Transseptal Antegrade Transcatheter Aortic Valve Replacement for Patients With No

Other Access Approach – A Contemporary Experience

Mauricio G. Cohen¶ M.D, Vikas Singh¶ M.D, Claudia A. Martinez M.D, Brian P. O'Neill M.D,

Carlos E. Alfonso M.D, Pedro O. Martinezclark M.D, Alan W. Heldman M.D,

William W. O'Neill M.D.

From the Cardiovascular Division, Department of Medicine, and the Elaine and Sydney

Sussman Cardiac Catheterization Laboratory, University of Miami Hospital, Miller School of

Medicine, Miami, Florida

Short title: Cohen at al. Transseptal Antegrade TAVR

Key Words: Aortic stenosis, Transcatheter Aortic Valve Replacement, Transseptal approach.

¶Drs Cohen and Singh contributed equally to this manuscript and share 1st authorship.

Word count: 3,611 (all inclusive)

Disclosure: Drs. Cohen and W. O’Neill have received consulting fees from Edwards

Lifesciences. Drs. Martinezclark and W. O’Neill have received consulting fees from Medtronic.

Drs. Heldman and Cohen have received research funding from Edwards Lifesciences. All other

authors do not have any conflicts of interest to disclose. 

This article has been accepted for publication and undergone full peer review but has not beenthrough the copyediting, typesetting, pagination and proofreading process which may lead todifferences between this version and the Version of Record. Please cite this article asdoi: 10.1002/ccd.25036

2

Correspondence: Mauricio G. Cohen, MD, University of Miami Hospital, 1400 NW 12th

Avenue, Suite 1179 Miami, Florida 33136. tel: (305) 243-5050; fax: (305) 243-5578; e-mail:

mgcohen@med.miami.edu

Abstract:

Objective: To assess the feasibility and outcomes in patients undergoing transvenous transseptal

(TS) transcatheter aortic valve replacement (TAVR).

Background: TS approach for TAVR was abandoned in favor of retrograde transfemoral,

transaortic or transapical approaches. TS TAVR may still be warranted in patients for whom no

other approach is feasible.

Methods: Observational consecutive case series at a single center, to evaluate technical

outcomes in inoperable patients with aortic stenosis who had contraindications for other

approaches and who underwent TAVR via a transvenous TS antegrade approach using the

Edwards-Sapien (ES) valve.

Results: Over a 4-month period, 9 patients underwent TS TAVR with 26mm (n=4) and 23mm

(n=5) ES valves. Mean age was 84.5±6.6 years and Society of Thoracic Surgeons predicted risk

of mortality was 7.8 ± 2.8%. Specific contraindications for other access included iliofemoral

arterial diameter < 7mm in 9 (100%), porcelain aorta in 6 (66%) patients, multiple (≥2)

sternotomies in 2 (22%) patients, severe pulmonary disease in 3 (33%), extreme frailty in 1

(11%), spinal stenosis with impaired ability to rehabilitate post-surgery in 1 (11%) and apical left

ventricular thrombus in 1 (11%) patient. Antegrade deployment of the ES prosthetic valve was

technically feasible in 8 patients. Major bleeding occurred in 4 patients, two patients suffered

3

acute kidney injury without need for dialysis and one patient required a permanent pacemaker.

The median (25th, 75th percentiles) fluoroscopy time was 49 (34, 81) minutes and contrast

volume was 150 (120, 225) ml. No patient had hemodynamically significant post-TAVR aortic

insufficiency nor damage to the mitral valve. At 6 months follow-up, there were no

cerebrovascular events or rehospitalizations and mean NYHA Class improved from 3.4 to 1.7.

Conclusions: The antegrade TS approach to TAVR is a technically feasible option for “no-

access" patients. Prospective assessment of the safety and efficacy of this approach in the current

era warrants further study.

