Standard Balloon Research Articles

1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.

This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2μg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions. Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness. Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 3:1 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1month of the index procedure), and patient outcomes were analyzed. Mean lesion length was 82.5 ± 48.9mm for the Ranger DCB group (n=278) and 79.9 ± 49.3mm for the control group (n=98). Ranger DCB was superior to PTA (82.9% [n=194 of 234] vs. 66.3% [n=57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval: 5.5% to 27.7%; p=0.0013). Noninferior freedom from major adverse events (94.1% [n=241 of 256] vs. 83.5% [n=76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval: 2.5% to 18.8%; noninferiority p<0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p=0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively. The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).

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.

Excimer laser atherectomy in complex peripheral artery disease: a prospective European registry.

This study aimed to investigate performance, effectiveness, and safety of excimer laser atherectomy for the treatment of complex lower limb artery disease in a real-world setting. In our prospective, multicenter registry, consecutive patients with complex lower limb lesions underwent excimer laser atherectomy with optional standard balloon angioplasty, paclitaxel-coated balloon angioplasty, and bailout stenting. Primary outcome was technical success. Secondary outcomes were device performance of the excimer laser system, freedom from target lesion revascularization (TLR), peri-procedural complications, and amputation-free survival in patients with critical limb ischemia (CLI). A total of 294 patients were enrolled at 14 European centers (mean lesion length 109±103 mm, total occlusions 56.8% [167 of 294 lesions], CLI 47.3% [132 of 279 patients]. Adjuvant balloon angioplasty was conducted in 283 (96.3%), and complementary stent implantation in 98 patients (33.3%). Technical success was achieved in 95.3% of patients. Increasing lesion length was associated with decreased laser atherectomy performance (odds ratio [OR] per 10 mm: 0.94 [95% confidence interval [CI] 0.90 to 0.99], P=0.01). A total of 66 patients (22.4%) completed the 12-month follow-up. Freedom from TLR was 83.5% (95% CI: 74.9 to 92.1) at 12 months. Chronic total occlusions were associated with more TLR (OR 5.03 [95% CI: 1.01 to 25.1], P=0.049). Amputation -free survival in patients with CLI was 93.1% (95% CI: 83.9 to 100). Excimer laser atherectomy substantially contributed to technical success of endovascular treatment of complex infra-inguinal lesions. Freedom from 12-month TLR was reasonable.

Height and volume restoration in osteoporotic vertebral compression fractures: a biomechanical comparison of standard balloon kyphoplasty versus Tektona\xae in a cadaveric fracture model

BackgroundStandard balloon kyphoplasty represents a well-established treatment option for osteoporotic vertebral compression fractures. Aim of the present study was to evaluate two different methods of percutaneous augmentation (standard balloon kyphoplasty (BKP) versus Tektona® (TEK)) with respect to height restoration.MethodsFour-teen vertebral bodies of two female cadavers were examined. Fractures were created using a standardized protocol. CT-scans were taken before and after fracture, as well as after treatment. Afterwards two groups were randomly assigned in a matched pair design: 7 vertebral bodies (VB) were treated with BKP (Kyphon, Medtronic) and 7 vertebral bodies by TEK (Spineart, Switzerland) Anterior, central and posterior vertebral body heights were evaluated by CT-scans. Volumetry was performed using the CT-scans at three different timepoints.ResultsValues before fracture represent 100%. The anterior height after fracture was reduced to 75.99 (± 4.8) % for the BKP group and to 76.54 (± 9.17) % in the TEK Group. Statistically there was no difference for the groups (p = 1). After treatment the values increased to 93.06 (± 5) % for the BKP Group and 87.71 (± 6.2) % for the TEK Group. The difference before and after treatment was significant for both groups (BKP p = 0.0006; TEK p = 0.03). Within the groups, there was no difference (p = 0.13).The Volume of the vertebral body was reduced to 82.29 (± 8.4) % in the BKP Group and to 76.54 (± 8.6) % in the TEK Group. After treatment the volume was 89.26 (± 6.9) % for the BKP Group and 88.80 (± 8.7) % for the TEK Group. The difference before and after treatment was significant only for the TEK group (BKP p = 0.0728 n.s.; TEK p = 0.0175). Within the groups, there was no difference (p = 0.2).The average cement volume used was 6.1 (range 3.6–9 ml) for the BKP group and 5.3 (3–7.2 ml) for the TEK group respectively.ConclusionsBased on our results the new System Tektona® in osteoporotic compression fractures might represent a promising alternative for the clinical setting, especially preserving bone. Further biomechanical tests and clinical studies have to proof Tektona®`s capabilities.

