Aortic and Pulmonic Balloon Valvuloplasty


Balloon Aortic Valvuloplasty

Balloon aortic valvuloplasty (BAV) for severe aortic stenosis (AS), a common disease of the elderly, was introduced by Dr. Cribier in 1986. Initial experience demonstrated the technical feasibility, acceptable safety, and fairly modest improvement in valve areas. In spite of an only modest improvement in valve area, patients experienced significant symptomatic benefit, resulting in an initially enthusiastic embrace by interventional cardiologists. However, the subsequent recognition of high restenosis rates within a year of the procedure quickly tempered enthusiasm. Large series have demonstrated restenosis rates of 40% to 80% within 5 to 9 months and a failure to improve survival despite palliative benefits of BAV. The clinical lag in symptomatic recurrence extends the palliative benefit 6 to 9 months beyond hemodynamic restenosis. Therefore an overall quality-of-life (QOL) benefit after BAV may last up to between 1 and 1.5 years in elderly patients who are generally less concerned about durable efficacy.

Background

Calcific AS is the most common expression of primary valvular heart disease in adults. Moderate to severe AS is observed in 4.6% of patients older than 75 years of age. Surgical aortic valve replacement (AVR) is the preferred treatment strategy for patients of all age groups, although it has limitations in octogenarians and nonagenarians. Eight retrospective studies of patients over 80 years of age showed a pooled 30-day mortality rate of 9.2% for isolated AVR and 20.9% for combined AVR and coronary bypass grafting. Transcatheter AVR (TAVR) has expanded the option for valve replacement therapy in elderly patients who are at high risk for surgery because of comorbidities and frailty. Although TAVR offers a more durable improvement for the treatment of AS than BAV, BAV is being carried out with increasing frequency for a number of reasons. In the largest registry (i.e., National Heart, Lung, and Blood Institute [NHLBI]), outcomes of procedures performed in the late 1980s demonstrated the significant limitation in clinical benefit for younger patients in their late 70s, predominantly linked to restenosis. High complication rates were also reported in these early series (i.e., 25% in the NHLBI series; Table 5–1 ).

TABLE 5–1
NHLBI BAV Registry
Demographics and Outcomes
Years enrolled 1987-89
No. enrolled 674
No. centers 24
Mean age 78 years
Female 377 (56%)
CAD 248 (43%)
Unknown 97 (15%)
Presentation
CHF NYHA class III/IV 76%
Angina class III/IV 23%
Syncope/presyncope 34%
Inappropriate for surgery 80%
Mean gradient (intraprocedural) Mean
Baseline 55 mm Hg
Postvalvuloplasty 29 mm Hg
Mean valve area (intraprocedural)
Baseline 0.50 cm 2
Postvalvuloplasty 0.80 cm 2
Follow-up (echocardiographic) N=182
Baseline mean gradient 49 mm Hg
Gradient (mean or peak) Mean
Postvalvuloplasty 38 mm Hg
6-Month follow-up 43 mm Hg
Valve area
Baseline 0.57 cm 2
Postvalvuloplasty 0.78 cm 2
6-Month follow-up 0.65 cm 2
Symptomatic improvement 75% at 1 year
Cause mortality
Procedure 3%
At hospital discharge 10%
30 Days 14%
1 Year 45%
2 Years 65%
3 Years 77%
Complications During or Within 24 Hours After Valvuloplasty Procedure
Complication n (%)
Death 17 (3)
Patients with any severe complication 167 (25)
Type of complication
Hemodynamic
Prolonged hypotension 51 (8)
CPR required 26 (4)
Pulmonary edema 19 (3)
Cardiac tamponade 10 (1)
IABP use 11 (2)
Aortic valvular insufficiency 6 (1)
Cardiogenic shock 15 (2)
Neurological
Focal neurological event 13 (2)
Respiratory
Intubation 28 (4)
Arrhythmia
Treatment required 64 (10)
Persistent bundle-branch block 34 (5)
AV block requiring pacing 30 (4)
VF of VT requiring countershock 18 (3)
Vascular
Vascular surgery performed 33 (5)
Systematic embolic event 11 (2)
Transfusion required 136 (20)
Ischemic
Acute myocardial infarction 10 (1)
Other severe complications
Pulmonary artery perforation 1 (0.1)
Acute tubular necrosis 1 (0.1)
AV, Atrioventricular; CAD, coronary artery disease; CHF, congestive heart failure; CPR, cardiopulmonary resuscitation; IABP, intraaortic balloon pump; NHLBI, National Heart, Lung, and Blood Institute; NYHA, New York Heart Association; VF, ventricular fibrillation; VT, ventricular tachycardia.

