# Influence of valve depth implantation in relation to membranous septum length of Edwards Sapien 3 valve on conduction abnormalities, a single center retrospective study

Jasim Hasan

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Jasim Hasan. Influence of valve depth implantation in relation to membranous septum length of Edwards Sapien 3 valve on conduction abnormalities, a single center retrospective study. Cardiology and cardiovascular system. 2024. dumas-04728822

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THESE D'ETAT DE DOCTEUR EN MEDECINE

Spécialité: Médecine Cardiovasculaire

Jeudi 27 Juin 2024 à 18 heures

SALLE DU CONSEIL UFR DE MEDECINE

3 RUE DES LOUVELS – AMIENS

Monsieur Jasim HASAN

TITRE DE LA THESE :

INFLUENCE DE LA PROFONDEUR D'IMPLANTATION DE LA VALVE EDWARDS SAPIEN 3 SUR LES TROUBLES DE CONDUCTION ET L'IMPLANTATION D'UN STIMULATEUR CARDIAQUE EN RELATION AVEC LA LONGUEUR DU SEPTUM MEMBRANEUX, UNE MONOCENTRIQUE RETROSPECTIVE EXPERIENCE.

Vu : les Membres de Jury

Le Président de Jury,

Monsieur le Professeur Laurent LEBORGNE

Les Juges,

Monsieur le Professeur Christophe TRIBOUILLOY

Monsieur le Professeur Maciej KUBALA

Le Directeur de thèse,

Monsieur le Professeur Laurent LEBORGNE
**Title:**

Influence of valve depth implantation in relation to membranous septum length of Edwards Sapien 3 valve on conduction abnormalities, a single center retrospective study

**Abstract:**

**Introduction:**

Aortic stenosis is a most common valvular disease. TAVI has proved its efficacy, safety and so far, durability as compared to surgical valvular replacement on different patient levels. Despite the advancement in the TAVI procedure, some risks are not yet avoidable. One of the prominent risks is conduction abnormalities post TAVI necessitating a permanent pacemaker. Many studies explored the predictive risk factors for this complication. One of the determinants of such an outcome is the implantation depth in relation to the length of membranous septum. In this study, we will focus on those entities in the scope of other predictive factors.

**Methodology:**

This is a single center retrospective cohort study evaluating patients known to have severe aortic stenosis undergoing TAVI with SAPIENS 3 valve in a single center between January 2021 to December 2022. Any patients with pacemaker, Implantable cardioverter-defibrillator or CRT were excluded from the study. The pre-TAVI assessment was done using echocardiography and Multidetector Computed Tomography. The MS was measured by MDCT post implantation in retrospect. The MS is identified from the virtual annulus to the lowest point of the fibrous tissue (septum membranous). Post TAVI, the patients were monitored for conduction abnormalities within the hospital stay according to the local hospital protocol. Multivariate and univariate statistical analysis were performed using SPSS.

**Results:**

The average age of the included patients is 78.57±7.8 years with predominance of males and pre-op moderate risk according to the EUROSCORE II. The most common pre-TAVI conduction abnormality was atrioventricular block type 1 (28.1%) followed by left anterior fascicular block (25.1%) then right bundle branch block (20.1%). The average MS length is 5,5827±2,928mm. The mean implantation depth is 5.574±2.257 while the implantation depth at the level of the non-coronary cusp is 5.975±2.614. The PPM implantation rate within hospital stay is 25.1%. The leading cause of PPM is type 3 atrioventricular block then new left bundle block with AVB. Baseline conduction abnormality like RBBB was a predictive factor (odds ratio [OR]:5.4 ; 95% confidence interval [CI]: 2.7 to 10.7 ;p < 0.001) for PPM implantation along with mean of implantation depth for NC and LC (odds ratio [OR]: 1.2; 95% confidence interval [CI]: 1 to 1.3;p 0.003), MS septum length (odds ratio [OR]: 0.8 ; 95% confidence interval [CI]: 0.7 to 0.9 ;p 0.022). All delta MS-ID were predictive factors with statistical significance. On the multivariate logistic
regression analysis, the RBBB remains the high predictive factor for implantation of PPM post TAVI (odds ratio: 5.516 [95% confidence interval:2.564-11.688] p = 0.000).

**Conclusion:**

This study emphasizes the importance of MS length and implantation depth. Risk stratification of patients receiving SAPIEN 3 valves will help a better plan for the procedure to avoid post implantation conduction abnormalities needing a PPM. MS length raise as a risk modifier rather than an independent risk factor. Adjustment of the current implantation technique by higher implantation of TAVI especially in high-risk patients might help lower the need of PPM post TAVI. Further studies considering previously described risk factors with other factors which need further evaluation like inferoseptal recess length, NC calcification and right trigone calcification.

