MethodsIn total, 85 patients (age 56 ± 15 years, 45% women) with DCM underwent serial CMR (median interval 1.5 years) for assessment of LVEF and fibrosis. The primary outcome was all-cause mortality; the secondary outcome was a composite of heart failure hospitalization, aborted sudden cardiac death, left ventricular (LV) assist device implantation, or heart transplant. ResultsOn CMR-1, fibrosis (median 0.0 [interquartile range: 0% to 2.6%]) of LV mass was noted in 34 (40%) patients. On CMR-2, regression of fibrosis was not seen in any patient. Fibrosis findings were stable in 70 (82%) patients. Fibrosis progression (increase >1.8% of LV mass or new fibrosis) was seen in 15 patients (18%); 46% of these patients had no fibrosis on CMR-1. Although fibrosis progression was on aggregate associated with adverse LV remodeling and decreasing LVEF (40 ± 7% to 34 ± 10%; p < 0.01), in 60% of these cases the change in LVEF was minimal (<5%). Fibrosis progression was associated with increased hazards for all-cause mortality (hazard ratio: 3.4 [95% confidence interval: 1.5 to 7.9]; p < 0.01) and heart failure–related complications (hazard ratio: 3.5 [95% confidence interval: 1.5 to 8.1]; p < 0.01) after adjustment for clinical covariates including LVEF. ConclusionsOnce myocardial replacement fibrosis in DCM is present on CMR, it does not regress in size or resolve over time. Progressive fibrosis is often associated with minimal change in LVEF and identifies a high-risk cohort.

July 2020 at a glance: focus on imaging and cardiomyopathies

Data on epidemiology of cardiomyopathies are limited.1-3 Merlo et al.4 showed a reduction in mortality, heart transplantation, left ventricular (LV) assist device implantation and sudden cardiac death in the last decade, compared with the previous ones, in patients with non-ischaemic dilated cardiomyopathy (DCM). Outcomes were also dependent on specific phenotypes with the poorest in patients with chemotherapy-induced DCM and the best in those with tachycardia-induced DCM. An analysis of the Swedish Heart Failure (HF) Register of the young patients with HF, compared with the others, showed that patients aged <55 years were more likely to have DCM, obesity, congenital heart disease, and a low LV ejection fraction (LVEF). Patients aged <55 years had a five times higher mortality risk compared with control subjects with the highest risk in the youngest ones, 18-34 years old.5 Diabetes is a known risk factor for cardiovascular death in patients with a recent myocardial infarction.6 Shin et al.7 showed the independent prognostic value for HF hospitalizations or cardiovascular death of glycated haemoglobin (A1C) levels (adjusted hazard ratio 1.11, 95% confidence interval 1.01–1.21 per 1% higher A1C) and LVEF in patients with type 2 diabetes and a recent acute coronary syndrome. Cardiac magnetic resonance (CMR) has a major role in the detection and quantification of myocardial fibrosis and adipose tissue, two major determinants of the phenotype and outcomes of patients with HF and preserved ejection fraction (HFpEF).8, 9 Quarta et al.10 review the role of CMR in the management of HFpEF patients. Tayal et al.11 used CMR to evaluate LV reverse remodelling in DCM. Absolute LV contractile reserve by dobutamine stress CMR and female gender predicted LVEF increase over 12 months. Nauta et al.12 retrospectively evaluated the association between LV geometry, clinical and biomarker phenotypes, and therapeutic response in patients with chronic HF. Compared to patients with an eccentric hypertrophy pattern, those with a concentric one had a different clinical and biomarker phenotype and did not benefit from the up-titration of beta-blockers and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Left ventricular ejection time (LVET) was an independent predictor of HF in a community-based cohort studied by echocardiography.13 Patel et al.14 explored its prognostic role in 545 HF outpatients stratified by LVEF. LVET was shorter in HF patients with reduced ejection fraction (HFrEF) vs. those with HFpEF and its longer duration was independently associated with better 1-year outcomes in HFrEF but not in HFpEF patients. Left atrial (LA) structure and function are major determinants of outcomes in patients with HF and atrial fibrillation.15, 16 LA diameter predicted 4-year mortality also in HF patients with mitral regurgitation treated by percutaneous repair.17 Impaired LA strain may contribute to reduced exercise capacity.18 Sugimoto et al.19 showed that a blunted LA strain is associated with lower stroke volume and cardiac output response to exercise and worse outcomes in HF patients. Pulmonary hypertension and right ventricular dysfunction are major prognostic markers in HF and valve disease.20-23 Santiago-Vacas et al.24 assessed the long-term trajectories of systolic pulmonary artery pressure (SPAP), tricuspid annular plane systolic excursion (TAPSE) and TAPSE/SPAP ratio in 1557 HF patients. These parameters were independent determinants of outcomes and increasing SPAP and declining TAPSE and TAPSE/SPAP ratio in the preceding period were associated with higher mortality. Sodium–glucose co-transporter type 2 inhibitors were found to reduce HF events25, 26 and are studied in major clinical trials in HF patients.27-30 A pre-specified analysis from the Dapagliflozin And Prevention of Adverse-outcomes in HF (DAPA-HF) study showed the lack of interaction between LVEF and the beneficial effect of dapagliflozin on outcomes in HFrEF patients.31 Breast cancer therapies can lead to late-onset HF.32 A pro-inflammatory state, detected by biomarker measurements, can cause cardiac dysfunction even 10 years after treatment in breast cancer survivors.33 Heart rate is a major prognostic marker, especially in patients in sinus rhythm.34, 35 Anker et al.36 identified elevated resting heart rate as associated with increased levels of HF biomarkers and poor outcomes in treatment-naïve cancer patients.