4

Introduction

Transcatheter aortic valve replacement (TAVR) has gained worldwide acceptance and

emerged as a novel alternative therapeutic option for patients with aortic stenosis (AS).1, 2 The

initial TAVR approach described by Cribier et al in 2002 was antegrade transvenous transseptal

3. But the procedural complexity and technical complications with this approach led to its

replacement by the transfemoral (TF) arterial retrograde approach. Currently, there are two

TAVR systems with wide clinical experience: the balloon expandable Edwards-Sapien (ES)

valve (Edwards Lifesciences,Irvine, CA), which can be implanted retrograde via the femoral

artery (TF) or the ascending aorta (transaortic - TAo), or antegrade via the left ventricular apex

(transapical - TA); and the self-expandable Medtronic-CoreValve ReValving system (Medtronic,

Minneapolis, MN) which can only be implanted retrograde via TF, TAo or subclavian/axillary

artery approaches4, 5. Despite the availability of these options, a subgroup of patients with

symptomatic severe aortic stenosis has anatomic or physiologic features making none of these

approaches feasible.

In the United States, the TA and TF approaches are approved by the Food and Drug

Administration (FDA). In regards to the TF approach, the 23 mm and 26 mm ES valves, with

their 22F (outer diameter 25 Fr, 8.4 mm) and 24F (outer diameter 28 Fr, 9.2 mm) femoral artery

sheaths are available for clinical use. However, approximately one third of screened patients are

technically suited for the TF approach with this technology 6. Of those who cannot be treated TF,

many also have a combination of clinical features precluding the other commonly used

approaches. For example, peripheral vascular disease with iliofemoral vessels smaller than 7

mm in diameter precluding the retrograde TF approach may coexist with “porcelain” aorta with

heavy circumferential calcification of the ascending aorta and arch, precluding the TAo

5

approach, and chest wall disease or severe pulmonary disease precluding the TA approach. We

report a contemporaneous first US experience with the antegrade transvenous transseptal (TS)

approach in patients with severe AS who were not candidates for valve surgery and who had no

other access option for TAVR.

Methods:

We conducted an observational analysis of a case series to evaluate technical outcomes of TAVR

with the Edwards-Sapien (ES) valve via an antegrade transvenous TS approach. All patients had

severe aortic stenosis (AS) and were deemed inoperable by two cardiac surgeons because

surgical aortic valve replacement (SAVR) would be associated with a predicted probability of ≥

50% of death within 30 days after surgery or development of a serious irreversible complication.

All patients had an iliofemoral arterial diameter < 7 mm and contraindications for both TAo and

TA access. Severe aortic stenosis was defined as an aortic valve area < 0.8 cm2, with a mean

aortic-valve gradient ≥ 40 mm Hg or peak Doppler aortic jet velocity ≥ 4.0 m/sec. All patients

had congestive heart failure with New York Heart Association (NYHA) class III or IV

symptoms. All underwent pre-procedural coronary angiography to assess the need of

revascularization. The aortic annulus was measured by transthoracic (TTE) or transesophageal

(TEE) echocardiography, and immediately prior to the procedure by TEE and by rotational

aortography with computerized tomographic reconstruction (DynaCT, Siemens AG, Forchheim,

Germany). Patients with annular dimensions 1.8 to 2.5 cm were eligible for TAVR.

The primary outcome measure of this study was the combined occurrence of death from any

cause or repeat hospitalization within 30 days, 3 months and 6 months after the index procedure

due to valve-related or procedure related clinical deterioration. Secondary outcome measures

6

were procedural success (defined as 1 valve implanted, with less than moderate aortic

regurgitation (AR), and the patient left the procedure room alive); NYHA functional class; repeat

hospitalization due to valve-related or procedure related clinical deterioration; new pacemaker

implantation; and the rates of myocardial infarction, stroke, acute kidney injury, vascular

complications, and bleeding. Prosthetic valve performance was assessed as prosthetic aortic

valve area, gradient and severity of paravalvular regurgitation. All endpoints were defined per

Valve Academic Research Consortium criteria 7.

Technique

All procedures were performed under general anesthesia. Vascular access in both right and left

femoral arteries and veins was established; fluoroscopic and real-time ultrasound imaging

guidance were used for vascular puncture. Root aortography was performed during rapid

ventricular pacing, with rotational imaging and computerized tomographic reconstruction.

