Estrada, J Raider

Friant, Janet

Lang, Roberto M.

Nathan, Sandeep

Paul, Jonathan D.

Retzer, Elizabeth

Shah, Atman P.

Tabit, Corey E.

Elsevier - Publisher Connector 

Group A Group B
Sex 177M vs 44F 168M vs 49F
Age 62,411 65,811
Mean EF [%] 28,86,9 27,458
Atrial ﬁbrillation [%, p¼ns] 16,2 18,8
NYHA III & IV [%, p¼ns] 29,8 32,7
Chronic kidney disease stage III-V [%, p¼0,02] 32,3 42,4
Diabetes [%, p¼0,04] 38,4 47,9
Parameter Baseline 6 months P value
NYHA III/IV %)
(n¼10)
80/20 20/0 NA
6 MWD (m)
(n¼9)
342  139 369  92 0.096
NT-Pro-BNP (pmol/L) (n¼9) 193  153 262  210* 0.370
MLWHF score
(n¼10)
54  18 31  17 0.009
Table 1. Predictors of Survival
Survivors Non-Survivors p-value
Age (years) 62.33  6.51 57.00  15.33 0.30
Male Gender (#, %) 2 (67%) 4 (80%) 0.72
BMI (kg/m2) 30.91  4.12 29.90  8.72 0.43
Etiology, ICM (#, %) 2 (67%) 3 (60%) 0.86
DM (#, %) 0 (0%) 3 (60%) 0.06
GFR (mL/min/BSA) 82.00  30.35 39.60  4.39 0.02
Device Size (mm, %) 18 (33%),
25 (33%),
30 (33%)
30 (80%), 35 (20%) 0.03
PA Systolic Pressure
(mmHg)
25.50  6.36 54.60  6.50 < 0.01
PA Mean Pressure
(mmHg)
18.00  0.00 38.40  4.16 < 0.01
PA Saturation (%) 68.40  8.20 49.36  6.68 0.01
D WBC @ 96hr (K/mL) 0.03  0.81 6.40  2.74 < 0.01
D Platelet @ 96hr (K/mL) -32.00  31.42 -168.50  98.69 0.04
D LDH @ 96hr (U/L) 157.67  110.55 2287.75  1223.89 0.02
D Total Bilirubin
@ 96hr (mg/dL)
-3.10  6.42 11.88  6.32 0.01
www.jacctctabstracts2014.com SATURDAY, SEPTEMBER 13, 2014, 5:00 PM–7:00 PMTCT-76
Percutaneous Ventricular Restoration (PVR) therapy using the Parachute
Device in Patients with Ischemic Dilated Heart Failure: PARACHUTE III,
European Post Market Trial, Primary Endpoint Results
Martyn Thomas1, Christoph A. Nienaber2, Hüseyin Ince3, Andrejs Erglis4,
Vladan Vukcevic5, Ulrich Schäfer6, Rui C. Ferreira7, Corrado Tamburino8
1Department of Cardiology, St. Thomas’ Hospital, London, UK, London, United
Kingdom, 2University of ROSTOCK, Rostock, Germany, 3University of Rostock,
Rostock, Germany, 4Pauls Stradins Clinical University Hospital, Riga, Latvia,
5Clinical Center of Serbia, Belgrade, Serbia, 6Department of Cardiology, Asklepios
Klinik St. Georg, Hamburg, Germany, Hamburg, Germany, 7Hospital Santa Marta,
Lisbon, Lisbon, 8University of Catania, Catania, Italy
Background: Left ventricle (LV) remodeling after anterior wall myocardial infarction
(AWMI) leads to increased LV volumes, myocardial stress, and ultimately heart
failure (HF). Treatment options are limited for these high-risk HF patients.
Methods: Aims: The primary objective is to continue to assess the long term safety
of the CardioKinetix Parachute Implant System in the partitioning of the left
ventricle in patients with heart failure due to ischemic heart disease. One hundred
patients with NYHA class II-IV HF secondary to AWMI, with akinetic or dyski-
netic wall motion abnormality, and LV ejection fraction < 40%, were enrolled in
Europe. The primary endpoint was site-reported procedural and device related
MACE in real world use of the Parachute Implant through 5 years of clinical
follow-up. Secondary endpoints included changes in LVESVi, LVEDVi, 6MWT,
and the number of and time to the combined cardiovascular mortality and morbidity
that includes all cause death, hospitalization for heart failure, myocardial infarc-
tion, and stroke, whichever is earlier, within 6, and 12 months from the date of
implantation of the study device.
Results: As of the last data cut in early 2014, a pooled analysis which included 77 of
the 100 PARACHUTE III patients, showed signiﬁcant reductions (p < 0.05) in
LVESVi and LVEDVi at 1 year as well as a signiﬁcant improvement in the 6MWT
data. One-year follow-up of the full cohort of 100 patients will be available for the
TCT conference in September 2014.
Conclusions: The analysis of the post market data conﬁrms the safety and longer term
efﬁcacy of the Parachute device in treating HF.
TCT-77
Midterm results of a Novel Interatrial Shunt Therapy for Heart Failure and
Preserved Ejection Fraction
Finn Gustafsson1, Filip Malek2, Petr Neuzil3, Lars Sondergaard4, Tony Walton5
1Rigshospitalet, Copenhagen, Denmark, 2Na Homolce Hospital, Prague, CZ,
3Nemocnice na Homolce, Prague, Czech Republic, 4MDSc, Copenhagen, Denmark,
5Epworth Hospital, Richmond, Australia
Background: Approximately 50% of patients presenting with clinical features of
