Balloon AorticValvuloplasty in theTranscatheter AorticValve Replacement Era

Sammy Elmariah, MD, MPHa,b, Dabit Arzamendi, MD, MSca,b,Igor F. Palacios, MDa,b,*

KEYWORDS

� Balloon aortic valvuloplasty� Transcatheter aortic valve replacement� Calcific aortic stenosis � Heart valve disease

In the United States, heart valve disease is esti-mated to affect 4.2 to 5.6 million people and tocontribute to more than 25,000 deaths annually.1–3

Calcific aortic valve disease, which frequentlyculminates in severe aortic valve stenosis (AS), isthe most common cause of valvular heart diseasein the Western world, present in more than 20%of older adults,4,5 and leading to $1 billion in UShealth care expenditures.6 Moreover, critical AS isprevalent in as much as 2% to 3% of the NorthAmerican population older than 75 years of age,and its prevalence is rising as the populationages.7 Surgical aortic valve replacement (SAVR)has historically been the only durable treatment ofpatients with symptomatic severe AS and asymp-tomatic patients with severe AS undergoinganother cardiac surgery.8 Although SAVR isroutinely performedwith relatively lowmortality,9,10

up to one-third of patients are precluded fromsurgery because of advanced age and comorbidconditions,11 despite a dismal average survival ofonly 2 to 3 years in patients with symptomaticsevere AS who do not undergo surgery.8,12

Percutaneous balloon aortic valvuloplasty (BAV)was first performed in patients with acquiredsevere AS by Cribier in 1985, at which time it

a Interventional Cardiology, Cardiology Division, MassacFruit Street, GBR 800, Boston, MA 02114, USAb Structural Heart Disease, Cardiology Division, MassachFruit Street, GBR 800, Boston, MA 02114, USA* Corresponding author. Interventional Cardiology, 55 FBoston, MA 02114.E-mail address: ipalacios@partners.org

Intervent Cardiol Clin 1 (2012) 129–137doi:10.1016/j.iccl.2011.11.0012211-7458/12/$ – see front matter � 2012 Elsevier Inc. All

was anticipated to be an alternative to SAVR.13

In the current era, BAV is recommended for thetreatment of severe AS in children and youngadults,8 but initial enthusiasm surrounding thistechnique as an alternative to SAVR in olderpatients with calcific AS waned because of theperceived failure of the procedure to alter thenatural history of calcific severe AS and becauseof significant initial procedural morbidity.14–16

Despite data suggesting that technical andprocedural advances have decreased proceduralcomplication rates in high-risk patients,17–19

prolongation of survival has not been demon-strated.20–22 Consequently, BAV has been reservedas a palliative procedure for high-risk patientswho cannot undergo valve replacement, eithersurgical or transcatheter, or as a bridge to surgeryin hemodynamically unstable patients.8

More recently, transcatheter aortic valvereplacement (TAVR) has emerged as a viable alter-native to SAVR in inoperable patients or in thosewith high surgical risk.23,24 Although this advanceis considered the end of BAV by some, this view-point has been largely refuted by the continuedinterest and use of the procedure throughout theinterventional community, in part because of

husetts General Hospital, Harvard Medical School, 55

usetts General Hospital, Harvard Medical School, 55

ruit Street, GBR 800, Massachusetts General Hospital,

rights reserved. interventional.th

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Elmariah et al130

TAVR. Here we review the indications, technicalaspects, and outcomes of BAV for calcific aorticstenosis as well as discuss the current role ofBAV in the TAVR era.

