Update Interventional Cardiology Herbsttagung 2013_Stephan W… · AHA/ACC Guidelines 2001 (9-12...

Update Interventional Cardiology

St Gallen, 21 November 2013

Stephan Windecker

Department of CardiologySwiss Cardiovascular Center and Clinical Trials Unit Bern

Bern University Hospital, Switzerland

UPDATEINTERVENTIONAL

CARDIOLOGY

AORTIC

STENOSIS

(TAVI)

PATENT

FORAMEN

OVALE

REFRACTORY

ARTERIAL

HYPERTENSION

MITRALREGURGITATION

(MITRACLIP)

CORONARY

ARTERY

DISEASE

NEWER-GENERATION METALLIC DESStefanini, Taniwaki, Windecker. Heart 2013

ARTERIAL HEALING AFTER CORONARY STENTS IMPLANTATIONStefanini G, Holmes D. N Eng J Med 2013;368:254-65

BMS Early DES New DES

18.6%

7.8%

6.3%

Overall P<0.001

Early vs. Newer DES P=0.005

Target Lesion Revascularization

11,557 Women enrolled into 26 Randomized Trials between 2000 and 2013

SAFETY AND EFFICACY OF DES VS BMS IN WOMENStefanini G et al. Lancet 2013

1.3%2.1%

1.1%

Overall P=0.01

Early vs. Newer DES P=0.002

Definite/Probable ST by Stent Type

11,557 Women enrolled into 26 Randomized Trials between 2000 and 2013

SAFETY AND EFFICACY OF DES VS BMS IN WOMENStefanini G et al. Lancet 2013

Death or MI by Stent Type

12.8%

10.9%

9.2%

Overall P=0.001Early vs. Newer DES P=0.01

11,557 Women enrolled into 26 Randomized Trials between 2000 and 2013

SAFETY AND EFFICACY OF DES VS BMS IN WOMENStefanini G et al. Lancet 2013

DES vs. BMS in Large Coronary ArteriesKaiser C et al. N Eng J Med 2010; 363:2310-9

2.6

3.2

4.8

HR 0.60 (0.39-0.93)P=0.022

Courtesy: C Kaiser for the BASKET-PROVE Investigators

Overall

Large Investigator-Driven Trial: BASKET-PROVE

EES vs. SES vs. BMS DES Pooled vs. BMS

- DES are indicated based on an individual basis taking intoaccount baseline characteristics, coronary anatomy, andbleeding risk

I A

NSTE-ACS Hamm C et al. Eur Heart J 2011

STEMI Steg PG et al. Eur Heart J 2012

- Stenting is recommended for primary PCI I A- DES should be preferred over BMS if the patient has no

contraindications to prolonged DAPT and is likely to becompliant

IIa A

Evidence-Based MedicineRecommendations for the Use of DES

- DES are recommended for reduction of restenosis/re-occlusion I A

Stable CAD Wijns W et al. Eur Heart J 2010

Cypher Stent®

Launch2003

AHA/ACCGuidelines

2001(9-12 months post PCI) (TAXUS stent 6 months post PCI)

(Cypher stent 3 months post PCI)

AHA/ACC/SCAIUpdated Guidelines

2005

ESC PCIUpdated Guidelines

2010(6-12 months post PCI)

BMS Era DES Era

CURE (PCI-CURE)

20011 year

TAXUS®

Express2TM Stent Launch

2004

FDA, ACC/AHA/SCAI Recommendations

2011(1 year post PCI in pts at

low risk of bleeding)

Dual Anti-Platelet Therapy After PCI

Death

Stent thrombosis

Extended DAPT Duration After DESCassese S, Byrne R, et al. Eur Heart J 2012; 33:3078-87

Cerebrovascular Events

TIMI Major Bleeding

Extended vs Control DAPT in 4 RCTs including 8,158 Patients

Definite or Probable ST

Cardiac Death

Cessation of DAPT and Cardiac Events After PCIPARIS Study - Mehran R et al. Lancet 2013

1.00 (Ref)

0.62 (0.41, 0.93)

1.50 (0.94, 2.39)

