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Circulation: Cardiovascular Interventions

ORIGINAL ARTICLE

Transcarotid Compared With Other


Alternative Access Routes for
Transcatheter Aortic Valve Replacement

See Editorial by Praz and Wenaweser Chekrallah Chamandi, MD


Ramzi Abi-Akar, MD
BACKGROUND: The optimal access for patients undergoing Josep Rodés-Cabau, MD
transcatheter aortic valve replacement (TAVR) who are not candidates for Didier Blanchard, MD
a transfemoral approach has not been elucidated. The purpose of this Eric Dumont, MD
Christian Spaulding, MD
study was to compare the safety, feasibility, and early clinical outcomes of
Daniel Doyle, MD
transcarotid TAVR compared with thoracic approaches.
Jean-Yves Pagny, MD
METHODS AND RESULTS: From a multicenter consecutive cohort of 329 Robert DeLarochellière,
alternative-access TAVR patients (2012–2017), we identified 101 patients MD
Antoine Lafont, MD
who underwent transcarotid TAVR and 228 patients who underwent a
Jean-Michel Paradis, MD
transapical or transaortic TAVR. Preprocedural success and 30-day clinical
Rishi Puri, MD
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outcomes were compared using multivariable propensity score analysis Nicole Karam, MD
to account for between-group differences in baseline characteristics. Frédéric Maes, MD
All transcarotid cases were performed under general anesthesia, mainly Tania Rodriguez-Gabella,
using the left common carotid artery (97%). Propensity-matched MD
groups had similar rates of 30-day all-cause mortality (2.1% versus Stéphan Chassaing, MD
4.6%; P=0.37), stroke (2.1% versus 3.5%; P=0.67; transcarotid versus Olivier Le Page, MD
transapical/transaortic, respectively), new pacemaker implantation, Dimitri Kalavrouziotis,
and major vascular complications. Transcarotid TAVR was associated MD*
with significantly less new-onset atrial fibrillation (3.2% versus 19.0%; Siamak Mohammadi, MD*
P=0.002), major or life-threatening bleeding (4.3% versus 19.9%;
P=0.002), acute kidney injury (none versus 12.1%; P=0.002), and shorter
median length of hospital stay (6 versus 8 days; P<0.001).
CONCLUSIONS: Transcarotid vascular access for TAVR is safe and feasible
and is associated with encouraging short-term clinical outcomes. Our
data suggest a clinical benefit of transcarotid TAVR with respect to
atrial fibrillation, major bleeding, acute kidney injury, and length of stay
compared with the more invasive transapical or transaortic strategies.
Randomized studies are required to ascertain whether transcarotid TAVR
yields equivalent results to other alternative vascular access routes. *Drs Kalavrouziotis and Mohammadi
contributed equally to this work.

Key Words:  aortic valve ◼ cohort


studies ◼ heart valve prosthesis
◼ humans ◼ propensity score

© 2018 American Heart Association, Inc.

https://www.ahajournals.org/journal/
circinterventions

Circ Cardiovasc Interv. 2018;11:e006388. DOI: 10.1161/CIRCINTERVENTIONS.118.006388 November 2018 1


Chamandi et al; Comparison of Transcarotid vs Transthoracic TAVR

cardiology and cardiac surgery departments across 3 tertiary-


WHAT IS KNOWN care hospitals from Canada and France. We identified 329
consecutive TAVR patients who underwent alternative non-
• Transfemoral transcatheter aortic valve replace- transfemoral approaches including transapical, transaortic,
ment (TAVR) is associated with excellent outcomes or transcarotid, between January 2012 and June 2017. A
in patients with intermediate and high surgical risk. transapical or transaortic TAVR was performed in 228 cases
• Up to 1 in 5 patients may not be candidates for (159 transapical and 69 transaortic), whereas the transca-
transfemoral access because of anatomic reasons. rotid approach was used in 101 cases. To adjust for poten-
• Transcarotid access is a safe and feasible option tial differences in patient perioperative risk, patients in the
for TAVR, but its merits relative to transthoracic combined transapical/transaortic TAVR group were matched
alternative access options are not clearly known. to patients in the transcarotid TAVR group using a propensity
score analysis, as described in the statistical analysis section.
WHAT THE STUDY ADDS The matched final study population consisted of 163 patients
• Transcarotid TAVR is safe compared with receiving transapical/transaortic TAVR and 94 patients receiv-
transthoracic access with comparable mortality ing transcarotid TAVR.
and stroke risk. At each participating institution, patients with severe aortic
• Transcarotid TAVR may offer several advantages stenosis considered by the local multidisciplinary heart team
over transthoracic TAVR, including lower rates of to be at high or prohibitive surgical risk were considered for
atrial fibrillation, major bleeding, and renal failure, TAVR. Multimodality vascular evaluation was performed in
as well as reduced hospital stay. all cases to select the optimal vascular access. Whenever fea-
sible, transfemoral was considered as the first-line approach.
Patients with unfavorable iliofemoral anatomy (minimal lumen