PATIENT SELECTION AND INDICATIONS

Calcific AS is a progressive disease that remainsasymptomatic for several decades. With the onsetof symptoms, typically dyspnea, angina, heartfailure, or syncope,12 expected survival decreasesdramatically with 1-year, 2-year, and 3-yearsurvival rates of 57%, 37%, and 25%, respec-tively.25 Once symptoms develop, SAVR shouldbe performed as the standard of care (AmericanCollege of Cardiology/American Heart Association(ACC/AHA) class I recommendation).8 The role ofBAV should consequently be considered only inthose who are not surgical candidates. In thesehigh-risk patients, the ACC/AHA guidelines statethat BAV may be considered (class IIb recommen-dation) as a bridge to surgery in hemodynamicallyunstable patients or as a palliative option in inoper-able candidates.8 In addition, BAV is widelyaccepted as beneficial in children and adolescentswith bicuspid AS who are symptomatic or whohave electrocardiographic changes, either at rest

Table 1Indications for BAV

ACC/AHA Guidelines

Class I Young patient with symptomatic AS an

Young patient with asymptomatic AS a

Young patient with asymptomatic AS arest or with exercise and a peak tran

Class IIa Young patient with asymptomatic AS adesires to play sports or become pre

In a young patient with AS, BAV is pro

Class IIb Bridge to SAVR in an unstable patient

Palliation in an inoperable patient wit

Massachusetts General Hospital Practice

Symptomatic AS caused by rheumatic h

Bridge to TAVR in a patient with symp

Cardiogenic shock in a patient with sev

Patient with symptomatic calcific AS in

Diagnostic evaluation of symptoms inpotentially responsible comorbid con

a Refers to peak-to-peak gradient during catheterization.Data from Bonow RO, Carabello BA, Chatterjee K, et al. 20

guidelines for the management of patients with valvular heology/American Heart Association Task Force on Practice Guidfor the Management of Patients With Valvular Heart Disease)gists, Society for Cardiovascular Angiography and Interve2008;118(15):e523–661.

or with exercise, and a peak gradient greaterthan 50 mm Hg or in asymptomatic patients witha peak gradient greater than 60 mm Hg.8 In theseyoung patients without heavy valve calcification,BAV often results in significant durable improve-ments in measures of AS severity.26–29

In addition to these accepted guidelines, ourinstitution has found BAV useful in several otherclinical situations (Table 1). First, we believe thatBAV may have a role in patients with rheumaticAS. The lack of heavy leaflet calcification and thepresence of commissural fusion may be amenableto balloon commissurotomy, because it is in themitral position, and recent data support thisnotion.30 BAV may also be used to reduce therisk of major noncardiac surgery in patientswith severe calcific AS, whether symptomatic orasymptomatic.31,32 As an extension of the ACC/AHA recommendation for BAV as a bridge toSAVR,8 we and others have used BAV as a bridgeto TAVR.33 Although TAVR may ultimately befeasible in unstable patients, the current avail-ability of TAVR technologies solely within clinicaltrials often limits their use in this regard. Suchinstability also precludes the extensive evaluationsnecessitated by ongoing TAVR trials. In a subsetof patients with left ventricular dysfunction, the

d peak transvalvular gradient �50 mm Hga

nd peak transvalvular gradient �60 mm Hga

nd ST or Twave changes on electrocardiogram atsvalvular gradient �50 mm Hga

nd peak transvalvular gradient �50 mm Hg whognanta

bably preferable to SAVR

with symptomatic calcific AS

h symptomatic calcific AS

eart disease

tomatic calcific AS

ere calcific AS

need of other major surgery

a patient with severe calcific AS and anotherdition

08 focused update incorporated into the ACC/AHA 2006art disease: a report of the American College of Cardi-elines (Writing Committee to Revise the 1998 Guidelines: endorsed by the Society of Cardiovascular Anesthesiolo-ntions, and Society of Thoracic Surgeons. Circulation

Balloon Aortic Valvuloplasty 131

modest alleviation of the aortic valve obstructionseen with BAV has resulted in significant improve-ments in left ventricular function. In so doing, BAVbefore SAVR in high-risk patients has been as-sociated with improved surgical outcomes.34,35

