Distal Balloon Research Articles

Preclinical evaluation of a novel endovascular thrombectomy device in a modified swine model for iliac vein thrombosis

ObjectiveTo evaluate the safety and efficacy of a novel endovascular thrombectomy device in a modified swine model of iliac vein thrombosis. MethodsA modified swine model for iliac vein thrombosis was created using proximal‒distal balloon occlusion combined with autologous venous thrombus and thrombin injections. The safety and efficacy of the newly developed Zylox endovascular thrombectomy system were evaluated in this animal model and its performance was compared with that of the AcoStream aspiration thrombectomy device. ResultsBilateral iliac vein thrombosis models were successfully created in 12 swine, with 23 iliac veins used for device testing and one for anatomical observation. The thrombus length in the Zylox group was greater than in the AcoStream group (98.42 ± 17.56 mm vs. 84.12 ± 13.30 mm), while thrombus scores were not significantly different between the two groups. Although Grade I thrombus clearance was achieved in all iliac veins in both groups, blood loss in the Zylox group was significantly less than in the AcoStream group (81.09 ± 27.26 ml vs. 162.50 ± 61.96 ml, P < 0.001). Three swine (6 iliac veins) in each group underwent repeat venography evaluations 28 days postthrombectomy, showing that all the veins were patent without any rethrombosis. Histopathologic evaluation immediately and 28 days postthrombectomy revealed no differences between the two groups. No complications or deaths occurred in the swine during the entire process. ConclusionThe current modified swine model is stable, reproducible, and appropriate for testing endovascular devices. This study preliminarily verified the safety and efficacy of the Zylox thrombectomy system for thrombus removal in this animal model and demonstrated its advantage in controlling blood loss. Future randomized controlled trials in humans are needed to further verify the safety and efficacy of the device.

Prophylactic Radiologic Interventions for Postpartum Hemorrhage Control in Women With Placenta Accreta Spectrum Disorder: A Systematic Review and Meta-analysis.

To quantify the association between prophylactic radiologic interventions and perioperative blood loss during cesarean delivery in women with placenta accreta spectrum disorder through a systematic review and network meta-analysis. On January 3, 2023, a literature search was conducted in PubMed, EMBASE, Cochrane Library, and Web of Science. We also checked ClinicalTrials.gov retrospectively. Prophylactic radiologic interventions to reduce bleeding during cesarean delivery involved preoperative placement of balloon catheters, distal (internal or common iliac arteries) or proximal (abdominal aorta), or sheaths (uterine arteries). The primary outcome was volume of blood loss; secondary outcomes were the number of red blood cell units transfused and adverse events. Studies including women who received an emergency cesarean delivery were excluded. Two authors independently screened citations for relevance, extracted data, and assessed the risk of bias of individual studies with the Cochrane Risk of Bias in Non-randomized Studies of Interventions tool. From a total of 1,332 screened studies, 50 were included in the final analysis, comprising 5,962 women. These studies consisted of two randomized controlled trials and 48 observational studies. Thirty studies compared distal balloon occlusion with a control group, with a mean difference in blood loss of -406 mL (95% CI, -645 to -167). Fourteen studies compared proximal balloon occlusion with a control group, with a mean difference of -1,041 mL (95% CI, -1,371 to -710). Sensitivity analysis excluding studies with serious or critical risk of bias provided similar results. Five studies compared uterine artery embolization with a control group, all with serious or critical risk of bias; the mean difference was -936 mL (95% CI, -1,522 to -350). Reported information on adverse events was limited. Although the predominance of observational studies in the included literature warrants caution in interpreting the findings of this meta-analysis, our findings suggest that prophylactic placement of balloon catheters or sheaths before planned cesarean delivery in women with placenta accreta spectrum disorder may, in some cases, substantially reduce perioperative blood loss. Further study is required to quantify the efficacy according to various severities of placenta accreta spectrum disorder and the associated safety of these radiologic interventions. PROSPERO, CRD42022320922.

