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Complete atrioventricular block after percutaneous device closure of perimembranous ventricular septal defect: A single-center experience on 1046 cases
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Complete atrioventricular block after percutaneous device closure of perimembranous ventricular septal defect: A single-center experience on 1046 cases Yuan Bai, MD, Xu-Dong Xu, MD, Chang-Yong Li, MD, Jia-Qi Zhu, MD, Hong Wu, MD, Shao-Ping Chen, MD, Feng Chen, MD, Xiao-Hua You, MD, Xian-Xian Zhao, MD, Yong-Wen Qin, MD From the Department of Cardiology, Changhai Hospital, Second Military Medical University, Shanghai, China. BACKGROUND Complete atrioventricular block (cAVB) has been deemed a rare complication after transcatheter closure for ventricular septal defect (VSD). However, this serious event appears to be underrecognized and is worth being investigated further. OBJECTIVES To determine the incidence and predisposing factors of cAVB associated with closure of VSD using a modified double-disk occluder (MDO). METHODS From December 21, 2001 to December 31, 2014, 1046 patients with perimembranous ventricular septal defect underwent percutaneous closure using the MDO. Electrocardiography was evaluated before the procedure, within 1 week after the procedure, and then at 1, 3, 6, and 12 months and every year thereafter. Other baseline and procedural parameters were also evaluated and a comparison between patients requiring pacemakers and those not suffering from cAVB was done. RESULTS cAVB occurred in 17 patients (1.63%) after the procedure. Of the 17 patients, 8 (0.8%) underwent permanent pacemaker (PPM) implantation. The cAVB occurred within 30 days after the procedure in 14 patients and after 1 year in 3 patients. In comparison patients aged r18 years, patients aged 418 years
Introduction Percutaneous device closure of perimembranous ventricular septal defect (pmVSD) has been widely accepted and also associated with excellent rates of closure.1–3 Avoiding sternotomy and cardiopulmonary bypass, the transcatheter approach is assumed to reduce perioperative morbidity and mortality as compared to conventional surgical repair. Nevertheless, the transcatheter technique has subsequent complications, such as embolization of the occluder, valve impairment, and arrhythmia. Complete atrioventricular block (cAVB) is a Drs Bai and Xu contributed equally to this work. Grant support was received from the National High-Tech R&D Program of China (“863” Program) (No. 2006AA02Z4D7). Address reprint requests and correspondence: Dr Yong-Wen Qin or Dr Xian-Xian Zhao, Department of Cardiology, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, China. E-mail address: xianxianz2010@ 163.com; [email protected].
were more prone to cAVB (P ¼ .025). Logistic regression revealed no significant parameter to predict later requirement for PPM. CONCLUSIONS The incidence of cAVB after transcatheter closure of VSD was acceptable, as part of the cAVB population recovered after administration of corticosteroid and application of a temporary pacemaker. Late cAVB (41 year) appears to make it more difficult to restore normal conduction block. Because of the recurrence of cAVB, life-long follow-up with periodic electrocardiography examination may be mandatory. KEYWORDS Complete atrioventricular block; Perimembranous ventricular septal defect; Complication; Percutaneous ABBREVIATIONS AV ¼ atrioventricular; cAVB ¼ complete atrioventricular block; CRBBB ¼ complete right bundle branch block; ECG ¼ electrocardiography; MDO ¼ modified double-disk occluder; pmVSD ¼ perimembranous ventricular septal defect; PPM ¼ permanent pacemaker; TTE ¼ transthoracic echocardiography; VSD ¼ ventricular septal defect (Heart Rhythm 2015;0:-1–9) I 2015 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
4–6
Previous rare but serious complication of the procedure. literature has described that cAVB can occur immediately or later after transcatheter occluder closure.7–9 Since the exact mechanism of postoperative cAVB is not fully investigated, the occurrence of cAVB in patients treated with percutaneous interventions is unpredictable. Additionally, there is a lack of studies describing incidence of cAVB and predictors of pacemaker requirement following ventricular septal defect (VSD) closure. Therefore, the aim of this study was to determine the evolution of cAVB and predisposing factors of pacemaker implantation associated with VSD closure using a modified double-disk occluder (MDO) in a single institution.
Methods Study population From December 21, 2001 to December 31, 2014, 1046 patients with pmVSD underwent percutaneous closure
1547-5271/$-see front matter B 2015 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
http://dx.doi.org/10.1016/j.hrthm.2015.05.014
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using an MDO in Changhai Hospital, Shanghai. The patients or, if minors, patients’ parents gave their written informed consent to the procedure. The local Ethics Committee approved this protocol. This study complied with the Declaration of Helsinki. The criteria for inclusion in this study included: (1) age Z1 year; (2) body weight Z12 kg; (3) maximum diameter of VSD r16 mm by transthoracic echocardiography (TTE); (4) defect located at 9 to 12 o’ clock positions in the short axis parasternal view of TTE (Figure 1); (5) a significant left-to-right shunt across the defect; (6) a distance of Z1 mm from the VSD to the aortic valve; and (7) mean pulmonary artery pressure r70 mm Hg evaluated by catheter. Exclusion criteria included patients with endocarditis, NYHA class III and IV, severe pulmonary hypertension (470 mm Hg), sepsis, and contraindications to antiplatelet therapy.
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Description of modified double-disk occluder The MDO is a self-expandable double-disk device made from a Nitinol wire mesh (ShangHai Shape Memory Alloy Co Ltd, Shanghai, China). There are a total of 3–5 polyester patches in each disk. The polyester patches filled in the disks can guarantee the sealing of the occluder. There were 3 subtypes of MDO: symmetric occluder, asymmetric occluder, and thin-waist occluder. In the symmetric occluder, the left disk is symmetric. The diameter of the disk is 4 mm larger than that of the waist. In an asymmetric occluder, the flange of the left ventricular disk, which faces the aortic valve, is 0 mm larger than the waist, while the flange of the disk that is on the opposite side of the aortic valve is 6 mm larger than the waist. The diameter of the left ventricular disk of the thin-waist occluder was 8 mm larger than that of the waist. The right ventricular disc of the asymmetric and thin-waist
Figure 1 Graphic examples of the criteria for study inclusion. A: Transthoracic echocardiography image (short axis parasternal view) confirms the location of the defect (arrow) to the perimembranous area. B: Schematic diagram of the location of ventricular septal defect (the defect located at 9 to 12 o’clock positions in the short axis parasternal view).
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Bai et al 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 P 212 R 213 I 214 N 215 T 216 & W 217 E 218 B 219 4 220 C 221 / 222 F 223 P O 224 225 F2 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244
Figure 2
Heart block after ventricular septal defect closure
3
Modified double-disk occluders and corresponding schematic diagrams. A: Symmetric occluder; B: thin-waist occluder; C: asymmetric occluder.
occluder is the same as that of the symmetric occluder.10 The waist length of the occluder is between 2.5 mm and 4 mm according to the diameter of the disk (Figure 2). Owing to the complexity of defect shape, we used the patent ductus arteriosus closure device to close the VSD in a handful of patients.
Percutaneous ventricular septal defect closure procedure The implantation procedure for these occluders has been described in detail previously.10 Left ventriculography was performed to detect the shape, size, and location of the defect and the distance from the aortic valve to the defect. Right heart catheterizations were performed to assess the degree of shunting and to evaluate pulmonary vascular resistance. Aortography was also performed before releasing the occluder to ensure that the aortic valve had not been compromised. After the release of the occluder, TTE, aortography, and left ventriculography were performed again to detect tricuspid and/or aortic valve regurgitation and residual shunts.
All patients received postoperative intravenous injections of penicillin for 1 day and oral aspirin (3 mg/kg body weight) for 180 days. For patients who presented with heart block after the closure, corticosteroid therapy was administered to reduce occluder-related myocardial edema. Dexamethasone was started at a dosage of 5–10 mg/day for 20 days. A temporary pacemaker was implanted for those who suffered transient bradycardia. The patients with cAVB were further evaluated on a daily or weekly basis until 1:1 conduction was restored. If the cAVB did not disappear 20 days later, a permanent pacemaker (PPM) was implanted.
