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Ranjit John - One of the best experts on this subject based on the ideXlab platform.
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results of the post u s food and drug administration approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation a prospective study using the intermacs interagency registry for mechanically assisted circ
Journal of the American College of Cardiology, 2011Co-Authors: Randall C Starling, Keith D Aaronson, Ulrich P Jorde, Andrew J Boyle, Ranjit John, Yoshifumi Naka, Stuart D Russell, John V Conte, Gonzalo V Gonzalezstawinski, Edwin C McgeeAbstract:Objectives The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. Background After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. Methods The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Results Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. Conclusions The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.
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mechanical circulatory support in patients with heart failure secondary to transposition of the great arteries
Journal of Heart and Lung Transplantation, 2009Co-Authors: David L Joyce, Ranjit John, Sheri Crow, James D St Louis, Elizabeth A Braunlin, Lee A Pyles, Paula Kofflin, Lyle D JoyceAbstract:Advances in palliation of congenital heart disease have resulted in improved survival to adulthood. Many of these patients ultimately develop end-stage heart failure requiring left ventricular assist device implantation (LVAD). However, morphologic differences in the systemic ventricle of these patients require careful attention to cannula placement. We report on the evolution of our surgical technique for implanting LVADs in 3 patients with transposition of the great arteries and congenitally corrected transposition of the great arteries. Applying standard LV cannulation techniques to the systemic ventricle led us too anteriorly in our first patient, creating obstruction by the moderator band. Subsequent use of epicardial and transesophageal echocardiography allowed for intraoperative localization of the intracardiac muscular structures to identify the optimal cannulation site. The acute angle of the inflow cannula on the DeBakey LVAD (MicroMed Technology, Houston, TX) required flipping the device 180°. The HeartMate II device (Thoratec, Pleasanton, CA) could be shifted towards the midline. One patient underwent successful transplant and 2 are home waiting for a donor organ. We conclude from our experience that LVAD surgery can be safely performed in patients with congenital heart disease when implanted under echocardiographic guidance.
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effects of pulsatile and continuous flow left ventricular assist devices on left ventricular unloading
Journal of Heart and Lung Transplantation, 2008Co-Authors: Santiago Garcia, Forum Kandar, Andrew J Boyle, Monica Colvinadams, Kenneth Lliao, Lyle D Joyce, Ranjit JohnAbstract:Background 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. Methods 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. Results 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 p p -values not statistically significant). Conclusions 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.
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is severe right ventricular failure in left ventricular assist device recipients a risk factor for unsuccessful bridging to transplant and post transplant mortality
The Annals of Thoracic Surgery, 2004Co-Authors: Jeffrey A. Morgan, Ranjit John, Brian J. Lee, Yoshifumi NakaAbstract:Abstract Background Bridging to transplant with a left ventricular assist device (LVAD) can be limited by severe right ventricular failure (RVF). The focus of this study was to ascertain whether early implantation ( Methods We conducted a 10-year review of our bridge to transplant experience using the Heartmate device (Thoratec, Pleasanton, CA, USA), studying patients who required an Abiomed RVAD (Abiomed, Danvers, MA, USA). Results There were 243 patients who underwent LVAD implantation, of which 17 (7.0%) required an RVAD. Ten patients underwent early RVAD insertion ( 24 hours). Bridging to transplant was successful in 11 (64.7%) RVAD patients versus 163 (72.1%) non-RVAD patients ( p = 0.046). Of the 10 patients who underwent early RVAD insertion, 7 (70.0%) were successfully bridged. Of the 7 patients who underwent delayed RVAD insertion, 4 (57.1%) were successfully bridged ( p p = 0.366). Pretransplant RVAD support was not a risk factor for post-transplant mortality ( p = 0.864). Conclusions Severe RVF adversely impacted bridging to transplant, although survival was improved with early RVAD insertion. The trend toward worse post-transplant survival in the RVAD cohort raises the possibility that if additional patients were evaluated, a difference in survival might be observed, suggesting the need for a multicenter analysis.
