Cardiovascular Surgical and Interventional Procedures Worldwide, 2015-2022

In 2016, the cumulative worldwide volume of the the following CVD procedures is projected to approach 15.05 million surgical and transcatheter interventions:

  • roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),
  • close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
  • about 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
  • over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);
  • more than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);
  • close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
  • over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
  • almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).

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CABG: Coronary artery bypass graft; PCI: Percutaneous coronary intervention; AAA: Abdominal aortic aneurysm; TAA: Thoracic abdominal aneurysm; CVI: Chronic venous insufficiency; DVT: Deep vein thrombosis; PE: Pulmonary embolectomy.

Source: MedMarket Diligence, LLC; Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.” (To request report excerpts, click here.)

Percutaneous Transluminal Angioplasty and Stenting Reconsidered

Originally developed by the Swiss physician Andreas Gruentzig as a less traumatic alternative to CABG, and first performed in the U.S. in 1978, percutaneous transluminal coronary angioplasty (PTCA) has soon emerged as a mainstream revascularization modality, particularly well-suited for singular concentric coronary artery occlusions.

PTCA is a minimally invasive procedure intended to restore normal (or nearly normal) blood circulation in occluded coronary arteries through a radial dilation of atherosclerotic plaque and its compression against arterial wall with transluminally-placed inflatable balloon.

In PTCA procedure, occluding coronary lesion is first crossed with appropriate guidewire, which is typically inserted under fluoroscopic guidance through a puncture in femoral artery and brought to the treatment site via iliac artery and aortic tree. A special balloon-tipped catheter is then deployed over the guidewire across the targeted lesion and repeatedly inflated to provide a required reopening of the arterial lumen. The catheter is then withdrawn and arterial puncture is secured with the use of external pressure aids or special vascular puncture closure device.

Despite some indisputable benefits of “plain old balloon angioplasty,” its ultimate clinical efficacy was seriously compromised by the disappointingly high rate of restenosis that ran as high as 50% at six months and typically required re-intervention. Introduction of coronary bare metal stents (BMS) in the early 1990s allowed to partially alleviate that problem by reducing the average restenosis rate by about one-half. Stents also helped to virtually eliminate many of the complications of conventional angioplasty, such as abrupt and unpredictable collapse and closure of the vessel, which resulted in emergency bypass surgery.

Since the introduction of bare metal coronary stents, the usage of angioplasty expanded considerably, supplanting CABG as the most commonly employed modality of myocardial revascularization.

By the beginning of the past decade, though, growth in PTCA and coronary stenting caseloads started to slow down in the U.S., Europe, and Japan reflecting significant penetration of technically feasible CAD indications and a disappointingly high rate of post-PTCA and in-stent restenosis. The problem of restenosis represented a single major handicap of coronary angioplasty/stenting, which hampered its ultimate clinical outcomes and often forced a revision and eventual conversion to bypass surgery.

In the opinion of many leading clinicians and industry’s analysts, introduction of drug-eluting stents (DES) represented the single most important innovation in endovascular therapy, since the advent of stenting and angioplasty that was bound to have a revolutionary impact on interventional cardiology practices.  In addition to effectively remedying the nagging problem of coronary restenosis (by reducing its rates to mid-low digit figures), the drug-eluting devices also enabled interventional cardiologists to successfully manage coronary indications and patient caseloads that were traditionally deemed unsuited for angioplasty and stenting. The latter include treatment of small diameter vessels, long and bifurcated lesions, left main artery and multivessel disease, as well as expanded coverage of high-risk patient cohorts with advanced diabetes, renal insufficiency/failure and recent major AMI.

Unfortunately, in the middle of the past decade, one could witness a gradually growing concerns about relatively high incidence (compared to BMS) of late and very late stent thrombosis (often leading to AMI and death) and overall safety of DES, that have prompted several warning letters, but were generally ignored due to initial exuberance about superb antirestenotic performance of DES technology. Following a release of disturbing findings from several major studies in 2006, the cited concerns appeared to reach a “critical mass” bringing the safety issues to the forefront of renewed DES debates and ultimately prompting a very significant decline in DES usage and cumulative PCI procedure volumes in the U.S. and Europe.

