Usefulness of Echocardiographic Criteria for Transcatheter Aortic Valve Implantation without Balloon Predilation: A Single-Center Experience Fabian Islas, MD, Carlos Almerıa, MD, Eulogio Garcıa-Fernandez, MD, Pilar Jimenez, MD, PhD, Luis Nombela-Franco, MD, Carmen Olmos, MD, PhD, Pedro Marcos-Alberca, MD, PhD, Ana Cuadrado, MD, Antonio Fernandez-Ortiz, MD, PhD, Carlos Macaya, MD, PhD and Leopoldo Perez de Isla, MD, PhD, FESC, Madrid, Spain

Background: Transcatheter aortic valve implantation (TAVI) is an alternative therapy for high-risk patients with symptomatic aortic stenosis. TAVI without balloon aortic predilation (BPD) has been found to be as feasible and safe as the standard approach with predilation. The aim of this study was to show the usefulness of transesophageal echocardiographic (TEE) criteria during patient selection for TAVI without BPD and compare the results with those from a control group. Methods: Two hundred forty-nine consecutive patients with severe symptomatic aortic stenosis underwent echocardiographic evaluation before TAVI. Two-dimensional and three-dimensional TEE imaging was used to evaluate the aortic annulus and root, leaflet mobility and degree of calcification, orifice characteristics, valve area, and aortic regurgitation. After TEE data were reviewed, patients were considered to be favorable candidates, or not, for TAVI without BPD on the basis of specific echocardiographic criteria. Results: The mean age was 82 6 5 years. Seventy-nine patients underwent TAVI without BPD, and 170 patients underwent TAVI with BPD. The mean aortic valve area was 0.61 6 0.16 cm2, and the mean aortic annular diameter was 2.2 6 0.25 cm. In the group without BPD, Edwards SAPIEN XT valves were implanted in 64.6% (n = 51) and Medtronic CoreValve prostheses in 35.4% (n = 28). In this group, residual paravalvular aortic regurgitation immediately after valve deployment was seen in 53.2% of patients, without differences from those who underwent TAVI with BPD. Permanent pacemaker implantation was less frequent in the group of patients without BPD (6.3% vs 14.1%, P = .030). Procedure-related mortality was significantly lower in patients without BPD (2.5% vs 11.8%, P = .018). Conclusions: Thorough TEE assessment of aortic valve features permits the selection of patients with ideal conditions for TAVI without BPD, regardless of the type of prosthesis. Using the echocardiographic criteria described here, it is possible to achieve a good rate of procedural success with a low complication rate in patients undergoing TAVI without BPD. (J Am Soc Echocardiogr 2015;28:423-9.) Keywords: 3D echocardiography, Balloon predilation, TAVI

Over the past decade, transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients with severe aortic stenosis who are at high surgical risk or are not candidates for surgery. Performance of balloon aortic predilation (BPD) before device placement has been considered a mandatory step in TAVI, to facilitate the implantation of the prosthesis and to ensure optimal device expansion. There are several concerns regarding BPD, such as potential cerebrovascular embolic events, conduction disturbances, acute aortic regurgitation, and consequent

From the Cardiology Department, Hospital Clınico San Carlos, Madrid, Spain. n Islas, MD, Unidad de Imagen Cardiovascular, Hospital Reprint requests: Fabia Clınico San Carlos, Calle Profesor Martın Lagos S/N, 28040 Madrid, Spain (E-mail: [email protected]). 0894-7317/$36.00 Copyright 2015 by the American Society of Echocardiography. http://dx.doi.org/10.1016/j.echo.2015.01.003

hemodynamic instability. One study previously reported the safety and feasibility of TAVI without BPD with the Medtronic CoreValve (CV) prosthesis (Medtronic, Minneapolis, MN).1 We conducted this study to demonstrate that proper transesophageal echocardiographic (TEE) assessment of the aortic valve might improve patient selection and guidance of TAVI without BPD, using both the CV and the Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, CA) and avoiding the risks inherent to other imaging techniques.

