Invasive Endovascular Procedures Research Articles

Anemia to Median Nerve Palsy.

Mesenteric angina has a high mortality rate. Occlusion of the superior mesenteric artery is the most common cause. Increasingly, it is managed endovascularly instead of by open revascularization. Despite the lower risk of complications in minimally invasive procedures, it is important to be mindful of long-term sequelae of minor complications. Patient education regarding risks and complications is paramount for better clinical outcomes. The risks of transbrachial angiography procedures are low. Postprocedural vigilance for interventionists and written educational advice to patients are paramount in all minimally invasive endovascular procedures, especially because most of these patients with a complication require urgent operative correction.

The Double Burden: Deciphering Chronic Limb-Threatening Ischemia in End-Stage Renal Disease

ObjectivesChronic Limb-Threatening Ischemia (CLTI) in patients with End-Stage Renal Disease (ESRD) poses significant challenges in clinical management due to its unique pathology and poor treatment outcomes. This review calls for a tailored classification and risk assessment for these patients to guide better revascularization choices with early minor amputation as a first-line strategy in advanced stages. MethodsThis review consolidates key findings from recent literature on CLTI in ESRD, focusing on disease mechanisms, treatment options, and patient outcomes. It evaluates the literature to clarify the decision-making process for managing CLTI in ESRD. ResultsCLTI in ESRD patients often results in worse clinical outcomes, such as non-healing wounds, increased limb loss, and higher mortality rates. While the literature reveals ongoing debates regarding the optimal revascularization method, recent retrospective studies and meta-analyses suggest potential benefits of Endovascular Treatment (EVT) over Open Bypass Surgery (OB) in reducing mortality and wound complications, with comparable Amputation-free Survival rates. ConclusionsThe selection of revascularization methods in ESRD patients with CLTI is complex, necessitating individualized strategies. The importance of early detection and timely intervention is critical to decelerate disease progression and improve revascularization outcomes. There is a shift in these treatments strategies towards less invasive endovascular procedures, acknowledging the limitations these patients face with open revascularization surgeries. Considering early minor amputations after revascularization could prevent worse consequences, reflecting a shift in the approach to managing CLTI in ESRD patients.

Characterization of a 3D Printed Endovascular Magnetic Catheter

Minimally invasive endovascular procedures rely heavily on catheter devices. However, traditional catheters lack active steering requiring considerable skill on the surgeon’s part to accurately position the tip. While catheter tips could be made steerable using tendon-driven and Pneumatic Artificial Muscle (PAM) approaches, remote magnetic actuation is uniquely suited for this task due to its safety, controllability, and intrinsic miniaturization capabilities. Soft composite magnetic materials feature embedding distributed magnetic microparticles compared with attaching discrete permanent magnets proving beneficial in steerability and control. This work demonstrates the fabrication of a soft hollow magnetic tip that can be attached to a catheter to make the assembly steerable. The catheter tip is extensively characterized in terms of bending hysteresis, bending force, and dynamic response. The catheter showed average hysteresis between 5% and 10% and bending forces up to 0.8 N. It also showed a good dynamic response by changing its bending angle in <200 ms under a step response.

A multifunctional soft robot for cardiac interventions.

In minimally invasive endovascular procedures, surgeons rely on catheters with low dexterity and high aspect ratios to reach an anatomical target. However, the environment inside the beating heart presents a combination of challenges unique to few anatomic locations, making it difficult for interventional tools to maneuver dexterously and apply substantial forces on an intracardiac target. We demonstrate a millimeter-scale soft robotic platform that can deploy and self-stabilize at the entrance to the heart, and guide existing interventional tools toward a target site. In two exemplar intracardiac procedures within the right atrium, the robotic platform provides enough dexterity to reach multiple anatomical targets, enough stability to maintain constant contact on motile targets, and enough mechanical leverage to generate newton-level forces. Because the device addresses ongoing challenges in minimally invasive intracardiac intervention, it may enable the further development of catheter-based interventions.

Model-based Design of the COAST Guidewire Robot for Large Deflection.

