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Multivariate analysis of risk factors for related complications of chemical
ablation on hypertrophic obstructive cardiomyopathy
‫ع لى ال ك يم يائ ية االج ت ثاث ال ص لة ذات ل م ضاع فات ال خطر عوامل ال م ت غ يرات م ت عدد ال تح ل يل‬
‫ياالن سداد ال ضخامي ال ق لب ع ض لة اع ت الل‬
The first author and the corresponding author: Cheng-yang LI, M.D.
‫ ي ان غ ت ش نغ ال م قاب لة ال مؤل ف‬LI ‫ال ماج س ت ير درجة‬
Email: [email protected]
‫اإلل ك ترون ي ال بري د‬: [email protected]
Telephone no: 86-18809894635
‫ال هات ف رق م‬: 86-18809894635
The second author: Zhan-quan LI, M.D.
‫ ت ش يوان ت شان ال ثان ي ال كات ب‬LI ‫ال ماج س ت ير درجة‬
Email: [email protected]
‫اإلل ك ترون ي ل بري د‬: meilixinqing [email protected]
Telephone no: 86-024-24016114
‫ال هات ف رق م‬: 86-024-24016114
Running title: Risk factors for PTSMA complications
‫ ل م ضاع فات ال خطر عوامل ال توال ي ع نوان‬PTSMA
Department of Cardiology
‫ال ق لب أمراض ق سم‬
Liaoning Provintial People's Hospital
‫ ل ياون ي نغ م س ت ش فى‬Provintial ‫ال ش ع ب ية‬
Mail address: No. 33 Wenyi Road, Shenhe District, Shenyang City, Liaoning
Province, China
Zip code: 110016
‫ رق م ال بري د ع نوان‬33 ‫ م نط قة ال طري ق ي ى ون‬SHENHE ‫ل ياون ي نغ م قاط عة ش ن يان غ مدي نة‬
‫ال ص ين‬
‫ ال بري دي ال رمز‬110016
Multivariate analysis of risk factors for related complications of chemical
ablation on hypertrophic obstructive cardiomyopathy
Abstract
Objective: To investigate the risk factors of related complications of percutaneous
transluminal septal myocardial ablation (PTSMA) for hypertrophic obstructive
cardiomyopathy.
Methods: The clinical data as well as one-year follow-up results of patients with
hypertrophic obstructive cardiomyopathy, who were performed PTSMA between
January 2000 and July 2013, were analyzed retrospectively for judging risk factors for
operative complications.
Results: PTSMA was performed in 224 patients (male 120, female 104; mean age
48.20±14.34 years old). The incidence of PTSMA procedure related complications
was 36.23% (66/224), which included 3 cardiac death , 2 cardiac shock, 1 st-segment
elevated myocardial infarction, 2 ventricular fibrillation, 20 third-degree
atrioventricular block (4 patiens were implanted permanent pacemaker), 32 complete
right bundle branch block, 2 complete left bundle branch block and 4 puncture related
complications. After multivariate logistic regression analysis, age, sex, coronary
artery diseases, diabetes, heart rate, cardiac function on admission, number of ablation
septal and volume of alcohol were not the independent risk factors correlated to the
whole complications except for hypertension (OR: 4.856; 95% CI 1.732-13.609).
Early experience seemed to be associated with the occurrence of complications.
Conclusion: Hypertension was the independent risk factor for PTSMA procedure
related complications. And PTSMA procedures should be restricted only to
experienced centers according to the analysis result for learning curve.
Key words: Hypertrophic obstructive cardiomyopathy; Percutaneous transluminal
septal myocardial ablation (PTSMA); Complication; Hypertension
Introduction
Hypertrophic obstructive cardiomyopathy (HOCM) is defined as primary myocardial
hypertrophy with a dynamic left ventricular outflow tract (LVOT) obstruction and
diastolic dysfunction of left ventricle. HOCM, which induces symptoms of angina,
dyspnea and syncope, is a genetically determined disorder that is caused by mutations
in genes that encode sarcomeric contractile proteins [1]. The long-term symptomatic
effectiveness of myectomy has been proven in patients with HOCM with severe drug
refractory symptoms and possibly improves survival [2-6]. Percutaneous transluminal
septal myocardial ablation (PTSMA) was introduced in 1995 as an alternative to
myectomy and has been shown to reduce the LVOTO and associated symptoms [7-9].