Transseptal puncture was made from the right femoral vein using a Brockenbrough needle and

Mullins sheath, under fluoroscopic and TEE guidance. Either a 7F balloon tipped catheter, or 6F

AL1 angiographic catheter was advanced through the Mullins sheath, looped in the LV and used

to direct the passage of a 0.035” floppy tipped Wholey guidewire antegrade across the aortic

valve into the ascending aorta and arch. If needed, this wire was snared in the descending aorta

from the left femoral artery using a 12-20 mm three-lobed vascular snare (Atrieve, Angiotech),

to permit the introduction of a 6F 125 cm long multipurpose angiographic catheter through the

TS sheath and around the aortic arch. Through catheter, a 400 cm flexible shaft 0.035” nitinol

wire (Nitrex, EV3) was advanced into the descending aorta, snared, and externalized through the

left femoral artery. A 6 French MPA1 guiding catheter was advanced retrograde over the

externalized wire and to the aortic root, to maintain control of the wire loop in the left ventricle.

7

At times this catheter was also advanced retrograde across both aortic and mitral valves, and

used to protect the native valves from guidewire injury. The Mullins sheath was removed and

atrial septostomy was performed using a 10 x 30 mm diameter peripheral vascular balloon and/or

a 14 x 50 mm diameter esophageal balloon (Figure 1). At this stage, the inflated septostomy

balloon was advanced through the left ventricular loop to assure unobstructed passage in

anticipation of delivery of a crimped ES valve. From the right femoral venous access, a 24 F

Edwards Retroflex sheath was inserted to the upper segment of the inferior vena cava. Aortic

valvuloplasty was done by either the retrograde or antegrade approach, with rapid ventricular

pacing. Using the crimper included in the Edwards Valve Kit, the valve was mounted on a

balloon according to size; 23 mm ES valves were crimped onto a 23 mm x 3 cm Edwards

Retroflex balloon; 26 mm ES valves were crimped onto 25 mm x 3-5 cm Z-Med balloons

(NuMED, Inc., Hopkinton, New York) (Figure 2).Valve orientation on the balloon was for

antegrade delivery.

Delivery of the valve was from the femoral vein, across the interatrial septum, though the

mitral valve, looping in the left ventricle, and antegrade into the aortic valve position. The co-

registered CT reconstructed image was used as an overlay on live fluoroscopy to guide

positioning (Figure 3). The retrograde multipurpose guiding catheter was positioned against the

tip of the antegrade delivery balloon and used to prevent upward displacement of the valve

during deployment (Figure 4). Three operators participated in all procedures. Two operators

stood at the right side of the patient and one stood at the left side of the patient. Operator one

(right side) obtained vascular access, performed transseptal puncture, septostomy, and advanced

the valve. Operator two (right side) was in charge of the inflation device for valve deployment,

contrast injection, and maintaining the position of the venous end of the guidewire loop in the

8

LV. Operator three snared and externalized the guidewire from the left femoral artery to

maintain the position of the arterial end of the guidewire loop in the LV and applied retrograde

pressure with a multipurpose catheter against the delivery balloon to prevent movement of the

prosthesis into the aorta during deployment.

After valve implantation, hemodynamics were recorded in the LV and aorta (Figure 5). The

guidewire was withdrawn, with care to maintain a catheter positioned to protect the valves from

guidewire laceration. The Retroflex delivery sheath was removed from the right femoral vein and

hemostasis achieved with manual pressure and a topical hemostatic patch. Arterial hemostasis

was achieved using either manual pressure or a vascular closure device.

Analysis

Data were collected using a prospectively designed database approved by the University of

Miami Human Subjects Research Office. Numeric variables are presented as means ± SD or as

median (25th, 75th quartiles). Categorical data are presented as frequencies with their respective

percentages.

Results

From March 2012 to June 2012, 9 patients (5 men and 4 women) considered inoperable

with severe symptomatic AS underwent antegrade TS TAVR with ES valves (Table 1). Mean

age was 84.5±6.6 years; Society of Thoracic Surgeons predicted risk of mortality (STS PROM)

was 7.8 ± 2.8%; hemoglobin 11.2±1.6 g/dL; and serum creatinine 1.1± 0.6 mg/dL. Diabetes was

present in 4 (44%) patients, and atrial fibrillation in 2 (22%). All patients had severe congestive

heart failure ≥ NYHA class 3. Previous cardiac procedures included percutaneous coronary

interventions in 5 (55%) patients and coronary bypass surgery in 3 (33%). Transthoracic

9

echocardiography demonstrated aortic valve area 0.61±0.23 cm2, mean gradient 39.9±8.0

mmHg, and Doppler aortic velocity 4.16±0.35 m/sec. The aortic annulus diameter was 2±0.2 cm,

and left ventricular ejection fraction 51.7 ± 11.6 %.

