Download Predictive factors of difficult implantation procedure in cardiac

Europace (2010) 12, 1141–1148
doi:10.1093/europace/euq146
CLINICAL RESEARCH
Pacing and CRT
Predictive factors of difficult implantation
procedure in cardiac resynchronization therapy
Laurence Bisch 1, Antoine Da Costa 1*, Virginie Dauphinot 2,
Cécile Romeyer-Bouchard 1, Lila Khris 1, Alassane M’Baye 1, and Karl Isaaz 1
1
Division of Cardiology, University Jean Monnet, Saint-Etienne, France; and 2Neurology Unit D, Memory Research Center, University Medical Hospital P. Wertheimer, Lyon, France
Received 9 January 2010; accepted after revision 14 April 2010; online publish-ahead-of-print 23 June 2010
Aims
The usefulness of cardiac resynchronization therapy (CRT) in patients with congestive heart failure is offset by its
long, user-dependent, and technical procedure. No studies have been published regarding factors related to CRT
implantation procedure duration and X-ray exposure. Additionally, only a few studies have investigated the predictive
factors of primary left ventricular (LV) lead implant failure. The aim of this prospective study was two-fold: (i) to
evaluate the prevalence and predictive factors of prolonged CRT implantation procedure and (ii) to identify the predictive factors of primary LV lead implantation failure.
.....................................................................................................................................................................................
Methods
Between November 2008 and September 2009, 128 consecutive patients underwent CRT implantation; of these, 22
patients (17.2%) were excluded because of CRT generator replacement. Population characteristics were a mean age
and results
of 69 + 10 years, 28.3% female, New York Heart Association class 3.2 + 0.3, LV ejection fraction (LVEF; 29 + 6%),
and QRS width 146 + 23 ms. Cardiac resynchronization therapy implantation was attempted in 106 patients, and first
LV lead implantation was obtained in 96 of 106 patients (90.5% primary success). Ten primary implantations failed
(9.5%), due to unsuccessful LV lead implants. A second procedure was successfully attempted in six patients with
a second more experienced operator (5.7%). Among the remaining four patients, one patient required a surgical epicardial LV lead implantation, and the implantation was not reattempted in the other three patients. The overall
success rate of CRT system implantation was 96.2% (102 of 106 patients). Procedure parameters were as follows:
LV threshold (1.4 + 0.9 V); LV wave amplitude (15 + 8 mV); LV impedance (874 + 215 ohm); median procedure
time (skin to skin), 55 min (45–80); and median of procedure fluoroscopy time, 11 min (6.2 –29). In 24 patients
(22.6%), difficult procedures requiring ≥85 min of implantation duration occurred. By univariate analysis, predictive
factors of difficult implantation were LV ejection fraction (25.6 + 6 vs. 30.2 + 8%; P ¼ 0.02), LV end-diastolic diameter (72.4 + 11 vs. 66 + 11 mm; P ¼ 0.01), LV end-systolic diameter (LVESD; 62 + 12 vs. 56 + 12 mm, P ¼ 0.04),
and the operator’s experience (very experienced operator vs. less experienced operator, P ¼ 0.006). By multivariate
analysis, only primary LV lead implantation failure, LVESD, and operator’s experience were independently associated
with difficult procedures. In this patient subset with primary LV lead implant failure (n ¼ 10), the only independent
predictive factor was the LV end-systolic volume (P ¼ 0.03).
.....................................................................................................................................................................................
Conclusion
In this study, the rate of difficult CRT device implantation procedures approached 25%. Both the degree of LV dysfunction and the operator’s experience were independent predictors of surgical difficulties. Left ventricular end-systolic volume was the only independent predictor of primary LV lead implant failure.
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Heart failure † Cardiac resynchronization † Unsuccessful implant † Procedure complications † Technical aspects
* Corresponding author. Service de Cardiologie, Hôpital Nord, Centre Hospitalier Universitaire de Saint-Etienne, 42055 Saint-Etienne Cedex 2, France. Tel: +33 4 77 82 81 13;
fax: +33 4 77 82 81 64, Email: [email protected]
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2010. For permissions please email: [email protected].