And according to Kimmelstiel and Maron, there have been an estimated 3000
PTSMA procedures performed worldwide by 2005 [10]. However,
despite advances in the judgement of indication, operating skill, optimal medical
treatment and the management of complications, the PTSMA related complications
remained high during the peri-operative period. The most common complication is
right bundle branch block. The most significant complications include high degree
conduction block needing permanent pacemaker, acute myocarial infarction, cardiac
shock, cardiac death as well as the puncture site complications. Unfortunately, the
analysis results of risk factors for related complications are few and sometimes
contradictory to date. In this report, we attempted to identify the risk factors related to
PTSMA procedure complications by launching a retrospective review of 319 HOCM
patients.
Methods
The study population comprised 319 patients with HOCM who were referred to the
cardiology department of LIAO NING Province Hospital of China considering septal
reduction therapy with PTSMA between January 2000 and July 2013. PTSMA is the
preferred treatment option for patients without concomitant CAD or valvular heart
disease in our institution [11]. Two hundred and fifty-eight out of 319 patients met the
inclusion criteria for septal reduction therapy with resting left ventricular outflow tract
gradient (LVOTG) ≥30 mmHg or exercised-induced LVOTG ≥50 mmHg, and New
York Heart Association functional class >2 despite optimal medical treatment[12].
The diagnostic criteria for HOCM were end diastolic wall thickness >15 mm and a
non-dilated left ventricle (LV) with ejection fraction (EF) ≥50% [13]. Exclusion
criteria were hypertrophy of other causes (n=17), history of myocardial infarction
(n=10), and prior intervention with PTSMA (n=7) or septal myectomy (n=0). Patients
with CAD (coronary artery stenosis ≥50% evaluated at coronary angiography)
without myocardial infarction, mild, or moderate valvular heart disease unrelated to
HCM, and patients on antihypertensive therapy were not excluded.
Diabetes was defined according to the guidelines [14]. Hypertension was defined as
either a systolic or a diastolic elevation of the blood pressure (>140/90 mmHg) or
ongoing antihypertensive therapy. Hypercholesterolemia was defined as a total
cholesterol level >5.0 mmol/l or current treatment with lipid-lowering medications.
The study complied with the Declaration of Helsinki. The local ethics committee of
the LIAO NING Province Hospital approved the study protocol and all patients gave
informed consent.
Echocardiography
Before and during the procedure and at follow-up, all patients underwent transthoracic
echocardiography using a Hewlett-Packard Sonos 1500 echocardiograph with an
interfaced 2.5-MHz transducer. The following parameters were measured:
intraventricular septum (IVS) thickness, left ventricular posterior wall (LVPW)
thickness, and endsystolic and end-diastolic dimensions from the minor axis M-mode
of the left ventricle obtained from a 2-dimensional standard left parasternal view; the
LVOT PG was measured by a continuous-wave Doppler probe positioned at the
cardiac apex. The ejection fraction (EF) was automatically calculated.
Dobutamine stress echocardiography
Dobutamine was administered by an infusion pump at a starting rate of 5
μg·kg-1·min-1, with increments of 5 μg·kg-1·min-1 every three minutes to a
maximum dose of 40 μg·kg-1·min-1. The stress induced echocardiography endpoint
is the end of the eighth stage of the dobutamine protocol or following chest pain,
dyspnea, a drop in arterial pressure of 20 mmHg or more and an ST-segment shift of 1
mm or more.
