TY - JOUR
T1 - Does targeted positioning of the left ventricular pacing lead towards the latest local electrical activation in cardiac resynchronization therapy reduce the incidence of death or hospitalization for heart failure?
AU - Kronborg, Mads Brix
AU - Frausing, Maria Hee Jung Park
AU - Svendsen, Jesper Hastrup
AU - Johansen, Jens Brock
AU - Riahi, Sam
AU - Haarbo, Jens
AU - Poulsen, Steen Hvitfeldt
AU - Eiskjær, Hans
AU - Køber, Lars
AU - Øvrehus, Kristian
AU - Sommer, Anders Munck
AU - Schou, Morten
AU - Nørgaard, Bjarne Linde
AU - Risum, Niels
AU - Poulsen, Mikael Kjær
AU - Søgaard, Peter
AU - Sandgaard, Niels
AU - Kofoed, Klaus F.
AU - Hansen, Thomas Fritz
AU - Graff, Claus
AU - Pedersen, Susanne S.
AU - Skals, Regitze Gyldenholm
AU - Nielsen, Jens Cosedis
N1 - Funding Information:
This trial was funded by grants from the Novo Nordisk Foundation (grant no. NNF17OC0029148 ) and the Danish Heart Foundation (grant no. 17-R116-A7405-22046 & 21-R151-A9920-22199 ).
Funding Information:
In Denmark, CRT implantations are centralized to 5 high-volume centers. This study is planned and conducted in a close collaboration between device specialists, heart failure specialists, and specialists in cardiac imaging from all 5 centers: Copenhagen University Hospital - Herlev and Gentofte, Odense University Hospital, Copenhagen University Hospital - Rigshospitalet, Aalborg University Hospital, and Aarhus University Hospital (coordinating center). Recently, this study group completed the DANISH trial on the effect of prophylactic ICDs in patients with nonischemic HF. 21 Follow-up is well-organized and based on experiences from daily clinical practice. Remote monitoring can be established successfully in >95% of the enrolled CRT patients. Imaging core lab is located at Copenhagen University Hospital - Rigshospitalet, statistical core lab and core lab for ECG analysis at Aalborg University, and core lab for patient-reported outcomes (PROs) and QoL analyses at Odense University Hospital. Positive, negative, neutral, or inconclusive results will be published. This trial is conducted in accordance with the latest version of the Declaration of Helsinki (2013) and approved by the Ethics Committee of Central Denmark Region. The study is registered under the common notification system of the Danish Data Protection Agency and will adhere to the Danish Act on Processing of Personal Data. The study is supported by funding form Novo Nordisk Foundation (NNF17OC0029148), Danish Heart Foundation (17-R116-A7405-22046, and 21-R151-A9920-22199) and Danish Pacemaker and ICD Register. Information about the work and composition of Data and Safety Monitoring Board is provided in the appendix.
Funding Information:
JCN is supported by grants from the Novo Nordisk Foundation (NNF16OC0018658, NNF17OC0029148), JHS reports membership of advisory committee in Medtronic, research grant outside this work from Medtronic and speakers’ honorarium from Medtronic. LK report speakers’ honorarium from AstraZeneca, Bayer, Boehringer, Novartis and Novo, not related to this manuscript. MHJPF reports speakers’ honorarium from Medtronic outside submitted work. Remaining authors report no conflicts of interest.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023
Y1 - 2023
N2 - Background: Cardiac resynchronization therapy (CRT) improves symptoms, health-related quality of life and long-term survival in patients with systolic heart failure (HF) and shortens QRS duration. However, up to one third of patients attain no measurable clinical benefit from CRT. An important determinant of clinical response is optimal choice in left ventricular (LV) pacing site. Observational data have shown that achieving an LV lead position at a site of late electrical activation is associated with better clinical and echocardiographic outcomes compared to standard placement, but mapping-guided LV lead placement towards the site of latest electrical activation has never been investigated in a randomized controlled trial (RCT). The purpose of this study was to evaluate the effect of targeted positioning of the LV lead towards the latest electrically activated area. We hypothesize that this strategy is superior to standard LV lead placement. Methods: The DANISH-CRT trial is a national, double-blinded RCT (ClinicalTrials.gov NCT03280862). A total of 1,000 patients referred for a de novo CRT implantation or an upgrade to CRT from right ventricular pacing will be randomized 1:1 to receive conventional LV lead positioning preferably in a nonapical posterolateral branch of the coronary sinus (CS) (control group) or targeted positioning of the LV lead to the CS branch with the latest local electrical LV activation (intervention group). In the intervention group, late activation will be determined using electrical mapping of the CS. The primary endpoint is a composite of death and nonplanned HF hospitalization. Patients are followed for a minimum of 2 years and until 264 primary endpoints occurred. Analyses will be conducted according to the intention-to-treat principle. Enrollment for this trial began in March 2018, and per April 2023, a total of 823 patients have been included. Enrollment is expected to be complete by mid-2024. Conclusions: The DANISH-CRT trial will clarify whether mapping-guided positioning of the LV lead according to the latest local electrical activation in the CS is beneficial for patients in terms of reducing the composite endpoint of death or nonplanned hospitalization for heart failure. Results from this trial are expected to impact future guidelines on CRT. ClinicalTrials.gov identifier: NCT03280862.
AB - Background: Cardiac resynchronization therapy (CRT) improves symptoms, health-related quality of life and long-term survival in patients with systolic heart failure (HF) and shortens QRS duration. However, up to one third of patients attain no measurable clinical benefit from CRT. An important determinant of clinical response is optimal choice in left ventricular (LV) pacing site. Observational data have shown that achieving an LV lead position at a site of late electrical activation is associated with better clinical and echocardiographic outcomes compared to standard placement, but mapping-guided LV lead placement towards the site of latest electrical activation has never been investigated in a randomized controlled trial (RCT). The purpose of this study was to evaluate the effect of targeted positioning of the LV lead towards the latest electrically activated area. We hypothesize that this strategy is superior to standard LV lead placement. Methods: The DANISH-CRT trial is a national, double-blinded RCT (ClinicalTrials.gov NCT03280862). A total of 1,000 patients referred for a de novo CRT implantation or an upgrade to CRT from right ventricular pacing will be randomized 1:1 to receive conventional LV lead positioning preferably in a nonapical posterolateral branch of the coronary sinus (CS) (control group) or targeted positioning of the LV lead to the CS branch with the latest local electrical LV activation (intervention group). In the intervention group, late activation will be determined using electrical mapping of the CS. The primary endpoint is a composite of death and nonplanned HF hospitalization. Patients are followed for a minimum of 2 years and until 264 primary endpoints occurred. Analyses will be conducted according to the intention-to-treat principle. Enrollment for this trial began in March 2018, and per April 2023, a total of 823 patients have been included. Enrollment is expected to be complete by mid-2024. Conclusions: The DANISH-CRT trial will clarify whether mapping-guided positioning of the LV lead according to the latest local electrical activation in the CS is beneficial for patients in terms of reducing the composite endpoint of death or nonplanned hospitalization for heart failure. Results from this trial are expected to impact future guidelines on CRT. ClinicalTrials.gov identifier: NCT03280862.
U2 - 10.1016/j.ahj.2023.05.011
DO - 10.1016/j.ahj.2023.05.011
M3 - Journal article
C2 - 37220821
AN - SCOPUS:85161310255
VL - 263
SP - 112
EP - 122
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -