Non-compliant Balloon Research Articles

Home-made fenestrated amplatzer occluder for atrial septal defect and pulmonary arterial hypertension

We report the management of a patient with secundum atrial septal defect (ASD) and severe pulmonary hypertension. A 65-year-old male with recently diagnosed atrial septal defect was referred to our centre for decompensated right heart failure with rest and exercise induced dispnea and severe pulmonary hypertension. Right heart catheterization confirmed a mean pulmonary pressure of about 55 mmHg and a Qp/Qs of 2.7. An occlusion test with a compliant large balloon demonstrated partial fall of pulmonary arterial pressure. The implantation of a home-made fenestrated Amplatzer ASD Occluder (ASO) was planned in order to decrease left-to-right shunt and promote further decrease of pulmonary arterial pressure in the long-term. Thus, by means of mechanical intracardiac echocardiography study with a 9F 9 MHz UltraIce catheter (Boston Scientific Corp.), we selected a 34 mm ASO for implantation. Four millimeter fenestration was made inflating a 4 mm non-compliant coronary balloon throughout the waist of the ASO, which was successfully implanted under intracardiac echocardiography. After six months, a decrease of pulmonary arterial pressure to 24 mmHg and full compensated right heart failure was observed on transthoracic echocardiography and clinical examination. This case suggests that transcatheter closure with home-made fenestrated ASD in elderly patients with severe pulmonary hypertension is feasible.

Trans‐pleural pericardiocentesis: Revisiting an old technique

Percutaneous access to the pericardial space serves both diagnostic and therapeutic purposes. Multiple approaches have been described, which include the apical, sub-xiphoid, trans-atrial, and trans-bronchial techniques. Occasionally, in the presence of both left pleural effusion and posterior pericardial effusion, echocardiographically guided pleuropericardial drainage can be carried out using the left axillary approach. Here we revisit the use of this technique in a patient. Future development of this technique, using a noncompliant balloon to expand the pleuropericardial interface, may avoid the need for a pericardial window in oncology and rheumatology patients with recurrent pericardial effusions.

Comparison Between Angioplasty Using Compliant and Noncompliant Balloons for Treatment of Cerebral Vasospasm Associated With Subarachnoid Hemorrhage

Considerable controversy exists regarding the choice of balloon used for performing angioplasty as treatment of cerebral vasospasm associated with subarachnoid hemorrhage. To determine the impact of compliant and noncompliant balloons on angiographic and clinical outcomes among patients with subarachnoid hemorrhage-related cerebral vasospasm. Consecutive patients with cerebral vasospasm who underwent balloon angioplasty were included. Patient characteristics, rate of angiographic recurrence, and occurrence of cerebral infarcts in the affected vessel distribution were compared between arteries treated using different balloons. A total of 30 patients underwent a first-time angioplasty using compliant (n = 34) or noncompliant (n = 51) balloons. At admission, patients were classified Hunt and Hess grade I to III (n = 20) and Hunt and Hess grade IV to V (n = 10). Fisher grades in patients were I (n = 1), II (n = 3), III (n = 20), and IV (n = 6). No significant differences in the rate of angiographic recurrence (32% vs 53%; P = .14), need for repeat angioplasty (21% vs 20%; P = .97), and occurrence of cerebral infarcts in the affected arterial distribution (21% vs 10% P = .39) were observed with compliant and noncompliant balloons, respectively. Independent of the balloon type, a significant reduction in the need for repeat angioplasty was observed when the initial angioplasty resulted in a normal or supranormal diameter compared with a subnormal diameter (63.5% vs 36.5%; P = .01). No clear difference was observed between compliant and noncompliant balloons for therapeutic angioplasty in preventing angiographic recurrence or the need for repeat angioplasty in patients with subarachnoid hemorrhage-related cerebral vasospasm. An immediate normal or supranormal vessel diameter after the first-time angioplasty resulted in a significant reduction in the need for repeat angioplasty.