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Bridging to transplant with the HeartMate left ventricular assist device: The Columbia Presbyterian 12-year experience
The Journal of thoracic and cardiovascular surgery, 2004Co-Authors: Jeffrey A. Morgan, Ranjit John, Vivek Rao, Alan D. Weinberg, Brian J. Lee, Pamela A. Mazzeo, M. Flannery, Jonathan M. Chen, Yoshifumi NakaAbstract:Abstract Objective Implantation of a left ventricular assist device as a bridge to transplantation has become an acceptable approach for patients with end-stage heart failure. Our long-term results with 3 Thoratec HeartMate devices are presented to outline improvements in successful bridging to transplantation and post-transplant survival. Methods From August 1990 through January 2003, 243 patients underwent implantation of Thoratec HeartMate devices as a bridge to transplantation. This included 52 (21.4%) pneumatic devices, 17 (7.0%) dual-lead vented electric devices, and 174 (71.6%) single-lead vented electric devices. Results Mean age was 49.7 ± 13.7 years. Mean support time was 78.1 ± 82.9 days (0-541). Bridging success increased from 63.5% (n = 33) for pneumatic devices to 64.7% (n = 11) for dual-lead vented electric devices and 72.4% (n = 126) for single-lead vented electric devices ( P = .005). Posttransplant 1-, 3-, and 5-year actuarial survival increased from 87.5%, 78.1%, and 71.9% in patients with pneumatic devices to 91.5%, 86.9%, and 81.3%, respectively, for patients with single-lead vented electric devices. Device infection and malfunction occurred in 17.7% (n = 43) and 12.8% (n = 31) of patients, respectively. Conclusions Successful bridging to transplantation and posttransplant survival has improved over time. Left ventricular assist devices have become increasingly more effective in bridging patients with end-stage heart failure to transplantation. This is likely due to a combination of better patient selection, improvements in clinical practice, and evolution in device design.
Francis D. Pagani - One of the best experts on this subject based on the ideXlab platform.
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pump thrombosis in the Thoratec heartmate ii device an update analysis of the intermacs registry
Journal of Heart and Lung Transplantation, 2015Co-Authors: James K Kirklin, Francis D. Pagani, Joseph G. Rogers, Robert L. Kormos, Mark S Slaughter, Michael A Acker, David C Naftel, S L Myers, Lynne W StevensonAbstract:Background Pump thrombosis in durable continuous-flow pumps is a barrier to long-term mechanical circulatory support. Earlier Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data identified an increasing risk of pump thrombosis in recent years with the HeartMate II (HMII) left ventricular assist device. The current analysis examines pump thrombosis in the patient cohort extended through June 2014. Methods The INTERMACS identified 9,808 adult patients from 144 institutions receiving a primary HMII implant between April 2008 and June 30, 2014. Pump thrombosis was identified at time of explant, transplant or death. Risk factors for pump thrombosis were examined by multivariable analysis in the hazard function domain. The association between pump thrombosis and implant year was modeled in the hazard domain. Results Parametric hazard modeling of thrombosis by year of implant identified an increasing risk of pump thrombosis from 2009 through 2013, followed by a decrease in the risk during the first half of 2014, which was most apparent during the first 3 months post-implant. Risk factors for pump thrombosis included younger age ( p p = 0.02), history of non-compliance ( p = 0.004), severe right heart failure ( p = 0.02), later date of implant ( p p p Conclusions The small, but progressive increase in the incidence of pump thrombosis observed between 2010 and 2013 with the HMII pump had reversed somewhat in the first half of 2014. Identification of marked elevation of lactate dehydrogenase during the first month offers an opportunity for early intervention strategies.
