HANOI MEDICAL UNIVERSITYNGUYEN CONG HA Research about short and medium-term results of transcatheter closure of perimembranous VSD using the symmetrical double-disc device Major : Inter
Trang 1HANOI MEDICAL UNIVERSITY
NGUYEN CONG HA
Research about short and medium-term results
of transcatheter closure of perimembranous VSD using the symmetrical double-disc device
Major : Internal Cardiology Code : 62720141
MEDICAL DOCTORATE THESIS
HANOI - 2020
Trang 2Scientific Supervisor: Professor Nguyen Lan Viet
1 st Peer-reviewer: Assoc Prof PhD Pham Huu Hoa
2 nd Peer-reviewer: Assoc Prof PhD Nguyen Ngoc Quang
3 nd Peer-reviewer: Assoc Prof PhD Ta Manh Cuong
Ph.D Thesis will be evaluated by the Hanoi medical UniversityThesis Board
Trang 3Ventricular septal defect (VSD) is when there iscommunication between the left ventricle chamber (LV) and theright ventricle (RV) with each other VSD is one of the mostcommon congenital heart diseases (CHDs) accounting for 20 -30% of CHDs
In the treatment of VSD, the classic method is open surgerywith the support of cardiopulmonary bypass (CPB) technique, which
is considered as the gold standard method, but still, have somecomplications of CPB, anesthetic resuscitation, infection, andneurological complication …
The first device designed to close of perimembranous VSDs(pVSD) is called Amplatzer muscular VSD occluder (AVSO)manufactured by AGA In 2002, Hijazi et al reported that this devicewas used for 6 patients with the result that there were no cases ofresidual shunt and significant complications After that, many studiesapplied Amplatzer instruments, but the rate of atrioventricular block(AVB) was still high, with a study of 5.7% which is much higher thanthat open surgery so now this AVSO device has stopped being applieddue to this complication
To increase efficiency and minimize complications, some newdevices have recently been launched to overcome the disadvantages
of Amplatzer Nit-Occlud® Lê VSD-Coils (Lê VSD Coils) have beenapplied and have been highly successful, despite the reduction ofcomplications such as ABV, AVR but the rate of residual shunt andhemolysis is still high Dr Nguyen Lan Hieu and other authors alsoused devices that use for the closure of ductus arteriosus (DO) toclose VSDs and had good short- and medium-term outcomes butthere are still some complications
Trang 4The symmetrical double-disc device was also created for thesame purpose, this device has improved the design of Amplatzer withtwo symmetrical discs, the smaller left disc had larger thickness Thisdevice has been studied and applied clinically for high success andlow rate of complications in the long-term follow-up.
In Vietnam, Nguyen Lan Hieu and other colleagues haveapplied various types of devices to close perimembranous VSDs such
as Le VSD Coils, PDA closure devices and have some reports forgood outcomes in short and medium-term The symmetrical double-disk devices have also been used and have good clinical results butthere have been no specific studies on the safety and efficacy of thisdevice Therefore, we carried out the study: "Evaluate the Short andMedium-term outcomes of Transcatheter Closure of PerimembranousVSDs using Symmetrical Double-disc Devices" to:
1 Evaluate the feasibility, short and medium-term results of transcatheter closure of perimembranous VSDs using the symmetrical double-disc device at Hanoi Heart Hospital.
2 Find out some factors that affect the outcome of the technique.
NEW CONTRIBUTIONS OF THE THESIS
The study had 84 patients with perimembranous VSDs who had transcatheter closure of perimembranous VSDs using the
symmetrical double-disc device from January 2012 - December
2015 81 patients successfully performed closure procedure ( 96.4%)
The follow-up of patients after the procedure was the longest
61 months (≈ 5 years), the shortest was 20 months, during the
follow-up time, none of the patients left the study
Trang 5The study showed that high efficacy, low complications, safety in patients with pVSDs selected with the size of defects ≤ 8mm, aortic edge ≥ 2,0 mm After the procedure, we evaluated clinical symptoms such as delayed weight gain, recurrent pneumonia,heart failure and absent of typical systolic murmur of VSD The parameters on cardioechography such as Left Ventricular End Diastolic Dimension (LVEDd), Pulmonary Arterial pressure (PAP) also decreased significantly after the procedure Major complications were mild complications and recovered, had 1 patient (1.2%) had worsened TVR (3/4) after the follow-up time, especially no patients with grade III AVB which is one of the critical complications but we did not have any case in our study.
