Abstract
Background
Permanent pacemaker (PPM) placement occurs in 5–20% of patients after transcatheter aortic valve replacement (TAVR). Although predictors of pacemaker implantation have been established, features that predispose patients to pacemaker utilization on follow up have not been widely reported.
Methods
We performed a retrospective review of patients undergoing commercial TAVR between 2011 and 2016. We collated patients that underwent in-hospital PPM implantation and had a follow up of at least 3 months. Data abstraction was performed for electrophysiological studies (EPS), pacemaker indication, timing, and device interrogation for pacemaker dependency on follow up.
Results
A total of 24 patients received in-hospital PPM post-TAVR (14% of total cohort), and mean follow up was 22 months. Indications for PPM included resting complete heart block (CHB; 15/24, 63%), left bundle branch block and abnormal electrophysiological study (EPS; 7/24, 29%), alternating bundle branch block (1/24, 4%) and tachy-brady syndrome (1/24, 4%). Pacemaker dependency (underlying ventricular asystole, complete heart block, or >50% pacing) occurred in 8/24 patients (33%) during follow-up, 7 of whom had resting CHB, and one with CHB invoked during EPS.
Conclusion
Pacemaker dependency after TAVR is common among those that exhibited CHB, but not among those with a prolonged HV delay during EPS. Although preliminary, these observations are relevant to management of rhythm disturbances after TAVR, and may inform the practice of EPS-based PPM implantation.
1
Introduction
Among patients undergoing transcatheter aortic valve replacement (TAVR) heart block occurs between 5 and 20% of cases and is partly dependent on depth of implantation, valve type, and native cardiac rhythm . The deployed valves can cause direct damage to the HIS bundle and AV node leading to worsening conduction, either transiently or permanently . Although sustained complete heart block is a clear indication for pacemaker implantation, there is no broad consensus about the management of new bundle branch or transient complete heart block. Accordingly, practice patterns are heterogeneous and range from prolonged monitoring to electrophysiological testing or even pacemaker implantation for less stringent indications. Pacemaker implantation has been associated with increased short- and long-term mortality – an observation that may represent the inherent conduction abnormality or a feature associated with the pacemaker implantation or operation itself. These issues have profound ramifications for the aggregate cost and quality of life improvements ascribed to TAVR.
Although predictors of pacemaker implantation have been established , there have yet to be consensus on predictors for pacemaker utilization once implanted. The aim of this study was to review our institutional experience with conduction abnormalities post-TAVR, and to determine if EPS-driven indications are corroborated with PM-dependency on subsequent follow up.
2
Methods
2.1
Patient population
The study design was retrospective observational in nature. Data was derived from review of patients undergoing commercial TAVR between November 2011 and Jan 2016. We collated patients that underwent in-hospital PPM implantation and had a follow up of at least three months. Patients with a prior history of PPM were excluded. Fig. 1 represents corresponding flow chart of our study.
2.2
Clinical and EKG criteria
Data abstraction was performed for pacemaker indication, timing, and device interrogation for pacemaker dependency on follow up. Baseline demographics, medical comorbidities and current medications were recorded. Pre-procedural electrocardiographic data were collected from the 12-lead electrocardiograms (EKGs) obtained 12–24 h prior to the procedure. Post-procedure electrocardiographic data were also obtained and reviewed. The EKGs were analyzed for baseline cardiac rhythm, conduction intervals and abnormalities.
2.3
Criteria for pacemaker implantation after the procedure
The indications for pacemaker implantation following TAVR were derived from the clinical documentation and specific electrophysiology consultations describing the conduction disturbance(s) that prompted implantation of PPM. They were subsequently categorized as follows: (1) complete heart block; (2) left bundle branch block, and abnormal EPS study (HV >55 ms, or elicitation of CHB). The timing of PPM implantation was also recorded.