Cardiac Catheterization, Gradient Determination and Ablation Procedure
The right femoral and the right radial arteries, as well as the right femoral vein, were
cannulated using a standard Judkins technique. After an intravenous bolus of 100-150
U/kg of heparin, a 6F pacemaker lead was placed in the right ventricle, a 6F pigtail
catheter was positioned in the left ventricular apex and a 6F Judkins guiding catheter
was placed in the left coronary artery. The resting LVOT PG was determined by
simultaneous pressure recording. Provocation after premature ventricualr contraction
caused by pigtail catheter was performed if necessary. The adequate septal branch was
identified on the coronary angiogram after which a 0.014-inch guidewire was inserted
into the septal branch and then a 1.5/2.0/2.5 mm diameter, 10/20 mm length over
the-wire balloon catheter was placed in the proximal part of the septal branch. After
balloon inflation at 2–6 atm, the correct balloon position was determined by injection
of contrast medium via the guiding catheter into the left coronary artery, and then by
injection through the balloon catheter shaft into the septal branch. To determine the
target septal branch, probationary balloon inflation and/or myocardial contrast
echocardiography (MCE) was performed. When sufficient decrease in the LVOT PG
was observed by probationary balloon inflation, the septal branch was identified as
the target. MCE was routinely performed according to the routine methods [15]. If
necessary, another septal branch was cannulated using the balloon and then the same
examination was performed to determine the critical septal branch. When the target
septal branch was determined, after intravenous administration of diamorphine 5mg,
1–3ml of absolute alcohol was slowly injected through the balloon catheter shaft; 10
min later, the balloon was deflated and contrast medium was injected via the guiding
catheter to ascertain that the septal branch was completely blocked. If it was not, an
additional 1–3 ml of alcohol was injected. The LVOT PG measurements were
repeated. If satisfactory PG reduction (>50% of pre-procedural gradient) was not
achieved, another septal branch was examined by MCE and ablated in a similar
manner if possible. According to our protocols, patients were monitored (including
telemetry) in coronary care units for 3 days after the PTSMA procedure. The vascular
sheaths were removed after normalization of the coagulation variables. After 48 hours,
the temporary pacemaker was removed if the patient seemed to have normal cardiac
conduction. If high-grade atrioventricular (AV) conduction disturbances were seen
during the following days, a permanent pacemaker (PPM) implantation was offered.
Patients were discharged to follow-up in our outpatient clinics.
Complications
Complications during PTSMA procedures and in-hospital monitoring were registered.
Events were acute heart failure, cardiac shock and cardiac death, and arrhythmic
events were bradycardia, asystole, and sustained and nonsustained ventricular
tachycardia and ventricular fibrillation (VF). Coronary artery complications were
coronary dissection, coronary perforation, acute myocardial infarction, acute
pericardial effusion, pericardial tamponade, and alcohol displacement. Bundle branch
block and AV block, including advanced heart block, leading to PPM implantation
were registered. Advanced heart block was defined as bifascicular block, second- or
third-degree AV block. Asystole due to third-degree AV block was classified as
third-degree AV block (ie, advanced heart block). Puncture related complications
would also be included for the final analysis.
Patient Follow-up
Patients were carefully monitored in the coronary care unit for at least 3 days after the
procedure and back-up pacing was continued via the femoral vein if necessary.
In-hospital assessment was performed for all clinical outcomes, including
hemorrhagic and vascular complications (femoral artery pseudoaneurysm and
puncture hematoma were also included for analysis). After discharge, monthly clinical
follow-up examinations were conducted on an outpatient basis to monitor the
occurrence of adverse events. Examinations by catheterization were not performed
routinely, only when residual or recurrent symptoms were observed after discharge,
and PTSMA was repeated if necessary. A failed outcome after PTSMA was defined as
the necessity for re-intervention because of the absence of clinical improvement or the
recurrence of symptoms and a significant LVOT gradient. To analyze the influence of
a learning curve in relation to the PTSMA complications, patients would be separated
into 3 chronological groups (early experience: from 2000 to 2004; intermediate
experience: from 2005 to 2009; late experience: from 2010 to 2013) according to the
experience with PTSMA.
Statistical analysis
All data analysis was performed with SPSS 19.0 statistical package.A P value less
than 0.05 (2-tailed) was considered to be statistically significant. Data with normal
distribution were expressed as mean±SD. The differences between groups were
analyzed for statistical significance using Student's t test. Data with abnormal
distribution interquartlle range were expressed as median and interquartile range. The
frequency was compared using Chi-squared (χ2) test. The multivariate stepwise
logistic regression was used to select the independent variables.