Follow-up protocol All patients had a baseline electrocardiogram (ECG). Then, all patients underwent continuous ECG telemetry monitoring for 7 days after the procedure. Follow-up ECG examination and TTE were performed on every outpatient, scheduled at 1, 3, 6, and 12 months and yearly thereafter. Chest radiograph evaluation was scheduled at 1 year. To enable analysis of predictors of PPM requirement after VSD closure, cAVB occurring within 7 days after the index procedure was
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Table 1 Baseline characteristics of all patients who underwent transcatheter ventricular septal defect procedure Patients (n)
1046
Male/female Age, y (range) Age groups r18 years 418 years Combined procedures (n) ASD closure PDA closure Pulmonary valvuloplasty Ruptured sinus of Valsalva aneurysm closure Types of modified double-disk VSD occluder* Symmetric Asymmetric Thin-waist occluder PDA occluder
520/526 17 (1–72) 556 490
Results
32 17 2 2
There were 1046 patients undergoing VSD closure procedure at our centers from December 2002 to December 2014. Their baseline characteristics and procedure data are shown in Table 1. Of the 1046 patients, 17 (1.63%) developed new-onset cAVB (n ¼ 12) or aggravation of pre-existing conduction disturbances (n ¼ 5). The median interval for the development of cAVB was 5 days (1–3285) following the procedure. This rhythm abnormality occurred in acute phase in 12 patients, subacute in 1 patient, and late in 4 patients, according to the study protocol (Figure 3). After cAVB occurrence, the PPM was implanted in 3 acute patients (25%), 1 subacute patient (100%), and 4 late patients (100%) without related complications. Thus, cAVB had resolved to normal atrioventricular (AV) conduction in 9 patients after corticosteroid therapy. Of the PPMs, 5 (62.5%) had single chamber and 3 (37.5%) had dual chamber. Their clinical descriptions are shown in Table 2. In 1 patient with preexisting Mobitz type II second-degree AV block, we performed percutaneous balloon pulmonary valvuloplasty at the same session. Another subject with pre-existing complete right bundle branch block (CRBBB) þ I AVB underwent a combined atrial septal defect closure procedure at the same session. During follow-up, TTE showed in all 17 patients that all devices were in the proper position and that there was no residual shunt.
431 360 250 10
ASD ¼ atrial septal defect; PDA ¼ patent ductus arteriosus; VSD ¼ ventricular septal defect. * There are 5 patients who had multiple VSDs undergoing successful transcatheter closure using 2 overlapping occluders.
classified as acute; that occurring at 47 days up to 30 days was classified as subacute, and that occurring after 30 days was classified as late. In this study, patients with new-onset cAVB or aggravation of a pre-existing high-degree AV conduction disturbance were defined as patients with cAVB.
Statistical analysis All statistical analyses were performed using commercially available software (PASW Statistics v18.0.0; SPSS, Inc, Chicago, IL). Data distribution was evaluated with the Kolmogorov-Smirnov normality test. A 2-sided .05 significance level was used for hypothesis testing. Descriptive data for continuous variables are presented as mean (SD). Categorical variables are presented as relative frequencies. Fisher exact test was performed to detect significant differences between groups. For comparison of continuous variables between 2 groups, the t test was used (2-tailed tests were used for all analyses). To determine the predisposing factors of PPM, we compared the following variables between patients with and without PPM: age, sex, weight, ratio of device to defect
P R I N T & W E B 4 C / F P O
Figure 3
size, type of device, ECG findings before VSD closure, and the onset time of cAVB. Variables with P values o.1 in univariate analysis were entered into the multivariate model. Multivariate analyses were performed by means of a logistic regression model.
Patients and procedural data
Heart block in acute and subacute phase Complete AV block was observed 1–30 days after closure procedure in 13 patients. After corticosteroid and isoprenaline administration, cAVB had resolved to right bundle branch block in 5 patients, to left anterior hemiblock in 1 patient, to junctional rhythm in 1 patient, and to normal conduction in 2 patients within 2 weeks. In the case of Patient 4, with pulmonary stenosis, the patient’s preprocedural ECG
Time course to the development of complete atrioventricular block (cAVB).
359 360 361 362 363 364 365 366 367 368 369 370 T1 371 372 373 374 375 376 F3 377 378 379 380 381 382 383 T2 384 385 386 387 388 389 Q5 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415
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Clinical characteristics of patients with heart block after ventricular septal defect closure
Age Patients Sex (y)
Weight (kg)
VSD size by TTE (mm) Comorbidity
Size of Type of device (mm) device
1 2 3 4
F M F M
25 15 4 15
45 63 14 41.8
6 4 6 15
12 5 9 24
Asymmetric Symmetric Asymmetric Symmetric
5 6 7 8
M M M M
21 7 33 56
58.5 21 61.5 74
5 4 6 4.5
14 6 10 5
Asymmetric Asymmetric Thin-waist Thin-waist
9 10 11 12 13 14
F F M M F M
38 20 30 42 46 50
58 55.5 60 90 64 75
4 6 7 8 8 4
Thin-waist Asymmetric Symmetric Symmetric Asymmetric Thin-waist
15
M
36
52
8
5 10 8 10 10 Postoperative 6 residual VSD 14
16 17
F F
24 57
46.5 60
5 5
8 7
PS
ASD
Pre-ECG
Post-ECG
Onset (d)
Recovery (d)
ECG in follow-up
Normal Normal Normal Mobitz II seconddegree AVB Normal Normal Normal CRBBB þ intermittent III AVB CRBBB þ I AVB Normal Normal Normal Normal CRBBB þ LAH
Normal Normal CRBBB Junctional rhythm
5 5 5 1
15 15 15 7
T T T N
Normal Normal Normal CRBBB þ intermittent III AVB CRBBB þ I AVB Normal Normal Normal CRBBB þ LAH CRBBB þ LAH
5 5 3 5
10 7 7 N
CRBBB CRBBB IRBBB Junctional rhythm Normal IRBBB LAH Pacing rhythm
43 1201 1927/2417 14/1175 4/143 2
N N 1942/N 16/N 10/N N
Pacing rhythm Pacing rhythm Pacing rhythm Pacing rhythm Pacing rhythm Pacing rhythm
P P P T/P T/P T/P
CRBBB þ LAH
3285
N
Pacing rhythm P
Normal Normal
5 3
9 8
CRBBB Normal
PDA CRBBB occluder Symmetric Normal Symmetric Normal
Pacemaker
N N N P
Heart block after ventricular septal defect closure
Table 2
T N
ASD ¼ atrial septal defect; AVB ¼ complete atrioventricular block; CRBBB ¼ complete right bundle branch block; ECG ¼ electrocardiogram; LAH ¼ left anterior hemiblock; IRBBB ¼ incomplete right bundle branch
Q8 block; N ¼ no pacemaker; P ¼ permanent; PDA ¼ patent ductus arteriosus; PS ¼ pulmonary stenosis; T ¼ temporary; TTE ¼ transthoracic echocardiography; VSD ¼ ventricular septal defect.
5 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529
6 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560Q6 561 562 563 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586
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Table 3 Comparison of patient characteristics for complete atrioventricular block and non–complete atrioventricular block patients Patient characteristic Age r18 years 418 years Sex Male Female Type of VSD occluder Symmetric Asymmetric Thin-waist PDA occluder
Non-cAVB
cAVB
552 477
4 13
Statistical significance .025 .475
510 519
10 7 .262
425 354 246 9
6 6 4 1
cAVB ¼ complete atrioventricular block; PDA ¼ patent ductus arteriosus; VSD ¼ ventricular septal defect.
showed Mobitz type II second-degree AV conduction block. The minimum heart rate in this patient with second- or thirddegree AV block on 24-hour ambulatory ECG monitoring was obtained 1–7 days after the closure procedure. During the next 9 years of follow-up, neither cAVB nor long pause (43 seconds) was observed. A PPM was implanted in the remaining 3 patients. Patient 8 presented with transient cAVB before VSD closure. Five days after the procedure, the patient experienced syncope with bradycardia. He underwent a complete cardiologic evaluation that showed paroxysmal cAVB requiring PPM implantation. Patients 12 and 13 suffered from cAVB following the closure with 30 days. Then the cAVB had resolved to normal conduction following corticosteroid and isoprenaline administration. However, both patients developed cAVB again a few months after the procedure and were implanted with PPMs. Patient 14, who underwent surgical VSD closure 30 years prior, presented with CRBBB and left anterior hemiblock before VSD closure. However, 1 day after the procedure, his ECG showed cAVB. A PPM was implanted into this patient, who had not recovered stable sinus rhythm 1 week later.
