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.

Duplex ultrasound criteria for in-stent restenosis of mesenteric arteries.

OBJECTIVE: Duplex ultrasound (DUS) criteria are well defined for evaluating high-grade stenosis (≥70%) of the native superior mesenteric artery (SMA) and celiac artery (CA). It has been shown that native vessel criteria overestimate the degree of in-stent restenosis (ISR) and that velocity criteria for SMA and CA ISR are not well established. The objective of this study was to define DUS velocity criteria for high-grade ISR of the SMA and CA. METHODS: A retrospective review of all patients who underwent SMA or CA stenting from a single institution was performed from 2004 to 2013. Patients were excluded if they did not have a DUS examination <4 months before angiography to assess stent patency or adequate angiographic visualization of the ISR. RESULTS: There were 103 paired DUS scans and angiograms analyzed: 66 SMA studies and 37 CA studies. The average peak systolic velocity (PSV) for SMAs was 367 cm/s with <70% ISR and 536 cm/s with ≥70% ISR. The average PSV for CAs was 302 cm/s with <70% ISR and 434 cm/s with ≥70% ISR. For an ISR ≥70% in the SMA, a PSV ≥445 cm/s produced the highest sensitivity (83%) and specificity (83%), with a positive predictive value of 81% and a negative predictive value of 86%. For an ISR ≥70% in the CA, a PSV ≥289 cm/s produced the highest sensitivity (100%) and specificity (57%), with a positive predictive value of 79% and negative predictive value of 100%. CONCLUSIONS: Increasing PSV correlates with an increasing degree of ISR for both the SMA and CA. Stented vessels have increased PSV, and therefore native PSV criteria are unreliable for the determination of ISR. The PSV criteria for ≥70% stenosis are higher for ISR than for native visceral vessel stenosis. The proposed new velocity criteria define ≥70% ISR as ≥445 cm/s in stented SMAs and ≥289 cm/s in stented CAs.

Comparative analysis of celiac versus mesenteric artery outcomes after angioplasty and stenting.

BACKGROUND: Open bypass is the gold standard for treatment of mesenteric ischemia. With the refinement of endovascular therapy, visceral stenting is an attractive minimally invasive alternative, but the data are limited and which vessel responds best to stenting has not been addressed. This study compares the outcomes of superior mesenteric artery (SMA) and celiac artery (CA) stenting. METHODS: All consecutive patients who underwent visceral stenting between January 2002 and May 2009 were reviewed. Standard statistical analyses, including Kaplan-Meier tests, were performed. Primary patency was defined as peak systolic velocities <350 cm/s for CAs and <450 cm/s for SMAs. Clinical patency was maintenance of either primary patency or the absence of recurrent symptoms. At arteriography, stenosis ≥70% was considered a loss of primary patency. RESULTS: One hundred twenty-one patients received 140 visceral stents in the SMA (n = 92; 65.7%), the CA (n = 40; 28.6%), and the inferior mesenteric artery (n = 8; 5.7%). Twenty-nine stents were placed in men (20.7%) and 111 stents were placed in women (79.3%) with a mean age of 72.9 years (range, 20.5-93.9). The combined SMA/CA stent mean follow-up was 12.8 months. Technical success was 100% for all. Overall 30-day morbidity and mortality rates were 14% and 0.8%, respectively. One-year primary patency was significantly higher for SMA than for CA stents: 55% versus 18%, respectively (P < .0001). Six-month clinical patency was 86% for the SMA and 67% for the CA (P < .005). Loss of CA primary patency was associated with stent diameter <6 mm (P = .042) and age <50 years (two patients; P = .038). These factors did not correlate with loss of primary patency for SMA. Overall freedom from bypass was 93% at 4 years. CONCLUSIONS: Visceral stenting has an exceptionally high technical success rate with low procedural morbidity and mortality. Clinical primary patency and primary patency were significantly higher for the SMA group than for the CA group. Our data suggest that CA atherosclerotic lesions do not respond well to endovascular stenting, bringing into question its clinical utility.

Subintimal angioplasty of chronic total occlusion in iliac arteries: a safe and durable option.

