No Difference in Mid-term and Long-Term Mortality After Vascular Paclitaxel Exposure

Background: Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid-term and long-term patient-level mortality in three trials from our institution. Methods: Patient data from the DRECOREST I and II trials, as well as the FINNPTX-trial, were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX-trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry, as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data. Results: A total of 142 patients were included, 76 treated with paclitaxel-eluting device, and 66 without. The mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I-trial, 35.5% of patients died in the pacli-taxel group and 37.9% in the control group (P = 0.84). In the DRECOREST II, overall mor-tality was 55.6% in the paclitaxel group and 44.4% in the control group (P = 0.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (P = 0.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (P = 0.733), followed by malignancy (14.8% vs. 14.3% in the groups respectively). Conclusions: No significant difference was seen in the overall analysis between the pacli-taxel and the control group. A statistically nonsignificant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individ-ual trials are small and should be interpreted in the context of future patient-level meta -analysis.Peer reviewe

Ultraääniohjattu perkutaaninen endovaskulaarinen aneurysman korjaus lokaalianestesiassa on kultainen standardi

Vatsa-aortan aneurysma korjataan nykyään yleensä suonensisäisellä tekniikalla. Jos potilaan aneurysman ja aortan anatomia eivät sovi suonensisäiselle toimenpiteelle, harkitaan avoleikkausta. Suonensisäisessä korjauksessa aneurysma eristetään verenkierron ulkopuolelle stenttiproteesin avulla, joka viedään aorttaan perkutaanisesti nivusvaltimoiden kautta. Endovaskulaarinen hoito edellyttää myös sitä, että valtimoissa ei ole merkittävää kalkkista ahtaumaa tai mutkaisuutta, joka estäisi stentin kulun aorttaan. Femoraalisuonten sulkulaitteiden käyttö suonensisäisten aneurysman korjausleikkauksissa vähentää komplikaatioiden ilmenemistä, vähentää aikaa hemostaasiin, sekä mahdollistaa aikaisemman potilaan mobilisaation toimenpiteen jälkeen. Sulkulaitteiden asennukseen liittyy kuitenkin komplikaatioriskejä. Tavallisimmat komplikaatiot ovat vuoto, verenpurkauman kehittyminen, pseudoaneurysma ja suonen tukkiutuminen. Aikaisemmissa tutkimuksissa on todettu MANTA-sulkulaitteella olevan pienempi komplikaatioriski verrattuna ProGlide-sulkulaitteeseen. Tämä tutkimus tehtiin kuitenkin aikana jolloin sulkulaitteita ei asennettu ultraääniohjatusti. Tämän retrospektiivisen tutkimuksen tarkoituksena oli selvittää, vaikuttaako ultraäänilaitteen käyttö ProGlide-sulkulaitteen komplikaatioriskiin. Tutkimuksen aineisto koostui 2.1.2017-9.2.2022 välisenä aikana kerättyyn aineistoon HUSpotilastietojärjestelmästä. Potilaiden tapahtumia seurattiin toimenpiteestä kotiutumiseen koko sairaalaolon ajan. Kaikissa toimenpiteissä oli käytössä ultraäänilaite sulkulaitteen asennusvaiheessa. Lopullinen potilasaineisto koostui 637 potilaasta, joista 12 peruuntui sairastumisen vuoksi. Hoidettuja nivusia oli kokonaisuudessaan 1235, joista 1046 elektiivisiä, 129 stabiileja aneurysman ruptuuroita ja 60 epästabiileja aneurysman ruptuuroita. ProGlide-sulkulaitetta käytettiin elektiivisissä toimenpiteissä 973 kertaa, stabiileissa ruptuuroissa 119 kertaa ja epästabiileissa 32 kertaa. MANTA-sulkulaitetta käytettiin yhteensä 37 kertaa, Angioseal-sulkulaitetta 37 kertaa, suoraan avotoimenpiteeseen ilman sulkulaitteita päädyttiin 33 kertaa. ProGlide vaihdettiin toiseen sulkulaitteeseen 19 kertaa sekä konvertoitiin avoleikkaukseen 30 kertaa. Primaari päätetapahtuma on onnistunut sulkulaitteen käyttö ilman vaihtoa toiseen sulkulaitteeseen tai avoleikkaukseen. Sekundaari päätetapahtuma on femoraalisuonten jälkikorjausten määrä ja akuutin raajaiskemian tai infektion insidenssi toimenpiteen jälkeen. ProGlide-sulkulaittetta käytettiin ilman komplikaatioita elektiivisesti 936 kertaa (96,20%), stabiileissa RAAA-potilaissa 111 kertaa (93,28%), epästabiileissa RAAA-potilaissa 28 kertaa (87,50%). Tutkimuksen päätelmänä on, että ProGlide sulkulaite on turvallinen ja tehokas väline nivuspunktioiden sulkemiseen aortan aneurysmien hoidossa silloin, kun punktion yhteydessä käytetään ultraääniohjausta. Lisäksi todettiin että instabiileilla aneurysmaruptuuroilla sukulaitetta ei aina voida asentaa ennen aortan sulkupallon asennusta

