[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5438-5439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02985]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Use of Cardiac
Resynchronization Therapy: A Systematic Review Update
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Use of Cardiac
Resynchronization Therapy: A Systematic Review Update, which is
currently being conducted by the AHRQ's Evidence-based Practice Centers
(EPC) Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before March 25, 2019.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Use of Cardiac
Resynchronization Therapy: A Systematic Review Update. AHRQ is
conducting this systematic review pursuant to Section 902(a) of the
Public Health Service Act, 42 U.S.C. 299a(a).
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Use of Cardiac Resynchronization Therapy: A Systematic
Review Update, including those that describe adverse events. The entire
research protocol is available online at: https://www.ahrq.gov/research/findings/ta/index.html.
This is to notify the public that the EPC Program would find the
following information on Use of Cardiac Resynchronization Therapy: A
Systematic Review Update helpful:
[ballot] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ballot] For completed studies that do not have results on
ClinicalTrials.gov, please provide a summary, including the following
elements: Study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ballot] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ballot] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution will be very beneficial to the EPC Program.
Materials submitted must be publicly available or able to be made
public. Materials that are considered confidential; marketing
materials; study types not included in the review; or information on
indications not included in the review cannot be used by the EPC
Program. This is a voluntary request for information, and all costs for
complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
The Key Questions
KQ1a: Is cardiac resynchronization therapy with defibrillator (CRT-
D) effective in reducing heart failure symptoms, improving myocardial
function, reducing hospitalization and/or improving survival in
patients with an LVEF <=35% and a QRS duration >=120ms?
KQ1b: Does the effectiveness of cardiac resynchronization therapy
with defibrillator (CRT-D) vary by the following subgroups:
Age
Gender
Cardiomyopathy subtype
QRS morphology
Left ventricular ejection fraction
NYHA class
Atrial fibrillation
KQ2: What are the adverse effects or complications associated with
CRT-D implantation?
KQ3a: Is cardiac resynchronization therapy in the absence of
defibrillator capacity (CRT-P) effective in reducing heart failure
symptoms, improving myocardial function, reducing hospitalization and/
or improving survival in patients with LVEF <=35% and a QRS duration
>=120ms?
KQ3b: Does the effectiveness of cardiac resynchronization therapy
in the absence of defibrillator capacity (CRT-P) vary by the following
subgroups:
Age
Gender
Cardiomyopathy subtype
QRS morphology
Left ventricular ejection fraction
NYHA class
Atrial fibrillation
KQ4: What are the adverse effects or complications associated with
CRT-P implantation?
[[Page 5439]]
KQ5: What is the effectiveness of CRT-D versus CRT-P in reducing
heart failure symptoms, improving myocardial function, reducing
hospitalization and/or improving survival in patients with LVEF <=35%
and a QRS duration >=120ms?
KQ6: What are the adverse effects or complications associated with
CRT-D versus CRT-P implantation?
KQ7a: What is the effectiveness of alternative CRT techniques
(adaptive CRT, multipoint pacing, His bundle pacing, quadripolar)
versus conventional CRT techniques in reducing heart failure symptoms,
improving myocardial function, reducing hospitalization and/or
improving survival in patients with an LVEF <=35% and a QRS duration
>=120ms?
KQ7b: Does the effectiveness of alternative CRT techniques
(adaptive CRT, multipoint pacing, His bundle pacing, quadripolar) vary
by the following subgroups:
Age
Gender
Cardiomyopathy subtype
QRS morphology
Left ventricular ejection fraction
NYHA class
Atrial fibrillation
KQ8: What are the adverse effects or complications associated with
alternative CRT techniques (adaptive CRT, multipoint pacing, His bundle
pacing, quadripolar)?
KQ9: What is the effectiveness of His bundle pacing or CRT versus
RV pacing in reducing heart failure symptoms, improving myocardial
function, reducing hospitalization and/or improving survival in
patients with an LVEF between >=36% to <=50% and atrioventricular
block?
KQ10: What are the adverse effects or complications associated with
His bundle pacing or CRT versus RV pacing in reducing heart failure
symptoms, improving myocardial function, reducing hospitalization and/
or improving survival in patients with an LVEF between >=36% to <=50%
and atrioventricular block?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Population(s)
KQ1-KQ8: Subjects of age >=18, with a left ventricular ejection
fraction <=35% and a QRS duration >=120 ms.
KQ9-10: Subjects of age >=18, with an LVEF between >=36% to <=50%
and atrioventricular block [We will use a recently published systematic
review to address KQs 9-10].
Interventions
Cardiac resynchronization therapy with a defibrillator (CRT-D)
Cardiac resynchronization without a defibrillator (CRT-P)
Alternative cardiac resynchronization therapy alternative CRT
techniques (adaptive CRT, multipoint pacing, His bundle pacing,
quadripolar)
Comparators
CRT-D vs. implantable cardioverter defibrillator (ICD)
CRT-P vs. optimal medical therapy
CRT-D vs. CRT-P
Alternative CRT techniques versus conventional CRT techniques
Outcomes
KQ1a, 3a, 5, and 7a (Effectiveness)
Clinical outcomes
6 minute hall walk distance
Left ventricular end diastolic volume/volume index
Left ventricular end systolic volume/volume index
Left ventricular ejection fraction
Packer Score \17\
Quality of life
Minnesota Living with Heart Failure Inventory Score
Kansas City Cardiomyopathy Score
SF-36
Health outcomes
Hospitalizations for heart failure
All-cause mortality
KQ2, KQ4, KQ6, and KQ8 (Harms)
Procedure related complications
Length of hospital stay
Pneumothorax
Pocket hematoma
Device Infection
Cardiac perforation/tamponade
Lead dislodgement
Ventricular arrhythmias
Death (within a week)
Inappropriate ICD shocks (CRT-D and alternative CRT-D
techniques only)
KQ1b, KQ3b, 7b (Subgroups)
Age
Gender
Cardiomyopathy subtype
QRS morphology
Left ventricular ejection fraction
NYHA class
Atrial fibrillation
Timing
KQ1a, 3a, 5, and 7a, (Effectiveness)
Outcomes from CRT-D, CRT-P, and alternative CRT techniques at
3-6 months, 1 year, and >=2 year end-points
KQ2, 4, 6, and 8 (Harms)
Outcomes from CRT-D, CRT-P, and alternative CRT techniques at
any time point
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2019-02985 Filed 2-20-19; 8:45 am]
BILLING CODE 4160-90-P