Long-Term Outcomes of Transcatheter Closure of Ruptured Sinus Valsalva Aneurysms Using Patent Ductus Arteriosus Occluders

Abstract

Background: Transcatheter closure (TCC) of ruptured sinus of Valsalva aneurysm (RSVA) is an alternative strategy to surgery, but there is a lack of long-term outcome data.

Methods and Results: From 2004 to 2012, 17 patients (8 males, 9 females) were treated with patent ductus arteriosus (PDA) occluders by antegrade venous approach and were followed for 18–102 months. Of the 17 patients, transthoracic echocardiography revealed rupture of the right coronary sinus into the right ventricle in 9 and into the right atrium in 4, and noncoronary sinus rupture into the right ventricle in 3 and into the right atrium in 1. Most (10/17) were in New York Heart Association (NYHA) functional class III or IV. Aortography showed that the size of the defect was 7.71±2.84 mm (4–15 mm). TCC was attempted using PDA occluders 2–5 mm larger than the aortic end of the defects. The device sizes ranged from 8/6 to 18/16 mm (median, 10/8 mm). The procedure was successful in 16 (94.1%), and all of them had complete occlusion at discharge. On a median follow-up of 42 months, 14 patients were in NYHA class I and 2 were in class II, and there was no residual shunt, device embolization, infective endocarditis, or aortic regurgitation.

Conclusions: TCC of RSVA is a safe and effective alternative to surgery with favorable long-term follow-up results. (Circ J 2014; 78: 2197–2202)

Ruptured sinus of Valsalva aneurysm (RSVA) is a rare but well-recognized clinical entity, with a higher incidence in Oriental populations than in Western patients.¹ Though it can be acquired from infection, operation, trauma, degenerative or inflammatory processes, SVA is usually congenital and caused by absence of the elastic lamellae of the aortic media, which weakens the aortic wall and leads to aneurysmal formation. SVA is found most often in the right coronary sinus (RCS), less often in the noncoronary sinus (NCS), and least often in the left coronary sinus. SVAs are generally silent until rupture into a cardiac chamber, which causes an aortocardiac shunt with significant hemodynamic effects and various symptoms.

As RSVA poses a significant risk for the patient,² it needs to be securely closed. Surgical repair has been the conventional treatment of these patients since 1957 and although the operative mortality is generally low, potential morbidity from cardiopulmonary bypass and thoracotomy is the underlying hazard.³

Percutaneous closure of RSVA was first attempted by Cullen et al⁴ in 1994 using a Rashkind umbrella, and since then successful transcatheter closure (TCC) is being increasingly reported with encouraging follow-up results.^5–9 But to date, both large-scale and long-term follow-up results for this technique are scarce.^6,8 Thus, the aim of the present study was to evaluate the safety and efficacy of TCC of RSVA and to characterize patients’ long-term clinical outcomes.

Methods

Patients

From February 2004 to May 2012, a total of 17 RSVA patients (8 males, 9 females; age range 4–58 years, mean 33±16.9 years) were referred for TCC. All of them had a continuous murmur and only 2 patients were asymptomatic. The major symptoms observed in the other 15 patients were dyspnea, palpitation, angina, dizzy, edema, and fatigue. After detailed clinical examination, electrocardiography and chest radiography, all patients were evaluated by 2-dimensional transthoracic echocardiography (TTE), Doppler and color flow imaging. Left to right shunt and its location were confirmed in all patients. Concomitant cardiac lesion was only found in 1 patient with a ventricular septal defect (VSD); 1 patient had previous cardiac surgeries. Written informed consent was given by all patients or their parents.

