Rapid Deployment Versus Conventional Bioprosthetic Valve Replacement for Aortic Stenosis

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

VOL. 71, NO. 13, 2018

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

Rapid Deployment Versus Conventional Bioprosthetic Valve Replacement for Aortic Stenosis Stephan Ensminger, MD, DPHIL,a Buntaro Fujita, MD,a Timm Bauer, MD,b Helge Möllmann, MD,c Andreas Beckmann, MD,d Raffi Bekeredjian, MD,e Sabine Bleiziffer, MD,f Sandra Landwehr, PHD,g Christian W. Hamm, MD,h Friedrich W. Mohr, MD,i Hugo A. Katus, MD,e Wolfgang Harringer, MD,j Thomas Walther, MD,k Christian Frerker, MD,l and the GARY Executive Board

ABSTRACT BACKGROUND Surgical aortic valve replacement using conventional biological valves (CBVs) is the standard of care for treatment of old patients with aortic valve disease. Recently, rapid deployment valves (RDVs) have been introduced. OBJECTIVES The purpose of this study was to report the nationwide German experience concerning RDVs for treatment of aortic valve stenosis and provide a head-to-head comparison with CBVs. METHODS A total of 22,062 patients who underwent isolated surgical aortic valve replacement using CBV or RDV between 2011 and 2015 were enrolled into the German Aortic Valve Registry. Baseline, procedural, and in-hospital outcome parameters were analyzed for CBVs and RDVs using 1:1 propensity score matching. Furthermore, 3 RDVs were compared with each other. RESULTS A total of 20,937 patients received a CBV, whereas 1,125 patients were treated with an RDV. Patients treated with an RDV presented with significantly reduced procedure (160 min [25th to 75th percentile: 135 to 195 min] vs. 150 min [25th to 75th percentile: 127 to 179 min]; p < 0.001), cardiopulmonary bypass (83 min [25th to 75th percentile: 68 to 104 min] vs. 70 min [25th to 75th percentile: 56 to 87 min]; p < 0.001), and aortic cross clamp times (60 min [25th to 75th percentile: 48 to 75 min] vs. 44 min [25th to 75th percentile: 35 to 57 min]; p < 0.001), but showed significantly elevated rates of pacemaker implantation (3.7% vs. 8.8%; p < 0.001) and disabling stroke (0.9% vs. 2.2%; p < 0.001), whereas in-hospital mortality was similar (1.7% vs. 2.2%; p ¼ 0.22). These findings persisted after 1:1 propensity score matching. Comparison of the 3 RDVs revealed statistically nonsignificant different pacemaker rates and significantly different post-operative transvalvular gradients. CONCLUSIONS In this large, all-comers database, the incidence of pacemaker implantation and disabling stroke was higher with RDVs, whereas no beneficial effect on in-hospital mortality was seen. The 3 RDVs presented different complication profiles with regard to pacemaker implantation and transvalvular gradients. (German Aortic Valve Registry [GARY]; NCT01165827) (J Am Coll Cardiol 2018;71:1417–28) © 2018 by the American College of Cardiology Foundation.

From the aDepartment of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany; bDepartment of Cardiology, University of Giessen, Giessen, Germany; cDepartment of Internal Medicine I, St.-Johannes-Hospital, Dortmund, Germany; e

d

German Society of Thoracic, Cardiac and Vascular Surgery, Berlin, Germany;

Department of Cardiology, University of Heidelberg, Heidelberg, Germany; fClinic for Cardiovascular Surgery, German Heart

Center Munich, Munich, Germany; gBQS Institute for Quality and Patient Safety, Düsseldorf, Germany; hDepartment of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany; iDepartment of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany;

j

Department of Thoracic and Cardiovascular Surgery, Klinikum Braunschweig,

Listen to this manuscript’s

Braunschweig, Germany; kDepartment of Cardiac Surgery, Kerchoff Heart and Thorax Center, Bad Nauheim, Germany; and the

audio summary by

l

JACC Editor-in-Chief

dation; the Dr. Rolf M. Schwiete Foundation; the German Society of Thoracic, Cardiac and Vascular Surgery; and the German Cardiac

Dr. Valentin Fuster.

Society. Dr. Ensminger has served as a proctor and consultant for Edwards Lifesciences; has served as a proctor and member of the

Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. Funding was obtained from the German Heart Foun-

scientific advisory board of JenaValve; and has received travel support from Medtronic. Dr. Bleiziffer has served as a proctor and consultant for Medtronic; and has served as a proctor for Boston Scientific, JenaValve, and Highlife. Dr. Hamm has served on the Advisory Board of Medtronic; and has served as an advisor for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Ensminger and Fujita contributed equally to this work and are joint first authors. Manuscript received November 7, 2017; revised manuscript received January 18, 2018, accepted January 22, 2018.

ISSN 0735-1097/$36.00

https://doi.org/10.1016/j.jacc.2018.01.065

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RDVs for Aortic Stenosis

ABBREVIATIONS AND ACRONYMS

S

urgical aortic valve replacement has

It has been proposed that these valve prostheses may

been the standard of care for invasive

be particularly beneficial in patients who are undergo-

treatment

aortic

ing combined cardiac surgery, which typically necessi-

valve disease for decades. Throughout the

tates prolonged aortic cross clamp (X-clamp) times. In

past 15 years, transcatheter aortic valve

the past, 3 RDVs have gained regulatory approval for

valve

replacement (TAVR) was established and is

commercial use: the self-expanding, nitinol-based 3F

CPB = cardiopulmonary bypass

now recognized as a treatment option in

Enable

patients who are at high and intermediate

balloon

surgical risk (1,2). During the same time

Lifesciences, Irvine, California), and the Perceval

period, so-called rapid deployment valves

sutureless valve (Sorin/LivaNova Group, Saluggia,

(RDVs) (also known as sutureless valves)

Italy). Although the self-expanding, nitinol-based

have been introduced (3). RDVs are made of biolog-

valve has been withdrawn from the market, the

ical tissue mounted on an atypical stent frame.

balloon-expandable and sutureless valves are increas-

CABG = coronary artery bypass grafting

CBV = conventional biological

RDV = rapid deployment valve TIA = transient ischemic attack X-clamp = cross clamp

of

patients

with

valve

(Medtronic,

expandable

Dublin,

INTUITY

Ireland),

valve

the

(Edwards

ingly being implanted. However, unlike TAVR, treat-

SEE PAGE 1429

ment with RDVs has so far not been extensively

These valve prostheses are implanted surgically (with

investigated in randomized trials. It is unclear at pre-

cardiopulmonary bypass [CPB] and cardioplegia) after

sent whether RDVs can clinically outperform conven-

resection of the calcified native aortic valve cusps.

