Novel predictors of permanent pacemaker implantation following transcatheter aortic valve replacement

Table 1 Demographics and clinical characteristics of the patient population

Characteristics	No PPM	PPM	P value
	n = 300 (%)	n = 57 (%)
Age	81.0 (8.2)	80.3 (7.6)	0.530
Male	158 (52.7)	30 (52.6)	1.00
BMI	30.5 (6.6)	31.4 (6.6)	0.380
STS risk score			0.168
High (≥ 8%)	194 (64.7)	41 (73.2)
Intermediate (4%-7%)	72 (24)	12 (21.4)
Low (< 4%)	34 (11.3)	3 (5.4)
Cardiovascular history
AF	128 (42.7)	28 (49.1)	0.385
CAD	260 (86.7)	51 (89.5)	0.670
MI	62 (20.7)	16 (28.1)	0.223
HF	280 (93.3)	54 (94.7)	1.00
NYHA HF class			0.495
1	4 (1.5)	1 (1.9)
2	101 (38.1)	18 (34)
3	148 (55.8)	30 (56.6)
4	12 (4.5)	4 (7.5)
PCI or stent	134 (44.7)	29 (50.9)	0.469
CABG	47 (15.7)	13 (22.8)	0.182
Previous AV replacement	24 (8.0)	1 (1.8)	0.151
Hypertension	284 (94.7)	56 (98.2)	0.493
Dyslipidemia	271 (90.3)	51 (89.5)	0.810
Diabetes	122 (40.7)	34 (59.6)	0.009
PVD	73 (24.3)	20 (35.1)	0.101
Stroke/TIA	32 (10.7)	8 (14)	0.491
Balloon valvuloplasty	149 (50)	35 (62.5)	0.108
Other comorbidities
COPD	89 (29.7)	11 (19.3)	0.147
Liver disease	4 (1.3)	1 (1.8)	0.583
Cancer	142 (47.3)	26 (45.6)	0.885
Anemia	259 (86.3)	51 (89.5)	0.670
Dialysis	15 (5)	4 (7)	0.521

P values and mean ± SD from a 2-sample t-test were reported for continuous variables. Counts (%) and P values from Fisher’s exact test were reported for categorical variables. Kruskal-Wallis test was used for ordinal variables (STS and NYHA HF class). BMI: Body mass index; PPM: Permanent pacemaker; CAD: Coronary artery disease; COPD: Chronic obstructive pulmonary disease; TIA: Transient ischemic attack; PVD: Peripheral vessel disease; PCI: Percutaneous coronary intervention; HF: Heart failure; MI: Myocardial infarction; AF: Atrial fibrillation; STS: Society of thoracic surgeons; PPM: Permanent pacemakers; NYHA: New York Heart Association; CABG: Coronary artery bypass graft.

Table 2 Baseline electrocardiographic and echocardiogram findings

	All	No PPM	PPM	P value
	n = 357	n = 300	n = 57
EKG rhythm abnormalities				0.054
Sinus	265 (74.2)	229 (76.3)	36 (63.2)
Atrial fibrillation	84 (23.5)	66 (22.0)	18 (31.6)
Atrial flutter	4 (1.1)	2 (0.7)	2 (3.5)
Junctional rhythm	2 (0.6)	1 (0.3)	1 (1.8)
Other	2 (0.6)	2 (0.7)	0 (0)
Sinus bradycardia	38 (10.6)	35 (11.7)	3 (5.3)	0.229
Sinus tachycardia	3 (0.8)	3 (1)	0 (0)	1.00
Conduction abnormalities
RBBB	51 (14.3)	33 (11)	18 (31.6)	< 0.001
LBBB	29 (8.1)	24 (8)	5 (8.8)	0.794
AV block I	55 (15.4)	46 (15.3)	9 (15.8)	1.00
AV block IIa	0	0	0	-
AV block IIb	0	0	0	-
AV block III	0	0	0	-
Bifascicular block	5 (1.4)	5 (1.7)	0 (0)	1.00
Left anterior fascicular block	16 (4.5)	12 (4)	4 (7)	0.299
Left posterior fascicular block	1 (0.3)	0 (0)	1 (1.8)	0.16
Abnormal QRS (≥ 120 ms)	89 (25)	62 (20.7)	27 (47.4)	< 0.001
Prolonged QTc (≥ 470 ms)	97 (27.2)	70 (23.4)	27 (47.4)	< 0.001
Echocardiogram findings
Left ventricular EF	58.1 (12.7)	58.5 (11.9)	56 (16.1)	0.272
AV peak velocity	4.1 (0.7)	4.1 (0.7)	4.1 (0.7)	0.957
AV mean gradient	42 (14.7)	42.1 (14.7)	41.3 (14.8)	0.707
AV peak gradient	68.4 (21.9)	68.4 (21.7)	68.1 (23.2)	0.933
AV regurgitation				0.247
None	147 (43.9)	116 (41.6)	31 (55.4)
Mild	162 (48.4)	141 (50.5)	21 (37.5)
Moderate	23 (6.9)	19 (6.8)	4 (7.1)
Severe	3 (0.9)	3 (1.1)	0 (0)
MV regurgitation				0.242
None	28 (8.2)	24 (8.4)	4 (7.1)
Mild	255 (74.8)	208 (73.0)	47 (83.9)
Moderate	52 (15.2)	48 (16.8)	4 (7.1)
Severe	6 (1.8)	5 (1.8)	1 (1.8)
TV regurgitation				0.129
None	19 (5.6)	19 (6.6)	0 (0)
Mild	272 (79.8)	226 (79.0)	46 (83.6)
Moderate	43 (12.6)	36 (12.6)	7 (12.7)
Severe	7 (2.1)	5 (1.7)	2 (3.6)
Pulmonary artery pressure	46.9 (14.1)	45.9 (13.1)	51.6 (17.7)	0.073
Annulus area	0.8 (0.2)	0.8 (0.2)	0.8 (0.3)	0.968
Aortic sinus diameter	3.2 (0.5)	3.2 (0.5)	3.3 (0.5)	0.074
CT annulus diameter 1	25.1 (4.4)	25 (4.3)	25.2 (4.8)	0.849
CT annulus diameter 2	24.2 (4.2)	24.1 (4.2)	24.8 (4.3)	0.273
LV diastolic diameter	4.7 (0.8)	4.7 (0.8)	4.8 (0.8)	0.290
LVOT	20.9 (1.9)	20.8 (1.9)	21.1 (1.9)	0.354

