Transcarotid Transcatheter Aortic Valve Replacement

Transcarotid Transcatheter Aortic Valve Replacement

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 20, 2016 ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 1936-8798/$36.00 PUBLISHED BY...

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JACC: CARDIOVASCULAR INTERVENTIONS

VOL. 9, NO. 20, 2016

ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

ISSN 1936-8798/$36.00

PUBLISHED BY ELSEVIER

http://dx.doi.org/10.1016/j.jcin.2016.08.013

STRUCTURAL

Transcarotid Transcatheter Aortic Valve Replacement General or Local Anesthesia Nicolas Debry, MD,a Cédric Delhaye, MD,a Alexandre Azmoun, MD,b Ramzi Ramadan, MD,b Sahbi Fradi, MD,b Philippe Brenot, MD,b Arnaud Sudre, MD,a Mouhamed Djahoum Moussa, MD,a Didier Tchetche, MD,c Said Ghostine, MD,b Darren Mylotte, MD,d Thomas Modine, MD, PHDa

ABSTRACT OBJECTIVES The study sought to assess the safety and efficacy of a minimally invasive strategy (MIS) (local anesthesia and conscious sedation) compared to general anesthesia (GA) among the largest published cohort of patients undergoing transcarotid transcatheter aortic valve replacement (TAVR). BACKGROUND Transcarotid TAVR has been shown to be feasible and safe. There is, however, no information pertaining to the mode anesthesia in these procedures. METHODS Between 2009 and 2014, 174 patients underwent transcarotid TAVR at 2 French centers. All patients were unsuitable for transfemoral TAVR due to severe peripheral vascular disease. An MIS was undertaken in 29.8% (n ¼ 52) and GA in 70.1% (n ¼ 122). One-year clinical outcomes were available in all patients and were described according to the Valve Academic Research Consortium-2 consensus. RESULTS Transcarotid vascular access and transcatheter valve deployment was successful in all cases. Thirty-day mortality was 7.4% (n ¼ 13) and 1-year all-cause and cardiovascular mortality were 12.6% (n ¼ 22) and 8.0% (n ¼ 14), respectively. According to the type of anesthesia, there was no between group difference in 30-day mortality (GA 7.3% vs. MIS 7.6%; p ¼ 0.94), 1-year mortality (GA 13.9% vs. MIS 9.6%; p ¼ 0.43), 1-month clinical efficacy (GA 85.2% vs. MIS 94.2%; p ¼ 0.09), and early safety (GA 77.8% vs. MIS 86.5%; p ¼ 0.18). There were 10 (5.7%) periprocedural cerebrovascular events: 4 strokes (2.2%) and 6 transient ischemic attacks (3.4%) among those treated with GA. There was neither stroke nor transient ischemic attack in the MIS group (p < 0.001). CONCLUSIONS The transcarotid approach for TAVR is feasible using general or local anesthesia. A higher rate of perioperative strokes was observed with GA. (J Am Coll Cardiol Intv 2016;9:2113–20) © 2016 by the American College of Cardiology Foundation.

T

ranscatheter aortic valve replacement (TAVR)

commonly used vascular access for TAVR, however,

is an alternative to conventional surgical

many patients have concomitant peripheral vascular

aortic valve replacement for patients with

disease that may render this access impossible or at

symptomatic severe aortic valve stenosis at high oper-

high risk of bleeding and vascular complications (2).

ative risk (1). A transfemoral approach is the most

We have previously described the technique of

From the aHeart Team, Cardiology and Cardiovascular Surgery Departments, Institut Cardiopulmonaire, CHRU Lille, Lille, France; b

Heart Team, Cardiology and Cardiovascular Surgery Departments, Centre Médico-Chirurgical Marie Lannelongue (CCML),

Le Plessis-Robinson, France; cClinique Pasteur, Toulouse, France; and the dGalway University Hospitals, Galway, Ireland. Dr. Sudre has served as a consultant for Edwards Lifesciences and Medtronic. Dr. Modine has served as a proctor and consultant for Medtronic and Microport. Dr. Mylotte has served as a proctor for Medtronic and Microport. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received May 27, 2016; revised manuscript received August 2, 2016, accepted August 11, 2016.