AS-099 Stent Expansion after Additional Non-Compliant Balloon High Pressure Inflation in Patients with Drug-Eluting Stent Underexpansion: An Intravascular Ultrasound Study

AS-099 Stent Expansion after Additional Non-Compliant Balloon High Pressure Inflation in Patients with Drug-Eluting Stent Underexpansion: An Intravascular Ultrasound Study

Contrast Staining Outside the Sirolimus-Eluting Stent Leading to Coronary Aneurysm Formation

A 69-year-old man with prior myocardial infarction (hypertension; dyslipidemia; smoking; no diabetes; and no history of allergy, autoimmune disease, or vasculitis) underwent sirolimus-eluting stent (SES) implantation (3.0 mm in diameter; 33 mm in length) for chest pain on exertion with chronic total occlusion of the left anterior descending coronary artery (LAD) (Figure 1A through 1C and Video 1). Intravascular ultrasound examination after SES implantation demonstrated well-expanded stent struts without evidence of incomplete stent apposition (ISA) (Figure 1D through 1F). Figure 1. Baseline angiographic and intravascular ultrasound findings. A, Chronic total occlusion of the proximal LAD before percutaneous coronary intervention (arrow); B, collateral flow into the LAD from the right coronary artery (arrow); C, LAD after SES (3.0 mm in diameter; 33 mm in length) implantation (arrows); D through F, intravascular ultrasound images after SES implantation demonstrating well-expanded stent struts without evidence of incomplete stent apposition. Follow-up angiography at 8 months after initial SES implantation demonstrated multifocal contrast staining outside the stent contour with no evidence of angiographic restenosis (Figure 2A and Video 2). Subsequently, at 16 months after stenting, coronary angiography showed that the areas of contrast staining outside the stent contour increased in size (Figure 2B and Video 3). At 23 months after stenting, coronary artery aneurysm (CAA) formation was demonstrated in the midportion of the SES (Figure 2C and Video 4). The first 8-month …

Optical Coherence Tomography Assessment of the Effect of High-pressure Non-compliant Balloon Postdilation on Underexpansion and Malapposition in Drug-eluting Stents

Concerns of an increased risk of thrombosis in drug-eluting stents (DES) and the association, in human pathology studies of stent thrombosis, of delayed healing with malapposition of stent struts has fostered a renewed interest in stent implantation optimisation techniques. We investigated the rationale of the use of optical coherence tomography (OCT), an intravascular imaging technique with 10-fold better resolution than intravascular ultrasound (IVUS), in the guidance of percutaneous coronary intervention (PCI) with respect to the correction of stent underexpansion and malapposition in DES. In 12 patients with OCT characteristics of frank malapposition immediately after DES implantation, high-pressure postdilation with a non-compliant balloon was performed. We concluded that high-pressure non-compliant balloon postdilation for underexpansion and malapposition in DES significantly improves minimal stent diameter (MSD) and minimum cross-sectional area (CSA), as assessed with OCT. There was a highly significant decrease in the percentage of malapposed struts. Larger series, correlated with OCT and clinical follow-up, will shed light on the clinical implications of postdilation in case of severe acute incomplete stent apposition (ISA).

ABSORB BVS Implantation in Bifurcation Lesions – Current Evidence and Practical Recommendations

The introduction of the ABSORB bioresorbable vascular scaffold (BVS) provides a new tool for stenting in interventional cardiology. Initially, relatively simple coronary artery lesions were treated with this novel device; nowadays, we are gaining clinical experience when treating a wide variety of lesions with the ABSORB BVS, including bifurcation lesions. Unfortunately, data are limited in terms of the use of the ABSORB BVS in coronary bifurcation lesions, so little is known about the safety and feasibility of these procedures. Bench testing and case reports showed that single provisional scaffold placement is feasible with fenestration of the scaffold towards the side branch and sequential non-compliant balloon inflation in the side and main branches. However, no prospective randomised clinical data with optical coherence tomography (OCT) imaging for different bifurcation stenting techniques are available. Based on the available data and our own experience we would recommend the use of the provisional single scaffold technique and only to fenestrate the scaffold if a severely pinched ostium combined with impaired flow seen on angiogram.

ABSORB BVS Implantation in Bifurcation Lesions - Current Evidence and Practical Recommendations.

The introduction of the ABSORB bioresorbable vascular scaffold (BVS) provides a new tool for stenting in interventional cardiology. Initially, relatively simple coronary artery lesions were treated with this novel device; nowadays, we are gaining clinical experience when treating a wide variety of lesions with the ABSORB BVS, including bifurcation lesions. Unfortunately, data are limited in terms of the use of the ABSORB BVS in coronary bifurcation lesions, so little is known about the safety and feasibility of these procedures. Bench testing and case reports showed that single provisional scaffold placement is feasible with fenestration of the scaffold towards the side branch and sequential non-compliant balloon inflation in the side and main branches. However, no prospective randomised clinical data with optical coherence tomography (OCT) imaging for different bifurcation stenting techniques are available. Based on the available data and our own experience we would recommend the use of the provisional single scaffold technique and only to fenestrate the scaffold if a severely pinched ostium combined with impaired flow seen on angiogram.

