Products, Systems and Opportunities in Heart Failure Management

· 265 pages   · 51 Exhibits   · 34 Company Profiles   · April 2004   · Report #C301

Press Release

This report is a thorough assessment of the current and emerging clinical practice, products and systems for the prevention, screening, diagnosis and management of heart failure. The report details the incidence and prevalence of heart failure, projecting the trend as a result of demographics, intervention or other changes to the population of patients. The report details the current approaches applied by physicians (primary care & cardiologists) and healthcare systems to heart failure. The report addresses clinician and system approaches, detailing the practices, products, and services in use and under development. Products addressed include monitoring, medicines/drugs and devices. The report provides a detailed review of heart failure programs in place through disease management companies, and hospital, home care and outpatient programs. The report details the status of research toward improving heart failure programs. The report details the market outlook for products in heart failure management encompassing diagnostics, monitoring products, drugs/medicines and devices.

Table of Contents

SECTION 1:        BACKGROUND: HEART FAILURE AND MANAGEMENT

1.1       What is Heart Failure?

1.2       Use of Clinical Guidelines

1.3       What Caused the Heart Failure Epidemic?

1.4       Preventing Heart Failure

1.5       Managing Heart Failure

1.6       Specialist vs. General Cardiologist or Primary Care Physician

1.6.1          Treating Heart Failure

1.6.1.1       Sodium Restriction

1.6.1.2       Pharmacological Treatment of HF

1.6.1.3       Interventional Therapy

1.6.1.4       Surgical Treatment

1.6.1.5       Ventricular end-diastolic support: Dynamic cardiomyoplasty and CorCap/Acorn

1.6.1.6       Cardiomyoplasty

1.6.1.7       ACORN Device

1.6.1.8       Can Heart Failure Be Reversed or Cured?

1.6.1.9       ICD/Biventricular Pacemaker/ Cardiac Resynchronization Therapy

1.6.1.10     Beta-Blocker Therapy

SECTION 2:        HOME-BASED HEART FAILURE MANAGEMENT: THE ROLES OF DISEASE MANAGEMENT SERVICE COMPANIES AND SUPPLIERS OF TELEHOMECARE

2.1       Heart Failure Programs: Bridging the Gap in Patient Care

2.1.1          Third-Party Disease Management Services with Focus in Heart Failure

2.1.2          Hospital-Based Heart Failure Programs

2.1.3          Telehomecare

2.1.3.1       Remote Patient Monitoring

2.1.4          In-Home Patient Monitoring: Measurements, Tools and Methods Used

2.1.4.1       Changes in Patient Weight

2.1.4.2       Blood Pressure

2.1.4.3       Electrocardiogram (ECG/EKG)

2.1.4.4       Patient Self-Described Symptoms

2.1.4.5       Video Teleconferencing

2.1.4.6       Pulse Oximetry

2.2       Implementing a Home-Based Heart Failure Management Program

2.2.1          Reimbursement for Heart Failure Programs

2.2.1.1       Active Involvement of HFSA Leadership in the HF Disease Management Reimbursement Issue

2.3       2.3 Finding Future Opportunities in Heart Failure Patient Home Monitoring