T
ranscatheter aortic valve replacement (TAVR) has diameter, ≤6 mm; severe calcification/tortuosity), signifi-
become a reasonable alternative to surgical aortic cant disease of the thoracoabdominal aorta, or prior periph-
valve replacement for patients with severe symp- eral arterial interventions were not considered eligible for a
transfemoral approach. Selection of alternative access was
tomatic aortic stenosis who are at intermediate-to-high/
then individualized to each patient’s anatomic features and
prohibitive surgical risk.1–3 Although transfemoral access
comorbidities. However, transcarotid access was the favored
is considered the default access strategy, 10% to 15% of approach during the latter part of the study period, if feasible,
TAVR candidates do not have favorable iliofemoral anat- as described below. Transapical and transaortic were reserved
omy for safe transfemoral access.4 As experience with for patients who were not considered candidates for a trans-
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alternative access routes is growing, transcatheter heart carotid approach, with selection between transapical and
valve (THV) technologies have evolved considerably over transaortic largely based on anatomy and comorbidity (previ-
time, and important iterations have been implemented ous cardiac surgery, severely calcified ascending aorta, left ven-
in many of the latest generation devices to diminish the tricular dysfunction with or without calcified apical aneurysm,
proportion of patients deemed to be poor candidates severe chronic lung disease, etc). The yearly proportion of total
for transfemoral access.5 However, each access option TAVR cases that were not transfemoral TAVR in the 3 partici-
has unique advantages and limitations that must be pating centers, from January 2012 to June 2017 was 18.4%,
20.1%, 16.7%, 15.4%, 20.9%, and 14.6% (Appendix in the
individualized to the patient’s anatomy.6
Data Supplement; Figure I in the Data Supplement). The study
The carotid artery has been recently suggested as a was approved by the institutional review board of each partici-
feasible alternative access during TAVR, with encour- pating institution. All patients gave written informed consent
aging short- and medium-term outcomes, harboring for participation in the registry, and this study met the require-
specific advantages over the more invasive transapi- ments of each participating institutional review board.
cal or transaortic strategies.7–11 There are currently
limited comparative data among the alternative TAVR Preprocedural Screening
approaches, and, therefore, we performed a multi- All patients referred for TAVR underwent cardiac catheter-
center comparison between transcarotid and transapi- ization (followed by percutaneous revascularization if severe
cal/transaortic approaches with respect to safety and stenosis or functionally significant intermediate coronary ste-
early clinical outcomes. nosis was detected), as well as cardiac and global vascular
assessment with multislice computed tomography (CT) stud-
METHODS ies. Aortic annulus area and perimeter, Valsalva sinus size,
Agatston calcium score, and distance between the aortic
The data, analytic methods, and study materials will not be
valve annulus and coronary arteries were measured from CT
made available to other researchers for purposes of reproduc-
studies, which informed the decision on the appropriate size
ing the results because of restrictions imposed by the patient
and prosthesis type. In patients not suitable for a transfemoral
consent process.
approach, the carotid arteries were assessed by Doppler ultra-
sound and multislice CT evaluation of carotid and supra-aortic
Patient Population arch vessels to detect any functionally significant stenosis or
This prospective multicenter, observational registry was flow disturbance. Transcarotid access was considered feasible
developed following the collaboration of the interventional when the 2 following criteria were satisfied: (1) the presence

Circ Cardiovasc Interv. 2018;11:e006388. DOI: 10.1161/CIRCINTERVENTIONS.118.006388 November 2018 2