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Transcarotid TAVR and Anesthesia

ABBREVIATIONS

transcarotid vascular access for TAVR using

minimal luminal diameter threshold of $6.0 mm was

AND ACRONYMS

either local or general anesthesia (GA) (3–5).

consideration appropriate for transcarotid vascular

GA = general anesthesia MIS = minimally invasive strategy

MRA = magnetic resonance

The use of anesthesia varies greatly during

access. Prior ipsilateral carotid artery intervention,

TAVR, with no clear consensus of the optimal

contralateral carotid artery occlusion, or stenosis or

strategy (6). Transfemoral TAVR with a mini-

occlusion of the vertebral arteries were also consid-

mally invasive strategy (MIS) (local anesthesia

ered to be contraindications to transcarotid TAVR.

and conscious sedation) is the preferred

Cerebral magnetic resonance angiography (MRA)

strategy, and it has been associated with

can accurately delineate the components of the circle

tomography

similar safety and efficacy to GA (7,8). There

of Willis and determine the adequacy of cerebral

TIA = transient ischemic attack

remain no comparative data for these strate-

collateral blood flow (10). Screening cerebral MRA was

TAVR = transcatheter aortic

gies with the transcarotid approach.

performed and interpreted by neuroimaging special-

angiography

MSCT = multislice computed

The purpose of this study was to report

valve replacement

ists to evaluate collateral cerebral blood flow, and pa-

early safety and efficacy for transcarotid TAVR

tients with suspected inadequate collateral flow were

managed with minimally invasive or GA strategies.

excluded. In cases with equivocal cerebral MRA, transcranial echo Doppler was used to further identify

SEE PAGE 2121

patients with the potential for cerebral hypoperfusion.

METHODS

PROCEDURES. Procedures

were

performed

in

a

hybrid operating theater by a multidisciplinary team PATIENT

SELECTION. Between

and

including anesthesiologists, interventional cardiolo-

December 2014, consecutive patients undergoing

April

2009

gists, and cardiac surgeons. Initially, the left common

transcarotid TAVR at 2 French institutions (Hôpital

carotid artery was preferentially selected, as it

Cardiologique, CHRU Lille, Lille, France; Centre

afforded simpler cardiac catheterization and oper-

Médico-Chirurgical Marie Lannelongue CCML, Le

ating room configuration. With experience, however,

Plessis-Robinson, France) were included in a dedi-

the right side was chosen with increasing frequency.

cated prospective database (around 6% of total TAVR

Selection of the bioprosthesis (Edwards SAPIEN

patients in these institutions). All patients had severe

[Edwards Lifesciences, Irvine, California], Medtronic

symptomatic aortic valve stenosis (indexed aortic

CoreValve [Medtronic Inc., Minneapolis, Minnesota],

valve area <0.6 cm 2/m 2) and multiple comorbidities.

Medtronic CoreValve Evolut R, or Boston Scientific

The institutional multidisciplinary heart teams agreed

Lotus Valve, [Boston Scientific, Marlborough, Massa-

each patient should proceed to TAVR. In all cases, the

chusetts]) was determined following aortic root

transfemoral approach was precluded by severe peri-

assessment using MSCT.

pheral arterial disease or prior iliofemoral intervention

Standard transcarotid TAVR implantation tech-

or surgery. Many patients also manifested relative

nique was followed as previously described (4,11)

contraindications to other alternate access routes for

(Figures 1 and 2). Procedures were performed using

TAVR: subclavian access with patent internal thoracic

the same protocol and materials for both sides;

arterial grafts, or transapical or direct aortic approach

however, the hybrid room setup was changed ac-

with respiratory dysfunction (9). All patients gave

cording to the access side. In selected cases, accord-

written informed consent for the procedures.

ing to operator preference, a drain was placed at the

PRE-PROCEDURAL

SCREENING. Suitable

carotid

artery anatomy was assessed with contrast angiography or more recently with pre-operative multislice computed tomography (MSCT). Patients with small caliber (#6 mm), heavily calcified, severely tortuous,

carotid incision site. Prosthetic valve function was assessed by transthoracic echocardiography at the end of the procedure, post-operative day 1, prior to discharge, and at 30 days. Doppler imaging of the carotid artery was performed before discharge.

