The Clinical Implications of Balloon Rupture During Cardiovascular Interventions

Abstract: Balloon rupture is an infrequent complication of cardiac catheterization that can lead to vessel injury. We report 6 cases that highlight the potential consequences of balloon rupture, including perforation, dissection, balloon entrapment, and distal embolization, and discuss prevention and treatment strategies. 

J INVASIVE CARDIOL 2015;27(4):E45-E50

Key words: percutaneous coronary intervention, balloon rupture

_____________________________________

Balloon rupture during percutaneous coronary intervention (PCI) is rare, but can result in vessel perforation, intimal dissection, balloon entrapment and air embolization.^1-6 In the present manuscript, we present 6 cases of balloon rupture and provide a brief review regarding their prevention and management. 

Case #1. A 67-year-old man with diabetes mellitus, chronic kidney disease, prior myocardial infarction (MI), and prior PCI presented with non-ST segment elevation acute MI. Coronary angiography demonstrated a left main bifurcation lesion (Figure 1A). The patient was deemed inoperable and PCI was recommended. The left main artery was engaged with a 7 Fr XB 3.5 guide. A 0.014˝ BMW guidewire (Abbott Vascular) was advanced to the distal left anterior descending (LAD) artery and a Whisper ES wire (Abbott Vascular) was advanced to the distal left circumflex (LCX) artery. The mid-LCX was successfully predilated and stented with a 2.75 x 12 mm drug-eluting stent (DES). In spite of multiple high-pressure balloon inflations, the LAD lesion could not be expanded (Figure 1B). A 4.0 x 10 mm cutting balloon (Boston Scientific) was inflated to 20 atm (maximal inflation pressure per manufacturer is 10-12 atm), which led to balloon rupture and vessel perforation (Ellis grade-III) (Figure 1C). The ruptured balloon was removed and a 3.5 x 20 mm balloon was inflated in the proximal vessel, preventing further blood extravasation. Bedside echocardiography demonstrated a small pericardial effusion and protamine 30 mg was administered intravenously. After prolonged balloon inflation, the perforation was successfully sealed (Figure 1D). Repeat echocardiography demonstrated no change in the small pericardial effusion and the patient had an uneventful recovery. 

Case #2. A 52-year-old man with a history of hypertension was found to have aortic coarctation and was referred for stenting (Figure 2A). Using a 0.035˝ Amplatz Super-Stiff guidewire (Boston Scientific), serial balloon dilations were performed with 14 x 40 mm and 16 x 40 mm ZMed II balloons (B. Braun Interventional Systems) inflated to 8 atm. A Palmaz 3110 stent (Cordis Corporation) mounted on a 20 x 40 mm Bib balloon (NuMed) was advanced to the site of coarctation and positioned using hand injections through the sheath. The stent was deployed with the inner balloon inflated to 5 atm and the outer balloon inflated to 4 atm. The outer balloon was reinflated to postdilate the stent, resulting in balloon rupture (Figure 2B) that caused a dissection proximal to the stent. A second Palmaz 3110 stent  was deployed proximally and overlapped with the first stent, covering the area of dissection. The stents were postdilated with the outer balloon reinflated to 4 atm. Repeat pressure measurement revealed no gradient and final angiography demonstrated patent aortic root and proper stent positioning (Figure 2C).

Case #3. A 65-year-old man with prior coronary artery bypass graft surgery presented with worsening angina. Coronary angiography demonstrated a proximal and mid-LAD chronic total occlusion with the distal LAD filling from a saphenous vein graft (SVG) to the first diagonal branch (D1) (Figure 3A). PCI of the LAD-CTO was recommended. Bilateral femoral arterial access was obtained using 8 Fr sheaths and heparin was used for anticoagulation. The left main coronary artery and SVG to D1 were engaged with an EBU 3.75 and a multipurpose guide, respectively. The LAD-CTO was crossed with an UltimateBros 3 wire (Asahi Intecc) advanced through a CrossBoss catheter (Boston Scientific). After wire exchange for a workhorse guidewire, serial balloon inflations were performed with a 2.0 x 20 mm balloon, followed by a non-compliant 2.5 x 27 mm balloon. Following inflation to 16 atm, the balloon ruptured and became entrapped in the proximal LAD (Figure 3B). After prolonged retrieval attempts that involved use of a Guideliner catheter, the ruptured balloon was partially retrieved (Figure 3C); however, its distal part remained embedded in the lesion. Intravascular ultrasound confirmed that the balloon fragment did not prolapse into the left main coronary artery (Figure 3D). Two everolimus-eluting stents were implanted, “crushing” the balloon fragment against the arterial wall, as confirmed by optical coherence tomography (Figure 3E). Final angiography revealed well-apposed stents with TIMI-3 flow and <20% residual stenosis (Figure 3F).