1.51 (1.08, 2.11)

12.28 (5.78, 26.09)

1.18 (0.29, 4.75)

1.27 (0.87, 1.84)

On-DAPT

Discontinuation

Interruption

Disruption

0-7 Days

8-30 days

>30 days

0.021

0.091

0.017

<0.001

0.815

0.215

Hazard Ratio (95% CI) p value

0.25 0.5 1 2 4 8 16 32

Cessation of DAPT and Cardiac Events After PCIPARIS Study - Mehran R et al. Lancet 2013

Overall Population DES - Sensitivity Analysis

Risk of Major Cardiac Adverse Events

Risk of MACE Following Noncardiac Surgeryin Patients With Coronary Stents

Hawn MT et al. JAMA 2013, online on October 7, 2013

28,029 Patients Undergoing Noncardiac Surgery After Stent Implantation

0

5

10

15

20

25

30

35

40

Cum

ulat

ive

inci

denc

e (%

)

0 6 12 18 24 30 36 42 48Months after index PCI

Adj HR (95% CI): 1.59 (1.26-2.00); p<.0001

Atrial Fibrillation and Outcome in Patients Undergoing PCI

№ at riskAfib 323 285 279 265 229 191 143 98 72No Afib 5718 5379 5296 5134 4615 3810 2913 2130 1590

Death, MI, Ischemic Stroke, and BARC Bleeding 3b, 3c, 5a, 5b

Pilgrim et al. Eurointervention 2013

Thrombotic and Bleeding Events By Antithrombotic Regimen in Afib Patients After AMI/PCI

Lamberts M et al. Circulation 2012;126:1185-1193

11,480 Afib ptsadmitted with AMI or for PCI between 2000 and 2009 in

Denmark

Efficacy and Safety of Different Antithrombotic Regimens in Afib Patients After AMI/PCI

Lamberts M et al. J Am Coll Cardiol 2013

12,165 Afib pts hospitalized with AMI and/or undergoing PCI between 2001 and 2009 in Denmark

WOEST trial

573 patients on OAC undergoing stent (DES/BMS) implantation

Follow-up:Primary endpoint:Secondary endpoint:

Dewilde W, Ten Berg JM. Am Heart J 2009;158:713-718

1 year

any bleedingischemic events

randomization

oral anticoagulants*

clopidogrel 75 mg qd**

aspirin 80 mg qd

oral anticoagulants*

clopidogrel 75 mg qd**

* INR as originally indicated

** BMS 1 monthDES and/or ACS 1 year

+ +

+

Primary Endpoint - Total Bleeding Events

NNT = 4

Dewilde W et al. Lancet 2013;381:1107-15

Primary Endpoint: Bleeding events TIMI classification

05101520253035404550

TIMIMinimal

TIMIMinor

TIMIMajor

Any TIMIbleeding

Doubletherapygroup

Tripletherapygroup

6.5

16.7

11.2

27.2

3.35.8

19.5

44.9

%

p<0.001

p<0.001

p<0.001

p=0.159

WOEST Dewilde W et al. Lancet 2013;381(9872):1107-15

Intracoronary Stenting and Antithrombotic Regimen ISAR TRIPLE (NCT00776633 )

Oral Anticoagulation,Aspirin +

Patients with CAD after PCI with DES, with a concomitant Indication for Oral Anticoagulation

Clopidogrel 6 weeks Clopidogrel 6 months

Primary Composite Outcome: Death, Myocardial Infarction, Definite Stent Thrombosis, Stroke or Major Bleeding at 9 Months

Randomization 1:1Estimated enrollment: 600 Patients

Deutsches Herzzentrum München

Drug-Eluting Stents versus Bare Metal Stents Bangalore S et al. BMJ 2013; 125:2873-91

Network Meta-Analysis

Management of Antithrombotic Therapy in AfibPatients With ACS and/or Undergoing PCIESC WG Thrombosis Consensus Document: Lip G et al. Eur Heart J 2010;31:1311-18