or stenotic iliofemoral anatomy, and those with

ANESTHESIA MANAGEMENT. Intraoperatively, cere-

significant descending aortic pathology were consid-

bral perfusion was continually monitored using

ered candidates for transcarotid TAVR. The di-

cerebral oximetry with near infrared spectrometry

mensions of the carotid, subclavian, and vertebral

(Equanox 7600, Nonnin Medical Inc., North Plymouth,

arteries were carefully assessed using MSCT. Patients

Minnesota). Systolic blood pressure was maintained

with significant ($50%) common or internal carotid

above 100 mm Hg throughout the procedure. Since

artery stenosis, plaque considered to be at high risk

2009, the number of procedures managed using an MIS

of embolization, or those with congenital variants of

(local sedation and conscious sedation) has increased

the aortic arch (e.g., Bovine arch) were not considered

gradually. In these patients, the level of sedation was

for transcarotid TAVR. A common carotid artery

controlled after a transient carotid artery cross-

Debry et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 20, 2016 OCTOBER 24, 2016:2113–20

Transcarotid TAVR and Anesthesia

F I G U R E 1 Left Carotid Access Under General Anesthesia

F I G U R E 2 Transcatheter Heart Valve Implantation

Surgical exposure and carotid preparation using an Edwards SAPIEN S3 valve delivering a 21-F sheath (Edwards Lifesciences, Irvine, California).

clamping test for 3 min. This entailed assessment of consciousness and clinical neurological status during transient

carotid

artery

cross-clamping.

Trans-

esophageal echocardiography was not used in these patients. Exposure of the right or left carotid artery was performed under local anesthesia with lidocaine and an infusion of remifentanil. Among those undergoing TAVR with GA, pre-medication, induction, and maintenance of anesthesia was performed using standard

Implantation of an Edwards SAPIEN S3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve via the left common carotid artery.

techniques. Intraoperative cerebral monitoring was performed to maintain a bispectral cerebral monitoring index between 40 and 50. Transesophageal echocardiography was used in GA these patients when required. CLINICAL ENDPOINTS. The primary endpoints of

interest were 1-month early safety and 1-month clinical efficacy, as defined by the updated Valve Academic Research Consortium (VARC)-2 consensus (12). Secondary endpoints included all-cause and cardiovascular mortality at 1 year as well as stroke. The latter was of particular interest, and was defined according to VARC-2 consensus (12). Stroke diagnosis required input from a stroke physician or diagnostic neuroimaging. Nonfocal global encephalopathy was not defined as stroke without neuroimaging evidence of cerebral infarction (12). The duration of symptoms or the demonstration of an ischemic or hemorrhagic lesion on neuroimaging further defined stroke ($24 h; positive imaging) or transient ischemic attack (TIA) (<24 h; negative imaging).

symmetrically distributed or, otherwise, as median (interquartile range). The normality of distribution was assessed using Shapiro-Wilk test and normality diagrams. Results for categorical variables were expressed as frequencies and percentages. Comparative analyses were obtained using the chi-square test for categorical data; when not applicable because of the sample size, Fisher’s exact test was used. For numerical variables, we used an analysis of variance test or Kruskal-Wallis test if normality of distribution was not present. Survival was graphically depicted using KaplanMeier curves and between-group differences were compared using the log-rank test. Cox proportional hazards regression analysis was used to determine independent predictors of 1-year mortality. Only unique variables with a p value <0.10 in univariable analysis were entered into the final multivariable model. We considered p values <0.05 statistically significant. Statistical analysis was performed using commercial

STATISTICAL ANALYSIS. Results for continuous var-

software (SAS version 9.3, SAS Institute, Cary, North

iables were expressed as mean  SD when data were

Carolina).

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Transcarotid TAVR and Anesthesia

achieved through a temporary femoro-carotid shunt.

T A B L E 1 Baseline Characteristics of All Transcarotid TAVR Patients

All Patients (N ¼ 174)

General Anesthesia (n ¼ 122)

Minimally Invasive Strategy (n ¼ 52)

80.5  7.9

80.3  8.0

96 (55.1)

This was achieved by inserting an 8-F sheath into the ipsilateral femoral artery and connecting this p Value

to a carotid shunt (POLYSHUNT, Perouse Medical,

81.0  7.5

0.61

Ivry-le-Temple, France), which was introduced in a

62 (50.8)

34 (65.3)

0.07

more distal segment of the carotid artery after a small

146 (83.9)

104 (85.2)

42 (80.7)

0.46

arteriotomy. In both cases, a second cross-clamping

Smoker

10 (5.7)

7 (5.7)

3 (5.7)

1.0

test yielded no change in neurological status. In total,

Diabetes

55 (31.6)

43 (35.2)

12 (23.0)

0.11

Body mass index, kg/m2

26.1  6.4

27.1  7.4

25.0  4.5

0.08

4 patients (7.6%) converted from MIS to GA, due to

Coronary artery disease

91 (52.2)

53 (43.4)

38 (73.0)

<0.001*

Previous PCI

36 (20.6)

30 (24.5)

26 (50.0)

0.001*

Previous CABG

35 (20.1)

18 (14.7)

19 (36.5)

0.001*

have any cerebrovascular or adverse events. Conver-

Severe renal dysfunction (GFR <30 ml/min)

40 (22.9)

26 (21.3)

14 (26.9)

0.42

sion to surgical aortic valve replacement did not occur.

