Pre-operation and post-operation evaluation method for PFO (perfluorooctanoic acid) occlusion by multi-mode ultrasonic

Abstract

The invention provides a PFO plugging preoperative and postoperative evaluation method based on multi-modal ultrasound integration radiography, and the method comprises the following steps: S1, preoperative evaluation and surgical planning: collecting preoperative multi-modal ultrasound data, extracting PFO dissection and hemodynamic quantitative parameters, and outputting plugging device model and release position suggestions. The method comprises the following steps: constructing a pre-operation and post-operation quantitative evaluation system, collecting data such as 3DTEE and cTEE 24-48 hours before an operation, and extracting PFO dissection and blood flow parameters; data are collected within 10-15 minutes after an operation, parameters such as the compression ratio of the plugging device are provided, composite scores are calculated through a weighting formula after preprocessing, subjective traditional evaluation is avoided, the plugging effect can be accurately reflected, and an objective basis is provided for curative effect judgment.

Description

Technical Field

[0001] This invention relates to the field of medical assessment technology, specifically to a method for pre- and post-operative assessment of PFO closure using multimodal ultrasound integrated contrast imaging. Background Technology

[0002] Patent foramen ovale (PFO) closure is a key surgical procedure for treating PFO-related cardiac diseases (such as stroke of unknown cause), and contrast-enhanced ultrasound is the core tool for evaluating the effectiveness of this procedure. Clinically, transesophageal contrast-enhanced ultrasound (cTEE) requires the use of standard oscillating saline contrast agent to observe the PFO shunt and classify it (RLS classification); three-dimensional transesophageal ultrasound (3DTEE) requires the acquisition of three-dimensional volume data of biatrial sections, aortic short-axis sections, and PFO sagittal sections, providing a basis for understanding the anatomical features of PFO preoperatively (such as the long diameter and interatrial septum thickness) and determining the position of the occluder postoperatively. However, there is currently a lack of systematic integration and application of these multimodal ultrasound data.

[0003] Current PFO closure assessment techniques have several key shortcomings, and these problems are prominent in clinical practice. First, the assessment dimensions are extremely one-sided, generally relying solely on a single ultrasound indicator to judge efficacy, ignoring multi-parameter synergistic analysis. For example, in some clinical scenarios, the success of closure is judged solely on the low number of residual microbubbles after surgery, without considering whether the compression ratio of the occluder meets the standard. In some cases, this has led to insufficient support of the occluder, resulting in displacement one month after surgery, causing shunt recurrence and increasing the risk of secondary treatment for patients. Secondly, there is a lack of standardized and quantitative evaluation systems, leading to highly subjective judgments of efficacy. Different medical institutions, and even physicians in the same department, have significantly different criteria for determining "effective occlusion": some physicians consider 80% marginal coverage as acceptable, while others require more than 90%. At the same time, there is a lack of standardized procedures for parameter measurement; the PFO-related anatomical diameter measurements for the same patient may differ by 1.5-2 mm, resulting in low reliability of evaluation results and making it difficult to establish a unified basis for efficacy judgment. Finally, postoperative decision-making recommendations lack personalization, with a prevalent "one-size-fits-all" follow-up and intervention model. Regardless of the postoperative closure effect, a standard 6-month follow-up is uniformly arranged, without adjusting the plan according to different efficacy outcomes. For example, some patients showed signs of occluder misalignment postoperatively, but due to the lack of timely intervention and adjustment, the shunt worsened during follow-up, necessitating a second surgery. This increased patient suffering, medical costs, and treatment risks. Summary of the Invention

[0004] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a pre- and post-operative evaluation method for PFO closure using multimodal ultrasound integrated contrast imaging, which solves the problems of multiple key deficiencies in existing PFO closure evaluation techniques and prominent issues in clinical practice.

[0005] (II) Technical Solution To achieve the above objectives, the present invention provides the following technical solution: a method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound-integrated angiography, comprising the following steps: S1. Preoperative assessment and surgical planning: Collect preoperative multimodal ultrasound data, extract PFO anatomical and hemodynamic quantitative parameters, and output suggestions on occluder type and release location; S2. Immediate postoperative data acquisition: Multimodal ultrasound data are acquired within 10-15 minutes after the occluder is released. S3. Preoperative-postoperative quantitative parameter integration and extraction: Parameters such as PFO anatomical diameter and RLS grade are extracted from preoperative data, and parameters such as occluder compression ratio and edge coverage are extracted from postoperative data. After standardized preprocessing, a feature set is formed. S4. Composite score calculation: Calculate the preoperative-postoperative composite score S based on the feature set using a weighted formula; S5. Efficacy Grading and Decision Recommendations: Efficacy is graded based on the composite score S and the status of core parameters, and targeted clinical decision recommendations are matched accordingly.

