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Letter
TO THE EDITOR
Transcaval Retrograde
Transcatheter Aortic
Valve Replacement for
Patients With No Other
Access
First-in-Man Experience With CoreValve
The first transcatheter aortic valve replacement
(TAVR) approach was antegrade transvenous trans-
septal. This approach obligated transseptal catheter-
ization and a more circuitous path to deploy the
valve. The procedural complexities associated with
the transseptal approach led to its replacement by the
“less complex” and most commonly utilized trans-
femoral (TF) arterial retrograde approach (1). How-
ever, approximately two-thirds of screened patients
are not suited for the TF approach because of
peripheral arterial disease (2). In addition, the TF
approach is associated with a significantly higher rate
of vascular complications when compared with other
approaches (1,3). The available alternatives are
transapical for the Edwards Sapien valve (Edwards
Lifesciences, Irvine, California), subclavian/axillary
for the self-expandable Medtronic CoreValve
ReValving system (CV) (Medtronic, Minneapolis,
Minnesota), and transaortic for both prostheses.
Despite these options, more than 3% of patients with
symptomatic severe aortic stenosis are believed to
have anatomic or physiological features making none
of these approaches feasible (2). We report our first-
in-man experience and demonstrate the intra-
procedural safety of the CV percutaneous aortic valve
implantation using the novel retrograde caval-aortic
approach in a subgroup of inoperable patients with
severe aortic stenosis.
All procedures were performed under general
anesthesia and with aseptic technique. Vascular
access in both right and left femoral arteries and veins
was established. Unfractionated heparin was used for
anticoagulation for a target activated clotting time
between 250 to 300 s. A transvenous pacemaker was
placed through the left femoral vein, and a pigtail
catheter was introduced through the right femoral
artery. Root aortography was performed during rapid
ventricular pacing with rotational imaging and
computerized tomographic reconstruction in order to
confirm the best aortic valve angulation. Through
standard right femoral vein access, a stiff 0.014-inch
guidewire (Asahi Confianza Pro 12, Abbott Vascular,
Santa Clara, California) inside a 0.035-inch wire con-
verter (PiggyBack, Vascular Solutions, Minneapolis,
Minnesota) was loaded in a Quick-Cross catheter
(Spectranetics, Colorado Springs, Colorado) inside a
5-F Cobra catheter (Terumo, Somerset, New Jersey)
(Fig. 1). The distal end of the Confianza Pro 12 guide-
wire was connected to the cautery set in cut mode at
50 to 70 W. A vascular EV3 GooseNeck snare (Covi-
dien, Plymouth, Minnesota) was positioned in the
distal aorta and was used to capture the guidewire
from the vena cava. Confirmation of the orientation
was performed using 15
right anterior oblique and
70
left anterior oblique views at the infrarenal level
with the least amount of calcification. Once the entire
system was in position, and with the guidewire
pointing to the snare in the aorta, the cautery was
turned on, and the wire was advanced from the
inferior vena cava to the distal aorta through the
lumen of the snare. The wire was then captured in the
snare and advanced to the ascending aortic curva-
ture; the PiggyBack wire was advanced loaded onto a
0.035-inch Quick-Cross catheter. Once in the aortic
arch, the PiggyBack converter and the Confianza Pro
12 guidewire were removed, and the 0.35-inch Quick-
Cross catheter was left in the aortic arch to allow the
exchange of a 0.035-inch Amplatz Super Stiff guide-
wire (Boston Scientific, Natick, Massachusetts). An
18-F 40-cm Cook introducer sheath (Cook Medical,
Bloomington, Indiana) was introduced from the
venous access connecting the femoral vein to the
aorta. The self-expanding CV, mounted in the cath-
eter system, was then advanced to the left ventricular
outflow tract to be deployed using the standard
technique. Closure of the aorto-caval fistula was
completed with an Amplatzer Muscular VSD Occluder
(St. Jude Medical, St. Paul, Minnesota). Arterial he-
mostasis was achieved using either manual pressure
or a vascular closure device: Angio-Seal (St. Jude
Medical) or Proglide (Abbott Vascular).
