Periprocedural Complications Research Articles

First Reported Series of Cerebral Angiography Performed at an Outpatient Center: Safety and Satisfaction Results.

Ambulatory surgery centers (ASCs) are increasingly common venues for same-day neurosurgical procedures, allowing for cost-effective, high-quality patient care. We present the first and largest series of patients undergoing diagnostic cerebral angiography at an ASC to demonstrate the effectiveness, safety, and efficiency of outpatient endovascular care. We retrospectively reviewed data for consecutive patients who underwent diagnostic cerebral angiography at our ASC between January 1, 2024, and May 29, 2024. Data collected included vascular access approach, procedural duration, turnover time, and periprocedural complications. Using a standardized 2-week postprocedural survey, patients were asked to provide comments and rate their subjective satisfaction from a 1 to 5 scale, with "5" being completely satisfied. All cases were performed with a physician team comprising 1 attending neuroendovascular neurosurgery and 1 neuroendovascular fellow present. Fentanyl and midazolam were administered for conscious sedation in all cases. Among the 67 patients included in this series, the mean procedural duration was 29.4 ± 8.6 minutes. The mean turnover time was 13.7 ± 3.6 minutes. Between transradial (46 of 67 [68.7%]) and transfemoral (21 of 67 [31.3%]) access site approaches, there were no statistically significant differences in mean procedural duration (29.4 ± 8.0 vs 29.2 ± 9.9 minutes, respectively; P = .72) or turnover time (14.0 ± 3.9 vs 12.9 ± 2.8 minutes, respectively; P = .4). No complications occurred periprocedurally or within the 2-week follow-up period. A total of 48 (71.6%) of 67 patients responded to the postprocedural survey, all of whom unanimously reported a score of "5." We found that diagnostic cerebral angiography performed at our ASC was safe and effective for patient care. In addition, all survey respondents (71.6% of those provided the survey) reported highest levels of satisfaction. The integration of neuroendovascular procedures into ASCs potentially offers a cost-effective and highly efficient option in an evolving economic landscape.

Obesity paradox in patients with reduced ejection fraction eligible for device implantation - an observational study.

Patients with obesity have an overall higher cardiovascular risk, at the same time obesity could be associated with a better outcome in a certain subgroup of patients, a phenomenon known as the obesity paradox. Data are scarce in candidates for cardiac resynchronization therapy (CRT). We aimed to investigate the association between body mass index (BMI) and all-cause mortality in patients eligible for CRT. Altogether 1,585 patients underwent cardiac resynchronization therapy between 2000-2020 and were categorized based on their BMI, 459 (29%) patients with normal weight (BMI<25kg/m2), 641 (40%) patients with overweight (BMI 25-<30kg/m2) and 485 (31%) with obesity (BMI≥30kg/m2). The primary endpoint was all-cause mortality, heart transplantation, and left ventricular assist device implantation. We assessed periprocedural complications and 6-month echocardiographic response. Normal-weight patients were older compared to patients with overweight or obesity (70years vs. 69years vs. 68years; P ‹0.001), respectively. Sex distribution, ischaemic aetiology, and CRT-D implantation rates were similar in the three patient groups. Diabetes mellitus (BMI<25kg/m2 26% vs. BMI 25-<30kg/m2 37% vs. BMI≥30kg/m2 48%; P ‹0.001) and hypertension (BMI<25kg/m2 71% vs. BMI 25-<30kg/m2 74% vs. BMI≥30kg/m2 82%; P ‹0.001) were more frequent in patients with overweight and obesity. During the mean follow-up time of 5.1years, 973 (61%) reached the primary endpoint, 66% in the BMI<25kg/m2 group, 61% in the BMI 25-<30kg/m2 group and 58% in the BMI≥30kg/m2 group (log-rank P‹0.05). Patients with obesity showed mortality benefit over normal-weight patients (HR 0.78; 95%CI 0.66-0.92; P=0.003). The obesity paradox was present in patients free from diabetes, atrial fibrillation, and ischemic events. Periprocedural complication rates did not differ in the three groups (BMI<25kg/m2 25% vs. BMI 25-<30kg/m2 28% vs. BMI≥30kg/m2 26%; P=0.48). Left ventricular ejection fraction improved significantly in all patient groups (BMI<25kg/m2 median -LVEF 7% vs. BMI 25-<30kg/m2 median -LVEF 7.5% vs. BMI≥30kg/m2 median -LVEF 6%; P<0.0001) with a similar proportion of developing reverse remodeling (BMI<25kg/m2 58% vs. BMI 25-<30kg/m2 61% vs. BMI≥30kg/m2 57%; P=0.48); P=0.75). The obesity paradox was present in our HF cohort at long-term, patients underwent CRT implantation with obesity and free of comorbidities showed mortality benefit compared to normal weight patients. Patients with obesity showed similar echocardiographic response and safety outcomes compared to normal weight patients.