(prednisone 1 mg/kg/d) for 2 weeks. The cAVB disappeared completely. Unfortunately, this patient was readmitted to our hospital for repeated cAVB 16 months after reverting to a normal sinus rhythm from cAVB in the postprocedural period (5.3 years). Then a VVI-type PPM was implanted.
Associated risk factors for complete atrioventricular block and permanent pacemaker There was no significant difference in sex and type of occluder between patients with and without AVB. However, in comparison with the group aged r18 years, patients younger than 18 years were more prone to cAVB (P ¼ .025) (Table 3). Univariate findings of potential predisposing factors for PPM are summarized in Table 4. In older patients and those with late cAVB (430 days), it appears more difficult to restore normal conduction block and there is greater need for PPM implantation. Three parameters with P o .1 (age, weight, and onset time of cAVB) were included into the multivariate analysis. However, logistic regression revealed no significant parameter to predict later requirement for PPM implantation for AVB (age, P ¼ 1.0; weight, P ¼ .984; onset time of cAVB, P ¼ .99).
Discussion Atrioventricular block has been reported after VSD device closure. The incidence of transient cAVB after transcatheter closure of VSD is about 1%–5% in recent studies.11–14 This retrospective study of a large consecutive series in a single institution indicates that percutaneous VSD closure using the MDO also can be associated with cAVB. A total of 17 patients experienced cAVB during the period of the study. The 1.63% incidence of cAVB in our overall patient group is comparable to published data. Complete AV block is also a Table 4 Univariate findings of potential predisposing factors for permanent pacemaker Parameter
Late heart block During outpatient follow-up, 4 patients who developed cAVB more than 30 days after the procedure underwent PPM implantation. In Patient 9, the ECG showed a CRBBB and first-degree AVB at the end of the procedure. The patient developed a cAVB 43 days after the procedure and was implanted with a PPM. Patient 10, a 24-year-old woman, experienced syncope 3 years after VSD closure with an 8-mm asymmetric occluder. ECG revealed cAVB with a heart rate of 40 beats per minute. Device removal together with surgical repair of VSD was performed emergently. However, AV conduction block did not recover, and a PPM was implanted. Patient 11 was a 30-year-old man with a 7-mm VSD that was successfully closed with an 8-mm symmetric occluder. He was seen in an outpatient clinic 5.3 years later because of presyncope, and ECG showed complete heart block. We decided to treat him with corticosteroid therapy
Age* r18 years 418 years Weight (Kg)* Male/female Onset* r7 days 7-30 days 430 days Device/defect Pre-ECG Normal Heart block Type of occluder Symmetric Asymmetric Thin-waist PDA occluder
No PPM (n¼9)
PPM (n¼8)
4 5 45.7 (17.8) 5/4
0 8 66.1 (12.7) 5/3
9 0 0 1.7 (0.5)
3 1 4 1.4 (0.3)
8 1
3 5
4 4 1 0
2 2 3 1
Statistical significance P ¼ .031 P ¼ .017 P ¼ .772 P ¼ .019
P ¼ .095 P ¼ .79 P ¼ .35
ECG ¼ electrocardiogram; PDA ¼ patent ductus arteriosus; PPM ¼ permanent pacemaker.
587 588 589 590 591 592 593 594 595 596 597 598 599 T3 600 T4 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 Q9 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 Q10
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Heart block after ventricular septal defect closure
complication of surgical intervention of VSD. Surgical repair for VSD in experienced centers has achieved excellent outcomes with minimal mortality and low incidence of AVB nowadays. Tucker et al15 reported on 4432 surgical VSD closures with a 1.1% incidence of PPM implantation for AV block. In a more recent study, Siehr et al16 reported that a total of 64 patients (7.7%) developed surgical AVB. Among those patients who developed AVB, 48 patients (75%) had transient AVB. Sixteen patients (1.9%) required a pacemaker. However, this comparison between surgical repair and device closure is difficult to interpret, as it is widely accepted that the surgical repair allows the closure of larger defects than the devices do. Also, the selection of suitable patients (shape and size of VSD diameter) is crucial to device closure success. Usually, abnormalities of AV conduction occur during or early after occluder implantation. In the majority of patients who developed cAVB (70.6%), it occurred within the first 7 days after implantation. These findings indicate that continuous postoperative ECG monitoring should be performed for at least 7 days in all patients after VSD closure. Although the exact mechanism of acute cAVB remains speculative, mechanical compression, progressive device flattening, friction of the device disk on the septal myocardium, and inflammatory response may be the main issues. Given the proximity of the conduction system to the margins of the pmVSD, a larger device can interfere with AV conduction. Instead, the ratio of device size to defect size is not a risk factor for cAVB in this study. High-dose corticosteroids, isoprenaline, and temporary pacemaker insertion were effective in our patient for reversing early cAVB. However, on the basis of our experience, we cannot be sure about the long-term efficacy of steroids. There are 3 cases of reappearance of cAVB requiring a definitive pacemaker implantation after an initial successful reversal using both steroids and temporary pacemaker. In addition, the empirical therapy with corticosteroid was not effective in this late recurrent cAVB. Nearly 50% of patients developed AV block later after corticostereoid therapy, as shown in the results. Based on past experience in our center, the more important issue to avoid occurrence of cAVB after device implantation is to prevent compression of conduction tissue by retentional disks. Exceptionally, however, cAVB may occur very late following device closure, without premonitory signs. Lastly, the very late cAVB may occur as a consequence of anomalous development of the conduction tissue in the context of a cardiac malformation. The finding of late AV block in which a PPM was placed more than 9 years after VSD closure is interesting. The present finding of 3 of 1046 patients (0.3%) developing AV block more than 1 year after percutaneous closure of VSD is important. This fact should be considered when counseling patients, their parents, and their personal physicians about symptoms that might develop and that need appropriate evaluation. Yang et al,7 reporting on a series of 244 patients, deduced that the time of AV block emergence was an independent predictor
7 of cAVB persistence. They showed that the earlier a cAVB developed after closure of the pmVSD, the more difficult was a recovery to normal conduction. Compared with the data of Yang et al, the late cAVB (430 days) appears to make it more difficult to restore normal conduction block and appears to increase the need for PPM implantation in the current study. Recent publications suggest that a progressive ongoing inflammatory process and scar formation in the conduction tissue may be another cause of late cAVB.8 Furthermore, progressive device flattening of an originally oversized occluder should account for the late cAVB after percutaneous VSD closure. Yang et al17 report that 1 patient who developed transient cAVB 7 days after transcatheter VSD closure had recurrent cAVB 42 months after the procedure. During the follow-up, the shape of the device had changed significantly 42 months after closure of the VSD. Although the occluder returned gradually to its original size and shape, it compressed and caused persistent damage in the conduction tissue. Our experience also shows that recurrent cAVB may appear several months after cAVB has reverted to a normal sinus rhythm in the early postprocedural period. A total of 3 patients (Patients 11, 12, and 13) suffered from recurrent AV block. Particularly, Patient 11 presented with cAVB more than 5 years following the procedure. In spite of his late presentation, corticosteroid therapy was effective for him, and this patient remained asymptomatic for 18 more months. But this recovery was temporary, and the patient had recurrent cAVB, which necessitated the implantation of a PPM. The late response to corticosteroid therapy may support the theory of an ongoing inflammatory process in septal after VSD device closure. The occurrence of transient postprocedural AV block was found to be significantly associated with delayed AV block. It implies that long-term follow-up, perhaps lifelong, may be mandatory. Although some authors have emphasized that young age, low weight, and Down syndrome are risk factors for the occurrence of cAVB, these factors were not confirmed by our study.13 There was an apparent relationship between patient age and late heart block in our series. The proposed explanation for the development of late heart block after closure is that fibrosis around the area of the device might extend into the AV node and impair conduction. Most of our patients were adults or older children, whereas the majority of patients in several other studies were children. In the present comparison of patient groups, patients who have cAVB seem to be older than those who do not have cAVB. In the older patients (418 years) it appears more difficult to restore normal conduction block and more likely that they will need PPM implantation. Also, the subtype of device is not associated with postoperative cAVB. Additionally, in this study, patients who have PPM implantation are significantly older than those who do not have PPM implantation. Implantation of PPMs and timing of implantation remain controversial topics. According to the follow-up results, older patients with cAVB pose more difficulty to restoration of normal conduction and need PPM implantation.