Case #4. A 65-year-old man with a history of multiple prior PCIs presented with ST-segment elevation acute myocardial infarction following surgery for partial nephrectomy and removal of enterocutaneous fistula. Emergency coronary angiography demonstrated mid-LAD stent thrombosis (Figure 4A). The left main coronary artery was engaged with an XB 3.5 guide and aspiration thrombectomy was performed followed by dilation with a 2.5 x 12 mm balloon inflated to 20 atm. Balloon rupture ensued, leading to transient no-reflow (Figure 4B). Adenosine and intracardiac nitroglycerin were administered and repeat aspiration was performed. Intravascular ultrasound showed a well-apposed but underexpanded stent (Figure 4C). Additional dilations were performed with restoration of antegrade TIMI-3 flow. Final angiography showed an excellent result (Figure 4D). The patient was transferred to the intensive care unit in critical condition and was discharged with no cardiac symptoms 10 days after the procedure.

Case #5. A 77-year-old man with angina refractory to medications was referred for PCI of a mid-right coronary artery (RCA) CTO (Figure 5A). Heparin was used for anticoagulation and the patient was preloaded with clopidogrel. Antegrade wiring was first attempted with Fielder XT, Pilot 200, and Confianza Pro 12 guidewires through a Corsair microcatheter (Asahi Intecc), without success. Use of the CrossBoss catheter was also unsuccessful due to insufficient guide support. A Sion guidewire (Asahi Intecc) was advanced via septal collaterals to the right posterior descending artery. The CTO was successfully crossed using the reverse controlled antegrade and retrograde tracking (reverse CART) technique and an R350 wire (Vascular Solutions) was externalized. The RCA was stented with four everolimus-eluting stents (Figure 5B). Postdilation with a 3.0 x 30 mm balloon at 20 atm resulted in balloon rupture and a large mid-RCA perforation (Figure 5C). Prolonged balloon inflations with a 3.5 x 12 mm balloon were performed, but extravasation continued after 2 hours. Echocardiography showed a right ventricular wall hematoma and a small pericardial effusion (Figure 5D). Attempts to deliver a 2.8 x 19 mm Graftmaster covered stent (Abbott Vascular) to the perforation site failed. Pericardiocentesis was performed, resulting in removal of 200 mL of blood and improvement in hemodynamics. Following protamine administration and repeat prolonged balloon inflations (Figure 5E), the perforation was sealed (Figure 5F). The patient had an uneventful recovery. 

Case #6. A 62-year-old man was referred for aortic valve evaluation in preparation for aortobifemoral bypass grafting for severe claudication. Mean transaortic gradient was 58 mm Hg with a calculated valve area of 0.5 cm². Aortic valvuloplasty was recommended prior to surgery and was performed with inflation of an 18 mm Tyshak balloon (B. Braun Interventional Systems) advanced through an 8 Fr right brachial sheath. Balloon inflation was performed under pacing at 180 beats/min. Inflation of the 18 mm Tyshak balloon failed to decrease the gradient significantly; therefore, inflation of the 20 mm balloon was attempted, which decreased the gradient to 46 mm Hg (Figure 6A). Inflation of the 20 mm balloon resulted in rupture without acute complications (Figures 6B and 6C). The patient tolerated the procedure well and was discharged after 3 days. However, he presented again with right peripheral vision loss 1 week after the procedure. Computed tomography of the head without contrast revealed an acute occipital lobe infarction (Figure 6D). The patient was treated with conservative measures and underwent aortofemoral bypass 1 month later after neurologic and surgical evaluation.

Discussion

Our cases highlight four potential complications of balloon rupture: (1) perforation and tamponade; (2) dissection; (3) equipment entrapment; and (4) distal embolization.

Balloon rupture is a well-described complication and was more common in the early days of PCI. Simpfendorfer et al described 55 cases of balloon rupture in 1500 PCIs (3.6%). Balloon rupture occurred at a mean pressure of 10.7 atm and lesion calcification was present in 7 of the 55 lesions (12.7%).⁷ Overall, 3 patients required coronary bypass graft surgery (2 due to intimal dissection that compromised coronary flow and 1 due to acute vessel closure). Alfonso et al reported balloon rupture in 66 of 1139 coronary lesions in which stenting was attempted (5.8%). In 50 patients, the procedure was successfully completed without complications, yet in 16 patients the balloon rupture caused a coronary dissection.⁴ Three patients died due to cardiac tamponade, acute myocardial infarction, and distal embolization of the balloon material, respectively.

