TAVI

Table Proglide vs Manta vs Ch

Characteristic Overall
N = 1481
Proglide
N = 1061
Manta
N = 421
p-value2
Sex


0.464
    Female 88 (59%) 65 (61%) 23 (55%)
    Male 60 (41%) 41 (39%) 19 (45%)
Age (years) 80.6 (5.3) 80.2 (5.7) 81.5 (4.1) 0.271
Hypertension 125 (84%) 87 (82%) 38 (90%) 0.203
Diabetes 55 (37%) 37 (35%) 18 (43%) 0.367
Dyslipidemia 93 (63%) 65 (61%) 28 (67%) 0.544
Smoking


<0.001
    Actual Smoker 10 (6.8%) 9 (8.6%) 1 (2.4%)
    Former Smoker 26 (18%) 25 (24%) 1 (2.4%)
    No 111 (76%) 71 (68%) 40 (95%)
Family History of CV Disease 12 (8.1%) 10 (9.4%) 2 (4.8%) 0.510
Lone AF 3 (2.0%) 3 (2.8%) 0 (0%) 0.558
Recurrent Paroxysmal AF 9 (6.1%) 7 (6.6%) 2 (4.8%) >0.999
Recurrent Persistent AF 4 (2.7%) 3 (2.8%) 1 (2.4%) >0.999
Permanent AF 21 (14%) 14 (13%) 7 (17%) 0.587
Cirrhosis 1 (0.7%) 1 (0.9%) 0 (0%) >0.999
Chronic Kidney Disease 35 (24%) 25 (24%) 10 (24%) 0.977
Dialysis 1 (0.7%) 1 (1.0%) 0 (0%) >0.999
COPD 23 (16%) 16 (15%) 7 (17%) 0.812
Neurological Dysfunction 12 (8.1%) 8 (7.5%) 4 (9.5%) 0.742
Porcelain Aorta



    0 148 (100%) 106 (100%) 42 (100%)
Peripheral Arterial Disease 11 (7.4%) 7 (6.6%) 4 (9.5%) 0.508
Prior Ulcers 2 (1.4%) 1 (0.9%) 1 (2.4%) 0.488
Malignancy 6 (4.1%) 5 (4.7%) 1 (2.4%) 0.675
Critical Preoperative State 1 (0.7%) 0 (0%) 1 (2.4%) 0.284
Comorbidities 62 (42%) 40 (38%) 22 (52%) 0.104
Prior Cardiac Surgery (non-CABG) 8 (5.4%) 7 (6.6%) 1 (2.4%) 0.441
Pre-TAVI Balloon Valvuloplasty



    0 148 (100%) 106 (100%) 42 (100%)
Prior TAVI 1 (0.7%) 1 (0.9%) 0 (0%) >0.999
Prior Cardiac Surgery 13 (8.8%) 11 (10%) 2 (4.8%) 0.351
Prior CABG 4 (2.7%) 3 (2.8%) 1 (2.4%) >0.999
Prior SAVR 10 (6.8%) 9 (8.5%) 1 (2.4%) 0.283
Prosthesis Type 10 (6.8%) 9 (8.5%) 1 (2.4%) 0.283
Prior PCI 25 (17%) 18 (17%) 7 (17%) 0.963
Prior MI 19 (13%) 17 (16%) 2 (4.8%) 0.064
Prior TIA 3 (2.0%) 1 (0.9%) 2 (4.8%) 0.194
Prior Stroke 8 (5.4%) 5 (4.7%) 3 (7.1%) 0.688
Prior Pacemaker 11 (7.4%) 5 (4.7%) 6 (14%) 0.076
Heart Failure Hospitalizations 20 (14%) 12 (11%) 8 (19%) 0.215
CCS Angina Class


0.131
    0 113 (76%) 76 (72%) 37 (88%)
    1 21 (14%) 18 (17%) 3 (7.1%)
    2 14 (9.5%) 12 (11%) 2 (4.8%)
Syncope 13 (8.8%) 7 (6.6%) 6 (14%) 0.194
Angina


