High-pressure Balloon Angioplasty Research Articles

Efficacy of cutting balloon angioplasty versus high-pressure balloon angioplasty for the treatment of arteriovenous fistula stenoses in patients undergoing hemodialysis: Systematic review and meta-analysis.

This systematic review and meta-analysis aimed to assess and compare the therapeutic outcomes of cutting balloon angioplasty and high-pressure balloon angioplasty for arteriovenous fistula stenosis in hemodialysis patients. All studies indexed in PubMed, Embase, and Cochrane Library Web of Science were retrieved. The retrieval deadline was July 15, 2023. Risk of bias 2.0 was used to evaluate the quality of the included studies. Revman 5.4 software was used for data analysis. This review included three studies and 180 patients, with 90 patients in the cutting balloon angioplasty group and 90 patients in the high-pressure balloon angioplasty group. The results of the meta-analysis suggested that compared with high-pressure balloon angioplasty, cutting balloon angioplasty can improve primary lesion patency rates of internal arteriovenous fistulas at 6 months (relative risk, 1.45; 95% confidence interval, 1.08-1.96; P = 0.01). However, there were no significant differences between the technical success rate (relative risk, 0.99; 95% confidence interval, 0.93-1.05; P = 0.72) and clinical success rate (relative risk, 1.01; 95% confidence interval, 0.95-1.07; P = 0.73). Therefore, cutting balloon angioplasty is likely to increase primary lesion patency rates at 6 months. However, more high-quality, large-sample, multicenter, randomized controlled trials are needed for further validation due to the limited number of included studies.

Abstract 14961: Revitalizing Graft Patency: Intravascular Lithotripsy in Calcified Saphenous Vein Graft to Left Anterior Descending Artery Stenosis

A 73-year-old man with coronary artery disease (CAD), coronary artery bypass graft, heart failure [EF 25%] & hypertension presented with Non-ST Segment Myocardial Infarction. Angiography revealed multivessel CAD with chronic total occlusion (CTO) of mid-left anterior descending (LAD) after a large first diagonal branch, CTO of mid-left circumflex & distal right coronary artery. Saphenous vein graft (SVG) to obtuse marginal was patent. SVG-diagonal & SVG-ramus intermedius were occluded. Mid SVG-LAD showed severe calcified stenosis (Fig. 1A). Native LAD beyond the SVG provided left to right collaterals to right posterior descending artery. Complex high-risk coronary intervention was performed on the SVG-LAD with mechanical circulatory support (MCS; Impella CP). SVG-LAD had a balloon undilatable lesion despite high pressure inflation with 4.0 mm cutting balloon (Fig. 1B). Intravascular ultrasound (IVUS) revealed severe stenosis with extensive circumferential calcification (Fig. 1C). Subsequently, intravascular lithotripsy (IVL) with 4.0 mm Shockwave balloon followed by high pressure balloon angioplasty with 4.5 mm noncompliant (NC) balloon was performed with significant luminal gain and fractures in calcium (Fig. 1D). The lesion was treated with 5.0 mm drug eluting stents that were post dilated with 5.0 mm NC balloon with excellent angiographic and IVUS result (Figs. 1E & F). MCS was successfully removed at the end of the case.SVG grafts are associated with poor long-term patency compared to arterial grafts. PCI to SVG has a high failure rate and PCI of native vessel is often preferable. High risk SVG interventions with atherectomy have been recently reported, though data is limited. IVL has been safely used in heavily calcified native coronary arteries, however, its use in SVG disease is rare. We report the first off-label use IVL of SVG-LAD with MCS for treatment of a last-remaining conduit. Additional studies to assess IVL efficacy in vein grafts are warranted.

Evaluation and management of drug-eluting stent in-stent restenosis.

In-stent restenosis (ISR) is the most common cause of stent failure. Although the rate of ISR is significantly lower with contemporary drug-eluting stents (DES), it remains a challenging clinical entity to treat. In this review, we focus on a practical approach to management of DES ISR with intravascular imaging at its core, as supported by several recently published articles. This facilitates assessment of the underlying mechanism(s) essential to the successful treatment of ISR allowing for a tailored selection of treatment modalities. The successful treatment of DES ISR requires identification of the causative mechanism(s). Individualized treatment may include high-pressure balloon angioplasty alone, cutting or scoring balloons, intravascular lithotripsy, atheroablative therapies and a selection of either repeat DES implantation or drug-coated balloon treatment.

