Saint Paul, MN, United States
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Bank A.J.,St Paul Heart Clinic | Bank A.J.,University of Minnesota | Burns K.V.,St Paul Heart Clinic | Burns K.V.,University of Minnesota | And 11 more authors.
Journal of Cardiac Failure | Year: 2012

Background: Several clinical trials have confirmed that cardiac resynchronization therapy (CRT) improves outcomes in well defined patient populations. It is uncertain, however, whether outcomes are similar in real-world clinical settings. This study compared outcomes after CRT with defibrillator (CRT-D) in a large real-world private-practice cardiology setting with those in the COMPANION multicenter trial. Methods and Results: A total of 429 consecutive patients who received CRT-D for standard indications (group 1) were retrospectively compared with the 595 patients (group 3) in the COMPANION CRT-D cohort regarding survival and survival free of cardiovascular (CV) hospitalization. A subgroup of the group 1 patients who met the COMPANION entrance criteria (group 2) was also compared with the COMPANION cohort (group 3) both with and without propensity-matching statistical analysis. Survival and survival free of CV hospitalization was better in group 1 than in group 3. Survival in group 2 with and without propensity matching was similar to group 3. However, survival free of CV hospitalization was better in the real-world patients (group 2) even after adjustment for differences in baseline characteristics. Conclusions: Survival and CV hospitalization outcomes in a real-world clinical setting are as good as, or better than, those demonstrated in the COMPANION research trial. © 2012 Elsevier Inc. All rights reserved.


Voros S.,Piedmont Hospital | Rivera J.J.,South Beach Preventive Cardiology | Berman D.S.,Cedars Sinai Medical Center | Blankstein R.,Brigham and Women's 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.


Chung E.S.,Christ Hospital | Dan D.,Piedmont Hospital | Solomon S.D.,Brigham and Women's 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.


Costanzo M.R.,Edward Heart Hospital | 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.


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.


Kaufman C.L.,St. Paul Heart Clinic | Kaiser D.R.,Medtronic Inc. | Burns K.V.,St. Paul Heart Clinic | Kelly A.S.,St. Paul Heart Clinic | Bank A.J.,St. Paul Heart Clinic
Clinical Cardiology | Year: 2010

Background: The aims of this study were to assess the ability of several echo measures of dyssynchrony to predict CRT response and to characterize the global effect of CRT. Hypothesis: We hypothesized that after CRT there would be significant reductions in mechanical dyssynchrony in all 3 orthogonal planes of cardiac motion and that those patients with significant dyssynchrony prior to implant would have the best echocardiographic response. Methods: Standard echocardiograms were performed pre-CRT and post-CRT (138 ± 63d) in 70 heart failure patients. Longitudinal dyssynchrony was calculated as the standard deviation (SD) of time to peak systolic displacement and velocity of 12 segments from 3 apical views. Using midventricular short axis views and speckle-tracking methods, the SD of time to peak radial and circumferential strain in 6 segments were calculated. Cardiac resynchronization therapy echo responsewas defined as ≥ 15%decrease in left ventricular end-systolic volume. Results: Cardiac resynchronization therapy significantly improved systolic function in the longitudinal, radial, and circumferential planes. The CRT echo response rate was 57%. Echo responders (CRTR) had significantly (P< .05) more dyssynchrony at baseline as compared to nonresponders (CRTNR). Cardiac resynchronization therapy significantly (P <.05) reduced longitudinal and radial, but not circumferential, dyssynchrony in CRTR. Dyssynchronywas unchangedin CRTNR. Receiver-operatorcharacteristic (ROC) curve analysis indicated significant, but modest sensitivity and specificity for longitudinal and radial intraventricular dyssynchrony and for interventricular dyssynchrony. Combining radial and longitudinal dyssynchrony measures improved positive prediction of CRT response. Conclusions: Cardiac resynchronization therapy improves left ventricular function in 3 orthogonal planes of motion. Longitudinal, radial, and interventricular dyssynchrony modestly predict reverse remodeling. © 2010 Wiley Periodicals, Inc.


Bank A.J.,St Paul Heart Clinic | Bank A.J.,University of Minnesota | Kaufman C.L.,St Paul Heart Clinic | Burns K.V.,St Paul Heart Clinic | And 7 more authors.
European Journal of Heart Failure | Year: 2010

Aims Right ventricular (RV) pacing is an iatrogenic cause of heart failure (HF) that has not been well studied. We assessed whether HF patients paced from the right ventricle (RVp) adversely remodel and respond to cardiac resynchronization therapy (CRT) in a similar way to HF patients without right ventricular pacing (nRVp). Methods and results Echocardiograms were performed before and ∼5 months after CRT in 31 RVp and 49 nRVp HF patients. Longitudinal intraventricular dyssynchrony using tissue Doppler imaging (TDI) was calculated as the standard deviation of time to peak systolic displacement by tissue tracking (SD-TT) of 12 segments. Longitudinal dyssynchrony within a wall (intramural dyssynchrony) was assessed by two methods: quantifying the number of segments with initial abnormal apical displacement (IMD score) and using a cross-correlation synchrony index (CCSI). Despite similar ejection fractions (EFs) of 28 prior to CRT, left ventricular end-diastolic volume was significantly smaller (143 ± 54 vs. 183 ± 62, P = 0.004) in RVp. The standard deviation of time to peak systolic displacement by tissue tracking (83.4 ± 34.9 vs. 67.9 ± 26.6, P = 0.03) and IMD score (3.1 ± 1.8 vs. 1.3 ± 1.7, P < 0.001) were greater in RVp. Cardiac resynchronization therapy significantly improved EF and volumes in both groups. Ejection fraction increased more in RVp (12.8 ± 9.2 vs. 7.4 ± 7.6, P = 0.007). Intraventricular dyssynchrony and both measures of intramural septal dyssynchrony improved to a greater extent post-CRT in RVp.Conclusion Right ventricular pacing patients differ from nRVp HF patients in that they have smaller ventricles and greater intraventricular and intramural septal dyssynchrony. Right ventricular pacing HF patients respond better to CRT with greater improvements in EF, and intraventricular and intramural septal dyssynchrony. © 2010 Author.