P values and mean ± SD from a 2-sample t-test reported for continuous variables. Counts (%) and P values from Fisher’s exact test were reported for categorical variables. RBBB: Right Bundle Branch Block; LBBB: Left Bundle branch block; CT: Computed tomography; AV: Aortic valve; MV: Mitral valve; TV: Tricuspid valve; PPM: Permanent pacemakers; LVOT: Left ventricular outflow tract.

Table 3 Procedural characteristics and peri-procedural complications

	All	No PPM	PPM	P value
	n = 357	n = 300	n = 57
Urgency				0.699
Elective	344 (96.6)	288 (96.3)	56 (98.2)
Emergency	12 (3.4)	11 (3.7)	1 (1.8)
Valve				0.471
Balloon expandable	192 (53.8)	164 (54.7)	28 (49.1)
Self-expandable	165 (46.2)	136 (45.3)	29 (50.9)
Valve size	26.9 (3)	26.8 (2.9)	27.3 (3)	0.266
Valve index	129.4 (14.9)	129.3 (15.1)	129.9 (13.5)	0.792
Valve sheath access site				0.270
Right femoral	241 (68.5)	206 (69.8)	35 (61.4)
Left femoral	94 (26.7)	72 (24.4)	22 (38.6)
Right subclavian	2 (0.6)	2 (0.7)	0 (0)
Left subclavian	4 (1.1)	4 (1.4)	0 (0)
Right radial	2 (0.6)	2 (0.7)	0 (0)
Transaortic	9 (2.6)	9 (3.1)	0 (0)
Procedure time	1.5 (0.8)	1.4 (0.8)	1.6 (0.9)	0.056
Perioperative complications
Atrial fibrillation	1 (0.3)	1 (0.3)	0 (0)	1.00
Atrial flutter	1 (0.3)	1 (0.3)	0 (0)	1.00
AV block I	6 (1.7)	6 (2)	0 (0)	0.595
AV block II	0	0	0	-
Complete AV block	24 (6.7)	1 (0.3)	23 (40.4)	< 0.001
Ventricular tachycardia	0	0	0	-
Ventricular fibrillation	0	0	0	-
Bleeding	8 (2.2)	8 (2.7)	0 (0)	0.365
Stroke	1 (0.3)	1 (0.3)	0 (0)	1.00
Transfusion	3 (0.8)	3 (1)	0 (0)	1.00
Site bleeding	0	0	0	-
Left axis deviation	3 (0.8)	2 (0.7)	1 (1.8)	0.408
LBBB	0	0	0	-
RBBB	0	0	0	-
Left anterior fascicular block	0	0	0	-
Left posterior fascicular block	0	0	0	-
MI	1 (0.3)	1 (0.3)	0 (0)	1.00
Other	31 (8.7)	24 (8)	7 (12.3)	0.305

P values and mean ± SD from a 2-sample t-test reported for continuous variables except for procedure time which was heavily right skewed. Median (IQR) and P value from a Wilcoxon rank sum test reported for procedure time. Counts (%) and P values from Fisher’s exact test reported for categorical variables. The following tests excluded patients due to missing values: Procedure urgency (1), valve index (2), valve sheath access site (5), procedure time (37). RBBB: Right Bundle Branch Block; LBBB: Left Bundle branch block; AV: Aortic valve; MI: Myocardial infarction; PPM: Permanent pacemakers.