Tumor Embolization via the Meningohypophyseal and Inferolateral Trunk in Patients with Skull Base Tumors Using the Distal Balloon Protection Technique.

Tumor embolization through the meningohypophyseal trunk and inferolateral trunk is known to be effective in skull base tumors; however, microcatheter cannulation into these arteries is difficult, and the number of cases that can be safely embolized is limited. In this study, we present a novel embolization procedure for the meningohypophyseal trunk and inferolateral trunk using the distal balloon protection technique and detail its clinical efficacy and complication risks. We developed this procedure to allow safe embolization in patients who cannot be adequately cannulated with microcatheters into these arteries. Patients who underwent meningohypophyseal trunk or inferolateral trunk embolization using the distal balloon protection technique for skull base tumors at our institution between 2010 and 2023 were included. In this procedure, the ICA was temporarily occluded with a balloon at the ophthalmic artery bifurcation, the microcatheter was guided to the meningohypophyseal trunk or inferolateral trunk vicinity, and embolic particles were injected into the arteries. The balloon was deflated after the embolic particles that had refluxed into the ICA were aspirated. A total of 25 meningohypophyseal trunks and inferolateral trunks were embolized during 21 operations. Of these 25 arteries, only 9 (36.0%) were successfully cannulated with microcatheters. Nevertheless, effective embolization was achieved in all cases. Permanent complications occurred in only 1 case (4.8%) in which the central retinal artery was occluded during inferolateral trunk embolization, resulting in a visual field defect. No permanent complications resulting from the embolic cerebral infarction were observed. Of 16 cases that underwent MR imaging within a week after embolization, however, 11 (68.8%) demonstrated embolic cerebral infarctions. In patients with skull base tumors with meningohypophyseal trunk or inferolateral trunk feeders that cannot be catheterized directly, embolization using the distal balloon protection technique for tumor supply can be considered as a salvage technique.

The Current Status of Endovascular Treatment for Extracranial Vertebral Artery Stenosis in Japan: A Subanalysis of the Japanese Registry of Neuroendovascular Therapy 4.

Endovascular treatment (EVT) is a potential therapeutic option for extracranial vertebral artery (VA) stenosis; however, its efficacy or optimal procedures remain unknown. This study aimed to investigate the recent status of EVT for extracranial VA stenosis in Japan using a nationwide registry. We conducted a post hoc analysis of the Japanese Registry of Neuroendovascular Therapy 4 that enrolled patients who underwent EVT at 166 hospitals in Japan from 2015 to 2019. The outcomes of this study were as follows: procedural success indicating that the planned procedure was completed, modified Rankin Scale (mRS) score at 30 days, and procedure-related complications evaluated according to the procedure during EVT (percutaneous transluminal angioplasty vs. stenting and with or without the use of embolic protection devices [EPDs]). Of 308 eligible patients, 301 (95%) were treated for atherosclerotic stenosis, predominantly by stenting (74%). EPDs were used in 43%, primarily with the distal balloon (63%). The proportion of procedural success was 98%. Functional independence (mRS of 0-2) at 30 days was achieved in 80% of the total cohort, and there were no differences between patients treated with or without stenting or EPDs (74% vs. 82%, p = 0.12, and 80% vs. 80%, p = 0.93). Procedural complications occurred in 28 (9.1%) patients similarly in each group, with distal embolism and vessel dissection being common. In conclusion, EVT is a reasonable option for extracranial VA stenosis as a daily clinical practice. This study emphasizes the potential of EVT in managing extracranial VA stenosis and the need for further research to refine treatment strategies.

TCT-365 Comparison of Distal Filter Protection Versus Proximal Balloon Occlusion for Carotid Artery Stenting: Results From a Registry of 2,180 Patients

TCT-365 Comparison of Distal Filter Protection Versus Proximal Balloon Occlusion for Carotid Artery Stenting: Results From a Registry of 2,180 Patients

Successful simultaneous retrieval of two dislodged and entangled intracoronary stents using distal balloon inflating technique

Stent loss in coronary arteries is a rare complication of coronary intervention. Furthermore, the entanglement of a lost stent with a second previously deployed stent leading to a very complicated scenario has not been reported previously. In this case, we are presenting the first case report of a stent loss due to the entanglement of a stent with the ostial part of the second already deployed side branch stent leading to distortions of the second stent and entrapment. This is also the first case report describing the successful and simultaneous retrieval of both the lost and entangled deployed stents percutaneously using the distal inflating balloon technique.

