MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI Trial.

BACKGROUND: Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. METHODS: The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. RESULTS: At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. CONCLUSIONS: SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.

Cleaner XT Rotational Thrombectomy: An Efficacious Endovascular Technique for Salvage of Thrombosed Arteriovenous Access and a 12 Month Outcome Analysis.

PURPOSE: This study aims to describe an efficacious method using Cleaner XT rotational thrombectomy with catheter-directed thrombolysis and drug-eluting balloon angioplasty for the salvage of thrombosed arteriovenous fistulae and grafts. MATERIALS AND METHODS: Retrospective analysis of all patients with thrombosed hemodialysis accesses who underwent endovascular salvage using the Cleaner XT rotational thrombectomy system at a single institution between June 2019 and September 2020 was performed. Patency was presented as Kaplan-Meier survival curves, and regression analysis was performed to examine predictors of postintervention primary patency and assisted primary patency based on Cox proportional-hazards model. RESULTS: Thirty-four patients with thrombosed accesses underwent Cleaner XT rotational thrombectomy between June 2019 and September 2020. Technical and clinical success were both 100%. Mean procedure time was 62 ± 20 minutes. Mean postintervention primary patency time was 152 ± 51 days; 30, 90, 180, and 365 day postintervention primary patency rates were 89%, 80%, 68%, and 56%, respectively. Mean postintervention-assisted primary patency time was 157 ± 59 days; 30, 90, 180, and 365 day postintervention-assisted primary patency rates were 91%, 82%, 71%, and 59%, and 180 and 365 day secondary patency rates were 97.2% and 94.4%, respectively. CONCLUSION: The Cleaner XT rotational thrombectomy device demonstrates excellent clinical and technical success rates, with good patency results at all time points up to 12 months postintervention.

Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population - 24-month outcome data from the BIOLUX P-III Global Registry 24-month Asian outcomes of BIOLUX P-III.

BACKGROUND: Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians. METHODS: A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC). RESULTS: AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p < 0.05), had more diabetes (87.8% vs 45.3%, p < 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p < 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p < 0.05) and mortality (37.9% vs 10.6%, p < 0.05) at 24 months. CONCLUSION: Passeo-18 Lux™ use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.

Medium-Term Survival After Unrepaired Ruptured Abdominal Aortic Aneurysm.

PURPOSE: Ruptured abdominal aortic aneurysm (AAA) is almost always considered fatal without open surgical or endovascular repair. We report a case that has defied this norm and explore the possible factors involved in this exceedingly rare outcome. CASE REPORT: An 87 year old gentleman presented with an acute ruptured AAA with left retroperitoneal hematoma. He was counseled for emergent repair, but opted for conservative management instead. He has remained well at the time of writing, 13 months from the rupture, with clinical resolution of symptoms along with radiological resolution of the hematoma. CONCLUSION: Timely repair remains the mainstay of management for ruptured AAA, although this rare case highlights that it is possible for ruptured AAA to seal spontaneously with patient surviving up to 13 months. We have sought to hypothesize the factors in this case that may have contributed to prolonged survival following untreated ruptured AAA. CLINICAL IMPACT STATEMENT: While the overwhelming evidence is that a ruptured AAA left unrepaired is fatal, our case report illustrates a rare case that shows it is possible for ruptured AAA to seal spontaneously, with patient surviving up to 13 months. We seek to hypothesize the factors that may contribute to such prolonged survival.

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months.

INTRODUCTION: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). MATERIAL AND METHODS: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. RESULTS: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001) and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%). CONCLUSIONS: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.

The modified frailty index-11 predicts medium-term outcomes after endovascular revascularisation for chronic limb threatening ischaemia in Asian patients.