METHODS Study Population The study cohort comprised 249 consecutive patients with severe symptomatic aortic stenosis who underwent TAVI from January 2009 to August 2014. Seventy-nine patients underwent TAVI without BPD, and 170 patients underwent TAVI with BPD. All patients were evaluated 423

424 Islas et al

Abbreviations

BPD = Balloon aortic predilation

CV = CoreValve ES = Edwards SAPIEN XT LVOT = Left ventricular outflow tract

MSCT = Multislice computed tomography

Journal of the American Society of Echocardiography April 2015

by a multidisciplinary team and were considered to be at high risk or to have contraindications to surgical treatment. Before the procedure, patients underwent TEE assessment of the aortic valve. All patients gave written informed consent for TEE imaging and TAVI, in accordance with a protocol approved by the institutional review committee.

TAVI = Transcatheter aortic valve implantation

Two-Dimensional (2D) and Three-Dimensional (3D) regurgitation TEE Imaging PPI = Permanent pacemaker The equipment used was implantation an iE33 xMATRIX echocarTEE = Transesophageal diographic system (Philips echocardiographic Ultrasound, Bothell, WA), with 3D TEE capabilities. All images 3D = Three-dimensional obtained were processed with 2D = Two-dimensional the quantitative analysis software QLAB (Philips Ultrasound). Different operators in our lab performed preprocedural TEE imaging. In every case, image acquisition and postprocessing of the 3D images were supervised, performed, and rechecked by our most experienced operator in TEE imaging related to TAVI. The initial preimplantation TEE study should confirm the severity of aortic stenosis by 2D and 3D imaging, as well as by Doppler interrogation of the valve. Our TEE protocol, through the use of both 2D and 3D imaging, offered all details of the aortic valve features needed to determine whether patients were optimal candidates for TAVI without BPD. Measurement of the aortic annulus was obtained at 120 to 140 , ensuring a perpendicular position of the aorta relative to the left ventricle. By means of QLAB’s multiplanar tool, coaxial planes were used to generate an orthogonal plane that allowed the measurement of the 3D cross-sectional area and diameter of the aortic annulus and root. Thickness of the aortic leaflets, mobility, and calcium distribution were assessed in 45 and 120 to 140 views in end-diastole using both 2D and 3D tools (Figure 1). Distribution and degree of valve calcification were classified as mild (1), moderate (2), or severe (3). To classify valve calcification, the thickness of each leaflet was measured; the mean value of the three leaflets together was obtained as well. Calcification was considered mild when the mean leaflet thickness was 5 mm, with large nodules and diffuse calcification of the aortic annulus. In addition, calcium distribution on the aortic valve was designated as regular or irregular, with irregular distribution considered to be asymmetric presence of calcium at the commissures or leaflets. The presence of calcium nodules near the coronary ostia or at the left ventricular outflow tract (LVOT) was described to evaluate its potential effect on prosthesis deployment and function. The mobility of aortic cusps was visually classified as slightly restricted (1), moderately restricted (2), or severely restricted (3). PVAR = Paravalvular aortic

