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Percutaneous balloon aortic valvotomy for native aortic stenosis in adults

Percutaneous balloon aortic valvotomy for native aortic stenosis in adults
Literature review current through: May 2024.
This topic last updated: Dec 05, 2023.

INTRODUCTION — Aortic valve replacement (AVR) is the mainstay of treatment of symptomatic severe aortic stenosis (AS) as it offers substantial improvements in symptoms and life expectancy (see "Indications for valve replacement for high gradient aortic stenosis in adults"). The role of transcatheter aortic valve implantation (TAVI; also known as transcatheter aortic valve replacement [TAVR]) as an alternative to surgical aortic valve replacement (SAVR) for patients with severe AS is established in some patient subsets and is evolving in others. Percutaneous balloon aortic valvotomy (BAV; also known as balloon aortic valvuloplasty) is a less invasive means to treat severe AS, but its potential risks outweigh its potential benefits in many cases. A multidisciplinary team approach is recommended in approaching patients with symptomatic AS and choosing among SAVR, TAVI, percutaneous BAV, and medical therapy [1-3].

This topic will review isolated percutaneous BAV for native valve calcific AS in adults. Overview of management of AS, indications for AVR, considerations for SAVR and TAVI, estimating the risk of aortic valve surgery, medical therapy of symptomatic AS, and management of congenital AS are discussed separately. (See "Indications for valve replacement for high gradient aortic stenosis in adults" and "Choice of prosthetic heart valve for surgical aortic or mitral valve replacement" and "Choice of intervention for severe calcific aortic stenosis" and "Estimating the risk of valvular procedures" and "Medical management of symptomatic aortic stenosis" and "Bicuspid aortic valve: General management in adults" and "Valvar aortic stenosis in children".)

PROCEDURE AND MECHANISM — Percutaneous BAV is performed with a catheter-based balloon which is introduced via a vascular access site and positioned across the stenotic aortic valve and inflated [4]. The most common mechanism by which BAV relieves stenosis is by fracturing calcific deposits within the valve leaflets [5]. Scattered leaflet microfractures, stretching of the aortic annulus, and separation of the calcified commissures may also contribute to valve opening, though the effects of valvotomy have not been fully elucidated.

Most aortic balloon valvuloplasty catheters are 9F or greater (although there are some 8F compatible systems) and therefore require a large bore access approach with associated risk of vascular complications. The conventional approach for BAV is via the femoral artery for retrograde access to the aortic valve.

Indications for alternative access include distal aortic occlusion or severe peripheral arterial disease. Alternative access sites include the brachial, axillary, and subclavian arteries for retrograde access; the femoral vein is used for a transseptal antegrade approach [6].

USE

Role of BAV among treatment options for aortic stenosis — Aortic valve replacement (by surgical aortic valve replacement [SAVR] or transcatheter aortic valve implantation [TAVI]) is the treatment of choice in patients with symptomatic severe calcific AS, and the role of BAV is very limited. When an indication for valve replacement for AS is present, the choice of intervention is based upon factors including the estimated benefit and risk of the procedures, patient frailty, and comorbid conditions including coronary artery disease (table 1). For patients with AS being considered for valve intervention (SAVR, transcatheter aortic valve replacement [TAVR], or BAV), a multidisciplinary Heart Valve Team (including cardiologist, cardiovascular surgeon, and interventionalist) should collaborate to optimize care [1,3]. Risk assessment for valvular surgery is discussed further separately. (See "Estimating the risk of valvular procedures".)

Indications for percutaneous balloon aortic valvotomy

Use in calcific aortic stenosis — Given the limitations observed with percutaneous BAV, this procedure is not a substitute for valve replacement in adults with calcific aortic valve disease [3].

Use of BAV is generally limited to the following settings. Patients in these settings should be referred to a Heart Valve Team to assess the potential benefits and risks of percutaneous BAV:

For patients with severely symptomatic calcific AS (eg, with refractory pulmonary edema or cardiogenic shock), percutaneous BAV may be used as a bridge to SAVR or TAVI [7]. Similar recommendations are included in the 2020 American College of Cardiology/American Heart Association (ACC/AHA) and 2017 European Society of Cardiology (ESC) valve guidelines [2,3]. (See "Medical management of symptomatic aortic stenosis", section on 'Critically ill patients awaiting valve replacement'.)

