Conventional Balloon Angioplasty Research Articles

Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial

The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as <30% residual stenosis without any adjunctive stenting. Primary end points included technical success, primary patency, binary in-lesion restenosis (>50%), and freedom from target lesion recanalization. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA (p = 0.29). According to 3-year Kaplan-Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. 92.1% in groups CRYO and COBA, respectively, p = 0.60). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio [HR] 1.3; 95% CI 0.6-2.6, p = 0.45). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2; 95% CI 1.1-4.3, p = 0.02). Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5; 95% CI 1.2-5.3, p = 0.01). Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.

Very Late Clinical Cardiac Event After BMS Implantation: In Vivo Optical Coherence Tomography Examination

intracoronary bare-metal stent (bms) implantation is an important treatment after conventional balloon angioplasty ([1,2][1]). After >5 years, however, atherosclerotic changes and consequent plaque vulnerability may occur in the previously stented segments ([3,4][2]). Recently, we experienced 4

Response to Letter Regarding Article, “Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Coated Stent for the Treatment of Coronary In-Stent Restenosis”

We appreciate the comments by Dr Alfonso and colleagues on the Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease II (PEPCAD II) trial. Intracoronary radiation was the first successful treatment option for in-stent restenosis avoiding the stent-in-stent approach. However, implantation of a second (drug-eluting) stent has since become the first treatment option for in-stent restenosis. The implantation of a drug-eluting stent in a restenotic stent results in better acute lumen gain and lower restenosis rates compared with conventional balloon angioplasty or brachytherapy.1,2 The main determinant of restenosis after coronary stent implantation is neointimal hyperplasia. Other factors such as elastic vessel recoil and negative remodeling have no relevant impact on this scenario. Therefore, late lumen loss has been accepted as the most important …

Stent Graft versus Balloon Angioplasty for Failing Dialysis-Access Grafts

The leading cause of failure of a prosthetic arteriovenous hemodialysis-access graft is venous anastomotic stenosis. Balloon angioplasty, the first-line therapy, has a tendency to lead to subsequent recoil and restenosis; however, no other therapies have yet proved to be more effective. This study was designed to compare conventional balloon angioplasty with an expanded polytetrafluoroethylene endovascular stent graft for revision of venous anastomotic stenosis in failing hemodialysis grafts. We conducted a prospective, multicenter trial, randomly assigning 190 patients who were undergoing hemodialysis and who had a venous anastomotic stenosis to undergo either balloon angioplasty alone or balloon angioplasty plus placement of the stent graft. Primary end points included patency of the treatment area and patency of the entire vascular access circuit. At 6 months, the incidence of patency of the treatment area was significantly greater in the stent-graft group than in the balloon-angioplasty group (51% vs. 23%, P<0.001), as was the incidence of patency of the access circuit (38% vs. 20%, P=0.008). In addition, the incidence of freedom from subsequent interventions at 6 months was significantly greater in the stent-graft group than in the balloon-angioplasty group (32% vs. 16%, P=0.03 by the log-rank test and P=0.04 by the Wilcoxon rank-sum test). The incidence of binary restenosis at 6 months was greater in the balloon-angioplasty group than in the stent-graft group (78% vs. 28%, P<0.001). The incidences of adverse events at 6 months were equivalent in the two treatment groups, with the exception of restenosis, which occurred more frequently in the balloon-angioplasty group (P<0.001). In this study, percutaneous revision of venous anastomotic stenosis in patients with a prosthetic hemodialysis graft was improved with the use of a stent graft, which appears to provide longer-term and superior patency and freedom from repeat interventions than standard balloon angioplasty. (ClinicalTrials.gov number, NCT00678249.)