**Introduction:**

Aortic stenosis is most common valvular disease and is known to have a high mortality rate.(1) Valvular replacement has shown an improvement at the level of quality of life, morbidity, and mortality.(2,3) Transcatheter Aortic Valve Implantation (TAVI) has emerged as successful intervention for aortic stenosis. Despite the good outcomes, the procedure carries variable risks. One of the common complications is conductive abnormalities necessitating the implantation of pacemakers. Along the years, different techniques and valves were developed to minimize such complications. It was noticed that the height of implantation of the Edwards Sapien valve plays a rule in the outcome of procedure from a conductive system point of view(4). With Edwards Sapien valve (S3 prothesis), the need for implanting a permanent pacemaker was lower as compared to the other valves.(5) Despite that, the rate of conductive abnormality remains high.(5,6) The height of the prothesis implantation was correlated to the development of such complication where a higher implantation level may reduce the risk of developing such conductive abnormality. (6) These results were replicated in other studies. Baseline conductive abnormalities are a precursor to developing such complication. (7) But the implantation height still played a major role in developing conductive abnormalities or the need of implanting a pacemaker(4). Another independent predicting factor for conductive abnormalities is the length of membranous septum (MS) measured by the computed tomography (CT) scan. A short MS was associated with higher rate of conductive abnormality and permanent pacemaker implantation among all types of TAVI valves(8). Previous studies for SAPIEN 3 valve did not show a statistically significant result for the length of MS and had several limitations where other studies did not take into consideration the MS length (9,10). Hence, evidence has shown a new possible correlation between MS length and implantation depth with conduction abnormality, thus, this possible correlation needs to be further studied and investigated in SAPIENS valves. This study aims to evaluate the risk of conductive abnormality and permanent pacemaker implantation by considering the MS length in correlation to implantation depth (ID) in patients receiving TAVI with SAPIENS 3 valves. This will help in more understanding of the factors leading to PPM implantation and eventually improve procedural and clinical outcomes.
**Methodology:**

This is a retrospective cohort study evaluating patients known to have severe aortic stenosis undergoing TAVI with SAPIENS 3 valve in a single center between January 2021 to December 2022. The inclusion criteria are as follows: 1) All patients who benefited from Transcatheter Aortic Valve Implantation (TAVI) with Edwards SAPIENS 3 valve (S3). The exclusion criteria were: 1) known to have PPM, CRT or DAI 2) Valve-in-valve. The patients were evaluated with echocardiography, CT scan clinical evaluation. The clinical records were examined to assess PPM implantation before or after the TAVI procedure within hospital stay. Some of the patients were transferred to a peripheral hospital early after the procedure, a review of the clinical records was done to assess PPM implantation within hospital stay. Discharge was as per the centers and caring team protocol. The decision for PPM implantation was taken based on local center's protocol after a multidisciplinary decision between the operating team, electrophysiology team and the cardiologist.

A multidetector computed tomography (MDCT) was done before the procedure and analyzed by either a radiologist or an interventional cardiologist. The S3 size was based on MDCT analysis, and the vendor recommendations chosen by the operating team. The virtual annules was determined as the plane where a contour connects the most basal point i.e. the nadir of the aortic cusps. The SM was measured from the virtual annulus to the lowest point of the septum membranous. The implantation depth was measured from the valve annulus defined as the connection line of the deepest cusp point to the end of the valve stent.

The statistical analysis was done using SPSS version 19 (IBM, Armonk, NY, USA) and statistical significance was defined as a p value < 0.05. The quantitative data were stated as mean ± standard deviation. On the other hand, categorical data were expressed as counts with percentages. Student t test was the model used for quantitative data. Categorical data used chi-square or Fisher's exact test. To identify the predictive factors of PPM implantation, a univariable model using logistic regression was used. A multivariable model was used the variables included were: EUROSCORE II, RBBB, AV surface, MS and average implantation depth.

Regarding the patient's characteristics, the chronic kidney disease is defined as creatinine clearance less than 60 ml/min/m². Coronary artery disease is defined as presence of significant coronary artery disease on angiography or coronary CT scan and history of acute coronary syndrome.

**Results:**

239 patients who underwent TAVI with S3 balloon expandable valves were included in the study. The patient characteristics, clinical data, echocardiography, MDCT and the procedure data are presented in table 1. The studied population had an average age of 78.57±7.8 years with a predominance of males. We observe a moderate risk group reflected by EUROSCORE II. Hypertension was the predominant risk cardiac risk factor followed by diabetes mellitus then chronic kidney disease in chronological order 82%, 36.4% and 35.1%. In terms of electrocardiogram, the leading conductive abnormality is type 1 atrio-ventricular block (28.1%) followed by left anterior fascicular block (25.1%) then right bundle branch block (20.1%). While 28% of the patients had either permanent or paroxysmal atrial fibrillation. As for the aortic valve measurements, Most the patients have a preserved ejection fraction (56.07±14.17) where Vmax
was 436.45±63.9 m/s and mean gradient was 49.55±14.61 mmHg. The aortic valve surface area was 0.78±0.19 cm² indexed at 0.40±0.11 cm²/m². In contrast, the surface area of the aortic valve annulus measured by MDCT was 498.59±85.76 mm². The calcium score 3103±1495. The Membranous septum length 5,58±2,92mm. As for procedural data, the most common valve size used is 26mm received 122 patients (51.2%) followed by the 29mm received 80 patients (33.6%), finally the least used valve was the 23mm received by 36 patients (15.1%). The average oversizing is 10.6%. Implantation depth of NC, LC and mean presented as 5.97±2.61, 5.17±2.43 and 5.57±2.25. The delta MS-ID for NC, LC and mean were as follows -0,33±4,06 / 0,44±3,92 / -0,04±3,77.

