REVIEW ARTICLE

Anesthetic and Perioperative Considerations for Transapical TranscatheterAortic Valve Replacement

Frederick C. Cobey, MD, MPH, FASE,* Renata G. Ferreira, MD,† Tariq M. Naseem, MD,* Jonathan Lessin, MD,‡

Michael England, MD,* Michael N. D’Ambra, MD,§ Stanton K. Shernan, MD, FAHA, FASE,§ G. Burkhard

Mackensen, MD, PhD, FASE,† Steven A. Goldstein, MD, FACC,¶ and John G. Augoustides, MD, FAHA, FASE║

From the *Tufts Medical Center, Tufts University, Boston, MA;†University of Washington, Seattle, WA; ‡Washington Hospital Center,Georgetown University, Washington, DC; §Brigham and Women’sHospital, Harvard Medical School, Boston, MA; ¶Medstar HeartInstitute, Washington Hospital Center, Washington, DC; and ║Perel-man School of Medicine, University of Pennsylvania, Philadelphia, PA.

Address reprint requests to Frederick C. Cobey, MD, Department ofAnesthesiology, Tufts Medical Center, Tufts University, 800 Washing-ton, Street, Box 298, Boston, MA 02111. E-mail: fcobey@gmail.com© 2014 Elsevier Inc. All rights reserved.1053-0770/2601-0001$36.00/0http://dx.doi.org/10.1053/j.jvca.2013.11.006

AORTIC VALVE REPLACEMENT (AVR) continues tobe the standard for treatment of aortic stenosis. The

overall operative mortality for patients undergoing a surgicalAVR (SAVR) ranges from 2.5%-4%.1–4 With increasing age,the risk for octogenarians and nonagenarians ranges between(4.9% and 9.6%), and this can be as high as 25% in patientswith significant co-morbidities.1,5–7 As such, up to 30% ofthese patients are not considered candidates for traditional opensurgical intervention.8,9 Balloon aortic valvuloplasty results inonly temporary relief of symptoms by a small increase in valvearea.10–12 In 2002, Cribier performed the first catheter-basedaortic valve replacement in a human, and in 2007, transcatheteraortic valve replacement (TAVR) was introduced into com-mercial use.13,14 According to the Placement of Aortic Trans-catheter Valve (PARTNER) trial, TAVR reduces mortality inhigh-risk patients who are not candidates for surgical inter-vention.15 The technology has evolved rapidly and TAVR isnow used routinely. In Europe, 23% of tissue valves in elderlypatients are TAVR.16 Experience with this technology also isgrowing in North and South America, the Middle East, andAsia.17 The two commonly used approaches to TAVR aretransfemoral (TF) and transapical (TA).15,18 Other accessoptions include axillary/subclavian artery and the direct aorticapproach.19–21 In Europe, TA-TAVRs comprise about 16% ofTAVR cases.22 Each approach presents a unique challenge tothe anesthesiologist. The present study is a review of (1) thespecific characteristics of the TA-TAVR population that makethem distinct from those patients undergoing TF-TAVR, (2) thedifferent approaches to providing anesthesia for these patientsas reported in the literature, and (3) the procedural stepsparticular to these cases so that anesthesiologists are able toanticipate intraoperative events and issues in a proactivefashion.

PATIENT SELECTION AND PREOPERATIVE RISK

ASSESSMENT FOR TA-TAVRS

The transapical approach has evolved over the past 5 yearsas an alternative for patients under consideration for TAVRwith unfavorable iliofemoral artery anatomy (Fig 1). Manycenters use a “transfemoral first” or “groin first” approach, asrecently reported in the US PARTNER trial.15,23 This strategyselects for a cohort of high-risk patients as candidates forthe TA-TAVR procedures24 (Table 1). Patients chosen for

Journal of Cardiothoracic and Vascular Anesthesia, Vol ], No ] (Month), 2

TA-TAVR have higher rates of diabetes and dyslipidemia withconcomitant increased rates of peripheral vascular disease,porcelain aortas, and history of previous myocardial infarctioncompared with patients chosen for TF-TAVRs.9 When authorshave specifically studied pre-procedure risk scores, mean STSscores (Society of Thoracic Surgeons scores) and logisticEuroSCORES (European System for Cardiac Operative RiskEvaluation scores) are higher for patients undergoing trans-apical procedures.23 Indeed, there is one review of TA-TAVRwith a mean logistic EuroSCORE of 48.24 It should be notedthat both the STS score and the EuroSCORE were designed topredict mortality for cardiac surgery patients. While the Euro-SCORE was designed for all cardiac surgery patients, the bulkof the model is based on coronary artery bypass graft patients.25

The STS score is more accurate for evaluating the risk ofpatients undergoing aortic valve replacement alone.3,25,26 Theapplicability of these scores to TAVR patients has beenreviewed.27 The logistic EuroSCORE tends to overestimatethe risk in TAVR patients.28 This also appears to be the casefor the new EuroSCORE II.29 Therefore, the STS risk modelmay be a better predictor of outcome in these patients.25 Ofnote, other factors such as frailty of the patients also should beconsidered.23,30,31 A risk factor analysis for patients undergoingTA-TAVR and not using the groin-first approach found thatreduced pulmonary function as measured by vital capacity andmitral regurgitation were risk factors for 30-day mortality, incontrast to the STS score and EuroSCORE, which were notpredictive.32 Severity of tricuspid regurgitation also has beenidentified as a risk factor for death.23 A new method to riskstratify these patients is needed.

014: pp ]]]–]]] 1

Fig 1. Transapical transcatheter aortic valve replacement. This

image illustrates the placement of a transcatheter aortic valve via

transapical approach. The prosthetic valve is delivered through the

left ventricular apex, accessed via a small anterolateral thoracotomy.

With echocardiographic guidance, the left ventricular cavity is

accessed via a needle puncture. The guidewire is advanced into the

left ventricle through the aortic valve. The apical access site is dilated

to accommodate the introducer sheath, which is then advanced into

the ventricular cavity. It is critical to ensure that the mitral valve

apparatus is free of the introducer. Fluoroscopy and echocardiogra-

phy both play a vital role in confirming placement of the valve sheath

system. After valve deployment and removal of the introducer,

hypertension must be avoided to mitigate the risk of potentially

catastrophic apical bleeding. (Color version of figure is available

online.)

COBEY ET AL2

Surgical Procedure

A detailed description of the technical considerations of theTA-TAVR procedure has been described previously33 (Fig 2,Video clip 1). There are particular aspects important toanesthesiologists that deserve attention. At most institutions,TA-TAVRs and TF-TAVRs are done in either a cardiaccatheterization laboratory or in a hybrid surgical suite. TheTAVR team is multidisciplinary and includes cardiac surgery,anesthesia, perfusion, and cardiology. The TA-TAVR approachrequires a left anterior lateral minithoracotomy and a trans-apical puncture of a beating heart and, hence, is more invasivethan TAVR done with transfemoral access. The patient ispositioned with the left chest elevated to facilitate exposure ofthe minithoracotomy. This is done through the fifth or sixthintercostal space to expose the apex of the ventricle. Aftersuturing epicardial pacing wires and pericardial stay sutures,apical purse-string sutures with pledgets are placed to create aninternal diameter of 1 to 2 cm.23,34 Typically, the introducer

that the surgeon places through the apex of the heart rangesbetween 18F and 22F (Fig 3). Anticoagulation is achieved withheparin administration, before placing the larger sheath, and ismaintained at an activated clotting time (ACT) of approxi-mately 250 to 300 seconds. Toward the end of the procedure,this is reversed with protamine sulfate. Identification of the trueapex is preferable to the left ventricular free wall, because thereis lower tension due to the greater convexity (Laplace’s law)and it avoids the distal left anterior descending artery. This hasobvious implications for suture retention and postoperativebleeding.33 Rapid ventricular pacing is required during balloonvalvuloplasty and during deployment of the Edwards SAPIENprosthetic valve. The purpose of rapid pacing is to momentarilydecrease ventricular outflow to minimize the risk of valvemigration. This is accomplished during inflation, at a rate of160 to 220 beats/min, either by transvenous pacing wires orepicardial electrodes. The goal is to achieve systolic bloodpressure o70 mmHg with a pulse pressure o20 mmHg.35,36

Medtronic (Minneapolis, MN), which does produce valves forTF-TAVRs, currently does not have a valve approved for TA-TAVRs. Edwards SAPIEN (Edwards Lifesciences, Irvine, CA)currently has only three valve sizes available in the UnitedStates (23 mm, 26 mm, and 29 mm). After valve deployment,the function of the valve must be assessed with attention givento the presence of and severity of aortic regurgitation. Incidenceof any paravalvular regurgitation is approximately 85% and isfrequently minor.35 If significant or greater than mild regur-gitation is diagnosed, reinflation of the balloon can be helpfulin cases of incomplete prosthesis expansion and poor coapta-tion with the wall; however, a secondary device or valve withina valve or even an AMPLATZER™ Septal Occluder devicemay be considered.37 After valve deployment and subsequentremoval of the delivery sheath, the apical purse-string suturesare secured and the thoracotomy is closed.

