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Intracardiac ultrasound (ICE) is an emerging echocardiographic diagnostic technique that emits and receives high-frequency ultrasound signals by placing a catheter equipped with a miniature ultrasound transducer probe inside the heart chamber through a vascular pathway to achieve real-time imaging
of the anatomy of the heart.
At present, ICE has been used in
a variety of structural heart disease surgeries such as atrial fibrillation radiofrequency ablation, left atrial appendage closure, atrial septal defect closure, mitral valvuloplasty, endocardial myocardial biopsy, etc.
The clinical results show that the application of ICE can effectively improve the precision, safety and efficiency of atrial fibrillation radiofrequency ablation and left atrial appendage occlusion, reduce the risk of surgery, reduce postoperative complications, reduce surgical costs, and improve patient comfort
.
Based on significant clinical advantages, the market demand space of ICE is very broad, and many companies around the world are actively deploying ICE-related product
pipelines.
As early as the 50s of the 20th century, researchers began to explore the use of catheterization and ultrasound technology to image
the structure of the heart.
However, due to the limitation of the level of technology, the exploration at that time was not successful
.
Until the 80s of the 20th century, with the development of ultrasound imaging technology and catheter interventional technology, ICE was applied
.
However, at the beginning of application, the transducer frequency of the ICE system is high (20~40MHz), and the tissue penetration ability is limited, which cannot be used to obtain cardiac anatomical maps
.
Since then, researchers have developed low-frequency (9MHz) transducers that allow ICE systems to image cardiac structures, but these systems still suffer from the shortcomings
of catheters with low flexibility, low imaging depth, and inability to observe complete cardiac structures.
In this regard, some R&D manufacturers have developed transducers with lower frequencies (5MHz) to optimize the imaging depth of the ICE system, but the large size of the transducer limits the clinical application of
the corresponding products.
The application of ultrasonic phased array technology in the field of ICE not only solves the problem of large transducer size, but also promotes the further expansion
of the clinical application scope of ICE system.
Specifically, phased array ICEs provide greater imaging depth, clearer images, and a variety of imaging information
.
Ultrasound transducers are gradually developing in the direction of miniaturization, promoting the widespread use of rotary ICE in clinical practice
.
Rotary ICE and phased array ICE have their own advantages: rotary ICE provides higher near-field resolution when applied; Phased array ICE provides information such as cardiac anatomy, color blood flow signals, spectral Doppler images
, and more.
At present, phased array ICE is more widely
used.
At the beginning of the 21st century, Siemens Healthineers launched the world's first two-dimensional ICE catheter, ACUSON AcuNav
.
The product was initially mainly used to guide atrial septal puncture, and later began to be used in various structural heart disease surgeries
such as atrial septal defect closure and left atrial appendage closure.
The two-dimensional ICE supports two- or three-plane imaging that can show two or three different flat views, but doctors need to reconstruct these images in their minds into three-dimensional anatomy
.
With the wide application of ICE, its performance has been continuously optimized, and it has gradually developed from two-dimensional imaging to three-dimensional imaging, which greatly enhances the guidance and visualization capabilities
.
3D ICE can directly present 3D anatomical diagrams when applied, making it easier for doctors to perform surgery
.
In recent years, Siemens, Johnson & Johnson and other companies have innovated and launched real-time 3D ICE systems
.
Compared with 2D ICE, real-time 3D ICE can not only be imdated in real time, but also can be used to display information such as the three-dimensional structure and blood flow of the heart, and the images presented are clearer and more accurate
.
From the perspective of product development, it is expected that more and more ICE systems will develop from two-dimensional to three-dimensional, and even from three-dimensional to real-time three-dimensional and four-dimensional, to the direction
of clearer, more accurate and multi-functional imaging.
Obvious clinical advantages Previously, there have been related applications of transesophageal ultrasound (TEE) and transthoracic ultrasound (TTE) in clinical practice
.
Compared to TEE, ICE is more flexible and can be imaged from the inside of the heart, which helps to detect blood clots more accurately and guide surgery
.
In addition, when performing surgery with TEE, general anesthesia is required for certain special populations; The use of ICE requires only local anesthesia, and avoids the uncomfortable experience of esophageal intubation, as well as mechanical damage to the esophageal wall mucosa by the TEE probe and thermal damage
that may be caused during scanning.
Compared with TTE, the application of ICE is not affected by factors such as obesity, emphysema, and thoracic deformity, and can achieve shorter distance and higher precision imaging
.
At the same time, compared with traditional methods such as TEE and TTE, ICE can monitor the surgical risk of potential complications such as intraoperative thrombosis and pericardial effusion in real time, thereby effectively improving the safety of surgery.
At the same time, ICE can be operated independently by surgeons, not relying on ultrasound and anesthesiologists, making surgical arrangements more flexible, reducing surgical personnel costs, improving surgical efficiency, and reducing the time-consuming
operation of all aspects.
Clinically, TEE results have been the gold standard
for detecting left atrial and left atrial appendage thrombosis prior to catheter ablation or left atrial appendage closure.
It is worth noting that clinical data show that ICE and TEE are equally accurate in the assessment of left atrial appendage thrombosis, and the image quality of ICE is higher; In terms of the effectiveness of the diagnosis of left atrial appendage thrombosis, ICE is superior
to TEE.
