Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://cr.elmerpub.com

Original Article

Volume 17, Number 6, December 2026, pages 606-615

Outcomes After Transcatheter Aortic Valve Implantation Using the Self-Expanding Allegra Valve in Daily Practice

↓ Figure 2. Postinterventional regurgitation after Allegra transcatheter aortic valve implantation in patients with native aortic stenosis (AS) or degenerated aortic bioprosthesis as valve-in-valve (ViV) procedure.

↓ Figure 3. Mean and maximal (max) transvalvular pressure gradients pre-, post-, and after 30 days of Allegra transcatheter aortic valve implantation (TAVI) in patients with native aortic stenosis (AS, n = 109) or degenerated aortic bioprosthesis as valve-in-valve (ViV, n = 24) TAVI. * P < 0.01 versus pre-Allegra TAVI, each.

↓ Figure 4. Kaplan–Meier survival rates for patients with native aortic stenose (AS) or degenerated aortic bioprosthesis (valve-in-valve (ViV)).

↓ **Table 1.** Clinical Characteristics of All Patients (N = 142) at Baseline
Data are presented as median, interquartile range, frequency, and percentage. AV: atrioventricular; CABG: coronary artery bypass grafting; COPD: chronic obstructive pulmonary disease; ECG: electrocardiogram; ES: EuroSCORE; GFR: glomerular filtration rate; ICD: implantable cardioverter defibrillator; LVEF: left ventricular ejection fraction; LVEDV: left ventricular end-diastolic volume; MI: myocardial infarction; NT-proBNP: N-terminal pro-brain natriuretic peptide; NYHA: New York Heart Association; PAP: pulmonary artery pressure; PCI: percutaneous coronary intervention; TIA: transient ischemic attack; TEE: transesophageal echocardiography; TTE: transthoracic echocardiography.
Age (years)	82 (80–85)
Female/male (n)	92/50
Body mass index (kg/m²)	27 (24–31)
NYHA classification ≥ III (n)	77 (54.2%)
Coronary artery disease (n)	96 (67.6%)
Prior MI (n)	15 (10.6%)
Prior PCI (n)	36 (25.4%)
Prior CABG (n)	20 (14.1%)
COPD (n)	15 (10.6%)
Extracardiac arteriopathy (n)	34 (23.9%)
Previous stroke/TIA (n)	15 (10.6%)
ECG
Sinus rhythm (n)	91 (64.1%)
AV block (n)	25 (17.6%)
Bundle branch block (n)	35 (24.6%)
Atrial fibrillation (n)	64 (45.1%)
Pacemaker/ICD (n)	22 (15.5%)
TTE/TEE
LVEF (%)	57 (50–63)
LVEDV (mL)	86 (68–109)
Mitral regurgitation ≥ II (n)	35 (24.6%)
Tricuspid regurgitation ≥ II (n)	22 (15.5%)
Systolic PAP (mm Hg)	38 (31–46)
Creatinine (mg/dL)	1.0 (0.7–1.2)
GFR (mL/min)	63 (46–80)
NT-proBNP (ng/L)	1,713 (659–5,212)
Logistic ES I (%)	17.4 (12.1–26.7)
Logistic ES II (%)	4.0 (2.6–7.3)

↓ Table 1. Clinical Characteristics of All Patients (N = 142) at Baseline

Data are presented as median, interquartile range, frequency, and percentage. AV: atrioventricular; CABG: coronary artery bypass grafting; COPD: chronic obstructive pulmonary disease; ECG: electrocardiogram; ES: EuroSCORE; GFR: glomerular filtration rate; ICD: implantable cardioverter defibrillator; LVEF: left ventricular ejection fraction; LVEDV: left ventricular end-diastolic volume; MI: myocardial infarction; NT-proBNP: N-terminal pro-brain natriuretic peptide; NYHA: New York Heart Association; PAP: pulmonary artery pressure; PCI: percutaneous coronary intervention; TIA: transient ischemic attack; TEE: transesophageal echocardiography; TTE: transthoracic echocardiography.