0.246
    0 112 (76%) 76 (72%) 36 (86%)
    1 29 (20%) 24 (23%) 5 (12%)
    2 7 (4.7%) 6 (5.7%) 1 (2.4%)
Dyspnea


0.350
    0 13 (8.8%) 7 (6.6%) 6 (14%)
    1 45 (30%) 31 (29%) 14 (33%)
    2 56 (38%) 41 (39%) 15 (36%)
    3 34 (23%) 27 (25%) 7 (17%)
NYHA Class


0.896
    II 67 (45%) 47 (44%) 20 (48%)
    III 80 (54%) 58 (55%) 22 (52%)
    IV 1 (0.7%) 1 (0.9%) 0 (0%)
Weight (kg) 71 (14) 69 (12) 80 (18) 0.066
Height (cm) 1.58 (0.09) 1.57 (0.09) 1.61 (0.10) 0.375
BMI (kg/m²) 28.1 (4.9) 27.4 (4.6) 31.2 (5.3) 0.036
Heart Failure 1.71 (0.18) 1.68 (0.16) 1.85 (0.24) 0.069
ARBs 67 (45%) 49 (46%) 18 (43%) 0.710
ACE Inhibitors 33 (22%) 24 (23%) 9 (21%) 0.873
Nitrates 7 (4.7%) 5 (4.7%) 2 (4.8%) >0.999
Amiodarone 3 (2.0%) 2 (1.9%) 1 (2.4%) >0.999
Digitalis 2 (1.4%) 0 (0%) 2 (4.8%) 0.079
Beta-blockers 88 (59%) 65 (61%) 23 (55%) 0.464
Aspirin 84 (57%) 63 (59%) 21 (50%) 0.296
P2Y12 Inhibitors 39 (26%) 30 (28%) 9 (21%) 0.392
Anticoagulants 33 (22%) 23 (22%) 10 (24%) 0.781
Statins 103 (70%) 77 (73%) 26 (62%) 0.200
Calcium-channel Blockers 36 (24%) 25 (24%) 11 (26%) 0.739
Loop Diuretics 70 (47%) 50 (47%) 20 (48%) 0.961
Loop Diuretics Dose (daily) 46 (51) 36 (25) 69 (83) 0.077
Thiazide Diuretics 34 (23%) 25 (24%) 9 (21%) 0.779
Thiazide Dose (daily)


0.718
    2.5 2 (7.7%) 1 (5.3%) 1 (14%)
    5 3 (12%) 3 (16%) 0 (0%)
    12.5 14 (54%) 10 (53%) 4 (57%)
    25 5 (19%) 4 (21%) 1 (14%)
    50 2 (7.7%) 1 (5.3%) 1 (14%)
Potassium-sparing Diuretics 13 (8.8%) 9 (8.5%) 4 (9.5%) >0.999
MRA Dose (daily)


0.055
    25 1 (9.1%) 0 (0%) 1 (33%)
    50 9 (82%) 8 (100%) 1 (33%)
    100 1 (9.1%) 0 (0%) 1 (33%)
Gastroprotective Therapy 103 (70%) 77 (73%) 26 (62%) 0.172
Insulin Therapy 17 (11%) 11 (10%) 6 (14%) 0.569
Oral Hypoglycemic Agents 48 (32%) 36 (34%) 12 (29%) 0.528
Sinus Rhythm 109 (84%) 78 (84%) 31 (86%) 0.753
Heart Rate (bpm) 71 (13) 71 (13) 71 (11) 0.805
Atrial Fibrillation 18 (15%) 13 (15%) 5 (14%) 0.926
First-degree AV Block 17 (16%) 9 (12%) 8 (29%) 0.067
Left Bundle Branch Block 11 (10%) 8 (10%) 3 (11%) >0.999
Right Bundle Branch Block 18 (17%) 14 (18%) 4 (14%) 0.775
T Wave Abnormalities 40 (37%) 32 (41%) 8 (28%) 0.202
EuroSCORE II 3.57 (2.29 - 4.62) 3.73 (2.38 - 4.91) 2.52 (2.10 - 4.61) 0.173
STS Mortality Risk 6 (4 - 10) 7 (4 - 10) 6 (3 - 8) 0.482
Serum Creatinine (Pre-procedure) 1.07 (0.53) 1.08 (0.56) 1.04 (0.43) 0.756
Creatinine Clearance (Pre-procedure) 51 (25) 50 (24) 58 (27) 0.389
Hemoglobin (Pre-procedure) 11.95 (1.90) 11.70 (1.91) 12.55 (1.76) 0.021
Hematocrit (Pre-procedure) 35.7 (5.4) 35.1 (5.5) 37.3 (4.9) 0.031
Right Coronary Artery (RCA) Disease 10 (9.0%) 10 (12%) 0 (0%) 0.115
Left Anterior Descending (LAD) Disease 24 (22%) 19 (23%) 5 (19%) 0.715
Circumflex (CX) Disease 9 (8.2%) 6 (7.1%) 3 (12%) 0.439
Concomitant PCI 11 (9.2%) 9 (10%) 2 (5.9%) 0.726
Renal Guard Protocol 3 (2.9%) 1 (1.3%) 2 (6.7%) 0.196
Additional Device