Procedure

The procedure was attempted under general/local anesthesia with fluoroscopic and TTE guidance. The femoral vein and artery were percutaneously accessed. Intravenous heparin (50 IU/kg) and antibiotic prophylaxis were given. Routinely, right and left cardiac catheterization were performed to obtain pressure data and to assess the magnitude of the left to right shunt (Qp/Qs ratio). Aortic root angiography was performed using pigtail catheters in the long axial oblique view and right anterior oblique views to delineate the SVA, the origin of the RSVA and its fistulous connections to the cardiac chambers (Figures 1A,2A). Based on the measurement of the narrowest opening of the RSVA on angiogram, a patent ductus arteriosus (PDA) occluder (Lifetech Ltd, Shenzhen, China) that was 2–5 mm larger was selected.

Figure 1.

Aortic root angiography in the left anterior oblique view with cranial angulation showing (A) noncoronary sinus aneurysm rupturing into the right ventricle and (B) complete occlusion with the patent ductus arteriosus occluder.

Figure 2.

Residual shunt requiring repeat intervention. (A) Aortic root angiography in the right anterior oblique view shows an aneurysm of the right coronary sinus ruptured into the right ventricle and (B) following placement of a 14/12-mm patent ductus arteriosus (PDA) occluder, there is a small residual shunt. (C) Complete occlusion was achieved on the third day with the largest available 18/16-mm PDA occluder after mechanical hemolysis had been identified.

Next, a Judkins right coronary catheter was introduced to cross the defect with a Terumo wire (Terumo Inc, Tokyo, Japan), which was then exchanged for a 260-cm long noodle wire (AGA Medical, Golden Valley, MN, USA). The noodle wire was snared and pulled out with an Amplatz gooseneck snare (Microvena, White Bear Lake, MN, USA) introduced from the femoral vein. Thus, a stable arterial-venous wire loop was established via the RSVA. Over the wire a Lifetech delivery sheath was introduced from the femoral vein through the RSVA to the ascending aorta. Under the guidance of fluoroscopy and TTE, the correctly sized PDA occluder with its corresponding delivery cable was inserted through the sheath, and the device was deployed in the opening of the RSVA. After that, aortography and TTE were repeated to confirm that the RSVA was closed completely or with only a small residual shunt, and that there was no significant aortic regurgitation (AR), tricuspid regurgitation, or aggravation of other aortic insufficiency because of the device (Figures 1B,2B,C). Selective coronary angiography was performed to eliminate any encroachment on the coronary arteries if aortography could not clearly display the coronary ostia, especially the right coronary ostia. The occluder was released only when these findings were satisfactory. All the successfully closed patients received antibiotics for 3 days after the procedure, and were discharged after 2-day observation. All patients received aspirin (3–5 mg·kg^–1 ·day^–1) or clopidogrel (75 mg/day) for a 6-month period.⁹

Follow-up Protocol

Clinical examination, ECG monitoring, chest radiography, and TTE were performed at 1, 6, and 12 months after the procedure and yearly thereafter. Complications, including device embolization, infective endocarditis, machinery hemolysis, AR, thrombi, and residual shunts, were particularly evaluated by TTE and prospectively recorded.

Results

Patients

The detailed clinical data of the 17 patients are shown in the Table. Because no acquired features or pathogenic factors were present in these 17 cases, all SVAs were believed to be congenital in origin;¹⁰ there was 1 case of rupture during a pregnancy. Rupture of the RCS into the right ventricle (RV) occurred in 9 patients, and into the right atrium (RA) in 4; 3 patients had rupture of the NCS into the RV and 1 into the RA. Dyspnea was presented in 13 cases; palpitations in 4; angina in 8; dizziness in 1; peripheral edema in 2; and fatigue in 1; all the patients had a continuous murmur. The New York Heart Association (NYHA) functional class was I in 3 patients, II in 4, III in 9, and IV in 1. The diameter of the RSVA at the aortic end ranged from 4 to 15 mm (mean 7.71±2.84 mm). The Qp/Qs was 1.2–3.0 (mean 1.63±0.42). The pulmonary arterial pressure was normal in 10 patients (<25 mmHg), and mildly to moderately elevated in 7;¹¹ the mean pulmonary artery pressure was 25.82±7.52 mmHg. The mean device size was 11.25±2.44 mm at the aortic end: 10/8 mm in 7 patients, 12/10 mm in 4 patients, 8/6 mm in 2 patients, 14/12 mm in 2 patients, 18/16 mm in 1 patient. The mean procedure time was 78±32 min, and the fluoroscopy time was 19.1±10.4 min.