[0006] Preferably, in S1, preoperative data acquisition is completed within 24-48 hours before the occlusion procedure, cTEE uses standard oscillating saline contrast agent, and 3DTEE data must include three-dimensional volume data of biatrial sections, aortic short-axis sections, and PFO sagittal sections.

[0007] Preferably, the preoperative quantitative parameters in S3 include: PFO long diameter / short diameter / minimum diameter, atrial septum thickness, maximum ASA bulging amplitude, RLS classification, and peak shunt flow rate; The postoperative quantitative parameters include: occluder compression ratio, edge coverage, aortic side protrusion, number of residual microbubbles, and shunt width; The standardized preprocessing includes 3D data registration, cTEE microbubble signal segmentation, and color Doppler shunt beam enhancement.

[0008] Preferably, in step S4, the formula for calculating the composite score S is: S = (W1 × occluder compression ratio) + (W2 × edge coverage) - (W3 × aortic lateral protrusion) - (W4 × number of residual microbubbles) - (W5 × shunt width) + (W6 × preoperative RLS improvement rate). Where W1-W6 are weighting coefficients, satisfying W1+W2+W3+W4+W5+W6=1, and W1 and W2 take values ​​of 0.25-0.35, W3 and W5 take values ​​of 0.05-0.15, W4 takes values ​​of 0.15-0.25, and W6 takes values ​​of 0.05-0.15.

[0009] Preferably, the efficacy grading criteria in step S5 are as follows: Excellent: S ≥ 8 points and all core parameters meet the standards; Good: 5 points ≤ S < 8 points and no serious abnormalities in core parameters; Poor: S < 5 points or any core parameter is severely abnormal.

[0010] Preferably, the decision recommendations include: Advantages: Surgery completed, routine follow-up every 6 months; Good: No intraoperative intervention required. Follow-up should be strengthened one month after surgery, and guidance should be given to avoid strenuous exercise. Poor: Adjust the position of the occluder / change its model during the operation, reassess until the efficacy target is achieved, and conduct intensive follow-up after the operation.

[0011] (III) Beneficial Effects This invention provides a method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound-integrated angiography. It offers the following advantages: 1. This invention utilizes integrated multimodal ultrasound contrast imaging data to construct a quantitative preoperative and postoperative assessment system. Data such as 3DTEE and cTEE are collected 24-48 hours before the procedure to extract PFO anatomy and blood flow parameters. Data is collected within 10-15 minutes after the procedure to provide parameters such as the occluder compression ratio. After preprocessing, a weighted formula is used to calculate a composite score, avoiding the subjectivity of traditional assessments and accurately reflecting the occlusion effect, thus providing an objective basis for efficacy judgment.

[0012] 2. This invention links composite scoring with efficacy grading and decision-making recommendations, classifying scores as excellent, good, or poor, and corresponding to different plans, such as "excellent" for routine follow-up and "poor" for intraoperative adjustments. This avoids the blindness of uniform treatment, allows for timely optimization of surgical or follow-up strategies, improves postoperative management efficiency, and ensures the treatment effect for patients. Detailed Implementation

[0013] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0014] Example 1: This invention provides a method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound-integrated angiography, comprising the following steps: S1. Preoperative assessment and surgical planning: Collect preoperative multimodal ultrasound data, extract PFO anatomical and hemodynamic quantitative parameters, and output suggestions on occluder type and release location; S2. Immediate postoperative data acquisition: Multimodal ultrasound data are acquired within 10-15 minutes after the occluder is released. S3. Preoperative-postoperative quantitative parameter integration and extraction: Parameters such as PFO anatomical diameter and RLS grade are extracted from preoperative data, and parameters such as occluder compression ratio and edge coverage are extracted from postoperative data. After standardized preprocessing, a feature set is formed. S4. Composite score calculation: Calculate the preoperative-postoperative composite score S based on the feature set using a weighted formula; S5. Efficacy Grading and Decision Recommendations: Efficacy is graded based on the composite score S and the status of core parameters, and targeted clinical decision recommendations are matched accordingly.

[0015] Preferably, in S1, preoperative data acquisition is completed within 24-48 hours before the occlusion procedure, cTEE uses standard oscillating saline contrast agent, and 3DTEE data must include three-dimensional volume data of biatrial sections, aortic short-axis sections, and PFO sagittal sections.

