Mobility Rates After Lower-Limb Amputation for Patients Treated with Physician-Led Collaborative Care Model.

BACKGROUND: Clinical outcomes after major lower-limb amputation have been historically poor. The current care provided to most amputees is often disorganized and without physician supervision. The primary purpose of this study is to examine rates of postamputation mobility achieved with a prosthesis by patients with chronic limb-threatening ischemia and/or diabetes who required major lower-limb amputation and were treated under an established physician-led collaborative care pathway. The secondary purpose is to describe the structure and utilization of the care pathway by multiple independent vascular surgery practices in the United States to enable future exploration of its impact on key clinical outcomes within this patient population. METHODS: Clinical records of 2,475 patients from 6 vascular practices that adopted this collaborative care pathway between 2017 and 2020 were retrospectively reviewed. Only records with sufficient documented histories of amputation surgeries, prosthetic services, and mobility status were included. RESULTS: Of 2,475 patient records reviewed, 1,787 patients (2,157 major amputations) were eligible for analysis. Sixty-two-point 2 percent (n = 1,111) of patients achieved mobility with the collaborative care pathway. Mobility rate varied by amputation level in the study. Prosthetic mobility was achieved in 73.5% of transtibial amputations, 40.4% of transfemoral amputations, and 35.7% of through-knee amputations, regardless of patient laterality, which is superior or equivalent to the best published rates of mobility. CONCLUSIONS: The study describes the structure and utilization of a physician-led collaborative care pathway for treating patients who require lower-limb amputation that meets 5 of the 7 recommendations from the 2019 Global Vascular Guidelines on the Management of Chronic Limb Threatening Ischemia. Internal data analysis results suggest that patients treated via this care pathway can potentially achieve improved mobility rates with a prosthesis following amputation. This collaborative care pathway should be further evaluated for its ability to directly improve mobility and other clinically relevant amputation outcomes.

Evaluating the optimal training paradigm for transcarotid artery revascularization based on worldwide experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases. METHODS: Physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures, (2) supervised training on human cadavers, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, or device failure, occurring within 24 hours were recorded). Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates, adjusted for age, sex, and symptomatic status, were 1.0% (95% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.

In situ bypass and extra-anatomic bypass procedures result in similar survival in patients with secondary aortoenteric fistulas.

OBJECTIVE: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF. METHODS: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and operative and postoperative variables were recorded. The primary outcome was long-term mortality. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariate analyses were performed. RESULTS: During the study period, 182 patients at 34 institutions from 11 countries presented with SAEF (median age, 72 years; 79% male). The initial aortic procedures that resulted in SAEF were 138 surgical grafts (76%) and 42 endografts (23%), with 2 unknown; 102 of the SAEFs (56%) underwent complete excision of infected aortic graft material, followed by in situ (in-line) bypass (ISB), including antibiotic-soaked prosthetic graft (53), autogenous femoral vein (neoaortoiliac surgery; 17), cryopreserved allograft (28), and untreated prosthetic grafts (4). There were 80 patients (44%) who underwent extra-anatomic bypass (EAB) with infected graft excision. Overall median Kaplan-Meier estimated survival was 319 days (interquartile range, 20-2410 days). Stratified by EAB vs ISB, there was no significant difference in Kaplan-Meier estimated survival (P = .82). In comparing EAB vs ISB, EAB patients were older (74 vs 70 years; P = .01), had less operative hemorrhage (1200 mL vs 2000 mL; P = .04), were more likely to initiate dialysis within 30 days postoperatively (15% vs 5%; P = .02), and were less likely to experience aorta-related hemorrhage within 30 days postoperatively (3% aortic stump dehiscence vs 11% anastomotic rupture; P = .03). There were otherwise no significant differences in presentation, comorbidities, and intraoperative or postoperative variables. Multivariable Cox regression showed that the duration of antibiotic use (hazard ratio, 0.92; 95% confidence interval, 0.86-0.98; P = .01) and rifampin use at time of discharge (hazard ratio, 0.20; 95% confidence interval, 0.05-0.86; P = .03) independently decreased mortality. CONCLUSIONS: These data suggest that ISB does not offer a survival advantage compared with EAB and does not decrease the risk of postoperative aorta-related hemorrhage. After repair, <50% of SAEF patients survive 10 months. Each week of antibiotic use decreases mortality by 8%. Further study with risk modeling is imperative for this population.