Procedural Complications

While the precise rate of complications is difficult toevaluate given the differences in definitions and reportingbetween authors, trends can still be observed.38 Apical bleedinghas been described as an “Achilles’ heel” of the TA-TAVRprocedure, occurring in 2% to 5% of TA-TAVR cases1,22,33,39

(Table 2). The introduction of apical closure devices may helpmitigate some of this risk.23,40 Complications regarding suturedehiscence can present as an acute catastrophic hemorrhage.41

Subacute and chronic presentations of apical pseudoaneurysmsare also well documented.33,42–45 Bleeding from the intercostalarteries also may be clinically relevant.46 Unique to TA-TAVRcases, fatalities resulting from intramyocardial hemorrhage/dissection may occur. Such instances occur from trauma tothe septum while advancing the device and from the apicalpuncture.43 Transapical access, low weight, and underlyingcoronary artery disease were risk factors for bleeding in TAVRcases.41 In a review of 4,571 cases, there was a significantlyhigher rate of transfusion requirement in TA-TAVR versus TF-TAVR patients (20.8% v 15%, p o 0.01).22 Although oftenshowing trends in greater bleeding with TA-TAVR comparedwith TF-TAVR cases, other smaller reviews are less consis-tent.1,9,47,48 Periprocedural hypertension raising ventricularwall tension increases the risk of bleeding, left apical access

Table 1. Demographic characteristics

Demographic Characteristics

Di Mario22 Thomas1 Gilard46 Rodes-Cabau66 Gurvitch45 Guinot9

n ¼ 749 n ¼ 575 n ¼ 567 n ¼ 177 n ¼ 101 n ¼ 28

TA-TAVR

EF o50% 35.2 37 46

Coronary Artery Disease (any) 56 59.4 70.1 78 90

Previous MI 22.1 25 51.4 46

Prior CABG 26.9 30 37.9 50

COPD (any) 22.3 29.4 22.7 31.1 22 25

Pulmonary Artery Systolic Pressure 460mmHg 27.7 26

Peripheral Vascular Disease 27.5 48.1 50.3 66 39

Porcelain Aorta/Severe Aortic Calcification 11.5 1.8 18.6 28

Previous Stroke 24 11

Dialysis 7.5 3.1 1.7

Mean Logistic EuroSCORE 22.2 (�14.2) 29.1 (�16.3) 24.8 (�14.7) 25 (17-34)

Mean STS-PROM 15.1 (�13.8) 10.5 (�6.9) 11.2 16 (11-24)

Di Mario22 Thomas1 Gilard46 Rodes-Cabau67 Gurvitch45 Guinot9

n ¼ 3390 n ¼ 463 n ¼ 2361 n ¼ 168 n ¼ 169 n ¼ 62

TF-TAVR

EF o50% 32.1 36 34

Coronary Artery Disease (any) 47.4 44.4 67.9 75 55

Previous MI 15.4 14.5 50.6 13

Prior CABG 17.6 15.2 30.2 23

COPD (any) 25.3 25.4 25.3 27.8 28 39

Pulmonary Artery Systolic Pressure 460 mmHg 21.6 24

Peripheral Vascular Disease 10.9 12.5 19.1 16 8

Porcelain Aorta/Severe Aortic Calcification 4.6 5.5 17.3 10

Previous Stroke 15 15

Dialysis 6.1 2.6 4.3

Mean Logistic EuroSCORE 19.6 (�12.9) 25.7 (�14.5) 21.2 (�14.7) 23 (15-31)

Mean STS-PROM 14.5 (�11.9) 9 (�5.8) 8.5 15 (11-20)

Values are expressed as percentages. EuroSCORE and STS-PROM are expressed as mean values � standard deviation. Standard deviation

was not available for Gurvitch et al. Interquartile range (25th to 75th percentile) rather than standard deviation was used by Guinot et al.

Abbreviations: CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; EF, ejection fraction; EuroSCORE, European

System for Cardiac Operative Risk Evaluation; MI, myocardial infarction; STS-PROM, Society of Thoracic Surgeons Predicted Risk of Mortality;

TA-TAVR, transapical transcatheter aortic valve replacement; TF-TAVR, transfemoral transcatheter aortic valve replacement.

TRANSCATHETER AORTIC VALVE REPLACEMENT CONSIDERATIONS 3

tear, myocardial dissection, and pseudoaneurysm formation.Injury to the distal left anterior descending artery causing apicalischemia may predispose to suture dehiscence.49

Predictably, bleeding events negatively impact survival afterTAVR.41 Importantly, the clinical implication of a majorvascular event is not the same for the two procedures.According to the SOURCE registry, there was no statisticallysignificant difference in 30-day survival between TF-TAVRpatients who had a major vascular event and those who did not.In contrast, TA-TAVR patients who endured such an event hada mortality rate of approximately 50%.1

The Valve Academic Research Consortium, which stand-ardized endpoints for TAVRs to be used in larger outcomestudies, and recently revised their endpoints to be morecomprehensive in 2013, did not include respiratory parame-ters.38,50 Accordingly, pulmonary outcomes such as duration ofmechanical ventilation, reintubation rates, and pneumonias arenot addressed specifically in published reviews of large Euro-pean TAVR registries.1,22 Pulmonary comorbidity is commonin TAVR patients and is a significant problem that theperioperative providers must address. The prevalence of chronicobstructive pulmonary disease among patients presenting for

TA-TAVRs appears similar to patients having TF-TAVRS andranges between 20% to 40%.1,22,23 However, the consequencesof preexisting pulmonary disease in TA-TAVR patients may bemore clinically relevant given the need for intubation and thepresence of a thoracotomy incision. In one small review of 53TA-TAVR patients from a single institution, the need forreintubation was 11.3%.51 Similarly, in a slightly larger multi-center trial of 150 TA-TAVR patients, 8.7% of patients wereconsidered to have respiratory failure.52 Postprocedure pleuraleffusions have been reported to occur in 18% to 26% ofpatients.9,52 Poor respiratory function defined as a vital capacityless that 70% has been observed to be an independent risk factorfor perioperative mortality in a review of 299 TA-TAVRpatients.32 In a review from Canada of 135 TA-TAVRs, ofthe 16 patients who died in the hospital, 7 patients (44%) diedfrom respiratory complications.53 Although less well docu-mented in the literature, the second Achilles’ heel of the TA-TAVR may be postprocedural pulmonary dysfunction. Furtherresearch is needed in this area.

Stroke has been identified repeatedly as a major source ofmorbidity in TAVR cases.54 Embolic lesions seen withmagnetic resonance imaging may occur in up to 84% of

Fig 2. Fluoroscopic guidance of transapical transcatheter aortic valve replacement. A transcatheter aortic valve replacement is a

fluoroscopic-based procedure. (A) Shows the presence of aortic regurgitation and the identification of the apex of the left ventricle. (B) The

advancement of the introducer through the apex of the ventricle. (C) Careful positioning and deployment of the aortic valve prosthesis so that

60% of the valve is above the outflow tract above the aortic annulus but is below the coronaries. (D) The fully deployed prosthetic aortic valve in

the correct position. (Courtesy of Dr. Andrew Weintraub, Tufts Medical Center).

