Sex difference in the impact of smoking on left ventricular assist device outcomes.

BACKGROUND: Active smoking is associated with worse clinical outcomes following left ventricular assist device (LVAD) implantation. However, the effect of sex differences in conjunction with smoking status remains uninvestigated. METHODS: Consecutive patients who underwent LVAD implantation between January 2013 and September 2018 were included. Clinical outcomes were retrospectively compared between the current smokers and never smokers among male cohorts and female cohorts separately. RESULTS: About 130 patients, with a median age of 56 years, were included. Among the male cohort (N = 85), the current smokers (N = 25/85) had a higher total readmission rate than the never smokers (N = 60/85) with an adjusted incidence rate ratio of 2.38 (95% confidence interval, 1.16-3.85, P = .014), dominantly due to higher rates of gastrointestinal bleeding, stroke, and hemolysis. Among the female cohorts (N = 45), never smokers (N = 36/45) had a statistically comparable total readmission rate (2.80 vs 2.50 events per year; P = .37) compared with current smokers (N = 9/45). CONCLUSION: Among male patients with LVAD, active smoking was associated with higher rates of adverse events. Female patients with LVAD had a high rate of adverse events irrespective of smoking status. Gender-specific therapeutic approaches might be required to prevent LVAD-related comorbidities.

Omega-3 and hemocompatibility-related adverse events.

BACKGROUND: Hemocompatibility-related clinical adverse events (HRAEs) are major causes of readmission in patients with left ventricular assist devices (LVADs). Omega-3 is an unsaturated fatty acid that possesses anti-inflammatory and antiangiogenic properties. We aimed to investigate the impact of omega-3 therapy on HRAEs during LVAD support. METHODS: Consecutive LVAD patients who were followed for 6 months were enrolled, and stratified by the use of omega-3. Freedom from any HRAEs and net burden of HRAEs, which was calculated by using a hemocompatibility score (using 4 escalating tiers of hierarchal severity to derive a total score for events), were compared between those with and without omega-3 therapy. RESULTS: Among 169 LVAD patients (57 years old and 124 males), 31 patients received 4 g/d of omega-3 therapy and 138 patients were in the control group. During the 6-month observational period, freedom from any HRAEs was 90% in the omega-3 group compared with 70% in the control group with a hazard ratio of 0.35 (95% confidence interval 0.11-0.87 and P = .042). The average hemocompatibility score in the omega-3 group was significantly lower compared with the control group (0.23 vs 0.91; P = .042), due to reduced Tier I scores (mild HRAE; P = .003) and Tier IIIB scores (severe HRAE; P < .001). The similar trends remained at propensity-matched populations. CONCLUSIONS: Omega-3 therapy was associated with reduced HRAEs including both bleeding and thromboembolic events in LVAD patients.

Improvement in Biventricular Cardiac Function After Ambulatory Counterpulsation.

BACKGROUND: The NupulseCV intravascular ventricular assist system (iVAS), which consists of a durable pump placed through the subclavian artery, provides extended-duration ambulatory counterpulsation. This study investigated the effect of iVAS on biventricular cardiac function. METHODS AND RESULTS: We reviewed all heart failure patients who received iVAS implantation as a bridge to transplantation or a bridge to candidacy since April 2016 as part of the iVAS first-in-humans and subsequent feasibility study. We compared data of transthoracic echocardiography performed just before implantation (without iVAS support) and again at 30 days or just before explantation (on iVAS support). Eighteen patients (58.8 ± 7.4 years old and 15 male) received iVAS support for 53 ± 43 days. Fourteen patients were bridged to cardiac replacement therapy after 35 ± 19 days and the remaining 4 patients had been supported for 118 ± 41 days. There were no deaths during iVAS support. At 30 days, there was a significant improvement in left ventricular ejection fraction (16.5% ± 11.9% vs 24.4% ± 12.8%; P = .007) and marked reduction in left atrial size (62.7 ± 35.7 mL/m2 vs 33.8 ± 17.2 mL/m2; P < .001). Right ventricular fractional area change improved dramatically (25.4% ± 12.9% vs 42.1% ± 12.4%; P < .001). All other right ventricular and right atrial parameters improved significantly as well (size, tricuspid annular plane systolic excursion, and velocity of tricuspid annular systolic motion). CONCLUSIONS: Improvement in biventricular cardiac function was observed after 30 days of iVAS support. Further studies should examine the use of this technology as a bridge to recovery.