Mortality after radial-only balloon aortic valvuloplasty: a long-term follow-up and a bridge-to-TAVI analysis

Abstract Background The benefits of distal radial balloon aortic valvuloplasty were recently reported: same efficacy as the classical femoral approach, with no vascular complications. The long-term outcomes for these patients remain unknown. Methods We retrospectively analyzed the long-term mortality and the impact of TAVI in a cohort of 30 patients who underwent distal radial (DR) BAV. Results The mean age was 78.3 ± 7.14 years and the median follow-up was 22.8 months. The indication for BAV was stable aortic stenosis in 70% of patients, while 23% of patients had concomitant acute heart failure symptoms and 6.6% of patients were in cardiogenic shock. A total of 16 patients (53.3%) received TAVI during follow-up after their BAV procedure while the remainder only received BAV. All-cause mortality was 20%, with only 1 death (6.3%) in the “BAV + TAVI” group compared to 5 deaths (35.7%) in the “BAV only” group (p = 0.089). All of the TAVI procedures were performed within 7 months after BAV. Cumulative incidence of TAVI was 40.0% at 5 months and 50.0% at 10 months. Cumulative incidence of death was 6.7% at 5 months, 13.3% at 10 months, 16.7% at 15 months, and 20.0% at 25 months. The probability of being alive without TAVI decreased from 53.3% at 5 months to 30.0% at 25 months. Conclusion In the present study, we could show that half of the patients undergoing BAV eventually need TAVI, most of them within 5 months after BAV, and that BAV remains associated with high mortality after the procedure, with 35% of those undergoing isolated BAV dying during short-term follow-up.

Detection of the Vesical Arteries Using Three-dimensional Digital Subtraction Angiography Relevant to Intra-arterial Infusion Chemotherapy for Bladder Cancer Using Double-balloon Catheters.

This study aims to assess and measure the origin of the superior vesical artery and its distance from the anterior trunk of the internal iliac artery, to which the anticancer drug is infused via double-balloon-occluded arterial infusion bladder-preserving therapy for locally invasive bladder cancer. The 160 pelvic sides of 80 patients were analyzed. Double-balloon catheters were bilaterally introduced into the contralateral superior gluteal artery via the internal iliac arteries using a bilateral transfemoral approach. The proximal balloon is placed at the internal iliac artery, proximally from superior gluteal artery bifurcation, whereas the distal balloon at the origin of the superior gluteal artery to isolate the anterior trunk of the internal iliac artery discharging to the targeted vesical arteries between the balloons. The side hole between the distal and proximal balloons was adjusted at the origin of the anterior trunk of the internal iliac artery to allow clear visualization of the angiographic flow into the bladder. After the distal and proximal balloons were inflated, three-dimensional rotational digital subtraction angiography was performed by simultaneous contrast injection from one extension tube connected to bilateral catheters. The distance (X) between the origins of anterior trunk of the internal iliac artery and superior vesical artery was measured on three-dimensional digital subtraction angiography images, and the origin of the inferior vesical artery was investigated. All superior vesical artery originated from anterior trunk of the internal iliac artery. The mean x was 7.2 mm (range 1.0-22.0 mm). All inferior vesical arterys branched from anterior trunk of the internal iliac artery or its branches. Superior vesical artery commonly originates from the proximal portion of anterior trunk of the internal iliac artery close to superior gluteal artery bifurcation.

Distal Balloon Inflation Technique - A Bailout Method of Difficulty in Crossing Balloon-Expandable Valve Delivery System Due to Unfavorable Guidewire Position During Transcatheter Aortic Valve Replacement.