We successfully performed TAVR with caval-aortic
access in 4 patients with a mean age of 81.5 Æ 8.5
years (3 women and 1 man), mean Society of Thoracic
J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 7 , N O . 9 , 2 0 1 4
ª 2 0 1 4 B Y 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 F O U N D A T I O N I S S N 1 9 3 6 - 8 7 9 8 / $ 3 6 . 0 0
P U B L I S H E D B Y E L S E V I E R I N C .
Downloaded From: http://interventions.onlinejacc.org/ by Vikas Singh on 08/13/2014
Surgeons predicted risk of mortality of 8 Æ 4.8%, and
mean logistic EuroSCORE of 11 Æ 5.8%. All patients
had severe symptomatic aortic stenosis and were
deemed inoperable by cardiac surgeons. All patients
had peripheral arterial disease and contraindications
for both transaortic and subclavian/transaxillary ac-
cess. Valve sizes were 26, 29, and 31 mm (2 patients).
One patient required permanent pacemaker place-
ment. There were no other complications per Valve
Academic Research Consortium criteria (4). The mean
New York Heart Association functional class
improved from 3.5 to 1.25, and the mean aortic valve
area increased from 0.46 to 2 cm2
. At 6 months
follow-up, all patients were free from rehospitaliza-
tion and noted a significant improvement in func-
tional capacity.
Caval-aortic approach was recently described by
Halabi et al. (5) in 14 swine in which access to the
abdominal aorta was gained via the femoral vein or
inferior vena cava. In that report, the caval-aortic
tracts were created by energizing a coronary
guidewire with an electrosurgery unit, and the tracts
were closed using Amplatzer Duct occluders (St. Jude
Medical) or Memopart VSD occluders (Lepu Medical,
Shanghai, China) (5). This approach has also been
described in humans with the Edwards Sapien valve;
however, this option has not been explored for CV (6).
This rapid and uncomplicated novel technique in-
corporates advantages of both venous and arterial
approaches without the need of a transseptal punc-
ture and prevents femoral arterial complications. The
more compliant and distensible veins can accommo-
date larger catheter sheaths, thus avoiding any ilio-
femoral arterial complications; the caval-aortic
fistulas did not seem to be acutely life threatening
and could easily be closed with the currently avail-
able devices (5). The operators should therefore be
mindful of the caval-aortic approach, especially for a
subgroup of patients with no arterial access because
of small-caliber, tortuous, calcific, or otherwise
obstructed iliofemoral arteries. Prospective assess-
ment of the safety and efficacy of this approach with
FIGURE 1 Procedural Steps
(A) Venography and aortography before the procedure; (B) Confianza Pro 12 guidewire entering the snare in the aorta; (C) wire captured in the
snare and advanced to the ascending aortic curvature; (D) 18-F introducer sheath introduced from the venous access connecting femoral vein to
aorta; (E and F) Medtronic CoreValve ReValving catheter system advanced to the left ventricular outflow tract; (G and H) valve deployment;
and (I) closure of the caval-aortic fistula with the Amplatzer Muscular VSD Occluder device.
Letter to the Editor J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 7 , N O . 9 , 2 0 1 4
S E P T E M B E R 2 0 1 4 : - – -
2
Downloaded From: http://interventions.onlinejacc.org/ by Vikas Singh on 08/13/2014
TAVR warrants further study with a larger number of
patients.