Aortic Insufficiency and Hemocompatibility-related Adverse Events in Patients with Left Ventricular Assist Devices.

AIM: Hemocompatibility-related adverse events (HRAE) are a major cause of readmissions in patients with left ventricular assist devices (LVAD). The impact of aortic insufficiency (AI) on HRAE remains uncertain. We aimed to investigate the impact of AI on HRAE. METHODS AND RESULTS: Patients who underwent LVAD implantation between August 2014 and July 2017 and had echocardiograms 3 months post-LVAD implantation were enrolled. AI severity was assessed by measuring the systolic/diastolic ratio of flow and the rate of diastolic flow acceleration using Doppler echocardiography of the outflow cannula. Regurgitation fraction was derived from these parameters. Significant AI was defined as regurgitation fraction > 30%. Among 105 patients (median age, 56 years; 76% male), 36 patients (34%) had significant AI. Baseline characteristics were statistically not significantly different between those with and without significant AI except for higher rates of ischemic etiology and atrial fibrillation in the significant AI group (P < 0.05 for both). One-year survival free from HRAE was 44% in patients with AI compared to 67% in patients without significant AI (P = 0.018). The average hemocompatibility score, which defines the net burden of HRAE, was higher in the AI group (1.72 vs 0.64; P = 0.009), due mostly to higher tier I (mild HRAE; P = 0.034) and tier IIIB scores (severe HRAE; P = 0.011). CONCLUSION: Significant AI, as assessed by Doppler echocardiographic parameters, was associated with HRAE during LVAD support.

Laparoscopic procedures in patients with cardiac ventricular assist devices.

BACKGROUND: Cardiac left ventricular assist device (LVAD) placement is a common therapy for heart failure. Non-cardiac surgical care of these patients can be complex given the need for anticoagulation, perioperative monitoring, comorbidities, and anatomical considerations due to the device itself. There are no guidelines or significant patient series reported to date for laparoscopic procedures in this population. We herein report the techniques and outcomes for commonly performed laparoscopic procedures in patients with LVADs at a high volume center. METHODS: From our database of patients with ventricular assist devices, we retrospectively identified patients who underwent laparoscopic abdominal surgery. Intraoperative and perioperative data were collected, including anticoagulation management, transfusions and complications. Techniques and preoperative considerations from the surgeons were also compiled and described. RESULTS: Of 374 patients that had placement of LVADs, 17 had an elective laparoscopic procedure: enteral access placement (n = 7), cholecystectomy (n = 6), hernia repair (n = 2), small bowel resection (n = 1) and splenectomy (n = 1). Preoperative evaluation routinely included radiologic imaging to evaluate driveline location. The most common abdominal entry technique was a periumbilical open Hasson technique (11/17). No cases were converted to open. Overall, the average blood loss was 132 ± 64 mL and the average operative time was 1.8 ± 0.3 h. Five of the 17 patients required intraoperative blood transfusion. No patients suffered perioperative thrombotic events or LVAD complications secondary to holding anticoagulation. No patients required interventions or reoperation for bleeding complications. There were no mortalities related to these procedures. CONCLUSIONS: Laparoscopic abdominal procedures are safe and feasible in patients with LVADs. Although special consideration for bleeding and thrombotic risks, placement of ports and perioperative management is required, the presence of a LVAD itself should not be considered a contraindication for laparoscopic surgery and may in fact be the preferred method for access in these patients.

Long-Acting Octreotide Reduces the Recurrence of Gastrointestinal Bleeding in Patients With a Continuous-Flow Left Ventricular Assist Device.

