Transcatheter aortic valve implantation: impact on clinical and valve-related outcomes.
ABSTRACT Transcatheter aortic valve implantation is an alternative to open heart surgery in patients with aortic stenosis. However, long-term data on a programmatic approach to aortic valve implantation remain sparse.
Transcatheter aortic valve implantation was performed in 168 patients (median age, 84 years) in the setting of severe aortic stenosis and high surgical risk. Access was transarterial (n=113) or, in the presence of small iliofemoral artery diameter, transapical (n=55). The overall success rate was 94.1% in this early experience. Intraprocedural mortality was 1.2%. Operative (30-day) mortality was 11.3%, lower in the transarterial group than the transapical group (8.0% versus 18.2%; P=0.07). Overall mortality fell from 14.3% in the initial half to 8.3% in the second half of the experience, from 12.3% to 3.6% (P=0.16) in transarterial patients and from 25% to 11.1% (P=0.30) in transapical patients. Functional class improved over the 1-year postprocedure period (P<0.001). Survival at 1 year was 74%. The bulk of late readmission and mortality was not procedure or valve related but rather was due to comorbidities. Paravalvular regurgitation was common but generally mild and remained stable at late follow-up. At a maximum of >3 years and a median of 221 days, structural valve failure was not observed.
Transcatheter aortic valve implantation can result in early and sustained functional improvement in high-risk aortic stenosis patients. Late outcome is determined primarily by comorbidities unrelated to aortic valve disease.
- [show abstract] [hide abstract]
ABSTRACT: The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results. With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation. Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.Circulation 01/2003; 106(24):3006-8. · 15.20 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported. The valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial valve and a fabric cuff. After routine aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the aortic arch and through the stenotic valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous aortic prosthetic valve implantation was attempted in 18 patients (aged 81+/-6 years) in whom surgical risk was deemed excessive because of comorbidities. Iliac arterial injury, seen in the first 2 patients, did not recur after improvement in screening and access site management. Implantation was successful in 14 patients. After successful implantation, the aortic valve area increased from 0.6+/-0.2 to 1.6+/-0.4 cm2. There were no intraprocedural deaths. At follow-up of 75+/-55 days, 16 patients (89%) remained alive. This initial experience suggests that percutaneous transarterial aortic valve implantation is feasible in selected high-risk patients with satisfactory short-term outcomes.Circulation 03/2006; 113(6):842-50. · 15.20 Impact Factor
- The Journal of thoracic and cardiovascular surgery 06/2006; 131(5):1194-6. · 3.41 Impact Factor
Transcatheter Aortic Valve Implantation
Impact on Clinical and Valve-Related Outcomes
John G. Webb, MD*; Lukas Altwegg, MD*; Robert H. Boone, MD; Anson Cheung, MD;
Jian Ye, MD; Samuel Lichtenstein, MD, PhD; May Lee, MSc; Jean Bernard Masson, MD;
Christopher Thompson, MD; Robert Moss, MD; Ron Carere, MD; Brad Munt, MD;
Fabian Nietlispach, MD; Karin Humphries, PhD
Background—Transcatheter aortic valve implantation is an alternative to open heart surgery in patients with aortic
stenosis. However, long-term data on a programmatic approach to aortic valve implantation remain sparse.
Methods and Results—Transcatheter aortic valve implantation was performed in 168 patients (median age, 84 years) in
the setting of severe aortic stenosis and high surgical risk. Access was transarterial (n?113) or, in the presence of small
iliofemoral artery diameter, transapical (n?55). The overall success rate was 94.1% in this early experience.