Results
A total of 224 subjects from 9 to 82 years old were included in this study. The mean
age of the subjects was 48.20±14.34 years and 120 (53.6%) were male. The most
common symptoms were palpitation, dyspnea or stress-induced squeezing chest
discomfort. There were 47 patients with hypertension, 3 patients with diabetes
millitus. 15 patients (6.7%) had cardiac dysfunction (5 in New York Heart Association
class III and 10 in New York Heart Association class II). The other demographic and
echocardiographic characteristics were shown in Table 1.
Table 1 Clinical characteristics of 224 patients with hypertrophic obstructive
cardiomyopathy (HOCM) on admission
Patients on admission (n=224)
Age (years)
48.20±14.34
Male/female
120/104
New York Heart
functional class
CAD
Association
1.08±0.36
13
Hypertension
47
DM
3
Stroke
HR (beats/min)
1/
70.92±11.66
LVOTD (mm)
9.38±2.52
0.65±0.07
CAD: coronary artery disease; DM: diabetes mellitus;
HR: heart rate; LVOTD: left ventricular outflow tract diameter
EF: ejection fra
EF
Acute results
Changes to hemodynamic results during the intervention:
One patient with 82 years old was dead during the injection of alcohol for acute
pericardial tamponade. A mean of 1.17±0.45 (one to three) septal branches were
occluded by injection of 2.07±0.89 (range 0.5ml to 6.5ml) of alcohol. A reduction of
the LVOT gradient could be attained in all patients. The mean systolic pressure
difference in LVOT at rest decreased from 67.91±37.23 to 16.24±19.13 (P<0.01). The
post premature gradient was reduced from 119.42±38.44 to 40.83±22.61 (P<0.01).
Improvement of clinical course:
All patients complained of a marked chest pain during the alcohol injection and a
feeling of discomfort in the left thorax lasted up to 30h (10h to 30h). Clinical
symptoms were greatly improved in 190 patients (85%). No significant differences
were found in New York Heart Association functional class (from 1.08±0.36 to
1.01±0.09).
Complications:
Two patients developed ventricular fibrillation after the alcohol injection and sinus
rhythm was restored by a 200J defibrillation. Two patients suffered from cardiac
shock for the prolonged occlusion of the septal arteries. One case of thrombosis in the
left anterior descending artery during the PTSMA procedure was observed. He was
successfully treated, and coronary flows were normalized. Temporary right bundle
branch block and left bundle branch block occurred in 32 patients and 2 patients
respectively. 20 patients developed a trifascicular block, but only 4 patients developed
a complete AV block, requiring permanent pacemaker implantation. Puncture related
complications occurred in 4 patients (femoral artery pseudoaneurysm in 2 and
puncture hematoma in 2) which were successfully treated by compression bandage.
One-year noninvasive follow-up
No patients were lost to follow up. No other complications or severe major adverse
cardiac events happened during clinical follow-up except that PTSMA was
successfully performed again in one patient for the recurrent angina pectoris.
The analysis of risk factors for related complications of PTSMA was shown in Table 2.
The risk factors that might predispose patients to operative related complications were
found after a univariate analysis. Age, sex, alcohol volume, number of ablation septal
and comorbidities with CAD, hypertension, DM as well as stroke were associated
with increased occurrence of complications. The results of a multiple logistic
regression analysis were presented in Table 3. In multiple logistic models, except for
hypertension (OR: 4.856; 95% CI 1.732-13.609), age (OR: 0.995; 95% CI
0.959-1.031), sex (OR: 0.527; 95% CI 0.198-1.399), alcohol volume (OR: 0.757; 95%
CI 0.403-1.420), number of ablation septal (OR: 0.682; 95% CI 0.370-2.253),
comorbidities with CAD (OR: 0.761; 95% CI 0.132-4.407) and DM (OR: 6.620; 95%
CI 0.428-12.527) were not potential risk factors for predicting related complications
of PTSMA.