tional biological valves (CBVs). In addition, specific

Valve implantation is performed without placing cir-

criteria for the definition of patient groups to be

cular annular sutures (4). RDVs are equipped with

treated with this kind of valve prosthesis have not

alternative anchoring mechanisms that enable faster

been elaborated.

implantation through minimally invasive incisions

GARY (German Aortic Valve Registry) is a prospec-

(i.e., ministernotomy or intercostal minithoracotomy).

tive, collaborative, multicenter all-comers registry

F I G U R E 1 Flowchart of Patient Selection

Isolated sAVR GARY 2011-2015

CBV n = 20,937

sAVR+CABG GARY 2011-2015

RDV n = 1,125

RDV n = 403

1:1 Propensity score match

1:1 Propensity score match age, gender, BMI, NYHA III/IV, CAD, s/p MI, s/p PCI, s/p cardiac surgery, occlusive disease, COPD, pulmonary hypertension, diabetes mellitus, creatinine >2 mmol/L, chronic dialysis, atrial fibrillation, s/p pacemaker/ICD implantation, LVEF, MR ≥2°, TR ≥2°, access

CBV n = 1,021

CBV n = 14,474

RDV n = 1,021

age, gender, BMI, NYHA III/IV, CAD, s/p MI, s/p PCI, s/p cardiac surgery, occlusive disease, COPD, pulmonary hypertension, diabetes mellitus, creatinine >2 mmol/L, chronic dialysis, atrial fibrillation, s/p pacemaker/ICD implantation, LVEF, MR ≥2°, TR ≥2°, number of grafts, number of central anastomoses, number of coronary anastomoses

CBV n = 354

RDV n = 354

Patients registered at GARY who underwent isolated sAVR or in combination with CABG were identified. Within the 2 procedure groups, outcomes were compared according to the implanted valve type. 1:1 propensity score matching was performed to account for differences in baseline characteristics. BMI ¼ body mass index; CABG ¼ coronary artery bypass graft; CAD ¼ coronary artery disease; CBV ¼ conventional biological valve; COPD ¼ chronic obstructive pulmonary disease; GARY ¼ German Aortic Valve Registry; ICD ¼ implantable cardioverter-defibrillator; LVEF ¼ left ventricular ejection fraction; MI ¼ myocardial infarction; MR ¼ mitral regurgitation; NYHA ¼ New York Heart Association; PCI ¼ percutaneous coronary intervention; RDV ¼ rapid deployment valve; sAVR ¼ surgical aortic valve replacement; s/p ¼ status post; TR ¼ tricuspid regurgitation.

Ensminger et al.

JACC VOL. 71, NO. 13, 2018 APRIL 3, 2018:1417–28

RDVs for Aortic Stenosis

T A B L E 1 Baseline Characteristics Before and After PS Matching for Patients Undergoing Isolated sAVR

Before PS Match CBV (n ¼ 20,937)

After PS Match

RDV (n ¼ 1,125)

p Value

CBV (n ¼ 1,021)

RDV (n ¼ 1,021)

p Value

Demographics Age, yrs

72 (66–77)

75 (71–78)

<0.001

75 (71–79)

75 (71–78)

0.56

Female

40.6 (8,508)

58.2 (655)

<0.001

58.6 (598)

58.9 (601)

0.89

BMI, kg/m2

28 (25–31)

28 (25–31)

0.55

28 (25–31)

28 (25–31)

0.71

NYHA functional class III or IV

61.1 (12,795)

60.6 (682)

0.74

61.7 (630)

61.1 (624)

0.79

Coronary artery disease

21.6 (4,520)

24.4 (275)

0.02

25.5 (260)

24.4 (249)

0.57

5.2 (1,093)

5.8 (65)

0.42

4.9 (50)

5.9 (60)

0.33

Previous PCI

9.0 (1,881)

11.2 (126)

0.01

10.9 (111)

10.8 (110)

0.94

Previous cardiac surgery

8.0 (1,664)

5.7 (64)

0.01

5.2 (53)

5.5 (56)

0.77

0.3 (69)

0.5 (5)

0.57

0.3 (3)

0.5 (5)

0.73

Previous MI

Previous BAV Occlusive disease

14.0 (2,927)

15.3 (172)

0.22

15.0 (153)

14.6 (149)

0.80

Central

6.1 (1,285)

7.3 (82)

0.12

7.4 (76)

7.3 (75)

0.93

Peripheral

4.5 (948)

5.7 (64)

0.07

6.4 (65)

5.2 (53)

0.26

COPD with medication

6.5 (1,363)

6.9 (78)

0.58

8 (82)

6.9 (70)

0.31

Pulmonary hypertension

5.2 (1,066)

5.0 (55)

0.77

4.7 (48)

4.8 (49)

0.92

Diabetes mellitus

8.3 (1,730)

9.2 (103)

0.29

7.4 (76)

9.2 (94)

0.15

Creatinine >2 mg/dl

1.8 (379)

1.3 (14)

0.16

1.4 (14)

1.4 (14)

1.00

Chronic dialysis

1.0 (201)

1.2 (13)

0.51

0

0

—

Atrial fibrillation

10.0 (2,094)

11.0 (124)

0.27

12.8 (131)

10.6 (108)

0.11

Pacemaker/ICD

4.6 (955)

3.5 (39)

0.09

3.4 (35)

3.6 (37)

0.81

Renal dysfunction

Echocardiography LVEF Poor, <30% Intermediate, 30%–50% Good, >50%

3.8 (794)

3.3 (379)

0.39

2.4 (24)

3.3 (34)

0.18

19.8 (4,151)

14.1 (159)

<0.001

16.1 (164)

14.2 (145)

0.24 0.60

76.4 (15,992)

82.6 (929)

<0.001

81.6 (833)

82.5 (842)

0.7 (0.6–0.9)

0.7 (0.6–0.8)

<0.001

0.7 (0.6–0.8)

0.7 (0.6–0.8)

0.65

MPG, mm Hg

47 (37–57)

47 (40–58)

0.01

47 (39–57)

47 (40–58)

0.40

MR $2

9.0 (1,803)

7.8 (85)

0.21

7.9 (85)

7.9 (85)

>0.99

TR $2

3.8 (751)

2.9 (31)

0.12

2.0 (22)

2.9 (31)

0.21

EOA, cm2

Risk scores STS PROM, %

2.0 (1.3–3.0)

2.3 (1.7–3.3)

<0.001

2.3 (1.6–3.4)

2.3 (1.7–3.3)

0.71

log EuroSCORE, %

5.8 (3.6–9.4)

6.6 (4.8–10.1)

