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Mariell Jessup

Publications and source records attributed to Mariell Jessup.

At least 19 recordsLinked to original sources
PubMed2006

Mitral valve surgery in heart failure: insights from the Acorn Clinical Trial.

OBJECTIVE: The study objective was to evaluate in a prospective, randomized, multicenter trial the safety and efficacy of mitral valve surgery with and without the CorCap cardiac support device (Acorn Cardiovascular, St Paul, Minn) in patients with New York Heart Association Class II to IV heart failure. BACKGROUND: Although mitral valve surgery has been performed successfully in patients with heart failure, the safety and long-term efficacy have not been established in a multicenter prospective trial. Cardiac support devices that reduce ventricular wall stress and promote beneficial reverse remodeling have been proposed as a new treatment option as a stand-alone procedure and as an adjunct to mitral valve surgery. METHODS: A subgroup of 193 patients were enrolled in the mitral valve repair or replacement stratum of the Acorn Clinical Trial; 102 patients were randomized to the mitral valve surgery alone group (control) and 91 patients were randomized to mitral valve surgery with implantation of the CorCap cardiac support device. Patients were followed for a median duration of 22.9 months. RESULTS: For the entire mitral valve surgery group, the 30-day operative mortality rate was only 1.6% at 30 days. Mitral surgery was associated with progressive reductions in left ventricle end-diastolic volume, left ventricle end-systolic volume, and left ventricular mass, and increases in left ventricle ejection fraction and sphericity index, all consistent with reverse remodeling. Recurrence of clinically significant mitral regurgitation was uncommon. Quality of life, exercise performance, and New York Heart Association functional class were all improved. Finally, the addition of the CorCap cardiac support device led to greater decreases in left ventricular end-diastolic volume and left ventricular end-systolic volume, a more elliptical shape, and a trend for a reduction in major cardiac procedures and improvement in quality of life compared with mitral surgery alone. CONCLUSIONS: These findings suggest that there is clear benefit to the surgical elimination of mitral regurgitation and that there is additional benefit with the CorCap cardiac support device. Given the improvement in left ventricle structure and function, along with a low mortality rate, physicians should strongly consider offering mitral valve surgery in combination with the CorCap cardiac support device to patients with heart failure who are on an optimal medical regimen.

Cardiac Surgical Procedures↗
PubMed2006

Predictors of remodeling in the CRT era: influence of mitral regurgitation, BNP, and gender.

BACKGROUND: We analyzed quantitative echocardiographic data from a large heart failure cohort receiving medical and cardiac resynchronization therapy (CRT) to determine baseline predictors of progressive left ventricular (LV) enlargement. METHODS AND RESULTS: Quantitative echocardiograms were obtained at baseline and after 6 months in 776 outpatients with chronic heart failure who participated in MIRACLE (Multicenter InSync Randomized Clinical Evaluation) and MIRACLE-ICD (Multicenter InSync ICD Randomized Clinical Evaluation). We used multivariable regression to determine clinical, therapeutic, and echocardiographic characteristics that predicted a subsequent change in left ventricular end-diastolic volume (LVEDV). Over 6 months, LVEDV increased in 308 (40%) and decreased in 468 (60%) patients. Baseline mitral regurgitation and levels of plasma brain natriuretic peptide (BNP) independently predicted LV enlargement, whereas CRT predicted a decrease in LVEDV (all P < .01). In all models tested, male gender was an independent risk factor for progressive LV enlargement (P < .0001). CONCLUSION: Men show more prominent LV dilation than women in chronic heart failure despite medical and device therapy. Rates of LV remodeling are influenced further by mitral regurgitation, plasma BNP, and CRT. Future studies should take these clinical factors into account when determining the influence of genetic factors and novel therapies on ventricular remodeling in chronic heart failure.

Aged↗
PubMed2006

Validation of prognostic models among patients with advanced heart failure.