Minimally invasive endovascular procedures involve the manual placement of a guidewire, which is made difficult by vascular tortuosity and the lack of precise tip control. Steerable guidewire systems have been developed with tendon-driven, magnetic, and concentric tube actuation strategies to enable precise tip control, however, selecting machining parameters for such robots does not have a strict procedure. In this paper, we develop a systematic design procedure for selecting the tube pairs of the COaxially Aligned STeerable (COAST) guidewire robot. This includes the introduction of a mechanical model that accounts for micromachining-induced pre-curvatures with the goal of determining design parameters that reduce combined distal tip pre-curvature and minimize abrupt changes in actuated tip position for the COAST guidewire robot through selection of the best flexural rigidity between the tube pairs. We present adjustments in the kinematics modeling of COAST robot tip bending motion, and use these to characterize the bending behavior of the COAST robot for varying geometries of the micromachined tubes, with an average RMSE value for the tip position error of 0.816 mm in the validation study.

Initial clinical experience with the Bendit steerable articulating tip microcatheter for intracranial access and intervention.

The increasing complexity and sophistication of neurovascular implants and other therapeutic devices depend on access and delivery systems. Advancements in access technologies are required to improve minimally invasive endovascular procedures. Steerable catheters have been available in other disciplines, however, their implementation in neurovascular interventions has been a barrier previously due to issues with miniaturization and vascular caliber/complexity. A retrospective review of the neurovascular stroke database was conducted in accordance with local IRB to identify patients that received neurointerventional endovascular procedures using a novel first iteration 0.021'' microcatheter with controlled articulating tip flexion. Indications, management, demographics, comorbidities, and clinical and technical outcomes were recorded and analyzed. Primary operator feedback on the novel catheter was collected and reviewed. Ten consecutive patients receiving treatment that involved a novel steerable 0.021'' microcatheter were identified and analyzed. No complications were reported. Novel useful features of the catheter were reported on a case-by-case basis. Initial clinical experience with the controlled articulation that permits flexion at the tip of the microcatheter demonstrated it to be safe. Access to difficult proximal origin curves, and distal clinoidal/ophthalmic segment anatomy may be improved due to the high torque transmission, and acute angulation of this microcatheter. Further experience with the delivery of therapeutic devices will be necessary to better understand the potential role that the present catheter may play in modern neurointerventional procedures.

#5918 ENDOVASCULAR CREATION OF AN ARTERIOVENOUS FISTULA (ENDOAVF) FOR HEMODIALYSIS ACCESS: A RETROSPECTIVE MONOCENTRIC EXPERIENCE

Abstract Background and Aims Functioning vascular access is an essential element for life-saving hemodialysis therapy. Surgical creation of a radiocephalic arteriovenous fistula (AVF) is the gold standard of vascular access for hemodialysis. However an endovascular approach to arteriovenous fistula creation (endoAVF) has increasingly gained acceptance over the last years as an alternative to the conventional surgical method. It offers a minimally invasive method for the formation of arteriovenous shunts and allows the creation of fistulas with minimal vessel trauma. There are currently two technologies available for this purpose, the Ellipsys Vascular Access System (Medtronic, Avenu Medical, San Juan Capistrano, Calif) and the Wavelinq endoAVF System (BD Medical, Franklin Lakes, NJ). At our centre (Careggi University Hospital, Florence), we developed an integrated service, based on a multidisciplinary approach between Interventional Radiology and Interventional Nephrology for percutaneous arteriovenous fistulas utilizing both Ellipsys and Wavelinq. We describe our experience with a case series of 39 patients, showing feasibility and outcome of this treatment option. Method Between December 2020 and January 2023 we created an endoAVF in 39 patients. Patients were suitable for the procedure after a pre-therapeutic ultrasound vascular mapping showed adequate brachial, radial and ulnar vessels and no ipsilateral central venous stenosis. After procedure, we performed a regular clinical and ultrasound monitoring. Therefore, we collected data regarding patient characteristics, initial technical success rate, number of access lost and number of endoAVF meeting primary and secondary patency. Results Of the total of 39 patients treated with endoAVF, 29 (74.3%) were male, with a mean age of 60.1 ± 33.9 years. The Wavelinq procedure was performed in 32 patients (82.0%) and the Ellipsys procedure in 7 patients (17.9%). Initial technical success was achieved in 38 (97.4%) cases, while in 1 case we had a primary failure of the fistula (Figure 1). Among these 38 patients, 4 (10.5%) were lost to follow-up because of death from other causes (3 patients) and because of kidney transplantation (1 patient), while 2 other patients (5.2%) have not required hemodialysys yet. Of the remaining 32 patients, we had 2 fistulas lost because of complications and a cumulative functional patency of 93.7% (30 fistulas), with a primary patency rate of 76% (23 fistulas). Conclusion The endoAVF appears to be feasible and safe for the creation of arteriovenous fistula suitable for hemodialysis access. Our data show an high functional cumulative patency of the endoAVF and a good primary patency, reducing the necessity of further interventions. Furthermore, in the prevalent hemodialysis population, the minimally invasive endovascular arteriovenous fistula procedure should help improving long wait times for vascular access creation. Further studies with more patients and multicentric data are needed to assess long-term outcomes.

