The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement

JACC: CARDIOVASCULAR INTERVENTIONS

VOL. 11, NO. 22, 2018

ª 2018 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER

The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement Matched Comparison of the Evolut PRO and Evolut R Katharina Hellhammer, MD,a Kerstin Piayda, MD,a Shazia Afzal, MD,a Laura Kleinebrecht, MD,a Matthias Makosch, BA,a Inga Hennig, BA,a Christine Quast, MD,a Christian Jung, MD, PHD,a Amin Polzin, MD,a Ralf Westenfeld, MD,a Malte Kelm, MD,a,b Tobias Zeus, MD,a Verena Veulemans, MDa

ABSTRACT OBJECTIVES The aim of this study was to investigate the hemodynamic and clinical performance of the Evolut PRO compared with its direct predecessor, the Evolut R. BACKGROUND Recently, the newest commercially available generation of the self-expandable Medtronic CoreValve prosthesis, the CoreValve Evolut PRO, was introduced to the market. This prosthesis is based on the previous Evolut R model and specifically designed to mitigate paravalvular leakage. Because of the design changes, the Evolut PRO needs a larger sheath size (16-F vs. 14-F). METHODS Patients receiving either the Evolut R (n ¼ 148) or the Evolut PRO (n ¼ 74) from September 2015 to January 2018 were compared in a 2:1 fashion after propensity score matching. Baseline characteristics, cardiovascular imaging, and pre- and periprocedural outcomes were prospectively collected and assessed. RESULTS Both cohorts represent a high-risk, real-world collective with increased perioperative mortality risk (logistic European System for Cardiac Operative Risk Evaluation score, Evolut R vs. Evolut PRO: 24.7  13.7% vs. 25.1  12.5%; p ¼ 0.881). Procedural success was 100%, and the mean transvalvular pressure gradient was substantially reduced (Evolut R vs. Evolut PRO: 7.9  3.9 mm Hg vs. 7.5  3.5 mm Hg; p ¼ 0.348). Mild paravalvular leakage was observed in 16.2% of Evolut R patients and in 14.9% of Evolut PRO patients (p ¼ 0.794). In the Evolut R group, moderate aortic regurgitation was documented in 2 patients (Evolut R vs. Evolut PRO: 1.4% vs. 0%; p ¼ 1.000). No differences regarding clinical parameters, such as major bleeding events (Evolut R vs. Evolut PRO: 1.4% vs.1.3%; p ¼ 0.868) and vascular complications were observed. CONCLUSIONS Both prostheses show excellent hemodynamic performance with a low incidence of paravalvular leakage and comparable clinical outcomes. (J Am Coll Cardiol Intv 2018;11:2314–22) © 2018 by the American College of Cardiology Foundation.

S

ince the introduction of transcatheter aortic

Medtronic CoreValve (MCV) (Medtronic, Minneapolis,

valve replacement (TAVR) in 2002, extensive

Minnesota) system is 1 of the major players world-

research has been conducted on new devices

wide (1–3). The MCV shows excellent short- and

and techniques to increase their efficacy and improve

long-term

patients’ outcomes. Since 2003 the self-expanding

flow velocities due to its supra-annular design.

hemodynamic

performance

with

low

From the aUniversity Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany; and the bCardiovascular Research Institute Düsseldorf, Düsseldorf, Germany. Drs. Veulemans, Westenfeld, and Zeus have received consulting fees, travel expenses, or study honoraria from Medtronic and Edwards Lifesciences outside of this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Hellhammer and Piayda contributed equally to this work. Manuscript received May 21, 2018; revised manuscript received June 28, 2018, accepted July 17, 2018.

ISSN 1936-8798/$36.00

https://doi.org/10.1016/j.jcin.2018.07.023

Hellhammer et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 11, NO. 22, 2018 NOVEMBER 26, 2018:2314–22

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Medtronic CoreValve Evolut R Versus Evolut PRO in TAVR

A conforming frame achieves annular sealing to pro-

approved by the local ethics committee, per-

ABBREVIATIONS

hibit paravalvular leakage (PVL). The latter remains

formed in accordance with the Declaration of

AND ACRONYMS

a major concern with a significant impact on short-

Helsinki and registered at ClinicalTrials.gov

and long-term outcomes and increased mortality

(NCT01805739).

