Innovative Technologies in Cardiovascular Medicine Hamid Afshar, MD Baylor College of Medicine Houston, Texas
New Technology for the Prevention of Sudden Cardiac Death
The SICD is now in widespread clinical use as an alternative to the transvenous ICD • I have performed over 80 successful SICD implants in the US and around the world. • The S-ICD has proven to be a reliable alternative to transvenous ICD for the right patient: – Preferred : No vascular access, history of TV ICD infection or fracture, renal failure, immuno-compromised. – Strongly considered : young patients with primary electrical problems, congenital disorders, prosthetic valves. – Avoid : Brady indicated, CRT indicated, recurrent monomorphic VT.
Left Subclavian Vein Complete Occlusion
Right Subclavian Vein Complete Occlusion
Patient implanted with SICD
The SICD is now in widespread clinical use as an alternative to the transvenous ICD
The S-ICD Clinical Experience • The subcutaneous ICD (S-ICD) is now in widespread clinical use as an alternative to the transvenous ICD • Occasional patients exhibit high defibrillation threshold (DFT) with the S-ICD • Some predictors of Ineffective Defibrillation Thresholds have surfaced
Occasional patients exhibit high defibrillation threshold (DFT) with the S-ICD • Similar to transvenous ICDs, there are occasional patients who exhibit high defibrillation thresholds with the S-ICD. • One challenge of the S-ICD is that the implant factors which determine the defibrillation threshold have not been fully explained. • What we have learned is that device/lead location and sub-coil and sub-can fat are key in determining the outcome of defibrillation thresholds.
Evaluating Device/Lead Location with Flouroscopy (Device too low)
Evaluating Device/Lead Location with Flouroscopy (Electrode too lateral)
Sub-Optimal Lead Placement (lead not in the fascial plane)
Troubleshooting High DFT with the S-ICD Failed DFT Successful DFT (114 Ohms) (80 Ohms) Brouwer et al, JACC-EP 2016:2(1);89-96
Troubleshooting High DFT with the S-ICD • Sub-coil fat significantly increases shock impedance • High lead impedance may be a sign of sub- coil/sub-can fat, but not ant/post can position • Consider anterior can position, and sub-coil/sub- can fat when troubleshooting high DFT
Some predictors of Ineffective Defibrillation Thresholds have surfaced • My Houston VA colleagues and I evaluated 170 patients (188 Defibrillations) to see if we could find any predictors of ineffective defibrillation thresholds. • What we found is that there is a strong correlation between a high shock impedance (> 100 ohms) and a failed DFT threshold test.
Some predictors of Ineffective Defibrillation Thresholds have surfaced
Some predictors of Ineffective Defibrillation Thresholds have surfaced
Summary of SICD • The S-ICD has proven to be a reliable alternative to transvenous ICD for the right patient • “Ideal” S -ICD placement includes posterior can positioning with minimal sub-coil and sub-can fat • DFT with “Ideal” S -ICD placement is likely to have a substantial safety margin with the 80J S-ICD in both normal and dilated hearts • Anterior can positioning and sub-coil and sub-can fat markedly increase DFT, especially in combination • Sub-coil fat significantly increases impedance.
New Technology for the Management of Atrial Fibrillation
Atrial Fibrillation Mechanisms A very rapidly firing drives the atria and maintains AF through short which cause spiraling (fibrillatory) conduction .
AF is a Growing Problem Associated with Greater Morbidity and Mortality • Higher stroke risk for older AF = most common AF increases risk of cardiac arrhythmia, patients and those with prior stroke and growing stroke or TIA 12M • 15-20% of all strokes are AF- related < 5M • AF results in greater disability ‘15 ‘20 ‘30 ’40 ‘50 compared to non-AF-related stroke ~5 M 5x people with AF in U.S., greater risk of stroke expected to more than with AF 2 • High mortality and stroke double by 2050 1 recurrence rate Go AS. et al, Heart Disease and Stroke Statistics — 2013 Update: A Report From the American Heart Association. Circulation. 2013; 127: e6-e245. 1. Holmes DR, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:528 – 536. 2.
