Original Article
Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device
N Engl J Med 2009; 361:2241-2251December 3, 2009
- Abstract
Background
Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices.
Methods
In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity.
Results
Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P=0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups.
Conclusions
Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.)
Media in This Article
Animation
Comparison of a Volume-Displacement Pump and an Axial-Flow Pump.
Figure 1
Pulsatile-Flow (Panel A) and Continuous-Flow (Panel B) Left Ventricular Assist Devices (LVADs).Article Activity
- Article
Animation
Comparison of a Volume-Displacement Pump and an Axial-Flow Pump.
Medical and electrical therapies for systolic heart failure have improved outcomes and altered the natural history of the disease.1-9 However, heart failure commonly progresses and becomes refractory to current treatments. Continuous intravenous inotropic support may improve clinical status in the short term but results in a survival rate at 1 year of only 10 to 30%.10,11 Cardiac transplantation is available for only a minority of patients, because of a lack of suitable donor hearts. The paucity of effective therapies for advanced heart failure led to the evaluation of mechanical circulatory-support devices as permanent therapy.
To date, only two completed trials, one randomized12 and one nonrandomized,13 have evaluated patients with advanced heart failure who were ineligible for transplantation and compared optimal medical therapy with the use of a pulsatile left ventricular assist device. The survival status, functional capacity, and quality of life were superior in the patients treated with the pulsatile left ventricular assist devices. However, the 2-year survival rate among patients with a left ventricular assist device in the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial (ClinicalTrials.gov number, NCT00000607) was only 23%, as compared with 8% among patients receiving medical therapy.12 Despite these substantial improvements in outcomes, broader application of left ventricular assist devices for advanced heart failure has been limited by the large size of the pump and drive line, clinically significant adverse events, and limited device durability.
Newer designs of left ventricular assist devices, involving rotary-pump technology to provide blood flow with reduced pulsatility, have undergone clinical investigation. These continuous-flow left ventricular assist devices have improved the hemodynamics, end-organ function, quality of life, and functional capacity of patients awaiting transplantation.14,15 They are also smaller, quieter, and more durable than pulsatile-flow devices, making them potentially better suited for long-term support.
This study reports the results of a randomized trial comparing outcomes in patients with advanced heart failure who were ineligible for transplantation and received either a pulsatile-flow left ventricular assist device or a continuous-flow left ventricular assist device.
Methods
Study Organization
The study was conducted at 38 centers in the United States. Data were collected by study coordinators at participating centers, analyzed by the sponsor (Thoratec, Pleasanton, CA), and audited by the sponsor. The authors vouch for the completeness and accuracy of the data and analyses. An independent data and safety monitoring board monitored the study and reviewed the protocol compliance and outcome data. An independent clinical events committee adjudicated the causes of death and adverse events. The protocol was approved by each participating center's institutional review board.
Study Patients
Patients with advanced heart failure who were ineligible for heart transplantation and whose heart failure was refractory to optimal medical management were considered for study enrollment. Detailed inclusion and exclusion criteria are listed in the Supplementary Appendix (available with the full text of this article at NEJM.org). Enrolled patients met the following criteria: a left ventricular ejection fraction of less than 25%; a peak oxygen consumption of less than 14 ml per kilogram of body weight per minute, or less than 50% of the predicted value; and New York Heart Association (NYHA) class IIIB or IV symptoms for at least 45 of the 60 days before enrollment or dependence on an intraaortic balloon pump for a period of 7 days or inotropes for a period of at least 14 days before enrollment. Exclusion criteria included irreversible, severe renal, pulmonary, or hepatic dysfunction or active infection. All patients or an authorized representative provided written informed consent.
Study Design
Patients were randomly assigned, in a 2:1 ratio, to receive either a continuous-flow left ventricular assist device or a pulsatile-flow left ventricular assist device. Randomization was stratified according to study center and with the use of permuted blocks to maintain the 2:1 ratio over time. Baseline data — including demographic characteristics, concomitant use of medications, health history, responses on the Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaires, and clinical laboratory values — were collected for all patients. After implantation of the left ventricular assist device, device performance, laboratory results, and medication use were initially recorded at daily to weekly intervals and after hospital discharge were recorded monthly. Quality-of-life assessments and the 6-minute walk tests were completed at baseline, 1 month, 3 months, 6 months, and then every 6 months until study completion at 24 months. Adverse events were recorded throughout the study, with the use of standardized definitions (see the Supplementary Appendix). All causes of death were determined by means of autopsy or through examination of medical records, with final adjudication by the clinical events committee.
