Outcome of Femoral Angioplasty/Stenting Procedures in Different Ethnic Groups in England: A Retrospective Analysis of Hospital Episode Statistics and Review of Literature

Purpose Various studies, mainly from North America, report worse outcomes in ethnic minority populations submitted to revascularization for peripheral arterial disease (PAD). Limited nationwide data in relation to ethnicity are available from Europe. Objective The objective of the study is to compare the outcomes of femoral angioplasty/stenting procedures among different ethnic groups in England during the 10-year period from 2006 to 2015. Materials and Methods The “Hospital Episode Statistics” database has been searched using International Classification of Diseases, Tenth Revision ( ICD-10) codes to identify all cases of femoral angioplasty or stenting from English NHS Hospitals between January 1, 2006, and December 31, 2015. Subsequent mortality, second open or endovascular infrainguinal procedures, and major amputations on the same side within 2 years after the first procedure have been recorded. Patients were broadly categorized according to ethnicity as whites, Asians, and blacks. Chi-square test was used to demonstrate significant differences among ethnic groups and odds ratios (ORs) were calculated using white ethnic group as reference. Results A total number of 70 887 femoral endovascular procedures were recorded in patients from the 3 ethnic groups. Two-year mortality in whites, Asians, and blacks was 18.3%, 22.1%, and 19.5% (p<0.001); rates of second endovascular procedure were 12.1%, 13.1%, and 13.5% (p=0.24); rates of open infrainguinal procedure were 5.6%, 4.5%, and 8.0% (p<0.001); and rates of major amputation were 4.8%, 4.1%, and 7.0% (p<0.001), respectively. Mortality was higher in Asians (OR=1.26, 95% confidence interval [CI]=1.10-1.45, p<0.01) compared with whites. On the contrary, blacks underwent more open arterial operations (OR=1.48, 95% CI=1.19-1.83, p<0.01) and more amputations (OR=1.49, 95% CI=1.18-1.87, p<0.01). There were no significant differences in the rates of second endovascular procedures. Conclusion Two-year mortality after femoral angioplasty/stenting is higher in Asians, whereas risk of limb loss is higher in blacks compared with whites. Reasons of these ethnic differences in outcomes following femoral endovascular procedures for PAD merit further study.

Change in Abdominal Aortic Aneurysm Sac Diameter After Endovascular Repair: A Single-Center Experience From Taiwan

Purpose: The purpose of this study was to investigate the change in the diameter of infrarenal abdominal aortic aneurysm (AAA) sacs after endovascular aortic repair (EVAR) in Taiwanese patients and to depict its association with clinical outcomes. Materials and Methods: This retrospective cohort study was conducted on patients who underwent EVAR for infrarenal AAA between January 2011 and December 2016. All preoperative and follow-up computed tomography (CT) images were reviewed. Postoperative CT angiography was arranged after 1 month and annually thereafter. The maximal diameter on the axial plane and the maximal diameter perpendicular to the centerline on the coronal and sagittal planes were measured. The study examined post-EVAR sac diameter change over time and compared the differences in adverse events (AEs) among groups. Results: The survey included a total of 191 patients with a median follow-up duration of 2.5 (interquartile range: 1.1–2.9) years. Overall survival rates at 1, 2, and 5 years were 92%, 81%, and 76%, respectively. According to their last CT scans, the patients were categorized into 3 groups as follows: shrinkage, stationary, and enlargement, which comprised 58 (30.4%), 118 (61.8%), and 15 (7.9%) patients, respectively. Pre-EVAR characteristics and sac diameters were similar among the groups. Sac shrinkage was exclusively observed in the first 2 years, whereas sac enlargement developed at all follow-up periods. Patients with sac enlargement had higher incidence rates of endoleaks, complications, and reintervention than the other groups. Conclusion: Based on our observations, post-EVAR sac shrinkage only occurs in the first 2 years; however, post-EVAR sacs may enlarge at any point and even after 5 years. In our study, patients with sac enlargement had higher rates of adverse events and reintervention.