<table><caption>**Table 1 Patients characteristics**</caption><thead><tr><th>Variable</th><th>results</th></tr></thead><tbody><tr><td><strong>Clinical characteristics</strong></td><td></td></tr><tr><td>Age (years)</td><td>78.57±7.78</td></tr><tr><td>Sex female n (%)</td><td>79 (33.1)</td></tr><tr><td>BMI (kg/m²)</td><td>28.31±5.60</td></tr><tr><td>Hypertension n (%)</td><td>196 (82)</td></tr><tr><td>Diabetes mellitus n (%)</td><td>87 (36.4)</td></tr><tr><td>Chronic kidney disease n (%)</td><td>84 (35.1)</td></tr><tr><td>Coronary artery disease n (%)</td><td>134 (56.1)</td></tr><tr><td>Euroscore I additive</td><td>8.0±2.15</td></tr><tr><td>Euroscore I logistic</td><td>11.11±7.88</td></tr><tr><td>Euroscore II</td><td>3.26±3.51</td></tr><tr><td><strong>Symptoms</strong></td><td></td></tr><tr><td>NYHA class I n (%)</td><td>20 (8.4)</td></tr><tr><td>NYHA class II n (%)</td><td>121 (50.6)</td></tr><tr><td>NYHA class III n (%)</td><td>77 (32.2)</td></tr><tr><td>NYHA class IV n (%)</td><td>21 (8.8)</td></tr><tr><td><strong>Electrocardiogram</strong></td><td></td></tr><tr><td>AVB type I n (%)</td><td>68 (28.1)</td></tr><tr><td>LAFB n (%)</td><td>60 (25.1)</td></tr><tr><td>LPFB n (%)</td><td>4 (1.7)</td></tr><tr><td>LBBB n (%)</td><td>31 (12)</td></tr></tbody></table>
<table><tr><td>RBBB n (%)</td><td>48 (20.1)</td></tr><tr><td>Paroxysmal atrial fibrillation (%)</td><td>24 (10)</td></tr><tr><td>Permanent atrial fibrillation (%)</td><td>43 (18)</td></tr><tr><td><strong>Echocardiography and CT scan</strong></td><td></td></tr><tr><td>Ejection fraction (%)</td><td>56.07±14.17</td></tr><tr><td>Vmax (m/s)</td><td>436.45±63.90</td></tr><tr><td>Mean gradient (mmHg)</td><td>49.55±14.61</td></tr><tr><td>Aortic valve surface (cm²)</td><td>0.78±0.19</td></tr><tr><td>Aortic valve surface – indexed (cm²/m²)</td><td>0.40±0.11</td></tr><tr><td>Short axis annular diameter (mm)</td><td>22.67±2.56</td></tr><tr><td>Long axis annular diameter (mm)</td><td>27.79±2.64</td></tr><tr><td>Annular perimeter (mm)</td><td>80.04±7.81</td></tr><tr><td>Annular surface (mm²)</td><td>498.59±85.76</td></tr><tr><td>Aortic valve calcium score</td><td>3103±1495</td></tr><tr><td>Buscipid aortic valve n (%)</td><td>9 (3.8)</td></tr><tr><td>Aortic valve STJ diameter (mm)</td><td>28.62±3.77</td></tr><tr><td>Membernous septum length (mm)</td><td>5.58±2.92</td></tr><tr><td><strong>TAVI procedure</strong></td><td></td></tr><tr><td>Bioprothetic valve size</td><td></td></tr><tr><td>23mm</td><td>36 (15.1%)</td></tr><tr><td>26mm</td><td>122 (51.2%)</td></tr><tr><td>29mm</td><td>80 (33.6%)</td></tr><tr><td>Oversizing (%)</td><td>10.63 (14.169)</td></tr><tr><td>Predilation (%)</td><td>59 (24.7)</td></tr><tr><td>Implantation depth - mean (mm)</td><td>5.57±2.25</td></tr><tr><td>Implantation depth - NC (mm)</td><td>5.97±2.61</td></tr><tr><td>Implantation depth - LC (mm)</td><td>5.17±2.43</td></tr><tr><td>Implantation depth – Δ mean (mm)</td><td>-0.04±3.77</td></tr><tr><td>Implantation depth – Δ NC (mm)</td><td>-0.33±4.06</td></tr><tr><td>Implantation depth – Δ LC (mm)</td><td>0.44±3.92</td></tr></table>
With regard to post procedural PPM implantation within the hospital stay, 60 of the 239 patients (25.1%) found to have an indication for PPM with variable cause demonstrated in table 2. It is observed that 60% of the patients who received PPM were for complete heart block followed by 21.6% for new LBBB with AVB. Less prominent causes were presented in 4 patients (6.6%) with persistent LBBB, 3 patients (5%) with sinus node dysfunction and pause, 2 patients (3.3%) with alternating bundle branch block and finally 2 patients (3.3%) after electrophysiological study with a HV duration more than 70ms. The characteristics of the PPM group are demonstrated in table 3. The group who benefited from pacemaker implantation tend to be older (p-value 0.042). In terms of other cardiovascular risk factors, the two groups were similar and there were no significant differences. It was found that 70% of patients with PPM post TAVI had a history of coronary artery disease (p-value 0.012) and 35% had peripheral artery disease (P-value 0.011). The PPM group in comparison to no PPM post TAVI had higher EUROSCORE II 4.3±5.1, 2.8±2.6 (P-value 0.038). The level of symptoms did not differ a lot between the two groups. We notice that baseline pre-TAVI ECG with conductive abnormality is more in the PPM group. We found that 43.3% of the PPM group had a RBBB, 43.3% had BAV type 1 and 16.7% had bifascicular block all were statistically significant. On the contrary, the group who did not need a PPM post TAVI had less baseline conduction abnormality. The echocardiography characteristics did not differ between the two groups except for mean gradient where the no PPM group had higher transvalvular gradient. As to MDCT, the PPM patients had a bigger annular surface as compared to no PPM group (P-value 0.002). The length of membranous septum is shorter (4.8±2.2) in the PPM group in contrast to no PPM group (5.8±3), which was statistically significant (P-value 0.007).