[0016] Preferably, the preoperative quantitative parameters in S3 include: PFO long diameter / short diameter / minimum diameter, atrial septum thickness, maximum ASA bulging amplitude, RLS classification, and peak shunt flow rate; The postoperative quantitative parameters include: occluder compression ratio, edge coverage, aortic side protrusion, number of residual microbubbles, and shunt width; The standardized preprocessing includes 3D data registration, cTEE microbubble signal segmentation, and color Doppler shunt beam enhancement.

[0017] Preferably, in step S4, the formula for calculating the composite score S is: S = (W1 × occluder compression ratio) + (W2 × edge coverage) - (W3 × aortic lateral protrusion) - (W4 × number of residual microbubbles) - (W5 × shunt width) + (W6 × preoperative RLS improvement rate). Where W1-W6 are weighting coefficients, satisfying W1+W2+W3+W4+W5+W6=1, and W1 and W2 take values ​​of 0.25-0.35, W3 and W5 take values ​​of 0.05-0.15, W4 takes values ​​of 0.15-0.25, and W6 takes values ​​of 0.05-0.15.

[0018] Preferably, the efficacy grading criteria in step S5 are as follows: Excellent: S ≥ 8 points and all core parameters meet the standards; Good: 5 points ≤ S < 8 points and no serious abnormalities in core parameters; Poor: S < 5 points or any core parameter is severely abnormal.

[0019] Preferably, the decision recommendations include: Advantages: Surgery completed, routine follow-up every 6 months; Good: No intraoperative intervention required. Follow-up should be strengthened one month after surgery, and guidance should be given to avoid strenuous exercise. Poor: Adjust the position of the occluder / change its model during the operation, reassess until the efficacy target is achieved, and conduct intensive follow-up after the operation.

[0020] Example 2: 1. Multimodal preoperative data acquisition: Collection time: 36 hours before the occlusion procedure.

[0021] 3DTEE data acquisition: Using an X7-2t probe, with a frame rate of 35fps and a volume angle of 90°×90°, three-dimensional volume data were acquired sequentially in the bi-atrial long-axis section, aortic short-axis section, and PFO sagittal section. Three cardiac cycles were acquired for each section. The system automatically verified the data quality, and the clarity score was 9 points (pass).

[0022] cTEE data acquisition: A standard oscillating saline contrast agent (3 ml of 0.9% sodium chloride injection + 1.5 ml of air, oscillated at high frequency for 12 seconds) was prepared and rapidly injected via the right median cubital vein (injection time < 2 seconds). Simultaneously, dynamic images of both atria were acquired in the resting state and under Valsalva maneuver (frame rate 25fps), and shunt-related information was recorded.

[0023] Color Doppler data acquisition: Switch to PWDoppler mode, place the sampling volume at the PFO port, adjust the gain to eliminate background noise, and detect the direction of the shunt and the peak flow velocity; then switch to CWDoppler mode to measure the trans-bar pressure difference.

[0024] 2. Preoperative quantitative parameter extraction: After standardized preprocessing (3D data registration, cTEE microbubble segmentation), the system automatically extracts the following parameters:

[0025] 3. Preoperative surgical planning output: Based on the planning logic of the above parameters, the system outputs: Recommended occluder model: "PFO minimum diameter 4.2mm, recommended 8mm eccentric occluder (matching ASA bulging characteristics)"; Release position instructions: "PFO is 6.5mm from the aortic valve annulus. Avoid the occluder protruding more than 3mm from the aortic side during release."

[0026] Step 2: Immediate postoperative data collection; Timing of data collection: 12 minutes after the release of the 8mm eccentric occluder, when the occluder position is stable.

[0027] 4. Content to be collected: 3DTEE data: The acquisition section is consistent with the preoperative section, focusing on the area where the occluder waist meets the atrial septum, and the volume data ensures that the occluder edge sharpness is 90%; cTEE data: Contrast agent preparation was the same as before the procedure. Images of three cardiac cycles were acquired after the Valsalva maneuver, and the system automatically locked the microbubble counting region. Color Doppler data: High-sensitivity mode scan of the occluder waist and disk edge showed no obvious shunt.

[0028] 3. The system automatically extracts the following postoperative parameters:

[0029] 6. Composite score calculation: Weight setting: The weight coefficients derived from multi-factor logistic regression (W1=0.3, W2=0.3, W3=0.1, W4=0.2, W5=0.1, W6=0.1) are used, satisfying W1+W2+W3+W4+W5+W6=1.

