Evolutionary trends and innovations in cardiovascular intervention.

Cardiovascular diseases remain a global health challenge, prompting continuous innovation in medical technology, particularly in Cardiovascular MedTech. This article provides a comprehensive exploration of the transformative landscape of Cardiovascular MedTech in the 21st century, focusing on interventions. The escalating prevalence of cardiovascular diseases and the demand for personalized care drive the evolving landscape, with technologies like wearables and AI reshaping patient-centric healthcare. Wearable devices offer real-time monitoring, enhancing procedural precision and patient outcomes. AI facilitates risk assessment and personalized treatment strategies, revolutionizing intervention precision. Minimally invasive procedures, aided by robotics and novel materials, minimize patient impact and improve outcomes. 3D printing enables patient-specific implants, while regenerative medicine promises cardiac regeneration. Augmented reality headsets empower surgeons during procedures, enhancing precision and awareness. Novel materials and radiation reduction techniques further optimize interventions, prioritizing patient safety. Data security measures ensure patient privacy in the era of connected healthcare. Modern technologies enhance traditional surgeries, refining outcomes. The integration of these innovations promises to shape a healthier future for cardiovascular procedures, emphasizing collaboration and research to maximize their transformative potential.

Objective Methods to Assess Aorto-Iliac Calcifications: A Systematic Review.

Vascular calcifications in aorto-iliac arteries are emerging as crucial risk factors for cardiovascular diseases (CVDs) with profound clinical implications. This systematic review, following PRISMA guidelines, investigated methodologies for measuring these calcifications and explored their correlation with CVDs and clinical outcomes. Out of 698 publications, 11 studies met the inclusion criteria. In total, 7 studies utilized manual methods, while 4 studies utilized automated technologies, including artificial intelligence and deep learning for image analyses. Age, systolic blood pressure, serum calcium, and lipoprotein(a) levels were found to be independent risk factors for aortic calcification. Mortality from CVDs was correlated with abdominal aorta calcification. Patients requiring reintervention after endovascular recanalization exhibited a significantly higher volume of calcification in their iliac arteries. Conclusions: This review reveals a diverse landscape of measurement methods for aorto-iliac calcifications; however, they lack a standardized reproducibility assessment. Automatic methods employing artificial intelligence appear to offer broader applicability and are less time-consuming. Assessment of calcium scoring could be routinely employed during preoperative workups for risk stratification and detailed surgical planning. Additionally, its correlation with clinical outcomes could be useful in predicting the risk of reinterventions and amputations.

Intraoperative Staff Radiation Exposure During Aortic Endovascular Procedures.

BACKGROUND: The risk of radiation exposure in the surgical operating room (OR) and/or catheterization laboratory is now well established. Complex endovascular procedures often require multiple approaches and different positioning of the staff members around the patient, potentially increasing the levels of radiations exposure. Our goal was to evaluate the levels of radiation exposure of the members of the staff during endovascular aortic procedures in order to propose radioprotection optimization. METHODS: We included 41 aortic endovascular procedures out of 114 procedures performed between January 12, 2014, and August 31, 2015, including 24 standard endovascular aortic aneurysm repair (EVAR), 7 EVAR with iliac branch (EVARib), 8 complex fenestrated/branched EVAR (F/B EVAR), and 2 thoracic EVAR (TEVAR). Procedures were performed in an OR equipped with a carbon fiber table and a mobile fluoroscopy C-arm. We collected the usual dosimetry data given by the C-arm as well as the patient's peak skin dose (PSD). In all staff members, radiation exposure was measured with thermoluminescent chip dosimeters placed on both temples, on posterior sides of both hands, and on both lower legs. RESULTS: PSD levels were low for EVAR because 24 patients had values below the reading threshold. PSD significantly increased with more complex procedures. Main operator (MO) received the higher level of irradiation on whole body, hands, and ankles. Eye lenses irradiation was higher on both assistant operators (AOs). Other members received low levels of irradiation. We found a high ranges of radiation exposure with a high risk of exposure for the AO, mainly for F/B EVAR and EVARib. CONCLUSIONS: Even if all personal protections are used, staff positioning is a major point that must be considered. If MO is supposed to be the most exposed to X-rays, specific conditions of positioning of the AO may be at risk of exposure.

Experimental multiparametric magnetic resonance imaging characterization of iliocaval venous thrombosis pathological changes.