Chamandi et al; Comparison of Transcarotid vs Transthoracic TAVR

of a common carotid artery (CCA) minimal lumen diam- of stroke or transient ischemic attack (TIA), history of myocar-
eter ≥7 mm and (2) the absence of a contralateral carotid dial infarction, peripheral vascular disease, and the following
artery occlusion, significant (≥50%) internal or CCA stenosis, 2 interaction terms: age and peripheral vascular disease, age
and occlusion or stenosis of vertebral arteries. Brain CT or and hypertension. The goodness-of-fit of the model using the
magnetic resonance imaging were not routinely performed. Hosmer-Lemeshow test indicated that the final model was
Patients with a history of cerebrovascular events were all eval- a good fit (χ2=4.52 with df=8; P=0.81). Matching was then
uated by a neurologist before the procedure and, if recom- performed on the propensity score without replacement of
mended, had further preprocedural imaging. case and control subjects (many to many or complete match-
ing) using the greedy algorithm. A detailed description of the
matching algorithm is available in the Appendix in the Data
Procedural Technique Supplement. This complete matching algorithm allows for
In all cases, TAVR was performed under general anesthe- maximal use of patients by minimizing exclusion of outliers.
sia, with invasive hemodynamic monitoring and continu- Using this procedure, 94 of 101 transcarotid patients (93.1%)
ous cerebral saturation assessment with the INVOS system were matched to 163 transapical/transaortic patients, creat-
(Medtronic, Minneapolis, MN). Additional simultaneous elec- ing a series of 58 matched sets with no limitation of the ratio
troencephalogram monitoring was used in 2 of the 3 cen- of transcarotid to control patients. After full matching, statis-
ters.12 Radial or femoral arterial access was used for pigtail tical analyses used a weighted approach, taking into account
guidance to the plane of the aortic valve, and a temporary the clustering of patients within each stratum of match. In
pacemaker was implanted either by jugular or femoral vein addition, a second propensity score model was fit forcing
access. Fluoroscopic and transesophageal echocardiography institution into the model to assess for a potential confound-
guidance were performed, with unfractionated intravenous ing effect by center. Continuous variables are expressed as
heparin given to achieve an activated clotting time of ≥250 weighted mean±SD and analyzed using the linear regression
seconds. All patients were receiving at least single-antiplatelet model adjusted for stratification (blocking factor). Categorical
therapy at the time of TAVR. variables are expressed using proportions and analyzed with
Transcarotid TAVR was performed following a previously a linear model and a logit link function adjusted for strati-
published technique.13 To summarize, an intraprocedural fication (blocking factor). Statistical significance was present
indirect evaluation of the functional integrity of the arterial when the 2-tailed P value was <0.05. Analyses were per-
circle of Willis and patency of the contralateral CCA were per- formed using SAS, version 9.4 (SAS Institute, Inc, Cary, NC).
formed in 1 of the 3 centers. For this purpose, the proximal
CCA was clamped during a 2-minute period during which
time the distal arterial pressure and cerebral oximetry were
RESULTS
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measured. A decrease of the mean backflow pressure to <30


mm Hg or a decrease of ≥50% in cerebral saturation during Baseline clinical and echocardiographic data compar-
the clamp test that did not respond to moderate hemody- ing unmatched and propensity score-matched transca-
namic support was considered an indication to perform a rotid compared with transapical/transaortic patients are
temporary femorocarotid external shunt. If these criteria were shown in Table 1 (see Appendix in the Data Supplement
not met, no carotid bypass shunt was indicated. In this series, for standardized differences). In the unmatched cohorts,
these criteria were not met in all patients in whom the test patients in the transcarotid group were slightly older
was performed no carotid shunt was implanted. The choice of
(mean age, 80.4±8.4 versus 78.2±7.3 years; P=0.02),
valve type, balloon valvuloplasty, and post-dilatation was left
to the discretion of the operator.
with a higher prevalence of peripheral vascular dis-
ease (66.3% versus 47.4%; P=0.002), but comparable
Society of Thoracic Surgeons predicted risk of mortal-
Clinical End Points and Definitions ity (6.6±5.7 versus 6.1±4.4; P=0.32) and EuroSCORE
The outcomes of interest in this study included periprocedural II (8.7±7.5 versus 8.8±7.3; P=0.91; transcarotid versus
and 30-day all-cause mortality, stroke, device success, early transapical/transaortic, respectively).
safety, and major outcomes according to the Valve Academic
Initially, 104 patients had been selected for trans-
Research Consortium-2 consensus definitions.14
carotid access. In 3 of these patients, the transcarotid
approach was abandoned after CCA exposure. Two cases
Statistical Analysis were because of extensive calcification of the CCA when
A continuous propensity score analysis was performed to assessed by the surgeon on palpation before the punc-
adjust for the intergroup clinical differences. A propensity ture, which was not evident on preprocedural imaging.
score representing the likelihood of having a transcarotid The other case was because of a low CCA bifurcation
was calculated for each patient by the use of multivariable
precluding safe access to the vessel. These 3 patients all
logistic regression analysis that identified variables indepen-
dently associated with transcarotid. Continuous variables
underwent successful transaortic TAVR at the same sit-
were checked for the assumption of linearity in the logit ting. Therefore, successful vascular access was achieved
and the graphical representations suggested linear relation- in all patients in the transapical/transaortic group and
ships. Interactions between variables were allowed only if it in 101 (97.1%) patients in the transcarotid group.
was supported clinically and statistically (P<0.20). Variables Procedural characteristics are summarized in Table  2.
retained in the final model were age, hypertension, history Most patients (89.4%) in the transapical/transaortic