(4,5). Therefore, new-generation valve models have

Prospective

data

acquisition

included

AR = aortic regurgitation CT = computed tomography logEuroSCORE = logistic

been designed to address this issue. In August 2017,

baseline

Medtronic introduced its newest valve generation,

procedural imaging data from transthoracic

the Evolut PRO (Figure 1), which is based on the Evo-

echocardiography and cardiac CT, procedural

lut R platform and features an outer porcine pericar-

and post-interventional in-hospital data, and

dial wrap at the lower 2 rows of the stent frame

30-day follow-up. Cardiac CT was performed

with the objective to decrease PVL. The ability to

as native and contrast-enhanced multislice

recapture and resheath the prosthesis is maintained.

CT, and images were transferred to a dedi-

VARC-2 = Valve Academic

Currently available sizes are 23, 26, and 29 mm.

cated workstation for evaluation (3mensio

Research Consortium-2

Compared with the previous valve generation, a

Structural Heart, Pie Medical Imaging, Maas-

larger introducer sheath (Evolut R vs. Evolut PRO:

tricht, the Netherlands). We assessed the device

14-F vs. 16-F) is needed, and a minimum vessel diam-

landing zone calcification score, which is a semi-

eter of 5.5 mm (Evolut R: 5 mm) is required.

demographic

information,

pre-

PVL = paravalvular leakage TAVR = transcatheter aortic valve replacement

quantitative method to grade the severity of calcifi-

ranging from 1 to 4 by visual assessment (6).

compared with its direct precursor, the Evolut R, with specific focus on residual aortic regurgitation (AR) due to PVL, as well as safety and efficacy outcomes

F I G U R E 1 Evolut PRO

after TAVR. Because both valves are commercially available but sold at different prices, the pivotal question is whether the Evolut PRO reaches its announced target in a real-world setting. To allow meaningful comparability of the cohorts, we matched in accordance with logistic European System for Cardiac Operative Risk Evaluation (logEuroSCORE) score and selected computed tomography (CT)– derived anatomic aortic valve characteristics.

METHODS In a single-center observational study, we identified 361 eligible patients who underwent transfemoral TAVR with the MCV system from September 2015 to January 2018. We excluded 19 patients to match valve size (Evolut R 34 mm [n ¼ 11] and Evolut R 23 mm [n ¼ 8] for valve-in-valve procedures). Subsequently, we performed propensity score matching in a 2:1 parameters:

MCV = Medtronic CoreValve

cusps) and the left ventricular outflow tract on a scale

In this study, for the first time, the Evolut PRO was

(matching

Operative Risk Evaluation

cation load of the aortic valve (annular and valvular

SEE PAGE 2323

fashion

European System for Cardiac

logEuroSCORE,

perimeter-derived annular diameter, cover index, and device landing zone calcification score). A modified Consolidated Standards of Reporting Trials flow diagram (Figure 2) provides an overview of the patient selection process and study aims. Patients were discussed by our interdisciplinary heart team and considered eligible for TAVR because of severe symptomatic aortic stenosis and high surgical risk

The Evolut PRO features a supra-annular valve design, a self-

or contraindication to conventional heart surgery.

expanding conforming frame with an external wrap to increase

All patients provided written informed consent

surface contact and a porcine pericardial tissue.

for data acquisition and analysis. The study was

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Medtronic CoreValve Evolut R Versus Evolut PRO in TAVR

F I G U R E 2 Modified Consolidated Standards of Reporting Trials Flow Diagram

DLZCS ¼ device landing zone calcification score; logEuroSCORE ¼ logistic European System for Cardiac Operative Risk Evaluation; MCV ¼ Medtronic CoreValve; TAVR ¼ transcatheter aortic valve replacement; ViV ¼ valve-in-valve.

