Comparison of Reported Outcomes With Percutaneous Versus Surgical Closure of Ruptured Sinus of Valsalva Aneurysm Emy M. Kuriakose, MD, Puneet Bhatla, MD, and Doff B. McElhinney, MD* Sinus of Valsalva aneurysm is a rare cardiac malformation that stems from incomplete fusion of the aortic media and the aortic valve annulus, a weakness that may result in rupture of the sinus, large left-to-right shunt, and severe congestive heart failure. Historically, this lesion has been repaired surgically, but percutaneous closure (PC) has emerged as a therapeutic intervention over the last 20 years. We review and contrast 34 studies detailing the PC approach with 16 studies on surgical closure (SC), together comprising a total of 877 patients who were treated for ruptured sinus of Valsalva aneurysm from 1956 to 2014. Both groups had similar sites of rupture, age distribution, and clinical symptoms at presentation. Selection bias ultimately prohibits a direct comparison between the 2 groups as patients who underwent SC often had worse aortic regurgitation and more complex associated lesions, including endocarditis, bicuspid aortic valve, tunnel-type fistulous connections, larger defect size, and multiple site of rupture. In conclusion, although SC is indicated and reserved for these more complicated patients, our review of previously published reports reveals that PC in patients who are too ill to undergo bypass, with mild or no aortic regurgitation and simple associated defects (muscular ventricular septal defects, secundum atrial septal defect, small patent ductus arteriosus), can be safe, effective, and practical. Ó 2015 Elsevier Inc. All rights reserved. (Am J Cardiol 2015;115:392e398) Sinus of Valsalva aneurysm (SOVA) is a rare cardiac malformation that stems from incomplete fusion of the aortic media and the aortic valve annulus, the cause of which is a deficiency in the elastin layer of the aortic wall. A ruptured aneurysm in this location has historically been repaired surgically. However, since Cullen et al1 described the first percutaneous closure (PC) in 1994, this less invasive approach has been increasingly used and can be a viable alternative to closure in select cases.2 The rarity of SOVA and its scattered multinational incidence make it a difficult entity to track and study. We present a systemic review of 37 retrospective case studies (1994 to 2014) with a total of 136 patients who underwent PC of ruptured SOVA. We also reviewed 16 studies (1988 to 2013) from surgical cohorts, representing 741 individual patients. Although selection bias, difference in era of intervention, and limitations in long-term follow-up inevitably prohibit a direct comparison of outcomes between the 2 groups, we offer a discussion of the results and potential guidelines for management. Pathophysiology Edwards and Burchell3 described SOVA in autopsy specimens as defects above the level of the aortic cusps in

which there is lack of continuity between the aortic media and the annulus fibrosis. This may later initiate aneurysm formation, leading to local flow turbulence, laminar flow separation, or dilatation of the annulus and valve cusps. Most commonly, the right coronary or noncoronary sinuses are implicated in rupture, communicating anteriorly with the right ventricle (through the outlet septum or crista supraventricularis) or posteriorly to the right atrium.4 Rupture may be due to a gradual enlargement of a congenital defect or may be secondary to bacterial endocarditis or atherosclerosis. The incidence of acute endocarditis associated with rupture is unknown, although between 2% and 30% of patients reported remote histories of endocarditis in larger surgical series.5e7 In patients undergoing open heart surgery, SOVA is more prevalent in Asian (1.2% to 4.9%) than in Western populations (0.14% to 1.5%).4e7 A ventricular septal defect is the most commonly associated defect (49% in surgical series), along with bicuspid aortic valve, infundibular pulmonary stenosis, patent ductus arteriosus, atrial septal defect, coarctation and aortic regurgitation (AR), or aortic stenosis.7e19 Asian populations more frequently had ventricular septal defects (VSDs) of the supracristal type.6,13,14,16 Surgical Repair of Ruptured SOVA

Department of Pediatric, New York University Langone Medical Center, New York, New York. Manuscript received August 1, 2014; revised manuscript received and accepted November 4, 2014. Funding: None. See page 396 for disclosure information. *Corresponding author: Tel: 650-739-6842. E-mail address: [email protected] (D.B. McElhinney). 0002-9149/14/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved.