Risk factors for balloon rupture include balloon oversizing/overinflation, severe vessel calcification,⁸ and treatment of in-stent restenosis.^9,10 Severe calcification decreases vessel compliance and may also tempt the operator to apply higher balloon pressures, predisposing to rupture. Inflation of a balloon beyond the manufacturer’s limit may also increase the risk for rupture, although it is commonly required in areas of vessel and stent underexpansion. Balloon rupture may cause arterial rupture, although the latter is most commonly associated with the use of oversized balloons. In an experimental model, Zollikofer et al could demonstrate arterial rupture only with 100% overdilation, and arterial rupture preceded balloon rupture.¹¹ 

A sudden drop in pressure of the inflating device should alert the operator that balloon rupture has occurred. Occasionally, the vessel may be opacified by the leaking contrast. The balloon should be immediately deflated and removed, and immediate angiography should be performed to screen for complications.

Balloon rupture is best prevented by avoiding inflation to very high pressures, by using a slightly undersized balloon in resistant lesions (case #1), or by careful preparation of the target coronary vessel before high-pressure balloon inflations, such as with atherectomy or laser. High-pressure (40 atm or more) non-compliant balloons have been developed (Schwager OPN balloon; SIS Medical), but are not currently available in the United States.¹² It is important to know the rated burst pressure and percentage diameter growth of the available balloons and avoid exceeding them whenever possible. For example, inflating the cutting balloon at >14 atm pressure (case #1) should be avoided. Regardless of the occurrence of complications, if balloon rupture occurs during stenting, intravascular imaging is important to confirm good stent expansion and stent strut apposition.¹³  

Most often, balloon rupture does not lead to adverse outcomes, although several complications are possible, such as perforation and tamponade, dissection, equipment entrapment, and distal embolization.¹⁴ 

Coronary perforation occurred in 2 cases in our series and led to tamponade in 1 of the 2 patients. Perforation is likely the result of forceful contrast jets through the ruptured balloon. Perforation is more likely to occur when balloon rupture occurs at “weakened” vessel areas — for example, in patients in whom subintimal crossing techniques were used (case #5). Early recognition of the perforation is important to expedite management; hence, contrast injection should be performed immediately after rupture is confirmed. The ruptured balloon should be promptly removed and a second balloon (that matches the vessel size) should be inserted and inflated as soon as possible at low pressure to halt continued blood extravasation into the pericardium and prevent tamponade. Maintaining distal wire position is critical to avoid treatment delays. Prolonged balloon inflations will usually seal the perforation; however, anticoagulation reversal and/or implantation of a covered stent may be occasionally required.¹ A major limitation of the currently available covered stents in the United States is their high profile, which can hinder delivery (as shown in case #5, where a covered stent could not be delivered despite the excellent support provided by an externalized guidewire).

Balloon rupture can lead to coronary or aortic dissection. In the former, obstruction of the antegrade coronary flow may be seen.^2,6 As described above, maintaining wire position is critical, as it enables delivery of additional balloons and stents to treat the dissection. If wire position is lost, it may be challenging or impossible to rewire the distal true lumen, and emergent surgery to restore distal flow is sometimes required. Retrograde techniques and reentry techniques, such as the Stingray balloon and guidewire, are commonly employed in CTO-PCI and may enable wire passage into the distal true lumen if the original wire position is lost.¹⁵

Balloon entrapment can occur after rupture, likely due to balloon deformation.¹⁶ It is commonly reported in cases where dilation of a heavily calcified or restenotic lesion is attempted.^17,18 Attempts to retrieve the entrapped equipment may result in serious complications, such as extraction of a previously deployed stent.¹⁹ In addition, pulling on the entrapped equipment may cause balloon shaft rupture, leaving a portion of the balloon within the coronary artery or the aorta. In such cases, it is critical to ascertain the length of the retained balloon segment. This can be accomplished by comparing the retrieved balloon with a new balloon (Figure 3D) or with the use of intravascular imaging. If the balloon fragment is located entirely within the occlusion segment, it can be “crushed” against the vessel wall with a stent without adverse consequences (case #3).²⁰ If, however, a piece of the balloon extends into the left main coronary artery or the aorta, then percutaneous or surgical retrieval is required. 

Finally, balloon rupture may lead to distal embolization (cases #4 and #6). Embolization can be due to air retained within the balloon due to poor preparation, or due to balloon fragments that “break loose” when fracture occurs. Meticulous balloon preparation is, therefore, essential to minimize the risk of air embolization should balloon rupture occur. This is particularly important for large balloons, such as valvuloplasty balloons, since they may contain a large amount of air and rupture increases the chance of systemic thromboembolism, such as stroke.

Conclusion

Balloon rupture during cardiovascular interventions can lead to severe complications. Adequate prevention and treatment strategies are required to maximize the likelihood of uneventful recovery after balloon rupture occurs.