For this purpose, we took into account commissure fusion. We considered mobility to be slightly restricted when all commissures seemed to be open, moderately restricted when there was one fused commissure, and severely restricted when there were two or more fused commissures. Aortic valve residual orifice was classified into two groups by using a 3D multiplanar tool, obtaining a short-axis plane of the valve: central or eccentric and irregular orifice (Figure 2). Aortic valve area was estimated by the continuity equation as well as with 3D planimetry. Aortic regurgitation before TAVI was classified into one of four groups, absent (0), mild (1), moderate, (2) or severe (3), according to the European guidelines on valvular heart disease.2 Our criteria for favorable or unfavorable TAVI without BPD are presented in Table 1. After echocardiographic data were reviewed with the interventional team, patients who fulfilled all favorable criteria (valve area > 0.4 cm2, central orifice, calcification # grade 2, mobility # grade 2, no LVOT calcification, absence of calcium nodules in the ‘‘landing zone’’ of the prosthesis, and aortic regurgitation # grade 2) underwent TAVI without BPD (Figure 3). The interventional team defined the type and size of the prosthesis according to the manufacturer’s recommendations. Within the procedure, 3D TEE imaging was used in almost all steps of TAVI. Once the device was delivered into the native aortic valve, and by using the 3D multiplanar tool, we ensured that 50% to 60% of the total device height was at the LVOT; after confirming proper positioning, the device was deployed just below the aortic annulus in a subcoronary location, and its function was immediately evaluated. Procedural success was defined as successful delivery and deployment, correct positioning of the device in the proper anatomic location with adequate performance of the prosthetic heart valve, and a final mean transaortic gradient # 20 mm Hg, without aortic regurgitation $ grade 2 and no valve embolization or need to implant a second valve or conversion to surgery. Postprocedural aortic regurgitation degree was classified in accordance with Valve Academic Research Consortium 2 criteria.3 After the procedure, patients were closely observed for periprocedural and 30-day major adverse cardiac and cerebrovascular events (stroke, myocardial infarction, aortic valve reintervention or surgery, need for new permanent pacemaker implantation (PPI), procedurerelated mortality, and all-cause mortality). Subsequent follow-up was done in an outpatient setting. Statistical Analysis Continuous variables are reported as mean 6 SD. They were compared by using two-tailed Student t tests. Categorical variables are expressed as frequencies and percentages and were compared by using c2 tests and Fisher exact tests as appropriate. All tests were two sided, and differences were considered to be statistically significant at P < .05. Statistical analysis was performed with Stata/IC version 12.1 (StataCorp LP, College Station, TX).

RESULTS Clinical and echocardiographic baseline characteristics of the study population (n = 249) are presented in Table 2. The mean age was 82.7 6 5.6 years, and 65% (n = 162) were women.

Islas et al 425

Journal of the American Society of Echocardiography Volume 28 Number 4

Figure 1 (A) Two-dimensional orthogonal views of the aortic valve. (B) Three-dimensional multiplanar reconstruction of the aortic valve confirming a central orifice (asterisk) and regular calcification of the valve.

All TAVI procedures were elective and performed via the transfemoral approach. Seventy-nine patients (31.7%) underwent TAVI without BPD, and 170 patients (68.3%) underwent TAVI with BPD. No significant differences were found between these two groups regarding echocardiographic baseline parameters and clinical characteristics. In patients without BPD, CV devices were used in 28 patients (35.4%) and ES devices in 51 patients (64.5%). In the group of patients with BPD, ES valves were implanted in 115 patients (67.6%), and CV prostheses were used in 55 patients (32.4%). Postprocedural clinical and echocardiographic data are presented in Table 3. Some grade of paravalvular aortic regurgitation (PVAR) immediately after implantation occurred in 51.2% of patients, without differences between patients who underwent TAVI with and without BPD. Neither were differences found in the proportion of patients with moderate PVAR (3.8% vs 3.2%, P = .805) or severe PVAR (1.2% vs 1.5%, P = .742). In almost all cases (90.2%), localization of the jet was posterior at 120 to 135 and between 9 and 3 o’clock in the short-axis view. Because of either the presence of PVAR grade $ 2 or that of more than one leak, balloon postdilation was performed in 18.8% (n = 32) of patients with BPD and 17.7% (n = 14) of patients without BPD. No statistical significant differences were found. In the group of patients without BPD, 48.1% (n = 38) had no PVAR at the end of the procedure, 48.1% (n = 38) had grade 1, 2.5% (n = 2) had grade 2, and one patient with grade 3 PVAR remained so despite postdilation and required further elective surgical replacement of the valve. In patients with BPD, 50% (n = 85) of patients had no PVAR at the end of the procedure, 45.3% (n = 77) had grade 1, 3.5% (n = 6) had grade 2, and no grade 3 PVAR was observed. There were no statistically significant differences between groups. The procedural success rate was 92.3% in patients without BPD and 90.1% in patients with BPD, without significant differences between them.