En bloc resection of visceral aorta and right kidney due to aortic sarcoma using temporary extracorporeal bypass grafting

Aortic sarcomas have not been linked to Lynch syndrome in humans, although other soft tissue malignancies have been. We report the case of a 31-year-old man with Lynch syndrome, who presented with abdominal pain and severe claudication. The clinical and diagnostic workup revealed near occlusion of the infrarenal aorta due to aortic angiosarcoma. En bloc resection of the visceral and infrarenal aorta with right nephrectomy was performed, facilitated by temporary extracorporeal bypass to the visceral arteries. The aorta was reconstructed with a bifurcated Dacron graft. At the 24-month follow-up examination, the patient was free of disease but was experiencing chronic diarrhea.Peer reviewe

Antitrombotisk medicinering inom kirurgin

English summary

Peripheral Vascular Restenosis : A Retrospective Study on the Use of Drug-Eluting Balloons in Native Arteries, Vein Grafts and Dialysis Accesses

Background and Aims: The objective of this study is to analyze outcomes of the first experiences with drug-eluting balloons in native arteries, vein grafts, and vascular accesses. The study is also a pilot for our future prospective, randomized, and controlled studies regarding the use of drug-eluting balloons in the treatment of the stenosis in bypass vein graft and dialysis access. Materials and Methods: A total of 93 consecutive patients were retrospectively analyzed and in the end 81 were included in the study. Inclusion criteria included at least one previous percutaneous angioplasty to the same lesion. Patients were divided into three groups according to the anatomical site of the lesion: native lower limb artery, vein bypass graft, or vascular access. Time from the previous percutaneous angioplasty to the drug-eluting balloon was compared to the time from the drug-eluting balloon to endpoint in the same patient. Endpoints included any new revascularization of the target lesion, major amputation, or new vascular access. Results: The median time from the drug-eluting balloon to endpoint was significantly longer than the median time from the preceding percutaneous angioplasty to drug-eluting balloon in all three groups. This difference was clearest in native arteries and vein grafts, whereas the difference was smaller from the beginning and disappeared over time in the vascular access group. No significant differences were seen between the groups with regard to smoking, antiplatelet regime, diabetes, Rutherford classification, or sex. Conclusion: Although the setup of this study has several limitations, the results suggest that there could be benefit from drug-eluting balloons in peripheral lesions. Very little data have been published on the use of drug-eluting balloons in vein grafts and vascular accesses, and randomized and controlled prospective studies are needed to further investigate this field.Peer reviewe

Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries : A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Objective: There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD). Method: This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed. Results: In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I-2 = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies. Conclusion: There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.Peer reviewe

Routine Inferior Mesenteric Artery Embolisation is Unnecessary Before Endovascular Aneurysm Repair

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Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial

Peer reviewe

Drug-Eluting Stent Shows Similar Patency Results as Prosthetic Bypass in Patients with Femoropopliteal Occlusion in a Randomized Trial

Background: Claudication and critical limb threatening ischemia are significant causes of mortality in the elderly. The gold standard of superficial femoral artery (SFA) revascularization is thus far considered to be the femoropopliteal bypass. The aim of this study was to compare mid-term patency between drug-eluting stents (DESs) and prosthetic bypass grafts (BSX). Studies have reported comparable results for both the methods. Methods: Forty-six patients with claudication or rest pain due to a 5-25 cm SFA occlusion were randomized between DES and BSX groups. The follow-up period was 24 months, and the primary outcome measure was overall patency. Secondary outcome measures were primary and primary assisted patency, change in ankle-brachial index (ABI), and amputation-free survival. Results: Forty-one patients were eventually analyzed. Six-month secondary patency was 91% (DES) versus 83% (BSX) (P = 0.450). The corresponding numbers at 12 months in the DES and BSX groups were 74% and 80% (P = 0.750), respectively. At 24 months, the respective numbers were 56% and 71% (P = 0.830). There were no statistically significant differences in primary or assisted primary patency at 1, 6, or 12 months. Conclusion: There were no demonstrable differences in patency rates or clinical outcomes such as ABI or major amputations between DES and BSX. Although underpowered, the results suggest noninferiority of the DES compared with prosthetic bypass surgery.Peer reviewe