BACKGROUND: Recurrent gastrointestinal bleeding is one of the most significant adverse events in patients with left ventricular assist devices (LVADs). METHODS: We enrolled LVAD patients who had received an intramuscular injection of 20 mg octreotide every 4 weeks as secondary prevention for recurrent gastrointestinal bleeding despite conventional medical therapies and repeated transfusions. The frequency of gastrointestinal bleeding and other associated clinical outcomes before and during octreotide therapy were compared. RESULTS: Thirty LVAD patients (66.4 ± 8.8 years old, 16 men [53%]) received octreotide therapy for 498.8 ± 356.0 days without any octreotide-associated adverse events. The frequency of gastrointestinal bleeding was decreased significantly during octreotide therapy (from 3.4 ± 3.1 to 0.7 ± 1.3 events/year; P < .001), accompanied by significant reductions in red blood cell and flesh frozen plasma transfusions, days in hospital, and need for endoscopic procedures (P < .05 for all). CONCLUSIONS: Octreotide therapy reduced the frequency of recurrent gastrointestinal bleeding and may be considered for secondary prevention.

Decoupling Between Diastolic Pulmonary Arterial Pressure and Pulmonary Arterial Wedge Pressure at Incremental Left Ventricular Assist Device (LVAD) Speeds Is Associated With Worse Prognosis After LVAD Implantation.

BACKGROUND: Decoupling between diastolic pulmonary arterial pressure (dPAP) and pulmonary arterial wedge pressure (PAWP) is an index of pulmonary vasculature remodeling and provides prognostic information. Furthermore, decoupling may change during incremental left ventricular assist device (LVAD) speed changes. METHODS AND RESULTS: In this prospective study, patients underwent an echocardiographic and hemodynamic ramp test after LVAD implantation and were followed for 1 year. The change in decoupling (dPAP - PAWP) between the lowest and highest LVAD speeds during the ramp test was calculated. Survival and heart failure admission rates were assessed by means of Kaplan-Meier analysis. Eighty-seven patients were enrolled in the study: 54 had a Heartmate II LVAD (60.8 ± 9.3 years of age and 34 male) and 33 had an HVAD LVAD (58.6 ± 13.2 years of age and 20 male). Patients who experienced greater changes in decoupling (Δdecoupling >3 mm Hg) had a persistently elevated dPAP at incremental LVAD speed and had worse 1-year heart failure readmission-free survival compared with the group without significant changes in the degree of decoupling (41% vs 75%; P = .001). CONCLUSIONS: An increase in decoupling between dPAP and PAWP at incremental LVAD speed changes was associated with worse prognosis in LVAD patients.

Cannula and Pump Positions Are Associated With Left Ventricular Unloading and Clinical Outcome in Patients With HeartWare Left Ventricular Assist Device.

BACKGROUND: Cannula and pump positions are associated with clinical outcomes such as device thrombosis in patients with HeartMate II; however, clinical implications of HVAD (HeartWare International, Framingham, Massachusetts) cannula position are unknown. This study aims to assess the relationship among cannula position, left ventricular (LV) unloading, and patient prognosis. METHODS AND RESULTS: Twenty-seven HVAD patients (60.0 ± 12.6 years of age and 19 males [70%]) underwent ramp test. Device position was quantified from chest X-ray parameters obtained at the time of the hemodyamic ramp test: (1) cannula coronal angle, (2) pump depth, (3) cannula sagittal angle, and (4) pump area. Lower cannula coronal angle was associated with LV unloading (as measured by smaller LV diastolic dimension and lower pulmonary capillary wedge pressure). Smaller pump area was associated with LV dynamic unloading, as assessed by steeper negative slopes of LV diastolic dimension and pulmonary capillary wedge pressure during incremental rotational speed change. Cannula coronal angle ≤65° was associated with reduced heart failure readmission rate (hazard ratio, 10.33; P = .007 by log-rank test). CONCLUSION: HVAD cannula and pump positions are associated with LV unloading and improved clinical outcomes. Prospective studies evaluating surgical techniques to ensure optimal device positioning and its effects on clinical outcomes are warranted.

Combined Left Ventricular Assist Device and Coronary Artery Bypass Grafting Surgery: Should We Bypass the Bypass?