*Pedro O. Martinez-Clark, MD
Vikas Singh, MD
Jairo A. Cadena, MD
Angela Maria Cucalon Reyes, MD
Cesia Gallegos, MD
Antonio Dager, MD
Adam Greenbaum, MD
William W. O’Neill, MD
*Interventional Concepts
2520 Coral Way
Suite # 2120
Miami, Florida 33145-3438
E-mail: pmclark@interventionalconcepts.net
http://dx.doi.org/10.1016/j.jcin.2014.03.008
Please note: Dr. Martinez-Clark is on the speakers’ bureaus of Medtronic and
AstraZeneca; is the medical director and a shareholder of Syntheon: has
received research support from Avinger, CeloNova Biosciences, and MitraSpan;
and is on the board of directors of Corquest Inc. Dr. Dager has served as a proctor
for CoreValve Medtronic. Dr. Greenbaum is a patent owner of products for
caval-aortic access and closure. Dr. O’Neill is a consultant for Medtronic and
Edwards Lifesciences. All other authors have reported that they have no re-
lationships relevant to the contents of this paper to disclose. Drs. Martinez-Clark
and Singh contributed equally to this work.
R E F E R E N C E S
1. Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve
implantation in high-risk patients. N Engl J Med 2012;366:1705–15.
2. Jilaihawi H, Bonan R, Asgar A, et al. Anatomic suitability for present and
next generation transcatheter aortic valve prostheses: evidence for a com-
plementary multidevice approach to treatment. J Am Coll Cardiol Intv 2010;3:
859–66.
3. Popma JJ, CoreValve US Clinical Investigators. CoreValve US Pivotal Trial
Extreme Risk Iliofemoral study results. Presented at: TCT2013; November 28,
2013; San Francisco, CA.
4. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint
definitions for transcatheter aortic valve implantation: the Valve Academic
Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60:
1438–54.
5. Halabi M, Ratnayaka K, Faranesh AZ, Chen MY, Schenke WH, Lederman RJ.
Aortic access from the vena cava for large caliber transcatheter cardio-
vascular interventions: pre-clinical validation. J Am Coll Cardiol 2013;61:
1745–6.
6. Greenbaum AB, O’Neill WW, Paone G, et al. Caval-aortic access to allow
transcatheter aortic valve replacement in otherwise ineligible patients: initial
human experience. J Am Coll Cardiol 2014;63:2795–804.
J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 7 , N O . 9 , 2 0 1 4 Letter to the Editor
S E P T E M B E R 2 0 1 4 : - – -
3
Downloaded From: http://interventions.onlinejacc.org/ by Vikas Singh on 08/13/2014

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Transcaval Retrograde Transcatheter Aortic Valve Replacement for Patients With No Other Access

  • 1. Letter TO THE EDITOR Transcaval Retrograde Transcatheter Aortic Valve Replacement for Patients With No Other Access First-in-Man Experience With CoreValve The first transcatheter aortic valve replacement (TAVR) approach was antegrade transvenous trans- septal. This approach obligated transseptal catheter- ization and a more circuitous path to deploy the valve. The procedural complexities associated with the transseptal approach led to its replacement by the “less complex” and most commonly utilized trans- femoral (TF) arterial retrograde approach (1). How- ever, approximately two-thirds of screened patients are not suited for the TF approach because of peripheral arterial disease (2). In addition, the TF approach is associated with a significantly higher rate of vascular complications when compared with other approaches (1,3). The available alternatives are transapical for the Edwards Sapien valve (Edwards Lifesciences, Irvine, California), subclavian/axillary for the self-expandable Medtronic CoreValve ReValving system (CV) (Medtronic, Minneapolis, Minnesota), and transaortic for both prostheses. Despite these options, more than 3% of patients with symptomatic severe aortic stenosis are believed to have anatomic or physiological features making none of these approaches feasible (2). We report our first- in-man experience and demonstrate the intra- procedural safety of the CV percutaneous aortic valve implantation using the novel retrograde caval-aortic approach in a subgroup of inoperable patients with severe aortic stenosis. All