Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening Ischemia.

PURPOSE: Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. METHODS: This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method. RESULTS: Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC. CONCLUSIONS: This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting. CLINICAL IMPACT: Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.

The Dutch chronic lower limb-threatening ischemia registry (THRILLER): A study protocol for popliteal and infrapopliteal endovascular interventions.

INTRODUCTION: Chronic limb-threatening ischemia (CLTI) is the end stage of peripheral arterial disease (PAD) and is associated with high amputation rates, mortality and disease-related health care costs. In infrapopliteal arterial disease (IPAD), endovascular revascularization should be considered for the majority of anatomical and clinical subgroups of CLTI. However, a gap of high-quality evidence exists in this field. The aim of the Dutch Chronic Lower Limb-Threatening Ischemia Registry (THRILLER) is to collect real world data on popliteal and infrapopliteal endovascular interventions. METHODS: THRILLER is a clinician-driven, prospective, multicenter, observational registry including all consecutive patients that undergo a popliteal or infrapopliteal endovascular intervention in seven Dutch hospitals. We estimate that THRILLER will include 400-500 interventions annually. Standardized follow-up visits with wound monitoring, toe pressure measurement and duplex ultrasonography will be scheduled at 6-8 weeks and 12 months after the intervention. The independent primary endpoints are primary patency, limb salvage and amputation free survival. Patients must give informed consent before participation and will be included according to predefined reporting standards. A data log of patients who meet the inclusion criteria but are not included in the registry will be maintained. We intend to conduct the first interim analysis two years after the start of inclusion. The results will be published in a scientific journal. DISCUSSION: Despite innovations in medical therapy and revascularization techniques, patients with CLTI undergoing endovascular revascularization still have a moderate prognosis. Previous prospective cohort studies were hampered by small sample sizes or heterogeneous reporting. Randomized controlled trials (RCTs) have high costs, potential conflicts of interest and give a limited reflection of daily practice. THRILLER aims to provide the largest prospective well phenotyped up-to-date dataset on treatment outcomes in CLTI patients to answer multiple underexplored research questions regarding diagnostics, medication, patient selection, treatment strategies and post intervention follow-up.

Vessel Preparation in Infrapopliteal Arterial Disease: A Systematic Review and Meta-Analysis.

PURPOSE: Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore, different vessel preparation devices have been developed to contribute to better peri- and postprocedural outcomes. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug-coated balloon (DCB) angioplasty with POBA or DCB alone in infrapopliteal arterial disease. METHODS: Medline, EMBASE, and Cochrane databases were searched for studies published between 2000 and 2022 assessing the value of adjunctive vessel preparation in infrapopliteal arterial disease. The primary outcomes were 12-month primary patency and limb salvage. RESULTS: A total of 1685 patients with 1913 lesions were included in 11 POBA studies. Methodological quality was assessed as poor to moderate in these studies. Only 2 studies with 144 patients assessed vessel preparation in conjunction with DCB angioplasty. These randomized trials were assessed as high quality and found no significant benefit of adjunctive atherectomy to DCB angioplasty. The pooled Kaplan-Meier estimates of 12-month primary patency and limb salvage in the POBA studies were 67.8% and 80.9% for POBA, 62.1% and 86.4% for scoring balloons, 67.9% and 79.6% for mechanical atherectomy (MA), and 79.7% and 82.6% for laser atherectomy, respectively. Within the pooled data only scoring balloons and MA demonstrated significantly improved 12-month limb salvage compared to POBA. CONCLUSIONS: Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and MA. However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation. CLINICAL IMPACT: Infrapopliteal arterial disease is associated with chronic limb-threatening ischemia (CLTI) and generally complex to treat due to small vessel diameter, long lesion length, multilevel disease and severe calcification. A wide range of vessel preparation devices have been developed to contribute to improved peri- and postprocedural outcomes in these complex lesions. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug coated balloon (DCB) angioplasty with POBA or DCB angioplasty alone in infrapopliteal arterial disease. Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and mechanical atherectomy (MA). However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.

[Recent developments in secondary cardiovascular prevention: the pros and cons of dual pathway inhibition]. / Antitrombotica ter preventie van cardiovasculaire complicaties.

The population of elderly with cardiovascular diseases and multimorbidity is rapidly growing. For decades, different antithrombotic therapies have been studied to find the most effective therapy in reducing the risk of cardiovascular events. Recently, large trials have investigated a new antithrombotic therapy consisting of a platelet aggregation inhibitor and a low-dose anticoagulant (aspirin plus rivaroxaban). This combination inhibits both primary and secondary haemostasis, and is therefore called 'dual pathway inhibition' (DPI). DPI leads to a further reduction of the risk of ischemic cardiovascular events as compared to aspirin monotherapy, but increases the risk of bleeding. The population at high risk of ischemic events, but without an increased bleeding risk, is expected to experience the highest risk reduction and therefore the highest net clinical benefit of DPI. This population consists of patients with polyvascular disease, heart failure, renal insufficiency, diabetes mellitus and other uncontrolled risk factors.

Mobile applications in peripheral arterial disease (PAD): a review and introduction of a new innovative telemonitoring application: JBZetje.

Introduction:Peripheral arterial disease (PAD) is an occlusive vascular disease of the lower extremities with increasing incidence and prevalence numbers and therefore rising health care costs. Mobile applications have great potential to improve health system efficiency and can assist in overcoming the increasing health care costs. In this review all available mobile applications developed for PAD are summarized and a new innovative application is introduced.Areas covered:Available applications for PAD are scarce and currently aim at prevention, teleconsultation and telemonitoring via questionnaires and activity tracking. Integration in the daily workflow of the physician is an overlooked aspect of these applications. JBZetje is an innovative mobile application that provides remote care, information services and self-service tools, and enables connection with the electronic health record (EHR).Expert opinion:Connection of the application with the EHR generates a complete overview of a patient's current health status. This will reinforce the tendency toward personalized medicine and will probably lead to reduced health care costs and increase the quality of care. Future feasibility studies should answer the question whether the use of mobile applications is feasible in the PAD population.