COPD

49 (28.1)

34 (27.8)

15 (28.8)

0.89

Atrial fibrillation

70 (40.2)

43 (35.2)

27 (51.9)

0.25

Prior stroke/TIA

24 (13.7)

18 (14.7)

6 (11.5)

0.57

Pulmonary hypertension (PASP >40 mm Hg)

70 (40.2)

50 (40.9)

20 (38.4)

0.75

Pre-operative pacemaker

22 (12.6)

12 (9.8)

10 (19.2)

0.08

n ¼ 3), and Boston Scientific Lotus Valve 1.1% (n ¼ 2). The distribution of valve types was similar between

Age, yrs Male NYHA functional class III/IV

patient discomfort (n ¼ 2), or respiratory distress (n ¼ 2), and were classified in the MIS group. They did not

Successful carotid vascular access was achieved in all cases. We had no valve embolization. The implanted transcatheter valves were Medtronic CoreValve 79.8% (n ¼ 139), Medtronic CoreValve Evolut R 2.2% (n ¼ 4), Edwards SAPIEN 16.6% (XT n ¼ 26, S3

GFR (MDRD), ml/min

50.4  20.8

51.6  21.0

48.4  20.4

0.36

Indexed AVA, cm2/m2

0.43  0.20

0.43  0.24

0.42  0.14

0.91

Mean aortic transvalvular pressure gradient, mm Hg

44.4  12.9

44.7  12.3

43.9  12.9

0.69

Left ventricular ejection fraction, %

53.8  13.6

54.5  13.2

51.6  14.7

0.29

Logistic EuroSCORE 1, %

20.1  13.1

19.5  13.7

20.9  12.5

0.56

STS PROM score, %

8.4  4.6

7.3  4.8

8.7  4.1

0.10

anesthesia groups, and device success was achieved in 88% and 93% of the MIS and GA patients, respectively (p ¼ 0.26). Three patients (1.7%) required implantation of a second transcatheter valve during the

Values are mean  SD or n (%). *p < 0.05. AVA ¼ aortic valve area; CABG ¼ coronary artery bypass grafting; COPD ¼ chronic obstructive pulmonary disease; EuroSCORE ¼ European System for Cardiac Operative Risk Evaluation; GFR ¼ glomerular filtration rate; MDRD ¼ Modification of Diet in Renal Disease; NYHA ¼ New York Heart Association; PASP ¼ pulmonary artery systolic pressure; PCI ¼ percutaneous coronary intervention; STS ¼ Society of Thoracic Surgeons predicted risk of mortality; TAVR ¼ transcatheter aortic valve replacement; TIA ¼ transient ischemic attack.

index procedure due to low or high implantation. The series included 7 (4.0%) cases where a transcatheter valve was placed inside a failing aortic bioprosthesis. MORTALITY. In the entire cohort, 30-day mortality

was 7% (n ¼ 13), and all-cause and cardiovascular 1-year mortality was 12% (n ¼ 22) and 8% (n ¼ 14), respectively. There were 3 procedural deaths due to

RESULTS The baseline demographic, clinical, and echocardiographic characteristics of the study population are summarized in Table 1. The mean patient age was 80.5  7.9 years and most 55.1% (n ¼ 96) were men. The average Society of Thoracic Surgeons predicted risk of mortality score was 8.4  4.6%. There were few differences between the MIS and GA groups: the MIS cohort had significantly more coronary artery disease (p < 0.001) and prior revascularization (p ¼ 0.001).

cardiac tamponade (left ventricular wire perforation, right ventricular pacing lead perforation, and annulus rupture). There was no difference in mortality according to the anesthesia strategy (log rank p ¼ 0.21) (Figure 3). On

multivariate

analysis,

only

post-operative

stroke or TIA was significantly associated with 1-year mortality (odds ratio: 0.24; 95% confidence interval: 0.08 to 0.72; p ¼ 0.01). MORBIDITY. The VARC-2–defined 30-day combined

safety and efficacy endpoint occurred in 80.4%

GA (n ¼ 122) was the predominant anesthetic

(n ¼ 140) and 87.9% (n ¼ 153), respectively. Minor

approach used in the first years of the study (95% GA

vascular complications occurred in 20 patients (11%):

vs. 5% MIS). In 2011, we performed the first MIS pro-

11 involved the carotid vascular access and 9 involved

cedure, and this strategy has become more common

the femoral venous access. There were no major

over time, with 70% of cases using GA and 30% using

vascular complications involving the carotid access.