The reemergence of BAV since 2000 resulted from a more clear definition of its palliative role in high-risk patient subsets, its requirement for predilation in TAVR, and its utility in clarifying the role of AS in symptomatic patients with multiple disease states before TAVR. In addition, broader adoption has resulted from improvements in technique. Recent series have highlighted improved outcomes and reduced complications (Table 5–2) .

TABLE 5–2
Two Large BAV Registry Experiences in U.S. of Procedures Performed Since 2000
Washington Hospital Center
Jan. 2000-Dec. 2009
Minneapolis Heart Institute
Jun. 2003-Feb. 2012
I. Demographics
Patients 262 332
Procedures 301 412
Age (years) 81.7 ± 9.8 85.5 ± 6.6
STS score > 10 (%) 69.1 42.7
Female sex 145 (55.3%) 186 (56.0%)
Coronary artery disease 168 (64.1%) 184 (55.4%)
II. Patient BAVs
Total number of patients 262 332
Patients with single BAV 223 (85.1%) 252 (75.9%)
Patients with 2 BAVs 29 (11.0%) 53 (16.0%)
Patients with 3 BAVs 8 (3.1%) 25 (7.5%)
Patients with 4 BAVs 2 (0.8%) 2 (0.6%)
III. A. Procedural Data
Balloon size (mm) 22.9 ± 1.9 23.9 ± 1.2
# of Inflations 1.7 ± 0.9 3.2 ± 1.5
III. B. Combined BAV + PCI
Total 52 (17.2%) 56 (17.0%)
PCI-1 vessel 44 (84.6%) 37 (66.1%)
PCI-2 vessel 6 (11.6%) 15 (26.8%)
PCI-3 vessel 2 (3.8%) 4 (7.1%)
IV. Intraprocedural Hemodynamics
Mean gr pre-BAV (mmHg) 46.3 ± 19.7 49.8 ± 16.7
Mean gr post-BAV (mmHg) 21.4 ± 12.4 25.2 ± 10.4
AVA pre-BAV (cm 2 ) 0.58 ± 0.3 0.64 ± 0.2
AVA post-BAV (cm 2 ) 0.96 ± 0.3 N/A
V. Echocardiography
Mean gr pre-BAV (mm Hg) 42.0 ± 13.9 43.55 ± 13.71
Mean gr post-BAV (mm Hg) 31.9 ± 11.8 26.78 ± 11.18
AVA pre-BAV (cm 2 ) 0.68 ± 0.15 0.61 ± 0.16
AVA post-BAV (cm 2 ) 0.87 ± 0.19 0.84 ± 0.30
LVEF pre-BAV (%) 45.4 ± 18.4 43.81 ± 12.84
LVEF post-BAV (%) 47.0 ± 18.0 45.74 ± 9.09
AR gr pre-BAV 0.8 ± 0.7 1.1 ± 0.8
AR gr post-BAV 1.0 ± 0.7 0.9 ± 0.6
MR gr pre-BAV 1.5 ± 1.2 2.4 ± 0.8
MR gr post-BAV 1.4 ± 1.0 2.2 ± 1.0
VI. Serious Adverse Events
Intraprocedural death 5 (1.6%) 9 (2.2%)
Stroke 6 (1.99%) 5 (1.2%)
Coronary occlusion 2 (0.66%) 1 (0.2%)
Emergent interventions Hypotension requiring CPR, intubation, cardioversion 5 (1.6%) Intubations 7 (2.11%) Cardioversions 6 (1.81%) Emergent IABPs 5 (1.5%)
Tamponade 1 (0.3%) 2 (0.5%)
TPM N/A 2 (0.5%)
PPM 3 (0.99%) 2 (0.5%)
Vascular complications 21 (6.9%) Requiring any intervention 3 (0.7%) Requiring surgical intervention
AR, Aortic regurgitation; AVA, aortic valve area; BAV, balloon aortic valvuloplasty; CPR, cardiopulmonary resuscitation; gr, grade; IABP, intraaortic balloon pump; LVEF, left ventricular ejection fraction; MR, mitral regurgitation; PCI, percutaneous coronary intervention; PPM, permanent pacemaker; STS, Society of Thoracic Surgery; TPM, temporary pacemaker.