2.4
Post-procedural and follow-up data
Data on pacemaker dependency (in-hospital, within 3 months, and later than 3 months) were collected. Pacemaker dependency was defined as: 1) more than 50% pacing upon device interrogation; 2) underlying complete heart block; 3) underlying asystole >5 s; or 4) symptoms in the setting of bradycardia (rate < 50 bpm).
2.5
Statistical analyses
Our study was purely descriptive and no comparative statistical analysis was performed.
2
Methods
2.1
Patient population
The study design was retrospective observational in nature. Data was derived from review of patients undergoing commercial TAVR between November 2011 and Jan 2016. We collated patients that underwent in-hospital PPM implantation and had a follow up of at least three months. Patients with a prior history of PPM were excluded. Fig. 1 represents corresponding flow chart of our study.
2.2
Clinical and EKG criteria
Data abstraction was performed for pacemaker indication, timing, and device interrogation for pacemaker dependency on follow up. Baseline demographics, medical comorbidities and current medications were recorded. Pre-procedural electrocardiographic data were collected from the 12-lead electrocardiograms (EKGs) obtained 12–24 h prior to the procedure. Post-procedure electrocardiographic data were also obtained and reviewed. The EKGs were analyzed for baseline cardiac rhythm, conduction intervals and abnormalities.
2.3
Criteria for pacemaker implantation after the procedure
The indications for pacemaker implantation following TAVR were derived from the clinical documentation and specific electrophysiology consultations describing the conduction disturbance(s) that prompted implantation of PPM. They were subsequently categorized as follows: (1) complete heart block; (2) left bundle branch block, and abnormal EPS study (HV >55 ms, or elicitation of CHB). The timing of PPM implantation was also recorded.
2.4
Post-procedural and follow-up data
Data on pacemaker dependency (in-hospital, within 3 months, and later than 3 months) were collected. Pacemaker dependency was defined as: 1) more than 50% pacing upon device interrogation; 2) underlying complete heart block; 3) underlying asystole >5 s; or 4) symptoms in the setting of bradycardia (rate < 50 bpm).
2.5
Statistical analyses
Our study was purely descriptive and no comparative statistical analysis was performed.
3
Results
3.1
Baseline demographics & electrocardiographic parameters
We identified a total of 24 patients who underwent TAVR implantation and in-hospital PPM placement between 2011 and 2016, representing 14% (24/171) of the commercial TAVR population at our center. The mean age of this group was 83 years (78–88). The majority of patients were male (54%) and were in sinus rhythm (66.7%) at the time of TAVR. More than half the patients had previous MI (54%) and left ventricular ejection fraction averaged at 51 ± 7%. Clinical parameters are summarized in Table 1 .
| Variable | Value |
|---|---|
| Total study group | 24 |
| Age, years | 83 ± 5 |
| Sex, men/women (%) | 13/11 (54/46%) |
| Left ventricular ejection fraction, LVEF (%) | 51 ± 7 |
| Prior MI n (%) | 13 (54) |
| Prior stroke n (%) | 3/24 (12) |
| Diabetes mellitus, n (%) | 11 (46) |
| Renal insufficiency n (%) | 10 (42%) |
| Hypertension n (%) | 23 (96) |
3.2
Procedural parameters
All patients underwent TAVR via the transfemoral approach. The majority of deployed valve were self-expanding (CoreValve, 22/24, 92%) with sizes distributed as follows: 26 mm (6/24, 25%), 29 mm (13/24, 54%) and 31 mm (3/24, 12.5%). The remaining 2 valves were 27 mm Boston Scientific Lotus. The mean time from TAVR to PPM implant was 3 days (range 1–6). Electrocardiographic data and results of electrophysiological studies are summarized in Table 2 .
