Right heart failure and "failure to thrive" after left ventricular assist device: clinical predictors and outcomes.

This study determined predictors of early post-operative right heart failure (RHF) and its consequences, as well as predictors of those who clinically thrive longer term after insertion of a continuous-flow left ventricular assist device (LVAD). Pre-operative and latest follow-up data were analyzed for 40 consecutive patients who received third-generation centrifugal-flow LVADs. RHF was defined using previously described criteria, including post-operative inotropes, pulmonary vasodilator use, or right-sided mechanical support. Patients were also categorized according to clinical outcomes after LVAD insertion. LVADs were implanted as a bridge to transplantation (BTT) in 33 patients and as destination therapy in 7. Before LVAD implant, 22 patients were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1, and 17 were at level 2. Temporary mechanical assistance was present in 50% of the cohort at LVAD implantation. The 6-month survival/progression to transplant was 92.5%. Average LVAD support time was 385 days (range, 21-1,011 days). RHF developed postoperatively in 13 of 40 patients (32.5%). RHF patients had more severe pre-operative tricuspid incompetence than non-RHF patients. The BTT patients with evidence of RHF had poorer survival to transplant (6 of 11 [54.5%]) than those without RHF (20 of 22 [90.9%]), p = 0.027). There were no other hemodynamic or echocardiographic predictors of short-term RHF. After LVAD, 22 of the 40 patients (55%) thrived clinically. For BTT patients, 20 of 21 (95%) of those who thrived progressed to transplant or were alive at latest follow-up vs 6 of 12 (50%) of those who failed to thrive (FTT; p < 0.005). The thrivers had lower New York Heart Association class (1.5 vs 2.9, p < 0.001), spent less time in the hospital, and had less ventricular tachycardia than the FTT patients. However, no differences were noted in pre-operative INTERMACS level, echocardiographic, hemodynamic, and biochemical indices, or in early post-operative RHF. Age was the only significant predictor: the thrivers were significantly younger (43.7 ± 15.9 vs 60.3 ± 12.6 years; p < 0.001). This age difference was unchanged after exclusion of destination strategy patients. RV function deteriorated in the FTT patients and remained stable in those who thrived. Early post-operative RHF results in poorer survival/progression to transplantation for BTT patients and is predicted by greater pre-operative tricuspid incompetence. The most important predictor for those who will clinically thrive longer-term after LVAD insertion is younger age.

Baumwol J ，Macdonald PS ，Keogh AM ，Kotlyar E ，Spratt P ，Jansz P ，Hayward CS ... -  《-》

Right heart failure after left ventricular assist device implantation in patients with chronic congestive heart failure.

Dang NC ，Topkara VK ，Mercando M ，Kay J ，Kruger KH ，Aboodi MS ，Oz MC ，Naka Y ... -  《-》

Post-cardiac transplant survival after support with a continuous-flow left ventricular assist device: impact of duration of left ventricular assist device support and other variables.

John R ，Pagani FD ，Naka Y ，Boyle A ，Conte JV ，Russell SD ，Klodell CT ，Milano CA ，Rogers J ，Farrar DJ ，Frazier OH ... -  《-》

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 Circul

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. 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. 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. 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. 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.

Starling RC ，Naka Y ，Boyle AJ ，Gonzalez-Stawinski G ，John R ，Jorde U ，Russell SD ，Conte JV ，Aaronson KD ，McGee EC Jr ，Cotts WG ，DeNofrio D ，Pham DT ，Farrar DJ ，Pagani FD ... -  《-》

Predictors of death and transplant in patients with a mechanical circulatory support device: a multi-institutional study.

Holman WL ，Kormos RL ，Naftel DC ，Miller MA ，Pagani FD ，Blume E ，Cleeton T ，Koenig SC ，Edwards L ，Kirklin JK ... -  《-》