Valve Histopathology and Balloon Aortic Valvuloplasty Mechanism of Action

Calcific AS is characterized by increased leaflet thickness, calcification, and rigid immobility, generally in the absence of commissural fusion. Until recently, calcific AS was considered to be histopathologically degenerative or passive in origin. It is now recognized as a complex, active, cellular process with features of atherosclerosis and biomineralization similar to osteogenesis in bone formation.

The effects of BAV on stenosed aortic valves are poorly understood, but several mechanisms appear likely. Primarily, balloon-induced fracturing of calcified nodules create hingepoints, and along with the creation of cleavage planes in collagenous stroma, improve leaflet flexibility and valve opening. Separation of fused leaflets is uncommon given its infrequent occurrence in nonrheumatic patients. Enhanced compliance or stretching of the adjacent annulus and calcified aortic root have also been suggested.

Restenosis is generally believed to occur from scar tissue (cell-rich pattern of fibroblasts, capillaries, and inflammatory infiltrate) within small leaflet tears. Heterotopic ossification (bone formation) was reported to occur in another small series. On occasion, recoil of the elastic valve components may result in early valve renarrowing within hours to days.

Patient Selection

Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines are listed in Box 5–1 . The substantial increase in BAV volumes over the past 5 to 10 years has come about for two primary reasons. The first is based on a realization that an increasing population of elderly patients with comorbidities and who are at high risk or otherwise poorly suited for surgical AVR derive significant palliation. Multiple published experiences have shown a consistent reduction in New York Heart Association (NYHA) functional class, the preponderance improving from functional class III/VI to I/II. The demonstrated safety in serial BAVs for patients with recurrent restenosis extends the opportunity for achieving longer periods of enhanced QOL. In general, these authors like to see at least 6 months of benefit before performing a subsequent BAV. In cases where this time is shorter, underdilation on the previous intervention may offer the opportunity for more aggressive increments in balloon sizing. Although unproven, some authors have suggested a survival benefit as well. With improved technique, symptomatic AS patients who are not candidates for surgical AVR or TAVR should be offered palliative BAV in place of medical therapy alone.

BOX 5–1
2006 ACC/AHA Guidelines

Aortic Balloon Valvotomy

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)

Class III

Aortic balloon valvotomy is not recommended as an alternative to AVR in adult patients with AS; certain younger patients without valve calcification may be an exception.

ACC, America College of Cardiology; AHA, American Heart Association; AS, aortic stenosis; AVR, aortic valve replacement (surgical).

Second, the option for TAVR in poor–surgical-risk groups has had an explosive impact on the use of BAV that is not only essential for predilation, but has now been reported to successfully bridge patients to TAVR. Patients initially too unstable in one series underwent successful TAVR after a mean interval of 59 ± 57 days. However, the precise role for BAV as a bridge requires further study. Many patients with severe AS and symptoms have other comorbidities such as severe lung disease that may play a significant role in their symptom complex. A “diagnostic” BAV can be performed to evaluate the role AS is playing, and if it is significant, BAV can then be followed by TAVR. Candidates in the current “TAVR era” for stand-alone BAV in the adult cardiology practice at Minneapolis Heart Institute (MHI) are shown in Box 5–2 .

BOX 5–2
Candidates for Stand-Alone BAV in MHI’s Adult Cardiology Practice in the TAVR Era

Patients with symptomatic AS poorly suited for eventual TAVR or AVR

High surgical risk profile secondary to comorbidities and/or frailty, plus one of the following:

  • 1.

    Very limited longevity (<2 years)

  • 2.

    Unsuitable cardiac or vascular anatomy for TAVR

  • 3.