Bilateral balloon expandable biodegradable stent (Y-stent) for postcholecystectomy perihilar biliary stricture.

Bilateral balloon expandable biodegradable stent (Y-stent) for postcholecystectomy perihilar biliary stricture.

Drug Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas

A prospective, single-blind, randomized, multicenter trial (entry dates not mentioned). After successful predilation with a high-pressure balloon of stenotic lesions in failing hemodialysis arteriovenous fistulas (AVFs), 152 patients underwent treatment with a drug-coated balloon (DCB) and 148 underwent treatment with a standard balloon (SB) at 29 international sites. The 6-month target lesion patency was significantly greater in the patients treated with a DCB (82%) compared with a SB (60%; P < .001). DCB was superior to SB for treatment of stenotic lesions in AVFs.

Procedural comparison of a standard PTA balloon for fistula and graft maintenance procedures with the novel Chameleon™ PTA balloon catheter.

The incidence of cephalic arch (CA) and central venous (CV) stenosis has been reported in the range of 30% in the literature. The purpose of this study is to compare contrast use, fluoroscopy time, and procedure time between standard imaging by injection of contrast through the access sheath versus injection of contrast through a novel PTA balloon with an integrated injection port. A multi-centered, retrospective evaluation of consecutive patients treated for CA and CV stenosis was performed. Data captured included demographics, co-morbidities, lesion characteristics/location, procedural details, volume of contrast used, fluoroscopy time, and procedure time. The control group was imaged and treated using standard practice with pre and post imaging performed through the sheath and intervention using standard PTA balloon. Imaging and treatment were performed using the Chameleon™ PTA catheter in the treatment arm. A total of 68 consecutive patients were included. There were 34 patients in Group A and 34 patients in Group B. Average age was 65.2 versus 66.5 (p = 0.284), respectively. There were no significant gender differences between groups. Prevalence of co-morbidities of hypertension, coronary artery disease, and diabetes was similar to national rates in both groups. Contrast volume, fluoroscopy time, and procedure time in Group B were significantly less when compared by multiple regression to Group A, correcting for potential confounders (p = 0.0001, 0.0180, and 0.0008, respectively). Use of a PTA balloon with an integrated injection port shows potential for significant reduction in contrast dose, fluoroscopy time, and procedure time.

Open versus endovascular REBOA control of blood loss during cesarean delivery in the placenta accreta spectrum: A single-center retrospective case control study

ObjectiveThe aim of this study was to compare two vascular control options for blood loss prevention and hysterectomy during cesarean delivery (CD22Cesarean delivery.): endovascular balloon occlusion of the aorta (REBOA33Resuscitative endovascular balloon occlusion of the aorta.) and open bilateral common iliac artery occlusion (CIAO44Common iliac artery occlusion.) in women with extensive placenta accreta spectrum (PAS55Placenta accreta spectrum.). Study designThis was retrospective comparison of cases of PAS using either CIAO (October 2017 through October 2018) or REBOA (November 2018 through November 2019) to prevent pathologic hemorrhage during scheduled CD. Women with confirmed placenta increta/percreta underwent either CD then intraoperative post-delivery, pre-hysterectomy open vascular control of both CIA66Common iliac artery. (CIAO group) or pre-operative, ultrasound-guided, fluoroscopy-free REBOA followed by standard CD and balloon inflation after fetal delivery (REBOA group). Intraoperative blood loss, transfusion volumes, surgical time, blood pressure, maternal and neonatal outcomes, hospitalization length and postoperative complications were compared. ResultsThe REBOA and CIAO groups included 12 and 16 women, respectively, with similar median age of 35 years and gestational age of 34–35 weeks. All REBOA catheters were successfully placed into aortic zone three under ultrasound guidance. The quantitated median intraoperative blood loss was significantly lower for the REBOA group, (541 [IQR 300–750] mL) compared to the CIAO group (3331 [IQR 1150−4750] mL (P = 0.001). As a result, the total volume of fluid and blood replacement therapy was significantly lower in the REBOA group (P < 0.05). Median surgical time in the REBOA group was less than half as long: 76 [IQR 64−89] minutes compared to 168 [IQR 90−222] minutes in the CIAO group (P = 0.001). None of the women with REBOA required hysterectomy, while 8/16 women in the CIAO group did (P = 0.008). Furthermore, the post-anesthesia recovery and hospital discharge times in the REBOA-group were shorter (P < 0.05). One thromboembolic complication occurred in each group. The only REBOA-associated complication was non-occlusive femoral artery thrombosis, with no surgical management required. No maternal or neonatal deaths occurred in either group. ConclusionFluoroscopy-free REBOA for women with PAS is associated with improved vascular control, perioperative blood loss, the need for transfusion and hysterectomy and reduces surgical time when compared to bilateral CIAO.

Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial.

This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. The primary effectiveness endpoint of the study is the primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (PSVR≤2.5) and without target lesion revascularization (TLR) within 12 months. The primary safety endpoint is the proportion of subjects who experience serious device-related adverse events within 30 days postprocedure. A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between June 2010 and February 2012. Patients with an in-stent restenosis lesion in the femoropopliteal region and a Rutherford classification from 2 to 5 could be enrolled. After screening, the patient was randomized to either treatment with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface or treatment with a standard PTA balloon. After the index procedure, follow-up visits at 1 month, 6 months, 12 months and 24 months were required. A color flow Doppler ultrasound was performed on all follow-up visits and a quantitative vascular angiography at the 12-month follow-up visit. In the VIABAHN® group, 39 patients (74.4% male; mean age 67.69±9.77 years) were enrolled and in the PTA group, 44 patients (72.7% male; mean age 68.98±9.71 years) were enrolled, which is comparable for both treatment groups. In the VIABAHN® group, 34 (87.2%) patients presented with claudication (Rutherford 2 and 3) and 5 (12.8%) patients had critical limb ischemia (Rutherford 4 and 5). In the PTA group, 36 (81.8%) patients were claudicants (Rutherford 2 and 3) and 8 (18.2%) presented with critical limb ischemia (Rutherford 4 and 5). The 12-month primary patency rates were 74.8% for the VIABAHN® group and 28.0% for the PTA group (P<0.001). No patients were reported to have device-related serious adverse events within 30 days postprocedure. The primary patency rate for the 24-month follow-up was 58.40% in the Viabahn group and 11.60% in the PTA group (P<0.001). The treatment of femoropopliteal in-stent restenosis with a VIABAHN® Endoprosthesis shows significantly better results than the treatment with a standard PTA balloon. This demonstrates that the use of the VIABAHN® Endoprosthesis is a very promising tool for the treatment of complex in-stent restenosis.

Design, concept and first in-vitro results of the percutaneous, pulsatile left ventricular assist device-PERKAT LV

Abstract Introduction A very high morbidity and mortality is associated with cardiogenic shock due to left ventricular failure despite encouraging developments in interventional cardiology. Patients suffering from cardiogenic shock often require temporary mechanical circulatory support to stabilize organ perfusion. In addition, an increasing number of patients with complex multi-vessel diseases cannot undergo surgical myocardial revascularization as recommended by recent guidelines due to their comorbidities. Those patients could benefit from a protected PCI approach using a temporary mechanical assist device. The available LVAD systems have specific advantages and disadvantages. Purpose It was our aim to develop a percutaneous, pulsatile assist device that unloads the left ventricle in a physiologic way. Methods The PERKAT-LV (“PERkutane KATheterpumptechnologie”) device consists of a self-expanding nitinol pump chamber which is covered by foils. Those foils carry multiple outflow valves at the proximal part of the pump chamber. A flexible suction tube with a pigtail-shaped tip and inflow holes are attached to its distal part. The system is designed for 16F percutaneous implantation via the femoral artery. Pulling back the outer sheath unfolds the nitinol chamber in the descending aorta while the flexible suction tube bypasses the aortic arch and ascending aorta with its tip in the left ventricle. In the second implantation step, a standard IABP balloon is placed into the pumping chamber and is connected to an external IABP console. Balloon deflation generates a blood flow from the left ventricle into PERKAT LV. During balloon inflation, blood leaves the system through the outflow foil valves in the descending aorta. Positioning and schematic drawing of PERKAT-LV is demonstrated in Figure 1. Results Preliminary in-vitro studies using a prototype of the PERKAT LV device were performed. It was tested in different afterload settings (0, 40, 80 and 120 mmHg) using a standard 30 ccl IABP balloon and varying inflation/deflations rates (70, 80, 90, 100, 110 and 120/min). We detected flow rates ranging from 2.0 to 3.0 L/min depending on the afterload setting and inflation/deflation rate. Conclusion The novel percutaneously implantable and pulsatile working PERKAT-LV device offers left ventricular unloading and circulatory support of up to 3.0 L/min in a first feasibility study. At the moment, the system is extensively studied under in vitro conditions. First in vivo evaluation will follow in the near future. Based on the current results, we believe that the system is a promising novel approach for percutaneous application of temporary left ventricular mechanical support. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German Federal Ministry of Education and Research