<0.001

6.6 (4.6–10.3)

6.6 (4.8–10.0)

>0.99

EuroSCORE II, %

1.8 (1.2–3.3)

2.0 (1.4–3.2)

<0.001

2.0 (1.4–3.3)

2.0 (1.4–3.2)

0.78

Values are median (25th to 75th percentile) or % (n). BAV ¼ balloon valvuloplasty; BMI ¼ body mass index; CBV ¼ conventional biological valve; COPD ¼ chronic obstructive pulmonary disease; EOA ¼ effective orifice area; ICD ¼ implantable cardioverter-defibrillator; LVEF ¼ left ventricular ejection fraction; MI ¼ myocardial infarction; MPG ¼ mean pressure gradient; MR ¼ mitral regurgitation; NYHA ¼ New York Heart Association; PCI ¼ percutaneous coronary intervention; PS ¼ propensity score; RDV ¼ rapid deployment valve; sAVR ¼ surgical aortic valve replacement; STS PROM ¼ Society of Thoracic Surgeons Predicted Risk of Mortality; TR ¼ tricuspid regurgitation.

that was initiated to analyze contemporary outcomes

Consecutive patients of the participating institutions

after invasive treatment of aortic valve stenosis.

were enrolled if elective or urgent treatment (i.e.,

Herein, we report the initial nationwide German

balloon valvuloplasty, TAVR, aortic valve recon-

experience with the 3 previously mentioned RDVs for

struction, or aortic valve replacement) was planned

the treatment of patients with aortic valve stenosis

and

and

Detailed descriptions of GARY have been published

provide

a

head-to-head

comparison

with

conventional biological aortic valve prostheses.

METHODS

patients

gave

written

informed

consent.

previously (5–8). PATIENT SELECTION. For the present study, all

patients who underwent isolated surgical aortic GARY is a voluntary, prospective registry that was

valve replacement (sAVR) using a xenograft or in

initiated in 2010 to monitor contemporary outcomes

combination with coronary artery bypass grafting

after treatment of aortic valve stenosis in Germany.

(CABG) between 2011 and 2015 were identified

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RDVs for Aortic Stenosis

T A B L E 2 Procedural Characteristics Before and After PS Matching for Patients Undergoing Isolated sAVR

Before PS match CBV (n ¼ 20,937)

After PS match

RDV (n ¼ 1,125)

p Value

<0.001

CBV (n ¼ 1,021)

RDV (n ¼ 1,021)

p Value

0.93

Access Conventional sternotomy

77.6 (16,255)

41.7 (469)

Other

22.4 (4,682)

58.3 (656)

39.4 (402)

39.6 (404)

60.6 (619)

60.4 (617)

Operating times 160 (135–195)

150 (127–179)

<0.001

161 (138–195)

150 (126–177)

<0.001

CPB time, min

83 (68–104)

70 (56–87)

<0.001

85 (71–105)

69 (56–87)

<0.001

X-clamp time, min

60 (48–75)

44 (35–57)

<0.001

62 (50–76)

44 (34–56)

<0.001

Procedure time, min

CBV type Stented

95.6 (20,069)

96.6 (986)

Stentless

4.1 (868)

3.4 (35)

RDV type Self-expanding, nitinol-based valve

10.5 (118)

9.8 (100)

Balloon-expandable valve

27.9 (314)

27.2 (278)

Sutureless valve

61.6 (693)

63.0 (643)

Values are % (n) or median (25th to 75th percentile). CPB ¼ cardiopulmonary bypass; X-clamp ¼ cross clamp; other abbreviations as in Table 1.

(Figure 1). Patients who underwent additional pro-

and other rare procedures) were excluded. Baseline

cedures

characteristics,

(mitral,

tricuspid,

or

pulmonic

valve

procedural

data,

and

in-hospital

replacement, repair, or valvulotomy; replacement of

outcomes were compared for patients undergoing

the ascending aorta; atrial ablation for arrhythmia;

isolated sAVR and for combined surgery with CABG

F I G U R E 2 Procedure, Cardiopulmonary Bypass, and Aortic Cross Clamp Times for Patients Undergoing Isolated sAVR

350 p < 0.001

overall p < 0.001

300

250 overall p < 0.001 p < 0.001

overall p < 0.001

3f Enable

p < 0.001

200

CBV

Time (Minutes)

150

100

Procedure Time

Bypass Time

Perceval S

INTUITY

RDV

Perceval S

INTUITY

3f Enable

RDV

CBV

Perceval S

INTUITY

3f Enable

0

RDV

50

CBV

1420

Aortic Cross Clamp Time

Operating times were significantly shorter for RDV implantation. In addition, within the 3 investigated RDVs, the operating times differed significantly. Abbreviations as in Figure 1.

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RDVs for Aortic Stenosis

T A B L E 3 In-Hospital Outcomes Before and After PS Matching for Patients Undergoing Isolated sAVR

Before PS Match CBV (n ¼ 20,937)

RDV (n ¼ 1,125)

Mortality

1.7 (362)

New-onset AF New pacemaker

After PS Match

p Value

CBV (n ¼ 1,021)

RDV (n ¼ 1,021)

p Value

2.2 (25)

0.22

1.8 (18)

2.2 (22)

0.52

5.3 (992)

4.5 (44)

0.24

5.8 (51)

4.4 (39)

0.16

3.7 (733)

8.8 (96)

<0.001

4.1 (40)

9.1 (90)

<0.001 >0.99

New ICD

0.1 (27)

0.0 (0)

0.23

0.1 (1)

0.0 (0)

Laparotomy

0.3 (59)

0.1 (1)

0.18

0.1 (1)

0.1 (1)

1.00

Sepsis

1.1 (229)

1.7 (19)

0.07

0.8 (8)

1.7 (17)

0.07

Neurological TIA

0.7 (145)

1.0 (11)

0.27

0.7 (7)

0.9 (9)

0.62

Disabling stroke

0.9 (198)

2.2 (25)

<0.001

1.2 (12)

2.4 (24)

0.04

Myocardial infarction Bleeding $4 U

0.4 (89)

0.3 (3)

0.3

0.4 (4)

0.3 (3)

>0.99

17.1 (3,522)

15.0 (167)

0.07

19.4 (197)

14.5 (147)

0.004

2.4 (499)

2.2 (25)

0.71

2.5 (26)

2.2 (22)

0.56

0.2 (45)

0.1 (1)

0.31

0.1 (1)

0.1 (1)

1.00

0.3 (54)

0.4 (4)

0.34

0.3 (3)

0.4 (4)

>0.99

New-onset dialysis Temporary Chronic Access site infection ICU stay, days Hospital stay, days

2 (1–3)

2 (1–4)

