Microsoft Word - CV- CFR MASTER 02-08-2006

Title – Subtitle 1 © 2004 HealthTech

The Future of Cardiovascular Services Clinical Focus Report

Revised: February 2006

Table of Contents

Cardiovascular Services – Clinical Focus Report – February 2 © 2006 Health Technology Center

Executive Summary 3

Technologies in the pipeline 5

OVERVIEW 6

Definition and scope 6

Emerging Technology 8

Diagnostics 8

Medical Therapies 9

Surgery 14

IT Support 15

Patient Experience 17

Care Setting and Facilities 19

Workforce 23

Care Delivery and Operations 25

Coverage and Reimbursement 27

Cost Implications 29

Expert Panelists and Expert Interviewees 31

Appendix and Glossary 33

Executive Summary


O

ver the next decade, cardiovascular services will continue to be distinguished by turbulence and change. The incidence of cardiovascular disease is increasing due not only to demographic

shifts and lifestyle patterns, but also to technology advances in detection. At the same time, revenue instability and physician turf battles will plague the service line as profound changes occur in the type and site of care.

Technologies like VADs, ICD/pacemakers, ablation and stent technologies are experiencing a stair stepping pattern of maturation. Each new iteration begins the

pattern of technology improvement, leads to increased adoption and benefit and concludes with an impact plateau. This stair stepping pattern will continue for the next 5-10 years with familiar technologies, until more disruptive therapies (such as stem cell and gene therapies and genetic testing) make their impact on the CVD diagnosis and treatment process.

In a future of reduced inpatient volume, complex co-morbidity considerations, and competition for market share, these emerging technologies - among others - will be vital to consider in planning a CVD service line.

Electrophysiology Procedure Explosion Rocks CV Services. –Look for a 20-30% annual increase in EP volumes for the next 5 years. This will force organizations to add more staff, space and equipment. Start implementations now to be ahead of the curve.

Next Generation VAD Technology Revitalizes Stalled Mechanical Ventricular Assistance - Most CV surgery programs will consider placing bridge and rescue VADs in the next 2 years. A few hardy organizations will expand to destination placement as technology becomes smaller, longer-lived, easier to place, maintain, and receive. Research will drive use to younger and less critically ill patients and will expand the bridge pool.

Diagnostic Imaging Arms Race Creates Expensive and Unpopular Battles – CT, MRI, PET, US, and fusion technologies are all going through massive iteration improvements causing an imaging arms race between technologies and departments. Each new generation offers more diagnostic capabilities but also fuels battles for space, access and ownership.

Healthcare Informatics Need to Move Faster Then Patients – Cordless communication devices, implant’s information transfers, POCT, RFID tracking, and EMR/PHR are enabling care to be on the move and patient, clinician and care site to be distant. Organizations will need new IT/biologic jobs and to rearrange care paths to capture these mobile patients. Minimally Invasive Surgery (MIS) Fallout Continues to Disrupt CV Services - Aneurysms, valves, ablations, vein harvesting and septal defect repairs move to MIS approaches. Shorter LOS and outpatient stays create a turbulent financial environment. Plan now for revenue disruption.

Space, Space and More Space for CV – Adaptable and convergent space that quickly and economically flexes in response to shifting CV volumes costs more now but saves time and money later. Hybrid space makes operational and economic sense but the politics remain difficult. Turf battles over space, staff, and equipment escalate as other specialties expand into CV home turf.

CV Device and Therapeutic Innovations Accelerate – Drug Eluting Stents evolve to biodegradable stents taking another 5-10% of CABGs in the next 2-5 years. Stent, valve, and CV pharmaceutical iterations mark a stair-step of technology improvement, process shift, and benefit plateau.

Cell and Gene Therapies Revolutionize CV Care In 10-15 Years. – Despite CV being a prime research target for cell and gene therapies, they are not ready for prime time. Cell therapies will initially be combined with surgical and interventional procedures but gene therapies are at least 10 years out.

Act Now

Hold the Course

Trends You Need to Know…

Executive Summary


*Diffusion is when an estimated 30-40% of the market has begun using a technology.

Overview


Definition and Scope Crucial drivers of change in cardiovascular care are

Increasing lifespan

Development of lifesaving and life prolonging technologies

The increase in patient lifespan is marked however, with the rising prevalence of chronic disease. Chronic disease increases the need for medical intervention. Chronic conditions involving the heart are the most prevalent and rise sharply in the over 65 age population.

Currently, 45% of the population has chronic disease, and as projections suggest a doubling of the over 65 population by 2030, the cardiac disease burden will rise exponentially. Cardiovascular services will shift the bulk of care from inpatient to outpatient and then to home monitoring of chronic conditions. Technologies are both creating the changing care patterns, as well as emerging to address the resulting array of conventional and new choices for care.

Key Environmental Factors

Advances in cardiac imaging uncover earlier cardiac disease and requires follow up with a physician for further care.

Decentralization of image interpretation occurs and many clinicians choose to interpret their own images.

Aging baby boomers demand painless, life-style enhancing technologies.

Patients’ increase in sophistication about their choices in management of CVD.

Direct to Consumer (DTC) marketing increases demand and treatment costs.

Obesity and metabolic syndrome increase cardiovascular disease onset and decrease age of onset.

Payers shift cost to consumers through tiered formulas and higher co-pays.

Rising awareness of CVD in women triggers additional research, education and protocols.

Unsure future of a legislative response regarding specialty hospitals is resulting in a defacto moratorium on development. In addition the changing nature of care towards lower-paid endovascular procedures are compromising the long-term viability of Heart Hospitals.

Change in the Scope of Services The scope of services for cardiovascular care is expanding and shifting at the same time to include less open procedures and more minimally invasive catheter-based techniques heavily dependent on imaging capabilities. This trend will continue with the expanded use of molecular imaging. Cardiovascular services will expand to include a larger emphasis on chronic care management via remote patient technologies. Care algorithms will be developed to signal when a patient’s condition deviates from expected norms, and to guide changes in therapy. Cardiovascular patients will form lengthier relationships with physicians and other disease management systems, as management of chronic conditions expands and acute episodes decrease.

Incidence of Disease Cardiovascular disease (CVD) is a principle cause of death in the United States, responsible for 38% of all deaths (1 of every 2.6). CVD mortality was nearly 60% of total mortality. From 1992-2002 death rates from CVD declined by 18.0%, in the same period actual deaths increased by 0.8%. According to the CDC/NCHS, if all forms of major CVD were eliminated, life expectancy would rise by almost 7 years. If all forms of cancer were eliminated, the gain would be only 3 years.

Cancer outpaced cardiovascular disease (CVD) as the top killer for the first time in 2005 but it hasn’t replaced itself as the number one

concern for hospitals and patients.

Overview


Now 45% of the over 65 population has cardiovascular disease. This population is expected to double by 2030 within the next 25 years.

Population Projection Increases by Decade and Age (in thousands)2

2000 2010 2020 2030 2040 2050

Total 282,125 308,936 335,805 365,584 391,946 419,854

% 10% 9% 9% 7% 7%

>65 35,061 40,243 54,632 71,453 80,049 86,705

% 15% 36% 31% 12% 8%

For years cardiovascular disease was thought to be a men’s killer, but women over the age of 65 have a nearly 3 times higher risk of CV disease then their male counterparts, while women between 45-64 actually have a one third lower risk than males. There is a significant difference in symptoms and treatment responses for women which has yet to be understood.

CV Disease Burden for Men and Women by Age3

The cost of CVD is significant. A staggering $400 billion dollars will be spent in 2005 in the US for both direct and indirect CVD costs. $400 billion dollars is the Gross National

2 Heart Disease and Stroke Statistics – 2005 Update American Heart Association from CDC/NCHS 3 Heart Disease and Stroke Statistics – 2005 Update American Heart Association from CDC/NCHS

Product for over 94% of countries in the world (including Russia, Taiwan and Australia).

All forms of cardiovascular diseases are expected to increase over the next 15 years including acute myocardial infarctions (AMI), cardiac dysrhythmias (CD), heart failure (HF), other ischemic heart disease (OIHD), aortic aneurysm (AA), and essential hypertension (EH) as demonstrated in the chart below based on population projections from Solucient using New York and California as examples:

CVD Disease Projections for 2004 – 20184

4 Source: Solucient 2005

0%

5%

10%

15%

20%

25%

30%

35%

age 45-64 Over 65

WomenMen

0102030405060708090

100

2004 2006 2008 2010 2012 2014 2016 2018

Cardiovascular Disease Projections, New York, 2004-2018

Num

ber o

f Adm

issi

ons

(per

100

0)

Years

OIHD

HF

AMI

CD

EH AA

0

20

40

60

80

100

120

140

160

2004 2006 2008 2010 2012 2014 2016 2018Num

ber o

f Adm

issi

ons

(per

100

0) Cardiovascular Disease Projections,

California, 2004-2018

Years

OIHD

HF

AMI

CD

EH

AA

Emerging Technology


Diagnostics Imaging in particular will play a prominent role in the transformation of cardiovascular services in the next 5 years and beyond. These technologies will lead to earlier detection of disease, better-targeted therapies, and overall improved outcomes. Advances in imaging, sensors, and eventually genetic testing will have a significant impact on how cardiovascular disease is prevented, diagnosed, and treated.

