Balloon rupture during transcatheter aortic valve replacement.

A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.

Management of balloon rupture during a percutaneous pulmonary valve implantation procedure.

Percutaneous pulmonary valve implantation is increasingly adopted as an alternative procedure to surgery in dysfunctional homograft, and in patients with "native" or wide right ventricle outflow tract dysfunction. Pre-stenting is mandatory in this category of patients for many reasons, one of which is to create an adequate landing zone for the bioprosthesis. Here we report on a tricky situation that occurred during pre-stenting, and we describe how we successfully overcame it.

A novel method to prevent recurrent balloon rupture during dilation of heavily calcified conduits in preparation for transcatheter pulmonary valve placement.

INTRODUCTION: A 24-year-old female presented for percutaneous pulmonary valve placement. She was born with tetralogy of Fallot and had initial palliation with a Blalock-Taussig shunt followed by complete repair at age of 4 years including placement of a homograft conduit in the right ventricle to pulmonary artery position. She had developed severe obstruction in the conduit. PROCEDURE: Angiography showed a heavily calcified conduit with moderate insufficiency. During pre-dilation, a total of six balloons ruptured due to heavy conduit calcification prior to reaching desired inflation diameter. Subsequently, double balloon technique was attempted using two 9-mm Conquest balloons. One of the conquest balloons was then replaced by 16-mm Atlas balloon and conduit dilation was performed. At full inflation, the Conquest balloon ruptured. The deflated ruptured Conquest balloon was kept in the conduit and the Atlas balloon was exchanged for 18 and then 20-mm Atlas balloons and both were used to dilate the conduit. The deflated ruptured Conquest balloon protected the Atlas balloons and conduit angioplasty proceeded successfully without further rupture of any balloon. Subsequently, four stents were placed in the conduit followed by delivery of Melody Valve using a 20-mm Ensemble system with excellent results. CONCLUSION: This case illustrates a novel method of using the body of a ruptured balloon to protect subsequent balloons from rupture due to heavy conduit calcification. This method requires the presence of two venous access lines but might save time, effort, and cost from repeated balloon ruptures.

Successful Retrieval of a Torn KUSABI Trapping Balloon Catheter From the Coronary Artery and Verification of the Reproducibility of Trapping Balloon Catheter Shaft Tears.

The balloon trapping technique is frequently used during percutaneous coronary intervention, which is a common treatment for ischemic heart disease. A 68-year-old man with induced ischemia, stenotic lesions, and arterial calcifications underwent catheterization of the circumflex artery and debulking of lesions. During the removal of the catheter, the tip of the balloon catheter used in the procedure dislodged and entered the circumflex artery. After successfully retrieving the catheter, we conducted a bench test of the balloon catheter to determine the cause of the tear. The results suggested that the tearing of the KUSABI balloon might have been caused by manual pulling of the shaft quickly at an inflation pressure of 14 atm and that twisted wires were not involved in balloon tearing. The tensile strength of the balloon catheter was 5N. We believe that the balloon tore owing to excessive force applied to dislodge the tip and because the trapping balloons were not properly deflated. As KUSABI trapping balloons have had a rupture rate of just 0.003% since their launch in 2013, we recommend paying attention to KUSABI balloon deflation within the guiding catheter before its retrieval in order to ensure that only a gentle pull is needed. If resistance is felt during the removal of the KUSABI balloon, it should be confirmed that the tip is in place after removing it.

Mechanism of balloon burst during transcatheter aortic valve replacement pre-dilatation: Image observation and validation by finite element analysis.