Intraprocedural mortality was 1.2%. Operative (30-day) mortality was 11.3%, lower in the transarterial group than the
transapical group (8.0% versus 18.2%; P?0.07). Overall mortality fell from 14.3% in the initial half to 8.3% in the
second half of the experience, from 12.3% to 3.6% (P?0.16) in transarterial patients and from 25% to 11.1% (P?0.30)
in transapical patients. Functional class improved over the 1-year postprocedure period (P?0.001). Survival at 1 year
was 74%. The bulk of late readmission and mortality was not procedure or valve related but rather was due to
comorbidities. Paravalvular regurgitation was common but generally mild and remained stable at late follow-up. At a
maximum of ?3 years and a median of 221 days, structural valve failure was not observed.
Conclusions—Transcatheter aortic valve implantation can result in early and sustained functional improvement in
high-risk aortic stenosis patients. Late outcome is determined primarily by comorbidities unrelated to aortic valve
disease. (Circulation. 2009;119:3009-3016.)
Key Words: aortic valve ? aortic valve stenosis ? catheters ? prosthesis ? valves ? valvuloplasty
aortic valve implantation (AVI), this therapeutic option has
rapidly gained credibility as a viable alternative to open heart
surgery in high-risk patients with aortic stenosis.4–8To date,
reports of transcatheter AVI have focused primarily on
procedural success, early mortality, and short-term clinical
outcomes. However, long-term data on transcatheter AVI
outcomes remain limited. In contrast, there is substantial
literature demonstrating improved long-term survival in
patients with symptomatic severe aortic stenosis undergo-
ing surgical open heart AVI.9Although current guidelines
suggest surgical valve replacement for all such patients,10
a substantial number of individuals remain who do not
undergo surgery because of comorbidities and the associ-
ated increased surgical risk of morbidity or mortality.11
Here, we report the short- and intermediate-term clinical
outcomes in a large single-center experience using a
collaborative approach of transarterial and transapical AVI
in patients at high surgical risk.
ince the initial demonstrations of the feasibility of per-
cutaneous transvenous,1transarterial,2and transapical3
Clinical Perspective on p 3016
The present analysis includes all patients (n?168) undergoing
transcatheter AVI at our institution between January 2005 and April
2008. This includes the first-in-human transarterial and off-pump
transapical case series. Procedures were approved for compassionate
use in patients with severe, symptomatic aortic stenosis and no
reasonable surgical option because of excessive risk. Acceptance for
the procedure required consensus by a group of senior cardiac
surgeons and cardiologists that patients were unsuitable for open
heart surgery because of excessive risk. Written informed consent
Patients were assessed with transthoracic echocardiography, se-
lective coronary angiography, and angiography of the aortic root and
the aortoiliofemoral system. With the availability of the transapical
procedure in October 2005, this route of access was used selectively
in patients with small-diameter femoral arteries (as a result of body
size or atherosclerotic disease) and in 3 patients with an unsuccessful
previous transarterial procedure. Patients were excluded if they were
considered eligible for conventional surgical valve replacement, if
Received November 24, 2008; accepted April 6, 2009.
From the Divisions of Cardiology and Cardiac Surgery, St Paul’s Hospital and the Centre for Health Evaluation and Outcome Sciences, University of
British Columbia, Vancouver, British Columbia, Canada.
*Drs Webb and Altwegg contributed equally to this article and are shared first authors.
Correspondence to John Webb, MD, St. Paul’s Hospital, 1081 Burrard St, Vancouver, BC, Canada V6Z 1Y6. E-mail email@example.com
© 2009 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.orgDOI: 10.1161/CIRCULATIONAHA.108.837807
the aortic annulus diameter was ?18 or ?26 mm, or if a reasonable
quality or duration of life was unlikely. There were no other criteria
Procedures and Devices
Transarterial and transapical procedures were performed as previ-
ously described.2,5,6Transarterial procedures were performed in a
cardiac catheterization laboratory; transapical procedures were per-
formed in an operating room. Transarterial access was gained by
percutaneous puncture of the femoral artery, whereas transapical
access was obtained by anterior minithoracotomy followed by direct
needle puncture of the left ventricular apex. Balloon valvuloplasty
was routinely performed before valve implantation. Burst rapid
pacing was used to reduce cardiac output during prosthesis deploy-
ment.12Early in the transarterial experience, the femoral access site
was closed surgically, whereas later, percutaneous closure (Prostar
XL, Abbott Inc, Chicago, Ill) was routinely used.
