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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.
https://www.ahajournals.org/journal/
circinterventions
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
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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Table 1. Baseline Clinical and Echocardiographic Characteristics of Patients Undergoing TA or TAo Versus TC Transcatheter
Aortic Valve Replacement
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
Table 2. Procedural and Echocardiographic Characteristics of Patients Undergoing TA or TAo Versus TC Transcatheter Aortic
Valve Replacement
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)
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
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.
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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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
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