    No candidate for antiplatelet therapy secondary to bleeding risk

Bridge to TAVR or AVR

  • 1.

    “Diagnostic” BAV in patients with severe AS and other potential causes for symptoms (i.e., lung disease)

  • 2.

    Patients in which a significant degree of myocardial dysfunction, prerenal insufficiency, or other organ system dysfunctions that may be reversible with BAV

  • 3.

    High risk for noncardiac surgery that is not elective

  • 4.

    Patients requiring high-risk PCI before TAVR (combine BAV + PCI)

  • 5.

    Acutely unstable patients

AS, Aortic stenosis; AVR, surgical aortic valve replacement; BAV, balloon aortic valvuloplasty; MHI, Minneapolis Heart Institute; PCI, percutaneous coronary intervention; TAVR, transcatheter aortic valve replacement.

Technique

BAV can be carried out using two different approaches that are well-described in the literature. The most commonly used approach is the retrograde technique. The antegrade technique, which will be discussed in less detail, is predominantly indicated in patients with inadequate arterial access (Figure 5–1) .

Figure 5–1, A, Retrograde arterial approach using a standard aortic balloon. B, Antegrade transseptal approach using an Inoue balloon

Retrograde Approach

Patient Preparation and Access

Over 50% of BAVs at MHI are performed electively by way of outpatient admission. Patients are pretreated with 325 mg of aspirin. A large-bore peripheral intravenous (IV) line and usually a Foley catheter are placed before transfer to the cardiovascular laboratory, especially in patients in whom postprocedure diuresis is anticipated. An intraaortic balloon pump (IABP) should be available in the room for patients who are hemodynamically unstable or those with left ventricular ejection fraction (LVEF) less than 30%. Defibrillation patches are placed in the lateral chest positions where they will not interfere with imaging. The procedure is carried out under conscious sedation using IV midazolam and fentanyl.

Both right and left groins are prepped. The authors most commonly use just the right side for arterial and venous access. Six-French femoral arterial and 8F femoral venous sheaths are placed when the patient is under local anesthesia. Care is taken to document appropriate landmarks to ensure arterial access through the anterior wall of the common femoral artery. After confirming common femoral artery access with a contrast injection, the arterial access site is preclosed using two 6F ProGlide devices (Abbott Vascular, Abbott Park, Ill.). Sutures are deployed sequentially at 90-degree angles to each other at the 10 o’clock and 2 o’clock positions and draped to either side with Kelly clamps. A 10F to 12F sheath is then exchanged for the initially placed sheath, depending on valvuloplasty balloon type and size. Alternatively, a single 10F Prostar device (Abbott Vascular, Abbott Park, Ill.) can be used. Patients are then given 70 units/kg of unfractionated IV heparin, which is titrated to achieve an activated clotting time (ACT) of 250 to 300 seconds.

Intraprocedural Diagnostic Evaluation

Coronary angiography is performed, most importantly, to rule out critical stenosis of the left main coronary artery before proceeding with BAV. An unprotected critical left main coronary artery, if anatomically suitable, should be stented before performing BAV. Other severe lesions felt to be clinically relevant can be treated safely after BAV as a combined procedure. See the subsequent discussion on combined coronary stenting and BAV.

Right heart catheterization is then performed with a Swan-Ganz catheter (Edwards Lifesciences, Inc., Irvine, Calif.). Given the incidence of disparity in cardiac outputs, the authors perform both thermodilution and estimated Fick outputs for use in the Gorlin formula when calculating the aortic valve area (AVA). The left heart catheterization is performed, and simultaneous left ventricular and aortic pressures using a dual lumen pigtail catheter are recorded to derive the mean valve gradient. Central aortic pressure from the ascending aorta should be sampled to prevent arterial amplification and a delay in the arterial waveform, which is seen when sampling from a peripheral site. It is imperative to place greater emphasis on the aortic valve index than the AVA when making treatment decisions. In large patients, AVA will significantly underestimate the severity of stenosis. A valve index greater than 0.6 cm 2 /m 2 is severe.