Comparison of conventional and cutting balloon angioplasty for congenital and postoperative pulmonary vein stenosis in infants and young children

Pulmonary vein stenosis (PVS) is a rare and often lethal condition in children. The optimal treatment for congenital and postoperative PVS is unknown. We compared outcomes of conventional balloon angioplasty performed for PVS from 1999 to 2003 against cutting balloon angioplasty performed from 2004 to 2007. A total of 100 previously undilated pulmonary veins in 54 patients were studied: 48 veins dilated with conventional balloons and 52 with cutting balloons. Acute results included significantly reduced gradients and increased lumen diameters with both treatments. Acutely, cutting balloon angioplasty and conventional angioplasty yielded similar relative reduction of the PVS gradient (median 78% vs. 63%, P = 0.08) and increase in lumen diameter (median 77% vs. 59%, P = 0.07). There was one procedural death of a critically ill infant, and four cardiac arrests, but no adverse events necessitating surgical intervention. Survival free from reintervention was poor in both groups, and shorter in the cutting balloon group (73% at 1 month, 11% at 6 months, and 4% at 1 year) than in the conventional angioplasty group (77% at 1 month, 35% at 6 months, and 23% at 1 year; P = 0.01). Both conventional and cutting balloon angioplasty were effective at decreasing gradient and increasing lumen size acutely in patients with congenital and postoperative PVS, but reintervention was common with both treatments. Both methods of angioplasty provided limited benefit, and neither was curative for this complex disease.

Abstract No. 207: Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: Long-term results from a prospective single-center randomized trial

Abstract No. 207: Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: Long-term results from a prospective single-center randomized trial

Traitement des sténoses anastomotiques des pontages des membres inférieurs par angioplastie au ballon coupant « Cutting Balloon »

Conventional balloon angioplasty of anastomotic stenosis following bypass surgery is insufficient at mid- and long-term. However, short-term results with cutting balloon angioplasty (CBA) are satisfactory. The purpose of this study is to determine the long-term results using this technique. Materials and methods. Between January 2002 and January 2006, all patients with anastomotic stenosis more than one month after bypass surgery, shorter than 2 cm and>50%, were referred without randomisation to CBA. A total of 19 patients with mean age of 63.5 years (55-82 years), 14 males and 5 females, were included. Twenty stenoses (femoral n=15, popliteal n=4 and calf n=1) managed with CBA affected 17 infrainguinal and 2 suprainguinal bypasses. One patient had anastomotic stenoses at both extremities. The rate of technical success aws 100%. Mean follow-up was 32 months (12-42). Three deaths occurred during follow-up. One patient presented with restenosis at 3 months, successfully treated with repeat CBA. No thrombosis or infection was observed. The results with CBA appear persistent and compete favorably with results from surgical repair. A randomized trial would be necessary to confirm these results.

Renal artery rupture following cutting balloon angioplasty for fibromuscular dysplasia: a case report.

Angioplasty with the use of cutting balloons has been suggested by some case reports and small series for the treatment of renal artery stenoses that are resistant to conventional balloon catheters. Based on this limited experience, the use of this technology has been suggested as safe. Herein, we report a renal artery rupture following angioplasty with a cutting balloon. The complication was salvaged with a stent graft. A 30-year-old white female patient with resistant hypertension caused by a severe renal artery stenosis attributed to fibromuscular dysplasia, was submitted to conventional balloon angioplasty without success. Dilatation of the lesion with a cutting balloon resulted in arterial rupture, with concomitant retroperitoneal hematoma. Cutting balloon angioplasty of renal artery lesions resistant to conventional balloon angioplasty should not be considered as safe as previously thought. When proceeding with such a procedure, a stent graft should be available for immediate use.

