Medicine Hamid Afshar, MD Baylor College of Medicine Houston, - - PowerPoint PPT Presentation

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 (114 Ohms) Successful DFT (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

patients and those with prior stroke or TIA

• 15-20% of all strokes are AF-

related

• AF results in greater disability

compared to non-AF-related stroke

• High mortality and stroke

recurrence rate

AF = most common cardiac arrhythmia, and growing ‘15 ‘20 ‘30 ’40 ‘50 5M 12M AF increases risk of stroke

< ~5 M

people with AF in U.S., expected to more than double by 20501

5x

greater risk of stroke with AF2

1. Go AS. et al, Heart Disease and Stroke Statistics—2013 Update: A Report From the American Heart Association. Circulation. 2013; 127: e6-e245. 2. Holmes DR, Atrial Fibrillation and Stroke Management: Present and Future, Seminars in Neurology 2010;30:528–536.

Classification of Atrial Fibrillation

Atrial fibrillation First detected Persistent not Self-terminating Long Standing Persistent Paroxysmal Self-terminating

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 Predictor Bleed Risk Clinical Predictor Risk Profile for Stroke & Bleeding

CHADS2

1

Score CHA2DS2VAS c2 Scor e HAS-BLED3 Score CHF 1 CHF / LVEF<40% 1 Hypertension 1 Hypertensi

• n

1 Hypertension 1 Abnormal Liver / Renal Function 1 Age >75 1 Age >75 2 Stroke History 1 Diabetes 1 Diabetes 1 Bleeding Risk 1 Stroke / TIA 2 Stroke/TIA/ VTE 2 Labile INRs 1 Vascular Disease 1 Elderly >65 1 Age 65-74 1 Drugs / Alcohol 1 Female 1 Score CHADS2 Stroke Risk CHA2DS2 VASc Stroke Risk HAS BLED Bleed Risk 1.9% 0.9% 1 2.8% 1.3% 3.4% 2 4.0% 2.2% 4.1% 3 5.9% 3.2% 5.8% 4 8.5% 4.0% 8.9% 5 12.5% 6.7% 9.1% 6 18.2% 9.8% Too Rare 7 9.6% Too Rare 8 6.7% Too Rare 9 15.2%

• 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 CHA2DS2-VASc score

– Score 1: Annual stroke risk 1%,

• ral anticoagulants or aspirin may be considered

– Score ≥2: Annual stroke risk 2%-15%,

• ral 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
• High non-adherence rates
• Regular INR monitoring
• Food and drug interaction issues
• Complicates surgical procedures

Novel Oral Anticoagulants

• Bleeding risk
• Daily regimen
• High non-adherence rates
• Complicates surgical procedures
• Lack of reversal agents
• High cost

0% 20% 40% 60% 80% 100% 1 2 3 4 5 6

CHADS2 Score

p < 0.001 (n=27,164)

AF Patients Using Anticoagulation

Anticoagulation Use Declines with Increased Stroke Risk1

• 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

Results from the NCDR PINNACLE Registry1

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2011 Q1 2011 Q2 2011 Q3 2011 Q4 2012 Q1 2012 Q2 2012 Q3 2012 Q4

Total on Oral Anticoagulat ion Warfarin NOACs Anticoagulant Use in Patients with NVAF and CHADS2 ≥ 2

n=25719 n=29194 n=31582 n=36490 n=67102 n=70667 n=70320 n=71396

• 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

• Stasis-related LA

thrombus is a predictor of TIA1 and ischemic stroke2.

• In non-valvular AF,

>90% of stroke- causing clots that come from the left atrium are formed in the LAA3.

AF Creates Environment for Thrombus Formation in Left Atrium

• 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

WATCHMAN™

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 hemorrhagic stroke, disabling stroke and cardiovascular death compared to warfarin

• ver long-term follow-up1,2

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.