Percutaneous Transluminal Angioplasty for Atherosclerotic Stenosis of Vertebral Artery Origin.

Background: In patients with vertebral artery origin (VAO) stenosis and concomitant stenoses of other cerebral feeding arteries, data on the risk of percutaneous transluminal angioplasty (PTA) alone and with stent placement (PTAS) for VAO stenosis are limited. We aimed to determine how the presence of polystenotic lesions in other cerebral feeding arteries and concomitant carotid artery stenting (CAS) affect the periprocedural risk and long-term effect of PTA/S for atherosclerotic VAO stenosis. Methods: In a retrospective descriptive study, consecutive patients treated with PTA/S for ≥70% VAO stenosis were divided into groups with isolated VAO stenosis and multiple stenoses. We investigated the rate of periprocedural complications in the first 72 h and the risk of restenosis and ischemic stroke (IS)/transient ischemic attack (TIA) during the follow-up period. Results: In a set of 66 patients aged 66.1 ± 9.1 years, polystenotic lesions were present in 56 (84.8%) patients. 21 (31.8%) patients underwent endovascular treatment for stenosis of one or more other arteries in addition to VAO stenosis (15 underwent CAS). During the periprocedural period, no patient suffered from an IS or died, and, in the polystenotic group with concomitant CAS, there was one case of TIA (1.6%). During a mean follow-up period of 36 months, we identified 8 cases (16.3%) of ≥50% asymptomatic VA restenosis, and, in the polystenotic group, 4 (8.9%) cases of IS. Conclusion: The presence of severe polystenotic lesions or concomitant CAS had no adverse effect on the overall low periprocedural risk of PTA/S of VAO stenosis or the risk of restenosis during the follow-up period.

Leadless pacemakers in patients with different stages of chronic kidney disease: Real-world data from the updated i-LEAPER registry

BackgroundLimited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD). ObjectiveThe purpose of this study was to investigate differences in the safety and efficacy of LPMs among patients stratified per different stages of renal function. MethodsConsecutive patients enrolled in the multicenter international i-LEAPER registry (International LEAdless PacemakEr Registry) were analyzed. Patients were divided into 3 groups according to CKD stage. The primary end point was the comparison of LPM-related major complication rate at implantation and during follow-up. Differences in electrical performance were deemed secondary outcomes. ResultsOf the 1748 patients enrolled, 33% were in CKD stage G3a/G3b and 9.4% were in CKD stage G4/G5. Patients with CKD presented cardiovascular comorbidities more frequently. During a median follow-up of 39 months (interquartile range [IQR] 18–59 months), major complication rate did not differ between groups (normal kidney function [NKF] group 1.8% vs CKD stage G3a/G3b group 2.9% vs CKD stage G4/G5 group 2.4%; P = .418). All-cause mortality resulted higher in the CKD stage G4/G5 group than in the NKF group (19.5% vs 9.8%; adjusted hazard ratio 1.9; 95% confidence interval 1.25–2.89; P = .003). LPM electrical performance was comparable between groups, except for patients with CKD who showed a slightly higher pacing threshold during 1-month follow-up (NKF group 0.50 V [IQR 0.35–0.70 V] vs G3a/G3b group 0.56 V [IQR 0.38–0.81 V] vs G4/G5 group 0.51 V [0.38–0.84 V] @ 0.24 ms; P < .001). ConclusionIn a real-world setting, patients with advanced CKD who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in patients with CKD up to first-month follow-up.