<0.001

2 (1–3)

2 (1–4)

<0.001

10 (8–13)

10 (8–14)

<0.001

10 (8–13)

10 (8–14)

0.01

Discharge echocardiography 12 (9–16)

13 (9–16.5)

0.32

11 (9–15)

13 (10–17)

<0.001

MPG $15 mm Hg

34.2 (4,106)

36 (261)

0.31

27.9 (156)

37.7 (248)

<0.001

MPG $20 mm Hg

12.2 (1,464)

12.8 (93)

0.60

9.8 (55)

13.8 (91)

0.03

0

91.7 (14,888)

89.4 (909)

0.01

90.3 (717)

89.7 (823)

0.70

1

7.9 (1,290)

9.4 (96)

0.09

9.1 (71)

9.1 (83)

0.99

0.4 (62)

1.2 (12)

<0.001

0.6 (5)

1.2 (11)

0.32

MPG, mm Hg

Residual AR

$2

Values are % (n) or median (25th to 75th percentile). AF ¼ atrial fibrillation; AR ¼ aortic regurgitation; ICU ¼ intensive care unit; TIA ¼ transient ischemic attack; other abbreviations as in Table 1.

(sAVR þ CABG). In a second step, all RDVs were pooled and were subsequently analyzed according

F I G U R E 3 In-Hospital Outcomes for the 3 RDVs After Propensity Score Matching

to the implanted RDV type. overall p < 0.001

25 STATISTICAL ANALYSIS. Continuous variables are

21.1

expressed as median (25th to 75th percentile) due 20

to non-normal distribution (as assessed by the test)

and

were

compared

between independent groups using the nonparametric Mann-Whitney U test. Discrete variables are presented as relative and absolute frequencies. The chi-square or Fisher exact tests were applied to test for differences

Incidence (%)

Kolmogorov-Smirnov

15

13.7 11.8

10

8.9

8.1

between groups. Patients who underwent isolated sAVR and those who underwent sAVR þ CABG were

5 2.9

analyzed separately. In both procedure groups, patients who received a CBV were compared with those who received an RDV. To account for differences in baseline characteristics, 1:1 propensity score (PS) matching was performed (Online Appendix). To

2.9

3.5 2

1

0

1 0

Mortality

Disabling Stroke 3f Enable

1.7

0

0

New Pacemaker INTUITY

AR ≥2°

MPG ≥20

Perceval S

compare the performance of the 3 RDVs among each other, 1:1:1 PS matching was performed (Online

The 3 investigated RDVs differed significantly in terms of post-procedural gradients. AR ¼

Appendix). A 2-sided p value <0.05 was considered

aortic regurgitation; MPG ¼ mean pressure gradient; other abbreviation as in Figure 1.

statistically significant. All statistical analyses were

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RDVs for Aortic Stenosis

performed using IBM SPSS Statistics for Windows,

well balanced after PS matching (Table 1). The pro-

version 19.0 (IBM, Armonk, New York) and RStudio:

cedure time (161 min [25th to 75th percentile: 138 to 195

Integrated

min] vs. 150 min [25th to 75th percentile: 126 to 177

Development

(R.

RStudio,

Boston,

Massachusetts).

min]; p < 0.001), CPB time (85 min [25th to 75th percentile: 71 to 105 min] vs. 69 min [25th to 75th

RESULTS

percentile: 56 to 87 min]; p < 0.001), and X-clamp time (62 min [25th to 75th percentile: 50 to 76 min] vs.

STUDY POPULATION, PROCEDURAL, AND IN-HOSPITAL

44 min [25th to 75th percentile: 34 to 56 min]; p <

OUTCOME: ISOLATED sAVR. For the isolated sAVR

0.001) were significantly shorter for the RDV group in

group, 20,937 patients were identified who received a

the PS-matched cohorts (Table 2). Regarding in-

CBV, whereas 1,125 patients were treated with an RDV.

hospital

Baseline characteristics of these patients are summa-

elevated incidences of new pacemaker implantation

rized in Table 1. Patients treated with an RDV were

(4.1% vs. 9.1%; p < 0.001), disabling stroke (1.2% vs.

significantly older (CBV 72 years [25th to 75th percen-

2.4%; p ¼ 0.04), and elevated mean pressure gradient

outcomes,

we

observed

significantly

tile: 66 to 77 years] vs. RDV 75 years [25th to 75th

(MPG) $20 mm Hg (9.8% vs. 13.8%; p ¼ 0.03) for RDVs.

percentile: 71 to 78 years]; p < 0.001), were more often

However, this group presented with significantly

female (40.6% vs. 58.2%; p < 0.001), presented with a

lower rates of bleeding requiring transfusion of $4 red

higher prevalence of coronary artery disease (21.6% vs.

blood cell units (19.4% vs. 14.5%; p ¼ 0.004) (Table 3,

24.4%; p ¼ 0.02), and more often had a history of PCI

Central illustration).

(9% vs. 11.2%; p ¼ 0.01), but had less previous cardiac operations (8% vs. 5.7%; p ¼ 0.01). Furthermore, pa-

STUDY POPULATION, PROCEDURAL, AND IN-HOSPITAL

tients who received an RDV more often had an LVEF

OUTCOME: sAVR D CABG. Of all patients undergoing

>50% (76.4% vs. 82.6%; p < 0.001) and higher risk

sAVR þ CABG, a total of 14,474 patients received a

scores. Procedural data are presented in Table 2. RDVs

CBV and 403 patients an RDV. In unmatched anal-

were significantly more often implanted through ac-

ysis, the 2 groups differed significantly in terms of

cess sites other than conventional sternotomy (22.4%

age (74 years [25th to 75th percentile: 70 to 78 years]

vs. 58.3%; p < 0.001). Patients treated with an RDV

vs. 76 years [25th to 75th percentile: 72 to 80 years];

presented with significantly reduced procedure times

p < 0.001), female sex (27.7% vs. 39.2%; p < 0.001),

(160 min [25th to 75th percentile: 135 to 195 min] vs.

patients on chronic dialysis (1.3% vs. 2.7%; p ¼ 0.01),

150 min [25th to 75th percentile: 127 to 179 min]; p <

LVEF distribution (p < 0.05), and risk scores (Online

0.001), CPB times (83 min [25th to 75th percentile: 68 to

Table 5). Similar to patients who underwent isolated

104 min] vs. 70 min [25th to 75th percentile: 56

sAVR, the procedure time (223 min [25th to 75th

to 87 min]; p < 0.001) and aortic X-clamp times (60 min

percentile: 185 to 270 min] vs. 210 min [25th to 75th

[25th to 75th percentile: 48 to 75 min] vs. 44 min [25th

percentile: 177 to 261 min]; p ¼ 0.002), CPB time

to 75th percentile: 35 to 57 min]; p < 0.001). In 61.9% of

(116 min [25th to 75th percentile: 94 to 144 min] vs.

