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VALVULAR HEART DISEASE

Original Studies
Feasibility of Transcatheter Intervention for Severe
Aortic Stenosis in Patients ‡90 Years of Age: Aortic
Valvuloplasty Revisited
Wes R. Pedersen,
1
*
MD, Paul J. Klaassen,
1,3
MD, Charlene R. Boisjolie, RN, Talia A. Pierce, RN,
Kevin M. Harris, MD, John R. Lesser, MD, Hidehiko Hara, MD, Michael R. Mooney, MD,
Kevin J. Graham, MD, Vibhu R. Kshettry, MD, Irvin F. Goldenberg,
2
MD,
Marc R. Priztker,
3
MD, Robert A. Van Tassel, MD, and Robert S. Schwartz, MD
Objectives: The goals of this study were to determine the feasibility, safety, and early
outcomes of balloon aortic valvuloplasty (BAV) for severe aortic stenosis in a nonage-
narian population. Background: This very elderly population is expanding rapidly, has
a high incidence of aortic stenosis, and uncommonly undergoes surgical aortic valve
replacement. These patients may best be treated with a transcatheter approach due to
comorbidities, surgical risk, and personal preference. Methods: We reviewed 31 con-
secutive patients 90 years of age who underwent BAV at our institution from July
2003 to August 2006 for data pertinent to patient characteristics, procedural techni-
ques, and 30-day outcomes. Results: Our patients had a mean age of 93 6 3.0 years
(90–101). The society of thoracic surgery risk score was 18.5 (610.2) and logistic Euro-
score was 35.8 (619.3). Twenty-five patients (81%) underwent retrograde BAV and 6
(19%) antegrade BAV. Five patients (16%) underwent combined BAV and coronary
stenting. Overall mean aortic valve area increased from 0.52 cm
2
(60.17) to 0.92 cm
2
(60.22) and mean New York Heart Association (NYHA) functional class improved from
3.4 to 1.8. Intraprocedural mortality occurred in one patient (3.2%) and 30-day mortality
in three patients (9.7%). Conclusions: BAV can be carried out in high risk nonagenar-
ian patients with an acceptable complication rate, low perioperative mortality, and
early improvement in NYHA functional class. ' 2007 Wiley-Liss, Inc.
Key words: balloon; aortic; valvuloplasty; nonagenarians
INTRODUCTION
The treatment of choice for severe symptomatic AS
is surgical aortic valve replacement (AVR) irrespective
of age. Nevertheless, in the rapidly expanding popula-
tion 90 years of age, patients uncommonly undergo
surgical AVR. With their increased perioperative mor-
tality, morbidity, and prolonged recovery time, physi-
cians caring for this group are less likely to recom-
mend open heart surgery and patients themselves less
likely to opt for this highly invasive approach. Further,
median survival after open-heart surgery in nonagenar-
ians has been reported in one series to be 2.6 years [1].
In a series by Eltchaninoff et al., patients over the
age of 80 years who had poor surgical risk, underwent
1
Minneapolis Heart Institute Foundation at Abbott Northwest-
ern Hospital, Minneapolis, Minnesota
2
Twin Cities Heart Foundation, Minneapolis, Minnesota
3
The University of Minnesota, Department of Cardiology,
Minneapolis, Minnesota
*Correspondence to: Wes R. Pedersen, MD, Minneapolis Heart
Institute, 920 East 28th Street, Suite 40, Minneapolis, MN 55407.
E-mail: Wesley.Pedersen@allina.com
Received 13 December 2006; Revision accepted 7 February 2007
DOI 10.1002/ccd.21161
Published online 14 May 2007 in Wiley InterScience (www.interscience.
wiley.com).
' 2007 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions 70:149–154 (2007)
balloon aortic valvuloplasty (BAV) with a mortality of
2.2% and an associated significant symptom improve-
ment [2]. The primary limitation of this percutaneous
approach is a restenosis rate of >80% at 1 year [3],
even though symptomatic benefits appear sustained for
slightly longer than this.
Prior series have not segregated outcomes following
BAV in patients exclusively 90 years of age. BAV
appears to be a promising alternative in the treatment
of these high surgical risk patients, independent of the
expected transcatheter valve implantation [4–7] or ad-
junctive therapies to prevent restenosis [8]. Defining
risks and short term benefits of BAV in this very
elderly population is key as the era of percutaneous
valve intervention approaches. We thus examined a
consecutive series of nonagenarians undergoing BAV
for aortic stenosis.