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device exchange after primary left ventricular assist device implantation indications and outcomes
The Annals of Thoracic Surgery, 2013Co-Authors: John M Stulak, Jennifer Cowger, Jonathan W Haft, Keith D Aaronson, Matthew A Romano, Francis D. PaganiAbstract:Background Patients are being supported for longer periods with implantable left ventricular assist devices (LVADs) owing to longer transplantation wait times and approval of LVADs for destination therapy. This comes with an increased potential need for device exchange when complications arise. There are few data examining this patient population. Methods Between August 1998 and January 2012, 45 patients (34 men) underwent 57 device exchanges after primary pulsatile or continuous-flow LVAD implantation. The median age at the initial LVAD implantation was 58 years (range, 28–78 years) and the median time to first device exchange was 15 months (range, immediate–56 months). Indications for primary LVAD included bridge to transplantation in all but 10 patients, and devices included the HeartMate I (Thoratec, Pleasanton, CA) in 16 patients, the HeartMate II (Thoratec) in 21 patients, the HeartWare HVAD (HeartWare, Framingham, MA) in 2 patients, the DuraHeart I (Terumo Heart, Ann Arbor, MI) in 1 patient, and other devices in 5 patients. Indications for reoperation included device/component failure (n = 24), major driveline infection (n = 15), pump thrombus (n = 15), and other indications (n = 2). Results Pumps implanted in 57 reoperations included the HeartMate I in 15 patients, the HeartMate II in 35 patients, the HeartWare HVAD in 2 patients, the DuraHeart I in 2 patients, and other devices in 3 patients. Early mortality occurred in 2/57 (3.5%) patients. Median follow-up was 18 months (range, 1–113 months); median length of LVAD therapy after the first device exchange was 13 months (range, 1–59 months). Actuarial 1-year survival and freedom from repeated device exchange after the first exchange was 89% and 79%, respectively. Conclusions Device exchange may be required after LVAD implantation. This can be performed with low early mortality and no adverse effect on late survival. Multiple reoperations may be required in some patients.
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long term use of the centrimag ventricular assist system as a right ventricular assist device a case report
Perfusion, 2012Co-Authors: Kevin E Griffith, Eric Jenkins, John M Stulak, T Paugh, Francis D. PaganiAbstract:Right ventricular failure (RVF) following implantation of a left ventricular assist system (LVAS) is associated with high morbidity and mortality.1-4 Numerous centers have reported short-term use of the CentriMag® Ventricular Assist System (CVAS) (Levitronix LLC, Waltham, MA) for treatment of cardiogenic shock, decompensated heart failure and right ventricular failure (RVF) following LVAS implantation.5-9 The present report reviews the clinical course of a patient requiring long-term right ventricular support utilizing the CVAS, following a HeartMate® II LVAS (Thoratec Corp. Pleasanton, CA) implantation. Elevated cytotoxic antibody levels complicated the patient’s treatment plan by precluding orthotropic heart transplantation. The CVAS operated for 304 days without mechanical difficulty until replaced with the HeartWare® Ventricular Assist System (HeartWare Inc. Miramar, FL).
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hemodynamic and exercise performance with pulsatile and continuous flow left ventricular assist devices
Circulation, 2007Co-Authors: Jonathan W Haft, William F Armstrong, D B Dyke, Keith D Aaronson, Todd M Koelling, David J Farrar, Francis D. PaganiAbstract:Background— Continuous-flow rotary pumps with axial design are increasingly used for left ventricular assist support. The efficacy of this design compared with pulsatile, volume displacement pumps, with respect to characteristics of left ventricular unloading, and exercise performance remains largely unstudied. Methods and Results— Thirty-four patients undergoing implantation with a pulsatile, volume displacement pump operating in a full-to-empty cycle (HeartMate XVE; Thoratec Inc, Pleasanton, Calif; n=16) or continuous-flow rotary pump with an axial design operating at a fixed rotor speed (HeartMate II; Thoratec Inc; n=18) were evaluated with right heart catheterization and echocardiography preoperatively and at 3 months postoperatively and cardiopulmonary exercise testing 3 months postoperatively. Support with either the XVE or II resulted in significant ( P 2 −XVE: 46.8±10.2 versus II: 49.1±13.6). Echocardiography at 3 months demonstrated a significantly ( P Conclusions— The HeartMate XVE or II provided equivalent degrees of hemodynamic support and exercise capacity. The XVE was associated with greater left ventricular volume unloading. Characteristics of left ventricular pressure and volume unloading between these pump designs and mode of operation do not influence early exercise performance.
