Durability of left ventricular assist devices: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2006 to 2011.

The present study compared the interval until device exchange or death from pump-related failure in patients with pulsatile versus continuous flow left ventricular assist devices. Data from Interagency Registry for Mechanically Assisted Circulatory Support (June 23, 2006, to March 31, 2011) compared the durability of implanted pulsatile and continuous flow left ventricular assist devices. The durability issues included pump replacement for infection, thrombosis-hemolysis, driveline failure, or pump drive unit failure, and death from driveline or pump drive unit failure. A total of 3302 left ventricular assist devices were implanted (486 pulsatile, 2816 continuous flow) and 98 pump exchanges or deaths from durability issues (46 pulsatile, 52 continuous flow; 3% of implants). The interval to device issue was greater for the continuous flow than for the pulsatile devices (P < .001). A comparisons of the causes for pump exchange or pump-related death showed (1) greater freedom from pump failure in the continuous flow compared with the pulsatile left ventricular assist devices (10 events/2816 continuous flow implants vs 39 events/486 pulsatile implants; P < .0001); (2) similar exchange or pump-related death for driveline failure (1/486 pulsatile vs 7/2816 continuous flow; P = .82); (3) similar exchange or pump-related death for thrombosis-hemolysis (2/486 pulsatile vs 28/2816 continuous flow; P = .25); and (4) fewer exchanges or pump-related deaths from infection in continuous flow left ventricular assist devices (4/486 pulsatile vs 7/2816 continuous flow; P = .034). Competing outcomes analysis corroborated this finding, with 54% of continuous flow versus 23% of pulsatile patients alive and receiving support at 12 months after implantation. The Analysis of Interagency Registry for Mechanically Assisted Circulatory Support data showed greater durability for continuous flow than for pulsatile left ventricular assist devices. Even longer durations of support can be expected if pump durability continues to improve.

Holman WL ，Naftel DC ，Eckert CE ，Kormos RL ，Goldstein DJ ，Kirklin JK ... -  《-》

Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device.

Kirklin JK ，Naftel DC ，Kormos RL ，Pagani FD ，Myers SL ，Stevenson LW ，Acker MA ，Goldstein DL ，Silvestry SC ，Milano CA ，Baldwin JT ，Pinney S ，Eduardo Rame J ，Miller MA ... -  《-》

Survival after biventricular assist device implantation: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database.

Patients requiring biventricular assist device (BiVAD) for mechanical circulatory support (MCS) have substantially worse outcomes than patients requiring left VAD (LVAD) support only. Patient-specific risk factors have yet to be consistently identified in a large, multicenter registry, which may underlie the poorer outcomes for BiVAD patients. The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a registry of U.S. Food and Drug Administration-approved durable MCS devices used for bridge-to-transplantation, destination therapy, or recovery. The purposes of this study were to 1) identify the underlying pre-implant characteristics of the population requiring BiVAD support that contribute to reduced survival, and 2) identify differences in postoperative outcomes with respect to adverse events compared with patients supported with LVAD alone. From June 2006 to September 2009, 1,646 patients were entered into the INTERMACS database in which adverse events and outcomes were recorded for primary implants with LVAD or BiVAD. Competing outcomes methodology was used to estimate the time-related probability of death, transplant, or recovery. Overall survival for all groups was analyzed with Kaplan-Meier methods and Cox proportional regression analysis. The distribution of primary device implants included 1,440 LVADs and 206 BiVADs. BiVAD patients presented with a lower INTERMACS profile 93% in INTERMACS 1 or 2, compared with 73% for LVAD patients (p < 0.001). Survival at 6 months was 86% for LVADs and 56% for BiVADs (p < .0001). Adverse event rates, expressed as episodes/100 patient-months for the BiVAD group compared with LVAD, were significantly higher for infection (33.2 vs 14.3), bleeding (71.6 vs 15.5), neurologic events (7.9 vs 2.6), and for device failure (4.9 vs 2.0). Patients requiring BiVAD support at the time of durable MCS implant are more critically ill at the time of MCS implant. BiVAD patients experience worse survival than patients supported with LVAD alone and higher rates of serious adverse events. Characteristics of the population present at the time of BiVAD implant likely influence post-implant MCS outcomes.

Cleveland JC Jr ，Naftel DC ，Reece TB ，Murray M ，Antaki J ，Pagani FD ，Kirklin JK ... -  《-》

Outcomes after implantation of partial-support left ventricular assist devices in inotropic-dependent patients: Do we still need full-support assist devices?

Sabashnikov A ，Popov AF ，Bowles CT ，Mohite PN ，Weymann A ，Hards R ，Hedger M ，Wittwer T ，Wippermann J ，Wahlers T ，Schoendube FA ，Simon AR ... -  《-》

Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support

A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. New device technology developed in the clinical research setting requires validation in a real-world setting. The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).

Jorde UP ，Kushwaha SS ，Tatooles AJ ，Naka Y ，Bhat G ，Long JW ，Horstmanshof DA ，Kormos RL ，Teuteberg JJ ，Slaughter MS ，Birks EJ ，Farrar DJ ，Park SJ ，HeartMate II Clinical Investigators ... -  《-》