0.732
    0 26 (90%) 12 (86%) 14 (93%)
    1 1 (3.4%) 1 (7.1%) 0 (0%)
    2 2 (6.9%) 1 (7.1%) 1 (6.7%)
Evolut R 23 mm 10 (7.4%) 9 (9.6%) 1 (2.4%) 0.174
Evolut R 26 mm 45 (33%) 30 (32%) 15 (36%) 0.664
Evolut R 29 mm 39 (29%) 34 (36%) 5 (12%) 0.004
Evolut R 34 mm 13 (9.6%) 5 (5.3%) 8 (19%) 0.023
Evolut PRO 23 mm 3 (2.2%) 1 (1.1%) 2 (4.8%) 0.225
Evolut PRO 26 mm 4 (2.9%) 4 (4.3%) 0 (0%) 0.311
Evolut PRO 29 mm 3 (2.2%) 0 (0%) 3 (7.1%) 0.028
Evolut PRO 34 mm 1 (0.7%) 0 (0%) 1 (2.4%) 0.309
Evolut ProPlus 26 mm 1 (0.7%) 0 (0%) 1 (2.4%) 0.311
Evolut ProPlus 29 mm 1 (0.7%) 0 (0%) 1 (2.4%) 0.309
MyVal 21.5 mm 3 (2.2%) 1 (1.1%) 2 (4.8%) 0.225
MyVal 23 mm 4 (2.9%) 3 (3.2%) 1 (2.4%) >0.999
MyVal 24.5 mm 3 (2.2%) 2 (2.1%) 1 (2.4%) >0.999
Allegra 27 mm 4 (2.9%) 4 (4.3%) 0 (0%) 0.311
Evolut FX 34 mm 2 (1.5%) 1 (1.1%) 1 (2.4%) 0.524
Pre-procedural Femoral PTA



    0 134 (100%) 95 (100%) 39 (100%)
Anticoagulation 3 (15%) 2 (18%) 1 (11%) >0.999
Transfemoral Access 130 (99%) 91 (99%) 39 (100%) >0.999
Transapical Access 1 (0.8%) 1 (1.1%) 0 (0%) >0.999
TEE-guided Procedure



    0 52 (100%) 30 (100%) 22 (100%)
Intraprocedural Complications 33 (32%) 19 (27%) 14 (45%) 0.068
Optimal Valve Implantation 93 (97%) 66 (97%) 27 (96%) >0.999
High Implantation



    0 74 (100%) 57 (100%) 17 (100%)
Low Implantation 1 (1.4%) 1 (1.8%) 0 (0%) >0.999
Failed Implantation 1 (1.0%) 0 (0%) 1 (3.3%) 0.306
Post-dilation



    0 90 (100%) 64 (100%) 26 (100%)
Valve-in-Valve Procedure 11 (8.1%) 10 (10%) 1 (2.5%) 0.174
Coronary Ostium Occlusion