METHODS
Patient Characteristics
We performed a total of 104 BAVs from July 2003
to August 2006 at our institution. These predominantly
elderly patients with severe symptomatic AS had
accompanying comorbidities placing them at increased
surgical risk for AVR. Thirty-one (30%) of these
patients were 90 years old. It is this consecutive se-
ries of nonagenarians who underwent BAV for severe
AS associated with functional class II–IV symptoms
which forms the basis of our report.
Baseline patient characteristics, procedural aspects,
and outcomes in those undergoing BAV were ana-
lyzed. Online calculators were used to quantitate both
Society of Thoracic Surgery (STS) risk scores [9] and
logistic Euroscores [10] to estimate operative mortal-
ities for surgical AVR.
We also queried the STS database for nonagenarians
who underwent AVR and received 30-day outcomes
on the 902 reported patients operated on from July
2000 to June 2005. While the STS database population
differs from our higher risk BAV group except for
age, 30-day outcomes in this group were also deter-
mined. The majority of our patients, i.e., 21/31 (68%)
were either not referred by the cardiologist or declined
by a cardiac surgeon for surgical AVR and therefore
likely to be at greater risk than those reported by the
STS database.
A total of 13 patients in this cohort participated in
our RADiation following Percutaneous Balloon Aortic
Valvuloplasty to Prevent Restenosis (RADAR) pilot
study evaluating the safety and feasibility of external
beam radiation to prevent aortic valve restenosis
following BAV. Patient characteristics and valvulo-
plasty technique in the RADAR patient group were
not significantly different from the 18 non-RADAR
patients [8].
Anatomic and Hemodynamic Data
Left ventricular ejection fraction (LVEF) was
obtained from pre-op echocardiography within 30 days
of the BAV procedure. All reported pre and post-BAV
mean gradients and valve areas were obtained from
cardiac catheterization derived hemodynamic measure-
ments at the time of valvuloplasty.
PROCEDURE
Diagnostic Catheterization
Left and right heart catheterization was performed
from the percutaneous transfemoral approach. Aortic
valve mean gradients were determined from simultane-
ous, ascending aortic, and LV pressure recordings. Car-
diac output was determined by standard thermodilution
technique and aortic valve area (AVA) calculated by
using the Gorlin formula. Coronary angiography was
performed if not contraindicated by severe renal insuf-
ficiency, i.e., >2.5 mg/dl in the absence of chronic
hemodialysis. Coronary stenting for severe stenosis
was carried out in combination with BAV if clinically
indicated, i.e., felt likely to limit the symptomatic ben-
efit of BAV alone.
Retrograde BAV Approach
Balloon valvuloplasty was performed by previously
established retrograde techniques in 25 of 31 cases
(81%) [11–13] (see Figure 1 with retrograde balloon
inflation across A.V.). Sequential single balloon infla-
tions were carried out using cylindrical balloons rang-
ing from 20 to 25 mm in diameter positioned across
the aortic valve over a 260 cm, 0.035-in. extra stiff
guidewire with a 6 cm soft tip. Generally, in stable
patients, between two and three balloon inflations were
carried out with each balloon size used. Aortic valve
gradients and thermodilution COs were repeated before
determining the need for upsizing to a larger balloon
diameter. We sought to achieve a 50 to 100% im-
provement in AVA. Twelve or fourteen French arterial
sheaths were used in all patients for valvuloplasty bal-
loon access. Intraprocedural arterial pressures were
monitored from the access sheath side port. Simultane-
ous transvenous rapid right ventricular pacing was per-
formed at 200–220 ppm during balloon inflations to
limit transaortic valve flow and thus assist in securing
balloon position. After achieving full balloon expan-
sion, the valvuloplasty balloon was pulled back into
the aorta as it was being deflated. Patients were pre-
treated with 325 mg of aspirin and intraoperatively
with 70–90 U/kg of heparin to achieve an ACT of
150 Pedersen et al.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
200–250 sec. A 300–600 mg clopidogrel oral load was
given intraoperatively to patients who underwent com-
bined coronary stenting. Postoperatively, all patients
were maintained on 81–325 mg aspirin daily and in
those who underwent combined coronary stenting,
75 mg of clopidogrel. Final postvalvuloplasty AVA
was then determined by remeasuring both the trans-
valvular mean gradient and thermodilution cardiac out-
put. Immediately following the procedure, 20–30 mg
of protamine was administered IV to achieve an ACT
<150 sec prior to femoral arterial sheath removal. The
arteriotomy site was compressed for 30–40 min followed
by 6–8 hr of bed rest. We did not use suture or other per-
cutaneous closure devices as previously reported by
others [14].