BACKGROUND: Balloon burst during transcatheter aortic valve replacement (TAVR) is serious complication. This study pioneers a novel approach by combining image observation and computer simulation validation to unravel the mechanism of balloon burst in a patient with bicuspid aortic valve (BAV) stenosis. METHOD: A new computational model for balloon pre-dilatation was developed by incorporating the element failure criteria according to the Law of Laplace. The effects of calcification and aortic tissue material parameters, friction coefficients, balloon types and aortic anatomy classification were performed to validate and compare the expansion behavior and rupture mode of actual balloon. RESULTS: Balloon burst was dissected into three distinct stages based on observable morphological changes. The mechanism leading to the complete transverse burst of the non-compliant balloon initiated at the folding edges, where contacted with heavily calcified masses at the right coronary sinus, resulting in high maximum principal stress. Local sharp spiked calcifications facilitated rapid crack propagation. The elastic moduli of calcification significantly influenced balloon expansion behavior and crack morphology. The simulation case of the calcific elastic modulus was set at 12.6 MPa could closely mirror clinical appearance of expansion behavior and crack pattern. Furthermore, the case of semi-compliant balloons introduced an alternative rupture mechanism as pinhole rupture, driven by local sharp spiked calcifications. CONCLUSIONS: The computational model of virtual balloons could effectively simulate balloon dilation behavior and burst mode during TAVR pre-dilation. Further research with a larger cohort is needed to investigate the balloon morphology during pre-dilation by using this method to guide prosthesis sizing for potential favorable outcomes.

Balloon rupture with eversion during innominate vein angioplasty requiring surgical retrieval.

Balloon rupture during angioplasty can with calcified or recalcitrant lesions. A 61-year-old woman presented with worsening arm and facial swelling. She had a history of left upper extremity thrombolysis and stenting of the innominate vein 6 years prior. Venography showed severe in-stent stenosis. After crossing the lesion, a 12-mm balloon was inflated, which ruptured at nominal pressure. The balloon became stuck and could not be moved over the wire even after retraction of the sheath. A limited surgical cutdown was performed, and the balloon and the wire were removed together. The ruptured balloon part was found to be everted and circumferentially wrapped around the wire, preventing the wire exchange. After cutting the everted portion of the balloon, the catheter was removed without losing wire access. A high-pressure balloon was subsequently used to treat the lesion successfully. Her symptoms had resolved on follow-up, and the stent remained patent after 6 months.

Traumatic transcatheter aortic valve replacement.

A 76-year-old female with severe symptomatic aortic stenosis underwent cardiac CT angiography imaging. Severe calcification of the ascending aorta (porcelain aorta) (Figures 1A and 1B) precluded surgical aortic valve replacement. The aortic annular area, perimeter, and diameter were 372 mm2, 68.5 mm, and 20 mm, respectively. Transcatheter aortic valve replacement (TAVR) was performed with direct implantation of a 23 mm Sapien S3 valve (Edwards Lifesciences). The valve was delivered via the right femoral artery and a pigtail catheter was delivered to the aortic root via the left femoral artery. The balloon ruptured during valve implantation (Video).

Entrapment of fractured balloon after angioplasty in an AV access using a covered stent.

Fracture of the angioplasty balloon is a known complication during endovascular procedures in arteriovenous (AV) fistulas and grafts. We describe a case of a patient with end-stage renal disease (ESRD) on dialysis with a brachiocephalic AV fistula that had become dysfunctional. After a percutaneous angioplasty procedure during balloon withdrawal, a portion of the balloon fractured and separated due to the balloon being caught in the struts of a previously placed bare metal stent. A covered stent was used to contain the segment of the fractured balloon to the wall of the fistula. The use of a covered stent in jailing the fractured balloon to prevent further complications is not well described. This strategy may be implemented in some circumstances such as this case to avoid surgical interventions.

Bioprosthetic Valve Fracturing: In vitro Testing of Edwards PERIMOUNT Model P 2900.

