TCT-791 Improvement in Aortic Valve Area Using a New "Hour Glass" Shaped Valvuloplasty Balloon Compared with Standard Cylindrical Balloons in Severe Aortic Stenosis Patients

Pedersen, Wesley R.; Pedersen, Christopher; Mooney, M.; Drasler, William J.; Krueger, Dean; Garberich, Ross; Thorsgard, Marit; Schwartz, Robert S.

doi:10.1016/j.jacc.2013.08.1543

Cited by 3 publications

(6 citation statements)

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“…Thus, it produces a controlled, iterative improvement in PV hemodynamics. 9 In addition, the V8 balloon's rapid inf lation and def lation times reduce the need for rapid ventricular pacing. None of our patients underwent pacing, nor did they experience hemodynamic compromise.…”

Section: Discussionmentioning

confidence: 99%

“…9 We describe our successful experience with the V8 balloon in 3 patients with PVS, and we detail our balloon sizing technique.…”

Section: -8mentioning

confidence: 99%

“…4 Attempts to minimize these problems through the use of double balloons, triple balloons, and the Inoue Balloon (Toray Industries, Inc.) have been described, but these procedures are cumbersome, time-consuming, and expensive. [4][5][6][7][8] The V8 Aortic Valvuloplasty Balloon Catheter (InterValve Medical, Inc.; acquired by Venus Medtech in 2017) 9 is an hourglass-shaped balloon with 2 bulbous segments, separated by a narrowed waist. During balloon aortic valvuloplasty (BAV), the design improves fixation and enables better leaf let opening without compromising the annulus.…”

Section: New Pulmonary Valvuloplasty Techniquementioning

confidence: 99%

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New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis

Kılıç¹,

Şahı̇n²,

Karaüzüm³

et al. 2018

Texas Heart Institute Journal

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P ercutaneous balloon pulmonary valvuloplasty (BPV), first described by Kan and colleagues 1 in 1982, has replaced surgical valvotomy as the preferred treatment for congenital and acquired pulmonary valve stenosis (PVS).2,3 Many patients have had satisfactory long-term results after BPV, but conventional balloon designs have limited effectiveness when pulmonary valve (PV) annular diameters range from 18 to 30 mm; in some cases, effective balloon diameters >30 mm are needed. Cylindrical balloons as large as 30 mm in diameter are commercially available; however, they have several drawbacks, including slow inf lation times, which can prolong systemic hypotension; difficulty maintaining catheter position during systole with the potential for intracardiac trauma; and low nominal burst pressures. 4Attempts to minimize these problems through the use of double balloons, triple balloons, and the Inoue Balloon (Toray Industries, Inc.) have been described, but these procedures are cumbersome, time-consuming, and expensive. 4-8The V8 Aortic Valvuloplasty Balloon Catheter (InterValve Medical, Inc.; acquired by Venus Medtech in 2017) 9 is an hourglass-shaped balloon with 2 bulbous segments, separated by a narrowed waist. During balloon aortic valvuloplasty (BAV), the design improves fixation and enables better leaf let opening without compromising the annulus. The Inoue balloon also has an hourglass shape, and investigators have reported better BAV outcomes with it than with cylindrical balloons. 7,8,10 However, it has a large sheath and rigid properties. 11,12 Moreover, the Inoue is a compliant, low-inf lation pressure balloon, and its hourglass shape disappears during peak inf lation. In contrast, the V8 balloon is semicompliant and retains its shape throughout inflation. The waist and bulbous segments reach predetermined diameters at specified volume-driven inf lations. The waist diameter increases through incremental stepwise inf lations.Although the V8 balloon has provided good results in BAV procedures, its use has not been reported for BPV. 9 We describe our successful experience with the V8 balloon in 3 patients with PVS, and we detail our balloon sizing technique. Device DesignThe distal end of the V8 balloon catheter system features an hourglass-shaped dilation balloon (Fig. 1). Three radiopaque markers on the catheter shaft correspond to the center of the waist segment and to the distal and proximal shoulders of the bulbous balloon segments (Fig. 2). The length of the fully inf lated balloon is 32 mm: the waist segment is 12 mm, and each of the bulbous segments is 10 mm. The waist segment is more compliant than the bulbous segments, so it expands to a greater degree. The TechniquesTeoman Kilic, MD

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Section: Discussionmentioning

confidence: 99%

“…9 We describe our successful experience with the V8 balloon in 3 patients with PVS, and we detail our balloon sizing technique.…”