Left Ventricular Assist Devices
The two left ventricular assist devices used in this study were the pulsatile-flow HeartMate XVE and the continuous-flow HeartMate II (both from Thoratec). These implanted pumps draw blood from the apex of the left ventricle and deliver it to the ascending aorta. Both are electrically driven by means of a percutaneous lead that connects the pump to an external system controller and power source (Figure 1Figure 1
Pulsatile-Flow (Panel A) and Continuous-Flow (Panel B) Left Ventricular Assist Devices (LVADs)., and the animation 16 available with the full text of this article at NEJM.org). The continuous-flow left ventricular assist device has a volume of 63 ml and a weight of 390 g, as compared with 450 ml and 1250 g for the pulsatile-flow left ventricular assist device. Both devices are capable of a flow rate up to 10 liters per minute at a mean pressure of 100 mm Hg. Antithrombotic management included aspirin for all patients and warfarin (with a targeted international normalized ratio of 2.0 to 3.0) only for those with the continuous-flow device.Statistical Analysis
The primary end point was a composite of survival at 2 years, free of disabling stroke (stroke with a Rankin score >3) or reoperation to replace the device. The percentage of patients in whom the primary composite end point was reached was compared between the two treatment groups with the use of Fisher's exact test. Cox proportional-hazards analyses, with the data stratified on the basis of the treatment assignment, were used to calculate hazards ratios and 95% confidence intervals for the primary end point and component events. Analysis of the primary composite end point was conducted on the basis of the intention-to-treat principle. Patients who had undergone randomization but not implantation of a device were considered to have had treatment failure, as were patients who had device failure requiring either device explantation or urgent heart transplantation.
Secondary study end points included actuarial survival, frequency of adverse events, functional status, and the quality of life. The secondary end points were evaluated with the use of an as-treated analysis of all data until use of the treatment device was discontinued. Data on the categorical variables were compared with the use of Fisher's exact test. Longitudinal changes in functional status and quality of life were analyzed by means of linear mixed-effects modeling. Adverse-event rates and relative risks were compared between the two treatment groups with the use of Poisson regression. Actuarial-survival analysis was performed by means of the Kaplan–Meier method and the results were compared between the two groups with the use of log-rank analysis. P values of less than 0.05 were considered to indicate statistical significance. All reported P values are two-sided and were not adjusted for multiple testing.
A total of two interim analyses were conducted, one each after 27% and 67% of the patients had reached the 2-year time point. The false positive rate was limited to 5% by means of the O'Brien–Fleming spending function.
Results
Study Patients
A total of 200 patients were randomly assigned to undergo implantation of a continuous-flow left ventricular assist device (134 patients) or a pulsatile-flow left ventricular assist device (66 patients) between March 2005 and May 2007. The baseline characteristics of each of the two treatment groups were similar, except more women were in the continuous-flow device group (Table 1Table 1
Baseline Characteristics of the Study Patients, According to Treatment Group.). Resynchronization therapy had failed in more than 60% of patients, nearly 80% were receiving intravenous inotropic agents, and over 20% had an intraaortic balloon pump at the time of enrollment. There was no significant difference between the two groups in the destination therapy risk score.17 Clinical Course
Five patients randomly assigned to receive a pulsatile-flow left ventricular assist device and three patients randomly assigned to receive a continuous-flow device did not undergo implantation with a device; however, these patients were counted as having treatment failure (see the flow chart in the Supplementary Appendix). Three patients who had a small body size and who had been randomly assigned to the pulsatile-flow device group received the smaller continuous-flow device instead, because of difficulty with anatomical fitting. One patient randomly assigned to the continuous-flow device group received a pulsatile-flow left ventricular assist device instead, because the patient's health insurance would only cover the pulsatile-flow device.
The remaining patients, whose data were included in the as-treated analyses, consisted of 133 who underwent implantation of a continuous-flow left ventricular assist device and 59 who underwent implantation of a pulsatile-flow left ventricular assist device. The median duration of support was 1.7 years (range, 0.0 to 3.7) and 0.6 years (range, 0.0 to 2.1) for the continuous-flow left ventricular assist device and the pulsatile-flow device, respectively, with a cumulative follow-up of 211 and 41 patient-years, respectively. Cardiac transplantation was performed in 17 patients randomly assigned to the continuous-flow left ventricular assist device and 9 patients randomly assigned to the pulsatile-flow left ventricular assist device, after contraindications to transplantation resolved while the device was providing support.
The mean (±SD) cardiac index increased from 2.0±0.6 liters per minute per square meter of body-surface area preoperatively to 2.9±0.7 liters per minute per square meter by 24 hours after implantation of the continuous-flow left ventricular assist device (P<0.001) and from 2.1±0.6 to 2.9±0.7 liters per minute per square meter after implantation of the pulsatile-flow left ventricular assist device (P<0.001). At the same time points, the pulmonary-capillary wedge pressure decreased from 24±8 to 17±7 mm Hg (P<0.001) with the continuous-flow left ventricular assist device and from 24±9 to 16±6 mm Hg (P<0.001) with the pulsatile-flow left ventricular assist device.