The quest for a 'better mousetrap'

Percutaneous coronary intervention has been limited by the diminution of acute luminal gain over time. The limitations of conventional balloon angioplasty spawned a variety of different devices, all with the hope of identifying a device that would durably preserve acute luminal gains with an excellent safety profile. To date, the evolutionary victor in this search appears to be the drug-eluting stent. Commercially available drug-eluting stents have demonstrated durable long-term results.1 Despite this, questions concerning both the long-term efficacy and safety of drug-eluting stents have persisted, be it catch up restenosis or late stent thrombosis.2 Thus, the quest for the ideal device continues. Byrne and colleagues report a randomized trial of three limus agent-eluting stents with biodegradable or permanent polymer coating (the ISAR-TEST-4 Study).3 This study of >2600 patients is the largest randomized trial of a biodegradable polymer-based drug-eluting stent to date, and compares a novel biodegradable polymer-based, rapamycin-eluting stent with the two leading limus-based drug-eluting stents, sirolimus (Cypher) and everolimus (Xience). As such, it builds on the experience of other major randomized trials, observational studies, and registries utilizing biodegradable polymer-based drug-eluting stents.2,4–6 Combined, this provides an expanding platform by which to study and develop what may potentially prove to be the next iteration of coronary drug-eluting stent technology. The appeal of a biodegradable polymer drug-eluting stent is readily evident. Drug-eluting stents were developed utilizing antiproliferative agents to inhibit the neoimtimal hyperplasia that results from bare …

Comparison between balloon angioplasty and additional coronary stent implantation for the treatment of drug-eluting stent restenosis: 18-month clinical outcomes

To evaluate the long-term outcomes after different modalities of treatment of drug-eluting stent (DES) in-stent restenosis (ISR) in a 'real world' setting. Actually, few and conflicting data are available about the management of in-stent restenosis (ISR) after DES implantation. In our 'real world' registry 1082 consecutive patients who received a DES implantation were included. At 9-month angiographic follow-up, 93 patients presented a DES ISR that was treated with 'homo-DES' (HMD) (N = 27), 'hetero-DES' (HTD) (N = 19) and conventional balloon angioplasty (POBA) (N = 47). We evaluated the clinical outcomes in terms of major adverse cardiac event (MACE) (death, myocardial infarction and target vessel revascularization) at 18 months. There was no difference for clinical and angiographic characteristics between the three groups, except for the presence of silent ischaemia as clinical presentation (7.7 HMD vs. 2.2% POBA; P = 0.0001). No late stent thrombosis was found. At 18-month clinical follow-up patients treated with HMD, HTD and POBA presented a rate of MACE of 10.2, 0 and 8.7%, respectively (P = NS). Kaplan-Meier survival probability showed that HTD and POBA treatment tended to have more favourable outcomes at 18 months than the HMD treatment. In our registry, POBA seems to be as effective as other DES implantations in cases of DES ISR, especially in cases of focal type (Mehran classification IA, IC), in terms of long-term outcomes.

Twenty-two years angiographic and clinical follow-up of the first patient treated with intracoronary stent placement for acute vessel closure following percutaneous transluminal coronary angioplasty

We report here the longest follow-up of a patient treated with intracoronary stent placement for acute vessel closure following conventional balloon angioplasty. The patient is a 52-year-old lady who developed abrupt left anterior descending coronary artery (LAD) closure shortly after double vessel percutaneous coronary intervention (PCI) for symptomatic stenoses to the right coronary artery (RCA) and LAD on 13 June …

