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Endovascular Treatment of Popliteal Artery Aneurysms Has Comparable Long-Term Outcomes to Open Repair with Shorter Length of Stay

Shah, Noor G; Rokosh, Rae S; Garg, Karan; Safran, Brent; Rockman, Caron B; Maldonado, Thomas S; Sadek, Mikel; Lamparello, Patrick; Jacobowitz, Glenn R; Barfield, Michael E; Veith, Frank; Cayne, Neal S
OBJECTIVE:Over the past two decades, the treatment of popliteal artery aneurysms (PAAs) has undergone a transformation. While open surgical repair (OR) remains the gold standard for treatment, endovascular repair (ER) has become an attractive alternative in select patient populations. The objective of this study was to compare the outcomes of open versus endovascular repair of PAAs at a single institution. METHODS:We performed a retrospective chart review of all patients between 1998 and 2017 who underwent repair for PAA. Patient baseline, anatomic, and operative characteristics as well as outcomes were compared between the open and endovascular cohorts. The intervention and treatment were at the discretion of the surgeon. RESULTS:Between 1998 and 2017, a total of 64 patients underwent repair of 73 PAAs at our tertiary care center. Twenty-nine patients with 33 PAAs underwent OR, and 35 patients with 40 PAAs underwent ER. When comparing the 2 cohorts, there were no statistically significant differences in demographic characteristics such as age, gender, or number of run-off vessels. There were significantly more patients in the ER group (21/53%) than the OR group (7/21%) with hyperlipidemia (p=.008) and a prior carotid intervention (6% vs. 0%, p=.029). Overall, the presence of symptoms was similar amongst the two groups; however, patients in the OR group had a significantly higher number of patients presenting with acute ischemia (p=.01). Length of stay (LOS) was significantly shorter in the ER cohort (mean 1.8 days [1-11]) compared to the OR group (5.4 days [2-13]) (p<.0001). There was no significant difference in primary or secondary patency rates between the two groups. In the ER group, good runoff (≥2 vessels) was a positive predictor for primary patency at 1 year (3.36 [1.0-11.25]), however, it was not in the OR group. Post-operative single and/or dual anti-platelet therapy did not affect primary patency in either cohort. CONCLUSIONS:The results of our study demonstrate that ER of PAAs is a safe and durable option with comparable patency rates to OR and a decreased LOS, with good run-off being a positive predictor for primary patency in the ER cohort.
PMID: 33957229
ISSN: 1097-6809
CID: 4866682

Management of inferior vena cava thrombosis with the FlowTriever and ClotTriever systems

Shah, Noor G; Wible, Brandt C; Paulisin, Joseph A; Zaki, Mina; Lamparello, Patrick; Sista, Akhilesh; Sadek, Mikel; Jacobowitz, Glenn R; Maldonado, Thomas S
OBJECTIVE:Although inferior vena cava (IVC) thrombosis is infrequently encountered, it carries a significant risk of post-thrombotic syndrome and pulmonary embolus. Recent studies show no difference in the incidence of post-thrombotic syndrome in patients with iliofemoral deep venous thrombosis (DVT) treated with pharmacothrombolysis vs anticoagulation alone; however, there is an associated increased risk of bleeding. The treatment of IVC thrombosis is less well-studied and the hemodynamic changes may be more significant with pharmacothrombolysis, although the bleeding risk remains. The ClotTriever and FlowTriever systems remove thrombus from veins without the use of thrombolytics. Our study evaluates outcomes of patients undergoing mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and FlowTriever devices. METHODS:A retrospective chart review was performed to identify consecutive patients who underwent mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and/or FlowTriever systems from November 2018 to January 2020 at four data-sharing institutions. The decision of which device(s) to use was at the discretion of the surgeon. Patient demographics, symptomatology, and imaging characteristics were captured at presentation and follow-up. RESULTS:A total of 15 patients met the inclusion criteria; 10 were male, and the average age was 59 years. The majority of patients were symptomatic at presentation (n = 14), had a prior history of DVT (n = 13), and had a preexisting IVC filter (n = 8). Eleven patients presented with acute onset (<1 week) of symptoms, whereas three patients had subacute (1-4 weeks) symptoms. Most patients had an associated iliofemoral DVT (n = 13) and were treated with both ClotTriever and FlowTriever (n = 8); others were treated with either ClotTriever or FlowTriever alone (n = 5 and n = 2, respectively). Technical success was achieved in all but two patients, one who had a nonocclusive thrombus densely adherent to a preexisting IVC filter and another who had a chronic rubbery clot in the IVC that could not be cleared. No patient required concomitant lytic therapy or a postoperative stay in the intensive care unit. Furthermore, there were no postoperative bleeding events, myocardial infarctions, pulmonary emboli, renal impairments, or deaths. The median length of stay was 3 days (range, 1-37 days). Patients underwent postoperative follow-up (n = 7) as well as extended follow-up (>6 months; n = 8). All patients who achieved technical success were asymptomatic without evidence of reocclusion of the IVC on follow-up imaging. CONCLUSIONS:In our multicenter series of 15 patients, The ClotTriever and FlowTriever showed promise in the treatment of IVC thrombosis without the use of fibrinolytic drugs, with no bleeding events and no requirement for intensive care unit stay.
PMID: 33045392
ISSN: 2213-3348
CID: 4663452

