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Richard C Daly,
Yan Topilsky, Lyle Joyce,
Tal Hasin,
Manish Gandhi,
Charles Rosen,
Julie Heimbach,
Brooks S Edwards,
Naveen Pereira,
John M Stulak,
Christopher J Arendt,
Soon J Park,
Sudhir S Kushwaha
Transplantation 01/2013; 95(2):e2-4. · 4.00 Impact Factor
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Tal Hasin,
Yariv Marmor,
Walter Kremers,
Yan Topilsky,
Cathy J Severson,
John A Schirger,
Barry A Boilson,
Alfredo L Clavell,
Richard J Rodeheffer,
Robert P Frantz,
Brooks S Edwards,
Naveen L Pereira,
John M Stulak, Lyle Joyce,
Richard Daly,
Soon J Park,
Sudhir S Kushwaha
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ABSTRACT: OBJECTIVES: The purpose of this study was to determine the occurrence and causes of readmissions after implantation of axial flow left ventricular assist device (LVAD). BACKGROUND: Based on the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) study experience, readmissions after LVAD implantation are thought to be frequent. METHODS: We retrospectively analyzed admissions to our facility in a cohort of 115 patients implanted between January 2008 and July 2011 with the HeartMate II axial flow LVAD, of whom 42 were bridged to transplant. To account for repeated events, Andersen-Gill models were used to determine possible predictors. RESULTS: The patients were followed for 1.4 ± 0.9 years. There were 224 readmissions in 83 patients. The overall readmission rate was 1.64 ± 1.97 per patient-year of follow-up. The readmission rate for the first 6 months was 2.0 ± 2.3 and decreased to 1.2 ± 2.1 during subsequent follow-up. Leading causes were bleeding (66 readmissions in 34 patients), mostly gastrointestinal bleed (51 in 27 patients), cardiac (51 in 36 patients, most for HF or arrhythmia), infections (32 in 25 patients) of which 6 were pump related, and thrombosis (20 in 15 patients) including 13 readmissions due to hemolysis. Preoperative variables associated with (fewer) readmissions in a multivariate model include residence within our hospital-extended referral zone of Minnesota and the neighboring states (hazard ratio: 0.66; 95% confidence interval: 0.48 to 0.91; p = 0.011), hemoglobin (hazard ratio: 0.91, 95% confidence interval: 0.84 to 0.99; p = 0.027) and N-terminal pro-B-type natriuretic peptide (hazard ratio: 0.98; 95% confidence interval: 0.96 to 1.0 per 1,000-unit increase, p = 0.022). C-statistic for the model: 0.63. CONCLUSIONS: Readmission rates after axial flow LVAD implantation decrease during the first 6 months and then stabilize. The leading causes are bleeding, cardiac (heart failure and arrhythmia), infections, and thrombosis.
Journal of the American College of Cardiology 11/2012; · 14.16 Impact Factor
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Tal Hasin,
Yan Topilsky,
Walter K Kremers,
Barry A Boilson,
John A Schirger,
Brooks S Edwards,
Alfredo L Clavell,
Richard J Rodeheffer,
Robert P Frantz, Lyle Joyce,
Richard Daly,
John M Stulak,
Sudhir S Kushwaha,
Soon J Park,
Naveen L Pereira
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ABSTRACT: The goal of this study was to describe the predictors and significance of poor exercise tolerance after left ventricular assist device (LVAD) implantation. Despite LVAD therapy, some patients continue to exhibit exercise intolerance. The predictors and outcomes of these patients are unknown. A retrospective review of 65 LVAD recipients who performed 6-minute walk tests was conducted. Patients walking <300 m were considered to have poor exercise tolerance. Twenty patients exhibited poor exercise tolerance (221 ± 45 m), compared to 45 patients with better exercise tolerance (406 ± 76 m). Postoperatively, poor performers were not easily identified by functional symptoms alone, because 42% of these patients reported New York Heart Association functional class I or II symptoms. Preoperative New York Heart Association class, inotrope therapy, and intra-aortic balloon pump use were similar between the 2 groups. Multivariate analysis using all adequately powered (n >50) univariate predictors identified diabetes mellitus (odds ratio 10.493, p = 0.003) and elevated 1-month right atrial pressure (odds ratio 2.985 for every 5 mm Hg, p = 0.003) as significant predictors of poor performance (<300 m; area under the curve 0.85). The poorly performing group had increased mortality (p = 0.011), with 21% increased risk for overall mortality for every 10 m short of 300 m (fitted Cox model: hazard ratio 1.211, p = 0.0001). The distance walked in meters in a postoperative 6-minute walk test was the strongest predictor of late post-LVAD mortality (p = 0.0002). In conclusion, despite similar severity of heart failure preoperatively, some LVAD recipients may have persistent exercise intolerance postoperatively as assessed by the 6-minute walk test that is independently associated with subsequent reduced survival.