Age (years)

82 (80–85)

Female/male (n)

92/50

Body mass index (kg/m²)

27 (24–31)

NYHA classification ≥ III (n)

77 (54.2%)

Coronary artery disease (n)

96 (67.6%)

Prior MI (n)

15 (10.6%)

Prior PCI (n)

36 (25.4%)

Prior CABG (n)

20 (14.1%)

COPD (n)

15 (10.6%)

Extracardiac arteriopathy (n)

34 (23.9%)

Previous stroke/TIA (n)

15 (10.6%)

ECG

Sinus rhythm (n)

91 (64.1%)

AV block (n)

25 (17.6%)

Bundle branch block (n)

35 (24.6%)

Atrial fibrillation (n)

64 (45.1%)

Pacemaker/ICD (n)

22 (15.5%)

TTE/TEE

LVEF (%)

57 (50–63)

LVEDV (mL)

86 (68–109)

Mitral regurgitation ≥ II (n)

35 (24.6%)

Tricuspid regurgitation ≥ II (n)

22 (15.5%)

Systolic PAP (mm Hg)

38 (31–46)

Creatinine (mg/dL)

1.0 (0.7–1.2)

GFR (mL/min)

63 (46–80)

NT-proBNP (ng/L)

1,713 (659–5,212)

Logistic ES I (%)

17.4 (12.1–26.7)

Logistic ES II (%)

4.0 (2.6–7.3)

↓ **Table 2.** Clinical Characteristics at Baseline Separated for Patients With Native Aortic Stenosis (AS) or Degenerated Aortic Bioprosthesis and Valve-in-Valve (ViV) Procedure
	Native AS (n = 117)	ViV (n = 25)
P < 0.05, *P < 0.01. Data are presented as median, interquartile range, frequency, and percentage. AV: atrioventricular; CABG: coronary artery bypass grafting; COPD: chronic obstructive pulmonary disease; ECG: electrocardiogram; ES: EuroSCORE; GFR: glomerular filtration rate; ICD: implantable cardioverter defibrillator; LVEF: left ventricular ejection fraction; LVEDV: left ventricular end-diastolic volume; MI: myocardial infarction; NT-proBNP: N-terminal pro-brain natriuretic peptide; NYHA: New York Heart Association; PAP: pulmonary artery pressure; PCI: percutaneous coronary intervention; TIA: transient ischemic attack; TEE: transesophageal echocardiography; TTE: transthoracic echocardiography.
Age (years)	82 (80–86)	80 (73–84)**
Female/male (n)	79/38	13/12
Body mass index (kg/m²)	28 (24–31)	26 (23–29)
NYHA classification ≥ III (n)	58 (49.6%)	19 (76.0%)*
Coronary artery disease (n)	77 (65.8%)	19 (76.0%)
Prior MI (n)	12 (10.3%)	3 (12.0%)
Prior PCI (n)	29 (24.8%)	7 (28.0%)
Prior CABG (n)	9 (7.7%)	11 (44.0%)**
COPD (n)	12 (10.3%)	3 (12.0%)
Extracardiac arteriopathy (n)	20 (17.1%)	14 (56.0%)**
Previous stroke/TIA (n)	13 (11.1%)	2 (8.0%)
ECG
Sinus rhythm (n)	76 (65.0%)	15 (60.0%)
AV block (n)	18 (15.4%)	7 (28.0%)
Bundle branch block (n)	24 (20.5%)	11 (44.0%)*
Atrial fibrillation (n)	52 (44.4%)	12 (48.0%)
Pacemaker/ICD (n)	13 (11.1%)	9 (36.0%)**
TTE/TEE
LVEF (%)	57 (53–63)	49 (34–59)**
LVEDV (mL)	81 (65–100)	119 (81–178)**
Mitral regurgitation ≥ II (n)	22 (18.8%)	13 (52.0%)**
Tricuspid regurgitation ≥ II (n)	14 (12.0%)	8 (32.0%)*
Systolic PAP (mm Hg)	38 (30–45)	43 (36–49)
Creatinine (mg/dL)	0.9 (0.7–1.1)	1.4 (1.0–2.3)**
GFR (mL/min)	67 (53–81)	42 (21–64)**
NT-proBNP (ng/L)	1,510 (581–3,538)	5,278 (1,575–27,500)**
Logistic ES I (%)	15.3 (11.3–23.2)	35.8 (25.1–78.9)**
Logistic ES II (%)	3.3 (2.5–5.7)	14.4 (6.6–25.3)**