1142
Introduction
The purpose of cardiac resynchronization therapy (CRT) is to
restore ventricular relaxation and contraction sequences by simultaneously pacing both ventricles.1 – 6 Several studies reported positive long-term effects in terms of symptoms, exercise tolerance,
well-being, and CRT prognosis.3 – 10 Therefore, the increase in indications for CRT has logically resulted in an increased number of
device implantations. However, potential clinical benefits of CRT
depend on the proper implantation of the left ventricular (LV)
lead, which remains technically challenging.11,12 Cardiac resynchronization therapy needs transvenous pacing of the LV lead via the
coronary sinus (CS) branches. Procedures may be long and difficult, due to CS access, CS vein anatomy, need for CS angiography,
and lack of operator’s experience.6,10 – 12 Although the availability of
multiple lead designs and LHDS options may improve the procedure’s success, problems still remain, with failure occurring in
5 –15% of cases, particularly for a primary LV lead implant.6,12
Moreover, despite the use of systematic antibioprophylaxis,13 a
124% increase in the rate of device-related infections (DRI) was
reported in a published series,14 and most investigators agree that
infections occurring within 1 year of implantation are usually due
to contamination during prolonged surgery.15 More recently, our
group has found that the prevalence of CRT DRI was 4.3% at 2.6
years and that both procedure duration and surgical re-intervention
were the independent predictors of DRI.16 Owing to the lack of
published studies, more data are required regarding the effects of
prolonged CRT implantation procedure duration and X-ray
exposure. Additionally, only few published studies have investigated
the predictive factors of primary LV lead implant failure.17 – 19 These
studies, however, provided debatable results, due to several
methodological issues: the use of retrospective study designs,
number of variables tested, type of parameters studied, and
absence of right anatomical evaluation.17 – 19
Consequently, the aim of this prospective study was two-fold: (i)
to evaluate both the prevalence and the predictive factors of difficult CRT implantation procedures and (ii) to identify the predictive
factors of primary LV lead implant failure.
Methods
Patient selection
Between November 2008 and September 2009, 128 consecutive
patients underwent CRT implantation in our centre. Among these,
22 patients (16.4%) were referred for CRT generator replacement
and excluded from the study. All patients included in the trial provided
written informed consent. Inclusion criteria required that all of the following conditions be met: (i) New York Heart Association (NYHA)
functional class III or IV heart failure (HF); (ii) QRS width ≥120 ms
with a left bundle branch block pattern or QRS ≥ 180 ms for paced
patients [measured on three or more surface electrocardiographic
(ECG) leads]; (iii) chronic LV systolic dysfunction defined by an LV
ejection fraction (LVEF) ≤35% and LV end-diastolic diameter
(LVEDD ≥60 mm) on echocardiography; (iv) optimal medical treatment for HF including angiotensin-converting enzyme inhibitors or
AT1 receptor antagonists, diuretics, b-receptor blockers, and spironolactone; and (v) patients requiring atrioventricular (AV) node ablation
for atrial fibrillation (AF) with moderate LV dysfunction (LVEF ≤ 40%)
L. Bisch et al.
with or without QRS ≥ 120 ms in accordance with the PAVE study
results.20 The exclusion criteria were: (i) hypertrophic or restrictive
cardiomyopathy; (ii) suspected acute myocarditis; (iii) correctable valvulopathy; (iv) acute coronary syndrome; (v) recent coronary revascularization (previous 3 months) or planned revascularization; (vi)
treatment-resistant hypertension; (vii) severe obstructive lung
disease; and (viii) reduced life expectancy not associated with cardiovascular disease.
Study design
Between 5 and 30 days prior to implantation, the patients underwent a
clinical examination, 12-lead ECG, transthoracic echocardiography, and
Doppler evaluation.
Echocardiographic measurements
Transthoracic Doppler echocardiography was performed at least 24 h
before the procedure by an observer (L.B. or L.K.) who was blinded to
the patient’s status. Ultrasound studies were performed with a Vivid 7
imaging system using a 2.5 MHz transducer (second harmonic activation). M-mode and bi-dimensional measurements were made
according to the recommendations of the American Society of Echocardiography. Right atrial anatomical two-dimensional echocardiographic measurements were performed as well as the septal isthmus
length measurement. Right and left atrial surface were measured by
planimetry (in cm2). All two-dimensional echocardiographic and
Doppler-derived pulmonary pressure measurements were averaged
over five cardiac cycles. Tricuspid regurgitation was evaluated and considered significant when the grade was 3 or more.