OBJECTIVE: Iliocaval thrombotic obstruction is a challenging condition, especially because thrombus age and corresponding pathological remodeling at presentation are unknown, which directly impacts management. Our aim was to assess the ability of magnetic resonance imaging (MRI) in determining age thresholds of experimentally created inferior vena cava (IVC) thrombosis in pigs. METHODS: We used a previously described swine model of IVC thrombosis. The animals underwent MRI at baseline, immediately after thrombosis creation, and after a follow-up period extending from 2 to 28 days. Thirteen pigs were divided into three groups according to disease chronicity: acute group (AG; n = 5), subacute group (SAG; n = 4), and chronic group (CG; n = 4), with a mean thrombosis age of 6.4 ± 2.5 days, 15.7 ± 2.8 days, and 28 ± 5.7 days, respectively. A T1-weighted volumetric interpolated breath-hold examination sequence was used to anatomically delineate IVC thrombus as a region of interest. Three other MRI sequences were used to assess the thrombus signal. RESULTS: The Kruskal-Wallis test showed a statistically significant difference in T1 relaxation times after contrast injection (P = .026) between the three groups of chronicity. The AG (360.2 ± 102.5 ms) was significantly different from the CG (336.7 ± 55.2 ms; P = .003), and the SAG (354.1 ± 89.7 ms) was significantly different from the AG (P = .027). There was a statistically significant difference in native T2 relaxation times (P = .038) between the three groups. The AG (160 ± 86.7 ms) was significantly different from the SAG (142.3 ± 55.4 ms; P = .027), and the SAG was significantly different from the CG (178.4 ± 11.7 ms; P = .004). CONCLUSIONS: This study highlighted MRI characteristics in a swine model that might have the potential to significantly differentiate subacute and chronic stages from an acute stage of deep vein thrombosis in humans. Further clinical studies in humans are warranted. CLINICAL RELEVANCE: In addition to providing a better understanding of venous thrombosis remodeling over time, magnetic resonance imaging has the potential to be a tool that could allow us to characterize the composition of venous thrombus over an interval, allowing for a refined analysis of the local evolution of venous thrombosis. We propose a noninvasive and innovative method to characterize different thresholds of chronicity with magnetic resonance imaging features of central deep vein thrombosis of the inferior vena cava experimentally obtained using a totally endovascular in vivo swine model, mimicking human pathophysiology. Being able to determine these features noninvasively is critical for vascular specialists when it comes to choosing between fibrinolytic therapy, percutaneous thrombectomy, or surgical management.

What We Know From Reports on Type III Endoleak in the Literature.

Objective: To analyse case reports published on the latest generations of endograft (EG) and understand the mechanisms of type III endoleak (EL) development. Methods: A literature review was undertaken of English language case reports and series that concerned modular junction or component disconnection (type IIIa EL) and fabric perforations (type IIIb EL) after endovascular aneurysm repair. Results: Of the 2 785 studies, 56 full texts were chosen to review 73 cases. Type III EL was diagnosed with computed tomography angiography in 67.1% and digital subtraction angiography in 12.3%; the rest were identified during surgery. Of the 73 EG, 65 (89.0%) were made of polyethylene terephthalate and seven (9.6%) were polytetrafluoroethylene. The type of material was not mentioned in one (1.4%) case report. There were 25 (34.2%) type IIIa and 48 (65.8%) type IIIb EL. The most frequent were trunk-trunk in nine (12.3%) and trunk-limb overlap separations in 14 (19.2%). Type IIIb EL in the trunk area was identified in 27 (37.0%) cases, while 21 (28.8%) defects were found in the limbs. Stent fractures were recognised as an underlying mechanism of type IIIb EL development in one report. A combination of fabric lesions in the trunk and limb area was found in one case. Seven type IIIb EL were related to suture disruption or suture-fabric abrasions. Four cases were related to stent-fabric abrasions, and two developed as a result of fabric fatigue owing to kinking. Information on the mechanisms of degradation was only occasionally and scarcely presented. Given the small number of reports and lack of detailed analysis, no definitive conclusions could be drawn. Conclusion: The available information is scarce and does not allow any definitive conclusions to be drawn on the mechanisms that lead to the development of type III EL. Further explant analyses would be beneficial.

A Tubular Vena Cava Conduit Used to Lengthen a Kidney Transplant Renal Artery Injured During Organ Procurement.