Classification of Atrial Fibrillation Atrial fibrillation First detected Paroxysmal Persistent not Self-terminating Self-terminating Long Standing Persistent
Options in the Management of Atrial Fibrillation • 1- Stroke Prevention: Medication vs. LAAC device (New Technology) • 2- Rate control • 3- Rhythm control : - DC Cardioversion - Antiarrhythmic - Pulmonary Vein Isolation (PVI)
Patients with AF that are at high risk of stroke and/or high risk of bleeding on anticoagulation Stroke Risk Clinical Bleed Risk Clinical Risk Profile for Stroke & Predictor Predictor Bleeding 1 HAS-BLED 3 CHADS 2 Score CHA 2 DS 2 VAS Scor Score Score CHADS 2 CHA 2 DS 2 HAS BLED c 2 e Stroke Risk VASc Bleed Risk Stroke Risk CHF 1 CHF / 1 Hypertension 1 LVEF<40% 0 1.9% 0 0.9% Hypertensi 1 Hypertension 1 Abnormal 1 1 2.8% 1.3% 3.4% on Liver / Renal Function 2 4.0% 2.2% 4.1% Age >75 1 Age >75 2 Stroke History 1 3 5.9% 3.2% 5.8% 4 8.5% 4.0% 8.9% Diabetes 1 Diabetes 1 Bleeding Risk 1 5 12.5% 6.7% 9.1% Stroke / 2 Stroke/TIA/ 2 Labile INRs 1 6 18.2% 9.8% Too Rare TIA VTE 7 9.6% Too Rare Vascular 1 Elderly >65 1 Disease 8 6.7% Too Rare Age 65-74 1 Drugs / 1 9 15.2% Alcohol Female 1 2. Lip Gy, et al J Am Coll Cardiol 2011 Jan 11:572(2):173-180 3. Pisters R, et al Chest 2010 Nov;138(5):1093-100 1 Antithrombotic Therapy In Atrial Fibrillation: American College of Chest Physicians Evidenced Based Clinical Practice Guidelines
2014 ACC/AHA/HRS Treatment Guidelines to Prevent Thromboembolism in Patients with AF • Assess stroke risk with CHA 2 DS 2 -VASc score – Score 1: Annual stroke risk 1%, oral anticoagulants or aspirin may be considered – Score ≥2: Annual stroke risk 2% -15%, oral anticoagulants are recommended • Balance benefit vs. bleeding risk January, CT. et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. JACC. 2014; doi: 10.1016/j.jacc.2014.03.022
Oral Anticoagulation is Standard of Care, but Not Ideal for All Warfarin • Bleeding risk • Daily regimen Anticoagulation Use • High non-adherence rates Declines with • Regular INR monitoring 100% Increased Stroke • Food and drug interaction issues Risk 1 p < 0.001 • Complicates surgical procedures 80% (n=27,164) AF Patients Using Anticoagulation Novel Oral Anticoagulants 60% • Bleeding risk • Daily regimen • 40% High non-adherence rates • Complicates surgical procedures • Lack of reversal agents 20% • High cost 0% 1 2 3 4 5 6 CHADS 2 Score 1. Piccini, et al.. Pharmacotherapy in Medicare beneficiaries with atrial fibrillation. Heart Rhythm. 2012;9:1403-1408
Despite Increasing NOAC Adoption, Overall Rate of Anticoagulation in High Risk NVAF Patients has Not Improved Anticoagulant Use in Patients 100% with NVAF and CHADS 2 ≥ 2 90% 80% 70% Total on 60% 50% Oral 40% Anticoagulat 30% ion 20% 10% Warfarin 0% 2011 2011 2011 2011 2012 2012 2012 2012 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 NOACs n=25719 n=29194 n=31582 n=36490 n=67102 n=70667 n=70320 n=71396 Results from the NCDR PINNACLE Registry 1 1. Jani, et al. Uptake of Novel Oral Anticoagulants in Patients with Non-Valvular and Valvular Atrial Fibrillation: Results from the NCDR-Pinnacle Registry. ACC 2014
Connection Between Non-Valvular AF-Related Stroke and the Left Atrial Appendage AF Creates Environment for Thrombus Formation in Left Atrium • Stasis-related LA thrombus is a predictor of TIA 1 and ischemic stroke 2 . • In non-valvular AF, >90% of stroke- causing clots that come from the left atrium are formed in the LAA 3 . 1. Stoddard et al. Am Heart J. (2003) 2. Goldman et al. J Am Soc Echocardiogr (1999) 3 Blackshear JL. Odell JA ., Annals of Thoracic Surg ( 1996)
Introducing the WATCHMAN™ LAAC Device A first-of-its-kind, proven alternative to long-term warfarin therapy for stroke risk reduction in patients with non-valvular AF Most studied LAAC therapy, only one proven with long-term data from randomized trials or multi-center registries Comparable stroke risk reduction, and statistically superior reductions in INTRODUCING WATCHMAN™ hemorrhagic stroke, disabling stroke and cardiovascular death compared to warfarin over long-term follow-up 1,2 1. Reddy, V et al. JAMA 2014; Vol. 312, No. 19. 2. Reddy, V et al. Watchman I: First Report of the 5-Year PROTECT-AF and Extended PREVAIL Results. TCT 2014.
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