Table. Clinical Data of Patients With Ruptured Sinus of Valsalva Aneurysm and Their Immediate and Long-Term Outcomes

Case no.	Age (years)	Sex	NYHA class	Defect location	Defect size (aortic end) (mm)	Device size (mm)	Complications	Residual shunt at discharge	Residual shunt on follow-up	NYHA class on follow-up (6 month)	Qp/Qs	PA pressure: systolic/diastolic (mean) (mmHg)	AO pressure: systolic/diastolic (mean) (mmHg)	Follow-up period (months)
1	8	F	I	RCS-RA	6	10/8	0	0	0	I	1.6	52/34 (40)	126/62 (91)	102
2	56	M	III	RCS-RV	7	10/8	0	0	0	II	1.5	27/14 (19)	147/77 (108)	90
3	34	M	III	RCS-RV	7	10/8	0	0	0	I	1.8	30/13 (19)	133/65 (96)	78
4	49	F	III	RCS-RV	6	10/8	0	0	0	I	1.5	25/15 (20)	118/59 (97)	78
5	50	F	III	RCS-RV	5	10/8	0	0	0	I	1.1	29/13 (20)	136/68 (102)	78
6	12	F	III	RCS-RA	5	8/6	0	0	0	I	1.7	32/15 (21)	122/70 (95)	66
7	58	M	IV	NCS-RV	10	14/12	0	0	0	II	1.9	58/32 (40)	108/52 (75)	66
8	32	M	II	RCS-RV	11	14/12	0	0	0	I	1.4	32/12 (19)	134/54 (89)	42
9	38	F	I	RCS-RV	7	12/10	0	0	0	I	1.9	40/20 (26)	130/73 (103)	42
10	23	F	II	RCS-RA	4	8/6	0	0	0	I	1.7	34/12 (21)	125/75 (92)	30
11	49	M	III	RCS-RV	13	18/16	IRBBB, hemolysis	0	0	I	1.2	49/18 (16)	129/63 (93)	30
12	4	F	I	NCS-RV	7	10/8	0	0	0	I	1.2	31/16 (23)	86/39 (55)	30
13	29	F	III	RCS-RA	15	–	–	–	–	–	1.6	46/32 (38)	162/82 (114)	0
14	48	M	II	NCS-RV	7	12/10	First-degree AVB	0	0	I	3.0	65/15 (35)	127/65 (94)	30
15	35	M	II	RCS-RV	7	10/8	0	0	0	I	1.9	39/18 (27)	131/66 (95)	18
16	9	F	III	RCS-RV	6	12/10	0	0	0	I	1.3	30/15 (23)	117/61 (88)	18
17	27	M	III	NCS-RA	5	12/10	0	0	0	I	1.5	31/12 (19)	132/63 (94)	18

AO, aorta; AVB, atrioventricular block; IRBBB, incomplete right bundle branch block; NYHA, New York Heart Association; NCS, noncoronary sinus; PA, pulmonary artery; RA, right atrium; RCS, right coronary sinus; RV, right ventricle.

Successful Deployment

Of the 17 patients, 16 (94.1%) had successful occlusion of the RSVA with a PDA occluder. Patient no. 13 had a moderate residual shunt despite deployment of the largest PDA occluder (18/16 mm). The device was retrieved before release from the delivery cable and the patient subsequently underwent surgical closure. Patient no. 7 underwent a successful emergency endovascular closure procedure with a 14/12 mm PDA occluder after presenting with cardiogenic shock, hepatic dysfunction and renal insufficiency.

Postprocedural Evaluation

On both aortography and TTE performed prior to releasing the device, residual shunt occurred in only 2 (nos. 11 and 13 (failed)) of the 17 patients. In all cases, the murmur was reduced or eliminated.