Distal Balloon Inflation Technique - A Bailout Method of Difficulty in Crossing Balloon-Expandable Valve Delivery System Due to Unfavorable Guidewire Position During Transcatheter Aortic Valve Replacement.

A phantom study: Evaluation of a novel three-lumen balloon catheter for potential treatment of intractable limb ischemia.

Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease (PAD) which induces extremity rest pain, extremity gangrene or ulcers that mostly might lead to limb loss. One of the most common criteria of CLI is 50 mmHg or less systolic ankle arterial pressure. In this study, a custom made three-lumen catheter (9 Fr) including a distal inflatable balloon in between the inflow and outflow lumen holes was designed and fabricated based on the patented design of Hyper Perfusion Catheter. The proposed catheter design aims to increase ankle systolic pressure to 60 mmHg or more to promote healing and/or alleviating severe pain due to intractable ischemia for patients with CLI. To simulate the blood circulation of related anatomy, in vitro CLI model phantom was designed and constructed by using a modified hemodialysis circuit, a hemodialysis pump and a tube set for cardio-pulmonary bypass surgery. A blood mimicking fluid (BMF) with dynamic viscosity of 4.1 mPa.s was used at 22 ºC to prime the phantom. The data was collected by a custom-made circuit design in real time and all measurements were verified with commercial certificated medical devices. The results of in vitro CLI model phantom experiments have shown that it is feasible to elevate the pressure distal to the occlusion (representing ankle pressure) above 80 mmHg without affecting the systemic pressure.

Abstract Number ‐ 67: A case of Carotid blowout syndrome, case report, and review.

Introduction Carotid blowout syndrome (CBS) is a potentially fatal carotid artery rupture. It is an unforeseen complication during mechanical thrombectomy that can be catastrophic without timely diagnosis and intervention. CBS develops when a damaged arterial wall cannot sustain its integrity, especially in patients who have undergone surgery or radiotherapy due to cancer. Carotid blowout syndrome is classified as threatened (type1), impending (type2), and acute (type3). Endovascular techniques have emerged as preferable alternatives to surgical ligation for treatment of CBS. Previous systemic reviews and meta‐analyses demonstrated that both coil embolization and stent grafting may be safe treatment options for CBS. This case study aims to show that early detection and endovascular management with transient distal balloon occlusion and stenting are lifesaving measures. Methods Case‐report Results Case presentation: 60‐year‐old male with past medical history of lung cancer s/p chemotherapy and radiation, hypertension, and methamphetamine abuse presented with left‐sided weakness and dysarthria, onset was 2 hours prior to arrival, his NIHSS was 11, CT head was negative for hemorrhage, CT angiogram of head and neck showed tandem occlusion of right ICA and right MCA bifurcation, he was in window for intravascular thrombolysis without contraindication, so he received Alteplase, he was brought into Angio‐suite for mechanical thrombectomy, On Right CCA injection there was complete occlusion of Right ICA with TICI‐0 flow, distal branches of Right ACA and MCA were not visualized. Mechanical thrombectomy was done on Right ICA and Right MCA. During clot retrieval, flow arrest was achieved by inflating the balloon guide with diluted contrast. Post thrombectomy there was extravasation around the right CCA and ICA, so the balloon guide was reinflated to have a florist around the catheter and hemostasis in the right ICA, two carotid stents were deployed sequentially with rapid exchange technique with overlapping technique, an endovascular graft was introduced and deployed at mid cervical segment at the point of leak and dissection. Post mechanical thrombectomy, TICI‐3 flow in the right ICA, and MCA were achieved, the patient was discharged to rehab in a stable condition on dual antiplatelet regimen. Conclusions CBS is a rare complication during mechanical thrombectomy, early and aggressive intervention in CBS is crucial to prevent devastating consequences, Transient balloon occlusion distal to the carotid blowout of the ICA is a reasonable technique for completing endovascular management with stenting.

Endoaortic Balloon Occlusion in Totally Endoscopic and Percutaneous Robotic Cardiac Surgery.