Medical imaging technologies will have the most significant effect on quality of care and clinical outcomes for cardiovascular diseases. Medical imaging will focus primarily on Computed Tomography (CT) and Magnetic Resonance (MR). Throughput for CT is faster than for MR, an important factor in efficiency. There is an increased interest in the imaging of gene expression to visualize the molecular basis of disease using Positron Emission Tomography (PET). Fusion of PET/CT and SPECT/CT provide functional information from PET or SPECT merged with anatomical information from CT.

Sensor technology is being integrated into textiles, furniture, and other consumer devices to track and record basic physiological indicators. These technologies are beginning to appear on the market as smart shirts and life vests that monitor cardiac and pulmonary function. Sensors will evolve from passive monitors of physiologic indicators to “smart sensors” that continuously monitor a value and initiate a response when these values indicate a potential problem. Examples of this type of technology include a heart monitor that activates drug release in CHF patients, and a cardiac pacemaker that uses pressure and oxygen saturation readings from multiple sites in the body to pace the heart.

Genetic testing will take longer to evolve, but will eventually result in the identification of genetic targets for medical management of cardiac disease. Early applications will be

applied to congenital diseases caused by single genes of high penetrance, followed by more sophisticated tests for complex common diseases of the cardiovascular system.

Two to Five Years: Imaging

• 64-Slice CT • PET/CT and SPECT/CT • 3D ultrasound • 3T MRI

Sensors • Point-of-Care testing for real-time lab testing

• Sensors to aid in management of chronic disease and frailty

• Biometric monitoring for arrhythmias, CHF, hypo and hyperperfusion

Genetic Testing

• Genetic Testing for single gene disease

Five to Ten Years:

Imaging • 5-7T MRI • Radiopharmaceutical Advances • Flat Panel CT

Sensors • Stereotactic Catheter Navigation • Smart implantable and external

devices for chronic conditions • Continuous Nano Sensors • Closed Loop devices

Genetic Testing

• Test for diabetes and metabolic syndrome

• Predisposition testing for complex common cardiovascular diseases

Emerging Technology


Top Drivers and Barriers of Diagnostic Technology Development and Adoption

Drivers Barriers

Imaging Consumer demand for non-invasive procedures Capital costs and inadequate reimbursement and coverage

More accurate diagnosis and staging of disease Inability of the IT system to accommodate the increased volume of procedures driven by multiple integrated technologies

Potential to apply molecular imaging for diagnosis and treatment of disease

Shortage of radiologists and technicians

Sensors Rapidly increasing number of patients with chronic conditions FDA approval of sensor devices

Heightened emphasis in healthcare delivery system on care management

Appropriate IT support for sensors used in Remote Patient Management

Genetic Testing Completion of the Human Genome Project Patient concerns regarding confidentiality and discrimination in

employment and insurance

Increased understanding of complex common diseases with some genetic basis

Complexity of genetic/environmental interactions as cause for disease

Marketing efforts by labs and developers Inadequate supply of genetics professionals for interpretation of results

Medical Therapies Advances in drug delivery systems, cardiovascular pharmaceuticals/biologicals, organ assistance and substitution, tissue and fluid bioengineering and stem cell technology, will significantly increase the therapies available for cardiovascular disease. Next generation drug-eluting and bioabsorbable stents are expected to have a substantial impact on utilization rates as the technology improves and is expanded beyond current applications.

Drug-eluting stents (DES) have demonstrated rapid diffusion paralleled only by laparoscopic cholycystectomy a decade ago. These stents cost approximately two to three times the amount of bare metal stents and roughly halve the need for repeat procedures from restenosis.

Broader applications and increasing popularity of drug-eluting stents will increase facility utilization, creating the potential to benefit from dual purpose OR and cath labs. The use of DES is expanding, though solid evidence is lacking for the treatment of some types of blockages, and is

not yet justified in SVG, unprotected left main, ISR, branches of bifurcations, AMI and thrombus containing lesions.5

Providing cutting edge technology offers value to the patient and improvement in clinical outcomes, but generates poor rate of return despite improved reimbursement from public and private payers. Hospitals will be caught by the growing debate over:

Appropriate criteria for patient eligibility

Treatment moves to non-coronary arteries

5 Peterson, Lynne. “Trends in Medicine: Transcatheter Cardiovascular Therapeutics.” Trends-In-Medicine : Sept. 2003. Accessed October 20, 2005. <www.trends-in-medicine.com>.

Emerging Technology


Second generation stents may include an anti-coagulant as part of the drug therapy.

Drug-eluting stents now account for 90% of percutaneous transluminal coronary angioplasty (PTCA) procedures. This treatment will now move to carotid arteries, renal arteries and eventually peripheral arteries over the next two years

CMS is considering reimbursement improvements in the form of per-stent reimbursement, or multi-vessel reimbursement. Health plans are expected to follow.

The actual drop in CABG volumes is 15 to 20 percent between 2003 and 2005. Open procedures will not be replaced by drug-eluting stents in patients with multiple clogged heart arteries due to recent data on comparative outcomes. CABG volume is expected to plateau for the next 2 years. Coronary Artery Bypass Graft (CABG) procedures were initially forecast to decrease in volume by 35 percent because of drug-eluting stents.

The need for interventional rooms and recovery areas will increase despite reductions in restenosis rates as procedural volumes rise and broaden to include implantation in non-coronary vessels.

A majority of drug-eluting stent implant procedures will move to outpatient settings and freestanding centers in the next five years. The length of stay associated with drug-eluting stent implantation is shortening.

Development and implementation of appropriate protocols and clinical guidelines for drug-eluting stent implantation, for specific risk levels and for the number of stents per procedure will be important in managing patient outcomes and reimbursement.

Higher volumes of patients receiving PTCA and shifts in types of patients treated (i.e., diabetic patients, lesions in proximal left anterior descending

6 Peterson, Lynne. “Trends in Medicine: Transcatheter Cardiovascular Therapeutics.” Trends-In-Medicine : Sept. 2003. Accessed October 20, 2005. <www.trends-in-medicine.com>.

(LAD) coronary artery, and small coronary vessel diameters) will require additional interventional space and staff.

Health plans are likely to develop multistent or multivessel reimbursement policies based on accepted practice guidelines.

Competing technologies: Coronary Artery Bypass Graft (CABG), off-pump CABG, PTCA for contraindicated cases, photoangioplasty, intravascular sonotherapy, cryoplasty, angiogenic gene therapy, and vascular brachytherapy.

There do not appear to be any blockbuster cardiovascular pharmaceuticals emerging from drug pipelines in the near future. Change in this arena is more likely to come from increases in the proportion of CVD patient who receive appropriate therapy. Only 40% of patients who would benefit from existing drug therapies actually receive them, up from 30% in the last 3 years.7

Statins continue to improve and decrease side effects and statins have also increased the age of CVD onset by 3-4 years. New drugs that mimic high-density lipoprotein (APO-1 Milano) are also being tested to reverse plaque in coronary arteries. So far, the research has been limited.

Promising advances in anti-thromboic medications, such as Factor Xa, may offer the first alternative in 50 years to warfarin.8 These drugs offer few side effects, no drug-food interactions, few drug-drug interactions and rapid onset and offset effect and would mark significant improvements over warfarin therapy.9 All of these long-term pharmaceutical prospects will serve to decrease the number of acute cardiac episodes requiring inpatient care, and the latter may eliminate the need for coumadin clinics.

7 Reuters Health Information, “Use of Proven Heart Disease Therapies has Increased, but Still Suboptimal” quoting from research in Circulation 2006; 113. Accessed January 11, 2006 8 Associated Press. “New Blood Thinner Found Safer than 50-year old Standard.” CNN. November 3, 2003. Accessed September 30, 2005. <www.cnn.com>. 9 F.A. Spencer and R.C. Becker. Novel inhibitors of Factor X for use in Cardiovascular Diseases. Current Cardiology Reports 2:395-404, 2000

Emerging Technology


Organ Assist Devices include:

VAD - ventricular assist devices

TAH - total artificial heart

Hemofiltration

Ventricular assist devices (VADs) are emerging as destination and improving as bridge therapy. Destination therapy refers to the implantation of a ventricular assist device (VAD) for long-term use, rather than as a bridge-to-transplantation or recovery. VADs augment cardiac performance in severe heart failure (HF) patients for the following reasons:

Myocardial recovery occurs during VAD support

Myocardial recovery is more likely in acute forms of myocardial injury < 6 months

Characteristics of those more likely to experience myocardial recovery include:

Younger age

Shorter duration of illness

Structural changes do not always correlate to functional recovery

VADs create appropriate milieu for recovery

But predictions for current VAD utilization have been limited for the following reasons:

Lack of device utilization has been tied to unreliability and less then optimal clinical effectiveness

Co-morbidities have unmask device shortcomings differently and affect is not completely known

Patient preferences for therapy change based on outcome and perceived risk

Variations in CHF referral for VAD therapy

Improvements in VAD technologies will increase the adoption of VADs and lead many hospitals to adopt VAD bridge programs and some hospitals that are not heart transplant centers to decide to adopt destination programs.

VAD Improvements over 1st Generation technologies include Axial or continuous flow pumps and 2nd and 3rd generation VADs that are smaller and allow for easier implantation, and decreased external interfaces that decrease thrombosis and infection complications.