Feature-Based Electromagnetic Tracking Registration Using Bioelectric Sensing

Catheter tracking is essential during minimally invasive endovascular procedures, and Electromagnetic (EM) tracking is a widely used technology for this purpose. When preoperative patient images are available, they can be used to guide EM-tracked interventions. However, a registration step between preoperative images and intraoperative EM tracking space is usually required. Most existing solutions for this registration process require manual interactions, which can add additional steps to the workflow. In this paper, a novel automatic feature-based registration method is proposed, based on electric sensing of vascular geometry by the catheter, also known as Bioelectric sensing. The technique employs the Bioelectric sensing capabilities of the catheter to identify vascular features, such as bifurcations, aneurysms, or stenosis. The known EM position of these features is then utilized to register the EM tracking space and the preoperative images. The registration is refined using iterative closest point (ICP) registration algorithms. Unlike existing solutions, the proposed method does not require external markers, interventional imaging, or additional surgeon actions, and hence does not impact the interventional workflow.

Extending bioelectric navigation for displacement and direction detection

PurposeBioelectric navigation is a navigation modality for minimally invasive endovascular procedures promising non-fluoroscopic navigation. However, the method offers only limited navigation accuracy between anatomical features and expects the tracked catheter to move only in one direction at all times. We propose to extend bioelectric navigation with additional sensing capabilities, allowing for the estimation of the distance traveled by the catheter, thereby improving accuracy between feature locations and allowing to track also under alternating forward- and backward motion.MethodsWe perform experiments in finite element method (FEM) simulations and in a 3D printed phantom. A solution for estimating the traveled distance using a stationary electrode is proposed, together with an approach on how to evaluate the signals obtained with this additional electrode. We investigate the effects of surrounding tissue conductance on this approach. Finally, the approach is refined in order to mitigate the effects of parallel conductance on the navigation accuracy.ResultsThe approach allows to estimate the catheter movement direction and the distance traveled. Simulations show absolute errors below 0.89 mm for non-conducting surrounding tissue, but errors up to 60.27 mm when the tissue is electrically conductive. This effect can be mitigated by a more sophisticated modeling (errors up to 33.96 mm). In experiments in a 3D printed phantom, the mean absolute error over 6 catheter paths is 6.3 mm, with standard deviations smaller than or equal to 1.1 mm.ConclusionsExtending the setup of bioelectric navigation with an additional stationary electrode allows to estimate the distance traveled by the catheter, as well as the movement direction. The effects of parallel conductive tissue could be partially mitigated in simulations, but further research is needed to investigate these effects in real biological tissue, and to bring the introduced errors down to a clinically acceptable level.