2.4       Home-Based Heart Failure Monitoring Market

SECTION 3:        OVERVIEW OF CURRENT AND FUTURE HEART FAILURE MANAGEMENT AND TREATMENT PRODUCTS

3.1       Medical Management of Heart Failure

3.1.1          Usage of Current Drugs

3.1.1.1       ACE Inhibitors

3.1.1.2       Beta-Blockers

3.1.1.2.1          Comparing Currently Used Beta-Blockers

3.1.1.3       Investigating Hypertension Drugs in Heart Failure

3.1.1.3.1          Angiotensin II Receptor Blockers

3.1.1.3.2          Reducing Mortality in Post-Acute Myocardial Infarction Heart Failure

3.1.1.3.3          Addressing Cost Concerns in Treating Hypertension

3.1.1.3.4          Increasing Efforts to Aggressively Manage Hypertension

3.1.1.4       Tracking the Use of Evidence-Based Guidelines in Heart Failure Management

3.1.2          New and Investigational Drugs for Heart Failure Management

3.1.2.1       Diuretic Agents

3.1.2.2       Inotropic Agents

3.1.2.3       Vasodilator Agents

3.1.2.3.1          Human B-type Natriuretic Peptide

3.1.2.3.2          Endothelin Receptor Antagonists

3.1.2.4       Vasopeptidase Inhibitors Inhibitors

3.1.2.5       Other Drugs Under Development

3.1.2.5.1          Selective Aldosterone Receptor Antagonists

3.1.2.5.2          Xanthine Oxidase Inhibitors

3.2       Interventional Therapies

3.2.1          Cardiac Resynchronization Therapy

3.2.1.1       How CRT Evolved

3.2.1.2       Current and Future Investigations of CRT Devices

3.2.1.3       CRT Products

3.2.1.3.1          Guidant

3.2.1.3.2          Medtronic

3.2.1.4       Market Considerations

3.2.1.4.1          Adoption and Reimbursement

3.2.1.4.2          Addition of CRT Technology to HFSA Practice Guidelines

3.2.2          Mechanical Diuresis in Decompensated Heart Failure

3.2.2.1       Ultrafiltration as an Alternative to Intravenous Diuretic Therapy

3.2.2.1.1          CHF Solutions and Ultrafiltration

3.2.3          Ventricular Assist Devices

3.2.3.1       Current Product Offerings

3.2.3.1.1          Left Ventricular Assist Devices as a Permanent or Destination Therapy

3.2.3.1.2          Cost and Reimbursement Issues

3.2.3.2       Future Products and Next-Generation Technologies

3.2.3.2.1          Seond-Generation VADs

3.2.3.2.2          Continuous Flow Technology

3.2.3.2.3          Next-Generation Centrifugal Flow Pumps

3.2.3.2.4          Early Development-Stage Technologies

3.2.3.2.5          Percutaneous Ventricular Assist Devices

3.2.4          External Counterpulsation

3.2.4.1       CardioMedics

3.2.4.2       CPC of America

3.2.4.3       Vasomedical

3.2.4.4       External Counterpulsation in Heart Failure

3.2.5          Sleep-Disordered Breathing

3.2.5.1       Treating Sleep-Disordered Breathing in Heart Failure Patients

3.2.5.2       Developments in Sleep-Disordered Breathing Diagnosis

3.2.5.2.1          Market Activities and Product Developments

SECTION 4:        THE ROLE OF NON-INVASIVE HEMODYNAMIC ASSESSMENT FOR CARDIOVASCULAR DISEASE AND THE DIAGNOSIS AND MANAGEMENT OF HEART FAILURE