BACKGROUND: Traditionally, aortobifemoral bypass has been the intervention of choice for iliac artery chronic total occlusions (CTOs). However, it is associated with significant morbidity and mortality, limiting its use in high-risk patients. To reduce procedural risk, subintimal angioplasty (SIA) for femoropopliteal CTO has been utilized by many, but few have extended this endovascular technique to treating iliac artery CTOs. We present our experience with 101 successful SIAs for iliac artery CTOs. METHODS: A retrospective review of consecutive patients with iliac artery CTOs treated with subintimal angioplasty from June 2000 to January 2009 was completed. Demographic and risk factor data were obtained, along with procedural data. Primary and secondary patency, survival, freedom from claudication, and limb salvage rates were determined by Kaplan-Meier survival analysis. Univariate and multivariate analyses were completed to identify factors adversely affecting primary patency. RESULTS: One hundred twenty patients underwent an attempted SIA of an iliac artery CTO, and 101 iliac artery CTOs were successfully treated, giving a technical success rate of 84%. Technical failure was due to the inability to re-enter the lumen in all cases. Indications for intervention were lifestyle-altering claudication in 64 patients (63%) and critical limb ischemia (CLI), in 37 (37%). Eighty-five patients underwent percutaneous SIA, while 11 patients underwent a combined SIA with surgical outflow procedure. Lesions were classified as TransAtlantic InterSociety Consensus (TASC) B, 39 (39%); TASC C, 27 (27%); and TASC D, 35 (35%). In 82 (81%) lesions, stents were deployed with an average of 1.2 (range, 0-3) stents utilized. A re-entry device was used in 14 (14%) lesions. Major complication rate was 3.0%, with a 30-day mortality rate of 1.0%. Primary and secondary patency rates at 1, 2, and 3 years were 86% and 94%, 76% and 92%, and 68% and 80%, respectively. Survival rate was 67% at 5 years, reflecting the poor health of this cohort. Limb salvage for CLI patients at 1 and 5 years was 97% and 95%, respectively. Freedom from claudication at 1 and 3 years was 89% and 73%. Univariate analysis identified hyperlipidemia, coronary artery disease, and prior surgical bypass in treated limb as factors for loss of primary patency; however, on multivariate analysis, no factors remained statistically significant. CONCLUSION: This study demonstrates that SIA of iliac CTOs is feasible and can be performed safely and effectively, even in high-risk patients. Excellent patency and limb salvage rates can be achieved. In our experience, the safety and durability of SIA makes it an attractive first-line therapy for iliac artery occlusive disease.

Retrograde open mesenteric stenting for acute mesenteric ischemia is a viable alternative for emergent revascularization.

OBJECTIVES: Significant comorbidities and an exhausted physiologic reserve lead to high mortality rates during operations for acute mesenteric ischemia. We present our experience with retrograde open mesenteric stenting. METHODS/RESULTS: A total of 3 female patients (mean age = 74.1 years) with acute mesenteric ischemia underwent exploratory laparotomy. Operative technique included isolating the superior mesenteric artery for cannulation and retrograde endovascular angioplasty and stenting. One required small bowel resection. All 3 patients survived. Mean follow-up was 8.4 months (range: 1.2-16.6). All remain with a 100% primary patency rate. CONCLUSION: Retrograde open mesenteric stenting for acute mesenteric ischemia is a viable alternative to bypass.

Successful repair of a ruptured Stanford type B aortic dissection during pregnancy.

We present our experience with an acute Stanford type B aortic dissection in a 25-year-old, 26-week gravid patient without a known connective tissue disorder and discuss a literature-based treatment strategy. After failed conservative treatment manifest by aneurysm rupture, emergency cesarean section delivery and immediate repair of her thoracic aorta was performed. Seven months later, she is fully caring for her healthy baby. During pregnancy, thoracic aortic dissection occurs from physiologic and hemodynamic changes. Emergency cesarean delivery, followed by immediate aortic repair, is the treatment choice if malperfusion syndrome, rupture, uncontrolled hypertension, or unremitting pain occurs.

Renal artery stent infection and pseudoaneurysm management.

BACKGROUND: Infection of a renal artery stent and pseudoaneurysm is extremely uncommon, with four reports in the literature. We present a fifth case and the complex management resulting in kidney salvage. METHODS AND RESULTS: A 56-year-old female underwent right renal artery stenting for hypertension. Postoperatively, she developed methicillin-resistant Staphylococcus infection, treated with antibiotics. Eight-month follow-up duplex ultrasound revealed a right renal artery pseudoaneurysm just distal to the stent. Computed tomography angiography (CTA) showed 2.8 cm proximal and 4.2 cm distal mycotic aneurysms. Antibiotics and planning angiogram were prescribed. A Chevron incision and duodenal kocherization were employed. The aorta below the superior mesenteric artery and below the renal vein was mobilized, as were the right renal artery and vein, hepatic artery, and saphenous vein. Following heparinization, the aorta was cross-clamped, as was the right renal artery at the hilum. The kidney was infused with cold saline. The renal artery stent was explanted, and aneurysmectomy was performed. The renal artery ostium was oversewn. A renal artery to hepatic artery saphenous vein bypass was fashioned, and patency was confirmed with intraoperative duplex ultrasound. Postoperatively, creatinine was normal, renal scan showed the right kidney to be functional, and duplex ultrasound showed a patent bypass graft. The patient was discharged on postoperative day 11 on long-term antibiotics. Eight-month follow-up duplex and CTA showed a patent bypass and durable repair. CONCLUSION: Renal artery stent infection with pseudoaneurysm is rare and can be diagnosed with duplex ultrasound. Renal salvage can be obtained but requires stent removal and autologous bypass grafting.

Endoleak after endovascular aneurysm repair: duplex ultrasound imaging is better than computed tomography at determining the need for intervention.

