Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022

Publishing June 2016:
Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022

This is a global report from MedMarket Diligence detailing from 2015 to 2022 the volume of interventional and surgical cardiovascular procedures, including open heart, peripheral vascular, cerebrovascular and all associated endovascular interventions.

Table of Contents

Executive Summary

Section 1: Common Acute and Chronic Cardiovascular Conditions Targeted by Surgical and Transcatheter Interventions

1.1     Ischemic Heart Disease

1.1.1     Angina Pectoris
1.1.2     Acute Myocardial Infarction
1.1.3     Incidence, Prevalence, Established Treatment Modalities

1.2     Heart Failure

1.2.1     Incidence, Prevalence, Established Treatment Modalities

1.3     Peripheral Artery Disease

1.3.1     Critical Limb Ischemia
1.3.2     Incidence, Prevalence, Established Treatment Modalities
1.3.3     Aortic Aneurysm
1.3.4     Incidence, Prevalence, Established Treatment Modalities

1.4     Peripheral Venous Disorders

1.4.1     Deep Venous Thrombosis and Pulmonary Embolism
1.4.2     Chronic Venous Insufficiency and Varicose Veins
1.4.3     Incidence, Prevalence, Established Treatment Modalities

1.5     Cerebrovascular Disorders

1.5.1     Cerebrovascular Occlusions and Acute Ischemic Stroke
1.5.2     Cerebral Aneurysm & AVM and Hemorrhagic Stroke
1.5.3     Incidence, Prevalence, Established Treatment Modalities

1.6     Structural Heart Disorders

1.6.1     Congenital Heart Defects

1.6.1.1     Incidence, Prevalence, Established Treatment Modalities

1.6.2     Valvular Disorders

1.6.2.1     Incidence, Prevalence, Established Treatment Modalities

1.7     Cardiac Rhythm Disorders

1.7.1     Bradycardia
1.7.2     Tachycardia

1.7.2.1     Atrial Fibrillation

1.7.3     Incidence, Prevalence, Established Treatment Modalities

Section 2: Current and Projected Volumes of Therapeutic Interventional and Surgical Cardiovascular Procedures

2.1    Coronary Artery Revascularization

2.1.1    Coronary Artery Bypass Graft Surgery

2.1.1.1    Utilization Trends and Procedure Volumes

2.1.2    Percutaneous Coronary Interventions

2.1.2.1    Coronary Angioplasty and Stenting

2.1.2.1.1 Utilization Trends and Procedure Volumes

2.1.2.2    CoronaryMechanical and Laser Atherectomy

2.1.2.2.1 Utilization Trends and Procedure Volumes

2.1.2.3    Mechanical Thrombectomy

2.1.2.3.1 Utilization Trends and Procedure Volumes

2.2    Acute and Chronic Heart Failure Management

2.2.1    Ventricular Assist Device Placement

2.2.1.1    Utilization Trends and Procedure Volumes

2.2.2    Total Artificial Heart Implantation

2.2.2.1    Utilization Trends and Procedure Volumes

2.2.3    Donor Heart Transplantation

2.2.3.1    Utilization Trends and Procedure Volumes

2.3    Peripheral Artery Revascularization

2.3.1    Lower Extremity Arterial Bypass Surgery

2.3.1.1    Utilization Trends and Procedure Volumes

2.3.2     Percutaneous Transcatheter Interventions

2.3.2.1    Angioplasty and Stenting

2.3.2.1.1 PTA and Bare Metal Stenting
2.3.2.1.2 PTA and Drug-Eluting Stenting
2.3.2.1.3 PTA with Drug-Coated Balloons
2.3.2.1.4 Utilization Trends and Procedure Volumes

2.3.2.2    Mechanical and Laser Atherectomy

2.3.2.2.1 Utilization Trends and Procedure Volumes

2.3.2.3    Catheter-Directed Thrombolysis and Thrombectomy

2.3.2.3.1 Utilization Trends and Procedure Volumes

2.4    Aortic Aneurysm Repair

2.4.1    Surgical AAA and TAA Repair
2.4.2    Endovascular AAA and TAA Repaire
2.4.3    Utilization Trends and Procedure Volumes

2.5    DVT and CVI Management

2.5.1    Vena Cava Filter Placement

2.5.1.1    Utilization Trends and Procedure Volumes

2.5.2    Endovenous Ablation

2.5.2.1    Utilization Trends and Procedure Volumes

2.5.3    Venous Revascularization

2.5.3.1    Mechanical Thrombectomy
2.5.3.2    Venous Angioplasty and Stenting
2.5.3.2     Utilization Trends and Procedure Volumes

2.6    Acute Stroke Prophylaxis and Treatment

2.6.1    Carotid Artery Stenosis Management

2.6.1.1    Carotid Endarterectomy
2.6.1.2    Carotid Artery Stenting
2.6.1.3    Utilization Trends and Procedure Volumes

2.6.2    Cerebral Thrombectomy

2.6.2.1    Utilization Trends and Procedure Volumes

2.6.3    Cerebral Aneurysm and AVM Repair

2.6.3.1    Cerebral Aneurysm and AVM Surgical Clipping
2.6.3.2    Cerebral Aneurysm and AVM Coiling & Flow Diversion
2.6.3.3    Utilization Trends and Procedure Volumes

2.7    Treatment of Structural Heart Disorders

2.7.1     Congenital Heart Defect Repair

2.7.1.1    Utilization Trends and Procedure Volumes

2.7.2    Heart Valve Repair and Replacement

2.7.2.1    Heart Valve Repair and Replacement Surgery
2.7.2.2    Utilization Trends and Procedure Volumes
2.7.2.3    Transcatheter Valve Repair and Replacement
2.7.2.4    Utilization Trends and Procedure Volumes

2.8    Cardiac Rhythm Management

2.8.1    Implantable Pulse Generator-Based Therapy

2.8.1.1    Pacemaker Implantation
2.8.1.2    Implantable Cardioverter Defibrillator Placement
2.8.1.3    Cardiac Resynchronization Therapy Device Placement
2.8.1.4    Utilization Trends and Procedure Volumes

2.8.2    Arrhythmia Ablation Therapy

2.8.2.1    Standard SVT Ablation
2.8.2.2    Utilization Trends and Procedure Volumes
2.8.2.3    AFib Ablation

2.8.2.3.1 Surgical AFib Ablation
2.8.2.3.2 Transcatheter AFib Ablation
2.8.2.3.3 Utilization Trends and Procedure Volumes

Section 3: Country Healthcare Profiles

3.1    United States and Other Americas

3.1.1    United States
3.1.2    Brazil
3.1.3    Canada
3.1.4    Mexico

3.2    Largest West European States

3.2.1    France
3.2.2    Germany
3.2.3    Italy
3.2.4    Spain
3.2.5    United Kingdom

3.3    Major Asian States

3.3.1    China
3.3.2    India
3.3.3    Japan


Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022
June 2016
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Medical technologies at startups, July 2014

Below is a list of technologies under development at medical technology startups identified in July 2014 and included in the Medtech Startups Database.

  • thrombectomyInstrumentation for electrophysiology diagnosis and treatment.
  • Products for the treatment of hypertension and other chronic disease by interventional cardiologists
  • Surgical stapling device for use during natural orifice transluminal endoscopic surgery.
  • Low cost medical technologies to improve patient management in emerging markets.
  • Heart valve for the treatment of mitral valve regurgitation
  • Thrombectomy catheter
  • Microstaple bandage for wound closure.
  • Whole-body cryotherapy chambers as well as devices for local cryotherapy and cryosurgery.
  • Minimally invasive surgical device for the treatment of glaucoma
  • Electrical muscle stimulation.

For a historical listing of medical technologies at startups, see link.