    0 102 (100%) 72 (100%) 30 (100%)
Residual Aortic Insufficiency (Angiographic)


0.727
    0 90 (94%) 65 (94%) 25 (93%)
    1 5 (5.2%) 3 (4.3%) 2 (7.4%)
    2 1 (1.0%) 1 (1.4%) 0 (0%)
Prolonged Hypotension 1 (0.9%) 0 (0%) 1 (3.1%) 0.294
Cardiopulmonary Resuscitation



    0 112 (100%) 79 (100%) 33 (100%)
Pulmonary Edema 1 (0.9%) 1 (1.3%) 0 (0%) >0.999
Cardiac Tamponade



    0 112 (100%) 79 (100%) 33 (100%)
Intra-aortic Balloon Pump



    0 112 (100%) 79 (100%) 33 (100%)
Cardiogenic Shock



    0 112 (100%) 79 (100%) 33 (100%)
Stroke (Intra-procedural) 1 (0.9%) 1 (1.3%) 0 (0%) >0.999
Transient Ischemic Attack (Intra-procedural)



    0 112 (100%) 79 (100%) 33 (100%)
New Onset Bundle Branch Block 13 (12%) 7 (8.8%) 6 (18%) 0.196
First-degree AV Block (Intra-procedural) 1 (0.9%) 0 (0%) 1 (3.1%) 0.291
Second-degree AV Block (Intra-procedural)



    0 110 (100%) 79 (100%) 31 (100%)
Advanced AV Block (Intra-procedural) 8 (7.2%) 4 (5.1%) 4 (13%) 0.224
Atrial Fibrillation (Intra-procedural) 1 (0.9%) 1 (1.3%) 0 (0%) >0.999
Ventricular Fibrillation



    0 112 (100%) 79 (100%) 33 (100%)
Ventricular Tachycardia 1 (0.9%) 1 (1.3%) 0 (0%) >0.999
Bleeding 2 (1.8%) 1 (1.3%) 1 (3.1%) 0.492
Femoral Occlusion 2 (1.8%) 2 (2.5%) 0 (0%) >0.999
Femoral Artery Dissection 3 (2.7%) 3 (3.8%) 0 (0%) 0.557
Residual Stenosis >70%



    0 111 (100%) 79 (100%) 32 (100%)
Vascular Surgery Required



    0 111 (100%) 79 (100%) 32 (100%)
Femoral Stent Placement 4 (3.6%) 3 (3.8%) 1 (3.1%) >0.999
Femoral Balloon Angioplasty 3 (2.7%) 1 (1.3%) 2 (6.5%) 0.191
Embolism 1 (0.9%) 1 (1.3%) 0 (0%) >0.999
Transfusions 1 (0.9%) 1 (1.3%) 0 (0%) >0.999
Number of Blood Units 1 (0.9%) 1 (1.3%) 0 (0%) >0.999
Periprocedural MI



    0 112 (100%) 80 (100%) 32 (100%)
Intubation 2 (1.8%) 2 (2.5%) 0 (0%) >0.999
Conversion to Cardiac Surgery