Only one clinical cerebrovascular event was reported in the group of patients without BPD. Procedure-related mortality was significantly lower in patients without BPD (2.5% vs 11.8%, P = .018). To provide further insight into the group of patients without BPD, we compared patients who received ES valves and those who received CV prostheses. The amount of contrast used in the procedure was significantly higher in patients who received CV prostheses. No other significant differences in procedural results or patients’ inhospital evolution were found between the two groups (Table 4).

DISCUSSION Treatment of patients with high-risk or inoperable symptomatic severe aortic stenosis is challenging. TAVI is now a therapeutic alternative for this group of patients.4 BPD has experienced a new role as a preliminary step in the TAVI procedure, recommended in a position statement by the European Association of Cardio-Thoracic Surgery and the European Society of Cardiology because of its theoretical advantages.5 It is known that the practice provides a gain in the aortic orifice by crushing calcified nodules, separating fused commissures, and stretching the aortic annulus. However, it is also known that BPD carries risks such as stroke, conduction disturbances, aortic regurgitation, tamponade, and acute hemodynamic instability in up to 15% of patients undergoing this procedure.6 Grube et al.1 first reported the possibility of performing TAVI without BPD of the native valve, with a technical success rate of 96.7%, postdilation in 16.7% of patients, and new permanent pacing in 11.7% of patients. Those results showed that TAVI without BPD was feasible, with similar safety and efficacy as the current standard approach of TAVI with previous BPD. In Grube et al.’s1 study, all patients received self-expanding CV prostheses. However, some series have reported significantly higher

426 Islas et al

Journal of the American Society of Echocardiography April 2015

Figure 2 (A) Heavy calcification of the aortic leaflets and commissures. (B) Irregular and bulky calcification of the aortic valve in a patient with valve area < 0.4 cm2. (C) Central valve residual orifice with fusion of one commissure. (D) Aortic valve with no commissure fusion and regular calcium distribution. (A,B) Examples of aortic valves with unfavorable features for TAVI without balloon predilation. (C,D) Examples of aortic valves with favorable features for this technique.

Table 1 Echocardiographic criteria for TAVI without predilation Favorable for TAVI without BPD 2

Unfavorable for TAVI without BPD

Valve area > 0.4 cm

Valve area < 0.4 cm2

Central orifice

Eccentric and/or irregular orifice

Calcification # grade 2

Calcification > grade 2

Mobility # grade 2

Mobility > grade 2

No LVOT calcification

LVOT calcification

Absence of calcium nodules*

Calcium nodules*

AR # grade 2

AR > grade 2

AR, Aortic regurgitation. *Calcium nodules in the territory to be occupied by the prosthesis close to the coronary ostia or in the LVOT (‘‘landing zone’’).

success rate with ES valves compared with the CV; moreover, the CV has shown higher rates of PVAR, valve embolization, need for a second valve, and new PPI.7,8 Because of the safety profile and success rate provided by ES valves, we decided to perform TAVI without BPD using both devices. Previously, we reported our initial

experience in 16 patients undergoing TAVI without BPD using the ES valve, with an excellent success rate and a very low percentage of complications.9 In our series, TEE imaging played an essential role, providing anatomic and functional information to the interventional team regardless of the device chosen. Previous reports have demonstrated that TEE protocols, including 3D tools, have a vital role within a multidisciplinary TAVI program and contribute to excellent outcomes.10 Nowadays, the multimodality approach is considered the best way to assess patients undergoing TAVI, but it is important to consider that many of these patients have several comorbidities that might decrease the quality of certain imaging studies. For instance, multislice computed tomography (MSCT) is essential in evaluating vascular anatomy and assessing aortic root anatomy and typically requires a gated, contrast study. Some candidates for TAVI may not have the conditions for proper MSCT, including patients with impaired renal function, precluding the use of contrast. Besides, MSCT is not always available, or there is not enough experience in evaluating aortic valve features with this imaging technique. In this sense, TEE imaging has a major role in structural heart disease and has been shown to add incremental information for interventional cardiologists. Particularly, 3D TEE imaging is a suitable alternative to MSCT for the assessment of the aortic valve and root features.11,12