Implant procedure
The method of implantation was published elsewhere.21 Patients were
systematically shaved and had an antiseptic shower with a povidone
iodine 10% aqueous solution on the night before the operation. Antisepsis was performed immediately before surgery, and the skin was
painted with two solutions: an aqueous povidone iodine 10% solution
followed by a povidone iodine 7.5% solution. Implantations were performed by the same two operators (A.C. and C.R.B.) under local
anaesthesia and conscious sedation. All patients received the same
antibiotic prophylaxis.13 Venous administration was performed
30 min prior to the incision using a single dose of cefazolin (1.5 g).
No local antibiotic pocket wash was used. Patients were examined
daily until hospital discharge. All devices were implanted subcutaneously. Total implant procedure duration (skin to skin), total
X-ray time, X-ray time for LV lead implantation, and pacemaker
lead-related data (threshold, impedance, and amplitude signal) were
recorded, as were complications during the procedure and postoperative period. In all patients receiving an implantable cardioverterdefibrillator (ICD) CRT, a defibrillation test was performed. All
patients received a biventricular DDD-R device in the presence of
sinus rhythm (SR), and a biventricular VVI-R device in the presence
of permanent AF.
Endpoints
The primary aim was to evaluate both the prevalence and the predictive factors of difficult CRT implantation associated with long procedure duration. The definition of long procedure duration was
based on the cut-off value associated with a higher risk of CRT DRI
in our previous study.16 A median of procedure duration ≥85 min
was found to be independently correlated with a higher risk of CRT
DRI.16 The secondary aim was the identification of predictive factors
for primary LV lead implant failure.
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CRT and technical success
The following factors were tested: age, gender, body mass index
(BMI), cardiovascular risk factors, chronic kidney failure, device procedure category (CRT-P, CRT-D, or upgrading), aetiology of cardiomyopathy, NHYA class, LVEF, LV volumes and dimensions, the
presence of AF, systolic arterial pulmonary pressure level, right atrial
dimensions, tricuspid regurgitation graduation, right ventricular dimensions, the septal isthmus (length between the CS ostium and the septal
tricuspid leaflet, reflecting the CS insertion level), lead manufacturer,
and lead position (posterior, posterolateral, lateral, and anterolateral).
The operator’s experience in a high-volume centre was also examined,
with CRT implantation experience of at least 10 years (ADC) vs.
experience ,10 years and more than 5 years (CRB).
Re-intervention
Surgical re-intervention was defined as a surgical procedure required
for a non-infectious or infectious complication of the implant, and
was further stratified as occurring early (≤5 days) or late (.5 days).
The overall success of implantation was determined after the second
LV lead implantation attempt.
Follow-up
Prospective data includes: (i) patients’ demographic and clinical characteristics; (ii) echocardiographic measurements; (iii) CRT characteristics
(pacemaker or defibrillator implantation, and primo-implants or
system upgrade of pulse generators or leads); (iv) type of implanted
device and number of leads; (v) procedure duration (skin to skin)
and total X-ray exposure as wells as LV lead procedure duration estimated by X-ray exposure; and (vi) occurrence of complications requiring re-intervention.
Patients’ follow-ups were conducted by three cardiologists (A.C.,
L.B., and C.R.-B.). Electrocardiograms, device controls, and chest
X-rays were performed the day after the procedure (Day 1) and on
Day 5, just prior to discharge. The patients’ scars and sutures, and
chest X-rays, were examined in the outpatient clinic on Day 10 and
at 3 months; a physical examination and device interrogation were
also carried out on these occasions.
Statistical analysis
All clinical variables were assessed at the time of the device implantation. The echo parameters were evaluated during the hospitalization
by two operators who were blinded to the patients’ status (L.B.
and L.K.).
Continuous variables were presented as mean + SD or median with
inter-quartiles as appropriate. Comparisons between the patients’
groups were performed on continuous variables using, respectively,
unpaired Student’s t-test or the Mann– Whitney test. Categorical variables were compared using x2 tests or Fisher’s exact test as
appropriate.
Univariate logistic regression models were fitted to study the
relationship between each covariate and the risk of a prolonged procedure time on the one side, and the risk of primary LV lead implantation failure on the other side. Backward elimination was used,
removing the least significant variables at each step to elaborate multivariate models. Risks were presented as odds ratio and their 95% confident interval (CI).