Effect of intravascular ultrasound-guided adjuvant high-pressure non-compliant balloon post-dilation after drug-eluting stent implantation

Drug-eluting stent (DES) expansion characteristics after aggressive high-pressure post-dilation using a non-compliant (NC) balloon have not been fully investigated. We evaluated 58 patients with native coronary lesions treated with DESs [24 paclitaxel eluting stents (PES) and 34 sirolimus-eluting stents (SES)]. After post-dilation (12-14atm) using a stent-mounted semi-compliant balloon to reduce stent edge injury, adjuvant high-pressure post-dilation using NC balloon was performed within the stents. Stent size, stent length, and NC balloon size were selected based on preinterventional intravascular ultrasound (IVUS) assessment. Stent underexpansion was defined according to criteria of the Multicenter Ultrasound Stenting in Coronaries (MUSIC) study as a minimal stent cross-sectional area <90% of the average reference lumen area. Resultant endpoint was to obtain optimal stent expansion. Serial changes of stent expansion and stent symmetry were calculated in each group. After stent-mounted semi-compliant balloon post-dilation, both stents could not achieve adequate percent stent expansion (PES 73±18% vs. SES 67±9%, p=0.38). After high-pressure post-dilation using an NC balloon, percent stent expansion was 97±14% in PES and 91±13% in SES, respectively (p=0.25). Axial stent symmetry indices also significantly improved in both groups. Although radial stent symmetry indices improved significantly in PES group, those in the SES group had no significant changes. Finally, frequency of stent underexpansion significantly reduced, 87-20% in PES and 92-15% in SES, respectively (p=0.01) without any significant stent edge injury. DES expansion improved safely after adjuvant high-pressure post-dilation using an NC balloon under IVUS guidance.

Subclavian venoplasty by the implanting physicians in 373 patients over 11 years

The need to add a lead(s) despite subclavian/innominate obstruction is increasing. Subclavian venoplasty may be a good alternative to the commonly employed options; however, there are few reports in the literature, and all are by interventional radiologists. To describe the procedural details, results and safety of venoplasty by implanting physicians in a large group of consecutive patients. Safety, lead function and success were established from review of the procedure reports and clinical complications in 373 consecutive venoplasty patients from 1999-2010. Procedural details were obtained by review of the angiograms (venograms) and procedural flow charts of 152 consecutive patients from 2004-2007. Venoplasty was successful in 371 of 373 patients without damage to the existing leads and without clinical complications. Total angiographic occlusion was demonstrated in 65% of cases by peripheral venogram, but in only 20% of cases by contrast injection at the site of obstruction; 86% were crossed with a hydrophilic wire. Microdissection and excimer laser were used to cross three of the four wire-refractory occlusions. Obstruction was both central and peripheral in 22.1% of cases and central only in 17%. The time required to cross the obstruction and perform venoplasty was 13 ± 21 minutes. A noncompliant balloon was successful in most, but an ultranoncompliant balloon was required in 13% of cases. Contrast extravasation was common during crossing of a total obstruction and also was observed with balloon rupture on three occasions, but was not clinically significant. Subclavian venoplasty is a safe, practical lead-management option that can be used by implanting physicians.

TCT-155: Clinical Benefit of Use of Kissing Balloon Inflation and Non-Compliant Balloon in the Crush Technique for Bifurcation Coronary Lesions

TCT-155: Clinical Benefit of Use of Kissing Balloon Inflation and Non-Compliant Balloon in the Crush Technique for Bifurcation Coronary Lesions

TCT-260: Stent Expansion After Additional Non-compliant Balloon High-pressure Inflation In Patients With Drug-eluting Stent Underexpansion: An Intravascular Ultrasound Study

TCT-260: Stent Expansion After Additional Non-compliant Balloon High-pressure Inflation In Patients With Drug-eluting Stent Underexpansion: An Intravascular Ultrasound Study

Intravascular radiation therapy with a Re-188 liquid-filled balloon in patients with in-stent restenosis