HemorrhagicRisk

Clinical Setting Stent Type Recommendation

Low orintermediate

Elective BMS 1 month: ASA, Clop, OACLifelong: OAC alone

Elective DES 3 months: ASA, Clop, OAC3-12 months: Clop, OACLifelong: OAC alone

ACS BMS/DES 6 months: ASA, Clop, OAC6-12 months: OAC, ASA or ClopLifelong: OAC alone

High Elective BMS 2-4 weeks: ASA, Clop, OACLifelong: OAC alone

ACS BMS 4 weeks: ASA, Clop, OAC1-12 months: Clop, ASA or ClopLifelong: OAC alone

Management of Antithrombotic Therapy in Patients withAtrial Fibrillation – Personal Recommendation

Stable CAD Acute Coronary Syndrome

PCI

BMS (Novel) oral anticoagulant lifelong

Clopidogrel 75 mg for 1 month

Aspirin cardio 100 mg 1-0-0 after one month

DES (Novel) oral anticoagulant lifelong

Clopidogrel 75 mg for 1 month

Aspirin cardio 100 mg 1-0-0 after one month

Bioresorbable Coronary Scaffolds

1996

Van der Giessen Circulation

Animal studiespolymeric scaffoldsrevealing excessive

inflammatory reactions

Igaki TamaiFirst fully

biodegradable non drug eluting scaffold

N=15

TamaiCirculation

Bioresorbable vascular scaffold

first bioabsorbable drug eluting scaffold

N=31

OrmistonLancet

AMS-1first bioabsorbablemetallic non drug-

eluting scaffoldN=64

ErbelLancet

2000 2007 2008

JabaraPCR 2009

2010

REVAPolycarbonate stent,

radiopaque, non drug-eluting scaffold

N=31

IDEAL BDSPolyanhidride

ester and salicylic acid, drug-eluting scaffold

N=11

AbizaidPCR 2011

DREAMSfirst drug-eluting

bioabsorbablemetallic scaffold

N=22

HaudeLancet

2013

Late Stent Thrombosis? Late Restenosis ?

P-Interaction=0.02

Neoatherosclerosis

Acute MI

Diabetes

Diffuse Multivessel CAD

CAD Progression

Nakazawa G et al. JACC 2011

Cook S et al. Circulation 2009

Stone GW et al. Circulation 2011

Silber S et al. Lancet 2011

Jolicoeur E et al. CJC 2012

Limitations and Unmet Needs of Coronary Stents

DREAMSHaude M et al Lancet 2013; 381:836-44

PP 6M 1Y

6 to 24 Month OCT Results – Serial Analysis

Restoration of Normal Physiology With BRSWhat Has Been Shown: Device Resorption

ABSORB Cohort B (Group 1)Ormiston J et al. Circ Cardiovasc Interv 2012;5:620-32 DESolve

Preclinical Studies

ABSORB @ 2 years BIOSOLVE-I

Serruys P et al. Lancet 2009;373:897-910 Haude M et al Lancet 2013; 381:836-44

Physiological Vasomotion

Restoration of Normal Physiology With BRS

Late Lumen Enlargement

Potentials of Fully Bioresorbable Coronary ScaffoldsOrmiston J et al. Circ Cardiovasc Interv 2012;5:620-32

BL 6 Ms (B1) 12 Ms (B2) 24 Ms (B1) 36 Ms (B2)Neointimal Thick, µm 0 210 220 254 285

BVS area, mm2 7.47 / 7.73 7.70 7.51 8.24 8.64MLA, mm2 7.23 / 7.69 6.07 6.01 5.99 6.09

Neocap - Plaque Sealing

Potentials of Fully Bioresorbable Coronary ScaffoldsOrmiston J et al. Circ Cardiovasc Interv 2012;5:620-32

Safety and Impact on Ischemic OutcomesWhat Has Been Shown:

Promising Clinical Outcomes, No Stent Thrombosis

Clinical Outcomes at 3 y

ABSORB Cohort B (N=100)

BIOSOLVE-I(N=43)

Haude M et al Lancet 2013; 381:836-44Ormiston J et al. Circ Cardiovasc Interv 2012;5:620-32