↓ Table 2. Clinical Characteristics at Baseline Separated for Patients With Native Aortic Stenosis (AS) or Degenerated Aortic Bioprosthesis and Valve-in-Valve (ViV) Procedure

Native AS (n = 117)

ViV (n = 25)

*P < 0.05, **P < 0.01. Data are presented as median, interquartile range, frequency, and percentage. AV: atrioventricular; CABG: coronary artery bypass grafting; COPD: chronic obstructive pulmonary disease; ECG: electrocardiogram; ES: EuroSCORE; GFR: glomerular filtration rate; ICD: implantable cardioverter defibrillator; LVEF: left ventricular ejection fraction; LVEDV: left ventricular end-diastolic volume; MI: myocardial infarction; NT-proBNP: N-terminal pro-brain natriuretic peptide; NYHA: New York Heart Association; PAP: pulmonary artery pressure; PCI: percutaneous coronary intervention; TIA: transient ischemic attack; TEE: transesophageal echocardiography; TTE: transthoracic echocardiography.

Age (years)

82 (80–86)

80 (73–84)**

Female/male (n)

79/38

13/12

Body mass index (kg/m²)

28 (24–31)

26 (23–29)

NYHA classification ≥ III (n)

58 (49.6%)

19 (76.0%)*

Coronary artery disease (n)

77 (65.8%)

19 (76.0%)

Prior MI (n)

12 (10.3%)

3 (12.0%)

Prior PCI (n)

29 (24.8%)

7 (28.0%)

Prior CABG (n)

9 (7.7%)

11 (44.0%)**

COPD (n)

12 (10.3%)

3 (12.0%)

Extracardiac arteriopathy (n)

20 (17.1%)

14 (56.0%)**

Previous stroke/TIA (n)

13 (11.1%)

2 (8.0%)

ECG

Sinus rhythm (n)

76 (65.0%)

15 (60.0%)

AV block (n)

18 (15.4%)

7 (28.0%)

Bundle branch block (n)

24 (20.5%)

11 (44.0%)*

Atrial fibrillation (n)

52 (44.4%)

12 (48.0%)

Pacemaker/ICD (n)

13 (11.1%)

9 (36.0%)**

TTE/TEE

LVEF (%)

57 (53–63)

49 (34–59)**

LVEDV (mL)

81 (65–100)

119 (81–178)**

Mitral regurgitation ≥ II (n)

22 (18.8%)

13 (52.0%)**

Tricuspid regurgitation ≥ II (n)

14 (12.0%)

8 (32.0%)*

Systolic PAP (mm Hg)

38 (30–45)

43 (36–49)

Creatinine (mg/dL)

0.9 (0.7–1.1)

1.4 (1.0–2.3)**

GFR (mL/min)

67 (53–81)

42 (21–64)**

NT-proBNP (ng/L)

1,510 (581–3,538)

5,278 (1,575–27,500)**

Logistic ES I (%)

15.3 (11.3–23.2)

35.8 (25.1–78.9)**

Logistic ES II (%)

3.3 (2.5–5.7)

