Babaliaros, Vasilis

Condado, Jose F.

Hayek, Salim S.

Keegan, Patricia

Lerakis, Stamatios

Lin, Shuang

Macnamara, James P.

Spilias, Nikolaos

Thourani, Vinod

Zheng, Shuai

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J O U R N A L O F T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y , V O L . 6 6 , N O . 1 5 , S U P P L B , 2 0 1 5 B283RESULTS The Portico TAVI system was successfully implanted in 100
patients. Total procedural time was 4019 min, total implant time
1312 min, and ﬂuoroscopy time 197 min. An average of 19276 ml of
contrast were used during the implant procedure. Resheathing was
used in 24 patients (23%) and was successful in all instances. Average
implant depth was 6.1mm. TAVI resulted in a signiﬁcant decrease in
mean gradient from 4514 mmHg at baseline to 94 mmHg at 30 days
and an increase in aortic valve area from 0.60.2 cm2 at baseline to
1.70.4 cm2 at 30 days, respectively in the absence of signiﬁcant
postprocedural aortic regurgitation. This was associated with a signif-
icant improvement in the functional status as determined by a decline
in the New York Heart Association class. Rate of all cause of death was
2.9 and 11.8%, of cardiovascular death 2.9 and 7.8%, acute kidney injury
stage 3 2.0 and 3.9%, life-threatening or disabling bleeding 3.9 and
3.9%, disabling stroke 2.9 and 4.9%, non-disabling stroke 1 and 2%,
major vascular complications 5.9 and 6.9% at 30 days and 1 year
respectively. Implantation of a new pacemaker was required in 9.8%
and 10.8% of the patients at 30 days and 1 year, respectively.
CONCLUSIONS The novel Portico Transcatheter Aortic Valve allows
for safe repositioning and optimization of the device position. The
functional and symptomatic outcomes up to the 12 months follow
appear to support the efﬁcacy and safety of the device.
CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-694
“Rural” United States Experience of Incorporation of a Technologically
Advanced and Procedurally Complex Cardiovascular Program – The
Sanford Trans-catheter Aortic Valve Replacement Experience
Amol Raizada,1 Tom P. Stys,2 Adam Stys,2 Jamal Dodin,1
Terezia Petraskova,1 Maria Molga1
1University of South Dakota, Sioux Falls, SD; 2Sanford Heart Hospital,
Sioux Falls, SD
BACKGROUND The need for trans-catheter aortic valve replacement
(TAVR) coverage in a large geographical region that is sparsely popu-
lated poses peculiar challenges, especially related to low volumes of
operations both at institutional and operator level, coupled with the
need to provide these services to patients within reasonable proximity
to where they live. We compared the TAVR data at Sanford Heart
Hospital in Sioux Falls, South Dakota to the national registry data with
the aim of looking at differences in TAVR outcomes in a “rural” setting.
METHODS We analyzed the data of the ﬁrst 52 patients that underwent
TAVR at Sanford Medical Center between September 2012 and June
2014. Once severe symptomatic aortic stenosis was conﬁrmed and the
patient deemed to be either inoperable or high-risk for surgical aortic
valve replacement, they were screened for TAVR eligibility. Trans-
esophageal echocardiogram and CT-angiogram of chest, abdomen, and
pelvis were used for anatomic assessment prior to the procedure. As in
the national registry, our endpoint deﬁnitions were harmonized with
the Valve Academic Research Consortium (VARC) and VARC-2 deﬁni-
tions for stroke, transient ischemic attack, aortic valve reintervention,
major bleeding, and major vascular complications. Our data was
compared to outcomes noted for the national TAVR registry.
RESULTS As in the national registry, majority of Sanford TAVR patient
procedures were performed through femoral access (73%). In-hospital
outcomes revealed fewer cases of death from any cause, cardiac arrest,
myocardial infarction, renal failure. Median length of hospital stay
were also better compared to the national data (Table 1). Thirty day
outcomes of Sanford TAVR program compared to the registry showed
lower all cause death (1.9% vs. 7.6%), stroke (1.9% vs.2.8%) and need for
aortic valve reintervention (0% vs. 0.5%). Improvement in NYHA class
was seen in 84.6 % cases at Sanford compared to 72.4% in the registry.
Statistical analysis did not suggest a signiﬁcant difference in these
outcomes, except in the incidence of cardiac arrest.
CONCLUSIONS The Sanford data showed high quality outcomes for
the TAVR program implemented in rural United States. Although the
p-value for these outcome measures did not attain statistical signiﬁ-
