Small balloon strategy associated with low pacemaker implantation rate after self-expanding transcatheter valve implantation

doi:10.5847/wjem.j.1920-8642.2021.01.008

Abstract

Abstract:

BACKGROUND: This study aims to investigate whether small balloon aortic valvuloplasty (BAV) reduces the need for permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI).

METHODS: This was a retrospective analysis using data from our local TAVI database. Small BAV was defined as a small balloon size (=18 mm) pre-dilatation. Normal BAV was defined as a balloon size >18 mm. The primary endpoint was the incidence of new PPMI.

RESULTS: Of 99 consecutive TAVI patients, five patients were excluded due to pre-existing permanent pacemaker. Patients in the small BAV group (n=57) had a significantly lower PPMI rate compared with the normal BAV group (n=37) (3.5% vs. 18.9%, P=0.026). Moderate or severe aortic valve regurgitation post-procedure was similar between the small BAV and normal BAV groups (5.3% vs. 8.1%, P=0.480); likewise, the mean aortic gradient post-procedure did not differ significantly (11.5±5.2 mmHg vs. 12.2±7.3 mmHg, 1 mmHg=0.133 kPa, P=0.580) between the groups. Device success rates were also similar (94.7% vs. 91.8%, P=0.680). In multivariable analysis, small BAV (P=0.027), the ratio of prosthesis diameter to annulus diameter (P=0.048), and mean aortic gradient by echo in the basement (P=0.021) were independent predictors of PPMI.

CONCLUSIONS: The small BAV strategy is associated with a low rate of permanent pacemaker implantation after transcatheter self-expanding valve implantation in this single-center observational study.

Key words: Transcatheter aortic valve implantation, Balloon aortic valvuloplasty, Balloon size, Permanent pacemaker implantation

Yuan Zhang, Wen-zhi Pan, Li-hua Guan, Xiao-chun Zhang, Sha-sha Chen, Li-fan Yang, Lei Zhang, Ming-fei Li, Dan-dan Chen, Da-xin Zhou, Jun-bo Ge. Small balloon strategy associated with low pacemaker implantation rate after self-expanding transcatheter valve implantation[J]. World Journal of Emergency Medicine, 2021, 12(1): 48-53.

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Parameters	Small BAV (balloon size=18 mm, n=57)	Normal BAV (balloon size >18 mm, n=37)	P-value
Age (years), mean±SD	78.5±7.3	77.2±6.1	0.38
Male, n (%)	37 (64.9)	26 (70.3)	0.66
BMI (kg/m²), mean±SD	23.1±3.2	22.2±3.7	0.26
STS score (%), mean±SD	9.6±5.8	9.8±6.2	0.94
Logistic EuroSCORE, mean±SD	4.2±2.6	5.8±7.7	0.22
NYHA functional class, n (%)
III	25 (43.9)	17 (45.9)	0.54
IV	7 (12.3)	7 (18.9)	0.42
Aortic annulus diameter by MSCT (mm), mean±SD	24.8±2.6	25.9±2.9	0.12
ECG characteristics, n (%)
LBBB	3 (5.2)	4 (11.1)	0.69
RBBB	6 (10.3)	4 (11.1)	0.62
Echocardiographic characteristics
AV mean gradient (mmHg), mean±SD	53.3±19.8	52.8±15.6	0.90
Aortic valve area (cm²), mean±SD	0.66±0.13	0.68±0.18	0.67
LVEDD (mm), mean±SD	49.0±7.6	51.3±6.7	0.14
Bicuspid valve, n (%)	25 (43.9)	18 (48.6)	0.68
LVEF (%), mean±SD	57.5±10.3	54.6±12.4	0.22
AVR more than moderate, n (%)	22 (38.6)	14 (37.8)	0.35
MVR more than moderate, n (%)	62.4±7.8	57.7±10.7	0.06

Parameters	Small BAV (balloon size=18 mm, n=57)	Normal BAV (balloon size >18 mm, n=37)	P-value
Prosthesis size (mm), mean±SD	25.7±1.8	27.6±1.9	<0.001
Post-dilation, n (%)	19 (33.3)	15 (40.5)	0.520
Post-dilation balloon size (mm), mean±SD	21.0±1.6	22.1±2.7	0.140
Prosthesis (diameter/annulus diameter), mean±SD	1.04±0.09	1.05±0.08	0.670
Implantation depth (mm), mean±SD	4.2±3.1	4.9±3.7	0.330
Device success, n (%)	54 (94.7)	34 (91.8)	0.680
Mean gradient post procedure (mmHg), mean±SD	11.5±5.2	12.2±7.3	0.580
Severe or moderate AVR, n (%)	3 (5.3)	3 (8.1)	0.480
Aortic valve area post TAVI (m²)	1.8±0.4	1.8±0.3	0.720
LVEF post procedure (%), mean±SD	61.6±8.5	58.1±10.1	0.080
Permanent pacemaker implantation, n (%)	2 (3.5)	7 (18.9)	0.026
Conversion to surgery, n (%)	0	1 (2.7)	0.400
Stroke or TIA, n (%)	0	0	-
Duration of hospitalisation (days), mean±SD	12.2±6.0	12.6±6.8	0.800
30-day mortality, n (%)	0	1 (2.7)	0.400

Variables	Univariate analysis				Multivariable analysis
Variables	OR	Lower 95% CI	Upper 95% CI	P-value	OR	Lower 95% CI	Upper 95% CI	P-value
Age	1.01	0.91	1.11	0.910	-	-	-	-
Male	0.55	0.11	2.83	0.480	-	-	-	-
NYHA III or IV	0.99	0.92	1.07	0.830	-	-	-	-
STS score	0.95	0.80	1.11	0.510	-	-	-	-
Logistic EuroSCORE	0.81	0.54	1.23	0.330	-	-	-	-
CAD	1.70	0.40	7.23	0.480	-	-	-	-
AVA by echo base	2.90	0.04	227.77	0.630	-	-	-	-
Mean aortic gradient by echo at basement	1.04	1.00	1.07	0.060	-1.08	-1.01	-1.16	0.021
LVEF	0.97	0.92	1.03	0.320	-	-	-	-
Pre-existing LBBB	0.71	1.80	2.83	0.630	-	-	-	-
Pre-existing RBBB	1.78	0.42	7.58	0.440	-	-	-	-
Device brand	3.07	0.27	35.55	0.400	-	-	-	-
Valve size	1.24	0.87	1.77	0.240	-	-	-	-
Prosthesis diameter/annulus diameter (per 0.1 increment)	2.12	0.98	4.59	0.056	2.70	1.00	7.31	0.048
Implantation depth	1.24	1.01	1.52	0.038	1.18	0.89	1.57	0.250
Small balloon valvuloplasty	6.41	1.25	32.86	0.026	21.30	1.41	321.18	0.027
Post-dilation	1.15	0.27	4.92	0.850	-	-	-	-
Post-dilation balloon size	0.78	0.36	1.70	0.530	-	-	-	-