COBEY ET AL4

patients. Most of these are clinically silent.55 In the PARTNERtrial, the risk of neurologic events (strokes and transientischemic events) at 30 days was 5.5% and at 1 year was8.3%.14 Relevant to the perioperative physician, the risk ofstroke is highest within the first week after TAVR.56,57 ingeneral, predictors of clinically detectable stroke after TAVRinclude a history of a prior stroke, severe atheroma, and smalleraortic valve area.56 During TA-TAVR procedures, air entrainedfrom the apical access site often can be visualized on TEE.Calcified debris from the aortic valve and aortic atheroma alsocan embolize. It has been hypothesized that the TA-TAVRapproach, which largely avoids manipulation of large 22F and24F catheters in the aortic arch, might have a lower rate ofembolic complications.58 However, available data do notsupport this. When patients were evaluated separately withtranscranial Doppler and magnetic resonance imaging, nosignificant differences were observed between the 2 proce-dures.59,60 The accumulation of silent strokes over time maycontribute to cognitive impairment.54 Cognitive functionassessed with neuropsychological testing after TA-TAVRs ismild and thus far does not seem to correlate with cerebralembolic burden.60,61 Data from the SOURCE registry suggestthat despite the higher rate of carotid disease in the TA-TAVRgroup, the clinical stroke rates at 30 days are similar.1 Similar

lack of statistical difference was seen in the larger Trans-catheter Valve Treatment Sentinel Pilot Registry.22

Although preexisting conduction abnormalities are similar inSAVR and TAVR patients, ranging between 40% to 50%, theneed for permanent pacemaker post-TAVR is higher, and ratesas high as 15.5% have been reported.22,62 In TA-TAVRpatients, who currently only receive an Edwards SAPIEN valve,the rates of heart block range from 7% to 13.6%.1,9,22,47,48

Importantly, the Medtronic CoreValve, which is currently usedonly in TF-TAVRs, is associated with a significantly higher rateof postprocedure pacemaker dependence than in patients receivingthe Edwards SAPIEN valve.22,63 Differences in valves ratherthan aspects of the procedure likely account for occasionaldifferences in the need for a pacemaker postprocedure betweenTA and TF patients.22 In TA-TAVRs, the presence ofepicardial pacing leads decreases the immediate significanceof conduction disturbances during the procedure, but clearlysuch complications add to the complexity of the perioperativecare. Most conduction abnormalities occur during or immedi-ately after the procedure.62 New-onset atrial fibrillation is morelikely in patients undergoing TA-TAVR than in patients havingTF-TAVR.9,22,47 The use of epidurals may decrease the rate ofpostprocedure atrial fibrillation.53 Myocardial infarctionsappear uncommon in both TA-TAVRs and TF-TAVRs.22

Fig 3. Left ventricle apical access, introducer insertion, and apical

closure. The image depicts the minithoracotomy used to gain access

to the left chest. (A) Depicts needle access of the left ventricle after

apical sutures are placed with pledgets. Identification of the true

apex is done using transesophageal guidance. (B) The advancement

of the introducer after insertion of the guidewire through the needle.

(C) The apical closure. (Courtesy of Dr. Hassan Rastegar, Tufts

Medical Center). (Color version of figure is available online.)

Table 2. Procedural Complications

Complications

Di Mario22 Thomas1 Gilard46 Gurvitch47 Guinot9

n ¼ 749 n ¼ 575 n ¼ 567 n ¼ 101 n ¼ 28

TA-TAVR

Surgical Conversion 3.2 3.5 0.7 0

Vascular (major) 2.2 2.4 1.9 3.9 7

Bleeding (life

threatening)

1.4

Bleeding (major) 3.4

Transfusion 20.8 8.9 18

Heart Block/New

Pacemaker

4.5 7.3 13.6 5.9 7

New Atrial Fibrillation 9 11.9 11

Pneumonia 8.9 11

Stroke Rate 1.6 2.6 2 0

New Dialysis 2.4 7.1 4.9

30 All-Cause Mortality 12.8 10.3 13.9 12.7 8

Di Mario22 Thomas1 Gilard46 Gurvitch47 Guinot9

n ¼ 3390 n ¼ 463 n ¼ 2361 n ¼ 169 n ¼ 62

TF-TAVR

Surgical Conversion 4.7 1.7 0.7

Vascular (major) 2.9 10.6 5.5 8.3 11

Bleeding (life

threatening)

1.2

Bleeding (major) 1.5

Transfusion Rate 15 9.9 23

Heart Block/New

Pacemaker

15.5 6.7 15.2 5.9 19

New Atrial

Fibrillation

5.1 0 6

Stroke Rate 1.9 2.4 4.1 5

Pneumonia 1.8 6

New Dialysis 1.2 1.3 1.2

30 All-Cause

Mortality

5.9 6.3 8.5 6.5 8

NOTE. Values are expressed as percentages. Definitions are based

on the Valve Academic Research Consortium criteria.37

Abbreviations: TA-TAVR, transapical transcatheter aortic valve

replacement; TF-TAVR, transfemoral transcatheter aortic valve

replacement.

TRANSCATHETER AORTIC VALVE REPLACEMENT CONSIDERATIONS 5

Development of renal failure requiring dialysis also appears tobe more common after TA-TAVR and ranges between 2.4% to12% of patients, although the rate of preexisting renal impair-ment is also higher in this group of patients.1,22,23

The frequency of complications arising from technicalaspects of seating the valve does not vary by access route. Therate of valve embolization and coronary occlusion appears to

be less than 1% in both TA and TF-TAVRs.1,22 The need toconvert to an open sternotomy also does not appear to bestatistically different between both approaches and, in thelarger reviews, is generally less than 5%.1,22,48 Residual aorticregurgitation in TAVRs is associated with higher in-hospitaland long-term mortality.64,65 For correct functioning of aTAVR valve, it is important that the prosthesis reaches itsfinal ex vivo shape after implantation. The calcification of thenative aortic valve and annulus may lead to stent deformationand a noncircular stent shape with resulting leaflet distortions.There may be subtle differences between TA-TAVRs’ andTF-TAVRs’ valve deployment, resulting in a greater degree ofleaflet asymmetry in TA-TAVR cases.66 The clinical impli-cations of this subtle finding are unclear. Most residual aorticregurgitation in TAVRs is paravalvular rather than central. Ina review of more than 1,000 patients, postproceduremoderate-to-severe aortic regurgitation was observed in1.5% of TF patients and 2.3% of TA patients.1 Two of the

COBEY ET AL6

strongest predictors of regurgitation appear to be valve sizingand the extent and asymmetric distribution of calcium.65

Access route is not discussed in the literature as a predictorof residual regurgitation. Patient prosthetic mismatch occursin 7.6% of TA-TAVRs and appears to be associated with aconsiderably increased risk of early mortality.67 However,again the rates of mismatch in TA-TAVRs appear similar toTF-TAVRs.68

The long-term outcomes in TA and TF-TAVR cohorts inthe PARTNERS trial are not significantly different.15 This ismirrored in a multicenter Canadian study.69 However, ananesthesiologist focused on a patient’s perioperative care maybe more concerned with immediate short-term outcomes. The30-day experience reported by the same Canadian study founda trend toward a slightly higher mortality for the TA-TAVR(n ¼ 177) 11.3% than TF-TAVR (n ¼ 168) patients 9.5%.70

This difference also was seen in other larger studies. Accordingto a study of 1,038 patients using the Edwards-SAPIEN AorticBioprosthesis European Outcome (SOURCE) Registry ofTAVR cases from Jan 2007 to Jan 2009, there was higher30-day mortality for patients undergoing transapical valveplacement (6.3% v 10.3%).1 The Transcatheter Valve TreatmentSentinel Pilot Registry, in which a total of 4,571 patientsunderwent TAVR between January 2011 and May 2012 in 137European centers across 10 countries, was reviewed. Themortality rate again was lower in transfemoral (5.9%) thanin transapical (12.8%) patients.22 In 40 “extreme risk” patientswith EuroSCORES 435% having TA-TAVRs, there was a 5%on-table death rate and 20% in-hospital mortality.24 The high-risk nature of the procedure itself also may contribute to thesetrends. In the French Aortic National CoreValve and Edwards(FRANCE 2) Registry of over 3,000 TAVR patients, TA-TAVR was an independent predictor of decreased survival.48

The Transapical Transcatheter Aortic-Valve Replacement ver-sus Surgical Aortic-Valve Replacement in Low-Surgical RiskElderly Patients with Aortic Stenosis (STACCATO) trial wasdiscontinued early because of increased 30-day adverse eventsrate (mortality, stroke, and renal failure) in the TA-TAVRversus SAVR arm (14.7% v 2.8%). The mean STS score in thisprospective study was only 3.1 in the TA-TAVR group.71

It is important to consider the presence of a learning curvewhen interpreting TAVR outcome data. Multiple institutionshave reported that outcomes improve as TAVR teams gainexperience.23,33,48,72–76 However, the impact of the learningcurve on 30-day survival outcomes is unclear. In one review of101 TA-TAVRs in a single institution, there was a strong trendtoward improvement in hospital mortality from 17.6% in thefirst half to 7.8% in the second half.47 The same trend wasevident in a slightly larger institutional review of 299 patients,in which the 30-day mortality fell from 11.3% in the first halfto 6.0% in the second.32 However, neither of these studies wasstatistically significant.32,47 A multi-institutional review of2,339 patients from the SOURCE registry reported that whilethe frequency of procedural complications trended down over atwo-year period, reflecting a learning curve, the 30-day mortal-ity remained unchanged.77 Other clinicians have advocated thatthe use of a structured training may favorably benefit TA-TAVR outcomes. The institution reviewing their experience of500 TA-TAVR cases using a system of external and internal

proctoring to new members of the team had a much lower thanexpected 30-day mortality rate of only 4.6%.78,79

ANESTHETIC CONSIDERATIONS FOR TA-TAVRS

The Heart Team in TAVRs

Although a team approach to the care of patients has been alongstanding and integral part of clinical practice in othermedical fields, such as oncology and organ transplant pro-grams, only more recently has it been emphasized in the care ofcardiovascular patients.80 The importance of a multidisciplinaryapproach to patient care is particularly relevant in TAVRpatients given the complexity of these procedures.81 The heartteam approach is in fact mandated by the Food and DrugAdministration and The Centers for Medicare and MedicaidServices.80,82–85 The composition of the team can vary byinstitution and adjusted to fit the specific needs of a givenclinical scenario. In general, the team will involve not onlycardiologists and surgeons, but also cardiac anesthesiologistswho are vital not only to the technical success of the procedure,but also have a role in patient selection and the access routechosen.35,80 The implementation of a heart team strategyclearly carries with it the usual logistical hurdle of bringing amultidisciplinary team together. As precise choreography ofTAVR is absolutely mandatory for its success, this initialinvestment in gathering and involving all the members of theheart team in planning the procedure is crucial.

Induction and Maintenance

Principal goals for the anesthesiologist in TA-TAVR casesinclude maintaining hemodynamic stability, avoiding on-tablepatient movement, and achieving early extubation. Given theinvasive nature of the procedure and the need for transesopha-geal echocardiography (TEE), most institutions use generalanesthesia.22 Double-lumen endotracheal intubation, althoughhistorically used in earlier TA-TAVRs, generally is unneces-sary.86 Moreover, single-lung ventilation could have unfavorablecardiopulmonary implications in these cases. Two institutionshave reported performing TA-TAVRs with patients awakerelying on epidurals for pain control.87,88 In one of these reports,2 of 7 patients were converted to general anesthesia. One patienthad a panic attack and another required sternotomy.88 Althoughsedation for these cases may be feasible, the authors of this paperwould advise caution with such an approach, given the potentialprocedural complications described. This is in contrast to TF-TAVRs, in which the role of local anesthesia with sedationlargely has been established, is practiced routinely on theEuropean continent, and is being used in a small but growingnumber of centers in the United States.17,22 Neuromuscularblockade is advised to prevent catastrophic patient movementsduring valve deployment. Implications of such movements orcoughing include poor placement of the valve, paravalvular leak,valve embolization, and aortic dissection. As in any case, thechoice of medications to achieve and maintain general anesthesiais less important than how they are used. Short-acting intra-venous medications should be considered to facilitate rapidextubation. The adoption of a “fast-track” protocol for this groupof patients should be considered.89

TRANSCATHETER AORTIC VALVE REPLACEMENT CONSIDERATIONS 7

Access and Monitoring

The anesthesiologist’s plan for intravenous access andmonitoring in a TA-TAVR should be similar to that for asurgical AVR. Central venous access is required for theadministration of inotropic medications and fluids to facilitaterapid resuscitation in emergencies. Strong consideration needsto be given to arterial and venous groin access for thepossibility of emergent cardiopulmonary bypass.89 An arterialline is mandatory. The use of a pulmonary artery catheter canbe helpful with the management of hemodynamic instability,especially after rapid pacing and valve deployment. Hemody-namic management of patients with poor ventricular functioncan be particularly challenging during this period and makesthe presence of a pulmonary artery catheter quite valuable.Cerebral oximetry and noninvasive cardiac output monitoringdevices have been used and can provide additional helpfuldata.90 Transesophageal echocardiography in TA-TAVRpatients has a uniquely important role and will be discussedbelow. Given the small size of the thoracotomy and difficultyusing internal paddles, external pads placement in advance isrequired.89

Echocardiographic Evaluation

Echocardiography in TAVRs has been reviewed in depthelsewhere.91–93 The use of perioperative TEE in TAVRs isvariable, because it commonly requires the use of generalanesthesia. Although there are centers that perform TEE on

Fig 4. Identification of left ventricular apex with three-dimensional ec

graphy have been found to be helpful in the identification of the true left

image, x-plane imaging is used in real time as the surgeon palpates the ap

may have implications for postoperative bleeding. Additionally, accessin

guidewire being directed toward the mitral rather than the aortic valve.

sedated patients during TF-TAVRs, this practice is uncom-mon.17 Alternatives to TEE for TF-TAVRs done undersedation include transthoracic echocardiography, nasal TEE,and intracardiac echocardiography.17,92 In contrast, most cen-ters that perform TA-TAVRs use general anesthesia, facilitat-ing the use of a TEE probe. Use of TEE in TF-TAVRs and inTA-TAVRs can be helpful, because there are many similarsteps involved in these procedures, such as determination of theannular size and measuring the distance between the coronaryostia and the aortic annulus.91–93 Real-time 3D-TEE mayimprove the accuracy of these measurements in both TA-TAVR and TF-TAVR cases.94,95 Intraoperative TEE duringTA-TAVRs has two additional roles that are not seen in TF-TAVR. Echocardiographic imaging aids the surgeon in theidentification of the true left ventricular apex, for which a three-dimensional x-plane can be helpful (Fig 4, Video 2). Trans-thoracic and apical epicardial echocardiography also have beenused for this purpose.86 As previously discussed, accessing thetrue apex may have implications for postoperative bleeding,given the decreased wall stress at this point.33 Additionally,accessing the free wall of the ventricle can result in the axis ofthe needle and guidewire orientated toward the mitral valverather than the aortic valve.73 Accurate ultrasound imaging alsois needed to ensure that the guidewire and device are notentangled in the mitral valve apparatus, because this can causesevere mitral regurgitation43 (Fig 5, Video clip 3). Rarely,structural damage such as severed chordae may result from theguidewire acting in a “cheese-cutter” fashion.93 After valve

hocardiography and x-plane imaging. Various modes of echocardio-

ventricular apex, including three-dimensional x-plane imaging. In this

ex of the heart. The decreased wall stress at the apex (Laplace’s law)

g the free wall rather than the apex of the ventricle can result in the

(Color version of figure is available online.)

Fig 5. Guidewire entanglement in the mitral apparatus. It is particularly important in the execution of TA-TAVR procedures to ensure that

the guidewire, which is introduced through the apex of the left ventricle, is not entangled with the subvalvular apparatus of the mitral valve. (A)

Shows initial trace to mild mitral regurgitation in a patient undergoing a TA-TAVR. (B) Shows the guidewire impinging on the mitral valve and

its chordae, which resulted in (C) worsening mitral regurgitation, causing associated hypotension. Both the mitral regurgitation and

hypotension improved after the guidewire was removed. However, permanent structural damage to the mitral apparatus also can occur.

(Color version of figure is available online.)