Ruptured SOVA was always repaired, even if patients were asymptomatic and only diagnosed when a continuous murmur was found on routine examination. Although its natural history is not well understood, asymptomatic, unruptured SOVA, usually found during unrelated imaging studies, was almost always repaired in larger surgical series,

Review/Percutaneous Versus Surgical Closure of Ruptured SOVA


Figure 1. The characteristics of the ruptured and drainage sites for each repair group. LA ¼ left atrium; LC ¼ left cusp; LV ¼ left ventricle; NC ¼ noncoronary cusp; PA ¼ pulmonary artery; RA ¼ right atrium; RC ¼ right cusp; RV ¼ right ventricle. (Image reproduced in black and white in print; for full color, please see the electronic version.)

and documented anecdotal cases advocate for early intervention.4,11,15,17 For example, a Jehovah’s Witness with an unruptured aneurysm had refused surgery, but over the next 4 years, he developed severe AR, extension of the aneurysm to the right and left coronary sinuses, and dilatation of the aortic annulus.4 Vural et al17 proposed that patients with unruptured, stable aneurysms should be anticoagulated, followed at 6-month intervals, and then repaired if symptoms develop or the size of the sinus is >50% of the average size of the other 2 normal Valsalva sinuses, compresses or distorts surrounding chambers or tissues, or increases in consecutive echocardiographic examinations. For the purpose of this discussion, only surgical series that investigated ruptured SOVA (n ¼ 741, 67% men) were considered. The chambers of rupture and drainage are shown in Figure 1. Until the use of routine 2-dimensional echocardiography, most patients were diagnosed with angiography. Several investigators report an echocardiographic accuracy rate of >90%, with the most error occurring in the accurate identification of the chamber of drainage. In the current era, angiography is typically reserved for characterization of coronary artery disease in older patients.5,7,8,16,20,21 Of the 656 patients in whom symptoms were reported, 88% (n ¼ 583) presented with exertional dyspnea, palpitations, fever, chest pain, fatigability, or a combination of these.9e11 Symptom onset was further characterized in 328

patients, with 36% (n ¼ 121) of patients presenting suddenly, requiring early repair. The remaining patients were repaired electively within 2 to 4 months. New York Heart Association class was reported in 517 patients, with 52% (n ¼ 269) presenting in class 3and 4, and mean Qp:Qs (reported in 140 patients) was 2.35 (range 1.9 to 2.9). Investigators chose 1 of 3 accepted operative approaches to closure: through the ruptured cardiac chamber, through an aortotomy, or by a combined approach. The ruptured sites were closed directly or with prosthetic or pericardial patches. Some investigators describe a greater incidence of recurrent fistulas in patients who underwent direct closure, although others found no differences in recurrence or AR related to surgical approach, and this remains an area of contention.7,9,10,14e18 Of the 741 patients (Table 1), early mortality was low at 1.5% (n ¼ 11). The range of follow-up tracking late deaths was extremely variable, from several months to 37 years. Abe and Komatsu14 reported a late actuarial survival rate at 25 years of 86  7%. Typical causes of late death included anticoagulation-related hemorrhage, endocarditis, other organ failure, and congestive heart failure from myocardial disease. Total event-free survival has collectively improved over the last 2 decades.8,18 When taking only studies that reported the incidence of AR (n ¼ 696 patients), the occurrence was 34% (n ¼ 236). Of patients with AR, severity was quantified in 144 and was


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Table 1 Demographics and outcomes for surgical repair of ruptured sinus of Valsalva aneurysm Publication (years of recruitment)

Number of patients

Age (years)

31 22

23 (3-58) 28.5 (15-45)

12 (38%) 8 (36%)

5 (16%) not reported 5 (9%) 0

53 34 104

36 (13-65) 31.6 (7-57) 27.5 (5-62)

23 (43%) 24 (70%) 45 (43%)

14 (26%) 0 11 (32%) not reported 27 (26%) 3 (2.9%)

Abe14 (1961-87) Agrawal13 (1979-90) Au22 (1978-96) Azakie10 (1970-98) Choudhary16 (1977-96) Dong C20 (1996-01) Dong R23 (1997-07) Hamid21 (1978-93) Jung24 (1990-06) Kirali8 (1985-99) Lin25 (1980-01) Lui26 (1993-03) Murashita18 (1963-98) van Son9 (1956-93) Wang7 (1988-06) Yan5 (1980-07) TOTAL

67 43 25 56 20 17 20 35

32 29 26 33.2 28.3 33.5 37.5 27.5

31 83 100 741

29 30.7 31 30.24

Aortic regurgitation

Aortic valve New aortic repair regurgitation

(2-57) 12 (17%) 12 (18%) (11-50) 15 (34%) not reported (11-49) not reported not reported (14-64) 8 (14%) 9 (16%) (14-55) 4 (20%) 4 (20%) (22-59) 8 (47%) 8 (47%) (16-58) not reported 0 (6-64) 9 (26%) 0