MIS by the final year. Two patients in the MIS group had

New permanent pacemaker was required in 18.9%

loss of consciousness occurring during the initial ca-

(n ¼ 33), all with self-expanding devices. There

rotid cross-clamping test. In both cases, removal of the

were 15 (8.6%) cases of new onset atrial fibrillation. No

clamp afforded complete recovery within a few sec-

prosthesis thrombosis, endocarditis, or other pros-

onds. To ensure cerebral perfusion during these pro-

thetic valve–associated complications were observed.

cedures, passive antegrade carotid perfusion was

Post-implantation hemodynamics demonstrated a

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reduction

in

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Transcarotid TAVR and Anesthesia

transvalvular

mean

gradient from

44.4  12.9 mm Hg to 8.4  1.6 mm Hg (p < 0.001), and

F I G U R E 3 Midterm Survival Following Transcarotid TAVR

an increase in the effective orifice area from 0.76  0.28 cm 2 to 1.86  0.32 cm 2 (p < 0.001). There was no difference in 30-day safety (86.5% MIS vs. 77.8% GA; p ¼ 0.18) or efficacy (94.2% MIS vs. 85.2% GA; p ¼ 0.09) between the anesthesia strategies. No significant differences between the 2 groups were observed in the incidence of VARC-2–defined complications (myocardial infarction, acute kidney injury, and vascular and bleeding complications) (Table

2).

Post-procedural

aortic

regurgitation

grade $2 occurred in 8.6% (n ¼ 15) and was not significantly different between the anesthesia groups (9.6% MIS vs. 8.1% GA; p ¼ 0.76). The average length of hospital stay was 9.2  7.5 days, and was significantly longer in the GA group compared with the MIS group (11.3  8.6 days vs. 6.0  3.3 days; p < 0.001). CEREBROVASCULAR EVENTS. There were 10 (5.7%)

30-day

VARC-2–defined

cerebrovascular

events

(Table 3): 4 (2.2%) stroke (modified Rankin scale: 3, 2, 1, and 1) and 6 (3.4%) TIA, as assessed by clinical and

Survival (months) following transcarotid TAVR shown on a Kaplan-Meier curve. GA ¼ general anesthesia; MIS ¼ minimally invasive strategy; TAVR ¼ transcatheter aortic valve replacement.

neuroimaging criteria. These events only occurred in patients managed under GA (p < 0.001), and all occurred in the first two-thirds of our experience. Importantly, the duration of the procedure was not different between the anesthesia groups. The cerebrovascular events were localized as ipsilateral (n ¼ 2) or contralateral (n ¼ 6) to the carotid vascular

T A B L E 2 Post-Procedural Outcomes

access site. Clinical features of the events included confusion (n ¼ 1), hemiparesis (n ¼ 2), hemiplegia (n ¼ 6), and aphasia (n ¼ 1), neuroimaging showed new

All Patients (N ¼ 174)

General Anesthesia (n ¼ 122)

Minimally Invasive Strategy (n ¼ 52)

p Value

Procedural variables and outcomes

ischemic lesions in the 4 stroke cases (multiple embolic

Left carotid access

144 (82.7)

118 (96.7)

26 (50.0)

<0.001*

lesions). Two patients who suffered a stroke had pre-

Medtronic CoreValve

139 (79.8)

95 (77.8)

44 (84.6)

0.30

TAVR atrial fibrillation. Pre-operatively, all patients

Valve in valve

7 (4.0)

5 (4.0)

2 (3.8)

0.93

were prescribed antiplatelet therapy and all received

Acute kidney injury stage 2 to 3

17 (9.7)

10 (8.1)

7 (13.4)

0.28

intraprocedural heparin. Three additional cases of

IH stroke/TIA

10 (5.7)

10 (8.1)

0 (0.0)

<0.001*

New pacemaker implantation

33 (18.9)

21 (17.2)

12 (23.0)

0.36

IH vascular complications

20 (11.4)

17 (13.9)

3 (5.7)

0.12

transient nonfocal global encephalopathy with normal neuroimaging were not defined as stroke/TIA.