Ablation technology markets

Ablation technologies are used to destroy ("ablate") diseased or traumatized tissue for therapeutic benefit.  This includes destruction of cancerous tumors, ablation of endometrial tissue associated with endometriosis or abnormal uterine bleeding, creation of myocardial lesions to block the errant electrical signals in arrhythmia, and numerous others.

The largest share of the market for energy-based ablation devices is used in cancer therapy, primarily using the radiation therapy modality. Following that is general surgery with its use of electrocautery and electrosurgical devices, RF ablation, cryotherapy, etc. Cardiovascular applications are growing, particularly for cryoablation and radiofrequency ablation for arrhythmia, and now represent hold the third largest clinical area of ablation. The remaining applications are relatively small and fall in line behind the three leading sectors.

In the aggregate (i.e., for each modality worldwide), the largest segment is radiation-based ablation technologies, based to a large degree on the cost of the systems and their well-established use in clinical practice. 

Below is a chart of the 2011 markets for ablation technologies by modality, with their projected compound annual growth rates (CAGRs) from 2011 to 2019.

Source: "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities" (MedMarket Diligence Report #A145)

Ablation Technologies in Treatment of Atrial Fibrillation

(From “Ablation Technologies Worldwide Market, 2008-2017:  Products, Technologies Markets, Companies and Opportunities.”  Published 2008 by MedMarket Diligence, LLC. See link.)

Several types of energy-based therapies have a variety of applications to CV disease—the number one killer in most of the world.

When the heart has to work too hard to maintain adequate blood output, it can begin to change shape, with the left ventricle (the heart’s main pumping chamber) often growing larger, less flexible and weaker. Prolonged compensation for these impairments can change both the heart structure and its function. Remodeling of the heart results in errant signals transmitted from the SA node that cause unsynchronized heartbeats. These are treatable with a variety of energy-based therapies including implantable resynchronization devices and surgical ablation therapies. Energy is also being employed in the fight against CV disease as a means to open occluded vessels and revascularize damaged heart muscles.

The chart (“Energy-Based Therapies for Cardiovascular Diseases”) highlights symptoms and energy-based therapies for different cardiovascular diseases.

CV Ablation Therapies
CV Ablation Therapies

Atrial Fibrillation
Atrial arrhythmias may be focal (arising from only one place in one of the atria) or multifocal (arising from many different places in the atria). Inappropriate sinus tachycardia is a relatively rare and generally harmless condition in which the heart is normal but the heart rate is unusually fast, both at rest and in response to physical activity. Treatment is available, but the cause is unknown.

Premature atrial contractions (PACs) are often referred to as premature supraventricular contractions. PACs are harmless irregular heart rhythms that generally do not need to be treated. They are often due to stress or use of substances such as caffeine and alcohol. They occur when one of the heart’s upper chambers contracts prematurely in the heartbeat cycle. However, in some patients, ablation may be advisable to treat PACs before they can trigger atrial fibrillation.

Paroxysmal atrial tachycardia is a condition originating in the atria, in which the heartbeat increases for several minutes to a number of hours. Treatment may be necessary for short, sudden episodes that begin and end rapidly. Most people with this condition are young with normal hearts. The condition may be exacerbated by the use of even small amounts of caffeine or alcohol. This condition has also been associated with overly high levels of digitalis (a cardiotonic drug) in the bloodstream. Atrial flutter is a specific type of atrial tachycardia in which atria contract regularly, but extremely rapidly. Patients with atrial flutter may have as great a risk of stroke as patients with atrial fibrillation. Treatment such as surgical ablation is often recommended.

Atrial fibrillation (AF) is the result of rapid, disorganized signals in the atria that prompt the ventricles to contract irregularly. When the atria fibrillate (or quiver) instead of beating, blood is not effectively passed through the heart’s chambers and may pool in the atria. A blood clot may form and may travel throughout the body, which could lead to a stroke or heart attack. With AF, electrical signals in the heart’s upper chambers, or atria, cause the heart muscle to flutter wildly, which in turn reduces the efficiency of the ventricles. This allows blood to pool and form clots that can lead to strokes.