Similarly, patients precluded from TAVR trialsbecause of severe left ventricular dysfunctionmay qualify for trials if significant improvementsin left ventricular ejection fraction are seen afterBAV. We have had success in treating patientswith severe aortic stenosis and cardiogenic shockwith BAV. In a series of patients from Mas-sachusetts General Hospital, emergent BAV inthis setting resulted in an increase in systolicblood pressure from 77 � 3 to 116 � 8 mm Hg(P 5 .0001) and in cardiac index from 1.84 �0.13 to 2.24 � 0.15 L/min/m2 (P 5 .06).36 In raresituations, we have used BAV as a diagnostictechnique to definitively determine whetherpatient symptoms are secondary to severe ASbefore subjecting them to more high-risk proce-dures such as SAVR or TAVR. Such cases haveincluded patients with systolic dysfunction,restrictive and constrictive heart disease, severelung disease, mixed valve disease, neurologicdysfunction, deconditioned state, and low-gradient,low-output AS.

Given that BAV is mostly used for palliation inpatients without other therapeutic options, weconsider the only absolute contraindications tobe the presence of left ventricular thrombus. Inaddition, significant obstructive disease withinthe left main coronary artery confers high proce-dural mortality. Aortic valvuloplasty has been per-formed safely in patients with cardiogenic shock,severe aortic regurgitation, and, as described,severe peripheral arterial disease.36–38 However,when the goal of BAV is to bridge a patient to eitherSAVR or TAVR, estimation of short-term mortalityis of great benefit. Consequently, we evaluatedpredictors of short-term survival in 292 patientsundergoing their first BAV from 2001 to 2007 atthe Mount Sinai Hospital.39 Within this cohort, wefound that of all the individual variables within theEuroSCORE and baseline hemodynamic data,40

critical status (ventricular tachycardia or fibrilla-tion, aborted sudden death, preoperative ventila-tion, preoperative inotropic support, intra-aorticballoon counterpulsation, or preoperative anuriaor oliguria), renal dysfunction (creatinine >2.26mg/dL), right atrial pressure, and low-cardiacoutput (�4.1 L/min) were highly predictive of30-day mortality after BAV.39 Using these vari-ables, we derived a clinical prediction score, theCRRAC (critical status, renal dysfunction, rightatrial pressure, and cardiac output) the AV riskscore (Fig. 1), which identified high-risk patients

with better discrimination than either the additiveor logistic EuroSCORE. When categorized into ter-tiles, the increase in risk seemed concentratedamong individuals in the highest tertile (score�20) of risk score, such that compared with thelowest tertile (score �10), the hazard ratio for 30-day mortality was 1.10 (95% confidence interval[CI] 0.34–3.61; P 5 .87) in the middle tertile and5.82 (95% CI 2.38–14.19; P<.0001) in the highesttertile. Similarly, the 30-day survival of individualsin the highest tertile of risk score was 72.2%, incontrast to 94.4% and 92.2% for those in thelowest and middle tertiles, respectively (seeFig. 1).39 Although validation of the CRRAC theAV risk score is yet to be performed, it may identifya high-risk cohort in which bridging BAV is lesslikely to succeed.

PROCEDURAL DETAILS

Percutaneous BAV can be performed via the retro-grade approach, and in rare situations when theiliofemoral vasculature or aorta are prohibitivelydiseased, the anterograde approach, with similarhemodynamic results.37 When the extent ofperipheral arterial disease is unknown, we performan iliofemoral angiogram in all patients afterachieving insertion of a 5-Fr arterial introducer.For those patients with reduced iliofemoral arterycaliber, the anterograde approach should beconsidered.

The anterograde approach is the more chal-lenging, requiring a higher grade of experiencebecause of the potential damage of the mitralvalve. Right femoral venous access is obtained inthe usual fashion and transseptal puncture per-formed using a modified Brockenbrough needleand a Mullins sheath (Medtronic, Inc., Minneapo-lis, MN, USA) to allow for left atrial entry. A balloonwedge catheter is advanced through the Mullinssheath into the left ventricle and then anterogradethrough the stenotic aortic valve. The balloonshould remain partially inflated during passagefrom the left atrium to the aorta to minimize therisk of entangling the mitral subvalvular apparatus.A soft 0.97-mm (0.038-inch) exchange wire isadvanced through the catheter into the ascendingand descending aorta. The wire is snared in thedescending aorta with a gooseneck snare andexternalized through the femoral artery. An arte-riovenous loop is created that allows thevalvuloplasty balloon to be advanced throughthe septum and positioned across the aortic valve.The chosen dilating balloon catheter is thenadvanced anterograde across the mitral valve,placed across the aortic valve, and valvuloplastyperformed during rapid pacing to maintain