Table 2
Complications (n=66)
No Complications (n=158)
Age (years)
51.27±14.13
46.91±14.28
Male/female
27/39
92/66
1.10±0.40
1.08±0.33
5
8
Hypertension
19
27
DM
3
0
Stroke
1
0
HR (beats/min)
71.55±11.92
71.08±12.29
New York Heart
functional class
CAD
Association
P
valu
e
0.03
8
0.00
0
0.56
6
0.00
0
0.00
0
0.00
0
0.12
2
0.79
2
LVOTD (mm)
9.13±2.64
9.33±2.54
EF
0.63±0.13
0.66±0.08
Alcohol volume
2.14±0.88
1.85±0.91
Number of ablation septal
1.19±0.43
1.07±0.27
0.60
4
0.50
6
0.02
3
0.03
4
CAD: coronary artery disease; DM: diabetes mellitus; HR: heart rate; LVOTD: left
ventricular outflow tract diameter; EF: ejection fraction
Table 3 Multivariate logistic regression for potential risk factors for PTSMA complications
P value
Odds ratio
CI
Age (years)
0.767
0.995
0.959-1.031
Male
0.198
0.527
0.198-1.399
CAD
Hypertension
DM
0.761
0.003
0.176
0.761
4.856
6.620
0.132-4.407
1.732-13.609
0.428-12.527
Alcohol volume
0.385
0.757
0.403-1.420
Number of ablation septal
0.436
0.682
0.370-2.253
CAD: coronary artery disease; DM: diabetes mellitus;
As listed in Table 4, the patients were divided in 3 groups according to experience
with PTSMA chronologically. However, in-hospital complications occurred more
often in patients who performed PTSMA procedures in the early stage (from 2000 to
2004), less in later and experienced time period (P=0.022).
Table 4 In hospital complications and late interventional failure according to
experience
Early experience
(n=75)
Intermediate experience
(n=93)
Late experience
(n=56)
P value
Events
31
22
13
0.022
No events
44
71
43
Discussion
PTSMA is a nonsurgical technique of reducing the septal mass by producing a
septal infarction using the catheter techniques reported by Sigwart [7]. The creation of
permanent septal necrosis by injecting alcohol into the septal branches supplying the
myocardium that is responsible for the LVOT obstruction, because of its abnormal
structure and function, effectively reduces the pressure gradients in patients with
HOCM. This technique has the advantage of microtrauma and high success rate as
well as the low mortality (0–1.8%) [16-19]. In the present cohort, a successful
reduction in LVOT PG was achieved in the majority of patients during the procedure
(85%) (at rest: from 67.91±37.23 to 16.24±19.13 mmHg, P<0.01; post premature beat:
119.42±38.44 to 40.83±22.61mmHg, P<0.01) and at discharge (96%).
However, the occurrence of PTSMA procedure related complications was of note.
In this study, 14.35% (32/223) patients had ever occurred transient complete bundle
branch block (32/223) as well as 0.90% (2/223) for complete left bundle branch block.
This phenomenon was consistent with previous report [20]. The right bundle is
usually supplied by the proximal septal perforators, and thus, PTMSA frequently
leads to complete right bundle branch block, and septal myectomy causes complete
left bundle branch block in a majority of patients. That was why PTMSA had caused
more complete left bundle branch and less complete left bundle branch block in our
study. Not more than 10% patients had high degree atrio-ventricular block but PPM
were only performed in 4 patients (1.79%), which showed superiority in comparasion
with other PTSMA centers (46% and 38%) [21-22]. Serious complications are not
uncommon. The most significant complication of the procedure is heart block [12],
which led up to the deaths in 2 patients in the study. In addition, reports of in-hospital
VF in relation to PTSMA have attracted considerable attention [23-24]. We found 2
(0.89%) cases of in-hospital VF. Other centers have reported an in-hospital incidence
of ventricular tachycardia, VF, or sudden death of 2% to 3% during or after PTSMA
[23, 25]. According to our experience, in-hospital ventricular arrhythmia could be
handled safely but warrants careful monitoring. As for other serious nonfatal
complications, the acute myocardial infarction which was caused by the spill of
alcohol into the left anterior descending coronary artery had ever occurred in one
patient and no coronary dissection and nonfatal cardiac tamponade had ever
happened.