<table><caption>**Table 2 PPM indication**</caption><thead><tr><td>PPM indication</td><td>Implanted PPM [n = 60 (25.1%)]</td></tr></thead><tbody><tr><td>Atrioventricular block grade 3</td><td>36 (60%)</td></tr><tr><td>New LBBB with AVB</td><td>13 (21.6%)</td></tr><tr><td>New persistent LBBB</td><td>4 (6.6%)</td></tr><tr><td>Sinus dysfunction and pause</td><td>3 (5%)</td></tr><tr><td>Alternating bundle branch block</td><td>2 (3.3%)</td></tr><tr><td>After electrophysiological study HV > 70</td><td>2 (3.3%)</td></tr></tbody></table>

<table><caption>**Table 3 patients characteristics**</caption><thead><tr><th>Variable</th><th>Implanted PM (n = 60)</th><th>PM indication is absent (n=179)</th><th>P value</th></tr></thead><tbody><tr><td><strong>Clinical characteristics</strong></td><td></td><td></td><td></td></tr><tr><td>Age (years)</td><td>80.33±7.61</td><td>77.97±7.77</td><td>0.042</td></tr><tr><td>male n (%)</td><td>46 (76.7)</td><td>114 (63.7)</td><td>0.064</td></tr><tr><td>female n (%)</td><td>14 (23.3)</td><td>65 (36.3)</td><td>0.064</td></tr></tbody></table>
<table><tr><td>BMI (kg/m²)</td><td>28.50±5.27</td><td>28.25±5.72</td><td>0.760</td></tr><tr><td>Hypertension n (%)</td><td>49 (81.7)</td><td>147 (82.1)</td><td>0.937</td></tr><tr><td>Diabetes mellitus n (%)</td><td>24 (40)</td><td>63 (35.2)</td><td>0.503</td></tr><tr><td>Chronic kidney disease n (%)</td><td>23 (38.3)</td><td>61 (34.1)</td><td>0.550</td></tr><tr><td>CrCl</td><td>64.30±25.61</td><td>71.77±25.66</td><td>0.52</td></tr><tr><td>Coronary artery disease n (%)</td><td>42 (70)</td><td>92 (51.4)</td><td>0.012</td></tr><tr><td>Peripheral artery disease n (%)</td><td>21 (35)</td><td>34 (19)</td><td>0.011</td></tr><tr><td>Paroxystic atrial fibrillation n (%)</td><td>8 (13.3)</td><td>16 (8.9)</td><td>0.327</td></tr><tr><td>Permanent atrial fibrillation n (%)</td><td>14 (23.3)</td><td>29 (16.2)</td><td>0.213</td></tr><tr><td>Euroscore I - A</td><td>8.372±2.37</td><td>7.88±2.06</td><td>0.133</td></tr><tr><td>Euroscore I - L</td><td>13.05±10.24</td><td>10.45±6.83</td><td>0.073</td></tr><tr><td>Euroscore II</td><td>4.38±5.18</td><td>2.894±2.65</td><td>0.038</td></tr><tr><td>Symptoms n (%)</td><td></td><td></td><td></td></tr><tr><td>NYHA class I n (%)</td><td>7 (11.7)</td><td>13 (7.3)</td><td>0.141</td></tr><tr><td>NYHA class II n (%)</td><td>24 (40)</td><td>97 (54.2)</td><td>0.141</td></tr><tr><td>NYHA class III n (%)</td><td>25 (41.7)</td><td>52 (29.1)</td><td>0.141</td></tr><tr><td>NYHA class IV n (%)</td><td>4 (6.7)</td><td>17 (9.5)</td><td>0.141</td></tr><tr><td>Angina n (%)</td><td>5 (8.3)</td><td>18 (10.1)</td><td>0.695</td></tr><tr><td>Syncope n (%)</td><td>3 (5)</td><td>6 (3.4)</td><td>0.562</td></tr><tr><td>Electrocardiogram</td><td></td><td></td><td></td></tr><tr><td>AVB type 1 n (%)</td><td>26 (43.3)</td><td>42 (23.5)</td><td>0.003</td></tr><tr><td>LAFB n (%)</td><td>20 (33.3)</td><td>40 (22.3)</td><td>0.089</td></tr><tr><td>LPFB n (%)</td><td>1 (1.7)</td><td>3 (1.7)</td><td>0.996</td></tr><tr><td>LBBB n (%)</td><td>9 (15)</td><td>22 (12.3)</td><td>0.589</td></tr><tr><td>RBBB n (%)</td><td>26 (43.3)</td><td>22 (12.3)</td><td>&lt;0.001</td></tr><tr><td>Bifascicular block n (%)</td><td>10 (16.7)</td><td>8 (4.5)</td><td>0.002</td></tr><tr><td>Echocardiography and CT scan</td><td></td><td></td><td></td></tr><tr><td>Ejection fraction</td><td>54.53±14.85</td><td>56.59±13.93</td><td>0.332</td></tr><tr><td>Vmax (m/s)</td><td>426.42±62.99</td><td>439.85±64.02</td><td>0.164</td></tr><tr><td>Mean gradient (mmHg)</td><td>46.3±12.03</td><td>50.66±15.26</td><td>0.047</td></tr></table>