Introduction: Organ transplantation is limited by the supply of transplantable organs, and the supply of organs cannot meet the needs of patients on the waiting list. Ensuring transplantation of any procured organ is therefore mandatory. Organ injury, mostly to the organ's vasculature, can occur during multi-organ procurement, preventing subsequent transplantation. In such a context, vascular reconstructions of arterial or venous organ injuries can be useful. Report: This report describes the case of an obese 64 year old female with a history of diabetic nephropathy who underwent a cadaveric kidney transplant (right kidney with one main renal artery, one inferior polar artery, one vein, and one ureter). The ex situ preparation of the graft revealed that the main renal artery was injured and cut close to the renal hilum (0.8 cm length, 6 mm diameter), not allowing graft implantation. In order to increase the length of the main renal artery, the donor inferior vena cava was used to create a tubular conduit, allowing subsequent graft implantation. Cold and warm ischaemic times were respectively 12 hours and 36 minutes, with immediate graft function. The patient was discharged on day 8 (serum creatinine level was 95 µmol/L). Twelve month follow up was uneventful (serum creatinine level was 108 µmol/L and duplex ultrasonography showed homogeneous blood flow throughout the graft). Discussion: This case report highlights the possibility of overcoming an injured kidney graft artery by creating a tubular vena cava conduit in order to allow subsequent transplantation. Vascular reconstructions of organs injured during procurement should be considered.

Aortobifemoral Bypass in Kidney Transplant Candidates: A Ten-Year Experience.

In patients with severe aorto-iliac calcifications, vascular reconstructions can be performed in order to allow kidney transplantation. The aim of this study was to analyze the outcomes of kidney transplant candidates who underwent an aortobifemoral bypass (ABFB) for aorto-iliac calcifications. A retrospective study including all kidney transplant candidates who underwent an ABFB between 2012 and 2022 was performed. Primary outcome was 30-day morbidity-mortality after ABFB. Secondary outcome was accessibility to kidney transplant waiting list. Twenty-two ABFBs were performed: 10 ABFBs in asymptomatic patients presenting severe aorto-iliac circumferential calcifications without hemodynamic consequences, and 12 ABFBs in symptomatic patients in whom aorto-iliac calcifications were responsible for claudication or critical limb threatening ischemia. Overall 30-day mortality was 0%. Overall 30-day morbidity was 22.7%: 1 femoral hematoma and 1 retroperitoneal hematoma requiring surgical drainage in the asymptomatic group, and 2 digestive ischemia requiring bowel resection and 1 femoral hematoma requiring surgical drainage in the symptomatic group. Among the 22 patients, 20 patients could access to kidney waiting list and 8 patients underwent a kidney transplantation, including 3 living-donor transplantations. Aorto-iliac revascularization can be an option to overcome severe calcifications contraindicating kidney transplantation.

Editor's Choice -- Type IIIb Endoleaks: Fabric Perforations of Explanted New Generation Endoprostheses.

OBJECTIVE: To analyse explanted endografts (EGs) and describe fabric degradation responsible for type IIIb endoleaks. METHODS: As part of the European collaborative retrieval programme, 32 EGs with fabric defects on macroscopic evaluation were selected. The explanted EGs were processed and studied based on the ISO 9001 certified standard protocol. It includes instructions on the collection, transportation, cleaning, and examination of explanted material. The precise analysis was performed with a digital microscope of 20 - 200 times magnification. Possible perforation mechanisms were assessed in stress tests. RESULTS: The median time to explantation of the 32 EGs was 54 months. The explants included 65 separate EG modules, with 46 (70.8%) having a combined 388 fabric perforations. Each EG had a median of 4.79 mm2 (interquartile range [IQR] 9.86 mm2) of cumulated hole area (an average of 0.13% of an EG's area). There were 239 (61.6%) expanded polytetrafluoroethylene (ePTFE; 11 EGs) and 149 (38.4%) polyethylene terephthalate (PET; 21 EGs) fabric ruptures, with no difference in hole distribution between these types of material. Overall, 126 (32.5%) stent related and 262 (67.5%) non-stent related fabric perforations were identified. Perforations caused by fabric fatigue in ePTFE (151, 63.2%) and material kinking in PET (41, 27.5%) were the most common. The stent related perforations were larger in size (0.80 mm2) than non-stent related perforations (0.19 mm2); p < .001. Wider interstent spaces and prolonged implantation duration were associated with an increased risk of stent related perforation development; p < .001 and p = .004, respectively. Large stent related perforations were also detected in the short term, suggesting mechanical issues as underlying causes. CONCLUSION: The fabric of EGs may degrade and lead to the development of perforations. The largest perforations are stent related. Their occurrence and size depend on the implantation time and the EG shape affected by arterial tortuosity. The conclusions are limited to the samples from a select explant group.