| Pre- TAVI | Post- TAVI Day 2 | Valve Type | PPM Indication | 3- Month follow up | Time to PPM Implant (days) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | ECG | ECG | AH | HV | Escape Rhythm | Dependent | Rhythm | |||
| 1 | Afib, LBBB | Afib, RBBB | N/A | N/A | Wide QRS | CORE (29 mm) | Alternating BBB | No | Afib, RBBB | 5 |
| 2 | SR | SR, 3rd | N/A | N/A | Narrow QRS | CORE (29 mm) | CHB | No | SR | 4 |
| 3 | SR | SR, 3rd | N/A | N/A | Narrow QRS | ⁎ 2 CORE (29 & 31 mm) | CHB | No | SR, 3rd | 3 |
| 4 | SR | SR, 3rd | N/A | N/A | Narrow QRS | CORE (29 mm) | CHB | No | SR | 3 |
| 5 | SR, 1st | SR, 3rd | N/A | N/A | Wide QRS | CORE (26 mm) | CHB | No | SR, 1st | 2 |
| 6 | SR | SR, 3rd | N/A | N/A | Narrow QRS | CORE (26 mm) | CHB | No | SR | 2 |
| 7 | AFlutter, RBBB, LAFB | AFlutter, 3rd | N/A | N/A | Wide QRS | CORE (29 mm) | CHB | No | AFlutter, RBBB | 5 |
| 8 | SR, 1st | SR, 3rd | N/A | N/A | Narrow QRS | CORE (26 mm) | CHB | No | SR, 1st | 3 |
| 9 | Afib | Afib, 2nd | N/A | N/A | NA | CORE (29 mm) | Tachy-brady | No | Afib, 2nd | 2 |
| 10 | Afib, RBBB | Afib, 3rd | N/A | N/A | Wide QRS | CORE (29 mm) | CHB | Yes | Afib, 3rd | 2 |
| 11 | SR, RBBB | Aflutter, 3rd | N/A | N/A | Wide QRS | CORE (29 mm) | CHB | Yes | Aflutter, 3rd | 1 |
| 12 | SR, RBBB | SR, 3rd | N/A | N/A | Wide QRS | CORE (29 mm) | CHB | Yes | SR, 3rd | 3 |
| 13 | SR, 1st + RBBB | SR, 3rd | N/A | N/A | Wide QRS | Evolut R CoreValve 26 mm | CHB | Yes | SR, 1st + RBBB | 6 |
| 14 | SR, 1st | SR, 3rd | N/A | N/A | Wide QRS | CORE (31 mm) | CHB | Yes | SR, 3rd | 5 |
| 15 | SR | SR, 3rd | N/A | N/A | Narrow QRS | CORE (26 mm) | CHB | No | SR | 2 |
| 16 | SR, RBBB | SR, 3rd | N/A | N/A | Wide QRS | CORE (31 mm) | CHB | Yes | SR, 3rd | 3 |
| 17 | Afib | SR, 3rd | N/A | N/A | Wide QRS | CORE (29 mm) | CHB | Yes | SR, 3rd | 2 |
| 18 | SR, 1st | SR, 1st + New LBBB | 110 | 55 | Wide QRS | Lotus (27 mm) | Abnormal EPS ⁎ | Yes | SB | 2 |
| 19 | Afib | Afib, New LBBB | 80 | 75 | Wide QRS | CORE (29 mm) | Abnormal EPS | No | Afib | 2 |
| 20 | SR | SR, New LBBB | 110 | 71 | Wide QRS | CORE (29 mm) | Abnormal EPS | No | SR, 1st | 1 |
| 21 | AFlutter | Aflutter, 2nd | 100 | 75 | NA | CORE (26 mm) | Abnormal EPS | No | SB | 2 |
| 22 | SR, 1st | SR, New LBBB | 120–130 | 90 | Wide QRS | CORE (29 mm) | Abnormal EPS | No | SR, 1st | 2 |
| 23 | SR | SR, New LBBB | 120 | 83 | Wide QRS | Lotus (27 mm) | Abnormal EPS | No | SR | 2 |
| 24 | SR, 1st | SR, transient 3rd | 110 | 65 | Wide QRS | CORE (26 mm) | Abnormal EPS | No | Afib | 2 |
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