    0 112 (100%) 80 (100%) 32 (100%)
Intra-procedural Death



    0 136 (100%) 97 (100%) 39 (100%)
Serum Creatinine (Post-procedure Peak) 1.00 (0.80 - 1.40) 1.00 (0.80 - 1.40) 1.00 (0.80 - 1.30) 0.417
Delta Creatinine 0.10 (0.00 - 0.20) 0.10 (0.00 - 0.20) 0.00 (-0.10 - 0.20) 0.530
Percentage Change in Creatinine 0 (NA%) 0 (NA%) 0 (NA%)
Acute Kidney Injury 14 (9.9%) 11 (11%) 3 (7.5%) 0.757
Creatinine Clearance (Post-procedure Peak) 47 (27) 46 (26) 60 (36) 0.339
Nadir Hemoglobin 9.83 (1.64) 9.64 (1.54) 10.30 (1.79) 0.045
Nadir Hematocrit 29.3 (4.8) 28.7 (4.7) 30.6 (4.9) 0.042
Creatinine at 24h 1.07 (0.41) 1.07 (0.40) 1.07 (0.44) 0.945
Creatinine at 72h 1.13 (0.66) 1.14 (0.71) 1.09 (0.57) 0.913
Creatinine Reduction 1.08 (0.60) 1.10 (0.64) 1.05 (0.47) 0.762
Clearance Improvement 51 (26) 50 (26) 57 (26) 0.463
Hemoglobin Reduction 10.28 (1.39) 10.15 (1.31) 10.59 (1.56) 0.092
Hematocrit Reduction 30.7 (4.0) 30.4 (3.9) 31.4 (4.4) 0.216
Drop in Hemoglobin -2.20 (-3.10 - -1.30) -2.20 (-3.00 - -1.30) -2.10 (-3.20 - -1.30) 0.963
Death at Follow-up 23 (22%) 18 (22%) 5 (21%) 0.885
Major Stroke at Follow-up 2 (67%) 2 (100%) 0 (0%) 0.333
Minor Stroke at Follow-up 1 (1.2%) 1 (1.5%) 0 (0%) >0.999
TIA at Follow-up 1 (1.2%) 0 (0%) 1 (6.3%) 0.193
MI at Follow-up 2 (2.4%) 2 (2.9%) 0 (0%) >0.999
New Pacemaker at Follow-up 23 (26%) 16 (23%) 7 (37%) 0.244
Bleeding at Follow-up 35 (38%) 23 (33%) 12 (57%) 0.045
Heart Failure at Follow-up 6 (7.1%) 6 (8.6%) 0 (0%) 0.585
1 n (%); Mean (SD); Median (Q1 - Q3)
2 Pearson’s Chi-squared test; Wilcoxon rank sum test; Fisher’s exact test

Regressione per morte ed endpoint composito

Call:
coxph(formula = Surv(FU_Composite_timing, FU_Composite_Endpoint) ~ 
    EMODINAMICA_Chiusura_accesso, data = df)

  n= 136, number of events= 56 
   (15 osservazioni eliminate a causa di valori mancanti)

                                    coef exp(coef) se(coef)     z Pr(>|z|)
EMODINAMICA_Chiusura_accessoManta 0.1684    1.1834   0.3033 0.555    0.579

                                  exp(coef) exp(-coef) lower .95 upper .95
EMODINAMICA_Chiusura_accessoManta     1.183      0.845    0.6531     2.144

Concordance= 0.525  (se = 0.032 )
Likelihood ratio test= 0.3  on 1 df,   p=0.6
Wald test            = 0.31  on 1 df,   p=0.6
Score (logrank) test = 0.31  on 1 df,   p=0.6
Call:
coxph(formula = Surv(FU_Composite_timing, FU_Composite_Endpoint) ~ 
    EMODINAMICA_Chiusura_accesso + BASELINE_ETA + `BASELINE_Euroscore II` + 
        LABORATORIO_Creatinina_Pre, data = df)

  n= 51, number of events= 22 
   (100 osservazioni eliminate a causa di valori mancanti)

                                       coef exp(coef)  se(coef)      z Pr(>|z|)
EMODINAMICA_Chiusura_accessoManta  0.048183  1.049363  0.561986  0.086    0.932
BASELINE_ETA                       0.002597  1.002601  0.039511  0.066    0.948
`BASELINE_Euroscore II`           -0.121203  0.885854  0.106134 -1.142    0.253
LABORATORIO_Creatinina_Pre         0.328849  1.389369  0.218676  1.504    0.133

                                  exp(coef) exp(-coef) lower .95 upper .95
EMODINAMICA_Chiusura_accessoManta    1.0494     0.9530    0.3488     3.157
BASELINE_ETA                         1.0026     0.9974    0.9279     1.083
`BASELINE_Euroscore II`              0.8859     1.1289    0.7195     1.091
LABORATORIO_Creatinina_Pre           1.3894     0.7198    0.9051     2.133

Concordance= 0.614  (se = 0.052 )
Likelihood ratio test= 2.61  on 4 df,   p=0.6
Wald test            = 2.99  on 4 df,   p=0.6
Score (logrank) test = 3.17  on 4 df,   p=0.5