701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 725 726 727 728 729 730 731 Q7732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 757
8 758 759 760 761 762 F4 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787 788 789 790 791 792 793 794 795 796 797 798 799 800 801 802 P 803 R 804 I 805 N T 806 & 807 W 808 E 809 B 810 4 811 C 812 / F 813 P 814 O
The minor ECG changes after closure are very valuable for clinical arrhythmias. It is also notable that cAVB is more likely to occur in the subjects who had left anterior hemiblock and CRBBB immediately after implantation (Patients 13 and 15) (Figure 4). Ovaert et al,9 reporting on 2 patients, described patients presenting with cAVB in whom surgical removal of the device and VSD closure were associated with rapid and complete recovery of the AV conduction.
Heart Rhythm, Vol 0, No 0, Month 2015 However, in our cases, cAVB regression was not noticed either without any treatment, after steroid administration, or after device removal in the tenth patient. Surgical occluder removal associated with VSD closure in cases of acute cAVB might allow recovery of the conduction system. Recovery of sinus rhythm with device removal has been uncertain for patients with late cAVB. Therefore, how well the conduction system recovers after this surgical removal is still unknown.
Figure 4 Patient 13 with left anterior hemiblock and complete right bundle branch block. A: The patient has a normal electrocardiogram before ventricular septal defect closure. B: She developed left anterior hemiblock and complete right bundle branch block immediately after implantation. C: Her heart block was first noted 4 days after closure.
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Heart block after ventricular septal defect closure
When should surgical removal treatment be started in patients with cAVB? According to current published literature, subjects with cAVB should be sent to surgery for restoration of sinus rhythm within 1 month after implantation.
Limitations There are several limitations to our study. The presented data are a single-center experience. Furthermore, this is a retrospective chart review, which relied on available medical records. Owing to an inadequate number of measurements (such as the distance below the aortic valve), many factors of cAVB were not analyzed from the multivariate analysis. Another weakness of our study is that the number of cAVB events was not large enough to perform meaningful analyses, especially multivariate analyses. Especially, the number of PPM outcomes is, unfortunately, really too small to expect that multivariate analysis will be very persuasive.
Conclusions This study demonstrates that the incidence of early and late complete heart block after percutaneous closure of pmVSD is relatively low at 1.63%. Older patient age and late cAVB after VSD closure seem to be the major predisposing factors for PPM. This study also underscores the importance of long-term follow-up for these patients, particularly those patients who have transient postoperative cAVB. Careful patient and device selection, improvements in the design of the device system, and standardized endovascular manipulation could be conducive to preventing cAVB. Larger series are needed to validate these preliminary findings.
Acknowledgments The authors thank the Ye Xiao-fei for assistance with statistical data.
References 1. Yang J, Yang L, Wan Y, et al. Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes. Eur Heart J 2010;31:2238–2245. 2. Carminati M, Butera G, Chessa M, De Giovanni J, Fisher G, Gewillig M, Peuster M, Piechaud JF, Santoro G, Sievert H, Spadoni I, Walsh K. Investigators of the European VSD Registry. Transcatheter closure of congenital ventricular septal defects: results of the European Registry. Eur Heart J 2007;28:2361–2368.
9 3. Knauth AL, Lock JE, Perry SB, McElhinney DB, Gauvreau K, Landzberg MJ, Rome JJ, Hellenbrand WE, Ruiz CE, Jenkins KJ. Transcatheter device closure of congenital and postoperative residual ventricular septal defects. Circulation 2004;110:501–507. 4. Bentham JR, Gujral A, Adwani S, Archer N, Wilson N. Does the technique of interventional closure of perimembranous ventricular septal defect reduce the incidence of heart block? Cardiol Young 2011;21:271–280. 5. Zhou T, Shen XQ, Zhou SH, Fang ZF, Hu XQ, Zhao YS, Qi SS, Zhou Z, Li J, Lv XL. Atrioventricular block: a serious complication in and after transcatheter closure of perimembranous ventricular septal defects. Clin Cardiol 2008;31: 368–371. 6. Fu YC, Bass J, Amin Z, Radtke W, Cheatham JP, Hellenbrand WE, Balzer D, Cao QL, Hijazi ZM. Transcatheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: results of the U.S. phase I trial. J Am Coll Cardiol 2006;47:319–325. 7. Yang R, Kong XQ, Sheng YH, Zhou L, Xu D, Yong YH, Sun W, Zhang H, Cao KJ. Risk factors and outcomes of post-procedure heart blocks after transcatheter device closure of perimembranous ventricular septal defect. JACC Cardiovasc Interv 2012;5:422–427. 8. Yalonetsky S, Lorber A. Late high degree atrioventricular block after percutaneous closure of a perimembranous ventricular septal defect. Cardiol Young 2009;19:298–300. 9. Ovaert C, Dragulescu A, Sluysmans T, Carminati M, Fraisse A. Early surgical removal of membranous ventricular septal device might allow recovery of atrioventricular block. Pediatr Cardiol 2008;29:971–975. 10. Qin Y, Chen J, Zhao X, Liao D, Mu R, Wang S, Wu H, Guo H. Transcatheter closure of perimembranous ventricular septal defect using a modified double-disk occluder. Am J Cardiol 2008;101:1781–1786. 11. Masura J, Gao W, Gavora P, Sun K, Zhou AQ, Jiang S, Ting-Liang L, Wang Y. Percutaneous closure of perimembranous ventricular septal defects with the eccentric Amplatzer device: multicenter follow-up study. Pediatr Cardiol 2005;26:216–219. 12. Holzer R, de Giovanni J, Walsh KP, Tometzki A, Goh T, Hakim F, Zabal C, de Lezo JS, Cao QL, Hijazi ZM. Transcatheter closure of perimembranous ventricular septal defects using the Amplatzer membranous VSD occluder: immediate and midterm results of an international registry. Catheter Cardiovasc Interv 2006;68:620–628. 13. Betura G, Carminati M, Chessa M, Piazza L, Micheletti A, Negura DG, Abella R, Giamberti A, Frigiola A. Transcatheter closure of perimembranous ventricular septal defects: early and long-term results. J Am Coll Cardiol 2007;50: 1189–1195. 14. Butera G, Carminati M, Chessa M, Piazza L, Abella R, Negura DG, Giamberti A, Claudio B, Micheletti A, Tammam Y, Frigiola A. Percutaneous closure of ventricular septal defects in children aged o12: early and mid-term results. Eur Heart J 2006;27:2889–2895. 15. Tucker EM, Pyles LA, Bass JL, Moller JH. Permanent pacemaker for atrioventricular conduction block after operative repair of perimembranous ventricular septal defect. J Am Coll Cardiol 2007;50:1196–1200. 16. Siehr SL, Hanley FL, Reddy VM, Miyake CY, Dubin AM. Incidence and risk factors of complete atrioventricular block after operative ventricular septal defect repair. Congenit Heart Dis 2014;9:211–215. 17. Yang R, Sheng YH, Cao KJ, Zou JG, Zhang H, Hou XF, Xu D, Yong YH, Zhou L, Kong XQ. Late recurrent high degree atrioventricular block after percutaneous closure of a perimembranous ventricular septal defect. Chin Med J (Engl) 2011;124(19):3198–3200.
CLINICAL PERSPECTIVES In our retrospective study, we determined the incidence and predisposing factors of complete atrioventricular block (cAVB) associated with closure of ventricular septal defect (VSD) using a modified double-disk occluder. We also demonstrated that the incidence of early and late complete heart block after percutaneous closure of perimembranous VSD is relatively low, and that older patient age and late cAVB after VSD closure seem to be the major predisposing factors for pacemaker implantation. Recovery of sinus rhythm with device removal has been uncertain for patients with late cAVB. With this knowledge, clinicians should be aware that patients should be followed for life after device closure of VSD even in the setting of normal hemodynamics, with special attention to the conduction system. Careful patient and device selection, improvements in the design of the device system, and standardized endovascular manipulation could be conducive to the prevention of cAVB.