David J Farrar - One of the best experts on this subject based on the ideXlab platform.
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hemodynamic and exercise performance with pulsatile and continuous flow left ventricular assist devices
Circulation, 2007Co-Authors: Jonathan W Haft, William F Armstrong, D B Dyke, Keith D Aaronson, Todd M Koelling, David J Farrar, Francis D. PaganiAbstract:Background— Continuous-flow rotary pumps with axial design are increasingly used for left ventricular assist support. The efficacy of this design compared with pulsatile, volume displacement pumps, with respect to characteristics of left ventricular unloading, and exercise performance remains largely unstudied. Methods and Results— Thirty-four patients undergoing implantation with a pulsatile, volume displacement pump operating in a full-to-empty cycle (HeartMate XVE; Thoratec Inc, Pleasanton, Calif; n=16) or continuous-flow rotary pump with an axial design operating at a fixed rotor speed (HeartMate II; Thoratec Inc; n=18) were evaluated with right heart catheterization and echocardiography preoperatively and at 3 months postoperatively and cardiopulmonary exercise testing 3 months postoperatively. Support with either the XVE or II resulted in significant ( P 2 −XVE: 46.8±10.2 versus II: 49.1±13.6). Echocardiography at 3 months demonstrated a significantly ( P Conclusions— The HeartMate XVE or II provided equivalent degrees of hemodynamic support and exercise capacity. The XVE was associated with greater left ventricular volume unloading. Characteristics of left ventricular pressure and volume unloading between these pump designs and mode of operation do not influence early exercise performance.
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results of a multicenter clinical trial with the Thoratec implantable ventricular assist device
The Journal of Thoracic and Cardiovascular Surgery, 2007Co-Authors: Mark S Slaughter, David J Farrar, Robert L. Kormos, Steven Tsui, A Elbanayosy, Benjamin Sun, Dale K Mueller, Todd H Massey, T B Icenogle, Donald J HillAbstract:Objective The Thoratec Implantable Ventricular Assist Device (Thoratec Corporation, Pleasanton, Calif) can be used for univentricular or biventricular support in patients with a body surface area as low as 1.3 m 2 . Results of the multicenter clinical trial are reviewed. Methods Between October 2001 and June 2004, a total of 39 patients at 12 institutions were supported with the Thoratec Implantable Ventricular Assist Device. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to transplantation (n = 30) and postcardiotomy failure (n = 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device. Results Twenty-eight male and 11 female patients, with mean age of 48 years (16–71 years) and body surface area of 1.9 m 2 (1.3–2.4 m 2 ) were supported for 3938 patient-days (10.8 patient-years). Mean left ventricular assist device flow index on the first postoperative day was 2.5 ± 0.5 L/(min·m 2 ). Mean duration of support was 101 days (9–597 days). Eighteen patients were discharged after a mean duration of 96 days. There were no ventricular assist device failures. Complications included 13 cases of bleeding requiring reexploration (33.3%), 1 embolic and 2 hemorrhagic strokes (7.7%), 5 driveline infections (12.8%), and 2 pocket infections (5%). Support to successful outcomes was 70% for bridge to transplantation and 67% for postcardiotomy recovery, versus historical results for the paracorporeal ventricular assist device of 69% for bridge to transplantation and 48% for postcardiotomy recovery. Conclusion The Thoratec Implantable Ventricular Assist Device is a new implantable pulsatile ventricular assist device that allows hospital discharge for patients as a bridge to transplantation or for postcardiotomy failure. It is the first Food and Drug Administration–approved implantable ventricular assist device with biventricular capability.