Previous studies have shown that the endoaortic balloon occlusion (EABO) can provide satisfactory aortic cross-clamping with comparable surgical outcomes to thoracic aortic clamping in the setting of minimally invasive and robotic cardiac surgery. We described our approach to EABO use in totally endoscopic and percutaneous robotic mitral valve surgery. Preoperative computed tomography angiography is required to evaluate the quality and size of the ascending aorta, identify access sites for peripheral cannulation and endoaortic balloon insertion, and screen for other vascular anomalies. Continuous bilateral upper extremity arterial pressure and cranial near-infrared spectroscopy monitoring are essential to detect obstruction of the innominate artery due to distal balloon migration. Transesophageal echocardiography is needed for continuous monitoring of balloon positioning and antegrade cardioplegia delivery. Direct fluorescent visualization of the endoaortic balloon on the robotic camera allows for verification of balloon and efficient repositioning if needed. The surgeon should assess hemodynamic and imaging information simultaneously during the balloon inflation and delivery of antegrade cardioplegia. Aortic root pressure, systemic blood pressure, and balloon catheter tension affect the position of the inflated endoaortic balloon in the ascending aorta. The surgeon should eliminate all slack in the balloon catheter and lock it into position to prevent proximal balloon migration after the completion of antegrade cardioplegia. Using scrupulous preoperative imaging assessment and continuous intraoperative monitoring, the EABO can achieve adequate cardiac arrest in totally endoscopic robotic cardiac surgery, even in patients with previous sternotomy without compromise of surgical outcomes.

Embolic protection devices for carotid artery stenting: A network meta-analysis.

Carotid artery stenting (CAS) is an alternative treatment option for patients at high risk for carotid endarterectomy (CEA) but has been correlated with increased risk for distal embolization and periprocedural stroke despite the use of adjunctive embolic protection devices (EPD). This study compared four types of EPDs and their intra and periprocedural related complications. A systematic review of the literature was conducted in PubMed/Medline to identify studies that investigated the outcomes of CAS with adjuvant use of EPDs, including Proximal Balloon (PB), Distal Filter (DF), and Distal Balloon (DB) strategy. Continuous flow reversal performed via transcarotid approach by a commercially available device as an embolic protection strategy was intentionally excluded based on its distinct procedural characteristics and lack of availability outside of the United States. This network meta-analysis was performed according to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Overall, 45 studies, consisting of 7600 participants satisfied the predetermined search criteria and were included in this network meta-analysis. Overall, 13 studies provided data regarding the number of patients with new ischemic lesions detected in the DW-MRI. DF (OR: 3.15; 95% CI: 1.54-6.44; p = 0.002) and DB (OR: 2.28; 95% CI: 1.58-3.29; p < 0.001) were associated with higher odds of new ischemic lesions compared to PB on DW-MRI imaging. No statistical difference was identified between DB versus DF groups (OR: 1.48; 95% CI: 0.73-2.59; p = 0.317). 36 and 27 studies reported on periprocedural stroke and transient ischemic attack (TIA) rates, respectively, showing similar odds of neurologic adverse events between all three groups. PB deployment during CAS is superior to DF and DB in preventing distal embolization phenomena. However, no statistically significant difference in TIA and stroke rate was found among any of the analyzed EPD groups. Further research is warranted to investigate the association of embolic phenomena on imaging after CAS with clinically significant neurologic deficits.

New Distal Balloon Protection System for Transradial Carotid Artery Stenting After Percusurge Guardwire Withdrawal: Jailbreak Technique

