Tóm tắt Luận án The clinical characteristics andefficacy ofinfrapopliteal percutaneous transluminal angioplasty in patient with lower extremity arterial disease

Nội dung tài liệu: Tóm tắt Luận án The clinical characteristics andefficacy ofinfrapopliteal percutaneous transluminal angioplasty in patient with lower extremity arterial disease

1. MINISTRY OF EDUCATION AND TRAINING MINISTRY OF DEFENCE 108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCES -------------------------------------------------------- LUONG TUAN ANH THE CLINICAL CHARACTERISTICS ANDEFFICACY OFINFRAPOPLITEAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN PATIENT WITH LOWER EXTREMITY ARTERIAL DISEASE Speciality: Cardiology Code: 62.72.01.41 ABSTRACT OF MEDICAL PHD THESIS Hanoi – 2019
2. THE THESIS WAS DONE IN:108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCES Supervisor: 1. Ass.Prof.PhD. Le Van Truong 2. Ass.Prof.PhD. Vu Dien Bien Reviewer: 1. 2. 3. This thesis will be presented at Institute Council at:108 Institute of Clinical Medical and Pharmaceutical Sciences Day Month Year 2019 The thesis can be found at: 1. National Library of Vietnam 2. Library of 108 Institute of Clinical Medical and Pharmaceutical Sciences
3. 1 INTRODUCTION Lower extremity arterial disease (LEAD) is very common, prevalence 3-7% of the population, 20% in people over 75 years old. Ulcers and gangrenelower limb is the end- stages of the disease, threatened amputation, loss of limb functiondue to infrapopliteal arterial lesions. Below the knee revascularizationis the most important in limb salvage for this disease. There are two methods of infrapopliteal arterial revascularization: bypass surgery and percutaneous angioplasty, so bypass surgery is difficult due to below the knee artery small, long lesions, bad run-off, elderly patients, many serious diseases combined. Percutaneous transluminal angioplasty (PTA)is becoming as important treatments for this area. Currently LEAD with infrapopliteal lesions was concerned, innitial step was deployed in Vietnam, yet researchs on medium and long-term effectiveness, small sizes, should we proceed subject with two purposes: 1. Study on clinical characteristics of lower extemity arterial disease with infrapopliteal lesions. 2. Evaluate mid-term outcomes and factors influencing clinical outcomes of infrapopliteal angioplasty in patient with lower extremity arterial disease.
4. 2 Chapter 1 OVERVIEW 1.1. LEAD Concept Lower extremity arterial disease (LEAD) is only partially or entirely in the lower limbs is not provided with adequate blood, responding to physiological activities, with a duration of time more than two weeks. This concept excludes acute limb ischemia, vessel wounds, vascular complications. The cause of LEAD is the development of atherosclerotic plaques, which cause a narrowing or complete blockage of the limb vessels. Below the knee (BTK) arteriesincludes tibial artery (aterior tibial artery, posterior tibial artery, peroneal artery), pedal artery (dorsal pedal artery, medial plantar artery, lateral plantar artery). 1.2. Clinical Characteristics of LEAD LEAD progresses through several stages, from asymptomatic, claudication, rest pain, ulcer and gangrene. Critical limb ischemia (CLI, including rest pain, ulcer and gangrene lower limb) with infrapopliteal arterial lesion, considered the end stage of the LEAD, threaten to limb losss. LEAD is a common chronic cardiovascular disease caused by atherosclerosis, with coronary artery disease and stroke, the prevalence of 3-7% of the population (20% in people over 70 years of age), of which the rate of CLI is 1 % population. Common risk factors of LEAD are elderly age (> 50 years), smoking, diabetes, hypertension, and dyslipidemia.
5. 3 Table 1.2. Rutherford classification of PAD Grade Category Clinical 0 0 Asymptomatic I 1 Mild claudication I 2 Moderate claudication I 3 Severe claudication II 4 Rest pain III 5 Minor tissue loss IV 6 Major tissue loss 1.3. LEAD Diagnostics Hemodynamic tests Imaging Diagnostics ABI index Doppler and Duplex Ultrasound TBI index CTA Treadmill test MRA Segmental systolic pressure Angiography TcPO2, SPP In which the diagnostics tests are used in Vietnam are measuring ABI index, ultrasound of lower extremities arterial lesions, CTA before percutaneous transluminal angioplasty, and angiography in intervention procedure. 1.4. PTA of LEAD with Infrapopliteal lesions 1.4.1. Treatment Purposes + Reduce symptoms of limb ischemia. + Limb salvage.
6. 4 1.4.2. Indications + Clinical stage . CLI . Moderate claudication or severe claudication does not respond to medical treatment. + Arterial lesion classification TASC B, C, D (TASC 2000). + Multi-level of lower extremity arterial lesion . Aortoiliac lesions: aorto-iliac occlusion, aorto-iliac stenosis in patient when life expectancy is not over 2 years. . Femoro-popliteal lesions: short lesions (< 25cm), long lesions (≥ 25cm) in patient when life expectancy is not over 2 years. 1.4.3. Techniques of infrapopliteal revascularization There are currently two techniques of infrapopliteal revascularization are: balloon angioplasty (plain balloon, drug coated balloon), stenting (covered and uncovered stent), with specified is: + Balloon angioplasty is the priority technique. + Stenting if the ballooning is not effective. BTK intervention is considered to be a revascularization method with a high effectiveness of limb preservation, less complications than bypass surgery. In which, plain ballooning is the priority method, assessing the effectiveness of normal ballooning with different types of infrapopliteal lesions as well as combining with additional techniques (drug-coated balls, atherectomy, ...) in order to reduce the rate of restenosis is still needing further research to confirm the effect.