Reewarm™ PTX drug-coated balloon in the treatment of femoropopliteal artery disease: A multi-center, randomized controlled trial in China

BackgroundDrug-coated balloons (DCB) have demonstrated satisfactory clinical results in the treatment of femoropopliteal artery diseases. ObjectiveTo evaluate the efficacy and safety of the Reewarm™ PTX DCB in the treatment of femoropopliteal artery lesions compared with plain balloon. MethodsThis was a multi-center, parallel-group, randomized controlled trial in patients with femoropopliteal artery lesions in China,. The participants were randomized 1:1 to percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA group) after pre-dilatation with a residual stenosis less than 70%. The primary endpoint was late lumen loss (LLL) at 6 months in the intent-to-treat set. The secondary endpoints included the target lesion revascularization (TLR) and major advance events(MAE)rate at 12 months. ResultsBetween July 2014 and April 2017, a total of 200 patients were enrolled. The mean age of the subjects was 67.8 ± 9.2 years in the DCB group (n = 100) and 69.4 ± 10.3 years in the PTA group (n = 100). The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001). The TLR rate in the DCB group was lower than in the PTA group at 12 months (15.0% vs. 29.0%, P < 0.05). The occurrence of MAE4 in the DCB group by 12 months was lower than in the PTA group (23.0% vs. 38.0%, P < 0.05). ConclusionReewarm-PTX drug-coated balloon is associated with better efficacy and safety than the plain balloon for femoropopliteal lesion.

Endoscopic Wedge Excisions with CO2 Laser for Subglottic Stenosis.

Endoscopic Wedge Excisions with CO2 Laser for Subglottic Stenosis.

Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas

BackgroundStandard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes.MethodsIn this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data.ResultsA total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, −0.2 percentage points; 95% CI, −5.5 to 5.0; P=0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses.ConclusionsDrug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit–related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.)

Comparison of the effects of methadone and butorphanol combined with acepromazine for canine gastroduodenoscopy

ObjectiveTo evaluate the feasibility of gastroduodenoscopy in dogs premedicated with acepromazine in combination with butorphanol or methadone. Study designProspective, randomized, double-blinded clinical trial. AnimalsA group of 40 client-owned dogs. MethodsDogs were randomly allocated to one of two groups and give intramuscular acepromazine 0.02 mg kg–1 combined with either butorphanol 0.3 mg kg–1 (group ACEBUT) or methadone 0.2 mg kg–1 (group ACEMET). General anaesthesia was induced with propofol and ketamine and maintained with sevoflurane (2.3%) in oxygen. Cardiopulmonary variables were recorded at 5 minute intervals during anaesthesia. Feasibility of the entire gastroduodenoscopy was evaluated with a visual analogue scale (VAS) from 0 (best) to 100 (worst) (primary outcome of the study). Lower oesophageal sphincter dilatation and duodenal intubation were scored. Pylorus diameter was measured with standard endoscopic inflatable balloons. Overall cardiovascular stability was assessed during anaesthesia, using a VAS (0-100), as was the presence of fluid in the oesophagus, regurgitation, need for mechanical ventilation, and intraoperative and postoperative rescue analgesia (secondary outcomes of the study). Differences between treatments were analysed with Mann–Whitney U, Student t test, Fisher exact test or mixed model analysis of variance as appropriate. Subsequently, feasibility VAS of the gastroduodenoscopy was assessed for noninferiority between groups. The noninferiority margin was set as –10. ResultsAll gastroduodenoscopies were successfully completed in both groups using an endoscope tip diameter of 12.8 mm in all but one dog. Feasibility of gastroduodenoscopy was evaluated as 2.9 ± 5.6 in group ACEBUT and 5.1 ± 5.8 in group ACEMET. No significant differences between groups were detected in any measured or assessed variables, and noninferiority was confirmed. Conclusion and clinical relevanceIn our study population, the effects of methadone and butorphanol when combined with acepromazine were comparable.