Exploiting the Transformation Temperature to Reform an Infolded Nitinol Self-Expanding Peripheral Stent

Purpose: Nickel-titanium (nitinol) alloys possess a special set of properties that allow for a wide range of applications. Specifically, the transformation temperature for self-expanding nitinol peripheral stents allows for easy crimping at or below room temperature and reformation at body temperature becoming superelastic. Case Report: We report the case of an elderly man with iliac stenting 1 month prior, who presented several weeks after recovering from coronavirus disease 2019 with recurrent anterior-wall ST-elevation myocardial infarction. This was complicated by deformation and infolding of the previously implanted nitinol self-expanding stent in his right common iliac artery (CIA). Understanding nitinol’s specific properties, we proceeded with rapid injections of iced saline to cool the nitinol stent to its transformation temperature while nudging the distal end of the stent with a partially inflated balloon. This maneuver softened the nitinol stent, allowing us to “unfold” and reappose it against the wall of the right CIA, resulting in successful restoration of the original shape of the nitinol self-expanding stent. Conclusion: This represents the first reported case describing treatment of an infolded nitinol self-expanding peripheral stent by exploiting the transformation temperature of nitinol using iced cold saline to successfully restore the stent’s original shape and structure.

Reverse Cheese-Wire Septotomy to Create a Distal Landing Zone for Thoracic Endovascular Aortic Repair

Purpose: The objective of this study is to describe a novel method for creating a distal landing zone for thoracic endovascular aortic repair (TEVAR) in chronic aortic dissection. The technique is described in a patient with prior total arch and descending aortic replacement, with false lumen expansion. Technique: A cheese-wire endovascular septotomy was desired to create a single lumen above the celiac axis. To avoid dividing the septum caudally across the visceral segment, we performed a modified septotomy in a cephalad direction. Stiff wires were passed into the prior surgical graft, through true lumen on the right and false lumen on the left. An additional wire was passed across an existing fenestration at the level of the celiac axis, and snared and externalized. 7F Ansel sheaths were advanced and positioned tip-to-tip at the fenestration. Using the stiff wires as tracks, the through-wire was pushed cephalad to endovascularly cut the septum. Angiogram demonstrated successful septotomy, and TEVAR was performed to just above the celiac with successful aneurysm exclusion and no endoleak or retrograde false lumen perfusion. Follow-up computed tomography angiogram (CTA) showed continued exclusion without false lumen perfusion. Conclusions: This novel modification in a reverse direction provides an alternative method for endovascular septotomy, when traditional septotomy may threaten the visceral vessels.

Fiber Optic RealShape (FORS) Technology for Endovascular Navigation in Severe Tortuous Vessels

Purpose: The purpose of this study was to describe the use of a wire and catheters embedded with optical fiber (Fiber Optic RealShape [FORS]) to catheterize tortuous target vessels avoiding radiation. Technique: A virtual biplane vies was simulated coupling traditional x-ray system, preoperative CT scan, and FORS system to treat an isolated hypogastric aneurysm. Despite the complex anatomy, catheterization of all target vessels was possible in 12 minutes with 19 seconds of fluoroscopy time (Radiation Exposure 3.8 mGy×cm2). A minimal invasive endovascular exclusion of the aneurysm was achieved through selective coil-embolization of the iliolumbar artery and implantation of balloon expandable covered stents, thus preserving the perfusion of the superior gluteal artery. Conclusion: FORS guidance allowed catheterization of a target vessel with challenging anatomy with a low radiation exposure.

A System for Accurate Deployment of Unconstrained Triple-Fenestrated Aortic Arch Endografts