Factors affecting the outcome of the procedure areinappropriate anatomy size of defect such as large defects, lack ofaortic edge are factors that directly affect 3 failure cases of theprocedure Other difficult obstacles such as difficulty in passingdevices through the defects, re-taking the snare, redo the proceduresteps, exchanging larger devices due to the assessment of the defect
on cardioechography and the incorrect image of the LV chamber; arelimitations of the procedure The trans-thoracic Dopplercardioechography during the procedure also enhances the procedure
LAYOUT OF THE THESIS
The thesis consists of 153 pages consisting of 4 chapters; 45pages of overview, 21 pages of subjects and research methods, 50pages of results, 31 pages for discussion, 2 pages of conclusion, 1page of recommendations Tables; there are 57 tables; 14 charts; 24figures; 180 references; 7 references in Vietnamese; 173 references inEnglish
Trang 6CHAPTER 1: OVERVIEW1.1 Prevalence and anatomy of VSDs
VSD is the most common CHD, accounting for about 20-30%
of CHD, of which pVSD accounts for about 70-80% of the total VSDtypes Hoffman's meta-analysis of 22 statistics found that theprevalence of VSD was 31% in CHDs
An important anatomical feature is that the VSD is not aligned
as a wall to separate the two ventricular chambers from which the VSDhas a curved structure because of the round shape of the LV and thecrescent shape of the RV hug the right front of the LV It must also beremembered that VW's structure varies with the position of the wall.pVSD is when the membrane part of the ventricular septum isnot fully formed, the opening is near the anterior leaf edge and theleaf wall of TV Not only is the defect in the membrane part but itseems to be surrounded by the fibrous tissue, membrane and tends toclose This fibrous tissue is also called the TI auxiliary organization,which can form a bulging sac structure Van Praagh differentiatedtrue pVSD, which is only a small hole in the membrane's septum It
is more accurate to call VSD with the perimeter around themembrane, because some VSDs have intact membrane but defectsare around the membrane part, so the name pVSD is used more often.This VSD is closely related to the AV conduction path, which passesthrough the TI ring and follows the lower posterior edge of the defectthen divides into the left and right branches Therefore, when surgery
to patch or close the defect with a device, there is a risk of damage tothis transmission line
Trang 7Figure 1.1: Illustration of atrioventricular conduction pathway;
and related to pVSD.
1.2 Pathophysiology and clinical characteristics
VSD which has no more cardiac defect causes left and rightventricular shunts that increase circulation to the lungs, increase leftventricular volume, and increase PA pressure The degree of shuntingdepends on the diameter of the defect and the resistance of PA
In newborns, the PA resistance is high and decreasesgradually from the first days after birth and decreases rapidly in thefirst 4-6 weeks and returns to normal 2-3 months later However, due
to the high PA resistance, it is often not detected by clinicalexamination in the first months because the left-right shunts are notlarge enough to generate systolic murmur as well as other clinicalsymptoms After 4-6 weeks of birth, the resistance to PA decreases,the shunt will grow then the murmur and symptoms of heart failurewill be more significant
1.3 Diagnosis
Patients with small defects are usually diagnosed when a systolicmurmur is heard at the left sternum When the resistance of the PAsystem increases, the murmur is weak and shorter
The Doppler cardioechography is the best diagnostic tool for VSD.Cardioechography can detect very small defects, locate very preciselybecause it is possible to cut many different cross-sections, this is an
Trang 8advantage over cardiography when limited to a few angles and usinglimited contrast agent.
