Background SCIPIO is a first-in-human, phase 1, randomized, open-label trial of autologous c-kit+ cardiac stem cells (CSCs) in patients with heart failure of ischemic etiology undergoing coronary artery bypass grafting (CABG). Here, we report the surgical aspects and interim cardiac magnetic resonance (CMR) results. Methods and Results A total of 33 patients (20 CSC-treated and 13 controls) met final eligibility criteria and were enrolled in SCIPIO. CSCs were isolated from the right atrial appendage harvested and processed during surgery. Harvesting did not affect cardiopulmonary bypass, cross-clamp, or surgical times. In CSC-treated patients, CMR showed a marked increase in both LVEF (from 27.5 ± 1.6% to 35.1 ± 2.4 % [P=0.004, n=8] and 41.2 ± 4.5 % [P=0.013, n=5] at 4 and 12 months after CSC infusion, respectively) and regional EF in the CSC-infused territory. Infarct size (late gadolinium enhancement) decreased after CSC infusion (by manual delineation: -6.9 ± 1.5 g [-22.7%] at 4 months [P=0.002, n=9] and -9.8 ± 3.5 g [-30.2%] at 12 months [P=0.039, n=6],). LV non-viable mass decreased even more (-11.9 ± 2.5 g [-49.7%] at 4 months [P=0.001] and -14.7 ± 3.9 g [-58.6%] at 12 months [P=0.013]), while LV viable mass increased (+11.6 ± 5.1 g at 4 months after CSC infusion [P=0.055] and +31.5 ± 11.0 g at 12 months [P=0.035]). Conclusions Isolation of CSCs from cardiac tissue obtained in the operating room is feasible and does not alter practices during CABG surgery. CMR shows that CSC infusion produces a striking improvement in both global and regional LV function, a reduction in infarct size, and an increase in viable tissue, which persist at least 1 year and are consistent with cardiac regeneration. Clinical Trial Registration This study is registered with clinicaltrials.gov, trial number NCT00474461.

who assisted with the development of the analytic plan and concept development. Dr Ellis was not compensated.

Background Ventricular assist devices (VADs) improve survival and quality of life in patients with advanced heart failure, but their use is frequently complicated by infection. There are limited data on the microbiology and epidemiology of these infections. Methods and Results 150 patients scheduled for VAD implantation were enrolled (2006–2008) at 11 U.S. cardiac centers and followed prospectively up to transplantation, explantation for recovery, death, or for one year. 86 (57%) patients received Heartmate II® devices. Data were collected on potential pre-, intra-, and post-operative risk factors for infection. Clinical, laboratory, and microbiologic data were collected for suspected infections and evaluated by an infectious diseases specialist. 33 (22%) subjects developed 34 VAD-related infections with an incidence rate of 0.10 per 100 person-days (95% CI, 0.073–0.142). The median time to infection was 68 days. The driveline was the most commonly infected site (n=28); 18 (64%) were associated with invasive disease. Staphylococci were the most common pathogen (47%), but Pseudomonas or other Gram-negative bacteria caused 32% of infections. A history of depression and elevated baseline serum creatinine were independent predictors of VAD infection (HRadj=2.8,P=0.007 and HRadj=1.7,P=0.023, respectively). The Heartmate II® was not associated with a decreased risk of infection. VAD infection increased one-year mortality (HRadj=5.6, P<0.0001). Conclusions This prospective, multicenter study demonstrates that infection frequently complicates VAD placement and is a continuing problem despite the use of newer, smaller devices. Depression and renal dysfunction may increase the risk of VAD infection. VAD infection is a serious consequence as it adversely affects patient survival.