The American journal of cardiology 07/2012; 110(9):1322-8. · 3.58 Impact Factor
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ABSTRACT: A universal loss of von Willebrand factor (vWF) high-molecular-weight multimers (HMWM) has been demonstrated in continuous-flow left ventricular assist device (HeartMate II) recipients. However, no reliable clinical or laboratory predictors for an increased bleeding tendency in this patient population have been identified. This study evaluated the ability of a new automated latex particle-enhanced immunoturbidimetric vWF activity assay (ALPEIVA) to predict non-surgical bleeding risk in HeartMate II recipients.
As part of a prospective multicenter trial, pre-surgical, 7-day, and 30-day post-implantation blood samples were collected from 24 patients. ALPEIVA-assessed vWF activities were compared among patients with and without non-surgical bleeding complications after HeartMate II implantation. Additional laboratory testing included factor VIII activity (FVIII:C), vWF antigen (vWFAg), vWF ristocetin cofactor activity (vWF:RCo), and vWF multimer analysis.
All 24 patients had HMWM losses after HeartMate II implantation. Five patients (20%) developed non-surgical bleeding complications between 14 days and 6 months after HeartMate II implantation. Among various laboratory variables, only mean ALPEIVA/vWFAg ratios (referred to as the "bleeding ratio") were significantly lower in patients with clinically relevant bleeding (mean, 0.70 ± 0.06) compared with patients without bleeding (mean, 0.78 ± 0.09; p = 0.02) when measured at 30 days.
The post-surgical bleeding ratio could potentially predict non-surgical bleeding risk and guide anti-platelet and anti-coagulation strategies in HeartMate II recipients.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 04/2012; 31(7):750-6. · 3.54 Impact Factor
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Tal Hasin,
Yan Topilsky,
John A Schirger,
Zhuo Li,
Yanjun Zhao,
Barry A Boilson,
Alfredo L Clavell,
Richard J Rodeheffer,
Robert P Frantz,
Brooks S Edwards,
Naveen L Pereira, Lyle Joyce,
Richard Daly,
Soon J Park,
Sudhir S Kushwaha
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ABSTRACT: The aim of this study was to determine renal outcomes after left ventricular assist device (LVAD) implantation.
Renal dysfunction before LVAD placement is frequent, and it is unclear whether it is due to primary renal disease or to poor perfusion.
A retrospective single-center analysis was conducted in 83 consecutive patients implanted with HeartMate II continuous-flow LVADs (Thoratec Corp., Pleasanton, California). Calculated glomerular filtration rate (GFR) was assessed on admission and 1, 3, and 6 months after implantation. To define predictors for improvement in GFR, clinical variables were examined in patients with decreased renal function (GFR <60 ml/min/1.73 m(2)) before LVAD, surviving and dialysis-free at 1 month (n = 44).
GFR significantly increased from admission (53.2 ± 21.4 ml/min/1.73 m(2)) to 1 month after LVAD implantation (87.4 ± 27.9 ml/min/1.73 m(2)) (p < 0.0001). Subsequently, at 3 and 6 months, GFR remained significantly (p < 0.0001) above pre-LVAD values. Of the 51 patients with GFRs <60 ml/min/1.73 m(2) before LVAD surviving at 1 month, 34 (67%) improved to GFRs >60 ml/min/1.73 m(2). Univariate pre-operative predictors for improvement in renal function at 1 month included younger age (p = 0.049), GFR improvement with optimal medical therapy (p < 0.001), intra-aortic balloon pump use (p = 0.004), kidney length above 10 cm (p = 0.023), no treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (p = 0.029), higher bilirubin (p = 0.002), higher Lietz-Miller score (p = 0.019), and atrial fibrillation (p = 0.007). Multivariate analysis indicated pre-operative improved GFR (slope = 0.5 U per unit improved; 95% confidence interval: 0.2 to 0.8; p = 0.003), atrial fibrillation (slope = 27; 95% confidence interval: 8 to 46; p = 0.006), and intra-aortic balloon pump use (slope = 14; 95% confidence interval: 2 to 26; p = 0.02) as independent predictors.