4.1       Use of Patient Hemodynamics in Clinical Decisions

4.1.1          Applications for the Use of Non-Invasive Hemodynamic Measurements

4.1.1.1       Cardiovascular Disease and Heart Failure Risk Stratification

4.1.1.2       Hypertension Control

4.1.1.3       Relation to Cardiovascular Risk Factors in Healthy Young Adults (The Bogalusa

4.2       Methods Used in Capturing Hemodynamic Data Non-invasively

4.2.1          Electrical Impedance Cardiography

4.2.1.1       Direct Current Component of Bioimpedance

4.3       Current Products in Non-invasive Hemodynamic Monitoring

4.3.1          Intra-Cardiac Monitoring in Heart Failure

4.3.2          Non-Invasive Cardiac Output

4.4       Ambulatory Blood Pressure Monitoring

4.4.1          ABP Monitors

4.4.1.1       Alternatives to the Use of ABP Monitors

4.4.2          Clinical Applications for ABPM

4.4.3          White-Coat Hypertension

4.4.3.1       Determinations of Damage to the Heart from Hypertension

4.4.3.2       Missed Potential in White-Coat Hypertension

4.4.4          Predicting Kidney Damage in Diabetics

4.4.5          Price Erosion

4.4.6          Who Pays?

4.4.7          Who Will Care?

4.5       ABPM Market

4.5.1          Year-to-Year Projections

4.5.2          ABPM Market Drivers

4.5.3          Ambulatory Blood Pressure Monitoring Market

4.5.3.1       Reimbursement

4.5.4          Barriers to Use

4.5.4.1       Price Erosion

4.5.5          Market Potential for Use of ABPM in Diagnosed Diabetics

4.5.6          Other Emerging Applications of Note

4.5.6.1       Pregnancy

4.5.6.2       Elevated Ambulatory and Normal Office Blood Pressure

4.5.6.3       Market for WCH Application

4.5.6.3.1          Third-Party Service Model

SECTION 5:        COMPANY PROFILES

5.1       Manufacturers Involved in Assessing Risk of and Managing Heart Failure

5.1.1          A&D Medical

5.1.1.1       Products

5.1.2          AtCor Medical Pty. Ltd.

5.1.2.1       Products

5.1.3          CardioDynamics International Corp.

5.1.3.1       Financial Information

5.1.4          CardioMEMS, Inc.

5.1.5          CVP Diagnostics

5.1.6          Data Sciences International

5.1.6.1       Financial Information

5.1.7          Guidant

5.1.7.1       Financial Information

5.1.8          Hemonix, Inc.

5.1.9          Hemo Sapiens, Inc.

5.1.10        Hypertension Diagnostics, Inc.

5.1.10.1     Financial Information

5.1.11        Medtronic

5.1.11.1     Cardiac Resynchronization Therapy

5.1.11.2     Intra-Cardiac Hemodynamic Monitoring

5.1.11.3     Financial Information

5.1.12        Noninvasive Technologies, LLC

5.1.13        Pulse Metric, Inc.

5.1.14        Remon Medical Technologies Ltd.

5.1.14.1     Financial Information

5.1.15        ROZINN Electronics, Inc.

5.1.16        Savacor

5.1.17        SORBA Medical Systems, Inc.

5.1.18        SunTech Medical Instruments

5.1.19        Transoma Medical

5.1.20        VivoMetrics, Inc.

5.2       Cardiovascular Disease Management Service Companies

5.2.1          Alere Medical, Inc.

5.2.1.1       Products and Services

5.2.1.2       Heart Failure Disease Management Activities

5.2.1.3       Financial Information

5.2.2          American Healthways, Inc.

5.2.2.1       Heart Failure Disease Management Activities

5.2.2.2       Financial Information

5.2.3          Cardiocom Multi-Disease Management

5.2.3.1       Products and Services

5.2.3.2       Heart Failure Disease Management Activities

5.2.4          CorSolutions Medical, Inc.

5.2.5          CyberCare, Inc.

5.2.5.1       Financial Information

5.2.6          Health Hero Network, Inc.

5.2.6.1       Products and Services

5.2.6.2       Heart Failure Disease Management Activities

5.2.7          HomMed, LLC

5.2.7.1       Products and Services

5.2.7.2       Financial Information

5.2.8          I-trax, Inc.

5.2.8.1       Financial Information

5.2.9          LifeMasters Supported SelfCare, Inc.

5.2.9.1       Heart Failure Disease Management Activities

5.2.9.2       Financial Information

5.2.10        Landacorp, Inc.

5.2.10.1     Financial Information

5.2.11        McKesson Health Solutions, LLC

5.2.11.1     Financial Information

5.2.12        Pfizer Health Solutions

5.2.12.1     Financial Information

5.2.13        Protocol Driven Healthcare, Inc.

5.2.14        QMed Interactive Heart Management

5.2.14.1     Financial Information

Appendix I:  Disease Management Company Listing

Appendix II:  Device & Pharmaceutical Company Listing

List of Exhibits

Exhibit 1-1:  American College of Cardiology and the American Heart Association Stages of Heart Failure

Exhibit 1-2:  Comparison of General Cardiologists and Heart Failure Specialists in Diagnosis, Initial Treatment and Management of Heart Failure

Exhibit 1-3:  Surgical Procedures to Treat Heart Failure (Cleveland Clinic)

Exhibit 2-1:  Methods and Assessment Tools Used by Selected Disease Management Providers

Exhibit 2-2:  Patient’s Needs in Heart Failure Programs

Exhibit 2-3:  Heart Failure Patient Management at Home:  Programs and Methods

Exhibit 2-4:  Methods and Assessment Tools Used by Selected Disease Management Providers