Axial or continuous flow pumps are demonstrating some improvement over 1st generation VADs. They have the following advantages over current VAD technologies are:

1/10th size of pulsatile pumps

Less complicated surgery

3-5 years durability

1/3 cost of pulsatile

One disadvantage is that the patient no longer has a pulse, a disquieting experience for healthcare workers taking care of a live patient.

3rd Generation VADs include magnetically suspended rotary pumps. Some of their benefits will include:

Designed for chronic use

Durability of about 20 years

Minimal power requirements

Small & totally implantable

Complete blood washout, so non-thrombogenic

No vibration decreasing infection and discomfort

Minimal blood damage due to frictionless pumping and lack of heat buildup

Jarvik Flow Maker1

Emerging Technology


Total artificial hearts (TAH) will be used as a bridge to transplant and eventually as a destination therapy.

Use of extracorporeal hemofiltration devices will also assist patients with advanced congestive heart failure, accelerating recovery from acute episodes.10

Tissue and fluid bioengineering merges biology and chemistry with engineering to create products that mimic aspects of the body’s natural

cardiovascular tissues and its ability to respond to physiological and environmental conditions. Technologies that will impact cardiovascular care include:

Artificial blood (hemoglobin based oxygen carriers (HBOC) and perfluorocarbons (PFC)),

Artificial vascular grafts, hybrid vascular grafts grown in vitro

Polymer-released growth factors

Heart valves and blood vessels grown on biodegradable scaffolds are also being developed to substitute for their natural counterparts.

These technologies will be likely to reach the market with autologous products. The use of cell/vector delivered growth factors to promote angiogenesis in an ischemic heart may reach clinical use within 5-10 years, though concerns exist regarding cancer and genetic manipulation.

Stem cell technology has shown early promise in the amelioration of heart failure: in a recent study stem cell injections to the left ventricle improved the health of four out of five patients.11 Stem cell technology will most likely emerge as an adjunctive therapy and may eventually develop as a replacement technology.

10 For information on extracorporeal hemofiltration devices, see the HealthTech Alert dated July 16, 2003. 11 Perrin EC, et al. “Transendocardial, Autologous Bone Marrow Cell Transplantation for Severe, Chronic Ischemic Heart Failure.” Circulation. 107(2003): 2994-2302.

Use of stem cells or cardiomyocytes to augment or repair cardiac muscle will compete with existing approaches, such as angioplasty and ventricular assist devices. The in vitro development of whole organs is the focus of considerable attention in research, but is unlikely to reach clinical use within the timelines of this report.

Source: www.texasheartinstitute.org/j2000.html accessed 10/25/05

Benefit of Combined Off – Pump CABG (OPCAB) with Stem Cells in Mean Left Ventricular Ejection Fractions

Left Ventricular Ejection Fraction Percentage

OPCAB N = 10

OPCAB + Stem Cell

N = 10 P Value Pre-Op 30.7 29.4 0.381 Post-Op 1 month

36.4 42.1 0.002

Post-Op 3 months

36.5 45.5 0.0004

Post Op 6 months

37.2 46.1 0.0007

Navigant Consulting Inc.,

0500

1,0001,5002,0002,5003,0003,500

2005 2007 2009 2011 2013 2015

Future US Stem Cell Therapeutics Market 2005-2015

US

Dol

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Emerging Technology


Key Therapeutic Technologies and Time of Market Entry

Two to Five Years:

Drug Delivery Systems

• Drug-eluting stents for other vascular applications • 2nd generation Drug-Eluting Stents • Bioabsorbable Stents

Cardiovascular Pharmaceuticals and Biologics

• Increased utilization of currently available drugs • Approval of a “polypill” for widespread use

Organ Assistance and Substitution

• Ventricular assist devices (VAD) • Total artificial heart (TAH) for small number of patients • Extracorporeal hemofiltration

Tissue and Fluid Bioengineering

• Synthetic blood (HBOC and PFC)

Five to Ten Years:


• Improved Stents including metal, polymer, drug • Nano technology for targeted drug delivery


• Novel anti-thrombotics (factor Xa and VII inhibitors) • Ability to profile patients for pre-disposition to adverse drug effects


• Improvement in VADs and TAHs • Renal dialysis with human or porcine cells • Use of stem cell and gene therapies to adjunct surgery


• Hybrid and autologous vascular and arterial grafts grown in vitro • Use of cell or other vector delivered growth factors • (VEGF/PDGF) to promote angiogenesis in an ischemic heart • Stem cells for some cases of heart failure

Emerging Technology


Top Drivers and Barriers to Therapeutic Technology Development and Adoption

13 Recent research demonstrates advances that may solve these durability issues. For example, see Masuzawa T, et al. “Magnetically suspended centrifugal blood pump with an axially levitated motor.” Artificial Organs 27(7):631-638.

Drivers Barriers


Increased number of patients with cardiovascular disease High cost of R&D

Effectiveness of DES Financial penalty hospital incurs for using drug eluting stents

Medicare coverage and reimbursement for drug eluting stents Coverage, but reimbursement that is below costs


Expansion of indications for the use of existing drugs Failure of delivery systems to adhere to evidence-based guidelines

Direct-to-Consumer marketing by companies Growing number of un- or underinsured patients

Increasing number of drugs per patient for comorbidities Patient’s poor adherence to medication regimens and high costs relative to income


Increase in CHF patients Requirements for clinical trials

Potential market expands to include pediatric patients High cost of research and development

Convergence of technological advances Limited durability of devices13


Need for implants with multiple applications FDA approach to hybrid products and high initial cost

Reduced expense of harvesting autologous tissues/cells No cost-effectiveness data

Bioengineered instead of synthetic grafts and valves will grow with the person

Concerns about tumor formation on account of gene delivery

Stem Cell Technology

Milestones in technological development Political and legal issues surrounding direction and funding of research

Memorial Cardiac and Vascular Institute Robotic Mitral Valve Surgery

Emerging Technology


Surgery

Advances in robotics minimally invasive surgery are closely linked and will have significant impacts on cardiovascular

Minimally invasive surgery (MIS) advances in this field include endovascular surgeries. These technologies will reduce the overall number of open procedures that are performed, but will also result in an increase in the number of patients eligible for and likely to opt for percutaneous interventions.

Repair of abdominal aortic aneurysms,

Ablative treatment of cardiac arrhythmias

Atrial and ventricular septal defects15

Vein harvesting

Valve repairs

These advances are closely linked to advances in imaging capabilities and surgical tools.

Robotics are poised to have an impact on minimally invasive procedures, although to date the adoption of robotic enhancement has been limited. Surgical robots will enable new procedures like cardiac surgery in utero, and valve repairs that would traditionally call for valve

14 FDA Center for Devices and Radiological Health. New Device 15 FDA Center for Devices and Radiological Health. New Device

replacement. Procedures that benefit from robotics include Mitral valve repair and mammary artery dissection and circumstances include holding the camera for endo- and laparoscopic procedures. Remote surgery via robotics is unlikely to be widely diffused, due to cost and liability considerations.

Key Surgical Technologies and Timing of Market Entry

Two to Five Years:

MIS/Robotics • Improved endoscopes and endovascular technologies, such as computer-directed and stereotactic navigational devices

• Bioabsorbable Stents • Automatic anastomosis devices for

reconnecting arteries • Laparoscopic vein harvesting • Continued migration of CV

procedures to endovascular including aneurisms, valves and septal defects

Five to Ten Years:

MIS/Robotics • Intravascular delivery of biologics such as growth factors and stem cells

• Improved imaging systems for intraoperative applications

Top Drivers and Barriers to Surgical Technology Development and Adoption

Drivers Barriers

MIS/Robotics Patient demand for the least disruptive interventions High cost of R&D because of lack of commercial and

government investment

Competition for market share; need to be seen as ‘state of the art’

Limited evidence for improved outcomes or assured cost-savings

Advances in computer vision and navigation Safety and liability concerns

Emerging Technology


IT Support

Integrated IT systems will assume a mission critical role in cardiovascular care.

Computerized physician order entry (CPOE) that allows direct entry of information for billing and prescription purposes, clinical decision support systems,

Picture archiving and communication systems (PACS) to view and archive imaging studies online are continuing to diffuse within delivery systems.

These systems will help to better marshal and manage the vast volumes of information produced by imaging and sensor devices, increased patient volume and throughput, and the proliferation of devices, networks, and security needs. The deposit of patient data streams into an electronic medical record will facilitate data collection, outcomes management and overall quality improvement.

Remote patient management will play an important role in the future direction of cardiovascular care. Remote patient management (RPM) technologies will:

Serve as intermediaries between clinicians and patients to enable remote clinical evaluation and management

Mediate several types of interactions, including communication between patients, primary care providers, specialists, ancillary service providers, or providers of disease management

Improvements in RPM technologies will enable better outcomes for Disease Management programs. These technologies will be most effective when they combine objective and subjective data related to a patient’s condition. Advances in wireless and battery life will resolve the limitations of dependence on a patient’s home phone line to connect these technologies. These technologies may be synchronous, working in real time data acquisition, transmission, and evaluation, or asynchronous, with offline capability to acquire, transmit and evaluate data that is not presented in real time.

