Bài giảng Can thiệp dụng cụ trong tăng huyết áp - GS.TS. Huỳnh Văn Minh

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Bài giảng Can thiệp dụng cụ trong tăng huyết áp do GS.TS. Huỳnh Văn Minh biên soạn trình bày các nội dung chính sau: Các kỹ thuật can thiệp dụng cụ tăng huyết áp; Cầu nối động-tĩnh mạch chậu trung tâm; Kích thích não sâu; Kích thích thần kinh giữa.

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Nội dung Text: Bài giảng Can thiệp dụng cụ trong tăng huyết áp - GS.TS. Huỳnh Văn Minh

GS.TS. Huỳnh văn Minh, FACC, FAsCC, MISH Chủ tịch Phân hội THA Việt nam P. Chủ tịch Hội Tim mạch Việt nam GĐ Trung tâm Tim mạch BV ĐHYD Huế PGĐ. Trung tâm Tim mạch BVTW Huế
Tình hình THA trên thế giới 1/ 3 người lớn bị THA 1/ 3 người THA không biết mình bị bệnh 1/3 người bị THA đựơc điều tri không đạt mục tiêu HA
3
Interventional therapy for Resistant Hypertension 30’s-50’s 2009-Renal Carotid Iliac A-V Surgical sympathectomy Denervation Baroreceptor anastomosis Stimulation
CÁC KỶ THUẬT CAN THIỆP DỤNG CỤ THA Deep Brain Stimulation BAT Carotid Body Ablation Carotid Bulb restoration Aortic Baroreceptor stimulation Vagal Nerve Stimulation Renal Denervation AV anastomosis Median Nerve Stimulation Lobo, Sobotka, Pathak. EHJ 2016
New targets Carotis Bulb Baroreceptor Restoration Stimulation Aortic Arch Stimulation Renal Denervation AV Fistula Median Nerve stimulation
1. Điều trị cắt đốt thần kinh – thận 7
Office systolic BP change at 6 months Combined hypertension (CH): Isolated systolic hypertension (ISH): • SBP >140 mmHg, DBP >90 mmHg • SBP >140 mmHg, DBP
N = 535
Published randomized RDN controlled studies: effects on BP HTN 2 OSLO PRAGUE -15 DENER HTN RDN RDN plus previous antihypertensive RDN plus previous RDN plus optimal Comparator antihypertensive treatment antihypertensive treatment Vs therapy RDN plus a SSAHT vs vs RDN vs control vs clinically adjusted drug intensified pharmacological treatment previous therapy by using the a SSAHT guided by home BP including spironolactone (if tolerated antihypertensive HOTMAN treatment system and not contradicated) Entire study population (n) 106 (52 vs 54) 19 (9 vs 10) 106 (52 vs 54) 106 (53vs 53) (RDN vs Control) Age(years) 58 60 58 55 Confirmation of dRHTN with ABPM No Yes Yes Yes Number of antihypertensive medications 5.2 vs 5.3 5.1 vs 5 5.1 vs 5.4 The same SSAHT at baseline (RDN vs Control) Changes in office SBP (mmHg) -32 vs +1 -8 vs -28 -12.4 vs -14.3 -15.1 vs -9.5 (RDN vs Control) Δ in changes in office SBP between groups (mmHg) (RDN vs Control) -33 +20 -5.8 (NS) -5.6 (NS) Changes in 24h SBP mmHg) -11/-3 -10/-21 -8.6 vs -8.1 -15.4 vs -9.5 (RDN vs Control) Δ in changes 24h S BP between groups (mmHg) -8 NA -0.5 (NS) -5.9 (P=0.0238) (RDN vs Control) RDN device Symplicity Symplicity Symplicity Symplicity Investigator witnessed intake Morisky score plus drug Assessment of medication diary of their antihypertensive Plasma drug concentrations concentration adherence morning medications Tsioufis, Schmieder, Mancia: Interventional therapies for essential and secondary hypertension, Springer 2016
On-going RDN clinical trials in hypertension by using RF Key characteristics of the Primary efficacy end Trial Sponsor Ablation system n study point of study •Multi center, randomized, blinded study with Sham ablation arm (1:1) SPYRAL HTN- SYMPLICITY SPYRAL 100 Change in ABPM •Main body and branch ablation OFF MED Medtronic at 3 months •No specific baseline medication requirement •Multi center, randomized, blinded study with Sham ablation arm (1:1) SPYRAL HTN-ON MED •Main body and branch ablation SYMPLICITY SPYRAL 100 Change in ABPM Medtronic Fixed drug regimen: 1 vs 2 vs 3 medications, classes, max dose at 3 months Vessix™ Renal Denervation System REINFORCE BOSTON 2:1 Randomization Balloon-based technology for 100 Change in ABPM delivery of Radiofrequency at 2 months energy Randomized ,Sham-controlled, 525 Blinded EnligHTNed SJM Standardizing antihypertensive EnligHTN™ on triple Change in ABPM regimen at 6 months Testing for adherence antihypertensive drugs