Low-frequency avoidable errors during transcarotid artery revascularization

Teter, Katherine; Lamparello, Patrick J; Barfield, Michael; Rockman, Caron B; Macdonald, Sumaira; Maldonado, Thomas S
OBJECTIVE:Transcarotid artery revascularization (TCAR) seems to be a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in the management of carotid artery stenosis with potential for a significant decrease in periprocedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with infrequent complications related to user technical error, most of which are preventable. Our goal is to describe these low-frequency events, and to provide guidelines for avoiding them. METHODS:The U.S. Food and Drug Administration (FDA) requires that all medical device manufacturers create a system for receiving, reviewing, and evaluating complaints (Code 21 of Federal Regulations 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established a process by which all feedback, including complaints that may not meet FDA criteria, is captured and stored in a database for detailed analysis. More than 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and periprocedural complications, above and beyond the device-related events that must be reported to the FDA. RESULTS:A total of 13,334 patients have undergone TCAR worldwide between early 2011 and December 2019 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate) of the common carotid artery at the access point, of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Errors in the location of stent deployment occurred in 16 cases (0.13%), with the most common site being the external carotid artery (75%). One wrong side carotid artery stent was placed in a patient with a high midline pattern of the bovine arch. Cranial nerve injury was reported in 11 cases (0.08%), only one of which persisted beyond 3 months. There have been three reported pneumothoraces and one reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail. CONCLUSIONS:In high-risk patients requiring treatment for carotid artery stenosis, TCAR has been proven as an alternative to TF-CAS with an excellent safety profile. As with CEA or TF-CAS, this procedure has the potential for infrequent complications, often as a result of user technical error. Although significant, these events can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described.
PMID: 33065241
ISSN: 1097-6809
CID: 4798402

Intraoperative Management and Factors Contributing to Intolerance of Reversal of Flow in Transcarotid Artery Revascularization [Meeting Abstract]

Teter, K; Rockman, C; Lamparello, P; Garg, K; Barfield, M; Jacobowitz, G; Maldonado, T S
Objective: In patients deemed high risk for carotid endarterectomy (CEA) who are indicated for treatment of carotid artery stenosis (CAS), transcarotid artery revascularization (TCAR) has been demonstrated to be a safe and effective alternative to transfemoral CAS. Compared with CEA, in which approximately 12% of patients undergoing awake intervention do not tolerate internal carotid artery clamping, only 1% to 2% of patients were observed to have intolerance to flow reversal during TCAR based on data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) 1 and 2 trials. This study reviewed awake interventions from those trials to assess factors associated with intolerance to flow reversal and to review how those cases were managed.
Method(s): This is a retrospective review of prospectively collected data from the ROADSTER multicenter trial along with the subsequent postapproval (ROADSTER 2) trial. The subset of patients from both trials undergoing awake TCAR was analyzed to compare demographics, procedural details, and anatomic factors between patients who did and did not experience intolerance to reversal of flow to assess for predisposing factors. Patients were deemed intolerant to flow reversal at the discretion of the operator, often related to changes in completion of neurologic tasks, hemodynamic stability, or patient-reported symptoms.
Result(s): There were 103 patients from ROADSTER and 194 patients from ROADSTER 2 who underwent TCAR under local/regional anesthesia. Of these, eight patients had intolerance to flow reversal, although all cases were successfully completed. Four cases were completed under low-flow reversal, three cases were successfully weaned from low to high flow during several minutes, and one case required general anesthesia. No significant association was found between intolerance to flow reversal and comorbidities including diabetes mellitus, hypertension, hyperlipidemia, congestive heart failure, prior myocardial infarction or angina, preoperative CAS-related symptoms, prior stroke, prior CAS or CEA, prior neck irradiation, tandem stenosis, high cervical stenosis, or hostile neck (Tables I and II). A trend toward significance was seen with chronic obstructive pulmonary disease (P =.086) and contralateral carotid artery occlusion (P =.139).
Conclusion(s): Despite intolerance to flow reversal, most cases were successfully completed by adjusting reversal of flow rate and did not require conversion to general endotracheal anesthesia. Whereas factors contributing to intolerance of flow reversal during TCAR remain poorly understood, this study identified a trend toward significance with an association of pre-existing chronic obstructive pulmonary disease and contralateral carotid artery occlusion. Given the low number of patients who experienced this issue, a larger sample size is required to better elucidate these trends. [Formula presented] [Formula presented]
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EMBASE:2006737413
ISSN: 1097-6809
CID: 4521792

