Balloon Inflation Pressure Research Articles

A novel minimally invasive and versatile kyphoplasty balloon-based model of porcine spinal cord injury.

Spinal cord injury (SCI) animal models often utilize an open surgical laminectomy, which results in animal morbidity and also leads to changes in spinal canal diameter, spinal cord perfusion, cerebrospinal fluid flow dynamics, and spinal stability which may confound SCI research. Moreover, the use of open surgical laminectomy for injury creation lacks realism when considering human SCI scenarios. We developed a novel, image-guided, minimally invasive, large animal model of SCI which utilizes a kyphoplasty balloon inserted into the epidural space via an interlaminar approach without the need for open surgery. The model was validated in 5 Yucatán pigs with imaging, neurofunctional, histologic, and electrophysiologic findings consistent with a mild compression injury. Few large animal models exist that have the potential to reproduce the mechanisms of spinal cord injury (SCI) commonly seen in humans, which in turn limits the relevance and applicability of SCI translational research. SCI research relies heavily on animal models, which typically involve an open surgical, dorsal laminectomy which is inherently invasive and may have untoward consequences on animal morbidity and spinal physiology that limit translational impact. We developed a minimally invasive, large animal model of spinal cord injury which utilizes a kyphoplasty balloon inserted percutaneously into the spinal epidural space. Balloon inflation results in a targeted, compressive spinal cord injury with histological and electrophysiological features directly relevant to human spinal cord injury cases without the need for invasive surgery. Balloon inflation pressure, length of time that balloon remains inflated, and speed of inflation may be modified to achieve variations in injury severity and subtype.

Jailed high-pressure balloon technique is superior to jailed wire technique in protecting side branch of coronary bifurcation lesions

Objectives. This study investigated the influence of higher pressure protection with a small diameter balloon of side branch (SB) on bifurcation lesions. Background. Of the different coronary stent implantation techniques, the modified jailed balloon technique has become a viable option for bifurcation lesions. However, there was no detailed study on the relationship between the balloon inflation pressure of the main vessel (MV) and SB. Methods. In this study, we collected information of patients who underwent percutaneous coronary intervention (PCI) for bifurcated lesions between March 2019 and December 2022. They were divided into two groups according to the operation way: active jailed balloon technique (A-JBT) group and jailed wire technique (JWT) group. Results. A total of 216 patients were enrolled. The A-JBT group had a larger SB stenosis diameter (1.53 ± 0.69 vs. 0.95 ± 0.52, p < .001), the lower degree of stenosis (44.34 ± 18.30 vs. 63.69 ± 17.34, p < .001) compared to the JWT group. However, the JWT group had a higher incidence of SB occlusion (18.0% vs. 1.9%, p < .001) compared to the A-JBT group. Nevertheless, the success rate for both groups was 100%. Conclusions. This novel high inflation pressure and small diameter balloon approach we propose has significant advantages. There is a lower rate of SB occlusion and SB dissection, which is more cost-effective and provides better clinical outcomes for the patient. This method should be considered in the future for treating bifurcation lesions.

A Randomized Controlled Trial Comparing the Effect of Two-Time Durations of Balloon Compression During Percutaneous Balloon Compression in Resistant Trigeminal Neuralgia