Purpose: To achieve accurate rotational orientation and the axial position of unconstrained triple-fenestrated physician-modified endografts upon deployment in the aortic arch during total arch thoracic endovascular aortic repair (TA-TEVAR). Materials and Methods: Following a detailed study of reconstructed computerized tomography angiography images of patients’ arch anatomy, customized, sealable fenestrations with radio-opaque margins are created onsite on Valiant Captivia (Medtronic) endografts, transposing the arch branch ostial anatomic interrelationship onto the endograft precisely. Radio-opaque figure-of-8 markers, indicating the 12 o’clock (superior) position, are attached to the endograft on the surface and brought up to the surface under the endograft cover during resheathing. Resheathing without any twist in the endograft is achieved by lining up the welds in each endograft stent segment in a straight line. The fluoroscopic working view for arch endograft delivery and deployment is the left anterior oblique view that is orthogonal to the plane of the arch, which, in turn, is the right anterior oblique view in which parts of a stiff indwelling guidewire in the ascending and descending aorta precisely overlap. During introduction in the working view, the endograft delivery system is rotated in the descending thoracic aorta so that the 12 o’clock figure-of-8 markers are viewed on the edge and situated at the outer aortic curvature; continued advancement into the arch without any further rotation will ensure superior orientation of the figure-of-8 markers and, consequently, correct endograft rotational orientation. Proper axial endograft positioning requires locating the left common carotid artery (LCCA) fenestration just proximal to a taut externalized LCCA-femoral guidewire loop marking the posterior limit of the LCCA ostium. After endograft deployment during rapid cardiac pacing, the target arch branches are cannulated through their respective fenestrations using hydrophilic 0.035-inch guidewires that are externalized via distal sheaths to create femoral-arch branch (through-and-through) loops over which covered fenestrated stents are introduced and deployed. Results: This technique was used successfully in 31 consecutive patients undergoing TA-TEVAR; systemic blood pressure was obtained in all arch branches immediately after endograft deployment, indicating adequate blood flow. All arch branches were successfully cannulated and stented. Conclusion: This system enables accurate deployment of unconstrained triple-fenestrated arch endografts simply and reliably during TA-TEVAR.

Early Clinical Outcomes of the Active Seal Technology of the AFX Endovascular Aortic Aneurysm System With the VELA Cuff for Patients With a Conical Proximal Neck

Purpose: To evaluate the efficacy of the Active Seal technology employed in the AFX endovascular aortic aneurysm system (AFX), during endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysms (AAAs) having a conical proximal neck. Materials and Methods: A retrospective analysis of the EVAR for AAA with a conical proximal neck using the AFX was performed at 17 Japanese hospitals between January 2016 and August 2020. The conical proximal neck was defined as a cone-shaped proximal neck, with more than 10% diameter increase within a 15 mm length at the proximal landing zone. All anatomical analyses were performed in the core laboratory, and cases with parallel walls within the proximal neck adequate for the landing zone were excluded from the study. Results: This study included 53 patients, but only 39 patients (mean age, 76.6 ± 6.7 years; 87.0% males; mean aneurysm diameter, 52.0 ± 8.0 mm) were analyzed after being characterized as having a pure conical neck by the core laboratory. The mean proximal neck diameters at the lower renal artery and proximal edge of the aneurysm were 20.0 ± 2.9 mm and 27.5 ± 4.9 mm, respectively. The mean proximal neck length was 21.5 ± 6.0 mm. Instructions for use violations other than the conical neck were observed in 15 patients (38.5%). The VELA cuff was used in all cases; however, additional proximal cuff was required in 9 more cases (23.1%). The Active Seal technology was able to significantly extend the proximal sealing zone from 21.5 ± 6.0 to 26.0 ± 12.2 mm ( p = .047). Thirty-six patients completed the 12-month follow-up (one patient was lost to follow-up, and 2 patients died from causes unrelated to the aneurysm), and there were no type-1a and 3 endoleaks with only one reintervention (2.6%) related to type 1b endoleak in the 12-month period. Furthermore, there was no significant enlargement of the proximal neck diameter at 12 months (at 1 month: 20.6 ± 3.4 mm and at 12 months: 21.3 ± 3.8 mm; p = .420). Conclusion: The Active Seal technology of the AFX significantly extended the proximal seal zone and no type-1a endoleak and proximal neck dilation was observed in patients with conical proximal neck at 12 months.

