The use of andexanet alpha in the Polish setting: An interdisciplinary protocol. Expert consensus statement of the Polish Cardiac Society.

Andexanet alfa (AA) is a recombinant inactive analog of human activated factor X (FXa), effectively reversing the effects of its inhibitors - rivaroxaban and apixaban, which are available in Poland. The drug was approved for clinical use registration after the publication of the results of the ANNEXA-4 trial (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXa Inhibitors 4), in which its efficacy in restoring hemostasis in life-threatening hemorrhages in patients receiving using the aforementioned anticoagulants was demonstrated. Hence, AA is now recommended for patients on apixaban or rivaroxaban therapy with massive and uncontrollable hemorrhages, including hemorrhagic strokes (HS) and gastrointestinal bleeding. Drug-specific chromogenic anti-Xa assays are generally best suited for estimating rivaroxaban and apixaban plasma levels, aside from direct assessment of their concentrations. The absence of anti-Xa activity, determined using these assays, allows us to rule out the presence of clinically relevant plasma concentrations of any FXa inhibitor. On the other hand, the dose of AA should not be modified based on the results of coagulation tests, as it depends solely on the time that elapsed since the last dose of FXa inhibitor and oon the dose and type of FXa inhibitor. AA is administered as an intravenous (i.v.) bolus, followed by an i.v. infusion of the drug. The maximum reversal of anti-Xa activity occurs within two minutes of the end of the bolus treatment, with the continuation of the continuous i.v. infusion allowing the effect to be maintained for up to two hours afterwards. Because anticoagulant activity can reappear after the infusion is completed, it is currently unclear at what point after AA administration FXa inhibitors or heparin should be re-administered. In Poland AA is starting to become available and its urgent need to administer it to patients with severe bleeding on apixaban or rivaroxaban.

The Dilemma after Sealing an Endovascular Aortic Aneurysm - Three Ways Out.

INTRODUCTION: Endovascular aneurysm sealing (EVAS) was commercially introduced in 2013. The initial results of EVAS were positive, leading to its widespread use. The mid- and long-term reports showed greater than expected rates of migration, which led to a recall of the device. In the present article, we describe our experience in managing type Ia endoleaks and migration occurring with the Nellix system in three different ways: open repair with Nellix explantation, Nellix-in-Nellix application (NINA technique), and the use of the multibranched Colt device originally dedicated to the treatment of thoracoabdominal aneurysms. MATERIALS AND METHODS: From February 2014 to June 2021, we performed 20 procedures for failed EVAS or ChEVAS (migration, type Ia endoleak, secondary aneurysm rupture). All patients treated for EVAS failure were male, aged 65 - 79. RESULTS: Seven Nellix explantations were performed. Three patients were admitted to our hospital with ruptured aneurysms that occurred 3 weeks to 4 years (mean 124 weeks) after EVAS, and another four with type Ia endoleak. In all but one case, removal of the Nellix system was easy. In two patients, tube grafts were implanted and in the remaining five cases, bifurcated grafts were implanted. In four patients, graft legs were anastomosed with the internal iliac arteries. One patient with secondary aneurysm rupture died from multiorgan failure on the 4th postoperative day. In two cases, transient renal failure was noticed in the perioperative period. All patients were admitted to the intensive care unit for 1 to 4 days (mean 2 days). The mean hospital stay was 9 days. All patients stayed in follow-up (3 - 56 months), but no other complications occurred. Eight patients were treated with the NINA technique: five for distal migration of the Nellix and three for failed ChEVAS. Four patients had a NINA procedure performed with three chimneys, three with two and one with one chimney. In one case, two iliac limbs were implanted to avoid kinking of the external iliac arteries. The median hospitalization time after the procedure was 9 days (range 3 - 12). Four patients developed transient acute renal insufficiency in the perioperative period. The follow-up ranged between 4 and 72 months. In one patient, deterioration of preexisting chronic renal insufficiency developed 5 months after the procedure, but dialysis was not required. One patient died from exacerbation of heart failure 7 months after the NINA procedure. The Colt device was implanted in five patients for the treatment of distal migration with type Ia endoleaks. None of the patients developed any signs of spinal cord ischemia. All patients were admitted to the intensive care unit for 1 or 2 days. In two cases, transient acute renal failure was noticed in the perioperative period. The mean hospital stay was 9 days. All patients remained in follow-up (6 - 22 months). In one case, the occlusion of the celiac trunk branch was found in contrast computed tomography 1 month after implantation of the Colt device, but without any symptoms. No other complications occurred. CONCLUSIONS: Normal strategies for the management of complications for late failure of EVAR, including stent-graft extensions, are not suitable after EVAS; therefore, alternatives are necessary. Conversion to open repair carries an extensive burden on the patient, so it is not recommended for patients with high surgical risk. The use of a Nellix-in-Nellix application to treat late failure of EVAS is not within the instructions for use but could be an effective strategy for a type Ia endoleak with or without migration. The use of this technique has been extremely limited since the Nellix system was recalled from the market. The use of the Colt multibranched device may be an alternative option, but due to the small number of patients, this method needs further evaluation.

Results of endovascular aortic arch repair using the Relay Branch system.