BACKGROUND: Percutaneous balloon compression of the trigeminal nerve’s gasserian ganglion for the treatment of trigeminal neuralgia is an interventional pain procedure with results comparable to microvascular decompression surgery. The procedure is safe in experienced hands and has less morbidity associated with it. However, there is a lack of clear-cut guidelines about the details of the technique like balloon shape, inflation pressure, and duration of inflation. So, keeping the inflation pressure and shape of the balloon constant, we studied the effect of the duration of inflation of the balloon and its effect on pain relief in refractory trigeminal neuralgia cases. OBJECTIVES: To study the outcome with 2 different durations of balloon inflation times in terms of pain relief and complications after percutaneous balloon compression. STUDY DESIGN: Prospective parallel design randomized, controlled trial. SETTING: The study was conducted in a tertiary care hospital in North Eastern India after obtaining approval from the Institutes’ ethics committee (Dean/2018/EC/449). The study was also registered with the Clinical Trials Registry of India (CTRI no. CTRI/2019/03/018166). All patients referred to a pain clinic for unilateral facial pain were screened for the study over 2 years from April 2019 to March 2021. METHODS: Forty patients who met the diagnosis of trigeminal neuralgia and who did not respond satisfactorily to medications were included in the study. They underwent routine blood investigations and a magnetic resonance image of the brain to rule out any medical or surgical conditions. Percutaneous balloon compression was conducted under C-arm guidance using a 12 gauge cannula and a 4 Fr Fogarty balloon was used for compressing the gasserian rootlets. RESULTS: Patients who underwent 90 seconds as well as 120 seconds showed good pain relief. The 2 groups did not show any significant difference in pain relief based on the duration of compression. Visual analog scale scores were reduced from 7-8 to 0-3. Masseter muscle weakness was present in 47.5% of patients post-procedure and recovered in all except one patient. LIMITATIONS: We have followed up with our patients for a short period of 6 months only. We could not measure the intra-luminal compression pressure of the balloon. CONCLUSION: There is no difference in the pain relief obtained by the 2 different durations of compressions. A longer duration of compression, however, has more incidence of side effects. KEY WORDS: Idiopathic trigeminal neuralgia, percutaneous balloon compression, time duration, shape of balloon, masseter muscle weakness, facial numbness, corneal dysesthesia

Myocardial Perfusion in ST-Segment Elevation Myocardial Infarction Patients After Percutaneous CoronaryIntervention:Influencing Factors and Intervention Strategies.

Aim We aim to explore the factors influencing myocardial perfusion in patients with acute ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PPCI)and evaluate the effects of different intervention strategies on myocardial perfusion improvement. Methods A retrospective analysis was conducted on 300 patients withSTEMIwho underwent primary percutaneous coronary intervention (PPCI) at our hospital between January 2020 and December 2022. Based on post-procedural coronary angiography results using the thrombolysis in myocardial infarction (TIMI) blood flow grade and myocardial blush grade (MBG), patients were categorized into two groups: the normal perfusion group (TIMI grade 3 or MBG 2-3, n=180) and the impaired perfusion group (TIMI grades 0-2 or MBG 0-1, n=120). The impaired perfusion group was further divided using a random number table into the thrombus aspiration-only group (control group, n=60) and the thrombus aspiration combined with nicorandil group (nicorandil group, n=60). A 1:1 propensity score matching method was employed to adjust for baseline characteristics between the groups. Clinical characteristics, hematological parameters, coronary lesion features, and percutaneous coronary intervention (PCI) technical parameters were compared between the matched groups. Additionally, a multivariate logistic regression analysis was performed to identify independent risk factors influencing myocardial perfusion. Furthermore, the post-procedural myocardial perfusion, cardiac function, and clinical prognosis were compared between the control and nicorandil groups. Results After matching, the baseline characteristics of the two groups were compared. The impaired perfusion group had older age, higher proportion of male patients, higher rates of diabetes and hypertension, longer time from symptom onset to balloon dilation, higher peak cardiac troponin I (cTnI) levels, higher proportion of left main or multivessel involvement, heavier coronary lesion burden, and lower balloon inflation pressure (P<0.05). Multivariate logistic regression analysis revealed that age of ≥65 years (odds ratio {OR}=2.34, 95% confidence interval {CI}=1.23-4.46, P<0.01), time from symptom onset to balloon dilation of ≥6 hours (OR=3.12, 95% CI=1.67-5.83, P<0.01), peak cTnI level of ≥100 ng/mL (OR=4.27, 95% CI=2.18-8.36, P<0.01), left main or multivessel involvement (OR=2.86, 95% CI=1.51-5.41, P<0.01), and balloon inflation pressure of <8 atm (OR=3.45, 95% CI=1.79-6.65, P<0.01) were independent risk factors affecting myocardial perfusion. In the intervention analysis, the nicorandil group showed superior post-procedural TIMI blood flow grade, MBG, left ventricular ejection fraction (LVEF), and New York Heart Association (NYHA) functional classification compared to the control group (P<0.05). During a six-month follow-up, the nicorandil group had a lower incidence of major adverse cardiovascular events (MACE) compared to the control group (P<0.05). Conclusion Age, time from symptom onset to balloon dilation, peak cTnI level, extent of coronary artery lesions, and balloon inflation pressure were identified as independent risk factors affecting myocardial perfusion in STEMI patients after PCI. Compared to simple thrombus aspiration, thrombus aspiration combined with nicorandil demonstrated better improvement in myocardial perfusion, cardiac function, and clinical outcomes for patients with impaired perfusion.