Step, Error, and Event Frameworks in Endovascular Aortic Repair

Objective: Competency-based surgical education requires detailed and actionable feedback to ensure adequate and efficient skill development. Comprehensive operative capture systems such as the Operating Room Black Box (ORBB; Surgical Safety Technologies, Inc), which continuously records and synchronizes multiple sources of intraoperative data, have recently been integrated into hybrid rooms to provide targeted feedback to endovascular teams. The objective of this study is to develop step, error, and event frameworks to evaluate technical performance in elective endovascular aortic repair (EVAR) comprehensively captured by the ORBB (Surgical Safety Technologies, Inc; Toronto, Canada). Methods: This study is based upon a modified Delphi consensus process to create evaluation frameworks for steps, errors, and events in EVAR. International experts from Vascular Surgery and Interventional Radiology were identified, based on their records of publications and invited presentations, or serving on relevant journal editorial boards. In an initial open-ended survey round, experts were asked to volunteer a comprehensive list of steps, errors, and events for a standard EVAR of an infrarenal aorto-iliac aneurysm (AAA). In subsequent survey rounds, the identified items were presented to the expert panel to rate on a 5-point Likert scale. Delphi survey rounds were repeated until the process reached consensus with a predefined agreement threshold (Cronbach α>0.7). The final frameworks were constructed with items achieving an agreement (responses of 4 or 5) from greater than 70% of experts. Results: Of 98 invited proceduralists, 38 formed the expert consensus panel (39%), consisting of 29 vascular surgeons and 9 interventional radiologists, with 34% from North America and 66% from Europe. Consensus criteria were met following the third round of the Delphi consensus process (Cronbach α=0.82–0.93). There were 15, 32, and 25 items in the error, step, and event frameworks, respectively (within-item agreement=74%–100%). Conclusion: A detailed evaluation tool for the procedural steps, errors, and events in infrarenal EVAR was developed. This tool will be validated on recorded procedures in future work: It may focus skill development on common errors and hazardous steps. This tool might be used to provide high-quality feedback on technical performance of trainees and experienced surgeons alike, thus promoting surgical mastery.

Arterial Embolization of Polycystic Kidneys for Heterotopic Transplantation

Introduction: The purpose of this study was to evaluate the efficacy of polycystic kidney embolization, performed to reduce kidney volume before heterotopic kidney transplantation, as this technique could be an alternative to pretransplant nephrectomy. Materials and Methods: All patients who underwent pretransplant embolization of polycystic kidneys were included in a prospective register from June 2014 to February 2020. All patients underwent computed tomography (CT) scan with volumetric reconstruction (OsiriX, Bernex, Switzerland) before embolization and were then followed up at 3 and 6 months after embolization. Primary outcome was percentage of kidney volume reduction. Secondary outcomes were 30 day mortality and morbidity. Results: Thirty-one embolizations performed on 29 patients (medium age = 55.6; 62.1% male) were included between June 2014 and February 2020. All patients were under dialysis before embolization (9 peritoneal dialysis and 20 hemodialysis). Technical success was observed in 96.8% of cases. Mean procedural time was 65 minutes (range = 35–106 minutes) and mean length of in-hospital stay was 3.8 days (range = 3–6 days). A volume reduction allowing a kidney transplant was obtained for 28 patients (96.5%). The mean volume reduction was 39.9% (range = 6.01–68.2). The main observed complication was postembolization pain in 10 cases (32.2%). One patient needed complementary nephrectomy due to insufficient volume reduction. Twenty-three patients (79.3%) received renal transplant during follow-up with a mean delay of 19.5 month (range = 4–54). Conclusion: Polycystic kidney embolization is an effective and safe minimally invasive technique. It can be proposed as the first-choice technique for kidney transplant recipients as an alternative to pretransplantation nephrectomy.

Use of On-Site Digital Subtraction Angiography for Left Subclavian Artery Management During Hybrid Aortic Arch Repair in DeBakey I Dissection

Purpose: A hybrid aortic repair using the frozen elephant trunk (FET) technique with an open distal anastomosis in zone 2 and debranching of the left subclavian artery (LSA) has been demonstrated to be favorable and safe. Although a transposition of the LSA reduces the risk of cerebellar or medullar ischemia, this may be challenging in difficult LSA anatomies. Case Report: We present the case of a 61-year old patient with DeBakey I aortic dissection, treated with FET in moderate hypothermic circulatory arrest (26°C) and selective cerebral perfusion using a Thoraflex-Hybrid (Vascutek Terumo) prosthesis anchored in zone 2, with overstenting of the LSA orifice and no additional LSA debranching. Sufficient perfusion of the LSA was proved intraoperatively using LSA backflow analysis during selective cerebral perfusion in combination with on-site digital subtraction angiography (ARTIS Pheno syngo software). No neurologic dysfunction or ischemia occurred in the postoperative course. An angiographic computed tomography revealed physiologic LSA perfusion, with subsequent thrombotic occlusion of the false lumen in the proximal descending aorta after 7 days. Conclusion: Using an angiography-guided management in patients with complex DeBakey I dissection and difficult anatomy may simplify a proximalization of the distal anastomosis in zone 2 for FET, even without an additional LSA debranching.