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development of an intracorporeal Thoratec ventricular assist device for univentricular or biventricular support
Asaio Journal, 2000Co-Authors: David J Farrar, Steven H Reichenbach, Stephen A Rossi, Jason R WeidmanAbstract:There is a need for a small, simple, and versatile intracorporeal ventricular assist device (IVAD) as an alternative to the large implantable electromechanical LVAD systems in current use. Because the basic design of the Thoratec paracorporeal VAD has been demonstrated in over 1,000 patients, weighing from 17 to 144 kg, and for durations up to 515 days including patient discharge (by using the portable driver), we are developing a new intracorporeal version of our VAD. This IVAD has a smooth contoured, polished titanium housing, and maintains the same blood flow path and Thoralon polyurethane blood pumping sac as the paracorporeal VAD. The IVAD is controlled with the Thoratec TLC-II Portable VAD Driver, which is a small briefcase sized, battery powered, pneumatic control unit. Intracorporeal LVADs and/or RVADs are implanted in a preperitoneal position, with a single small (9 mm OD) percutaneous pneumatic driveline for each VAD. The major advantages of the new IVAD design are size and simplicity. The IVAD weight (339 g) and implanted volume (252 ml) are substantially smaller than current implantable electromechanical LVAD systems. Only the small blood pump is implanted, leaving the more complex control unit external, where it can be serviced and replaced. The versatile design is intended for left and/or right heart support in large or small patients. The IVAD in combination with the TLC-II portable driver will be a viable and attractive alternative to large, implanted electromechanical systems.
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recovery of major organ function in patients awaiting heart transplantation with Thoratec ventricular assist devices Thoratec ventricular assist device principal investigators
Journal of Heart and Lung Transplantation, 1994Co-Authors: David J Farrar, J D HillAbstract:The time course of recovery of hepatic and renal function was determined in 193 patients receiving Thoratec ventricular assist devices while awaiting transplantation at 41 hospitals in eight countries. The duration of circulatory support averaged 26 days (maximum 248 days) and the average ventricular assist device blood flow index was 2.7 ± 0.5 L/min/m 2 compared with a preoperative cardiac index of 1.4 ± 0.7 L/min/m 2 . Renal and hepatic function improved in most patients in 1 to 3 weeks of support. When comparing patients with the longest durations on the ventricular assist device (60 to 248 days) to patients with the shortest durations (< 7 days), laboratory values were significantly improved: creatinine (−29%, from 1.7 ± 1.2 to 1.2 ± 0.5 mg/dl), blood urea nitrogen (−32%, from 37 ± 27 to 25 ± 14 mg/dl), serum glutamic-oxaloacetic transaminase (−81%, from 397 ± 702 to 76 ± 45 IU) and total bilirubin (−79%, from 7.0 ± 8.6 to 1.5 ± 0.7 mg/dl)
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Preoperative predictors of survival in patients with Thoratec ventricular assist devices as a bridge to heart transplantation. Thoratec Ventricular Assist Device Principal Investigators.
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 1994Co-Authors: David J FarrarAbstract:Approximately two-thirds of patients implanted with ventricular assist devices recover sufficiently to requalify for heart transplantation, and the other one-third die of complications that are often secondary to delayed ventricular assist device implantation and subsequent end-organ failure. To determine whether any preoperative predictors of survival exist, univariate statistics and multivariate stepwise logistic regression analysis were performed on pre-ventricular assist device demographics, hemodynamics, and blood chemistry in 186 patients receiving Thoratec ventricular assist devices (Thoratec Laboratories Corp., Berkeley, Calif.) while awaiting transplantation. The duration of circulatory support averaged 19.6 days (maximum, 226 days). One hundred thirty-seven patients (74%) received biventricular support, 47 received isolated left ventricular assist devices, and two received right ventricular assist devices. The average blood flow was 5.0 +/- 0.9 L/min. One hundred eighteen patients (63%) ultimately received heart transplants, of whom 96 patients were discharged. Age, gender, weight, and diagnosis were not related to survival, nor were preoperative cardiac index, pulmonary capillary wedge pressure, intraaortic balloon pumps, or cardiac arrests. Pre-ventricular assist device creatinine levels (p = 0.24) and total bilirubin levels (p = 0.09) were not significant, but blood urea nitrogen level (p = 0.02) and previous operations (p = 0.05) were related to survival, using univariate techniques. Patients with cardiac operations more than 30 days previously had the lowest survival-to-transplantation (39%) compared with patients with no previous operations (67%) or operations within the previous 30 days (61%). Blood urea nitrogen level was the only parameter found to be significant (p = 0.016) in a multivariate model.(ABSTRACT TRUNCATED AT 250 WORDS)
Yoshifumi Naka - One of the best experts on this subject based on the ideXlab platform.