Background: Bioprosthetic valve fracturing (BVF) results in low gradients following valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). For the commonly used Edwards PERIMOUNT valve data from bench-testing are lacking to provide technical specifications for successful BVF during ViV-TAVR. Methods: Using four Perimount 19- and 21-mm valves, in-vitro high-pressure balloon valvuloplasty with the True Dilatation Balloon Valvuloplasty Catheter and Atlas Gold PTA Dilatation Catheter was performed to analyze balloon-oversizing and pressure-thresholds to successfully achieve BVF. Results: High-pressure balloons one millimeter larger than the labeled valve size and pressure rates of 20 atm (for Perimount 19-mm) and > 22 atm (for Perimount 21-mm) were required to achieve BVF. Caliper measurements demonstrated 2.5 mm (Perimount 19-mm) and 1.5 mm (Perimount 21-mm) enlarged inner prosthetic diameters after BVF. The Atlas TM Gold PTA Dilatation Catheter achieved BVF with the Perimount 21-mm, whereas the True TM Dilatation Balloon Valvuloplasty Catheter failed in the Perimount 21-mm either for balloon-rupture or pinhole-defect. Conclusion: Both 19-mm and 21-mm Perimount P 2900 are amendable to BVF, thereby increasing the inner prosthetic diameter. High-pressure balloons 1 mm larger than the labeled valves are essential for this purpose, and the Atlas Gold PTA Dilatation Catheter alone should ensure success in the 21-mm prosthetics.

Balloon Rupture During Balloon Mitral Valvotomy.

The reuse of sterilized Inoue catheters is practiced widely in developing countries to bring down the procedure cost. However, blood can enter the space between the latex layers and become embedded in the mesh layer, which is difficult to clean when sterilizing the catheters. This is a common cause of rupture. Proper meticulous inspection of reused Inoue balloons for deformity or leakage through the small holes is necessary to prevent such complications.

Challenging Case of Balloon Mitral Valvuloplasty: Coronary Balloon to the Rescue.

Owing to the demonstrated safety and cost-effectiveness, balloon mitral valvuloplasty is frequently performed using reused hardware. However, chances of hardware malfunction are higher in such settings, making it pertinent for operators to be adept at recognition and management of such complications. This case illustrates that when the rent is small, a coronary balloon may be used to tackle the inflation failure.

Type E coronary artery dissection caused by intravascular lithotripsy balloon rupture; vessel anatomy and characteristics in a lithoplasty complication case as detailed by optical coherence tomography: a case report.

BACKGROUND: Intravascular lithotripsy is a new method used to treat calcified coronary lesions (CCLs). Percutaneous coronary intervention of CCLs has conventionally been classified as a complex procedure. In the majority of calcified cases, atherectomy is required for sufficient plaque modification prior to stent implantation. Intravascular lithotripsy has been shown to be safe and effective in clinical trials, but as worldwide usage increases, cases of complications are beginning to emerge. CASE SUMMARY: We describe a 71-year-old woman, who after an episode of non-ST-elevation acute coronary syndrome underwent coronary angiography. The culprit vessel was identified to be a severely stenosed left anterior descending artery which was also heavily calcified and tortuous. Intravascular lithotripsy (IVL) was employed for calcium modification prior to stent implantation, but the IVL balloon ruptured during shockwave lithotripsy, resulting in coronary artery dissection. Subsequent management steps and stent deployment resulted in favourable angiographic results. Our findings are further detailed on optical coherence tomography, demonstrating certain features which might predispose to IVL balloon rupture. DISCUSSION: We discuss the mechanism of action during intravascular lithotripsy, and how the shockwaves from the lithotripter modify calcified lesions, whilst keeping soft tissue unharmed. Results from clinical trials and multiple real-world studies have shown that complication rates are low. This case report aims to illustrate how the rupture of an intravascular lithotripsy balloon can result in coronary artery dissection. Optical coherence tomography can help in identifying potential anatomical features which may precede such complications.

Rotatripsy: synergistic effects of complementary technologies: a case report.