Key Support Technologies and Time of Market Entry

Two to Five Years: Remote Patient Management

• Remote patient management for chronic disease

• Structured clinical messaging (email systems)

• Remote inpatient management (electronic ICU)

• Passive monitoring devices • Consumer devices, textiles and

furniture embedded with sensors

Computerized physician order entry (CPOE)

• Expanded use of CPOE • Dynamic portable CPOE • Expanded use of e-prescribing

Clinical Decision Support

• Integration of passive information into clinical decision support systems

• Messaging and communication in clinical decision support

Picture Archiving and Communication Systems (PACS)

• Cheaper, faster, more reliable storage online

• Improved interfaces among modalities

• Improved integration of RIS with PACS for real-time radiology

Five to Ten Years: Remote Patient Management

• Mobile wireless videophones • Smart sensors

Computerized physician order entry (CPOE)

• Better integration and penetration of CPOE

Clinical Decision Support

• Mobile devices proliferate to include language interpretation at point of care

• Rules-based decision support due to computer aided patient management

Picture Archiving and Communication Systems (PACS)

• PACS becomes standard component of RIS and EMR

Emerging Technology


Top Drivers and Barriers to Support Technology Development and Adoption

Drivers Barriers

Remote Patient Management

Commercial availability of point of care technologies Current Medicare reimbursement does not support remote patient management

Education of patients and providers regarding the benefits of remote patient management

Inconsistent computer literacy among patients and physicians; resistance to change

Shortage of physicians and support staff within specialty areas such as ICUs

Cost of installation, clinician resistance

CPOE, Clinical Decision Support

Push to integrate information to EMR Capital outlay

Limited evidence that technologies control cost Lack of standards within the industry

Advances in networking and security Physician resistance to process redesign

PACS

Ongoing shortage of radiologists and radiology technologists Capital outlay

Increasing number of slices for scans and general modality growth

Cultural resistance to process redesign

Increase patient throughput Lack of access to high bandwidth necessary to transmit image data

Patient Experience


Consumer Expectations of Cardiovascular Services Patients expect to take an informed, active role in management of their disease, and will expect state of the art care as a result of changes. Some drivers of increasing access to information include:

Direct-to-consumer advertising

Health-related resources available on the Internet

Work of advocacy groups all educate patients about the options available for their care

Patient and Consumer View of Emerging Technologies

Prefer medical therapies that do not significantly impact their active lifestyle or have undesired cosmetic consequences

Expect IT-based medical solutions and will view them as part of ‘state of the art’ care

Have high expectations for these technologies as they come into clinical use

View diagnostic technologies as a crucial part of the care that can keep them out of the hospital in the long run

Genetic testing will be seen as a positive part of personalized medicine, although concerns about confidentiality remain to be resolved. The use of imaging technology to detect and stage disease in high-risk, pre-symptomatic patients will lead to improved disease management through preventive interventions. In instances where third-party payers do not cover pre-symptomatic testing or imaging, patients may be willing to pay out of pocket for such information.

New medical technologies in drug delivery and cardiovascular pharmaceuticals may provide patients with almost total freedom from managing drug regimens and will provide effective long-term treatment for some cardiovascular chronic conditions. Patients will view these advances as a convenience.

Advances in the portability of sensor and remote patient management technologies will provide patients and

family with a greater sense of freedom and security. These technologies will be viewed as a method of creating continuity from patient to provider, especially by patients who have a fragmented history of care, live in remote areas, or are frail and homebound. Patients and family will use remote

patient technologies to take a more active role in their disease management. The point of view of the patient will change, as they come to understand their care is supported by a network of caregivers and ancillary services.

End stage patients will welcome organ assistance and

substitution technologies, primarily VADs, as an alternative to waiting or being ineligible for a heart transplant. Patients will be more comfortable with technology to enhance the natural function of the heart, than with the use of a total artificial heart that replaces the diseased organ. Advances in tissue and fluid bioengineering will be viewed similarly, as patients will welcome hybrid advances that incorporate autologous tissues rather than allogeneic options. Particular subsets of patients will benefit from advances in blood substitute technology, as religious practices preclude their receiving blood from donors.

MIS and robotic technologies will be looked on favorably for the positive clinical outcomes associated with their use. Patients will view this technology as state of the art, and will become more and more comfortable with robotic interactions in healthcare.

Patients will be more comfortable with technology to enhance the

natural function of the heart, than with the use of a total artificial heart

that replaces the diseased organ.

Patient Experience


The Impact of Emerging Technologies on Patient Experience Patients’ quality of life will improve as advances in diagnostics, medical therapies, and support technologies result in:

Patient Education Education will be necessary to familiarize patients with new technologies incorporated into their care. Additional information will be necessary as cardiovascular technologies impact these areas:

Imaging: The risks of radiation exposure due to increased imaging events per patient will have to be explained as an issue of patient safety.

Drug Delivery and Cardio pharmaceuticals: Patients will have to be educated on new additions to their drug regimens, and how those drugs may interact with other treatments prescribed for co-morbidities. The lack of an external control mechanism and the technical complexity of many drug delivery systems in this subcategory will require substantial patient education.

Remote Patient Management: Patients will have to be educated in self-management to maximize the potential benefits of this technology.

Organ Assistance and Substitution, Sensors: Education will have to be provided for all levels of implantable electronic devices. Issues include how to transmit data from the device to a caregiver and how to recognize potential problems with a device.

Genetic testing: Advancements in the production of a genetic test for complex common cardiovascular condition will result in a need for increased patient education regarding the benefits and drawbacks of predisposition genetic information.

More Patients Become Eligible and Likely to Take Advantage of Minimally Invasive Surgery Techniques

Faster, More Accurate Staging of Disease

Less Isolation in Home Care Management

Less Responsibility Placed on the Patient to Stick to a Drug Regimen

Choices From an Array of Treatments that may be Appropriate for a Given Condition

Increased Quality of Home-Based Care

More Effective Rehabilitation Employing Robot Technology

Improved Patient

Experience

Decreased Pain, Morbidity, Length of Stay, and Recovery Time

Care Setting and Facilities


Impact of Emerging Technologies on Physical Space Requirements

Imaging technologies will have a significant impact on facility and space requirements. Intraoperative MRI systems and video camera systems will be most useful in rooms designed to have these technologies ceiling-mounted rather than on rolling carts. As MRI and CT angiography replaces some diagnostic angiography, the cath lab will become mainly a therapeutic space. Clinicians will be likely to employ both imaging modalities as they emerge, though HealthTech experts expect that CT will be more cost-effective than MR in the long run.

The expanding coverage of ICD’s is likely to increase implantation volumes and Electrophysiology Lab space needs. A nearly 20-30% growth can be expected for the next 3-5 years as Medicare and health plans increase coverage criteria.

Increased movement of procedures to endovascular will increase the need for interventional space. As the complexity of endovascular procedures increases and new technologies employ prosthetic materials with stricter sterility requirements, there will be a need for rooms that convert quickly from percutaneous approaches to either hybrid or open procedures. Non-sterile environments increase the possibility of hospital-acquired infections, of which some will be drug-resistant. Breaks in sterile techniques are rare, but in one review of infection following stent placement, 19 of 21 infections occurred in an angiography suite rather than in a sterile operating room.17

17 Dosluoglu HH, Curl R, Doerr RJ, et al. “Stent-related iliac artery and iliac vein infection: Two unreported presentations and reviews of the literature.” J Endovascular Ther. 2001; 8:202-209.

Equipping such a suite may include primary components for intraoperative ateriography and fluoroscopy, with general preference for ceiling mounting C-arm imaging equipment. Carotid stenting, peripheral stenting, and CV stenting each require slightly different equipment.18 Hospitals with the need to maintain a low volume cath lab may want hybrid suites that can be used for interventional radiology and more complex interventional cardiology. Combination OR and Cath lab rooms may be a practical solution.

Remote patient management technologies for acute care (ICU) require that more space be allocated in the clinical area for video support, wiring, data capture, and transmission. HealthTech experts have also envisioned a control center where patient data flows into a single location that is triaged and supervised by an appropriate caregiver.

Advanced technologies that combine biological and prosthetic components have facility implications for large tertiary centers that become centers of excellence for these technologies. It is unlikely that these technologies will diffuse to community and rural centers because of the laboratory and technical requirements associated with their use. Organ assistance and substitution technologies will require additional lab and storage space. Tracking systems will be implemented to keep track of implants, equipment, and supplies. Additional air filtration systems may be necessary in operating rooms where these technologies are used.

Advances in tissue and fluid bioengineering will have space implications for regional facilities that have central labs for the creation of hybrid materials. Synthetic blood will become a commodity, with a reduced need for refrigerated storage and cross matching activities. Most likely, the in vitro growth of tissues and organs will have to be conducted at central labs of large hospitals or academic centers.

Systems will have to be created to track all the components of stem cell technology, including storage of cord blood, cell donations, and cell and tissue therapies.

18 Diethrich EB. “The Dedicated Endosuite.” Endovascular Today. Jan/Feb 2003. Accessed at www.endovasculartoday.com. October 1, 2003.

Remote patient management technologies for acute care (ICU)

require that more space be allocated in the clinical area for

video support, wiring, data capture, and transmission.