A value of P , 0.05 was considered statistically significant. All analyses were performed using StatVieww5.0 (StatView IV, Abacus
Concept, Berkeley, CA, USA).
Results
Baseline population characteristics
Baseline clinical data is summarized in Table 1. The CRT implantation was attempted in 106 patients, and first LV lead implantation
was achieved in 96 of 106 patients (90.5% primary success). Ten
primary implantations failed (9.5%) due to unsuccessful LV lead
implants: four patients failed due to the inability to catheterize
the CS and six patients due to the inability to find tributary vein.
A second procedure was attempted with a more experienced
operator (A.C.) in six patients (5.7%), and the success was
achieved in all six patients. Among the remaining four patients,
one required a surgical epicardial LV lead implantation, and implantation was not reattempted in the remaining three patients, due to
the investigators’ decision not to proceed (n ¼ 2) or patient
decision (n ¼ 1). The overall success rate of CRT system implantation was 102 of 106 (96.2%) patients. Of the 106 patients, 77
were in SR, 29 were in AF, and 12 had a previous device [pacemaker (PM) in 2 patients and ICD in 10 patients]. The medical
treatment was as follows: 97 patients were treated with
angiotensin-converting enzyme inhibitors or AT2 receptor antagonists (91.5%), 106 patients with diuretics (100%), 80 patients
with b-receptor blocker (75.5%), 52 patients with aldosterone
Table 1 Patients’ characteristics
Study population
(n 5 106)
................................................................................
Age (years)
69.2 + 9.9
Gender (% women)
28.3
QRS width (ms)
Aetiology of myocardiopathy
146.2 + 33.1
Idiopathic dilated cardiomyopathy
53 (50.0%)
Ischaemic cardiomyopathy
Valvular
39 (36.8%)
14 (13.2%)
NYHA
Class III
Class IV
85 (80.2%)
21 (19.8%)
Procedure duration (skin to skin) (min)a
55.0 (45.00–80.00)
Total X-ray exposure (min)a
LV implantation based on X-ray exposure
(min)a
LVEF (%)
11.00 (6.2– 29.0)
9.7 (4.2–20.8)
LVEDD (mm)
67.1 + 11.5
LVEDV
TLAD (mm)
173.3 + 72.8
42 + 6
29.2 + 8.3
BMI
1.86 + 0.2
Primary unsuccessful implant, n (%)
Final LV lead implant success, n (%)
10 (9.4%)
102/106 (96.2%)
Values are mean + SD. NYHA, New York Heart Association; LVEF, left
ventricular ejection fraction; LVEDD, left ventricular end-diastolic diameter;
LVEDV, left ventricular end-diastolic volume; TLAD, transversal left atrial
diameter; BMI, body mass index.
a
Median (inter-quartiles).
1144
L. Bisch et al.
antagonists (49.1%), 48 patients with vitamin K antagonists (45.3%),
and 58 patients with aspirin (54.7%).
mentioned, one patient required surgical LV lead implantation
with a CRT-D device.
Implantation and technical aspects
Predictive factors of difficult cardiac
resynchronization therapy implantation
Procedure parameters were as follows: LV threshold (1.4 + 0.9 V);
LV wave amplitude (15 + 8 mV), LV impedance (874 + 215 ohm),
procedure time (skin to skin) (median of 55 min), and overall procedure fluoroscopy time (median of 11 min). The direct LV lead
was successfully positioned as follows: lateral vein in 65 patients
(63.7%), posterolateral vein in 25 patients (24.6%), posterior in 7
patients (6.8%), and anterolateral in 5 patients (4.9%). The anterolateral vein was used in the primary implantation in four patients
and only one patient required this target vein during the second
procedure. The mean fluoroscopy time for LV implantation was
17 + 16 min. The 102 devices implanted were CRT PMs in 16
patients (15.7%), CRT ICDs in 75 patients (73.5%), and upgrading
to CRT in 11 patients (10.8%) (PM, n ¼ 2; ICD, n ¼ 9). As
In 24 patients (22.6%), difficult procedures requiring ≥88 min of
implantation duration occurred. By univariate analysis, predictive
factors of difficult implantation were LV ejection fraction (25.6 +
6 vs. 30.2 + 8%; P ¼ 0.02), LVEDD (72.4 + 11 vs. 66 + 11 mm,
P ¼ 0.01), LV end-systolic diameter (LVESD; 62 + 12 vs. 56 +
12 mm, P ¼ 0.04), and the operator’s experience (very experienced operator vs. less experienced operator, P ¼ 0.006)
(Table 2). By multivariate analysis, only primary LV lead implantation failure, LVESD, and operator’s experience were independently associated with difficult procedures (Table 3). Right
anatomic ventricular parameters were not associated with difficult
CRT procedures, neither was left atrial or right atrial dimension
Table 2 Comparison of patients’ characteristics according to prolonged (total procedure time ≥85 min) and
non-prolonged procedure times
Prolonged procedure
time (n 5 23)
Non-prolonged
procedure time (n 5 83)
69.5 + 11.2
19
69.2 + 9.6
66
P-value
...............................................................................................................................................................................