Call:
coxph(formula = Surv(Deathdays, COMPLICANZE_death_fu) ~ EMODINAMICA_Chiusura_accesso, 
    data = df)

  n= 105, number of events= 23 
   (46 osservazioni eliminate a causa di valori mancanti)

                                          coef exp(coef) se(coef)      z
EMODINAMICA_Chiusura_accessoManta     -0.02111   0.97911  0.50926 -0.041
EMODINAMICA_Chiusura_accessoChirurgia       NA        NA  0.00000     NA
                                      Pr(>|z|)
EMODINAMICA_Chiusura_accessoManta        0.967
EMODINAMICA_Chiusura_accessoChirurgia       NA

                                      exp(coef) exp(-coef) lower .95 upper .95
EMODINAMICA_Chiusura_accessoManta        0.9791      1.021    0.3609     2.657
EMODINAMICA_Chiusura_accessoChirurgia        NA         NA        NA        NA

Concordance= 0.5  (se = 0.045 )
Likelihood ratio test= 0  on 1 df,   p=1
Wald test            = 0  on 1 df,   p=1
Score (logrank) test = 0  on 1 df,   p=1
Call:
coxph(formula = Surv(Deathdays, COMPLICANZE_death_fu) ~ EMODINAMICA_Chiusura_accesso + 
    BASELINE_ETA + `BASELINE_Euroscore II` + LABORATORIO_Creatinina_Pre, 
    data = df)

  n= 40, number of events= 12 
   (111 osservazioni eliminate a causa di valori mancanti)

                                          coef exp(coef) se(coef)      z
EMODINAMICA_Chiusura_accessoManta     -0.91047   0.40234  1.06189 -0.857
EMODINAMICA_Chiusura_accessoChirurgia       NA        NA  0.00000     NA
BASELINE_ETA                          -0.01289   0.98720  0.05059 -0.255
`BASELINE_Euroscore II`               -0.07956   0.92352  0.09700 -0.820
LABORATORIO_Creatinina_Pre             0.58905   1.80228  0.25039  2.353
                                      Pr(>|z|)  
EMODINAMICA_Chiusura_accessoManta       0.3912  
EMODINAMICA_Chiusura_accessoChirurgia       NA  
BASELINE_ETA                            0.7989  
`BASELINE_Euroscore II`                 0.4121  
LABORATORIO_Creatinina_Pre              0.0186 *
---
Signif. codes:  0 '***' 0.001 '**' 0.01 '*' 0.05 '.' 0.1 ' ' 1

                                      exp(coef) exp(-coef) lower .95 upper .95
EMODINAMICA_Chiusura_accessoManta        0.4023     2.4855    0.0502     3.225
EMODINAMICA_Chiusura_accessoChirurgia        NA         NA        NA        NA
BASELINE_ETA                             0.9872     1.0130    0.8940     1.090
`BASELINE_Euroscore II`                  0.9235     1.0828    0.7636     1.117
LABORATORIO_Creatinina_Pre               1.8023     0.5549    1.1033     2.944

Concordance= 0.685  (se = 0.097 )
Likelihood ratio test= 5.04  on 4 df,   p=0.3
Wald test            = 6.65  on 4 df,   p=0.2
Score (logrank) test = 8.33  on 4 df,   p=0.08

Forest

Characteristic
Composite Endpoint
Death FU
HR1 95% CI1 p-value HR1 95% CI1 p-value
Closure Type





    Proglide

    Manta 1.05 0.35, 3.16 >0.9 0.40 0.05, 3.22 0.4
    Chirurgia





BASELINE_ETA 1.00 0.93, 1.08 >0.9 0.99 0.89, 1.09 0.8
BASELINE_Euroscore II 0.89 0.72, 1.09 0.3 0.92 0.76, 1.12 0.4
LABORATORIO_Creatinina_Pre 1.39 0.91, 2.13 0.13 1.80 1.10, 2.94 0.019
1 HR = Hazard Ratio, CI = Confidence Interval