OBJECTIVE: The aim was to evaluate the utility of frailty, as defined by the modified Frailty Index-1 1 (mFI-11) on predicting outcomes following endovascular revascularisation in Asian patients with chronic limb-threatening ischaemia (CLTI). METHODS: CLTI patients who underwent endovascular revascularisation between January 2015 and March 2017 were included. Patients were retrospectively scored using the mFI-11 to categorise frailty as low, medium or high risk. Observed outcomes included 30-day complication rate and unplanned readmissions, 1-, 6- and 12-month mortality, and ambulation status at 6- and 12 months post-intervention. RESULTS: A total of 233 patients (250 procedures) were included; 137 (58.8%) were males and the mean age was 69.0 (±10.7) years. 202/233 (86.7%) were diabetic and 196/233 (84.1%) had a prior diagnosis of peripheral arterial disease (PAD). The mean mFI-11 score was 4.2 (±1.5). 28/233 (12.0%), 155/233 (66.5%), and 50/233 (21.5%) patients were deemed low (mF-11 score 0-2), moderate (mFI-11 score 3-5) and high (mFI-11 score 5-7) frailty risk, respectively. High frailty was associated with an increased 12-month mortality (OR 8.54, 95% CI 1.05-69.5; p = 0.05), 30-day complication rate (OR 9.41, 95% CI 2.01-44.1; p < 0.01) and 30-day unplanned readmission (OR 5.06, 95% CI 1.06-24.2; p = 0.04). Furthermore, a high score was associated with a significantly worse 6- (OR 0.320, 95% CI 0.120-0.840; p = 0.02) and 12-month (OR 0.270, 95% CI 0.100-0.710; p < 0.01) ambulatory status. CONCLUSION: The mFI-11 is a useful, non-invasive tool that can be readily calculated using readily available patient data, for prediction of medium-term outcomes for Asian CLTI patients following endovascular revascularisation. Early recognition of short- and mid-term loss of ambulation status amongst high-frailty patients in this challenging cohort of patients could aid decision-making for whether a revascularisation or amputation-first policy is appropriate, and manage patient and caregiver expectations on potential improvement in functional outcome.

Editor's Choice - Decrease in Mortality from Abdominal Aortic Aneurysms (2001 to 2015): Is it Decreasing Even Faster?

OBJECTIVE: The early twenty first century witnessed a decrease in mortality from abdominal aortic aneurysms (AAA), which was associated with variations in the prevalence of cardiovascular risk factors. This study investigated whether these trends continued into the second decade of the twenty first century. METHODS: Information on AAA mortality (2001 - 2015) using International Classification of Diseases codes was extracted from the World Health Organization (WHO) mortality database. Data on risk factors were extracted from the Institute of Health Metrics and Evaluation and WHO InfoBase, and data on population from the World Development Indicators database. Regression analysis of temporal trends in cardiovascular risk factors was done independently for correlations with AAA mortality trends. RESULTS: Seventeen countries across four continents met the inclusion criteria (Australasia, two; Europe, 11; North America, two; Asia, two). Male AAA mortality decreased in 13 countries (population weighted average: -2.84%), while female AAA mortality decreased in 11 countries (population weighted average: -1.64%). The decrease in AAA mortality was seen in both younger (< 65 years) and older (> 65 years) patients. The decrease in AAA mortality was more marked in the second decade of the twenty first century (2011 - 2015) compared with the first decade (2001 - 2005 and 2006 - 2010). Trends in AAA mortality positively correlated with smoking (males: p = .03X, females: p = .001) and hypertension (males: p = .001, females: p = .01X). Conversely, AAA mortality negatively correlated with obesity (males: p = .001, females: p = .001), while there was no significant correlation with diabetes. CONCLUSION: AAA mortality has continued to decline and seems to have declined at an even faster rate in the second decade of the twenty first century, albeit with heterogeneity among countries. These variations are multifactorial in origin but further efforts targeting smoking cessation and blood pressure control will probably contribute to continued reductions in AAA mortality.

Treatment of lower limb ischaemia in patients with diabetes.