The aim of this study was to evaluate the feasibility and safety of intravascular radiation therapy (IVRT) using Re-188 filled balloon system in patients with in-stent stenosis. A total of 39 patients with in-stent restenosis were enrolled as the IVRT (22 patients) and control groups (17 patients) of this study after a successful coronary angioplasty. For irradiation the angioplasty balloon was replaced by a noncompliant balloon of the same diameter but 10 mm longer in length with a proximal and distal radio-opaque marker to deliver the dose of 18 Gy at 0.5 mm depth from the surface of the balloon into the vessel wall. Angiographic follow-up was performed after 6 months. The length of the irradiated segment was between 9.14 and 22 mm and the diameter between 2.5 and 3 mm. In the IVRT group, two patients who did not receive antiplatelet therapy had myocardial infarction. Four patients who presented with stable angina earlier also had angiographically documented in-stent occlusion (two patients) and edge stenosis (two patients) of the target lesion and received angioplasty (18.1%). In the control group, three patients with recurrent angina and four asymptomatic patients had documented in-stent occlusion angiographically at 6 months and these seven patients underwent target lesion revascularization (41.2%). The overall restenosis rate in the IVRT and control groups were 23.91 and 39.86%, respectively (P=0.013). No complications were documented, except anginal pain and ST segment changes. Our results indicated that the Re-188 liquid-filled balloon is feasible, safe, and effective in patients with in-stent restenosis.

Ureteroenteric Anastomotic Stricture: Novel Use of a Cutting Balloon Dilator

Management of ureteroenteric strictures presents a significant challenge because of its intraabdominal location and morbidity associated with open surgical management. The peripheral cutting balloon microsurgical dilatation device (PCBD), approved by The United States Food and Drug Administration (USFDA) for use in coronary angioplasty, features a 2-cm noncompliant balloon with four microsurgical blades mounted longitudinally on its outer surface. We evaluated the feasibility and outcome of this cutting balloon dilator in the treatment of ureteroenteric anastomotic strictures. Three patients with a 1-cm or less ureteroenteric stricture underwent a transluminal incision under fluoroscopic guidance. Percutaneous access was obtained and a guidewire was introduced into the renal pelvis and ureter in antegrade fashion and passed through the stricture. The exact length of the strictured segment was measured. The PCBD was deployed over the guidewire and the balloon was inflated at the stricture site. The maximum diameter of the inflated balloon was 8 mm. Approximately 30 seconds later, the balloon was deflated and the enlarged passage from the ureter to the ileal loop was verified under fluoroscopy. A ureteral stent was placed and removed at 6 weeks after the procedure. Postoperative computed tomography scans at 12 months revealed improved hydronephrosis. All patients were asymptomatic postoperatively. One patient had a solitary kidney and creatinine level decreased significantly following the procedure. Dilatation and incision with PCBD is a novel approach for the treatment of the short ureteroenteric anastomotic strictures. Long-term data need to be obtained to establish the efficacy of this technique.

A noncompliant, high pressure balloon to manage undilatable coronary lesions

Undilatable coronary lesions, due to coronary calcification, are encountered with increasing frequency. Percutaneous intervention of such lesions comes with the risk of stent underexpansion, which increases the risk of stent thrombosis and restenosis. A variety of techniques and devices are available to assist the interventionist in the treatment of calcified lesions. The OPN NC (SIS-Medical AG, Winterthur, Switzerland) is a high-pressure balloon (rated burst pressure 35 atm) that uses a novel, twin-layer balloon technology to ensure uniform balloon expansion, eliminating "dog-boning." We report four cases of successful treatment of calcified lesions with the OPN NC balloon after dilatation with standard noncompliant balloons to high-pressure failed.

AS-176: Comparison of Predilation with a Noncompliant Balloon Versus a New Scoring Balloon for Coronary Stenting

AS-176: Comparison of Predilation with a Noncompliant Balloon Versus a New Scoring Balloon for Coronary Stenting

Use of a low‐profile, compliant balloon for percutaneous aortic valvuloplasty

To determine the safety and immediate efficacy after balloon aortic valvuloplasty (BAV) with a new, low-profile balloon. BAV has a continuing role in the management of high-risk patients with severe aortic stenosis (AS). BAV with traditional noncompliant balloons requires a large femoral arteriotomy and is associated with high rates of access site complications. We retrospectively reviewed medical records of 20 consecutive patients undergoing BAV for severe AS. Retrograde transfemoral BAV was performed with a low-profile, compliant valvuloplasty balloon. Before and after BAV, transaortic gradients were measured invasively and by echocardiography, and aortic valve area (AVA) calculated. Access site complications, functional class and survival were recorded. Patients were 79 +/- 12 years old and had an estimated mortality from open aortic valve replacement of (12.5 +/- 9.6)%. By catheterization, mean aortic gradient fell from 44 +/- 15 to 29 +/- 10 mm Hg (P < 0.001) and AVA increased from 0.63 +/- 0.22 to 0.89 +/- 0.33 cm(2) (P < 0.001). New York Heart Association functional class improved from 3.5 +/- 0.7 to 2.7 +/- 0.8. Procedural mortality was 0%. There were no vascular complications or significant worsening of aortic regurgitation. Transfemoral BAV using a low-profile compliant balloon is feasible with acceptable immediate results and safety.