A total of 114 of the 133 patients (86%) with the continuous-flow left ventricular assist device and 45 of the 59 (76%) with the pulsatile-flow left ventricular assist device were discharged from the hospital with the device in place. The median length of stay after surgery was 27 days in the continuous-flow device group and 28 days in the pulsatile-flow device group. The percentage of total time spent out of the hospital after device implantation was 88% with the continuous-flow left ventricular assist device, as compared with 74% with the pulsatile-flow device (P=0.02).
Primary End Point
All 200 patients were followed for at least 2 years or until death, transplantation, or device explantation. The primary composite end point was achieved in more patients assigned to receive a continuous-flow left ventricular assist device than in those assigned to receive a pulsatile-flow left ventricular assist device (46% vs. 11%; hazard ratio, 0.38; 95% confidence interval [CI], 0.27 to 0.54; P<0.001) (Table 2Table 2
Primary End Point and Hazard Ratios, According to Treatment Group.). Failure to reach the primary end point was influenced by reoperation to repair or replace the left ventricular assist device and death within 2 years after device implantation, the rates of which were reduced with the continuous-flow device.Of the 59 patients who underwent implantation with a pulsatile-flow left ventricular assist device, 20 required 21 pump replacements (3 replaced with another pulsatile-flow device and 18 with a continuous-flow device) — and an additional 1 patient required urgent transplantation and 3 additional patients required device explantation — owing to bearing wear, valve malfunction, or infection. In the 133 patients who underwent implantation with a continuous-flow left ventricular assist device, 12 required 13 pump replacements with a continuous-flow device owing to breakage of the percutaneous lead (in 10 of the 13 replacements), pump thrombosis (in 2), or outflow elbow disconnection (in 1). One additional patient required device explantation because of a broken lead.
Actuarial Survival
On the basis of the as-treated analysis, the Kaplan–Meier estimate of actuarial survival was significantly better for patients who had a continuous-flow left ventricular assist device as compared with those with a pulsatile-flow left ventricular assist device (relative risk, 0.54; 95% CI, 0.34 to 0.86; P=0.008) (Figure 2Figure 2
Kaplan–Meier Estimates of Survival from the As-Treated Analysis, According to Treatment Group.). Estimates of the 1- and 2-year survival rates were 68% (95% CI, 60 to 76) and 58% (95% CI, 49 to 67), respectively, with the continuous-flow device and 55% (95% CI, 42 to 69) and 24% (95% CI, 1 to 46%) with the pulsatile-flow device. Eighteen of the pulsatile-flow left ventricular assist devices were replaced with a continuous-flow device during the follow-up period, leaving only two patients with a pulsatile-flow device (which had been replaced) at 2 years.Functional Status and Quality of Life
Early and sustained improvements in functional capacity were seen in both groups. A total of 80% of patients with a continuous-flow left ventricular assist device had NYHA functional class I or II symptoms at 24 months, with a doubling of the mean distance on the 6-minute walk test (vs. the distance at baseline) (Table 3Table 3
Functional Status and Quality-of-Life Secondary End Points, Based on the As-Treated Analysis, According to Time Point.). Similar trends were seen with quality-of-life metrics. As compared with the baseline scores, scores on the Minnesota Living with Heart Failure questionnaire and the Kansas City Cardiomyopathy questionnaires improved by over 30 points in both groups at each time point (except the 24-month point in the single patient tested who had a pulsatile-flow device) (P<0.001).Adverse Events
The adverse-event data are shown in Figure 3Figure 3
Adverse Events and Associated Relative Risks from the As-Treated Analysis, According to Treatment Group. (with details in the Supplementary Appendix). As compared with patients with a pulsatile-flow left ventricular device, there were significant reductions in the rates of major adverse events among patients with a continuous-flow left ventricular assist device — including device-related infection (relating to the percutaneous lead, pump, or pump pocket), non–device-related infection, right heart failure, respiratory failure, renal failure, and cardiac arrhythmia. The incidence of stroke did not differ significantly between the continuous-flow group (which had 0.13 events per patient-year [stroke in 17% of patients]) and the pulsatile-flow group (which had 0.22 events per patient-year [stroke in 14% of patients]). There was a 38% relative reduction in the rate of rehospitalization among patients with a continuous-flow left ventricular assist device as compared with those with a pulsatile-flow device.The leading causes of death among the patients with a continuous-flow left ventricular assist device were hemorrhagic stroke (in 9% who underwent device implantation), right heart failure (in 5%), sepsis (in 4%), external power interruption (in 4%), respiratory failure (in 3%), cardiac arrest (in 3%), and bleeding (in 3%). Among the patients with a pulsatile-flow left ventricular assist device, the leading causes of death were hemorrhagic stroke (in 10% who underwent device implantation), right heart failure (in 8%), multisystem organ failure (in 7%), and ischemic stroke (in 5%).