Contemporary Outcomes After Partial Resection of Infected Aortic Grafts.

INTRODUCTION: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. METHODS: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. RESULTS: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material.

Intraoperative repair of mitral paravalvular leak with Amplatzer plug.

BACKGROUND AND AIM OF THE STUDY: Significant paravalvular leaks may complicate mitral valve replacement (MVR), especially in the setting of mitral annular calcification. Correction has been accomplished postoperatively by endovascular delivery of Amplatzer plugs (Abbott Medical) with good results. Intraoperative delivery of Amplatzer plugs at the index operation may reduce postoperative paravalvular leaks. METHODS: A retrospective review of eight patients who underwent placement of Amplatzer plugs for treatment of paravalvular leak during MVR at a single institution is reported. RESULTS: Seven patients had ≤1+ residual mitral valve insufficiency and one patient had 1-2+ residual mitral valve insufficiency intraoperatively by transesophageal echocardiogram. At 222 days average follow-up, echocardiogram revealed ≤ 1+ residual mitral valve insufficiency in all surviving patients. CONCLUSION: Intraoperative delivery of Amplatzer plugs for treatment of paravalvular leaks during MVR appears to be safe and effective at reducing postoperative mitral valve insufficiency.

Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm.

OBJECTIVE: Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA. METHODS: In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months. RESULTS: In this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months. CONCLUSIONS: In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.

Options for treatment of spontaneous mesenteric artery dissection.

OBJECTIVE: Mesenteric artery dissection was once thought to be rare but has been identified more frequently with increasing use of computerized tomographic angiographic imaging. Multiple reports advocate a wide range of treatment including medical therapy, endovascular, and surgical intervention, with no clear guidelines for the application of each treatment. METHODS: A systematic review of the literature was analyzed and used to create a treatment algorithm that was applied to nine patients in our institution. RESULTS: Although medical therapy is adequate for most patients with mesenteric artery dissection, 14% failed medical therapy, sometimes with severe consequences. Asymptomatic status on presentation predicted successful medical therapy for superior mesenteric artery dissection (P = .0037). CONCLUSIONS: Intensive surveillance is indicated during medical therapy, and invasive intervention may be necessary.

Risk Factors for Acute Renal Failure After Endovascular Aneurysm Repair.

BACKGROUND: Acute kidney injury (AKI) after endovascular aortic aneurysm repair (EVAR) is uncommon though carries significant morbidity. Procedural risk factors are not well established for acute renal failure (ARF) that requires initiation of dialysis. The goal of this study was to examine the impact of ARF on patients undergoing EVAR and identify risk factors for ARF using a large, national dataset. METHODS: Patients undergoing EVAR were identified from the National Surgical Quality Improvement Program (NSQIP) database over 9 years, ending in 2019. Demographics, indication for repair, comorbidities, procedural details, complications, hospital and ICU LOS, and mortality were recorded. Patients were stratified by presence of ARF and compared. Patients were further stratified by indication for EVAR and presence of ARF. Multivariable logistic regression (MLR) analysis was performed to determine the independent predictors of ARF. RESULTS: 18 347 patients were identified. Of these 234 (1.3%) developed ARF requiring dialysis. Mortality (40 vs 1.8%, P < .0001), ICU LOS (5 vs 0 days, P < .0001), and hospital LOS (11 vs 2 days, P < .0001) were all significantly increased in patients with ARF. Multivariable logistic regression identified increasing diameter, creatinine, operative time, preoperative transfusions, ASA class, emergent repair, female gender, and juxtarenal/suprarenal proximal landing zone as predictors of ARF. CONCLUSIONS: ARF after EVAR causes significant morbidity, prolongs hospitalizations, and increases mortality rates. Those patients at risk of ARF after EVAR should be closely monitored to reduce both morbidity and mortality.