Complications

Minor complications occurred in 2 patients; incomplete right bundle branch block (IRBBB) in 1 and first-degree atrioventricular block (AVB) in the other.

No residual shunt at discharge was found in 16 patients. The patient (case no. 11) with the small residual shunt after the procedure developed hemolysis and hemoglobinuria on the next day. Complete occlusion of the defect with an 18/16 mm PDA occluder replacing the previous device was achieved on the third day. No patient had device embolization, infective endocarditis, or AR.

Follow-up

All patients were followed up until October 2013. On median follow-up of 42 months (range 18–102 months), 14 patients were in NYHA class I, and 2 were in class II (Table), and complete regression of symptoms was noted. There was no residual shunt, device embolization, infective endocarditis, or AR during follow-up.

Discussion

SVA is uncommon and usually congenital. When present, it is in either the right or the NCS, rarely in the left sinus. A classification system published by Sakakibara and Konno,¹² which has been used as the standard nomenclature, divided SVAs in the following morphologic types: type I, the most common, arises from the left part of the right sinus; type II is rare and arises from the central portion of the right sinus; type III arises from the posterior portion of the right sinus; and type IV arises from the right portion of the NCS. Pathologically, the relative defect of elastic fibers and muscular tissue leads to the formation of the SVA, which progresses over time and eventually ruptures into the cardiac chamber.¹³ The physiologic consequences of rupture depend on the rapidity of the rupture, the size of the ruptured orifice, and the chamber into which the rupture occurs.¹⁰ Based on the cases presented here, a patient with an acute, large rupture leading to sudden hemodynamic collapse would present with dramatic onset of marked angina or severe dyspnea with low aortic diastolic pressure and high pulmonary pressure.

TCC is a relatively recent technique for the closure of RSVAs. Because no devices have been specially designed for these defects, several devices, such as the Gianturco coil,¹⁴ Amplatzer septal occluder,^5,9 Amplatzer duct occluder,^{5–7,9,15–17} VSD occluder,^18–20 and PDA occluder^19,21 have been used to close RSVAs, since the first attempt using a Rashkind umbrella by Cullen et al.⁴ Of these different devices, duct occluders are believed to be the most suitable for TCC of RSVA, because the RSVA commonly has a “wind-sock”-like appearance, with a broader aortic end. In the past 10 years, duct occluders have been most commonly used and proved to be effective and safe. In this study, we evaluated 17 patients who underwent TCC of RSVAs using locally manufactured PDA occluders.

Among the 17 patients, 16 has successful TCC of their RSVAs, including a high-risk patient with poor general condition and severe comorbidities, the largest RSVA that was successfully closed was 12 mm at the aortic end. Hence, we believe that it is feasible and effective to perform TCC using PDA occluders in patients with an isolated RSVA that has an aortic end diameter <13 mm. The only failure in this study was a 29-year-old woman with pregnancy-induced hypertension (Case 13). TTE found a RSVA of 15 mm at the aortic end and 8 mm at the rupture site without other anomalies needing surgical repair. Desirous to keep the fetus, she elected to undergo interventional therapy of RSVA and an 18/16 mm PDA occluder was deployed at the aortic end of the RSVA. Unfortunately, moderate residual shunting was detected by both TTE and aortography and the device was retrieved. Complete occlusion could have been achieved by using a larger ASO or VSD occluder,¹⁸ but we did not wish to further prolong the procedure because of the increased risk of abortion and hemodynamic disturbance. On retrospective review, we consider the failure was related to the large RSVA and the particular condition of pregnancy.

In addition, we also believe that emergency TCC of RSVA is safe and effective, even in high-risk patients. To our best knowledge, this is the first case being reported. A 58-year-old man complained of dyspnea and angina of 4 days’ duration; on imaging a 15×14 mm SVA originating from the NCS was found to have ruptured into RV (10 mm at the aortic end and 7 mm at the rupture site). The patient also had liver injury and acute renal failure, believed to be secondary to the RSVA. Therefore, urgent deployment at the aortic end of a 14/12 mm PDA occluder was carried out carefully after selective coronary angiography ruled out coronary lesions. After TCC was performed, no residual shunt existed and the patient was discharged in 22 days (Movies S1,S2).