Discussion
Our study shows that implantation of a continuous-flow left ventricular assist device, as compared with a pulsatile-flow device, significantly improved the probability of survival free of stroke and reoperation for device repair or replacement at 2 years in patients with advanced heart failure in whom current therapy had failed and who were ineligible for transplantation. In addition, the actuarial survival over a 2-year period of support by a left ventricular assist device was significantly better with the continuous-flow device than with the pulsatile-flow device in a population of patients whose 2-year survival rate while receiving medical therapy has been shown to be approximately 10%.12,13 The continuous-flow left ventricular assist device was also associated with significant reductions in the frequency of adverse events and the rate of repeat hospitalization, as well as with an improved quality of life and functional capacity. The survival rate at 2 years among our patients with a pulsatile-flow left ventricular assist device was similar to that among patients with a left ventricular assist device in the REMATCH trial,12 whereas the survival rate among our patients with a continuous-flow device was more than twice the rate among the REMATCH patients.
Device durability is an important limitation to use of the currently approved pulsatile-flow left ventricular assist device as long-term therapy, because valve or bearing failures occurred routinely by 18 months. The need for pump replacement in the continuous-flow left ventricular assist device occurred at a rate of 6 events per 100 patient-years, almost one eighth the incidence seen with the pulsatile-flow device, and was mainly required because of damage to the percutaneous lead. There were no primary-pump or bearing failures in patients with a continuous-flow left ventricular assist device, with 62 patients having functioning devices for at least 2 years (and 1 patient with ongoing device support at 4 years). Redesign of the percutaneous lead and development of modular components may further reduce the infrequent need for replacement of the continuous-flow device.
Concerns persist that left ventricular assist devices may predispose patients to an undue burden of thromboembolic and infectious events. The rate of ischemic stroke among patients with a continuous-flow left ventricular assist device (6 events per 100 patient-years) is similar to that among patients with advanced heart failure who do not have device support and have other cardiovascular conditions such as atrial fibrillation.18,19 In our study, the rate of bleeding events associated with either type of left ventricular assist device were almost 10 times the rate of thromboembolic events. This finding was also noted in the HeartMate II bridge to transplant trial20 and has led many centers to reduce the targeted international normalized ratio to 1.5 to 2.5 for the continuous-flow left ventricular assist device. The smaller pump and percutaneous lead in the continuous-flow left ventricular assist device also requires less surgical dissection for implantation, which reduces the potential for infection, as compared with the pulsatile-flow device. Patients with a continuous-flow left ventricular assist device had a rate of device-related infection nearly 50% of that among patients with a pulsatile-flow device, which contributed to their reduced need for rehospitalization.
A critical therapeutic goal in treating patients with advanced heart failure is to enhance their quality of life and functional capabilities. There are few data from medical-therapy trials involving this population of patients that highlight exercise or quality-of-life benefits.1,8,9 A retrospective analysis of patients with NYHA class IV symptoms who were treated with cardiac-resynchronization therapy showed an increase of 45 m in the 6-minute-walk distance, a 25-point improvement in the Minnesota Living with Heart Failure score, and improvement in symptoms corresponding to a reduction by at least one NYHA functional class in 78% of the patients.21 The exercise and quality-of-life benefits with a continuous-flow left ventricular assist device in our trial consist of a doubling of the 6-minute-walk distance, an average improvement of 35 points in the quality-of-life scores, and an increase in the number of patients whose symptoms showed improvement, to NYHA functional class I or II. Patients in both groups in our study had significant early and sustained improvements in the 6-minute-walk distance and the functional class, suggesting that the exercise benefits are related to the reduction of cardiac filling pressures and improvement in cardiac output rather than being related to the characteristics of either pulsatile or continuous flow. The patient-reported symptom burden and heart-failure–related quality-of-life scores reflected similar improvements in the two groups over the duration of the study, with a trend toward greater improvement with the continuous-flow left ventricular assist device as compared with the pulsatile-flow device.
This study was a randomized, controlled clinical trial, but it was not possible to ensure that the patients and investigators were unaware of the treatment assignments. Thus, there is potential for bias, particularly regarding patient-reported outcomes such as functional abilities and the quality of life. Several sites had limited experience with the continuous-flow device before the study began, and several enrolled a small number of patients. Previous studies have shown a link between the volume of implantations with a left ventricular assist device and outcomes.22 In addition, most participating centers had more experience with the pulsatile-flow left ventricular assist device used in this trial than with the particular continuous-flow device, potentially biasing the analysis against the study device. Finally, the trial was performed in a select patient population, and applicability to the broader population of patients with heart failure, including those with less hemodynamic and functional compromise than our patients, would be speculative.
