New Therapies for the Heart Patient. Wilson They said "There's nothing more that can be done." Robert Federici MD, Presbyterian Heart

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1 New Therapies for the Heart Patient Wilson 2016 They said "There's nothing more that can be done." Robert Federici MD, Presbyterian Heart

2 Disclosure Boston Scientific Physician Proctor for CTO's, Clinical Trial Investigator, Speaker Medtronic Physician Proctor for Aortic Stent Grafts

3 Objectives Review common cardiovascular diseases that are treated in the cath lab Increase therapy awareness of interventional cardiology tools and procedures Discuss new strategies for treatment of common cardiac conditions

4 New Therapies for the Heart Patient Atrial Fibrillation Mitral Regurgitation Complex Coronary Disease in the High Risk Patient Chronic Total Occlusions Hypertrophic Cardiomyopathy

5 A fib Fun Facts Prevalence increases with age 6% of people over 65 have a fib Annual stroke risk from 1% to >10% per year Anticoagulants can reduce the stroke risk by 60% Only 50% of the people that should be on anticoagulants are on anticoagulants 90% of the strokes due to a fib have clot that originates in the left atrial appendage

6 CHADS2 vs. CHADSVASC

7 CHADS2 vs. CHADSVASC

8 The PREVAIL Trial

9 The PREVAIL Trial Hypothesis: Left atrial appendage (LAA) occlusion with the Watchman device will not be inferior in stroke prevention to Coumadin in patients with non valvular afib. Result: LAA occlusion with Watchman is not inferior to Coumadin for stroke prevention. Complication Rate: 2.2% with 1.9% of that being pericardial effusion. 1.5% treated with pericardiocentesis and 0.4% needed surgical repair. Conclusion: LAA occlusion is a reasonable alternative to Coumadin for the prevention of stroke in patients's non valvular a fib.

10 The PREVAIL Trial

11 AFIB Patient Story 72 yo man with paroxysmal atrial fibrillation with a CHADSVASC score of 3 which translates to an annual stroke risk of 3.2%. He has a HASBLED Score 4 largely due to hx of GI bleeding and active alcohol use which translates to a annual risk of major bleeding of 8.7%. Through a shared decision making process the options of aspirin alone, coumadin, target specific anticoagulants and Watchman were discussed. The patient elected to have a Watchman device which will give him the stroke protection without the increased bleeding risk.

12 Risk of Bleeding on Warfarin

13 Risk of bleeding with warfarin

14 Watchman A self expanding plug Placed via the groin It is positioned across the intra-atrial septum into the LAA The procedure takes about 1 hour under general anesthesia using TEE (transesophageal echo) guidance The patient is discharged the next day

15 Who to refer for Watchman Our patient did well and and now has a reduction in stroke risk without the increased risk of bleeding. Afib with CHADSVASC >2 who are at high risk for bleeding HASBLED >3 or Who have bled on coumadin or Who are at fall risk or Those 50% of afib patients that are not being treated!

16 Mitral Regurgitation The mitral valve allows blood to flow from the left atrium into the left ventricle. It acts as a one way door so that blood flow backwards. In mitral regurgitation, the valve is a leaky and blood to flows back into the left atrium and into the lungs. 2 types of mitral regurgitation; structural (MV prolapse; disease of the valve itself) and functional (left ventricular failure/dilation; disease of the ventricle)

17 Mitral Regurgitation We treat the 2 types of MR differently Structural MR when severe responds well to surgery; (MVR) mitral valve repair or replacement Functional MR is a disease of the ventricle so we treat what's causing the LV dysfunction

18 Treatment of Structural MR Usually associated with mitral valve prolapse or rheumatic mitral valve disease Responds well to mitral valve repair or replacement Unlike with AS, we usually don't wait for symptoms because the LV fails and doesn't recover We operate for symptoms (SOB), LV dilation or reduced LV ejection fraction.

19 MR Patient Story TB is an 86 yo woman with increasing SOB over the last 3 months. She was diagnosed with severe MR with MV prolapse. She could walk only 20 feet on a flat surface before getting profoundly SOB. She stop going to see her beloved LOBOs play bc she could not walk to her seats. She was treated with lasix with minimal improvement. She was thought too high risk for surgery give her age and frailty.

20

21 MV Clip We discussed it amongst the heart team and felt that a new procedure MV clip might benefit her. The MV Clip is placed percutaneously and approximates the MV leaflets and reduces the MR. MV Clip is an outpatient procedure that is has low morbidity

22 MR Patient TB was discharged after an overnight stay. Her SOB has improved and is enjoying her Lobos again MV Clip is indicated for patients with severe structural MR who are too high risk for traditional MV surgery

23 Complex Coronary Intervention in the High Risk Patient In order to understand complex intervention, we will first talk about standard coronary intervention Percutaneous Coronary Intervention (PCI) began in 1977 and has gone through iterative improvements and become safer with more predictable outcomes.