RDV patients, the sutureless valve was implanted,

103 min [25th to 75th percentile: 80 to 131 min]; p <

whereas 27.9% received the balloon-expandable valve

0.001), and aortic X-clamp time (83 min [25th to 75th

and 10.5% the self-expanding, nitinol-based pros-

percentile: 67 to 103 min] vs. 70 min [25th to 75th

thesis. When comparing the 3 RDVs, we observed a

percentile: 52 to 92 min]; p < 0.001) were signifi-

significant decrease of procedure, CPB, and X-clamp

cantly lower with RDVs compared with CBVs (Online

times in the following order: self-expanding, nitinol-

Figure 5, Online Table 6). Patients treated with an

based valve; the balloon-expandable valve; and the

RDV showed significantly elevated rates of new

sutureless valve (Figure 2). In-hospital outcomes are

pacemaker implantation (3.2% vs. 9.5%; p < 0.001) as

shown in Table 3 and Figure 3. In-hospital mortality was

well as increased duration of intensive care unit stay

similar with both prosthesis types (1.7% vs. 2.2%;

(2 days [25th to 75th percentile: 1 to 5 days] vs. 3 days

p ¼ 0.22). Patients treated with an RDV presented with

[25th to 75th percentile: 1 to 6 days]; p ¼ 0.001) and

significantly elevated rates of new pacemaker im-

hospital stay (11 days [25th to 75th percentile: 8 to

plantation (3.7% vs. 8.8%; p < 0.001), disabling stroke

14 days] vs. 12 days [25th to 75th percentile: 9 to

(0.9% vs. 2.2%; p < 0.001), and residual aortic

17 days]; p < 0.001) (Online Table 7).

regurgitation $2  (0.4% vs. 1.2%; p < 0.001), whereas

After PS matching, 354 pairs were found for each

the need for transfusion of $4 red blood cell units

valve prosthesis type in patients undergoing sAVR þ

tended to be lower with RDVs (17.1% vs. 15%; p ¼ 0.07).

CABG. Baseline characteristics were well balanced in

After PS matching, 1,021 pairs treated with CBVs and

the PS-matched cohorts (Online Table 5). Patients

RDVs were identified. Baseline characteristics were

treated with RDVs presented with decreased CPB

Ensminger et al.

JACC VOL. 71, NO. 13, 2018 APRIL 3, 2018:1417–28

RDVs for Aortic Stenosis

C ENTR AL I LL U STRA T I O N In-Hospital Outcomes After Isolated sAVR With CBVs and RDVs

Before Propensity Score Match 20 18

Incidence (%)

16 *

14

12.2 12.8

12 8.8

10 8

*

*

6 4 2 0

3.7 1.7

2.2

2.2 0.9

Mortality

0.4

Disabling Stroke

New Pacemaker

1.2

AR ≥2°

MPG ≥20

After Propensity Score Match 20

*

18 16 *

Incidence (%)

14

13.8

12 9.8

9.1

10 *

8 6

4.1 4 2 0

1.8

2.4

2.2

Mortality

1.2 Disabling Stroke

0.6 New Pacemaker CBV

1.2

AR ≥2°

MPG ≥20

RDV

Ensminger, S. et al. J Am Coll Cardiol. 2018;71(13):1417–28.

After propensity score matching, patients who underwent isolated sAVR with RDVs presented with significantly elevated rates of disabling stroke, new pacemaker implantation, and increased transvalvular gradients compared with CBVs. *p < 0.05. AR ¼ aortic regurgitation; CBV ¼ conventional biological valve; MPG ¼ mean pressure gradient; RDV ¼ rapid deployment valve; sAVR ¼ surgical aortic valve replacement.

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RDVs for Aortic Stenosis

nitinol-based prosthesis was used in 162, the balloon-

T A B L E 4 Comparison of the 3 RDVs Before PS Matching

Self-Expanding, Nitinol-Based Valve (n ¼ 162)

Balloon-Expandable Valve (n ¼ 466)

expandable valve in 466, and the sutureless valve in Sutureless Valve (n ¼ 900)

900 patients (Table 4). In all 3 RDV groups, the treated p Value

patients presented with a similar BMI (p > 0.99), effective orifice area (p ¼ 0.07), and MPG (p ¼ 0.07).

Baseline characteristics BMI

28 (25–31)

28 (25–31)

28 (25–31)

>0.99

The fraction of patients with reduced LVEF <30%

EOA

0.7 (0.6–0.8)

0.8 (0.6–0.9)

0.7 (0.6–0.8)

0.07

differed nonsignificantly between groups (p ¼ 0.21),

MPG

47 (36–60)

45 (36–54)

46 (39–57)

0.07

whereas the Society of Thoracic Surgeons Predicted

LVEF poor

4.9 (8)

3.6 (17)

2.6 (23)

0.21

STS PROM

2.4 (1.5–3.9)

2.5 (1.8–3.6)

2.7 (2–4)

0.01

Isolated sAVR

72.8 (118)

67.4 (314)

77.0 (693)

sAVR þ CABG

27.2 (44)

32.6 (152)

23.0 (207)

Conv. sternotomy

61.0 (72)

45.9 (144)

36.5 (253)

Other

39.0 (46)

54.1 (170)

63.5 (440)

5.8 (9)

4.9 (23)

—

Procedural characteristics

presented the lowest and the sutureless valve group

Procedure 0.001

the highest STS PROM score (3F Enable 2.4% [25th to 75th percentile: 1.5% to 3.9%] vs. INTUITY 2.5% [25th to 75th percentile: 1.8% to 3.6%] vs. Perceval S 2.7%

Access (only isolated sAVR) <0.001

[25th to 75th percentile: 2% to 4%]; p ¼ 0.01). All 3 RDVs were more often implanted as isolated sAVR

RDV sizes 19

Risk of Mortality (STS PROM) score differed significantly: the self-expanding, nitinol-based valve group

<0.001

than in combination with CABG, and this distribution differed significantly among the RDV types (Table 4).