Abstract No. 231: Featured Abstract

To evaluate efficacy, safety and patency of Cryoplasty versus “Plain Old Balloon Angioplasty” (POBA) for popliteal arterial occlusive disease. Patients with de-novo stenoses or occlusions of the popliteal artery were randomized to Cryoplasty or conventional balloon angioplasty as the initial treatment strategy. Primary objective was target lesion patency at 9 months. Secondary endpoint was anatomical treatment success (<30% residual stenosis, absence of hemodynamically relevant dissection/ recoil, no need for stent placement). F/U with ABI and CCDS was performed at 3, 6, 9 and 15 months, angiography was performed for cases of suspected restenosis. 77 pts. (mean-age 72,2 years; range, 50-94) were enrolled so far, 35 randomized to Cryoplasty, 42 to POBA. Demografics, risk factors, clinical stage of disease and lesion details are comparable in both groups, with the majority of patients being claudicants (Cryo: 74,3%; POBA: 81%). Mean number of Cryoplasty performances per lesion was 2 ± 0,6. Mean inflation time of conventional angioplasty was 2,9 ± 1,3 minutes. On intention-to-treat basis, treatment success was 29%(10/35) for Cryoplasty versus 52% (22/42) for POBA including long term dilatation (p=0,035). Rate of relevant dissection after Cryoplasty alone was 37 %, versus 26% following POBA (p=0,14). In 60% (21/35) of Cryoplasty patients additional long-term PTA with a conventional balloon was performed. Rate of stent placement for persistent dissection and/or residual stenosis was 29% after Cryoplasty (including long-term dilation) and 40% after POBA (p=0,28). Target lesion patency at 9 months and is 63,3 % for POBA and 75,7 % for Cryoplasty, however results are not significant (p=0,18). Cryoplasty of the popliteal artery alone shows a lower anatomical success when compared to POBA. Combined with optional long-term PTA, however, stent placement is not needed more often. There is a trend towards higher patency after Cryoplasty, but long-term follow-up has to be awaited. This study also demonstrates that modern recanalization techniques in the popliteal artery achieve patency rates comparable to angioplasty in the femoral artery.

Use of the Angiosculpt Scoring Balloon for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: 1-Year Outcome

The AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) is composed of a semicompliant balloon encircled by three nitinol spiral struts providing targeted lesion scoring on balloon inflation. Between April 2005 and April 2006, procedural and follow-up data on 31 patients (mean age 76 years; 54.8% males) endovascularly treated for severe infrapopliteal disease were collected. The AngioSculpt catheter was used to treat 36 complex, tibioperoneal, atherosclerotic lesions. All patients had symptomatic critical limb ischemia (Rutherford 4-5) and single-vessel runoff to the ankle. Complication-free survival at 1 month was the safety end point, whereas primary patency and limb salvage were the efficacy end points evaluated at 1 year. The AngioSculpt balloon was successfully inflated in all 36 target lesions. Eleven patients (35.5%) required additional stenting for minor dissections or suboptimal stenosis reduction. The 1-month complication-free survival was 96.8%. One-year survival, primary patency, and limb salvage rates were 83.9 +/- 6.6%, 61.0 +/- 9.3%, and 86.3 +/- 6.4%, respectively. The 1-year data show the AngioSculpt Scoring Balloon Catheter to be an effective and safe treatment for infrapopliteal, atherosclerotic lesions in patients with critical limb ischemia. However, more patients, a longer follow-up, and randomized studies comparing it with conventional balloon angioplasty and stenting in the infrapopliteal region are required.

Re-Restenosis and Target Lesion Revascularization After Treatment of Sirolimus-Eluting Stent Restenosis Retrospective Analysis From 4 Japanese Hospitals

There is limited information about optimal management of drug-eluting stent (DES) restenosis. This study evaluated the incidences of re-restenosis and re-target lesion revascularization (TLR) after the treatment of sirolimus-eluting stent (SES) restenosis. A total of 102 lesions in 101 patients who underwent TLR for SES restenosis were classified according to: (1) focal (lesion length < or = 10 mm) or non-focal restenosis (>10 mm); and (2) use of DES for TLR: (1) focal restenosis treated with DES (focal-DES, n=40); (2) focal restenosis treated by balloon angioplasty (focal-balloon, n=31); (3) non-focal restenosis with DES (non-focal-DES, n=17); and (4) non-focal restenosis by balloon angioplasty (non-focal-balloon, n=14). Re-restenosis and re-TLR were observed in 6 (19.4%) and 5 lesions (12.5%) of the focal-DES group, in 13 (65.0%) and 11 (35.5%) of the focal-balloon group, in 7 (50.0%) and 6 (35.3%) of the non-focal-DES group, and in 8 (61.5%) and 7 (50.0%) of the non-focal-balloon group, respectively (P<0.05 for restenosis and TLR between the focal-DES group and other groups). Re-DES implantation for focal DES restenosis results in lower re-restenosis and re-TLR rates compared to re-DES implantation for non-focal DES restenosis or conventional balloon angioplasty either for focal or non-focal DES restenosis.