Impact of Patient and Procedural Factors on Outcomes Following Mesenteric Bypass.

BACKGROUND: Mesenteric bypass (MB) for patients with acute (AMI) and chronic mesenteric ischemia (CMI) is associated with cardiovascular (CV) and pulmonary morbidity. METHODS: Patients with AMI and CMI from 2008 to 2019 were identified to determine independent predictors of CV (cardiac arrest, MI, DVT, and stroke) and pulmonary (pneumonia and ventilator time>48 h) morbidities in patients undergoing MB. RESULTS: 377 patients were identified. Patients with AMI had higher rates of preoperative SIRS/sepsis (28 vs 12%, P < .0001), were more likely to be ASA class 4/5 (55 vs 42%, P = .005), were more likely to require bowel resection (19 vs 3%, P < .0001), and were more likely to have vein utilized as their bypass conduit (30 vs 14%, P < .0001). There were no differences in use of aortic or iliac inflow (P = .707) nor in return to the OR (24 vs 19%, P = .282). Both postoperative sepsis (12 vs 2.6%, P = .003) and mortality (31.4% vs 9.8%, P < .0001) were significantly increased in patients with AMI. After adjusting for both patient and procedural factors, multivariable logistic regression (MLR) identified international normalized ratio (INR) (OR 3.16; 95% CI 1.56-6.40, P = .001) and chronic heart failure (CHF) (OR 5.88; 95% CI 1.15-29.97, P = .033) to be independent predictors of pulmonary morbidity, while preoperative sepsis (OR 1.96; 95% CI 1.45-2.66, P < .0001) alone was predictive of CV morbidity in all patients undergoing MB. DISCUSSION: Mesenteric bypass for mesenteric ischemia leads to high rates of morbidity and mortality, whether done in an acute or chronic setting. Preoperative sepsis, independent of AMI or CMI, predicts CV morbidity, regardless of bypass configuration or conduit, while elevated INR or underlying CHF carries a higher risk of pulmonary morbidity.

Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

Aortoduodenal fistula after endograft repair of abdominal aortic aneurysm secondary to a retained guidewire.

Aortoduodenal fistula is a well-known complication of abdominal aortic aneurysm repair and has been described after endovascular repair. A unique complication of duodenal perforation by intentionally placed embolic material in the aneurysm sac is described. Intentional off-label use of material to promote aneurysm sac thrombosis should be avoided.

Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHA2DS2-VASc Score: Results of the Randomized ATLAS Trial.

OBJECTIVE: Patients with elevated CHA2DS2-VASc scores are at high risk for atrial fibrillation (AF) and thromboembolic events (TE) after cardiac surgery. Left atrial appendage exclusion (LAAE) is a permanent, continuous approach to stroke prevention in AF, overcoming limitations of oral anticoagulation (OAC). We report ATLAS trial results focused on LAAE technical success and perioperative safety and TE rates with and without LAAE in cardiac surgery patients who developed postoperative AF (POAF). METHODS: ATLAS (NCT02701062) was a prospective, multicenter, feasibility trial. Patients age ≥18 years, undergoing structural heart procedure, with no preoperative AF, CHA2DS2-VASc ≥2, and HAS-BLED ≥2 were randomized 2:1 to LAAE or no LAAE. Patients who developed POAF and/or received LAAE were followed for 1 year. LAAE was evaluated with intraoperative transesophageal echocardiography. RESULTS: A total of 562 patients were randomized to LAAE (n = 376) or no LAAE (n = 186). Mean CHA2DS2-VASc (3.4 vs 3.4) and HAS-BLED (2.8 vs 2.9) scores were similar for LAAE and no LAAE groups. LAAE success (no flow nor residual stump >10 mm) was 99%. One LAAE-related serious adverse event (0.27%) occurred and was resolved without sequelae. There were 44.3% of patients who developed POAF. Through 1 year, 3.4% of LAAE patients and 5.6% of no LAAE patients had TE. OAC was used by 32.5% of POAF patients. Bleeding was higher with OAC than without (16.1% vs 5.4%, P = 0.008). CONCLUSIONS: ATLAS demonstrated a high rate of successful LAAE with low LAAE-related serious adverse events in cardiac surgery patients. Study results should be considered in future trial design to further evaluate prophylactic LAAE for stroke prevention in cardiac surgery patients with elevated stroke risk.