14.4 (6.6–25.3)**

↓ **Table 3.** Procedural Characteristics of Allegra Transcatheter Aortic Valve Implantation in Patients With Native Aortic Stenosis (AS) or Degenerated Aortic Bioprosthesis as Valve-in-Valve (ViV) Procedure
	Native AS (n = 117)	ViV (n = 25)
P < 0.05, *P < 0.01. Data are presented as median, interquartile range, frequency, and percentage. ECMO: extracorporeal membrane oxygenation; M-TEER: transcatheter edge-to-edge repair of the mitral valve; TAVI: transcatheter aortic valve implantation; PCI: percutaneous coronary intervention.
Intervention time (min)	60.0 (48.5–73.0)	62.0 (56.5–110.5)
Fluoroscopy time (min)	14.1 (10.3–20.0)	15.3 (13.2–32.9)*
Contrast dye (mL)	90 (65–130)	60 (40–80)**
Size of Allegra
23 mm (n)	18 (15.4%)	16 (64.0%)**
27 mm (n)	62 (53.0%)	9 (36.0%)
31 mm (n)	35 (39.9%)	—**
Preimplanted aortic prothesis
Epic supra (n)	—	1 (23 mm)
Hancock II (n)	—	1 (27 mm)
Magna (n)	—	1 (23 mm)
Mitroflow (n)	—	1 (23 mm), 2 (25 mm)
Mosaic (n)	—	1 (23 mm)
Perceval (n)	—	1 (size S)
Perimonut (n)	—	1 (21 mm), 2 (23 mm),3 (25 mm), 1 (27 mm)
Trifecta (n)	—	2 (23 mm)
Preimplanted TAVI prothesis
Acurate (n)	—	1 (size M)
Evolut R (n)	—	1 (26 mm)
Sapien 3 (n)	—	1 (20 mm), 2 (23 mm),3 (26 mm)
Preimplant balloon dilatation (n)	114 (97.4%)	3 (12.0%)**
Postimplant balloon dilatation (n)	68 (58.1%)	18 (72.0%)
Concomitant planned procedures
Diagnostic coronary angiography (n)	2 (1.7%)	1 (4.0%)
PCI (n)	5 (4.3%)	2 (8.0%)
Coronary protection(balloon/stent) (n)	2 (1.7%)	2 (8.0%)
M-TEER (n)	—	1 (4.0%)
Cerebral protection device (n)	1 (0.9%)	3 (12.0%)*
ECMO (n)	—	1 (4.0%)

↓ Table 3. Procedural Characteristics of Allegra Transcatheter Aortic Valve Implantation in Patients With Native Aortic Stenosis (AS) or Degenerated Aortic Bioprosthesis as Valve-in-Valve (ViV) Procedure

Native AS (n = 117)

ViV (n = 25)

*P < 0.05, **P < 0.01. Data are presented as median, interquartile range, frequency, and percentage. ECMO: extracorporeal membrane oxygenation; M-TEER: transcatheter edge-to-edge repair of the mitral valve; TAVI: transcatheter aortic valve implantation; PCI: percutaneous coronary intervention.

Intervention time (min)

60.0 (48.5–73.0)

62.0 (56.5–110.5)

Fluoroscopy time (min)

14.1 (10.3–20.0)

15.3 (13.2–32.9)*

Contrast dye (mL)

90 (65–130)

60 (40–80)**

Size of Allegra

23 mm (n)

18 (15.4%)

16 (64.0%)**

27 mm (n)

62 (53.0%)

9 (36.0%)

31 mm (n)

35 (39.9%)

—**

Preimplanted aortic prothesis

Epic supra (n)

—

1 (23 mm)

Hancock II (n)

—

1 (27 mm)

Magna (n)

—

1 (23 mm)

Mitroflow (n)

—

1 (23 mm), 2 (25 mm)

Mosaic (n)

—

1 (23 mm)

Perceval (n)

—

1 (size S)

Perimonut (n)

—

1 (21 mm), 2 (23 mm),3 (25 mm), 1 (27 mm)

Trifecta (n)

—

2 (23 mm)

Preimplanted TAVI prothesis

Acurate (n)

—

1 (size M)

Evolut R (n)

—

1 (26 mm)

Sapien 3 (n)

—

1 (20 mm), 2 (23 mm),3 (26 mm)

Preimplant balloon dilatation (n)

114 (97.4%)

3 (12.0%)**

Postimplant balloon dilatation (n)

68 (58.1%)

18 (72.0%)

Concomitant planned procedures

Diagnostic coronary angiography (n)

2 (1.7%)

1 (4.0%)

PCI (n)

5 (4.3%)

