Women Experience More Late Readmissions Than Men after Left Ventricular Assist Device Implantation

Women Experience More Late Readmissions Than Men after Left Ventricular Assist Device Implantation

The 23rd Annual Scientific Meeting  HFSA Simon Staempfli1, Felix Tanner1, Paul Erne7, Alex McMonnachie2, John G.F. Cleland2; 1Heart Center, Univ. Ho...

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The 23rd Annual Scientific Meeting  HFSA

Simon Staempfli1, Felix Tanner1, Paul Erne7, Alex McMonnachie2, John G.F. Cleland2; 1Heart Center, Univ. Hospital, Zurich, Switzerland; 2Robertson Centre for Biostatistics, Univ. of Glasgow, Glasgow, United Kingdom; 3Heart and Vascular Clinic, Tbilisi, Georgia; 4Amosov National Institute of Cardiovascular Surgery, Kiev, Ukraine; 5Heart Institute, Ministry of Health of Ukraine, Kiev, Ukraine; 6Indiana Univ., Fort Wayne, IN; 7Univ. Svizzera Italiana, Lugano, Switzerland

Table 1. Bridging Strategies

499 In-Hospital Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement in Relation to the Presence of Heart Failure in the United States: An Analysis of the National Inpatient Sample Hardikkumar Patel1, Kevin Buda2, Rutu Patel3; 1Mount Sinai St.Luke’s and Mount Sinai West, New York, NY; 2Hennepin County Medical Center, Minneapolis, MN; 3 AMC MET Medical College, Ahmedabad, India Introduction: Transcatheter aortic valve replacement (TAVR) is an increasingly common method of valve replacement in patients that are not candidates for open heart surgery. As TAVR is reserved for patients with intermediate risk, most patients who undergo TAVR are older. Although comorbid conditions are often present in these patients, there is a dearth of national studies evaluating outcomes in the presence of heart failure. We investigate whether the presence of heart failure impacts hospital utilization and mortality. Methods: The 2016 National Inpatient Sample (NIS) was used to find all patients that underwent TAVR in 2016, comparing those with to those without heart failure (based on ICD10-CM Codes). The codes for chronic systolic and diastolic heart failure were used, in addition to the code for combined systolic and diastolic heart failure to create a subgroup of heart failure patients. The codes for percutaneous endoscopic aortic valve replacement and other non-chronic forms of heart failure were excluded. STATA Version 15.1 (College Station, TX) was used for statistical analysis. Multivariate regression was used to calculate weighted nationwide estimates of hospital mortality, length of stay, and total charge. We adjusted for patient (age, sex, ethnicity, and Charlson Comorbidity Index), socioeconomic (median household income, insurance provider), and hospital factors (hospital bed size, region, teaching status, day and month of admission). Results: A total of 40,005 patients who underwent TAVR in 2016 were identified. Of those, 12,080 had chronic heart failure. There was a significantly decreased length of stay (coefficient -1.97, p=0.000), total hospital cost (coefficient= -20685.16, p=0.000), and mortality (OR: 0.453, p=0.001) in patients with heart failure undergoing TAVR when compared to those without (Table 1). Conclusion: Our study was the first to show decreased total hospital cost, length of stay, and in-hospital mortality among heart failure patients undergoing TAVR compared to those without heart failure. Further studies are required to elucidate the etiology of this difference.

Table 1 Variable

Coefficient/OR Standard Error P value 95% Confidence Interval

Length of Stay -1.97466 Total Hospital Cost -20685.16 Inpatient Mortality 0.453

0.149 5027.915 0.108

0.000 0.000 0.001

S183

-2.268 -1.680 -30545.58 -10824.73 0.2839 0. 7244

500 First in Human VisONE Heart Failure Study: Asymptomatic Diaphragmatic Stimulation for Chronic Heart Failure: One Month Results Michel Zuber1, Robin Young2, Tamaz Shaburishvili3, Kostyantyn Rudenko4, Vitaly Demyanchuk5, Ana Jorbenadze3, Roman Buriak4, Borys Todurov5, Michael Mirro6,