Kelly A.S.,University of Minnesota | Gonzalez-Campoy J.M.,Minnesota Center for Obesity | Rudser K.D.,University of Minnesota | Katz H.,Allina Hospitals and Clinics | And 3 more authors.
Journal of Clinical Hypertension | Year: 2012

The authors hypothesized that carvedilol controlled-release plus lisinopril combination therapy (C+L) would increase endothelial function and decrease oxidative stress to a greater extent than hydrochlorothiazide plus lisinopril combination therapy (H+L) in obese patients with hypertension. Twenty-five abdominally obese patients (aged 54.4±7.3 years; 14 women) with hypertension/prehypertension were enrolled in a 7-month (two 3-month treatment periods separated by a 1-month washout), randomized, double-blind, controlled, crossover clinical trial comparing C+L vs H+L. Endothelial function, measured by digital reactive hyperemic index (RHI), circulating oxidized low-density lipoprotein (oxLDL), 8-isoprostane, and asymmetric dimethylarginine (ADMA) were obtained at baseline, post-period 1, post-washout, and post-period 2. Analyses were adjusted for baseline measurements by analysis of covariance, with robust variance estimation for confidence intervals and P values. C+L treatment compared to H+L treatment significantly improved RHI (0.74, 95% confidence interval, 0.31-1.19, P=.001). This difference persisted after adjustment for the change in systolic blood pressure. No significant treatment differences were observed for oxLDL, 8-isoprostane, or ADMA. These data provide evidence that independent of blood pressure-lowering, C+L therapy improves endothelial function to a greater extent than H+L therapy. Levels of oxidative stress were not significantly different between treatments, suggesting that other mechanisms may be responsible for the improvement in endothelial function. © 2011 Wiley Periodicals, Inc.


Burns K.V.,St. Paul Heart Clinic | Burns K.V.,University of Minnesota | Kaufman C.L.,St. Paul Heart Clinic | Kelly A.S.,St. Paul Heart Clinic | And 3 more authors.
Journal of Cardiac Failure | Year: 2011

Background: Chronic right ventricular pacing may lead to left ventricular dyssynchrony, systolic dysfunction, remodeling, and heart failure. Cardiac mechanics may differ between paced and nonpaced heart failure patients, and their optimal treatment may also differ. Methods and Results: Echocardiograms were analyzed using tissue Doppler imaging and speckle tracking echocardiography in 20 patients with chronic right ventricular pacing for complete heart block (RVP group), 29 nonpaced patients with different heart failure etiologies but ejection fractions similar to the RVP group (HF group), and 25 control subjects without pacemakers or heart failure (control group). Left ventricle volumes were smaller in RVP than HF (end-diastolic volume = 93.6 ± 25.1 mL vs. 112.1 ± 22.8 mL), but intraventricular longitudinal and radial dyssynchrony were similar. Dyssynchrony within the septum was greater (number of segments lengthening during systole = 1.9 ± 1.7 vs. 0.9 ± 1.8), systolic torsion was lower (6.2 ± 7.3° vs. 10.6 ± 4.2°), untwisting was delayed (time from peak torsion to peak untwist rate = 188 ± 141 ms vs. 102 ± 73 ms), and apical rotation was reversed in more subjects (35% vs 0%) in RVP than HF groups (P < .05 for all). Conclusions: Intraventricular dyssynchrony was similar between RVP and HF groups with similar ejection fraction. However, RVP subjects had smaller ventricles, greater dyssynchrony within the septum, lower torsion, altered apical rotation, and delayed untwisting. © 2011 Elsevier Inc. All rights reserved.


PubMed | St Paul Heart Clinic
Type: Comparative Study | Journal: Journal of cardiac failure | Year: 2012

Several clinical trials have confirmed that cardiac resynchronization therapy (CRT) improves outcomes in well defined patient populations. It is uncertain, however, whether outcomes are similar in real-world clinical settings. This study compared outcomes after CRT with defibrillator (CRT-D) in a large real-world private-practice cardiology setting with those in the COMPANION multicenter trial.A total of 429 consecutive patients who received CRT-D for standard indications (group 1) were retrospectively compared with the 595 patients (group 3) in the COMPANION CRT-D cohort regarding survival and survival free of cardiovascular (CV) hospitalization. A subgroup of the group 1 patients who met the COMPANION entrance criteria (group 2) was also compared with the COMPANION cohort (group 3) both with and without propensity-matching statistical analysis. Survival and survival free of CV hospitalization was better in group 1 than in group 3. Survival in group 2 with and without propensity matching was similar to group 3. However, survival free of CV hospitalization was better in the real-world patients (group 2) even after adjustment for differences in baseline characteristics.Survival and CV hospitalization outcomes in a real-world clinical setting are as good as, or better than, those demonstrated in the COMPANION research trial.

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