The balloon-expandable Cribier-Edwards equine valve2was used
early in the series, although the majority of procedures used the
Edwards SAPIEN bovine valve (Edwards Lifesciences LLC, Irvine,
Calif).6More recently, a limited number of patients received the
next-generation cobalt-chromium bovine valve (SAPIEN XT).13
Initial transarterial and transapical procedures were performed with
the RetroFlex delivery catheter.6This was subsequently replaced
with the RetroFlex II transarterial catheter incorporating a retractable
nose cone13and the Ascendra transapical catheter (all Edwards
Definitions and Data Collection
Patients were followed up as part of an ongoing prospective
registry. Transthoracic echocardiograms were obtained at base-
line, before discharge, and at 1, 6, and 12 months and yearly
thereafter. Clinical follow-up occurred at similar intervals. All
patients in whom valve implantation was attempted but in whom
the procedure was not successful were followed up to 30 days. No
patient was lost to follow-up.
Procedural success was defined as implantation of a functioning
prosthetic valve within the aortic annulus and without intraproce-
dural mortality. Procedure-related events were defined as occurring
during or as a direct result of the index procedure. Events that
occurred before extubation were similarly classified as procedural.
Outcome measures included procedural success, functional status
(New York Heart Association [NYHA] class), major adverse cardiac
and cerebrovascular events (MACCEs) at 30 days, major adverse
valve-related events (MAVREs), and survival. MACCEs included
death, myocardial infarction, stroke, or aortic valve reintervention/
operation. MAVREs included valve-related mortality, valve-related
morbidity, and need for new permanent pacemaker or defibrillator
within 14 days after the procedure. Valve-related morbidity was
defined as any structural deterioration or nonstructural prosthesis
dysfunction, valve thrombosis, embolism, bleeding events, and
prosthetic valve endocarditis.14
Frailty was defined according to the criteria of Fried et al.15Renal
failure was defined according to RIFLE (Risk, Injury, Failure, Loss,
and End-stage kidney disease) criteria.16Major vascular injury was
defined as vascular rupture with fatal bleeding or need for urgent
vascular surgery or dissection of the aorta.14
To allow comparison with the surgical literature, valve-related
morbidity and events were reported in accordance with published
reporting guidelines for valve surgery.14Major bleeding was defined
as any bleeding requiring transfusion, disabling or fatal.14Nonstruc-
tural valve dysfunction was defined as major valve dysfunction (such
as severe paravalvular regurgitation or late embolization) not occur-
ring as a result of a structural problem, thrombosis, or infection.14
Continuous variables are presented as mean?SD when normally
distributed and as medians and first (Q1) and third quartiles (Q3)
when not normally distributed. Categorical variables are given as
frequencies and percentages. Normality was tested with the Shapiro-
Wilks goodness-of-fit test. Continuous variables were tested for
differences between procedure types with the Student t test or the
Kruskal-Wallis test. Categorical variables were tested by the ?2test
or, when necessary, the Fisher exact test. For comparison of continuous
variables before and after transcatheter AVI, differences were calculated
and the 1-sample Student t test or Wilcoxon signed-rank test was
applied. Trends in functional class (NYHA class versus I/II) over
time were analyzed with a logistic regression model adjusted for the
baseline NYHA class and with general estimating equations meth-
odology assuming compound symmetry to adjust for the correlation
between repeated measurements from the same patient; results are
presented as odds ratio with 95% confidence intervals (CIs). For
comparison of procedural success over time, transarterial and
transapical procedures were divided into 2 groups of consecutive
patients. Thirty-day MACCE rates are given as percentages. Time-
related events up to 2 years included survival, valve-related mortal-
ity, MAVREs, and readmission; they are presented as Kaplan-Meier
curves and were tested for procedural differences with the log-rank
test. Patients with unsuccessful procedures were followed up for 30
days after the procedure. To identify predictors of death after
transcatheter AVI, a Cox proportional-hazard model was applied,
and results are reported as adjusted hazard ratios with 95% CIs.