Aspiration thrombectomy for the management of acute deep venous thrombosis in the setting of venous thoracic outlet syndrome

Teter, Katherine; Arko, Frank; Muck, Patrick; Lamparello, Patrick J; Khaja, Minhaj S; Huasen, Bella; Sadek, Mikel; Maldonado, Thomas S
PMID: 31888420
ISSN: 1708-539x
CID: 4251272

Endovascular Treatment of Nutcracker Syndrome

Policha, Aleksandra; Lamparello, Patrick; Sadek, Mikel; Berland, Todd; Maldonado, Thomas
OBJECTIVES: Nutcracker syndrome, or mesoaortic compression of the left renal vein (LRV), with associated symptoms related to venous hypertension in the left kidney, is a rare entity that may result in severe symptoms requiring operative intervention. We report on three patients who presented with nutcracker syndrome, including one patient with a circumaortic LRV resulting in posterior nutcracker syndrome, who underwent successful endovascular treatment with renal vein stenting. A review of existing literature on endovascular management of nutcracker syndrome follows. METHODS: Three women (age range 28 to 43 years) presented with symptoms and imaging studies consistent with nutcracker syndrome. Symptoms included pelvic and flank pain in all three patients, and episodes of hematuria in two. Imaging studies demonstrated compression of the LRV between the superior mesenteric artery and aorta in two of the patients. The third patient was noted to have a circumaortic LRV. RESULTS: All three patients underwent venography and LRV stenting. Stents included a 12 x 40 mm self-expanding nitinol stent, 14 x 60 mm Wallstent, and 16 x 40 mm Wallstent. All patients were placed on clopidogrel post-operatively. The duration of follow-up ranged from six to twenty-seven months. At follow up, all three patients reported significant symptomatic improvement, and duplex ultrasonography demonstrated stent patency in all. CONCLUSIONS: Nutcracker syndrome is a rare condition that can be successfully treated with renal vein stenting via an endovascular approach. Results are encouraging at follow-up periods beyond two years.
PMID: 27321979
ISSN: 1615-5947
CID: 2159032

Endovascular solutions to arterial injury due to posterior spine surgery (vol 55, pg 1477, 2012) [Correction]

Loh, SA; Maldonado, Thomas; Rockman, CB; Lamparello, PJ; Adelman, MA; Kalhorn, SP; Frempong-Boadu, A; Veith, FJ; Cayne, NS
ISI:000382224900166
ISSN: 0741-5214
CID: 2726052