Preliminary outcomes of endovascular treatment of moyamoya disease

PurposeThis study aimed to investigate the effectiveness and safety of endovascular revascularisation of intracranial artery occlusion and stenosis in moyamoya disease using stent angioplasty. Materials and methodsWe recruited 12 patients (8 women and 4 men) with occlusion and stenosis of intracranial arteries in the context of moyamoya disease who underwent endovascular stent angioplasty. Clinical data, baseline conditions, lesion location, treatment outcomes, periprocedural complications, and follow-up outcomes were analysed. ResultsThe occlusion was located at the M1 segment of the middle cerebral artery in 8 patients, at both the M1 and A2 segments in one patient, and at the C7 segment of the internal carotid artery in 3. Thirteen stents were deployed at the occlusion site, including the low-profile visualized intraluminal support (LVIS) device in 8 patients, an LVIS device and a Solitaire AB stent in one, and a Leo stent in 3, with a success rate of 100% and no intraprocedural complications. Plain CT imaging after stenting revealed leakage of contrast agent, which disappeared on the second day, resulting in no clinical symptoms or neurological sequelae. Follow-up angiography studies were performed in all patients for 6–12 months (mean, 8.8). Slight asymptomatic in-stent stenosis was observed in 2 patients (16.7%), and no neurological deficits were observed in the other patients. All preoperative ischaemic symptoms completely disappeared at follow-up. ConclusionStent angioplasty is a safe and effective treatment for occlusion and stenosis of intracranial arteries in moyamoya disease.

Mechanical versus biological mitral valve replacement: Insights from propensity score matching on survival and reoperation rates

ObjectivesPatients with symptomatic mitral valve disease unsuitable for repair can be sufficiently treated with surgical mitral valve replacement. The decision between biological and mechanical mitral valve replacement can be difficult, especially due to the question of the lesser of 2 evils: anticoagulation versus reoperation. MethodsThis single-center, retrospective study included all patients undergoing mitral valve replacement between 2001 and 2020. Thirty-day mortality and periprocedural complications were analyzed. Propensity score matching adjusted for age, gender, weight, height, endocarditis, diabetes, hypertension, peripheral arterial occlusive disease, atrial fibrillation, chronic kidney disease, cancer, and history of neurological disorders was performed. After propensity score matching, survival and cumulative incidence of reoperation at time of follow-up were analyzed. ResultsThe study included 2027 patients in 2 main groups: 1658 patients with biological mitral valve replacement and 369 patients with mechanical mitral valve replacement; 51.2% were male. Age at surgery was 65.9 ± 12.9 years. Median follow-up time was 6.83 years (interquartile range, 1.11-10.61 years). Concomitant procedures were performed in 1467 cases (72.4%). Propensity score matching yielded comparable groups of 339 pairs. Both groups showed comparable survival (P = .203). Survival after mechanical mitral valve replacement and biological mitral valve replacement was comparable for all analyzed time points over the course of 20 years. Patients with mechanical mitral valve replacement showed a significantly lower cumulative incidence for reoperation (20 years: 15% vs 59%, P < .001). ConclusionsFollow-up of 20 years at a high-volume center demonstrates comparable survival after mechanical or biological mitral valve replacement, whereas reoperation rates are significantly lower after mechanical mitral valve replacement.

Initial Experience with a New Self-Expanding Open-Cell Stent System with Antithrombotic Hydrophilic Polymer Coating (pEGASUS Stent) in the Treatment of Wide-Necked Intracranial Aneurysms.