Renal artery rupture following cutting balloon angioplasty for fibromuscular dysplasia: a case report

IntroductionAngioplasty with the use of cutting balloons has been suggested by some case reports and small series for the treatment of renal artery stenoses that are resistant to conventional balloon catheters. Based on this limited experience, the use of this technology has been suggested as safe. Herein, we report a renal artery rupture following angioplasty with a cutting balloon. The complication was salvaged with a stent graft.Case presentationA 30-year-old white female patient with resistant hypertension caused by a severe renal artery stenosis attributed to fibromuscular dysplasia, was submitted to conventional balloon angioplasty without success. Dilatation of the lesion with a cutting balloon resulted in arterial rupture, with concomitant retroperitoneal hematoma.ConclusionCutting balloon angioplasty of renal artery lesions resistant to conventional balloon angioplasty should not be considered as safe as previously thought. When proceeding with such a procedure, a stent graft should be available for immediate use.

Conventional Balloon Angioplasty versus Peripheral Cutting Balloon Angioplasty for Treatment of Femoropopliteal Artery In-Stent Restenosis: Initial Experience

To prospectively determine whether cutting balloon angioplasty, when compared with conventional balloon angioplasty (CBA), improves morphologic and clinical outcome in patients with femoropopliteal in-stent restenosis. Patients with symptomatic femoropopliteal in-stent restenosis were randomly assigned to undergo CBA or peripheral cutting balloon angioplasty (PCBA) for treatment of lesions up to 20 cm in length. Patients were followed up clinically and with duplex ultrasonography (US) at 1, 3, and 6 months for occurrence of a restenosis of 50% or higher. The Fisher exact test and Mann Whitney U test were used for statistical analyses. Forty patients were enrolled; one patient was lost to follow-up. In the remaining patients, CBA was performed in 22 patients; PCBA was used in 17 patients. Average lesion length was 80 mm +/- 68 (standard deviation). Restenosis rates at 6 months were 65% (11 of 17; 95% confidence interval: 42%, 88%) after PCBA versus 73% (16 of 22; 95% confidence interval: 54%, 92%) after CBA (P = .73). Ankle brachial index (0.83 vs 0.75, P = .26) and maximum walking capacity on the treadmill (117 m vs 103 m, P = .97) at 6 months were also not significantly different between the two groups. PCBA failed to prove superiority compared with CBA for treatment of femoropopliteal in-stent restenosis in this pilot study. In restenotic lesions with an average length of approximately 8 cm, both treatment modalities yielded disappointing 6-month patency rates.

Comparison of Cutting Balloon versus High-Pressure Balloon Angioplasty for Resistant Venous Stenoses of Native Hemodialysis Fistulas

To compare the technical success, safety, and patency of cutting balloon angioplasty versus high-pressure balloon angioplasty in the treatment of resistant native hemodialysis fistula stenoses. The authors retrospectively reviewed 1,220 percutaneous transluminal angioplasty procedures performed to treat dysfunctional native hemodialysis fistulas. Seventy patients with stenoses resistant to conventional balloon angioplasty (up to 24 atm) were included in this study: 35 patients underwent cutting balloon angioplasty from September 2003 through February 2005, and 35 patients underwent high-pressure balloon angioplasty from March 2005 through April 2006. Evaluation included technical success, complications, and postintervention patency rates up to 6 months. The technical success rates were similar between the cutting balloon (100%) and high-pressure balloon (97.1%) groups. After cutting balloon angioplasty, the primary lesion patency rates were 100% (35/35), 88.6% (31/35), and 71.4% (25/35) at 1 month, 3 months, and 6 months, respectively. After high-pressure balloon angioplasty, the primary lesion patency rates were 97.1% (34/35), 62.9% (22/35), and 42.9% (15/35) respectively. The primary lesion patency rates at 3 and 6 months were significantly better with cutting balloon angioplasty than with high-pressure balloon angioplasty (P = .018 and .009, respectively). There were no device-related complications in the cutting balloon group. Six device-related extravasations occurred in the high-pressure balloon group. The results of this retrospective study suggest that, for resistant stenoses in native hemodialysis fistulas, both high-pressure balloon and cutting balloon angioplasty are effective; however, cutting balloon angioplasty seems to provide more long-standing primary patency at 6-month follow-up.

