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Saint Paul, MN, United States

Crossley G.H.,St. Thomas University at Miami Gardens | Exner D.,Liibin Cardiovascular Institute of Alberta | Mead R.H.,Sequoia Hospital | Sorrentino R.A.,Georgia Regents University | And 3 more authors.
Heart Rhythm | Year: 2010

Background: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure. Optimal left ventricular (LV) lead placement is useful in enhancing response from CRT. Three significant obstacles to LV lead placement are patient-specific variations in coronary venous anatomy, phrenic nerve stimulation, and a significant rate of LV lead dislodgement or microdislodgement. Objective: The primary objective of this study was to determine the safety and effectiveness of the Medtronic StarFix active fixation LV lead. Secondary objectives evaluated implant success, lead placement and procedure time, lead handling and lobe deployment, additional electrical performance, and all adverse events reported in the study. Methods: There were 441 patients enrolled in this multicenter study. Standard cardiac resynchronization therapy (CRT) inclusion criteria were used. Patients were followed up for a mean of 23 months. Implant data, success with CRT, LV lead performance, clinical outcomes, and experience with LV lead revisions were prospectively evaluated. Results: The mean LV stimulation threshold at implant was 1.3 ± 1 volts and was stable over time. Sensing was also excellent. In 96.3% of the implantations in this study, the physician was able to place the lead in a nonanterior position. Extracardiac (phrenic nerve) stimulation required invasive intervention in 11 subjects (2.5%). Only 3 dislodgements (0.7%) were observed. Two occurred in the first 5 implants and were attributed to inadequate engagement of the venous subbranch. Conclusion: The Medtronic 4195 is safe and highly efficacious. It affords the physician more choices in lead placement location and has a remarkably low dislodgement rate. © 2010 Heart Rhythm Society. Source

Traverse J.H.,Abbott Laboratories | Traverse J.H.,University of Minnesota | Henry T.D.,Abbott Laboratories | Henry T.D.,University of Minnesota | And 46 more authors.
JAMA - Journal of the American Medical Association | Year: 2012

Context: While the delivery of cell therapy after ST-segment elevation myocardial infarction (STEMI) has been evaluated in previous clinical trials, the influence of the timing of cell delivery on the effect on left ventricular function has not been analyzed. Objectives: To determine the effect of intracoronary autologous bone marrow mononuclear cell (BMC) delivery after STEMI on recovery of global and regional left ventricular function and whether timing of BMC delivery (3 days vs 7 days after reperfusion) influences this effect. Design, Setting, and Patients: A randomized, 2 x 2 factorial, double-blind, placebo-controlled trial, Timing In Myocardial infarction Evaluation (TIME) enrolled 120 patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤45%) after successful primary percutaneous coronary intervention (PCI) of anterior STEMI between July 17, 2008, and November 15, 2011, as part of the Cardiovascular Cell Therapy Research Network sponsored by the National Heart, Lung, and Blood Institute. Interventions: Intracoronary infusion of 150 × 106 BMCs or placebo (randomized 2:1) within 12 hours of aspiration and cell processing administered at day 3 or day 7 (randomized 1:1) after treatment with PCI. Main Outcome Measures: The primary end points were change in global (LVEF) and regional (wall motion) left ventricular function in infarct and border zones at 6 months measured by cardiac magnetic resonance imaging and change in left ventricular function as affected by timing of treatment on day 3 vs day 7. The secondary end points included major adverse cardiovascular events as well as changes in left ventricular volumes and infarct size. Results: The mean (SD) patient age was 56.9 (10.9) years and 87.5% of participants were male. At 6 months, there was no significant increase in LVEF for the BMC group (45.2% [95% CI, 42.8% to 47.6%] to 48.3% [95% CI, 45.3% to 51.3%) vs the placebo group (44.5% [95% CI, 41.0% to 48.0%] to 47.8% [95% CI, 43.4% to 52.2%]) (P=.96). There was no significant treatment effect on regional left ventricular function observed in either infarct or border zones. There were no significant differences in change in global left ventricular function for patients treated at day 3 (-0.9% [95% CI, -6.6% to 4.9%], P=.76) or day 7 (1.1% [95% CI, -4.7% to 6.9%], P=.70). The timing of treatment had no significant effect on regional left ventricular function recovery. Major adverse events were rare among all treatment groups. Conclusion: Among patients with STEMI treated with primary PCI, the administration of intracoronary BMCs at either 3 days or 7 days after the event had no significant effect on recovery of global or regional left ventricular function compared with placebo. Trial Registration: clinicaltrials.gov Identifier: NCT00684021. ©2012 American Medical Association. All rights reserved. Source

Voros S.,Piedmont Heart Institute | Rivera J.J.,South Beach Preventive Cardiology | Berman D.S.,Cedars Sinai Medical Center | Blankstein R.,Brigham and Womens Hospital | And 13 more authors.
Journal of Cardiovascular Computed Tomography | Year: 2011