Study endpoints were defined in accordance with

parameters, such as device landing zone calcification

Valve Academic Research Consortium-2 (VARC-2)

score, cover index, and perimeter-derived annular

definitions (7). All patients underwent transthoracic

size to reach comparability with regard to mortality

echocardiography before discharge, and residual AR

and PVL between both groups. After matching,

was determined using the following algorithm: we

continuous variables are expressed as the mean  SD

visually screened for a jet toward the left ventricular

and were compared using the Student’s t-test or

outflow tract and measured the circumferential

Mann-Whitney U test depending on the variable dis-

extent of the jet in the short-axis view (<10%, mild

tribution. Categorical variables were compared using

PVL; 10% to 29%, moderate PVL; >30%, severe PVL

a chi-square test or the Fisher exact test. A

[VARC-2 criteria]) (7).

p value <0.05 was considered to indicate statistical

Statistical analysis was performed using SPSS (IBM,

significance.

Armonk, New York). The propensity score was developed using bilinear logistic regression, and pa-

RESULTS

tients in either group were matched in a 2:1 fashion if they had related probability scores (nearest neigh-

BASELINE

borhood method). Included variables for the match-

score matching, we compared 148 patients who

CHARACTERISTICS. After

ing were logEuroSCORE and selected CT-derived

received the Evolut R prosthesis with 74 patients who

propensity

Hellhammer et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 11, NO. 22, 2018 NOVEMBER 26, 2018:2314–22

were treated with the Evolut PRO. Baseline characteristics did not differ except for atrial fibrillation

T A B L E 1 Baseline Characteristics and Echocardiographic Assessment

(Evolut R vs. Evolut PRO: 33.1 vs. 50%; p ¼ 0.015) and

Evolut R (n ¼ 148)

Evolut PRO (n ¼ 74)

p Value

81.2  5.6

81.4  4.5

0.821

BMI (kg/m )

26.9  5.8

26.2  4.43

0.362

LogEuroSCORE (%)

24.7  13.7

24.9  12.5

0.881

Female

110 (74.3)

50 (67.5)

0.290

Diabetes mellitus

36 (24.3)

15 (20.2)

0.498

CHD Previous CABG

105 (70.9) 9 (6.1)

53 (71.6) 8 (10.8)

0.834 0.212

COPD

49 (33.1)

14 (18.9)

0.028

Atrial fibrillation

49 (33.1)

37 (50)

0.015

Arterial hypertension

132 (89.1)

65 (87.8)

0.764

PAD

24 (16.2)

7 (9.5)

0.171

43.4  14.6

41.7  13.5

0.456

4 (2.7)

5 (6.7)

0.149

Previous pacemaker

16 (10.8)

9 (12.1)

0.764

Hemoglobin (mg/dl)

12.2  1.6

12.3  1.5

0.682

chronic obstructive pulmonary disease (33.1% vs. 18.9%; p ¼ 0.028). Further baseline information is displayed in Table 1. Echocardiographic assessment of valve function showed an aortic valve area of 0.6  2

2

0.2 cm in the Evolut R group and 0.8  0.2 cm in the Evolut PRO group (p < 0.001). At baseline, the mean transvalvular pressure gradient was increased (Evolut R vs. Evolut PRO: 42  14.7 mm Hg vs. 38.6  15.7 mm Hg; p ¼ 0.870). Further baseline transthoracic echocardiographic data are shown in Table 1. Cardiac CT analysis demonstrated equal calcification load distribution, perimeter-derived annular diameter, and cover index in both groups after matching (Table 2, Figures 3A and 3B). Moreover, annular eccentricity index was comparable (Evolut R vs. Evolut PRO: 18.9  6.5 vs. 20.1  6.5; p ¼ 0.203).