Introduction: Asymptomatic Diaphragmatic Stimulation (ADS) is a novel devicebased HF therapy under investigation. Prior studies have shown that ADS transiently modulates intrathoracic pressure, thereby reducing intra-cardiac pressures and increasing stroke volume. Hypothesis: Chronic ADS therapy using a novel system delivered via a trans-abdominal laparoscopic approach improves heart failure function and exercise tolerance in patients with HFrEF but without ventricular dyssynchrony. Methods: Patients with moderately severe symptoms, LVEF 35% but no evidence of ventricular dyssynchrony underwent laparoscopic implantation of the VisONE ADS system (NCT03484780). Post implant in-clinic tests were conducted to determine the acute effects of ADS on cardiac function at stimulation levels imperceptible to the patient. At discharge, therapy was programmed to chronically deliver ADS. Patients will be followed for 12 months to assess measures of cardiac function, HF status, diaphragmatic function, and standard safety measures. Baseline and one month data are reported as median [IQR]. Results: Fifteen men (60 [56, 67] years, EF 27 [23, 33] %, NYHA class II (53%)/III (47%), 100% sinus rhythm) received implants. Temporary activation of ADS post implant while conscious increased CO (4.8 [4.0, 5.4] vs. 5.7 [4.5, 5.9] l/min, p<0.01, n=14) without change in HR. The time from implant to hospital discharge was 3.3 § 2.4 days. All patients were discharged without therapy-related complications with ADS turned on at a confirmed imperceptible pacing output. At 1 month, 1 SAE (mild) and 3 AEs (1 mild, 1 moderate, 1 severe) were reported on 3 patients; none were device related. Between discharge with ADS off and one month with ADS on, SBP (123 [115, 127] vs. 122 [110, 140] mmHg, p=NS) did not change while heart rate fell (79 [74, 86] vs. 68 [64, 78] bpm, p<0.05). LVEF increased (26 [22, 38] vs. 30 [26, 43] %, p<0.05, n=11), while LVEDVI (183 [175, 221] vs. 193 [174, 225] ml/m2, p=NS, n=11) and NT-proBNP (1020 [858, 2068] vs. 1280 [898, 2001] pg/ml, p=NS) were unchanged but 6MWTD improved (315 [300, 330] vs. 323 [320, 337] m, p< 0.05) and LA Vol tended to decrease (84 [59, 101] vs. 66 [58, 101] ml, p=NS, n=13). Conclusions: These data suggest that the ADS system can be implanted safely with a short in-hospital stay. Acute improvements to cardiac output and key measures of heart failure after 1 month without ADS related events are encouraging. Further investigation of ADS in randomized clinical trials should be considered.

501 Women Experience More Late Readmissions Than Men after Left Ventricular Assist Device Implantation Jessica Quaggin-Smith, Ramsey M. Wehbe, Allen S. Anderson, Kambiz Ghafourian, Ike Okwuosa, Esther Vorovich, Jane Wilcox, Faraz Ahmad, Duc T. Pham, Jonathan D. Rich; Northwestern, Chicago, IL Background: Few studies have evaluated sex differences in LVAD morbidity and mortality, and they have yielded mixed results. A likely explanation is these studies have relied on ‘time to first event’ analysis, which ignores recurrent events that are clinically meaningful and add statistical power. We sought to compare outcomes after LVAD in women vs. men including the burden of hospital readmissions. Methods: We included consecutive adult patients implanted with LVAD at our institution from 2008-2018. We used propensity score matching to match men and women on clinically relevant preoperative characteristics. We used a competing risks regression with cause-specific hazards to compare the risk of death and transplant between men and women. We used a joint frailty model to simultaneously model recurrent hospitalizations and competing terminal events of death, cardiac transplant, and device explant. Results: The overall cohort included 338 patients (77 women, 261 men). After propensity score matching, there were 77 women and 77 men with balanced pre-operative characteristics. There was a non-significant trend towards increased risk of death (HR 1.49, p=0.12) and no significant difference in transplant (HR=0.87, p=.58) in women compared to men. We found a non-significant trend towards increased allcause hospitalization in women (RR=1.30, p=0.12). This was driven by a significantly increased rate of “late” readmissions in women occurring more than 1 year postimplant (RR=2.38, p=0.01; figure 1). When evaluating reasons for hospital admission, women had a non-significant increase in rates of all causes with the exception of uncontrolled hypertension and subtherapeutic INR (figure 2). Women were at significantly higher risk of being admitted for anemia evaluation (RR=3.12, p=0.04). Conclusions: We found a strong trend towards an increase in recurrent all-cause hospitalizations in women vs. men, driven primarily by a significantly higher rate of late readmissions after the first year post implant in women. These findings require further study in a larger cohort and if confirmed, deserve further investigation to better understand the underlying reasons for such disparities in outcomes in women supported by LVADs.

S184 Journal of Cardiac Failure Vol. 25 No. 8S August 2019

Figure 1. Recurrent event plots (A) and mean cumulative function (B) off all-cause hospitalization for men vs women over time.