Read on to understand: Why most heart programs will be adopting some form of VADs in the next few years. Why most heart programs will not be adopting destination VADs in the next 2-5 years. El Camino Hospital is an example of a community hospital with a cutting edge heart program. They currently have a heart program that does 150 cardiovascular surgeries/cases a year. Their cardiovascular surgeons are Stanford University affiliated and Stanford University Medical Center is the nearest heart transplant center. El Camino is not a heart transplant center, but the association with Stanford's Cardiothoracic Transplantation program places it in a unique situation. El Camino is instituting a program to place Ventricular Assist Device (VAD) in patients as bridge therapy until they can either be referred to Stanford for a heart transplant or for their heart to recover so that the device can be removed. The development of such a program could eventually lead this center to consider placing VADs as destination therapy for those patients who cannot receive a heart transplant. But, few active transplant and heart failure centers across the country are placing more than 4-5 destination VADs annually. Community hospitals such as El Camino are not likely to generate a critical mass needed to make adoption of destination VADs feasible, given the current state of these devices, which require extensive support in the operative and ongoing management period. At this point, a destination device program would necessitate extensive infrastructure support and cost that render it prohibitive to a hospital of El Camino’s size. El Camino Hospital however, is initially considering placing VADs as bridge therapy, given the understanding that VADs provide an opportunity to bridge a patient in severe life threatening cardiogenic shock and support their heart function until they can recover some heart function, receive a heart transplant or have a destination VAD placed. As such, VADs are likely to see increased use as bridge therapy: Bridge-to-destination- a temporary VAD bridging the patient until they can have a long-term or permanent VAD. Placement

is decided on usually at a heart transplant center. Bridge-to-transplant- a temporary VAD bridging the patient until they can have a heart transplant. This is only an option for

patients who qualify for heart transplantation and a heart becomes available. Bridge-to-recovery- a temporary VAD to assist the heart muscle to rest and recover some function at which time the VAD

can be removed. Research is demonstrating that some patients will recover heart tissue and function where VADs are used making this a viable option for some patients.

The reason El Camino Hospital like many community hospitals will consider placing bridge VADs is that any reasonably sized heart program potentially may have at least 2-3 patients for every 100 cardiovascular surgeries that will need this lifesaving therapy, if only temporarily until other options can be explored. Even without surgery, some patients who present with a massive myocardial infarction and show evidence of cardiogenic shock may benefit from placement of a VAD as a life-saving measure. Short-term VADs are less expensive and make it more feasible for a community based cardiovascular surgery program to afford keeping this technology on the shelf. Abiomed has just such a product that has a current list price of $18,000 and is capable of a bedside switch out to a long-term product if it is needed later for an additional $45,000. Although some VADs such as the HeartMate XVE by Thoratec Corp. and Novacor by WorldHeart Corp. have been approved for bridge and destination therapy, these technologies have current list prices between $71,500 and $84,500. The cost outlays for expensive product inventory and the cost of creating a VAD program for destination/long-term therapy are extensive requiring significant infrastructure to provide the long-term care these patients require. The upfront expenses and limited volume are prohibiting many facilities from choosing to extend their current cardiovascular programs to include destination VADs in the near future. Those facilities that are more likely to adopt VAD’s as destination who are not currently heart transplant centers will likely be very big private facilities or university based programs. In the next year or two, Jarvik Heart Inc. and Thoratec Corp. expect to have their Axial pumps FDA approved, but the reviews of this technology is currently mixed, leading organizations like El Camino Hospital to plan to use pulsitile short-term VADs like Abiomed until more data and experience with axial pumps proves valuable to their patient population.

Case Study: LVADs as Bridge versus Destination



Key Impacts of Emerging Technologies on Utilization

Imaging utilization will increase as the number of patients and technologies increase. The number of images per patient is rising and some health plans are considering utilization review companies to help manage the rising cost.

Drug Delivery Systems will have an unquestionable impact on facility utilization rates:

Stents will result in fewer restenosis procedures and ED visits

Stents reduced need for angioplasty and CABG procedures

Although a growing population of patients 65 and over will help soften the impact of overall declines in use rates.

Inpatient rates will decrease, but overall the ED will remain busy with CHF and AMI patients. This is related to demographics, an expanding population of diabetics and the alarming increase in obesity. Advances in cardio pharmaceuticals will result in a decreased need for space for:

Warfarin clinics

Cardiac-related urgent hospital admissions

Sensor technologies will result in a decrease in hospital utilization. By one estimate, sensors will cause a 20% reduction in hospital admissions for CHF, although initial inpatient LOS may increase due to the larger number of seriously ill patients. Sensors will result in fewer crisis episodes, a decreased number of emergency room visits, and an overall decrease in visits in general.

Remote patient management technologies will shift the site of care from the doctor’s locale (hospital, office, and clinic) to

the patient’s home. Quality of care improvements through early detection and monitoring will reduce crisis episodes and result in a decreased need for ED visits and hospitalization for patients with CVD.

Organ assistance and substitution technologies like VADs will increase the use of the OR and the number of inpatients for facilities that decide to add VAD surgeries to their CV options. With the approval of VADs as destination therapy, new VAD centers will arise without the need to be attached to a heart transplant center. ED visits related to device malfunction will rise, and other unanticipated device-related problems will occur as more devices are implanted. A growing number of patients with implantable devices will have multiple co-morbidities. These patients will have sophisticated needs and will require more care, both hospital and outpatient, as they age. This will translate into an education need in the home communities as these patients return there for follow up care.

Tissue and fluid bioengineering technology will potentially reduce outpatient and home-care follow up needs. Eliminating the need to perform arterial or venous autograft harvesting at the time of surgery will reduce the time needed for this additional procedure. Because harvesting (donor) sites are often problematic, the use of bioengineered vascular grafts will reduce the length of stay, nursing needs, and outpatient follow-up. Trauma centers, emergency departments and transplant centers will reap the largest gains from these technology advances.

OVERALL IMPACT OF NEW TECHNOLOGIES ON FACILITY UTILIZATION

• Length of Stay (LOS) • Emergency Room Visits (ED)

• Outpatient Procedures• Outpatient Volumes

Quality of care improvements through early detection and monitoring will

reduce crisis episodes and result in a decreased need for ED visits and

hospitalization for patients with CVD.



Forecasted Change in Care Setting

Robotic technologies for cardiac care will not drastically impact the amount of space required for procedures.

Robot-assisted cardiac surgery may lead to a modest increase in the population eligible for intervention and require inpatient operating rooms and hospital stays

Robots in operating rooms will need to be sized and equipped to interface with IT systems and imaging modalities

Robots used to assist physical therapy for stroke recovery patients are proving effective and efficient

Robot-equipped outpatient gyms will leverage space, equipment, and the use of PT personnel

Stem Cell Technology will impact facility needs at tertiary care facilities providing these services. It is likely that this technology will not diffuse to the level of community hospital because of complex biological maintenance networking support needs. At this point, delivery systems may want to consider the ultimate impact of stem cell technology on facility needs in the 10-20 year frame, and, if interested, take steps now to become involved in clinical trials to prepare to be an early implementer of this technology.



The Rise and Fall of the Specialty Hospital The past ten years saw an explosion of freestanding cath labs and specialty heart hospitals across the country but that proliferation has ground to a halt. Key drivers of the previous explosion included relatively high reimbursement rates for certain procedures, physicians’ desire for greater control over management decisions that affect productivity and quality, and specialists desire to increase their income in the face of reduced reimbursement for professional services.19

Although specialty hospitals currently have a small national market share, they treat a relatively large share of patients with specific medical conditions or needing specific medical procedures.20 These specialty facilities pose a significant challenge to community hospitals that depend on the high financial margins of cardiovascular service line to cross-subsidize other hospital services. The enactment of the Prescription Drug and Medicare Modernization Act of 2003 effectively prohibited the development of new physician-owned specialty hospitals and limited the expansion of existing facilities for the 18 months. Insecurity regarding future legislative actions towards specialty hospitals has created a defacto inhibition on building such facilities even though the 18 months limit has expired.

19 Devers KJ, Brewster LR, Ginsburg PB. “Specialty Hospitals: Focused Factories or Cream Skimmers?” Center for Studying Health System Change. Issue Brief no. 62, April 2003. 20 United States.. General Accounting Office. Report to Congressional Requesters. Specialty Hospitals: Geographic Location, Services Provided, and Financial Performance Washington: GAO-04-167. October 2003. <www.gao.gov>.

As biological therapies diffuse to community hospitals the need for more training of staff will emerge.

Workforce


Overall Impact of Emerging Technologies on Workforce The emergence of the “new consumer” will result in patients demanding direct access to cardiologists, bypassing the primary care physician for anything other than routine care.

Advances in imaging will spur the decentralization of imaging into medical and surgical specialties and select locations such as the ED, ICU, cath labs and outpatient centers. Radiologists will face competition from cardiac surgeons, cardiologists and other specialists for control of non-invasive imaging modalities such as CTA, MRA, 3-D Ultrasound and functional imaging. Interventional cardiologists, cardiac surgeons, interventional radiologists and even neurosurgeons will compete for eligibility to perform percutaneous interventions.

Disease management strategies will increase the workload for disease management nurses while decreasing the workload on their inpatient colleagues. Increased survival rates for patients with multiple co-morbidities and conditions will drive demand for additional nurses and other care providers, particularly in long-term care facilities and home care settings.