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Complete atrioventricular block after percutaneous device closure of perimembranous ventricular septal defect: A single-center experience on 1046 cases Yuan Bai, MD, Xu-Dong Xu, MD, Chang-Yong Li, MD, Jia-Qi Zhu, MD, Hong Wu, MD, Shao-Ping Chen, MD, Feng Chen, MD, Xiao-Hua You, MD, Xian-Xian Zhao, MD, Yong-Wen Qin, MD From the Department of Cardiology, Changhai Hospital, Second Military Medical University, Shanghai, China. BACKGROUND Complete atrioventricular block (cAVB) has been deemed a rare complication after transcatheter closure for ventricular septal defect (VSD). However, this serious event appears to be underrecognized and is worth being investigated further. OBJECTIVES To determine the incidence and predisposing factors of cAVB associated with closure of VSD using a modified double-disk occluder (MDO). METHODS From December 21, 2001 to December 31, 2014, 1046 patients with perimembranous ventricular septal defect underwent percutaneous closure using the MDO. Electrocardiography was evaluated before the procedure, within 1 week after the procedure, and then at 1, 3, 6, and 12 months and every year thereafter. Other baseline and procedural parameters were also evaluated and a comparison between patients requiring pacemakers and those not suffering from cAVB was done. RESULTS cAVB occurred in 17 patients (1.63%) after the procedure. Of the 17 patients, 8 (0.8%) underwent permanent pacemaker (PPM) implantation. The cAVB occurred within 30 days after the procedure in 14 patients and after 1 year in 3 patients. In comparison patients aged r18 years, patients aged 418 years
Introduction Percutaneous device closure of perimembranous ventricular septal defect (pmVSD) has been widely accepted and also associated with excellent rates of closure.1–3 Avoiding sternotomy and cardiopulmonary bypass, the transcatheter approach is assumed to reduce perioperative morbidity and mortality as compared to conventional surgical repair. Nevertheless, the transcatheter technique has subsequent complications, such as embolization of the occluder, valve impairment, and arrhythmia. Complete atrioventricular block (cAVB) is a Drs Bai and Xu contributed equally to this work. Grant support was received from the National High-Tech R&D Program of China (“863” Program) (No. 2006AA02Z4D7). Address reprint requests and correspondence: Dr Yong-Wen Qin or Dr Xian-Xian Zhao, Department of Cardiology, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, China. E-mail address: xianxianz2010@ 163.com; [email protected].
were more prone to cAVB (P ¼ .025). Logistic regression revealed no significant parameter to predict later requirement for PPM. CONCLUSIONS The incidence of cAVB after transcatheter closure of VSD was acceptable, as part of the cAVB population recovered after administration of corticosteroid and application of a temporary pacemaker. Late cAVB (41 year) appears to make it more difficult to restore normal conduction block. Because of the recurrence of cAVB, life-long follow-up with periodic electrocardiography examination may be mandatory. KEYWORDS Complete atrioventricular block; Perimembranous ventricular septal defect; Complication; Percutaneous ABBREVIATIONS AV ¼ atrioventricular; cAVB ¼ complete atrioventricular block; CRBBB ¼ complete right bundle branch block; ECG ¼ electrocardiography; MDO ¼ modified double-disk occluder; pmVSD ¼ perimembranous ventricular septal defect; PPM ¼ permanent pacemaker; TTE ¼ transthoracic echocardiography; VSD ¼ ventricular septal defect (Heart Rhythm 2015;0:-1–9) I 2015 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
4–6
Previous rare but serious complication of the procedure. literature has described that cAVB can occur immediately or later after transcatheter occluder closure.7–9 Since the exact mechanism of postoperative cAVB is not fully investigated, the occurrence of cAVB in patients treated with percutaneous interventions is unpredictable. Additionally, there is a lack of studies describing incidence of cAVB and predictors of pacemaker requirement following ventricular septal defect (VSD) closure. Therefore, the aim of this study was to determine the evolution of cAVB and predisposing factors of pacemaker implantation associated with VSD closure using a modified double-disk occluder (MDO) in a single institution.
Methods Study population From December 21, 2001 to December 31, 2014, 1046 patients with pmVSD underwent percutaneous closure
1547-5271/$-see front matter B 2015 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
http://dx.doi.org/10.1016/j.hrthm.2015.05.014
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using an MDO in Changhai Hospital, Shanghai. The patients or, if minors, patients’ parents gave their written informed consent to the procedure. The local Ethics Committee approved this protocol. This study complied with the Declaration of Helsinki. The criteria for inclusion in this study included: (1) age Z1 year; (2) body weight Z12 kg; (3) maximum diameter of VSD r16 mm by transthoracic echocardiography (TTE); (4) defect located at 9 to 12 o’ clock positions in the short axis parasternal view of TTE (Figure 1); (5) a significant left-to-right shunt across the defect; (6) a distance of Z1 mm from the VSD to the aortic valve; and (7) mean pulmonary artery pressure r70 mm Hg evaluated by catheter. Exclusion criteria included patients with endocarditis, NYHA class III and IV, severe pulmonary hypertension (470 mm Hg), sepsis, and contraindications to antiplatelet therapy.
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Description of modified double-disk occluder The MDO is a self-expandable double-disk device made from a Nitinol wire mesh (ShangHai Shape Memory Alloy Co Ltd, Shanghai, China). There are a total of 3–5 polyester patches in each disk. The polyester patches filled in the disks can guarantee the sealing of the occluder. There were 3 subtypes of MDO: symmetric occluder, asymmetric occluder, and thin-waist occluder. In the symmetric occluder, the left disk is symmetric. The diameter of the disk is 4 mm larger than that of the waist. In an asymmetric occluder, the flange of the left ventricular disk, which faces the aortic valve, is 0 mm larger than the waist, while the flange of the disk that is on the opposite side of the aortic valve is 6 mm larger than the waist. The diameter of the left ventricular disk of the thin-waist occluder was 8 mm larger than that of the waist. The right ventricular disc of the asymmetric and thin-waist
Figure 1 Graphic examples of the criteria for study inclusion. A: Transthoracic echocardiography image (short axis parasternal view) confirms the location of the defect (arrow) to the perimembranous area. B: Schematic diagram of the location of ventricular septal defect (the defect located at 9 to 12 o’clock positions in the short axis parasternal view).
131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187
Bai et al 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 P 212 R 213 I 214 N 215 T 216 & W 217 E 218 B 219 4 220 C 221 / 222 F 223 P O 224 225 F2 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244
Figure 2
Heart block after ventricular septal defect closure
3
Modified double-disk occluders and corresponding schematic diagrams. A: Symmetric occluder; B: thin-waist occluder; C: asymmetric occluder.
occluder is the same as that of the symmetric occluder.10 The waist length of the occluder is between 2.5 mm and 4 mm according to the diameter of the disk (Figure 2). Owing to the complexity of defect shape, we used the patent ductus arteriosus closure device to close the VSD in a handful of patients.
Percutaneous ventricular septal defect closure procedure The implantation procedure for these occluders has been described in detail previously.10 Left ventriculography was performed to detect the shape, size, and location of the defect and the distance from the aortic valve to the defect. Right heart catheterizations were performed to assess the degree of shunting and to evaluate pulmonary vascular resistance. Aortography was also performed before releasing the occluder to ensure that the aortic valve had not been compromised. After the release of the occluder, TTE, aortography, and left ventriculography were performed again to detect tricuspid and/or aortic valve regurgitation and residual shunts.
All patients received postoperative intravenous injections of penicillin for 1 day and oral aspirin (3 mg/kg body weight) for 180 days. For patients who presented with heart block after the closure, corticosteroid therapy was administered to reduce occluder-related myocardial edema. Dexamethasone was started at a dosage of 5–10 mg/day for 20 days. A temporary pacemaker was implanted for those who suffered transient bradycardia. The patients with cAVB were further evaluated on a daily or weekly basis until 1:1 conduction was restored. If the cAVB did not disappear 20 days later, a permanent pacemaker (PPM) was implanted.