Testing was carried out as 2-sided tests with a significance level of
0.05. All analyses were conducted with SAS version 9.1 (SAS
Institute Inc, Cary, NC).
The authors had full access to and take full responsibility for the
integrity of the data. All authors have read and agree to the manuscript
A total of 168 patients underwent attempted transcatheter
AVI, 113 transarterial and 55 transarterial. Median age was
84 years (Q1 and Q3, 79 and 87 years). All patients had
echocardiographically confirmed severe aortic stenosis with a
median calculated aortic valve area of 0.6 cm2(Q1 and Q3,
0.5 and 0.7 cm2). Baseline characteristics are shown in Table
1. Common comorbidities included the presence of coronary
artery disease (67.9%), mitral regurgitation grade ?3?
(39.9%), porcelain aorta (21.4%), frailty (25.9%), and a
history of previous thoracotomy (39.9%).
All patients were at high risk for conventional surgery as
reflected by a median logistic EuroSCORE of 28.6 (Q1 and
Q3, 17.9 and 41.0) and a median Society of Thoracic
Surgeons (STS) score of 9.1 (Q1 and Q3, 6.3 and 13.0).
Standard estimates of surgical risk predicted a high operative
mortality in 73.8% (STS ?10% and/or logistic EuroSCORE
?20%). In the remaining 26.2% of patients, surgeons iden-
tified specific conditions likely to contribute to excessive
perioperative risk that were not reflected in EuroSCORE and
STS risk scores. Specific conditions were surgical technical
concerns (15.9%), age ?90 years (13.6%), morbid obesity
(body mass index ?35; 9.1%), end-stage lung disease (9.1%),
moderate to severe mitral regurgitation likely requiring
double-valve surgery (9.1%), critical liver disease (6.8%),
cancer (2.3%), and multiple debilitating comorbidities asso-
ciated with frailty, cachexia, and immobility (34.1%). In
particular, the presence of a porcelain aorta, a common reason
for surgical refusal present in 21.4% of the entire cohort, was
not accounted for by STS risk estimates.
Intraprocedural mortality was 1.2%. A 23-mm-diameter
transcatheter valve was successfully implanted in 59 patients,
June 16, 2009
and a 26-mm valve was implanted in 100 patients. With
transcatheter AVI, the echocardiographic median aortic valve
area increased from 0.6 cm2(Q1 and Q3, 0.5 and 0.7 cm2) to
1.6 cm2(Q1 and Q3, 1.3 and 1.9 cm2) (P?0.001). Median
hospital stay was 6 days (Q1 and Q3, 4 and 10 days).
Procedural success was 94.1%, increasing from 89.3% to
98.8% from the initial half to the second half of the experi-
ence (P?0.01). Mortality at 30 days was 11.3% overall,
decreasing from 14.3% in the initial half to 8.3% in the
second half (P?0.22) (Figure 1). Logistic EuroSCORE and
STS estimates of surgical risk were not significantly different
between the first and second halves of the experience.