OBJECTIVES: Our goal was to evaluate results of endovascular aortic arch repair using the Relay Branch system. METHODS: Forty-three patients with thoracic aortic pathology involving the aortic arch have been treated with the Relay Branch system (Terumo Aortic, Sunrise, FL, USA) in 10 centres. We assessed in-hospital mortality, neurological injury, treatment success according to current reporting standards and the need for secondary interventions. In addition, outcome was analysed according to the underlying pathology: non-dissective disease versus residual aortic dissection (RAD) (defined as remaining dissection after previous type A repair, chronic type B aortic dissections). RESULTS: In-hospital mortality was 9% (0% in patients with RAD). Disabling stroke occurred in 7% (0% in patients with RAD); non-disabling stroke occurred in 19% (7% in patients with RAD). Early type IA and B endoleak formation occurred in 4%. Median follow-up was 16 ± 18 months. During the follow-up period, 23% of the patients died. Aortic-related deaths were low (3% in patients with RAD). CONCLUSIONS: The results of endovascular aortic arch repair using the Relay Branch system in a selected patient population with regard to technical success are good. In-hospital mortality is acceptable, the number of disabling strokes is low and technical success is high. Non-disabling stroke is a major concern, and every effort has to be taken to reduce this to a minimum. The best outcome is seen in patients with underlying RAD. Finally, more data are needed.

Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results.

OBJECTIVES: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side. METHODS: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment. RESULTS: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thrombo-embolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. CONCLUSIONS: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability.

Replacement of infected aortoiliac vascular grafts with bifurcated BioIntegral Surgical No-React® bovine pericardial xenografts.

The infection of a vascular prosthesis is potentially fatal, and its effective treatment still remains the greatest challenge for vascular surgeons. We present our initial experience using bovine pericardial vascular prostheses to replace infected aortoiliac vascular grafts. Six consecutive patients with infection of the graft were prospectively included in this study. Infection of the vascular graft was confirmed by clinical symptoms, laboratory tests and the results of computed tomography and positron emission tomography/computed tomography. In all cases, the infected aortoiliac graft was surgically removed and replaced by the bovine-pericardial BioIntegral aortic-bifemoral prosthesis. Technical success was achieved in every case with no in-hospital or 30 days mortality. One patient required revision of distal anastomosis due to recurrent bleeding at day four after surgery. One patient presented with upper gastrointestinal tract bleeding during the postoperative period, which was managed endoscopically. The mean hospital stay was 14 days (range 9-19). The control CT scan performed 2 months after surgery showed significant regression of abscesses and periprosthetic inflammation. Two patients died within 32 months of follow-up: one due to heart attack, the other due to generalized sepsis, which was correlated with the previous infection. Four patients are still in follow-up. The BioIntegral prosthesis is patent in all four cases, with no clinical or ultrasonographic signs of infection. Our brief investigation shows that a bovine pericardial prosthesis may be a valuable option in the treatment of vascular grafts infections.

Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results.

OBJECTIVES: To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms. METHODS: A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality. RESULTS: Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter. CONCLUSIONS: The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194.

Percutaneous thrombin injection to complete SMA pseudoaneurysm exclusion after failing of endograft placement.

Visceral aneurysms are potentially life-threatening vascular lesions. Superior mesenteric artery (SMA) pseudoaneurysms are a rare but well-recognized complication of chronic pancreatitis. Open surgical repair of such an aneurysm, especially in patients after previous surgical treatment, might be dangerous and risky. Stent graft implantation makes SMA pseudoaneurysm exclusion possible and therefore avoids a major abdominal operation. Percutaneous direct thrombin injection is also one of the methods of treating aneurysms in this area. We report a first case of percutaneous ultrasound-guided thrombin injection to complete SMA pseudoaneurysm exclusion after an unsuccessful endograft placement. Six-month follow-up did not demonstrate any signs of aneurysm recurrence.

[New possibilities in treatment of atherosclerosis--increase of nitric oxide synthesis by L-arginine supplementation]. / Nowe mozliwosci leczenia miazdzycy--zwiekszenie syntezy tlenku azotu poprzez suplementacje L-argininy.

Diseases such as heart attack, stroke or critical atherosclerotic leg ischaemia are very common in the developed countries. It is estimated that they are the main cause of deaths in the age group over 40 years. Patients with advanced leg ischaemia can be treated surgically. However in distal disseminated occlusions, surgery is technically impossible. In such cases amputation is the treatment of choice, but postoperative death ratio in this group is still high. That is why new ways of atherosclerosis treatment are needed. Progress in vascular biology brings new methods of treatment. Discovering of vasodilatory effect of nitric oxide makes us seek for ways of increasing its endogenous synthesis in endothelium of blood vessels. Studies on angiogenic cytokine application, amplification of NO synthesis expression and other gene engineering techniques are carried out in order to increase the concentration of nitric oxide in endothelium. It has been found that an increase of nitrix oxide synthesis can be achieved by administering L-arginine. Numerous trials suggest that supplementation of this amino acid can be of great therapeutic importance in patients with various atherosclerotic diseases. Clinical effectiveness of L-arginine is comparable to conventional pharmacotherapy. It seems that in the near future L-arginine supplementation may contribute to better results of atherosclerosis treatment.