Follow-up protocol All patients had a baseline electrocardiogram (ECG). Then, all patients underwent continuous ECG telemetry monitoring for 7 days after the procedure. Follow-up ECG examination and TTE were performed on every outpatient, scheduled at 1, 3, 6, and 12 months and yearly thereafter. Chest radiograph evaluation was scheduled at 1 year. To enable analysis of predictors of PPM requirement after VSD closure, cAVB occurring within 7 days after the index procedure was
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Table 1 Baseline characteristics of all patients who underwent transcatheter ventricular septal defect procedure Patients (n)
1046
Male/female Age, y (range) Age groups r18 years 418 years Combined procedures (n) ASD closure PDA closure Pulmonary valvuloplasty Ruptured sinus of Valsalva aneurysm closure Types of modified double-disk VSD occluder* Symmetric Asymmetric Thin-waist occluder PDA occluder
520/526 17 (1–72) 556 490
Results
32 17 2 2
There were 1046 patients undergoing VSD closure procedure at our centers from December 2002 to December 2014. Their baseline characteristics and procedure data are shown in Table 1. Of the 1046 patients, 17 (1.63%) developed new-onset cAVB (n ¼ 12) or aggravation of pre-existing conduction disturbances (n ¼ 5). The median interval for the development of cAVB was 5 days (1–3285) following the procedure. This rhythm abnormality occurred in acute phase in 12 patients, subacute in 1 patient, and late in 4 patients, according to the study protocol (Figure 3). After cAVB occurrence, the PPM was implanted in 3 acute patients (25%), 1 subacute patient (100%), and 4 late patients (100%) without related complications. Thus, cAVB had resolved to normal atrioventricular (AV) conduction in 9 patients after corticosteroid therapy. Of the PPMs, 5 (62.5%) had single chamber and 3 (37.5%) had dual chamber. Their clinical descriptions are shown in Table 2. In 1 patient with preexisting Mobitz type II second-degree AV block, we performed percutaneous balloon pulmonary valvuloplasty at the same session. Another subject with pre-existing complete right bundle branch block (CRBBB) þ I AVB underwent a combined atrial septal defect closure procedure at the same session. During follow-up, TTE showed in all 17 patients that all devices were in the proper position and that there was no residual shunt.
431 360 250 10
ASD ¼ atrial septal defect; PDA ¼ patent ductus arteriosus; VSD ¼ ventricular septal defect. * There are 5 patients who had multiple VSDs undergoing successful transcatheter closure using 2 overlapping occluders.
classified as acute; that occurring at 47 days up to 30 days was classified as subacute, and that occurring after 30 days was classified as late. In this study, patients with new-onset cAVB or aggravation of a pre-existing high-degree AV conduction disturbance were defined as patients with cAVB.
Statistical analysis All statistical analyses were performed using commercially available software (PASW Statistics v18.0.0; SPSS, Inc, Chicago, IL). Data distribution was evaluated with the Kolmogorov-Smirnov normality test. A 2-sided .05 significance level was used for hypothesis testing. Descriptive data for continuous variables are presented as mean (SD). Categorical variables are presented as relative frequencies. Fisher exact test was performed to detect significant differences between groups. For comparison of continuous variables between 2 groups, the t test was used (2-tailed tests were used for all analyses). To determine the predisposing factors of PPM, we compared the following variables between patients with and without PPM: age, sex, weight, ratio of device to defect
P R I N T & W E B 4 C / F P O
Figure 3
size, type of device, ECG findings before VSD closure, and the onset time of cAVB. Variables with P values o.1 in univariate analysis were entered into the multivariate model. Multivariate analyses were performed by means of a logistic regression model.
Patients and procedural data
Heart block in acute and subacute phase Complete AV block was observed 1–30 days after closure procedure in 13 patients. After corticosteroid and isoprenaline administration, cAVB had resolved to right bundle branch block in 5 patients, to left anterior hemiblock in 1 patient, to junctional rhythm in 1 patient, and to normal conduction in 2 patients within 2 weeks. In the case of Patient 4, with pulmonary stenosis, the patient’s preprocedural ECG
Time course to the development of complete atrioventricular block (cAVB).
359 360 361 362 363 364 365 366 367 368 369 370 T1 371 372 373 374 375 376 F3 377 378 379 380 381 382 383 T2 384 385 386 387 388 389 Q5 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415
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Clinical characteristics of patients with heart block after ventricular septal defect closure
Age Patients Sex (y)
Weight (kg)
VSD size by TTE (mm) Comorbidity
Size of Type of device (mm) device
1 2 3 4
F M F M
25 15 4 15
45 63 14 41.8
6 4 6 15
12 5 9 24
Asymmetric Symmetric Asymmetric Symmetric
5 6 7 8
M M M M
21 7 33 56
58.5 21 61.5 74
5 4 6 4.5
14 6 10 5
Asymmetric Asymmetric Thin-waist Thin-waist
9 10 11 12 13 14
F F M M F M
38 20 30 42 46 50
58 55.5 60 90 64 75
4 6 7 8 8 4
Thin-waist Asymmetric Symmetric Symmetric Asymmetric Thin-waist
15
M
36
52
8
5 10 8 10 10 Postoperative 6 residual VSD 14
16 17
F F
24 57
46.5 60
5 5
8 7
PS
ASD
Pre-ECG
Post-ECG
Onset (d)
Recovery (d)
ECG in follow-up
Normal Normal Normal Mobitz II seconddegree AVB Normal Normal Normal CRBBB þ intermittent III AVB CRBBB þ I AVB Normal Normal Normal Normal CRBBB þ LAH
Normal Normal CRBBB Junctional rhythm
5 5 5 1
15 15 15 7
T T T N
Normal Normal Normal CRBBB þ intermittent III AVB CRBBB þ I AVB Normal Normal Normal CRBBB þ LAH CRBBB þ LAH
5 5 3 5
10 7 7 N
CRBBB CRBBB IRBBB Junctional rhythm Normal IRBBB LAH Pacing rhythm
43 1201 1927/2417 14/1175 4/143 2
N N 1942/N 16/N 10/N N
Pacing rhythm Pacing rhythm Pacing rhythm Pacing rhythm Pacing rhythm Pacing rhythm
P P P T/P T/P T/P
CRBBB þ LAH
3285
N
Pacing rhythm P
Normal Normal
5 3
9 8
CRBBB Normal
PDA CRBBB occluder Symmetric Normal Symmetric Normal
Pacemaker
N N N P
Heart block after ventricular septal defect closure
Table 2
T N
ASD ¼ atrial septal defect; AVB ¼ complete atrioventricular block; CRBBB ¼ complete right bundle branch block; ECG ¼ electrocardiogram; LAH ¼ left anterior hemiblock; IRBBB ¼ incomplete right bundle branch
Q8 block; N ¼ no pacemaker; P ¼ permanent; PDA ¼ patent ductus arteriosus; PS ¼ pulmonary stenosis; T ¼ temporary; TTE ¼ transthoracic echocardiography; VSD ¼ ventricular septal defect.
5 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529
6 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560Q6 561 562 563 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586
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Table 3 Comparison of patient characteristics for complete atrioventricular block and non–complete atrioventricular block patients Patient characteristic Age r18 years 418 years Sex Male Female Type of VSD occluder Symmetric Asymmetric Thin-waist PDA occluder
Non-cAVB
cAVB
552 477
4 13
Statistical significance .025 .475
510 519
10 7 .262
425 354 246 9
6 6 4 1
cAVB ¼ complete atrioventricular block; PDA ¼ patent ductus arteriosus; VSD ¼ ventricular septal defect.
showed Mobitz type II second-degree AV conduction block. The minimum heart rate in this patient with second- or thirddegree AV block on 24-hour ambulatory ECG monitoring was obtained 1–7 days after the closure procedure. During the next 9 years of follow-up, neither cAVB nor long pause (43 seconds) was observed. A PPM was implanted in the remaining 3 patients. Patient 8 presented with transient cAVB before VSD closure. Five days after the procedure, the patient experienced syncope with bradycardia. He underwent a complete cardiologic evaluation that showed paroxysmal cAVB requiring PPM implantation. Patients 12 and 13 suffered from cAVB following the closure with 30 days. Then the cAVB had resolved to normal conduction following corticosteroid and isoprenaline administration. However, both patients developed cAVB again a few months after the procedure and were implanted with PPMs. Patient 14, who underwent surgical VSD closure 30 years prior, presented with CRBBB and left anterior hemiblock before VSD closure. However, 1 day after the procedure, his ECG showed cAVB. A PPM was implanted into this patient, who had not recovered stable sinus rhythm 1 week later.