1.4 Treatment
1.4.1 Disease natural course and prognosis
Most patients with small defects of VSD grow up normally.Some studies have found that VSD self-closing rate is up to ¾ cases.The size of the defects tends to get smaller and the highest self-closing ratio in the first years In adults with small defects, Qp / Qs
<2, without PAH, the prognosis is very good The rate of AVR andendocarditis is very low, if there is arrhythmia, it is benign
About 1/6 of VSD cases present with congestive heartfailure requiring medical treatment and most likely occur within 6months after birth Some respond to medical treatment and do notneed surgery right away, these patients often have PAH due tolarge defects and are at risk of developing lung disease, possiblybefore 2 years of age
1.4.2 Medical treatment
For medical treatment, if symptoms of heart failure occur, themedications used are digoxin, diuretic and ACE inhibitors orAngiotensin receptor inhibitors Medical treatments only postponesurgery or follow up because the defect may close or may shrink Ifthe defect is small, without increasing PA pressure, there is no need tolimit physical activity Prevention of endocarditis is very important
1.4.3 Surgical treatment of closing defects
This is the classic treatment method, considered the goldstandard method, especially VSD in newborns, multi-hole VSD,broad-hole VSD, receiving chamber VSD, under two arterial valvestype and VSD with other lesions The surgical mortality rate is <1%.Complications like grade 3 ABV about 1-2%, residual shunts are ≈
Trang 95% MI and TI may also be rare Besides, there may be complicationssuch as infections, neurological complications due to CPB
1.4.4 Transcatheter closure of perimembranous
VSDs using devices
Since the application of VSD by devices through the catheterhas been controversy about the safety, the effectiveness of thismethod compared to the surgical method The development of VSDclosure devices has undergone many changes to increase efficiencyand reduce complications, especially pVSD closing devices
The asymmetrical double-disc device designed for pVSD(Amplatzer) with a high ABV rate in the short-medium-term, withresearch up to 5.7% so this device is not applied anymore
To increase efficiency and minimize accidents, recently severalchoices have been applied Le VSD Coils has the advantage ofreducing the ABV catastrophe, but the residual shunt and hemolysisare still high
Nguyen Lan Hieu and other authors used PDA closing devices
to seal VSD and reported very good medium-term results, the successrate of about 96%
The symmetrical double-disk design is based on the AmplatzerAGA (should also be called a modified 2-disc device), the designchanges to overcome the Amplatzer's disadvantages (high ABV rate).These changes are two equal concentric discs with a diameter largerthan waist circumference 4mm (shrinking from eccentric disc largerthan 6mm waist to concentric disc larger than 4mm waist), 3mm ofthe thickness (1.5 mm larger than with Amplatzer) The size namestands for the diameter of the waist (Figure 1.2)
Trang 10(2002-In 2014, Yang et al reported a prospective, randomized,controlled clinical trial study of percutaneous pVSD closing orsurgery Criteria to assess the safety and effectiveness of the twoabove treatments The data collected tracked over 2 years andcompared the two groups and concluded that: the two methods abovehave very good results in the short and mid-term Percutaneous VSDhas the advantage over surgery as it causes less damage to the heartmuscle, less blood transfusion, and shorter procedure and hospitalstay It costs less
In 2014, Yang et al summarized the effectiveness andcomplications of pVSD closing methods The systematic review ofstudies published in English-language world journals, they searchedPubMed from 2003-5 / 2012, excluding small studies, studies withacquired VSD As a result, 37 published studies included 4406 VSDpatients (including 3754 pVSD patients, 419 mVSD, 47 VSD underthe aortic valve, 36 VSD under two great arteries, 16 patients withmulti-hole VSD, 7 cases without differential type), devices are usedwith many different types (Amplatzer, Coils, PDO, 2 symmetricaldouble discs ) Analysis of these 37 studies concluded that closing
3 mmm
2 mmm
2 mmm
Trang 11VSD by devices is effective and safe The limitation of this analysis