Medical Center from October 2018 to March 2019. We found two cases that were treated with Cangrelor. Results: First patient had Heart Mate implanted 02/01/ 2017. She had undergone pump exchange for pump thrombosis 03/16/2018. She was not a candidate for further pump exchange or transplant due to socioeconomic issues. She was admitted with elevated LDH of 1400. She was initially started on heparin and integrillin drips with no significant change in LDH for 3 days (1097,1466,1541). There was also ongoing increase in Plasma free hemoglobin (62,82, 107). At this point it was decided to discontinue Integrilin and start Cangrelor. The LDH level started decreasing immediately and was back to baseline level of nearly 600 in 4 days. Free hemoglobin normalized in 5 days. She had no major bleeding complications. She was discharged from the hospital without any major events. Second patient had Heart Mate II implanted January 2017. He had suffered subarachnoid hemorrhage, when treated with heparin and Integrilin drip for elevated LDH. He subsequently underwent LVAD exchange on 8/29/2018. Patient did well for few months after the pump exchange. However, he started having intermittent flash pulmonary edema, power fluctuations and was subsequently hospitalized for transplant evaluation. While admitted he was noted to have elevated LDH to more than 1000 with increase in plasma free hemoglobin. Due to his history of subarachnoid hemorrhage with Integrilin, we chose to use Cangrelor with standard dose heparin drip for treatment of pump thrombosis. He was initially given 4mcgm/kg/min with rapid reduction in LDH and free hemoglobin. He was then maintained on 0.75mcgm/kg/min. This dose was increased to 1.5mcg/kg/min as LDH started to rebound. Patient went on to get heart transplant and did well without any bleeding complications. Conclusions: Cangrelor can be used along with heparin for pump thrombosis. It has been used effectively in decreasing the LDH levels without any major bleeding complications. It may be considered as safe alternative to other modalities of anticoagulation.

503 Moderate Correlation between Central Aortic Pressure and Non-Invasive BP Monitoring in Patients Supported with Left Ventricular Assist Device Therapy Andrew Rosenbaum, Alfredo Clavell, John Stulak, Atta Behfar; Mayo Clinic, Rochester, MN

Figure 2. Forest plot of rate ratios for readmissions for women vs. men derived from joint frailty models.

502 Cangrelor -Safe and Effective Agent for Treating Pump Thrombosis in LVAD Patients Roopa Rao, Eve Anderson, Mark Jones; Indiana University, Indianapolis, IN Background: Pump thrombosis (PT) is a major complication of Left Ventricular Assist Device (LVAD). One of the early markers of PT is elevation in Lactate Dehydrogenase (LDH). Aggressive anti coagulation regimen can sometimes decrease LDH levels and prevent surgical need for pump exchange. Several treatment strategies have been utilized including escalating anti thrombotic therapy. There is minimal data regarding the role of Cangrelor for treatment of PT. Purpose: Cangrelor, which is a novel antiplatelet agent in the treatment of PT. Method: Review of cases of suspected pump thrombosis as evidenced by elevated LDH and Plasma free hemoglobin, who were treated with Cangrelor at University

Background: The present gold standard for non-invasive measurement of blood pressure in patients supported on continuous-flow left ventricular assist device (CF-LVAD) therapy is Doppler sphygmomanometry. However, the relationship with central aortic pressures is unknown. Hypothesis: Non-invasive blood pressure measurements will systematically underestimate central aortic pressures. Methods: We evaluated patients on CF-LVAD therapy undergoing left heart catheterization at our institution between 2015 and 2018 for any indication. We correlated non-invasive mean blood pressure measurements (NIBP-MAP) with catheterderived mean central aortic pressures (Ao-MAP), and attempted to stratify by putative variables. Results: In a cohort of 55 patients with available NIBP data, we found a NIBP-MAP of 81.1 § 12.5 mmHg and an Ao-MAP of 81.3 § 10.8 mmHg. There was a significant albeit moderate correlation between NIBP and AoP (R2 = 0.52, p < 0.0001) with a tendency of NIBP to underestimate Ao-MAP at high and low Ao-MAP values. This association did not vary by pump type (R2 = 0.55 for HM2 and R2 = 0.47 for HW, both with p<0.001). The mean absolute difference between NIBP-MAP and Ao-MAP was 7.4 § 4.8 mmHg, and the range of differences between Ao-MAP and NIBP-MAP values was -20 mmHg to +18 mmHg. A narrower aortic pulse pressure weakened the correlation but narrower pulse pressure on NIBP did not affect the correlation. Disagreement between NIBP-MAP and AoMAP was not affected by age, gender, BMI, aortic valve opening, LVAD type, or speed (p=ns for all). Conclusions: Correlations between NIBP measurements and AoP pressures are moderate but NIBP does not systematically over- or underestimate central pressures. Further work should seek to improve on current methods of measuring blood pressure and determine the role of invasive monitoring for longitudinal management.