Transcatheter valve-in-valve therapy using six different devices in four anatomic positions – clinical outcomes and technical considerations

Conradi L, Silaschi M, Seiffert M, Lubos E, Blankenberg S, Reichenspurner H,

Schäfer U, Treede H

University Heart Center Hamburg

Disclosures

Proctorship:

- JenaValve Technology GmbH, Munich, Germany

- Medtronic, Inc., MA, USA

- Symetis SA, Ecublens, Switzerland

Consultancy:

- Edwards Lifesciences, Inc., CA, USA

Background

88% biological valvesin 2014!

Background

Development of aortic valve procedures University Heart Center Hamburg

Primary procedures Redo procedures

52.4%

47.6%51.6%

48.4%

TAVI procedures at UHC Hamburg

31/03/2015

Edwards Sapien (XT) 598TF 295TA 301TS/Ax 1TAo 1

V-i-V 31

Edwards Sapien 3 243TF 183TS/Ax 5TA 54TAo 1

V-i-V 7

Medtronic CoreValve 178TF 168TS/Ax 6TAo 4

V-i-V 28

JenaValve 160 TF 6TA 154 V-i-V 2

Symetis Acurate 161 TF 47TA 114

Medtronic Engager 86 TA 81TAo 5 V-i-V 2

Directflow Medical 18 TF 18

Boston Scientific Lotus 23 TF 23 V-i-V 3

SJM Portico 5 TF 5 V-i-V 3

Biotronik Biovalve 12 TF 12

n = 1484

ResultsBaseline demographics I

Baseline demographics All ViV(n=75)

Aortic(n=54)

Mitral(n=17)

Pulmonary(n=2)

Tricuspid(n=2)

Age (years) 74.1±12.9 77.9±8.0 69.6±14.5 37-60 28-44Male gender, n (%) 38 (50.7) 31 (57.4) 4 (23.5) 1 (50) 2 (100)BMI 26.2±4.8 26.6±4.3 24.9±6.8 24-26 25-26Logistic EuroSCORE I (%) 26.2±17.8 28.4±18.3 23.0±15.2 8-11 1-5STS Score (%) 8.8±7.4 8.7±7.7 10.7±8.2 1-2 1-2Diabetes mellitus, n (%) 10 (13.3) 7 (13.0) 3 (17.6) 0 0Peripheral vascular disease, n (%) 22 (29.3) 20 (37.0) 2 (11.8) 0 0Creatinine (mg/dl) 1.4±1.2 1.5±1.3 1.2±0.4 0.9-1.0 1.0-1.1Atrial fibrillation, n (%) 12 (16.0) 7 (12.9) 5 (29.4) 0 0Previous stroke / TIA, n (%) 15 (20.0) 7 (13.0) 8 (47.1) 0 0Left ventricular ejection fraction

- normal (>50%), n (%)- moderate reduction (30-50%), n (%)- severe reduction (<30%), n (%)

68 (90.7)

4 (5.3)3 (4.0)

47 (87.0)

4 (7.4)3 (5.6)

17 (100)

00

2 (100)

00

2 (100)

00

NYHA functional class, n (%)- I/II- III/IV

8 (10.7)

67 (89.3)

5 (9.3)

49 (90.7)

1 (5.9)

16 (94.1)

0

2 (100)

2 (100)

0

Baseline demographics All ViV(n=75)

Aortic(n=54)

Mitral(n=17)

Pulmonary(n=2)

Tricuspid(n=2)

> 1 previous valve replacement, n (%) 7 (9.3) 4 (7.4) 3 (17.6) 0 0

Interval to index procedure (years) 9.3±4.9 9.8±4.9 8.8±5.1 1-3 6-8

Type of previous valve, n (%)- stented- stentless- unknown

64 (85.3)10 (13.3)

1 (1.3)

45 (83.3)8 (14.8)1 (1.9)

17 (100)

00

0

2 (100)0

1 (50)1 (50)

0

Size of previous valve, n (%)- ≤21mm- 23mm- ≥25mm- Unknown

12 (16.0)27 (36.0)35 (46.7)

1 (1.3)

12 (22.2)27 (50.0)15 (27.8)

0

00

17 (100)0

00

2 (100.0)0

00

2 (100)0

Mode of deterioration, n (%)- stenosis- regurgitation- mixed

29 (38.7)28 (37.3)18 (24.0)

24 (44.4)19 (35.2)11 (20.4)

4 (23.5)8 (47.1)5 (29.4)

1 (50)

01 (50)

00

2 (100)

Valve gradient (mmHg) - 35.9±16.9 14.0±6.5 34-47 8-9

Valve regurgitation ≥ moderate, n (%) 43 (57.3) 26 (48.2) 14 (82.4) 1 (50.0) 2 (100)

ResultsBaseline demographics II

ResultsProcedural data I

Periprocedural results All ViV(n=75)

Aortic(n=54)

Mitral(n=17)

Pulmonary(n=2)

Tricuspid(n=2)