Age (years)
NYHA class III
0.9
0.7
NYHA class IV
4
17
BMI
Procedure time (skin to skin) (min)a
1.85 + 0.2
110.0 (90.0– 120.0)
1.87 + 0.2
50.0 (43.0–60.0)
0.8
,0.0001
0.7
Total X-ray exposure (min)a
57.4 (30.2–61.0)
9.0 (5.5– 16.2)
,0.0001
LV lead X-ray time (min)a
Atrial fibrillation
55.0 (25.5–58.0)
5/23 (21.7%)
6.4 (3.3– 14.0)
24/83 (28.9%)
,0.0001
0.5
Dilated cardiomyopathy
14/23 (60.9%)
39/83 (47.0%)
0.5
Ischemic cardiomyopathy
Valvular cardiomyopathy
7/23 (30.4%)
2/23 (8.7%)
32/83 (38.6%)
12/83 (14.5%)
0.5
0.5
LVEF
25.6 + 6.3
30.2 + 8.5
0.02
LVEDD (mm)
LVESD (mm)
72.4 + 11.4
61.7 + 12.1
65.6 + 11.1
55.7 + 11.6
0.01
0.04
LVEDV (mL)
192.0 + 73.7
168.1 + 73.7
0.2
LVESV (mL)
LAS (cm2)
148.2 + 62.2
26.4 + 6.5
120.2 + 62.2
26.7 + 10.6
0.06
0.9
RAS (cm2)
18.3 + 5.8
19.8 + 7.1
0.4
RVEDD (mm)
RVESD (mm)
37.7 + 10.5
27.8 + 10.4
37.1 + 8.9
27.1 + 9.2
0.8
0.7
RVEDV (mL)
49.9 + 30.1
49.6 + 24.4
0.9
RVESV (mL)
Operator’s experience in CRT procedure
28.7 + 24.2
26.5 + 17.9
0.7
≥10 vs. ,10 years and .5 years
Primary LV lead implantation failure
5/23 (22%) vs. 18/23 (78%)
45/83 (54%) vs. 38/83 (46%)
9/23 (39.1%)
1/83 (1.2%)
0.006
,0.0001
LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; M-mode and bi-dimensional measurements were made according to the recommendations of the
American Society of Echocardiography. LAS, left atrial surface; RAS, right atrial surface, BMI, body mass index; LVEDD, left ventricular end-diastolic diameter; LVESD, left
ventricular end-systolic diameter; LVEDV, left ventricular end-diastolic volume; LVESV, left ventricular end-systolic volume; RVEDD, right ventricular end-diastolic diameter;
RVESD, right ventricular end-systolic diameter; RVEDV, right ventricular end-diastolic volume; RVESV, right ventricular end-systolic volume; CRT, cardiac resynchronization
therapy.
a
Median (inter-quartiles).
1145
CRT and technical success
Table 3 Univariate and multivariate logistic regression
models: factors predicting a prolonged intervention
time
OR
95% CI
P-value
(n.s.). Several other variables were tested but did not correlate
with CRT implantation difficulties (n.s.): age, presence of AF,
NYHA class, cardiovascular risk factors, aetiology of myocardiopathy, QRS width, device type, LV lead brand, inferior vena cava
diameter, tricuspid, LV lead definitive position, and BMI.
................................................................................