We report our initial experience with endovascular embolization of intracranial aneurysms using this new self-expanding open-cell stent system (pEGASUS stent system) with the antithrombogenic hydrophilic polymer coating. We retrospectively reviewed all patients treated with stent-assisted coiling or the Woven EndoBridge device using the pEGASUS stent system between September 2022 and June 2023. Demographic, clinical, and angiographic data were analyzed as well as short-term follow-up, including procedural complication rates and aneurysmal occlusion rates using the Raymond-Roy occlusion classification (RROC). Twelve patients with 12 wide-necked intracranial aneurysms were treated with the pEGASUS stent system, including 2 acutely ruptured aneurysms embolized in an emergency setting. The treated aneurysms were located at the anterior communicating artery (25.0%), the basilar artery (50.0%), the middle cerebral artery (16.7%), and the internal carotid artery (8.3%). All stents were deployed successfully. Immediate complete aneurysmal occlusion (RROC class I) was achieved in 83.3% (10/12) and near-complete occlusion (RROC II) in 16.7% (2/12). No periprocedural complications occurred in patients treated in the elective setting. A single case of intraoperative in-stent thrombus formation occurred during the treatment of an acutely ruptured basilar aneurysm and was resolved with intravenous Tirofiban. No other periprocedural complications occurred. Eleven out of 12 patients were available for follow up (mean 7.4 months). Complete aneurysmal occlusion without in-stent stenosis (ISS) was seen in 10 patients (90.9%). One patient (9.1%) showed aneurysmal reperfusion (RROC IIIb) with asymptomatic moderate ISS. Our initial results demonstrate that the pEGASUS stent system appears to be a safe and effective device for stent assisted embolization of wide-necked intracranial aneurysms. More data is necessary to evaluate long-term follow-up.

Procedural Outcome and 1-Year Follow-Up of Young Patients Undergoing Implantable Cardioverter-Defibrillator Implantation-Insights from the German DEVICE I+II Registry.

Background: The number of young patients receiving ICDs or CRT-Ds has been increasing in recent decades and understanding the key characteristics of this special population is paramount to optimized patient care. Methods: The DEVICE I+II registry prospectively enrolled patients undergoing ICD/CRT-D implantation or revision from 50 German centers between 2007 and 2014 Data on patient characteristics, procedural outcome, adverse events, and mortality during the initial stay and 1-year follow-up were collected. All patients under the age of 45 years were identified and included in a comparative analysis with the remaining population. Results: A total number of 5313 patients were enrolled into the registry, of which 339 patients (6.4%) were under the age of 45 years. Mean age was 35.0 ± 8.2 vs. 67.5 ± 9.7 years, compared to older patients (≥45 years). Young patients were more likely to receive an ICD (90.9 vs. 69.9%, p < 0.001) than a CRT-D device (9.1 vs. 30.1%). Coronary artery disease was less common in younger patients (13.6 vs. 63.9%, p < 0.001), whereas hypertrophic cardiomyopathy (10.9 vs. 2.7%, p < 0.001) and primary cardiac electrical diseases (11.2 vs. 1.5%, p < 0.001) were encountered more often. Secondary preventive ICD was more common in younger patients (51.6 vs. 39.9%, p < 0.001). Among those patients, survival of sudden cardiac death (66.7 vs. 45.4%, p < 0.001) due to ventricular fibrillation (60.6 vs. 37.9%, p < 0.001) was the leading cause for admission. There were no detectable differences in postoperative complications requiring intervention (1.5 vs. 1.9%, p = 0.68) or in-hospital mortality (0.0 vs. 0.3%, p = 0.62). Median follow-up duration was 17.9 [13.4-22.9] vs. 16.9 [13.1-23.1] months (p = 0.13). In younger patients, device-associated complications requiring revision were more common (14.1 vs. 8.3%, p < 0.001) and all-cause 1-year-mortality after implantation was lower (2.9 vs. 7.3%, p = 0.003; HR 0.39, 95%CI: 0.2-0.75) than in older patients. Conclusions: Young patients < 45 years of age received defibrillator therapy more often for secondary prevention. Rates for periprocedural complications and in-hospital mortality were very low and without differences between groups. Young patients have lower mortality during follow-up but experienced a higher rate of postoperative complications requiring revision, potentially due to a more active lifestyle.

Safety and effectiveness of tunneled peripherally inserted central catheters versus conventional PICC in adult cancer patients.