In the first half of the experience, 4 patients had unsuccessful
transfemoral procedures. Three went on to have successful
transapical procedures, and 1 had a successful repeat transfemo-
ral procedure. Results are based on the initial 168 procedures,
with unsuccessful procedures followed up for 30 days after the
In-hospital and 30-day adverse outcomes are detailed in
Table 2. The most common complications observed were the
need for transfusion (11.5%), major vascular surgery (6.6%),
or a pacemaker (5.4%); renal failure (6.0%); and pneumonia
(4.8%). The rate of combined MACCEs at 30 days was
14.9% (Figure 2). MACCEs were accounted for primarily by
mortality in that no patient underwent repeat valve interven-
tion, myocardial infarction was infrequent, and stroke was
generally a fatal event. Only 1 patient surviving to 30 days
Table 1.Baseline Characteristics of 168 Patients Undergoing Transcatheter Aortic Valve Implantation
Body mass index, kg/m2
Predicted risk by logistic EuroSCORE
Predicted risk by STS
Male gender, n (%)
Diabetes mellitus, n (%)
Hyperlipidemia, n (%)
Hypertension, n (%)
Smoking, n (%)
Previous myocardial infarction, n (%)
Previous coronary artery bypass, n (%)
Previous cerebrovascular event, n (%)
Coronary artery disease, n (%)
Congestive heart failure, n (%)
NYHA class ?III, n (%)
Porcelain aorta, n (%)
Atrial fibrillation, n (%)
Pacemaker, n (%)
Severe chronic pulmonary disease, n (%)
Chronic renal failure, n (%)
Peripheral vascular disease, n (%)
LVEF ?35%, n (%)
Mitral regurgitation ?3?
Mean systolic transaortic gradient, mm Hg
Aortic valve area, cm2
Systolic pulmonary artery pressure, mm Hg
Aortic annulus, mm
Pulmonary hypertension ?60 mm Hg, n (%)
LVEF indicates left ventricular ejection fraction. Continuous variables are presented as mean?SD or median (Q1 to Q3). Categorical variables are
defined on the basis of STS definitions unless noted otherwise.
*Significant difference between procedural types.
Figure 1. Procedural success and 30-day mortality combined
and separated by procedure type and experience. Combined
and transarterial procedures are displayed by temporal halves.
*Significant differences between the first and second halves.
Webb et alTranscatheter AVI
was left with a disabling stroke (0.6%). The causes and times
of death occurring within 30 days of the procedure are
detailed in Table 3.
Patients selected for a transapical procedure as opposed to a
transarterial procedure were more likely to have peripheral
vascular disease (76.4% versus 15.9; P?0.0001), have prior
myocardial infarction (83.6% versus 68.1%; P?0.03), be
female (60.0% versus 42.5%; P?0.03), have a lower body
mass index (23.4 kg/m2[Q1 and Q3, 21.6 and 26.8 kg/m2]
versus 25.7 kg/m2[Q1 and Q3, 22.3 and 28.3 kg/m2],
P?0.02), and be in NYHA class I or II (23.6% versus 8.8%;
P?0.01). Transapical patients were at higher risk for conven-
tional surgery as predicted by both a higher STS score (10.3%
[Q1 and Q3, 6.8% and 17.7%] versus 8.7% [Q1 and Q3, 6.0
and 12.1%]; P?0.03) and logistic EuroSCORE (35.0% [Q1
and Q3, 20.0 and 50.3%] versus 25.0% [Q1 and Q3, 16.0 and
Table 2.Adverse Outcomes at Hospital Discharge and 30 Days for All Patients Combined and Separated by Procedure Type
Adverse OutcomeCombined (n?168), n (%) Transarterial (n?113), n (%)Transapical (n?55), n (%)P
Transfusion ?5 packed cells
Major vascular injury
Cardiopulmonary bypass, emergent
Conversion to open heart surgery
Acute renal failure15
Atrial fibrillation, new
Need for permanent pacemaker
Ventilation ?48 h
Hospital stay, median (Q1–Q3), d
Mortality at 30 d
MACCEs at 30 d
Categorical variables are defined on the basis of the STS definitions unless noted otherwise.
*Significant difference between procedural types.
Figure 2. MACCEs at 30 days as defined by current surgical
standards.14C indicates combined transapical and transarterial;
F, femoral access; A, apical access; AMI, acute myocardial
infarction; and Re-OP, subsequent cardiac surgery.