For patients with symptomatic severe calcific AS who require urgent noncardiac surgery where valve replacement by surgery or TAVI is not appropriate, options include proceeding with noncardiac surgery with careful perioperative management with or without preoperative percutaneous BAV [2]. Most asymptomatic patients with severe AS can undergo urgent noncardiac surgery at relatively low risk with careful intraoperative and postoperative management, including careful monitoring and attention to fluid balance, as noted by the 2014 AHA/ACC valve guideline committee and other expert groups [3,8,9]. (See "Noncardiac surgery in adults with aortic stenosis".)

The utility of percutaneous BAV in the following clinical settings is uncertain:

For patients with severe calcific AS with other potential causes for symptomatology (eg, lung disease) or organ dysfunction (eg, left ventricular dysfunction) that may be reversible with percutaneous BAV, some experts have suggested that percutaneous BAV may be helpful for diagnostic purposes. The 2013 Society of Thoracic Surgeons aortic valve guidelines and 2017 ESC valve guidelines include similar recommendations [1,2], but this indication is not endorsed in the AHA/ACC valve guidelines [3]. One inherent difficulty with this approach is that a lack of effect of valvuloplasty does not equate to lack of effect of definitive treatment such as TAVR.

For patients with symptomatic severe calcific AS who are not candidates for SAVR or TAVI, the role of BAV is uncertain since the risk of complications may outweigh the potential temporary symptomatic benefit.

Improvements in both balloon technology and procedural technique may lead to a resurgence in the clinical application of BAV [5], although most clinical settings in which BAV was previously considered may now be better addressed by TAVI. A low-profile compliant balloon with conventional retrograde approach [10] may decrease vascular complications. Given the availability of 8F compatible systems, the more technically complex transseptal antegrade approach [11] is no longer used. (See "Choice of intervention for severe calcific aortic stenosis".)

Use in congenital aortic stenosis — By contrast to the limited role for BAV for calcific AS, BAV is a first-line therapy in children and younger adults with AS due to congenital disease (generally due to bicuspid commissural fusion) without significant valve calcification. Indications for percutaneous BAV for congenital AS are discussed separately. The role of valve intervention prior to and during pregnancy in women with BAV with severe AS is also discussed separately. (See "Bicuspid aortic valve: Preconception and pregnancy care" and "Bicuspid aortic valve: Intervention for valve disease or aortopathy in adults", section on 'Balloon valvotomy' and "Valvar aortic stenosis in children", section on 'First-line treatment (balloon aortic valvotomy)'.)

Contraindications — Percutaneous BAV should not be performed if any of the following contraindications are present: moderate or severe aortic regurgitation (given the risk of worsening regurgitation), infective endocarditis, irreversible noncardiac disease severely limiting life expectancy, or prohibitive peripheral vascular disease limiting vascular access.

EVIDENCE

Calcific aortic stenosis — Observational data suggest that the efficacy and safety of percutaneous BAV are limited. While percutaneous BAV causes a reduction in the transvalvular pressure gradient (eg, reduction in mean transvalvular gradient from 49.1 to 24.5 mmHg in contemporary series [12]), which is often accompanied by an improvement in symptoms, the post-procedure valve area infrequently exceeds 1.0 cm2 (mean post-procedure valve area 0.9±0.3 cm2 in contemporary series [12]), leaving the patient with persistent severe AS [4,13].

Complication rates including mortality following percutaneous BAV have declined but remain substantial as illustrated by two studies:

The United States inpatient database study of patients >60 years old with AS undergoing 2127 percutaneous BAV procedures found that in-hospital mortality and vascular injury declined over a span of 11 years [14]:

Hospital mortality for BAV decreased from 11.5 percent in 1998 to 1999 to 8.8 percent in 2009 to 2010. Predictors of in-hospital mortality included the presence of greater comorbidities, an unstable patient, any complication, and weekend admission. Higher operator volume was associated with substantially lower mortality. Mortality rates are particularly high among patients presenting with cardiogenic shock [15].

A complication rate of 28.9 percent of admissions was reported. Although the overall rate of complications did not change during the study period, the rate of vascular injury fell from 6 percent in 1998 to 2.9 percent in 2010. The most common complications were respiratory (7.7 percent), cardiac (7.3 percent), and vascular (6.8 percent). Predictors of complications included increasing comorbidities, female sex, and unstable clinical status.

Similarly, a systematic review of percutaneous BAV series including 25 studies with a total of 4123 patients found that mortality and major complication rates declined over time, while other complication rates have not significantly changed [12]:

In-hospital mortality was 8.5 percent for patients studied during 1985 to 2004 and declined to 4.6 percent for patients studied during 2005 to 2011.