Age (yrs) 2

PAsys (mm Hg) Dialysis

GFR (ml/min/1.72 m2)

55.7  20.6

54.7  19.5

0.706

3,332.5  6,725.4

3,948.8  7,586.5

0.538

42.0  14.7 65.7  27.0 0.62  0.20

38.6  15.7 61.2  23.6 0.79  0.18

AR None/trace Mild Moderate Severe

68 (45.9) 54 (36.5) 25 (16.9) 1 (0.67)

23 (31.1) 39 (52.7) 12 (16.2) 0 (0)

0.038 0.020 0.898 1.000

Left ventricular function Normal Moderate Severe

138 (93.4) 4 (2.7) 6 (4.1)

67 (78.4) 5 (18.9) 2 (2.7)

0.475 0.148 0.610

PROCEDURAL CHARACTERISTICS. The mean pro-

NT-proBNP (ng/l)

cedure duration (Evolut R vs. Evolut PRO: 105.5  31.2

Echocardiographic assessment dPmean (mm Hg) dPmax (mm Hg) Aortic valve area (cm2)

min vs. 83.4  25.9 min; p < 0.001), fluoroscopy time (Evolut R vs. Evolut PRO: 21.4  8.8 min vs. 17.4  6.5 min; p < 0.001), and contrast agent administered (Evolut R vs. Evolut PRO: 125.9  41.1 ml vs. 101.7  32.5 ml; p < 0.001) were significantly lower in the Evolut PRO cohort. Pre-dilatation was performed more often in the Evolut R group (Evolut R vs. Evolut PRO: 77.7% vs. 28.3%; p < 0.001), whereas postdilatation

was

more

frequent

in

the

Evolut

PRO group (Evolut R vs. Evolut PRO: 4.1% vs. 18.9%; p < 0.001). Procedural success was achieved in all cases. Mean implantation depth did not differ between groups (Evolut R vs. Evolut PRO: 5.8  2.7 mm vs. 5.2  2.9 mm; p ¼ 0.115). Unplanned secondary namic results were necessary in only 3 patients of the Evolut R group because of malpositioning deep in the left ventricular outflow tract with subsequent severe AR (Evolut R vs. Evolut PRO: 2% vs. 0%; p ¼ 0.218).

AR ¼ aortic regurgitation; BMI ¼ body mass index; CABG ¼ coronary artery bypass grafting; CHD ¼ coronary heart disease; COPD ¼ chronic obstructive pulmonary disease; dPmax ¼ maximum transvalvular pressure gradient; dPmean ¼ mean transvalvular pressure gradient; GFR ¼ glomerular filtration rate; NT-proBNP ¼ N-terminal pro– brain natriuretic peptide; PAD ¼ peripheral artery disease; PAsys ¼ pulmonary artery pressure (systolic).

transthoracic echocardiographic values and supplemental procedural data are listed in Table 3. COMPLICATIONS. New permanent pacemaker im-

HEMODYNAMIC PERFORMANCE. The post-procedural

plantation was necessary in 13.5% of patients (Evolut

AR index (8) was similar in both groups (Evolut R

R vs. Evolut PRO: 10.8% vs. 18.6%; p ¼ 0.096). Clinical

vs. Evolut PRO: 23.8  8.1 vs. 24.6  7.6; p ¼ 0.602).

outcomes according to the VARC-2 criteria were

Every patient underwent transthoracic echocardiog-

similar in both groups. We did not observe differ-

raphy before discharge, and the mean transvalvular

ences regarding major bleeding events (Evolut R vs.

pressure gradient was significantly reduced in both

Evolut PRO: 1.4% vs. 1.3%; p ¼ 0.868) or vascular

groups after valve implantation (Evolut R vs. Evolut

complications (both groups 0%, p ¼ 1.000). Disabling

PRO: 7.9  3.9 mm Hg vs. 7.5  3.5 mm Hg; p ¼ 0.348)

stroke occurred in 1.4% (Evolut R vs. Evolut PRO:

(Figure 3C). Mild PVL was observed in 14% (Evolut R

1.4% vs. 0.7%; p ¼ 1.000), and acute kidney injury

vs. Evolut PRO: 16.2% vs. 14.9%; p ¼ 0.794), and 2

stage 3 or new onset of renal replacement therapy was

patients (1.4%) in the Evolut R group presented with

observed in 2 patients (Evolut R vs. Evolut PRO: 0%

moderate PVL, whereas no severe AR was detected in

vs. 2.6%; p ¼ 0.209). Thirty-day mortality was 1.4%.

the

Two patients died because of septicemia and multiple

cohort

(Figure

3D).