Drug-coated balloon for early recurrent arteriovenous fistula dysfunction.

To report the efficacy and safety of a drug-coated balloon (Ranger, Boston Scientific) in patients with dysfunctional autogenous arteriovenous fistula. In this investigator-initiated, prospective observational cohort study, 25 participants with dysfunctional arteriovenous fistula were enrolled from January 2018 to June 2019. The drug-coated balloon was applied after successful vessel preparation by high-pressure balloon angioplasty. The primary endpoint was the target lesion primary patency rate at 6 months. The secondary outcome included anatomical and clinical success rate, postoperative major adverse events within 30 days, and the target lesion primary patency rate at 12 months. Statistical analysis of the data was performed. The χ test or Fisher's exact test was used for analyzing categorical variables, and continuous variables were analyzed using Student's t-test. Also, Kaplan-Meier analysis was used to evaluate the target lesion primary patency days with the log-rank test. At 6 months, the target lesion primary patency rate was 68% in the drug-coated balloon treatment group. The anatomical and clinical success rates were 100%. One patient had thrombosed access 10 days after the index procedure, and two died of cardiovascular events 4 months after the operation. Subgroup analysis showed that the early recurrent stenosis group had non-inferior mean drug-coated balloon primary patency days (less than 90 days after prior percutaneous angioplasty, n = 10) compared with the late recurrence group (prior PTA patency days more than 90 days, n = 10), 179.3 ± 102.9 versus 257.1 ± 71 days (p = 0.153). DCB angioplasty had significant improvement in primary patency days for early recurrent stenosis (67.7 ± 19.3 vs 179.3 ± 102.9, p < 0.001). The results demonstrated the appliance of Ranger DCB in stenotic AVFs is a safe and effective treatment modality, especially for early recurrent AVF stenosis.

Relationship Between Intimal Thickness on Ultrasonography and Long-Term Patency of Arteriovenous Fistula Restenosis After Cutting Balloon Versus High Pressure Balloon Angioplasty

To investigate the relationship between intimal thickness on ultrasonography and long-term patency of arteriovenous fistula restenosis after cutting balloon and high pressure balloon angioplasty. We retrospectively compared the outcomes between cutting balloon angioplasty and high pressure balloon angioplasty in 149 patients with hemodialysis access restenosis. The relationship of intimal thickness and primary assisted patency of hemodialysis access on ultrasonography was investigated as the primary outcome, using Kaplan-Meier survival analysis and Cox proportional hazards model. The second outcomes included residual diameter, blood flow, and venous pressure of hemodialysis access before and after angiography and balloon diameter and inflation pressure. Primary assisted patency in cutting balloon angioplasty was 90.6%, which was significantly (P=0.001) more than that of 37.9% in high pressure balloon angioplasty during the 20-month follow-up period. Cox proportional hazards model screened significant factors including procedure type (high pressure or cutting, P=0.004), inflation pressure (P=0.013), preoperative intimal thickness (P=0.009), and difference of intimal thickness (P=0.029). Finally, procedure type (P=0.012) and preoperative intimal thickness (P=0.033) were identified for predicting primary assisted patency by multivariate Cox proportional hazards model. Compared to high pressure balloon angioplasty for treating patients with hemodialysis access restenosis, cutting balloon angioplasty had a better primary assisted patency. The increase of intimal thickness on ultrasonography after angiography was inversely correlated with primary assisted patency.

Comparative efficacy and safety of four common balloon angioplasty techniques for an arteriovenous fistula or graft stenosis: a systematic review and network meta-analysis of randomized controlled trials.