24 Standard PCI/Stents Procedure: outpatient, via the wrist, 10 minutes to take pictures, minutes to fix the artery, often can go home the same day Success rates: 98% Major complications: 2% stroke 1:1000, death 1:200, emergency surgery 1:1000, major heart attack 1:100

25 Complex Chronic Total Occlusion (CTO)

26 Complex Unprotected Left Main Blockage

27 Complex Disease and a High Risk Patient MW is an 83 yo woman who lives alone with 4 dogs and goes out to breakfast everyday with friends. 2 weeks prior to admission, she developed severe SOB and gets winded walking 10 feet to the bathroom. She was diagnosed with a small heart attack and acute systolic heart failure with and Ejection Fraction of 25% (normal 60%). She underwent heart cath and was found to have Left Main, LAD and Circumflex disease. She was referred for heart surgery (CABG). The surgeons felt she was too high risk for surgery.

28 Complex Blockages and High Risk Patients Success Rates: 90-95% Major Complications 4-8%: death, heart attack, stroke, emergency surgery, major bleeding and kidney failure Time in the lab: 60 minutes to 3 hours Requires special planning, tools, techniques and training Rotoblator Laser Advanced wire skills LV support devices - Impella Collaborative approach with heart surgeons

29 High Risk Patient Story We were consulted by our heart surgeons to see if we could help her Problems: Poor LV function - means not much reserve if we run into a problem Complex and Unprotected LM lesion increasing the risk and consequences of procedural complications Calcification of the arteries

30 High Risk Patient Story Problem #1: poor LV function Problem #2: complex bifurcation LM Problem #3: calcification Solution #1: LV assist device Solution #2: plan the work using advanced techniques Solution #3: use rotoblator to modify the calcified plaque

31 Impella The IMPELLA is a left ventricular assist device that pulls blood out of the LV into the aorta and can create liters per minute of cardiac output (normal CO heart 5 liters/minute) Placed in the groin at the time of the intervention Improves outcomes and shortens hospital stay

32 Rotoblator Diamond tip burr that spins at 155,000 rpm Polishes the inside of the coronary vessel and preferentially cuts calcium Allows balloons and stents to more easily and fully expand Calcium is in bone; imagine trying to change the configuration of a bone with a balloon

33 Complex Disease and a High Risk Patient MW had severe symptoms and complex disease which normally requires open heart surgery Happily with the heart team approach and using advanced tools and techniques we were able to open the arteries and discharge her to home within a day post procedure She's feeling well and back home without CP or SOB

34 Chronic Total Occlusion (CTO) CTO is a chronic total occlusion that has been present over 3 months Often very difficult to open with traditional success rates of 60% With training and experience, success rates can reach 90%.

35 CTO Patient Story DP is a 76 yo man with daily angina despite maximal medical therapy taking 6-8 nitro tabs a day for 6 years. He was cathed and found to have only one artery blocked; his Right Coronary Artery (RCA). The RCA was a chronic total occlusion. 2 attempts by different cardiologists using a standard skill set were unsuccessful. I learned about a new technique that was developed in Japan called retrograde reverse CART. I trained in the technique and DP agreed to let me try one last time.

36 Improved Success Using Japanese Retrograde Techniques

37 Retrograde PCI via collateral blood vessels A CTO is a chronic total occlusion that has been present for over 3 months. The goal is to get a wire across the CTO blockage so that you can balloon/stent it. The idea is that you use the collateral blood vessels to approach the blockage from the other side.

38 Before and After

39 CTO Patient Story DP had been suffering with daily angina and taking 6-8 nitro's per day. Now, DP has been pain free for the last 5 years.

40 Hypertrophic Cardiomyopathy Hypertrophic Obstructive Cardiomyopathy (HOCM) is sometimes called IHSS (Idiopathic Hypertrophic Subaortic Stenosis) Genetic component Associated with sudden death Symptoms include chest pain, SOB and syncope

41 HOCM Patient Story LW is a 91 yo lady who was referred because a hx of syncope and a murmur. She was told about the murmur for years. She recently was having progressive dizziness. One day she was bending over to pick up something from the floor and she had syncope which caused her to fracture her pelvis and arm. She was diagnosed with HOCM by ECHO and placed on Metoprolol. She continued to have daily dizziness and pre syncope.

42 HOCM Patient Story The problem stems from the stress on her heart from the outflow obstruction caused by the sub-aortic hypertrophy. Treatments include beta blockers, surgery to remove the excess muscle or alcohol ablation to cause the excess muscle to shrink. Given her severe sx and her age, the best approach was alcohol ablation in the cath lab.

43

44 The septal artery is closed, causing a heart attack that causes the obstructing muscle to shrink > >

45 The outflow gradient is dramatically decreased

46 Before and After Alcohol Ablation LW has no further dizziness or syncope.

47 New Therapies Atrial Fibrillation: Watchman device to reduce stroke in patients that are high risk on warfarin/tsoac Mitral Regurgitation: Mitral Valve Clip to reduce MR in patients too high risk for surgical replacement. High Risk Intervention: IMPELLA is a Left ventricular assist device that allows us to do high risk cases safely CTO (Chronic total occlusion) techniques allow us to open arteries that we couldn't open before and get rid of angina HOCM (Hypertrophic obstructive cardiomyopathy) patients can have symptom relief through alcohol septal ablation or surgical myomectomy

48 Conclusions New procedures and new techniques create new hope for our patients We can help people who before have not had any options Robert Federici MD (505) cell phone

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