Table 3.Time and Cause of Death Occurring Within 30 Days
Time From Procedure to Death, d Mortality CauseProcedure
June 16, 2009
Patients undergoing a transarterial procedure had (nonsignifi-
cantly) higher rates of major vascular surgery (8.0% versus
3.6%; P?0.5) and stroke (5.3% versus 1.8%; P?0.43). A
transapical procedure was more likely to be associated with the
need for temporary hemodialysis (5.5% versus 0%; P?0.03),
new atrial fibrillation (12.7% versus 0%; P?0.001), and longer
median hospital stay (7 days [Q1 and Q3, 5 and 12 days] versus
5 days [Q1 and Q3, 3 and 9 days]; P?0.0001; Table 2).
Outcomes are shown in Figure 1 for sequential halves of
the entire group and the transarterial and transapical experi-
ences. In the combined group, there was a significant increase
in the rate of procedural success from 89.3% in the first half
to 98.8% in the later half (P?0.01). In the transarterial
experience, mortality at 30 days fell from 12.3% to 3.6%
(P?0.16). Similarly, mortality at 30 days fell from 25.0% to
11.1% in the first and second halves of the transapical
NYHA Functional Class
For patients surviving to 1 year, there was an improving trend
in the functional class over the year (P?0.001); patients were
less likely to be in class NYHA III/IV compared with NYHA
I/II (odds ratio, 0.66; 95% CI, 0.55 to 0.78). After transcath-
eter AVI, substantial improvement was observed within the
first month (Figure 3). At baseline, 2 (1%), 17 (12%), 88 (61%),
and 37 (26%) of the 144 patients with successful transcatheter
AVI and alive at 30 days were in NYHA class I, II, III, and
IV, respectively; at the 30-day follow-up, 124 (86%) were in
class I or II. The most improvement occurred in patients who
were in class III and IV at baseline, of whom 78 (88.6%) and
37 (100%) had improved by at least 1 functional class. This
increase in functional class was sustained over time, with 77
(78%) of the 99 patients with actuarial follow-up at 1 year
being in class I or II.
Echocardiographic Valve Function
Transaortic mean gradient decreased from 46.1?6.7 mm Hg
at baseline to 10.0?0.4 mm Hg before discharge (P?0.01).
1 year (P?0.07). Aortic valve area increased from 0.6?0.2
cm2at baseline to 1.6?0.4 cm2before discharge (P?0.01); it
subsequently decreased slightly to 1.5?0.3 cm2at 1 year
(P?0.04). Paravalvular aortic regurgitation was a frequent
finding at all time points but was trace to mild in the majority
of cases; eg, immediately after the procedure, 84 (58%), 53
(37%), and 7 (5%) of the patients alive at 30 days showed
grade 0/1?, 2?, and 3? paravalvular aortic regurgitation,
respectively (Figure 4). The degree of valvular regurgitation
was even less, with 97 (77%) and 66 (67%) of the patients
with actuarial follow-up at 6 and 12 months, respectively,
showing only none/trace or mild valvular regurgitation. No
severe aortic regurgitation was observed. A minority of patients
showed moderate regurgitation, which remained unchanged
over time. At a median follow-up of 221 days (Q1 and Q3, 49
and 401 days) and a maximum of 1111 days, structural valve
deterioration was not observed.
Survival at 1, 12, and 24 months was 88.7%, 73.8%, and
60.9%, respectively. The following variables were examined
as possible predictors of death: age, gender, history of prior
coronary artery bypass, poor left ventricular systolic function,
chronic renal failure, moderate to severe mitral regurgitation
at baseline, moderate to severe functional class impairment at
baseline, logistic EuroSCORE ?20%, STS score ?10%, pres-
ence of frailty, body mass index, and baseline creatinine. By
multivariate analysis, only transapical access and chronic renal
failure were significantly associated with increased mortality
(hazard ratios, 1.85 [95% CI, 0.99 to 3.43] and 3.48 [95% CI,
1.78 to 6.83], respectively).