Balloon angioplasty could decrease restenosis of hemodialysis vascular access. The present study investigated the comparative effects and safety of commonly available balloon angioplasty techniques for treating patients with failing autogenous arteriovenous fistulas (AVFs) and grafts (AVGs) stenosis. A comprehensive literature search, including an updated search of PubMed and Embase (via Ovid) and screening of published meta-analyses, was conducted. Primary patency at 6 and 12 months was the primary outcome, and the incidence of complications was the secondary outcome. The random-effects model was used to conduct all statistical analyses, which were performed using RevMan 5.3 and ADDIS 1.16.8. A total of 20 eligible studies involving four balloon angioplasty techniques were entered into the final analysis. Although the direct meta-analysis indicated that cutting balloon angioplasty (CtBA) significantly improved primary patency at 6 [odds ratio (OR), 1.91; 95% confidence interval (CI): 1.27 to 2.86] and 12 (OR, 1.56; 95% CI: 1.13 to 2.15) months compared with conventional balloon angioplasty (CBA), this was not supported by network meta-analysis, which suggested that CtBA was associated with a higher risk of complications compared with drug-coated balloon angioplasty (DcBA) [OR, 0.05; 95% credible interval (CrI): 0.00 to 0.83], high-pressure balloon angioplasty (HBA) (OR, 0.04; 95% CrI: 0.00 to 0.69), and CBA (OR, 0.11; 95% CrI: 0.02 to 0.59). Subgroup analysis of AVFs did not detect any significant differences. In failing AVF and AVG stenosis, HBA might be a preferential option as it is related to a lower risk of complications and has numerically higher primary patency than DcBA and CBA. Further studies are needed to confirm these findings.

Choosing the right treatment for the right lesion, part I: a narrative review of the role of plain balloon angioplasty in dialysis access maintenance.

The majority of patients with end-stage renal disease (ESRD) requiring hemodialysis (HD) do so via an arteriovenous fistula (AVF) or graft. Both of these accesses are complicated by dysfunction related to neointimal hyperplasia (NIH) and subsequent stenosis. Percutaneous balloon angioplasty using plain balloons is the first line treatment for clinically-significant stenosis, with excellent initial response rates, however, with poor long-term patency and need for frequent reintervention. Recent research has sought to improve patency rates utilizing antiproliferative drug-coated balloons (DCBs), however, their role in treatment has not yet been fully determined. In part one of this two-part review, we aim to provide a comprehensive overview of the mechanisms of arteriovenous (AV) access stenosis, the evidence behind their treatment with high-quality plain balloon angioplasty techniques, and treatment considerations for specific stenotic lesions. An electronic search was performed on PubMed and EMBASE to identify relevant articles from 1980 to 2022. The highest available level of evidence regarding stenosis pathophysiology, angioplasty techniques, and approaches to treating different types of lesions within fistulas and grafts were included as part of this narrative review. NIH, and subsequent stenoses, develop via a combination of upstream events, causing vascular damage, and downstream events, representing the subsequent biologic response. The large majority of stenotic lesions can be treated utilizing high-pressure balloon angioplasty, with the addition of ultra-high pressure balloon (UHPB) angioplasty for resistant lesions and prolonged angioplasty with progressive balloon upsizing for elastic lesions. Additional treatment considerations must be taken into account when treating specific lesions, including cephalic arch and swing point stenoses in fistulas and graft-vein anastomotic stenoses in grafts, amongst others. High-quality plain balloon angioplasty, performed utilizing the available evidence-basis regarding technique and considerations for specific lesion locations, is successful in treating the large majority of AV access stenoses. While initially successful, patency rates remain non-durable. Part two of this review will discuss the evolving role of DCBs, which seek to improve angioplasty outcomes.

Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: cuttIng ballooN angioplaSTy combined wITh paclitaxel drUg-coaTed balloon angioplasty, an observatIONal study (INSTITUTION Study).