Diabetic chronic limb-threatening ischaemia is a challenging clinical problem with patients at high risk of diabetic foot ulceration (DFU) and limb loss. Patients often remain asymptomatic even in the presence of severe pedal ischaemia until first presenting with tissue loss such as DFU or frank gangrene. Limb salvage units should have the facilities and expertise to provide multidisciplinary team-based holistic care through best medical therapy, rapid diagnosis, prompt revascularisation with endovascular or open surgical techniques and expert wound management. Endovascular revascularisation has become the first line strategy in contemporary clinical practice because of similar outcomes in wound healing and amputation rates in most patients when compared with open surgery. The primary goal is restoration of pulsatile in-line blood flow to the ankle or foot, with an angiosome-directed approach possibly achieving superior outcomes especially in diabetics with poor collaterals. A comprehensive overview of conventional endovascular techniques (such as antegrade true lumen and subintimal approaches), advanced techniques for complex disease (such as retrograde subintimal and pedal-plantar loop approaches or even deep venous arterialisation) and the various treatment options are described. Diabetic limb salvage rates can be excellent with suitable multidisciplinary expertise and care.

Utility of a novel high pressure non-compliant balloon for tibial atherosclerotic lesions in Asian patients with chronic limb threatening ischaemia.

Background: The aim was to evaluate the safety and efficacy of a high pressure, non-compliant balloon in the treatment of infrapopliteal occlusive disease in Asian patients with chronic limb threatening ischaemia (CLTI) from Singapore. Patients and methods: Prospective, multi-centre, single arm, non-randomized study. Immediate technical success, 6-month primary vessel patency (determined by Duplex ultrasonography), limb salvage, one-year clinically driven target lesion re-intervention (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. Results: 86 patients (63% males, mean age 68.9 ± 9.9 years) were enrolled over a 15-month period. Diabetes mellitus (DM) and end-stage renal failure (ESRF) were present in 94% and 38% of patients respectively. All had some degree of tissue loss at baseline (Rutherford scale 5 and 6 = 91% and 9% respectively). Of the 86 legs, 72% had 3 crural vessel disease and 84% had moderate/severe vessel wall calcification. 90% had > = 1 TASC D tibial lesion. Acute technical success was 89%. One month mortality was 3.5% and one-year freedom from TLR was 91%. 6-month tibial patency was 73%. 54/66 (82%) patients had at least one target treated tibial artery open at 6 months. A lower baseline toe pressure (OR 1.03, 95%CI 1.00-1.05) and elastic recoil post angioplasty (OR 0.20, 95%CI 0.05-0.79) were associated with a worse 6 month tibial patency. One-year AFS was 67%. 47/66 (71%) patients had a clinical improvement of at least one Rutherford class at 6 months and 52/59 (88%) experienced complete wound healing at 12 months. Conclusions: Use of a high pressure non-compliant balloon is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging population of CLTI patients with a high incidence of DM and ESRF. It is associated with highly satisfactory acute technical success, 6-month target lesion patency and one-year limb salvage.

Fenestrated Endovascular Repair of Zones 1 and 2 Aortic Arch Pathologies.

BACKGROUND: Surgical management of aortic arch pathologies is complex, and endovascular developments have now enabled total or hybrid endovascular aortic arch repair. We present our early experience with fenestrated aortic arch repairs in Ishimaru zones 1 and 2 pathologies. METHODS: In a single tertiary institution, all consecutive endovascular aortic arch repairs were reviewed. A preoperative computed tomography aortogram was performed to assess anatomic suitability, which we defined as having a proximal sealing zone with a maximum diameter of 38 mm and minimum length of 20 mm, absence of significant aortic tortuosity, and suitable sealing zones in target vessels. RESULTS: From September 2015 to February 2018, 5 cases of fenestrated aortic arch endovascular repairs were performed. There were 3 male patients. The patients were between 57 and 83 years old, all of whom were American Society of Anesthesiologists (ASA) class II or III. Indications for surgery included aortic arch aneurysms (n = 3), a symptomatic aortic dissection, and a left subclavian artery aneurysm. Three patients had a scallop to the innominate artery, and one patient had a scallop to the left common carotid artery. Fenestrations were made to 3 left common carotid arteries and 3 left subclavian arteries. In 2 patients, a left carotid-subclavian bypass was performed, and the left subclavian artery origin occluded with a vascular plug. Technical success was 100%. One patient developed a right occipital infarct and acute myocardial infarction. The mean duration of surgery was 164 min, and the mean length of stay was 4.2 days. The mean follow-up period was 14.4 months. CONCLUSIONS: The use of fenestrated grafts in the aortic arch is a feasible treatment option. However, certain limitations still exist, and preoperative planning is important in ensuring clinical success. Although this procedure appears feasible in the short term, long-term results and durability remain to be seen.