This study aimed to compare the safety and effectiveness of tunneled peripherally inserted central catheters (T-PICC) vs. conventional PICCs (C-PICC) in adult cancer patients. A multicentre randomized controlled trial was conducted between April 2021 and January 2022 in seven hospitals in China. 564 participants were randomly assigned to T-PICC or C-PICC. These data were collected and compared: the baseline characteristics and catheterization-related characteristics, periprocedural complications, and long-term complications. Five-hundred fifty-three participants (aged, 52.6 ± 12.3 years; female, 39.1%) were ultimately analyzed. No significant differences in periprocedural complications were found between the T-PICC and C-PICC groups (all p > 0.05). Compared with C-PICC, T-PICC significantly reduced the incidence of long-term complications (26.4% vs. 39.9%, p < 0.001). Specifically, reduced complications were found in central line-associated bloodstream infection (1.8% vs. 5.1%, p = 0.04), thrombosis (1.1% vs. 4.0%, p = 0.03), catheter dislodgement (4.7% vs. 10.1%, p = 0.01), non-infectious oozing (17.3% vs. 28.6%, p = 0.002), local infection (3.6% vs. 7.6%, p = 0.04), skin irritation (6.1% vs. 10.9%, p = 0.046), and reduced unplanned catheter removal (2.2% vs. 7.2%, p = 0.005). No significant differences were found between T-PICC and C-PICC regarding catheter occlusion (6.5% vs. 5.8%, p = 0.73) or skin damage (2.2% vs. 2.9%, p = 0.58). T-PICC is safe and effectively reduces long-term complications. The tunneled technique is effective in reducing PICC-related long-term complications. Thus, it is recommended for cancer patients at high risk of PICC-related complications. The registration number on https://www.chictr.org.cn/ is ChiCTR2100044632. The name of the trial registry is "A multicenter randomized controlled study of clinical use of tunneled vs. non-tunneled PICC". Cather-related complications are associated with the technique of catheterization. Compared with conventional PICC, tunneled PICC reduced catheter-related long-term complications. Tunneled PICC placement provides an alternative catheterization method for cancer patients.

Safety and Efficacy of Radial Artery Access for Peripheral Vascular Intervention: A Single-Center Experience

Radial artery (RA) access has been increasingly utilized for coronary procedures due to lower rates of access-site complications and improved patient satisfaction. However, limited data are available for RA access for peripheral vascular intervention (PVI). We performed a retrospective review of 143 patients who underwent PVI via RA access from February 2020 to September 2022 at a single institution. Baseline characteristics and follow-up data were ascertained from a prospectively maintained institutional database. Of 491 PVI, 156 (31.8%) were performed through the RA. Anatomical location for intervention were the femoral (44.8%), iliac (31.1%), popliteal (9.6%) peroneal (2.7%), tibial (9.9%), and subclavian (1.9%) arteries. Procedural access was obtained through the right RA (92.9%), left RA (4.5%), or right ulnar artery (2.6%) using the 6 French R2P Destination Slender sheath in 85 cm, 105 cm, and 119 cm lengths. Atherectomy was used in 34.7%. Mean contrast volume was 105.5 mL and the average fluoroscopy time was 18.5 minutes. Conversion to femoral access occurred in 3 cases (1.9%) due to arterial spasm and non-crossable lesions. Concomitant pedal access occurred in 2 cases (1.3%). Periprocedural complication rate was 3.84%, of which access-site hematoma was most common (3.2%); none required blood transfusion, surgical intervention, or additional hospital stay. There was 1 case (0.64%) of in-hospital stroke. The mortality rate at 30-day, 6-month, and 1-year was 1.4%, 2.8%, and 4.2%, respectively. In conclusion, RA access is feasible for diverse PVI, and future studies are needed to assess safety and benefit compared to femoral artery access.

Intravascular lithotripsy in peripheral lesions with severe calcification and its use in TAVI procedure - a meta-analysis.

Background: Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator during catheter-based cardiovascular interventions. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and represents a promising technique for plaque modification in patients with severe calcification in peripheral arteries. Purpose: Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). Patients and methods: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL in the peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence of peri-procedural complications was assessed using a random-effects model. Results: 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analysed. The mean age of the cohort was 70.6 ± 17.4 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2 = 0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2 = 90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2 = 92.8%), and a concomitant low rate of complications. The procedure was free from dissection in 97% (95% CI: 91%-100%, I2 = 81.4%) while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2 = 85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2 = 0%) of the cases, with only 4% (95% CI: 0%-12%, I2 = 68.96%) presenting dissections of any sort. Conclusions: IVL seems to be an effective and safe technique for modifying severely calcified lesions in peripheral arteries and it is a promising modality in TAVI settings. Future prospective studies are needed to validate our results.