Clinical Outcomes at 1 y

DESolve Nx Trial(N=123)

Clinical Outcomes at 6 m

% % %

Verheye S et al JACC Intv 2013, online

• Stable Coronary Artery Disease– BRS versus newer generation DES

• At least equivalent efficacy and safety• Extension of results to more complex lesions/patients

– BRS versus medical treatment in symptomatic CAD

• Acute Coronary Syndromes– BRS versus newer generation DES in culprit lesions– BRS versus medical treatment in non-culprit lesions

• Diabetic Patients– BRS versus newer generation DES

• Device Performance and Antiplatelet Therapy– Investigate optimal antiplatelet regimens

Perspectives on Bioabsorbable ScaffoldsWhat Needs to Be Demonstrated

UPDATEINTERVENTIONAL

CARDIOLOGY

PATENT

FORAMEN

OVALE

REFRACTORY

ARTERIAL

HYPERTENSION

MITRALREGURGITATION

(MITRACLIP)

CORONARY

ARTERY

DISEASE

AORTIC

STENOSIS

(TAVI)

TRANSFEMORAL TRANSAPICAL SUBCLAVIAN DIRECT AORTIC

TRANSCATHETER

AORTIC VALVE IMPLANTATION

N Engl J Med 2012;366:1705-15

FRANCE 2 – CURRENT ROUTINE CLINICAL PRACTICETRANSFEMORAL ACCESS ROUTE 74.6%

PARTNER BLeon et al. N Engl J Med 2010 Oct 21;363(17):1597-607

INOPERABLE PATIENTSWITH SYMPTOMATIC AS

Medical Treatment

VS

TAVI

0%

20%

40%

60%

80%

100%

0 6 12 18 24 30 36

ALL – CAUSE DEATH CARDIAC DEATH

TAVI VS. MEDICAL TREATMENT

IN INOPERABLE PATIENTS – 3 YEAR F/ULEON MB ET AL. NEJM 2010; PRESENTED AT TCT 2012, MIAMI

PARTNER B

30.7%

50.8%

43.0%

68.0%

54.1%

80.9%

Months

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

20.1%

25.0%

26.8%

NNT=5.0pts

NNT=4.0pts

NNT=3.7pts

Standard RxTAVI

0%

20%

40%

60%

80%

100%

0 6 12 18 24 30 36

20.5%

44.6%

30.7%

62.4%

41.4%

74.5%

HR [95% CI] = 0.41 [0.30, 0.56]p (log rank) < 0.0001

24.1%

31.7%

33.1%

NNT=4.1pts

NNT=3.2pts

NNT=3.0pts

PARTNER B

MORTALITY STRATIFIED BY

STS SCORE (ITT)

0%

20%

40%

60%

80%

100%

0 6 12 18 24 30 360%

20%

40%

60%

80%

100%

0 6 12 18 24 30 360%

20%

40%

60%

80%

100%

0 6 12 18 24 30 36

MO

RTA

LITY

(%)