Paving a Road Home: Developing Education for a Pediatric Home-Going VAD Program.

The objective was to create a multidisciplinary education plan for discharge home following implantation of a ventricular assist device (VAD) in pediatrics. Educational program was developed for the local community: emergency department, emergency medical services, medical transport team, as well as, the pediatric patient and their caregivers. Education geared to the individual learner included both lecture and hands-on training. A direct line for family and local providers to speak directly with a VAD-trained physician 24/7 was also created. Patient and caregivers required to 1) perform 10 supervised power exchanges; 2) qualify written quizzes on the controller, battery charger, alarms, and troubleshooting; 3) perform 10 supervised dressing changes; 4) pass simulation session responding correctly to alarm scenarios; and 5) take both an on-campus and off-campus field trip unaccompanied by support staff. Once the education plan is complete and the patient is medically stable, they are considered ready for discharge. From a mechanical support perspective, discharge home of a medically complex pediatric patient on a durable VAD can be accomplished safely, even in a low volume center, with attention to detail, creation of a robust education plan, and close partnership between the VAD team, the family, and the community.

Association of Obesity With Adverse Long-term Outcomes in Hypertrophic Cardiomyopathy

Patients with hypertrophic cardiomyopathy (HCM) are prone to body weight increase and obesity. Whether this predisposes these individuals to long-term adverse outcomes is still unresolved. To describe the association of body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) with long-term outcomes in patients with HCM in terms of overall disease progression, heart failure symptoms, and arrhythmias. In this cohort study, retrospective data were analyzed from the ongoing prospective Sarcomeric Human Cardiomyopathy Registry, an international database created by 8 high-volume HCM centers that includes more than 6000 patients who have been observed longitudinally for decades. Records from database inception up to the first quarter of 2018 were analyzed. Patients were divided into 3 groups according to BMI class (normal weight group, <25; preobesity group, 25-30; and obesity group, >30). Patients with 1 or more follow-up visits were included in the analysis. Data were analyzed from April to October 2018. Association of baseline BMI with outcome was assessed. Outcome was measured against overall and cardiovascular mortality, a heart failure outcome (ejection fraction less than 35%, New York Heart Association class III/IV symptoms, cardiac transplant, or assist device implantation), a ventricular arrhythmic outcome (sudden cardiac death, resuscitated cardiac arrest, or appropriate implantable cardioverter-defibrillator therapy), and an overall composite outcome (first occurrence of any component of the ventricular arrhythmic or heart failure composite end point, all-cause mortality, atrial fibrillation, or stroke). Of the 3282 included patients, 2019 (61.5%) were male, and the mean (SD) age at diagnosis was 47 (15) years. These patients were observed for a median (interquartile range) of 6.8 (3.3-13.3) years. There were 962 patients in the normal weight group (29.3%), 1280 patients in the preobesity group (39.0%), and 1040 patients in the obesity group (31.7%). Patients with obesity were more symptomatic (New York Heart Association class of III/IV: normal weight, 87 [9.0%]; preobesity, 138 [10.8%]; obesity, 215 [20.7%]; P < .001) and more often had obstructive physiology (normal weight, 201 [20.9%]; preobesity, 327 [25.5%]; obesity, 337 [32.4%]; P < .001). At follow-up, obesity was independently associated with the HCM-related overall composite outcome (preobesity vs normal weight: hazard ratio [HR], 1.102; 95% CI, 0.920-1.322; P = .29; obesity vs normal weight: HR, 1.634; 95% CI, 1.332-1.919; P < .001) and the heart failure composite outcome (preobesity vs normal weight: HR, 1.192; 95% CI, 0.930-1.1530; P = .20; obesity vs normal weight: HR, 1.885; 95% CI, 1.485-2.393; P < .001) irrespective of age, sex, left atrium diameter, obstruction, and genetic status. Obesity increased the likelihood of atrial fibrillation but not of life-threatening ventricular arrhythmias. Obesity is highly prevalent among patients with HCM and is associated with increased likelihood of obstructive physiology and adverse outcomes. Strategies aimed at preventing obesity and weight increase may play an important role in management and prevention of disease-related complications.