There are three main types of AF: paroxysmal (which starts and stops suddenly), persistent (which lasts longer and may require some medical intervention to terminate) and chronic or permanent. Chronic or permanent AF does not respond well to standard treatment.

Postoperative atrial fibrillation is one of the most common complications in cardiac surgery, occurring in 20%–50% of all patients within 2–4 days after heart surgery. Researchers estimate that postoperative atrial fibrillation costs the U.S. health system up to $1.5 billion dollars annually. Postoperative atrial fibrillation requires treatment before the patient is discharged from the hospital.

AF is the most common type of sustained arrhythmia, affecting 2 million people each year in the United States alone with annual incidence of new cases estimated at more than 700,000. It is estimated that AF affects over 4 million people in the developed world.

If left untreated, AF may lead to a variety of medical conditions, including stroke. Approximately 15% of strokes are a direct result of AF, a progressive disease that generally worsens over time. Since the incidence of AF increases as a population ages, the “graying” of world populations will likely lead to a significant increase in the number of cases of chronic AF.

Treatment options include AV nodal ablation with subsequent pacemaker implantation; this has been used successfully for many years in certain patients with chronic AF. Biventricular pacing, an area of significant clinician interest, is sometimes indicated for heart failure (HF) patients. Medical literature suggests benefits of biventricular pacing for such patients versus conventional right-ventricular approaches. However, this is a relatively new field that has not yet been extensively studied. In a study published in the New England Journal of Medicine, researchers found that for older patients at risk of stroke from atrial fibrillation, treatments to control heart rhythm were no better at preventing death than treatments to control heart rate. But other data suggest that for people whose main concern is quality of life, ablation may provide substantial relief. In this treatment, energy is used to burn away specific, tiny areas of tissue, particularly those on veins from the lungs to the heart that trigger arrhythmia.

Doctors have long assumed that the best way to treat atrial fibrillation is to get the heart back to a regular rhythm and maintain it, using electric shock or strong drugs. Restoring normal rhythm, or sinus rhythm, was thought to reduce the risk of strokes and death, make patients feel better and allow them to stop taking blood thinners. If that method does not work, a second approach consisting of simpler, cheaper medications to slow down the heart rate and ease symptoms of palpitations, dizziness and shortness of breath is often employed. Patients treated with this regimen continue to experience abnormal rhythms and continue taking blood thinners to prevent blood clots.

The chart, “Energy-Based Therapies for Atrial Arrhythmias,” shows products by energy modality and primary application being developed and approved for use in the treatment of atrial arrhythmias.

Ablation for atrial arrhythmias
Ablation for atrial arrhythmias

Links:
AtriCure (West Chester, OH; http://www.atricure.com)
ATS Medical (Minneapolis, MN; http://atsmedical.com)
Bard Electrophysiology (Lowell, MA; http://bardep.com)
Biosense Webster (Diamond Bar, CA; http://www.biosensewebster.com)
Biotronik (Berlin, Germany; http://www.biotronik.de)
Boston Scientific (Natick, MA; http://www.bostonscientific.com)
Cardima (Fremont, CA; http://www.cardima.com)
CryoCath Technologies (Montreal, Canada; http://www.cryocath.com)
CryoCor (San Diego, CA; http://www.cryocor.com)
Irvine Biomedical (See St. Jude Medical)
Johnson & Johnson (New Brunswick, NJ; http://jnj.com)
Medtronic (Minneapolis, MN; http://www.medtronic.com)
Spectrasonics (Wayne, PA; http://www.spectrasonics.com)
St. Jude Medical (St. Paul, MN; http://www.sjm.com)
Stereotaxis (St. Louis, MO; http://www.stereotaxis.com)


Data is drawn from “Worldwide Ablation Technologies 2007-2017, published September 2008, by MedMarket Diligence. See link for more details.