Frailty is Not Associated with Worse Outcomes following Lower Extremity Angiograms for Limb Ischemia in Nonagenarians

Endovascular interventions are performed routinely with minimal risk in younger populations. The safety and efficacy of endovascular interventions in nonagenarians is under examined. We sought to examine the following (1) mortality and limb salvage rates in the nonagenarian population and (2) whether frailty was associated with outcomes following lower extremity (LE) interventions for both acute limb ischemia (ALI) and chronic limb threatening ischemia (CLTI). A retrospective review of patients ≥90years who underwent a LE angiogram for ALI or CLTI over a 12-year period at a single institution was performed. Primary outcomes were 30-day and 12-month limb salvage and mortality rates. Patient demographics, 30-day complications, and 12-month target vessel reintervention (TVR) were reviewed. Frailty scores were calculated using the 11-factor modified frailty index (MFI-11). From 2009 to 2021, 76 patients (36% male) with a mean age of 93 (range: 90-102) underwent endovascular procedures for ALI (n=13) and CLTI (n=63). 30-day amputation and mortality rates were 6% and 8%, respectively. Patient demographics, preoperative functional status, and TVR rates were not different between patients who had early amputation (≤30days) and those who achieved limb salvage. Seventy-two patients (94%) had follow-up data at 30days. There was an 8% mortality rate at 30days. Of those alive at 30days, 94% of patients had successful limb salvage. Fifty-eight patients had complete follow-up data at 12months. Of the patients alive at 12-month follow-up (75%), the limb salvage rate was 98%. Patients with amputation at 30days had a significantly higher mortality rate at 12months compared to those who did not (83% vs. 19%; P<0.01). Based on MFI-11 scoring, 35% of the population was considered frail (≥0.27). Frail patients did not have significantly different 30-day outcomes (limb salvage: 94% vs. 88%; mortality 8% vs. 9%, P=0.41 and 0.94, respectively) or 12-month outcomes (limb salvage: 82% vs. 94%; mortality: 32% vs. 22%, P=0.28 and 0.39, respectively). Endovascular procedures can be done safely in nonagenarians with low mortality and amputation rates. Patients with early amputation are at significantly higher risk of death at 12months. Frailty, as measured by a validated index, was not associated with early or late outcomes. When compared to immediate amputation, nonagenarian patients and their families should be counseled as to the benefit from a minimally invasive endovascular procedure.

Proximal venous outflow obstructions and transfemoral approach in patients with arteriovenous fistula

Congratulations to the authors for their effort [1]. Endovascular treatment for central venous occlusions, which cause many vascular access problems among hemodialysis patients, has increased in recent years. Although most of these procedures have been applied via forearm vessels, there were studies reporting the use of the transfemoral approach in complicated cases [2,3]. In the publication, the authors reported that they applied a fistulogram by using a 6 Fr sheath from forearm veins and diagnosed the occlusion site. After the fistulogram, the authors used transfemoral access for other invasive procedures not to injure forearm vessels. We conclude that the invasive endovascular procedures for treating the occluded segment could be completed via the same access point, and the transfemoral approach must not be a routine route for access and reserved for more complicated cases or when the forearm is unavailable.

Prevalence of Penetrating Cerebrovascular Injuries in Craniofacial Ballistic Trauma

INTRODUCTION: Approximately 114,000 people in the US experience trauma by gunshot every year. Approximately 50% of those who survive will experience functional deficits. Although traumatic cerebrovascular injuries have been described, their association with ballistic injuries to the head and neck region have not been investigated. The goal of this study is to evaluate the prevalence of traumatic cerebrovascular injuries in patients who experienced ballistic trauma in the craniofacial region. METHODS: A retrospective chart review was completed on patients who sustained ballistic trauma to the head and face at a level 1 trauma center between January 1, 2016, and December 31, 2017. Clinical characteristics collected included demographics, injury characteristics, GCS scores, facial fracture location and pattern, details of the cerebrovascular injuries, and outcomes. RESULTS: A total of 64 patients sustained ballistic injury to the face and head. Among them n = 6 (9%) had radiographic evidence of cerebrovascular injuries. The presence of cerebrovascular injuries was associated with facial fracture (OR 5.74), especially mandible fractures (OR 14.57; Table). Two patients required additional invasive endovascular procedures. Three patients sustained major neurologic deficits as result of their vascular injuries. Table. - Odds Ratio of Vascular Injury Among Patients with or Without Facial Fractures Facial fracture type Number of patients with fracture type Number of cases with major head and neck vascular injuries Odds ratio (95% confidence interval) All facial fractures 32 5 5.74 (0.39-32.98) Mid facial fractures 19 2 1.21 (0.61-21.69) Mandible fractures 11 4 14.57 (0.55-23.57) Upper facial fractures 21 0 0 GCS below 15 22 3 2 (0.66-19.69) CONCLUSION: In our cohort, major cerebrovascular trauma was present in 9% of patients who sustained ballistic injury to the head and facial region. These devastating vascular injuries are associated with the presence of facial fractures, especially those with mandible fractures. Thus, CT angiogram should be considered in all patients who sustained ballistic injuries to the head and facial region.