Coronary artery calcium (CAC) scanning is an important tool for risk stratification in intermediate-risk, asymptomatic subjects without previous coronary disease. However, the clinical benefit of improved risk prediction needs to be balanced against the risk of the use of ionizing radiation. Although there is increasing emphasis on the need to obtain CAC scans at low-radiation exposure to the patient, very few practical documents exist to aid laboratories and health care professionals on how to obtain such low-radiation scans.The Tomographic Imaging Council of the Society for Atherosclerosis Imaging and Prevention, in collaboration with the Prevention Council and the Society of Cardiovascular Computed Tomography, created a task force and writing group to generate a practical document to address parameters that can be influenced by careful attention to image acquisition.Patient selection for CAC scanning should be based on national guidelines. It is recommended that laboratories performing CAC examinations monitor radiation exposure (dose-length-product [DLP]) and effective radiation dose (E) in all patients. DLP should be <200 mGy × cm; E should average 1.0-1.5 mSv and should be <3.0 mSv. On most scanner platforms, CAC imaging should be performed in an axial mode with prospective electrocardiographic triggering, using tube voltage of 120 kVp. Tube current should be carefully selected on the basis of patient size, potentially using chest lateral width measured on the topogram. Scan length should be limited for the coverage of the heart only.When patients and imaging parameters are selected appropriately, CAC scanning can be performed with low levels of radiation exposure. © 2011 Society of Cardiovascular Computed Tomography. Source

Chung E.S.,Heart and Vascular Center | Dan D.,Piedmont Hospital | Solomon S.D.,Brigham and Womens Hospital | Bank A.J.,St. Paul Heart Clinic | And 7 more authors.
Circulation: Heart Failure | Year: 2010

Background - Left ventricular (LV) remodeling has been attributed to the segmental loss of viable myocardium due to myocardial infarction (MI), which results in redistribution of cardiac workload, with increased regional wall stress in and around the infarct zone. Because ventricular pacing has been shown to reduce regional wall stress and workload in regions near the pacing site, this trial was designed to test whether chronic pacing near the infarct attenuates LV remodeling. Methods and Results - Eighty patients with an anterior MI, peak creatine kinase >2000 mU/mL, ejection fraction ≤35%, wall motion abnormality (WMA) in >5 of 16 segments, and QRS <120 ms, were randomized to either control (implantable cardioverter-defribillator [ICD]) or biventricular pacing with peri-infarct LV lead placement (cardiac resynchronization therapy [CRT]-D) arms between 2 and 14 days after the MI. The primary end point - change in LV end-diastolic volume (LVEDV) from baseline to 12 months - was not significantly different between the 2 groups (CRT, 10.6±27.7 mL; ICD, 11.2±31.2 mL; 2-sample t test P>0.05). In a hypothesis-generating secondary analysis, there was a sustained reduction in the WMA score at 12 months in paced patients (CRT, - 0.16±0.28; ICD, - 0.01±0.24, 2-sample t test P=0.03). No differences were found in the therapy-related event rate, hospitalizations, or mortality (all P>0.05). Conclusions - Chronic pacing in the infarct region did not alter the primary end point of LV remodeling over 1 year. © 2010 American Heart Association, Inc. Source

Costanzo M.R.,Midwest Heart Foundation | Ivanhoe R.J.,Paracor Medical Inc. | Kao A.,Mid American Heart Institute | Anand I.S.,Medical Center | And 10 more authors.
Journal of Cardiac Failure | Year: 2012

Background: Left ventricular (LV) remodeling predicts poor outcomes in heart failure (HF) patients. The HeartNet® cardiac restraint device (Paracor Medical Inc., Sunnyvale, CA) may reduce LV remodeling and improve functional capacity, quality of life, and outcomes in HF patients. To evaluate the safety and efficacy of the HeartNet Ventricular Support System in HF patients receiving optimal medical therapy. Methods and Results: Prospective, randomized, controlled, multicenter trial in patients with symptomatic HF and LV ejection fraction ≤35% on optimal medical and device therapy. The primary efficacy end points were changes in peak VO 2, 6-minute walk (6MW) distance, and Minnesota Living with Heart Failure (MLWHF) quality of life score at 6 months. The primary safety end point was all-cause mortality at 12 months. Because the planned adaptive interim analysis of the first 122 subjects with a completed 6-month follow-up indicated futility to reach the peak VO 2 end point, trial enrollment was suspended. Hence, the results on the 96 treatment and 114 control subjects are reported. Groups were similar at baseline. At 6 months, responder frequency for a prespecified improvement was similar between groups for peak VO 2 (P =.502) and MLWHF score (P =.184) but borderline higher for improvement in 6MW distance in the treatment compared with the control group (33 [38%] vs. 25 [25%]; P =.044). At 6 months, the treatment group had a significantly greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) (P < .001) and decrease in LV mass (P =.032), LV end-diastolic diameter (P =.015), LV end-systolic diameter (P =.032), and LV end-diastolic volume (P =.031) as compared with controls. At 12 months, all-cause mortality and responder rates were similar in the 2 groups. Success rate for the HeartNet implantation was 99%. Conclusion: Enrollment in the trial was stopped because an interim analysis showed futility of reaching the peak VO 2 end point. However, because of the device safety and favorable signals for LV remodeling and quality of life, further investigation of this device is warranted. © 2012 Elsevier Inc. All rights reserved. Source

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