To study the safety and efficacy of cutting balloon angioplasty (CBA) followed by paclitaxel drug-coated balloon (PCB) angioplasty for recurrent venous lesions in arteriovenous fistulas (AVFs). We conducted a prospective single-arm cohort study of CBA followed by PCB angioplasty for recurrent AVF stenoses between September 2017 and April 2019. In total, 44 participants were recruited. Target lesions were included if they had recurred within 12months post-angioplasty, were > = 0.5cm upstream from the arteriovenous anastomosis, and did not involve the central veins. Up to two non-target lesions per circuit/participant with the same definition were allowed. Lesions were considered separate when there was an intervening 2-cm segment of normal vessel. Technical success was defined as complete lesion effacement on angioplasty. End-points of target and circuit patency were evaluated clinically at 3, 6, and 12months post-procedure. Technical success was 96% (42/44): Two participants were excluded from analysis due to the need for high-pressure balloon angioplasty as the target lesions did not efface with CBA. The median follow-up duration was 337.5days. Mean stenosis pre- and post-angioplasty was 69.0% (51.6-84.8) and 20.8% (0-44.8), respectively. The target lesion primary, primary assisted and circuit patency for the entire study population (n = 42) were 61.6 ± 7.8%, 92.7 ± 4.0%, and 54.7 ± 7.9%, respectively, at 12months. For participants without non-target lesions (n = 22), the rates were 77.3 ± 8.9%, 90.9 ± 6.1%, and 60.7 ± 11.0%, respectively, at 12months. CBA followed by PCB angioplasty appears safe and feasible for treatment of recurrent venous lesions in dysfunctional AVFs.

Morphological Lesion Types Are Associated with Primary and Secondary Patency Rates after High-Pressure Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas

Background: Neointimal hyperplasia (NIH) is believed to be the main reason for arteriovenous fistula (AVF) dysfunction, but other mechanisms are also recognized to be involved in the pathophysiological process. This study investigated whether different morphological types of AVF lesions are associated with the patency rate after percutaneous transluminal angioplasty (PTA). Methods: This retrospective study included 120 patients who underwent PTA for autogenous AVF dysfunction. All the cases were evaluated under Doppler ultrasound (DU) before intervention and divided into 3 types: Type I (NIH type), Type II (non-NIH type), and Type III (mixed type). Prognostic and clinical data were analyzed by Kaplan-Meier analysis and the Cox proportional hazards model. Results: There was no statistical difference in baseline variables among groups, except for lumen diameter. The primary patency rates in Type I, Type II, and Type III groups were 78.4, 93.2, and 83.2% at 6 months and 59.5, 84.7, and 75.5% at 1 year, respectively. The secondary patency rates in Type I, Type II, and Type III groups were 94.4, 97.1, and 100% at 6 months and 90.5, 97.1, and 94.7% at 1 year, respectively. The Kaplan-Meier curve showed that the primary and secondary patency rates of Type I group were lower than those of Type II group. Multivariable Cox regression analysis demonstrated that postoperative primary patency was correlated with end-to-end anastomosis (hazard ratio [HR] = 2.997, p = 0.008, 95% confidence interval [CI]: 1.328–6.764) and Type I lesion (HR = 5.395, p = 0.004, 95% CI: 1.730–16.824). Conclusions: NIH-dominant lesions of AVF evaluated by DU preoperatively were a risk factor for poor primary and secondary patency rate after PTA in hemodialysis patients.

A UK Expert Consensus Approach for Managing Symptomatic Arteriovenous Fistula (AVF) Stenosis in Haemodialysis Patients.

Stenoses in mature arteriovenous fistulas (AVFs) are common and can negatively impact on the quality of haemodialysis, the longevity of the AVF and lead to debilitating symptoms. Multiple treatment options exist; however, management can vary between different centres. We aimed to establish multidisciplinary consensus on the optimal stepwise application of interventions based on evidence and consensus. A modified Delphi process was conducted with 13 participants from hospitals across the UK, all of whom have high-volume dialysis access practice. The usual intervention to rectify de novo stenoses of mature AVFs is fistuloplasty, although surgery for inflow segment stenoses is also clinically acceptable. Appropriate first-line interventions include plain old balloon angioplasty or high-pressure balloon angioplasty; if these fail during the fistuloplasty, consider upsizing the balloon, prolonged balloon inflation or using alternative interventions, such as cutting or scoring balloons and ultra-high-pressure balloons. Alternative or subsequent interventions vary by anatomical site and may require additional multidisciplinary team input. For a stenoses recurring between 3 and 12months, it is appropriate to consider interventions used de novo, but with a lower threshold for using drug-coated balloons (DCBs) in all regions and for using stent grafts in all regions but inflow segment. Recurrence after 12months should be treated as a de novo lesion, with DCBs considered if they have been used successfully during previous interventions. These recommendations aim to provide a practical guide to multidisciplinary teams in order to optimise the use of multiple interventions for rectifying AVF stenoses and provide unified evidence-based practice guidelines.