Interventional catheter treatment of bypass graft stenosis: comparison of intracoronary stent implantation and balloon angioplasty

Balloon angioplasty of a stenosed bypass graft has a much higher risk of recurrent stenosis than dilatation of a stenosed native coronary artery. Intracoronary stent implantation has established itself as the better treatment of native coronary artery stenosis than conventional balloon angioplasty. However, there is still uncertainty whether intracoronary stent implantation in stenosed bypass vessels gives better long-term results than conventional balloon angioplasty. Results were retrospectively analyzed of unrandomized 224 primarily successful interventions--122 balloon dilatations and 102 stent implantations--performed between January 1996 and June 1998 on stenosed coronary bypass grafts, re-examined by coronary angiography an average of 6 months later. All but 11 patients were on combined aspirin and ticlopidine antiplatelet aggregation treatment. There was a significantly lower 6-month restenosis rate (30.4%) after stent implantation than after balloon dilatation (51.6%). The re-intervention rate was also significantly lower after stent implantation. These data suggest that stent implantation of stenosed coronary bypass grafts under cover of platelet-aggregation inhibition with aspirin and ticlopidine provides a lower restenosis and thus higher revascularization rate than conventional balloon dilatation.

Intravaskuläre Ultraschalldiagnostik: In-vivo-Befunde vor und nach Angioplastie bei peripherer arterieller Verschlußkrankheit

In 15 patients (13 men, two women, mean age 63 [47-75] years) with peripheral arterial occlusive disease in stages IIB-IV (Fontaine) intravascular ultrasound findings were compared with the angiographic results before and after treatment. In 12 patients stenosis (n = 10) or occlusion (n = 2) of the iliac artery (n = 2) or the superficial femoral artery (n = 10) were treated by conventional balloon angioplasty; in three patients with occlusion of the superficial femoral artery excimer laser angioplasty was performed. There was good correlation between measurements of vessel diameter by the two techniques (r = 0.93, P less than 0.001). Ultrasound scanning provided additional informations regarding the thickness of the plaque, the density or firmness of the stenosis and the degree of calcification. The therapeutic outcome was quantified by measuring the gain in lumen diameter. The authors also assessed the morphological changes following angioplasty in the vicinity of the obstructing plaque. In the light of the ultrasound findings it was considered necessary to undertake further dilatation in four out of the 12 patients treated by balloon dilatation. The results indicate that intravascular ultrasound imaging is a valuable complement to angiography for monitoring of therapeutic results after vascular interventions.

P3-53 COMPARISON OF CUTTING BALLOON VERSUS HIGH-PRESSURE BALLOON ANGIOPLASTY FOR RESISTANT VENOUS STENOSES OF NATIVE DIALYSIS FISTULAS

MATERIALS AND METHODS: The authors retrospectively reviewed 1,220 percutaneous transluminal angioplasty procedures performed to treat dysfunctional native hemodialysis fistulas. Seventy patients with stenoses resistant to conventional balloon angioplasty (up to 24 atm) were included in this study: 35 patients underwent cutting balloon angioplasty from September 2003 through February 2005, and 35 patients underwent high-pressure balloon angioplasty from March 2005 through April 2006. Evaluation included technical success, complications, and postintervention patency rates up to 6 months.