Aortic stenosis valvuloplasty

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Percutaneous Aortic Balloon Valvotomy (PABV) or Aortic Valvuloplasty

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Joanna J. Wykrzykowska, M.D.; Associate Editor(s)-In-Chief: Mohammed A. Sbeih, M.D. [2]; Usama Talib, BSc, MD [3]; Arzu Kalayci, M.D. [4]

Overview

Although surgical aortic valve replacement is the mainstay of treatment of aortic stenosis as it improves both symptoms and life expectancy, some patients may not be surgical candidates due to comorbidities, and minimally invasive treatment such as percutaneous aortic balloon valvotomy (PABV) maybe an alternative to surgery as a palliative strategy. PABV is a procedure in which 1 or more balloons are placed across a stenotic valve and inflated to decrease the severity of aortic stenosis. This is to be distinguished from transcatheter aortic valve implantation (TAVI) which is a different method that involves replacement of the valve percutaneously.

Indications

  • ACC/AHA guidelines concluded that percutaneous aortic balloon valvotomy (PABV) is not a substitute for aortic valve replacement in adults. In adults with severe calcific AS who are not good candidates for this procedure as there is high restenosis rate (more than 10% of cases) and high risk of complications. Clinical deterioration occur within 6 to 12 months in most patients, and that is why balloon valvotomy is not a substitute for aortic valve replacement surgery. The procedure can be used in children and young adults with congenital, noncalcific AS.

Percutaneous Aortic Balloon Valvotomy (PABV) Technique

  • After preparing the patient, a guide wire is inserted through the femoral artery into the aorta (retrograde technique). 8 French femoral sheath can usually accommodate a 20 mm balloon and minimizes vascular complications. Alternatively two 6 Fr sheath from bilateral femoral approach and two smaller balloons can be used. The latter may be necessary in elderly female patients with concomitant peripheral vascular disease.
  • 0.035” straight wire is commonly used to cross the valve and advance via pig-tail or Amplatz catheter; right heart catheterization is done and transaortic gradient is typically measured pre-procedure. The 0.035” wire is then exchanged for a stiffer 0.038” Amplatz exchange length wire with the tip shaped into a pig-tail shape so as not to injure the left ventricle.
  • A long sheath is introduced over the guide wire, through the sheath a Mansfield balloon is introduced and 20–23 mm X 6 cm balloon is advance over the wire and positioned to straddle the aortic valve.
  • The balloon is manually inflated with a 60 cc syringe containing diluted contrast (slowly). Meticulous control of balloon position must be maintained at all times by backward traction on the balloon to prevent jumping forward and injuring/perforating the left ventricular apex.
  • If there is difficulty in maintaining the balloon across the aortic valve during inflation, temporary ventricular pacing at high rate can reduce the cardiac output and give stability to the balloon.
  • Balloon is deflated and the transvalvular gradient reassessed for success of the procedure. Repeated dilatations can be given if necessary.
  • The balloon should be de-aired and filled with dilute contrast to avoid the chance of air embolism in case of balloon rupture during dilatation.

Outcome

  • Immediately after the procedure a moderate reduction in the transvalvular pressure gradient is usually observed. The aortic valve area after the procedure rarely exceeds 1.0 cm2 but an early symptomatic improvement is usually observed.
  • Patient survival after repeat PABV is higher than that of untreated patients.

Complications

  • Vascular complications are most common thus suture (Perclose) or Angioseal closure after the procedure in this tenuous patient population is preferable.
  • It follows that attention to meticulous access technique is mandatory.
  • Antegrade approach ie venous access with transseptal approach can be done in select patients, however, hemodynamic effects of mitral valve incompetence as a stiff wire is placed across the mitral valve are often poorly tolerated; mitral valve injury has been reported in this approach.
  • There is a small but significant risk of development of aortic regurgitation as a result of the procedure which can lead to pulmonary edema.
  • The balloon may rupture while dilation of a calcified valve is performed.