Crossing the Aortic Valve and Guidewire Positioning

Patients undergoing BAV will be heparinized before the aortic valve is crossed. Nevertheless, it is important to routinely wipe wires and flush catheters with heparinized saline every 2 minutes during attempted crossing. Although one’s choice of catheters for crossing the valve is somewhat personal, most operators use 6F Amplatz left (AL; Cordis Corporation; Bridgewater, N.J.) diagnostic catheters to best achieve a coaxial trajectory with a straight wire to access the left ventricle. A preferred choice has been an AL-1; however, an AL-2 configuration, especially in patients with a horizontal root and vertical valve, may be preferred. The authors prefer to attempt crossing in a 20-degree to 40-degree left anterior oblique projection. A brief cine run for two to three cardiac cycles without contrast is first captured for defining the precise location of systolic leaflet separation. The catheter is then positioned within the systolic jet, which is confirmed fluoroscopically by visualizing catheter tip vibration. The softer end of the straight-tip wire is then used to gently probe the valve in the area where leaflet separation was documented. Clockwise and counterclockwise catheter rotations are generally required to fall into the correct anteroposterior plane of the valve orifice. Once the valve is crossed, an attempt to fix the wire in the middle of the ventricular cavity is made, at which point the working view is switched to a right anterior oblique projection for further wire and catheter positioning (Figure 5–2, A-E ) . With the straight-tip wire fixed, the AL catheter is advanced into the left ventricle, avoiding advancement of the catheter tip and wire forcefully into the apex or other endocardial segments. Myocardial perforation can occur in this context. The catheter may be fixed in the mid-left ventricular chamber when removing the guide wire, allowing the broad secondary curve of the AL catheter tip to point back retrograde toward the aortic valve. A 0.035-inch J -tipped exchange wire can then be advanced through the AL catheter and easily draped in a broad curve across the anterior, apical, and inferior wall segments. A dual lumen pigtail catheter is then advanced into the left ventricle over the exchange wire, and simultaneous left ventricular and central aortic pressures are recorded to obtain a mean aortic valve gradient.

Figure 5–2, A, Amplatz diagnostic catheter with straight-tip wire positioned in mid-left ventricular (LV) cavity. B, The Amplatz catheter tip directed retrograde toward the aortic valve while removing the straight-tip guidewire. C, Amplatz catheter positioned in mid-LV cavity after removing straight-tip guide-wire. D, 0.035-inch exchange wire being positioned in left ventricle and Amplatz catheter being withdrawn. E, 0.035-inch exchange wire draped in a broad curve across anterior and inferior LV wall segments before positioning the dual lumen pigtail catheter.

Rapid Ventricular Pacing

Rapid ventricular pacing has been invaluable for stabilizing balloon position across the aortic valve during inflation. The marked decrement in forward stroke volume with pacing significantly reduces the likelihood of the balloon being ejected into the aorta. A bipolar pacing lead is positioned in the right ventricle via the right femoral venous sheath, and stable capture thresholds are confirmed. Some operators have reported success in attaching an external pacemaker directly to the left ventricular wire and skin using alligator clips to achieve rapid pacing without the need for a transvenous pacemaker. A brief pacing run is carried out at 180 to 220 beats/min to ensure consistent 1:1 capture without intermittent loss of capture or 2:1 exit block. A drop in systolic blood pressure to less than 50 mmHg also needs to be confirmed with this rapid pacing sequence (Figure 5–3) . In patients with severe left ventricular systolic dysfunction, pacing at add 180 beats/min is often adequate to achieve significant drop in blood pressure. Test runs should be kept to a minimum to avoid provoking a transient decrease in LVEF and more prolonged hypotension. These high pacing rate commands can be given only by pacing from the atrial (not ventricular) connection terminal on the pacing box. A lower rate limit of 60 beats/min is programmed for backup pacing if necessary.

Figure 5–3, Rapid ventricular pacing. ( Art , Arterial; BP, blood pressure; HR, heart rate.)