Antegrade BAV Approach
Antegrade BAV was carried out in six patients (19%)
using an Inoue mitral valvuloplasty balloon as previ-
ously described [13] (see Figure 2 with antegrade Inoue
Balloon inflated across A.V.). Following diagnostic
catheterization, a 14 French sheath was placed in the
right femoral vein for transseptal catheterization. Tran-
septal puncture was then carried out by standard tech-
nique under intracardiac echo guidance. The left atrium
was accessed with an 8 French mullins sheath and 70–
90 U/kg of heparin was then administered. A 260 cm,
0.032-in. extra stiff guidewire was eventually positioned
across the atrial septum, and antegradely into the
abdominal aorta by exchange technique after first posi-
tioning a 7 French balloon tipped-end hole catheter over
a flexible guidewire. The 0.032-in. extra stiff guidewire
was then snared via a transfemoral arterial sheath for
additional guide wire support. A 26 mm Inoue balloon
was then advanced antegradely though the predilated
atrial septum and positioned across the aortic valve. The
24–26 mm inflations were carried out during simultane-
ous rapid ventricular pacing at 200–220 ppm. It is
important during this procedure to maintain a broad
guidewire and catheter loop in the LV apex to avoid
anterior mitral valve leaflet encroachment. Postvalvulo-
plasty measurement of the mean valve gradient, thermo-
dilution cardiac output, and AVA were then repeated
prior to completion of the procedure. Percutaneous
closure devices were not used in these patients.
Special Circumstances
In patients with baseline systolic blood pressure
(SBP) of <90 mm Hg, especially in the presence of
LVEF of 40% or thermodilution cardiac index of
2.0 l/(min m
2
), dopamine by IV infusion was initi-
ated to establish SBP >90 mm Hg prior to valvulo-
plasty. With balloon inflations, precipitous and in gen-
eral momentary drops in systemic blood pressure (BP)
uniformly occurred. To minimize the duration of hypo-
tension in patients undergoing a retrograde approach,
balloons were retracted into the aorta while deflation
was being initiated. One to two hundred micrograms
of neosynephrine was administered by intravenous
bolus as needed for delayed BP recovery. Further dila-
tions were not carried out until complete BP recovery
occurred. In addition, in patients with severe baseline
LV dysfunction, valvuloplasty was initiated with a sin-
gle \maximum" balloon size, avoiding a step-wise
approach. We have found patients with severe reduc-
tion in LVEF are more susceptible to prolonged epi-
sodes of hypotension following balloon deflation which
often negates a strategy of multiple, progressively larger,
balloon inflations.
RESULTS
Patient Characteristics
A total of 31 consecutive patients 90 years of age
underwent BAV at the Minneapolis Heart Institute
from July 2003 to August 2006. Demographic data are
summarized in Table I.
Procedural Characteristics
The mean maximal balloon inflation diameter was
23.5 mm (range 20–25 mm) for patients undergoing a
retrograde procedure. The mean maximal balloon infla-
TABLE I. Baseline Patient Characteristics
Number of patients 31
Age 93 6 3.0 years (90–101)
Female/male 20:11
NYHA functional class
II 3 (10%)
III 15 (48%)
IV 13 (42%)
Coronary artery disease 14/31 (45%)
Prior history of CABG 8/31 (26%)
Underwent combined coronary
stenting (at time of BAV) 5/31 (16%)
LVEF % 50% (615)
Comorbidities
Diabetes (all type II) 2 (6%)
Renal insufficiency (Cr >1.5) 7 (23%)
Chronic lung disease 3 (10%)
Prior stroke 1 (3%)
Malignancy (including
prostate cancer 3 2) 6 (19%)
Severe deforming arthritis 4 (13%)
STS score 18.5% (610.2)
Logistic Euroscore 35.8% (619.3)
NYHA, New York Heart Association; CABG, coronary artery bypass
graft; BAV, balloon aortic valvuloplasty; LVEF, left ventricular ejection
fraction; STS, society of thoracic surgery.
Aortic Valvuloplasty in Patients 90 Years Old 151
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
tion diameter using an Inoue balloon by antegrade
technique was 25.5 mm (range 25–26 mm).
