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PERCUTANEOUS STRUCTURAL UPDATES

• TAVR

• WATCHMAN(LEFT ATRIAL APPENDAGE OCCLUDERS)

• MITRACLIP

• PARAVALVULAR LEAK REPAIRS

• ASD/PFO CLOSURES

• VALVULOPLASTIES

Dr.Vinny K.Ram No disclosures

TAVR

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Lesson number 1:

TAVR should be the standard of care in the

inoperable patients because it saves lives

and improves quality of life

0%

20%

40%

60%

80%

100%

0 6 12 18 24 30 36

Numbers at Risk

Standard Rx 179 121 85 62 46 27 17

TAVR 179 138 124 110 101 88 70

All Cause Mortality (ITT) Crossover Patients Censored at Crossover

30.7%

50.8%

43.0%

68.0%

54.1%

80.9%

All

Cau

se M

orta

lity

(%)

Months

HR [95% CI] = 0.53 [0.41, 0.68] p (log rank) < 0.0001

20.1%

25.0%

26.8%

NNT = 5.0 pts

NNT = 4.0 pts

NNT = 3.7 pts

Standard Rx TAVR

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0%

20%

40%

60%

80%

100%

0 6 12 18 24 30 360%

20%

40%

60%

80%

100%

0 6 12 18 24 30 36

Repeat Hospitalization (ITT)

53.9%

27.0%

72.5%

34.9%

75.7%

42.3%

71.6%

44.1%

88.0%

56.5%

93.1%

66.3%

Numbers at Risk

Standard Rx 179 86 49 30 19 11 7 179 86 49 30 19 11 7 TAVR 179 115 100 89 77 64 49 179 115 100 89 77 64 49

Months Months

Reh

ospi

taliz

atio

n (%

)

Mor

talit

y or

Reh

ospi

taliz

atio

n (%

)

Rehospitalization Mortality or Rehospitalization

Standard Rx TAVR

33.4%

HR [95% CI] = 0.39 [0.28, 0.54] p (log rank) < 0.0001

NNT = 3.7 pts

NNT = 2.7 pts NNT = 3.0 pts NNT = 3.6 pts

NNT = 3.2 pts

NNT = 3.7 pts 37.6%

26.9%

26.8% 31.5%

27.5%

HR [95% CI] = 0.46 [0.36, 0.58] p (log rank) < 0.0001

TAVR 944 [233-1096] Standard Rx 368 [147-1096] p <.0001 Days Alive Out of Hospital Median [IQR]

Lesson number 2:

In patients with high surgical risk, TAVR is an acceptable

alternative

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TAVR 348 298 261 239 222 187 149

AVR 351 252 236 223 202 174 142

All-Cause Mortality (ITT)

No. at Risk

HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = 0.483

26.8%

24.3%

34.6%

33.7%

44.8%

44.2%

Lesson number 3

TAVR is associated with early stroke hazard

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0%

10%

20%

30%

40%

50%

0 6 12 18 24 30 36

All Stroke (ITT)

5.5%

11.2%

5.5%

13.7%

5.5%

15.7% Stro

ke (%

)

Months

HR [95% CI] = 2.77 [1.24, 6.19] p (log rank) = 0.0094

∆ = 5.7%

NNT = 17.5 pts NNT = 12.2 pts

NNT = 9.8 pts

∆ = 8.2% ∆ = 10.2%

Standard Rx

TAVR

Numbers at Risk

TAVR 179 128 116 105 96 82 65 Standard Rx 179 118 84 62 46 27 17

Lesson number 4:

Vascular complications matter, they can

affect survival and newer systems are better

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P (log rank) = 0.069

Major Vascular Complication (n=31) No Major Vascular Complication (n=148)

Mor

talit

y (%

)

Months

Mortality vs. Major Vasc Complics TAVI patients

27.7%

47.2%

Lesson number 5:

There are some patients where TAVR may not be of

benefit due to overwhelming co-morbidities

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Dea

th In

cide

nce

(%)

Months

0%

20%

40%

60%

80%

100%

0 6 12 18 24

STS 5-14.9

Numbers at Risk

STS <5

Months

0%

20%

40%

60%

80%

100%

0 6 12 18 24

28 26 25 24 16 12 8 7 6 5

Standard Rx TAVR

STS ≥15

0%

20%

40%

60%

80%

100%

0 6 12 18 24

Months

43 32 23 19 15 47 29 19 14 8

108 80 76 67 52 119 84 59 42 29

Mortality Stratified by STS Score (ITT)

19

Lesson number 6: Cost-effectiveness of TAVR is comparable to SAVR.