BACKGROUND: The ability to accurately predict heart failure outcomes is essential to guiding treatment decisions but several competing risk stratification models exist. METHODS AND RESULTS: We prospectively collected data on 280 patients with advanced heart failure recruited from 16 sites across the United States. Deaths and cardiac transplantations within the following 4 years were identified. Medline was searched to systematically identify widely cited heart failure severity classification models predicting long-term survival among patients with heart failure, and 4 were selected for validation. We used Kaplan-Meier survival curves, receiver-operating characteristic curves, and Cox proportional hazards modeling to identify the prognostic significance of each model's risk score and the individual contribution of the clinical components within each model. Average follow-up was 31.2 months; 148 deaths or transplantations occurred. Each model that we evaluated identified patients with significantly different prognoses. However, each was limited in overall predictive power, and many component patient characteristics did not have independent prognostic significance. Prognostic factors found to be most powerful within their models included: increasing age, ischemic cardiomyopathy, history of cardiomyopathy, ankle edema, decreased peak oxygen consumption, and absence of beta-blocker use. CONCLUSION: Although each of the models succeeded in risk-stratifying patients to some extent, all 4 models had shortcomings. There is a need for a contemporary model, derived from a patient population managed in accordance with current heart failure guidelines, applicable to all heart failure etiologies, relying on readily available clinical data.

Cardiac Output, Low↗
PubMed2005

ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society.

Explore the source record for details and available documents.

Adult↗
PubMed2005

Prolonged repolarization after ventricular assist device support is associated with arrhythmias in humans with congestive heart failure.

BACKGROUND: Recent observations indicate that the QTc interval often increases in the early postoperative period (<1 week) after mechanical unloading of severely failing hearts with a left ventricular assist device (LVAD). The present study examined whether early changes in ventricular repolarization after LVAD placement are associated with ventricular arrhythmias. METHODS AND RESULTS: An electrocardiogram was obtained within 4 days before LVAD placement, <12 hours after LVAD placement, and weekly thereafter. Patient records were reviewed for documented ventricular tachycardia (VT) or ventricular fibrillation (VF) for 1 week preoperatively and the first 2 weeks postoperatively. Differences in QTc interval between patients with and without VT were evaluated. Ten of 17 patients enrolled (59%) had VT or VF after LVAD placement. Of these, 4 required therapeutic intervention because of clinical instability or symptoms. The change in the QTc (DeltaQTc) between the preoperative and immediate postoperative period was significantly different among patients with VT/VF compared with patients without VT/VF (+23 ms vs. -68 ms, P < .001). CONCLUSION: The early period after initiation of LVAD support of the failing human heart is associated with a relatively high incidence of significant ventricular arrhythmias after LVAD placement. Beyond the impact of myocardial inflammation and wound healing occurring after all LVAD implants, early postoperative increases in the QTc interval after cardiac unloading appear to predispose to ventricular arrhythmias.

Electrocardiography↗
PubMed2005

New directions in the medical management of heart failure.

Like the introduction of digitalis more than 200 years ago, novel medical therapies today have the potential to significantly alter the course of heart failure (HF) and save thousands of lives. This review outlines new directions in HF medical management beyond the foundation of neurohormonal blockade. Furthermore, the role of novel risk factors in HF such as chronic renal insufficiency, anemia, and sleep apnea present tantalizing therapeutic targets to extend the morbidity and mortality benefits of current therapies. The course of time will tell which of these risk factors and therapies can hold promise, given the recent litany of negative trials in the HF arena. Advancements in molecular and genetic techniques have allowed us to begin to consider patient specific therapies and lay the groundwork for even further improvements in treatment of symptomatic HF. Finally, advances in telemedicine and device technology will allow the clinician to remotely monitor useful clinical parameters such as heart rate variability and pulmonary filling pressures to make more informed clinical decision-making and improve outcomes.

Adrenergic Antagonists↗
PubMed2004

Dyslipidemias and HMG-CoA reductase inhibitor prescription in heart transplant recipients.