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reinforcement of heartmate ii bend relief connection champagne bottle technique
The Annals of Thoracic Surgery, 2013Co-Authors: Takeyoshi Ota, Hiroo Takayama, Zain I Khalpey, Yoshifumi NakaAbstract:HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow ventricular assist devices may be exchanged through a subcostal approach, where the device body can be accessed easily and safely. The existing bend relief needs to be reattached to the new device body at the end of the operation, and this reattachment often results in a malalignment between the outflow graft, the bend relief, and the device body. This causes unexpected detachment and subsequent graft kinking. We present a new, simple technique to reinforce the bend relief connection.
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results of the post u s food and drug administration approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation a prospective study using the intermacs interagency registry for mechanically assisted circ
Journal of the American College of Cardiology, 2011Co-Authors: Randall C Starling, Keith D Aaronson, Ulrich P Jorde, Andrew J Boyle, Ranjit John, Yoshifumi Naka, Stuart D Russell, John V Conte, Gonzalo V Gonzalezstawinski, Edwin C McgeeAbstract:Objectives The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. Background After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. Methods The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Results Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. Conclusions The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.
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is severe right ventricular failure in left ventricular assist device recipients a risk factor for unsuccessful bridging to transplant and post transplant mortality
The Annals of Thoracic Surgery, 2004Co-Authors: Jeffrey A. Morgan, Ranjit John, Brian J. Lee, Yoshifumi NakaAbstract:Abstract Background Bridging to transplant with a left ventricular assist device (LVAD) can be limited by severe right ventricular failure (RVF). The focus of this study was to ascertain whether early implantation ( Methods We conducted a 10-year review of our bridge to transplant experience using the Heartmate device (Thoratec, Pleasanton, CA, USA), studying patients who required an Abiomed RVAD (Abiomed, Danvers, MA, USA). Results There were 243 patients who underwent LVAD implantation, of which 17 (7.0%) required an RVAD. Ten patients underwent early RVAD insertion ( 24 hours). Bridging to transplant was successful in 11 (64.7%) RVAD patients versus 163 (72.1%) non-RVAD patients ( p = 0.046). Of the 10 patients who underwent early RVAD insertion, 7 (70.0%) were successfully bridged. Of the 7 patients who underwent delayed RVAD insertion, 4 (57.1%) were successfully bridged ( p p = 0.366). Pretransplant RVAD support was not a risk factor for post-transplant mortality ( p = 0.864). Conclusions Severe RVF adversely impacted bridging to transplant, although survival was improved with early RVAD insertion. The trend toward worse post-transplant survival in the RVAD cohort raises the possibility that if additional patients were evaluated, a difference in survival might be observed, suggesting the need for a multicenter analysis.