References

1. Fischell TA, Carter AJ, Ashraf K, Birdsall J, Smoker S. Coronary artery rupture during balloon angioplasty, rescued with localized thrombin injection and coil embolization. Catheter Cardiovasc Interv. 2006;68(2):254-257.
2. Kuroda N, Kobayashi Y, De Gregorio J, et al. Coronary dissection due to overdilatation of an elastic membrane of the Multi-Link stent delivery system caused by balloon rupture. Jpn Circ J. 1999;63(11):912-913.
3. Chan AW, Rabinowitz A, Webb JG, et al. Adverse events associated with balloon rupture during percutaneous coronary intervention. Can J Cardiol. 1999;15(9):962-966.
4. Alfonso F, Perez-Vizcayno MJ, Hernandez R, et al. Clinical and angiographic implications of balloon rupture during coronary stenting. Am J Cardiol. 1997;80(8):1077-1080.
5. Kwan T, Huber MS, Jani H, Feit A. Multiple balloon rupture during coronary angioplasty. A case report. Angiology. 1994;45(10):891-896.
6. Rothschild R, Voda J. Coronary artery dissection caused by angioplasty balloon rupture. Cathet Cardiovasc Diagn. 1990;19(1):26-29.
7. Simpfendorfer CC, Dimas AP, Zaidi A, et al. Balloon rupture during coronary angioplasty. Angiology. 1986;37(11):828-831.
8. Carell ES, Schroth G, Ali A. Circumferential balloon rupture and catheter fracture due to entrapment in a calcified coronary stenosis. Cathet Cardiovasc Diagn. 1994;32(4):346-348.
9. Gonschior P, Christian V, Berthold H, Franz-Josef N. Rupture of an angioplasty balloon after treatment of a recurrent in-stent restenosis-lesion of the left anterior descending coronary artery with directional coronary atherectomy. J Invasive Cardiol. 2000;12(2):105-108.
10. Martin P, Cardenas A, Banuelos C, Alfonso F. Peri-stent abluminal hematoma and pin-hole balloon rupture during treatment of calcified drug-eluting stent in-stent restenosis. Circ J. 2013;77(6):1587-1589.
11. Zollikofer CL, Salomonowitz E, Castaneda-Zuniga WR, Bruhlmann WF, Amplatz K. The relation between arterial and balloon rupture in experimental angioplasty. AJR Am J Roentgenol. 1985;144(4):777-779.
12. Raja Y, Routledge HC, Doshi SN. A non-compliant, high-pressure balloon to manage undilatable coronary lesions. Catheter Cardiovasc Interv. 2010;75(7):1067-1073.
13. Zellner C, Sweeney JP, Ko E, Sudhir K, Chou TM. Use of intravascular ultrasound in evaluating repeated balloon rupture during coronary stenting. Cathet Cardiovasc Diagn. 1997;40(1):52-54.
14. Colombo A, Skinner JM. Balloon entrapment in a coronary artery: potential serious complications of balloon rupture. Cathet Cardiovasc Diagn. 1990;19(1):23-25.
15. Martinez-Rumayor AA, Banerjee S, Brilakis ES. Knuckle wire and stingray balloon for recrossing a coronary dissection after loss of guidewire position. JACC Cardiovasc Interv. 2012;5(10):e31-e32.
16. Iturbe JM, Abdel-Karim AR, Papayannis A, et al. Frequency, treatment, and consequences of device loss and entrapment in contemporary percutaneous coronary interventions. J Invasive Cardiol. 2012;24(5):215-221.
17. Sanchez-Recalde A, Galeote G, Martin-Reyes R, Moreno R. AngioSculpt PTCA balloon entrapment during dilatation of a heavily calcified lesion. Rev Esp Cardiol. 2008;61(12):1361-1363.
18. Giugliano GR, Cox N, Popma J. Cutting balloon entrapment during treatment of in-stent restenosis: an unusual complication and its management. J Invasive Cardiol. 2005;17(3):168-170.
19. Kawamura A, Asakura Y, Ishikawa S, et al. Extraction of previously deployed stent by an entrapped cutting balloon due to the blade fracture. Catheter Cardiovasc Interv. 2002;57(2):239-243.
20. Pappy R, Gautam A, Abu-Fadel MS. AngioSculpt PTCA Balloon Catheter entrapment and detachment managed with stent jailing. J Invasive Cardiol. 2010;22(10):E208-E210.

___________________________________________

From the VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, Texas.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Brilakis reports consulting honoraria/speaker fees from Sanofi, Janssen, St. Jude Medical, Terumo, Asahi, Abbott Vascular, Elsevier, and Boston Scientific; research grant from Guerbet; spouse is an employee of Medtronic. The remaining authors report no conflicts of interest regarding the content herein.

Manuscript submitted May 27, 2014, provisional acceptance given August 11, 2014, final version accepted August 25, 2014.

Address for correspondence: Emmanouil S. Brilakis, MD, PhD,  VA North Texas Health Care System, The University of Texas Southwestern Medical Center at Dallas, Division of Cardiology (111A), 4500 S. Lancaster Road, Dallas, TX 75216. Email: esbrilakis@gmail.com