Repeated Echocardiograms Do Not Provide Incremental Prognostic Value to Single Echocardiographic Assessment in Minimally Symptomatic Patients with Chronic Heart Failure: Results of the Bio-SHiFT Study

We aimed to compare the prognostic value of a single "baseline" echocardiogram with repeated echocardiography in stable chronic heart failure (CHF) patients. We hypothesized that repeated echocardiograms would contain incremental prognostic information. In the prospective Bio-SHiFT study, we performed 332 echocardiograms in 106 patients during a median follow-up of 2.3years. The endpoint comprised HF hospitalization, left ventricular (LV) assist device implantation, heart transplantation, and cardiovascular death. We compared hazard ratios (HRs; adjusted for N-terminal pro-brain natriuretic peptide) from Cox models for the first available measurement with HRs from joint models, which model individual trajectories based on the repeated measurements and link these to the time-to-event data. The mean age of the patients was 58.1years; 78.3% were male, 12.6% had New York Heart Association class>II, all had reduced ejection fraction, and the most common HF etiologies were cardiomyopathies (51%) and ischemia (40%). The endpoint occurred in 25 patients. Both the single measurements and the temporal trajectories were significantly associated with the endpoint (adjusted HR Cox model [95% CI] vs adjusted HR joint model [95% CI]): LV ejection fraction, 1.47 (0.93-2.31) vs 1.77 (1.13-2.93); diastolic LV diameter, 1.64 (1.09-2.47) vs 1.68 (1.12-2.57); systolic LV diameter, 1.72 (1.10-2.69) vs 1.68 (1.13-2.63); systolic left atrial diameter, 1.88 (1.18-3.00) vs 2.60 (1.48-4.97); E/A ratio, 2.73 (1.42-5.26) vs 3.87 (1.75-10.13); and E/e' ratio, 2.30 (1.38-3.84) vs 2.99 (1.68-6.19). None of the trajectories from the investigated parameters showed worsening prior to events. Although single baseline or repeatedly measured echocardiographic parameters were associated with the endpoint, all parameters remained on average stable during the 2.3years of follow-up in this largely minimally symptomatic CHF cohort. Thus, regular echocardiographic monitoring of systolic or diastolic LV function within this time frame does not carry incremental prognostic information over a single baseline measurement.

Rapid Fire Abstract Session: News on Hemodynamics and Outcomes in Patients Undergoing Valve Procedure and Assist Device Implantation

Rapid Fire Abstract Session: News on Hemodynamics and Outcomes in Patients Undergoing Valve Procedure and Assist Device Implantation

Impact of Temporary Mechanical Circulatory Support Prior to Implantation of a Ventricular Assist Device with a Follow-Up of 1 Year- A EUROMACS Analysis