Increased use of remote patient management, sensors and biological therapies will require bioengineers and highly skilled technical specialists to be present for early implementation of these devices. A well-defined and endorsed process will be critical to achieve the wider core expertise needed to implement this technology. Tissue and fluid bioengineering advancements will result in increased lab requirements at centers that adopt stem cell/tissue technology. This technology will require highly skilled lab staff with dedicated equipment, meticulous oversight, and tracking systems. In addition there will be a need for increased technical skills to manage the sophisticated Information Technology systems needed to integrate information from implanted devices, RPM systems and smart sensors.

Other emerging workforce issues will include:

The clinical pharmacist’s role will expand further into patient medication management.

New methods of drug delivery, drug-eluting stents in particular, may reduce the amount of time clinicians spend with established patients, but initial visits will probably be longer, resulting in no meaningful change in capacity in the short run.

Advancements in picture archiving and communication systems (PACS) will support offshore reading or off-site 24-hour radiologist availability in community hospitals.

A new hybrid of cardiovascular surgeon and interventionalist will enter the workforce in 2006.

Advances in virtual reality systems will improve surgical training by enabling dry run capabilities and certification of surgical competence. Experts estimate that some level of pre-operative simulation will become a workforce standard within two years.21

More procedures will be done under conscious sedation administered by CRNAs or RNs in place of general anesthesia.

Cardiologists are entering the field of endovascular intervention at a rapid pace, and they may have limited experience in physiologic vascular testing. Credentialing processes will be critical to ensure physicians possess a minimum level of quality and expertise at the outset.22

21 Smith J and Deaton D. “Simulation Training in 2005.” Endovascular Today. Sept 2003. 22 Jaff, MR. “The Vascular Lab.” Endovascular Today. Jan/Feb 2003

Cordis BX Velocity coronary stent; the sirolimus-coated version is called Cypher

Workforce


Mechanical measurement and recording of vital signs will be eliminated and remote provision of care will offer flexibility in the site of care. Initially, sensors will be a means of alerting nurses to a problem. These technologies will reduce nursing time presently required to obtain physiologic information.

Delivery systems that offer destination VADs will have to evolve a dedicated cardiac care support team designed to manage patient services such as education, support, nutrition, and home management.

As biological therapies diffuse to community hospitals the need for more training of staff will emerge. Within 5 years, training programs for tissue and cell technicians will be established regionally and commercial companies will offer supporting educational packages.

Expanded coverage of ICD placement will increase EP volumes by 20-30% annually for the next 3-5 years. Lack of EP lab space and staff will be a significant barrier to this expansion.

Genetic testing for complex common diseases will push the primary care physician into the era of genetic testing, and will require training in their ability to evaluate genetic risk and educate patients. An influx of genetic counselors will be added to the workforce to meet the need for pre-screening, pre and post counseling and testing.

Real time 24/7 IT support will be needed on hospital units to support mission critical applications.

Remote Physiological Monitoring: Innovation in the Management of Heart Failure July 2004 www.nehi.net

Care Delivery and Operations


Overall Impact of Emerging Technologies on Care Delivery and Operations

Specific Examples of Clinical Conditions That Will Be Impacted by Changes in Care Delivery and Operations

An increase in imaging, particularly Cardiac MRI and CT, will more accurately detect congenital heart defects, right ventricular dysplasia, coronary stenosis and occlusion, and areas of hypoperfusion in ischemic hearts. Accurate methods for sub clinical screening of coronary calcium may improve the accuracy of global cardiovascular risk prediction23 and allow for tracking patients into the health system before an adverse atherosclerotic event.

PET/CT fusion scanning may cause a change in the course of therapy prescribed by the physician. Blood can be more accurately quantified for better ischemic heart assessment. The accurate spatial localization

23 Shaw LJ, Raggi P, Berman DS, Callister TO. “Cost-effectiveness of screening for cardiovascular disease with measures of coronary calcium.” Prog Cardiovasc Dis.2003 Sep-Oct; 46(2):171-84.

offered by PET/CT fusion studies improves the assessment of response to treatment and changes clinical management for 20-30% of patients.24

Advances will shift many traditional “open” surgical procedures to minimally invasive procedures that can be done on an outpatient basis. The number of CABGs has fallen 15-20% as a result of the introduction of drug-eluting stents.

Primary angioplasty will replace thrombolytics as standard blockage treatment for selected patients within 3-5 years. Cath labs will not evolve in all community and rural hospitals, due to limited need and a shortage of interventional cardiologists. An increase in 12-lead EKG transmission from ambulances to hospitals will help clinicians assess incoming patients to determine whether they should be diverted to hospitals with cath labs. HealthTech

24 Bradley WG Jr. “PET/CT fusion imaging captures center stage”. Accessed September 19, 2003 <http://www.medscape.com/viewarticle/448633>.

Care Delivery and Operations


experts expressed concern about direct to PCI trends, as smaller care facilities would be unlikely to have sufficient volume to maintain clinician proficiency and quality outcomes.

Oral direct thrombin inhibitors will change care for heart disease by reducing the need for routine coagulation monitoring. Coumadin clinics will no longer be a part of care delivery, and use of warfarin will decrease substantially.

Patients with hypertension, congestive heart failure, and arrhythmias will receive continuing care through remote patient management and sensor technologies, resulting in reduced ED and hospitalization, earlier discharge after hospitalization and reductions in readmission rates.

Advances in endovascular access to abdominal aortic aneurysms, valve repairs, and endovascular ablative treatment (RF or cryoablation) of cardiac arrhythmias will move these conditions to the outpatient setting.

Expanded coverage of ICD placement will increase EP volumes by 20-30% annually for the next 3-5 years. Lack of EP lab space and staff will be a significant barrier to this expansion.

VADs for HF will diffuse to community centers within 5 years.25

Genetic testing for predisposition to complex common diseases of the cardiovascular system will push patients to preventive approaches including earlier treatment.

Emerging technologies in stem cells and tissue and fluid bioengineering will be likely to remain in tertiary care centers.

25 For more information on adoption scenarios for LVADs, please see the HealthTech High Impact Technology Report on Left Ventricular Devices published in October 2003.

Expected Changes in Cardiovascular Service Utilization Over the Next 10 Years: Market Impact Modeling

There will be a shift from inpatient to outpatient to home care in cardiovascular care.

Consider the examples of AMI and Congestive Heart Failure: Baseline forecasts indicate the number of inpatients in the event of no technology adoption. Minimum and maximum impacts of technology on volume of inpatients illustrate how adoption of technologies may reduce the inpatient volume. HealthTech’s Market Impact Modeler can create 15-year projections of how technology will impact inpatient and outpatient utilization rates in any locally defined market.26 Clearly, increases in demographics will not be significant enough to retain volumes equal to or above current use rates. The financial impacts of technology on inpatient cardiovascular service line utilization will dwarf the impact of increased volume for overall service line utilization.

26 The HealthTech Market Impact Modeler can be used to model the impacts technology will have on utilization rates within any local market. See www.healthtech.org for more details.

Coverage and Reimbursement


The Impact of Novel Technology for Cardiovascular Care on Hospital Revenue

Recent experience with the introduction of drug eluting stents, for which reimbursement does not cover the actual cost, is typical of what delivery systems can expect as new devices and procedures are introduced. Medicare reimburses other new therapies such as VADs, significantly below hospital costs.

At the same time, the aging population and rising cardiac disease rates driven by aging and obesity will steadily increase patient volume which will, if reimbursed at present rates, add to the negative impact on hospital finances. HealthTech experts believe that this situation is likely continue for several more years, and may never return to previous position of cardiac services as a generator of high margins and cross-subsidization.

Imaging, both inpatient and outpatient, will continue to be a source of income for hospitals, as faster patient throughout will result in greater ROI for imaging technologies. Overall, this increase in imaging revenue may be offset by fewer inpatient-hospitalizations.

Technologies such as stents, minimally invasive surgical devices, and MRI/CT modalities will increase the number of patients eligible for procedures, although length of stay and inpatient volumes will decrease. The increase in survival and functional status for these patients will require medical management over added years, eventually increasing outpatient services, but reducing the number of acute episodes.

Use of drug-eluting stents has reduced the number of CABG procedures and restenosis procedures, resulting in a loss of revenue for hospitals but should plateau in the next 2 years. For Medicare, reimbursement levels for this technology will remain below actual costs, and hospitals that adopt this technology bear a financial burden until stent prices decrease with competition widespread use, or improved reimbursement. For commercial reimbursement contracting specifics will impact this.

The inability of community and rural hospitals to maintain sufficient volumes for quality outcomes will result in a diversion of patients from smaller facilities to

larger ones that have 24/7 cath lab capabilities. This may be detrimental to the financial stability of smaller facilities. Cardiology groups that seek to build stand-alone cardiac catheterization (or interventional) suites similar to outpatient surgical centers may force local hospitals out of this service market. This issue is addressed in the discussion about Heart Hospitals.

Remote patient chronic disease management technologies have demonstrated that they can act as a cost saving mechanism for health plans and integrated delivery systems.

Implementation of this technology represents a cost center for health plans and providers in the short run, as maintenance, telecom, clinical logistics and workflow have to adapt. However, savings on inpatient care, ED care, and re-hospitalization will more than offset these considerations for health plans, and in certain cases for delivery systems with high uncompensated care burdens. Remote ICU coverage (VISICU) has been demonstrated to reduce length of stay, lower cost and improve mortality and morbidity. This may also be a market opportunity for hospitals with intensivist providers to contract with nearby hospitals lacking these resources.