Prevalence of Risk Factors in Patients with Postprocedural Ischemic Lesions after Coiling of Very Small Intracranial Aneurysms.

Background: Very small intracranial aneurysms, generally considered to be those 3 mm in diameter or smaller, pose particular technical challenges for endovascular surgeons. For this reason, very small aneurysms have been excluded from many relevant studies. The aim of our research was to establish the risk factors for the occurrence of stroke complications after endovascular embolization of ruptured and unruptured small intracranial aneurysms. Methods: During the period of 2009-2023, our team performed endovascular embolizations of intracranial aneurysms in 1567 patients across four different centers within the territory of Serbia and Montenegro. Within the total number of patients mentioned, aneurysms of less than 4 mm were treated 185 times, with 119 ruptured and 66 unruptured. Results: In the group of 119 patients with ruptured small intracranial aneurysms, 19 (16%) patients had ischemia after the endovascular treatment, 6 (5%) patients had minor neurological deficits, while 13 (10.9%) patients had major neurological deficits, of which 6 (5%) patients died. In the group of 66 patients with unruptured small intracranial aneurysms, 7 (10.6%) patients had ischemia after the endovascular treatment, 5 (7.6%) patients had minor neurological deficits, and 2 (3.03%) had major neurological deficits. Multivariate binary logistic regression showed that the risk factors for the occurrence of ischemia were the patient's age, smoking and alcohol consumption. The type of endovascular treatment used also had a statistically significant effect on the development of ischemia. Conclusions: Understanding the influence of possible risk factors for the occurrence of ischemic insult after embolization of small intracranial aneurysms is of great importance. By recognizing them, periprocedural complications can be reduced to a minimum.

Effects of percutaneous endovascular angioplasty for severe stenosis or occlusion of subclavian artery

To investigate the effect and safety of percutaneous endovascular angioplasty (PEA) with optional stenting for the treatment of severe stenosis or occlusion of subclavian artery, patients with severe stenosis ≥ 70% or occlusion of subclavian artery treated with PEA were retrospectively enrolled. The clinical data were analyzed. A total of 222 patients were retrospectively enrolled, including 151 males (68.0%) and 71 females (32.0%) aged 48–86 (mean 63.9 ± 9.0) years. Forty-seven (21.2%) patients had comorbidities. Subclavian artery stenosis ≥ 70% was present in 201 (90.5%) patients and complete subclavian occlusion in 21 (9.5%) cases. Angioplasty was successfully performed in all (100%) patients. Balloon-expandable stents were used in 190 (85.6%) cases, and self-expandable stents in 20 (9.0%) cases. Only 12 (5.4%) cases were treated with balloon dilation only. Among 210 patients treated with stent angioplasty, 71 (33.8% or 71/210) cases underwent balloon pre-dilation, 139 (66.2% or 139/210) had direct deployment of balloon-expandable stents, and 2 (1.0% or 2/210) experienced balloon post-dilation. Distal embolization protection devices were used in 5 (2.3% or 5/222) cases. Periprocedural complications occurred in 3 (1.4%) patients, including aortic dissection in 2 (0.9%) cases and right middle cerebral artery embolism in 1 (0.5%). No hemorrhage occurred. Among 182 (82.0%) patients with 6-month follow-up, restenosis > 70% occurred in 1 (0.5%) patient, and among 68 (30.6%) patients with 12-month follow-up, restenosis > 70% took place in 11 (16.2%) patients. Percutaneous endovascular angioplasty can be safely and efficiently performed for the treatment of severe stenosis ≥ 70% or occlusion of subclavian artery.

Continuous thermodilution and microvascular resistance reserve during the index procedure in acute coronary syndrome without obstructive coronary artery disease: A pilot study.