Treatment of an Aortic Arch Aneurysm with Scalloped and Fenestrated Thoracic Stent Graft and Left Carotid to Subclavian Artery Bypass.

We report a successful treatment of thoracic arch aneurysm using a combination of hybrid approach and a customized stent graft in a frail patient with challenging anatomy and concomitant large retrosternal goiter. The patient is an 82-year-old lady with multiple comorbidities who presented to her general practitioner for anorexia and significant weight loss. She was incidentally found to have a 6.6-cm saccular distal aortic arch aneurysm, a 5.5-cm infrarenal abdominal aortic aneurysm, and a large goiter adjacent to the left common carotid artery (CCA) with retrosternal extension. The arch aneurysm was successfully managed with an open left common carotid to left subclavian bypass followed by thoracic endovascular aneurysm repair (EVAR) with a Cook stent graft customized to the patient's anatomy incorporating a proximal scallop for the brachiocephalic artery and a fenestration for the left CCA, and Amplatzer plug for occlusion of the ostium of the left subclavian artery. There was no endoleak and she was discharged uneventfully. She is planned for staged EVAR of her abdominal aortic aneurysm at a later date. In the presence of difficult arch aneurysm anatomies, the hybrid approach with bespoke stent grafts is a feasible alternative to open aortic arch replacement.

Sex-related trends in mortality after elective abdominal aortic aneurysm surgery between 2002 and 2013 at National Health Service hospitals in England: less benefit for women compared with men.

AIMS: To quantify the difference in long-term survival and cardiovascular morbidity between women and men undergoing elective abdominal aortic aneurysm (AAA) repair at National Health Service hospitals in England. METHODS AND RESULTS: Patients having elective repair of AAA were reviewed using the Hospital Episode Statistics and Office for National Statistics (ONS) datasets. The primary outcome measure was 30-day mortality and the secondary outcomes were 1-year, 5-year, and aortic-related mortality and post-operative complication rates. We used logistic regression and survival models to assess risk factors on the primary and secondary outcomes. Between 1 April 2002 and 31 March 2013, a total of 31 090 patients (4795 women and 26 295 men) underwent open AAA repair. Between 1 January 2006 and 31 March 2013, a total of 16 777 patients (2036 women and 14 741 men) underwent endovascular aneurysm repair (EVAR). All-cause and aortic-related mortalities at 30 days, 1 year, and 5 years were all higher in women, despite a lower prevalence of pre-operative cardiovascular risk factors. Female sex was a significant independent risk factor for 30-day mortality in both open repair [odds ratio (OR) 1.39; 95% confidence interval (CI) 1.25-1.56; P < 0.001] and EVAR (OR 1.57; 95% CI 1.23-2.00; P < 0.001) groups. Based on an all-cause long-term survival model, conditional on 30-day survival, the estimated hazard for women in the open repair group was significantly (P = 0.006) higher than men, but the sex difference was not significant in the EVAR group (P = 0.356). In the open repair group, women had significantly (P < 0.001) higher cumulative incidence probabilities for both aortic-related mortality and other-cause mortality. In the EVAR group, women had significantly (P < 0.001) higher mean cumulative incidence probabilities for the aortic-related mortality compared with men, but not for the other-cause mortality (P = 0.235). CONCLUSION: Women undergoing elective AAA repair at National Health Service hospitals in England had increased short- and long-term mortality and post-operative morbidity compared with men. These findings can be used to improve pre-operative counselling for women undergoing AAA repair, and highlight the need for female-specific pre-, peri-, and post-operative management strategies.