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OBJECTIVES - The present report describes the authors' initial experience with implantation of the Heartware left ventricular assist devices (HeartWare Inc., Framingham, MA). via a minimally invasive surgical approach without cardiopulmonary bypass. A detailed overview of the anesthesiologist's role during the procedure, characteristics of the patient population, and short-term clinical outcomes are provided, and the clinical considerations that influence the decision to implant this device via an off-pump minimally invasive approach are outlined.
DESIGN - Retrospective medical record review.
SETTING - University hospital.
PARTICIPANTS - Thirteen patients with advanced heart failure deemed candidates for off-pump minimally invasive left ventricular Heartware implantation as a bridge to heart transplantation.
INTERVENTIONS - The Heartware left ventricular assist device was implanted in all 13 patients via a minimally invasive approach.
MEASUREMENTS AND MAIN RESULTS - One patient required unplanned cardiopulmonary bypass to control bleeding around the left ventricular outflow cannula. The average operating room time was 249.8 minutes±46.2 minutes. Six of 13 patients required no intraoperative red blood cell transfusions. Seven patients were extubated within 12 hours after surgery. Two patients required reintubation within 48 hours. No patients required reoperation for bleeding. Average intensive care unit and hospital lengths of stay were 7.2±3.9 days and 13.4±3.6 days, respectively. There were no in-hospital deaths.
CONCLUSIONS - Minimally invasive off-pump left ventricular Heartware implantation is an emerging alternative to placement by midline sternotomy. The authors speculate, based on their limited experience, that an off-pump thoracic strategy may be a desirable option for some patients and that clinical outcomes may be non-inferior to placement by midline sternotomy with cardiopulmonary bypass.
Copyright © 2015 Elsevier Inc. All rights reserved.
All patients supported with continuous flow-left ventricular assist devices (CF-LVADs) develop acquired von Willebrand syndrome due to the loss of von Willebrand factor (vWF) high molecular weight (HMW) multimers and this phenomenon has been associated with clinical manifestation of bleeding diatheses. The precise timing of postoperative recovery of HMW multimers and correction of this condition after CF-LVAD explantation and heart transplantation is unknown. We sought to determine the specific timing of HMW multimer recovery by serially quantifying plasma vWF multimer ratios after CF-LVAD explant and orthotopic heart transplantation (OHT) in a patient implanted with a HeartWare ventricular assist device. Using densitometric analysis of multimer patterns, we demonstrated complete recovery of HMW multimers within the first few hours following CF-LVAD explant and OHT. These findings have critical implications in the context of perioperative bleeding diatheses in patients bridged to transplantation with a CF-LVAD.
BACKGROUND - The HeartWare (HW) (Framingham, MA) and the HeartMate II (HM II) (Thoratec Inc, Pleasanton, CA) continuous-flow left ventricular assist devices (CF-LVADs) are commonly used to bridge patients to transplantation. We hypothesized that there are differences in perioperative blood product (BP) use and chest tube (CT) output between CF-LVAD types.
METHODS - We retrospectively evaluated BP use in 71 patients who were implanted with a CF-LVAD (HM II = 38; HW = 33) by median sternotomy for bridge to transplantation (BTT) indications from 2009 to 2013. Detailed BP use data were collected during the intraoperative and postoperative periods and included packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate.
RESULTS - Preoperative characteristics (age, left ventricular ejection fraction, previous sternotomy, ischemic cause), and risk stratification scores (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS]) profile, Leitz-Miller score, Kormos score) were comparable between groups (all p > 0.05). Total average intraoperative and postoperative BP use was different between device types: HW = 8.3 ± 13 versus HM II = 12.6 ± 14.0 units (p = 0.002) and HW = 6.1 ± 12.0 units compared with HM II = 13.5 ± 24.1 units (p = 0.022), respectively. Average postoperative CT output for HW (3,231 ± 3,648 mL) and HM II (3,463 ± 3,050) (p < 0.008) were different between device types. Multivariate analysis revealed that a higher preoperative Leitz-Miller score, implantation of an HM II CF-LVAD, previous sternotomy, and a longer duration of cardiopulmonary bypass (CPB) time were independently associated with increased need for BP use, whereas only use of the HM II device and a longer bypass time predicted a greater CT output.
CONCLUSIONS - Compared with HM II, implantation of the HW CF-LVAD was associated with reduced intraoperative and postoperative BP use and decreased CT output. Increased awareness of device-related differences in bleeding and BP use may improve CF-LVAD patient outcomes.
Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
BACKGROUND - Renal insufficiency is common in status 1B patients supported with inotropes or a continuous flow left ventricular device (CF-LVAD) as a bridge to heart transplantation. We evaluated the association of renal function and inotrope versus CF-LVAD support on posttransplant graft survival in status 1B patients.
METHODS - The Scientific Registry for Transplant Recipients database was analyzed for posttransplant survival in status 1B patients bridged with inotropes or CF-LVAD who underwent transplantation between 2003 and 2012. Pretransplant renal function was measured by estimating glomerular filtration rate (GFR) and was stratified as less than 45 mL · min(-1) · 1.73 m(-2), 45 to 59, and 60 or greater. Univariate Kaplan-Meier and multivariate Cox regression models were used to evaluate the main effects of GFR strata and inotropes versus CF-LVAD, and the interaction effect of GFR strata by CF-LVAD, on graft survival.
RESULTS - This study included 4,158 status 1B patients (74% male, aged 53 ± 12 years). Of those, 659 patients had a CF-LVAD (HeartMate-II [Thoratec, Pleasanton, CA], n = 638; HVAD [HeartWare, Framingham, MA], n = 21), and 3,530 were receiving inotropes (31 CF-LVAD patients were also receiving inotropes). Kaplan-Meier analyses demonstrated reduced graft survival (p = 0.022) in patients with pretransplant GFR less than 45 versus GFR 45 to 59 (p = 0.062) and versus GFR 60 or greater (p = 0.007), and no effect of inotrope versus CF-LVAD support on graft survival (p = 0.402). Multivariate analysis demonstrated that, after adjusting for the main effects of GFR stratum, CF-LVAD, and inotropes, status 1B patients bridged with a CF-LVAD and GFR in the lowest stratum had reduced graft survival (interaction effect p = 0.040).
CONCLUSIONS - Pretransplant renal insufficiency was associated with reduced posttransplant graft survival in status 1B patients. This risk is increased for patients bridged with a CF-LVAD (versus inotropes) who have GFR in the lowest stratum.
Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
BACKGROUND - Peripherally inserted central catheters (PICCs) are used to deliver continuous intravenous (IV) milrinone in stage D heart failure (HF) patients awaiting heart transplantation (HT).
METHODS - We retrospectively analyzed PICC adverse events (AEs) and associated cost in 129 status 1B patients from 2005 to 2012. End points were HT, left ventricular assist device (LVAD), and death. Regression analysis was used to identify AE risk factors.
RESULTS - Fifty-three PICC AEs occurred in 35 patients (27%), consisting of 48 infections, 4 thromboses, and 1 bleeding event. Median duration of PICC support was 63 (interquartile range [IQR] 34-131) days, and median time to first PICC infection was 44 (IQR 14-76) days. Among PICC infections, 9% required defibrillator removal and 30% were inactivated on the HT list for a mean of 23 ± 17 days. Rate of HT, LVAD, or death was similar between groups (P > .05). Regression analysis found that a double lumen PICC was associated with a shorter time to first PICC infection (hazard ratio 7.59, 95% CI 1.97-29.23; P = .003). Median cost per PICC infection was $10,704 (IQR $7,401-$26,083).
CONCLUSIONS - PICC infections were the most frequent AEs. PICCs with >1 lumen were associated with increased risk of infection. PICC AEs accounted for increased intensive care unit admissions, HT list inactivations, and overall cost.
Copyright © 2014 Elsevier Inc. All rights reserved.
BACKGROUND - There are increasing numbers of patients undergoing orthotopic heart transplantation (OHT) with left ventricular assist device (LVAD) explantation (LVAD explant-OHT). We hypothesized that LVAD explant-OHT is a more challenging surgical procedure compared to OHT without LVAD explantation and that institutional LVAD explant-OHT procedural volume would be associated with post-transplant graft survival. We sought to assess the impact of institutional volume of LVAD explant-OHT on post-transplant graft survival.
METHODS - This is a retrospective analysis of the Scientific Registry of Transplant Recipients for adult OHTs with long-term LVAD explantation. LVAD explant-OHT volume was characterized on the basis of the center's year-specific total OHT volume (OHTvol) and year-specific LVAD explant-OHT volume quartile (LVADvolQ). The effect of LVADvolQ on graft survival (death or re-transplantation) was analyzed.