<table><tbody><tr><td>Aortic valve surface (cm²)</td><td>0.77±0.19</td><td>0.784±0.19</td><td>0.837</td></tr><tr><td>Aortic valve surface – indexed (cm²/m²)</td><td>0.40±0.09</td><td>0.40±0.11</td><td>0.938</td></tr><tr><td>Presence of AR n (%)</td><td>30 (50)</td><td>97 (54.2)</td><td>0.574</td></tr><tr><td>AR grande 1</td><td>17 (58.6)</td><td>72 (76.6)</td><td>0.014</td></tr><tr><td>AR grade 2</td><td>10 (34.5)</td><td>22 (23.4)</td><td>0.014</td></tr><tr><td>AR grade 3</td><td>2 (6.9)</td><td>0 (0)</td><td>0.014</td></tr><tr><td>Annular diameter – short axis (mm)</td><td>23.32±2.23</td><td>22.46±2.63</td><td>0.28</td></tr><tr><td>Annular diameter – long axis (mm)</td><td>28.64±2.60</td><td>27.51±2.60</td><td>0.005</td></tr><tr><td>Annular perimeter (mm)</td><td>81.72±9.59</td><td>79.49±7.07</td><td>0.061</td></tr><tr><td>Annular surface (mm²)</td><td>528.94±78.54</td><td>488.76±85.91</td><td>0.002</td></tr><tr><td>Aortic valve calcium score</td><td>3306±1717</td><td>3035±1413</td><td>0.244</td></tr><tr><td>Aortic valve planimetry (mm²)</td><td>128.92±64.23</td><td>111.76±38.70</td><td>0.085</td></tr><tr><td>Bicuspid aortic valve n (%)</td><td>2 (3.3)</td><td>7 (3.9)</td><td>0.839</td></tr><tr><td>Aortic valve STJ diameter (mm)</td><td>29.86±3.69</td><td>28.21±3.72</td><td>0.004</td></tr><tr><td>Membranous septum length (mm)</td><td>4.81±2.23</td><td>5.83±3.08</td><td>0.007</td></tr><tr><td><strong>TAVI procedure</strong></td><td></td><td></td><td></td></tr><tr><td>Bioprosthetic valve size</td><td></td><td></td><td></td></tr><tr><td>23mm</td><td>4 (6.7)</td><td>33 (18.4)</td><td>0.014</td></tr><tr><td>26mm</td><td>28 (46.7)</td><td>94 (52.5)</td><td>0.014</td></tr><tr><td>29mm</td><td>28 (46.7)</td><td>52 (29.1)</td><td>0.014</td></tr><tr><td>Oversizing</td><td>8.62±11.14</td><td>11.28±14.99</td><td>0.220</td></tr><tr><td>Predilation (%)</td><td>13 (21.7)</td><td>46 (25.7)</td><td>0.531</td></tr><tr><td><strong>Implantation depth & Delta</strong></td><td></td><td></td><td></td></tr><tr><td>Implantation depth NC (mm)</td><td>7.05±3.0</td><td>5.60±2.36</td><td>&lt; 0.001</td></tr><tr><td>Implantation depth LC (mm)</td><td>5.61±2.74</td><td>5.02±2.30</td><td>0.103</td></tr><tr><td>Implantation depth - mean (mm)</td><td>6.33±2.52</td><td>5.31±2.10</td><td>0.002</td></tr><tr><td>Delta NC (ΔSM-ID NC)</td><td>-2.31±3.85</td><td>0.32±3.93</td><td>&lt; 0.001</td></tr><tr><td>Delta LC (ΔSM-ID LC)</td><td>-0.87±3.53</td><td>0.89±3.96</td><td>0.002</td></tr><tr><td>Mean delta (ΔSM-ID mean)</td><td>-1.595±3.428</td><td>0.483±3.749</td><td>&lt; 0.001</td></tr></tbody></table>
In table 4 Univariate logistic regression analysis showed that EUROSCORE II (odds ratio [OR]:1.1; 95% confidence interval [CI]: 1.0 to 1.2 ;p 0.01 ), peripheral vascular disease (odds ratio [OR]: 2.29; 95% confidence interval [CI]: 1.2 to 4.39;p 0.012 ), Coronary artery disease (odds ratio [OR]: 2.2; 95% confidence interval [CI]: 1.18 to 4.1;p 0.013 ), AVB grade 1 (odds ratio [OR]:2.49 ; 95% confidence interval [CI]: 1.34 to 4.6 ;p 0.004), RBBB (odds ratio [OR]:5.4 ; 95% confidence interval [CI]: 2.7 to 10.7 ;p < 0.001), Bifascicular block (odds ratio [OR]:4.2 ; 95% confidence interval [CI]: 1.6 to 11.4 ;p 0.004), Annular short axis diamater and long axis diameter respectivly (odds ratio [OR]:1.13, 1.18 and; 95% confidence interval [CI]: 1 to 1.2, 1 to 1.3;p 0.031, 0.006 ), STJ diameter (odds ratio [OR]: 1.1; 95% confidence interval [CI]: 1 to 1.2 ;p 0.005 ), Memberanous septum length (odds ratio [OR]: 0.8 ; 95% confidence interval [CI]: 0.7 to 0.9 ;p 0.022 ) Sapiens 3 valve size (odds ratio [OR]: 1.2; 95% confidence interval [CI]: 1 to 1.4 ;p 0.004 ), Implantation depth in the NC (odds ratio [OR]: 1.2; 95% confidence interval [CI]: 1.1 to 1.3 ;p < 0.001), The mean of implantation depth for NC and LC (odds ratio [OR]: 1.2; 95% confidence interval [CI]: 1 to 1.3;p 0.003), Delta NC (ΔSM-ID NC), Delta LC (ΔSM-ID LC) and Mean delta (ΔSM-ID mean) respeictvily (odds ratio [OR]:0.83, 0.88 and 0.84; 95% confidence interval [CI]: 0.76 to 0.9, 0.81 to 0.95, 0.77 to 0.92 ;p < 0.001, p 0.003 and p <0.001) are predictors for PPM post TAVI with SAPIEN 3.