At the same time, ICE scans layer by layer from one end of the left atrial appendage to the other through the catheter, which can fully display the maximum aperture, landing zone diameter and effective working depth of each axis of the left atrial appendage, which helps to guide the selection
of the closure device more accurately.
In addition, compared with traditional X-ray imaging technology, ICE can effectively reduce the amount of X-rays, reduce radiation to patients and doctors, and help doctors more clearly and accurately determine the patient's heart condition
during surgery.
Based on the advantages of ICE-guided surgery such as high precision, low safety risk, few postoperative complications, short hospital stay, and fast wound recovery, it is expected that this technology will be applied to a wider range of clinical applications
.
Huge market space From the perspective of application scenarios, at present, ICE has high clinical application value
in the treatment of atrial fibrillation, congenital heart disease, cardiogenic stroke, atrial septal defect, mitral stenosis, tricuspid stenosis, aortic stenosis and other diseases.
The group of patients with the above diseases in China is extremely large
.
With the steady improvement of residents' income level and the increasing demand for precision treatment of patients, ICE products are gradually developing into just-needed products
.
Strong market demand breeds a huge market
.
According to the market price of ICE catheters of 20,000 yuan / root and the market penetration rate of 10%, the market size of ICE catheters in China exceeds 10 billion yuan; According to the calculation of the market price of ICE host of 1 million yuan / unit, if each tertiary hospital is equipped with only one ICE host, the market size of ICE host in China exceeds 1.
4 billion yuan (excluding non-third-class hospitals).
The ICE market, despite its promise, is still in its early stages
of development.
According to the "China Structural Heart Disease Industry Report 2021" released in January this year by the Structural Cardiology Group of the Cardiovascular Medicine Branch of the Chinese Medical Doctor Association, in 2021, the number of transcatheter aortic valve replacement operations (excluding clinical studies) in China exceeded 6,500 cases, the number of transcatheter edge repair operations was about 350 cases, the number of left atrial appendage occlusion operations was about 14,000 cases, and the number of interventional operations for congenital heart disease was about 75,000 cases
。 It is worth noting that more and more new medical devices for the treatment of structural heart disease such as transcatheter mitral valve repair devices, transcatheter tricuspid annulus, and transfemoral tricuspid valve repair devices of domestic innovative enterprises have been approved for marketing
.
At the same time, relevant companies are increasing market education and academic promotion of
ICE technologies and products.
In this context, the penetration rate of interventional surgery for structural heart disease in China will continue to increase, and the use of ICE products for interventional surgery for structural heart disease will further increase
.
According to data released by Frost & Sullivan, the market size of interventional devices for structural heart disease in China has increased from 400 million yuan in 2017 to 2 billion yuan in 2021, with a compound annual growth rate of 48.
3%; The market size is expected to reach 10.
4 billion yuan by 2025, with a compound annual growth rate of 51%.
It is foreseeable that the size of the ICE market will also grow
rapidly.
At present, many medical device giants around the world, such as Siemens, Philips, GE, Johnson & Johnson, Abbott, Boston Scientific, etc.
, have deployed in the ICE field
.
Among them, Siemens, Johnson & Johnson, Philips and other companies have developed three-dimensional or even four-dimensional ICE products, and some products have been approved by
the US Food and Drug Administration (FDA).
In China, the ICE products that have been approved for listing are mainly from multinational enterprises
such as Siemens, Boston Scientific, Johnson & Johnson, and Abbott.
It is worth noting that many domestic innovative enterprises, such as Tingsheng Technology, Saihe Medical, Ice Crystal Intelligence, Xinhuan Technology, etcIt is also actively developing ICE products and has made breakthroughs
.
For example, Tingsheng Technology has successively developed two-dimensional imaging ICE systems, the former is mainly used for simple structural heart disease and electrophysiological surgery, and the latter is mainly used for complex structural heart disease and electrophysiological surgery
.
Together, the two are expected to meet the surgical treatment needs
of most structural heart disease and electrophysiology fields.
In March this year, Tingsheng Technology completed the first exploratory human clinical trial
of a domestic ICE product.
The ICE system independently developed by Sai Ho Medical successfully completed animal testing in August this year, and the results showed that the product has good safety and image function effectiveness
.
At present, the product has officially entered the clinical trial stage
.
Ice Crystal Intelligent completed an angel round of financing of 10 million yuan in August this year, and the funds raised will be mainly used for the research and development
of the company's HD-ICE (next-generation intracardiac ultrasound) products.
With its high control and high imaging clarity, it is expected to further improve the effectiveness and safety
of interventional surgery for structural heart disease.
In addition, Heartworld's ICE system is also in the research and development stage
.
For the above-mentioned innovative enterprises, on the one hand, because China's ICE market is still in the early stage of development, the market penetration rate of related products is low, and enterprises have greater room for development; On the other hand, many well-known medical device companies around the world are actively deploying the ICE field, which will bring huge competitive pressure
to domestic innovative enterprises.
Under this circumstance, local ICE enterprises should increase the investment of personnel, equipment, environment, capital and time, focus on the development and optimization of relevant processes, improve production efficiency and yield rate, ensure the mass production of ICE products, and reduce manufacturing costs as much as possible to further improve their own competitiveness
.
(Author: Arterial Network)
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