Left ventricular assist devices (LVADs) have become a mainstay of therapy for advanced heart failure. Although selected patients undergo concomitant coronary artery bypass grafting (CABG) at the time of LVAD implantation, the detailed implication of this combined surgical approach is not yet well studied. In this study, all ischemic cardiomyopathy patients who underwent concomitant CABG during LVAD implantation between 2010 and 2016 were enrolled. A control group matching for age, gender, and device type, were selected. Of 79 LVAD patients finally included, 28 patients underwent concomitant CABG (CABG group); whereas 51 did not (non-CABG group). There was no difference in the baseline characteristics between groups. There was a trend toward longer cardiopulmonary bypass time in the CABG group (169 vs. 147 min; p = 0.09). One month survival in the CABG group was significantly lower than the non-CABG group (75.0% vs. 94.1%; p = 0.014). No difference in the occurrence of ventricular arrhythmias was detected between the groups, nor was there a difference in the incidence or severity of right ventricular failure. Concomitant CABG surgery during LVAD implantation may carry significant perioperative mortality, and addition of CABG to LVAD surgery may be performed only in strictly selected cases.

Estimation of Central Venous Pressure by Pacemaker Lead Impedances in Left Ventricular Assist Device Patients.

Volume status assessment in left ventricular assist device (LVAD) patients remains challenging. Cardiac resynchronization therapy (CRT) devices are common in LVAD patients, and the impedance across the CRT leads may be associated with hemodynamics and serve as a tool for noninvasive estimation of volume status. Ninety-one sets of measurements including cardiac filling pressures and lead impedances were prospectively obtained during ramp tests from 11 LVAD patients (65.5 ± 9.7 years old; nine male) with CRT devices. Right atrial (RA), right ventricular (RV), and left ventricular (LV) lead impedances were all significantly associated with central venous pressure (CVP) (p < 0.05). We derived the following equation: estimated CVP = 47.90-(0.086 × RA lead impedance) + (0.013 × RV lead impedance)-(0.020 × LV lead impedance). The estimated CVP had a significant correlation (r = 0.795) and good agreement with the measured CVP (mean difference -0.14 ± 1.77 mmHg). Applying the above equation on the validation cohort of twenty-one patients also maintained a strong association with measured CVP (r = 0.705). In conclusion, we have derived a novel equation to estimate CVP using lead impedance measurements. This finding may allow noninvasive monitoring of volume status in LVAD patients.

HeartWare Ventricular Assist Device Cannula Position and Hemocompatibility-Related Adverse Events.

BACKGROUND: HeartWare ventricular assist device (HVAD) cannula position is associated with hemodynamics and heart failure readmissions. However, its impact on hemocompatibility-related adverse events (HRAEs) remains uncertain. METHODS: HVAD patients were followed for 1 year after index hospitalization, when cannula coronal angle was quantified from chest x-ray film. Invasive right heart catheterization and transthoracic echocardiography were performed. One-year occurrences of each HRAE were compared between those with and without a cannula coronal angle of greater than 65 degrees. RESULTS: Among 63 HVAD patients (median age 60 years, 63% male), 10 (16%) had a cannula coronal angle greater than 65 degrees. The wide-angle group had elevated intracardiac pressures and lower pulmonary artery pulsatility index (P < .05). They also had reduced right ventricular function by echocardiography. Freedom from HRAEs tended to be lower in the wide-angle group (24% vs 62%; P = .11). The rate of gastrointestinal bleeding was significantly higher in the greater than 65 degrees group (0.90 events/year vs 0.40 events/year; P = .013). The rates of stroke and pump thrombosis were statistically comparable irrespective of cannula angle (P > .05). CONCLUSIONS: HVAD cannula coronal angle was associated with reduced right ventricular function and HRAEs. Prospective studies evaluating surgical techniques to ensure optimal device positioning and its effects on HRAEs are warranted.

Effect of Concomitant Tricuspid Valve Surgery With Left Ventricular Assist Device Implantation.

BACKGROUND: Tricuspid regurgitation (TR) is common in advanced heart failure (HF) patients. However, the effect of concomitant tricuspid valve repair or replacement (tricuspid valve intervention [TVI]) with left ventricular assist device (LVAD) implantation is controversial. The aim of this study was to investigate the longitudinal trend of TR after LVAD implantation and the effect of TVI on the TR trend and clinical outcomes. METHODS: We retrospectively reviewed patients at our institution who underwent LVAD implantation between April 2014 and August 2018. We evaluated the grade of TR by echocardiography before and after LVAD implantation. Moderate or greater TR was defined as significant. RESULTS: Among 199 consecutive patients, 194 had at least 2 echocardiographic TR assessments before and after LVAD implantation. Of these patients, 108 were included in the TVI-positive (TVI+) group and 86 in the TVI-negative (TVI-) group. In the TVI+ group, the prevalence of significant TR decreased from 52% to about 20% in the first 6 months after implantation (P < .01). Overall survival and HF readmission-free survival were comparable between the TVI+ and TVI- patients. In contrast, patients in both groups who had significant postoperative TR during early follow-up had worse 2-year HF readmission-free survival (36% in patients with significant postoperative TR vs 55% in those without significant postoperative TR; P = .028). CONCLUSIONS: Concomitant TVI with LVAD implantation improved TR in most patients but did not have an impact on clinical outcomes. Significant postoperative TR after LVAD implantation, in patients with and without TVI, was associated with worse HF-free outcomes.