Months Months Months

STS: 0 - 4.9 STS  ≥  15STANDARD RX

TAVI

∆  =  66.8%NNT = 1.5 pts NNT = 4.5 pts NNT = 4.8 pts

∆  =  20.8%∆  =  22.3%

Numbers at Risk

Standard Rx 12 8 7 6 5 3 0 123 86 61 44 33 19 13 43 27 17 12 8 5 4

TAVR 28 26 25 24 21 19 16 113 84 79 70 65 55 44 38 28 20 16 15 14 10

100%

33.2%

86.6%

65.8%55.2%

77.5%

STS: 5.0 - 14.9

LEON MB ET AL. NEJM 2010; PRESENTED AT TCT 2012, MIAMI

PARTNER ASmith et al. N Engl J Med 2011 Jun 9;364(23):2187-98

HIGH - RISK PATIENTSWITH SYMPTOMATIC AS

VS

SAVR

COURTESY: C. HUBER

TAVI

INTENTION TO TREAT

POPULATION

AS TREATED

POPULATION

TAVI VS. SURGERYALL – CAUSE DEATH

KODALI ET AL. N ENGL J MED 2012;366:1686-95

PARTNER A

MECHANISMS OF AORTIC REGURGITATIONBUELLESFELD L ET AL. JACC CARDIOVASC INTERV 2012;5:578-81

TAVI VS. MEDICAL TREATMENTAORTIC REGURGITATION AND OUTCOMES

Makkar et al. N Engl J Med 2012;366:1696-704

15.3

34.3

20.1

31.3

52.1

29.9

11.84.5

0.7 0

0%

20%

40%

60%

80%

100%

30 DAYS 2 YEARS

Severe

Moderate

Mild

Trace

None

PARAVALVULAR AR

p=0.001

PARTNER B

IMPACT ON OUTCOMES

PARTNER I – NRCA ONLY

TAVI EXTREME RISK STUDYCOREVALVE US PIVOTAL TRIAL

JEFFREY J POPMA ON BEHALF OF THE COREVALVE US CLINICAL INVESTIGATORS

PRESENTED AS LBCT AT TCT 2013

90% IMPROVED AT LEAST 1 NYHA CLASS AT 1 YEAR FUP

60% IMPROVED AT LEAST 2 NYHA CLASSES BY 1 YEAR FUP

TAVI SAVR

TAVISAVR

AORTIC VALVE AREA MEAN AORTIC GRADIENT

TAVI VS. SURGERYECHOCARDIOGRAPHIC FINDINGS

KODALI ET AL. N ENGL J MED 2012;366:1686-95

PARTNER A

PATIENT-PROSTHESIS MISMATCHSURGICAL AORTIC VALVE REPLACEMENT AND MORTALITY

Head SJ et al. Eur Heart J 2012

NEW GENERATION TAVI DEVICES

TRANSCATHETER AORTIC VALVE IMPLANTATIONIN THE US (STS/ACC TVT REGISTRY)

EDWARDS SAPIEN XT (N=7710)224 PARTICIPATING CENTERS (11/2011 – 05/2013)

MACK MJ ET AL. JAMA. 2013;310:2069-2077

TAVI VS. SAVRIN INTERMEDIATE RISK PATIENTS

STS mortality risk ≥4%  and  ≤10%

Heart Team EvaluationConfirm Inclusion/Exclusion &

Intermediate Risk Classification

RandomizationStratified by need for

revascularization

SAVRMedtronic

CoreValve® TAVI

N=~2,000 PATIENTS

SURTAVI TRIAL PARTNER II TRIAL

OPERABLE PATIENTS

STS  ≥  4

TRANSFEMORAL

(TF)TRANSFEMORAL

(TF)

RANDOMIZATION 1:1

TF – TAVISAPIEN XT

TA – TAVISAPIEN XT

SAVR SAVR

N=2,000 PATIENTS

TRANSCATHETER AORTIC VALVE IMPLANTATION

AND CEREBROVASCULAR EVENTSSTORTECKY S, WINDECKER S CIRCULATION 2012;126:2921-4

TAVI VS. SAVRCEREBROVASCULAR ACCIDENTS (ITT)

p=0.12

Primary EP: MortalityRetrospective Assessment of stroke severityAge = 85±6EuroScore = 29±16Atrial fibrillation: 43%Cerebrovascular dz: 27%

SYNTAX (CABG group)Stroke = 2.2% @ 1 year

Age = 65±10EuroScore = 4±3

TRANSCATHETER AORTIC VALVE IMPLANTATIONIN THE US (STS/ACC TVT REGISTRY)

EDWARDS SAPIEN XT (N=7710)224 PARTICIPATING CENTERS (11/2011 – 05/2013)