The demographic characteristics of patients should be the potential risks for
PTSMA procedure complications. However, according to the previous report [23],
none of the studied baseline echo-cardiographic, clinical and PTSMA-related
characteristics were useful in predicting the PTSMA success rate as well as the
complications. But in the study by Chang et al [26], the peak creatinine kinase level
were found to be the independent predictors of successful outcomes but these
investigators could not identify independent predictors from baseline clinical or
echo-cardiographic characteristics to select patients who would benefit most from
PTSMA. In univariate analysis of our study, age, sex, alcohol volume, number of
ablation septal and comorbidities with CAD, hypertension as well as DM were
seemed to be associated with increased occurrence of complications. However, only
hypertension, not other characteristics, was shown to be a potential factor for
predicting complications (OR: 4.856; 95% CI 1.732-13.609) after multivariate logistic
regression analysis. Patients with hypertension were much elder and those patients
had more significant changes according to the echo-cardiographic results as well as
with more comorbidities (as shown in Table 5). We might put forward a hypothesis
that patients with hypertension had lower cardiac reserve function because of more
cardiovascular risks in this cohort. So that might be the reason why hypertension
could be the potential risk factor for PTSMA complications.
Table 5
Comparision of clinical and echocardiographic characteristics between
pateints with and without hypertension
Age
Hypertension
(n=46)
No hypertension
(n=178)
P value
58.13±10.10**
45.23±13.95
0.000
**
Female
28
75
0.025
DM
3**
0
0.007
CAD
5
8
0.000
History of heart failure
7*
LVOTD (mm)
HR (beats/min)
9.56±2.76
8
9.24±2.62
0.010
0.480
70.57±11.13
71.37±12.46
0.692
0.65±0.07
CAD: coronary artery disease; DM: diabetes mellitus; HR: heart rate; LVOTD:
left ventricular outflow tract diameter; EF: ejection fraction
EF
0.63±0.07
0.113
It is well known that clinical experience influences the results of a procedure.
Like the results seen from percutaneous coronary interventions [27, 28], a
high-volume load for operators and institutions is associated with better procedural
outcomes. The importance of a learning curve for PTSMA was confirmed in our study,
because a high incidence of late PTSMA failure was noted in the early experience
group of patients, whereas this number was significantly reduced with growing
experience. At a volume of approximately 16 treated patients per year, the incidence
of late PTSMA complication has been reduced from 41.33% to 23.21%, which is not
different from that of other experienced centers [29, 30]. Therefore, PTSMA
procedures should be restricted to experienced centers.
Limitations
Several important limitations have arisen during the present study. (1) One of the
most important limitations is that only a limited number of HCM patients was
examined. (2) In this study, whether the PTSMA procedures were chosen or not were
based on patients and physician preference. So those patients were not enrolled
consecutively. If the patient was elderly or had significant comorbidities conditions,
PTSMA was not that strongly suggested. For elderly patients, especially with
concomitant disease and without enough insurance, the medication or less aggressive
approach of PTSMA may be a better, or the only, choice, even with incomplete
elimination of the LVOT obstruction. (3) Judgement for the target septal artery was
performed on the available angiographic images as well as the assistant of MCE, but
we still cannot rule out that more targeted imaging might have yielded more
anatomically correct values.
Conclusion
In summary, PTSMA was effective in reducing the LVOTG in hypertrophic
obstructive cardiomyopathy patients. Hypertension was the only independent risk
factor for PTSMA procedure related complications after multivariate logistic
regression analysis. And PTSMA procedures should be restricted to experienced
centers according to the analysis result for learning curve.
ACKNOWLEDGMENTS
The authors are grateful to all the staff of the Cardiology Department of Liaoning
Provintial People's Hospital. Drs. YJ ZH and YQ SH had contributed to the collection
and analysis of the individual data. Not any form of payment was given to any
individual to produce this manuscript.
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