Follow up (years)

Re-operation for aortic regurgitation

Progressive aortic regurgitation

Early/Late Death

11.1 7.6 5 (0.5-10)

4 (13%) 0

4 (1.3%) 0

1/4 (3.2%/13%) 1/0 (4.5%/0%)

6.5 4.9 9.2 8.3 8.2 (1-20)

2 (3.8%) 6 (18%) 0

1 (1.9%) 6 (1.8%) 2 (1.9%)

0/5 (0%/9.4%) 0/4 (0%/12%) 2/1 (2%/2%)

0 2 (4.7%) 1 (4%) 4 (7.1%) 1 (5%) 1 (5.9%) 0 2 (5.7%)

1 (1.5%) 2 (4.7%) 3 (12%) 11 (20%) 0 1 (5.9%) 0 5 (14%)

not reported 2.1 (0.1-4.9) not reported 5.7 (1-10) not reported 5.5 (0.3-15) 5 (9%) 3.8 (0.1-15) 1 (5%) 4.4 (1-13) 0 11.5 (1-21) not reported 1.3 (1-20) 1 (2.9%) 16.2 9.4

1/1 (1.5%/1.5%) 0/0 1/1 (4%/4%) 0/2 (0%/3.6%) 1/0 (5%/0%) 0/1 (0%/5.9%) 1/0 (5%/0%) 0/1 (0%/2.9%)

(3-54) 13 (42%) 5 (1.6%) not reported 25.7 (0.3-37) 4 (13%) 3 (9.7%) 0/1 (0%/3.2%) (3-69) 21 (25%) 10 (8.3%) 0 9.6 3.8 0 not reported 0/1 (0%/1.2%) (14-57) 34 (34%) 22 (22%) not reported 15.6 3.9 not reported 6 (6%) 3/2 (3%/2%) (3-69) 236/696 132/673 7/390 (1.8%) 9 (0.1-37) 27/641 (4.2%) 45/658 (6.8%) 11/24 (34%) (20%) (1.5%/3.2%)

Table 2 Demographics and outcomes for percutaneous closure of ruptured sinus of Valsalva aneurysm Publication (years of recruitment)

Publication Type

Number of patients

Age (years)

Aortic regurgitation

Arora28 (1995-03) Chang29 (2003-04) Chen30 (2005-10) Guan31 (2005-10) Kerkar27 (2004-09) Liu26 (2003-13) Sen32 (2004-08) Sivadasanpillai2 (2006-08) Szkutnik33 (2007-08) Tong34 (2004-09) Zhao35 (2004-05) Zhao36 (2000-06) Multiple1,37e60 (1994-2013) TOTAL

Case Case Case Case Case Case Case Case

8 4 7 10 20 15 8 7

24.1 (14-35) 27.2 (18-47) 43.7 (25-65) 37.8 (19-63) 29.1 (17-52) 48 (24-74) 33þ/-10 44.8 (28-62)

Case Series Case Series Case Series Case Series Case Reports

5 13 4 10 25

32.2 28.7 37 37 33

Case Series 12 Case Reports 25


Series Series Series Series Series Series Series Series

(18-51) (18-38) (7-57) (7-69) (5-55)

34.9 (7-69)

New aortic regurgitation

Follow up (months)

Progressive aortic regurgitation


0 NR NR 2 (20%) 5 (25%) NR 1 (13%) 3 (43%)

0 0 0 1 (10%) 4 (20%) 2 0 0

2-96 3-18 6-12 22 (13-48) 24 (1-60) 1-60 11.3þ/-4.1 9.3 (8-17)

0 0 0 1 (0.07%) 0 0 0 0

1 Surgical (12.5%) none none none 1 Surgical (5%) 1 Surgical (6.7%) none none

NR 4 (30%) 2 (50%) 4 (40%) 1 (4.3%)

0 NR 0 NR 2 (8.7%)

14 (9-19) 43.4 (12-60) 3 3 0-18

0 0 0 0 1 (0.07%)

9/113 (8%)


2/136 (1.5%)