Pre-discharge

0.178 0.235 <0.001

Values are mean  SD or n (%).

valve-in-valve implantations with good hemody-

study

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Medtronic CoreValve Evolut R Versus Evolut PRO in TAVR

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Medtronic CoreValve Evolut R Versus Evolut PRO in TAVR

organ failure 7 and 8 days after the initial procedure. T A B L E 2 Computed Tomography–Derived Data Device Landing

Zone Calcification Score

Demers catheter infection in the other patient. One Evolut R (n ¼ 148)

Device landing zone calcification score Grade 1 Grade 2 Grade 3 Grade 4

Source of infection was pneumonia in 1 patient and a

Evolut PRO (n ¼ 74)

p Value

patient presented with sudden cardiac arrest and ventricular fibrillation, probably because of late coronary obstruction, 5 days after valve implantation.

18 (12.2) 44 (29.7) 58 (39.2) 28 (18.9)

13 (17.6) 17 (23.0) 26 (35.1) 18 (24.3)

0.273 0.287 0.557 0.349

Perimeter-derived annulus diameter (mm)

73  6.2

73  5.4

0.987

Annular area (mm2)

422.9  70.3

415.1  62.2

0.416

Mean annular diameter (mm)

23  1.9

23.0  1.8

0.948

During

Cover index

16.3  5.2

16.1  4.5

0.723

advancement of new-generation TAVR devices has

Annular eccentricity index

18.9  6.5

20.1  6.5

0.203

focused on improving hemodynamic performance by

The relatives declined autopsy, so the etiology could not be fully clarified. Further outcome characteristics are displayed in Table 3.

DISCUSSION

Values are n (%) or mean  SD. The device landing zone calcification score is a semiquantitative method to assess the severity of calcification load of the aortic valve (annulus and valvular cusps) and the left ventricular outflow tract on a scale ranging from 1 to 4 by visual assessment: grade 1, mild calcification; grade 2, moderate calcification; grade 3, heavy calcification (often associated with commissural fusion); grade 4, massive calcification (i.e., large calcification clumps outreaching the annular level).

the

past

several

years,

technological

maintaining a large effective orifice area as well as minimizing AR due to PVL. The newest generation CoreValve system, the Evolut PRO, features an outer pericardial wrap at the annular fixation zone to mitigate PVL. In this study, we compared the Evolut PRO with its direct predecessor (Evolut R), especially

F I G U R E 3 Selected Computed Tomography–Derived Data and Hemodynamic Outcomes After Transcatheter Aortic Valve Replacement Divided by Groups

(A) Selected computed tomography (CT)–derived data show high consistency between both groups. Values are displayed as mean with 95% confidence interval (CI) and were determined using multivariate analysis of variance. (B) Device landing zone calcification was equally distributed between groups after matching. (C) Mean pressure gradient reduction after valve implantation was sufficient in both groups (Evolut R vs. Evolut PRO: 7.9  3.9 mm Hg vs. 7.5  3.5 mm Hg; p ¼ 0.348). (D) Echocardiographic assessment of valve function after implantation revealed in the majority of cases no aortic regurgitation (AR) (Evolut R vs. Evolut PRO: 82.4% vs. 85.1%; p ¼ 0.610) and mild AR in 15.8% of patients (Evolut R vs. Evolut PRO: 16.2% vs. 14.9%; p ¼ 0.794). Two patients (1.4%) of the Evolut R group presented with moderate PVL, whereas no severe AR was detected in both groups. DLZCS ¼ device landing zone calcification score; TAVR ¼ transcatheter aortic valve replacement.