8 (4.5)

6 (4.9)

2 (3.8)

0.75

Hospital stay, days

9.2  7.5

11.3  8.6

6.0  3.3

<0.001*

increasing to 6.8% (n ¼ 12) at 1 year. Late cerebro-

Device success

160 (91.9)

114 (93.4)

46 (88.4)

0.26

vascular events included 3 strokes: an ischemic stroke

1-month outcomes

At 30 days, the rate of stroke or TIA was 5.7%,

IH major—LT bleeding

causing hemiparesis on day 34, an ischemic stroke

1-month clinical efficacy†

153 (87.9)

104 (85.2)

49 (94.2)

0.09

causing aphasia and visual field defect on day 51, and

1-month early safety‡

140 (80.4)

95 (77.8)

45 (86.5)

0.18

13 (7.4)

9 (7.3)

4 (7.6)

0.94

later a hemorrhagic stroke on day 409. In all, 2 strokes were disabling, and 5 were nondisabling (modified

1-month mortality 1-year outcomes 1-year NYHA functional class I to II

124 (81.5)

88 (83.8)

36 (76.5)

0.28

Rankin scale: 3, 1, and 1). Patients who suffered a

1-year mortality

22 (12.6)

17 (13.9)

5 (9.6)

0.43

stroke or TIA had higher 1-year mortality than did

1-year CV mortality

14 (8.0)

11 (9.0)

3 (5.7)

0.47

those that did not (p < 0.001).

DISCUSSION Herein, we describe the largest series of patients undergoing transcarotid vascular access for TAVR.

Values are n (%) or mean  SD. *p < 0.05. †Clinical efficacy (1 month): all-cause mortality, all stroke, requiring hospitalizations for valve-related symptoms or worsening congestive heart failure, NYHA functional class III to IV, valve-related dysfunction. ‡Early safety (1 month): all-cause mortality, all stroke, life-threatening (LT) bleeding, acute kidney injury stage 2 to 3, coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction. CV ¼ cardiovascular; IH ¼ intrahospital; other abbreviations as in Table 1.

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Transcarotid TAVR and Anesthesia

interventions. GA also involves volatile anesthetic

T A B L E 3 Details of 30-Day Stroke/TIA

Age, yrs Male Body mass index, kg/m2

agents that have been associated with immunosup-

All Patients (N ¼ 174)

Stroke/TIA (n ¼ 10)

No Stroke/TIA (n ¼ 164)

80.5  7.9

84.2  3.4

80.3  8.1

p Value

0.08

pression and an increased risk of post-operative pneumonia (19). Indeed, studies comparing local and GA with

96 (55.1)

5 (50.0)

91 (55.4)

0.73

26.1  6.4

25.5  5.6

26.2  6.5

0.72

transfemoral TAVR have demonstrated shorter pro-

Prior stroke/TIA

24 (13.7)

3 (30.0)

21 (12.8)

0.12

cedure time and mobilization when compared to GA

Prior AF

70 (40.2)

6 (60.0)

64 (39.0)

0.18

(13,20). Consistent with these data, we observed a

HTA

141 (81.0)

7 (70.0)

134 (81.7)

0.35

shorter hospital length of stay with the MIS compared

STS score, %

8.0  4.6

6.9  4.8

8.1  4.5

0.41

53.9  13.6

with the GA group. Importantly, the MIS approach

0.84

also affords the opportunity to assess cerebral

53.8  13.6 53.1  13.9

TTE LVEF, % TTE Vmax, m/s

4.2  0.6

4.2  0.5

4.3  0.6

0.79

Left carotid access

139 (79.8)

9 (90.0)

130 (79.2)

0.41

perfusion during procedure. This appears to have

Medtronic CoreValve

139 (79.8)

7 (70.0)

132 (80.4)

0.42

been of vital importance to the 2 patients with posi-

Valve size, mm

27.5  2.4

27.5  2.1

27.6  2.4

0.95

tive carotid cross-clamp tests, who may have man-

Ipsilateral localization

3 (1.7)

3 (30.0)





ifested post-operative stroke but for the ability to

Hemorrhagic stroke

0 (0.0)

0 (0.0)





change the vascular access strategy. This test appears

Delay between TAVR and stroke/TIA, days



0.8  1.0





to be of additive value to the monitoring of cerebral

Stroke leading to IH death

1 (0.5)