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Index admission resource use and costs,

Transfemoral cohort

647 TAVR/SAVR patients in the PARTNER A Trial

Overall index admission costs were not different between

TF-TAVR and SAVR $73,219 vs. $74,067, mean difference, $849; 95% CI: $8,977 to $7,014

Cumulative 1 year resource use and

costs, Transfemoral cohort

647 TAVR/SAVR patients in the PARTNER A Trial

Cumulative 12 month costs were not different between TF-

TAVR and SAVR $96,743 vs. $97,992 mean diff, $1,250; 95% CI: $18,132 to $13,867

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Lessons from the PARTNER Trial

1. Outcomes in Inoperable patients

2. Outcomes in high risk patients

3. Complications • Stroke

• Vascular complications

• Aortic regurgitation

4. Hemodynamics

5. Futility

6. Learning curve

7. Risk scores

8. Sapien XT/Novaflex

9. Cost effectiveness

LEFT ATRIAL APPENDAGE OCCLUDERS

1)People with AF have 5 times the risk of stroke compared to people without AF⁸ 2)Stroke is more severe for patients with AF, as they have a 70% chance of death or permanent disability⁹ AF-associated ischemic strokes generally occlude large intracranial arteries depriving a more extensive region of the brain of blood flow⁸ 3)Compared with non-AF patients, AF patients have poorer survival and more recurrences of stroke during the first year of follow-up⁷ 4)Relative or absolute contraindications to long-term anticoagulation are present in up to 40% of AF patients, usually due to a history of bleeding or an elevated risk of falls and trauma. In fact, anticoagulation is not currently utilized in up to 50% of eligible AF patients 5)The economic burden of stroke will continue to rise globally as the incidence of stroke increases⁴ 6)91% of stroke in AF is caused by thrombus formed in the LAA⁵

8-Holmes DR. Seminars in Neurology. 2010;30:528–536 9-Tu HT et al, Cerebrovascular Disease. 2010;30(4):389-95 7-Patel et al, Cardiol Res Pract. 2012; 2012: 610827 4Klein A et al, Datamonitor. July 2011 5Blackshear JL, Odell JA, Ann of Thor Surgery , 1996;61:755-759

Caution: In the United States, WATCHMAN is an investigational device limited by Federal law and investigational use only. Not for sale in the US. Prior to use please review device indications, contraindications, warnings, precautions, adverse events, and operational instructions. Only available according to applicable local law. CE Mark received in 2005

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The WATCHMAN® product is a device for percutaneous closure of the left atrial

appendage

• WATCHMAN is a self-expanding nitinol frame with fixation anchors and a permeable fabric cover • It is designed to be permanently implanted at or slightly distal to the opening of the LAA to trap potential emboli before they exit the LAA

• It is implanted via a trans-septal approach by use of a catheter based delivery system • The delivery catheter is capable of recapturing the device if necessary • Received CE mark in 2005

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PROTECT AF Primary Efficacy Results

Reddy, VY et al. Circulation. 2013;127:720-729

CONCLUSIONS

• Despite implantation in higher risk patients the Watchman device can be safely implanted by new operators

• The Watchman device is an alternative to oral anticoagulation therapy for thromboembolic prevention in patients with non valvular atrial fibrillation

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MITRACLIP

Percutaneous repair or Surgery for mitral regurgitation; Feldman et.al.,NEJM,Apr 2011,Vol.364,Pg1395-1406

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Percutaneous Mitral repair, Feldman et.al, JACC 2005 Dec:Vol.46,Pg2135-40

EVEREST II

Percutaneous repair or Surgery for mitral regurgitation; Feldman et.al.,NEJM,Apr 2011,Vol.364,Pg1395-1406

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REDUCTION OF MR

Percutaneous Mitral Interventions in the ACCESS-EU study; Maisano et.al., JACC 2013–Vol-62;No.12,Pg 1052-1061

QUESTIONS???

Vinny K.Ram, MD

Interventional Cardiovascular Medicine

Carondelet Heart and Vascular Institute

445 N.Silverbell Rd, Suite 201

Tucson,AZ 85745(St.Mary’s Hospital)

Office(520)-396-1370

Fax(520)-396-1375