Exhibit 2-5:  Selected Studies of Hospital-Based HF Management Programs

Exhibit 2-6:  Listing of Terms Used in Telehomecare

Exhibit 2-7:  In-Home Health Status Parameters Measured

Exhibit 2-8:  Heart Failure Home Monitoring, Forecast 2004-2008

Exhibit 3-1:  New York Heart Association Functional Classification

Exhibit 3-2:  Selected Currently Available Heart Failure Medications

Exhibit 3-3:  Completed Clinical Trials of ACE Inhibitor and Beta-Blocker Usage in Heart Failure

Exhibit 3-4:  Clinical Trials Impacting Hypertension, Heart Failure and Cardiovascular-Related Mortality

Exhibit 3-5:  Trials Tracking the Medical Management of Heart Failure

Exhibit 3-6:  New and Investigational Drugs for Heart Failure, by Physiologic Effect

Exhibit 3-7:  Diuretics Currently Under Development for Heart Failure

Exhibit 3-8:  Inotropic Agents Currently Under Development

Exhibit 3-9:  Vasodilators Currently Under Development for Heart Failure

Exhibit 3-10:  Other Drugs Under Development

Exhibit 3-11:  New York Heart Association Functional Classification

Exhibit 3-12:  Selected Completed Trials for Cardiac Resynchronization Therapy in Heart Failure

Exhibit 3-13:  Current Trials for Cardiac Resynchronization Therapy in Heart Failure

Exhibit 3-14:  Cardiac Resynchronization Devices in the U.S. Market

Exhibit 3-15:  Techniques of Hemofiltration

Exhibit 3-16:  Diuresis Performed with Intravenous Diuretic Therapy versus Ultrafiltration*

Exhibit 3-17:  Currently Marketed Ventricular Assist Devices in the U.S.

Exhibit 3-18:  Ventricular Assist Devices under Development

Exhibit 3-19:  Comparison of Products Used for External Counterpulsation

Exhibit 3-20:  Prevalence Estimates of Sleep-Disordered Breathing Among Key Cardiovascular Disease Groups

Exhibit 3-21:  Using Continuous Positive Airway Pressure Treatments in Heart Failure Patients

Exhibit 3-22:  New Developments in Diagnosis of Sleep Disordered Breathing

Exhibit 3-23:  Selected Developments in Sleep-Disordered Breathing Diagnostics

Exhibit 4-1:  Clinical Determinations Made with Non-Invasive Hemodynamic Monitoring Techniques/Devices

Exhibit 4-2:  Selected Studies using Hemodynamic Monitoring with Chronic Heart Failure Patients

Exhibit 4-3:  Methods Used in Invasive Measurement of Hemodynamic Parameters

Exhibit 4-4:  Technology Comparison:  Peripheral Artery Catheters versus Non-invasive Cardiac Output Monitors

Exhibit 4-5:  Selected Hemodynamic Measurements and their Usage

Exhibit 4-6:  Using Non-Invasive Hemodynamic Measurements within the Patient Management Continuum

Exhibit 4-7:  Using Non-Invasive Hemodynamics in Assessing Patient Risk and Determining Treatment

Exhibit 4-8:  Identifiable Causes of Hypertension

Exhibit 4-9:  Implications of Early Recognition of Heart Failure Risk

Exhibit 4-10:  Comparison of Pulmonary Artery Catheter and the VeriCor System

Exhibit 4-11:  Intra-cardiac Hemodynamic Monitoring Under Development for Heart Failure

Exhibit 4-12:  Blood Pressure and Hypertension:  Classifications, Types and Terms Used

Exhibit 4-13:  Selected Ambulatory Blood Pressure Monitors

Exhibit 4-14:  Hypertension Population Treated in the U.S.

Exhibit 4-15:  New Hypertension Patients Treated in the U.S.

Exhibit 4-16:  Ambulatory Blood Pressure Monitoring Market Projections, 2003-2007

Exhibit 4-17:  Drivers and Limiters of the Market for ABPM Devices