A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas

The role of paclitaxel-coated balloons has been established in the coronary and peripheral arterial circulations with recent interest in the use of paclitaxel-coated balloons to improve patency rates following angioplasty of arteriovenous fistulas. To assess the efficacy of paclitaxel-coated angioplasty balloons to prolong the survival time of target lesion primary patency in arteriovenous fistulas, we designed an investigator-led multi-center randomized controlled trial with follow up time variable for a minimum of one year. Patients with an arteriovenous fistula who were undergoing an angioplasty for a clinical indication were included but patients with one or more lesions outside the treatment segment were excluded. Following successful treatment with a high-pressure balloon, 212 patients were randomized. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. The primary endpoint was time to loss of clinically driven target lesion primary patency. Primary analysis showed no significant evidence for a difference in time to end of target lesion primary patency between groups: hazard ratio 1.18 with a 95% confidence interval of 0.78 to 1.79. There were no significant differences for any secondary outcomes, including patency outcomes and adverse events. Thus, our study demonstrated no evidence that paclitaxel-coated balloons provide benefit, following standard care high-pressure balloon angioplasty, in the treatment of arteriovenous fistulas. Hence, in view of the benefit suggested by other trials, the role of paclitaxel-coated angioplasty balloons remains uncertain.

Successful intravascular pulmonary lithotripsy in a child with chronic thromboembolic pulmonary hypertension.

Intravascular lithotripsy (IVL) is a novel method based on pulsatile ultrasonic pressure waves specifically aimed to modify circumferential and transmural calcium plaques. We report on the successful application of a shockwave IVL catheter® in a child with chronic thromboembolic pulmonary hypertension due to calcified thrombi in both lower lobes. Compared to conventional high-pressure balloon angioplasty, a significant perfusion-improvement was achieved with a shockwave IVL catheter® (4 mm) of the treated right pulmonary artery branch. Furthermore, subsequent surgical thrombectomy was reported to be considerably easier for the shockwave-treated thrombotic areas than the high-pressure balloon-only-treated thrombus. In conclusion, the shockwave IVL catheter® may be a promising option in chronic thromboembolic lesions in PA (pulmonary artery)position, and furthermore might be an option when treating children.

Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone

PurposeTo assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). Materials and MethodsThis prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. ResultsLLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). ConclusionsDespite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.

Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial

Previous studies have illustrated the potential superiority of drug-coated balloons (DCBs) in maintaining patency after initial angioplasty for arteriovenous fistula (AVF) dysfunction due to stenosis. Our trial evaluated the efficacy and safety of DCBs for preventing fistula restenosis in Chinese hemodialysis patients. Multicenter, prospective, randomized, open-label, blinded end point, controlled trial. A total of 161 hemodialysis patients with fistula dysfunction from 10 centers in China. Participants were randomized 1:1 to treatment with initial dilation followed by DCB angioplasty or conventional high-pressure balloon (HPB) angioplasty. The primary end point was target lesion primary patency defined as the target lesion intervention-free survival in conjunction with an ultrasonography-measured peak systolic velocity ratio (PSVR)≤2.0 at 6 months. The secondary end points included 1) device, technical, clinical, and procedural success; 2) major adverse events; 3) degree of target lesion stenosis at 6 months; and 4) clinically driven target lesion and target shunt revascularization within 12 months. The percentage with target lesion primary patency as defined by a PSVR≤2.0 was higher in the DCB group than in the control group (65% vs 37%, respectively; rate difference, 28% [95% CI, 13%-43%]; P<0.001) at 6 months. The target lesion and target shunt intervention-free survival of the DCB group were not superior to those of the control group at 6 months (P= 0.3 and P= 0.2, respectively) but were superior at 12 months (target lesion intervention-free survival: 73% for DCB vs 58% for control [P= 0.04]; target shunt intervention-free survival: 73% for DCB vs 57% for control [P= 0.04]). The average degree of target lesion stenoses at 6 months was not significantly different between the 2 groups (44% ± 16% for DCB vs 49% ± 18% for control; P= 0.09). There were no significant differences in major adverse events or in device, technical, clinical, or procedural success rates between the groups. Small sample size; short follow-up period; procedural differences between the 2 groups such as unequal inflation times and balloon lengths. Compared to conventional HPB angioplasty, DCB treatment achieved superior primary patency defined using PSVR measured at 6 months and superior intervention-free survival of both the target lesion and the target shunt at 12 months without evidence of greater adverse events. Funded by ZhuHai Cardionovum Medical Device Co., Ltd. Registered at ClinicalTrials.gov with study number NCT02962141.