CPOE, clinical decisions support, and PACS IT will initially represent a significant cost for the delivery system. Systems will see increased reimbursement from the investment only to the extent that PACS increases throughput and decreases the unit cost of studies, and CPOE and clinical decision support result in more captured billing and reduced medical error. Decisions on how to implement PACS – enterprise, phased, or incremental will have cost implications. While enterprise investment is the greatest up front cost, phased and incremental investments have higher long-term costs. The savings associated with

Coverage and Reimbursement


these IT investments are often ‘hidden’ in time saved and efficiency.

Facilities that offer VAD therapy to commercially insured individuals will capture a new source of revenue; however, for Medicare recipients will experience a loss. Training and maintaining a team for this technology will be a significant financial commitment.

While costs for tissue and fluid bioengineering may be high at first, benefits to providers and patients - shorter stays, faster recovery, and expanded treatment opportunities - will outweigh the initial costs. In the limited instances where blood substitutes can be used, they will provide greater value than buying donor blood because of high prices due to donor shortages and extensive screening processes and product expiration.

Cost Implications


nsurance coverage and adequate reimbursement for emerging imaging technologies continues to be a

major barrier for developers seeking large markets and for health systems acquiring capital equipment and providing services. This is driven by the reluctance of both public and private payers to pay for the increasing cost and volumes of imaging studies without restricting reimbursement to appropriate indications and limiting unit costs. High cost imaging procedures will continue to experience Medicare coverage barriers related to evidence requirements in the next 5 years. These include 64-slice CT for screening and diagnosis of coronary artery disease. In the case of PET, HealthTech experts felt that poor reimbursement will drive PET out of hospitals and into freestanding facilities. While demonstrating an impact on patient outcomes and shortening exam time considerably, combination imaging modalities (PET/CT) currently have no CPT for billing, making reimbursement processes troublesome.27

Advances in drug delivery, primarily drug-eluting stents, will have significant cost implications for hospitals. Hospitals will experience an increased revenue shortfall due to the high costs of the new technology, inadequate reimbursement, increased indications and utilization, and decreased admissions and revenue from CABG procedures. HealthTech experts believe that commercial payers will reimburse at a higher rate than Medicare, conceding to hospitals for the loss in revenue due to reduced CABG payments and re-admission for repeat procedures. In addition, many payers will push for per stent payment contracts, rejecting global per diem rates for the use of drug eluting stents. With market competition likely to decrease drug eluting stent prices by 2005, health plans may decrease hospitals payments for PCI with this technology. Medicare will look more closely at restricting who can do specific procedures and is moving towards greater emphasis on approved indications, making reimbursement of off-label use less certain.28

27 Finch E. “The Cost of Technology.” Imaging Economics Supplement. March 2003: 18. 28 Peterson, Lynne. “Trends in Medicine: Transcatheter Cardiovascular Therapeutics.” Trends-in-Medicine. Sept. 2003. Accessed October 20, 2005. <www.trends-in-medicine.com>.

Reimbursement for sensor and remote patient technologies may develop over the next 2-5 years as the impact on clinical outcomes is demonstrated. Companies developing sensor technologies and remote patient management technologies have been lobbying Medicare for coverage and reimbursement, though HealthTech experts have suggested that reimbursement must be for the technology and for the time a physician invests to manage the information. The cost savings in multiple demonstration projects at this point have been so significant that some non-Medicare payers (health plans, the VHA) are paying for the technology without waiting for Medicare to cover it. At this point 26 states reimburse some level of remote patient management through current Medicaid billing practices. Select private healthcare plans have begun to reimburse physicians for online consultations.29

CPOE, clinical decision support, and PACS IT technologies that impact the cardiovascular service line will be considered information technologies, and payers will not cover these as professional services. Cost without reimbursement will therefore be the issue for these technologies, although some health delivery systems may realize revenue enhancements due to automatic charge capture and faster throughput of imaging patients with PACS IT support.

VADs, an example of organ assistance and substitution technologies, will have both Medicare and commercial plan coverage and reimbursement at differing rates. Medicare expects 5,000 patients/year to receive VADs at

29 Blue Shield of California will offer physicians in select HMOs access to software to enable electronic communication with patients. The plan will reimburse physicians $25 per eligible consultation. <http://www.healthdatamanagement.com/html/news/NewsStory.cfm?DID=10958>

I

VADs, an example of organ assistance and substitution technologies, will have

both Medicare and commercial plan coverage and reimbursement at

differing rates.

Cost Implications


first, but estimates that as many as 60,000 have heart damage serve enough to warrant use. At $60,000 per device, with an additional $150,000 in hospital charges, the price for VADs could range from 1.05 billion to 12.6 billion per year nationally. Medicare has announced that it will pay approximately $70,000 total for implantation and patient hospitalization. This will be classified under DRG525. Developers plan to help hospitals apply for additional payments under outlier payment policies, hoping to bring reimbursement levels to $100,000. Reimbursement levels may also rise and hospital margins increase as prices fall with competition and effective management of adverse events. However, using VADs as destination therapy, hospitals serving Medicare patients will be forced to absorb losses or limit treatment to a few patients. Commercial insurers do not face the same reimbursement issues as Medicare and will reimburse at higher rates.

Lack of coverage will be a barrier to the use of robotics in cardiovascular surgery. Surgeries using robotic technologies will be reimbursed for the cost of the MIS, but not for the additional cost of the consumables. Novel robotic surgeries demonstrating superior outcomes (or those that can only be performed with robots) will qualify for additional reimbursement. To achieve this result, HealthTech’s Expert Panel felt developers would need to collect more data to show that robotic surgery definitively leads to equivalent or superior outcomes compared to conventional approaches. Inpatient services related to the use of cardiovascular surgical robots are considered health system costs rather than separate, reimbursable services. As such, these costs are included in contracted per diem or case rates under commercial health plans or Medicaid programs, and in DRG payments under Medicare.

One promising area for coverage and reimbursement is in robot-assisted rehabilitation for stroke patients. HealthTech Experts felt that over the next 2-5 years multi-robot gyms for this purpose will likely be covered and reimbursed as an

individual therapy session and that many institutions may be able to realize return on investment in 18 months.

With the exception of coverage and reimbursement for adult stem cell therapies (hematopoietic stem cell transplantation to treat impaired immunity or anemia, or to support high-dose ablative chemotherapy for cancer), coverage and reimbursement for stem cells will not be available in the next five years because of the experimental/investigational nature of these technologies.

Overall, current reimbursement does not reflect the actual costs and implementation of technologies. Health delivery systems will experience a net decrease in revenues as cardiovascular care processes shift from highly paid surgical interventions to less well-paid endovascular procedures and poorly paid outpatient and preventative services.

Lack of coverage will be a barrier to the use of robotics in cardiovascular

surgery.

Expert Panelists and Expert Interviewees


CARDIOVASCULAR SERVICES Expert Panel and Expert Interviewees

Deborah Aranoff Senior Consultant, Kaiser Permanente

Nancy L. Ascher, MD, PhD Professor and Chair, Department of Surgery, UCSF

Edward E. Berger, PhD Vice President, Government and External Relations, Abiomed, Inc.

Robert O. Bonow, MD Chief of Division of Cardiology, Northwestern Memorial Hospital, and Past President, American Hospital Association

James Carney, PhD Director of Advanced Sensor Technology, Medtronic, Inc.

Julie Cherry, RN Medical Director, HealthHero

G. Dennis Clifton, PharmD Director, Clinical Research Center, Sacred Heart Medical Center

Tim Fischell, MD Medical Director of Cardiology, Gorgess Research Institute

James Fonger, MD Cardiovascular Surgeon, Lenox Hill Hospital

Autumn Dawn Galbreath, MD

Director Disease Management Center, University of Texas Health Science Center

Robert Greene, MD Physician Advisor Cardiovascular Services, Sutter Health System

Brack G. Hattler, MD, PhD Professor of Surgery, University of Pittsburgh

Robert L. Kormos, MD Director, Artificial Heart Program and Cardiothoracic Transplantation, University of Pittsburgh

Margaret Kruk, MD, MPH Affiliate, Health Technology Center

Ian Leverton, MD VP of Clinical Integration, Sutter Health

Eleanor Levin, MD Chair, Chiefs of Cardiology of Northern California, The Permanente Medical Group

James Long, MD, PhD Medical Director, Utah Artificial Heart Program

Paul S. Malchesky, D.Eng President, International Center for Artificial Organs and Transplantation

Charles McKay, MD Chairman Cardiology Services, Harbor UCLA

Alan Mendelsohn, MD Associate Director of Medical Affairs for Cardiology, Centocor Pharmaceuticals

Thomas Metcalf Senior Vice President, Medical Simulation Corporation

Expert Panelists and Expert Interviewees


S. Lewis Meyer, PhD CEO, Imatron, Inc

Richard Pasternak, MD Director of Cardiology, Massachusetts General Hospital

Marc Pelletier, MD Medical Director, Stanford Cardiac Surgery Program at El Camino Hosptial

Russell Potts, PhD Vice President of Research, Cygnus, Inc.