Procedure time (minutes) 104.3± 47.2 101.7±50.8 110.4±33.2 140-170 55-100

Flouroscopy time (minutes) 15.5±12.4 13.3±12.7 15.5±10.2 35-38 14-33

Contrast agent (ml) 119.6±89.6 114.1± 81.6 93.9±80.5 195-378 134-150

Access route- transapical, n (%)- transvascular, n (%)- direct aortic, n (%)

40 (53.3)33 (44.0)

2 (2.7)

23 (42.6)29 (53.7)

2 (3.7)

17 (100)

00

0

2 (100)0

0

2 (100)0

THV type, n (%) - all Sapien - Sapien (XT) - Sapien 3 - all CoreValve - CoreValve - CoreValveEvolut - St. Jude Portico - Boston Lotus - Medtronic Engager - JenaValve

39 (52.0)31 (41.3)8 (10.7)

26 (34.7)12 (16.0)14 (18.7)

3 (4.0)3 (4.0)2 (2.7)2 (2.7)

21 (38.9)16 (29.6)

3 (5.6)26 (48.1)12 (22.2)14 (25.9)

3 (5.6)-

2 (3.7)2 (3.7)

14 (82.4)12 (70.6)2 (11.8)

----

3 (17.6)--

2 (100)2 (100)

--------

2 (100)1 (50)1 (50)

-------

Case examplesTricuspid V-i-V

RV Angiography

Case examplesMitral V-i-V

Lotus 25 mm in Hancock 27 mm

30-day clinical outcomes All ViV(n=75)

Aortic(n=54)

Mitral(n=17)

Pulmonary(n=2)

Tricuspid(n=2)

Length of stay ICU (days) 2.2±1.7 2.2±1.8 2.3±1.6 1-3 1

Duration of hospital stay (days) 7.4±13.7 6.5±15.6 10.7±6.2 6 4-7

Immediate procedural mortality (<72h), n (%) 2 (2.7) 1 (1.9) 1 (5.9) 0 0

All-cause death, n (%) 6 (8.0) 3 (5.6) 3 (17.6) 0 0

Cardiovascular death, n (%) 6 (8.0) 3 (5.6) 3 (17.6) 0 0

Any stroke, n (%) 0 0 0 0 0

Myocardial infarction, n (%) 1 (1.3) 1 (1.9) 0 0 0

Major vascular complication, n (%) 4 (5.3) 1 (1.9) 3 (17.6) 0 0

Major/life-threatening bleeding, n (%) 6 (8.0) 3 (5.6) 3 (17.6) 0 0

Acute kidney injury type II/III, n (%) 3 (4.0) 0 3 (17.6) 0 0

Permanent pacemaker implantation, n (%) 8 (10.7) 6 (11.1) 2 (11.8) 0 0

Early Safety, n (%) 12 (16.0) 7 (13.0) 5 (29.4) 0 0

Clinical efficacy, n (%) 49 (65.3) 31 (57.4) 14 (82.4) 2 (100) 2 (100)

ResultsVARC-2 acute clinical outcome

ResultsValve regurgitation

Acute hemodynamic outcomes All ViV(n=75)

Aortic(n=54)

Mitral(n=17)

Pulmonary(n=2)

Tricuspid(n=2)

Valve area (cm²) - 1.5±1.4 2.4±0.9 n.a. n.a.

Peak gradient (mmHg) - 34.1±14.2 14.2±8.2 22-29 8-12

Mean gradient (mmHg) - 20.1±7.1 4.7±3.1 12-15 4-9

Paravalvular regurgitation no/trace, n (%) 51 (68.0) 33 (61.1) 14 (82.4) 2 (100) 2 (100)

Paravalvular regurgitation mild, n (%) 24 (33.8) 21 (38.9) 3 (17.6) 0 0

Paravalvular regurgitation moderate/severe, n (%) 0 0 0 0 0

ResultsAcute hemodynamic outcomes

Residual transvalvular gradientsAortic V-i-V

Resultant indexed EOAAortic V-i-V

ResultsKaplan-Meier Survival

Valve-in-valve therapyConclusions

ViV therapy well established for treatment of SVD in aortic and mitral positions

Technical feasibility demonstrated in tricuspid and pulmonary positions

Multiple types of THV available for aortic and mitral ViV

Excellent hemodynamic outcome regarding PVL

Concern: elevated transvalvular gradients after aortic ViV, especially in valves ≤ 23 mm

Open questions: - Suitability of respective THV types?

- Balloon-expandable or self-expanding?

- Patient selection: ViV vs. redo surgery

Increasing importance of ViV can be anticipated (more bioprostheses in younger patients)

Thank you for your attention!

Case examplesTricuspid V-i-V

THV deployment (Sapien3 26 mm in Shelhigh 31 mm)

Case examplesMitral V-i-V

Lotus 25 mm in Hancock 27 mm

Case examplesMitral V-i-V

Lotus 25 mm in Hancock 27 mm