Two patients underwent late reoperation: one 4 months after
an unsuccessful but uncomplicated transarterial attempt and a
second who developed prosthetic endocarditis 1 year after success-
ful AVI. Major bleeding (n?9) was the predominant event,
observed in the 29 patients experiencing MAVREs at the last
follow-up (Table 4). The incidence of late valve-related events
was low (Figure 5).
The high rate of procedural success is encouraging in this
early experience. It appears that with careful screening,
Figure 3. Functional NYHA class in patients with successful
transcatheter AVI and alive at 30 days. Data are given for
patients with actuarial 30-day and 1-year follow-up. N is the
number of patients with actuarial follow-up, which includes all
patients alive and with actual follow-up for a given time point,
as well as patients theoretically at follow-up but who died in the
meantime. To compare changes among patients with different
baseline functional classes, data are presented according to the
baseline NYHA class, and whether the functional class improved
or deteriorated is indicated. Mortality is the percentage of
deaths in relation to the actuarial number of patients and is
given for the 1-year follow-up. For all follow-up time points,
most patients were in NYHA class I or II regardless of baseline
Webb et al Transcatheter AVI
current techniques, and experience, short-term procedural
success can be achieved in most patients in whom the
procedure is attempted. Similarly, a 30-day mortality of
11.3% with a transcatheter approach in very-high-risk pa-
tients compares favorably with standard estimates of surgical
mortality. In particular, the low mortality (3.6%) in the final
half of the transarterial experience suggests that outcomes
may further improve. An early learning curve is evident in the
overall experience. The transapical experience probably ben-
efited from lessons learned in the earlier transarterial experi-
ence. This learning curve has implications for dissemination
of this technology.
At a follow-up with a median time of 7.4 months and a
maximum of ?3 years, the incidence of late adverse valve-
related events14was low. In particular, structural valve failure
was not observed, and reoperation and endocarditis were rare.
The most common late valve-related event was bleeding
related to gastrointestinal disease, often seen in warfarin-
treated patients receiving postprocedural dual antiplatelet
therapy. Currently, we avoid combined antiplatelet and anti-
thrombotic therapy in our elderly patients with comorbidities.
Paravalvular regurgitation was common but generally mild
and remained stable at late follow-up.
Functional class improved at 1 month and was sustained,
with the majority of patients alive at 1 year being class I or II.
Admittedly, NYHA functional class is a relatively insensitive
and subjective measure. Future evaluation will require more
detailed measures of functional status. Survival at 1, 12, and
24 months was 89%, 74%, and 61%, respectively. A 1-year
survival of 74% in patients declined surgery compares favor-
ably with other reports. By way of comparison, Kojodjojo et
al17reported a 1-year survival of 51% in elderly aortic
stenosis patients who were not considered to be surgical
candidates and 66% in elderly surgical candidates who
declined surgery. Bach et al18reported a 1-year survival of
62% in unoperated patients.
Stroke occurred in 4.2% overall. Prior smaller studies report
an incidence varying from 0% to 9%.6–8,19–22Transcatheter
AVI may carry an inherent risk of aortic atheroemboli and
valvular calcific emboli. This concern may be greater with the
retrograde approach to the aortic valve, a concept that is
Figure 4. Aortic regurgitation (AR) in patients with successful
transcatheter AVI and alive at 30 days. Data are given for
patients with actuarial 30-day, 6-month, and 1-year follow-up. N
is the number of patients with actuarial follow-up, which
includes all patients alive and with actual follow-up for a given
time point, as well as patients theoretically at follow-up but with
missing/incomplete echocardiography data or death in the
meantime. For each time point, paravalvular (PV) AR is present-
ed to the left and valvular (V) AR to the right. To compare
changes among patients with different postprocedural AR
grades, data are presented according to the degree of AR after
successful transcatheter AVI, and whether the grade improved
or deteriorated is indicated. For completeness, patients with
incomplete echocardiographic follow-up or mortality are indi-
cated. Severe AR was not observed, and only a minority of
patients showed moderate AR, which improved or remained
unchanged over time.