In most patients with end-stage heart failure considered for LVAD implantation, renal dysfunction is reversible and likely related to poor renal perfusion.
Journal of the American College of Cardiology 01/2012; 59(1):26-36. · 14.16 Impact Factor
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ABSTRACT: Continuous-flow left ventricular assist devices (LVADs) such as the HeartMate II have become the therapy of choice in patients with end-stage heart failure. The aim of this study is to report the outcomes in patients receiving the HeartMate II LVAD at a single center and review the lessons learned from this experience.
From June 2005 to June 2010, 130 consecutive patients received the HeartMate II LVAD. Of these, 102 were bridge-to-transplant (BTT), 17 destination therapy, and 11 exchanges for failed HeartMate XVE. This study focuses on the 102 BTT patients. The HeartMate II was approved by the US Food and Drug Administration (FDA) as BTT in April 2008 and 64 patients received this device as BTT since that date. We review our experience with the device as BTT and report on patient survival and adverse events as well as the impact of FDA approval on outcomes.
Overall, mean age was 52.6 ± 12.8 years; 26 (25.5%) were female. Disease etiology was ischemic in 58, nonischemic in 36, and other in 8. Overall, 30-day, 6-month, and 1-year survival for the BTT patients was 95.1%, 83.5%, and 78.8%, respectively. The 6-month survival in 38 patients in the clinical trial (pre-FDA) was 88.8% and was not statistically significant compared with the 76.2% 6-month survival in the 64 patients in the post-FDA approval period (p value = 0.1). Major adverse events among the 102 BTT patients included right ventricular failure in 5 (4.9%), LVAD driveline infections in 25 (24.5%), neurologic events in 10 (9.8%), and gastrointestinal bleeding in 18 (17.6%) patients. In addition, 1 patient (0.98%) had pump thrombus requiring device replacement.
Despite significant morbidity, use of the HeartMate II LVAD as BTT provides excellent hemodynamic support and is associated with excellent survival and low mortality. In addition, there needs to be improvement and focused strategies in the areas of gastrointestinal bleeding, driveline infections, and adverse neurologic events for these devices to be able to provide a real long-term alternative to heart transplantation.
The Annals of thoracic surgery 11/2011; 92(5):1593-9; discussion 1599-600. · 3.74 Impact Factor
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Sheri Crow,
Dong Chen,
Carmelo Milano,
William Thomas, Lyle Joyce,
Valentino Piacentino,
Riti Sharma,
Jogin Wu,
Gowthami Arepally,
Dawn Bowles,
Joseph Rogers,
Nestor Villamizar-Ortiz
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ABSTRACT: Bleeding is a major cause of morbidity in recipients of continuous-flow left ventricular assist devices (CF-LVAD). A better understanding of the impact of CF-LVAD support on the hemostatic profile is necessary to establish better strategies for anticoagulation therapy and risk assessment for bleeding complications. A prospective multicenter study was conducted to characterize von Willebrand factor (vWF) profiles in patients undergoing CF-LVAD implantation.
Blood samples were collected before and after CF-LVAD implantation from 37 patients between July 2008 and April 2009 at Duke University and the University of Minnesota. Blood samples were analyzed for vWF, platelet and collagen-binding ability. The presence of high-molecular-weight (HMW) vWF multimers were detected through gel electrophoresis, and deficiency was graded on a scale of 0 (normal) to 3 (severe loss).
All 37 patients exhibited significant loss of HMW vWF multimers within 30 days of CF-LVAD implantation. Ten of the 37 patients experienced bleeding complications after CF-LVAD placement.
All CF-LVAD recipients had acquired von Willebrand syndrome after LVAD placement, demonstrated by reduced or absent HMW vWF multimer levels. However, not all recipients had bleeding complications. These findings suggest that loss of HMW vWF multimers alone cannot predict bleeding risk. Further refinement of laboratory techniques and a larger follow-up is required to identify risk factors for bleeding in CF-LVAD recipients.