[0030] Parameter normalization: Compression ratio 0.95 (normalized to 0.95 within the range of 0.8-1.2); Coverage 94% (normalized to 0.94); Prominence 2.1mm (normalized to 0.42 within the range of 0-5mm); The number of microbubbles was 3 (normalized to 0.06 within the range of 0-50). Shunt beam width 0mm (normalized to 0); The improvement rate was 66.7% (normalized to 0.67).

[0031] Scoring Calculation: S=(0.3×0.95)+(0.3×0.94)-(0.1×0.42)-(0.2×0.06)-(0.1×0)+(0.1×0.67) =0.285+0.282-0.042-0.012+0+0.067 =0.58 → Standardized to 8.8 points (0-10 points range).

[0032] 7. Treatment efficacy grading and decision-making recommendations: Therapeutic efficacy grading: S=8.8 points ≥ 8 points, and all core parameters meet the standards (compression ratio 0.95, coverage 94%, protrusion 2.1mm, 3 microbubbles, 0mm shunt), and is judged as "excellent".

[0033] Decision recommendation: The system outputs "End the surgery, follow up routinely 6 months post-surgery; inform the patient of the efficacy evaluation results and alleviate post-operative anxiety."

[0034] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound-integrated contrast imaging, characterized in that: Includes the following steps: S1. Preoperative assessment and surgical planning: Collect preoperative multimodal ultrasound data, extract PFO anatomical and hemodynamic quantitative parameters, and output suggestions on occluder type and release location; S2. Immediate postoperative data acquisition: Multimodal ultrasound data are acquired within 10-15 minutes after the occluder is released. S3. Preoperative-postoperative quantitative parameter integration and extraction: Parameters such as PFO anatomical diameter and RLS grade are extracted from preoperative data, and parameters such as occluder compression ratio and edge coverage are extracted from postoperative data. After standardized preprocessing, a feature set is formed. S4. Composite score calculation: Calculate the preoperative-postoperative composite score S based on the feature set using a weighted formula; S5. Efficacy Grading and Decision Recommendations: Efficacy is graded based on the composite score S and the status of core parameters, and targeted clinical decision recommendations are matched accordingly.

2. The method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound integrated contrast imaging according to claim 1, characterized in that: In S1, preoperative data acquisition is completed within 24-48 hours before the closure procedure. The cTEE uses standard oscillating saline contrast agent. The 3DTEE data must include three-dimensional volume data of biatrial sections, aortic short-axis sections, and PFO sagittal sections.

3. The method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound integrated contrast imaging according to claim 1, characterized in that: The preoperative quantitative parameters in S3 include: PFO long diameter / short diameter / minimum diameter, interatrial septal thickness, maximum ASA bulging amplitude, RLS classification, and peak shunt flow velocity. The postoperative quantitative parameters include: occluder compression ratio, edge coverage, aortic side protrusion, number of residual microbubbles, and shunt width; The standardized preprocessing includes 3D data registration, cTEE microbubble signal segmentation, and color Doppler shunt beam enhancement.

4. The method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound integrated contrast imaging according to claim 1, characterized in that: In S4, the formula for calculating the composite score S is: S = (W1 × occluder compression ratio) + (W2 × edge coverage) - (W3 × aortic lateral protrusion) - (W4 × number of residual microbubbles) - (W5 × shunt width) + (W6 × preoperative RLS improvement rate). in W1-W6 are weighting coefficients that satisfy W1+W2+W3+W4+W5+W6=1, with W1 and W2 ranging from 0.25 to 0.35, W3 and W5 ranging from 0.05 to 0.15, W4 ranging from 0.15 to 0.25, and W6 ranging from 0.05 to 0.

15.

5. The method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound integrated contrast imaging according to claim 1, characterized in that: The efficacy grading criteria in step S5 are as follows: Excellent: S ≥ 8 points and all core parameters meet the standards; Good: 5 points ≤ S < 8 points and no serious abnormalities in core parameters; Poor: S < 5 points or any core parameter is severely abnormal.

6. The method for pre- and post-operative evaluation of PFO closure using multimodal ultrasound integrated contrast imaging according to claim 1, characterized in that: The decision recommendations include: Advantages: Surgery completed, routine follow-up every 6 months; Good: No intraoperative intervention required. Follow-up should be strengthened one month after surgery, and guidance should be given to avoid strenuous exercise. Poor: Adjust the position of the occluder / change its model during the operation, reassess until the efficacy target is achieved, and conduct intensive follow-up after the operation.

Images