Five patients (16%) underwent combined coronary
stenting with BAV, treating a total of five lesions in
five target vessels. One lesion was treated with a bare
metal stent and four with drug eluting stents. Three
patients (60%) underwent coronary stenting just prior
to BAV and two patients (40%) immediately following
BAV. The IIb/IIIa inhibitors were not used in any of
these patients.
Procedural Outcomes
All patients achieved a minimum of 30% improve-
ment in AVA and 27 patients (86%) achieved 50%
improvement. Table II highlights the pre and post-
BAV mean gradients and AVA means. Data are
grouped by either retrograde or antegrade approach.
Data for the combined groups are then listed. Full dis-
closure graphs for the combined groups are displayed
in Fig. 3. The mean gradients for the combined group
pre and post-BAV were 53 mm Hg (619) and 25 mm
Hg (610), respectively. The AVA for the combined
group pre and post-BAV were 0.52 cm
2
(60.17) and
0.92 cm
2
(60.22), respectively.
Table III shows the periprocedural complications.
These included one stroke, one emergency AVR for
severe aortic insufficiency, and one intraprocedural
death. The stroke occurred in a 91-year-old male who
subsequently had atherothrombotic debris noted on
transesophageal echo in his aorta. He suffered residual
neurologic deficits and eventually died 12-days postop-
eratively. A 93-year-old female developed acute severe
aortic insufficiency (AI) immediately following her
BAV with a 20 mm balloon and was sent emergently
to the operating room where she underwent successful
tissue AVR for a flail leaflet. She was discharged from
the hospital to a nursing care facility on day 32. A 91-
year-old female patient died abruptly following the
final of six balloon inflations with a maximal balloon
diameter of 24 mm. This patient died with electrical–
mechanical dissociation. Intraprocedural transthoracic
echo demonstrated no LV mechanical systole and no
evidence of pericardial effusion, aortic dissection, or
significant AI. Autopsy on this patient was not granted.
No patients demonstrated vascular complications at the
percutaneous entry site requiring surgical intervention
or transfusion for bleeding. Neither pseudoaneurysms
nor arterial-venous fistulas were documented. No
patient developed renal failure.
Early Outcomes
Thirty-day outcomes were available for all patients.
One additional patient died following hospital dis-
charge secondary to refractory heart failure yielding an
overall 30-day mortality of 9.7% (3 of 31 patients).
Mean NYHA functional class improved from a base-
line of 3.4–1.8. There were no clinical subacute stent
thrombotic events or myocardial infarctions out to 30 days.
TABLE II. Hemodynamic Profiles
Prevalvuloplasty Postvalvuloplasty
Retrograde procedures (25/31)
Mean valve gradient (mm Hg) 54 (617) 26 (611)
Aortic valve area (cm
2
) 0.51 (60.18) 0.89 (60.23)
Antegrade procedures (6/31)
Mean valve gradient (mm Hg) 47 (612) 21 (67)
Aortic valve area (cm
2
) 0.53 (60.15) 1.05 (60.15)
Total procedures (31)
Mean valve gradient (mm Hg) 53 (616) 25 (610)
Aortic valve area (cm
2
) 0.52 (60.17) 0.92 (60.22)
Fig. 1. Retrograde BAV.
Fig. 2. Antegrade aortic valvuloplasty utilizing Inoue balloon.
152 Pedersen et al.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
DISCUSSION
This study determined the feasibility and safety of
BAV in the very elderly, those 90 years of age. The
study found that despite increased age, BAV can be
performed with acceptable safety and favorable 30 day
outcome using standard techniques with modifications
described under Methods and previously by others
[15]. We believe the following contributed favorably
to our procedural outcomes: (1) rapid ventricular pac-
ing in conjunction with balloon inflations, (2) cautious
hemodynamic management in patients at risk for pro-
longed hypotension, (3) careful percutaneous femoral
arteriotomy site management. In addition, although
only six patients (19%) underwent transvenous ante-
grade Inoue BAV, based on previous series, this may
have further contributed to low complication rates as
well as favorable postvalvuloplasty AVAs [13].