The Annals of thoracic surgery 10/2010; 90(4):1263-9; discussion 1269. · 3.74 Impact Factor
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ABSTRACT: A higher rate of nonsurgical bleeding has been observed in nonpulsatile left ventricular assist device (LVAD) recipients. von Willebrand factor (vWF) profiles were compared for nonpulsatile and pulsatile LVAD recipients to explore mechanisms that may contribute to the development of postimplant nonsurgical bleeding. The nonpulsatile mechanism may impair vWF function by creating a deficiency in vWF high molecular weight multimers (HMWMs), essential for hemostasis. High molecular weight multimer deficiency should result in low ristocetin cofactor (RCo) to vWF antigen ratios (vWF:RCo/vWF:Ag) because of impaired platelet (plt)-binding ability. von Willebrand factor profiles and HMWM were measured pre- and post-LVAD placement in 11 nonpulsatile (HeartMate II [HM II[) and 3 pulsatile (HeartMate XVE [HM XVE]) recipients. All the nonpulsatile LVAD recipients exhibited loss of HMWM 30 days postimplant. The vWF:RCo/vWF:Ag ratio was significantly lower after LVAD placement in the nonpulsatile group when compared with the pulsatile group. In addition, the vWF:RCo/vWF:Ag ratio decreased significantly from baseline 30 days postimplant within the nonpulsatile recipients. All nonpulsatile LVAD recipients had low vWF:RCo/vWF:Ag ratios 30 days post-LVAD even if the values were normal at baseline. These data suggest that nonpulsatile HM II recipients develop HMWM loss and impaired vWF platelet (plt)-binding ability after LVAD placement. Similar results were not observed in our small series of pulsatile HM XVE recipients. This finding could suggest a contributing factor to the increase in nonsurgical bleeding observed in nonpulsatile LVAD patients. Further investigation is ongoing to identify specific causes of vWF impairment.
ASAIO journal (American Society for Artificial Internal Organs: 1992) 08/2010; 56(5):441-5. · 1.39 Impact Factor
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ABSTRACT: The paucity of organ donors has necessitated redirecting research toward finding alternative means to a heart transplant, such as left ventricular assist devices (LVADs) that will serve not merely as bridge-to-transplant but also as destination therapy. To better understand hemorrhagic and thromboembolic complications that currently limit the use of such devices, we studied the endothelial and coagulation system changes in LVAD recipients with time.
We studied these markers of endothelial dysfunction: circulating endothelial cells and expression of E-selectin, vascular cell adhesion molecule, intercellular adhesion molecule, and tissue factor on circulating endothelial cells, thrombin generation (prothrombin fragments 1,2 and thrombin/antithrombin), and fibrinolysis (D-dimer). Our study group consisted of 21 LVAD recipients (on day 0 and on postoperative days 1, 7, 30, 90, and 180) and 7 control patients undergoing non-LVAD cardiac surgery.
Baseline values of intercellular adhesion molecule, E-selectin, tissue factor, thrombin/antithrombin, and D-dimer were significantly higher in LVAD recipients than the normal range. Markers of thrombin generation (thrombin/antithrombin and prothrombin fragments 1,2) and fibrinolysis (D-dimer) peaked postoperatively and declined to baseline levels or below by 3 months. But the expression of inducible endothelial markers (intercellular adhesion molecule, E-selectin, tissue factor) on circulating endothelial cells increased postoperatively, then decreased but remained elevated above preoperative levels for up to 6 months. In our control patients, baseline levels of intercellular adhesion molecule, E-selectin, tissue factor, D-dimer, and thrombin/antithrombin were lower and decreased significantly by day 7, as compared with LVAD recipients (p < 0.05).
Left ventricular assist device recipients experienced significant baseline activation of endothelial and coagulation systems, further accentuated in the early postoperative period. Left ventricular assist device recipients also had prolonged activation of the endothelial and coagulation systems, suggesting activation of the extrinsic (tissue factor) pathway of thrombosis mediated by sustained endothelial dysfunction in these patients. Further studies are needed to determine the clinical influence of such changes in LVAD recipients.
The Annals of thoracic surgery 10/2009; 88(4):1171-9. · 3.74 Impact Factor
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ABSTRACT: Newer continuous-flow left ventricular assist devices (LVAD) have the advantage of smaller size and increased durability. Questions remain regarding the safety and effects of long-term nonpulsatile flow, despite some animal and human studies showing that end-organ function is well maintained with pulsatile or axial-flow devices. This study investigated whether centrifugal devices have similar effects on end-organ function.