is that it is difficult to analyze different types of devices and it isdifficult to isolate VSD forms
In 2018, Krishna A Mandal et al reported the long-term result
of pVSD closing by symmetrical double-disk devices on 186patients The success rate is 96.8%, with no more shunts of 99.5%after 6 months There were 16 (8.9%) patients with stroke right afterthe procedure in which 1 (0.5%) patients with ABV grade 3 and 1(0.5%) had completely left bundle branch block, these 2 patientsrecovered after treatment with steroid During the mean follow-up of18.4 months, no major complications or BAV occurred The studyconcluded that the severity of the stroke was low, no patient had late-onset ABV, the success rate was high, so this method could replacethe surgical method in selected patients
CHAPTER 2: SUBJECTS AND METHODS OF THE STUDY 2.1 Criteria for selecting patients
Patients diagnosed at Hanoi Heart Hospital were diagnosed with pVSD, diameter more than 2mm with left-right shunt on cardiacDoppler ultrasound, weighing ≥ 8 kg or ≥ 1 year old, with aortic valve margin ≥ 2 mm or a membrane with aneurysm, plus one of the following: recurrent pneumonia, delayed weight gain, symptoms of heart failure, dilated LV on echocardiography or Qp / Qs ≥ 1.5
2.2 Exclusion criteria
VSDs had large defects or very small, no longer had
indications of closing Moderately-severe AI, with erupted
Valsalva sinus aneurysm, acquired pVSD or other
surgical-required lesions Patients with contraindications to aspirin,
patients with ABV, patients, family members who do not agree to
do the procedure nor participate in the study
2.3 Time and place of research
Trang 12The patients were eligible for the study and had procedures done from January 2012 - December 2015, then followed up,
collected and processed data
The study was conducted at Hanoi Heart Hospital
2.4 Type of research, devices used in research
Prospective research, single center, clinical intervention, comparison before and after, no control, convenient sample selection,follow up for at least 12 months after the procedure
Selected devices are symmetrical double-disk devices with
names: HEART symmetric membranous VSD Occluder của hãng Lifetech Scientific
2.5 Study process
The patient was researched according to the medical records, collected clinical data, ECG, CXR, Doppler echocardiography, the results of the procedure through 8 main steps The results monitored for complications, ECG and echocardiography within the first 24 hours and before discharge Appointment for follow-up visits after procedures 1, 3,
12, 18 months and annually or with any unusual manifestations Patients were re-examined clinically, performed ECG and echocardiogram The study selected 84 patients with pVSD and performed the procedure Successful 81 procedures, collected the data of procedures and tracked data over time, finished tracking in December 2017, then analyzed and processed the data, wrote the thesis
Trang 133.1 General characteristics of the study subjects
84 patients with pVSD were selected, and 81 patients
successfully had the procedure (81/84 ≈ 96.4%) The average duration
of follow-up was 42.7 months (20-61 months) No patients had left the study The average duration of hospital stay was 8.28 days
Gender, age, weight characteristics: the study included 43 males (53.1%) and 38 females (46.9%) The average age is 9.9 years (11 months - 55 years), ages <16 accounts for 81.5% The average weight is 23.8 kg (7-67 kg)
3.2 Characteristics of VSD defect and aortic edge on echocardiography
Table 3.1 Size of the defect and aortic edge on TTE
Size of defect (mm) 81 5,1 1,5 2,5 11,5
Comments: Size of VSD defect is mostly medium size, the average
size is 5.1 mm (2.5-11.5 mm) Aortic edge average size is 5.0 mm(1.5-11.5 mm)
3.3 Results of the VSD closing procedure
Methods of analgesia: In the study, 65/81 (80%) patientsunderwent intravenous propofol and 16/81 (20%) patients under localanesthesia The minimum age for anesthesia is 14 years old, theoldest age for anesthesia is 32 years old
Access: in the study, 71/81 (87.6%) patients had access to theright femoral artery and vein and 10 (12.4%) patients entered withthe left femoral artery and vein, no patients use other access routes.The systolic PAP has a mean value of 27.4 mmHg (17-40).The average Qp / Qs result is 2.33 (1.7 - 3.5)