In conclusion, this study shows improvements in the rate of survival, quality of life, functional capacity of patients, and device durability with the continuous-flow left ventricular assist device (HeartMate II) as compared with the pulsatile-flow left ventricular assist device (HeartMate XVE). Reductions in the frequencies of adverse events related to device characteristics and strategies of care for patients favorably affected the rate of rehospitalization. Our results support the use of continuous-flow, permanent left ventricular assist device therapy in selected patients as a means to provide long-term hemodynamic support that is linked to improvements in longevity and the quality of life.
Supported by Thoratec.
Dr. Slaughter reports receiving grant support from Thoratec and Heartware; Dr. Rogers, consulting fees and grant support from Thoratec; Dr. Milano, research and training grant support from Thoratec, Abiomed, and St. Jude and research grant support from Edwards Life Sciences and Sorin; Dr. Russell, training and consulting fees from Thoratec; Dr. Conte, training and consulting fees from Thoratec and grant support from Paracor; Dr. Feldman, grant support from Thoratec; and Dr. Sun, training grant support from Thoratec. Dr. Farrar reports being an employee of Thoratec with equity ownership in the company. Dr. Frazier reports receiving consulting and lecture fees from Thoratec, Terumo Heart, and Jarvik Heart. No other potential conflict of interest relevant to this article was reported. (Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.)
Drs. Slaughter, Rogers, and Milano contributed equally to this article.
This article (10.1056/NEJMoa0909938) was published on November 17, 2009, at NEJM.org.
Source Information
From Advocate Christ Medical Center, Oak Lawn, IL (M.S.S., A.J.T.); Duke University Medical Center, Durham, NC (J.G.R., C.A.M.); Johns Hopkins Hospital, Baltimore (S.D.R., J.V.C.); Ohio State University, Columbus (D.F., B.S.); Texas Heart Institute, Houston (R.M.D., O.H.F.); Intermountain Medical Center, Salt Lake City (J.W.L.); Clarian Methodist Hospital, Indianapolis (T.C.W., W.G.); and Thoratec, Pleasanton, CA (D.J.F.).
Address reprint requests to Dr. Slaughter at the Division of Thoracic and Cardiovascular Surgery, University of Louisville, 201 Abraham Flexner Way, Suite 1200, Louisville, KY 40202, or at mark.slaughter@louisville.edu.
The HeartMate II investigators are listed in the Appendix.
Appendix
In addition to the authors, the following surgeons, cardiologists, and study coordinators participated in this study: Advocate Christ Hospital, Oak Lawn, IL — M. Sobieski, C. Gallagher, P. Pappas, M. Silver; Duke University Medical Center, Durham, NC — A. Lodge, L. Blue; Johns Hopkins Hospital, Baltimore — A. Shah, D. Yuh, S. Ullrich, D. Dordunoo, D. Rivard; Texas Heart Institute, Houston — B. Kar, B. Radovancevic, I. Gregoric, A. Civitello, E. Massin, C. Gemmato, M. Jafar, R. Bogaev, F. Smart; Ohio State University, Columbus — J. Sirak, S. Sudhaker, T. Yanssens; Intermountain Medical Center (LDS Hospital), Salt Lake City — B. Reid, S. Horton, D. Renland, J. Revenaugh, M. Eidson; Clarian Methodist Hospital, Indianapolis — M. Turrentine, S. Becka; Allegheny General Hospital, Pittsburgh — D. Dean, S. Murali, G. Magovern, S. Bailey, G. Sokos, L. Kernickey; Barnes–Jewish Hospital, Washington University, St. Louis — N. Moazami, G. Ewald, K. Shelton, D. Anderson, I. Wang; Baptist Memorial Hospital, Memphis, TN — E. Garrett, T. Edwards, R. Carter, C. Porter; Brigham and Women's Hospital, Boston — P. Shekar, G. Couper, M. Givertz, S. Kelly; Bryan LGH Medical Center, Lincoln, NE — E. Raines, K. Miller, L. McClement-Green; California Pacific Medical Center, San Francisco — E. Haeusslein, G.J. Avery, P. Brandenhoff, J. Carnam, T. Oka, R. Courville; Cleveland