OBJECTIVE: Color duplex ultrasound (CDU) imaging is a noninvasive alternative to computed tomography (CT) for the detection of endoleak. This study compared CT and CDU imaging in the detection of endoleaks requiring intervention after endovascular aneurysm repair (EVAR). METHODS: All EVARs performed at our institution from 1996 to 2007 were retrospectively reviewed. CDU and CT scans < or =3 months were paired and the presence of an endoleak and its type were recorded. Clinical follow-up was reviewed and interventions for endoleak were recorded. Interventions were performed for type I, for type II with sac enlargement, and for type III endoleaks. The first analysis of clinical test outcomes used the findings of CT scan as a gold standard and the second used the findings at time of intervention as a gold standard. RESULTS: During the time period reviewed, 496 patients underwent EVAR, and 236 of these had CDU and CT follow-up studies paired < or =3 months of each other. Mean follow-up was 17 months (range, <1-111 months). We reviewed 944 studies or 472 pairs. Eighteen patients (7.6%) required intervention for 19 endoleaks: six type I, 11 type II, and two type III. Early endoleak (< or =1 month) requiring reintervention was detected in 1 vs late endoleak (mean, 28 months; range, 0.6-88 months) in 18. All type I and III endoleaks were treated with endovascular cuff or limb extension placement. Three type II endoleaks were treated with open ligation, and coil or glue embolization was used in eight. CDU imaging detected endoleaks requiring intervention in 89% of cases, whereas CT detected endoleak in 58% (P < .05). The ability to correctly identify the type of endoleak as confirmed at time of intervention was 74% with CDU imaging vs 42% by CT (P < .05). CDU, for the detection of endoleak requiring intervention, had a sensitivity of 90%, specificity of 81%, negative predictive value (NPV) of 99%, and positive predictive value (PPV) of 16%, while CT had a sensitivity of 58%, specificity of 87%, NPV of 98%, and PPV of 15%. CONCLUSIONS: CDU imaging has a high sensitivity in detecting endoleaks requiring intervention, is better at identifying the type of endoleak, and is an excellent test for graft surveillance after endovascular aneurysm repair. Compared with CT scan, CDU imaging in our experience is the preferred test on which to base an intervention for endoleak.

Carotid angioplasty and stenting in anatomically high-risk patients: Safe and durable except for radiation-induced stenosis.

OBJECTIVE: Carotid angioplasty and stenting (CAS) is used in patients considered high-risk for carotid endarterectomy (CEA). Patients qualify as high-risk because of medical comorbid conditions or for anatomic considerations (previous CEA, radical neck dissection, radiation). We compared the technical feasibility and durability of CAS in medically high-risk patients (MED) vs anatomically high-risk patients (ANAT). METHODS: A retrospective review was performed of all consecutive patients undergoing CAS by a single vascular surgery group. All patients were high risk and evaluated with duplex ultrasound imaging and angiography. Primary end points were technical success, 30-day stroke, myocardial infarction (MI), death, and in-stent restenosis. Standard statistical analysis included Kaplan-Meier life tables. RESULTS: From January 2003 to December 2007, 230 CAS (98 ANAT, 132 MED) procedures were attempted. The ANAT cohort comprised 84 patients with a single anatomic risk factor: 71 with a previous ipsilateral CEA, 6 high lesions, 6 history of neck radiation, and 1 with a tracheostomy. Ten patients had two or three anatomic risk factors: nine with radical neck dissection and radiation and one with neck radiation and ipsilateral CEA. The mean age was 71.1 years for ANAT vs 73.9 years for MED (P = .021). Technical success rates were 98% in ANAT and 98.5% in MED (P = .76). Thirty-day stroke rate was 1.0% in ANAT and 5.3% in MED (P = .14); the mortality rate was 2.0% in ANAT and 0.8% in MED (P = .79). The 2-year survival free from stroke was MED, 93.6% and ANAT, 98.9% (P = .118); and from restenosis was MED, 91.9%; and ANAT, 91.0% (P = .98). Two-year overall survival was significantly better in ANAT (84.6%) vs MED (70.1%; P = .026). Four of the seven restenoses in the ANAT group occurred in patients with previous neck radiation. The restenosis rate for radiation-induced (RAD) stenosis treated with CAS was significantly higher at 22.2% (4 of 18) compared with 3.8% (3 of 78) in ANAT group patients without a history of radiation (non-RAD; P = .028). The 2-year restenosis-free survival was 72.7% in the RAD group vs 95.9% in the non-RAD group (P = .017). CONCLUSION: CAS is as technically feasible, safe, and durable in anatomically high-risk patients as in medically high-risk patients, with similar rates of periprocedural stroke and death and late restenosis. However, patients with radiation-induced stenosis appear to be at an increased risk for restenosis.

Small bowel volvulus caused by migrating mesh plug.

The choice of material and technique for repair of inguinal hernias is broad. The mesh plug technique has become one of these techniques. The local complications of this technique are well known and include entrapment and damage of nervous and reproductive structures causing pain and even infertility. Migration of the mesh recently has become evident. We found a few cases of migrating mesh plug in the literature. We report a 76-year-old male patient who presented during admission for a neurosurgical procedure. His hospital course was complicated by migrating mesh eroding into the small intestine presenting as a small bowel obstruction. During exploratory laparotomy, a small bowel volvulus was found and reduced along with resection of the bowel-mesh complex. We discuss and review this technique's complications, including a 9-year review of adverse events reported to the U.S. Food and Drug Administration.