Islas et al 427

Journal of the American Society of Echocardiography Volume 28 Number 4

Table 2 Baseline characteristics

Variable

TAVI without BPD

TAVI with BPD

(n = 79)

(n = 170)

P

Age (y)

82.4 6 5.5

82.8 6 5.7

.644

Women

52 (65.7%)

110 (64.7%)

.871

Logistic EuroSCORE

18.6 6 9.8

17.9 6 9.6

.649

LVOT (mm)

19.3 6 0.3

19.4 6 0.2

.726

Aortic annulus (mm)

22.1 6 2.3

21.7 6 2.6

.234

Aortic root (mm)

29.1 6 5.1

29.5 6 4.1

.515

Sinotubular junction (mm)

24.9 6 4.6

25.8 6 4.3

.259

Ascending aorta (mm)

34.8 6 5.3

32.8 6 5.0

.381

Aortic root area (cm2)

6.7 6 2.0

7.1 6 2.3

.500

3D aortic annular area (cm2)

6.5 6 1.6

5.9 6 2.0

.248

3D aortic root area (cm2)

6.2 6 0.3

6.2 6 0.2

.986

Noncoronary cusp

4.7 6 1.4

5.1 6 1.3

.063

Left coronary cusp

4.6 6 1.1

5.0 6 1.1

.226

Right coronary cusp

4.9 6 1.2

5.2 6 1.4

.674

56.9 6 12.5

58.7 6 13.4

.359

Mean gradient (mm Hg)

47.3 6 14.7

50.1 6 17.7

.254

Maximum gradient (mm Hg)

80.7 6 23.8

82.9 6 26.5

.560

Valve area (cm2)

0.6 6 0.2

0.7 6 0.2

.409

Concomitant MR

71 (89.9%)

157 (92.4%)

.371

Cusp thickness (mm)

LVEF (%) Preprocedural gradients

Figure 3 Selection of patients with a favorable profile for performing TAVI without BPD. Calcification was considered to be mild (1) when the mean leaflet thickness was 5 mm, with large nodules and diffuse calcification of the aortic annulus. Mobility of the aortic cusps was visually classified as slightly restricted (1) when all commissures seemed to be open, moderately restricted (2) when there was one fused commissure, and severely restricted (3) when there were two or more fused commissures. Jilaihawi et al.13 reported the usefulness of 3D TEE imaging for greater control of coaxiality and to generate an orthogonal axial cross-sectional area of the aortic annulus to obtain all measurements. Reliability assessment of aortic annular measurements by cross-sectional 3D TEE imaging and MSCT showed excellent reproducibility and a moderate correlation between dimensions obtained by both methods. This study also demonstrated that 3D TEE assessment provides more accurate information than 2D TEE assessment for the performance of TAVI, with superior discrimination of PVAR. Regarding PVAR, Gripari et al.14 studied cross-sectional 3D TEE imaging and demonstrated that their area cover index (1 [annular area/prosthesis nominal area]) was an independent predictor of PVAR. Underestimation of aortic annular measurements is a significant factor in the occurrence of PVAR. Previous studies15,16 demonstrated that cross-sectional 3D TEE measurements were up to 1.3 mm smaller than those obtained by MSCT and cardiac magnetic resonance imaging. This could lead to prosthesis undersizing and subsequent PVAR. Hahn et al.17 demonstrated that 3D TEE measurements of the aortic annulus could be useful for device sizing and predicting PVAR.

EuroSCORE, European System for Cardiac Operative Risk Evaluation; LVEF, left ventricular ejection fraction; MR, mitral regurgitation. Data are expressed as absolute number (percentage) for categorical variables and as mean 6 SD for continuous variables.