Decoupling Between Diastolic Pulmonary Artery and Pulmonary Capillary Wedge Pressures Is Associated With Right Ventricular Dysfunction and Hemocompatibility-Related Adverse Events in Patients With Left Ventricular Assist Devices.

Background Decoupling between diastolic pulmonary artery pressure and pulmonary capillary wedge pressure is an index of pulmonary vascular damage. This study assessed the impact of decoupling on right heart function and hemocompatibility-related adverse events. Methods and Results In this prospective study, patients underwent invasive hemodynamic tests following left ventricular assist device implantation. Decoupling was defined as a difference of >5 mm Hg between diastolic pulmonary artery pressure and pulmonary capillary wedge pressure. Among 92 patients with left ventricular assist devices (median age, 61 years; 57% male), 44 patients (48%) had decoupling. Right heart function and size by echocardiographic assessment worsened during a 1-year observational period in the decoupling group as compared with the control group (P<0.05). The decoupling group had significantly lower 1-year freedom from any hemocompatibility-related adverse events (49% versus 79%; P=0.005), as well as a higher hemocompatibility score (2.14 versus 0.67; P=0.004). The scoring system depicts the severity of hemocompatibility-related adverse events using 4 escalating tiers. Increased tier I scores (1-2 gastrointestinal bleedings or medically managed pump thrombosis; P=0.027) and tier IIIB scores (disabling stroke or hemocompatibility-related adverse event-related death; P=0.041) occurred more frequently in the decoupling group. Conclusions The presence of decoupling between diastolic pulmonary artery pressure and pulmonary capillary wedge pressure was associated with worsening of right heart function and hemocompatibility-related adverse events in patients with left ventricular assist devices.

Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial.

BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery. METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial. RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support. CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.

Optimal haemodynamics during left ventricular assist device support are associated with reduced haemocompatibility-related adverse events.

AIMS: Left ventricular assist device (LVAD) therapy improves the haemodynamics of advanced heart failure patients. However, it is unknown whether haemodynamic optimization improves haemocompatibility-related adverse events (HRAEs). This study aimed to assess HRAEs in patients with optimized haemodynamics. METHODS AND RESULTS: Eighty-three outpatients [aged 61 (53-67) years, 50 male] underwent a haemodynamic ramp test at 253 (95-652) days after LVAD implantation, and 51 (61%) had optimized haemodynamics (defined as central venous pressure < 12 mmHg, pulmonary artery wedge pressure < 18 mmHg, cardiac index > 2.2 L/min/m2 ) following LVAD speed adjustment. One-year survival free of any HRAEs (non-surgical bleeding, thromboembolic event, pump thrombosis, or neurological event) was achieved in 75% of the optimized group and in 44% of the non-optimized group (hazard ratio 0.36, 95% confidence interval 0.18-0.73, P = 0.003). The net haemocompatibility score, using four escalating tiers of hierarchal severity to derive a total score for events, was significantly lower in the optimized group than the non-optimized group (1.02 vs. 2.00 points/patient; incidence rate ratio 0.51, 95% confidence interval 0.29-0.90, P = 0.021). CONCLUSION: Left ventricular assist device patients in whom haemodynamics can be optimized had greater freedom from HRAEs compared to those without optimized haemodynamics.

Association of Inflow Cannula Position with Left Ventricular Unloading and Clinical Outcomes in Patients with HeartMate II Left Ventricular Assist Device.