Univariate models
LVEF
0.92
0.86, 0.99
0.021
LVEDD
LVESD
1.06
1.04
1.01, 1.10
1.00, 1.09
0.015
0.040
LVEDV
1.00
1.00, 1.01
0.169
LVESV
Operator’s experience
1.01
0.23
1.00, 1.01
0.08, 0.69
0.063
0.009
Primary LV lead failure
52.71
6.19, 449.08
,0.0001
Multivariate model after backward elimination
LVESD
1.06 1.00, 1.12
Operator’s experience in CRT
procedure (≥10 vs. ,10
years and .5 years)
Primary LV lead implantation
failure
0.22
46.24
0.04
0.06, 0.80
0.03
4.69, 456.29
0.001
Predictive factors of successful vs.
unsuccessful primary left ventricular lead
implantation
A trend towards a correlation was found for three variables:
LVEDD (P ¼ 0.053), LV end-diastolic volume (P ¼ 0.084), and
the operator’s experience (P ¼ 0.09). The operator’s experience
affected the procedure duration (57.5 + 20 vs. 68 + 32 min, P ¼
0.05) and X-ray exposure (14 + 13 vs. 22 + 19 min, P ¼ 0.02),
mainly due to the LV placement (12 + 12 vs. 18 + 18 min, P ¼
0.07). By univariate and multivariate analyses, LV end-systolic
volume (LVESV) (P ¼ 0.03) was the only predictive factor of
primary LV lead failure (Tables 4 and 5).
Follow-up
During the follow-up period lasting at least 3 months,
re-intervention was necessary in 11.3% patients (12 of 106): a
Table 4 Comparison of patients’ characteristics according to primary LV lead failure
Primary LV lead failure (n 5 10)
Primary LV lead success (n 5 96)
P-value
...............................................................................................................................................................................
Age (years)
63.1 + 13.1
69.9 + 9.4
0.1
NYHA class III
NYHA class IV
9
1
76
20
0.4
0.4
BMI
1.84 + 0.1
1.87 + 0.2
Procedure time (skin to skin) (min)a
Total X-ray exposure (min)a
120.0 (110.0– 125.0)
60.0 (59.5– 61.5)
55.0 (45.0– 70.0)
10.1 (6.0–19.4)
,0.0001
,0.0001
LV lead X-ray time (min)a
55.5 (55.0– 58.5)
8.2 (3.6–16.2)
,0.0001
Atrial fibrillation
Dilated cardiomyopathy
2/10 (20.0%)
7/10 (70.0%)
27/96 (28.1%)
46/96 (47.9%)
0.6
0.4
Ischemic cardiomyopathy
2/10 (20.0%)
37/96 (38.5%)
0.4
Valvular cardiomyopathy
LVEF
1/10 (10.0%)
24.9 + 7.7
13/96 (13.5%)
29.6 + 8.2
0.4
0.09
0.7
LVEDD (mm)
74.0 + 12.1
66.4 + 11.2
0.046
LVESD (mm)
LVEDV (mL)
61.1 + 12.8
212.4 + 76.1
56.6 + 11.8
169.2 + 71.7
0.3
0.1
LVESV (mL)
169.1 + 69.8
121.8 + 60.2
0.07
LAS (cm2)
RAS (cm2)
27.7 + 6.9
19.1 + 6.4
26.5 + 10.1
19.5 + 6.9
0.7
0.9
RVEDD (mm)
37.4 + 8.2
37.2 + 9.3
0.9
RVESD (mm)
RVEDV (mL)
25.8 + 6.8
48.4 + 21.0
27.4 + 9.7
49.8 + 26.1
0.6
0.8
RVESV (mL)
26.7 + 23.1
27.0 + 19.0
0.9
Operator’s experience in CRT procedure
(≥10 vs. ,10 years and .5 years)
2/10 (20%) vs. 8/10 (80%)
48/96 (50%) vs. 48/96 (50%)
0.07
LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; M-mode and bi-dimensional measurements were made according to the recommendations of the
American Society of Echocardiography. LAS, left atrial surface; RAS, right atrial surface.
a
Median (inter-quartiles).
1146
L. Bisch et al.
Table 5 Univariate and multivariate logistic regression
models: factors predicting a primary LV lead
implantation failure
OR
95% CI
P-value
LVEDD
1.062
0.999, 1.129
0.053
LVESD
LVEDV
1.033
1.007
0.975, 1.094
0.999, 1.015
0.276
0.084
................................................................................