2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (VHD) [1][2]

Aortic Stenosis

Choice of Intervention

COR LOE RECOMMENDATION COMMENT/RATIONALE
I C For patients in whom TAVR or high-risk surgical AVR is being considered, a heart valve team consisting of an integrated, multidisciplinary group of healthcare professionals with expertise in VHD, cardiac imaging, interventional cardiology, cardiac anesthesia, and cardiac surgery should collaborate to provide optimal patient care. 2014 recommendation remains current.
I B-NR Surgical AR is recommended for symptomatic patients with severe AS (Stage D) and asymptomatic patients with severe AS (Stage C) who meet an indication for AVR when surgical risk is low or intermediate. MODIFIED: LOE updated from A to B-NR. Prior recommendations for intervention choice did not specify patient symptoms. The patient population recommended for surgical AVR encompasses both symptomatic and asymptomatic patients who meet an indication for AVR with low-to-intermediate surgical risk. This is opposed to the patient population recommended for TAVR, in whom symptoms are required to be present. Thus, all recommendations for type of intervention now specify the symptomatic status of the patient.
I A Surgical AVR or TAVR is recommended for symptomatic patients with severe AS (Stage D) and high risk for surgical AVR, depending on patient specific procedural risks, values, and preferences. MODIFIED: COR updated from IIa to I, LOE updated from B to A. Longer-term follow-up and additional RCTs have demonstrated that TAVR is equivalent to surgical AVR for severe symptomatic AS when surgical risk is high.
I A TAVR is recommended for symptomatic patients with severe AS (Stage D) and a prohibitive risk for surgical AVR who have a predicted post-TAVR survival greater than 12 months. MODIFIED:LOE updated from B to A. Longer-term follow-up from RCTs and additional observational studies has demonstrated the benefit of TAVR in patients with a prohibitive surgical risk.
IIa B-R TAVR is a reasonable alternative to surgical AVR for symptomatic patients with severe AS (Stage D) and an intermediate surgical risk, depending on patient-specific procedural risks, values, and preferences. NEW: New RCT showed noninferiority of TAVR to surgical AVR in symptomatic patients with severe AS at intermediate surgical risk.
IIb C Percutaneous aortic balloon dilation may be considered as a bridge to surgical AVR or TAVR for symptomatic patients with severe AS. 2014 recommendation remains current.
III: No Benefit C TAVR is not recommended in patients in whom existing comorbidities would preclude the expected benefit from correction of AS. 2014 recommendation remains current.

References

  1. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM, Thompson A (2017). "2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines". Circulation. 135 (25): e1159–e1195. doi:10.1161/CIR.0000000000000503. PMID 28298458.
  2. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM, Thompson A (2017). "2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines". J. Am. Coll. Cardiol. 70 (2): 252–289. doi:10.1016/j.jacc.2017.03.011. PMID 28315732.

AHA/ACC 2014 Guideline for the Management of Patients With Valvular Heart Diseases

Timing of Intervention

Class I
"1. AVR is recommended with severe high-gradient AS who have symptoms by history or on exercise testing (stage D1)(Level of Evidence: B)"
"2. AVR is recommended for asymptomatic patients with severe AS (stage C2)and LVEF <50% (Level of Evidence: B)"
"3. AVR is indicated for patients with severe AS (stage C or D) when undergoing other cardiac surgery (Level of Evidence: B)"
Class IIa
"1. AVR is reasonable for asymptomatic patients with very severe AS (stage C1, aortic velocity ≥5.0 m/s) and low surgical risk (Level of Evidence: B)"
"2. AVR is reasonable in asymptomatic patients (stage C1) with severe AS and decreased exercise tolerance or an exercise fall in BP (Level of Evidence: B)"
"3. AVR is reasonable in symptomatic patients with low-flow/low-gradient severe AS with reduced LVEF (stage D2) with a low-dose dobutamine stress study that shows an aortic velocity ≥ 4.0 m/s (or mean pressure gradient ≥ 40 mm Hg) with a valve area ≤ 1.0 cm2 at any dobutamine dose (Level of Evidence: B)"
"4. AVR is reasonable in symptomatic patients who have low-flow/low-gradient severe AS (stage D3) who are normotensive and have an LVEF ≥50% if clinical, hemodynamic, and anatomic data support valve obstruction as the most likely cause of symptoms (Level of Evidence: C)"
"5. AVR is reasonable for patients with moderate AS (stage B) (aortic velocity 3.0–3.9 m/s) who are undergoing other cardiac surgery (Level of Evidence: C)"
Class IIb
"1. AVR may be considered for asymptomatic patients with severe AS (stage C1) and rapid disease progression and low surgical risk (Level of Evidence: C)"