Percutaneous Coronary Intervention for Complex Bifurcation Lesions

Coronary bifurcations are prone to the development of atherosclerosis. They pose technical difficulties for angioplasty treatment and are a predictor of stent thrombosis and restenosis. Treatment of coronary bifurcations is still subject to debate, especially when the side branch (SB) is large, not easily accessible and narrowed by a long lesion. There is currently no indexed treatment for this type of lesion (Medina classification), as the strategy of provisional SB stenting with drug-eluting stents (DES) has proved to be equally efficient as the dualstent technique. Complex techniques are associated with poor outcome in certain lesion types, such as T-stenting when the angle between the two distal branches is small or the crush and culotte technique in the presence of an open angle. Provisional SB stenting may be used when primary dual stenting is required, with a low risk of failure provided that the following guidelines are implemented: stenting of the main branch through the protected SB with a stent diameter adapted to the distal main branch, immediate optimisation of the proximal stent segment (Finet’s law), guidewire exchange, kissing balloon inflation with non-compliant balloons selected according to the diameter of the distal branches and T-stenting of the SB before final kissing inflation.

Use of Internal Endoconduits as an Adjunct to Endovascular Aneurysm Repair in the Setting of Challenging Aortoiliac Anatomy

The combination of Trans-Atlantic Intersociety Consensus (TASC) D aortoiliac occlusive disease as well as a symptomatic abdominal aortic aneurysm (AAA) is not a common occurrence. Extensive calcified atherosclerotic disease, occlusions, and small iliofemoral segmental arteries make transfemoral access difficult, if not impossible, for endovascular aneurysm repair (EVAR) in these patients. We present a case in which "controlled rupture" of the external iliac artery with a covered stent allowed transfemoral delivery of an aortouni-iliac stent graft with a completion femoral-to-femoral bypass. The patient is a 60-year-old male with a 5.3 cm symptomatic infrarenal AAA and a history of one block right leg claudication. Preoperative computed tomography angiography revealed the patient to have occlusion of the right common iliac artery, extensive calcified stenoses of his aortoiliac segments, and a prohibitively small left external iliac artery, which measured 4.5 mm at its narrowest diameter. The patient, despite discussions concerning the suitability of his iliac arteries as conduits for the delivery of the stent graft, insisted on an endovascular approach to lessen his chances of postoperative sexual dysfunction as well as minimize his length of stay. Access was obtained through bilateral femoral artery cutdowns, and attempts at dilating the left external iliac artery using 16-French dilators were performed without success. An 8 mm x 5 cm covered self-expanding stent was deployed in the diseased 4.5 mm left external iliac artery, followed by angioplasty performed with an 8 mm noncompliant balloon to disrupt the vessel. This endoconduit now allowed accommodation of our 18-French introducer for the aortouni-iliac stent graft. The operation was completed with a femoral-femoral bypass. Flow to both hypogastric arteries was preserved. We believe use of such techniques will ultimately expand the number of patients eligible for EVAR and avoid devastating access-related complications.

Scanning electron microscopic assessment of the biodegradable coating on expanded biolimus-eluting stents

Biodegradable coatings on drug-eluting stents (DES) may help to avoid adverse long-term effects of DES such as late/very late stent thrombosis which is partly attributed to durable polymers. As the post-expansion morphology of biodegradable coatings is greatly unknown, we investigated the polylactic acid coating on biolimus-eluting BioMatrix stents. Scanning electron microscopy (SEM) was used to carefully examine five 3.5mm stents following expansion at 6-14atm (maximum 7% overstretch). SEM examination demonstrated only mild cracks of the coating after stent expansion at 6 atm. An increase in expansion pressure, associated with mild stent overstretch, resulted in more severe cracks. Lifting of the coating together with few sites of partial detachment of fragments was noticed after stent expansion in water at 14atm; these irregularities further increased after aggressive oversized partial postdilatation with a 5.0mm non-compliant balloon with additional secondary cracks. SEM assessment suggests a relatively low elasticity of the biodegradable coating on BioMatrix stents. At nominal pressure, stents showed predominantly mild cracks of the coating, while cracks increased after slight overstretch. Aggressive overexpansion of the stent, such as sometimes required in left main bifurcation stenting, worsened cracks and led to some detachment of fragments of the coating in vitro.