COBEY ET AL8

deployment, the valve must be assessed for regurgitation. Smallparavalvular leaks that do not occupy a significant portion ofthe ventricular outflow tract, do not exhibit any proximalconvergence zones above the deployed valve and do not showany flow reversal in the aorta can be left alone. Otherapproaches that can be considered in evaluating the severityof regurgitation include comparing the Doppler-derived strokevolumes in the right and left ventricular outflow tracts; theproportion that the prosthetic circumference the jet, or sum ofthe jets, occupies also can be used.92 Punctuate leaks arecaused by inadequate inflation of the device or calcifications inthe native valve that leaves a gap between the annulus and theprosthesis preventing a good seal. The guidewire itself caninterfere with cusp coaptation leading to central regurgitation,but removing the wire can resolve the problem.43 Moderate-to-severe paravalvular leak has been estimated to occur in 11.7%of cases and should be addressed given the negative impact on

Fig 6. Paravalvular leaks postvalve deployment. Paravalvular leaks

disturbingly, even mild regurgitation appears to be associated with an

severity of aortic regurgitation. (A) The long-axis view of the prosthetic

deemed acceptable. (B) In contrast, a different valve, again in the long-a

required a second balloon inflation. (Color version of figure is available o

survival96 (Fig 6). Given the complexity of TAVR cases andthe presence of what has been described as the “golden hour”of a TAVR procedure, the echocardiographer must be focusedwholly on the echocardiographic examination to providereliable data for rapid clinical decisions. It is very helpful tohave a dedicated physician who is an experienced andcredentialed echocardiographer (anesthesiologist or cardiolo-gist) who is not involved in the direct anesthetic care of thepatient perform the TEE.91

Hemodynamic Management

Precise blood pressure control is required to reduce the wallstress on the apical purse-string suture. Specific blood pressuretargets change according to the specific steps of the procedureand may vary by institution.89 If needed, short-acting intra-venous medications should be considered. Short-acting calcium

are common after transcatheter aortic valve replacement, and

increased mortality.65 Accordingly, it is important to evaluate the

aortic valve with a single and very small paravalvular leak that was

xis view, with two distinct and more pronounced jets. This patient

nline.)

TRANSCATHETER AORTIC VALVE REPLACEMENT CONSIDERATIONS 9

channel blockers, such as nicardipine or clevidipine, are goodoptions because they are not associated with the same degree ofreduction in preload as seen with other agents. It is importantfor the anesthesiologist to recognize that, despite relieving thepatient’s outflow obstruction with a new valve, cardiac functioninitially may be compromised. Pacing can induce ventriculararrhythmias that necessitate supportive cardiac massage and/orcardioversion.43,89 Rarely, occlusion of coronary ostia canproduce catastrophic ventricular failure. More commonly, thepatient’s stroke volume initially will be displaced physicallyby the device as the introducer is advanced through the narrowleft ventricle’s outflow tract. While the valve is being posi-tioned, there is a concomitant, acute decrease in the effectivevalve area. Inhaled nitric oxide and epoprostenol have beenused to treat pulmonary artery hypertension, which can beexacerbated during this critical period. Ventricular pacing, ifused post-valve deployment, causes ventricular dyssynchronyimpeding cardiac performance and can exacerbate mitralregurgitation.96–98 The corresponding lack of atrial pacingand atrial contraction in TAVR patients with attendant dias-tolic dysfunction will impair cardiac filling. Importantly, myo-cardial stunning related to rapid pacing of the ventricle alsooccurs.99–101 Cardiac biomarkers including troponin and CK-MB are higher after TA-TAVR than TF-TAVR and areassociated with a lower ejection fraction; however, they do notseem to affect overall outcome.102 Transient apical wall motionabnormalities at the insertion site have been observed and appearrelated to the size of the valve used.34 Low-dose inotropicsupport may be considered before initiation of rapid pacing inpatients with baseline reduced ventricular function and can beweaned quickly as stunning recovers over 24 hours.89,100

However, in severe cases of ventricular failure, balloon pumps,cardiopulmonary bypass, and, rarely, arterial-venous extracor-poreal membrane oxygenation (ECMO) may be needed.73,86,89

Pain Management

Adequate analgesia is required not only for patient comfort,but also is essential for facilitating early extubation. Alter-natives to opiates, such as intravenous acetaminophen, shouldbe considered. Medications that impair platelet function orimpair renal function probably should be avoided. Epiduralcatheters have been reported in TA-TAVRs.53,87,88 One insti-tution published their use of epidurals to help address thepostoperative thoracotomy pain and facilitate extubation in thisfrail group of patients and observed improved 30-day and1-year mortality.53 An alternative for pain control for the smallthoracotomy is the use of a paravertebral catheter. Thistechnique, when applied to a larger series of patients under-going minimally invasive valve surgeries via right-sided mini-thoracotomies, decreased time to extubation.103,104 Paraverte-bral catheters tend not to decrease blood pressure as do thoracicepidurals. Similarly, three-level paravertebral blocks with30 mL of 0.2% ropivacaine and 100 μg of clonidine withoutcatheters also have been applied in a small series of TA-TAVRpatients with nearly a 100% success rate of on-table extubation(personal communication, Christopher Connors, MD, April 13,2013. Maine Medical Center). Infiltration of the incision withlocal anesthetics also can be considered. Opiates do provide

effective analgesia. However, as with any cohort of elderlypatients with frequent lung disease, significant care should beused with dosing. Given these concerns, short-acting opiatessuch as remifentanil can be helpful.

Post-Procedure Care

The post-procedure care of TA-TAVRs is different fromTF-TAVR patients. When feasible, early extubation is a desiredgoal for all TAVR patients and is associated with a lower riskof in-hospital morality.24,89 Individuals undergoing TA-TAVRhave a lower rate of on-table extubation compared with thosehaving TF-TAVR.9,36 Early extubation is still feasible in theintensive care unit (ICU) and, in one series, occurred in 82% ofpatients within 5 hours.24 Continued vigilance throughout theperioperative period by the ICU team is required for thesepatients, with close attention to blood pressure management.The ICU team involved in postoperative management of thesepatients should be well aware of all the procedural details andbe able to anticipate complications such as bleeding, myocar-dial stunning, and impaired respiratory function. Given the highrisk of thromboembolism in this patient population, manyinstitutions initiate heparin infusion around postoperative day 2to day 3 (after risk of postoperative surgical bleeding goesdown) with a therapeutic partial thromboplastin time of 55 to70 seconds. This is later bridged to warfarin. Long-termanticoagulation includes dual antiplatelet therapy for 3 months(aspirin and clopidogrel) followed by aspirin indefinitely. Withregard to patients on warfarin, they are placed on clopidogreland warfarin for 3 months followed by aspirin and warfarinindefinitely. Some authors have argued for delaying theinitiation of warfarin in TA-TAVR patients.33 Overall, patientsundergoing TA-TAVR appear to stay in the hospital longerthan those having TF-TAVR. According to the Transcath-eter Valve Treatment Sentinel Pilot Registry, 22% of TF-TAVR patients stayed in the hospital for 410 days incomparison to 43.8% of TA-TAVR patients.22

Alternative Access Routes

The high risk and cost of TA-TAVRs have motivatedphysicians to investigate alternatives, such as the transaortic,subclavian/axillary, carotid, and the brachiocephalic approachfor patients with suboptimal iliofemoral artery anatomy.21,105–108

The published experience with these alternative techniquescomes predominantly from single-center reports with a limitednumber of patients, in contrast to the TA-TAVR and the TF–TAVR, for which there are multiple large national and interna-tional registries. The transaortic approach uses an upper mini-sternotomy to access the aortic valve. The technique has shownsome initial benefits with regard to respiratory and postoperativebleeding, with improved ICU length of stay in selectedpatients.21,106,107 Similarly, the transaxillary approach has shownpromise in the literature. One European center reported usingtransaxillary as their preferred approach over TA-TAVR inpatients with unfavorable ileofemoral anatomy, performing itunder local anesthesia.109 Given the preliminary nature of theexperience reported with these alternative techniques, additionalreview of their anesthetic implications is not reviewed further inthis paper.

COBEY ET AL10

CONCLUSION

The explosive growth of TAVR has created a “clinical dataconundrum,” rendering meaningful comparisons of outcomesbetween trials problematic, because early studies used differentdefinitions for endpoints.38 Still, the consistency of theavailable reports would suggest that the difference betweenthe two procedures is much deeper than simply access points.Patients undergoing TA-TAVR appear to represent a moreextreme subgroup of individuals with a higher disease burdenthan patients presenting for TF-TAVRs. The procedure itself ismore invasive and has a unique set of risks. From theperspective of resource management, a review of the PART-NER trial using quality-adjusted life-years showed thatTA-TAVRs are less cost-effective than TF-TAVRs relative to

surgical AVRs because of greater hospital resource use andpoorer short-term outcomes.110 From an anesthesiologist’smore clinically focused perspective, these cases are at least ascomplex as SAVRs. The fragility of TA-TAVR patientsdemands fastidious attention to a myriad of details, becausesuch patients tend not to recover from either surgical oranesthesia misadventures.73 A thorough understanding of theprocedural steps involved in TA-TAVRs, their physiologicconsequences and possible complications, allows the anesthesi-ologist to be proactive in the care of these patients.89

APPENDIX A. SUPPLEMENTARY INFORMATION

Supplementary data associated with this article can be foundin the online version at doi:10.1053/j.jvca.2013.11.006.