In the view of many leading clinicians, the higher propensity of drug-eluting stents to late (and very late) thrombosis is stemming from the very nature of current DES technology which is focused primarily on prophylaxis of binary restenosis via distortion and inhibition of natural healing processes involving neointimal outgrowth. The latter, by definition, lead to a significantly delayed epithelialization and protracted stent struts exposure to the blood stream, which have been identified as the main sources of thrombogenicity. According to multiple IVUS and pathology studies, incomplete endothelialization of DES (with associated bare strut exposure and device malapposition) is commonly observed at 3 to 4 years post-implantation, in contrast to full epithelial coverage of BMS occurring at 5 to 6 months after stent placement.

Early termination of dual (aspirin-clopidogrel) antiplatelet regimens due to patient’s non-compliance, serious complications, or other reasons appears to represent another major contributing factor to onset of late thrombotic events. Based on available data, the vast majority of DES-related thrombosis episodes tend to occur at 1.0 to 3.5 years post-implantation, or after the recommended 12-month period of dual antiplatelet therapy. According to clinical literature, other factors implicated in the occurrence of late and very late DES thrombosis include presence of inflammatory polymer on stent, incomplete drug elution, rate of drug elution, cytotoxicity of chosen drug, as well as poor DES patient selection (e.g., utilization of DES in high-risk diabetics, and their off-label uses in small diameter vessels, patients with long and bifurcated lesions, etc.).

Most of the cited problems were effectively addressed by the next-generation DES devices that combine sophisticated cobalt and platinum alloy stenting platforms and biodegradable drug coatings with super-low-profile delivery and minimally traumatic deployment systems.

It is assumed that clinical efficacy and utility of DES technology would be significantly enhanced with the advent of specialty bifurcation-targeting devices, vascular healing-focused biopharmaceutical coatings, and in increased adoption of fully biodegradable stenting systems.


For forecasts of off-pump CABG, on-pump CABG, primary PCI with stenting, and drug-eluting stent-based PCI procedures (separately for U.S. Western Europe, Asia/Pacific and Rest of World), as well as all major cardiovascular surgical and interventional procedures, see Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

New Global Cardiovascular Procedures Report Reveals Medtech Outlook

MedMarket Diligence has published, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.”

See link for report description, sources, table of contents, and list of exhibits. The report may be purchased for download.

The report details the therapeutic procedures that address acute and chronic conditions affecting myocardium and vascular system, with relevant prevalences, incidence rates, separate procedure counts for surgical versus interventional and other key splits of the procedure volume.

Screen Shot 2016-08-12 at 9.48.46 AMThe report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.

Each set of forecasts is accompanied by discussion per condition of the changing clinical practice and technology adoption rates, procedural limitations or drivers competitively, the surgical-interventional balance, and the resulting market outlook for cardio manufacturers.

Excerpts available on request.

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
Price:  $3,950 (print or PDF; add $200 for both).  Site/Global License also available.
For immediate download, order online or fax your order form.  Site/Global License also available.

 Questions? >> reports@mediligence.com.

 

 

Percutaneous accomplishes even more

Melody TranscatheterWith the FDA's approval of Medtronic's Melody Transcatheter Pulmonary Valve and Ensemble Delivery System (see link), another step has been made toward eliminating traditional surgery — at least that's the idea. The ability to implant a valve via a percutaneous procedure advances the art of less invasive intervention in ways akin to laparoscopic surgery, albeit at lower volume.

Percutaneous, NOTES (natural orifice transluminal endoscopic surgery) and laparoscopic surgery are progressively removing the need for invasive traditional surgery. 

It is precisely due to percutaneous procedures that coronary stents have been able to present such a clinical challenge to coronary artery bypass. Although minimally invasive approaches to CABG are an attempt to pull back some surgical caseload, they are technically complex, expensive and, therefore, are not likely to stem the tide toward the dominance of percutaneous procedures. Ironically, the one procedure that may save bypass is the transcatheter route.  With the approval of the Melody approach, it is clear that that is not impossible.