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.

Standard Balloon Angioplasty Versus Serranator Serration Balloon Angioplasty for the Treatment of Below-the-Knee Artery Occlusive Disease: A Single-Center Subanalysis From the PRELUDE-BTK Prospective Study

Background: Endovascular interventions in infrapopliteal occlusive artery disease are becoming more complex, and this frequently tests the standard method of treatment, plain old balloon angioplasty (POBA). The potential that serration angioplasty could produce a more acceptable tibial artery lumen was assessed in this study. Aim: The aim of this single-center subgroup analysis was to compare acute angiographic results after endovascular treatment using the Serranator serration balloon catheter in patients participating in the PRELUDE-BTK trial with POBA of the infrapopliteal arteries. A secondary objective was to assess post-treatment hemodynamic improvements. Methods: Our center enrolled 15 subjects and treated 17 lesions within the multicenter prospective core laboratory–adjudicated PRELUDE-BTK study. A 25 lesions analyzed separately were treated with POBA and then compared with the Serranator subset. In both cohorts, lesions were treated with either plain angioplasty or Serranator as a stand-alone therapy; subsequent methods, such as drug elution technologies, were not used. Acute angiographic results were analyzed by the SynvaCor angiographic core laboratory. To assess volumetric flow rates, data were analyzed with a fluid flow simulation software and compared against Poiseuille’s Law. Results: Final residual stenosis was 17.2%±8.2% in the Serranator group versus 33.7%±15.7% in the POBA group. The mean lumen diameter (MLD) gain for the Serranator group and the POBA group was 1.64±0.41 mm and 1.33±0.63 mm, respectively. The average atmospheric balloon inflation pressure was 5 ATM in the Serranator group versus 9 ATM in the POBA group. Neither group required a bailout stent; however, it was notable that there were significantly more chronic total occlusions (CTOs) treated in the Serranator group at 41.2% versus 12% in the POBA group. Regarding the effectiveness in improving hemodynamic blood flow for non-CTO lesions, the calculated average ratio of post-treatment to pre-treatment flow rates in the Serranator group was 238% than that for the POBA group. For CTO cases where pre-treatment flow rate was zero, final residual stenosis was used as the parameter for comparison. The Serranator group showed a 62% improvement in final residual stenosis over POBA. Conclusion: Endovascular treatment of the infrapopliteal arteries by use of the Serranator serration balloon provides a novel and promising method of action compared with standard balloon angioplasty and, thus, may have a leading role in complex below-the-knee arterial lesions. Clinical Impact The Serranator device might help to adequately address issues with conventional routine techniques for the treatment of complex lesions in infrapopliteal arteries in patients with advanced stages of PAD and critical limb ischemia. Integrating modern technologies such as the Serranator balloon catheter into clinical routine is mandatory in order to gain a more favorable outcome in these severely diseased patients and, particularly, to reduce mortality and morbidity.

Incidence and Characteristics of Incomplete Stent Apposition in Calcified Lesions: An Optical Coherence Tomography Study

BackgroundPersistent or late acquired incomplete stent apposition (ISA) may be associated with late or very late stent thrombosis following drug-eluting stent implantation. Presence of calcium at the target lesion may increase the risk of ISA even after rotational atherectomy (RA) followed by stenting with high pressure balloon inflation. The aim of this study is to examine the incidence and characteristics of ISA in heavily calcified lesions. MethodsA total of 52 heavily calcified coronary artery lesions requiring RA plus stenting were selected and studied. After successful ablation followed by stent implantation, optical coherence tomography (OCT) was performed to assess stent expansion and apposition. Presence or absence of ISA was examined and maximal stent strut to vessel wall distance (max SV distance) was measured. In lesions with repeated OCT at follow-up, serial changes in ISA were investigated. ResultsISA was documented in 51 of 52 (98%) lesions. Mean max SV distance was 713 ± 371 μm. In lesions with serial OCT images (n = 11), max SV distance decreased significantly (692.1 ± 420.2 to 462.5 ± 387.0 μm, P < 0.01) but persisted in all but 2 lesions (82%). ConclusionsISA is frequently documented in heavily calcified lesions requiring RA. Significant ISA still persisted with minimal improvement in SV distance at follow-up. Prognostic impact of the persistent ISA in such calcified lesions needs further investigations.

Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study

Purpose: The purpose was to evaluate the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in patients with infrapopliteal peripheral artery disease. Materials and Methods: A prospective, multicenter, single-arm feasibility study in 46 patients with claudication or chronic limb-threatening ischemia, Rutherford Clinical Category (RCC) 3 to 5, that required treatment of the infrapopliteal arteries above the tibiotalar joint. The primary efficacy outcome was device success—successful insertion, balloon inflation and deflation, and removal of the device(s) with a final diameter stenosis of <50%. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) through 30 day postprocedure. Other outcomes were change in RCC and ankle-brachial index, wound healing, and clinically-driven target lesion revascularization (CD-TLR). A subset of 9 patients were further evaluated by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) for the presence of serrations in treated lesions. Patient follow-up occurred at 30 days and 6 months. Results: Forty-six patients received treatment with the Serranator device and 55 lesions were treated. Fifty-three lesions were deemed analyzable by the core lab with data and reported hereafter. Device success was 91.7% and freedom from MALE + POD through 30 days was 95.7%. Pretreatment stenosis of 82% was reduced to 21.8% and only 1 lesion (1.9%) required a bailout stent for a grade D dissection. The average maximum balloon inflation pressure was 6 atmospheres. Serrations were present in all treated lesions (n=10) in 9 patients imaged with OCT/IVUS as reviewed by the core laboratory. The RCC score improved by 1 or more level in 70% of patients at 6 months with 42% having a score of 0. The 6 month freedom from CD-TLR was 97.7%. Conclusion: Serranator treatment of infrapopliteal lesions showed excellent lumen gain with minimal evidence of arterial injury and low 6 month CD-TLR. Imaging by IVUS and OCT showed serrations without significant dissection, supporting the device’s proposed mechanism of action.

Repeated balloon inflation under low pressure may reduce serious adverse events during endoscopic papillary large balloon dilation.

Highlight Kamada and colleagues devised a new technique for effective endoscopic papillary large balloon dilation without high balloon pressure. Advantages of the technique include the prevention of unintentional over-pressurization of the balloon by limiting the balloon inflation pressure and reduced risk of pancreatitis due to continuous pancreatic duct obstruction.

P0884 - Ex-vivo evaluation of intraurethral catheter balloon inflation pressures, urethral diametric strain and rupture thresholds in porcine and human specimens

P0884 - Ex-vivo evaluation of intraurethral catheter balloon inflation pressures, urethral diametric strain and rupture thresholds in porcine and human specimens

Mechanical performances of balloon post-dilation for improving stent expansion in calcified coronary artery: Computational and experimental investigations

Stent deployment in a calcified coronary artery is often associated with suboptimal outcomes such as stent underexpansion and malapposition. Post-dilation after stent deployment is commonly used for optimal stent implantation. There is no guideline for choosing the post-dilation balloon diameter and inflation pressure. In this work, ex-vivo/in-silico experiments were performed to investigate the efficacy of post-dilation balloon diameter and inflation pressure in improving the stent expansion in a calcified lesion. Post-dilations with three balloon diameters (3 mm, 3.5 mm, and 4 mm) were performed. For each balloon diameter, three inflation pressures (10 atm, 20 atm, and 30 atm) were sequentially applied. In ex-vivo experiments, optical coherence tomography images were acquired during the stenting procedure, i.e., pre- and post-deployment of 3 mm diameter stent, as well as after each post-dilation. The results from in-silico experiments were compared with ex-vivo experiments in terms of lumen area. In addition, stretch ratio analysis was developed to predict the stent-induced lumen area, along with the strain analysis and the in-silico experiments. Results have shown that target lumen area could be achieved with an oversized nominal balloon diameter of +0.5 mm (i.e., 0.5 mm greater than reference lumen diameter) at an inflation pressure of 20 atm. After each post-dilation, fibrotic tissue demonstrated a larger strain, contributing to improved lumen gain. However, minimal changes were observed in calcification. Moreover, a strong correlation (R2 = 0.95) between the stretch ratio of fibrotic tissue and lumen area after each post-dilation was observed. This indicated that the morphology of the fibrotic tissue could be a potential marker to predict the lumen gain. The detailed mechanistic quantifications of a single lesion cannot be generalized to all clinical cases. However, this work could be used to provide a fundamental understanding of the post-dilations, to develop experimental protocols for producing generalized guidelines, and to exploit their potential for optimal pre- and post-stent strategies.

Safe balloon inflation parameters for resuscitative endovascular balloon occlusion of the aorta.

Noncompressible hemorrhage is a leading cause of preventable death in civilian and military trauma populations. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a promising method for controlling noncompressible hemorrhage, but safe balloon inflation parameters are not well defined. Our goal was to determine the balloon inflation parameters associated with benchtop flow occlusion and aortic/balloon rupture in ex vivo human aortas and test the hypothesis that optimal balloon inflation characteristics depend on systolic pressure and subject demographics. Aortic occlusion parameters in human thoracic aortas (TAs) and abdominal aortas (AAs) from 79 tissue donors (median ± SD age, 52 ± 18 years [range, 13-75 years]; male, 52; female, 27) were recorded under 100/40, 150/40, and 200/40 mm Hg flow pressures for ER-REBOA and Coda balloons. Rupture tests were done with Coda balloons only without flow. In the TA, the average balloon inflation volumes and pressures resulting in 100/40 mm Hg flow occlusion were 11.7 ± 3.8 mL and 174 ± 65 mm Hg for the ER-REBOA, and 10.6 ± 4.3 mL and 94 ± 57 mm Hg for the Coda balloons. In the AA, these values were 6.2 ± 2.6 mL and 110 ± 47 mm Hg for the ER-REBOA, and 5.9 ± 2.2 mL and 71 ± 30 mm Hg for the Coda. The average balloon inflation parameters associated with aortic/Coda balloon rupture were 39.1 ± 6.5 mL and 1,284 ± 385 mm Hg in the TA, and 27.7 ± 7.7 mL and 1,410 ± 483 mm Hg in the AA. Age, sex, and systolic pressure all had significant effects on balloon occlusion and rupture parameters. Optimal balloon inflation parameters depend on anatomical, physiological, and demographic characteristics. Pressure-guided rather than volume-guided balloon inflation may reduce the risk of aortic rupture. These results can be used to help improve the safety of REBOA procedures and devices.

Factors affecting in-stent restenosis after angioplasty with the Enterprise stent for intracranial atherosclerotic diseases

This study investigated factors affecting the safety and in-stent restenosis after intracranial stent angioplasty using the Enterprise stent for symptomatic intracranial atherosclerotic stenosis. Between January 2017 and March 2019, patients with intracranial atherosclerotic stenosis treated with Enterprise stent angioplasty were enrolled, including 400 patients in the modeling group and 89 patients in the validation group. The clinical factors affecting in-stent restenosis after Enterprise stent angioplasty in the modeling group were analyzed, and a logistic regression model of these factors was established and validated in the validation group. The receiver operating characteristic (ROC) curve and the area under the ROC curve (AUC) were analyzed. In the modeling group with 400 patients, there were 410 lesions, including 360 stenotic lesions and 50 occluded lesions, with 176 (42.9%) lesions in the anterior circulation and 234 (57.1%) in the posterior circulation. Successful stenting was performed in 398 patients (99.5%). Stenosis was significantly (P < 0.05) improved after stenting compared with before stenting (27.7% ± 2.9% vs. 77.9% ± 8.0%). Periprocedural complications included ischemic stroke (3.25%), hemorrhagic stroke (0.75%), and death (0.50%), with a total periprocedural complication rate of 4.0%. The first follow-up angiography was performed in 348 (87.0%) patients with 359 lesions 3.5–14 months (mean 5.7 months) after stenting. In-stent restenosis occurred in 62 (17.3%) lesions, while the other 295 (82.7%) had no restenosis. Lesion location, calcification degree, balloon expansion pressure, residual stenosis, intraprocedural dissection, and cerebral blood flow TICI grade were significant (P < 0.05) risk factors for in-stent restenosis. The in-stent restenosis prediction model was established as follows: P = 1/[1 + e−(−6.070–1.391 location + 2.745 calcification + 4.117 balloon inflation pressure + 2.195 intraprocedural dissection + 1.163 residual stenosis + 1.174 flow TC grade)]. In the validation group, the AUC in the ROC curve analysis was 0.902 (95% CI: 0.836–0.969), and when the cutoff value was 0.50, the sensitivity and specificity of this model were shown to be 76.92% and 80.26%, respectively, in predicting in-stent restenosis at angiographic follow-up, with a total coincidence rate of 79.78%. In conclusion, in-stent restenosis after intracranial Enterprise stenting is affected by stenosis location, calcification, balloon inflation pressure, intraprocedural arterial dissection, residual stenosis, and cerebral flow grade, and establishment of a logistic model with these factors can effectively predict in-stent restenosis.