WATCHMAN Therapy

Indications for Use

The WATCHMAN™ Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

– Are at increased risk for stroke and systemic embolism based

• n CHADS2 or CHA2DS2-VASc scores and are recommended for

anticoagulation therapy; – Are deemed by their physicians to be suitable for warfarin; and – Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

WATCHMAN™ LAAC Closure Device

Minimally Invasive, Local Solution

• Available sizes: 21, 24, 27, 30, 33 mm diameter

Intra-LAA design

• Avoids contact with left atrial wall to help

prevent complications

Nitinol Frame

• Conforms to unique anatomy of the LAA to

reduce embolization risk

• 10 active fixation anchors - designed to engage

tissue for stability

Proximal Face

• Minimizes surface area facing the left atrium to

reduce post-implant thrombus formation

• 160 micron membrane PET cap designed to

block emboli and promote healing

Warfarin Cessation

• 92% after 45 days, >99% after 12 months1
• 95% implant success rate1

160 Micron Membrane Anchors

• 1. Holmes, DR et al. JACC 2014; Vol. 64, No. 1

WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device Procedure

• One-time implant that does not need to be replaced
• Performed in a cardiac cath lab/EP suite, does not need hybrid OR
• Performed by a Heart Team
• IC/EP or IC&EP, TEE, General Anesthesia, Surgical Back- up, WATCHMAN

Clinical Specialist

• Transfemoral Access: Catheter advanced to the LAA via the femoral vein

(Does not require open heart surgery)

• General

anesthesia*

• 1 hour procedure*
• 1-2 day hospital

stay*

* Typical to patient treatment in U.S. clinical trials

Most Studied LAAC Device. Only One with Long-Term Clinical Data

PROTECT AF CAP Registry PREVAIL CAP2 Registry Totals Enrollment 2005-2008 2008-2010 2010-2012 2012-2014 Enrolled 800 566 461 579 2406 Randomized 707

• 407
• 1114

WATCHMAN: warfarin (2:1) 463 : 244 566 269 :138 579 1877: 382 Mean Follow-up (years) 4.0 3.7 2.2 0.58 N/A Patient-years 2717 2022 860 332 5931

Most Studied LAAC Device. Only One with Long-Term Clinical Data

Characteristic PROTECT AF N=707 CAP N=566 PREVAIL N=407 CAP2 N=579 p-value CHADS2 Score 2.2 ± 1.2 2.5 ± 1.2 2.6 ± 1.0 2.7 ± 1.1 <0.0001 CHADS2 Risk Factors (% of Patients) CHF 26.9 23.3 19.1 27.1 0.004 Hypertension 89.8 91.4 88.8 92.5 0.15 Age ≥ 75 43.1 53.6 51.8 59.7 <0.001 Diabetes 26.2 32.4 24.9 33.7 0.001 Stroke/TIA 18.5 27.8 30.4 29.0 <0.0001 CHA2DS2-VASc 3.5 ± 1.6 3.9 ± 1.5 4.0 ± 1.2 4.5 ± 1.3 <0.0001

WATCHMAN™ Clinical Leadership

• The WATCHMAN™ LAAC Device is the most studied LAAC device and the only
• ne proven with long-term data from randomized trials or multi-center registries

– Five studies, >2400 patients, nearly 6000 patient-years of follow-up

• The WATCHMAN Device can be implanted safely1, enables patients to

discontinue warfarin2 and reduces AF stroke risk comparably to warfarin3. – 95% implant success rate4 – >92% warfarin cessation after 45 days, >99% after 1 year4

• WATCHMAN™ therapy demonstrated comparable stroke risk reduction, and

statistically superior reductions in hemorrhagic stroke, disabling stroke and cardiovascular death compared to warfarin over long-term follow-up5,6: – 32% in all cause stroke6 – 85% in hemorrhagic stroke5 – 63% in disabling stroke6 – 56% in cardiovascular death5

• 1. PROTECT AF, CAP, PREVAIL and CAP2; 2. PROTECT AF, CAP, PREVAIL; 3. PROTECT AF; 4. Holmes, DR et al. JACC 2014; Vol. 64, No. 1; 5. Reddy,

V et al. TCT 2014; 6. Reddy, V et al. JAMA 2014; Vol. 312, No. 19

New Technology for the Treatment

• f Bradycardia

The Need for New Technology

• 1 in 8 patients with traditional pacemakers

experience complications

– Lead related 2.4 - 5.5% – Pocket related 0.4 - 4.8% – Pneumothorax 0.9 - 2.2%

Udo, et al. Heart Rhythm. 2012; 9:728-35. Kirkfeldt, et al. Eur Heart J. 2014;35:1186-94

Micra: 93% Smaller than Traditional Pacemakers

Evolution of Pacemaker Technology

Transvenous Pacemaker Complications Mitigated by Micra

Micra Indications for use are the Same as Other Pacemakers

Patient implanted with Micra

– 71 year old male – Intermittent symptomatic bradycardia due to Wenckebach – ESRD with no access

Patient implanted with Micra

Patient implanted with Micra – LAO view

Patient implanted with Micra – RAO view

THANK YOU! Questions?