On-going RDN clinical trials in hypertension by using ultrasound Trial Key characteristics of the Ablation system n Primary efficacy end point of study study The RADIANCE-HTN FDA Approved study . Global multi- The PARADISE system for 292 Difference in Daytime systolic BP at 2 Trial center, randomized, sham-controlled, endovascular delivery of months post RDN blinded ultrasound Solo Cohort: Patients off HTN medication Trio Cohort: Patients on a standardized, single pill, fixed dose triple HTN medication regimen WAVE IV Double blind, Prospective, Non-Invasive Renal 132 Changes in office BP at 6 months follow Randomized Sham Controlled Clinical Denervation by up Trial using externally delivered focused ultrasound The Peregrine Post - Post-Market Study Single arm, open Alcohol-Mediated Renal 100 Change in 24-mean ABPM at 6 months Market Study label Denervation Based on the Peregrine System™
2. The CVRx® Rheos System Programming System Baroreflex Activation Leads Implantable Pulse Generator 13
2nd Generation Platform 1st Generation 2nd Generation
CVRx Barostim Platform CVRx Programmable Barostim Platform Designed to electronically activate baroreceptors which signal Barostim the brain to orchestrate a multi-systemic response to address chronic, progressive diseases: hypertension, heart failure, arrhythmia… Brain Autonomic Nervous System Reduce Sympathetic Activity Enhance Parasympathetic Activity HEART: rate slows, to allow more time for heart to fill with blood, and reduce workload and energy demand ARTERIES: relax, making it easier for blood to flow through the body and reducing cardiac exertion KIDNEYS: reduce fluid in the body, lowering excessive blood pressure and workload on the heart 3
Ability to Personalize and Control the Therapy 16
Office BP Response to Rheos Therapy Systolic Diastolic Heart Rate (Baseline = 183 mmHg) (Baseline = 105 mmHg) (Baseline = 78 BPM) 0 -5 Mean change in mmHg or BPM -5† -10 -7 † † -8 † -15 -15* -15* -20 1 Year (N=38) 2 Years (N=38) -25 -22* -21* 3 Years (N=22) -25* -30 -31* *p value < 0.001 -35 † p value = < 0.005 † † p value = 0.15 17
Cardiac Structure and Function Improvements N=18 Baseline Δ 12 Months LV Mass Index (g/m2) 132.8 ± 33.3 –25.0 ± 18.2* Left Atrial Dimension (mm) 44.1 ± 8.1 –2.4 ± 3.5* Mitral E Wave Velocity (cm/s) 85 ± 19 –5 ± 14 Mitral A Wave Velocity (cm/s) 83 ± 22 –10 ± 13* Values: mean ± SD *p value
FDA Approved Phase III Pivotal Clinical Trial • Prospective, randomized, double-blind, placebo-controlled, multi-center clinical trial • Up to 300 patients, 50 medical centers • Inclusion criteria: SBP ≥ 160 mmHg; 3+ medications • Endpoint: % patients dropping > 10 mmHg with sustained reduction Implant Randomization 6-Month Evaluation Period Long-Term 2:1 (Group A: Group B) Follow Up 6-Month Blinded Evaluation Period Group A - Device ON Group A - Device ON Group B - Device OFF Group B - Device ON 0 6 -1 12 Months 19
Procedure Details Variable N Mean ± SD Procedure Time (hours) 30 1:47 ± 0:28 Mapping Time (hours) 30 0:44 ± 0:28 • Excluding first 2 implants at sites, implant time averaged 1:37 ± 0:29 • Rheos average implant time about 3 hours, with average mapping about 1.25 hours 16