The relationship between the HeartMate II left ventricular assist device (LVAD) position and pump thrombosis has been reported. However, further clinical implications of device position are unknown. This study aimed to investigate optimal device position for better left ventricular (LV) unloading and patient prognosis. Patients undergoing a ramp test with right heart catheterization after HeartMate II LVAD implantation were enrolled to this study. Device position was quantified from the chest X-ray obtained at the time of the ramp test: (1) inflow cannula angle relative to horizontal line, (2) pump angle relative to spine, (3) pump depth, (4) angle between inflow cannula and pump, and (5) angle between pump and outflow graft. LV unloading was assessed by pulmonary capillary wedge pressure at set LVAD speed. Fifty-four patients (60 years old and 34 male [63%]) were enrolled. Nobody experienced device malfunction during the study period. Increased LV unloading (i.e., lower pulmonary capillary wedge pressure) was associated with a narrower inflow cannula angle relative to horizontal line. Inflow cannula angle <75° was associated with higher 1 year heart failure readmission-free survival rate (p < 0.05, hazards ratio 7.56 [95% confidence interval 2.32-24.7]). In conclusion, HeartMate II LVAD inflow cannula position was associated with LV unloading and patient prognosis. Prospective studies to ensure optimal device positioning and target better clinical outcomes are warranted.

Optimal Hemodynamics During Left Ventricular Assist Device Support Are Associated With Reduced Readmission Rates.

BACKGROUND: Left ventricular assist device (LVAD) therapy improves the hemodynamics of advanced heart failure patients. However, it is unknown whether hemodynamic optimization improves clinical outcomes. The aim of this study was to investigate whether hemodynamic optimization reduces hospital readmission rate in LVAD patients. METHODS AND RESULTS: LVAD patients undergoing an invasive hemodynamic ramp test were prospectively enrolled and followed for 1 year. LVAD speed was optimized using a ramp test, targeting the following goals: central venous pressure <12 mm Hg, pulmonary capillary wedge pressure <18 mm Hg, and cardiac index >2.2 L/(min·m2). The frequency and cause of hospital readmissions were compared between patients who achieved (optimized group) or did not achieve (nonoptimized group) these goals. Eighty-eight outpatients (median 61 years old, 53 male) underwent ramp testing 236 days after LVAD implantation, and 54 (61%) had optimized hemodynamics after LVAD speed adjustment. One-year survival after the ramp study was comparable in both groups (89% versus 88%). The total hospital readmission rate was lower in the optimized group compared with the nonoptimized group (1.15 versus 2.86 events/y, P<0.001). This result was predominantly because of a reduction in the heart failure readmission rate in the optimized group (0.08 versus 0.71 events/y, P=0.016). CONCLUSIONS: LVAD patients, in whom hemodynamics were optimized, had a significantly lower rate of hospital readmissions, primarily because of fewer heart failure admissions. These findings highlight the importance of achieving hemodynamic optimization in LVAD patients.

Increased Risk of Bleeding in Left Ventricular Assist Device Patients Treated with Enoxaparin as Bridge to Therapeutic International Normalized Ratio.

Anticoagulation therapy is used to prevent thromboembolic events in patients with left ventricular assist devices (LVADs). This study aims to determine the safety of low molecular weight heparin (enoxaparin) for bridging subtherapeutic international normalized ratio (INR) in LVAD patients. In this retrospective single-center study, all patients who underwent LVAD implantation were examined between January 1, 2013, and December 31, 2014. Patients were divided into two groups: enoxaparin bridge and no bridge, with identification of major bleeding episodes (MBEs) and thrombotic events (TEs). Major bleeding episode and TE incidence was compared between the two groups, with subanalysis of incidence in the enoxaparin group between the periods on and off treatment. One hundred eighteen patients were included in this analysis. Fifty-five patients received enoxaparin, whereas 63 patients did not receive enoxaparin, with no significant difference between groups in all baseline characteristics. For the study period, enoxaparin patients had no increased incidence of MBEs (0.53 vs. 0.35 MBE per year; p = 0.12). However, there was a fourfold increase in MBEs during the bridged period in the enoxaparin group (2.02 vs. 0.45 MBE per year; p = 0.03). Major bleeding episodes on versus off enoxaparin had no major difference in transfusion requirements (2.7 ± 2.9 vs. 2.5 ± 3.4 units; p = 0.57) or mortality (p = 0.11). The enoxaparin group trended to a higher incidence of TEs (0.20 vs. 0.11 events per year; p = 0.08). Enoxaparin bridging in patients with subtherapeutic INR is associated with a significantly increased risk of MBEs. Prospective studies are needed to confirm these findings; however, until then, caution should be used with enoxaparin for bridging in LVAD patients.

Analysis of Patients with Ventricular Assist Devices Presenting to an Urban Emergency Department.

INTRODUCTION: Left ventricular assist device (LVAD) insertion is an increasingly common intervention for patients with advanced heart failure; however, published literature on the emergency department (ED) presentation of this population is limited. The objective of this study was to characterize ED presentations of patients with LVADs with a focus on device-specific complications to inform provider education and preparation initiatives. METHODS: This was a retrospective chart review of all patients with LVADs followed at an urban academic medical center presenting to the ED over a five-year period (July 1, 2009, to June 30, 2014). Two abstractors reviewed 45 randomly selected charts to standardize the abstraction process and establish a priori categories for reason for presentation to the ED. Remaining charts were then divided evenly for review by one of the two abstractors. Primary outcomes for this study were (1) frequency of and (2) reason for presentation to the ED by patients with LVADs. RESULTS: Of 349 patients with LVADs identified, 143 (41.0%) had ED encounters during the study period. There were 620 total ED encounters, (range 1 to 32 encounters per patient, median=3, standard deviation=5.3). Among the encounters, 431 (69.5%) resulted in admission. The most common reasons for presentation were bleeding (e.g., gastrointestinal, epistaxis) (182, 29.4%); infection (127, 20.5%); heart failure exacerbation (68, 11.0%); pain (56, 9.0%); other (45, 7.3%); and arrhythmias (40, 6.5%). Fifty-two encounters (8.4%) were device-specific; these patients frequently presented with abnormal device readings (37, 6.0%). Interventions for device-specific presentations included anticoagulation regimen adjustment (16/52, 30.8%), pump exchange (9, 17.3%), and hardware repair (6, 11.5%). Pump thrombosis occurred in 23 cases (3.7% of all encounters). No patients required cardiopulmonary resuscitation or died in the ED. CONCLUSION: This is the largest study known to the investigators to report the rate of ED presentations of patients with LVADs and provide analysis of device-specific presentations. In patients who do have device-specific ED presentations, pump thrombosis is a common diagnosis and can present without device alarms. Specialized LVAD education and preparation initiatives for ED providers should emphasize the recognition and management of the most common and critical conditions for this patient population, which have been identified in this study as bleeding, infection, heart failure, and pump thrombosis.

Predictors of Hemodynamic Improvement and Stabilization Following Intraaortic Balloon Pump Implantation in Patients With Advanced Heart Failure.

OBJECTIVES: The intraaortic balloon pump (IABP) is currently an essential tool to improve hemodynamics in patients with advanced heart failure (HF). This study investigated predictors for hemodynamic improvement or stabilization with IABP therapy in patients with advanced HF. METHODS: Patients with advanced HF and hemodynamic deterioration treated with IABP were enrolled in this retrospective study. Invasive hemodynamics were measured before IABP implantation and 2 weeks after IABP initiation. Significant degree of hemodynamic improvement was defined as 30% improvement in all three of the following variables: central venous pressure (CVP); pulmonary capillary wedge pressure (PCWP); and cardiac index (CI). Hemodynamic stabilization was counted in patients reaching CVP <12 mm Hg, PCWP <18 mm Hg, and CI >2.0 L/min/m² or CI >2.2 L/min/m² on inotropes. RESULTS: Ninety-one patients (55 ± 12 years; 78% males) were evaluated. Seventeen patients (18.7%) achieved significant hemodynamic improvement, and baseline CVP >16 mm Hg was associated with this endpoint (P<.05). Thirty-two patients (35.2%) achieved hemodynamic stabilization; lower baseline heart rate (HR) and PCWP were associated with this stabilization (P<.05). Patients with HR <92 beats/min and PCWP <25 mm Hg achieved hemodynamic stabilization more frequently than those without HR <92 beats/min and PCWP <25 mm Hg (66.7% vs 19.7%; P<.05). CONCLUSION: Elevated CVP and lower HR and PCWP before IABP initiation help predict high response to IABP.