All patients who underwent LVAD implantation as bridge-to-transplant (BTT) therapy from January 2004 through May 2007 were reviewed. Excluded were patients on biventricular support, destination therapy, temporary support, and patients who died within 30 days after LVAD implantation. The centrifugal device was the VentrAssist (Ventracor Ltd, Sydney, Australia); axial, the HeartMate II; and pulsatile, the HeartMate XVE (Thoratec Corp, Pleasanton, CA).
During the study, 10 VentrAssist, 30 HeartMate II, and 18 HeartMate XVE devices were implanted. Among the 3 groups, age, gender, weight, duration of LVAD support, and cause of heart failure were comparable. No significant differences were found between groups with respect to baseline renal function, hepatic function, or hematologic function. At 1 and 3 months of follow-up, renal and hepatic function either improved or remained within normal limits in all groups.
Centrifugal, axial, and pulsatile LVADs all provide adequate circulatory support to maintain appropriate end-organ function in patients with end-stage heart failure. The advantages of the newer continuous-flow devices can be safely applied to an increasing number of patients. Long-term studies (>1 year) are needed to assess effects on end-organ function with continuous-flow devices, which may have important implications for use as destination therapy.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 05/2009; 28(4):352-9. · 3.54 Impact Factor
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The Journal of thoracic and cardiovascular surgery 02/2009; 137(1):e39-40. · 3.41 Impact Factor
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Sheri Crow,
Ranjit John,
Andrew Boyle,
Sara Shumway,
Kenneth Liao,
Monica Colvin-Adams,
Carol Toninato,
Emil Missov,
Marc Pritzker,
Cindy Martin,
Daniel Garry,
William Thomas, Lyle Joyce
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ABSTRACT: Pulsatile and nonpulsatile left ventricular assist devices are effective in managing congestive heart failure. Despite early evidence for clinical efficacy, the long-term impact of nonpulsatile flow on end-organ function remains to be determined. Our goal was to compare rates of gastrointestinal bleeding in nonpulsatile and pulsatile device recipients.
In a retrospective review of 101 left ventricular assist device recipients (55 nonpulsatile, 46 pulsatile) from October 31, 2003, to June 1, 2007, at a single center, gastrointestinal bleeding was defined as guaiac-positive stool with hemoglobin drop requiring transfusion of at least 2 units of packed red blood cells. To assess bleeding risk outside the initial postoperative course, any patients with a device in place for 15 days or less was excluded.
Twelve nonpulsatile and 3 pulsatile left ventricular assist device recipients had gastrointestinal bleeding 16 days or longer after device implantation. The event rates were 63 events/100 patient-years for nonpulsatile devices and 6.8 events/100 patient-years for pulsatile devices (P = .0004). This difference persisted for bleeding occurring 31 days or longer after device implantation, with 46.5 events/100 patient-years for nonpulsatile devices versus 4.7 events/100 patient-years for pulsatile devices (P = .0028). Mortalities were similar between groups (15% nonpulsatile vs 17% pulsatile, P = .6965).
Patients with nonpulsatile left ventricular assist devices appear to have a higher rate of gastrointestinal bleeding events than do pulsatile left ventricular assist device recipients. Further prospective evaluation is needed to determine potential etiologies and strategies for reducing gastrointestinal bleeding in this population.
The Journal of thoracic and cardiovascular surgery 02/2009; 137(1):208-15. · 3.41 Impact Factor
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ABSTRACT: Thromboembolic events can occur in up to 20% of patients with a left ventricular assist device. The aggressive use of anticoagulation with newer continuous-flow devices has potentially increased the risk of postoperative bleeding. The predecessor of the HeartMate II left ventricular assist device, the HeartMate XVE (Thoratec Corp, Pleasanton, Calif), was associated with an extremely low thromboembolic risk, even without anticoagulation, because of its unique textured surfaces. Even though several areas of the HeartMate II are textured, a protocol was adopted for this new axial flow pump requiring long-term anticoagulation with warfarin. In our study, we investigated whether the HeartMate II left ventricular assist device is associated with a similarly low thromboembolic risk as the HeartMate XVE.
At our institution, 45 patients (mean age, 57.24 +/- 14.2 years) underwent implantation of the HeartMate II; 30 underwent bridge-to-transplantation therapy, 7 underwent destination therapy, and 8 underwent left ventricular assist device exchange for a failed XVE left ventricular assist device. Total duration of HeartMate II support was 352.13 patient-months (mean duration, 7.2 +/- 5.2 months). All 45 patients were treated postoperatively with warfarin and aspirin. We recorded use of these 2 medications and monthly international normalized ratios. Prospectively, we also monitored patients for any clinical thromboembolic events and for pump thrombus.