At our center, the interventional team decided the size of the prosthesis in every case, according to the measurements obtained with 3D TEE imaging. By using those measurements, we obtained acceptable percentages of PVAR and balloon postdilation, similar to those reported in other series.18,19 Another factor we took into account to prevent the occurrence of PVAR was the amount and distribution of calcium on the aortic valve, the LVOT, and the ‘‘landing zone’’ of the prosthesis, defined as the area including the aortic valve (i.e., aortic annulus and valve cusps) and the LVOT (until the junction point of the anterior mitral leaflet); the presence of large clumps of calcium was associated with PVAR and need for postdilation.20 Colli et al.21 demonstrated that calcification of aortic leaflets and commissures was significantly associated with PVAR, possibly because the presence of bulky calcification at the commissures and leaflets prevents adequate alignment of the prosthetic stent against the aortic wall and leads to PVAR. These concepts were used to develop our criteria on mobility and calcification. Regarding the need for PPI after the procedure, it was required in only four patients (6.3%) in the group undergoing TAVI without BPD. This is interesting, as previous series have reported rates ranging from 9% to 39.3%. The indication for PPI was complete atrioventricular block in all cases. Conduction disturbances leading to PPI occurred either during or within the 24 hours after the procedure. In accordance with previous studies, the rates of conduction disturbances

428 Islas et al

Journal of the American Society of Echocardiography April 2015

Table 3 TAVI results TAVI without BPD

TAVI with BPD

(n = 79)

(n = 170)

8.5 6 3.4

9.0 6 5.4

.567

Concomitant MR

62 (78.4%)

142 (83.5%)

.574

PVAR (any grade)

42 (53.2%)

Variable

Mean gradient after TAVI (mm Hg)

PVAR (moderate or severe) Postdilation Second prosthesis

P

85 (50%)

.591

4 (5.0%)

8 (4.7%)

.795

14 (17.7%)

32 (18.8%)

.802

3 (3.8%)

9 (5.3%)

.229

Stroke

1 (1.2%)

3 (1.7%)

.783

Permanent pacemaker

5 (6.3%)

24 (14.1%)

.030

Conversion to surgery

2 (2.3%)

9 (5.2%)

Procedure duration (min)

108.5 6 35.6

133.7 6 46.9

Iodine contrast amount (mL)

.488 0.4 cm2. It has been described that patients with smaller valve areas had a higher risk for cerebrovascular events in the early period after TAVI.31 Furthermore, evaluating and grading aortic valve calcification and mobility allows us to avoid BPD and to achieve a percentage of postdilation comparable with those with BPD, decreasing the mechanical hazards of both procedures that cause interaction and trauma between the prosthesis and the calcified native valve, leading to diverse complications. The results of this study confirm the feasibility of TAVI without BPD using both CV and ES prostheses, with a high rate of success and acceptable rates of postdilation and PVAR. We describe some affordable TEE criteria that allow the selection of patients for TAVI without BPD. With these criteria, we were able to select each patient for different TAVI approaches, in order to perform safer procedures, with similar rates of procedural success to those published in the literature.

.444

PVAR (moderate or severe)

2 (7.1%)

2 (3.9%)

.403

Study Limitations

Postdilation

7 (25.0%)

7 (13.7%)

.421

Second prosthesis

2 (7.1%)

1 (2.0%)

.149

Stroke

1 (3.6%)

0 (0%)

.562

Permanent pacemaker

3 (10.7%)

2 (3.9%)

.308

This study comprised a relatively small cohort of patients at a single center. However, the baseline characteristics of our study population do not differ significantly from those of other TAVI series, and we believe that our information may be applicable to other populations. Recently, we started to routinely perform computed tomography before TAVI procedures; unfortunately, we do have enough data to compare our TEE measurements with those obtained by computed tomography. The Valve Academic Research Consortium 2 criteria for PVAR were applied in all cases. Since this study started in 2009, a blinded reassessment of PVAR according to these criteria has been performed. Finally, because this was an observational study, biases associated with this type of design cannot be excluded, and the superior rate of complications in the group of patients with BPD could reflect issues of the initial learning curve, as a higher proportion of patients from our early experience underwent TAVI with BPD.