Major vascular complication rates fell from 10.2 percent during 1985 to 2004 to 4.0 percent for 2005 to 2011.

Other complication rates were similar during early and late time periods with overall rates of 0.8 percent for myocardial infarction, 1.1 percent for stroke, 1.1 percent for severe aortic regurgitation, and 0.9 percent for cardiac tamponade.

Restenosis and clinical deterioration occur in most cases within 6 to 12 months after the procedure, and the long-term outcome resembles the natural history of untreated AS [13,16]. Contemporary data on the time course of symptomatic improvement were provided by a study of inoperable symptomatic AS patients enrolled in the PARTNER trial (Cohort B) [17]. Among 179 inoperable patients randomized to standard treatment (rather than transcatheter aortic valve implantation), 102 patients underwent BAV after randomization. Among patients in the standard treatment group, survival at three months was significantly greater in the BAV group compared with the no BAV group (88.2 versus 73.0 percent), but survival rates at six months were similar (74.5 versus 73.1 percent). There were improvements in quality of life parameters in the BAV group compared with the no BAV group at 30 days and 6 months but not at 12 months.

Repeat BAV can be performed, but most such attempts fail within six months [18].

Congenital aortic stenosis — Outcomes in children and young adults with AS without significant valve calcification are discussed separately. In summary, BAV is an effective therapy in selected children and young adults with AS (largely due to bicuspid aortic valve) without aortic valve calcification, although a significant number of patients require reintervention during long-term follow-up. (See "Bicuspid aortic valve: Intervention for valve disease or aortopathy in adults", section on 'Balloon valvotomy' and "Valvar aortic stenosis in children", section on 'First-line treatment (balloon aortic valvotomy)'.)

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Cardiac valve disease".)

SUMMARY AND RECOMMENDATIONS

Percutaneous balloon aortic valvotomy (BAV) is not a substitute for valve replacement in adults with symptomatic calcific aortic stenosis (AS) as it generally offers only transient symptomatic and hemodynamic relief, entails an approximately 10 to 20 percent risk of major procedural complications, and does not improve long-term survival. Aortic valve replacement (surgical aortic valve replacement [SAVR] or transcatheter aortic valve implantation [TAVI]) is the mainstay of treatment of symptomatic calcific AS, offering substantial improvements in symptoms and life expectancy. (See 'Calcific aortic stenosis' above and "Indications for valve replacement for high gradient aortic stenosis in adults".)

Use of BAV is generally limited to the following settings. Patients in these settings should be referred to a Heart Valve Team to assess the potential benefits and risks of percutaneous BAV (see 'Use in calcific aortic stenosis' above and 'Calcific aortic stenosis' above):

For patients with severely symptomatic calcific AS (eg, with refractory pulmonary edema or cardiogenic shock), percutaneous BAV may be used as a bridge to SAVR or TAVI. (See "Medical management of symptomatic aortic stenosis", section on 'Critically ill patients awaiting valve replacement'.)

For patients with symptomatic severe calcific AS who require urgent noncardiac surgery, options include proceeding with noncardiac surgery with careful perioperative management with or without preoperative percutaneous BAV. By contrast, most asymptomatic patients with severe AS can undergo urgent noncardiac surgery at relatively low risk with careful intraoperative and postoperative management, including careful monitoring and attention to fluid balance. (See "Noncardiac surgery in adults with aortic stenosis".)

For patients with severe calcific AS, the utility of percutaneous BAV in the following clinical settings is uncertain. (See 'Use in calcific aortic stenosis' above.)

For patients with other potential causes for symptomatology (eg, lung disease) or organ dysfunction (eg, left ventricular dysfunction) that may be reversible with percutaneous BAV, some experts have suggested that percutaneous BAV may be helpful for diagnostic purposes.

For patients with symptomatic severe AS who are not candidates for SAVR or TAVI, the role of BAV is uncertain since the risk of complications may outweigh the potential temporary symptomatic benefit.

By contrast to the limited role for BAV for calcific AS, BAV is a first-line therapy in children and younger adults with AS due to congenital disease (generally due to bicuspid commissural fusion) without significant valve calcification, as discussed separately. (See 'Use in congenital aortic stenosis' above and "Bicuspid aortic valve: Intervention for valve disease or aortopathy in adults", section on 'Balloon valvotomy' and "Valvar aortic stenosis in children", section on 'First-line treatment (balloon aortic valvotomy)'.)

ACKNOWLEDGMENT — The UpToDate editorial staff thank William Gaasch, MD, who contributed to earlier versions of this topic review.

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