Gautham Reddy, MD, MPH Assistant Professor of Radiology, University of California San Francisco

Robert Robbins, MD Stanford University, Professor of Cardiothoracic Surgery

Alan Rosenberg, MD Vice President, WellPoint Health Networks

Sim Rubinstein, MD Medical Director, Group Health Cooperative

Christobal Selecky CEO, Life Masters SelfCare, Inc

David Stewart, MD Cardiology Medical Director, Providence Everett Medical Center

Bruce Wilkoff, MD Director Cardiac Pacing and Tachyarythmia Devices, Cleveland Clinic

Pamela Woodard, MD Mallindcrodt Institute of Radiology and Former Chair of North American Society for Cardiac Imaging

Appendix


Glossary

3-D Ultrasound for CARDIAC Imaging Used in conjunction with traditional two-dimensional (2-D) ultrasound imaging, which has been in use for more than 25 years, 3-D/4-D ultrasound provides a higher resolution image in actual or “real” time. A computer takes multiple images and renders a life-like 3-D image. With 4-D ultrasound, the computer takes the images as multiple pictures while the technician holds the probe still and simultaneously renders a 3-D image in real time on a monitor. The difference between 3-D and 4-D is that 4-D is real-time imagery.

AAA (Triple A) Abdominal aortic aneurysm

Apo 1 Milano (aka Apo A-1 Milano) An HDL mimetic drug that significantly reduces plaque deposits (fat and calcium) on the interior coronary vessels and effectively lowers LDL. This drug is derived from an aberrant gene noticed in a population subset in Milan, Italy whose low HDL and high LDL did not lead to heart disease as would have been expected.

Axial Pumps Small continuous-flow pumps for heart implantation to adjunct the blood flow and ease the burden on the heart muscle. The pumps are approximately the diameter or a pencil.

Bio-artificial heart valves Hybrid valve created from both living tissue and man-made materials

BiV Bi-ventricular pacemaker

Bi-ventricular pacemaker A pacemaker that has a lead placed in each of the two ventricles to facilitate the synchronicity of the heart beat. Standard pacemakers have one lead.

CABG Coronary arterial bypass graft

Cardiac Mesh Support

A mesh wrap that is implanted around the heart to conform to and support the heart while allowing normal cardiac function. It is intended to prevent and reverse the progression of heart failure by improving the heart’s structure and function. Failed FDA approval 07/05

Cardiac MRI (without contrast) MRI uses radiofrequency waves as a strong magnetic field rather than x-rays to provide detailed pictures of cardiac tissues.

Cardiac PET PET combines tomographic imaging with radionuclide tracers of blood flow metabolism and receptors and tracer kinetic principles for non-invasively quantifying regional myocardial blood flow, substrate fluxes, biochemical reaction rates and neural control.

Carotid Artery Angioplasty with Stenting (bare metal or drug eluting stents)

Peripheral catheterization into the carotid artery with or without the placement of a stent.

CEA Carotid endarterectomy

Clot Retrieval/Extractor A clot extractor is a device that removes blood clots from the cardio or neurovascular systems. Such systems use a coiling device to snare the clot and subsequently remove it via a catheter.

Cryothermy (also called cryoablation) The application of extremely low temperatures to tissues in order to create transient or permanent lesions

CT Computed tomography

CVD Cardiovascular disease

ECHF Extracorporeal hemofiltration

Electron-Beam Computed Tomography (EBCT) EBCT is an especially fast form of X-ray imaging technology. It's particularly useful in evaluating bypass graft patency, intra- and congenital cardiac lesions. It is

Appendix


also used in quantifying right and left ventricular muscle mass, chamber volumes, and systolic and diastolic function (such as cardiac output and ejection fraction). Electron-beam CT can also measure calcium deposits in the coronary arteries.

Endovascular heart valve replacement and/or repair A synthetic valve is attached to a catheter and inserted endovascularly. The surgeon threads the valve to the damaged area and it is expanded and placed

Endovascular repair of abdominal aortic aneurysms (AAA) with Stent-Graft

A synthetic graft is attached to a catheter and inserted endovascularly. The surgeon threads the stent-graft to the weak part of the aorta where the aneurysm is located and the graft is expanded. The stent-graft reinforces the weakened section of the aorta to prevent rupture of the aneurysm.

Enhanced External Counterpulsation (EECP) EECP is a mechanical procedure in which long inflatable cuffs are wrapped around both of the patient’s legs. The leg cuffs are inflated and deflated with each heartbeat by a computer, which triggers off the patient’s ECG so that the cuffs deflate just as each heartbeat begins, and inflate just as each heartbeat ends. When the cuffs inflate they do so in a sequential fashion, so that the blood in the legs is “milked” upwards, toward the heart.

Extracorporeal hemofiltration Extracorporeal hemofiltration is used for congestive heart failure (CHF) patients to remove excess fluid from their systems much like dialysis is used in kidney failure patients

Factor Xa Oral direct thrombin inhibitor. More convenient anticoagulation treatment to help reduce the risk of myocardial infarction, stroke, or venous thromboembolism.

ICD Implantable cardioverter defibrillator

Implantable Cardioverter Defibrillator

An implantable cardioverter defibrillator is used in patients at risk for recurrent, sustained ventricular tachycardia or fibrillation. The device is connected to leads positioned inside the heart or on its surface. These leads are used to deliver electrical shocks, sense the cardiac rhythm and sometimes pace the heart, as needed.

IVUS Intravascular ultrasound

LVAD Left ventricular assist device

Maze procedure This surgical procedure consists of creating a number of incisions in the atrium that disrupt the re-entrant circuits. Once the incisions are made, they are sewn together again. The atrium can then hold blood on its way to the ventricle and can squeeze or contract to push the blood in to the ventricle, but the electrical impulse cannot cross the incisions. The procedure is used for the treatment of some atrial fibrillation.

Minimally Invasive Direct Coronary Bypass (MIDCAB) This procedure allows the surgeon to perform bypass surgery without splitting the entire breastbone. Unlike conventional open-heart bypass surgery, which requires a large incision, MIDCAB employs a tiny, 6-10 cm "port" incision on the patient's left chest to gain access to the heart. MIDCAB is typically done "off-pump."

MRI/A Magnetic Resonance Imaging/Angiography. MRI/A uses radiofrequency waves as a strong magnetic field rather than x-rays to provide detailed pictures of internal organs, tissues and arteries. Tesla (T) measures magnetic strength. Available strengths are: 1T, 1.5T, and 3T. A 7T MRI is under development.

Multidetector computed tomography (MDCT) A form of computed tomography (CT) technology for diagnostic imaging. In MDCT, a two-dimensional array of detector elements replaces the linear array of detector elements used in typical conventional and helical CT scanners. The two-dimensional detector array permits CT scanners to acquire multiple slices or

Appendix


sections simultaneously and greatly increase the speed of CT image acquisition. Image reconstruction in MDCT is more complicated than that in single section CT. Current computer tomography ranges from a 1-slice single detector to a 64-slice multidetector. (2-, 4-, 8-, 16-, and 32- slice multidetectors are available).

Off-Pump Coronary Artery Bypass (OPCAB)/Beating Heart Surgery

OPCAB is similar to conventional surgery (large incision, breastbone is split) but the heart-lung machine is not used. Instead, a stabilizing device is used to restrict movement of small segments of the heart so that the surgeon can operate while the heart is still beating. This procedure enables the surgeon to perform multiple (4-5) vessel bypass surgery on the beating heart.

OPCAB Off-Pump Coronary Artery Bypass “Beating Heart Surgery”

PET Positron Emission Tomography. PET combines tomographic imaging with radionuclide tracers of blood flow metabolism, receptors and tracer kinetic principles. It is used for non-invasively quantifying regional blood flow, substrate fluxes, biochemical reaction rates and neural control.

PTCA Peripheral transluminal catheter angioplasty.

PTCA with Stenting The placement of bare metal or drug-eluting stents into coronary arteries via peripheral catheterization

PVD Peripheral vascular disease

RACAB Robotic assisted coronary artery bypass

Radiofrequency Ablation Endovascular ablative treatment for arrhythmias. This non-surgical method of ablation involves inserting a thin tube catheter through a blood vessel (in the upper thigh, wrist or arm) up to the heart. At the tip of the tube is a

small wire, which can deliver energy to destroy the abnormal areas of the heart.

Robotic Assisted Coronary Artery Bypass (RACAB) Surgeons use a robotic device to enable coronary bypass without separating the breastbone at all. Surgeons do not have direct contact with the patient, but perform the operation while watching a video screen.

RPM Remote patient management

RVAD Right ventricular assist device

Statins LDL cholesterol lowering drugs

Stenting Metal scaffolding placed by endovascular means into heart vessels to keep them open. Bare metal or drug-eluting stents are used in the coronary, peripheral, and carotid arteries.

TAH Total artificial heart

TMR Transmyocardial revascularization

Transmyocardial Revascularization (TMR) TMR uses a "cold beam" excimer laser and a unique laser delivery system to create open channels in the heart. This technique is utilized to drill 10 -30 holes from a dying heart muscle to the left ventricle. Although these holes in the heart close, they are thought to trigger the growth of new tissue in the heart through angiogenesis.

VAD Ventricular assist device

VEG-F Growth Factor A vascular growth factor that promotes vascular wall proliferation

Ventricular Assist Devices (VADs), LVADs, or RVADs These devices do not replace the heart; they merely assist it.

Documents

Microsoft Word - CV- CFR MASTER 02-08-2006