Fig. 1. CRRAC the AV score. Predictors of 30-day mortality after BAV were identified and a risk prediction modelconstructed based on critical status, renal dysfunction, pre-BAV right atrial pressure, and cardiac output. Asshown in Kaplan-Meier curves stratified by tertile of the CRRAC the AV score, patients within the highest tertile(score �20) had poor survival. (From Elmariah S, Lubitz SA, Shah AM, et al. A novel clinical prediction rule for30-day mortality following balloon aortic valuloplasty: the CRRAC the AV score. Catheter Cardiovasc Interv2011;78(1):116; with permission.)

Elmariah et al132

balloon stability. Care is taken to maintain thewire/catheter loop within the left ventricle to avoidinjury to the mitral valve. After 2 or 3 inflations, theballoon is removed, keeping the arteriovenousloop in place. The Mullins sheath is then advancedto the left ventricle to reassess the transvalvulargradient (Fig. 2).In performing BAV via the retrograde approach,

the common femoral artery is cannulated asmentioned earlier and iliofemoral angiography per-formed. If the puncture site is adequate and thereis no significant stenosis of the common femoral,preclosure using 2 Perclose ProGlide (Abbott

Vascular, Santa Clara, CA, USA) suture systemscan be performed. The devices should be rotatedsuch that the second device is deployed 90� fromthe first. The 10-Fr to 14-Fr sheath is then insertedover the wire depending on the valvuloplastyballoon size to be used. Preclosure of the vascularaccess site results in immediate hemostasis oncompletion of the procedure and has greatlyreduced the vascular complications associatedwith BAV.18 We most frequently cross the stenoticvalve using a 6-Fr Amplatz left catheter anda straight 0.89-mm (0.035-inch) guidewire. Weprefer the Judkins right or a multipurpose catheter

Fig. 2. Anterograde BAV. Fluoroscopic images showing the stages of anterograde BAV. (A) A Mullins sheath isadvanced via transseptal puncture into the left ventricle. A wire is then advanced into the descending aortaand snared from the femoral artery. To avoid injury to the mitral valve, a large arteriovenous (AV) loop is createdwithin the left ventricle. An Inoue balloon catheter (IB) is then advanced while partially inflated through the leftventricle and across the aortic valve. (B) BAV is performed while pulling the Inoue balloon (IB) catheter againstthe aortic valve. SG, Swan-Ganz catheter.

Fig. 3. Retrograde BAV. Fluoroscopic images showingthe stages of retrograde BAV. The stenotic aortic valveis crossed with a straight wire using an Amplatz leftcatheter. After exchanging for a stiff wire withgenerous distal loop (Lp), the chosen balloon catheteris advanced across the valve and inflated during rapidventricular pacing. PW, temporary pacing wire; SG,Swan-Ganz catheter.

Balloon Aortic Valvuloplasty 133

if the aortic root is more horizontal. The straight an-teroposterior projection or slight left cranial angu-lation helps to identify the right and leftcusps. The Amplatz catheter is then exchangedfor a double-lumen pigtail catheter over an extra-stiff wire, the distal end of which should bemanually curved to increase the wire and todecrease the risks of ventricular perforationduring the valvuloplasty. After hemodynamicmeasurements are obtained, the pigtail catheteris exchanged for the valvuloplasty balloon. Weselect the initial balloon size to approximate theleft ventricular outflow dimension. The valvulo-plasty balloon is fully inflated during rapidventricular pacing at a rate of 180 beats perminute once the systolic blood pressure isreduced by at least half. Valvuloplasty can beperformed without rapid pacing, although thishas been shown to improve balloon stability.41

After 2 or 3 balloon inflations, the valvuloplastyballoon is removed, keeping the wire insidethe left ventricle, and the double-lumen pigtailcatheter is reinserted to assess the effectivenessof the valvuloplasty (Fig. 3). If a suboptimal resultis obtained, the valvuloplasty can be repeated

Elmariah et al134

using a larger balloon. At the completion of theprocedure, closure of the arteriotomy is per-formed using the preclosure device sutures.