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Chamandi et al; Comparison of Transcarotid vs Transthoracic TAVR

Table 1.  Baseline Clinical and Echocardiographic Characteristics of Patients Undergoing TA or TAo Versus TC Transcatheter
Aortic Valve Replacement

Unmatched Data Propensity Score-Matched Data*


TA/TAo TC TA/TAo TC
Variables (n=228) (n=101) P Value (n=163) (n=94) P Value
Age, y 78.2±7.3 80.4±8.4 0.02 79.4±5.4 79.7±8.2 0.57
Women 97 (42.5) 46 (45.5) 0.63 41.1 42.6 0.87
Diabetes mellitus 92 (40.4) 42 (41.6) 0.90 39.2 44.7 0.44
Atrial fibrillation/flutter 75 (32.9) 41 (40.6) 0.21 36.3 42.6 0.38
Hypertension 209 (91.7) 82 (81.2) 0.01 83.1 84.0 0.82
Stroke/TIA 60 (26.3) 16 (15.8) 0.05 16.6 17.0 0.93
Previous myocardial infarction 81 (35.5) 20 (19.8) 0.004 20.5 20.2 0.96
Coronary artery disease 169 (74.1) 64 (63.4) 0.05 75.4 64.9 0.11
Previous CABG 83 (36.4) 24 (23.8) 0.03 32.3 25.5 0.31
Previous pacemaker 41 (18.0) 15 (14.9) 0.53 22.2 16.0 0.26
Peripheral vascular disease 108 (47.4) 67 (66.3) 0.002 68.2 64.9 0.50
Chronic renal failure (eGFR <60 per 125 (54.8) 58 (57.4) 0.72 54.5 58.5 0.58
mL/min)
STS score 6.1±4.4 6.6±5.7 0.32 6.9±3.5 6.2±5.1 0.25
EuroSCORE II 8.8±7.3 8.7±7.5 0.91 9.2±5.3 8.4±6.9 0.29
Echocardiographic parameters
 LV ejection fraction, % 52±14 55±12 0.12 53±10 55±12 0.31
 Mean AV gradient, mm  Hg 38±15 51±13 <0.001 39±12 50±14 <0.0001
 AVA, cm2 0.72±0.27 0.66±0.15 0.05 0.7±0.21 0.67±0.16 0.10
 Moderate-to-severe AR 55 (24.1) 12 (11.9) 0.01 15.8 12.8 0.56

Values are expressed as percentage, n (%), or mean±SD. AR indicates aortic regurgitation; AV, aortic valve; AVA, aortic valve area;
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CABG, coronary artery bypass graft; eGFR, estimated glomerular filtration rate; LV, left ventricle; STS, Society of Thoracic Surgeons; TA,
transapical; TAo, transaortic; TC, transcarotid; and TIA, transient ischemic attack.
*The estimates obtained after propensity score matching are based on the means of a stratified sampling of weighted subjects. More
details are provided in the Appendix in the Data Supplement.