REFERENCES

1. Thomas M, Schymik G, Walther T, et al: Thirty-day results of theSAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry:A European registry of transcatheter aortic valve implantation using theEdwards SAPIEN valve. Circulation 122:62-69, 20102. Iung B, Baron G, Butchart EG, et al: A prospective survey of

patients with valvular heart disease in Europe: The Euro Heart Surveyon Valvular Heart Disease. Eur Heart J 24:1231-1243, 20033. Wendt D, Osswald BR, Kayser K, et al: Society of Thoracic

Surgeons score is superior to the EuroSCORE determining mortality inhigh risk patients undergoing isolated aortic valve replacement. AnnThorac Surg 88:468-474, discussion 474-475, 20094. O’Brien SM, Shahian DM, Filardo G, et al: The Society of

Thoracic Surgeons 2008 cardiac surgery risk models: Part 2—Isolatedvalve surgery. Ann Thorac Surg 88(suppl):S23-S42, 20095. Brown JM, O’Brien SM, Wu C, et al: Isolated aortic valve

replacement in North America comprising 108,687 patients in 10 years:Changes in risks, valve types, and outcomes in the Society of ThoracicSurgeons National Database. J Thorac Cardiovasc Surg 137:82-90, 20096. Grossi EA, Schwartz CF, Yu PJ, et al: High-risk aortic valve

replacement: Are the outcomes as bad as predicted? Ann Thorac Surg85:102-106, discussion 7, 20087. Kalavrouziotis D, Li D, Buth KJ, et al: The European System for

Cardiac Operative Risk Evaluation (EuroSCORE) is not appropriate forwithholding surgery in high-risk patients with aortic stenosis: Aretrospective cohort study. J Cardiothorac Surg 4:32, 20098. Iung B, Cachier A, Baron G, et al: Decision-making in elderly

patients with severe aortic stenosis: Why are so many denied surgery?Eur Heart J 26:2714-2720, 20059. Guinot PG, Depoix JP, Etchegoyen L, et al: Anesthesia and

perioperative management of patients undergoing transcatheter aorticvalve implantation: Analysis of 90 consecutive patients with focus onperioperative complications. J Cardiothorac Vasc Anesth 24:752-761,201010. Otto CM, Mickel MC, Kennedy JW, et al: Three-year outcome

after balloon aortic valvuloplasty. Insights into prognosis of valvularaortic stenosis. Circulation 89:642-650, 199411. Lieberman EB, Bashore TM, Hermiller JB, et al: Balloon aortic

valvuloplasty in adults: Failure of procedure to improve long-termsurvival. J Am Coll Cardiol 26:1522-1528, 199512. Feldman T: Core curriculum for interventional cardiology:

Percutaneous valvuloplasty. Catheter Cardiovasc Interv 60:48-56, 200313. Cribier A: Development of transcatheter aortic valve implanta-

tion (TAVI): A 20-year odyssey. Arch Cardiovasc Dis 105:146-152,2012

14. Cribier A, Eltchaninoff H, Bash A, et al: Percutaneous trans-catheter implantation of an aortic valve prosthesis for calcific aorticstenosis: First human case description. Circulation 106:3006-3008,200215. Smith CR, Leon MB, Mack MJ, et al: Transcatheter versus

surgical aortic-valve replacement in high-risk patients. N Engl J Med364:2187-2198, 201116. Reardon MJ: Cost-effectiveness analysis of TAVR. Methodist

Debakey Cardiovasc J 8:26-28, 201217. Bufton KA, Augoustides JG, Cobey FC: Anesthesia for trans-

femoral aortic valve replacement in North America and Europe.J Cardiothorac Vasc Anesth 27:46-49, 201318. Lichtenstein SV, Cheung A, Ye J, et al: Transapical transcatheter

aortic valve implantation in humans: Initial clinical experience.Circulation 114:591-596, 200619. De Robertis F, Asgar A, Davies S, et al: The left axillary artery—

A new approach for transcatheter aortic valve implantation. Eur JCardiothorac Surg 36:807-812, 200920. Modine T, Obadia JF, Choukroun E, et al: Transcutaneous aortic

valve implantation using the axillary/subclavian access: Feasibility andearly clinical outcomes. J Thorac Cardiovasc Surg 141:487-491,491.e1, 201121. Lardizabal JA, O’Neill BP, Desai HV, et al: The transaortic

approach for transcatheter aortic valve replacement: Initial clinicalexperience in the United States. J Am Coll Cardiol 61:2341-2345, 201322. Di Mario C, Eltchaninoff H, Moat N, et al: The 2011-12 pilot

European Sentinel Registry of Transcatheter Aortic Valve Implantation:In-hospital results in 4,571 patients. EuroIntervention 8:1362-1371,201323. Beller CJ, Schmack B, Seppelt P, et al: The groin first approach

for transcatheter aortic valve implantation: Are we pushing the limitsfor transapical implantation? Clin Res Cardiol 102:111-117, 201324. Ferrari E, Namasivayam J, Marcucci C, et al: Transapical aortic

valve replacement in extreme-risk patients: Outcome, risk factors andmid-term results. Eur J Cardiothorac Surg 43:978-985, 201325. Ben-Dor I, Gaglia MA Jr, Barbash IM, et al: Comparison

between Society of Thoracic Surgeons score and logistic EuroSCOREfor predicting mortality in patients referred for transcatheter aortic valveimplantation. Cardiovasc Revasc Med 12:345-349, 201126. Barili F, Di Gregorio O, Capo A, et al: Aortic valve replacement:

Reliability of EuroSCORE in predicting early outcomes. Int J Cardiol144:343-345, 201027. Piazza N, Wenaweser P, van Gameren M, et al: Relationship

between the logistic EuroSCORE and the Society of Thoracic Surgeons

TRANSCATHETER AORTIC VALVE REPLACEMENT CONSIDERATIONS 11

Predicted Risk of Mortality score in patients implanted with theCoreValve ReValving system—A Bern-Rotterdam Study. Am Heart J159:323-329, 201028. Osswald BR, Gegouskov V, Badowski-Zyla D, et al: Over-

estimation of aortic valve replacement risk by EuroSCORE: Implica-tions for percutaneous valve replacement. Eur Heart J 30:74-80, 200929. Haensig M, Holzhey DM, Borger MA, et al: Is the new

EuroSCORE II a better predictor for transapical aortic valve implanta-tion? Eur J Cardiothorac Surg 44:302-308, 201330. Afilalo J, Karunananthan S, Eisenberg MJ, et al: Role of frailty in

patients with cardiovascular disease. Am J Cardiol 103:1616-1621,200931. Purser JL, Kuchibhatla MN, Fillenbaum GG, et al: Identifying

frailty in hospitalized older adults with significant coronary arterydisease. J Am Geriatr Soc 54:1674-1681, 200632. Kempfert J, Rastan A, Holzhey D, et al: Transapical aortic valve

implantation: Analysis of risk factors and learning experience in 299patients. Circulation 124(suppl):S124-S129, 201133. Wong DR, Ye J, Cheung A, et al: Technical considerations to

avoid pitfalls during transapical aortic valve implantation. J ThoracCardiovasc Surg 140:196-202, 201034. Barbash IM, Dvir D, Ben-Dor I, et al: Impact of transapical aortic

valve replacement on apical wall motion. J Am Soc Echocardiogr 26:255-260, 201335. Holmes DR Jr., Mack MJ, Kaul S, et al: 2012 ACCF/AATS/