(prednisone 1 mg/kg/d) for 2 weeks. The cAVB disappeared completely. Unfortunately, this patient was readmitted to our hospital for repeated cAVB 16 months after reverting to a normal sinus rhythm from cAVB in the postprocedural period (5.3 years). Then a VVI-type PPM was implanted.
Associated risk factors for complete atrioventricular block and permanent pacemaker There was no significant difference in sex and type of occluder between patients with and without AVB. However, in comparison with the group aged r18 years, patients younger than 18 years were more prone to cAVB (P ¼ .025) (Table 3). Univariate findings of potential predisposing factors for PPM are summarized in Table 4. In older patients and those with late cAVB (430 days), it appears more difficult to restore normal conduction block and there is greater need for PPM implantation. Three parameters with P o .1 (age, weight, and onset time of cAVB) were included into the multivariate analysis. However, logistic regression revealed no significant parameter to predict later requirement for PPM implantation for AVB (age, P ¼ 1.0; weight, P ¼ .984; onset time of cAVB, P ¼ .99).
Discussion Atrioventricular block has been reported after VSD device closure. The incidence of transient cAVB after transcatheter closure of VSD is about 1%–5% in recent studies.11–14 This retrospective study of a large consecutive series in a single institution indicates that percutaneous VSD closure using the MDO also can be associated with cAVB. A total of 17 patients experienced cAVB during the period of the study. The 1.63% incidence of cAVB in our overall patient group is comparable to published data. Complete AV block is also a Table 4 Univariate findings of potential predisposing factors for permanent pacemaker Parameter
Late heart block During outpatient follow-up, 4 patients who developed cAVB more than 30 days after the procedure underwent PPM implantation. In Patient 9, the ECG showed a CRBBB and first-degree AVB at the end of the procedure. The patient developed a cAVB 43 days after the procedure and was implanted with a PPM. Patient 10, a 24-year-old woman, experienced syncope 3 years after VSD closure with an 8-mm asymmetric occluder. ECG revealed cAVB with a heart rate of 40 beats per minute. Device removal together with surgical repair of VSD was performed emergently. However, AV conduction block did not recover, and a PPM was implanted. Patient 11 was a 30-year-old man with a 7-mm VSD that was successfully closed with an 8-mm symmetric occluder. He was seen in an outpatient clinic 5.3 years later because of presyncope, and ECG showed complete heart block. We decided to treat him with corticosteroid therapy
Age* r18 years 418 years Weight (Kg)* Male/female Onset* r7 days 7-30 days 430 days Device/defect Pre-ECG Normal Heart block Type of occluder Symmetric Asymmetric Thin-waist PDA occluder
No PPM (n¼9)
PPM (n¼8)
4 5 45.7 (17.8) 5/4
0 8 66.1 (12.7) 5/3
9 0 0 1.7 (0.5)
3 1 4 1.4 (0.3)
8 1
3 5
4 4 1 0
2 2 3 1
Statistical significance P ¼ .031 P ¼ .017 P ¼ .772 P ¼ .019
P ¼ .095 P ¼ .79 P ¼ .35
ECG ¼ electrocardiogram; PDA ¼ patent ductus arteriosus; PPM ¼ permanent pacemaker.
587 588 589 590 591 592 593 594 595 596 597 598 599 T3 600 T4 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 Q9 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 Q10
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Heart block after ventricular septal defect closure
complication of surgical intervention of VSD. Surgical repair for VSD in experienced centers has achieved excellent outcomes with minimal mortality and low incidence of AVB nowadays. Tucker et al15 reported on 4432 surgical VSD closures with a 1.1% incidence of PPM implantation for AV block. In a more recent study, Siehr et al16 reported that a total of 64 patients (7.7%) developed surgical AVB. Among those patients who developed AVB, 48 patients (75%) had transient AVB. Sixteen patients (1.9%) required a pacemaker. However, this comparison between surgical repair and device closure is difficult to interpret, as it is widely accepted that the surgical repair allows the closure of larger defects than the devices do. Also, the selection of suitable patients (shape and size of VSD diameter) is crucial to device closure success. Usually, abnormalities of AV conduction occur during or early after occluder implantation. In the majority of patients who developed cAVB (70.6%), it occurred within the first 7 days after implantation. These findings indicate that continuous postoperative ECG monitoring should be performed for at least 7 days in all patients after VSD closure. Although the exact mechanism of acute cAVB remains speculative, mechanical compression, progressive device flattening, friction of the device disk on the septal myocardium, and inflammatory response may be the main issues. Given the proximity of the conduction system to the margins of the pmVSD, a larger device can interfere with AV conduction. Instead, the ratio of device size to defect size is not a risk factor for cAVB in this study. High-dose corticosteroids, isoprenaline, and temporary pacemaker insertion were effective in our patient for reversing early cAVB. However, on the basis of our experience, we cannot be sure about the long-term efficacy of steroids. There are 3 cases of reappearance of cAVB requiring a definitive pacemaker implantation after an initial successful reversal using both steroids and temporary pacemaker. In addition, the empirical therapy with corticosteroid was not effective in this late recurrent cAVB. Nearly 50% of patients developed AV block later after corticostereoid therapy, as shown in the results. Based on past experience in our center, the more important issue to avoid occurrence of cAVB after device implantation is to prevent compression of conduction tissue by retentional disks. Exceptionally, however, cAVB may occur very late following device closure, without premonitory signs. Lastly, the very late cAVB may occur as a consequence of anomalous development of the conduction tissue in the context of a cardiac malformation. The finding of late AV block in which a PPM was placed more than 9 years after VSD closure is interesting. The present finding of 3 of 1046 patients (0.3%) developing AV block more than 1 year after percutaneous closure of VSD is important. This fact should be considered when counseling patients, their parents, and their personal physicians about symptoms that might develop and that need appropriate evaluation. Yang et al,7 reporting on a series of 244 patients, deduced that the time of AV block emergence was an independent predictor
7 of cAVB persistence. They showed that the earlier a cAVB developed after closure of the pmVSD, the more difficult was a recovery to normal conduction. Compared with the data of Yang et al, the late cAVB (430 days) appears to make it more difficult to restore normal conduction block and appears to increase the need for PPM implantation in the current study. Recent publications suggest that a progressive ongoing inflammatory process and scar formation in the conduction tissue may be another cause of late cAVB.8 Furthermore, progressive device flattening of an originally oversized occluder should account for the late cAVB after percutaneous VSD closure. Yang et al17 report that 1 patient who developed transient cAVB 7 days after transcatheter VSD closure had recurrent cAVB 42 months after the procedure. During the follow-up, the shape of the device had changed significantly 42 months after closure of the VSD. Although the occluder returned gradually to its original size and shape, it compressed and caused persistent damage in the conduction tissue. Our experience also shows that recurrent cAVB may appear several months after cAVB has reverted to a normal sinus rhythm in the early postprocedural period. A total of 3 patients (Patients 11, 12, and 13) suffered from recurrent AV block. Particularly, Patient 11 presented with cAVB more than 5 years following the procedure. In spite of his late presentation, corticosteroid therapy was effective for him, and this patient remained asymptomatic for 18 more months. But this recovery was temporary, and the patient had recurrent cAVB, which necessitated the implantation of a PPM. The late response to corticosteroid therapy may support the theory of an ongoing inflammatory process in septal after VSD device closure. The occurrence of transient postprocedural AV block was found to be significantly associated with delayed AV block. It implies that long-term follow-up, perhaps lifelong, may be mandatory. Although some authors have emphasized that young age, low weight, and Down syndrome are risk factors for the occurrence of cAVB, these factors were not confirmed by our study.13 There was an apparent relationship between patient age and late heart block in our series. The proposed explanation for the development of late heart block after closure is that fibrosis around the area of the device might extend into the AV node and impair conduction. Most of our patients were adults or older children, whereas the majority of patients in several other studies were children. In the present comparison of patient groups, patients who have cAVB seem to be older than those who do not have cAVB. In the older patients (418 years) it appears more difficult to restore normal conduction block and more likely that they will need PPM implantation. Also, the subtype of device is not associated with postoperative cAVB. Additionally, in this study, patients who have PPM implantation are significantly older than those who do not have PPM implantation. Implantation of PPMs and timing of implantation remain controversial topics. According to the follow-up results, older patients with cAVB pose more difficulty to restoration of normal conduction and need PPM implantation.
