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