The continued need for infrarenal sealing endovascular aneurysm repair devices

Treatment of abdominal aortic aneurysms (AAA) has evolved from being a relatively high-risk surgical operation to a minimally invasive percutaneous endovascular procedure in 2022. The development of endovascular devices specific to this purpose represents remarkable achievement in the evolutionary treatment of vascular diseases and has transformed a deadly disease into a more manageable medical condition. The report of the W. L Gore Excluder Conformable (EXCC) US regulatory trial reflects the latest generation of endovascular aneurysm repair (EVAR) devices.

Realization and Clinical Study of Robotic Technology in Cardiovascular Interventional Surgery

The high incidence of cardiovascular diseases is a serious threat to human health, and endovascular surgery has become the standard treatment for most interventional cardiovascular diseases. The robotassisted endovascular surgery system further enhances surgeons' ability to perform minimally invasive endovascular procedures in interventional cardiology. This study presents a new robotic technique for coronary intervention from the perspective of clinical application. Aiming at clinical application scenarios, this scheme proposed an intuitive guide wire catheter mechanism design, which accurately and perfectly simulates the doctor's hand movements, realizes the positive and negative direction translation of the guide wire catheter, accurate torque control of the guide wire rotation and locking. The results of animal test showed that the R-OneTM has a high degree of dexterity, accuracy and stability,and meets the clinical needs.

Dual-Resonance (16/32 MHz) Piezoelectric Transducer With a Single Electrical Connection for Forward-Viewing Robotic Guidewire.

Peripheral artery disease (PAD) affects more than 200 million people globally. Minimally invasive endovascular procedures can provide relief and salvage limbs while reducing injury rates and recovery times. Unfortunately, when a calcified chronic total occlusion is encountered, ~25% of endovascular procedures fail due to the inability to advance a guidewire using the view provided by fluoroscopy. To enable a sub-millimeter, robotically steerable guidewire to cross these occlusions, a novel single-element, dual-band transducer is developed that provides simultaneous multifrequency, forward-viewing imaging with high penetration depth and high spatial resolution while requiring only a single electrical connection. The design, fabrication, and acoustic characterization of this device are described, and proof-of-concept imaging is demonstrated in an ex vivo porcine artery after integration with a robotically steered guidewire. Measured center frequencies of the developed transducer were 16 and 32 MHz, with -6 dB fractional bandwidths of 73% and 23%, respectively. When imaging a 0.2-mm wire target at a depth of 5 mm, measured -6 dB target widths were 0.498 ± 0.02 and 0.268 ± 0.01 mm for images formed at 16 and 32 MHz, respectively. Measured SNR values were 33.3 and 21.3 dB, respectively. The 3-D images of the ex vivo artery demonstrate high penetration for visualizing vessel morphology at 16 MHz and ability to resolve small features close to the transducer at 32 MHz. Using images acquired simultaneously at both frequencies as part of an integrated forward-viewing, guidewire-based imaging system, an interventionalist could visualize the best path for advancing the guidewire to improve outcomes for patients with PAD.