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The minor ECG changes after closure are very valuable for clinical arrhythmias. It is also notable that cAVB is more likely to occur in the subjects who had left anterior hemiblock and CRBBB immediately after implantation (Patients 13 and 15) (Figure 4). Ovaert et al,9 reporting on 2 patients, described patients presenting with cAVB in whom surgical removal of the device and VSD closure were associated with rapid and complete recovery of the AV conduction.
Heart Rhythm, Vol 0, No 0, Month 2015 However, in our cases, cAVB regression was not noticed either without any treatment, after steroid administration, or after device removal in the tenth patient. Surgical occluder removal associated with VSD closure in cases of acute cAVB might allow recovery of the conduction system. Recovery of sinus rhythm with device removal has been uncertain for patients with late cAVB. Therefore, how well the conduction system recovers after this surgical removal is still unknown.
Figure 4 Patient 13 with left anterior hemiblock and complete right bundle branch block. A: The patient has a normal electrocardiogram before ventricular septal defect closure. B: She developed left anterior hemiblock and complete right bundle branch block immediately after implantation. C: Her heart block was first noted 4 days after closure.
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Heart block after ventricular septal defect closure
When should surgical removal treatment be started in patients with cAVB? According to current published literature, subjects with cAVB should be sent to surgery for restoration of sinus rhythm within 1 month after implantation.
Limitations There are several limitations to our study. The presented data are a single-center experience. Furthermore, this is a retrospective chart review, which relied on available medical records. Owing to an inadequate number of measurements (such as the distance below the aortic valve), many factors of cAVB were not analyzed from the multivariate analysis. Another weakness of our study is that the number of cAVB events was not large enough to perform meaningful analyses, especially multivariate analyses. Especially, the number of PPM outcomes is, unfortunately, really too small to expect that multivariate analysis will be very persuasive.
Conclusions This study demonstrates that the incidence of early and late complete heart block after percutaneous closure of pmVSD is relatively low at 1.63%. Older patient age and late cAVB after VSD closure seem to be the major predisposing factors for PPM. This study also underscores the importance of long-term follow-up for these patients, particularly those patients who have transient postoperative cAVB. Careful patient and device selection, improvements in the design of the device system, and standardized endovascular manipulation could be conducive to preventing cAVB. Larger series are needed to validate these preliminary findings.
Acknowledgments The authors thank the Ye Xiao-fei for assistance with statistical data.
References 1. Yang J, Yang L, Wan Y, et al. Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes. Eur Heart J 2010;31:2238–2245. 2. Carminati M, Butera G, Chessa M, De Giovanni J, Fisher G, Gewillig M, Peuster M, Piechaud JF, Santoro G, Sievert H, Spadoni I, Walsh K. Investigators of the European VSD Registry. Transcatheter closure of congenital ventricular septal defects: results of the European Registry. Eur Heart J 2007;28:2361–2368.
9 3. Knauth AL, Lock JE, Perry SB, McElhinney DB, Gauvreau K, Landzberg MJ, Rome JJ, Hellenbrand WE, Ruiz CE, Jenkins KJ. Transcatheter device closure of congenital and postoperative residual ventricular septal defects. Circulation 2004;110:501–507. 4. Bentham JR, Gujral A, Adwani S, Archer N, Wilson N. Does the technique of interventional closure of perimembranous ventricular septal defect reduce the incidence of heart block? Cardiol Young 2011;21:271–280. 5. Zhou T, Shen XQ, Zhou SH, Fang ZF, Hu XQ, Zhao YS, Qi SS, Zhou Z, Li J, Lv XL. Atrioventricular block: a serious complication in and after transcatheter closure of perimembranous ventricular septal defects. Clin Cardiol 2008;31: 368–371. 6. Fu YC, Bass J, Amin Z, Radtke W, Cheatham JP, Hellenbrand WE, Balzer D, Cao QL, Hijazi ZM. Transcatheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: results of the U.S. phase I trial. J Am Coll Cardiol 2006;47:319–325. 7. Yang R, Kong XQ, Sheng YH, Zhou L, Xu D, Yong YH, Sun W, Zhang H, Cao KJ. Risk factors and outcomes of post-procedure heart blocks after transcatheter device closure of perimembranous ventricular septal defect. JACC Cardiovasc Interv 2012;5:422–427. 8. Yalonetsky S, Lorber A. Late high degree atrioventricular block after percutaneous closure of a perimembranous ventricular septal defect. Cardiol Young 2009;19:298–300. 9. Ovaert C, Dragulescu A, Sluysmans T, Carminati M, Fraisse A. Early surgical removal of membranous ventricular septal device might allow recovery of atrioventricular block. Pediatr Cardiol 2008;29:971–975. 10. Qin Y, Chen J, Zhao X, Liao D, Mu R, Wang S, Wu H, Guo H. Transcatheter closure of perimembranous ventricular septal defect using a modified double-disk occluder. Am J Cardiol 2008;101:1781–1786. 11. Masura J, Gao W, Gavora P, Sun K, Zhou AQ, Jiang S, Ting-Liang L, Wang Y. Percutaneous closure of perimembranous ventricular septal defects with the eccentric Amplatzer device: multicenter follow-up study. Pediatr Cardiol 2005;26:216–219. 12. Holzer R, de Giovanni J, Walsh KP, Tometzki A, Goh T, Hakim F, Zabal C, de Lezo JS, Cao QL, Hijazi ZM. Transcatheter closure of perimembranous ventricular septal defects using the Amplatzer membranous VSD occluder: immediate and midterm results of an international registry. Catheter Cardiovasc Interv 2006;68:620–628. 13. Betura G, Carminati M, Chessa M, Piazza L, Micheletti A, Negura DG, Abella R, Giamberti A, Frigiola A. Transcatheter closure of perimembranous ventricular septal defects: early and long-term results. J Am Coll Cardiol 2007;50: 1189–1195. 14. Butera G, Carminati M, Chessa M, Piazza L, Abella R, Negura DG, Giamberti A, Claudio B, Micheletti A, Tammam Y, Frigiola A. Percutaneous closure of ventricular septal defects in children aged o12: early and mid-term results. Eur Heart J 2006;27:2889–2895. 15. Tucker EM, Pyles LA, Bass JL, Moller JH. Permanent pacemaker for atrioventricular conduction block after operative repair of perimembranous ventricular septal defect. J Am Coll Cardiol 2007;50:1196–1200. 16. Siehr SL, Hanley FL, Reddy VM, Miyake CY, Dubin AM. Incidence and risk factors of complete atrioventricular block after operative ventricular septal defect repair. Congenit Heart Dis 2014;9:211–215. 17. Yang R, Sheng YH, Cao KJ, Zou JG, Zhang H, Hou XF, Xu D, Yong YH, Zhou L, Kong XQ. Late recurrent high degree atrioventricular block after percutaneous closure of a perimembranous ventricular septal defect. Chin Med J (Engl) 2011;124(19):3198–3200.
CLINICAL PERSPECTIVES In our retrospective study, we determined the incidence and predisposing factors of complete atrioventricular block (cAVB) associated with closure of ventricular septal defect (VSD) using a modified double-disk occluder. We also demonstrated that the incidence of early and late complete heart block after percutaneous closure of perimembranous VSD is relatively low, and that older patient age and late cAVB after VSD closure seem to be the major predisposing factors for pacemaker implantation. Recovery of sinus rhythm with device removal has been uncertain for patients with late cAVB. With this knowledge, clinicians should be aware that patients should be followed for life after device closure of VSD even in the setting of normal hemodynamics, with special attention to the conduction system. Careful patient and device selection, improvements in the design of the device system, and standardized endovascular manipulation could be conducive to the prevention of cAVB.
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