21

21.3 (33)

20.2 (94)

10.1 (83)

23

31.6 (49)

36.8 (171)

34.4 (282)

The self-expanding, nitinol-based valve was pre-

25

31.6 (49)

28.2 (131)

38.9 (319)

dominantly implanted through conventional ster-

27

8.4 (13)

9.9 (46)

16.5 (135)

notomy, whereas the sutureless valve was more often

29

1.3 (2)

—

—

Median (IQR)

23 (21–25)

23 (21–25)

25 (23–25)

<0.001

sutureless valve was more frequently used in larger

Mean  SD

23.4  2.2

23.4  2.1

24.2  1.8

<0.001

sizes than the other valves (p < 0.01) (Table 4).

implanted through alternative access sites. The

Operating times 178 (145–230)

175 (147–215)

152.5 (127–187)

<0.001

CPB time

90 (71–117)

85 (69–110)

69 (56–90)

<0.001

X–clamp time

56 (44–76)

56 (45–74)

44 (34–60)

<0.001

Procedure time

PS matching led to 3 cohorts of 102 patients each. Baseline characteristics were well balanced in the PS-matched cohorts, including effective orifice area, STS PROM score, procedure (i.e., isolated sAVR

In–hospital outcomes Mortality

3.7 (6)

2.6 (12)

2.8 (25)

0.75

or sAVR þ CABG), surgical access site, and the size of

New-onset AF

1.4 (2)

5.7 (23)

4.6 (36)

0.12

the implanted RDV (Table 5). Patients treated with the

New pacemaker

6.5 (10)

6.6 (30)

10.7 (93)

0.02

0.0 (0)

0.0 (0)

0.0 (0)

—

sutureless prosthesis presented with the shortest

New ICD Laparotomy

0.0 (0)

0.2 (1)

0.2 (2)

0.84

Sepsis

2.5 (4)

2.6 (12)

2.0 (18)

0.77

TIA

1.2 (2)

1.1 (5)

0.9 (8)

0.89

154.5 min [25th to 75th percentile: 130 to 197 min];

Disabling stroke

1.9 (3)

1.5 (7)

2.2 (20)

0.66

p ¼ 0.009), CPB time (86 min [25th to 75th percentile:

Neurological

Continued on the next page

procedure time (3f Enable 177 min [25th to 75th percentile: 145 to 234 min] vs. INTUITY 172 min [25th to 75th percentile: 141 to 209 min] vs. Perceval S

68 to 119 min] vs. 81 min [25th to 75th percentile: 64 to 103 min] vs. 74 min [25th to 75th percentile: 58 to

times (110 min [25th to 75th percentile: 89 to 140 min]

97 min]; p ¼ 0.003), and aortic X-clamp time (54 min

vs. 103 min [25th to 75th percentile: 80 to 131 min];

[25th to 75th percentile: 42 to 76 min] vs. 50 min [25th

p < 0.001) and aortic X-clamp times (79 min [25th to 75th percentile: 64 to 100 min] vs. 70 min [25th to 75th percentile: 52 to 91 min]; p < 0.001) (Online Table 6). The RDV group presented with significantly elevated rates of new pacemaker implantation (3.8% vs. 9.4%; p ¼ 0.003), and had longer intensive

to 75th percentile: 41 to 69 min] vs. 47 min [25th to 75th percentile: 36 to 64 min]; p ¼ 0.03) (Table 5). New pacemaker implantation rates were 11.8% vs. 8.1% vs. 13.7%, respectively (p ¼ 0.44). Within the RDV group, Perceval S treatment showed a significantly higher fraction of patients with a post-

care unit stay (2 days [25th to 75th percentile: 2 to

operative MPG of >20 mm Hg compared with the 3f

5 days] vs. 3 days [25th to 75th percentile: 2 to 6 days];

Enable and INTUITY (8.9% vs. 1.7% vs. 21.1%,

p ¼ 0.01) and hospital stay (10 days [25th to 75th

respectively; p < 0.001) (Table 5, Figure 3).

percentile: 8 to 14 days] vs. 12 days [25th to 75th percentile: 9 to 17 days]; p ¼ 0.02) (Online Table 7, Online Figure 6).

DISCUSSION

INDIVIDUAL PERFORMANCE OF THE 3 RDVs. Among

In this study, we investigated the early outcome of

all patients who received an RDV, the self-expanding,

patients treated with RDVs compared with CBVs for

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RDVs for Aortic Stenosis

treatment of aortic stenosis in an all-comers popula-

T A B L E 4 Continued

tion from GARY between 2011 and 2015. Due to dif-

Self-Expanding, Nitinol-Based Valve (n ¼ 162)

Balloon-Expandable Valve (n ¼ 466)

Sutureless Valve (n ¼ 900)

p Value

1.2 (2)

0.9 (4)

0.2 (2)

0.13

Temporary

2.5 (4)

2.9 (13)

2.8 (25)

0.97

Chronic

0.6 (1)

0.4 (2)

0.1 (1)

0.35

0.6 (1)

1.1 (5)

0.1 (1)

0.04

ferences in baseline characteristics, additional 1:1 PS matching was used for further adjusted comparison. The main findings can be summarized as follows: 1) implantation of RDVs was associated with significantly reduced procedure, CPB, and aortic X-clamp

Myocardial infarction New-onset dialysis

times; 2) patients treated with an RDV presented with

Access site infection

significantly elevated rates of new-onset pacemaker

ICU stay

implantation and disabling stroke, whereas the need

Median (IQR)

2 (1–4)

2 (1–4)

2 (1–4)

0.44

for blood transfusions was lower; and 3) there were

Mean  SD

45

47

46

0.66

differences in post-operative MPGs for the 3 analyzed

Hospital stay 11 (8–13)

10 (8–14)

11 (9–15)

12  6

13  10

13  8

Median (IQR)

RDVs (Central Illustration). Substantial experience with RDVs has been gained over the past decade, and outcomes with the 3 RDVs

Mean  SD

0.001 0.2

Discharge echocardiography MPG

are well documented in controlled, prospective,

Median (IQR)

10 (7.5–13)

9 (7–12)

14 (10–18)

<0.001

single-arm trials (9–14). These studies collectively

Mean  SD

10.8  5.3

9.8  4.7

14.6  7

<0.001

demonstrate that treatment with RDVs can effec-

MPG $15

20.0 (16)

14.4 (38)

44.5 (279)

<0.001

tively improve hemodynamics and relieve symptoms

MPG $20

10.0 (8)

3.4 (9)

15.3 (96)

<0.001

in patients with symptomatic and severe aortic ste-

Residual AR 0

88.5 (115)

96.8 (423)

88.2 (716)

<0.001

1

7.7 (10)

3.0 (13)

11.0 (89)

<0.001

$2

3.8 (5)

0.2 (1)

0.9 (7)

nosis with an acceptable safety profile (15). However, so far there was no compelling evidence comparing the performance of RDVs with CBVs. To fill this knowledge gap, data of the all-comers GARY registry were analyzed. The shorter observed procedural