Clinic Foundation, Cleveland — N. Smedira, R. Starling, J. Navia, G. Gonzalez, T. Mihaljevic, L. Teague; Columbia University, Presbyterian Hospital, New York — Y. Naka, K. Idrissi, A. Stewart; Emory University, Atlanta — D. Vega, A. Smith, R. Laskar, J. Thompson; Hahnemann University Hospital, Philadelphia — J. Entwistle, H. Eisen, S. Hankins, T. Metzger; Henry Ford Hospital, Detroit — R. Brewer, B. Czerska, C. Williams, B. Braxton; Hershey Medical Center, Hershey, PA — W. Pae, J. Boehmer, T. Stephensen, M. Lazar, A. Myers; Hospital of the University of Pennsylvania, Philadelphia — M. Acker, M. Jessup, R. Morris, S. Desai, M. O'Hara; INTEGRIS Baptist Medical Center, Oklahoma City — J. Long, D. Horstmanshof, J. Chaffin, C. Elkins, P. Kanaly, E. Leiker; Jewish Hospital, Louisville, KY — L. Gray, R. Dowling, S. Pagni, G. Bhat, P. Adkisson, S. Prabu, R. Sharma, S. Aggarwal; Massachusetts General Hospital, Boston — T. MacGillivray, A. Agnihotri, J. Madsen, G. Vlahakes, B. Rosengard, M. Semigran, S. Ennis, J. Camuso; Mayo Clinic, Rochester, MN — R. Daly, S. Park, L. Durham, B. Edwards, C. Anderson, I. Penev; Mayo Clinic, Scottsdale, AZ — F. Arabia, P. DeValeria, E. Guyah, L. Lanza, R. Scott, E. Steidley, K. McAleer; Medical City Hospital, Dallas — T. Dewey, M. Magee, M. Mack, A. Anderson, T. Worley; Montifiore Medical Center, New York — D. Goldstein, S. Maybaum, D. D'Alessandro, N. McAllister, K. Brooks; New England Medical Center, Boston — D. Denofrio, D. Pham, H. Rastegar, A. Ehsan, H. Cote; Newark Beth Israel, Newark, NJ — M. Camacho, M. Zucker, L. McBride, S. Shah, C. Carr; Royal Victoria Hospital, Montreal — R. Cecere, N. Giannetti, C. Barber; Sacred Heart Hospital, Spokane, WA — T. Icenogle, J. Everett, D. Sandler, M. Pulhman; Sentara Norfolk General Hospital, Norfolk, VA — J. Rich, J. Herre, L. Pine, K. Fleischer, M. McGrath; Shands Hospital, University of Florida, Gainesville — C. Klodell, J. Aranda, N. Staples; Sharp Memorial Hospital, San Diego, CA — W. Dembitsky, B. Jaski, R. Adamson, S. Baradarian, S. Chillcott; St. Luke's Medical Center, Milwaukee — A. Tector, B. Pisani, J. Crouch, F. Downey, D. Kress, M. McDonald, D. O'Hair, M. Savitt, M. Miller; Tampa General Hospital, Tampa, FL — C. Sheffield, C. Caldeira, L. DiChiara; Toronto General Hospital, Toronto — V. Rao, J. MacIver; University of Alabama, Birmingham — J. Kirklin, R. Bourge, D. McGiffin, S. Pamboukian, B. Rayburn, J. Tallaj, D. Baldwin; University of Colorado, Denver — J. Cleveland, J. Lindenfeld, A. Brieke, B. Reece, S. Shakar, E. Wolfel, A. Cannon; University of Maryland, Baltimore — B. Griffith, E. Feller, J. Brown, L. Romar; University of Michigan, Ann Arbor — F. Pagani, K. Aaronson, J. Haft, T. Koelling, B. Dyke, E. Devaney, S. Wright, L. McGowan; University of Minnesota, Minneapolis — A. Boyle, R. John, L. Joyce, M. Colvin-Adams, E. Missov, C. Toninato; University of Pittsburgh Medical Center, Pittsburgh — R. Kormos, D. McNamara, K. Lockard; University of Rochester, Strong Memorial Hospital, Rochester, NY — T. Massey, L. Chen, W. Hallinan, V. Chiodo, P. Hobart; University of Washington, Seattle — E. Verrier, D. Fishbein, C. Salerno, G. Aldea, S. Andrus, N. Mokadam; University of Wisconsin, Madison — N. Edwards, M. Johnson, W. Kao, T. Kohmoto, J. Yakey, A. Li; Washington Hospital, Washington, DC — S. Boyce, L. Miller, L. Sweet, K. Petro, M. Shah; Publication Committee — L. Miller, F. Pagani, O. Frazier, S. Russell, Y. Naka, M. Slaughter, D. Farrar; Data Safety and Monitoring Board — C. Yancy, S. Hunt, W. Holman, W. Richenbacher, D. Heitjan; Clinical Events Committee — S. Moore, V. Jeevanandam, C. Thomas, S. Gordon; Thoratec, Pleasanton, CA — L. Damme (study management), J. Heatley (biostatistics), S. Reichenbach (program management).