Choice of Surgical or Transcatheter Intervention

Class I
"1. Surgical AVR is recommended in patients who meet an indication for AVR with low or intermediate surgical risk. (Level of Evidence: A)"
"2. For patients in whom TAVR or high-risk surgical AVR is being considered, members of a Heart Valve Team should collaborate to provide optimal patient care (Level of Evidence: C)"
"3. TAVR is recommended in patients who meet an indication for AVR for AS who have a prohibitive surgical risk and a predicted post-TAVR survival >12 months (Level of Evidence: B)"
Class IIa
"1. TAVR is a reasonable alternative to surgical AVR in patients who meet an indication for AVR and who have high surgical risk (Level of Evidence: B)"
Class IIb
"1. Percutaneous aortic balloon dilation may be considered as a bridge to surgical or transcatheter AVR in severely symptomatic patients with severe AS. (Level of Evidence: C)"
Class III
"1. TAVR is not recommended in patients in whom existing comorbidities would preclude the expected benefit from correction of AS. (Level of Evidence: B)"

2008 Focused Update Incorporated Into the 2006 ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease and the Guidelines for the Management of Adults With Congenital Heart Disease (DO NOT EDIT)[1][2]

Recommendations for Aortic Valve Repair/Replacement and Aortic Root Replacement (DO NOT EDIT)[1]

Class I
"1. Aortic valvuloplasty, AVR, or Ross repair is indicated in patients with severe AS or chronic severe AR while they undergo coronary artery bypass grafting, surgery on the aorta, or surgery on other heart valves. (Level of Evidence: C)"
"2. AVR is indicated for patients with severe AS and LV dysfunction (LV ejection fraction less than 50%). (Level of Evidence: C)"
"3. AVR is indicated in adolescents or young adults with severe AR who have:
a. Development of symptoms. (Level of Evidence: C)
b. Development of persistent LV dysfunction (LV ejection fraction less than 50%) or progressive LV dilatation (LV end-diastolic diameter 4 standard deviations above normal). (Level of Evidence: C)"
"4. Surgery to repair or replace the ascending aorta in a patient with a BAV is recommended when the ascending aorta diameter is 5.0 cm or more or when there is progressive dilatation at a rate greater than or equal to 5 mm per year.[3] (Level of Evidence: B)"
Class III
"1. AVR is not useful for prevention of sudden death in asymptomatic adults with AS who have none of the findings listed under the Class IIa/IIb indications. (Level of Evidence: B)"
"2. AVR is not indicated in asymptomatic patients with AR who have normal LV size and function. (Level of Evidence: B)"
Class IIa
"1. AVR is reasonable for asymptomatic patients with severe AR and normal systolic function (ejection fraction greater than 50%) but with severe LV dilatation (LV end-diastolic diameter greater than 75 mm or end-systolic dimension greater than 55 mm*). (Level of Evidence: B)"
"2. Surgical aortic valve repair or replacement is reasonable in patients with moderate AS undergoing coronary artery bypass grafting or other cardiac or aortic root surgery. (Level of Evidence: B)"
Class IIb
"1. AVR may be considered for asymptomatic patients with any of the following indications
a. Severe AS and abnormal response to exercise. (Level of Evidence: C)
b. Evidence of rapid progression of AS or AR. (Level of Evidence: C)
c. Mild AS while undergoing coronary artery bypass grafting or other cardiac surgery and evidence of a calcific aortic valve. (Level of Evidence: C)
d. Extremely severe AS (aortic valve area less than 0.6 cm and/or mean Doppler systolic AV gradient greater than 60 mm Hg) in an otherwise good operative candidate. (Level of Evidence: C)
e. Moderate AR undergoing coronary artery bypass grafting or other cardiac surgery. (Level of Evidence: C)
f. Severe AR with rapidly progressive LV dilation when the degree of LV dilation exceeds an end-diastolic dimension of 70 mm or end-systolic dimension of 50 mm, with declining exercise tolerance, or with abnormal hemodynamic responses to exercise. (Level of Evidence: C)"
"2. Surgical repair may be considered in adults with AS or AR and concomitant ascending aortic dilatation (ascending aorta diameter greater than 4.5 cm) coexisting with AS or AR. (Level of Evidence: B)"
"3. Early surgical repair may be considered in adults with the following indications:
a. AS and a progressive increase in ascending aortic size. (Level of Evidence: C)
b. Mild AR if valve-sparing aortic root replacement is being considered. (Level of Evidence: C)"
*Consider lower threshold values for patients of small stature of either gender.

