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.

Aneurysm Sac Dynamics and its Prognostic Significance Following Fenestrated and Branched Endovascular Aortic Aneurysm Repair.

OBJECTIVE: This study aimed to assess aneurysm sac dynamics and its prognostic significance following fenestrated and branched endovascular aneurysm repair (F/BEVAR). METHODS: Patients undergoing F/BEVAR for degenerative complex aortic aneurysm from 2008 to 2020 at two large vascular centres with two imaging examinations (30 day and one year) were included. Patients were categorised as regression and non-regression, determined by the proportional volume change (> 5%) at one year compared with 30 days. All cause mortality and freedom from graft related events were assessed using Kaplan-Meier methods. Factors associated with non-regression at one year and aneurysm sac volume over time were examined for FEVAR and BEVAR independently using multivariable logistic regression and linear mixed effects modelling. RESULTS: One hundred and sixty-five patients were included: 122 FEVAR, of whom 34% did not regress at one year imaging (20% stable, 14% expansion); and 43 BEVAR, of whom 53% failed to regress (26% stable, 28% expansion). Following F/BEVAR, after risk adjusted analysis, non-regression was associated with higher risk of all cause mortality within five years (hazard ratio [HR] 2.56, 95% confidence interval [CI] 1.09 - 5.37; p = .032) and higher risk of graft related events within five years (HR 2.44, 95% CI 1.10 - 5.26; p = .029). Following multivariable logistic regression, previous aortic repair (odds ratio [OR] 2.56, 95% CI 1.11 - 5.96; p = .029) and larger baseline aneurysm diameter (OR/mm 1.04, 95% CI 1.00 - 1.09; p = .037) were associated with non-regression at one year, whereas smoking history was inversely associated with non-regression (OR 0.21, 95% CI 0.04 - 0.96; p = .045). Overall following FEVAR, aneurysm sac volume decreased significantly up to two years (baseline vs. two year, 267 [95% CI 250 - 285] cm3vs. 223 [95% CI 197 - 248] cm3), remaining unchanged thereafter. Overall following BEVAR, aneurysm sac volume remained stable over time. CONCLUSION: Like infrarenal EVAR, non-regression at one year imaging is associated with higher five year all cause mortality and graft related events risks after F/BEVAR. Following FEVAR for juxtarenal aortic aneurysm, aneurysm sacs generally displayed regression (66% at one year), whereas after BEVAR for thoraco-abdominal aortic aneurysm, aneurysm sacs displayed a concerning proportion of growth at one year (28%), potentially suggesting a persistent risk of rupture and consequently requiring intensified surveillance following BEVAR. Future studies will have to elucidate how to improve sac regression following complex EVAR, and whether the high expansion risk after BEVAR is due to advanced disease extent.

Treatment Outcome Trends for Non-Ruptured Abdominal Aortic Aneurysms: A Nationwide Prospective Cohort Study.

OBJECTIVE: The Dutch Surgical Aneurysm Audit (DSAA) initiative was established in 2013 to monitor and improve nationwide outcomes of aortic aneurysm surgery. The objective of this study was to examine whether outcomes of surgery for intact abdominal aortic aneurysms (iAAA) have improved over time. METHODS: Patients who underwent primary repair of an iAAA by standard endovascular (EVAR) or open surgical repair (OSR) between 2014 and 2019 were selected from the DSAA for inclusion. The primary outcome was peri-operative mortality trend per year, stratified by OSR and EVAR. Secondary outcomes were trends per year in major complications, textbook outcome (TbO), and characteristics of treated patients. The trends per year were evaluated and reported in odds ratios per year. RESULTS: In this study, 11 624 patients (74.8%) underwent EVAR and 3 908 patients (25.2%) underwent OSR. For EVAR, after adjustment for confounding factors, there was no improvement in peri-operative mortality (aOR [adjusted odds ratio] 1.06, 95% CI 0.94 - 1.20), while major complications decreased (2014: 10.1%, 2019: 7.0%; aOR 0.91, 95% CI 0.88 - 0.95) and the TbO rate increased (2014: 68.1%, 2019: 80.9%; aOR 1.13, 95% CI 1.10 - 1.16). For OSR, the peri-operative mortality decreased (2014: 6.1%, 2019: 4.6%; aOR 0.89, 95% CI 0.82 - 0.98), as well as major complications (2014: 28.6%, 2019: 23.3%; aOR 0.95, 95% CI 0.91 - 0.99). Furthermore, the proportion of TbO increased (2014: 49.1%, 2019: 58.3%; aOR 1.05, 95% CI 1.01 - 1.10). In both the EVAR and OSR group, the proportion of patients with cardiac comorbidity increased. CONCLUSION: Since the establishment of this nationwide quality improvement initiative (DSAA), all outcomes of iAAA repair following EVAR and OSR have improved, except for peri-operative mortality following EVAR which remained unchanged.