7. 5 Chapter 2 SUBJECTS AND METHODS 2.1. RESEARCH SUBJECTS 85 patients with 91 infrapopliteal arterial lesions, were reperfusioned by PTA in 108 hospital from May 2011 to June 2016. 2.1.1. Selection criteria - There are clinical symptoms of lower limbs ischemia, duration of time more than 2 weeks. - Infrapopliteal arterial stenosis is over 50% diameter or total occlusion (angiography), correspond to clinical symptoms of lower limbs ischemia. - Patients agree to participate in the research. 2.1.2. Exclusion criteria - Acute limb ischemia (ALI). - Non-atherosclerosis LEAD (Takayasu, Bueger, Raynaud,...). - Infrapopliteal arterial stenosis or occlusion due to external causes of vessel (tumor, trauma,...). - Venous disease of lower limbs (varicose veins, venous thrombosis,...). - Peripheral neuropathy of lower limb (peripheral neuritis, peripheral neuropathy due to diabetes,...). - Severe disease (liver failure, renal failure, heart failure, acute myocardial infarction, stroke, severe infections). 2.2. RESEARCH METHOD 2.2.1. Study design: prospective, intervention, follow-up.
8. 6 2.2.2. Research steps 2.2.2.1. Before lower limb PTA Patients should be screened and tested for investigation eligibility. Patients meet inclusion criteria will be asked to participate in this research. + Clinical examination: finding limb ischemia, duration of illness, cardiovascular risk factors (old age, diabetes, hypertension, smoking, metabolic lipid disorders, coronary artery disease, stroke,...). +Laboratory tests: - Blood tests: blood formulation, coagulation tests (Prothrombin, INR, APTT, Fibrinogen), blood biochemistry tests (Ure, Creatinine, Lipid, Protid, Albumin, Bilirubin, SGOT, SGPT, electrolytes), immunity tests (HBsAg, anti-HIV, anti-HCV). - Cardiopulmonary X-ray, ECG, echocardiography. - ABI index. ABI measured by Doppler handheld smartdrop 45 (Japan), from 2011 to 2013, when we did not have automatic ABI meter and by ABI automatic ABI meter VP1000 Plus (OMRON, Japan), from 2013 to 2016. +Lower limb arteries ultrasound by GE Vivid 7 (GE, USA), in cardiology department (108 hospital). +Lower extremity artery imaging byMSCT 16 slices Brivo 385 (GE, USA), in imaging diagnostic department (108 hospital). 2.2.2.2. Lower Limb PTA
9. 7 Iliac artery lesion and femoral artery lesion were revascularized before infrapopliteal artery lesion. It will be possible to open lesions in one or two sessions, depending on each patient. + Patient preparation: patients being screened, tested and explained deeply about disease and treatment method. Patients was asked to sign an informed consent, do not eating and drinking at least 6h before procedure. + Interventional procedure of iliac and femoral artery occlusion - Anesthesia: local anesthesia with 5-10ml lidocaine 2% in vascular access. - Patient posture: lying on the back. - Vascular access: common femoral artery or brachial artery. - Giving the catheter to the iliac and femoral artery occlusions, taking assessments the lesion, collateral branches and run-off. - Going through the occlusion by guidewire 0.035 inches, with intraluminal technique or subintimal technique (in case CTO over 3 months). We could use additional support catheters to increase the ability to pass through the complicated occlusion. - Open the occlusion by dilating balloon 6F, 6atm pressure, keeping 30s, then we do angiography after deflating balloon.Finishing procedure if the recurrence stenosis under 50% diameter, on the otherwhile choosing the bigger balloon or stenting when balloon failure. + Infrapopliteal PTA - Anesthesia: spinal anesthesia at L4-L5.
10. 8 - Patient posture: lying on the back. - Vascular access: femoral artery in the side of infrapopliteal lesion. - Evaluating the lesions of iliac and femoral artery, collateral circulation and run-off before intervention. - Revascularization femoral and popliteal artery occlusion (see above). - Giving guiding catheter to popliteal artery. Going through antegrade the infrapopliteal artery lesions by support catheter TrailBlazer 4F (Boston, USA), Controlwire 18 (Boston, USA). When failure, we could go retrograde from tibial artery or pedal artery, with sheath 4F. - Dilating the occlusions by balloon 3-3.5 mm diameter for tibial artery and balloon 2-2.5 mm diameter for pedal artery, with 100-200 in length. Keeping dilation from 30s to 2 minutes, from 6 to 14 atm pressure. - We do angiography after deflating balloon. Finishing procedure if the recurrence stenosis under 50% diameter, on the otherwhile ballooning again with a more suitable size balloon. 2.2.2.3. Follow-up after PTA - Clinical follow-up (FU), re-do all biochemical, hematological after PTA. Well treatment for patient until being discharged. - Measuring ABI and lower extremity arteries ultrasound after 1 day. Amputation gangrene and discharge. - Periodic follow-up 1, 3, 6 and 12 months after procedure include clinical examination, ABI measurement, ultrasound, and assessment of