<table><caption>**Table 4 Univariate logistic regression analysis**</caption><thead><tr><td>VARIABLE</td><td>Relative risk (odds ratio) for the need to PM implantation</td><td>P value</td></tr></thead><tbody><tr><td>Age</td><td>1.042 (1.001-1.085)</td><td>0.044</td></tr><tr><td>Male</td><td>0.534 (0.273-1.045)</td><td>0.067</td></tr><tr><td>BMI</td><td>1.008 (0.957-1.061)</td><td>0.759</td></tr><tr><td>NYHA</td><td>1.044 (0.713-1.529)</td><td>0.823</td></tr><tr><td>Angina</td><td>0.813 (0.288-2.294)</td><td>0.696</td></tr><tr><td>Syncope</td><td>1.1518 (0.368-6.265)</td><td>0.564</td></tr><tr><td>Euroscore1A</td><td>1.110 (0.969-1.271)</td><td>0.134</td></tr><tr><td>Euroscore1L</td><td>1.039 (1.003-1.076)</td><td>0.033</td></tr><tr><td>Euroscore2</td><td>1.111 (1.025-1.205)</td><td>0.010</td></tr><tr><td>Diabetes Miletus</td><td>1.228 (0.673-2.238)</td><td>0.504</td></tr><tr><td>Hypertension</td><td>0.970 (0.455-2.068)</td><td>0.937</td></tr><tr><td>Peripheral vascular disease</td><td>2.296 (1.200-4.393)</td><td>0.012</td></tr><tr><td>CrCl</td><td>0.988 (0.977-1.000)</td><td>0.054</td></tr><tr><td>Chronic kidney disease</td><td>1.202 (0.656-2.203)</td><td>0.550</td></tr></tbody></table>
<table>
  <tr>
    <td>Coronary artery disease</td>
    <td>2.207 (1.181-4.123)</td>
    <td>0.013</td>
  </tr>
  <tr>
    <td>Atrial fibrillation – paroxysmal</td>
    <td>1.567 (0.635-3.871)</td>
    <td>0.330</td>
  </tr>
  <tr>
    <td>Atrial fibrillation – Chronic</td>
    <td>1.574 (0.768-3.229)</td>
    <td>0.216</td>
  </tr>
  <tr>
    <td>AVB grade 1</td>
    <td>2.494 (1.346-4.621)</td>
    <td>0.004</td>
  </tr>
  <tr>
    <td>RBBB</td>
    <td>5.457 (2.770-10.751)</td>
    <td>&lt; 0.001</td>
  </tr>
  <tr>
    <td>LBBB</td>
    <td>1.259 (0.545-2.910)</td>
    <td>0.589</td>
  </tr>
  <tr>
    <td>LAFB</td>
    <td>1.737(0.915-3.301)</td>
    <td>0.092</td>
  </tr>
  <tr>
    <td>LPFB</td>
    <td>0.994 (0.101-9.744)</td>
    <td>0.966</td>
  </tr>
  <tr>
    <td>Bifascular block</td>
    <td>4.275 (1.602-11.409)</td>
    <td>0.004</td>
  </tr>
  <tr>
    <td>Ejection fraction</td>
    <td>0.990 (0.970-1.010)</td>
    <td>0.331</td>
  </tr>
  <tr>
    <td>Vmax (m/s)</td>
    <td>0.997 (0.992-1.001)</td>
    <td>0.164</td>
  </tr>
  <tr>
    <td>Mean gradient (mmHg)</td>
    <td>0.978 (0.957-1.000)</td>
    <td>0.049</td>
  </tr>
  <tr>
    <td>Aortic valve surface (cm²)</td>
    <td>0.845 (0.173-4.138)</td>
    <td>0.836</td>
  </tr>
  <tr>
    <td>Aortic valve surface – indexed (cm²/m²)</td>
    <td>1.147 (0.037-35.625)</td>
    <td>0.938</td>
  </tr>
  <tr>
    <td>Presence of AR</td>
    <td>0.845 (0.471-1.518)</td>
    <td>0.574</td>
  </tr>
  <tr>
    <td>AR grade</td>
    <td>2.566 (1.154-5.704)</td>
    <td>0.021</td>
  </tr>
  <tr>
    <td>Annular diameter – short axis (mm)</td>
    <td>1.138 (1.012-1.279)</td>
    <td>0.031</td>
  </tr>
  <tr>
    <td>Annular diameter – long axis (mm)</td>
    <td>1.187 (1.051-1.341)</td>
    <td>0.006</td>
  </tr>
  <tr>
    <td>Annular perimeter (mm)</td>
    <td>1.043 (0.998-1.089)</td>
    <td>0.060</td>
  </tr>
  <tr>
    <td>Annular surface (mm²)</td>
    <td>1.006 (1.002-1.009)</td>
    <td>0.003</td>
  </tr>
  <tr>
    <td>Aortic valve calcium score</td>
    <td>1.000 (1.000-1.000)</td>
    <td>0.245</td>
  </tr>
  <tr>
    <td>Aortic valve planimetry (mm²)</td>
    <td>1.007 (1.0001-1.014)</td>
    <td>0.033</td>
  </tr>
  <tr>
    <td>Aortic valve STJ diameter (mm)</td>
    <td>1.126 (1.036-1.224)</td>
    <td>0.005</td>
  </tr>
  <tr>
    <td>Membranous septum length (mm)</td>
    <td>0.870 (0.772-0.980)</td>
    <td>0.022</td>
  </tr>
  <tr>
    <td>Bicuspid aortic valve n (%)</td>
    <td>0.847 (0.171-4.194)</td>
    <td>0.839</td>
  </tr>
  <tr>
    <td>Sapiens 3 valve size</td>
    <td>1.255 (1.075-1.467)</td>
    <td>0.004</td>
  </tr>
  <tr>
    <td>Pre dilatation</td>
    <td>0.800 (0.397-1.610)</td>
    <td>0.531</td>
  </tr>
  <tr>
    <td>Implantation depth NC (mm)</td>
    <td>1.235 (1.100-1.388)</td>
    <td>&lt; 0.001</td>
  </tr>
  <tr>
    <td>Implantation depth LC (mm)</td>
    <td>1.105 (0.980-1.247)</td>
    <td>0.104</td>
  </tr>
  <tr>
    <td>Implantation depth - mean (mm)</td>
    <td>1.223 (1.070-1.398)</td>
    <td>0.003</td>
  </tr>
</table>
<table><tr><td>Delta NC (ΔSM-ID NC)</td><td>0.835 (0.768-0.909)</td><td>&lt; 0.001</td></tr><tr><td>Delta LC (ΔSM-ID LC)</td><td>0.882 (0.812-0.958)</td><td>0.003</td></tr><tr><td>Mean delta (ΔSM-ID mean)</td><td>0.848 (0.775-0.928)</td><td>&lt; 0.001</td></tr></table>