Purpose To describe the outcome of VAD implantation with respect to the clinical status and the presence of temporary mechanical circulatory support (tMCS) prior to VAD implantation. Methods We analysed all patients from the EUROMACS database, with 1-year follow-up analysis and included 2571 patients. 2008 patients had no tMCS prior to implantation of a durable device and 995 of those received inotropic support. Out of the 563 patients bridged by tMCS, 310 were supported by intraaortic balloon pump (IABP) and 334 by extracorporeal life support (ECLS), 81 patients were bridge by ECLS+IABP. Results Median age was 56 (IQR 47-62), 17.8% were female, 16.9% were intubated and 8% underwent prior CPR. Patients with tMCS were younger (54 vs.56 years, p=0.001) and had a higher rate of previous cardiac surgery (22.9 vs. 12.4%, p Conclusion Patients with tMCS prior to VAD implantation have a higher one-year mortality compared to patients without MCS. The presence of tMCS prior to implantation of a VAD within the EUROMACS database cohort is an independent predictor of one-year mortality. However other variables such as tricuspid regurgitation, low hemoglobin, low platelet counts and more than 3 inotropes predicted one-year mortality even to a higher extend.

Acute Metabolomic Changes after Implantation of a Left Ventricular Assist Device

Purpose Implantation of a left ventricular assist device (LVAD) is associated with a significant change in cardiac output for patients with severe heart failure. We hypothesized that this abrupt change circulatory flow would be associated with acute metabolic changes related to tissue oxygen delivery. Methods We enrolled 32 patients in a prospective observational cohort study undergoing elective LVAD placement at the University of Colorado from 2013 to 2017 and collected blood immediately before surgery and 24 hours post-operatively and performed clinical follow up for a minimum of 1 year. We performed UHPLC-MS based metabolomics to quantify 24 metabolites with heavy isotope labelled standards and measured an additional 91,413 features with a minimum signal to noise ratio of 3 and minimum relative ion intensity of 1000. We performed the statistical analysis with JMP v14 and for the metabolomics analysis we report false discovery rate corrected p values. Results Subsequent heart transplantation significantly increased survival in patients undergoing elective LVAD placement (Table 1). After surgery, we noted significant changes in patients’ metabolomic profile with glutamate decreasing and kynurenine and leucine/isoleucine increasing. We also identified 6941 out of 91,413 features with an FDR corrected p value less 0.05 that were significantly different between the pre-surgery and post-surgery samples (Figure 1) Conclusion LVAD placement resulted in significant metabolomic changes after 24 hours. Subsequent analyses have the potential to identify metabolomic profiles that predict clinical outcomes or guide therapies.

What Happens to Right Ventricular Strain and Function Following Tricuspid Valve Repair in Patients Undergoing Implantation of a Left Ventricular Assist Device?

Purpose Pre- and post-operative RV function were analyzed by echocardiography, including RV longitudinal strain in 80 patients with moderate or higher pre-implant TR to evaluate the impact of concomitant tricuspid valve repair during LVAD implantation on post-operative RV function. Methods Between 2008 and 2017, 100 patients with moderate (Mod), moderate-severe (M/S), or severe (Sev) TR underwent LVAD implantation at our institution. Forty-four (44) patients had concomitant TV repair (TVR) and 56 did not have TV repair (No-TVR). Preoperative and postoperative clinical, echocardiographic and hemodynamic parameters were recorded in 80 of the patients and included right ventricular (RV) freewall longitudinal strain (FLS) and RV Fractional Area Change (FAC) calculated retrospectively using speckle-tracking echocardiography. Results Preoperatively, 41% of patients in the TVR group and 77% in the No-TVR group had Mod TR (p Conclusion RV strain analysis tracks hemodynamic and echocardiographic parameters and does not add to the assessment of RV function in patients undergoing LVAD implantation with or without TVR. Repairing moderate TV regurgitation at the time of LVAD implantation is not associated with improved outcomes and emphasizes the need for a definitive prospective trial.

Intra-Aortic Balloon Pump Use before Left Ventricular Assist Device Implantation

Purpose To compare outcomes of Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) profile 2 and 3 patients with and without intra-aortic balloon pump (IABP) electively placed before Left Ventricular Assist Device (LVAD) implantation. Methods Data analysis (from 2012 to 2016) of INTERMACS 2 and 3 profiles with pre-LVAD IABP ( creatinine ,TBili, AST, LVEDD, MR ie., severe vs. non severe, RVEF ie., severe vs. non severe, Ischemic vs. non-ischemic and age) with similar non IABP pre-LVAD profiles comparing 30 day composite (mortality, RV failure, renal dysfunction, liver dysfunction) outcome. Results Out of the INTERMACS 2; total 4,233 patients and INTERMACS 3; total 4,170 patients, the presumed elective IABP before LVAD placement was able to be propensity matched for 1003 and 729 patients, respectively. Paired T test was performed to statistically compare the outcomes between the two groups and are shown in table 1. Conclusion There was no significant difference in 30 day outcomes for pre-LVAD IABP compared to those without for the entire cohort (INTERMACS 1 and 2) and for individual cohorts of INTERMACS profiles 1 or 2. The logistic regression analysis (see table 2) also suggests that the highest risk for adverse outcome may be age and ischemic etiology but may not be mitigated by IABP use in any cohort of patients studied.