Of our 45 study patients, 41 had a mean international normalized ratio of less than 2.0; of those 41 patients, 21 had a mean international normalized ratio of less than 1.6. Because of recurrent gastrointestinal bleeding episodes, 7 patients discontinued warfarin for a total duration of 39.1 patient-months. During the entire period of HeartMate II support, we noted 1 thromboembolic event. In addition, another patient had a suspected left ventricular assist device pump thrombus that resolved with a high-intensity heparin anticoagulation protocol (international normalized ratio, 1.3).
Our preliminary single-center analysis suggests that the HeartMate II is associated with an extremely low thromboembolic risk and with less stringent requirements for anticoagulation. Selected patients at high risk for bleeding can be safely followed with either no or extremely low anticoagulation requirements for prolonged periods.
The Journal of thoracic and cardiovascular surgery 12/2008; 136(5):1318-23. · 3.41 Impact Factor
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ABSTRACT: Pulsatile left ventricular assist devices (LVADs) are effective as bridge-to-transplant therapy, but they are limited by their large size and lack of durability. Smaller, more durable, continuous flow devices such as the HeartMate II LVAD are increasingly being used. The aim of this study is to report our single-center experience with this device as bridge-to-transplant therapy.
Overall, 47 patients received HeartMate II LVADs at our center from June 2005 to July 2007; 32 as bridge to transplant, 7 as destination therapy, and 8 as exchange therapy for a failed HeartMate XVE. We reviewed our experience with the device as bridge-to-transplant therapy and report on patient survival and adverse events.
The mean age of the bridge-to-transplant patients was 50.75 +/- 13.78 years; 10 (31.3%) were female. The cause of the underlying disease was ischemic in 18 patients (56.3%), idiopathic in 11 (34.4%), myocarditis in 1 (3.1%), postpartum cardiomyopathy in 1 (3.1%), and congenital heart disease in 1 (3.1%). The mean duration of HeartMate II support was 193.2 +/- 139.9 days. At 30 days after HeartMate II placement, the patient survival was 96.9% by Kaplan-Meier analysis; at 6 months (alive or transplanted), 86.9%. Major adverse events included bleeding requiring reexploration in 5 patients (15.6%), right ventricular failure requiring right ventricular assist device support in 2 (6.3%), LVAD-related infections in 4 (12.5%), neurologic or thromboembolic events in 2 (6.3%), and gastrointestinal bleeding in 5 (15.6%). We noted one serious device malfunction (3.1%) resulting in the patient's death; in addition, 2 patients experienced pump thrombosis (6.3%).
Despite morbidity, use of the HeartMate II LVAD as bridge-to-transplant therapy is associated with excellent survival and low mortality rates. We found a marked decrease in morbidity related to right ventricular failure, to device-related infections, and to thromboembolic events. However, the requirements for anticoagulation therapy may be associated with increased mediastinal and gastrointestinal bleeding. Strategies to optimize anticoagulation therapy may further improve results for these critically ill patients.
The Annals of thoracic surgery 11/2008; 86(4):1227-34; discussion 1234-5. · 3.74 Impact Factor
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ABSTRACT: In patients with end-stage heart failure, the use of left ventricular assist devices (LVADs) has improved clinical outcomes. Although newer continuous-flow devices have significant advantages, the effect of continuous flow on left ventricular unloading and hemodynamics is less well established. The aim of this investigation was to compare the effects of pulsatile- vs continuous-flow LVADs on left ventricular reverse remodeling and hemodynamic indices.
Thirty-five patients undergoing implantation with a pulsatile volume displacement pump operating at fixed speed (n = 15; HeartMate XVE; Thoratec Corp., Pleasanton, CA) or a continuous-flow rotary pump with an axial design operating at a fixed rotor speed (n = 20; HeartMate II; Thoratec) were evaluated. Right heart catheterization and echocardiography were performed pre-operatively, and at 1- and 6-month follow-up intervals.
Thirty-five of 40 eligible patients with end-stage heart failure were included in this study. When used at fixed speed, use of both devices led to a substantial reduction in left ventricular volumes and dimensions at 1 month (p < 0.01). A marked and sustained reduction in filling pressures was also noted with both devices at 1 and 6 months (p < 0.01). The volume and pressure unloading effects of the HeartMate XVE were not superior to those with the HeartMate II (all p-values not statistically significant).