Update About the Management of Low-Density Lipoprotein Cholesterol and Hypertriglyceridemia in Lower Extremity Peripheral Artery Disease Patients: Consensus of the French Society of Vascular Medicine and the French Society for Vascular and Endovascular Surgery.

BACKGROUND: A French intersociety consensus on behalf the Société Française de Médecine Vasculaire and the Société de Chirurgie Vasculaire et Endovasculaire was proposed in 2021 for the management of patients with lower extremity peripheral artery disease (LEAD). Recent studies have been published and an update of this consensus about the management of low-density lipoprotein cholesterol (LDLc) and hypertriglyceridemia was required. METHODS: A steering committee of 12 vascular physicians and surgeons defined questions of interest about LDLc and hypertriglyceridemia management. A French expert panel voted the proposals. Consensus was considered to have been achieved if more than 80% of the responses corresponded to either "Agreement" or "Disagreement". RESULTS: Among the 56 experts who were asked to participate, 46 (82%) accepted. After the first round of the Delphi procedure, the 4 proposals reached consensus. The following suggestions and recommendations were approved: 1. For LEAD patients treated by the highest tolerated statin dose ± ezetimibe and who have an LDLc ≥0.70 g/L, we recommend adding a proprotein convertase subtilisin/kexin type 9 inhibitor. 2. For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram. CONCLUSIONS: This update will help clinicians to improve LEAD patient management.

Calcium in the (Big) Pipes: Intra-TEVAR Calcifications!

Introduction: Calcification of a vascular endograft and adjacent tissues (adventitia, media, and neointima) can result in graft failure. This report shows a rare case of intraluminal calcifications in the distal end of a thoracic endovascular aortic repair (TEVAR) endograft implanted 11 years previously for grade IV blunt traumatic aortic injury (BTAI) in a young patient. Report: A 24 year old man required TEVAR for a BTAI caused by a motorcycle accident. The procedure consisted of TEVAR and an emergency left carotid subclavian venous bypass. Eleven years after the procedure, he had severe hypertension. Intra-TEVAR calcifications appeared, gradually increasing on computed tomography angiography (CTA). Calcifications in the distal luminal end of the TEVAR were responsible for a 60% stenosis on CTA. An open approach was indicated after multidisciplinary discussion, based on the gradient value. The patient underwent explantation, with total replacement of the aortic arch and descending thoracic aorta with re-implantation of the supra-aortic vessels, under extracorporeal circulation. Macroscopic analysis showed no device degeneration but revealed a solid mass at the distal end of the TEVAR. Both microcomputed tomography and histopathology confirmed the calcific nature of the lesions. Conclusion: This case highlights a rare long term graft failure due to calcified neo-atherosclerosis in a TEVAR.

Case Report and Literature Review of Prosthetic Cardiovascular Mucormycosis.

We report a rare case of aorto-bi-iliac prosthetic allograft mucormycosis in a 57-year-old immunocompetent patient in France. Outcome was favorable after surgery and dual antifungal therapy with liposomal amphotericin B and isavuconazole. In a literature review, we identified 12 other cases of prosthetic vascular or heart valve mucormycosis; mortality rate was 38%.

Do Not Forget the Oncovascular: Acute Limb Ischaemia Due to Aortic Epithelioid Angiosarcoma.

Introduction: Aortic epithelioid angiosarcoma (AEA) is a rare malignant tumour and can cause acute limb ischaemia. Report: A 66 year old man was admitted with acute pulmonary oedema due to bilateral renal artery stenosis. An incidental osteolytic left sacral lesion was found on computed tomography angiography, and extensive work up revealed an AEA. Follow up was marked by acute left lower limb ischaemia 13 months later and right chronic limb threatening ischaemia 15 months later. Discussion: Physicians need to consider AEA as an aetiology for acute or chronic limb ischaemia in patients with altered general status but mostly with intra-aortic irregular vegetations without any calcification and parietal involvement on computed tomography angiography.