2 (8.0%)

Coronary protection(balloon/stent) (n)

2 (1.7%)

2 (8.0%)

M-TEER (n)

—

1 (4.0%)

Cerebral protection device (n)

1 (0.9%)

3 (12.0%)*

ECMO (n)

—

1 (4.0%)

↓ **Table 4.** Outcome After Allegra Transcatheter Aortic Valve Implantation in Patients With Native Aortic Stenosis (AS) or Degenerated Aortic Bioprosthesis as Valve-in-Valve (ViV) Procedure
	Native AS (n = 117)	ViV (n = 25)
*P < 0.05. Data are presented as frequencies and percentages. AV = atrioventricular, TIA = transient ischemic attack.
Periprocedural mortality (≤ 30 days) (n)	8 (6.8%)	3 (12.0%)
Neurologic events
Stroke/TIA (n)	3 (2.6%)	—
Delirium (n)	4 (3.4%)	3 (12.0%)
Bleeding and transfusions
Type 1 (n)	1 (0.9%)	2 (8.0%)
Type 2 (n)	33 (28.2%)	5 (20.0%)
Type 3 (n)	3 (2.6%)	3 (12.0%)
Type 4 (n)	—	—
Vascular complications
Major (n)	6 (5.1%)	1 (4.0%)
Minor (n)	6 (5.1%)	1 (4.0%)
Cardiac structural complications
Major (n)	1 (0.9%)	—
Minor (n)	—	—
Other acute procedural and technical valve-related complications
Intraprocedural conversion to open surgery (n)	2 (1.7%)	1 (4.0%)
Valve embolization (n)	3 (2.6%)	2 (8.0%)
Ectopic valve deployment (n)	3 (2.6%)	1 (4.0%)
Conduction disturbances and arrhythmias
New bundle branch and/or AV block (n)	6 (5.1%)	—
New atrial fibrillation (n)	1 (0.9%)	—
New permanent pacemaker (n)	22 (18.8%)	—*
Acute kidney injury
Stage 1 (n)	6 (5.1%)	—
Stage 2 (n)	—	—
Stage 3 (n)	1 (0.9%)	—
Stage 4 (n)	3 (2.6%)	—

↓ Table 4. Outcome After Allegra Transcatheter Aortic Valve Implantation in Patients With Native Aortic Stenosis (AS) or Degenerated Aortic Bioprosthesis as Valve-in-Valve (ViV) Procedure

Native AS (n = 117)

ViV (n = 25)

*P < 0.05. Data are presented as frequencies and percentages. AV = atrioventricular, TIA = transient ischemic attack.

Periprocedural mortality (≤ 30 days) (n)

8 (6.8%)

3 (12.0%)

Neurologic events

Stroke/TIA (n)

3 (2.6%)

—

Delirium (n)

4 (3.4%)

3 (12.0%)

Bleeding and transfusions

Type 1 (n)

1 (0.9%)

2 (8.0%)

Type 2 (n)

33 (28.2%)

5 (20.0%)

Type 3 (n)

3 (2.6%)

3 (12.0%)

Type 4 (n)

—

Vascular complications

Major (n)

6 (5.1%)

1 (4.0%)

Minor (n)

6 (5.1%)

1 (4.0%)

Cardiac structural complications

Major (n)

1 (0.9%)

—

Minor (n)

—

Other acute procedural and technical valve-related complications

Intraprocedural conversion to open surgery (n)

2 (1.7%)

1 (4.0%)

Valve embolization (n)

3 (2.6%)

2 (8.0%)

Ectopic valve deployment (n)

3 (2.6%)

1 (4.0%)

Conduction disturbances and arrhythmias

New bundle branch and/or AV block (n)

6 (5.1%)

—

New atrial fibrillation (n)

1 (0.9%)

—

New permanent pacemaker (n)

22 (18.8%)

—*

Acute kidney injury

Stage 1 (n)

6 (5.1%)

—

Stage 2 (n)

—

Stage 3 (n)

1 (0.9%)

—

Stage 4 (n)

3 (2.6%)

—