Section: -8mentioning

confidence: 99%

Section: New Pulmonary Valvuloplasty Techniquementioning

confidence: 99%

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New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis

Kılıç¹,

Şahı̇n²,

Karaüzüm³

et al. 2018

Texas Heart Institute Journal

Self Cite

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“…A much less utilized approach is to deliver a balloon into the native aortic annulus using transvenous-trans-septal access [11]. From the trans-septal puncture into the left atrium, a single-lumen balloon catheter can be floated into the left ventricle femoral arterial sheath and still have enough room for arterial pressure measurement.…”

Section: Antegrade Bavmentioning

confidence: 99%

Balloon Aortic Valvuloplasty: Patient Selection and Technical Considerations

Feldman¹,

Sarraf²,

Pedersen³

2015

jshd

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BAV has had resurgence in association with the dissemination of TAVR. The lack of clear mortality benefit from BAV does not translate to lack of efficacy as a palliative therapy. BAV remains a useful bridge to surgical AVR or TAVR, and for symptom relief in patients who are not candidates for either AVR approach. It is also useful as a diagnostic test for patients with low gradient-low output AS, and for those with mixed pulmonary and aortic valvular disease. BAV is used commonly for TAVR pre dilatation, and this is sometimes helpful for annulus size assessment. Careful attention to balloon diameter selection and the details of technique are important for optimizing outcomes.

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“…The newly innovated Inoue balloon with the two major upgrades described above results in a safer balloon aortic valvuloplasty than the previous balloon with minimal inflation and improved stability. We believe that the novel Inoue balloon further improves the overall outcome after transcatheter aortic valve intervention by allowing secure valvuloplasty in high-risk patients with reduced cardiac function.The V8 and TAV8 aortic valvuloplasty balloon catheters (InterValve Medical) are equipped with an hourglass-shaped balloon similar to the Inoue balloon, which limits undesirable balloon movement during inflation by locking into the aortic valve orifice, making rapid ventricular pacing optional in some situations [7][8][9]. The NuCLEUS-X balloon aortic valvuloplasty catheter (B. Braun Interventional Systems Inc.) also features a waist in the middle of the balloon to facilitate seating in the valve annulus.…”

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confidence: 99%

A novel “proximal first” Inoue balloon catheter for retrograde aortic valvuloplasty: Initial case report

Onishi

Fukutomi

Ando

et al. 2022

Cathet Cardio Intervent

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The Inoue balloon, invented for percutaneous transseptal mitral commissurotomy for mitral stenosis, is initially dilated in the distal portion and then the proximal portion, forming an hourglass shape that stabilizes the balloon at the mitral valve orifice with a pulling action. The device has been successfully applied to antegrade aortic valvuloplasty; the hourglass shape stabilizes the balloon across the aortic valve without rapid ventricular pacing. Subsequently, an Inoue balloon was developed for retrograde aortic valvuloplasty using the same design as the antegrade balloon. The hourglass‐shaped balloon, however, has difficulty maintaining stability across the aortic valve because the distal portion of the balloon, which inflates first, directly receives systolic pressure from the left ventricle. A novel Inoue balloon was invented to overcome this issue by altering the manner of inflation: the proximal portion inflates first, followed by the distal portion. Theoretically, the proximal portion, which initially inflates just above the aortic valve, remains secure across the valve by applying a pressing force that counteracts the systolic forward pressure. Furthermore, a radiopaque marker is placed at the center of the balloon to enable rapid and precise balloon adjustment. We present a case involving a 65‐year‐old female hemodialysis patient with severe symptomatic aortic stenosis who we successfully treated with balloon aortic valvuloplasty using the novel Inoue balloon followed by transcatheter aortic valve implantation. The present case demonstrates the feasibility and effectiveness of the novel “proximal first” Inoue balloon for retrograde balloon aortic valvuloplasty for severe aortic stenosis.

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TCT-791 Improvement in Aortic Valve Area Using a New "Hour Glass" Shaped Valvuloplasty Balloon Compared with Standard Cylindrical Balloons in Severe Aortic Stenosis Patients

Cited by 3 publications

References 0 publications

New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis

New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis

Balloon Aortic Valvuloplasty: Patient Selection and Technical Considerations

A novel “proximal first” Inoue balloon catheter for retrograde aortic valvuloplasty: Initial case report

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