Pacemaker Ddd Clinical Trial
Official title:
Placement Of Cardiac PacemaKer Trial (POCKET)-RCT
Aim: To compare patient satisfaction with intramuscular placement of a pacemaker pocket to
subcutaneous placement.
Patients will be randomized (approximately half i each group) to receive the pacemaker
device either subcutaneously (current practise) or intramuscular)
Background: Implantation of a cardiac pacemaker may be indicated in patients with a
significant bradycardia according to current guidelines.1 Annually, around 691 pacemakers
per million inhabitants are implanted in Sweden.2 A pacemaker system consist of one or two
leads connected to a device that is implanted beneath the collarbone.3,4 Vessel access is
typically on the left side through the cephalic, axillary or subclavian vein. The pacemaker
is inserted into a pocket. Routinely this pocket is just above the pectoral fascia
(subcutaneously) or sometimes in skinny patients with a small amount of subcutaneous fat
between the pectoral muscular layer (intramuscular). Even though technical developments have
diminished the size of pacemakers markedly over time, complications due to superficial
implants still do occur.5,6 Occasionally the device erode the skin and a complete extraction
of the system is necessary. More frequently patients complain about the device being too
superficial which sometimes require surgical repositioning of the device.5,6 The device may
create discomfort, pain, and unsightly.5,6 The lateral corner of the device may disturb the
shoulder movement, sleep and the leads can be turned within the pocket (Twiddler's
syndrome). Minor branches from the supraclavicular nerves may result in discomfort. When
vessels from the subcutaneous adipose tissue are distorted, extensive bruising may be
bothersome and a large hematoma is a known risk of infection. The perfusion in the operation
area is diminished and the amount of fat over device may be reduced to an extent that was
unexpected at first implant. The change of device due to battery depletion can result in
even less surrounding tissue. An alternative approach is an intramuscular placement of the
device.7,8 This has been advocated by Kistler et al based on personal experience but there
are neither systematic observational studies nor randomized controlled studies to support
this approach.6 To the knowledge of the investigators no randomized controlled trial have
addressed the question about the optimal placement of a bradycardia pacemaker.
Aim: To compare patient satisfaction with intramuscular placement of a pacemaker pocket to
subcutaneous placement.
Research questions: Primary outcome: Is there a different in patient overall satisfaction
(on a Visual Analog Scale (VAS)-scale between 0-10) with the pocket between patients with
intramuscular placement of a pacemaker pocket and patients with subcutaneous placement at 24
months after implant? Secondary outcomes: Complications (revision of pocket, dislodgement,
hematoma requiring surgery, infection (local/systemic). Patient reported satisfaction at 1,
12, 24 months (overall satisfaction, pain, discomfort, degree of unsightly look, movement
problems due to device, and sleep problems due to device). Pacemaker nurse judgement of
unsightly look of the pacemaker pocket (month 1, 12, and 24). Picture of pocket (1, 12, 24
months) judged by an experienced implanting physician who is blinded to the group allocation
and has not operated on the patient.
Method: Power analysis: the investigators performed a power analysis based on expectations
and clinical experience of the research group. Figure 1 shows two hypothetical truncated
lognormal distributions of patient overall satisfaction with the pacemaker, where median
overall satisfaction of the intramuscular and the subcutaneous group are assumed to be 2.4
and 4, respectively. Monte Carlo-simulations from these distributions showed that a total of
200 patients, 100 in each arm, would yield a statistical power of 90% for Mann-Whitney
U-test at a significance level of 0.05.
In total, 200 consecutive patients with indication of are expected to be randomized in the
study (100 patients in each arm, intramuscular vs subcutaneously). In Region Gavleborg , the
annual primary implant volume of bradycardia pacemakers is approximately 220.
Figure 1. Assumed distributions of patient overall satisfaction in the power analysis, as
measured by an visual analogue scale where 0 means "very satisfied" and 10 means "very
dissatisfied". The intramuscular group is assumed to follow a lognormal distribution with
mean 1.5 and standard deviation of 1, on the logarithmic scale. The subcutaneous patients
are assumed to follow a lognormal distribution with mean 1.5 and standard deviation of 1, on
the logarithmic scale.
Randomization: At the time of implant 1:1 randomization (100 patients in each group) to
either subcutaneous (usual care) or intramuscular implant, in blocks with random block
sizes. The randomization is performed by a statistician with no insight in the ongoing
clinical work and patients' group allocation is revealed for implanting physician by the
assistant nurse at the start of the surgical procedure. Randomization procedure:
stratification (age strata: ≤65 years and >65 years) and sex (female, male); totally 4
strata). Consecutive group allocations will be stored in sealed opaque envelopes that will
be opened at the time of starting the implant procedure.
Inclusion: Indication of a bradycardia pacemaker (DDDR, VVIR). Exclusion: Cardiac
Resynchronisation Therapy Pacemaker (CRTP), Cardiac Resynchronisation Therapy Defibrillator
(CRTD), implantable cardioverter defibrillator (ICD). Very skinny patient deemed as such by
implanting physician to clearly benefit from intramuscular implant.
Surgical procedure: Standard procedure and vascular access by each operator's preference.
Blunt dissection of the pocket.
Statistical methods: For comparisons between groups: Mann-Whitney U-test. For test of
changes in VAS-estimations between 1, 12, and 24 months: pair-wise Wilcoxon signed-rank
test.
Informed consent: Written and oral information by nurse/physician before implant.
Ethical approval: Approved by Uppsala Regional Committee. Clinical Trial Registration:
Registration before start of study.
Variables:
Clinical variables: age, sex, coronary artery disease, open-heart surgery, diabetes, kidney
disease Pacemaker system: (VVIR, DDDR), brand, model (lead(s) and device. Vascular access:
(cephalic, axillary, subclavian vein), fluro-time, procedure time Periprocedural analgetics
(dosage): alfentanil, morphine, diazepam, paracetamol Pre och post-operative anticoagulant
medication (dosage and withdrawal with respect to procedure: acetylic acid, clopidogrel,
ticagrelor, dual oral anticoagulants, warfarin, low-molecular weight heparin) Preoperative
current medication: (psychoactive drugs, betablockers, corticosteroids, inflammatory
modulating drugs Outcome measurements: Patient satisfaction (overall, chronic pain,
discomfort, degree of unsightly look, movement disorder due to device, sleep problems due to
device) scale 0-10 (10 worst) Paper questionnaire at 1,12,and 24 months. Patient knowledge
if device was intramuscular or subcutaneously implanted at 24 months.
Pacemaker nurse judgement: unsightly look (0-10, 10 worst). Physician evaluation (blinded to
the patient and not operator in the study): photo of pocket (1, 12, 24 months) scale 0-10
(10 worst).
Complications requiring surgery: pocket revision, dislodgment, hematoma requiring surgery,
infection (local, systemic), pneumothorax, pericardial effusion requiring drainage, other.
Clinical perspectives: The surgical approach to the pacemaker pocket needs to be evaluated.
The optimal approach including patient reported outcomes may result in more long-term
satisfaction and may reduce the need for pocket revisions.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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