RESULTS - From 2004 to 2011, 2,681 patients underwent OHT with LVAD explantation (740 with HeartMate XVE, 1,877 with HeartMate II and 64 with HeartWare devices). LVAD explant-OHT at centers falling in the lowest LVADvolQ was associated with reduced post-transplant graft survival (p = 0.022). After adjusting for annualized OHTvol (HR = 0.998, 95% CI 0.993 to 1.003, p = 0.515 and pulsatile XVE (HR = 0.842, 95% CI 0.688 to 1.032, p = 0.098), multivariate analysis confirmed a significantly (approximately 37%) increased risk of post-transplant graft failure among explant-OHT procedures occurring at centers in the lowest volume quartile (HR = 1.371, 95% CI 1.030 to 1.825, p = 0.030).
CONCLUSION - Graft survival is decreased when performed at centers falling in the lowest quartile of LVAD explant-OHT for a given year. This volume-survival relationship should be considered in the context of limited donor organ availability and the rapidly growing number of LVAD centers.
Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
End-stage heart failure patients are being supported with continuous flow left ventricular assist devices (CF-LVAD) in increasing numbers. The severe physiologic and pharmacologic derangements associated with end-stage heart failure therapies predispose these patients to delirium. During a delirious episode, a patient may inadvertently disconnect CF-LVAD equipment, which may have dangerous consequences. Unfortunately, it is not yet routine to use readily available clinical monitoring tools to allow early detection of delirium in this high-risk population. The authors present a case of acute hyperactive delirium leading to pump power disconnection and cardiopulmonary arrest occurring 7 days after CF-LVAD implantation. The case highlights the need for delirium awareness in the cardiovascular intensive care unit and the unique challenges associated with resuscitation of CF-LVAD patients. The authors propose that cardiovascular intensive care unit patients undergo at least twice daily delirium monitoring and provide a novel resuscitation algorithm for patients who have CF-LVADs.
OBJECTIVE - To describe the care delivery structure and elements used for patient self-care education in ventricular assist device (VAD) programs.
BACKGROUND - Use of VADs as destination therapy and to sustain organ function until cardiac transplantation has increased 517% since 2007. Elements of VAD-specific self-care education have not been described.
METHODS - A 26-item survey measuring VAD self-care education resource use, organizational, employment, behavioral and labor variables was sent to VAD coordinators at all US VAD centers (N = 111) in 2011. Two subsequent mailings yielded a 63% (n = 71) return rate. Analysis included descriptive statistics and cluster analysis.
RESULTS - Element use varied across programs. Reliance on single educational and evaluation methods, and lack of return demonstration were noted. VAD coordinators reported extensive caregiver, hospital provider, and community educational responsibilities in addition to patient self-care education.
CONCLUSIONS - VAD self-care education programs varied by hospital. Future research is needed to determine if specific care delivery structures or elements used in self-care education improve VAD patient outcomes.
Copyright © 2014 Elsevier Inc. All rights reserved.
BACKGROUND - Mechanical circulatory support is an accepted strategy to bridge patients to heart transplantation (HTx). Among mechanical circulatory support patients who go on to HTx, factors associated with improved graft survival have not been fully elucidated.
METHODS - Using the Scientific Registry for Transplant Recipients, we identified adults who were treated with a left ventricular assist device (LVAD) or total artificial heart (TAH) before HTx. Kaplan-Meier and multivariate Cox regression models were used to identify patient, donor, and device characteristics associated with graft survival.
RESULTS - Between January 1997 and February 2012, 2,785 adults underwent HTx. Before HTx, 2,674 patients were treated with a LVAD (HeartMate XVE, 724; HeartMate II, 1,882; HeartWare, 68), and 111 were treated with a TAH. Follow-up averaged 25 ± 24 months. Gender mismatch occurred in 23%. Graft survival did not differ between LVAD groups (all p > 0.168), but TAH was associated with reduced graft survival compared with LVADs (p < 0.001). After controlling for device type (LVAD vs TAH), lower recipient pulmonary vascular resistance, shorter ischemic time, younger donor age, donor-to-recipient gender match, and higher donor-to-recipient body mass index ratio were independent predictors of longer graft survival (all p < 0.05).
CONCLUSIONS - TAH was associated with reduced graft survival after transplant, and survival did not differ between the LVAD device groups. Additional variables that were independently associated with graft survival were donor age, recipient peripheral vascular resistance, ischemic time, gender match, and donor-to-recipient body mass index ratio. Recognition of these factors may inform decisions regarding device support and donor suitability.
Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.