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Medtronic CoreValve Evolut R Versus Evolut PRO in TAVR

focusing on hemodynamic performance and clinical outcomes according to the VARC-2 criteria. The co-

T A B L E 3 Clinical and Hemodynamic Outcomes According to Valve Academic Research

Consortium-2 Criteria

horts were matched according to logEuroSCORE and anatomic aortic valve stenosis parameters. The major findings of our study are as follows: 1) both prostheses provide sophisticated technology with excellent hemodynamic performance; 2) the occurrence and degree of PVL after TAVR were similar

Procedure duration (min) Fluoroscopy time (min) Contrast agent administration (ml)

Evolut R (n ¼ 148)

Evolut PRO (n ¼ 74)

p Value

105.5  31.2

83.4  25.9

<0.001

21.4  8.8

17.4  6.5

<0.001

125.9  41.4

101.7  32.5

<0.001

Mean implantation depth (mm)

5.8  2.7

5.2  2.9

0.115

ARI post-implantation

23.8  8.1

24.4  7.6

0.602

Prosthesis size (mm) 26 29

70 (47.3) 78 (52.7)

38 (51.4) 36 (48.6)

0.568 0.568

HEMODYNAMIC PERFORMANCE. The primary goal of

Pre-dilatation

115 (77.7)

21 (28.3)

<0.001

TAVR is to achieve the maximum orifice area with a

Post-dilatation

6 (4.1)

14 (18.9)

<0.001

minimum flow velocity. The supra-annular design of

Valve-in-valve because of secondary AR

3 (2.0)

0 (0)

0.218

the Evolut PRO valve remained unchanged compared

Cardiopulmonary resuscitation

1 (0)

0 (0)

0.479

with the Evolut R and offers equally excellent he-

Conversion to heart surgery

0 (0)

0 (0)

1.000

modynamic results.

Intubation

2 (1.4)

0 (0)

0.315

in both groups; and 3) no differences between the 2 prostheses

could

be

observed

regarding

major

vascular and bleeding complications (Figure 4).

Moderate to severe PVL after TAVR is associated

Mechanical circulatory support

0 (0)

0 (0)

1.000

with increased mortality and a poor prognosis

Coronary obstruction during TAVR

0 (0)

0 (0)

1.000

(4,9,10). Therefore, this subject is a major focus of

Acute kidney injury

and technological challenge for new-generation valve

Myocardial infarction

models. The overall incidence of PVL has been

Bleeding Life threatening Major Minor

described in various studies as reaching up to 80% and is classified mostly as mild (11–13), whereas moderate to severe PVL is reported in approximately 7.4% (14) to 15% (15) of all cases. In this study, we observed mild PVL in 14.9% of Evolut PRO and 16.2% of Evolut R patients. In comparison, the Medtronic TAVR 2.0 US Clinical Study reported higher numbers of mild PVL after TAVR (27.6%) with the Evolut PRO valve (16). Likewise, the FORWARD study detected 30.9% of mild PVL after TAVR with the Evolut R prosthesis (17). The lower incidence of PVL in our study cohort might be attributed to long-standing experience with the MCV system at our center. Additionally, the FORWARD study was conducted as a multinational, multicenter observational study with varying expertise due to different volumes and familiarity with self-expanding valves. The consistency of a single institution with a well-trained implanting team can potentially remove hidden variability. All generations of the CoreValve family have been implanted over the years by an identical team of experienced cardiologists and a consistent team of

0 (0)

2 (2.6)

0.209

1 (0.68)

0 (0)

0.479

8 (5.1) 0 (0) 2 (1.4) 6 (4.1)

5 (6.6) 1 (1.3) 1 (1.3) 3 (4)

0.686 0.333 0.868 1.000

21 (14.2) 0 (0) 14 (9.5) 7 (4.7)

12 (16.2) 0 (0) 7 (9.4) 5 (6.6)

0.689 1.000 1.000 0.529

2 (1.4)

1 (1.4)

1.000

3 (2)

1 (1.3)