procedures were performed under general anesthesia and with aseptic technique. Vascular access in both right and left femoral arteries and veins was established. Unfractionated heparin was used for anticoagulation for a target activated clotting time between 250 to 300 s. A transvenous pacemaker was placed through the left femoral vein, and a pigtail catheter was introduced through the right femoral artery. Root aortography was performed during rapid ventricular pacing with rotational imaging and computerized tomographic reconstruction in order to confirm the best aortic valve angulation. Through standard right femoral vein access, a stiff 0.014-inch guidewire (Asahi Confianza Pro 12, Abbott Vascular, Santa Clara, California) inside a 0.035-inch wire con- verter (PiggyBack, Vascular Solutions, Minneapolis, Minnesota) was loaded in a Quick-Cross catheter (Spectranetics, Colorado Springs, Colorado) inside a 5-F Cobra catheter (Terumo, Somerset, New Jersey) (Fig. 1). The distal end of the Confianza Pro 12 guide- wire was connected to the cautery set in cut mode at 50 to 70 W. A vascular EV3 GooseNeck snare (Covi- dien, Plymouth, Minnesota) was positioned in the distal aorta and was used to capture the guidewire from the vena cava. Confirmation of the orientation was performed using 15 right anterior oblique and 70 left anterior oblique views at the infrarenal level with the least amount of calcification. Once the entire system was in position, and with the guidewire pointing to the snare in the aorta, the cautery was turned on, and the wire was advanced from the inferior vena cava to the distal aorta through the lumen of the snare. The wire was then captured in the snare and advanced to the ascending aortic curva- ture; the PiggyBack wire was advanced loaded onto a 0.035-inch Quick-Cross catheter. Once in the aortic arch, the PiggyBack converter and the Confianza Pro 12 guidewire were removed, and the 0.35-inch Quick- Cross catheter was left in the aortic arch to allow the exchange of a 0.035-inch Amplatz Super Stiff guide- wire (Boston Scientific, Natick, Massachusetts). An 18-F 40-cm Cook introducer sheath (Cook Medical, Bloomington, Indiana) was introduced from the venous access connecting the femoral vein to the aorta. The self-expanding CV, mounted in the cath- eter system, was then advanced to the left ventricular outflow tract to be deployed using the standard technique. Closure of the aorto-caval fistula was completed with an Amplatzer Muscular VSD Occluder (St. Jude Medical, St. Paul, Minnesota). Arterial he- mostasis was achieved using either manual pressure or a vascular closure device: Angio-Seal (St. Jude Medical) or Proglide (Abbott Vascular). We successfully performed TAVR with caval-aortic access in 4 patients with a mean age of 81.5 Æ 8.5 years (3 women and 1 man), mean Society of Thoracic J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 7 , N O . 9 , 2 0 1 4 ª 2 0 1 4 B Y 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 F O U N D A T I O N I S S N 1 9 3 6 - 8 7 9 8 / $ 3 6 . 0 0 P U B L I S H E D B Y E L S E V I E R I N C . Downloaded From: http://interventions.onlinejacc.org/ by Vikas Singh on 08/13/2014
  • 2. Surgeons predicted risk of mortality of 8 Æ 4.8%, and mean logistic EuroSCORE of 11 Æ 5.8%. All patients had severe symptomatic aortic stenosis and were deemed inoperable by cardiac surgeons. All patients had peripheral arterial disease and contraindications for both transaortic and subclavian/transaxillary ac- cess. Valve sizes were 26, 29, and 31 mm (2 patients). One patient required permanent pacemaker place- ment. There were no other complications per Valve Academic Research Consortium criteria (4). The mean New York Heart Association functional class improved from 3.5 to 1.25, and the mean aortic valve area increased from 0.46 to 2 cm2 . At 6 months follow-up, all patients were free from rehospitaliza- tion and noted a significant improvement in func- tional capacity. Caval-aortic approach was recently described by Halabi et al. (5) in 14 swine in which access to the abdominal aorta was gained via the femoral vein or inferior vena