Evaluation of superficial femoral artery-lesions after percutaneous transluminal angioplasty: color-coded summation images vs. monochromatic digital subtraction angiography

BackgroundPercutaneous transluminal angioplasty (PTA) is increasingly requested in the therapy of peripheral arterial occlusive disease. The evaluation of the technical result after balloon angioplasty with regard to bailout stenting is highly dependent on the operators´ subjective assessment and mainly based on the monochromatic digital subtraction angiography (DSA) images. The aim of this study was to compare color-coded single image as a novel diagnostic tool with monochromatic DSA for the analysis of flow limitation and need for stent implantation after PTA of superficial femoral artery (SFA) stenoses.MethodsDuring a period of 18 months, 213 SFA lesions were treated by PTA with a standard balloon in 170 patients, resulting in a total of 193 endovascular procedures. The median age of the patients was 77 years (range, 35–96 years). Median length of the treated lesions was 10.5 cm (range, 1.0–50 cm). Three interventional radiologists retrospectively evaluated the results of balloon angioplasty with monochromatic as well as post-processed color-coded DSA images for flow limitations to decide if subsequent stent implantation was necessary. Consensus reading of two experienced interventional radiologists 2 months after the initial review served as reference standard to perform a receiver operating characteristics (ROC) analysis.ResultsROC analysis for readers A, B and C showed area under the curve (AUC) values of 0.797, 0.865 and 0.804 for color-coded DSA and AUC values of 0.792, 0.843 and 0.872 for monochromatic DSA: a significant advantage of color-coded over conventional monochromatic DSA was not found for readers A and B (p > 0.05). Results of reader C were significantly better in the assessment of monochromatic images (p = 0.023). Diagnostic confidence using color-coded images was slightly higher than in monochromatic images (κ = 0.486 vs. κ = 0.459).ConclusionsIn this study, color coded DSA did not reveal to be superior to conventional monochromatic DSA when evaluating results of PTA and when deciding whether stent implantation is necessary or not. This technology, however, requires further experiences with special regard to homogeneously trained radiologists and to the time requirement.

Hybrid procedures in the dialysis fistula aneurysm treatment.

Dialysis fistula aneurysms are common complications which in selective cases require surgical revision. It is recommended to detect and treat outflow stenosis concurrent with a dialysis fistula aneurysm, but usually, the treatment is divided into two stages - the open and endovascular stages are performed separately. We describe the results of hybrid procedures composed of aneurysm resection and endovascular correction for outflow veins performed for a dialysis fistula aneurysm treatment. From March 2012, we performed hybrid procedures in 28 patients to correct dialysis fistula aneurysms. Patients, dialysis access, operative data, and the results obtained during a median follow-up of 28.5 months were analyzed. For dialysis fistula aneurysm correction, we performed 27 bypasses and 1 aneurysmorraphy. For outflow vein stenosis correction, we performed standard balloon angioplasty, no stents or stentgraft were used. The average increase in minimal diameter after angioplasty was 135.5% (range 57-275%). The 12- and 24-month primary patency rates of corrected fistulas in the observed group were 92.3% and 80%, respectively. A significant difference in the one-year patency rates between the urgent and planned procedures was observed (81.2% vs. 100%, respectively). No early complications related to endovascular or open procedures were observed. Late complications were observed in seven patients (25%) - mainly thrombosis caused by the recurrence of outflow vein stenosis (six patients, 21.5%), infection, lymphocele, and hematoma (one case of each complication). A hybrid procedure for the surgical correction of dialysis fistula aneurysms with the simultaneous correction of outflow pathologies enables effective long-term treatment. The obtained data showed the efficiency and good results of this procedure. Procedures performed for urgent indications significantly increase the risk for later complications, especially fistula thrombosis and loss of dialysis access.