Endovascular solutions to arterial injury due to posterior spinal surgery

Loh SA; Maldonado TS; Rockman CB; Lamparello PJ; Adelman MA; Kalhorn SP; Frempong-Boadu A; Veith FJ; Cayne NS
INTRODUCTION:: Iatrogenic arterial injury is an uncommon but recognized complication of posterior spinal surgery. The spectrum of injuries includes vessel perforation leading to hemorrhage, delayed pseudoaneurysm formation, and threatened perforation by screw impingement on arterial vessels. Repair of these injuries traditionally involved open direct vessel repair or graft placement, which can be associated with significant morbidity. METHODS:: We identified five cases of iatrogenic arterial injury during or after posterior spinal surgery between July 2004 and August 2009 and describe the endovascular treatment of these five patients. RESULTS:: In two patients, intraoperative arterial bleeding was encountered during posterior spinal surgery. The posterior wounds were packed, temporarily closed, and the patients were placed supine. Angiography in both patients demonstrated arterial injury necessitating repair. Covered stent grafts were deployed through femoral cutdowns to exclude the areas of injury. In three additional patients, postoperative computed tomography imaging demonstrated pedicle screws abutting or penetrating the thoracic or abdominal aorta. In all three patients, angiography or intravascular ultrasound (IVUS), or both, confirmed indention or perforation of the aorta by the screw. Aortic stent graft cuffs were deployed through femoral cutdowns to cover the area of aortic contact before hardware removal. All five patients did well and were discharged home in good condition. CONCLUSIONS:: Endovascular repair of arterial injuries occurring during posterior spine procedures is feasible and can offer a safe and less invasive alternative to open repair
PMID: 21215584
ISSN: 1097-6809
CID: 120626

Complications of endovenous lasers

Dexter, D; Kabnick, L; Berland, T; Jacobowitz, G; Lamparello, P; Maldonado, T; Mussa, F; Rockman, C; Sadek, M; Giammaria, L E; Adelman, M
Endovenous laser ablation (EVLA) and radiofrequencey ablation have become the procedures of choice for the treatment of superficial venous insufficiency. Their minimally invasive technique and safety profile when compared with operative saphenectomy have led to this change. As EVLA has replaced saphenectomy as the procedure of choice, the distribution of complications has changed. We evaluated the most common and most devastating complications in the literature including burns, nerve injury, arterio-venous fistula (AVF), endothermal heat-induced thrombosis and deep venous thrombosis. The following review will discuss the most frequently encountered complications of treatment of superficial venous insufficiency using EVLA. The majority of the complications described can be avoided with the use of good surgical technique and appropriate duplex ultrasound guidance. Overall, EVLA has an excellent safety profile and should be considered among the first line for treatment of superficial venous reflux.
PMID: 22312066
ISSN: 0268-3555
CID: 157762

Increasing ablation distance peripheral to the saphenofemoral junction may result in a diminished rate of ehits [Meeting Abstract]

Sadek M.; Kabnick L.S.; Berland T.; Giammaria L.E.; Zhou D.; Mussa F.; Cayne N.S.; Maldonado T.; Rockman C.B.; Jacobowitz G.R.; Lamparello P.J.; Adelman M.A.
Background: The treatment of venous insufficiency using endovenous laser ablation or radiofrequency ablation may result in endothermal heat induced thrombosis (EHIT), a form of deep venous thrombosis. This study sought to assess the effect of ablation distance peripheral to the deep venous system on the incidence of EHIT. Methods: This study was a retrospective review of a prospectively maintained database from 4/2007 to 7/2011. Consecutive patients undergoing great saphenous vein (GSV) or small saphenous vein (SSV) ablation were evaluated. Previous to 2/2011, all venous ablations were performed 2cm peripheral to the saphenofemoral or saphenopopliteal junctions (Group I). Subsequent to 2/2011, ablations were performed 2.5cm peripheral to the respective deep system junctions (Group II). The primary outcome was the development of EHIT II or greater, i.e. thrombus protruding into the deep venous system. Secondary outcomes included procedure-site complications such as hematomas and saphenous nerve injury. Chi-square tests were performed for all discrete variables, and unpaired Students t-tests were performed for all continuous variables. P<.05 was considered statistically significant. Results: A total of 3,526 procedures were performed, Group I (N=2672) and Group II (N=854). General demographics and CEAP classification did not differ significantly between the two groups. EHIT demonstrated a trend towards diminished frequency in Group II (Group I: 2.8% vs Group II: 1.6%, P=.077). There were no reported cases of EHIT III or IV in this patient cohort. Patients in Group I were treated using anticoagulation 56% of the time, and patients in Group II were treated using anticoagulation 100% of the time. The frequency of procedure site complications was low and did not differ significantly between the two groups. Conclusions: This study suggests that changing the treatment distance from 2cm to 2.5cm peripheral to the deep venous junction may result in a diminished incidence of EHIT. Ongoing evaluation is required to validate these results and to reaffirm the durability of the technique
EMBASE:70634301
ISSN: 0741-5214
CID: 149973