Thirty- to 35% of patients after transcatheter aortic valve implantation undergo implantation of a permanent pacemaker (PPM) because of development of atrioventricular block (AVB) or development of a condition with high risk of progression to AVB. There are insufficient data regarding long-term follow-up on pacing dependency. From February 2009 to July 2011, 191 transcatheter aortic valve implantation procedures were performed at the Rabin Medical Center (125 CoreValve and 66 Edwards SAPIEN). Thirty-two patients (16.7%) received a PPM (30 with CoreValve and 2 with Edwards SAPIEN). Data from the pacemaker clinic follow-up was available in 27 patients. After a mean follow-up of 52 weeks (range, 22 to 103), only 8 (29%) of 27 patients were pacing dependent. The indication of PPM in these 8 patients was complete AVB. In conclusion, in our center, the rate of PPM implantation was 16%, which is lower than that reported in the published works. Only 29% of those patients implanted with PPM were pacemaker dependent. Further studies are necessary to define reliable predictors for long-term pacing.
Transcatheter aortic valve implantation (TAVI), a relatively new technology, is rapidly becoming a mainstream therapy in the management of severe aortic stenosis. One of the most common complications after TAVI is conduction disorders, including high degree atrioventricular block (AVB). Consequently, permanent pacemaker (PPM) is frequently implanted after TAVI. Evidence suggests that conduction disorder after TAVI may resolve over time, and a relatively low proportion of patients implanted with PPM are actually paced. The aim of this study was to evaluate the long-term pacemaker dependency in a cohort of patients with TAVI from a single large-volume center.
Methods
From February 2009 to July 2012, 191 patients underwent TAVI, for severe aortic stenosis, at the Rabin Medical Center. The indications for TAVI were according to the European Society of Cardiology guidelines and the Heart Team decision. One hundred twenty-five patients were implanted with a CoreValve (CV) (Medtronic Inc., Minneapolis, Minnesota) and 66 with Edwards SAPIEN valve (ES) (Sapien or Sapien XT, Edwards Lifesciences, Irvine LLC, California). Thirty-two of these patients were implanted (after TAVI) with a PPM, 30 after CV and 2 after ES. Thirteen patients, who had a PPM implanted before the TAVI, were not included in this analysis.
All patients had a baseline electrocardiography (before TAVI) and continuous electrocardiographic monitoring after the TAVI. All patients had transvenous temporary cardiac pacing during the procedure. According to our protocol, the temporary pacing system was removed 4 hours after TAVI if no evidence of significant conduction disturbance was present.
Patients’ demographics, clinical features, and electrocardiographic findings were reviewed. Diagnostic criteria, as recommended by the World Health Organization and the International Society and Federation for Cardiology Task Force, were used for the diagnosis of left and right fascicular hemiblock and left and right bundle branch block.
The indication for PPM implantation was collected from the medical records of each patient. Pacing dependency was assessed for all patients during the pacemaker clinic follow-up. Patients were defined as pacemaker dependent if they had high degree AVB (second degree AVB or complete AVB) or intrinsic rhythm <30 beats/min during PPM inhibition.
This study was approved by our Institutional Review Board.
The results are presented as the median, interquartile range, and twenty-fifth and seventy-fifth percentiles for continuous variables and as percentage from all patients for categorical data. Mann-Whitney U test was used for comparison of the continuous variables, whereas chi-square test was used for categorical data with the use of Fisher’s exact test if needed. A 2-sided p value of <0.05 was considered statistically significant.
Results
Of the 191 patients who underwent TAVI, 32 patients (16.7%) were implanted with a PPM (30 after CV and 2 after ES implantation, respectively). Three patients died (non-PPM–related cause) before the first pacemaker clinic visit (2 after CV and 1 after ES implantation), and 2 patients were lost to follow-up (both with CV). Thus, pacemaker clinic follow-up data were available for 27 patients. To assess long-term pacemaker dependency, we collected data from the latest available visit for each patient, average 52 weeks (range, 22 to 103) after PPM implantation. Of these 27 patients, only 8 (29%) were pacing dependent, as previously defined.
When comparing patients who were pacemaker dependent to those who were not, there were no significant differences in demographics, baseline electrocardiographic findings, and TAVI characteristics between groups. Indications for PPM implantation are listed in Tables 1 and 2 .
| Patient | Size | Age (yrs) | Gender | ECG Before TAVI | Indication | PPM | Follow-Up |
|---|---|---|---|---|---|---|---|
| 1 | 26 | 77 | W | Narrow QRS | LBBB long PR | DDDR | Not dependent |
| 2 | 26 | 78 | W | Sinus IRBBB | Transient CAVB | DDD | Not dependent |
| 3 | 26 | 79 | W | IRBBB | LBBB long PR | DDDR | Not dependent |
| 4 | 29 | 81 | M | LBBB long PR | CAVB | VVIR | Not dependent |
| 5 | 26 | 81 | W | Narrow QRS | Transient CAVB | VVIR | Not dependent |
| 6 | 29 | 81 | W | Narrow QRS | LBBB long PR | VDDD | Not dependent |
| 7 | 29 | 82 | M | AF LAHB CRBBB | LBBB long PR | VVIR | Not dependent |
| 8 | 29 | 82 | M | AF Narrow QRS | LBBB | VVIR | Not dependent |
| 9 | 26 | 82 | M | CRBBB | Transient CAVB | DDDR | Not dependent |
| 10 | 29 | 85 | W | Sinus | CAVB | VVIR | Not dependent |
| 11 | 29 | 85 | W | Narrow QRS | CAVB | VVIR | Not dependent |
| 12 | 26 | 85 | M | Narrow QRS | LBBB long PR | VDDD | Not dependent |
| 13 | 29 | 86 | M | CAF IRBBB | LBBB | VVIR | Not dependent |
| 14 | 29 | 86 | M | Narrow QRS | SSS | DDD | Not dependent |
| 15 | 26 | 87 | W | Narrow QRS | LBBB long PR | DDDR | Not dependent |
| 16 | 29 | 89 | W | Narrow QRS | CAVB | VDDD | Not dependent |
| 17 | 29 | 91 | M | AF Narrow QRS | CAVB | VVI | Not dependent |
| 18 | 29 | 92 | M | Narrow QRS | LBBB long PR | VVIR | Not dependent |
| Patient | Size | Age (yrs) | Gender | ECG Before TAVI | Indication | PPM | Follow-Up |
|---|---|---|---|---|---|---|---|
| 1 | 29 | 68 | W | Narrow QRS | CAVB | VVIR | Dependent |
| 2 | 26 | 74 | W | CRBBB | CAVB | DDDR | Dependent |
| 3 | 29 | 75 | M | Narrow QRS | CAVB | DDDR | Dependent |
| 4 | 29 | 77 | W | Narrow QRS | CAVB | DDDR | Dependent |
| 5 | 29 | 82 | M | AF CRBBB LAHB | CAVB | DDD | Dependent |
| 6 | 26 | 87 | W | CRBBB | CAVB | VVI | Dependent |
| 7 | 29 | 85 | W | Narrow QRS | CAVB | VDDR | Dependent |
| 8 | 29 | 90 | W | Narrow QRS | CAVB | VVIR | Dependent |
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