Values are % (n) unless otherwise indicated. CABG ¼ coronary artery bypass graft; IQR ¼ interquartile range; other abbreviations as in Tables 1 and 3.

times are in line with previously published studies (9–14). Interestingly, the most commonly implanted RDV had the shortest operating times, indicating that

Our observation that RDV implantation is associ-

a reduction of these times may be related to operator

ated with an increased risk of stroke compared with

experience. In addition, RDVs were significantly

CBVs requires attention. The reason for this finding is

more often implanted via minimally invasive ap-

unclear, but some aspects of RDV implantation may

proaches compared with CBVs. Both of these findings

explain this. First, the 3 RDVs are characterized by

are also stated by an expert panel as the main ratio-

unique stent frame and leaflet designs. There is

nale to recommend RDVs for a variety of patient

limited experience regarding their potential influence

groups, including redo cases or delicate aortic wall

on thrombus formation, and hence, risk for stroke.

conditions (16). However, data of this GARY analysis

Notably, a recent publication has highlighted the high

demonstrate that a significant reduction of operating

rate of subclinical leaflet thrombosis after the

times as well as the utilization of minimally invasive

sutureless valve implantation. Second, it has been

approaches may not translate into a beneficial effect

recommended to not entirely decalcify the aortic

on in-hospital mortality. Moreover, neurological

annulus for RDV implantation to prevent inadequate

events were even elevated in patients undergoing

decalcification, which may lead to an uneven surface

RDV implantation. Whether these observations are

that, in turn, can lead to paravalvular leakage (PVL).

also true for specific subgroups remains to be inves-

This is in contrast to CBV implantation, where the

tigated. At this stage, however, it seems unlikely that

annulus is usually completely decalcified. It is

RDVs

possible that remaining (or partly mobilized) calcium

are

mentioned

safer

than

CBVs

subpopulations.

in

the

previously

Specifically,

in

redo

0.001

deposits break off after RDV implantation and lead to

cases, full sternotomy is usually indispensable, and

stroke. Third, no specific recommendations exist

the possibility of minimally invasive approaches

regarding anticoagulation regimen after RDV im-

seems limited. For delicate aortic wall conditions,

plantation. However, it is also possible that patients

such as a severely calcified aortic root, the risk for

receiving RDVs were more closely monitored, and the

stroke is already elevated; until additional evidence

increased rate of stroke is the result of reporting bias.

and adequately designed trials are available, such

CBVs are characterized by a very long track record

recommendations for potential advantages of RDV

of reliability, durability, and consistently low post-

need to be interpreted with caution.

operative permanent pacemaker and PVL rates. As

Ensminger et al.

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RDVs for Aortic Stenosis

was also implanted in larger sizes. As a consequence,

T A B L E 5 Comparison of the 3 RDVs After PS Matching

oversizing may have been one possible explanation.

Self-Expanding, Nitinol-Based Valve (n ¼ 102)

Balloon-Expandable Valve (n ¼ 102)

Sutureless Valve (n ¼ 102)

p Value

BMI

28 (25–30)

27 (25–31)

27 (24–31)

0.56

steel (INTUITY). Therefore, the results of this analysis

EOA

0.7 (0.6–0.8)

0.7 (0.6–0.9)

0.7 (0.6–0.8)

0.79

are in line with experience from TAVR, where self-

MPG

48 (36–60)

44 (34–57)

43 (39–53)

0.45

expanding nitinol-based valves (CoreValve family)

LVEF poor

6.9 (7)

3.9 (4)

2.9 (3)

0.38

STS PROM

2.6 (1.7–4)

2.7 (1.9–3.6)

2.9 (2–4)

0.3

tend

Isolated sAVR

71.6 (73)

71.6 (73)

68.6 (70)

0.87

sAVR þ CABG

28.4 (29)

28.4 (29)

31.4 (32)

Conv. sternotomy

66.7 (68)

69.6 (71)

66.7 (68)

Other

33.3 (34)

30.4 (31)

33.3 (34)

177 (145–234)

172 (141–209)

154.5 (130–197)

CPB time

86 (68–119)

81 (64–103)

74 (58–97)

0.003

X-clamp time

54 (42–76)

50 (41–69)

47 (36–64)

0.03

lower pacemaker rates (20,21).

1

cedure, CPB, and aortic X-clamp times, RDVs seem

In our view, another relevant factor is the stent ma-

Procedural characteristics

to

have

higher

pacemaker

rates

than

balloon-expanding valves made of stainless steel/ cobalt-chromium stents (Edwards SAPIEN family).

Procedure

Furthermore, we believe that the design of RDVs is an additional contributing factor, as all 3 valves are equipped with a subvalvular “portion” that may

Access 0.87

represent an additional risk to injure conduction pathways. This hypothesis is also in line with the

Operating times Procedure time

terial of the RDV, which is self-expanding nitinol (Perceval, 3f Enable) or balloon-expandable stainless

Baseline characteristics

0.009

TAVR experience, where a higher implantation position of the THV was associated with significantly As a consequence of significantly reduced pro-

RDV sizes 19 21

25.5 (26)

24.5 (25)

24.5 (25)

to be particularly suitable for patients requiring

23

36.3 (37)

39.2 (40)

37.3 (38)

concomitant surgery, for example, for coronary ar-

25

29.4 (30)

28.4 (29)

20.4 (30)

tery disease as also stated by the expert panel (16).

27

8.8 (9)

7.8 (8)

8.8 (9)

Median (IQR)

23.4  1.9

23.4  1.8

23.5  1.8

0.97

Mean  SD

23 (21–25)

23 (23–25)

23 (23–25)

0.98

Interestingly, the current GARY analysis could not

29

Continued on the next page

detect any beneficial effects on in-hospital outcomes in patients undergoing combined sAVR þ CABG who were treated with an RDV compared with a CBV, despite significantly decreased procedure times. For this patient cohort, CBV þ CABG is

RDVs have only been on the market for a limited time,

currently the standard of care, and future studies

long-term durability data are not available, and a

(most preferably randomized controlled trials) must

comparison with CBVs seems difficult as a conse-

investigate if the use of RDVs in complex proced-

quence of the specific and unique design of RDVs.

ures will translate into a substantial clinical benefit

Interestingly, PVL rates were similarly low in both

for the patient.

groups, but significantly elevated rates of pacemaker

As stated earlier, the 3 RDVs differ considerably in

implantation were observed with all 3 types of RDVs.

their design, which may be accompanied by different

This aspect needs attention as it represents a critical

complication profiles. The sutureless valve showed

point, for example, when a decision is to be made

significantly elevated post-operative transvalvular

between sAVR and TAVR for an active intermediate-

gradientsindependent

risk patient, as the low pacemaker rate after CBV

sizescompared with the self-expanding, nitinol-

still represents a strong argument in favor of sAVR.