Univariate models
LVESV
1.010
1.001, 1.020
0.031
Operator’s experience in CRT
procedure (≥10 vs. ,10
years and .5 years)
0.250
0.050, 1.239
0.090
Multivariate model after backward elimination
LVESV
1.01
1.00, 1.02
0.03
secondary LV lead placement was attempted in six patients with a
more experienced operator (A.C.) (5.6%), a surgical LV lead was
implanted in one patient (0.9%), a local infection was observed
in two patients requiring an extraction without any specific tool
(1.9%), and three lead dislodgements were observed (2.8%).
Phrenic nerve stimulation was resolved with a lower output LV
pacing.
Discussion
Major findings
This study found that the rate of difficult procedures in CRT device
implantation was close to 25%, mostly due to LV placement. Left
ventricular dysfunction severity and operator’s experience were
independently associated with both prolonged procedure time
and X-ray exposure duration. Moreover, LVESV was the only predictor of primary LV lead implant failure. Lastly, despite technical
difficulties, CRT devices were successfully implanted via the CS
in 96.2% of the entire study population.
Technical aspects and complication
related to cardiac resynchronization
therapy implantation
The increasing number of indications for CRT has logically led to an
increased number of device implantations. However, the potential
clinical benefits of CRT depend on the proper implantation of the
LV lead, which remains technically challenging.10 – 12,18,19,22,23 It has
been suggested that the successful outcome of LV lead placement
depends on several factors, such as CS anatomy, presence of the thebesian valve, presence of tributary CS veins, and operator’s experience.12,18 Despite several hypotheses, few studies have been
published in this field to date.17 – 19 Cardiac resynchronization
therapy implant procedure duration and X-ray exposure are still
too long, and prolonged surgery times are correlated with a high
rate of complications, particularly the risk of DRI.9 – 12,18,19,22,23
Mean durations of both CRT procedure and X-ray exposure
vary widely in the literature; they were reported to be 143 +
50 min for CRT procedure and 34 + 24 min for X-ray
exposure.10 – 12,23,24 High complication rates ranging from 5 to
18% were reported to be associated with CRT
implantations.10 – 12,18,19,22,23 Reported complications included
death, CS perforation or dissection, tamponade, inadvertent
occurrence of third-degree AV block, ventricular arrhythmias, LV
lead dislodgement, high LV pacing threshold, phrenic nerve
stimulation, ventricular oversensing, and infections requiring
removal of the entire system. Kautzner et al.,10 for example,
reported 4.3% subintimal CS dissection, 1.1% leak of contrast
liquid into the pericardial space (n.s.), 5.4% lead dislodgement or
phrenic nerve stimulation, 4.3% third-degree AV block during
introducer handling, and 2.2% rate of infection. In the Multicenter
Insync Randomized Clinical Evaluation (MIRACLE) study, the
authors reported two deaths, 4% coronary dissection, 2% CS
perforation requiring pericardiocentesis, 5.7% lead dislodgement,
and 1.3% rate of infection after a 6-month follow-up.9 More
recently, our group demonstrated that the risk of DRI was 4.3%
at 2.6 years, and we found that the risk of CRT DRI was correlated
with CRT implant procedure duration.16 Therefore, the knowledge
of predictors for both procedure duration and X-ray exposure
may allow for a higher rate of CRT implant success and lower
rate of complications.
Predictive factors of difficult cardiac
resynchronization therapy implantation
procedure and primary left ventricular
lead failure
Considering the technical complexity of CRT system implantation,
and the relative fragility of patients suffering from advanced HF, as
well as the risk of procedure complications, studies investigating
predictive factors of prolonged CRT implant procedure were
required. Although three studies have been published in this clinical
setting, their conclusions remain debatable or their results incomplete, owing to several technical shortcomings.17 – 19 In a retrospective study involving 212 patients, a mean procedure time of
120 min and a mean X-ray exposure of 35.6 min were reported
by Macı́as et al.17 Cardiac resynchronization therapy devices
were successfully implanted in 87.7% of patients, and two independent predictors of unsuccessful implantation were found: presence
of chronic AF and left atrial dimensions.17 The major limitations of
these studies were their retrospective design, the operators’ learning curve inclusion, and the use of old design leads for guiding catheters.17 – 19 Major results in this field of research were reported by
Gras et al.18 regarding patients enrolled in the CARE-HF trial. Successful LV lead implant was achieved in 95.6% of cases but the
success rate for primary implantation was only 86.7%. This study
allowed for a maximum of three attempts, and in order to increase
the likelihood of success, referral to more experienced centres
was possible, and even encouraged.18 The only variable predictive
of implant success was related to the experience of the participating medical centres, which is in line with previous observations
indicating that success rates depend on operators’ experience.