PROCEDURAL COMPLICATIONSDeath

In-hospital mortality occurs in 5% to 8% ofpatients, with 1 to 2% expiring within the catheter-ization laboratory.24,42–44 Most of these deathsoccur either as the result of fatal complications ofthe procedure, such as arrhythmia, aortic rupture,or ventricular perforation, or because of a progres-sive heart failure and cardiogenic shock in patientswith severely depressed left ventricular function. Inour experience, significant stenosis of the left maincoronary artery is a significant predictor of proce-dural mortality.

Vascular Complication

Given that vascular access for BAV is performedon frail patients of advanced age, most of whomhave significant peripheral arterial disease, vas-cular access complications are among the mostcommon. Vascular complications, including perfo-ration, dissection, hematoma, pseudoaneurysm,or arterial-venous fistula formation, retroperitonealbleeding, or atheroembolization occurred in asmany as 25% of patients in early studies.14,15,36

Moreover, these major vascular complicationsare associated with increased mortality andmorbidity; therefore adequate arterial access inthese patients is essential. Peripheral angioplastyballoons from 7 to 10 mm should be on handbecause if vascular perforation occurs rapid actioncan be lifesaving. The introduction of the vascularclosure devices has dramatically reduced theneed for surgery and blood transfusion.18,45

Vascular closure devices, perhaps the most sig-nificant advance in BAV over the last 25 years,have reduced the rate of vascular complications44

to approximately 5%.18,43,45

Severe Aortic Valve Regurgitation

Massive aortic regurgitation after BAV can bea fatal complication that occurs in approximately1% of patients during BAV.42,43 In patients withsmall stature or heavily calcified valves, it is rec-ommended to dilate the valve in a stepwisefashion from the small-sized to the larger-sizedballoon. If massive regurgitation occurs and thepatient is hemodynamically stable, urgent surgeryor TAVR has to be considered. In stable patients,the valve replacement procedure can be post-poned and performed electively.

Stroke

The occurrence of clinically apparent cerebralevents is less than 2%.24,42,43 These events arebelieved to be caused by embolism of atheroscle-rotic debris from the ascending aorta or the valvecusps during attempts to cross the valve or duringballoon inflation. Thrombus formation on cathetersor wires within the ascending aorta and leftventricle is also possible. Patients should conse-quently be treated with 50 to 70 units/kg of heparinat the beginning of the procedure. Aggressivecrossing of the valve should be avoided, and thewire and the catheter should be retrieved andflushed every 3 minutes if the valve is difficult tocross.

Left Ventricular Perforation and Tamponade

Cardiac perforation and tamponade during BAVcan be caused by the stiff wire used for catheterexchanges or by the valvuloplasty balloon itselfin approximately 1% of cases.43,45 Tamponadeis most often a result of sudden ventricular move-ment of the balloon during inflation, although posi-tioning of the balloon more ventricular than aorticcan also contribute. To avoid left ventricular perfo-ration, it is imperative to create a large curve on thedistal tip of the stiff wire. This strategy helps tomaintain balloon stability during inflations andalso helps to prevent wire perforation. In addition,by reducing cardiac output, rapid ventricularpacing helps to reduce sudden movement of thevalvuloplasty balloon.