Substantial left ventricular unloading and hemodynamic improvement is achieved with the HeartMate XVE and the HeartMate II. We conclude that continuous-flow LVADs are as effective as pulsatile-flow LVADs with regard to degree of left ventricular unloading and cardiac hemodynamics.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 03/2008; 27(3):261-7. · 3.54 Impact Factor
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ABSTRACT: Patients with refractory acute cardiogenic shock and multisystem organ failure have a poor outcome with implantation of permanent ventricular assist devices. We review our experience with the use of the CentriMag (Levitronix LLC, Waltham, Mass) circulatory support system in such patients whose neurologic status was uncertain.
From January 2004 to June 2006, 30 patients underwent CentriMag circulatory support system placement at the University of Minnesota. Of these patients, 12 were transferred from an outside hospital with refractory acute cardiogenic shock requiring biventricular support; they are the focus of this study.
Of our 12 study patients, 8 underwent successful bridging to the HeartMate XVE (Thoratec Corp, Pleasanton, Calif) ventricular assist device after biventricular support (mean support time of 9.4 days, range: 5-22 days). Another 2 patients underwent successful explantation (after 8 and 9 days); the remaining 2 patients died (after 4 days). Thus, the survival on CentriMag support, to either bridge or recovery, was 83% (10/12). Of the 8 patients who subsequently underwent HeartMate implantation, 5 also underwent a heart transplant within 6.9 months (range, 4.5-10 months), another 2 are still awaiting a transplant, and 1 died of sepsis and right ventricular failure 3 days after HeartMate implantation. Thus, for our 12 study patients, long-term survival was 75% at 1 month and 62.5% at 1 year.
Our aggressive strategy in this group of patients involved early operative intervention and implantation of biventricular support. By using this strategy, we avoided the urgent placement of expensive long-term ventricular assist devices in hemodynamically unstable patients with multisystem organ failure whose neurologic status was uncertain until end-organ recovery and excellent hemodynamic stability were achieved with the relatively inexpensive short-term CentriMag circulatory support system. The excellent midterm outcomes in this group of patients whose original prognosis was poor justify this therapeutic strategy.
The Journal of thoracic and cardiovascular surgery 09/2007; 134(2):351-8. · 3.41 Impact Factor
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ABSTRACT: Cardiovascular disease is a common cause of morbidity and mortality in organ transplant recipients, and cardiac surgery has become more common in this population. We performed a retrospective study of kidney transplant recipients who underwent cardiac surgery over the past 10 years at our institution with an emphasis on evaluating postoperative outcomes.
Seventy-four patients with previous abdominal transplants underwent cardiac surgery (93% coronary artery bypass grafting, 5.4% bypass grafting plus valve, and 1.4% valve) between 1995 and 2005. These recipients were compared with 895 adult nontransplant patients undergoing cardiac surgery between 2000 and 2005. Only kidney and kidney-pancreas recipients were included in the analysis (n = 70) because there were only 2 liver and pancreas alone transplants.
As compared with nontransplant patients, kidney transplant patients were younger (mean age 52.1 +/- 10 years vs 61 +/- 13 years; P < .001) and had an increased incidence of diabetes (92.9% vs 39.1%; P < .001), peripheral vascular disease (37.1% vs 19.1%; P < .001), chronic kidney insufficiency (73.0% vs 13.4%; P < 0.001), and unstable angina (44.8% vs 25.7%; P = .005) There was no difference between the two groups in the complication rate at 30 days after surgery, except that transplant patients were more likely to have postoperative kidney dysfunction (32.6% vs 6.1%; P < .001) and require hemodialysis (11.7% vs 1.1%; P < .0001). Thirty-day postoperative mortality was similar between groups (1.4% vs 2.9%; P = not significant). By multivariable analysis, preoperative congestive heart failure, nonelective surgery, prolonged cardiopulmonary bypass times, peripheral vascular disease, and lower creatinine clearance were significant risk factors for postoperative mortality; however, prior kidney transplant was not an independent risk factor for 30-day postoperative mortality.
Despite their increased incidence of comorbid conditions, the postoperative outcomes of cardiac surgery in kidney transplant recipients are similar to those in the nontransplant population except for a higher incidence of kidney dysfunction in transplant patients.
The Journal of thoracic and cardiovascular surgery 05/2007; 133(5):1212-9. · 3.41 Impact Factor