This suggests that the likelihood of successful implantation after
the first attempt may be significantly increased if the procedure
is repeated by a more experienced operator. This should
1147
CRT and technical success
encourage the development of centres of excellence. Lastly, Fatemi
et al.19 reported a primary LV implant success rate in 90% of cases,
but a second procedure was successful in four patients, resulting in
an overall success rate of 94%. No predictors of primary LV lead
placement were examined. Our study is the first prospective
report to look for predictive factors of prolonged CRT procedure.
In a previous work, our group demonstrated that prolonged
implantation duration increases infection risk,16 emphasizing that
CRT implantation is not a benign intervention and that experienced physicians as well as material improvements are needed.
Our study confirmed the predictive role of the operator’s experience, even in high-volume centres, but was also the first to emphasize the role of LV dysfunction severity, which is usually
accompanied by LV dilatation during CRT implant procedures.
Indeed, advanced cardiomyopathy is usually associated with
cavity enlargements, which may severely hamper access to the
CS ostium or LV lead stability, due to changes in anatomical
landmarks. The same observation was made when analysing
primary LV lead implant success rates, with the predictive role of
LV dilatation based on LVESV and LVESD. In conclusion, the rate
of CRT implant success, as well as the need for re-intervention,
procedure duration, and X-ray exposure, may be improved by
early selection of patients, prior to severe and definitive LV
deterioration.
Clinical implications
Implantation of special pacing leads for LV-based resynchronization
therapy for congestive HF is a rather technical procedure, usually
associated with a high rate of complications, including primary LV
lead failure, prolonged CRT procedure time, prolonged X-ray
exposure, LV lead dislodgement, and device-related infection. Prevention of these complications depends on multiple factors,
notably the identification of predictors of primary LV lead
implant failure and prolonged CRT implant procedure time. In
this clinical setting, our study confirms the need for experienced
centres, as well as the independent predictive role of the operator’s experience. Moreover, our study also demonstrates that
the heart dimensions and the severity of the cardiomyopathy are
the main factors leading to difficult procedures as well as
primary LV lead implant failures. Knight et al.11 reached similar conclusions in 443 patients requiring CRT device, with long-term
unsuccessful results observed in 20 patients (5%). The only predictive factor associated with CRT LV lead implant failure was LVEF.11
Therefore, in order to avoid unsuccessful LV lead implantation or
prolonged procedure duration, patients requiring CRT device
implantation may be selected at an earlier stage prior to severe
LVEF degradation or LV dilatation.11 It can be assumed that implantation in less severe patients would be associated with higher rates
of success, as was shown in the REVERSE study, publishing the
highest implant success rate ever reported (97%),24 as well as in
the MADIT-CRT study (98.4%).25 On the other side, our patients
were already with a relatively high LVEF compared with CRT compatible patients and the LVEF is probably in part a surrogate
marker for larger and pathological dimensions found in more
severely compromised cardiomyopathic hearts. Moreover, there
is still debate of the benefit and specifically cost regarding
implant in mildly symptomatic HF patients.
Study limitations
In our study, right atrial dimensions were not associated with prolonged procedure duration or primary LV lead implant failure. On
the other hand, right cavity dimensions are known to be difficult to
measure, and reproducibility is usually low and might explain these
results.26,27 Left ventricular ejection fraction is the main variable
which is significant as expected but the fact that all the other
factors regarding anatomic dimensions are not significant is probably the result of sample size. There is no mention of CS
anatomy which may play a part in success, but again with good
experience and small sample size, it would not be expected to
be prominent. Operators report CS implantation level or shape
as a main factor of LV lead instability; consequently, this variable
may also affect procedure duration or LV lead implant failure. A
study using intracardiac echocardiography or electron beam computed tomography could be complementary to standard fluoroscopic imaging and could be an optimal modality for imaging
structures that are highly relevant for the assessment of CS
anatomy.27,28
Conclusions
This study found that the rate of difficult procedures in CRT device
implantation approached 25%. Both the degree of LV dysfunction
and the operator’s experience were independent predictors of
surgical difficulties. Left ventricular dimensions were the only predictors of primary LV lead implant failure.
Conflict of interest: none declare.
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