Emergency tips recanalisation and gastroesophageal varices embolisation with an ethylene vinyl alcohol copolymer agent (Squid) and detachable coils

Transjugular intrahepatic portosystemic shunt (TIPS) is currently indicated as first therapeutic option in the main complications of portal hypertension, including bleeding gastroesophageal varices and refractory ascites. In case of bleeding gastroesophageal varices, an adjuvant embolisation within TIPS can be useful to prevent rebleeding. In the present technical note, the management in emergency of a patient with haemorrhagic shock due to bleeding gastroesophageal varices and occluded TIPS is reported. TIPS recanalisation with an adjunctive stent and high-pressure balloon angioplasty and gastroesophageal varices embolisation using detachable coils and a non-adhesive liquid embolic agent were performed during the same emergent procedure. After the procedure, clinical stabilisation of the patient was achieved, with blood transfusions suspension and Blakemore tube removal. At 6 months, regular TIPS patency at colour Doppler and no rebleeding episodes were recorded. To our knowledge, whilst coils are routinely used for varices embolisation, non-adhesive liquid embolic agents have been never mentioned. Liquid embolic agents seem to provide a stable plug strengthening the embolising action of the coils. Further studies involving a cohort of patients with long-term follow-up will be necessary to confirm whether this association can be more effective than coils alone in gastroesophageal varices embolisation.

Intravascular lithotripsy for calcific coronary and peripheral artery stenoses.

Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.

Hybrid salvage of thrombosed dialysis access grafts.

To report our experience and evaluate the results of a hybrid procedure comprising of surgical thrombectomy and adjuvant high pressure balloon angioplasty for management of thrombosed arteriovenous grafts (AVGs) with underlying venous anastomotic stenosis. Between January 2015 and June 2017, 148 patients with first-time thrombosis of AVGs were considered for treatment with surgical thrombectomy followed by high pressure balloon angioplasty of the underlying venous anastomotic lesions. Monitoring and surveillance was subsequently performed using clinical and hemodialysis criteria to detect a failing/failed access. Primary, assisted primary, and secondary patency rates were calculated using Kaplan-Meier analysis. This hybrid procedure was technically successful in 135 cases (91.2%) and clinically successful in 131 cases (88.5%). The postintervention primary patency rate of the target lesions was 68.2%, 52.4%, and 44.2% at 3, 6, and 12 months, respectively. Endovascular re-interventions increased significantly the postintervention assisted primary patency to 79.1%, 71.9%, and 66.8% (P=0.0004), and the postintervention secondary patency to 86.5%, 82.2%, and 78.6% (P<0.0001) at the same time points, respectively. Hybrid salvage of thrombosed AVGs using high pressure balloon angioplasty of the venous anastomotic stenosis following surgical thrombectomy by Fogarty catheter is a highly successful and safe procedure, with acceptable short-term primary patency. The need for repeated interventions demonstrates the necessity of continuous graft monitoring and surveillance to improve both assisted primary, and secondary patency rates.

Clinical outcomes of high-pressure balloon angioplasty for common femoral artery disease in contemporary practice.