Angiosome-directed revascularization in patients with critical limb ischemia.

OBJECTIVE: Direct revascularization (DR), according to the angiosome concept, provides direct blood flow to the site of tissue loss in patients with critical limb ischemia (CLI). DR may lead to improved outcomes; however, evidence for this is controversial. This systematic review and meta-analysis investigated the outcomes of surgical and endovascular DR compared with indirect revascularization (IR) in patients with CLI. METHODS: A systematic review was undertaken using the Cochrane Collaboration specified tool, and a meta-analysis was done according to the MOOSE (Meta-analysis of Observational Studies in Epidemiology) criteria. The electronic databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched for studies of DR compared with IR in patients with CLI with tissue loss. All articles were critically assessed for relevance, validity, and availability of data regarding patient and lesion characteristics and outcomes. When possible, data were systematically pooled, and a meta-analysis was performed for wound healing, major amputation, amputation-free survival, and overall survival. RESULTS: Of 306 screened abstracts, 19 cohort studies with 3932 patients were included. Nine scored 7 or higher on the Newcastle-Ottawa score. DR significantly improved wound healing (risk ratio [RR], 0.60; 95% confidence interval [CI], 0.51-0.71), major amputation (RR, 0.56; 95% CI, 0.47-0.67), and amputation-free survival rates (RR, 0.83; 95% CI, 0.69-1.00) compared with IR. This significance was lost in major amputation on sensitivity analysis for bypass studies. No significant difference was found in overall survival. In studies stratifying for collaterals, no differences between DR and IR were found in wound healing or major amputations in the presence of collaterals. CONCLUSIONS: DR significantly improves wound healing and major amputation rates after endovascular treatment in patients with CLI, supporting the angiosome theory. In the presence of collaterals, outcomes after IR are similar to outcomes after DR. Alternatively, patients without collaterals may benefit even more from DR as a primary treatment strategy. The angiosome theory is less applicable in bypass surgery, because bypasses are generally anastomosed to the least affected artery, with runoff passing the ankle to maintain bypass patency.

Drug-eluting balloons and uncoated balloons perform equally to rescue infrainguinal autologous bypasses at risk.

OBJECTIVE: Endovascular treatment of a significant stenosis in an infrainguinal autologous bypass prevents bypass occlusion and improves bypass patency. Drug-eluting balloons (DEBs) have been proven to possess antirestenotic features in the treatment of femoropopliteal stenoses and occlusions. This study evaluated the effects of DEB angioplasty vs uncoated balloon (UCB) angioplasty to rescue infrainguinal autologous bypass grafts at risk (BAR). METHODS: The study included all consecutive patients treated endovascularly for BAR from December 1, 2012, to July 31, 2015. As of April 1, 2014, the primary treatment of BAR was changed from UCBs to DEBs. Patients treated with DEBs were prospectively recorded in a database and retrospectively analyzed. Patients treated with UCBs were retrospectively collected from a historical cohort with a similar inclusion period length as the DEB cohort. The follow-up scheme did not differ between the two groups. The primary end point was the combined end point of freedom from recurrent stenosis or bypass occlusion. Secondary end points were primary assisted patency, secondary patency, technical success, major amputation, and mortality. RESULTS: Twenty-one patients were treated in the DEB group and 18 were treated in the UCB group. The two groups were evenly distributed in demographics, bypass, treatment, and lesion characteristics. No statistically significant differences were found in the combined end point of freedom from recurrent stenosis and the occlusion rate after 1 year between the UCB group (77.8%) and the DEB group (80.0%; P = .76). After 1 year, the primary assisted patency rate was 88.2% in the UCB group vs 95.2% in the DEB group (P = .47), and the secondary patency rate was 94.1% in the UCB group vs 95.2% in the DEB group (P = .91). During follow-up, restenosis developed in four patients (22.2%) in the UCB group and in four patients (19.0%) in the DEB group (P = .80). One bypass (5.6%) in the UCB group and one bypass (4.8%) in the DEB group occluded during follow-up (P = .884). CONCLUSIONS: DEBs and UCBs perform equally in the treatment of significant stenosis in infrainguinal autologous bypasses with regard to freedom from restenosis or bypass occlusion, primary assisted patency, and secondary patency at 1 year. We suggest using a less expensive UCB in the treatment of BAR.

Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins.

BACKGROUND: Many case series have been published on treatments of varicose veins, but comparative randomized controlled trials remain sparse. OBJECTIVE: To compare the anatomic success rate, frequency of major complications, and quality-of-life improvement of endovenous laser ablation (EVLA), ultrasound-guided foam sclerotherapy (UGFS), and conventional surgery (CS), after 1-year follow-up. METHODS: A total of 240 consecutive patients with primary symptomatic great saphenous vein reflux were randomized to EVLA, UGFS, or CS, consisting of high ligation and short stripping. Primary outcome was anatomic success defined as obliteration or absence of the treated vein on ultrasound examination after 1 year. Secondary outcomes were complications, improvement of the "C" class of the CEAP classification, and improvement of disease-specific (Chronic Venous Insufficiency Quality-of-Life Questionnaire) and general (EuroQol 5) quality-of-life scores. RESULTS: More than 80% of the study population was classified as C2 or C3 venous disease. After 1 year, the anatomic success rate was highest after EVLA (88.5%), followed by CS (88.2%) and UGFS (72.2%) (P < .001). The complication rate was low and comparable between treatment groups. All groups showed significant (P < .001) improvement of EuroQol 5 and Chronic Venous Insufficiency Quality-of-Life Questionnaire scores after therapy; 84.3% of all treated patients showed an improvement of the "C" of the CEAP classification. CONCLUSIONS: After 1-year follow-up, EVLA is as effective as CS and superior to UGFS according to occlusion on ultrasound duplex. Quality of life improves after treatment in all groups significantly.

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.

Secondary interventions in patients with autologous arteriovenous fistulas strongly improve patency rates.

BACKGROUND: Nowadays, as a result of more liberal selection criteria, dialysis-dependent patients have become substantially older, more likely to be female and diabetic, and have more comorbidity. The 1-year primary patency rates of arteriovenous fistulas (AVFs) are poor. To improve these results, several secondary interventions can be performed. The aim of this study was to evaluate the results after secondary interventions in patients with an upper extremity AVF. METHODS: Between January 2000 and December 2008, all consecutive patients who underwent construction of an autologous upper extremity AVF were included. Patient characteristics were collected retrospectively from digital patient files and a prospectively recorded database on hemodialysis patients. RESULTS: Between January 2000 and December 2008, 736 hemodialysis access procedures were performed. A total of 347 autologous arteriovenous fistulas (AVFs) were created in 294 patients. The mean age was 62.1 ± 14.7 years, and the majority (66%) of the patients was male. Mean follow-up of all 347 fistulas was 21.9 ± 21.6 months. During follow-up, failure occurred in 209 (60%) of the AVFs. A total of 133 of these failures were followed by a secondary intervention, of which 78 (59%) were endovascular interventions. Twenty-nine patients developed a third failure, and 25 of these patients underwent another intervention, of which 22 were percutaneous transluminal angioplasty for stenosis. Fifteen patients developed a fourth failure, and all of them underwent an intervention. One patient had 11 interventions. The 1- and 2-year primary patency rates were 46% and 36.8%, respectively. The 1- and 2-year primary assisted patency rates were 74.6% and 71.2%, respectively. The 1- and 2-year secondary patency rates were 79.2% and 77.8%, respectively. CONCLUSION: The primary patency rate of AVFs is disappointing. However, due to mostly endovascular secondary interventions, 2-year primary assisted and secondary patency rates of more than 70% can be obtained.

Postoperative pain after lobectomy: robot-assisted, video-assisted and open thoracic surgery.