BACKGROUND: Percutaneous coronary intervention (PCI) to calcified coronary lesions (CCLs) remains one of the most complex procedures. Latest modality to modify calcium, intravascular lithotripsy (IVL), has shown good safety and efficacy in preliminary research. However, it may be associated with acute complications, and as standalone therapy, is not sufficient for all CCLs. CASE SUMMARY: Eighty-two-year-old man, known case of coronary artery disease and multiple comorbidities, presented with worsening angina of 1 month duration. Coronary angiography revealed heavily calcified triple vessel disease with critical distal left main (LM) involvement. Owing to high surgical risk, he was offered intravascular ultrasound (IVUS) guided PCI with intra-aortic balloon support. While the diffuse, circumferential calcified lesions in LM and left anterior descending (LAD) artery were modified with rotablation (RA) followed by IVL with 3.5 and 3.0 mm balloons; ostial-proximal lesion in left circumflex (LCX) artery was treated with 3.0 mm IVL balloon as a standalone therapy. During second cycle of shockwave therapy in LCX, the 3.0 mm IVL balloon ruptured with type C dissection extending upto LM ostium which required emergent LM bifurcation stenting. We had a good angiographic result which was confirmed with IVUS. DISCUSSION: ntravascular lithotripsy and RA are complementary technologies in treating CCLs. Rotablation with a relatively small-sized burr is safe and can favourably modify superficial calcium which helps in smooth delivery of IVL balloon and ensures safe shockwave therapy, if required. Unselected upfront use of IVL without intravascular imaging may be associated with complications as described in this case.

Management of a doubly folded, partially inflated Melody valve after outer balloon rupture: a case report.

This is a report of a rare complication during implantation of a Melody valve in an adult patient in whom the valve failed to expand due to balloon rupture. An 18-year-old patient was admitted with an increased right ventricular pressure and severe pulmonary regurgitation for scheduled cardiac catheterization. Angiography revealed a proximal stenosis of the left pulmonary artery (LPA). First, a prestenting was performed. Three months later he came back for planned percutaneous pulmonary valve implantation (PPVI). Because of the proximity of the right coronary artery (RCA) to the right ventricular outflow tract (RVOT) and thus a relatively short landing zone, the Melody valve had been doubly folded. During the inflation of the outer balloon, it ruptured. At this point, the Melody valve was still fixed to the inner balloon. A second catheter was placed through the Melody valve and successful valve implantation was possible. This procedure was difficult because to push the catheter through the partly inflated Melody valve, the inner balloon had to be slowly and simultaneously deflated. The final angiograms and pressure measurements showed a good functional result and absent pulmonary regurgitation. Open heart surgery could be avoided after incomplete Melody valve dilatation using the contralateral pulmonary artery as a safe rail.

Retrieval strategy for ruptured balloon with circumferential tear during angioplasty for arteriovenous fistula in hemodialysis patients.

INTRODUCTION: Balloon angioplasty is a common endovascular procedure. The balloon for angioplasty sometimes ruptures (incidence, 3.6%-10%), and it is constructed such that it ruptures in a longitudinal direction and complications related to rupture are rare. However, on rare occasions, retrieval is challenging, especially in the case of ruptures with a circumferential tear. There is no established method for retrieval and careful retrieval is required due to the risk of embolization by the residual balloon fragment. TECHNIQUE: We describe two cases of balloon rupture in the transverse direction during percutaneous transluminal angioplasty for arteriovenous fistula in hemodialysis patients. In these cases, the balloon ruptured with a circumferential tear and dissected into two parts, and the tip edge remained in the vessel. We inserted an additional introducer at the side of the tip edge, caught the guidewire by a gooseneck snare, and hooked the residual balloon fragment. This also stabilized and increased the stiffness of the guidewire through the "pull-through technique." Then, we reintroduced the gooseneck snare to catch the residual balloon. We then inserted a cobra-head catheter from the first introducer and pushed the residual balloon. We finally retrieved the ruptured balloon by pulling back the gooseneck snare and pushing using the cobra-head catheter simultaneously. RESULTS: We could retrieve the ruptured balloons successfully using this technique and percutaneous transluminal angioplasty was continued in both cases. CONCLUSION: Our technique of retrieval may be suitable for cases of balloon rupture with a circumferential tear during percutaneous transluminal angioplasty. The technique enables less invasive retrieval and continuation of the percutaneous transluminal angioplasty thereafter.