22/115 (19%)

moderate to severe in 74%, usually owing to cusp prolapse of the affected sinus. In the 716 patients for whom it was documented, 19% (n ¼ 132) required concurrent aortic valve repair or replacement, typically those with moderate or severe AR.11 Aortic valve procedures were reserved only for those patients with concurrent severe aortic root dilation, moderate-to-severe AR, fibrotic changes of the valve, or involvement of multiple sinuses. Investigators were reticent

none none none none 1 Aortic valve replacement (4.3%) 4/136 (2.9%)

to intervene on minor aortic valve abnormalities as repair has been shown to increase operative mortality.4,7,11,14 Taking the 641 patients for whom the incidence of reintervention was reported, only 3.2% (n ¼ 18) had reoperation for a recurrent aneurysm and 4.2% (n ¼ 27) had reintervention for AR. New or progressive AR was found in 6.8% (n ¼ 45). Several investigators noted no progression of mild AR that was not treated at the time of SOVA closure.13,18,19

Review/Percutaneous Versus Surgical Closure of Ruptured SOVA Table 3 Device type and frequency of use Device


Size (mm)*


55 (48%)

Other PDA Occluder

39 (34%)

mVSD Device

12 (11%)

6/4 8/6 10/8 12/10 14/12 10/8 12/10 13 14/12 16/14 4 6 7 8 10 12 14 6 14 16 12 17


4 (2.6%)


3 (2.6%)

Coil Total

2 (1.8%) 115

Number* 3 10 16 11 12 6 5 2 9 8 1 2 1 4 1 2 1 2 1 1 1 2

(2.6%) (8.8%) (14%) (8.8%) (10%) (5.3%) (4.4%) (1.8%) (7.9%) (7%) (0.9%) (1.8%) (0.9%) (3.5%) (0.9%) (1.8%) (0.9%) (1.8%) (0.9%) (0.9%) (0.9%) (1.8%)

ADO ¼ Amplatzer Ductal Occluder (St. Jude Medical, St. Paul, MN, USA); ASO ¼ Amplatzer Septal Occluder (St. Jude Medical, St. Paul, MN, USA); mVSD ¼ muscular VSD; PDA ¼ patent ductus arteriosus. * Size and number used only where reported.

Percutaneous Closure of Ruptured SOVA Patients (n ¼ 136, 62% men) were carefully selected before PC. Contraindications were twofold: those related to the characteristics of the aneurysm and their secondary complications (moderate-to-severe AR, large defect size, fistulous or tunnel-type burrowing of the aneurysmal tract, multiple sites of rupture) and those stemming from fixed, previously existing conditions (large VSD, active endocarditis, other congenital defects warranting surgical intervention).26,27 Characteristics of the ruptured sites were similar to surgical series, although the chamber of drainage was more equally distributed between the right ventricle and right atrium (Figure 1). Likely due to selection bias, there was only a 7.3% (n ¼ 10) incidence of associated VSD, and of 121 patients for whom it was reported, none had moderate or severe AR; only 17% (n ¼ 21) had preprocedural mild AR (Table 2). New York Heart Association class and Qp:Qs (mean 2.3; range 1.2 to 4.3) were similar to surgical series. Of the 77 patients for whom it was reported, 60% (n ¼ 56) were in New York Heart Association class 3 to 4, an indication that symptom severity did not dictate the choice of closure method. In fact, there is evidence showing that PC could be a viable option in severely ill patients as at least 3 successfully repaired patients in the PC group were first denied surgical intervention—1 due to multiple reoperations and 2 due to multiorgan system failure.28,32,37 Investigators elected to use small waist double-disk nitinol ductal occluders, of which Amplatzer ductal