cant, likely due to the small sample size of our patients, the results
were deﬁnitely comparable if not better than the national data. This
data rationalizes the feasibility of developing advanced health ser-
vices in rural areas of the country which may lead to better access and
utilization of health care resources.Table 1In-hospital outcome Sanford (n[52)National Registry
(n[7710) p-valueDeath (Any cause) 0 (0%) 427 (5.5%) 0.0512Stroke 1 (1.9%) 156 (2.0%) 0.3722Cardiac arrest 0 (0 %) 447 (5.8%) 0.0443TIA 0 (0 %) 28 (0.4%) 0.8271Myocardial infarction 0 (0 %) 56 (0.7%) 0.6836New onset atrial ﬁbrillation 6 (11.5%) 460 (6.0%) 0.0540Renal failure needing dialysis 0 (0%) 145 (1.9%) 0.3714Creatinine>3 0 (0%) 276 (3.8%) 0.1493VARC major bleeding 2 (3.8%) 267 (3.5%) 0.2740New permanent pacemaker 4 (7.69%) 509 (6.6%) 0.1945Major vascular injury 2 (3.8%) 493 (6.4%) 0.1992Device success 50 (96%) 7069 (92%) 0.1191Transapical site access complications 0 (0%) 61 (0.8%) 0.6607Median stay of length (days) 4 6Live hospital discharges 52 (100%) 7286 (94.5%)CATEGORIES OTHER: Political, International and Societal Issues
KEYWORDS TAVR
TCT-695
The Incidence of Paravalvular Leak in Transthoracic Echocardiography-
guided deployment of Transcatheter Aortic Valve is Comparable to that of
Transesophageal Echocardiography-guided Deployment: An Update of the
Emory Experience
Salim S. Hayek,1 Jose F. Condado,1 Nikolaos Spilias,1 Shuang Lin,1
James P. Macnamara,1 Shuai Zheng,1 Patricia Keegan,2
Vasilis Babaliaros,3 Vinod Thourani,1 Stamatios Lerakis1
1Emory University, Atlanta, GA; 2Emory Healthcare, Atlanta, GA;
3Emory University, Atlanta, USA
BACKGROUND Transcatheter aortic valve replacement (TAVR) is
increasingly being performed in cardiac catheterization laboratories
using transthoracic echocardiography (TTE) to guide valve deploy-
ment. This minimalist approach has been shown to be less costly, and
associated with procedural outcomes equivalent to the standard
approach that uses transesophageal echocardiography (TEE) guidance
for valve deployment. The risk of paravalvular leak (PVL) remains a
concern. Whether TTE-guided valve deployment is associated with a
higher incidence of paravalvular leak (PVL) is unclear.
METHODS Medical records of 474 patients (mean age 828, 58%
male, 86% Caucasians) who underwent TAVR with Edwards SAPIEN
(60%) or SAPIEN-XT (40%) at Emory University Hospital from 2007 to
2014 via the transfemoral approach were reviewed and compared. 267
patients underwent TAVR in the cardiac catheterization laboratory
under TTE guidance, while 207 patients underwent TAVR using con-
ventional, TEE-guided approach in the hybrid operating room. Clin-
ical characteristics, procedural outcomes and echocardiograms at
baseline and follow-up were compared.
RESULTS Patients who underwent TTE-guided TAVR had a lower STS
score (9.24.4% versus 11.27.8%, P¼0.004), higher EF (5313% versus
4813%, P¼0.004) and were more likely to have received a SAPIEN-XT
valve (47% versus 33% P¼0.007) compared to those with conventional
TEE-guided approach. The incidence of at least mild post-TAVR PVL
was lower in the minimalist approach compared to the conventional
one (29% versus 37% respectively, P¼0.069). In a binary logistic
regression model including demographics, valve type and size, TAVR
approach, year of procedure and STS score, only valve size (OR 0.80,
95% CI [0.68,0.94]), male gender (OR 3.0, 95% CI [1.6,5.5]) were sig-
niﬁcant predictors of post-TAVR PVL. Procedure year, reﬂective of
experience was close to statistical signiﬁcance (OR 0.83, 95% CI
[0.68,1.01]). Neither valve type (P¼0.482) nor TAVR approach
(P¼0.368) were independently associated with post-TAVR PVL.
CONCLUSIONS The minimalist TAVR approach was not associated with
increased PVL. TTE-guided TAVR is likely safe and cost-effective. Multi-
center studieswith larger sample sizesare required to conﬁrmtheseﬁndings.
CATEGORIES STRUCTURAL: Valvular Disease: Aortic
KEYWORDS Paravalvular leak, Transcatheter aortic valve replacement


TCT-695 The Incidence of Paravalvular Leak in Transthoracic Echocardiography-guided deployment of Transcatheter Aortic Valve is Comparable to that of Transesophageal Echocardiography-guided Deployment: An Update of the Emory Experience 

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TCT-695 The Incidence of Paravalvular Leak in Transthoracic Echocardiography-guided deployment of Transcatheter Aortic Valve is Comparable to that of Transesophageal Echocardiography-guided Deployment: An Update of the Emory Experience

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