group received the Edwards SAPIEN, SAPIEN XT, or imaging and were assessed by a consultant neurologist.
SAPIEN 3 THV (Edwards Lifesciences, Irvine, CA). In the Two strokes were noted in the immediate postoperative
transcarotid group, the SAPIEN family of valves was period and 1 on postoperative day 6. This patient had
implanted in 58 patients (57.4%) and the Medtronic preoperative atrial fibrillation treated with oral anticoagu-
CoreValve and Evolut R THV (Medtronic, Minneapolis, lation and had a hemorrhagic stroke contralateral to the
MN) in 43 patients (42.6%). transcarotid access site. The other 2 patients had ischemic
After adjustment, there were no significant between- strokes ipsilateral to the accessed CCA. However, the risk
group differences on access site infection (n=1 in the of stroke/TIA was not significantly different between
transapical approach), cardiac tamponade, and pro- the matched transcarotid versus transapical/transaortic
cedural mortality (0% versus 2.1%; P=0.16; transca- groups (2.1% versus 3.5%; P=0.67). All patients were
rotid versus transapical/transaortic, respectively). In prescribed antiplatelet therapy before the procedure and
addition, there was no need to implant a second valve received therapeutic intraprocedural heparin.
or convert to sternotomy in the transcarotid group. Compared with transapical/transaortic TAVR,
Postimplantation hemodynamics demonstrated a sig- transcarotid TAVR was also associated with signifi-
nificant reduction in transvalvular aortic mean gradi- cantly less new-onset atrial fibrillation (3.2% versus
ent and an increase in the effective orifice area in both 19.0%; P=0.002), stage 2 or 3 acute kidney injury
groups (Figure). (0% versus 12.1%; P=0.002), major or life-threaten-
Postprocedural and 30-day clinical outcomes were ing bleeding (4.3% versus 19.9%; P=0.002), shorter
available in all patients surviving the procedure (Table 3). mean (7.0±6.1 versus 9.9±4.6 days; P=0.0002), and
At 30 days, there were 3 cases (2.9%) of Valve Academic median (6 versus 8 days; P<0.001) length of hospital
Research Consortium-2–defined strokes (2 disabling stay (LOS) in matched analyses. Rates of new pace-
fatal and 1 nondisabling) in the transcarotid group. maker implantation and myocardial infarction were
These patients underwent CT or magnetic resonance comparable between groups, with a tendency toward

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Chamandi et al; Comparison of Transcarotid vs Transthoracic TAVR

Table 2.  Procedural and Echocardiographic Characteristics of Patients Undergoing TA or TAo Versus TC Transcatheter Aortic
Valve Replacement

Unmatched Data Propensity Score-Matched Data*


TA/TAo TC TA/TAo TC
Variables (n=228) (n=101) P Value (n=163) (n=94) P Value
Procedural characteristics
 Prosthesis type
  Edwards SAPIEN 42 (18.4) 0 … 18.4 0 …
  SAPIEN XT 144 (63.2) 8 (7.9) … 65.6 8.5 …
  SAPIEN 3 18 (7.9) 50 (49.5) … 9.2 51.1 …
  CoreValve 1 (0.4) 8 (7.9) … 0.6 8.5 …
  Evolut R 3 (1.3) 35 (34.7) … 0 31.9 …
  Other 16 (7) 0 <0.0001 6.1 0 <0.0001
 Preimplant balloon valvuloplasty 174 (84.1) 35 (38.5) <0.0001 83.4 38.1 <0.0001
 Postimplant balloon valvuloplasty 48 (21.1) 4 (4.0) <0.0001 13.7 4.3 0.03
 Access site infection 1 (0.4) 0 1.0 0.2 0 0.71
 Cardiac tamponade 2 (0.9) 1 (1) 1.0 0.5 1.1 0.69
 Need of a second valve 5 (2.2) 0 0.33 1.1 0 0.32
 Conversion to sternotomy 11 (4.8) 0 0.02 4.9 0 0.03
 Procedural mortality 3 (1.3) 0 0.56 2.1 0 0.16
Echocardiography at discharge
 LV ejection fraction, % 51±13 57±10 0.0004 52±9 57±10 0.001
 Mean AV gradient, mm  Hg 11±4 12±7 0.13 10±4 12±6 0.04
 AVA, cm 2
1.45±0.5 1.54±0.45 0.28 1.47±0.26 1.54±0.45 0.36
 Moderate-to-severe AR 9 (4.0) 3 (3.0) 0.76 0.6 2.2 0.88
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Values are expressed as percentage, n (%), or mean±SD. AR indicates aortic regurgitation; AV, aortic valve; AVA, aortic valve area; LV, left
ventricle; TA, transapical; TAo, transaortic; and TC, transcarotid.
*The estimates obtained after propensity score matching are based on the means of a stratified sampling of weighted subjects. More details
are provided in Appendix in the Data Supplement.