MACK MJ ET AL. JAMA. 2013;310:2069-2077

5.5

2.0

0.40.7

0.0

2.0

4.0

6.0

8.0

10.0

DEATH STROKE TIA MI

IN-HOSPITAL CLINICAL OUTCOMES 30-DAY CLINICAL OUTCOMES

7.6

2.8

0.5

0.0

2.0

4.0

6.0

8.0

10.0

DEATH STROKE REINTERVENTION

% %

TAVI EXTREME RISK STUDYCOREVALVE US PIVOTAL TRIAL

JEFFREY J POPMA ON BEHALF OF THE COREVALVE US CLINICAL INVESTIGATORS

PRESENTED AS LBCT AT TCT 2013

N=471; 49% MALE GENDER; STS 10.3 ± 5.6; 92% NYHA III/IV

MANAGEMENT OF SEVERE AORTIC STENOSISESC GUIDELINES ON VALVULAR HEART DISEASE 2012

Severe AS

Symptoms

LVEF < 50%

No

Physically active

No

Presence of risk factors and low/intermediate individual surgical risk

No Yes

Re-evaluate in 6 months

AVR

AVR or TAVI

No Yes

Symptoms or fall in bloodpressure below baseline

No

Contraindication for AVR

No Yes

Short life expectancy

No

TAVI

Yes

Med Rx

High risk for AVR

Exercice test

No YesYes

Yes

Yes

Eur Heart J 2012 - doi:10.1093/eurheartj/ehs109 & Eur J Cardiothorac Surg 2012 - doi:10.1093/ejcts/ezs455

Severe AS

Symptoms

Yes

Contraindication for AVR

YesNo

Short life expectancyHigh risk for AVR

No

Yes

TAVI

TAVI

UPDATEINTERVENTIONAL

CARDIOLOGY

AORTIC

STENOSIS

(TAVI)

PATENT

FORAMEN

OVALE

REFRACTORY

ARTERIAL

HYPERTENSION

MITRALREGURGITATION

(MITRACLIP)

CORONARY

ARTERY

DISEASE

BIOLOGIC PLAUSIBILITY

PARADOXICAL EMBOLISM

MEDICAL THERAPY VERSUS PFO CLOSURERANDOMIZED EVIDENCE

HR 0.78 (95%CI 0.45–1.35)p=0.37

PFO CLOSURE VERSUS MEDICAL THERAPY

(N=909)

PFO Closure with the STARFlex Device (n=447)

Medical Therapy (n=462)Follow-Up Period 24 months

Furlan AJ et al. N Engl J Med. 2012;366:991-9

PRIMARY END-POINT: COMPOSITE OF STROKE OR TIA DURING 2 YEARS OF FUP, DEATH FROM ANY CAUSE DURING THE FIRST 30 DAYS, ANDDEATH FROM NEUROLOGIC CAUSES BETWEEN 31 DAYSAND 2 YEARS

HR 0.63 (95%CI 0.24–1.62)p=0.34

PFO CLOSURE VERSUS MEDICAL THERAPY

(N=414)

PFO Closure with the Amplatzer Device (n=204)

Medical Therapy (n=210)Follow-Up Period 60 months

PC – TRIAL

Meier B et al. N Engl J Med. 2013;368:1083-91

PRIMARY END-POINT: COMPOSITE OF DEATH, NONFATAL STROKE, TIA, ORPERIPHERAL EMBOLISM

Carroll JD et al. N Engl J Med. 2013;368:1092-100

PFO CLOSURE VERSUS MEDICAL THERAPY

(N=980)

PFO Closure with the Amplatzer Device (n=499)

Medical Therapy (n=481)Follow-Up Period up to 84 months

HR 0.49 (95%CI 0.22–1.11)p=0.08

PRIMARY END-POINT: COMPOSITE OF RECURRENT NONFATAL ISCHEMIC STROKE, FATAL ISCHEMIC STROKE, OR EARLY DEATH AFTERRANDOMIZATION