Surgical resection is the optimal procedure for early stage non-small cell lung cancer (NSCLC). Open thoracotomy, video-assisted thoracic surgery (VATS) and robot-assisted thoracic surgery (RATS) are different surgical modalities with possible different outcomes. The aim of this study was to analyze differences in outcome with a focus on postoperative pain. Patients undergoing lobectomy at the Maasstad Hospital in 2015 and 2016 were included. Postoperative pain was scored according to the Numerical Rating Scale (NRS). Additionally, duration of chest tube drainage and thoracic epidural analgesia (TEA), hospital length of stay and type of surgery were assessed. Lobectomy was performed in 57 patients. There was no significant difference in type of surgery, age, gender, right-sided surgery, postoperative NRS scores, duration of chest tube drainage and epidural anesthesia, and hospital length of stay (p > 0.05). Operative time for RATS was significantly longer (p = 0.002). Postoperative pain scores and other outcomes did not differ between the three different modalities in surgery for NSCLC. In the future, more minimally invasive surgery will be used in pulmonary surgery with thoracotomy as a safe alternative in selected cases. Future studies have to demonstrate if RATS will overcome the differences concerning cost-effectiveness over VATS.

[Centralisation of treatment of ruptured aneurysm]. / Centraliseren van behandeling geruptureerd aneurysma.

In the future, patients with a ruptured aneurysm will be treated at fewer hospitals in the Netherlands. Although there is a search for scientific support for this, the reason for centralisation is obvious: reduction of costs and reduction of workload for vascular surgeons during night and weekend shifts. Already there are a number of examples of regionally organised vascular surgeons who treat their patients with a ruptured aneurysm with great satisfaction and with good results.

[Hypothenar hammer syndrome; rare arterial disorder of the hand due to blunt trauma]. / Hypothenar-hamersyndroom: zeldzame arteriële stoornis van de hand door stomp trauma.

The hypothenar hammer syndrome is a condition characterised by ischaemia of a finger secondary to thrombosis or an aneurysm or pseudoaneurysm of the ulnar artery in the hand. It typically occurs in the dominant hand of middle-aged men whose occupational or recreational activities require the use of the hand as a hammer. Arteriography is considered to be the gold standard for diagnosing this condition. Severe symptomatic cases are treated by surgical resection and revascularisation. The pathophysiology of this syndrome, its diagnosis and its management are discussed in this article by means of two representative cases, each having a different clinical presentation, diagnostic method and treatment.

[The hybrid operating room: a cross between a catheterisation room and an operating room]. / De hybride operatiekamer: een kruising tussen een katheterisatiekamer en een operatiekamer.

A hybrid operating room is a space that meets all the stringent requirements of an operating room harbouring the facilities of an interventional radiology or cardiology room. This technical innovation facilitates complex endovascular and hybrid operations in a sterile environment. The high-end imaging technique with the ability to perform three-dimensional reconstructions will lead to improved quality of endovascular operations. Moreover, this technique enables physicians to explore and extend the boundaries not only of cardiovascular but also of navigated minimally invasive surgical techniques.

Blindness: a rare and serious complication after extensive mediastinal resection.

We describe the case of a patient in whom blindness developed as a result of superior vena cava syndrome after resection of a primary mediastinal nonseminomatous germ cell tumor.

Outcome after emergency surgery for acute perforated diverticulitis in 200 cases.

BACKGROUND: Mortality and morbidity rates of acute perforated diverticulitis remain high. The ideal treatment is still controversial. The object of this study was to compare patients with perforated diverticulitis treated either by resection with primary anastomosis (PA) or Hartmann's procedure (HP). METHODS: A multicenter study was carried out on 200 consecutive patients with acute perforated diverticulitis who were presented in the surgical units of four affiliated teaching hospitals in Rotterdam, The Netherlands, between 1995 and 2005. Mortality and morbidity were compared in relation to type of surgery, ASA classification, age, gender, Mannheim Peritonitis Index (MPI), Hinchey score, surgeon's experience, and the time of operation. RESULTS: There was a tendency for more severely affected patients (Hinchey, MPI, ASA and age) to undergo HP. Multivariate logistic regression analysis showed no significant difference in mortality between HP and PA. After HP, more patients needed one or more reinterventions to treat postoperative complications compared to PA. Besides, HP resulted in a longer total hospital and intensive care unit stay. Specialist colorectal surgeons performed significantly more frequently a PA instead of a HP and had fewer postoperative complications than general surgeons. The time of operation did not influence the choice of surgical procedure. CONCLUSION: Selected patients with perforated diverticulitis can be managed well by PA, as it does not seem to be inferior to HP in terms of severe postoperative complications that need surgical or radiological reintervention and mortality. This decision should be made while taking into account the patient's concomitant diseases, response on preoperative resuscitation and the availability of a surgeon experienced in colorectal surgery.