Inflation Pressure in Side Branch during Modified Jailed Balloon Technique Does Not Affect Side Branch Outcomes.

Objectives This study aimed to investigate the optimal jailed balloon inflation in the side branch during the modified jailed balloon technique for bifurcated lesions. Background The modified jailed balloon technique is one of the effective techniques to minimize the emergence of side branch (SB) compromise by preventing plaque or carina shifting during a single stent strategy in the main vessel with provisional SB treatment. However, there are no detailed studies on the method of optimal jailed balloon inflation. Methods We analyzed 51 consecutive patients who underwent percutaneous coronary intervention (PCI) for bifurcated lesions with a modified jailed balloon technique between September 2018 and December 2020. These 51 patients were divided into two groups according to the magnitude of inflation pressure of the jailed balloon: a higher pressure (HP) group and lower pressure (LP) group. Results No significant differences in procedural outcomes were observed between the two groups. The findings of SB compromise were relatively common with our procedure (30.0% in the HP group; 33.3% in the LP group). The patterns of SB compromise such as dissection or stenosis increase were observed at similar frequencies between them. In particular, SB dissection was noted in the SB lesion with some plaque burden, irrespective of the magnitude of the jailed balloon inflation pressure. Univariate analysis showed that calcification in the main vessel and SB lesion length was significantly associated with SB compromise. Finally, all PCI procedures were successfully completed without any provisional stent deployment in SB. Conclusions We speculate that lesion characteristics rather than the PCI procedural factors may be critical determinants to cause SB compromise.

A retrospective cohort study comparing high and low balloon inflation pressure on technical success and patency for treating central venous lesions in patients on chronic hemodialysis

Background We aimed to analyze the success rates and the access patency rates at 12 months between patients on chronic hemodialysis with symptomatic central venous stenosis (CVS) or occlusion (CVO), receiving high or low balloon inflation pressure for treatment. Methods We performed a retrospective study in which angioplasty balloons were inflated using a low-pressure or a high-pressure for the management of hemodialysis patients with CVS/CVO. The outcomes of this study were the success rate and the access patency rates at 12 months after balloon angioplasty, and the differences between groups were compared. Results We included a total of 74 patients on hemodialysis and assigned them to the low-pressure or the high-pressure groups. Success rates in patients of the high-pressure group (94.12%) were higher than those in patients of the low-pressure group (67.50%) (p = 0.005). With a total of 59 patients with technical success, at 6 and 12 months after angioplasty, the rates of access patency in the low-pressure group were 68 and 48%, respectively; on the other hand, the primary patency rates in the high-pressure group were 86.67% (6-months) and 76.67% (12-months). The 6 and 12 months post-interventional patency rates were higher in patients of the high-pressure group than those in patients of the low-pressure group (p = 0.10 at 6 months and p = 0.03 at 12 months). Conclusions Compared to balloon angioplasty using a low inflation pressure, hemodialysis patients with CVS/CVO receiving angioplasty using a high inflation pressure have significantly higher technical success and 12-month patency rates.

Restoring arteriovenous access: Pilot study using a scoring balloon in 50 patients.