Unilateral Lumbosacral Plexopathy Following Extra-Corporeal Membrane Oxygenation Managed with Burst Spinal Cord Stimulation: A Case Report

BACKGROUND: Lumbar plexopathy is considered a rare complication of minimally invasive endovascular or surgical procedures, but it has not been related to the use of extracorporeal membrane oxygenation (ECMO) so far. In cases of high-intensity neuropathic pain, neuromodulation should be considered early in the treatment. CASE REPORT: After receiving supportive ECMO therapy for 7 days, a 42-year-old woman developed lumbar plexopathy and high-intensity neuropathic pain and was referred to the pain unit 6 months later. After unsuccessful use of neuropathic drugs, spinal cord stimulation achieved global improvements of 90%. Sixteen months later, the patient continues to be asymptomatic, leading an active life as a mother of 4 children. CONCLUSIONS: The use of ECMO cannot be said to be the main cause of plexopathy in this case, but a multifactorial approach regarding this issue should be considered. Spinal cord stimulation can provide dramatic relief in localized neuropathic pain. KEY WORDS: Extracorporeal membrane oxygenation (ECMO), lumbosacral plexopathy, spinal cord stimulation

Comparing Manual and Robotic-Assisted Carotid Artery Stenting Using Motion-Based Performance Metrics.

Carotid artery stenting (CAS) is a minimally invasive endovascular procedure used to treat carotid artery disease and is an alternative treatment option for carotid artery stenosis. Robotic assistance is becoming increasingly widespread in these procedures and can provide potential benefits over manual intervention, including decreasing peri- and post-operative risks associated with CAS. However, the benefits of robotic assistance in CAS procedures have not been quantitatively verified at the level of surgical tool motions. In this work, we compare manual and robot-assisted navigation in CAS procedures using performance metrics that reliably indicate surgical navigation proficiency. After extracting guidewire tip motion profiles from recorded procedure videos, we computed spectral arc length (SPARC), a frequency-domain metric of movement smoothness, average guidewire velocity, and amount of idle tool motion (idle time) for a set of CAS procedures performed on a commercial endovascular surgical simulator. We analyzed the metrics for two procedural steps that influence post-operative outcomes. Our results indicate that during advancement of the sheath to the distal common carotid artery, there are significant differences in SPARC (F(1, 22.3) = 6.12, p = .021) and idle time (F(1, 22.6) = 6.26, p = .02) between manual and robot-assisted navigation, as well as a general trend of lower SPARC, lower average velocity, and higher idle time values associated with robot-assisted navigation for both procedural steps. Our findings indicate that significant differences exist between manual and robot-assisted CAS procedures. These are quantitatively detectable at the granular-level of physical tool motion, improving the ability to evaluate robotic assistance as it grows in clinical use.

Vertebral Body Erosion by a Chronic Contained Rupture of Thoracoabdominal Aortic Aneurysm: Systematic Review and Spine Surgical Recommendations

Vertebral body erosion (VBE) is commonly caused by neoplastic, inflammatory, or infectious diseases: it can be rarely associated with aortic wall disorders, such as chronic contained rupture of aortic aneurysm (CCR-AA). CCR-AA is a rare event comprising <5% of all reported cases. This condition is easily undiagnosed, differential diagnosis may be challenging, and there is no consensus or recommendation that dictates guidance on management of spinal surgical treatment. We performed a systematic review of the literature of all cases of VBE secondary to CCR-AA to identify clinical, radiologic, and surgical outcome characteristics with the aim of providing a basis for future research studies. The search returned 80 patients. All reported patients had a history of hypertension. In almost all patients, the AA size reported was high (mean diameter, 7.056 cm). The treatment of this condition involves various reported treatment strategies: a totally conservative approach, treatment of the aortic aneurysm through a minimally invasive endovascular procedure, or an open surgery and combined approach. Despite the wide variability in therapeutic strategy, the rate of good outcomes was relatively high at 80%. Back pain and pain along the vertebral column are such frequent symptoms that unusual causes or serious and life-threatening complications may be overlooked. In addition to the common traumatic and degenerative causes of back pain, AA must also be considered. A combined approach between vascular and spine surgery could be achieved without any increased risk.

Incidence of and predisposing factors for pseudoaneurysm formation in a high-volume cardiovascular center.