1 (10.0)





Modified Rankin (disability) scale <2 (at 1 year)

3 (1.7)

3 (30.0)





Disabling stroke/TIA 1-year mortality

oximetry (21). Of course, the MIS for carotid TAVR requires a period of adjustment for the TAVR team. A formal

2 (1.1)

2 (20.0)





22 (12.6)

7 (70.0)

15 (9.1)

<0.001*

Values are mean  SD or n (%). *p < 0.05. AF ¼ atrial fibrillation; HTA ¼ hypertension; LVEF ¼ left ventricular ejection fraction; IH ¼ intrahospital; TTE ¼ transthoracic echocardiography; Vmax ¼ maximal jet velocity (m/s); other abbreviations as in Table 1.

detailed discussion with the patient and his or her family is of paramount importance, so as to avoid confusion

during

the

procedure.

Furthermore,

communication between the team members during the procedure is critical to success, with 1 nurse staying with patient to monitor the clinical neurological status and no sedation until the cross clamp. The proximity of

The main findings from this study are that trans-

the vascular access to the patients’ head can create

carotid TAVR appears safe and feasible, with a 30-day

some potential problems for both patient and oper-

stroke or TIA rate of 5.7%, and that it may be managed

ator. Foremost among these is the potential for the

with minimally invasive or GA strategies.

patient to move during valve deployment due to ac-

Transcarotid TAVR with a self-expanding prosthesis

cess site discomfort. Generous local anesthesia and an

was first performed using the Medtronic CoreValve

appropriate level of sedation is therefore funda-

in Lille, France, in 2009 (11). This technique has sub-

mental. Overall, the requirement to convert from an

sequently been adopted by other centers, and has

MIS to GA strategy was low (5.7%), and similar to rates

evolved to include the use of local anesthesia (5) and

reported for transfemoral TAVR (22).

other valve types (3). In the current study, we compared for the first time 2 anesthesia strategies for

CEREBROVASCULAR EVENTS. In the current study,

transcarotid TAVR. An MIS has previously been

the 30-day stroke or TIA rate was 5.7%, with 4 strokes

described for transfemoral TAVR with favorable re-

(2 major, 2 minor), and 6 TIAs at 30 days. This stroke

sults (13,14), but there are no data on this technique for

rate is similar than that observed in real-world

transcarotid vascular access. We introduced the MIS

transfemoral TAVR registries (1). As previously

technique on the basis of encouraging data from TAVR

described (4), the frequent contralateral localization

and carotid endarterectomy studies (15–17). Indeed,

of neurological events and the pattern of post-

The EUROSTAR (European Stent/Graft Techniques for

infarction magnetic resonance imaging suggests that

Aortic Aneurysm Repair) registry suggested reduced

many of these events may not related to imple-

morbidity and possibly mortality with a locoregional

mentation of the carotid artery. Rather, likely etiol-

anesthesia approach among high-risk patients under-

ogies include: debris embolization during balloon

going endovascular aortic repair (17). Potential mech-

valvuloplasty and valve deployment, hypotensive

anisms by which an MIS may affect morbidity include

episodes triggered by anesthetic agents and rapid

early mobilization, avoidance of drugs potentially

ventricular pacing, atrial fibrillation, and inadequate

inducing hemodynamic compromise, avoidance of

collateral perfusion through the circle of Willis.

endotracheal intubation, mechanical ventilation (18),

Nevertheless, carotid artery intervention, by its very

and thus avoidance of complications from these

nature, must be associated with a risk of stroke, and

Debry et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 20, 2016 OCTOBER 24, 2016:2113–20

Transcarotid TAVR and Anesthesia

therefore should only be performed by clinicians with

collateral circulation, then an MIS may be beneficial.

considerable experience of carotid artery surgery.

In the present series, 4 (7.6%) of the patients were

The TAVR team should remain particular with respect

converted from MIS to GA; however, because of the

to vascular screening, assessment of collateral blood

limited number of patients, no conclusions can be

flow, anticoagulant and antiplatelet therapy, and

made regarding better patient selection.

periprocedural management of the carotid artery.