Carotid endarterectomy for treatment of in-stent restenosis.

In-stent restenosis (ISR) after carotid angioplasty and stenting is becoming evident as more patients undergo carotid stenting and duplex scan surveillance. While redo endovascular therapy has been immediately successful, recurrent stenosis remains a problem. The ideal management of ISR has not been determined. Three cases of symptomatic ISR that were successfully treated by standard carotid endarterectomy (CEA) with removal of the stent are reported herein. Current options for management of ISR are reviewed from the literature.

Evaluation of Staged TCAR and Cardiac Surgery or Structural Heart Intervention.

INTRODUCTION: The optimal treatment strategy for patients with concomitant carotid and cardiac disease remains controversial. Transcarotid artery revascularization stenting with reversed flow protection (TCAR) has achieved results equivalent to carotid endarterectomy (CEA) in high risk patients. METHODS: A retrospective review of all patients at a single center who received staged TCAR prior to cardiac intervention was performed. RESULTS: 37 patients underwent 42 TCAR procedures prior to cardiac intervention (25 requiring open cardiac surgery and 12 requiring percutaneous intervention). There were no myocardial or neurological complications following TCAR prior to cardiac intervention. Three patients (8%) developed a neck hematoma which required evacuation. CONCLUSION: A staged approach to combined carotid and cardiac pathology with TCAR prior to cardiac intervention appears to be a safe and effective strategy.

Extracellular Matrix Patches for Endarterectomy Repair.

Patch repair is the preferred method for arteriotomy closure following femoral or carotid endarterectomy. Choosing among available patch options remains a clinical challenge, as current evidence suggests roughly comparable outcomes between autologous grafts and synthetic and biologic materials. Biologic patches have potential advantages over other materials, including reduced risk for infection, mitigation of an excessive foreign body response, and the potential to remodel into healthy, vascularized tissue. Here we review the use of decellularized extracellular matrix (ECM) for cardiovascular applications, particularly endarterectomy repair, and the capacity of these materials to remodel into native, site-appropriate tissues. Also presented are data from two post-market observational studies of patients undergoing iliofemoral and carotid endarterectomy patch repair as well as one histologic case report in a challenging iliofemoral endarterectomy repair, all with the use of small intestine submucosa (SIS)-ECM. In alignment with previously reported studies, high patency was maintained, and adverse event rates were comparable to previously reported rates of patch angioplasty. Histologic analysis from one case identified constructive remodeling of the SIS-ECM, consistent with the histologic characteristics of the endarterectomized vessel. These clinical and histologic results align with the biologic potential described in the academic ECM literature. To our knowledge, this is the first histologic demonstration of SIS-ECM remodeling into site-appropriate vascular tissues following endarterectomy. Together, these findings support the safety and efficacy of SIS-ECM for patch repair of femoral and carotid arteriotomy.

Staged total exclusion of the aorta for chronic type B aortic dissection.