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.

Evaluation of Outpatient Anticoagulation Bridging after Left Ventricular Assist Device (LVAD) Implantation

Purpose The LVAD is a mechanical circulatory support device that provides hemodynamic support to patients with heart failure. An antithrombotic regimen including warfarin (target international normalized ratio [INR] 2.0-3.0) and aspirin is standard of care following LVAD implantation. The aim of this study is to evaluate the safety of outpatient anticoagulation bridging in the setting of a subtherapeutic INR following LVAD implantation. Methods This study is a retrospective, single-center cohort of adult patients who underwent LVAD implantation (HeartMate II™ or HeartMate 3™). Patients receiving warfarin and at least one dose of therapeutic enoxaparin or fondaparinux for anticoagulation bridging in the outpatient setting between September 1, 2015 and June 30, 2018 were included. The primary endpoint was the incidence of bleeding complications within 1 week of completing the bridging episode. Secondary endpoints included the incidence of new hemolysis or thrombotic events within 30 days, INR at the time of bridge initiation, duration of anticoagulation bridge, and management of bleeding events associated with the bridging episode. Results Data from 160 bridging episodes in 44 patients were analyzed. The majority of patients had implantation of a HeartMate II™ LVAD (93.2%). Enoxaparin was the predominant bridging anticoagulant (97.7%). The primary endpoint occurred during 25 encounters (15.6%) in 14 patients. Of these events, 11 systemic bleeding episodes (6.9%) occurred. Local bleeding complications included injection site bleeding (1.9%), bruising (6.3%), and hematomas (0.6%). The majority of bleeding episodes (81.0%) were self-managed by the patient or with monitoring [INR or bleeding] only. Data analysis of new hemolysis, stroke, and/or thrombosis within 30 days of any bridging episode is ongoing. The mean pre- and post-bridge INRs were 1.63 and 2.58, respectively. The average duration of a bridging episode was 4.6 days (median 3.8). Conclusion Outpatient anticoagulation bridging following LVAD implantation was associated with a modest risk of bleeding complications. The majority of bleeding episodes were localized events treated with self-management only. Results of this study may suggest an overall benefit of bridging during periods of subtherapeutic warfarin therapy following LVAD implantation, pending further data analysis.

Costs Associated with the First Clinical Trial Evaluating the Safety and Efficacy of the Thoracotomy Approach for Implantation of a Small Intrapericardial Centrifugal LVAD

Purpose Less invasive techniques for Left Ventricular Assist Device (LVAD) implantation have been increasingly prevalent over the last years and have been associated with improved clinical outcomes. The procedural economic impact of these techniques remains unknown. We sought to study and report economic outcomes associated with the thoracotomy implantation approach. Methods LATERAL is the first clinical trial evaluating the safety and efficacy of the thoracotomy approach for implantation of a small intrapericardial centrifugal LVAD. UB-04 forms were collected in parallel to the trial, allowing analysis of index hospitalization costs. All charges were converted to costs using hospital specific cost-to-charge ratios and were subsequently compared to Medicare cost data (Instant Health Data, IHD) for the same time period (2015-2016). Since thoracotomy implants were off-label for all LVADs during that period, the Medicare cohort was assumed to predominately consist of traditional sternotomy patients. Several sensitivity analyses were also conducted. Results Thoracotomy patients (N=97) demonstrated decreased costs compared to sternotomy patients (N=2,831) during the index hospitalization. Mean total index hospitalization costs for thoracotomy were $203,939 (±$87,401) vs. $260,492 (±$153,703) for sternotomy (p Conclusion In LATERAL, the first clinical trial evaluating the safety and efficacy of thoracotomy of a small intrapericardial centrifugal LVAD, costs were found to be lower than the ones reported in Medicare patient claims occurring over the same time period. Since Medicare data can be presumed to consist of predominately sternotomy procedures, Thoracotomy appears less expensive than traditional sternotomy.