Embolic protection devices are commonly used to prevent cerebral embolism during carotid artery stenting (CAS). However, the PercuSurge Guardwire device, a distal balloon protection device, was discontinued in April 2021. We present a case of successful CAS using a new distal balloon protection system. The procedure, referred to as the jailbreak technique, was performed via transradial access. A 67-year-old man underwent CAS, using the jailbreak technique, for right carotid stenosis with a vulnerable plaque. 6-French (Fr) and 4-Fr Simmons guiding sheaths were delivered into the right common carotid artery via the right and left transradial access, respectively. Distal balloon protection was provided using a 2.6-Fr dual-lumen balloon microcatheter (Pinnacle Blue 20, Tokai Medical Products, Aichi, Japan) via the 4-Fr Simmons guiding sheath. A 4.2-Fr catheter was coaxially delivered proximal to the balloon and distal to the lesion. After CAS was successfully performed via the 6-Fr Simmons guiding sheath, the Pinnacle Blue 20 was retrieved through the 4.2-Fr catheter without interfering with the distal stent flare and stent struts. Postprocedural neuroimaging revealed no evidence of ischemic stroke. The jailbreak technique allows distal balloon protection during transradial CAS. This is a useful treatment option for patients with carotid stenosis.

Balloon-Assisted Coil Embolization and Balloon Angioplasty for Post Subarachnoid Hemorrhage Vasospasm: Initial Experience with Scepter Mini Balloon.

The scope of this technical note is to report our experience with balloon remodeling for wideneck aneurysms and balloon angioplasty of post-subarachnoid hemorrhage vasospasm using the novel Scepter Mini balloon (SMB). Five cases were treated with balloon remodeling for aneurysmal subarachnoid hemorrhage, 2 of which were additionally treated with angioplasty due to post-bleeding vasospasm. All patients had their aneurysm located on parent vessels with a diameter smaller than 2 mm. Complete occlusion was noted in all aneurysms, and the patients had no short-term complications attributed to the catheterization. Additionally, we confirm the previously reported smooth navigation of the balloon through vessels with tortuous anatomy without catheter-induced vasospasm. Based on our experience, the SMB can be a safe and efficient device for applying the balloon remodeling technique for distally located wide-neck aneurysms and distal balloon angioplasty.

A Soft Robotic Balloon Endoscope for Airway Procedures.

Soft robots can provide advantages for medical interventions given their low cost and their ability to change shape and safely apply forces to tissue. This article explores the potential for their use for endoscopically-guided balloon dilation procedures in the airways. A scalable robot design based on balloon catheter technology is proposed, which is composed of five balloons together with a tip-mounted camera and LED. Its design parameters are optimized with respect to the clinical requirements associated with balloon dilation procedures in the trachea and bronchi. Possessing a lumen to allow for respiration and powered by the pressure and vacuum sources found in a clinical procedure room, the robot is teleoperated through the airways using a game controller and real-time video from the tip-mounted camera. The robot design includes proximal and distal bracing balloons that expand radially to produce traction forces. The distal bracing balloon is also used to perform balloon dilation. Three actuation balloons, located between the bracing balloons, produce elongation and bending of the robot body to enable locomotion and turning. An analysis of the actuation balloons, which incorporate helical coils to prevent radial collapse, provides design formulas by relating geometric parameters to such performance criteria as maximum change in actuator length and maximum robot bending angle. Experimental evaluation of a prototype robot inside rigid plastic tubes and ex vivo porcine airways is used to demonstrate the potential of the approach.

Endovascular Transcarotid Artery Revascularization Using the Walrus Balloon Guide Catheter: Preliminary Experience

The Walrus Balloon Guided System Catheter is a new generation of balloon guide catheter (BGC) designed to bypass some technical limitations of conventional BGC devices. Their utility in cervical carotid disease treatment has not been reported. We report our preliminary experience in cervical carotid treatment using the Walrus BGC to perform a modified endovascular transcarotid artery revascularization technique. Patients with cervical carotid disease undergoing endovascular treatment using the Walrus BGC at our institution were identified. The pertinent baseline demographics and procedural outcomes were collected and analyzed. Twelve patients were included (median age, 70; 58.3% females). All patients had an imaging-confirmed cervical carotid disease that indicated intervention: 6 with high-grade cervical arteriosclerotic carotid stenosis, 2 with intraluminal thrombi, 1 with traumatic carotid dissection, and 3 patients with cervical carotid tandem occlusion along with acute ischemic stroke secondary to large vessel occlusion that required mechanical thrombectomy. Carotid artery stenting was performed in all cases, except 2 of the 3 mechanical thrombectomy cases (angioplasty only). All patients had at least periprocedural follow-up of 30 days, with no stroke, myocardial infarction, or death encountered. We describe a modified endovascular transcarotid artery revascularization technique. We used a standard femoral access to navigate the Walrus catheter in the common carotid artery, followed by balloon inflation for proximal flow arrest or flow reversal (when connected to the aspiration pump) to deploy the carotid stent across the stenosis, while avoiding distal external carotid artery balloon occlusion. Successful treatment was achieved inall cases, with no periprocedural complications encountered.