Arteriovenous access failure is most often due to the development of neointimal hyperplastic stenoses. Balloon angioplasty remains standard of care for endovascular treatment of stenoses obstructing blood flow in hemodialysis fistulas and grafts. Scoring balloon technologies have been developed to disrupt the atheromatous plaque and have shown to be safe and effective for treating stenosis in the hemodialysis access circuit. However, improvement in patency has yet to be established. This prospective, single-arm study included 50 patients with stenosed hemodialysis fistula/grafts treated with the AngioSculpt® scoring balloon (Philips) and followed for 6 months. The primary endpoint was target lesion primary patency at 2 and 6 months defined as freedom from re-intervention. Treatment with the scoring balloon resulted in a reduction in stenosis from 78% ± 13.36% to 7.2% ± 7.57% (mean ± standard deviation). Scoring balloon inflation pressures averaged 11.4 atm; no slippage/dissections occurred. After 2 months, 10% of patients required re-intervention. At 6 months, 19% of patients required re-intervention. The 6-month freedom from re-intervention rate was higher for patients with stenosed fistulas (83.3%) compared to patients with stenosed grafts (71.4%). Six-month patency rates were highest for patients with no or one previous intervention (91.6% and 90.0%, respectively); patients with two to five preceding interventions had a 6-month patency rate of 80%, and those with more than five previous interventions had a 50% 6-month patency rate. Results from this pilot study suggest that the AngioSculpt scoring balloon may be a viable treatment option for stenosed arteriovenous fistula/graft access.

Catheter Balloon-trauma: Design, Development, and Ex-vivo Studies Using Intact Human Penis Specimens

To present a novel urethral catheter design with a pilot balloon to reduce intraurethral retention balloon inflation pressures and to provide a visual alert during catheter placement. We manufactured our pilot balloon prototype from both molded and extruded silicone components. Various pilot balloon thicknesses were tested in order to determine the ideal compliance. We studied the filling pressures of the retention balloon of our prototype in a mechanical urethral model. The prototype catheter was then tested in ex-vivo human penis specimens obtained from gender affirming surgery and changes in the size of the retention balloon were measured under fluoroscopy. The thickness of the pilot balloon was directly related to the inflation pressure of the retention balloon in the mechanical urethral model. The thickness chosen for the pilot balloon in our prototype was based on a retention balloon pressure of 70 kPa. In the ex-vivo human penis model, the presence of the pilot balloon resulted in a 40% reduction in the cross-sectional area of the retention balloon compared to a standard urinary catheter. The prototype urinary catheter appears to decrease the filling pressure and size of an improperly positioned retention balloon inside a urethra. This can potentially reduce the risk of iatrogenic urethral catheter injuries. In addition, the prototype urinary catheter may act as a visual warning sign for the healthcare practitioner.

The influence of angioplasty balloon sizing on acute post-procedural outcomes: a Finite Element Analysis.

Atherosclerosis is one of the most common vascular pathologies in the world. Among the most commonly performed endovascular treatments, percutaneous transluminal angioplasty (PTA) has been showing significantly positive clinical outcomes. Due to the complex geometries, material properties and interactions that characterize PTA procedures, finite element analyses of acute angioplasty balloon deployment are limited. In this work, finite element method (FEM) was used to simulate the inflation and deflation of a semi-compliant balloon within the 3D model of a stenosed artery with two different plaque types (lipid and calcified). Self-defined constitutive models for the balloon and the plaque were developed based on experimental and literature data respectively. Balloon deployment was simulated at three different inflation pressures (10, 12 and 14 atm) within the two plaque types. Balloon sizing influence on the arterial elastic recoil obtained immediately after PTA was then investigated. The simulated results show that calcified plaques may lead to higher elastic recoil ratios compared to lipid stenosis, when the same balloon inflation pressures are applied. Also, elastic recoil increases for higher balloon inflation pressure independent of the plaque type. These findings open the way for a data-driven assessment of angioplasty balloon sizing selection and clinical procedures optimization.Clinical Relevance- The FE model developed in this work aims at providing quantitative evaluation of recoil after balloon angioplasty. It may be useful for both manufacturers and clinicians to improve efficiency of angioplasty balloon device design and sizing selection with respect to plaque geometry and constitution, consequently enhancing clinical outcomes.

CRT-300.03 The Impact of Maximum Balloon Inflation Pressure on Stent Expansion as Measured by the Volumetric Method

Traditional stent expansion is based on the smallest cross-sectional lumen area within the stented segment and references. Unfortunately, the traditional methodology does not take into account vessel tapering and side branches. A recently developed optical coherence tomography (OCT) methodology with

Blood Pressure Monitoring During Intra-Aortic Balloon Pumping.

Blood Pressure Monitoring During Intra-Aortic Balloon Pumping.