Procedure duration (min)

122.0 6 30.9

105.2 6 37.2

.054

Iodine contrast amount (mL)

208.8 6 79.8

125.5 6 51.6

12 mm in the LVOT and a prosthetic contact surface of >90% between the interventricular septum and the stent of the prosthesis in diastole were strongly associated with the appearance of conduction disturbances. With TEE

CONCLUSIONS A correct assessment of aortic valve features with TEE imaging allows the selection of patients with the ideal conditions for TAVI without BPD, regardless of the type of prosthesis. Using our echocardiographic criteria, it is possible to achieve a high rate of success and safety, besides avoiding radiation and contrast use related to other imaging techniques.

Journal of the American Society of Echocardiography Volume 28 Number 4

REFERENCES 1. Grube E, Naber C, Abizaid A, Sousa E, Mendiz O, Lemos P, et al. Feasibility of transcatheter aortic valve implantation without balloon pre-dilation. A pilot study. JACC Cardiovasc Interv 2011;4:751-7. 2. Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, et al. Guidelines on the management of valvular heart disease (version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2012; 33:2451-96. 3. Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation. The Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol 2012;60:1438-54. 4. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al., for the PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607. 5. Vahanian A, Alfieri O, Al-Attar N, Antunes M, Bax J, Cormier B, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC). EuroIntervention 2008;4:193-9. 6. Ben-Dor I, Pichard AD, Satler LF, Goldstein SA, Syed AI, Gaglia MA Jr, et al. Complications and outcome of balloon aortic valvuloplasty in high-risk or inoperable patients. JACC Cardiovasc Interv 2010;3:1150-6. 7. Godino C, Maisano F, Montorfano M, Latib A, Chieffo A, Michev I, et al. Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center. The Milan experience. JACC Cardiovasc Interv 2010;3:1110-21. 8. Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, et al. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards SAPIEN and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention 2010; 5:659-65. 9. Garcıa E, Almerıa C, Unzue L, Jimenez P, Cuadrado A, Macaya C. Transfemoral implantation of Edwards SAPIEN XT aortic valve without previous valvuloplasty: Role of 2D/3D transesophageal echocardiography. Catheter Cardiovasc Interv 2014;84:868-76. 10. Smith LA, Dworakowski R, Bhan A, Delithanasis I, Hancock J, Maccarthy PA, et al. Real-time three-dimensional transesophageal echocardiography adds value to transcatheter aortic valve implantation. J Am Soc Echocardiogr 2013;26:359-69. 11. Hahn RT. Guidance of transcatheter aortic valve replacement by echocardiography. Curr Cardiol Rep 2014;16:442. 12. Bloomfield GS, Gillam LD, Hahn RT, Kapadia S, Leipsic J, Lerakis S, et al. A practical guide to multimodality imaging of transcatheter aortic valve replacement. JACC Cardiovasc Img 2012;5:441-55. 13. Jilaihawi H, Doctor N, Kashif M, Chakravarty T, Rafique A, Makar M, et al. Aortic annular sizing for transcatheter aortic valve replacement using cross-sectional 3-dimensional transesophageal echocardiography. J Am Coll Cardiol 2013;61:908-16. 14. Gripari P, Ewe SH, Fusini L, Muratori M, Ng AC, Cefal u C, et al. Intraoperative 2D and 3D transoesophageal echocardiographic predictors of aortic regurgitation after transcatheter aortic valve implantation. Heart 2012;98: 1229-36. 15. Tsang W, Bateman MG, Weinert L, Pellegrini G, Mor-Avi V, Sugeng L, et al. Accuracy of aortic annular measurements obtained from threedimensional echocardiography, CT and MRI: human in vitro and in vivo studies. Heart 2012;98:1146-52. 16. Ng AC, Delgado V, van der Kley F, Shanks M, van de Veire NR, Bertini M, et al. Comparison of aortic root dimensions and geometries before and after transcatheter aortic valve implantation by 2- and 3-dimensional trans-