The

need

for

intraprocedural

transesophagal

We observed a significantly higher rate of cerebro-

echocardiography and significant patient discomfort

vascular events with the GA strategy compared with

under previous MIS procedures are relative contra-

the MIS (8.2% vs. 0%; p < 0.001). Potential explana-

indications to the MIS technique. A common carotid

tions for this result include a procedural learning curve

artery luminal diameter #6.0 mm and a short neck

(first performed with GA; no stroke or TIA in the last

with significant adiposity are true contraindications.

one-third of GA procedures), the recent move toward

Furthermore,

less balloon aortic valvuloplasty (MIS is more recently

airway are unsuitable for this approach.

used), and the play of chance (small numbers of events). However, the vascular access sheath size and procedural duration were identical between anesthesia groups. Furthermore, the positive carotid-cross clamp tests observed in this series suggests that the MIS may have real potential in reducing cerebrovascular events among these patients. COMPARISON

TO

NONFEMORAL

patients

with

anticipated

difficult

STUDY LIMITATIONS. This prospective study is non-

randomized and is limited by the flaws inherent to this type of analysis, and in particular, the retrospective nature of data analysis, the small size of the cohort,

and

noncentralized

data

analysis

and

endpoint adjudications. These limitations can affect the validity of the study conclusions. Several factors,

APPROACHES.

including the small number of patients, patient se-

Patients requiring a nonfemoral approach are typi-

lection using MSCT, and operator experience of the

cally at increased risk compared with those suitable

technique could account for some of the difference

for a femoral procedure (1). The transapical approach

between MIS and GA. Device iteration with smaller

was initially considered the nonfemoral approach of

sheath size may also play a role.

choice. However, increased mortality compared to

The results achieved reflect those of 2 centers

transfemoral TAVR, probably relating to increased

specialized in transcarotid TAVR and must be

myocardial injury and respiratory failure, have seen

confirmed in a larger patient series. Importantly, it is

this approach diminish in popularity (23). A direct

possible that the rate of neurological events has been

transaortic approach has more recently been devel-

underestimated,

oped (24). This approach continues to require GA and

neurologist was not performed prior to and following

is not suitable in cases of porcelain aorta, or advanced

TAVR. We have been, however, very focused on

respiratory failure. The reported 30-day mortality

neurological outcomes, and there was a low threshold

(8%) with this technique compares unfavorably to the

for neurologist evaluation or neuroimaging. In addi-

current study, though the risk of stroke is low, at 2%

tion, we mostly used first-generation transcatheter

(25). The 30-day mortality in patients undergoing the

valves and new generation valves are likely to reduce

subclavian approach is reported to be 6%, with stroke

vascular complications.

as

systematic

evaluation

by

a

rates of 2% to 3% (26). This technique may be unsuitable for patients with severe axillary or subclavian artery disease or among those with patent

CONCLUSIONS

internal thoracic artery grafts. Taken together, these

Transcarotid TAVR appears to be both feasible and

data suggest that in patients requiring nonfemoral

appears safe, with high procedural success, 30-day

TAVR an individualized approach to vascular access

mortality of 7.4%, and a 30-day stroke or TIA rate of

is appropriate.

5.7%. These procedures may be performed using local

WHO SHOULD HAVE MIS FOR THIS APPROACH?

or GA, and the former may have a lower risk of stroke.

MIS may be more favorable in the following clinical

Further study is required to confirm these results.

situations: severe pulmonary disease or immunode-

ACKNOWLEDGMENT The authors would like to thank

ficiency (avoid pneumonia or delayed extubation),

Alan Grant for his kind review of the manuscript.

unstable hemodynamics (avoid risk of further hypotension with induction), and mild-moderate dementia

REPRINT REQUESTS AND CORRESPONDENCE: Dr.

(avoid further cognitive dysfunction or delirium with

Thomas Modine, Boulevard du Professeur Jules Leclercq,

anesthesia). If the patient has anatomy with ques-

Hôpital Cardiologique, CHRU Lille, Lille 59000, France.

tionable cerebral perfusion secondary to inadequate

E-mail: [email protected]

2119

2120

Debry et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 9, NO. 20, 2016 OCTOBER 24, 2016:2113–20

Transcarotid TAVR and Anesthesia

PERSPECTIVES WHAT IS KNOWN? Transcarotid TAVR has been shown

WHAT IS NEXT? Transcarotid TAVR under MIS can be

to be feasible and safe.

proposed as second choice approaches when transfemoral access is not available, with satisfying results at

WHAT IS NEW? Transcarotid TAVR procedures may be

1-year follow-up.

performed using local or GA with similar outcomes, and the former may have a lower risk of stroke.

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KEY WORDS aortic stenosis, general anesthesia, local anesthesia, transcarotid access, transcatheter aortic valve replacement