In 5%-25% of non-ST-elevation acute coronary syndrome (NSTE-ACS) patients, coronary angiography reveals no obstructive coronary arteries (MINOCA). Coronary microvascular disease (CMD) is a potential causal pathophysiological mechanism in these patients and can be diagnosed by continuous thermodilution assessment. Recently, the microvascular resistance reserve (MRR) has been introduced as a novel index to assess the vasodilatory capacity of the microcirculation. However, continuous thermodilution and MRR have never been investigated in the acute setting in MINOCA patients and invasive assessment of the microcirculation in these patients are currently lacking. The objectives of the study were to investigate the incidence of CMD (MRR ≤ 2.7) in patients with MINOCA and to evaluate the feasibility and safety of continuous thermodilution-based assessment during index coronary angiography in the acute setting. This study was a prospective, observational, pilot study investigating coronary physiology in the acute setting in MINOCA patients. Patients admitted with a diagnosis of NSTE-ACS were eligible for inclusion. In total, 19 MINOCA patients were included in this analysis;the mean age was 70 ± 9 years, and 79% were females. CMD was present in 6 patients (32%). Qrest was significantly higher in the MRR ≤ 2.7 group compared to the MRR > 2.7 group (0.076 [0.057-0.100] vs. 0.049 [0.044-0.071] L/min, p = 0.03). Rµ,rest was significantly lower in the MRR ≤ 2.7 group compared to the MRR > 2.7 group (1083 [710-1510] vs. 1563 [1298-1970]WU,p = 0.04). No periprocedural complications or hemodynamic instability have occurred during continuous thermodilution assessment during the index coronary angiography. In patients admitted for MINOCA undergoing immediate coronary angiography, continuous thermodilution assessmentand MRR are feasible and safe in the acute setting, and evidence of functional CMD could be observed in one-third of the MINOCA patients.

Clinical results of 30 consecutive patients of carotid artery stenosis treated with CASPER stent placement: 1-year follow-up and in-stent findings on intravascular ultrasound examination immediately and 6 months after treatment

BackgroundThe CASPER stent is expected to reduce periprocedural ischemic complications, but there is concern about restenosis in the early period. One-year follow-up results of CASPER stenting and findings on intravascular...

Treatment of renal artery fibromuscular dysplasia with drug-eluting balloon angioplasty and intravascular imaging: a case report

Fibromuscular dysplasia (FD) is a segmental, non-inflammatory and non-atherosclerotic disease of vascular smooth muscle of unknown etiology, which leads to stenosis of smalland medium-sized arteries. The choice of surgical treatment tactics for renal artery FD depends on the severity of clinical manifestations and the response to the conservative drug treatment used. Young age, female sex, high blood pressure with failure to achieve target values with therapy, as well as the absence of atherosclerotic involvement of other arterial systems gives reason to suspect renal artery FD. According to modern guidelines, the invasive treatment of hemodynamically significant renal artery stenoses includes transluminal drug-eluting balloon angioplasty. In this disease, renal artery stenting is not recommended. However, stent implantation is required if balloon angioplasty did not give the optimal result or in case of periprocedural complications, such as arterial dissection. Open reconstructive surgery is indicated for complex anatomy of the related artery, macroaneurysms in which stent grafts are ineffective, refractory intimal fibroplastic lesions, increased risk of endovascular treatment, or after unsuccessful endovascular intervention. The article presents a case of a young patient with renal artery FD, renovascular arterial hypertension, who successfully underwent renal artery transluminal drugeluting balloon angioplasty.

Impella Versus Non-Impella for Nonemergent High-Risk Percutaneous Coronary Intervention