Islas et al 429

esophageal echocardiography and multislice computed tomography. Circ Cardiovasc Imaging 2010;3:94-102. 17. Hahn RT, Khalique O, Williams MR, Koss E, Paradis JM, Daneault B, et al. Predicting paravalvular regurgitation following transcatheter valve replacement: utility of a novel method for three-dimensional echocardiographic measurements of the aortic annulus. J Am Soc Echocardiogr 2013;26: 1043-52. 18. Nombela-Franco L, Rodes-Cabau J, DeLarochelliere R, Larose E, Doyle D, Villeneuve J, et al. Predictive factors, efficacy, and safety of balloon postdilation after transcatheter aortic valve implantation with a balloonexpandable valve. JACC Cardiovasc Interv 2012;5:499-512. 19. Pasupati S, Sinhal A, Humphries K, Ivens E, Moss R, Thompson CR, et al. Re-dilation of balloon expandable aortic valves: what do we know? Am J Cardiol 2007;100:57. 20. John D, Buellesfeld L, Yuecel S, Mueller R, Latsios G, Beucher H, et al. Correlation of Device landing zone calcification and acute procedural success in patients undergoing transcatheter aortic valve implantations with the selfexpanding CoreValve prosthesis. JACC Cardiovasc Interv 2010;3:233-43. 21. Colli A, D’Amico R, Kempfert J, Borger MA, Mohr FW, Walther T. Transesophageal echocardiographic scoring for transcatheter aortic valve implantation: impact of aortic cusp calcification on postoperative aortic regurgitation. J Thorac Cardiovasc Surg 2011;142:1229-35. 22. Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, et al., German Transcatheter Aortic Valve Interventions-Registry Investigators. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J 2011;32:198-204. 23. Piazza N, Grube E, Gerckens U, den Heyer P, Linke A, Luha O, et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18F) CoreValve ReValving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. Eurointervention 2008;4:242-9. 24. Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, et al., FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (French Aortic National CoreValve and Edwards) registry. Eur Heart J 2011;32:191-7. 25. Roten L, Wenaweser P, Delacretaz E, Hellige G, Stortecky S, Tanner H, et al. Incidence and predictors of atrioventricular conduction impairment after transcatheter aortic valve implantation. Am J Cardiol 2010;106: 1473-80.  Velianou JL, Manazzoni J, 26. Bagur R, Rodes-Cabau J, Gurvitch R, Dumont E, et al. Need for permanent pacemaker as a complication of transcatheter aortic valve implantation and surgical aortic valve replacement in elderly patients with severe aortic stenosis and similar baseline electrocardiographic findings. JACC Cardiovasc Interv 2012;5:540-51. 27. Almerıa Valera C, de Agustın Loeches A, Hernandez-Antolın RA, Garcıa Fernandez E, Perez de Isla L, Fernandez Perez C, et al. Atrioventricular conduction disturbances after CoreValve aortic prosthesis implantation. Predictive role of transesophageal echocardiography. Rev Esp Cardiol 2011; 64:1202-6. 28. Astarci P, Glineur D, Kefer J, D’Hoore W, Renkin J, Vanoverschelde JL, et al. Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: comparison of transfemoral and trans-apical approaches using Edwards Sapiens valve. Eur J Cardiothorac Surg 2011;40:475-9. 29. Eltchaninoff H, Durand E, Borz B, Furuta A, Bejar K, Canville A, et al. Balloon aortic valvuloplasty in the era of transcatheter aortic valve replacement: acute and long-term outcomes. Am Heart J 2014;167:235-40. 30. Nombela-Franco L, Webb JG, de Jaegere PP, Toggweiler S, Nuis RJ, Dager AE, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation 2012;126:3041-53. 31. Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, et al. Occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg 2012;143:832-43.