BAV will be an essential step in the treatment of
these patients with transcatheter valve implantation or
with adjunctive therapies to prevent restenosis. As
such, it is imperative to clearly define the risks as well
as short term benefits. Overall mean valve area for this
group increased by 77%, from 0.52 cm
2
(60.17) to
0.92 cm
2
(60.22), similar to improvements docu-
mented in other series with younger patients. This
clearly suggests that BAV can be successfully per-
formed in nonagenarians compared with early large
registries evaluating patients with mean ages in their
late 70s [16–18] or later series evaluating octogenar-
ians [2].
There were no procedural myocardial infarctions de-
spite performing combined BAV and coronary stenting
in five patients (16%). Percutaneous coronary interven-
tion (PCI) was successfully carried out in each of these
patients. The overall prevalence of CAD in this study
was 45%. Patients with CAD who were not treated
with PCI had predominantly small branch vessel dis-
ease and/or were felt unlikely to gain additional symp-
tomatic or functional benefit.
There were no significant femoral complications re-
quiring surgical intervention, transfusion, ultrasound
compression, or thrombin injection. This was likely
due to attentive arteriotomy site management that
included protamine-induced heparin reversal, 30- to
40-min femoral arteriotomy site compression and 6–8
hr of bed rest. No sustained arrhythmias occurred as a
complication of concurrent rapid ventricular pacing to
prevent \watermelon seeding" during balloon inflation.
With increased numbers of nonagenarians who are
presenting with severe AS for consideration of open heart
surgery, physicians are increasingly confronted by the
growing dilemma of finding suitable therapy for this
very elderly patient group. Amongst the 902 nonage-
narians who underwent AVR from July 2000 to June
2005 in the STS database, the operative mortality was
13.3% and the postoperative stroke rate was 5.1%.
This is in spite of more rigorous selection criteria by
Fig. 3. Mean gradients (a) and AVA (b) for individual patients
within the combined group before and after BAV.
TABLE III. Procedural Complications
BAV group
(MHI) (July 2003
to August 2006)
Surgical AVR
(STS database)
(July 2000 to
June 2005)
Total procedures 31 902
Stroke 1 (3.2%) 46 (5.1%)
Femoral complications 0 (0%) NA
Transfusion for bleeding 0 NA
Surgical repair 0 NA
Emergency AVR for severe AI 1 (3.2%) NA
Acute renal failure 0 (0%) 104 (11.5%)
Procedural mortality 1 (3.2%) NA
In-hospital mortality 2 (6.7%) 115 (12.8%)
30-day mortality 3 (9.7%) 120 (13.3%)
BAV, balloon aortic valvuloplasty; MHI, Minneapolis Heart Institute;
AVR, aortic valve replacement; STS, society of thoracic surgery; AI,
aortic insufficiency.
Aortic Valvuloplasty in Patients 90 Years Old 153
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
virtue of the fact that they were candidates for open
heart surgery. Mean duration of postoperative hospital
stay in these very elderly patients has been found to
be consistently longer than 2 weeks, [19] the majority
of whom are discharged to a nursing care facility for
prolonged recovery.
BAV was initially developed in hopes of finding a
nonsurgical option in the 1980s for patients with
severe AS. A mean age of 78 6 9 years was reported
in the National Heart Lung and Blood Institute’s val-
vuloplasty registry and was typical of \younger"
patients who underwent BAV two decades ago [16–
18]. A consistent limitation of this therapy in younger
patients with greater longevity was a high restenosis
rate (i.e., >80% at 1 year) and need for reintervention.
In addition, this large registry reported a cumulative
hospital mortality of 10%. BAV was mostly abandoned
in these patients who were often good candidates for
AVR. Because patients 90 years of age are more fre-
quently seeking less invasive interventions to achieve
quality of life improvement, we have begun evaluating
the safety and short-term outcome of BAV in these
patients.
Study Limitations
These findings are limited by the single center na-
ture and small number of patients reported. Long-term
follow-up was not included given the goal of determin-
ing procedural complications and in-hospital outcomes
in an effort to understand the safety of BAV in this
very elderly patient group. Long term limitations of
BAV including hemodynamic and clinical restenosis,
which occur at an average of 6–12 months and 12–18
months respectively, have been well established in pre-
vious clinical series.
CONCLUSIONS
This study suggests that BAV in patients 90 years
of age can be performed with an acceptably low compli-
cation rate and early improvement in NYHA functional
class. This procedure appears useful as an alternative to
surgical AVR or medical therapy alone in this very
elderly, debilitated population desiring symptom palliation
and improved quality of life. BAV may be underutilized
in nonagenarians who often have limited treatment
options.
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