PMID- 32412126
OWN - NLM
STAT- MEDLINE
DCOM- 20210728
LR  - 20210728
IS  - 1540-8167 (Electronic)
IS  - 1045-3873 (Print)
IS  - 1045-3873 (Linking)
VI  - 31
IP  - 7
DP  - 2020 Jul
TI  - Novel two-lead cardiac resynchronization therapy system provides equivalent CRT 
      responses with less complications than a conventional three-lead system: Results 
      from the QP ExCELs lead registry.
PG  - 1784-1792
LID - 10.1111/jce.14552 [doi]
AB  - INTRODUCTION: The novel two-lead cardiac resynchronization therapy (CRT)-DX 
      system utilizes a floating atrial dipole on the implantable 
      cardioverter-defibrillator lead, and when implanted with a left ventricular (LV) 
      lead, offers a two-lead CRT system with AV synchrony. This study compared 
      complication rates and CRT response among subjects implanted with a two-lead 
      CRT-DX system to those subjects implanted with a standard three-lead CRT-D 
      system. METHODS AND RESULTS: A total of 240 subjects from the Sentus QP-Extended 
      CRT Evaluation with Quadripolar Left Ventricular Leads postapproval study were 
      selected to identify 120 matched pairs based on similar demographic 
      characteristics using a Greedy algorithm. The complication-free rate was 
      evaluated as the primary endpoint. All-cause mortality, heart failure 
      hospitalizations, device diagnostic data, New York Heart Association (NYHA) class 
      improvement, and defibrillator therapy were evaluated from clinical data, 
      in-office interrogations, and remote monitoring throughout the follow-up period. 
      Complication-free survival favored the CRT-DX group with 92.5% without a major 
      complication compared to 85.0% in the CRT-D cohort (P = .0495; 95% confidence 
      interval: 0.1%-14.9%) over a mean follow-up of 1.3 and 1.4 years, respectively. 
      Incidence of all-cause mortality, heart failure hospitalizations, NYHA changes at 
      6 months postimplant, and percent of LV pacing during CRT therapy were similar in 
      both device cohorts. Inappropriate shocks were more frequent in the CRT-D cohort 
      with 5.8% of subjects receiving an inappropriate shock vs 0.8% in the CRT-DX 
      cohort. CONCLUSION: The results of this subanalysis demonstrate that the CRT-DX 
      system can provide similar CRT responses and significantly fewer complications 
      when compared to a similar cohort with a conventional three-lead CRT-D system.
CI  - (c) 2020 The Authors. Journal of Cardiovascular Electrophysiology Published by 
      Wiley Periodicals LLC.
FAU - Shaik, Naushad A
AU  - Shaik NA
AUID- ORCID: 0000-0002-8344-0444
AD  - Department of Cardiac Electrophysiology, Advent Health Orlando, Orlando, Florida.
FAU - Drucker, Michael
AU  - Drucker M
AD  - Department of Cardiac Electrophysiology, Novant Health Cardiology of Forsyth 
      Medical Center, Winston-Salem, North Carolina.
FAU - Pierce, Christopher
AU  - Pierce C
AD  - Department of Cardiac Electrophysiology, Sanford Medical Center, Fargo, North 
      Dakota.
FAU - Duray, Gabor Z
AU  - Duray GZ
AUID- ORCID: 0000-0003-1286-6576
AD  - Department of Cardiology, Medical Centre, Hungarian Defense Forces, Budapest, 
      Hungary.
FAU - Gillett, Shane
AU  - Gillett S
AUID- ORCID: 0000-0002-8504-1324
AD  - Clinical Studies Department, Biotronik, Inc, Lake Oswego, Oregon.
FAU - Miller, Crystal
AU  - Miller C
AUID- ORCID: 0000-0002-7278-4495
AD  - Clinical Studies Department, Biotronik, Inc, Lake Oswego, Oregon.
FAU - Harrell, Camden
AU  - Harrell C
AD  - Clinical Studies Department, Biotronik, Inc, Lake Oswego, Oregon.
FAU - Thomas, George
AU  - Thomas G
AUID- ORCID: 0000-0001-7158-8305
AD  - Division of Cardiology, Weill Cornell Medical College, New York, New York.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200601
PL  - United States
TA  - J Cardiovasc Electrophysiol
JT  - Journal of cardiovascular electrophysiology
JID - 9010756
SB  - IM
MH  - *Cardiac Resynchronization Therapy
MH  - Cardiac Resynchronization Therapy Devices
MH  - *Defibrillators, Implantable/adverse effects
MH  - *Heart Failure/diagnosis/therapy
MH  - Humans
MH  - New York
MH  - Registries
MH  - Treatment Outcome
PMC - PMC7496977
OTO - NOTNLM
OT  - atrial fibrillation
OT  - atrial sensing
OT  - cardiac resynchronization therapy
OT  - heart failure
OT  - implantable cardioverter-defibrillator
EDAT- 2020/05/16 06:00
MHDA- 2021/07/29 06:00
PMCR- 2020/09/17
CRDT- 2020/05/16 06:00
PHST- 2020/04/01 00:00 [received]
PHST- 2020/05/05 00:00 [revised]
PHST- 2020/05/11 00:00 [accepted]
PHST- 2020/05/16 06:00 [pubmed]
PHST- 2021/07/29 06:00 [medline]
PHST- 2020/05/16 06:00 [entrez]
PHST- 2020/09/17 00:00 [pmc-release]
AID - JCE14552 [pii]
AID - 10.1111/jce.14552 [doi]
PST - ppublish
SO  - J Cardiovasc Electrophysiol. 2020 Jul;31(7):1784-1792. doi: 10.1111/jce.14552. 
      Epub 2020 Jun 1.