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The routine procedures for the treatment of lower limb artery disease are the opening of lesions, vascular preparation, evaluation, and determinative treatment.
treatments include BMS, DCB, DES, etc., and their choice depends on the evaluation results.
, the evaluation process is very important for the decision-making of the treatment mode of lower limb artery disease, and even the clinical efficacy.
At the 5th New Technology Summit on In-arterial Therapy in the Lower Extremities (LETS 2020), Professor Junhao Jiang, from Vascular Surgery at Sun Yat-sen Hospital, affiliated with Fudan University, first said that the current criteria and methods for the evaluation of vascular preparation were clearly unreasonable and inadequate, and then shared clinical experience with the vascular preparation assessment system.
the IGNITE study triggered by the thinking on adequate vascular preparation1, IGNITE research results IGNITE research for multi-center, forward-looking research, a total of 296 patients, POBA≤ treatment; Approximately 45% of patients with mezzanine type ≤B and pressure gradient ≤20 mm Hg) (Success BA group) did not have the ideal tube cavity (the exact opposite of the standard) (Failure BA group).
results, there was no significant difference in the first period of the six-month and 12-month groups (Figure 1).
the study concluded that long-term smoothness may depend on the application of the device and the nature of the lesions, and does not seem to be related to the results of vascular preparation.
, however, it is important to note that this study method shows a certain percentage of remedial stent implantation rates in both groups, indicating that there are other undisclosed basis for judging vascular preparation results in the study.
, the study also noted that balloon expansion time of >180 s is one of the key factors in obtaining the ideal tube cavity.
Combined with clinical experience, many short-term narrow lesions are caused by elastic retractation, and long-term balloon expansion can reduce the adverse effects of early elastic retractation, which may also be one of the reasons for the study's "no significant difference in the first phase of smoothness."
1. Phase I pass rate data 2, adequate vascular preparation? Whether adequate vascular preparation triggered by the IGNITE study is necessary is, in fact, a reflection on whether POBA is fully implanted in the stent after surgery.
, the concept of in-cavity therapy for lower limb artery disease was "leave something behind", while the current pursuit was "leave nothing behind".
Jiang Junhao thinks it's going from one extreme to the other.
, the limitations of stent application are mainly concerns about stent-related complications, such as broken stents, narrowing of stents, etc.
the widespread use of DCB improve the position of stents in the treatment of arterial diseases in the lower extremities? Based on this problem, vascular surgeons have done a series of controlled analysis studies.
DEBATE-ISR, FAIR, ISAR-PEBIS, AcoArt I. and IN.PACT Global study shows that the average postoperative narrowing rate of DCB is 18.6% (11.3% to 30.0%); The results of RCT show that the re-narrowing rate in the stent is 20% to 50% in the first year after surgery, and if the second stage is applied to DCC treatment and the re-narrowing rate is simply calculated at 18.6%, the second phase smoothness rate is above 90% (Figure 2), and the effect is satisfactory.
, vascular surgeons have been re-examining the role of stents as a good treatment strategy for lesions suitable for implantation.
Back to thinking about the treatment process for lower limb artery disease, the nature of the lesion should also be increased after the lesions are opened to determine the determining treatment model, if the final treatment is decided to be "leave right thing behind" the requirements for vascular preparation is more tolerant;
adequate vascular preparation requires a sound assessment system for evaluation.
The significance of vascular preparation can be seen in many clinical studies of coated balloons, including: expanding the volume of the tube cavity, reducing the flow-limiting mezzanine and vascular damage, beneficial to the absorption of drugs, and reducing implants.
, can you avoid stent implantation by doing "Leave Nothing Behind" with good vascular preparation? At present, the clinical use of optimized PTA technology, reduced capacity technology and coating balloons, with a view to achieving this goal (Figure 1).
Figure 2. Stent implantation weighted DBC, and then narrowing rate significantly reduced Figure 3. Vascular preparation assessment system for the treatment process of lower limb artery disease - assessment object 1, lesion classification (classified by implanted stent or stent as a remedy) Class I. Class I: remedial stent, including: short-term lesions (<10 cm), eccentricity, combined thrombosis, crotch lesions.
such lesions need adequate tube preparation, such as: eccentric lesions to DAART, combined thrombosis patients to PMT and other measures.
II. Class II: Stent implantation, including: long-stage lesions (≥10 cm), severe calcification lesions, unstable tube cavity, undertradural opening.
2, lesions partition to choose treatment methods, should also consider the lesions partition, clearly suitable for stent implantation site.
study showed a significant decrease in the flow rate of P2 lesions.
, P1 above is suitable for stent implantation (standard strict, any indicator appears to be treated), P2 is not suitable for stent implantation (standard from wide, meet multiple indicators to treat).
Vascular Preparation Assessment System - The evaluation criteria should be considered from the three aspects of objectivity, quantification and feasibility, so we can start with measuring the residual narrowness rate, mezzanine formation and pressure gradient.
1, residual stenosis is generally considered clinically only > 30% residual stenosis.
, however, in practice, the residual narrowness observed at different positions is different (Figure 4), and it is difficult to determine the specific residual narrowness ratio, so this parameter is complementary to decision-making judgment.
4. Residual stenosis observed at different positions is different 2, mezzanine dation At present, the division of lower limb artery mezzanine is mainly based on the treatment experience of coronary veins (Table 1).
it is generally believed that the occurrence of acute closure of type A and B mezzanine is low and can not be treated, while type C and above require stent intervention.
But the six-month follow-up 1 study showed that the re-narrowing rate, smoothness and TLR of the A/B mezzanine were not ideal, which suggested that the severity of the mezzanine was generally underestimated clinically.
2017, Fujihara and others found that although the A/B mezzanine first-phase pass rate was much higher than the C-F type, the one-year first-phase pass rate was only 65%, which is not ideal.
addition, for the same lesions, from different angles, different parting results may be obtained, resulting in different treatment strategies.
Table 1. NHLBI coronary mezzanine division 3, pressure measurement above two parameters are based on imaging performance, infer changes in blood flow forces, so there will be some deviation.
pressure measurement uses blood flow meliology standards to evaluate changes in blood flow forces with greater accuracy.
present, the outer arteries often use catheter pressure measurement, but its evaluation criteria have not yet been determined, generally refer to the visceral artery sp≥20 mm Hg.
in clinical work, Professor Jiang Junhao's standard for implanting stents is any one: residual narrowness rate >30%, mezzanine dation ≥C, or pressure measurement sP≥20 mm Hg.
evidence-based basis for total vascular preparation is still relatively small, mostly from clinical experience.
Professor Jiang Junhao's experience is that P1 or above is suitable for stent implantation lesions standard strict, any indicators appear need to be treated;
Figure 5. Vascular Preparation Evaluation System Outpatient Magazine Source: Outpatient New Horizons Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Originals" are owned by Mets Medicine and are not authorized to be reproduced by any media, website or individual, and must be reproduced with the words "Source: Mets Medicine".
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