Advances in Interventional Cardiology
Ganesh Raveendran, M.D., M.S. Director; Section of Interventional Cardiology & Cardiovascular Fellowship Program University of Minnesota Medical School
Andreas Grüntzig •
The first balloon angioplasty was performed by Andreas Grüntzig in 1977
•
At first, PTCA was limited to patients with a discrete, proximal, concentric and non‐calcific lesion in a single major coronary artery with no involvement of major side branches or angulations
Anrdeas Grüntzig, 1939‐1985
Landmark Trials Early BMS Studies STRESS n=410 mm
P<.001
P<.001
p=0.01
BENESTENT n=520 mm
PTCA
P<.001
P<.001
p=0.09
stent DL Fishman et al., N Engl J Med 1994
P Serruys et al., N Engl J Med 1994
SIRIUS: Angiographic and Clinical Endpoints In-stent Restenosis
MACE
p<0.001 91% reduction p<0.001
Sirolimus Stent
Bare Stent
Sirolimus Stent
Bare Stent
TAXUS IV Trial Target vessel revascularization p<0.0001
Angiographic & clinical outcome
Similar Clinical Events Increased Late Loss
20%
TVF (%)
15%
XIENCE V TAXUS
1‐year HR 0.73 [0.48, 1.10] P = 0.13
2‐year HR 0.68 [0.48, 0.98] P = 0.04 15.4% Δ 4.7%
10.8% 10%
5%
8.3%
0%
10.7%
Δ 2.5%
0
3
6
TVF = cardiac death, MI, or ischemia‐driven TVR
9
12
Months
15
18
21
24
Fully Biodegradable Stent Platforms
Van der Giessen Tamai Circulation Circulation
2000
1996
Erbel Lancet
Ormiston Lancet
2007
2008
AMS‐1
Animal studies
polymeric scaffolds revealing excessive inflammatory reactions
First fully biodegradable non drug eluting scaffold N=15
Abizaid TCT 2009
2009
Polyanhidride ester and salicylic acid, drug‐eluting scaffold N=11
REVA
Bioresorbable vascular scaffold first bioabsorbable drug eluting scaffold N=31
Haude PCR 2011
2011
IDEAL BDS
first bioabsorbable metallic non drug‐eluting scaffold N=64
Igaki Tamai
Jabara PCR 2009
DREAMS
first drug‐eluting bioabsorbable metallic scaffold N=22
Polycarbonate stent, radiopaque, non drug‐ eluting scaffold N=31
The Pathophysiology of AMI
p=0.0002
p=0.0003
Trends in Acute Reperfusion
Benefits of DTB reduction ?
PCI Without Surgery Back up Mayo Experience
PCI Without Surgery Back up Mayo Experience
Frequency of Cardiogenic Shock NRMI Registry1: N=293,633 NRMI STEMI Registry N=25,311 Total Shock
Jan 1995-May 2004 STEMI or new LBBB
Shock at Presentation
775 US Hospitals with on-site PCI Clinical Event
CS developed in 25,311 (8.6%) pts, CS present on admission in 2.9%
Worcester Heart Attack Study2 : 1975-88 7.5% Gusto-13: 1995 7.2% 1Babaev A
et al : JAMA 2005; 294:444-454 RJ NEJM 1991; 325:1117 3 Holmes DR JACC 1995 26:668 2Goldberg
History
Impellaâ&#x20AC;Š
Tandem Heart
30 Day Mortality
Cardiohelpâ&#x20AC;Š
The Evolu3on of Interven3onal Cardiology …… The evolution ….
1965 Do#er
1977 I PTCA
‘80s
’90s
DCA , ROTA and adjunc3ve devices PS stent
2002‐ … New BMS I Genera(on II Genera(on DES DES stents
what next ?
Calcific Aortic Stenosis
Natural History of Aortic Stenosis
Severe Symptomatic AS : 30% Untreated
Who Likes Surgery ?
Early Catheter‐based AV Designs
The Davis valve (1965)
The Andersen valve (1992)
Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis
First Human Case Description Alain Cribier, MD; Helene Eltchaninoff, MD; Assaf Bash, PhD; Nicolas Borenstein, MD; Christophe Tron, MD; Fabrice Bauer, MD; Genevieve Derumeaux, MD; Frederic Anselme, MD; François Laborde, MD; Martin B. Leon, MD
Adopted from TCT presentation: Dr. Leon
Market Share Across EU Countries 2010
2011
Others
Others Austria
Switzerland
Switzerland
Netherlands Germany
Netherlands
Germany
Spain
Spain
UK
UK
Italy
Italy France Source: BIBA Medical, UK‐based provider of market analysis for the medical device industry
France
Primary Endpoint: All Cause Mortality 100%
∆ at 1 yr = 20.0% NNT = 5.0 pts
80%
60%
All cause mortality
HR [95% CI] = 0.51 [0.38, 0.68] p (log rank) < 0.001 50.7%
Std Tx
30.7%
TAV R
40%
20%
0% 0
Numbers at Risk Std Tx 179 TAVR 179
6
12
18
24
56 103
24 60
Months 121 138
85 124
0.5
HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = 26.8 0.62
TAVR AVR
0.4 0.3
24.2
0.2 0.1 0 0
6
No. at Risk
12
18
24
Months
TAVR
348
298
260
147
67
AVR
351
252
236
139
65
Current TAVR Eligibility According To Operative Risk Low or Moderate
High
Inoperable
Reasonable
Adapted from S. Kodali
Balloon Valvuloplasty
Valve Implantation
Post Valve Implant Assessment
Implantation of Valve