The benefit of mechanical circulatory support (MCS) with Impella (Abiomed, Inc., Danvers, MA) for high-risk percutaneous coronary intervention (HR-PCI) is uncertain. PROTECT III registry data showed improved outcomes with Impella compared to historical data (PROTECT II) but lacks a direct comparison to the HR-PCI cohort without Impella support. We retrospectively identified patients meeting PROTECT III inclusion criteria for HR-PCI and compared this group (NonIMP) to the outcomes data from the PROTECT III registry (IMP). Baseline differences were balanced using inverse propensity weighting (IPW). The co-primary outcome was major adverse cardiac events (MACE) in-hospital and at 90 days. A total of 283 high-risk patients who did not receive Impella support; 200 patients had at 90-day event ascertainment and were included in the IPW analysis and compared with 504 patients in the IMP group. After calibration, few residual differences remained between groups. The primary outcome was not different in-hospital (3.0% vs. 4.8%, p=0.403) but lower in NonIMP at 90 days (7.5% vs. 13.8%, p=0.033). Periprocedural vascular complications, bleeding, and transfusion rate were not different between groups; however, acute kidney injury occurred more frequently in the NonIMP group (10.5% vs. 5.4%, p=0.023). In conclusion, under identical HR-PCI inclusion criteria for Impella use in PROTECT III, an institutional non-Impella-supported HR-PCI cohort demonstrated similar MACE in-hospital but lower MACE at 90 days, while there was no signal for periprocedural harm with Impella use. These results do not support routine usage of Impella for HR-PCI patients.

Procedural efficiency is enhanced combining the pentaspline pulsed field ablation catheter with three-dimensional electroanatomical mapping system for pulmonary vein isolation

Abstract Background Pulsed field ablation (PFA) offers a safe, non-thermal alternative for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Currently, the pentaspline PFA-system relies heavily on fluoroscopy for catheter manipulation, which poses challenges due to the complexity of left atrium anatomy. Incorporating three-dimensional electroanatomical mapping (3D-EAM) could improve procedural efficiency reducing dependency on fluoroscopy guidance. This study aims to evaluate the effects of integration of 3D-EAM with PFA during PVI. Methods Between September 2022 and December 2023, we retrospectively enrolled 248 patients with paroxysmal or persistent AF undergoing PVI at our center using the pentaspline PFA catheter. The control group (n = 104) received conventional PFA with fluoroscopic guidance alone, while the intervention group (n = 144) underwent PVI with PFA with 3D-EAM integration. Primary outcomes were procedural time, fluoroscopy time (FT), and dose area product (DAP). Secondary endpoints included acute procedural success and incidence of periprocedural complications. Results In the 3D-EAM-PFA group, procedural time was 63.3 ± 14.3 min, compared to 65.6 ± 14.9 min in the control group (p = 0.22). The 3D-EAM group experienced significantly reduced FT (9.7 ± 4.4 min vs. 16.7 ± 5.2 min) and DAP (119.2 ± 121.7 cGycm2 vs. 338.7 ± 229.9 cGycm2) compared to the control group, respectively (p &lt; 0.001). Acute procedural success was achieved in all cases. No major complications were observed in either group. Conclusion Integration of 3D-EAM with the pentaspline PFA catheter for PVI in AF treatment offers a promising approach, with significantly reduced fluoroscopy exposure without compromising procedural time and efficacy. Graphical abstract

Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial

BackgroundEndovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions.MethodsThis prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months.DiscussionEndovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a “leaving nothing behind” endovascular approach combining directional atherectomy and DCB compared to surgical therapy.Trial registrationClinicalTrials.gov NCT02517827.

Prostate Artery Embolization (PAE) with Small Beads for the Treatment of Benign Prostatic Hyperplasia (BPH).

Benign Prostatic Hyperplasia (BPH) is the most frequent cause of Lower Urinary Tract Symptoms (LUTSs) in elderly populations. Minimally invasive treatments of BPH are safe and effective and are gaining popularity among both professionals and patients. Prostate Artery Embolization (PAE) has proven to be effective in Trans-Urethral Resection of the Prostate (TURP) in terms of prostate volume reduction and LUTS relief. PAE entails the selective catheterization of the prostatic artery and later embolization of distal vessels with beads of various calibers. Universal consensus regarding the ideal particle size is yet to be defined. We retrospectively evaluated 24 consecutive patients (median age: 75 years; range: 59-86 years) treated with PAE at our institution from October 2015 to November 2022. Particles of different sizes were employed; 12 patients were treated with 40-120 µm particles, 5 with 100 µm, 5 with 100-300 µm and 2 with 250 µm. Technical success, defined as selective prostate artery catheterization and controlled release of embolizing beads, was achieved in all patients. Removal vs. retention of the urinary catheter at the first post-procedural urological visit was the main clinical objective. No major peri-procedural complications were recorded, with 56% of patients successfully removing the urinary catheter.