Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico™ valve
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Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico™ valve. / Walther, Thomas; Manoharan, Ganesh; Linke, Axel; Möllmann, Helge; Holzhey, David; Worthley, Stephen G; Kim, Won-Keun; Schäfer, Ulrich.
In: EUR J CARDIO-THORAC, Vol. 54, No. 3, 01.09.2018, p. 467-474.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico™ valve
AU - Walther, Thomas
AU - Manoharan, Ganesh
AU - Linke, Axel
AU - Möllmann, Helge
AU - Holzhey, David
AU - Worthley, Stephen G
AU - Kim, Won-Keun
AU - Schäfer, Ulrich
PY - 2018/9/1
Y1 - 2018/9/1
N2 - OBJECTIVES: To examine the incidence and timing of new-onset left bundle branch block (LBBB) and new permanent pacemaker implantation (PPI) in patients undergoing transcatheter aortic valve implantation (TAVI) using the repositionable, self-expanding Portico™ TAVI system (St. Jude Medical, St Paul, MN, USA). Clinical impact and periprocedural factors associated with new PPI were also assessed.METHODS: A total of 198 high-risk patients without pre-existing pacemaker [83.1 ± 4.7 years, 77.3% women, mean Society of Thoracic Surgeons (STS) 5.8%] from the Pre-CE Mark Portico TAVI system study were prospectively analysed. Twelve-lead electrocardiographic and echocardiographic data were collected prior to, during and after the procedure. Clinical follow-up was performed at 1 year.RESULTS: Transfemoral implantation of the Portico valve was associated with a new PPI rate of 15.2% at 30 days and 16.7% at 1 year. Overall, 53 of the 187 patients without pre-existing LBBB developed new-onset LBBB at 1 year (28.3%); 23 occurred during the procedure. At 30 days, new-onset LBBB spontaneously resolved in 61.0% of patients. New-onset LBBB post-TAVI was not associated with new PPI (P = 0.64); 8 of the 53 patients required new PPI. Multivariable regression analyses revealed pre-existing right bundle branch block (P = 0.004) and aortic annulus diameter (P = 0.001) as independent predictors of new PPI. New PPI at discharge (n = 29) was not associated with increased freedom from all-cause (odds ratio 92.7%, 95% confidence interval 73.7-98.1%; P = 0.49) and cardiovascular (odds ratio 96.6%, 95% confidence interval 77.9-99.5%; P = 0.47) mortality at 1 year.CONCLUSIONS: The Portico TAVI system demonstrated an acceptable rate of new PPI at 1 year without increased mortality risk to patients. New-onset LBBB was common during the procedure, with the majority of events spontaneously resolving by 30 days. No intraprocedural factors were shown to independently predict new PPI.Clinical trial registration number: NCT01493284.
AB - OBJECTIVES: To examine the incidence and timing of new-onset left bundle branch block (LBBB) and new permanent pacemaker implantation (PPI) in patients undergoing transcatheter aortic valve implantation (TAVI) using the repositionable, self-expanding Portico™ TAVI system (St. Jude Medical, St Paul, MN, USA). Clinical impact and periprocedural factors associated with new PPI were also assessed.METHODS: A total of 198 high-risk patients without pre-existing pacemaker [83.1 ± 4.7 years, 77.3% women, mean Society of Thoracic Surgeons (STS) 5.8%] from the Pre-CE Mark Portico TAVI system study were prospectively analysed. Twelve-lead electrocardiographic and echocardiographic data were collected prior to, during and after the procedure. Clinical follow-up was performed at 1 year.RESULTS: Transfemoral implantation of the Portico valve was associated with a new PPI rate of 15.2% at 30 days and 16.7% at 1 year. Overall, 53 of the 187 patients without pre-existing LBBB developed new-onset LBBB at 1 year (28.3%); 23 occurred during the procedure. At 30 days, new-onset LBBB spontaneously resolved in 61.0% of patients. New-onset LBBB post-TAVI was not associated with new PPI (P = 0.64); 8 of the 53 patients required new PPI. Multivariable regression analyses revealed pre-existing right bundle branch block (P = 0.004) and aortic annulus diameter (P = 0.001) as independent predictors of new PPI. New PPI at discharge (n = 29) was not associated with increased freedom from all-cause (odds ratio 92.7%, 95% confidence interval 73.7-98.1%; P = 0.49) and cardiovascular (odds ratio 96.6%, 95% confidence interval 77.9-99.5%; P = 0.47) mortality at 1 year.CONCLUSIONS: The Portico TAVI system demonstrated an acceptable rate of new PPI at 1 year without increased mortality risk to patients. New-onset LBBB was common during the procedure, with the majority of events spontaneously resolving by 30 days. No intraprocedural factors were shown to independently predict new PPI.Clinical trial registration number: NCT01493284.
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve/surgery
KW - Aortic Valve Stenosis/surgery
KW - Bundle-Branch Block/epidemiology
KW - Electrocardiography
KW - Female
KW - Heart Valve Prosthesis/adverse effects
KW - Humans
KW - Male
KW - Pacemaker, Artificial/statistics & numerical data
KW - Postoperative Complications/epidemiology
KW - Transcatheter Aortic Valve Replacement/adverse effects
U2 - 10.1093/ejcts/ezy078
DO - 10.1093/ejcts/ezy078
M3 - SCORING: Journal article
C2 - 29534170
VL - 54
SP - 467
EP - 474
JO - EUR J CARDIO-THORAC
JF - EUR J CARDIO-THORAC
SN - 1010-7940
IS - 3
ER -