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Bridging to transplant with the HeartMate left ventricular assist device: The Columbia Presbyterian 12-year experience
The Journal of thoracic and cardiovascular surgery, 2004Co-Authors: Jeffrey A. Morgan, Ranjit John, Vivek Rao, Alan D. Weinberg, Brian J. Lee, Pamela A. Mazzeo, M. Flannery, Jonathan M. Chen, Yoshifumi NakaAbstract:Abstract Objective Implantation of a left ventricular assist device as a bridge to transplantation has become an acceptable approach for patients with end-stage heart failure. Our long-term results with 3 Thoratec HeartMate devices are presented to outline improvements in successful bridging to transplantation and post-transplant survival. Methods From August 1990 through January 2003, 243 patients underwent implantation of Thoratec HeartMate devices as a bridge to transplantation. This included 52 (21.4%) pneumatic devices, 17 (7.0%) dual-lead vented electric devices, and 174 (71.6%) single-lead vented electric devices. Results Mean age was 49.7 ± 13.7 years. Mean support time was 78.1 ± 82.9 days (0-541). Bridging success increased from 63.5% (n = 33) for pneumatic devices to 64.7% (n = 11) for dual-lead vented electric devices and 72.4% (n = 126) for single-lead vented electric devices ( P = .005). Posttransplant 1-, 3-, and 5-year actuarial survival increased from 87.5%, 78.1%, and 71.9% in patients with pneumatic devices to 91.5%, 86.9%, and 81.3%, respectively, for patients with single-lead vented electric devices. Device infection and malfunction occurred in 17.7% (n = 43) and 12.8% (n = 31) of patients, respectively. Conclusions Successful bridging to transplantation and posttransplant survival has improved over time. Left ventricular assist devices have become increasingly more effective in bridging patients with end-stage heart failure to transplantation. This is likely due to a combination of better patient selection, improvements in clinical practice, and evolution in device design.
Abdallah G Kfoury - One of the best experts on this subject based on the ideXlab platform.
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pulsatility and the risk of nonsurgical bleeding in patients supported with the continuous flow left ventricular assist device heartmate ii
Circulation-heart Failure, 2013Co-Authors: Omar Weverpinzon, Craig H Selzman, Stavros G Drakos, Abdulfattah Saidi, Gregory J Stoddard, Edward M Gilbert, Mohamed Labedi, B B Reid, Erin Davis, Abdallah G KfouryAbstract:Background—Bleeding is an important cause of morbidity and mortality in patients with continuous-flow left ventricular assist devices (LVADs). Reduced pulsatility has been implicated as a contributing cause. The aim of this study was to assess the effects of different degrees of pulsatility on the incidence of nonsurgical bleeding. Methods and Results—The Utah Transplantation Affiliated Hospitals (U.T.A.H.) heart failure and transplant program databases were queried for patients with end-stage heart failure who required support with the continuous-flow LVAD HeartMate II (Thoratec Corp, Pleasanton, CA) between 2004 and 2012. Pulsatility was evaluated by means of the LVAD parameter pulsatility index (PI) and by the echocardiographic assessment of aortic valve opening during the first 3 months of LVAD support. PI was analyzed as a continuous variable and also stratified according to tertiles of all the PI measurements during the study period (low PI: 5.2). Major ...
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long term destination therapy with the heartmate xve left ventricular assist device improved outcomes since the rematch study
Congestive Heart Failure, 2005Co-Authors: James W Long, Carmelo A. Milano, Joseph G. Rogers, Mark S Slaughter, Abdallah G Kfoury, Marc A Silver, Reynolds M Delgado, O H FrazierAbstract:The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial demonstrated increased 1- and 2-year survival and improved quality of life for end-stage heart failure patients implanted with the HeartMate VE Left Ventricular Assist Device (LVAD) (Thoratec Corporation, Pleasanton, CA) compared with optimal medical management. This is the first report of Destination Therapy (DT) experience since REMATCH and incorporates improvements with the HeartMate XVE LVAD and patient management. Forty-two patients with end-stage heart failure at higher volume institutions were supported with the LVAD over a duration of 26.7 patient years (mean 232 days). Compared with REMATCH, DT patients had a 40% lower rate of death (0.49 vs. 0.84 deaths per patient year). Kaplan-Meier estimates of survival in the DT and REMATCH LVAD groups at 30 days were 90% and 81%, and at 1 year were 61% and 52%. The death rate due to sepsis was 8.3 times lower in DT patients (risk ratio, 0.12; 95% confidence interval, 0.02-0.90). DT patients were 2.1 times less likely to experience an adverse event (risk ratio, 0.47; 95% confidence interval, 0.35-0.63). These results demonstrate continued improvement with outcomes in long-term DT with LVADs. Given that these DT patients were similar to those in the REMATCH trial, the improved outcomes likely reflect improvements in the HeartMate XVE LVAD and experience with patient management.