less major vascular complications with the transca- No major differences in clinical outcomes were
rotid approach (3.2% versus 10.7%; P=0.05). At 30 observed by comparing transapical to transaor-
days, mortality rate in the matched cohort was 2× tic, except for the risk of acute kidney injury that
higher in the transapical/transaortic compared with was higher among transaortic patients (23.2% ver-
transcarotid group, although this difference did not sus 11.3%; P=0.03; unadjusted data; Appendix in
reach statistical significance (4.6% versus 2.1%; the Data Supplement; Tables IV through VI in the
P=0.37, respectively). Data Supplement). Institution-specific outcomes for
There was a greater proportion of the newer itera- the entire cohort of transcarotid patients were also
tions of THV in the transcarotid group. Therefore, we compared, and no major differences were observed
reevaluated outcomes after adjusting for prosthesis (Appendix in the Data Supplement; Table VII in the Data
type to mitigate a possible confounding effect related Supplement). When institution was forced into the pro-
to enhanced features of the newer THV, such as lower pensity score model to adjust for a potential confound-
profile delivery systems. The significant salutary effect ing effect by center, we obtained similar results to the
of transcarotid access on postprocedural atrial fibrilla- main analysis (Appendix in the Data Supplement; Table
tion persisted, despite adjusting for THV type. However, VIII in the Data Supplement).
the association between transcarotid access and major
or life-threatening bleeding became nonsignificant, as
was the association between THV type and bleeding. DISCUSSION
Taken together, these data suggest that, although THV This is the first report of a multicenter propensity score-
type may be partly responsible for the decreased risk matched comparison between transcarotid and trans-
of bleeding associated with transcarotid access, it does thoracic access. The main findings are (1) transcarotid
not entirely explain this protective effect (prosthesis- TAVR is safe and feasible in appropriately selected
adjusted analysis, Appendix in the Data Supplement). patients with a high rate of device success (87%); (2)

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Chamandi et al; Comparison of Transcarotid vs Transthoracic TAVR

Figure. Changes in mean aortic gradient and effective orifice area between baseline and discharge.
A, Mean aortic gradient; (B) effective orifice area. TA-TAO indicates transapical-transaortic; and TC, transcarotid.

compared with transapical and transaortic TAVR, the Despite their advantage of simplifying valve position-
transcarotid approach was associated with no signifi- ing, major surgical manipulation of the chest wall is
cant difference in rates of 30-day all-cause mortality, required. Furthermore, these techniques are limited by
stroke, new pacemaker implantation, major vascular relative contraindications, such as significant respira-
complications, and hemodynamic performance; (3) tory failure in case of transapical, and porcelain aorta,
transcarotid TAVR is associated with significantly less as well as previous heart surgery, in cases of transaor-
new-onset atrial fibrillation, acute kidney injury, major tic. Transcarotid TAVR was first performed in France in
or life-threatening bleeding, and shorter hospital stay. 2009,20 and then was subsequently adopted by several
TAVR technology has evolved considerably in the last other centers.7–9,21,22 These experiences demonstrated
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few years allowing for the treatment of 85% to 90% of that the surgical approach to the carotid artery is safe
patients via the transfemoral route.4,15,16 Until recently, and relatively uncomplicated because of its superficial
the transapical and transaortic approaches were con- location, and operative experience with the carotid
sidered the main alternative nontransfemoral routes, arteries is widespread among cardiovascular surgeons.
with comparable short- and long-term outcomes.17–19 We prefer performing transcarotid TAVR using the left

Table 3.  Clinical Outcomes at 30 Days of Patients Undergoing TA or TAo Versus TC Transcatheter Aortic Valve Replacement

Unmatched Data Propensity Score-Matched Data*


TA/TAo TC TA/TAo TC
Outcomes (n=228) (n=101) P Value (n=163) (n=94) P Value
Mortality 14 (6.1) 5 (5.0) 0.80 4.6 2.1 0.37
Stroke/TIA 11 (4.8) 3 (2.9) 0.56 3.5 2.1 0.67
New pacemaker implantation 25 (10.9) 7 (6.9) 0.23 13.2 8.8 0.34
New-onset atrial fibrillation 52 (22.8) 4 (4.0) <0.0001 19.0 3.2 0.002
Myocardial infarction 6 (2.6) 1 (1.0) 0.68 4.4 1.1 0.19
Major or life-threatening bleeding 32 (14.0) 4 (4.0) 0.01 19.9 4.3 0.002
Major vascular complication 16 (7.0) 3 (3.0) 0.20 10.7 3.2 0.05
Acute kidney injury (stage 2–3) 34 (14.9) 0 <0.0001 12.1 0 0.002
Median LOS, d 8 (6–11) 6 (3–8) <0.001 8 (6–12) 6 (3–8) <0.001
Composite end points
 Device success 197 (86.8) 86 (86.9) 1.0 89.8 89.1 0.75
 Early safety 161 (70.6) 93 (92.1) <0.0001 71.7 92.6 0.002