STROKEHR

PFO – CLOSURE VS. MEDICAL THERAPYPC TRIAL AND RESPECT

PFO – CLOSURE VS. MEDICAL THERAPYA NETWORK META-ANALYSIS

4 RCTS IN 2,963 PATIENTS3 RCTS PFO CLOSURE VS. MEDICAL THERAPY

1 RCT PFO CLOSURE USING 3 DIFFERENT DEVICES HEAD TO HEAD

Stortecky et da Costa et al., submitted

PFO CLOSURE

WITH HELEX

PFO CLOSURE

WITH STARFLEX

PFO CLOSURE

WITH AMPLATZER

PFO – CLOSURE VS. MEDICAL THERAPY

A NETWORK META-ANALYSIS

Stortecky et da Costa et al., submitted

AMPLATZER

STARFLEX

HELEX

AMPLATZER

STARFLEX

HELEX

AMPLATZER

STARFLEX

HELEX

AMPLATZER

STARFLEX

HELEX

PFO – CLOSURE VS. MEDICAL THERAPY

A NETWORK META-ANALYSIS

Stortecky et da Costa et al., submitted

PFO CLOSURE

WITH AMPLATZER

VERSUS MEDICAL

THERAPY

PFO CLOSURE

WITH STARFLEX

VERSUS MEDICAL

THERAPY

PFO CLOSURE

WITH HELEX

VERSUS MEDICAL

THERAPY

STROKENNT 29

(NNT 21 to NNT 109)NNH 1518

(NNT 31 to NNH 12)NNT 60

(NNT 21 to NNH 10)

TIANNT 45

(NNT 25 to NNH 70)NNH 132

(NNT 39 to NNH 7)NNH 92

(NNT 26 to NNH 4)

ALL – CAUSE MORTALITYNNT 265

(NNT 86 to NNH 44)NNT 198

(NNT 78 to NNH 41)NNT 672

(NNT 78 to NNH 18)

ATRIAL FIBRILLATIONNNH 43

(NNH  14  to  NNH  ∞)NNH 7

(NNH 3 to NNH 22)NNH 150

(NNT 73 to NNH 14)

UPDATEINTERVENTIONAL

CARDIOLOGY

AORTIC

STENOSIS

(TAVI)

PATENT

FORAMEN

OVALE

MITRALREGURGITATION

(MITRACLIP)

CORONARY

ARTERY

DISEASE

REFRACTORY

ARTERIAL

HYPERTENSION

Insulin resistance

Sleep Disturbances

BloodPressure

+ Increase co-morbidities

RENAL SYMPATHETIC NERVE ACITIVITYKidney as Origin & Recipient of Central Sympathetic Drive

Schlaich et al. Hypertension. 2009;54:1195-1201

RENAL SYMPATHETIC NERVES

RENAL NERVE ANATOMY ALLOWING A CATHETER

– BASED APPROACH TO DECREASE RENAL

SYMPATHETIC ACTIVITY AS TREATMENT APPROACH

FOR RESISTANT HYPERTENSION.

AFFERENT AND EFFERENT NERVES PRIMARILY

LIE WITHIN THE ADVENTITIA AND FOLLOW THE

RENAL ARTERY TO THE KIDNEYS

RENAL SYMPATHETIC DENERVATION

• 6F STANDARD FEMORAL ACCESS

• LOW – ENERGY APPLICATION

• SAFETY MECHANISM TO AVOID

INJURY

64

RENAL DENERVATION TECHNOLOGIES

65

RF ENERGY DEVICES

CLINICAL DATA

OneShot

UPDATEINTERVENTIONAL

CARDIOLOGY

AORTIC

STENOSIS

(TAVI)

PATENT

FORAMEN

OVALE

REFRACTORY

ARTERIAL

HYPERTENSION

CORONARY

ARTERY

DISEASE

MITRALREGURGITATION

(MITRACLIP)

MitraClipConceptAlfieri

Alfieri-Stitch

0.96 0.98

0.77

0.04 0.02

0.23

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Franzen 2010 Schillinger 2011 EVEREST II

MitraClip – Procedural Success

No device (17)

MI 3/4 (5) Partial detach (9) Other

Successful Unsuccessful

N=51 N=50 N=178

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Franzen 2010 Schillinger 2011 EVEREST II

MitraClip – Procedural Successand Type of Mitral Regurgitation

0.31

0.69

0.73

0.27

0.32

0.68

Successful Unsuccessful

Functional Degenerative

N=51 N=50 N=178

NOVEL TRANSCATHETER TECHNOLOGIES

FOR MITRAL VALVE REPAIR

Transvenous, Transseptal, Antegrade approach

TMVI Procedural Overview

73