_______
See Worldwide Coronary Stents Market.

DES and other coronary artery disease treatment tech trends

  *   *   *
See the December 2015 report, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast 2020”. A $500 advance discount is available until publication.
details
  *   *   *

A steady rate of technology development in coronary stents, producing an equally steady stream of new stent market introductions, is focused on expanding aggregate stent caseload (through penetration of what would otherwise be coronary artery bypass caseload) or shifting the balance even further toward concentration of stents sales to the drug-eluting stent (DES) variety.  While unit volumes are on the rise, pricing pressures have dampened this overall market growth and will continue to put a squeeze on stent margins.  This trend has been in force for the past two years (since the late stage thrombosis scare subsided), but going forward there will be more significant forces and developments impacting the stent market, principally the emergence of novel stent technologies like bioabsorbable stents, the emergence of drug-eluting balloons and the development of other anti-restenosis or anti-atherosclerosis options.  These dynamics are the focus of the MedMarket Diligence report #C245, the post below being a brief excerpt from that report.

The evolution of the coronary stent market has been driven by manufacturers focused on expanding the use of coronary stents into new caseload as well as penetrating the market shares of competitors.

Clinicians, for their turn as gatekeepers in this effort, are guided in the adoption of stent technologies by the availability of clinical evidence supporting expansion of stent use to patients whose coronary heart disease might otherwise be addressed by coronary artery bypass graft (CABG) surgery, with their selection of the specific stent used determined (to the extent that price is not an overriding attribute) by how well each stent’s clinical data stands up under scrutiny of possible clinical complications.

Manufacturers then take a hard view of both cost and complication rates.  Below are shown the potential complications ensuing from stent implantation and which have therefore become a focus of stent technology development:

Potential Complications Related to Implantation of Cardiovascular Stents

stent-complications

Source: MedMarket Diligence report #C245, “Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017.”

Some novel stent technologies are under development by: AdvanSource Biomaterials, Allvivo Vascular, Inc., Blue Medical Devices, CeloNova BioSciences, Hexacath, InspireMD, ITGI Medical Ltd., Miami Cardiovascular Innovations (MCVI), MoBeta, Inc., Nexeon MedSystems, Inc., OrbusNeich, Palmaz Scientific, and Prescient Medical.  Other technology developments in coronary artery disease treatments, beyond stent technologies, are also addressed in report #C245.


Download report #C245, “Worldwide Coronary Stent Market, 2008-2017,” PDF — $2,850.00
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Palmaz says the stent future is in bare metal

Dr. Julio Palmaz, who with Dr. Richard Schatz patented the balloon-expandable stent, believes that, while the market for stents has evolved from bare metal stents to drug-eluting stents (DES), the inevitable limitation of DES will be that they lead to inflammatory response and that their real drawback is that they create a barrier between tissue and the metal of the stent itself.

A plenary speaker during the XXX Congresso Nazionale Della Societa Italiana Di Cardiologia Invasiva (GISE), Dr Julio Palmaz (University of Texas Health Science Center, San Antonio) predicted that coatings "of any kind" will prove to be the downfall of drug-eluting stents—even the bioerodable polymers or the coatings used on fully bioerodable stents that today represent the next great hope in DES technology. Pointing to the failure of gold-coated stents back in 2000, Palmaz called on stent manufacturers to "learn from the mistakes of the past."

"Any coating, of any kind, will have the potential to [produce] nonspecific inflammatory changes," he predicted.

See full story on theheart.org at link.

Dr. Palmaz pointed out that, in a bare metal stent, the positive charges of the metal cause the natural formation of oxides that induce healing. The problem with first generation metal stents, he says, is that the constructions of the stents, and their deployment, cause an interruption of the smooth metal surface that lead to an "unhappy" environment surrounding the stent, leading to restenosis. Dr. Palmaz's focus now, through his own company, is to engineer "advanced metallurgical surface technologies" that address this.

Posted via email from medmarket's posterous


Global stent market, Report #C245.

Coverage of ongoing developments in interventional cardiology and surgical technologies

Through the course of tracking multiple subjects for ongoing awareness of new developments in clinical practice, product development, market development and other activity impacting the medtech markets we track, we have identified multiple worthwhile sources of content, which in turn has provided background to our in house research and analysis, which we publish through our proprietary Market and Technology Reports and the Medtech Startups Database, as well as through this blog.

For the purpose of providing regularly available information of interest to our core audience, we will be progressively building aggregates of our proprietary content and select outside sources through specific pages on the MedMarket Diligence website.  Initially, there are two specific topics we will be tracking and the regularly updated content on them are provided at the links below:

We will be expanding these topics as time permits.  We suggest you bookmark them for future reference.  

We welcome any feedback on other topics of interest, as well as any relevant newsfeed sources (many or all of which can be integrated).