Values are expressed as percentage, n (%), or mean ±SD. LOS indicates length of stay; TA, transapical; TAo, transaortic; TC, transcarotid;
and TIA, transient ischemic attack.
*The estimates obtained after propensity score matching are based on the means of a stratified sampling of weighted subjects. More
details are provided in Appendix in the Data Supplement.

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Chamandi et al; Comparison of Transcarotid vs Transthoracic TAVR

common carotid because it allows superior coaxial TAVR compared with alternative-access TAVR.28–30
alignment of the THV with the aortic annulus, although Furthermore, severe bleeding may be associated with
both sides can be used.9,10,21 postprocedural hypovolemia and may explain, in part,
In the current study, the 30-day crude stroke or TIA the reduction in the rates of severe acute kidney injury
rate in the transcarotid group was 3% (2 disabling and in transcarotid cases compared with the transapical/
1 nondisabling stroke), with no significant difference transaortic approach.31,32 Similar findings were previ-
compared with the transapical/transaortic group (as ously reported when comparing transapical or transaor-
previously described in smaller studies).10,11 This stroke tic with transfemoral access. Blackstone et al33 reported
rate is lower than that observed in the cohort of patients their results in 501 propensity score-matched patients
included in the multicenter French Transcarotid TAVR undergoing transapical versus transfemoral TAVR. More
Registry and others.8,9 As previously described,8,21 these patients in the transapical group experienced adverse
neurological events are not always localized ipsilateral procedural events, longer length of stay, slower recov-
to the CCA used for TAVR. This suggests that there are ery, and higher transfusion rates. Similar results were
other phenomena at play in addition to carotid arterial published by Arai et al,34 who reported significantly
manipulation, such as new-onset postprocedural atrial higher rates of life-threatening bleeding when compar-
fibrillation, periprocedural hypotension, inadequate ing transaortic (n=289) with transfemoral TAVR (n=467;
contralateral carotid perfusion, and the THV deploy- 6% versus 3%, respectively; P=0.021) without a signifi-
ment itself. Although the rates of preimplant and post- cant difference in other major outcomes. Our data also
implant balloon valvuloplasty were significantly higher suggest that the risk of major vascular complications are
in the transapical/transaortic group even after adjust- decreased with a transcarotid TAVR approach (matched
ment, this did not translate to a higher risk of stroke analysis, 3.2% versus 10.7%; P=0.05), although the
or TIA among the transapical/transaortic patients. The study was underpowered for this specific end point and
low rate of stroke observed in this study may be attrib- did not reach statistical significance.
uted to careful patient selection and the intraoperative Postoperative echocardiographic data showed
assessment of the functional integrity of the circle of favorable results in both groups, as either access pro-
Willis as used in one center in this study, using indi- vides direct aortic annular access and may allow supe-
rect methods, such as backflow blood pressure during rior positioning in particular anatomies (Figure). The
carotid clamping and cerebral oximetry monitoring.7 observed 30-day mortality in the adjusted analysis
However, the optimal preprocedural evaluation and
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(2.1% versus 4.6%; P=0.37; transcarotid versus trans-