SCAI/STS expert consensus document on transcatheter aortic valvereplacement: Developed in collabration with the American HeartAssociation, American Society of Echocardiography, European Associ-ation for Cardio-Thoracic Surgery, Heart Failure Society of America,Mended Hearts, Society of Cardiovascular Anesthesiologists, Society ofCardiovascular Computed Tomography, and Society for CardiovascularMagnetic Resonance. J Thorac Cardiovasc Surg 144:e29-e84, 201236. Billings FTt, Kodali SK, Shanewise JS: Transcatheter aortic valve

implantation: Anesthetic considerations. Anesth Analg 108:1453-1462, 200937. Poliacikova P, Hildick-Smith D: Paravalvular leak closure for

persisting aortic regurgitation after implantation of the corevalvetranscatheter valve. Catheter Cardiovasc Interv: [Epub ahead of print],2013 Oct 1538. Leon MB, Piazza N, Nikolsky E, et al: Standardized endpoint

definitions for Transcatheter Aortic Valve Implantation clinical trials: Aconsensus report from the Valve Academic Research Consortium. J AmColl Cardiol 57:253-269, 201139. Beller CJ, Bekeredjian R, Krumsdorf U, et al: Transcatheter

aortic valve implantation after previous mechanical mitral valvereplacement: Expanding indications? Heart Surg Forum 14:E166-E170, 201140. Blumenstein J, Van Linden A, Arsalan M, et al: Experimental

evaluation of a new apical access and closure device. Ann Thorac Surg94:1706-1709, 201241. Amabile N, Azmoun A, Ghostine S, et al: Incidence, predictors

and prognostic value of serious hemorrhagic complications followingtranscatheter aortic valve implantation. Int J Cardiol 168:151-156, 201342. Rosato F, Grossi C, Barili F: An unusual complication of

transapical aortic valve implantation: A left ventricular pseudoaneur-ysm infiltrating the thoracic wall. Heart 98:1837, 201243. Al-Attar N, Ghodbane W, Himbert D, et al: Unexpected

complications of transapical aortic valve implantation. Ann ThoracSurg 88:90-94, 200944. Calafiore AM, Ibrahim A, al Ahmari S, et al: Delayed bleeding

after transapical aortic valve implantation. J Thorac Cardiovasc Surg143:e5-e6, 201245. Al-Attar N, Raffoul R, Himbert D, et al: False aneurysm after

transapical aortic valve implantation. J Thorac Cardiovasc Surg 137:e21-e22, 2009

46. Lenders G, Van Schil P, Rodrigus I, et al: Intercostal arterypseudoaneurysm: A rare complication of transaortic transcatheter aorticvalve implantation. Interact Cardiovasc Thorac Surg 15:550-552, 201247. Gurvitch R, Tay EL, Wijesinghe N, et al: Transcatheter aortic

valve implantation: Lessons from the learning curve of the first 270high-risk patients. Catheter Cardiovasc Interv 78:977-984, 201148. Gilard M, Eltchaninoff H, Iung B, et al: Registry of transcatheter

aortic-valve implantation in high-risk patients. N Engl J Med 366:1705-1715, 201249. Dvir D, Assali A, Porat E, et al: Distal left anterior descending

coronary artery obstruction: A rare complication of transapical aorticvalve implantation. J Invasive Cardiol 23:E281-E283, 201150. Kappetein AP, Head SJ, Généreux P, et al: Updated standardized

endpoint definitions for transcatheter aortic valve implantation: TheValve Academic Research Consortium-2 consensus document. JThorac Cardiovasc Surg 145:6-23, 201351. Wilbring M, Tugtekin SM, Alexiou K, et al: Transapical trans-

catheter aortic valve implantation vs conventional aortic valve replace-ment in high-risk patients with previous cardiac surgery: A propensity-score analysis. Eur J Cardiothorac Surg 44:42-47, 201352. Walther T, Thielmann M, Kempfert J, et al: PREVAIL TRANS-

APICAL: Multicentre trial of transcatheter aortic valve implantationusing the newly designed bioprosthesis (SAPIEN-XT) and deliverysystem (ASCENDRA-II). Eur J Cardiothorac Surg 42:278-283; discus-sion 83, 201253. Amat-Santos IJ, Dumont E, Villeneuve J, et al: Effect of thoracic

epidural analgesia on clinical outcomes following transapical trans-catheter aortic valve implantation. Heart 98:1583-1590, 201254. Meller SM, Baumbach A, Brickman AM, et al: Clinical

implications for diffusion-weighted MRI brain lesions associated withtranscatheter aortic valve replacement. Catheter Cardiovasc Interv:[Epub ahead of print], 2013 Mar 455. Kahlert P, Knipp SC, Schlamann M, et al: Silent and apparent

cerebral ischemia after percutaneous transfemoral aortic valve implan-tation: A diffusion-weighted magnetic resonance imaging study.Circulation 121:870-878, 201056. Reidy C, Sophocles A, Ramakrishna H, et al: Challenges after

the first decade of transcatheter aortic valve replacement: Focus onvascular complications, stroke, and paravalvular leak. J CardiothoracVasc Anesth 27:184-189, 201357. Tay EL, Gurvitch R, Wijesinghe N, et al: A high-risk period for

cerebrovascular events exists after transcatheter aortic valve implanta-tion. JACC Cardiovasc Interv 4:1290-1297, 201158. Bleiziffer S, Ruge H, Mazzitelli D, et al: Results of percutaneous and

transapical transcatheter aortic valve implantation performed by a surgicalteam. Eur J Cardiothorac Surg 35:615-620; discussion 620-621, 200959. Kahlert P, Al-Rashid F, Dottger P, et al: Cerebral embolization

during transcatheter aortic valve implantation: A transcranial Dopplerstudy. Circulation 126:1245-1255, 201260. Rodes-Cabau J, Dumont E, Boone RH, et al: Cerebral embolism

following transcatheter aortic valve implantation: Comparison oftransfemoral and transapical approaches. J Am Coll Cardiol 57:18-28, 201161. Knipp SC, Kahlert P, Jokisch D, et al: Cognitive function after

transapical aortic valve implantation: A single-centre study with 3-month follow-up. Interact Cardiovasc Thorac Surg 16:116-122, 201362. Steinberg BA, Harrison JK, Frazier-Mills C, et al: Cardiac

conduction system disease after transcatheter aortic valve replacement.Am Heart J 164:664-671, 201263. Koos R, Mahnken AH, Aktug O, et al: Electrocardiographic and

imaging predictors for permanent pacemaker requirement after trans-catheter aortic valve implantation. J Heart Valve Dis 20:83-90, 201164. Abdel-Wahab M, Zahn R, Horack M, et al: Aortic regurgitation

after transcatheter aortic valve implantation: Incidence and early

COBEY ET AL12

outcome. Results from the German transcatheter aortic valve inter-ventions registry. Heart 97:899-906, 201165. Généreux P, Head SJ, Hahn R, et al: Paravalvular leak after

transcatheter aortic valve replacement: The new Achilles’ heel? A compre-hensive review of the literature. J Am Coll Cardiol 61:1125-1136, 201366. Allam B, Zegdi R, Blanchard D, et al: Transfemorally or

transapically deployed Sapien Edwards bioprosthesis is alwaysdeformed. J Interv Cardiol 25:53-61, 201267. Kukucka M, Pasic M, Dreysse S, et al: Patient-prosthesis

mismatch after transapical aortic valve implantation: Incidence andimpact on survival. J Thorac Cardiovasc Surg 145:391-397, 201368. Van Linden A, Kempfert J, Blumenstein J, et al: Prosthesis-patient

mismatch after transcatheter aortic valve implantation using the EdwardsSAPIEN Prosthesis. Thorac Cardiovasc Surg 61:414-420, 201369. Rodes-Cabau J, Webb JG, Cheung A, et al: Long-term outcomes

after transcatheter aortic valve implantation: Insights on prognosticfactors and valve durability from the Canadian multicenter experience.J Am Coll Cardiol 60:1864-1875, 201270. Rodes-Cabau J, Webb JG, Cheung A, et al: Transcatheter aortic

valve implantation for the treatment of severe symptomatic aorticstenosis in patients at very high or prohibitive surgical risk: Acute andlate outcomes of the multicenter Canadian experience. J Am CollCardiol 55:1080-1090, 201071. Nielsen HH, Klaaborg KE, Nissen H, et al: A prospective,

randomised trial of transapical transcatheter aortic valve implantationvs. surgical aortic valve replacement in operable elderly patients withaortic stenosis: The STACCATO trial. EuroIntervention 8:383-389, 201272. Webb JG, Altwegg L, Boone RH, et al: Transcatheter aortic

valve implantation: Impact on clinical and valve-related outcomes.Circulation 119:3009-3016, 200973. Pasic M, Buz S, Dreysse S, et al: Transapical aortic valve

implantation in 194 patients: Problems, complications, and solutions.Ann Thorac Surg 90:1463-1469; discussion; 1469-1470, 201074. Wendt D, Eggebrecht H, Kahlert P, et al: Experience and

learning curve with transapical aortic valve implantation [article inGerman]. Herz 34:388-397, 200975. Nielsen HH, Thuesen L, Egeblad H, et al: Single center

experience with transcatheter aortic valve implantation using theEdwards SAPIEN Valve. Scand Cardiovasc J 45:261-266, 201176. Nuis RJ, van Mieghem NM, van der Boon RM, et al: Effect of

experience on results of transcatheter aortic valve implantation using aMedtronic CoreValve System. Am J Cardiol 107:1824-1829, 201177. Wendler O, Walther T, Schroefel H, et al: The SOURCE Registry:

What is the learning curve in trans-apical aortic valve implantation? Eur JCardiothorac Surg 39:853-859; discussion; 859-860, 201178. Pasic M, Unbehaun A, Dreysse S, et al: Introducing transapical

aortic valve implantation (part 1): Effect of a structured trainingprogram on clinical outcome in a series of 500 procedures. J ThoracCardiovasc Surg 145:911-918, 201379. Pasic M, Unbehaun A, Dreysse S, et al: Introducing transapical

aortic valve implantation (part 2): Institutional structured trainingprogram. J Thorac Cardiovasc Surg 145:919-925, 201380. Holmes DR Jr., Rich JB, Zoghbi WA, et al: The heart team of

cardiovascular care. J Am Coll Cardiol 61:903-907, 201381. Holmes DR Jr, Mohr F, Hamm CW, et al: Venn diagrams in

cardiovascular disease: The Heart Team concept. Ann Thorac Surg 95:389-391, 201382. Holmes DR Jr, Mack MJ: Transcatheter valve therapy: A pro-

fessional society overview from the American College of CardiologyFoundation and the Society of Thoracic Surgeons. J Am Coll Cardiol58:445-455, 201183. Holmes DR Jr., Mack MJ, Kaul S, et al: ACCF/AATS/SCAI/

STS expert consensus document on transcatheter aortic valve replace-ment. J Am Coll Cardiol 59:1200-1254, 2012

84. Tommaso CL, Bolman RM 3rd, Feldman T, et al: Multisociety(AATS, ACCF, SCAI, and STS) expert consensus statement: Operatorand institutional requirements for transcatheter valve repair andreplacement, part 1: Transcatheter aortic valve replacement. J Am CollCardiol 59:2028-2042, 201285. Husten L: CMS Issues National Coverage Decision for TAVR.

Forbes : (May 1), 201286. Svensson LG, Dewey T, Kapadia S, et al: United States feasibility

study of transcatheter insertion of a stented aortic valve by the leftventricular apex. Ann Thorac Surg 86:46-54; discussion 55, 200887. Petridis FD, Savini C, Castelli A, et al: Awake transapical

aortic valve implantation. Interact Cardiovasc Thorac Surg 14:673-674,201288. Mukherjee C, Walther T, Borger MA, et al: Awake transapical

aortic valve implantation using thoracic epidural anesthesia. AnnThorac Surg 88:992-994, 200989. Fassl J, Walther T, Groesdonk HV, et al: Anesthesia manage-

ment for transapical transcatheter aortic valve implantation: A caseseries. J Cardiothorac Vasc Anesth 23:286-291, 200990. Paarmann H, Heringlake M, Heinze H, et al: Non-invasive

cerebral oxygenation reflects mixed venous oxygen saturation duringthe varying haemodynamic conditions in patients undergoing trans-apical transcatheter aortic valve implantation. Interact CardiovascThorac Surg 14:268-272, 201291. Patel PA, Fassl J, Thompson A, et al: Transcatheter aortic

valve replacement—Part 3: The central role of perioperative trans-esophageal echocardiography. J Cardiothorac Vasc Anesth 26:698-710, 201292. Zamorano JL, Badano LP, Bruce C, et al: EAE/ASE recom-

mendations for the use of echocardiography in new transcatheterinterventions for valvular heart disease. J Am Soc Echocardiogr 24:937-965, 201193. Jayasuriya C, Moss RR, Munt B: Transcatheter aortic valve

implantation in aortic stenosis: The role of echocardiography. J Am SocEchocardiogr 24:15-27, 201194. Chirojit M, Frederik H, David H, et al: Is real time 3D

transesophageal echocardiography a feasible approach to detect coro-nary ostium during transapical aortic valve implantation? J Cardio-thorac Vasc Anesth 27:654-659, 201395. Smith LA, Dworakowski R, Bhan A, et al: Real-time three-

dimensional transesophageal echocardiography adds value to trans-catheter aortic valve implantation. J Am Soc Echocardiogr 26:359-369,201396. Wong DT, Leong DP, Khurana S, et al: Severe mitral regur-

gitation due to right ventricular apical pacing. BMJ Case Rep : (Nov 2,2010), 201097. Langer F, Tibayan FA, Rodriguez F, et al: Altered mitral valve

kinematics with atrioventricular and ventricular pacing. J Heart ValveDis 14:286-294, 200598. Samet P, Castillo C, Bernstein WH: Hemodynamic sequelae of

atrial, ventricular, and sequential atrioventricular pacing in cardiacpatients. Am Heart J 72:725-729, 196699. Crouch GBJ, Sinhal A, Bradbrook C, et al: Early right

ventricular dysfunction after transcatheter aortic valve replacement(TAVI): A prospective cardiac magnetic resonance study of openversus transcatheter aortic valve replacement. J Cardiovasc MagnReson 15(suppl):278, 2013100. Dworakowski RBA, Brickham B, Wendler O, et al: BCS

Abstracts:164—Early haemodynamic changes and myocardial injuryafter transfemoral transcatheter aortic valve implantation (TAVI). Heart97:A91-A92, 2011101. Dworakowski R, Wendler O, Bhan A, et al: Successful trans-

catheter aortic valve implantation (TAVI) is associated with transientleft ventricular dysfunction. Heart 98:1641-1646, 2012

TRANSCATHETER AORTIC VALVE REPLACEMENT CONSIDERATIONS 13

102. Rodes-Cabau J, Gutierrez M, Bagur R, et al: Incidence,predictive factors, and prognostic value of myocardial injury followinguncomplicated transcatheter aortic valve implantation. J Am CollCardiol 57:1988-1999, 2011103. Carmona P, Llagunes J, Casanova I, et al: Continuous para-

vertebral analgesia versus intravenous analgesia in minimally invasivecardiac surgery by mini-thoracotomy [article in Spanish]. Rev EspAnestesiol Reanim 59:476-482, 2012104. Esper SSM, Glower D, Gaca JG, et al: Paravertebral catheter

infusion as the primary postoperative analgesia for minimally invasivevalve surgery. Presented at the Society of Cardiovascular Anesthesiol-ogists 35th Annual Meeting & Workshops, April 6 - 10, 2013, Miami,Florida.105. Leucker TM, Williams ML, Flaherty MP: Transcatheter aortic

valve replacement: A novel abdominal transaortic approach. CatheterCardiovasc Interv: [Epub ahead of print], 2013 Oct 15106. Etienne PY, Papadatos S, El Khoury E, et al: Transaortic

transcatheter aortic valve implantation with the Edwards SAPIEN

valve: Feasibility, technical considerations, and clinical advantages.Ann Thorac Surg 92:746-748, 2011107. Bapat V, Khawaja MZ, Attia R, et al: Transaortic Transcatheter

Aortic valve implantation using Edwards Sapien valve: A novelapproach. Catheter Cardiovasc Interv 79:733-740, 2012108. Schirmer J, Conradi L, Seiffert M, et al: Transcatheter aortic

valve implantation: Alternative access options. Minerva Cardioangiol61:429-435, 2013109. Taramasso M, Maisano F, Cioni M, et al: Trans-apical and

trans-axillary percutaneous aortic valve implantation as alternatives tothe femoral route: Short- and middle-term results. Eur J CardiothoracSurg 40:49-55, 2011110. Reynolds MR, Magnuson EA, Lei Y, et al: Cost-effectiveness

of transcatheter aortic valve replacement compared with surgicalaortic valve replacement in high-risk patients with severe aorticstenosis: Results of the PARTNER (Placement of Aortic Trans-catheter Valves) trial (Cohort A). J Am Coll Cardiol 60:2683-2692, 2012