THE CASE FOR TCAR UNDER LOCAL ANESTHESIA. Sumaira Macdonald MD, PhD Vascular Interventional Radiologist & Chief Medical Officer, Silk Road Medical
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1 THE CASE FOR TCAR UNDER LOCAL ANESTHESIA Sumaira Macdonald MD, PhD Vascular Interventional Radiologist & Chief Medical Officer, Silk Road Medical MUNICH VASCULAR COURSE DECEMBER
2 TCAR EQUIPMENT SUITE WITH TRANSCAROTID INDICATION: ENROUTE Transcarotid Neuroprotection & Stent System Working channel for interventional devices Blood flow is returned to femoral vein ENROUTE Transcarotid Stent System (57cm) Blood flow is reversed from the common carotid artery Dynamic Flow Controller & Integrated 200µ Filter Hi / Low / Off 2
3 TCAR PROCEDURE ANIMATION 3 3
4 1 (PIVOTAL & CONTINUED ACCESS) & 2: CLINICAL OUTCOMES Patients Treated Per Protocol (without protocol violations) n=203 n=362 n=385 Patients with 30-day F/U Patients with 30-day F/U All Patients Stroke/Death/MI 6 3.0% 4 1.1% 4 1.0% Stroke 1 0.5% 3 0.8% 3 0.8% Death 2 1.0% 1* 0.3% 1* 0.3% MI 3 1.5% 0 0.0% 0 0.0% Stroke/Death 3 1.5% 4 1.1% 4 1.0% Neurological Death 0 0.0% 0 0.0% 0 0.0% CNI (permanent) 0 0.0% 0 0.0% 0 0.0% *One patient expired ~2 weeks post-procedure due to ruptured AAA 4
5 General Local BY ANESTHESIA TYPE ( 1 LEAD-IN & PIVOTAL) Intention to Treat Analysis Per Protocol Analysis Lead-In Pivotal Combined Endpoint n=57 n=67 n=124 Lead-In Pivotal Combined Endpoint n=54 n=64 n=118 Stroke/Death/MI 3 5.3% 3 4.5% 6 4.8% Major Stroke 0 0.0% 0 0.0% 0 0.0% Minor Stroke 2 3.5% 0 0.0% 2 1.6% Death 0 0.0% 2 3.0% 2 1.6% MI 1 1.8% 1 1.5% 2 1.6% Stroke/Death 2 3.5% 2 3.0% 4 3.2% Stroke/Death/MI 3 5.6% 3 4.7% 6 5.1% Major Stroke 0 0.0% 0 0.0% 0 0.0% Minor Stroke 2 3.7% 0 0.0% 2 1.7% Death 0 0.0% 2 3.1% 2 1.7% MI 1 1.9% 1 1.6% 2 1.7% Stroke/Death 2 3.7% 2 3.1% 4 3.4% Lead-In Pivotal Combined Endpoint n=10 n=74 n=84 Stroke/Death/MI % 2 2.7% 4 4.8% Major Stroke % 0 0.0% 1 1.2% Minor Stroke 0 0.0% 2 2.7% 2 2.4% Death 0 0.0% 0 0.0% 0 0.0% MI % 0 0.0% 1 1.2% Stroke/Death % 2 2.7% 3 3.6% Lead-In 5 Pivotal Combined Endpoint n=7 n=72 n=79 Stroke/Death/MI 0 0.0% 1 1.4% 1 1.3% Major Stroke 0 0.0% 0 0.0% 0 0.0% Minor Stroke 0 0.0% 1 1.4% 1 1.3% Death 0 0.0% 0 0.0% 0 0.0% MI 0 0.0% 0 0.0% 0 0.0% Stroke/Death 0 0.0% 1 1.4% 1 1.3% 5
6 BREAKDOWN OF ANESTHETIC USE IN 1 AND 2 1 0% 22% 2 1% 47% 53% 77% General Anesthesia Local Anesthesia General Anesthesia Local Anesthesia Regional Block Regional Block 6
7 THE ROCHESTER EXPERIENCE (N=44) Parameter 2 Anesthesia Non-Study/ TCAR Surveillance Project Local 78% 33% General 22% 55% Regional Block 0% 0% Mean Skin-to-Skin (mins) Mean Reverse Flow Time (mins) 9 11 Mean Contrast Usage (cc) THE STONY BROOK EXPERIENCE (N=39) Parameter Anesthesia Non-Study/ TCAR Surveillance Project Local 51% General 46% Regional Block 0% Mean Skin-to-Skin (mins) 103 Mean Reverse Flow Time (mins) 18 Mean Contrast Usage (cc) 41 7
8 INFLUENCE OF ANESTHETIC MODALITY ON PERIPROCEDURAL MI: 8
9 N= 3,526 Lancet 2008; 372:
10 Lancet 2008; 372:
11 11
12 NOT A RANDOMIZED COMPARISON OF LA-CEA VERSUS GA-CEA J Vasc Surg 2016;64:3-8 12
13 Survival Free Of MI 13
14 INFLUENCE OF ANESTHETIC MODALITY BEYOND STROKE / DEATH / MI: 14
15 N= 21 STUDIES (orthopedic & other clinical settings) Journal of Alzheimer s Disease 22 (2010) S67 S79 15
16 16
17 Shunt use: 9.2% versus 82.2% for CEA under LA versus CEA under GA 1 If cerebral ischemia after clamping does not occur (collateral circulation) shunt use versus non shunting has an 8.8% stroke rate versus 2.1%, P < Cost effectiveness CEA under LA versus CEA under GA: $ ± versus $ ± , P < Angiology 2011;62: Neurosurgery 2007;61: Angiology 2012;63: JVS 1997;26:
18 CEA under LA versus CEA under GA length of stay: 2.4 ± 1.1 versus 4.1 ± 1.9 days, P < More patients undergoing CEA under GA have hypertensive events (systolic BP > 180mmHg) on the first post-operative day versus CEA under LA 4 The two fatalities in 1 were respiratory and both were treated under GA 5 4. EJVES 2011;41: JVS 2015;62:
19 CONCLUSIONS: THE USE OF LA DURING TCAR Is feasible & safe but requires specific anesthetic expertise Patient selection is an important consideration: stoic patients Benefits may include: Reduced post-operative respiratory morbidity & mortality Potential but as yet unproven reduction in myocardial complications A clear reduction in post-operative cognitive decline (elderly patients are more likely to have baseline deficits) By extrapolation from the CEA literature, a reduction in LOS & higher cost-effectiveness 19
20 20
21 WHEN TO RECOMMEND LOCAL FOR TCAR: Whenever possible (anesthetic support) Must be a stoic patient Elderly > 75 years (concerns about cognitive deficits) Respiratory concerns COPD Emphysema Home O 2 Marked Kyphosis Possibly CAD, Poor LVEF ( 35% is an eligibility criterion for TCAR), Zoll Life Vest 21
22 22
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