On the multivariate logistic regression analysis which included the EUROSCORE II, presence of RBBB pre-TAVI, the annular surface measured by MDCT, MS length measured by MDCT and depth of the valve implantation. All included variables had a statistical significance with a variable OR. The RBBB remains the high predictive factor for implantation of PPM post TAVI (odds ratio: 5.516 [95% confidence interval:2.564-11.688] p = < 0.001).

<table><caption>**Table 5 Multivariate logistic regression analysis**</caption><thead><tr><td>Variable</td><td>OR (CI)</td><td>P value</td></tr></thead><tbody><tr><td>EUROSCORE II</td><td>1.107 (1.012-1.212)</td><td>0.027</td></tr><tr><td>RBBB</td><td>5.516 (2.564-11.866)</td><td>&lt; 0.001</td></tr><tr><td>AV surface</td><td>1.004 (1.000-1.008)</td><td>0.049</td></tr><tr><td>MS</td><td>0.906 (0.796-1.032)</td><td>0.137</td></tr><tr><td>average depth</td><td>1.189 (1.017-1.389)</td><td>0.030</td></tr></tbody></table>

**Discussion:**

This study aims to explore the rate of PPM implantation after TAVI with SAPIENS 3 valve due to new conduction abnormalities in relation to the implantation depth and length of membranous septum. The leading findings of the study are 1) MS length, baseline conduction abnormality (1ste degree AVB or RBBB), implantation depth (specifically at the level of non-coronary cusp), EUROSCORE II, SAPIENS 3 valve (incremental) are all a predictive factor for PPM implantation 2) The delta length of valve implantation and MS is a strong predictor 3) MS length has less predictive weight if taken within other variables 4) Implantation depth remains a strong predictor of PPM implantation.