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Masahiko Ando, Takashi Nishimura, Yoshiaki Takewa, Shunei Kyo, Minoru Ono, Yoshiyuki Taenaka, Eisuke Tatsumi. (2012) Creating an ideal “off-test mode” for rotary left ventricular assist devices: Establishing a safe and appropriate weaning protocol after myocardial recovery. The Journal of Thoracic and Cardiovascular Surgery 143:5, 1176-1182
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Adam W. Lowry, Iki Adachi, Igor D. Gregoric, Aamir Jeewa, David L.S. Morales. (2012) The Potential to Avoid Heart Transplantation in Children: Outpatient Bridge to Recovery with an Intracorporeal Continuous-Flow Left Ventricular Assist Device in a 14-Year-Old. Congenital Heart Diseaseno-no
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Jennifer T. Thibodeau, Joseph D. Mishkin, Parag C. Patel, Pradeep P.A. Mammen, David W. Markham, Mark H. Drazner. (2012) IIIB or Not IIIB: A Previously Unanswered Question. Journal of Cardiac Failure 18:5, 367-372
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Daniel J. Goldstein, Ricardo Bello, Jooyoung J. Shin, Gerin Stevens, Ronald Zolty, Simon Maybaum, David D'Alessandro. (2012) Outcomes of cardiac transplantation in septuagenarians. The Journal of Heart and Lung Transplantation
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Vladimir M. Kushnir, Shivak Sharma, Gregory A. Ewald, Jonathan Seccombe, Eric Novak, I-Wen Wang, Susan M. Joseph, C. Prakash Gyawali. (2012) Evaluation of GI bleeding after implantation of left ventricular assist device. Gastrointestinal Endoscopy 75:5, 973-979
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Koichi Toda, Yumiko Yonemoto, Tomoyuki Fujita, Yusuke Shimahara, Shyunsuke Sato, Takeshi Nakatani, Junjiro Kobayashi. (2012) Risk Analysis of Bloodstream Infection During Long-Term Left Ventricular Assist Device Support. The Annals of Thoracic Surgery
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David Joyce, Sheri Crow, Zhuo Li, Lyle Joyce, Carmelo Milano, Joseph Rogers, Nestor Villamizar-Ortiz, Dong Chen. (2012) Pilot investigation of a novel testing strategy for bleeding in ventricular assist device recipients. The Journal of Heart and Lung Transplantation
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Todd Dardas, Nahush A. Mokadam, Francis Pagani, Keith Aaronson, Wayne C. Levy. (2012) Transplant Registrants With Implanted Left Ventricular Assist Devices Have Insufficient Risk to Justify Elective Organ Procurement and Transplantation Network Status 1A Time. Journal of the American College of Cardiology
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Jeffrey J. Teuteberg, Greg A. Ewald, Robert M. Adamson, Katherine Lietz, Leslie W. Miller, Antone J. Tatooles, Robert L. Kormos, Kartik S. Sundareswaran, David J. Farrar, Joseph G. Rogers. (2012) Risk Assessment for Continuous Flow Left Ventricular Assist Devices: Does the Destination Therapy Risk Score Work?. Journal of the American College of Cardiology
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Abraham J. Nunes, Holger Buchholz, Selvi Sinnadurai, Roderick G. MacArthur. (2012) Long-Term Mechanical Circulatory Support of an Adult Patient With Down Syndrome. The Annals of Thoracic Surgery 93:4, 1305-1307
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Kimberly A. Parks, Maria Rosa Costanzo. (2012) Thinking beyond resynchronization therapy in the failing heart. Heart Rhythm
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Yoshio Iwashima, Masanobu Yanase, Takeshi Horio, Osamu Seguchi, Yoshihiro Murata, Tomoyuki Fujita, Koichi Toda, Yuhei Kawano, Takeshi Nakatani. (2012) Serial Changes in Renal Function as a Prognostic Indicator in Advanced Heart Failure Patients With Left Ventricular Assist System. The Annals of Thoracic Surgery 93:3, 816-823
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James K. Kirklin, F. Bennett Pearce, Salpy V. Pamboukian, Jeffrey A. Alten, Santiago Borasino, Waldemer F. Carlo, William L. Holman. (2012) Implantation of the HeartWare HVAD in a Child After a Recent Thromboembolic Stroke. The Annals of Thoracic Surgery 93:3, 977-978
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J. Sanchez de Toledo, J. Balcells. (2012) Asistencia ventricular pediátrica: una realidad asistencial con un futuro alentador. Anales de Pediatría 76:3, 117-119
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Brian Paul Selgrade, George A. Truskey. (2012) Computational Fluid Dynamics Analysis to Determine Shear Stresses and Rates in a Centrifugal Left Ventricular Assist Device. Artificial Organsno-no
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Jeffrey A. Morgan, Gaetano Paone, Hassan W. Nemeh, Scott E. Henry, Brent Gerlach, Celeste T. Williams, David E. Lanfear, Cristina Tita, Robert J. Brewer. (2012) Non-cardiac surgery in patients on long-term left ventricular assist device support. The Journal of Heart and Lung Transplantation