Aortic Balloon Valvotomy Indications (DO NOT EDIT) [2]

Class III
"1. Aortic balloon valvotomy is not recommended as an alternative to AVR in adult patients with AS; certain younger adults without valve calcification may be an exception. (Level of Evidence: B) "
Class IIb
"1. Aortic balloon valvotomy might be reasonable as a bridge to surgery in hemodynamically unstable adult patients with AS who are at high risk for AVR. (Level of Evidence: C) "
"2. Aortic balloon valvotomy might be reasonable for palliation in adult patients with AS in whom AVR cannot be performed because of serious comorbid conditions. (Level of Evidence: C) "

Aortic Balloon Valvotomy Indications in Adolescents (DO NOT EDIT) [2]

Class I
"1. Aortic balloon valvotomy is indicated in the adolescent or young adult patient with AS who has symptoms of angina, syncope, or dyspnea on exertion and a catheterization peak LV-to-peak aortic gradient greater than or equal to 50 mm Hg without a heavily calcified valve. (Level of Evidence: C)*"
"2. Aortic balloon valvotomy is indicated for the asymptomatic adolescent or young adult patient with AS who has a catheterization peak LV-to-peak aortic gradient greater than 60 mm Hg. (Level of Evidence: C)*"
"3. Aortic balloon valvotomy is indicated in the asymptomatic adolescent or young adult patient with AS who develops ST or T-wave changes over the left precordium on ECG at rest or with exercise and who has a catheterization peak LV-to-aortic gradient greater than 50 mm Hg. (Level of Evidence: C)*"
Class III
"1. Aortic balloon valvotomy should not be performed when the asymptomatic adolescent or young adult patient with AS has a catheterization peak LV-to-peak aortic gradient less than 40 mm Hg without symptoms or ECG changes. (Level of Evidence: C)*"
Class IIa
"1. Aortic balloon valvotomy is reasonable in the asymptomatic adolescent or young adult patient with AS when catheterization peak LV-to-peak aortic gradient is greater than 50 mm Hg and the patient wants to play competitive sports or desires to become pregnant. (Level of Evidence C)*"
"2. In the adolescent or young adult patient with AS, aortic balloon valvotomy is probably recommended over valve surgery when balloon valvotomy is possible. Patients should be referred to a center with expertise in balloon valvotomy. (Level of Evidence: C)*"
* Gradients are usually obtained with patients sedated. If general anesthesia is used, the gradients may be somewhat lower.

References

  1. 1.0 1.1 Warnes CA, Williams RG, Bashore TM, Child JS, Connolly HM, Dearani JA; et al. (2008). "ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines on the Management of Adults With Congenital Heart Disease). Developed in Collaboration With the American Society of Echocardiography, Heart Rhythm Society, International Society for Adult Congenital Heart Disease, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons". J Am Coll Cardiol. 52 (23): e1–121. doi:10.1016/j.jacc.2008.10.001. PMID 19038677.
  2. 2.0 2.1 2.2 Bonow RO, Carabello BA, Chatterjee K; et al. (2008). "2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons". Circulation. 118 (15): e523–661. doi:10.1161/CIRCULATIONAHA.108.190748. PMID 18820172. Unknown parameter |month= ignored (help)
  3. Bonow RO, Carabello BA, Chatterjee K, de Leon AC, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS, Smith SC, Jacobs AK, Adams CD, Anderson JL, Antman EM, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B (2006). "ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing Committee to Revise the 1998 guidelines for the management of patients with valvular heart disease) developed in collaboration with the Society of Cardiovascular Anesthesiologists endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons". Journal of the American College of Cardiology. 48 (3): e1–148. doi:10.1016/j.jacc.2006.05.021. PMID 16875962. Retrieved 2012-11-12. Unknown parameter |month= ignored (help)


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