BACKGROUND: The treatment of dyslipidemias in orthotopic heart transplant (OHT) recipients is not highlighted in the National Cholesterol Education Program Adult Treatment Panel guidelines. Emerging data suggest that hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) safely reduce the risk of transplant rejection and coronary artery vasculopathy in OHT patients. OBJECTIVE: To assess the proportion of patients from our institution reaching the low-density lipoprotein cholesterol (LDL-C) target of <100 mg/dL, evaluate the impact of statins in reaching this goal, and evaluate the prescribing practice for statins in US OHT centers. METHODS: The management of dyslipidemia of OHT recipients followed at our institution was retrospectively evaluated. In addition, the use of statins in adult OHT centers in the US that performed >or=15 OHTs per year was assessed through a survey. RESULTS: Of the 328 patients from our institution, 58.5% achieved an LDL-C <100 mg/dL. Patients prescribed statins were more likely to reach this goal (p < 0.01). A total of 85.0% of centers responding to the survey use statins as a part of their post-OHT protocol, primarily to reduce coronary artery vasculopathy (70.6%). CONCLUSIONS: Due to the potential for improved outcomes, a large proportion of patients are prescribed a statin. Our results support previous findings that statins are safe and effective in reducing LDL-C in the management of dyslipidemias in OHT recipients. Nonetheless, dyslipidemias are suboptimally managed in many post-OHT patients.

Cholesterol, LDL↗
PubMed2004

Development and validation of a patient questionnaire to determine New York Heart Association classification.

BACKGROUND: New York Heart Association (NYHA) classification correlates with quality of life and is useful in tracking changes in status in clinical trials. We explored methods to determine NYHA class in multicenter trials where double-blind conditions could not be maintained. METHODS AND RESULTS: A questionnaire was developed containing 7 major questions based on the standard definitions of NYHA classes. The questionnaire was administered to 116 patients with varying degrees of heart failure. When comparing NYHA determined by physicians at the site to NYHA assigned by 3 independent physician graders, there was an approximate 60% concordance. Concordance between independent reviewers was approximately 75%. Results of repeat grading of 30 randomly selected questionnaires indicated that graders provided the same score 90% of the time. Thus, although there were some differences from the site determination of NYHA class, the questionnaire had good inter- and intragrader reproducibility. In a second group of 103 patients enrolled in an ongoing device-intervention trial, we demonstrated that it is feasible to employ the questionnaire in a multicenter trial. Finally, NYHA class was correlated with quality of life and peak exercise oxygen consumption. CONCLUSIONS: A standardized questionnaire provided an approximate 60% concordance in assigning NYHA classification compared to the site assessment with approximately 90% reproducibility. This approach may be useful to determine NYHA classification within the context of clinical trials where blinded conditions are not possible.

Clinical Trials as Topic↗
PubMed2004

Rationale, design, and methods for a pivotal randomized clinical trial for the assessment of a cardiac support device in patients with New York health association class III-IV heart failure.

BACKGROUND: Heart failure remains a progressive disease with incremental morbidity and mortality despite optimal medical therapy. A growing body of evidence suggests that progressive left ventricular (LV) remodeling is directly related to a deterioration in LV performance and untoward clinical outcomes for heart failure patients. Preclinical and early phase I clinical studies with the CorCap Cardiac Support Device (CSD), a passive cardiac support device that prevents cardiac remodeling, have shown that it is safe and is associated with improvements in LV structure and function, as well as patient symptomatology. METHODS AND RESULTS: The Acorn Pivotal Trial is a pivotal prospective, randomized, evaluation of the CorCap CSD in patients with New York Heart Association class III-IV heart failure. Patients will be enrolled into one of two different strata. Patients who require a mitral valve repair/replacement (MVR) will fall into the "MVR stratum" and will be randomized to either treatment (MVR surgery plus the CSD) or control (MVR surgery alone). Patients who do not have a clinical indication for MVR surgery will fall into the "no-MVR stratum" and will also be randomized to either treatment (CSD implant plus optimal medical therapy) or control (optimal medical therapy alone). A total of 300 patients (150 treatment and 150 control) will be enrolled. The primary endpoint of the trial is the change in clinical status from baseline to the end of the efficacy phase (1 year), as determined by a clinical composite score. Patients will be classified as improved, worsened, or unchanged based upon patient vital status, the occurrence of a major cardiac procedure indicative of heart failure progression, and a change in the assessment of New York Heart Association functional class. CONCLUSIONS: The Acorn Pivotal Trial will formally test the hypothesis that preventing LV remodeling using a passive cardiac support device will favorably impact the untoward natural history of heart failure and thus represents an important departure from all previous medical and device studies that have been reported to date.