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Roger Baskett, Richard Crowell, Darren Freed, Nadia Giannetti, Christopher S. Simpson. (2012) Canadian Cardiovascular Society Focused Position Statement Update on Assessment of the Cardiac Patient for Fitness to Drive: Fitness Following Left Ventricular Assist Device Implantation. Canadian Journal of Cardiology 28:2, 137-140
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C.W. Israel, S.D. Anker, G. Hasenfuß. (2012) Kommentar zu den ESC-Leitlinien zur Device-Therapie bei Herzinsuffizienz 2010. Der Kardiologe
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Robert J. Brewer, David E. Lanfear, Chittoor B. Sai-Sudhakar, Kartik S. Sundareswaran, Yazhini Ravi, David J. Farrar, Mark S. Slaughter. (2012) Extremes of body mass index do not impact mid-term survival after continuous-flow left ventricular assist device implantation. The Journal of Heart and Lung Transplantation 31:2, 167-172
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Shunei Kyo, Taishi Minami, Takashi Nishimura, Satoshi Gojo, Minoru Ono. (2012) New era for therapeutic strategy for heart failure: Destination therapy by left ventricular assist device. Journal of Cardiology
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Jean-Noël Trochu, Pascal Leprince, Marie Bielefeld-Gomez, Olivier Bastien, Florence Beauvais, Jean-Pierre Gueffet, Damien Logeart, Richard Isnard, Marie-Christine Iliou, Christophe Leclercq, Claude Girard. (2012) Left ventricle assist device: When and which patients should we refer?. Archives of Cardiovascular Diseases 105:2, 114-121
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R. V. Pruijsten, S. I. Lok, H. H. Kirkels, C. Klopping, J. R. Lahpor, N. de Jonge. (2012) Functional and haemodynamic recovery after implantation of continuous-flow left ventricular assist devices in comparison with pulsatile left ventricular assist devices in patients with end-stage heart failure. European Journal of Heart Failure
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John J. V. McMurray. (2012) Heart failure in 2011: Heart failure therapy—technology to the fore. Nature Reviews Cardiology 9:2, 73-74
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L. K. Murray, J. Gonzalez-Costello, S. N. Jonas, D. B. Sims, K. A. Morrison, P. C. Colombo, D. M. Mancini, S. W. Restaino, E. Joye, E. Horn, H. Takayama, C. C. Marboe, Y. Naka, U. P. Jorde, N. Uriel. (2012) Ventricular assist device support as a bridge to heart transplantation in patients with giant cell myocarditis. European Journal of Heart Failure
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Stephen Westaby, Kyriakos Anastasiadis, George M. Wieselthaler. (2012) Cardiogenic shock in ACS. Part 2: role of mechanical circulatory support. Nature Reviews Cardiology
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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. (2012) Changes in Renal Function After Implantation of Continuous-Flow Left Ventricular Assist Devices. Journal of the American College of Cardiology 59:1, 26-36
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Caroline A. Vitale, Rashmi Chandekar, Phillip E. Rodgers, Francis D. Pagani, Preeti N. Malani. (2012) A Call for Guidance in the Use of Left Ventricular Assist Devices in Older Adults. Journal of the American Geriatrics Society 60:1, 145-150
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Andrew Boyle. (2012) Arrhythmias in patients with ventricular assist devices. Current Opinion in Cardiology 27:1, 13-18
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S J Park, S S Kushwaha, C G A McGregor. (2012) State-of-the-Art Implantable Cardiac Assist Device Therapy for Heart Failure: Bridge to Transplant and Destination Therapy. Clinical Pharmacology & Therapeutics 91:1, 94-100
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Daisuke Yoshioka, Taichi Sakaguchi, Shunsuke Saito, Shigeru Miyagawa, Hiroyuki Nishi, Yasushi Yoshikawa, Satsuki Fukushima, Takayoshi Ueno, Toru Kuratani, Yoshiki Sawa. (2012) Initial Experience of Conversion of Toyobo Paracorporeal Left Ventricular Assist Device to DuraHeart Left Ventricular Assist Device. Circulation Journal 76:2, 372-376
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Tomoko S. Kato, P. Christian Schulze, Jonathan Yang, Ernest Chan, Khurram Shahzad, Hiroo Takayama, Nir Uriel, Ulrich Jorde, Maryjane Farr, Yoshifumi Naka, Donna Mancini. (2012) Pre-operative and post-operative risk factors associated with neurologic complications in patients with advanced heart failure supported by a left ventricular assist device. The Journal of Heart and Lung Transplantation 31:1, 1-8
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Ralph J. Petrucci, Joseph G. Rogers, Laura Blue, Colleen Gallagher, Stuart D. Russell, Dzifa Dordunoo, Brian E. Jaski, Suzanne Chillcott, Benjamin Sun, Tammy L. Yanssens, Antone Tatooles, Lalig Koundakjian, David J. Farrar, Mark S. Slaughter. (2012) Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsatile-flow left ventricular assist device support. The Journal of Heart and Lung Transplantation 31:1, 27-36
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