Hybrid techniques using extra-anatomic bypass of critical aortic branches to enable endovascular treatment of complex aortic pathology have been previously described. A staged endograft repair of a complex, chronic Stanford type B aortic dissection with aneurysmal degeneration is reported in a 50-year-old man. The aneurysmal portion of the dissection extended from the distal arch to both common iliac arteries and was covered with an endograft from the ascending aorta to both external iliac arteries. Aortic arch branches, visceral, and renal arteries were bypassed using open technique. The patient had no neurologic complications. This case report illustrates the feasibility of the hybrid technique in selected high-risk patients when confronted with complex aortic pathology.

Erosion of a right ventricular pacer lead into the left chest wall.

BACKGROUND: Erosion of a pacer lead into the chest wall may result in pericardial effusion with cardiac tamponade. Free rupture into the pleura or mediastinum can result in hypotension and cardiac arrest. CASE PRESENTATION: We report a unique case of a right ventricular pacer lead which eroded through the right ventricle into the left chest wall and penetrated a rib. The patient presented with a tender chest wall mass without pericardial or pleural effusion. The segment of rib which the pacing lead had penetrated was removed. CONCLUSIONS: The patient tolerated the procedure well and was discharged 1 week after the operation. This case adds to the current literature the justification of removal of temporary and non-functional pacing leads.

Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.

OBJECTIVES: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). BACKGROUND: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm. METHODS: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. RESULTS: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm2, and a 4.1% rate of moderate paravalvular leak at 30 days. CONCLUSIONS: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.

Endovascular management of iliac rupture during endovascular aneurysm repair.

BACKGROUND: Inadequate iliac artery diameter, calcification, and tortuosity are associated with increased incidence of iliac injury during abdominal (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Despite careful preoperative assessment and use of iliac conduits, inadvertent iliac rupture is a source of morbidity and mortality. This report details our single-center, 10-year experience with intraoperative iliac artery rupture and describes a successful endovascular salvage technique. METHODS: All patients undergoing EVAR and TEVAR between August 1997 and June 2008 were reviewed. Computed tomography (CT) measurements of access vessels were obtained for all patients. The smallest diameter of the external or common iliac artery was used to determine suitability for access based on the instructions for use for each device. Patients who underwent repair of a procedure-related iliac artery rupture were identified. Outcomes among patients who did not have an access vessel rupture (nonruptured group) and those who did (ruptured group) were compared. Patency of the endovascular iliac repair is reported. RESULTS: During the study period, 369 EVARs and 67 TEVARs were performed. Eleven iliac conduits were used, all during TEVAR (16%). There were 18 ruptured iliac arteries in 17 patients; 11 EVAR patients (2.98%) sustained iliac rupture vs six TEVAR patients (8.9%). One EVAR patient was converted to open repair. Seventeen ruptures in 16 patients were successfully treated with endovascular stent graft placement. Iliac rupture was more likely to occur during TEVAR (8.9%) than EVAR (2.98%; P = .0239, Fisher exact test). Significantly more women were in the ruptured group (76% vs 19%; P < .0001, Fisher exact test). Patients in the ruptured group had longer lengths of stay (7.6 vs 5.1 days; P = .0895, t test), no 30-day mortality, but a procedure-related mortality of 11.8%. In the nonrupture group, 30-day mortality was 6.6% (4 of 61) and 2.8% (10 of 358) for TEVAR and EVAR, respectively, and procedure-related mortality was 9.8% (6 of 61) and 3.1% (11 of 358). For endovascular repair of iliac rupture, primary and primary-assisted patency was 88.2% and 94.1%, respectively, with median follow-up of 40 months (range 10-115 months). CONCLUSION: Iliac rupture during EVAR or TEVAR can be successfully managed with endovascular stent grafting. Higher mortality and length of stay associated with iliac artery rupture confirm that there is no substitute for prevention. Access vessels of all patients undergoing EVAR should be examined closely for suitability. The threshold for using an iliac conduit, especially in women undergoing TEVAR, should be low.