heart failure have a preserved ejection fraction (“HFPEF”). The fundamental
pathophysiologic basis for the HFPEF phenotype is impaired diastolic reserve,
with elevated resting, or rapid increase in LVEDP, LAP and pulmonary artery
pressures during low level physical activity. We report the midterm results of a
novel device intended to lower left atrial pressure by creating a small permanent
atrial septal shunt. Objective: Evaluation of safety and potential beneﬁts of the intra
atrial shunt device (IASDTM) System in patients with symptomatic heart failure
with preserved or mildly reduced ejection fraction, despite appropriate medical
management
Methods: Eleven patients were enrolled under an approved protocol in a prospective
multicenter feasibility study. Key inclusion criteria were: EF > 45%; PCWP at rest
 15 or exercise  25mm Hg;  1 hospitalization for heart failure within prior 12
months, or persistent NYHA Class III/IV for at least 3 months.
Results: Mean age, and EF, were 75 Y, and 57 %, respectively. Most patients had
multiple comorbidities. The IASD Device was successfully implanted in each
patient. Two SAE occurred within 30 days, and both were resolved. At 30-90 days,
PCWP was reduced (4 mmHg, P< 0.001) with no change in CVP, and at 6 months
clinical symptoms had improved (See Table). One year follow-up data will be
presented.JACC Vol 64/11/Suppl B j September 13–17, 2014 j TCT Abstracts/Heart FailConclusions: This initial data demonstrates that the shunt device can be safely
implanted and that midterm clinical improvement can be obtained in patients with
heart failure and preserved or mildly reduced ejection fraction.
TCT-78
Predictors of Survival in Patients Undergoing Trans-Catheter Aortic Valve
Closure for Signiﬁcant Left Ventricular Assist Device Associated Aortic
Insufﬁciency
Elizabeth Retzer1, Corey E. Tabit1, J Raider Estrada1, Jonathan D. Paul1,
Sandeep Nathan2, Janet Friant1, Roberto M. Lang1, Atman P. Shah2
1University of Chicago, Chicago, IL, 2University of Chicago Medical Center,
Chicago, IL
Background: Left ventricular assist devices (LVADs) have been shown to in-
crease survival and quality of life in patients with end-stage congestive heart
failure. However, severe aortic insufﬁciency (AI) can develop in up to 50% of
patients with LVADs at 12 months resulting in signiﬁcant morbidity and mortality.
Trans-catheter treatment of LVAD associated AI has emerged as a potential
alternative to surgical treatment, but long term clinical beneﬁts are yet to be
determined.
Methods: We conducted a retrospective analysis of all patients undergoing trans-
catheter aortic valve closure using an Amplatzer Multi-Fenestrated Septal Occluder
“Cribiform” device (AGA Medical, Plymouth, Minnesota) at our institution be-
tween September 2011 and September 2013 to assess potential clinical and pro-
cedural factors associated with survival. Unpaired student’s t-tests were used to
compare baseline patient demographics and procedural characteristics, as well as
patient outcomes immediately post procedure and at 6 months. A p-value of < 0.05
was considered statistically signiﬁcant.
Results: A total of 8 patients (75% male, median age 59 years) were included in this
analysis. Technical success of the procedure including total cessation of AI without
evidence of coronary compromise was accomplished in 100% of patients with a
6 month survival rate of 38% (3/8). Predictors of survival include the absence of
signiﬁcant co-morbidities such as chronic renal insufﬁciency, smaller occlusion device
placement, and the absence of right heart failure (Table 1).Conclusions: Trans-catheter aortic valve closure successfully treats late severe AI
in LVAD patients, however, the presence or development of right heart failure
portends a worse prognosis. Further studies are needed to investigate the
potential right ventricular failure in patients undergoing trans-catheter aortic
valve closure.ure Therapies B23


TCT-78 Predictors of Survival in Patients Undergoing Trans-Catheter Aortic Valve Closure for Significant Left Ventricular Assist Device Associated Aortic Insufficiency 

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TCT-78 Predictors of Survival in Patients Undergoing Trans-Catheter Aortic Valve Closure for Significant Left Ventricular Assist Device Associated Aortic Insufficiency

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