All patients had inadequate iliac and femoral arteries for TF TAVR. Specific features

preventing SAVR, TA TAVR, or TAo TAVR included “porcelain” aorta in 6 (66%) patients,

multiple (≥2) sternotomies in 2 (22%) patients, severe pulmonary disease in 3 (33%), extreme

frailty in 1 (11%), spinal stenosis with impaired ability to rehabilitate post-surgery in 1 (11%)

and apical LV thrombus in 1 (11%) patient. Additional comorbidities included coronary artery

disease (n=8), peripheral arterial disease (n=7), and cerebrovascular disease (n=9). Table 1

depicts individual baseline characteristics.

Antegrade deployment of the ES prosthetic valve was technically feasible in 8 patients.

Valve sizes were 26 mm in 4 cases and 23 mm in 5 cases. In one case the ES valve could not be

antegrade across the mitral valve, because of severe mitral annular calcification. The prosthesis

was withdrawn to the femoral vein, where its removal caused venous laceration requiring

vascular repair. This patient left the hospital without consequences and died of congestive heart

failure after 135 days of follow-up.

Post-procedural TEE did not show significant aortic regurgitation or damage to the mitral

valve. Femoral artery complications occurred in 2 patients, related to retrograde balloon aortic

valvuloplasty. One patient suffered transient complete heart block and hemodynamic collapse

requiring pacing and balloon counterpulsation. VARC major bleeding occurred in 4 patients,

minor bleeding in one patient, and 7 patients received blood transfusion. One patient required a

permanent pacemaker and two patients suffered acute kidney injury without need for dialysis.

10

The median (25th, 75th percentiles) fluoroscopy time was 49 (34, 81) minutes and contrast

volume was 150 (120, 225) ml. The median length of intensive care unit stay was 3 (2, 3) days

and total length of hospital stay was 5 (5, 11) days. The total number of deaths were 0, 1 (11%)

and 2 (22%) at 30days, 3 months and 6 months follow-up. There were no cerebrovascular events

or re-hospitalizations and mean NYHA Class improved from 3.4 to 1.7. Table 2 displays a

detailed individual outcome analysis.

Discussion:

Our case series demonstrates the feasibility of TS TAVR using contemporary equipment,

with 89% (8/9) technical success in patients who had contraindications to SAVR, TF, TA and

TAo TAVR approaches. At 6 months follow up 7/9 patients were free of re-hospitalization and

noted a significant improvement in functional capacity.

ES TAVR is now commercially available and an increasing number of high risk patients

with AS are undergoing this procedure. The current challenge in TAVR technology is to improve

the deliverability of the device minimizing patient’s morbidity and mortality through device

development and patient selection.

The initial reports of successful TAVR using a transvenous, transseptal approach in

patients with severe symptomatic AS were accepted world-wide with enthusiasm. From 2002-

2005, valve placement was primarily done via the antegrade transseptal approach with a

procedural success rate of over 75% 8. The femoral vein was accessed and the valve delivered in

the aortic position by traversing the atrial septum and the mitral valve. This technique had

several advantages. It was easier to cross the smooth aspect of the native valve in the antegrade

rather than the retrograde direction, especially in case of excessive aortic valve calcification. In

11

addition, the distensible veins could accommodate the large catheter sheath and avoid any

aortofemoral arterial complications. This approach, however, was technically more demanding

with a more circuitous path to deploy the prosthetic valve and required more experience. The

major disadvantage of this approach was the need to externalize a long stiff guide wire through

the left femoral artery in order to provide support to track the prosthetic valve. It was difficult to

maintain a generous loop in the left ventricle, and straightening of the stiff guide wire loop

caused tethering of the anterior mitral valve leaflet, hence leading to severe mitral regurgitation

and hemodynamic collapse 9. These problems limited the expansion of this approach and induced

future improvements in the delivery system, and led to development of the retrograde approach.

We report our contemporaneous experience and demonstrate intraprocedural safety with

the TS approach for a subgroup of inoperable patients with severe AS and concomitant severe

peripheral vascular disease, pulmonary dysfunction, porcelain aorta, history of multiple

sternotomies or radiation exposure. One of our patients had an LV thrombus, which is of

particular concern because wire and device manipulation within the LV can increase the risk of

stroke and thromboembolic events. Patients with any intracardiac thrombus were excluded in

major pivotal randomized clinical trials. One of our patients had an apical aneurysm with an

organized and calcified mural thrombus. We made a conscious effort to avoid the apical area of

the ventricle during the procedure. The decision to proceed with TS TAVR was driven by the

lack of other viable treatment options. The patient did not suffer a stroke or any other

thromboembolic complication after the procedure.