Balloon Selection, Positioning, and Inflation

The authors use an Amplatz Extra Stiff 0.035-inch exchange wire for the balloon valvuloplasty. Before exchanging this wire through the double-lumen pigtail catheter (or other diagnostic catheter) in the left ventricle, a broad loop is shaped in the flexible end either using a dull instrument or finger tips ( Figure 5–4 ). Broader loops should be made for larger left ventricles. The curve is generally begun just proximal to the stiffer shaft transition into the more flexible segment, thereby avoiding a potential acute angled buckle in the wire capable of perforating the ventricle. In a right anterior oblique fluoroscopic projection, the wire is advanced into the ventricle and with the aid of the indwelling pigtail catheter, can be easily draped across the anterior, apical, and inferior wall segments. It is important to preserve this distal wire curve and left ventricular relationship during balloon inflation to avoid left ventricular perforations, which can occur during subsequent balloon inflations if the distal wire tip or sharply angled bend is pointed into the apex or inferior wall (Figure 5–5, A and B ) .

Figure 5–4, Amplatz Extra Stiff guidewire shaped by hand for BAV.

Figure 5–5, A, Correct wire position during balloon inflation. B, Example of incorrect wire position with balloon inflation that can result in stiff wire “sawing” through left ventricular apex.

Balloon sizing is generally more aggressive in stand-alone BAV than when predilation is carried out for TAVR. The authors use 4-cm noncompliant aortic balloons (e.g., Z-Med and Z-Med II [B. Braun Interventional Systems, Bethlehem, Pa.]) and generally begin with a balloon diameter-to-annulus ratio of 1:1 in stand-alone cases and 1 to 2 mm less when predilating for TAVR. The Maxi LD balloon (Cordis Corporation, Bridgewater, N.J.) is another popular choice; it is available in 4- or 6-cm lengths with a rated burst pressure of 5 to 6 atm and can be placed through smaller sheaths (8F to 12F) than the Z-Med balloons. More compliant balloons (e.g., Tyshak II [B. Braun Interventional Systems, Bethlehem, Pa.]) have the advantage of being lower in profile, and thus access sheaths ranging from 8F to 10F can be used. The more compliant balloons have less predictable inflation diameters, requiring the operator to use more conservative balloon diameters. In addition, rated burst pressures are just 2 atm or less. With these cylinder-shaped aortic balloons, antegrade migration can occur into the ascending aorta, even with rapid ventricular pacing. It is therefore important to choose a balloon diameter at least 1 to 2 millimeters less than the measured sinotubular junction diameter. Contrast used for balloon inflation is diluted to 1:8 or 1:10 to minimize viscosity and thus inflation/deflation times. The authors use a 60-cc handheld, disposable plastic syringe to inject the dilute contrast. Most balloons are filled using 20 to 30 cc of the dilute contrast. A 10-cc side syringe can be connected to a three-way stopcock on the balloon injection port to achieve more rapid filling or augment inflation volume. After positioning the uninflated balloon markers across the valve, rapid ventricular pacing is initiated. After confirming 1:1 capture and a systolic arterial blood pressure less than 50 mmHg, the balloon is inflated as rapidly as possible by the second operator or technician. The first operator holds the balloon catheter shaft, making adjustments under fluoroscopy to maintain a stable balloon position centered across the valve (Figure 5–6) . The balloon is fully inflated for 2 to 3 seconds before deflation. Arterial pressure is monitored from the femoral arterial sheath side-arm. After balloon inflation, the contrast is aspirated as rapidly as possible, and the balloon pulled promptly back into the aorta. The pacer is not turned off until most of the contrast is removed from the balloon. Generally no more than 2 to 3 inflations are performed with each balloon size in stand-alone BAV. Subsequent inflations are not carried out unless the arterial blood pressure has completely returned to baseline. If necessary, we use 100 to 200 μ of phenylephrine in IV boluses to maintain systolic blood pressures greater than 100 mmHg. If there is difficulty squarely landing the inflated balloon on the valve, more rapid pacing rates may be beneficial, providing 1:1 capture is preserved.

Figure 5–6, Catheter set up during balloon inflation.

After each set of inflations, the balloon catheter is exchanged for the double-lumen pigtail catheter, and an aortic valve gradient is remeasured. If hemodynamic targets are not achieved, a balloon that is 1 mm larger is used, and further dilations are carried out if the patient’s condition remains stable. Over 90% of the balloon diameters used for aortic valvuloplasty at MHI range from 22 to 25 mm.

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