0.721

New onset conduction disorder

30 (20.3)

18 (24.3)

0.489

New pacemaker implantation

16 (10.8)

14 (18.6)

0.096

2 (1.4)

1 (1.4)

1.000

Echocardiographic assessment dPmean (mm Hg) dPmax (mm Hg) Maximum velocity (m/s)

7.9  3.9 14.3  6.6 1.8  0.4

7.5  3.5 13.6  7.2 1.7  0.4

0.348 0.459 0.461

AR None/trace Mild Moderate Severe

122 (82.4) 24 (16.2) 2 (1.4) 0 (0)

63 (85.1) 11 (14.9) 0 (0) 0 (0)

0.610 0.794 1.000 1.000

Vascular complications Major Minor PCD failure Disabling stroke Sepsis

30-day mortality

Values are mean  SD or n (%). New pacemaker implantations were calculated only in patients without preexisting pacemakers. ARI ¼ aortic regurgitation index; PCD ¼ percutaneous closure device; TAVR ¼ transcatheter aortic valve replacement; other abbreviations as in Table 1.

specialty-trained TAVR nurses. The procedure itself is highly standardized and strictly follows standard

the severity and occurrence of PVL. In this study, pre-

operating procedures. Because we began implanting

interventional CT was mandatory. Looking at the

the Evolut PRO as soon it was offered on the market, a

computed tomographic data, we carefully matched

learning curve cannot be neglected in total but should

both

have had a minor influence.

hemodynamic performance, especially accounting for

Besides

technical

handling,

the

cohorts

to

gain

comparability

concerning

pre-existing

PVL risk factors. As previously described, the calcifi-

anatomic conditions have considerable impact on

cation load of the device landing zone (6,18) plays a

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NOVEMBER 26, 2018:2314–22

F I G U R E 4 Central Figure - Matched Comparison of the CoreValve Evolut Pro and CoreValve Evolut R in Patients Undergoing Transfemoral TAVR

The newest available generation of the self-expandable Medtronic CoreValve prosthesis, the CoreValve Evolut Pro, is specifically designed to mitigate paravalvular leakage (top left; adapted from Sinning et al. [15]) while retaining a large orifice area and other benefits, such as the possibility to reposition and recapture the valve. For the first time the Evolut PRO was compared with its predecessor (Evolut R) using a matched 1:2 design. Computed tomography (CT)–derived data were part of the matching algorithm and therefore did not differ between groups. Both valves showed a sufficient mean pressure gradient reduction after transcatheter aortic valve replacement (TAVR) (Evolut R vs. Evolut PRO: 7.9  3.9 mm Hg vs. 7.5  3.5 mm Hg; p ¼ 0.348). Aortic regurgitation after implantation was equally distributed and in the majority of cases graded as nonexistent (Evolut R vs. Evolut PRO: 82.4% vs. 85.1%; p ¼ 0.610). CI ¼ confidence interval.

F I G U R E 5 Vascular and Bleeding Complications According to Valve Academic Research Consortium-2 Criteria, Divided by Groups

Vascular and bleeding complications in accordance with Valve Academic Research Consortium-2 criteria were low and did not differ between the groups. PCD ¼ percutaneous closure device.

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JACC: CARDIOVASCULAR INTERVENTIONS VOL. 11, NO. 22, 2018 NOVEMBER 26, 2018:2314–22

Medtronic CoreValve Evolut R Versus Evolut PRO in TAVR

key role in this context. Therefore, patients were

experience with femoral access, the difference be-

matched for device landing zone calcification score,

tween 14-F and 16-F sheaths does not seem to have an

perimeter-derived annular diameter, and cover in-

impact on access-site or vascular complications (23)

dex. After implantation, both groups showed almost

but may limit valve deployment of the Evolut PRO

equal hemodynamic performance (Figure 3D). At this

in individual cases with complex peripheral anatomy.

time, our data do not support the hemodynamic

In our study population, we could not observe any

advantage and propagated superiority of the external

significant differences in terms of major bleeding or

pericardial wrap of Evolut PRO to mitigate PVL after

vascular complications between the groups (Figure 5).