Electrophysiologic Complications

Atrioventricular heart block may occur with BAV asa consequence of direct trauma to the conductionsystem. Atrioventricular block is more commonlyseen in those with underlying conduction systemdisease such as preexisting bundle branch blockand in those with small left ventricular outflowtracts. In our experience, atrioventricular blockcan be transient, although pacemaker implanta-tion has been reported in 1.5% of patients afterBAV.46

Ventricular arrhythmias are frequent during thewire and balloon manipulation inside the leftventricle. Simple repositioning of the wire orreleasing tension may be enough to end thesearrhythmias. On rare occasions, sustained ventric-ular tachycardia or fibrillation can occur, necessi-tating resuscitation and cardioversion.43

PATIENT OUTCOMES

According to early data from 2 large registries aswell as from our institution, the Massachusetts

Balloon Aortic Valvuloplasty 135

General Hospital, BAV resulted in significant acuteimprovement in aortic valve area (average of0.3 cm2), mean aortic valve gradients, cardiacoutput, symptoms, and functional class; however,the procedure was associated with significantperiprocedural and short-term morbidity andmortality.14,15,36 In the National Heart, Lung andBlood Institute Balloon Valvuloplasty registry,almost one-third of 674 high-risk elderly patientsexperienced a significant complication such asvascular injury, embolic event, or myocardial in-farction. Furthermore, long-term survival afterBAV was poor with 1-year, 2-year, and 3-yearsurvival rates of 55%, 35% and 23%, respec-tively,16 rates almost identical to the survivalseen in patients with untreated severe AS.25 Earlyhemodynamic improvements obtained immedi-ately after BAV also abated with accelerated valverecoil and restenosis after the procedure.47

Recent studies have maintained the lack ofsurvival benefit after BAV compared with historicalsurvival rates with medical therapy alone,24

although there may be a slight improvement insurvival with repeated BAV.42 Symptomatic reliefcan be expected to last 6 to 12 months,16 although1 recent report documented improvement foras long as 18 months.42 Within the PARTNER(Placement of Aortic Transcatheter Valve) trial,the mortality rate for patients within the standardtherapy arm, 85% of whom underwent BAV, was50% at 1 year,24 a rate consistent with previousfindings.16

IMPLICATIONS OF TAVR FOR BAV

Some have considered advances in SAVR tech-niques and the advent of TAVR to be the deathof BAV. However, the procedural volume forBAV has increased exponentially since the intro-duction of TAVR 5 years ago.43,45 The prolongedclinical evaluation often necessary for inclusionin TAVR trials frequently necessitates BAV asa bridging procedure. In addition, strict inclusionand exclusion criteria for TAVR clinical trialshave driven a significant number of patients toseek BAV or high-risk SAVR instead. Thesefactors may change once TAVR is approved foruse outside clinical trials. However, BAV isa component of the TAVR procedure, necessi-tating interventional cardiologists to maintain theskills involved in performing BAV. Conversely,because TAVR is more widely adopted, previousfamiliarity with BAV facilitates interventionalists’comfort with TAVR. For now, BAV and TAVR areintimately intertwined. The forthcoming ubiquitousimplementation of TAVR is sure to continuedriving the resurgence of BAV.

FUTURE DIRECTIONS

Antiproliferative drugs, such as rapamycin andpaclitaxel, have revolutionized interventional car-diology as a treatment of restenosis after coronarystenting. These agents act via inhibition of vas-cular smooth muscle cell proliferation and migra-tion, steps critical for stent restenosis.48,49

Assumptions that these agents may similarlyinhibit valve myofibroblasts has led to the hypoth-esis that antiproliferative agents may slow aorticvalve restenosis after BAV. A recent study evalu-ated the potential for local delivery of paclitaxelto the aortic valve using a paclitaxel-eluting valvu-loplasty balloon in pigs and found that drugconcentrations within the valve were at thera-peutic levels.50 Adopting a similar rationale,external beam radiation therapy (EBRT) has beenused in an attempt to slow valve restenosis. Withina small pilot study, 21% of patients receivingEBRT after BAV developed restenosis at 1 yearcompared with the historically expected rate ofw80%.51 These preliminary results are intriguing,but further study is needed to evaluate the use ofantiproliferative agents and radiation therapy inmanaging calcific aortic valve disease.

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