A Case of Balloon Rupture During Coronary Angioplasty: Slow Flow Requiring Swift Action.

We describe the case of a middle-aged man undergoing three-vessel coronary angioplasty due to unstable angina. Attempt to predilate a calcified lesion in the left circumflex artery with a semi-compliant balloon, inflated above the rated burst pressure, resulted in balloon rupture. Subsequently, the patient developed ST elevations and became hemodynamically unstable; slow flow in the index vessel was noted. The complication was managed with vasopressor and respiratory support, plus forceful injections of warm saline. Thrombolysis in myocardial infarction (TIMI)-3 flow was eventually restored, and the rest of the procedure was completed uneventfully. Following retrieval of the device, a longitudinal tear in the balloon was observed. This mode of rupture is considered to be safer, when compared to circumferential or pin-hole rupture. Rupture can occur when a balloon is aggressively inflated above nominal pressures and against calcific lesions. The ensuing micro- and macrovascular complications, including slow-flow, no-reflow, vessel dissection or perforation, and intramural hematoma, may induce myocardial ischemia and ultimately cardiogenic shock, malignant arrhythmias, and cardiac arrest. Management should be swift, and relies on supportive measures, depending on the degree of complications caused by the rupture.

Efficacy and safety of balloon-assisted microdissection with Sapphire® II 1.0-mm balloon in balloon-uncrossable chronic total occlusion lesions.

OBJECTIVE: Earlier studies have shown that the balloon-assisted microdissection (BAM) technique is feasible using a 1.2- to 1.5-mm small balloon in balloon-uncrossable chronic total occlusion (CTO) lesions. This study was performed to assess the efficacy and safety of the BAM technique with a Sapphire® II 1.0-mm balloon. METHODS: In this retrospective study, patients undergoing percutaneous coronary intervention for CTO were consecutively screened for balloon-uncrossable CTO lesions using BAM with the Sapphire® II 1.0-mm balloon. The patients' clinical and angiographic characteristics and procedural outcomes were collected for analyses. RESULTS: Twenty-four balloon-uncrossable CTO lesions were identified. Most of the CTO lesions were located in the right coronary artery, followed by the left anterior descending artery and left circumflex artery. The mean Japanese Multicenter CTO Registry (J-CTO) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS CTO) scores were 1.96 and 1.38, respectively. The total technical success rates were 91.6% (22/24) and 75.00% (18/24) for the lesions that were successfully treated with BAM. No patients developed major complications with the exception of one patient who developed a femoral hematoma. CONCLUSION: BAM with the Sapphire® II 1.0-mm balloon may be an effective and safe technique for balloon-uncrossable CTO lesions.

Delivery balloon rupture during transcatheter heart valve alignment procedure in extreme descending aorta tortuosity.

A 79-year-old man with a history of partial resection of the lung and the bladder due to cancer, hypertension, dyslipidemia, and heart failure, underwent transcatheter aortic valve replacement with a SAPIEN 3 (S3) valve (Edwards Lifesciences, Irvine, CA, USA). Preprocedural examination showed a bicuspid aortic valve and severe calcification of the leaflets. Computed tomography showed great tortuosity of the descending aorta. A 29-mm S3 valve prosthesis was advanced into the aorta, but a high degree of resistance was encountered in the middle of the descending aorta. The prosthesis was advanced to the level of aortic valve and an attempt was made to deploy the valve. However, the valve balloon did not expand. A balloon rupture was suspected. The balloon catheter was pulled back into the eSheath (Edwards Lifesciences), and the catheter and eSheath were removed together. Rupture of the balloon was confirmed. A new eSheath and prosthesis were prepared, with delivery supported with a Lunderquist guidewire (Cook Medical, Bloomington, IN, USA). The valve alignment procedure was performed in a straighter portion of the descending aorta. The new 29-mm S3 valve was then successfully implanted. .