TCC is attempted similar to perimembranous VSD closure. All devices were delivered from the antegrade venous route to avoid arterial complications and achieve a stable position, although it would make the procedure easier using the arterial route.²² Determining the correct size of the occluder is the key to this procedure. In this study, the devices finally deployed were 2–5 mm (mean 4.00±0.79 mm) larger than the aortic end of the SVAs measured on angiography. We attempted to close the RSVA at its aortic end because closure at the rupture site would leave behind a saccular region exposed to arterial pressure with the potential to rupture at another site in the long term.^6,23 However, it was more likely to interfere with aortic valve movements. Therefore, it was essential to rule out any interference with aortic valve movements by both TTE and aortography before the devices were released, as well as to eliminate residual shunt and encroachment of the device on the coronary arteries. Although selective coronary angiography and TEE have been suggested in some studies, in this study encroachment on the coronary arteries was carefully checked for on aortography because the coronary ostia are located quite high in relation to the SVA, and device impingement of the coronaries is only a theoretical possibility that has never been reported.^7,9,21,24

In case 11, TCC was performed twice in this patient because of procedure-related hemolysis. Although both aortography and TTE revealed small residual shunt after a 14/12-mm PDA occluder was deployed, we believed it tended to be invariably mild, or disappeared as presented in other studies, and therefore decided to release the device.¹⁷ However, the patient was noted to have dark-brown urine, highly suggestive of hemolysis and continued to have significant symptoms and murmur; TTE showed residual shunt remained on the next day, so TCC was repeated on the third day and the defect was completely closed with an 18/16-mm PDA occluder following transcatheter retrieval of the 14/12 device (Figure 2). Hence, caution should be taken with regard to residual shunt, even a small degree. As a previous study has reported that residual shunt can cause severe hemolysis requiring repeat intervention,⁹ complete occlusion of the RSVA is important.

Though the technique is still limited to a few heart centers with a small number of cases, the immediate and short to mid-term follow-up results for TCC of RSVA are good.^6,8 No serious complications were found in the follow-up period of the present study. Neither residual shunting nor AR was found at discharge or during the follow-up. There was 1 case each of newly detected IRBBB and first-degree AVB immediately after the procedure, but because neither abnormality is serious, we closely observed the patients on follow-up, and although the abnormalities persisted they did not progress. However, many issues need to be elucidated, such as indication, contra-indication, selection of occlusion device or invention of a specialized device, and so on.

Study Limitations

Although our study demonstrated significant benefits of TCC of RSVA, it nevertheless had some limitations. First, this was a single-center, non-randomized study, and the experiences of 1 centre may not be universally representative. Second, because of the small number of patients enrolled in this study, the success and complication rates of this technique may be biased.

Conclusions

This study showed that TCC of RSVA using a PDA occluder is feasible, with satisfactory preliminary immediate and long-term follow-up results. It can be a safe and effective alternative to surgical repair for isolated RSVA. Moreover, it is lifesaving for high-risk patients in poor general condition and with severe comorbidities. Longer follow-up is required to assess the long-term outcome of this technique.

Disclosures

Conflict of Interest: Drs Zhou and Fang were supported by the Key Clinical Program of the Ministry of Health of China (No. 2010-144). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Supplementary Files

Supplementary File 1

Movie S1. Sinus of Valsalva aneurysm originating from the noncoronary sinus rupturing into the right ventricle.

Supplementary File 2

Movie S2. Successful emergency transcatheter closure of a ruptured sinus of Valsalva aneurysm with a 14/12-mm patent ductus arteriosus occlude.

Please find supplementary file(s);

http://dx.doi.org/10.1253/circj.CJ-14-0106

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