Adolescent↗
PubMed2004

Worldwide clinical experience with the CorCap Cardiac Support Device.

It has been hypothesized that the mechanical burden associated with LV remodeling leads to increased myocardial wall stress and adverse remodeling, all of which serve to further impair cardiac performance and contribute to disease progression. The CorCap Cardiac Support Device (CSD) (Acorn Cardiovascular, Inc., St. Paul, Minnesota) is a mesh-like device that is surgically implanted around the heart. The device is designed to provide circumferential myocardial wall support, and reduce wall stress and myocyte stretch. Clinical experience with CorCap CSD implants in patients with heart failure can be divided into 3 phases: (1) initial safety studies, (2) randomized controlled trials, and (3) limited marketed release. Initial safety studies were undertaken in 48 patients recruited between April 1999 and April of 2001. In 11 patients with complete follow-up, it was noted that LV size, as measured by LV end-diastolic dimension, significantly decreased as early as 3 months postimplant, with an even greater reduction at 6 months. Most importantly, this benefit was sustained, so that the LV end-diastolic dimension stayed smaller at 1, 2, and 3 years of follow-up. There was also an improvement in LV function, as manifested by changes in LV ejection fraction. Ejection fraction was significantly increased by 3 months and appeared to reach a peak improvement by 6 months. This benefit was likewise maintained at 1, 2, and 3 years postsurgery. Hemodynamic data did not show any evidence of constrictive physiology. These preliminary safety studies had shown that the CorCap CSD could be implanted safely and without excess operative morbidity or mortality. The primary objective of the Acorn Randomized Clinical Trial is to assess the efficacy and safety of the CorCap CSD in patients with advanced heart failure despite optimal medical therapy. A randomized trial with 2 arms (mitral valve surgery randomized to CSD and cardiomyopathy randomized to medical therapy alone or with CSD) enrolled 300 patients. The primary endpoint of the trial is a change in clinical status from baseline to the end of the efficacy phase as determined by a clinical composite score. The Acorn CorCap CSD received CE mark approval in Europe in 2001 and has been available to a small number of centers in a Limited Market Release Surveillance Study (LMRSS).

Australia↗
PubMed2004

A prospective study of continuous intravenous milrinone therapy for status IB patients awaiting heart transplant at home.

BACKGROUND: We performed a prospective study to determine the feasibility and safety of continuous intravenous milrinone therapy administered at home in patients listed as Status IB for heart transplant. METHODS: Patients who were Status IB could participate if they met specific criteria including an optimal dose of milrinone < or =0.5 microg/kg/min, presence of an implantable cardioverter-defibrillator (ICD), and no other serious comorbidity. The primary end-point of the study was survival to transplant. Hospitalizations, quality of life and cost comparisons were assessed. RESULTS: From May 1999 through October 2002, a total of 60 patients (51 men, 9 women), aged 55.5 +/- 8.4 years, entered the study. Before milrinone therapy, cardiac index was 1.98 +/- 0.66 liters/min/m2 and peak oxygen consumption was 11.4 +/- 2.6 ml/kg/min. Mean time in the study was 160.1 +/- 151.8 days. Fifty-three patients (88.3%) underwent heart transplant. There were only 2 deaths during the study. There were 89 hospital admissions in 46 patients over the 43-month follow-up period; 58 of these admissions were for heart failure. There were 6 episodes of ICD firing for ventricular tachycardia. Quality-of-life measures in a sub-group of patients significantly improved 1 month after discharge. Substantial estimated cost savings occurred. CONCLUSIONS: Continuous intravenous milrinone therapy can be safely administered at home in selected patients with advanced heart failure who are listed for transplant. This strategy may be an acceptable alternative to prolonged hospitalization for patients dependent on continuous inotropic support. Re-hospitalization is to be expected. An implantable cardioverter-defibrillator should be present due to the incidence of ventricular tachycardia.

Cardiac Output↗