Influence of balloon location during proximal optimization technique (POT): A finite element analysis

Proximal Optimization Technique (POT)is a post-expansion technique that must be completed after single-stent implantation for the coronary bifurcation. The optimal location for the distal balloon shoulder during POT remains debatable. In the present study, the finite element method is applied to simulate POT after single-stent implantation in the coronary bifurcation. Three different balloon locations based on the distal shoulder relative to the carina cut plane were analyzed: 1) “proximal”:1mm before carina cut plane; 2) “standard”: at the carina cut plane; and 3) “distal”: 1 mm after the carina cut plane. The computational results showed differences in stent, vessel morphology, and vessel wall stress due to the different balloon locations. However, when distal balloon shoulder was located between two adjacent stent rings, it formed the distal cell of the stent, the best stent apposition, least stent structs obstruction at SB ostial. Moreover, best opening effect of distal cell of the stent can be achieved, with the least damage to the vessel wall.

Intensive therapies of delayed cerebral ischemia after subarachnoid hemorrhage: a propensity-matched comparison of different center-driven strategies.

Intensive therapies of delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) have still controversial and unproven benefit. We aimed to compare the overall efficacy of two different center-driven strategies for the treatment of DCI respectively with and without vasospasm angioplasty. Two hundred consecutive patients with aSAH were enrolled in each of two northern European centers. In an interventional center, vasospasm angioplasty was indicated as first line rather than rescue treatment of DCI using distal percutaneous balloon angioplasty technique combined with intravenous milrinone. In non-interventional center, induced hypertension was the only intensive therapy of DCI. Radiological DCI (new cerebral infarcts not visible on immediate post-treatment imaging), death at 1month, and favorable outcome at 6months (modified Rankin scale score ≤ 2) were retrospectively analyzed by independent observers and compared between two centers before and after propensity score (PS) matching for baseline characteristics. Baseline characteristics only differed between centers for age and rate of smokers and patients with chronic high blood pressure. In the interventional center, vasospasm angioplasty was performed in 38% of patients with median time from bleeding of 8days (Q1 = 6.5;Q3 = 10). There was no significant difference of incidence of radiological DCI (9% vs.14%, P = 0.11), death (8% vs. 9%, P = 0.4), and favorable outcome 74% vs. 72% (P = 0.4) between interventional and non-interventional centers before and after PS matching. Our results suggest either that there is no benefit, or might be minimal, of one between two different center-driven strategies for intensive treatment of DCI. Despite potential lack of power or unknown confounders in our study, these results question the use of such intensive therapies in daily practice without further optimization and validation.

Paradise™Ultrasound Renal Denervation System for the treatment of hypertension.

Catheter-based renal denervationis a novel treatment approach for patients with hypertension and initial unblinded trials have shown promising results. The Paradise™Ultrasound Renal Denervation System (ReCor Medical, CA, USA) is an ultrasound-based catheter with a distal balloon that acts as a coolant to protect the renal arterial wall. This device received CE-mark in 2012. Randomized, sham-controlled trials and postmarket studies have shown promising efficacy and safety results. Currently, three additional ongoing randomized, sham-controlled trials are underway in the USA, Europe, Japan and Korea, and the results will be pivotal in device approval in some of these countries. These studies with larger numbers of patients and longer duration of follow-up are needed to further confirm the safety and efficacy of this device.