Management of stent under-expansion

Stent under-expansion represents a negative prognostic factor, because of the risk to develop intrastent restenosis and stent thrombosis. It is often due to excessive calcium burden at the target lesion level. The list of devices available for the treatment of stent under-expansion includes super high-pressure non-compliant (NC) balloons, excimer laser and intravascular lithotripsy.NC OPNTM balloons (SIS Medical AG, Winterthur, Switzerland) reach much higher pressures than those of standard NC balloons (up to 35 atm), so they are able to overcome the resistance given by the calcific plaque. The excimer laser catheter instead generates ultraviolet light pulses with low penetration power. This one fragments the atherosclerotic material surrounding the implanted stent. This technology has proven to be extremely effective, however it requires specific operator experience to reduce the risk of serious complications. Intravascular lithotripsy is the most recent method, and it has shown very promising results so far. The Shockwave Medical device (S-IVL; Shockwave Medical Inc, Santa Clara, CA, USA) emits sound waves that act selectively on the calcific component, breaking it up and making the vessel more compliant.

Impact of balloon inflation on the insertion of endoscopic ultrasound: a prospective, randomized controlled trial.

Background and study aims During endoscopic ultrasound (EUS), patients may experience severe discomfort. The radial echoendoscope has a balloon around its tip. Balloon inflation prior to insertion may reduce contact injury and pharyngeal pain. The purpose of this study was to investigate the effect of balloon inflation on pharyngeal pain during insertion. Patients and methods Patients who underwent radial EUS for pancreatobiliary disease were randomized into standard insertion or balloon-inflated insertion. The primary outcome was the proportion of moderate-to-severe pharyngeal pain. Secondary outcomes were the degree of pharyngeal pain, risk factors for moderate pharyngeal pain, procedure-related adverse events, and pharyngeal pain depending on the experience of the endoscopist. Results A total of 481 patients were randomized into two groups: standard insertion (238) and balloon inflation (243). No statistically significant differences in proportion of moderate-to-severe pain were found (26.5 % vs. 20.2 %, P = 0.107). Balloon inflation (HR 0.65; 95 % CI (0.42–0.98, P = 0.041) was a protective factor against moderate pain. Balloon inflation reduced the proportion of patients with moderate-to-severe pain when performed by physicians with less than 3months of experience with EUS (44.7 % vs. 25.3 %, P = 0.012). Conclusion Balloon inflation did not reduce the absolute degree of post-procedural pain with EUS, but it reduced the number of patients with moderate-to-severe pain when performed by physicians with less than 3 months of experience.

The role of the fractional flow reserve in the coronary steal phenomenon evaluation caused by the coronary-pulmonary fistulas: case report and review of the literature

BackgroundCongenital coronary-pulmonary fistulas (CPFs) are commonly unilateral; however, bilateral and multilateral fistulas are relatively rare. The steal phenomenon aroused from bilateral or multilateral CPFs, and was uncertain and seldom reported. We possess a new tool to assess the hemodynamic significance of coronary artery fistulas. This study aimed to describe the clinical presentation, diagnostic modalities, and management of the coincidentally detected congenital bilateral CPFs.Case presentationA case of a 52 year-old female with 10 years history of typical palpitations and chest tightness was presented. The selective coronary arteriography showed a right dominant coronary circulation without significant stenosis; however, with anomalous vessels originating from the proximal right and left anterior descending coronary arteries, draining into the pulmonary artery through a plexus of small vessels. We introduced the fractional flow reserve (FFR) to evaluate the hemodynamic significance of CPFs. The patient was successfully treated with coil embolization.ConclusionsWe presented the case of a female with typical palpitations and chest tightness due to the steal phenomenon that aroused from bilateral CPFs. The fistulas were safely and successfully closed by coil embolization. We showed a new tool for the sophisticated evaluation of the hemodynamic significance of CPFs using FFR measurement and temporary occlusion of the fistula with a standard balloon. FFR could be a promising means for the treatment of decision making of the CPFs.

Simplifying transfemoral ACURATE neo implantation using the TrueFlow nonocclusive balloon catheter.

This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.