occluders (ADO; St. Jude Medical, St. Paul, Minnesota) were the most commonly deployed, followed by devices with similar designs in countries where ADO devices were too expensive or unavailable. Other less frequently used devices included muscular VSD occluders, Amplatzer septal occluders (ASO), Rashkind umbrella devices, and, rarely, coils (Table 3). Citing a shortened procedure time, Cullen et al1 originally advocated for PC from a retrograde arterial approach, although most authors have since favored transvenous closure (95%). An exchange length wire is typically inserted in retrograde fashion through the aorta and snared from the venous side to create an arteriovenous loop to gain access to the defect from the venous side. A transvenous approach may be advantageous for several reasons: shorter length from access site to defect, avoiding a tortuous catheter course around the aortic arch (through which catheter maneuverability and control across the SOVA may be difficult), and device positioning with the septal surface resting in the sinus. The mean minimal diameter of the ruptured site was 7 mm (2 to 15 mm), and accordingly, device sizes ranged 6/ 4 to 16/14 mm. The lesions were sized during the case by transesophageal echocardiography (Figure 2), and investigators always elected to use devices that were at least 2 to 4 mm larger than the defect. Five device embolizations were reported; 3 of these were retrieved and subsequently closed with other devices, whereas the remaining 2 were converted to surgical closure (SC).27,38e41 One of the largest lesions (14 mm)28 could not be closed with ASO or ADO devices, but Guan et al31 successfully closed a 15-mm lesion with a patent ductus arteriosus occluder. Only one 9-mm lesion, perhaps due to irregularity in morphology, could not be closed with the largest ADO device (16/14 mm).27 Although failures of small defect closure are difficult to predict, we offer that a large (>12 mm) lesion on transthoracic echocardiogram should prompt further investigation with computed tomography or magnetic resonance imaging before attempted PC. Devices were only released after confirming precise placement, making certain there was no significant AR, tricuspid regurgitation, right ventricular outflow tract obstruction, arrhythmia, or coronary encroachment. Acute, new postprocedural AR occurred in 9 patients (7%). Dobarro et al42 described a patient in whom severe AR developed at 1-week follow-up and required surgical aortic valve replacement. AR was believed to be related to prolapse of the noncoronary cusp caused by the weight of the ADO device, although this was not seen in any other patients. Rather, several investigators reported stability and improvement in mild AR over time.27,31,42 Notably, a few patients in India and China with small perimembranous VSDs underwent concurrent PC of the septal defect. Liu et al26 went on to recommend percutaneous VSD and SOVA closure for patients with up to mild AR and perimembranous defects, while reserving SC for those with the subaortic variety. Devices were not released after placement in 2 cases; one with ST-segment changes and another with acute moderate AR.27,33 Arora et al28 and Liu et al26 each described 1 case in which device placement caused persistent shunts and hemolysis, and these patients ultimately underwent SC.


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Figure 2. Intraprocedural transesophageal echocardiogram in short axis showing a typical windsock-like appearance of a ruptured sinus of Valsalva aneurysm of the right coronary cusp into the right atrium (A) with color Doppler (B). A 7-mm ASO device is placed in the ruptured aneurysm (C). Trivial residual shunt with color Doppler (D). AoV ¼ aortic valve; LA ¼ left atrium; RA ¼ right atrium; SOVA ¼ sinus of Valsalva aneurysm. (Image reproduced in black and white in print; for full color, please see the electronic version.)

Mean follow-up duration for the PC group was 15.5 months (0 to 92). Mild early residual shunting either remained stable or had completely disappeared by early follow-up (1 to 3 months). One death occurred 6 months after PC in a patient who failed to recover from pre-closure multiorgan system dysfunction secondary to severe congestive heart failure.28 Postintervention anticoagulation typically included aspirin for 6 months, with some investigators adding clopidogrel for the first 4 to 6 weeks.29,31,38,41,43 No reports clarified the duration of recommended dental prophylaxis. Because follow-up duration was limited in many studies, longer term outcomes are not defined. Newer devices not represented in this study that could also be useful in some patients might include the Amplatzer ADOII and AVPII devices. Symmetric or nearly symmetric devices, such as these and the Amplatzer ASO or cribriform devices, can be delivered either retrograde or anterograde, as long as a sufficient delivery sheath is available, but the ADO and similar devices, which have a distal skirt, are best delivered using a transvenous approach, with the retention disk on the higher pressure aortic side of the defect. Otherwise, specific anatomic features in a given case, including the potential effects of the device on the aortic valve and conduction system, for example, are important

factors that can help guide device selection. The studies reviewed in this report typically used a single or occasionally 2 types of devices and do not allow insight into relative utility or risks/benefits of different devices. Beyond efficacy of closure, the implications of device choice and sizing could potentially include differences in how the rigid device redistributes wall stresses or otherwise alters the mechanical behavior of the adjacent sinus wall, which may be intrinsically abnormal. We are not aware of any clinical or experimental data in this regard, and studies reviewed did not provide data on postclosure sinus remodeling, but it is reassuring that no recurrent ruptures were reported in the PC group. Although conventional SC under cardiopulmonary bypass offers excellent results for closure of ruptured SOVA, it is evident from our review that PC is generally a reasonable and safe alternative. Disclosures The authors have no conflicts of interest to disclose. 1. Cullen S, Somerville J, Redington A. Transcatheter closure of a ruptured aneurysm of the sinus of Valsalva. Br Heart J 1994;71: 479e480.

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Comparison of reported outcomes with percutaneous versus surgical closure of ruptured sinus of Valsalva aneurysm.

Sinus of Valsalva aneurysm is a rare cardiac malformation that stems from incomplete fusion of the aortic media and the aortic valve annulus, a weakne...
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