TAVR compared with its predecessor, the Evolut R. This fact may also be based on the high-quality standard of the Evolut R platform, which has provided good results for years, the best practice–based pre-procedural computed tomographic sizing, and the implantation strategies that pay special attention to PVL reduction at many European TAVR centers (13,19). PROCEDURAL

CHARACTERISTICS. Pre-dilatation

STUDY LIMITATIONS. Our study was only a single-

center investigation; thus, the results must be considered carefully. Currently, there is a lack of large randomized, controlled trials with longer study durations to accurately evaluate the hemodynamic parameters and clinical outcomes of the Evolut PRO prosthesis.

CONCLUSIONS

was observed significantly more often in the Evolut R group, which may be responsible for significantly

The MCV Evolut PRO shows excellent hemodynamic

longer procedure duration, fluoroscopy time, and

performance and is noninferior to its precursor, the

increased contrast agent administration. With each

MCV Evolut R. The incidence and degree of PVL is low

pre-dilatation,

but similar in both groups, and the periprocedural

contrast

agent

was

administered

simultaneously to observe calcific cusp mobilization,

outcomes are comparable.

AR, and coronary flow.

ACKNOWLEDGMENT The

COMPLICATIONS. New onset of conduction disor-

Scharlau for her commitment to patient care.

authors

thank

Jenni

ders requiring permanent pacemaker implantation after TAVR with new-generation self-expandable de-

ADDRESS

vices is reported to range from 14.7% to 26.7%.

Afzal, Division of Cardiology, Pulmonology and

Overall, the incidence remains controversial with

Vascular Medicine, University Hospital Düsseldorf,

large

Moorenstraße 5, 40225 Düsseldorf, Germany. E-mail:

variations,

and

further

investigations

are

needed (20). Augmented annular calcification may be

FOR

CORRESPONDENCE:

Dr.

Shazia

[email protected].

responsible for a higher permanent pacemaker implantation rate, as the incidence of conduction disorders is increased if higher calcification levels at

PERSPECTIVES

device landing zone are present (21,22). In our analysis, the overall new pacemaker implantation rate

WHAT IS KNOWN? The newest available generation of the

was low and comparable between groups (Evolut R

self-expanding MCV prosthesis, the Evolut PRO, is specifically

vs. Evolut PRO: 10.8% vs. 18.6%; p ¼ 0.096). Device

designed to mitigate PVL while retaining a large orifice area and

landing zone calcification can be excluded as a risk

other benefits, such as the possibility to reposition and recapture

factor, because it was an essential matching param-

the valve.

eter in this study. In addition to the external pericardial wrap, the Evolut PRO requires a larger sheath size than the Evolut R (Evolut R vs. Evolut PRO: 14 F vs. 16 F). Since the introduction of TAVR, when initial sheath sizes up to 24 F were needed, manufacturers have been able to reduce sheath size continuously. Downsizing has improved procedural capability and reduced vascular complications. The larger sheath size of the Evolut PRO may therefore be a step backward because of the potential for increased access-site bleeding or vascular complications. However, the key area of discussion shifted recently: because of extensive

WHAT IS NEW? We performed a real-world propensity score– matched analysis of the Evolut PRO compared with its direct predecessor, the Evolut RTM. Both valves showed equally high performance regarding hemodynamic and clinical outcome parameters, with no significant difference between groups. WHAT IS NEXT? Larger multicenter trials are needed to confirm our findings. The post-market, prospective interventional Forward PRO study (NCT03417011) will be conducted as a single-arm, multicenter trial with 600 patients and is in preparation.

2321

2322

Hellhammer et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 11, NO. 22, 2018 NOVEMBER 26, 2018:2314–22

Medtronic CoreValve Evolut R Versus Evolut PRO in TAVR

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KEY WORDS aortic regurgitation, CoreValve Evolut PRO, CoreValve Evolut R, paravalvular leakage, TAVR