Assessment of Thoracic Endovascular Aortic Repair Using Relay Proximal Scallop: Results of a French Prospective Multicentre Study.

OBJECTIVE: A proximal scallop design allows aortic arch repair without complex endovascular manipulation in the aortic arch. The aim was to assess the safety and efficacy at one year of the Relay proximal scallop stent graft. METHODS: A prospective multicentre study evaluated consecutive patients treated with the Relay proximal scallop stent graft in 10 French aortic centres. All consecutive patients eligible for elective thoracic endovascular repair with proximal scallop in the 10 participating centres between January 2015 and July 2018 were included. Primary endpoints were 30 day mortality, stroke, and spinal cord ischaemia (SCI) rates. Outcomes including safety and efficacy, technical and clinical success, all cause death, neurological events, vessel patency, and device specific complications were analysed. Survival and survival without severe complications were estimated using Kaplan-Meier estimates. RESULTS: Ten aortic centres treated 40 patients for thoracic aortic aneurysm (45%), penetrating atherosclerotic aneurysm (30%), and dissection (25%). Half of the procedures (50%) targeted zone 0 of the aortic arch (zone 0 in 17.5% and zones 0/1 in 32.5%), 37.5% targeted zone 2 (35% zone 2 alone; 2.5% zones 1/2), and 15% targeted zone 1 (12.5% zone 1 alone). Median follow up was one year. Thirty day mortality, stroke, and SCI rates were 10%, 5%, and 0% respectively. Primary technical success was 95%. Type Ia, Ib, and III endoleaks rates were 5.4%, 0%, and 0% respectively at one month. The overall mortality rate at one year was 17.5%. Aneurysm expansion was > 5 mm in one case at one year associated with type Ia endoleak (3%). There was no supra-aortic trunk thrombosis, one (2%) graft kink, and no migration. CONCLUSION: One year outcomes showed that the Relay proximal scallop stent graft is an acceptable answer to thoracic aortic disease to deal with short proximal landing zones.

Mechanical Comparison between Fenestrated Endograft and Physician-Made Fenestrations.

INTRODUCTION: A fenestrated endograft (FE) is the first-line endovascular option for juxta and pararenal abdominal aortic aneurysms. A physician-modified stent-graft (PMSG) and laser in situ fenestration (LISF) have emerged to circumvent manufacturing delays, anatomic standards, and the procedure's cost raised by FE. The objective was to compare different fenestrations from a mechanical point of view. METHODS: In total, five Zenith Cook fenestrations (Cook Medical, Bloomington, IN, USA) and five Anaconda fenestrations (Terumo Company, Inchinnan, Scotland, UK) were included in this study. Laser ISF and PMSG were created on a Cook TX2 polyethylene terephthalate (PET) cover material (Cook Medical, Bloomington, IN, USA). In total, five LISFs and fifty-five PMSG were created. All fenestrations included reached an 8 mm diameter. Radial extension tests were then performed to identify differences in the mechanical behavior between the fenestration designs. The branch pull-out force was measured to test the stability of assembling with a calibrated 8 mm branch. Fatigue tests were performed on the devices to assess the long-term outcomes of the endograft with an oversized 9 mm branch. RESULTS: The results revealed that at over 2 mm of oversizing, the highest average radial strength was 33.4 ± 6.9 N for the Zenith Cook fenestration. The radial strength was higher with the custom-made fenestrations, including both Zenith Cook and Anaconda fenestrations (9.5 ± 4.7 N and 4.49 ± 0.28 N). The comparison between LISF and double loop PMSG highlighted a higher strength value compared with LISF (3.96 N ± 1.86 vs. 2.7 N ± 0.82; p= 0.018). The diameter of the fenestrations varied between 8 and 9 mm. As the pin caliber inserted in the fenestration was 9 mm, one could consider that all fenestrations underwent an "elastic recoil" after cycling. The largest elastic recoil was observed in the non-reinforced/OC fenestrations (40%). A 10% elastic recoil was observed with LISF. CONCLUSION: In terms of mechanical behavior, the custom-made fenestration produced the highest results in terms of radial and branch pull-out strength. Both PMSG and LISF could be improved with the standardization of the fenestration creation protocol.