based and balloon-expandable valves, which may be

However, the average pacemaker rate reported for

related to its design. This finding is in contrast to past

RDVs in our study was approximately 9%, and was

studies (including the Perceval S CE mark study and

therefore closer to TAVR than sAVR with CBVs

several other single-arm trials with the sutureless

(17–19). The majority of patients currently undergoing

valve), where pressure gradients were markedly

sAVR are at intermediate to low surgical risk, with

lower than seen in the current analysis (10,22,23).

accordingly low expected complication rates. An

This discrepancy may be related to the well-known

additional risk for pacemaker implantation in such

issue that controlled trials often do not reflect real-

patients therefore requires justification. Several fac-

world clinical practice. However, at this early stage,

tors may have contributed to the observed increased

this finding seems of concern; additional evidence

pacemaker rates after RDV implantation. In this

from future studies that also analyze patients outside

analysis, the sutureless valve was associated with the

of controlled trials will be needed to determine if the

highest pacemaker rates (in unmatched analysis) and

increased gradients seen in patients treated with the

of

the

implanted

valve

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RDVs for Aortic Stenosis

sutureless valve have an effect on long-term out-

T A B L E 5 Continued

comes (e.g., durability, survival). Although the rea-

Self-Expanding, Nitinol-Based Valve (n ¼ 102)

sons for this finding could not be elaborated in this analysis, a recent publication by Dalen et al. (24) showed that 28% of the sutureless valve recipients

Balloon-Expandable Valve (n ¼ 102)

Sutureless Valve (n ¼ 102)

p Value

0.17

In-hospital outcomes Mortality

2.9 (3)

1.0 (1)

0.0 (0)

New-onset AF

9.0 (9)

3.3 (3)

8.8 (9)

0.22

New pacemaker

11.8 (12)

8.1 (8)

13.7 (14)

0.44

from transvalvular gradients, the incidence of pace-

Laparotomy

0.0 (0)

0.0 (0)

1.0 (1)

0.37

maker implantation ranged between 8.1% (INTUITY)

Sepsis

2.9 (3)

1.0 (1)

1.0 (1)

0.44

and 13.7% (Perceval S) on a significantly higher level

Neurological

at a single center presented with reduced leaflet motion, which may explain these findings. Apart

compared with CBVs. This is somewhat surprising, as

TIA

1.0 (1)

0.0 (0)

2.0 (2)

0.36

the controlled decalcification and omission of suture

Disabling stroke

2.9 (3)

2.0 (2)

0.0 (0)

0.24

Myocardial infarction

2.0 (2)

0.0 (0)

0.0 (0)

0.13

placement may in general reduce the risk for conduction disturbances. However, the material and design of each RDV is different, and the TAVR expe-

New-onset dialysis Temporary

2.9 (3)

2.0 (2)

1.0 (1)

0.60

Chronic

1.0 (1)

0.0 (0)

0.0 (0)

0.37

0.0 (0)

0.0 (0)

0.0 (0)

—

rience has shown that self-expanding valves tend to

Access site infection

have higher permanent pacemaker rates (25,26).

ICU stay

Although the exact mechanism remains elusive at

Median (IQR)

2 (1–4)

2 (1–3)

2 (1–4)

0.76

present, our data clearly demonstrate an increased

Mean  SD

45

34

47

0.37

risk for conduction disturbances with RDVs; this

Hospital stay 10 (8–13)

9 (8–12)

11 (9–14)

0.01

11  6

11  7

13  8

0.16

finding will have to be taken into consideration for appropriate patient selection. Finally, there was no statistically significant difference in PVL rates be-

Median (IQR) Mean  SD Discharge echocardiography MPG

tween the 3 RDVs. Therefore, at this stage, CBVs

Median (IQR)

10 (7.5–13)

10 (7–12)

13 (11–18.5)

<0.001

seem to be the safer option for the broad majority of

Mean  SD

10.5  4.9

10  4.3

14.7  5.7

<0.001

patients who are in need of sAVR. However, we

MPG $15

17.9 (10)

20.7 (12)

43.4 (33)

0.001

cannot rule out that specific subgroups who will

MPG $20

8.9 (5)

1.7 (1)

21.1 (16)

0.002

0

91.8 (78)

97.9 (92)

83.3 (80)

0.002

1

4.7 (4)

2.1 (2)

15.6 (15)

0.001

$2

3.5 (3)

0.0 (0)

1.0 (1)

benefit from RDVs may exist. This open question should be addressed in future studies to generate solid data that allow for clear recommendations for

Residual AR

the use of RDVs. STUDY LIMITATIONS. First, institutional participa-

Values are % (n) unless otherwise indicated. Abbreviations as in Tables 1 to 4.

tion in GARY is voluntary. However, almost all institutions in Germany participate, and therefore allow the registry to generate real-world data. Second,

ADDRESS

patients treated with RDVs may include patients that

Ensminger, Department of Thoracic and Cardiovascular

were also included in controlled trials.

Surgery, Heart and Diabetes Center NRW, Ruhr-University

FOR

CORRESPONDENCE:

Dr. Stephan

Bochum, Georgstrasse 11, 32545 Bad Oeynhausen,

CONCLUSIONS

Germany. E-mail: [email protected].

Shorter operating times with RDV implantation did

PERSPECTIVES

not translate into improved in-hospital outcomes in >36,000 patients treated with CBVs and RDVs alone or in combination with CABG. The pacemaker rate was increased in all RDVs, and we observed differences in post-operative MPGs between individual RDVs. However, specific subgroups that could benefit from RDV implantation may exist. Future trials should attempt to answer these open questions and identify such patient groups. ACKNOWLEDGMENT The

authors

SKILLS: In patients with aortic stenosis undergoing surgical bioprosthetic valve replacement, conventional biological prostheses were associated with better short-term clinical outcomes than rapid deployment valves prostheses. TRANSLATIONAL OUTLOOK: Randomized trials are needed to confirm these findings and identify specific subgroups of

express

their

sincere gratitude to Ms. Elke Schäfer for project management.

COMPETENCY IN PATIENT CARE AND PROCEDURAL

patients who gain more benefit from one type of bioprosthesis or the other.

0.13

1428

Ensminger et al.

JACC VOL. 71, NO. 13, 2018 APRIL 3, 2018:1417–28

RDVs for Aortic Stenosis

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KEY WORDS biological aortic valve prosthesis, German Aortic Valve RegistrY, rapid deployment heart valve, surgical aortic valve replacement, sutureless valve

A PPE NDI X For an expanded Methods section as well as supplemental tables and figures, please see the online version of this paper.