periprocedural neurological monitoring during transca- apical/transaortic, respectively) was also statistically
rotid TAVR are yet to be determined. Also, the optimal comparable between groups and lower than that previ-
antithrombotic regimen and the role of embolic pro- ously reported in transcarotid TAVR cohorts.8,9
tection devices23–25 require further study to determine
efficacy in the reduction of the risk of cerebral ischemia,
specifically in patients undergoing transcarotid TAVR as Study Limitations
literature is scarce in these patients. This report consists of a retrospective analysis of pro-
Other major findings of this study were that trans- spectively acquired data and is subject to the limita-
carotid TAVR was significantly associated with a reduc- tions inherent in this study design. Selection of patients
tion in major or life-threatening bleeding and shorter was not random and may not be generalizable to other
LOS, compared with transapical/transaortic TAVR. This centers. Other alternative approaches, such as the
could be explained by (1) less-invasive access site expo- subclavian route, were not evaluated because of the
sure in the case of transcarotid TAVR compared with limited number of patients undergoing TAVR by sub-
a minithoracotomy or hemisternotomy in the trans- clavian access at the participating centers. The super-
apical/transaortic approach; (2) less ventilator use and ficial position of the carotid artery coupled with the
shorter intensive care unit stay in transcarotid TAVR10; more complex exposure of the subclavian and its prox-
and (3) less pain during the postprocedural recovery imity to the brachial plexus, and the risks associated
and earlier patient mobilization. The lower incidence of with its use if an ipsilateral internal mammary artery
new-onset atrial fibrillation among transcarotid TAVR was used as a coronary bypass graft, have lead us to
patients may also partly explain shorter LOS. Any inci- favor transcarotid over the subclavian approach. As
sion of the thoracic cavity is associated with various well, specific end points, such as mortality, stroke, and
forms of supraventricular arrhythmia, most commonly major vascular complications, may have not reached
atrial fibrillation, which may then translate to a pro- statistical significance because of the small sample
longed hospital stay.26,27 A reduction of LOS is a critical size and short-term follow-up. However, this is the
component of current strategies to control overall costs largest multicenter study evaluating the transcarotid
associated with TAVR and may be the primary driver approach using a risk-adjusted comparator arm. Small
of reduced expenditure associated with transfemoral numbers did not permit us to ascertain device-specific

Circ Cardiovasc Interv. 2018;11:e006388. DOI: 10.1161/CIRCINTERVENTIONS.118.006388 November 2018 7


Chamandi et al; Comparison of Transcarotid vs Transthoracic TAVR

outcomes. However, adjusting the analysis for type of the safety and clinical efficacy of transcarotid TAVR
THV, we found that the association between decreased compared with alternative approaches.
major bleeding and the transcarotid approach was
modulated, in part, by the use of newer valve types
with their lower profile delivery systems but was not ARTICLE INFORMATION
entirely explained by this feature of the newer THVs Received January 3, 2018; accepted September 22, 2018.
The Data Supplement is available at https://www.ahajournals.org/doi/
(Appendix in the Data Supplement). Taken further, suppl/10.1161/CIRCINTERVENTIONS.118.006388.
this association may also be access site specific and
not entirely device specific. Accessing proximal high- Correspondence
pressure structures, such the left ventricular apex and Siamak Mohammadi, MD, FRCSC, Division of Cardiac Surgery, Quebec Heart
ascending aorta, may be associated with less ability to and Lung Institute, Laval University, 2725 chemin Ste-Foy, Quebec City, Quebec,
adequately control bleeding compared with distal arte- Canada. Email siamak.mohammadi@fmed.ulaval.ca

rial sites, such as the carotid artery. Device-specific fea-


tures of the newer TAVR prostheses, such as improved Affiliations
sealing skirts, did not influence postprocedural aortic Department of Cardiac Surgery and Cardiology, Quebec Heart and Lung Institute,
Laval University, Canada (C.C., J.R.-C., E.D., D.D., R.D., J.-M.P., R.P., F.M., T.R.-G.,
regurgitation, need for a permanent pacemaker, pres- D.K., S.M.). Department of Cardiac Surgery and Cardiology, Hôpital Européen
sure gradients, and overall procedural success rates in Georges Pompidou, Assistance Publique Hôpitaux de Paris, Université Paris
our study, which were similar between the transcarotid Descartes, France (R.A.-A., D.B., C.S., J.-Y.P., A.L., N.K.). Department of Cardiac
Surgery and Cardiology, Clinique St Gatien, Tours, France (D.B., S.C., O.L.P.).
and transapical/transaortic groups.
Periprocedural cerebral monitoring was variable Acknowledgments
among institutions during transcarotid TAVR, reflecting a
We thank Stéphanie Dionne, Serge Simard, and Mélanie Côté from the Quebec
lack of consensus in the literature, and the rates of neu- Heart and Lung Institute, for their help in the statistical analysis.
rological events may have been underestimated because
systematic evaluation by magnetic resonance imaging Disclosures
was not routinely performed following TAVR. However, Dr Chamandi has received a fellowship grant from Edwards Lifesciences. Dr
the incidence of stroke/TIA was low and did not dif- Rodés-Cabau has received research grants from Edwards Lifesciences and
Medtronic. The other authors report no conflicts.
fer among centers (Table VII in the Data Supplement);
the optimal perioperative neuromonitoring technique
Downloaded from http://ahajournals.org by on July 2, 2019

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