Conduction abnormalities necessitating a permanent pacemaker implantation were reported early in TAVI receiving SAPIEN 3 valves with long-term follow-up showed a rate of 12.5% of PPM implantation, where RBBB stands to be the leading predictive factor among other factors like age, annulus calcification, oversizing and implantation depth more than 6mm (11-14). Moreover, aortic valve cusps calcification volume has been quantified and found to be a predictor for post TAVI PM implantation at 30 days specifically the NC cusp calcification where a calcium volume > 225-239.2 mm3 is associated with higher rates of PPM implantation(15,16). A cut off value > 10mm3 of calcium in the LVOT was decided based on a study for residual aortic regurgitation(17). Arbitrary, this cut off was used to assess for other post TAVI complication including PPM rate where the implantation rate was similar between the compared groups, significant and non-significant LVOT calcification(18). Another method of LVOT extension where the presence of a calcific nodule in the LVOT with vertical extension, horizontal protrusion, and circumferential extension. The study found that presence of calcification extension from the NC cusp to the LVOT
is an independent predictive factor (19). Yet not all LVOT calcification is predictive for PPM post TAVI (20).

Besides clinical and pre-TAVI imaging characteristics, focus was on the anatomical variations which predispose this complication(21–25). The atrioventricular axis usually passes in the inferior edge of the membranous septum giving raise to the right and left bundle branches(26) but other variations has been reported(23). Here, the baseline risk factors, MS length as well as implantation depth play a major role in the outcome of the procedure. On different studies with different valves, respecting such anatomical variation led to decreasing the risk of PPM post TAVI(27–29). New studies suggest a high implantation is feasible and safe. This technique showed lower rates of conduction abnormalities post TAVI with SAPIEN 3 and lower rates of PPM implantations. Other variables were also in support to this technique(30). Various techniques are proposed to achieve a high implantation position where it showed its superiority as compared to the conventional technique while preserving the safety(31–33). Given our analysis, considering such technique may improve the overall outcome as recently it was reported that PPM implantation led to degradation of the LVEF at 5 years follow up, despite absence of increase rate of all-cause mortality or repeat hospitalization(14).

Another entity is the inferoseptal recess which is an anatomical area between the mitral valve and the septal portion of the left ventricle. Its fibrous tissue is in contact with the membranous septum. The inferoseptal recess has a close relation to the Mitral valve, specifically, the right trigone. Also, it is close to the right coronary cusp. Measurements by MDCT has been proposed and further studies are needed to assess for the rule of this part in conduction abnormalities post TAVI while taking into consideration the presence of calcification in this anatomical part or the surrounding anatomical structures such as the right trigone (34).

We have found that MS length still has weight with other factors for conduction abnormality. Even though the univariate model showed a statically significant effect of MS length to predict the need of PPM post TAVI, multivariate regression showed a statistically non-significance of MS length if taken with other variables. MS length can be a risk modifier rather than an independent predictive factor. The length of MS can be a determinant for valve choice, implantation technique or to simply explain the risk to the patient pre procedure. The high implantation rate of PPM in our study can be explained by high baseline conductive abnormalities (RBBB and AVB grade 1), sicker patients reflected by high EUROSCORE II or an intermediate MS length across all patients. Moreover, the newer generation of SAPIEN 3 is characterized by higher radial force as compared to other valves. This might explain that lower implantation depth carries higher risk as compared to other TAVI valves. A combination of low and short MS presented as delta value carries a very high risk of conduction abnormalities.

**Limitations:**

This is a retrospective observational study where included patients are not randomised. It was known that self-expandable valves carry more risk for post TAVI conductive abnormalities, this might explain why the included patients in this study had higher risk for PPM implantation with baseline RBBB, AVB grade I or other previously mentioned risk factors. This study lacks some of
other variables that might play a role in the outcome, for example calcium score for each cusp separately, calcium score for the LVOT. Unfortunately, a 30-day follow was not done. Some patients might end up having a PPM after hospitalization and within the 30-day period. The PPM group had high pre operative risk as reflected by EUROSCORE II. Even though the rate of post dilatation was very low, the study did not include this variable. Another prominent limitation is the implantation depth measurement which was realized in post implantation injection which carries the risk of under or over estimation. A more precise measurement with MDCT would be ideal for accurate measurement. Finally, Interaction by regression analysis is needed to understand more the relations of the other predictors not studied in the multivariate regression.

**Conclusion:**

This study demonstrated a support to older data for predictors of post TAVI conductive abnormalities needing PPM implantation. Furthermore, it highlights the importance of MS length and implantation depth. Risk stratification of patients receiving SAPIEN 3 valves will help a better plan for the procedure to avoid post implantation conduction abnormalities. MS length raise as a risk modifier rather than an independent risk factor. Adjustment of the current implantation technique by higher implantation of TAVI especially in high-risk patients might help lower the need of PPM post TAVI.

**Acknowledgement:**

**References**

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