cava. In that report, the caval-aortic tracts were created by energizing a coronary guidewire with an electrosurgery unit, and the tracts were closed using Amplatzer Duct occluders (St. Jude Medical) or Memopart VSD occluders (Lepu Medical, Shanghai, China) (5). This approach has also been described in humans with the Edwards Sapien valve; however, this option has not been explored for CV (6). This rapid and uncomplicated novel technique in- corporates advantages of both venous and arterial approaches without the need of a transseptal punc- ture and prevents femoral arterial complications. The more compliant and distensible veins can accommo- date larger catheter sheaths, thus avoiding any ilio- femoral arterial complications; the caval-aortic fistulas did not seem to be acutely life threatening and could easily be closed with the currently avail- able devices (5). The operators should therefore be mindful of the caval-aortic approach, especially for a subgroup of patients with no arterial access because of small-caliber, tortuous, calcific, or otherwise obstructed iliofemoral arteries. Prospective assess- ment of the safety and efficacy of this approach with FIGURE 1 Procedural Steps (A) Venography and aortography before the procedure; (B) Confianza Pro 12 guidewire entering the snare in the aorta; (C) wire captured in the snare and advanced to the ascending aortic curvature; (D) 18-F introducer sheath introduced from the venous access connecting femoral vein to aorta; (E and F) Medtronic CoreValve ReValving catheter system advanced to the left ventricular outflow tract; (G and H) valve deployment; and (I) closure of the caval-aortic fistula with the Amplatzer Muscular VSD Occluder device. Letter to the Editor J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 7 , N O . 9 , 2 0 1 4 S E P T E M B E R 2 0 1 4 : - – - 2 Downloaded From: http://interventions.onlinejacc.org/ by Vikas Singh on 08/13/2014
  • 3. TAVR warrants further study with a larger number of patients. *Pedro O. Martinez-Clark, MD Vikas Singh, MD Jairo A. Cadena, MD Angela Maria Cucalon Reyes, MD Cesia Gallegos, MD Antonio Dager, MD Adam Greenbaum, MD William W. O’Neill, MD *Interventional Concepts 2520 Coral Way Suite # 2120 Miami, Florida 33145-3438 E-mail: pmclark@interventionalconcepts.net http://dx.doi.org/10.1016/j.jcin.2014.03.008 Please note: Dr. Martinez-Clark is on the speakers’ bureaus of Medtronic and AstraZeneca; is the medical director and a shareholder of Syntheon: has received research support from Avinger, CeloNova Biosciences, and MitraSpan; and is on the board of directors of Corquest Inc. Dr. Dager has served as a proctor for CoreValve Medtronic. Dr. Greenbaum is a patent owner of products for caval-aortic access and closure. Dr. O’Neill is a consultant for Medtronic and Edwards Lifesciences. All other authors have reported that they have no re- lationships relevant to the contents of this paper to disclose. Drs. Martinez-Clark and Singh contributed equally to this work. R E F E R E N C E S 1. Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1705–15. 2. Jilaihawi H, Bonan R, Asgar A, et al. Anatomic suitability for present and next generation transcatheter aortic valve prostheses: evidence for a com- plementary multidevice approach to treatment. J Am Coll Cardiol Intv 2010;3: 859–66. 3. Popma JJ, CoreValve US Clinical Investigators. CoreValve US Pivotal Trial Extreme Risk Iliofemoral study results. Presented at: TCT2013; November 28, 2013; San Francisco, CA. 4. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60: 1438–54. 5. Halabi M, Ratnayaka K, Faranesh AZ, Chen MY, Schenke WH, Lederman RJ. Aortic access from the vena cava for large caliber transcatheter cardio- vascular interventions: pre-clinical validation. J Am Coll Cardiol 2013;61: 1745–6. 6. Greenbaum AB, O’Neill WW, Paone G, et al. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol 2014;63:2795–804. J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 7 , N O . 9 , 2 0 1 4 Letter to the Editor S E P T E M B E R 2 0 1 4 : - – - 3 Downloaded From: http://interventions.onlinejacc.org/ by Vikas Singh on 08/13/2014