PurposeTo evaluate factors associated with pseudoaneurysm (PSA) development.MethodsBetween January 2016 and May 2020, 30,196 patients had invasive vascular radiological or cardiac endovascular procedures that required arterial puncture. All patients with PSA were identified. A matched (age, gender, and type of the procedure) control group of 134 patients was created to reveal predictors of PSA formation.ResultsSingle PSAs were found in 134 patients. Fifty-three PSAs developed after radiological procedures (53/6555 [0.8%]), 31 after coronary artery procedures (31/18038 [0.2%]), 25 after non-coronary artery cardiac procedures (25/5603 [0.4%]), and 25 due to procedures in which the arterial puncture was unintended. Thirty-four PSAs (25.4%) were localized to the upper extremity arteries (vascular closure device [VCD], N = 0), while 100 (74.6%) arose from the lower extremity arteries (VCD, N = 37). The PSA prevalence was 0.05% (10/20478) in the radial artery, 0.1% (2/1818) in the ulnar artery, 1.2% (22/1897) in the brachial artery, and 0.4% (99/22202) in the femoral artery. Treatments for upper and lower limb PSAs were as follows: bandage replacement (32.4% and 14%, respectively), ultrasound-guided compression (11.8% and 1%, respectively), ultrasound-guided thrombin injection (38.2% and 78%, respectively), and open surgery (17.6% and 12%, respectively). Reintervention was necessary in 19 patients (14.2%). The prevalence of PSA for the punctured artery with and without VCD use was 37/3555 (1%) and 97/27204 (0.4%), respectively (OR, 2.94; 95% CI, 1.95–4.34; P<0.001). The effect of red blood cell (RBC) count (P<0.001), hematocrit value (P<0.001), hemoglobin value (P<0.001), international normalized ratio (INR; P<0.001), RBC count—INR interaction (P = 0.003), and RBC count—VCD use interaction (P = 0.036) on PSA formation was significant.ConclusionPatients in whom the puncture site is closed with a VCD require increased observation. Preprocedural laboratory findings are useful for the identification of patients at high risk of PSA formation.

Metabolic effects two years after renal denervation in insulin resistant hypertensive patients. The Re-Shape CV-risk study

Denervation of renal sympathetic nerves (RDN) is an invasive endovascular procedure introduced as an antihypertensive treatment with a potential beneficial effect on insulin resistance (IR). We have previously demonstrated a reduction in blood pressure (BP) six months after RDN, but severe hepatic and peripheral IR, assessed by glucose tracer and two step hyperinsulinemic-euglycemic clamp (HEC), did not improve. The aim of the current study was to evaluate IR and adipokines profiles in relation to BP and arterial stiffness changes two years after RDN. In 20 non-diabetic patients with true treatment-resistant hypertension, ambulatory and office BP were measured after witnessed intake of medications prior to, six and 24 months after RDN. Arterial stiffness index (AASI) was calculated from ambulatory BP. Insulin sensitivity (IS) was assessed using an oral glucose tolerance test (OGTT), the Homeostasis Model Assessment (HOMA-IR), HOMA-Adiponectin Model Assessment (HOMA-AD), the Quantitative Insulin Sensitivity Check Index (QUICKI), the Triglyceride and Glucose Index (TyG) and the Leptin-to-Adiponectin Ratio (LAR). These surrogate indices of IS were compared with tracer/HEC measurements to identify which best correlated in this group of patients. All measured metabolic variables and IS surrogate indices remained essentially unchanged two years after RDN apart from a significant increase in HOMA-AD. OGTT peak at 30min correlated best with reduction in endogenous glucose release (EGR) during low insulin HEC (r=-0.6, p=0.01), whereas HOMA-IR correlated best with whole-body glucose disposal (WGD) (r=-0.6, p=0.01) and glucose infusion rate (r=-0.6, p=0.01) during high insulin HEC. BP response was unrelated to IS prior to RDN. Nocturnal systolic BP and arterial stiffness before RDN correlated positively with a progression in hepatic IR at six-month follow-up. IR, adiponectin and leptin did not improve two years after RDN. There was no correlation between baseline IS and BP response. Our study does not support the notion of a beneficial metabolic effect of RDN in patients with treatment resistant hypertension.