With the recent advances in the field of percutaneous valve technology and the use of

contemporary equipment such as Edwards sheath, DynaCT, and nitinol wires, the procedure can

now be reconsidered as an alternative approach when no other access option is available. The use

12

of a Nitinol wire appeared to be instrumental in maintaining a wide ventricular loop to avoid

severe mitral regurgitation or mitral valve damage. In addition, to create a wide LV loop it is

necessary to perform the transseptal puncture under transesophageal or intracardiac

echocardiographic guidance to assure a posterior septostomy.

Operators should be mindful of TS approach especially for this subgroup of patients with

no arterial access. We continued to find tethering of the mitral valve a very challenging part of

the procedure, requiring careful coordination between all operators involved in the cases. Due to

the complexity and infrequent use of this procedure in the current era, it should be reserved for

operators who are experienced in transseptal catheterization and antegrade BAV. Operators naïve

to this procedure should perform a number of antegrade BAV procedures to become familiar

with the technical aspects of the procedure. Difficulties and complications were initially

encountered while conducting the procedures however; the learning curve became evident after

each case.

Conclusion:

Antegrade transvenous TS approach using currently available equipment is a technically feasible

option and still has a place in the current TAVR era for patients with no other access approach.

This approach should be revisited and studied in the current era with prospective clinical trials.

Our preliminary study suggests that antegrade transvenous TS TAVR can be incorporated to the

therapeutic armamentarium at high-volume and experienced sites.

13

Figures and tables legends:

Figure 1: Septostomy: Flouroscopic image depicting atrial septostomy using a 14 x 50 mm

diameter esophageal balloon.

Figure 2: Mounting and Crimping: Series of images demonstrating the sequence of mounting

and crimping of the ES valve using the Edwards Valve Kit. Valve orientation on the balloon was

for antegrade delivery.

Figure 3: DynaCT: The DynaCT reconstructed image as an overlay on live fluoroscopy to

guide positioning of the valve.

Figure 4: Deployment: Flouroscopic image showing the antegrade deployment of the ES valve.

Figure 5: Final image: Final angiogram after valve implantation showing no aortic

insufficiency.

Table 1 demonstrates baseline characteristics of the patients:

Table 2 demonstrates procedural outcomes:

14

References:

1. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb

JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria

JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S.

Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo

surgery. N Engl J Med.363(17):1597-1607.

2. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb

JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani

VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D,

Pocock SJ. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N

Engl J Med.364(23):2187-2198.

3. Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G,

Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic

valve prosthesis for calcific aortic stenosis: first human case description. Circulation.

2002;106(24):3006-3008.

4. Piazza N, Grube E, Gerckens U, den Heijer P, Linke A, Luha O, Ramondo A, Ussia G,

Wenaweser P, Windecker S, Laborde JC, de Jaegere P, Serruys PW. Procedural and 30-

day outcomes following transcatheter aortic valve implantation using the third generation

(18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation

registry 1-year following CE mark approval. EuroIntervention. 2008;4(2):242-249.

5. Webb JG, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R, Sinhal A, Carere

RG, Munt B, Ricci D, Ye J, Cheung A, Lichtenstein SV. Percutaneous transarterial aortic

15

valve replacement in selected high-risk patients with aortic stenosis. Circulation.

2007;116(7):755-763.

6. Jilaihawi H, Bonan R, Asgar A, Ibrahim R, Spyt T, Chin D, Kovac J. Anatomic

suitability for present and next generation transcatheter aortic valve prostheses: evidence

for a complementary multidevice approach to treatment. JACC Cardiovasc

Interv.3(8):859-866.

7. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff

MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ,

Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized

endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a

consensus report from the Valve Academic Research Consortium. J Am Coll

Cardiol.57(3):253-269.

8. Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici

D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter

implantation of heart valve prosthesis for the treatment of end-stage inoperable patients

with calcific aortic stenosis. J Am Coll Cardiol. 2004;43(4):698-703.

9. Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler

PY, Bessou JP, Babaliaros V. Treatment of calcific aortic stenosis with the percutaneous

heart valve: mid-term follow-up from the initial feasibility studies: the French experience.

J Am Coll Cardiol. 2006;47(6):1214-1223.

For Review O

nly

Figure 1: Septostomy: Flouroscopic image depicting atrial septostomy using a 14 x 50 mm diameter

esophageal balloon.

139x139mm (300 x 300 DPI)

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Figure 2: Mounting and Crimping: Series of images demonstrating the sequence of mounting and crimping of the ES valve using the Edwards Valve Kit. Valve orientation on the balloon was for antegrade delivery.

84x51mm (300 x 300 DPI)

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Figure 3: DynaCT: The DynaCT reconstructed image as an overlay on live fluoroscopy to guide positioning of the valve.

131x124mm (300 x 300 DPI)

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Figure 4: Deployment: Flouroscopic image showing the antegrade deployment of the ES valve. 129x119mm (300 x 300 DPI)

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Figure 5: Final image: Final angiogram after valve implantation showing no aortic insufficiency. 136x133mm (300 x 300 DPI)

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Table 1: Baseline characteristics of the patients:

STS PROM: Society of Thoracic Surgeons predicted risk of mortality, NYHA: New York Heart Association Functional Classification,

EF: Ejection Fraction, CAD: Coronary Artery Disease, BAV: Balloon Aortic Valvuloplasty.

Patient Age/Sex

STS

PROM

(%)

NYHA

Class

EF

(%)

AVA

(cm2)

Mean

Gradient

(mmHg)

Aortic

annulus

(cm)

Extent of

CAD (N of

vessels)

Prior BAV Creatinine (mg/dL)

1 78/F 9.9 4 55 0.93 25.8 1.9 1 Yes 1

2 86/M 4.54 3 45 0.94 35.3 2.3 3 Yes 1.1

3 87/F 5.2 3 55 0.43 49 1.8 0 Yes 1

4 89/M 7.9 4 65 0.58 41 2.3 2 Yes 1.1

5 92/M 7.9 3 60 0.64 32.8 2.2 2 Yes 0.7

6 83/F 7.3 3 55 0.78 47 2 2 Yes 1.7

7 90/M 9.4 3 25 0.32 39.1 1.9 1 Yes 2.7

8 85/F 12.96 4 55 0.4 50 1.8 2 No 1.4

9 71/M 4.7 4 50 0.44 39 2.1 3 No 1.2

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Table 2: Procedural outcomes:

Patient

BAV

modality

Valve

Size

(mm)

AVA/Mean

gradient

Complications

AI

(Angio/ECHO)

LOS

(Total/ICU)

Peak

Creatinine

Follow-up

NYHA class

1 Retrograde 23 1.5/9 Iliac artery dissection Trace/ Trace 4/1 1.3 1

2 Antegrade 26 NA

Valve could not be

advanced past mitral valve,

retrieval of the valve

required venous cutdown

9/3 1.4 3

3 Retrograde 23 1.6/7

Unstable SVT requiring

cardioversion

Mild/ Mild 5/3 1 1

4 Retrograde 26 1.6/6.5 None Mild/ Mild 5/3 1.1 2

5 Antegrade 26 1.3/12 None Trace/Mild 3/1 0.9 1

6 Antegrade 23 1.7/9

Common iliac artery

dissection, acute on

chronic kidney injury,

Trace/ Trace 12/3 3.3 1

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BAV: Balloon Aortic Valvuloplasty, AVA: Aortic Valve Area, AI: Aortic Insufficiency, LOS: Length of stay, NYHA: New York

Heart Association (NYHA) Functional Classification, SVT: Supraventricular Tachycardia, IABP: Intra aortic balloon pump, CPR:

Cardiopulmonary resuscitation, MR: Mitral regurgitation, ICU: Intensive care unit.

Gastrointestinal bleed

7

Not

performed

26 1.6/11

Complete heart block,

IABP-22hrs, Pacemaker,

CPR, Severe MR due to

wire impingement

Trace/Mild 11/7 3 2

8 Antegrade 23 1.6/9 None Trace/Mild 14/4 2.5 2

9 Antegrade 23 1.6/7 None Mild/ Trace 5/2 1.2 2

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