Table 4 Incidence of permanent pacemakers implantation

Variable	Group	n	Incidence (%)	P value
Age	< 65 yr	10	0 (0)	0.284
	65-85 yr	235	41 (17.4)
	> 85 yr	112	16 (14.3)
Sex	Male	169	27 (16.0)	1.00
	Female	188	30 (16.0)
Pre-operative risk	Low	37	3 (8.1)	0.168
	Intermediate	84	12 (14.3)
	High	235	41 (17.4)
Valve type	Balloon expanding	192	28 (14.6)	0.471
	Self-expanding	165	29 (17.6)
Prior BAV	Yes	184	35 (19.0)	0.116
	No	170	21 (12.4)
Procedure time	< 1.5 h	160	20 (12.5)	0.071
	≥ 1.5 h	160	33 (20.6)
Pre-op EKG rhythm abnormalities	Sinus	265	36 (13.6)	0.054
	Atrial fibrillation	83	18 (21.4)
	Atrial flutter	4	2 (50.0)
	Junctional rhythm	2	1 (50.0)
	Other	2	0 (0)
RBBB	Yes	51	18 (35.3)	< 0.001
	No	306	39 (12.7)
LBBB	Yes	29	5 (17.2)	0.794
	No	328	52 (15.9)
AV block I	Yes	55	9 (16.4)	1.000
	No	302	48 (15.9)
Bifascicular block	Yes	5	0 (0)	1.000
	No	352	57 (16.2)
Left anterior fascicular block	Yes	16	4 (25.0)	0.299
	No	341	53 (15.5)
Left posterior fascicular block	Yes	1	1 (100)	0.160
	No	356	56 (15.7)
QRS interval	Abnormal (≥ 120 ms)	89	27 (30.3)	< 0.001
	Normal	267	30 (11.2)
QTc interval	Prolonged (≥ 470 ms)	97	27 (27.8)	< 0.001
	Normal	259	30 (11.6)

EKG: Electrocardiographic; BAV: Balloon aortic valvuloplasty; RBBB: Right bundle branch block; LBBB: Left Bundle branch block; AV: Aortic valve.

Table 5 Incidence of permanent pacemakers implantation by QRS duration

Variable	Group	n	Incidence	P value
QRS interval	≤ 100	194	17 (8.8)	< 0.001
	101-120	74	14 (18.9)
	121-140	38	9 (23.7)
	141-160	40	16 (40.0)
	161-180	10	1 (10.0)
Pre-op EKG supraventricular arrhythmia	Supraventricular arrhythmia1	91	21 (22.8)	0.05
	Sinus rhythm	265	36 (13.6)

¹Supraventricular arrhythmia includes-atrial fibrillation, atrial flutter and junctional rhythms.

EKG: Electrocardiographic.

Table 6 Odds ratios for permanent pacemakers implantation

	OR	95%CI	P value
Age (per 5 yr)	0.95	0.8-1.12	0.549
Male	1.00	0.57-1.76	0.996
Prior AV replacement	0.21	0.03-1.55	0.125
CAD	1.31	0.53-3.25	0.563
HF	1.29	0.37-4.48	0.693
Self-expanding (Reference: balloon)	1.25	0.71-2.20	0.442
Prior conduction defect-RBBB	3.73	1.92-7.26	< 0.001
Prior conduction defect-LBBB	1.11	0.40-3.03	0.845
Prior conduction defect-LFAB	1.81	0.56-5.83	0.319
Valve index	1.00	0.98-1.02	0.806
Abnormal QRS (≥ 120 ms)	3.45	1.91-6.23	< 0.001
Prolonged QTc (≥ 470 ms)	2.94	1.64-5.28	< 0.001
Aortic valve area > 0.75	1.31	0.73-2.36	0.364
High preoperative risk (Reference: Low)	2.40	0.70-8.17	0.163
Intermediate preoperative risk (Reference: Low)	1.89	0.50-7.14	0.348
Supraventricular Arrhythmia on pre-op EKG (Reference: Sinus)	1.88	1.03-3.43	0.039

EKG: Electrocardiographic; RBBB: Right bundle branch block; LBBB: Left Bundle branch block; AV: Aortic valve; LFAB: Left anterior fascicular block; CAD: Coronary artery disease; HF: Heart failure; OR: Odds ratios.

Table 7 Adjusted odds ratios for permanent pacemakers implantation

	aOR	95%CI	P value
Diabetes	2.16	1.18-3.94	0.012
Prior RBBB	2.15	0.91-5.09	0.081
Abnormal QRS (≥ 120 ms)	2.18	1.02-4.66	0.045
Supraventricular arrhythmia on pre-op EKG (Reference: Sinus rhythm)	1.82	0.97-3.42	0.062

Adjusted odds ratios generated from logistic regression model of permanent pacemakers implantation regressed on diabetes, prior right bundle branch block, QRS interval, and pre-operative electrocardiographic Supraventricular arrhythmias. EKG: Electrocardiographic; RBBB: Right bundle branch block; aOR: Adjusted odds ratios.