In recent years, improvements in endovascular equipment and the technical skills of operators have led to an increasing number of percutaneous common femoral artery (CFA) interventions. However, there are few reports of the detailed treatment strategy for CFA intervention and its subsequent clinical outcomes. We evaluated the safety and efficacy of endovascular therapy (EVT) with a high-pressure balloon for CFA disease. Fifty-five consecutive patients (59 lesions) who underwent EVT with high-pressure ballooning were analyzed retrospectively. The primary endpoint was clinically driven target lesion revascularization (TLR). The median follow-up was 34.0months. The mean age was 68.0 ± 10.1years, and 70.1% were men. The procedural success rate was 98.3%. All patients underwent high-pressure balloon angioplasty (mean pressure 17.7atm). Clinically driven TLR-free rates at 2, 3, and 4years were 88.7%, 77.9%, and 74.2%, respectively. Endovascular interventions with high-pressure ballooning for CFA showed an acceptable mid-term freedom rate from TLR.

Acute and long-term effects of endovascular debanding of pulmonary arteries in a swine model.

The primary objective of this study was to demonstrate that pulmonary artery (PA) debanding via cardiac catheterization using balloon angioplasty is feasible and safe in swine. The secondary objectives were to determine the acute and long-term effects of this therapy. This is a chronic survival experimental study in newborn swine. PA bands are used in infants for transient palliation of congenital heart defects with excessive pulmonary blood flow. Although rare, if these defects should close spontaneously or become hemodynamically insignificant, a sternotomy and occasionally cardiopulmonary bypass may still be required for band removal. Alternatively, debanding could be accomplished through less invasive methods. The main pulmonary artery was banded in three piglets, and the left pulmonary artery in five piglets via mini-thoracotomy at a mean weight of 2.5 kg. Following a threefold increase in weight, the piglets underwent PA debanding via balloon angioplasty. Four piglets were sacrificed to evaluate the acute effects. The remainder were followed to evaluate long-term effects. Histopathology was performed on all piglets. Reintervention rates. Histopathologic consequences of high pressure balloon angioplasty used for PA debanding acutely and after reinterventions. Debanding was performed at a mean weight of 8.1 ± 2.23 kg. The median preintervention gradient across the band was 18 mm Hg. Debanding was successful in all piglets. The median postintervention gradient was 3.5 mm Hg. All piglets in the long-term model required re-interventions for recurrent stenosis at mean weights of 26 ± 1.6 and 61 ± 3.2 kg. Histopathology demonstrated vessel wall injury in only one piglet. Endovascular PA debanding can be safely achieved in a swine model. Angioplasty following debanding may be necessary for recurrent stenosis. This catheter-based therapy may provide a less-invasive alternative to surgery.

Endovascular Devices and Revascularization Techniques for Limb-Threatening Ischemia in Individuals With Diabetes.

Diabetes mellitus (DM) is a rapidly worsening global epidemic over the last thirty-five years. The increased prevalence of DM has changed the phenotypic expression of atherosclerotic limb threatening ischemia (LTI), resulting in an increase in lesions in the tibial vessels. These patients are also afflicted with peripheral neuropathy, foot deformities, and medial calcification of the vasculature. In response to the evolving phenotype of atherosclerosis, newer minimally invasive tools and techniques have been developed to improve the blood supply in LTI. Arterial access, traditionally obtained from the contralateral common femoral artery (CFA) in a retrograde fashion, is now also frequently being obtained in the ipsilateral limb in an antegrade fashion. Retrograde access of the tibial, pedal, tarsal, or calf collateral vessels is also being utilized to provide a route through which wires, catheters, balloons and stents may be placed. Wires have evolved to have a variety of diameters, materials and coatings providing interventionalists with a wide variety of choices when attempting to traverse blockages in the arteries. When catheters and wires fail to traverse the lesion, newer chronic total occlusion (CTO) devices have been developed to aid in the placement of a wire across the offending lesions. Due to medial calcification associated with DM, atherectomy devices have been developed to debulk the atherosclerotic plaque within the vessel. High pressure balloon angioplasty with or without stents remain the mainstay of intervention, with drug-coated balloons (DCBs) and drug-eluting stents (DESs) now being frequently used to prevent reocclusions of atherosclerotic lesions.