Table 4.MAVREs at the Last Follow-Up
MAVRE Patients, nFemoral, n Apical, n
Transient ischemic attack
Late valve migration
June 16, 2009
consistent with the trend to a lower stroke rate with transapi-
cal access. Approaches to reducing this risk include prepro-
cedural screening for friable aortic atheroma, more attention
to a gentle passage of catheters through the aortic arch, and
the use of embolic protection devices. The current trend to
lower-profile and less traumatic transarterial catheters will
likely reduce embolic risk.8,23,24Importantly, major stroke
was generally a fatal event and was largely accounted for in
the overall mortality. Only 1 patient surviving to 30 days was
left with a disabling stroke (0.6%).
Major vascular injury, primarily iliofemoral dissection or
perforation, was the most common transarterial complication,
occurring in 8% of patients. With improved screening, case
selection, and experience, it appears that the incidence of
vascular injury is falling. Still, given the large diameter of
current transarterial catheters, the potential for arterial injury
argues for transapical access in borderline cases. As with
stroke, it is hoped that the development of lower-profile and
less traumatic catheters will reduce the risk of vascular
Even mild worsening of renal function after conventional
cardiac surgery is associated with significant morbidity and
short- and long-term mortality.25Preexisting renal impair-
ment was a common reason for referral for transcatheter AVI,
and in this experience, renal impairment, even dialysis
dependency, was not an exclusion criterion. Postprocedural
acute renal failure was seen in 6%. Temporary hemodialysis
was required in 1.8% of the entire group (0% transarterial,
5.5% transapical; P?0.03). By multivariate analysis, chronic
renal failure was the strongest single predictor of mortality at
Estimates of Risk
Available predictors of surgical risk are often helpful. Nev-
ertheless, many determinants of operative risk (such as
porcelain aorta, frailty, planned multivalve surgery) are not
incorporated into commonly used predictive models. Approx-
imately one quarter of the patients in this experience would
not be considered high risk by logistic EuroSCORE or STS
risk estimates and yet were declined surgery because of such
factors. Of note, neither model predicted transcatheter AVI
mortality. Presumably, factors that determine risk with open
heart surgery, sternotomy and cardiopulmonary bypass, car-
dioplegia, and aortic cross-clamping are different from those
that predict risk with a transcatheter procedure.
Transcatheter AVI can result in early and sustained functional
improvement in high-risk aortic stenosis patients. Early out-
Figure 5. Kaplan-Meier curves of survival, valve-related mortality, and freedom from valve-related (VR) events and readmission. Late
survival was determined primarily by non–valve-related comorbidities.
Webb et alTranscatheter AVI
comes compare favorably with high-risk surgery, and late
outcome is determined primarily by comorbidities other than
aortic valve disease. An early learning curve has implications for
training and maintenance of competence.
Source of Funding
This study was funded in part by Edwards Lifesciences, Irvine, Calif.
Drs Cheung, Munt, and Webb are consultants to Edwards Life-
sciences. The other authors report no conflicts.
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Transcatheter aortic valve implantation was performed in 168 patients with severe aortic stenosis and high surgical risk in
this transarterial (n?113) and off-pump transapical (n?55) single-center experience. Intraprocedural mortality was 1.2%.
Operative (30-day) mortality was 11.3%, lower in the transarterial group than the transapical group (8.0% versus 18.2%).
Mortality fell from the initial half to the second half of this experience, from 12.3% to 3.6% in transarterial patients and
from 25% to 11.1% in transapical patients. There was early and sustained functional improvement. At a maximum of ?3
years and a median of 221 days, structural valve failure was not observed. Paravalvular regurgitation was common but
generally mild and remained stable at late follow-up. The bulk of late readmission and mortality was not procedure or valve
related but rather due to comorbidities. Late outcome after transcatheter aortic valve implantation for aortic stenosis is
determined primarily by comorbidities unrelated to aortic valve disease.
June 16, 2009