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The spinning of randomized controlled trials [Letter]

Veith, Frank J; Paraskevas, Kosmas I
PMID: 35738788
ISSN: 1097-6809
CID: 5280932

Regarding Comparison of Recent Practice Guidelines for the Management of Patients with Asymptomatic Carotid Stenosis

Abbott, Anne L; Brunser, Alejandro; Uyagu, Oliseneku D; Budincevic, Hrvoje; Spanos, Konstantinos; Veith, Frank J
PMID: 35750480
ISSN: 1940-1574
CID: 5282322

Non-reversed and Reversed Great Saphenous Vein Graft Configurations Offer Comparable Early Outcomes in Patients Undergoing Infrainguinal Bypass

Chang, Heepeel; Veith, Frank J; Rockman, Caron B; Cayne, Neal S; Jacobowitz, Glenn R; Garg, Karan
OBJECTIVE:Data on the efficacy of non-reversed and reversed great saphenous vein bypass (NRGSV and RGSV) techniques are lacking. The aim of the study was to compare the outcomes of patients undergoing open infrainguinal revascularisation using NRGSV and RGSV from a multi-institutional database. METHODS:The Vascular Quality Initiative database was queried for patients undergoing infrainguinal bypasses using NRGSV and RGSV for symptomatic occlusive disease from January 2003 to February 2021. The primary outcome measures included primary and secondary patency at discharge and one year. Secondary outcomes were re-interventions at discharge and one year. Cox proportional hazards models were used to evaluate the impact of graft configuration on outcomes of interest. RESULTS:Of 7 123 patients, 4 662 and 2 461 patients underwent RGSV and NRGSV, respectively. At one year, the rates of primary patency (78% vs. 78%; p = .83), secondary patency (90% vs. 89%; p = .26), and re-intervention (16% vs. 16%; p = .95) were similar between the RGSV and NRGSV cohorts, respectively. Subgroup analysis based on outflow bypass target and indication for revascularisation did not show differences in primary and secondary outcomes between the two groups. Multivariable analysis confirmed that RGSV (NRGSV as the reference) configuration was not independently associated with increased risk of primary patency loss (hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.91 - 1.13; p = .80), secondary patency loss (HR 0.94; 95% CI 0.81 - 1.10; p = .44), and re-intervention (HR 1.03; 95% CI 0.91 - 1.16; p = .67) at follow up. CONCLUSION/CONCLUSIONS:The study shows that RGSV and NRGSV grafting techniques have comparable peri-operative and one year primary and secondary patency and re-intervention rates. This effect persisted when stratified by outflow targets and indication for revascularisation. Therefore, optimal selection of vein grafting technique should be guided by the patient's anatomy, vein conduit availability, and surgeon's experience.
PMID: 35644738
ISSN: 1532-2165
CID: 5236032

Benefits and drawbacks of statins and non-statin lipid lowering agents in carotid artery disease

Paraskevas, Kosmas I; Gloviczki, Peter; Antignani, Pier Luigi; Comerota, Anthony J; Dardik, Alan; Davies, Alun H; Eckstein, Hans-Henning; Faggioli, Gianluca; Fernandes E Fernandes, Jose; Fraedrich, Gustav; Geroulakos, George; Golledge, Jonathan; Gupta, Ajay; Gurevich, Victor S; Jawien, Arkadiusz; Jezovnik, Mateja K; Kakkos, Stavros K; Knoflach, Michael; Lanza, Gaetano; Liapis, Christos D; Loftus, Ian M; Mansilha, Armando; Nicolaides, Andrew N; Pini, Rodolfo; Poredos, Pavel; Proczka, Robert M; Ricco, Jean-Baptiste; Rundek, Tatjana; Saba, Luca; Schlachetzki, Felix; Silvestrini, Mauro; Spinelli, Francesco; Stilo, Francesco; Suri, Jasjit S; Svetlikov, Alexei V; Zeebregts, Clark J; Chaturvedi, Seemant; Veith, Frank J; Mikhailidis, Dimitri P
International guidelines strongly recommend statins alone or in combination with other lipid-lowering agents to lower low-density lipoprotein cholesterol (LDL-C) levels for patients with asymptomatic/symptomatic carotid stenosis (AsxCS/SCS). Lowering LDL-C levels is associated with significant reductions in transient ischemic attack, stroke, cardiovascular (CV) event and death rates. The aim of this multi-disciplinary overview is to summarize the benefits and risks associated with lowering LDL-C with statins or non-statin medications for Asx/SCS patients. The cerebrovascular and CV beneficial effects associated with statins, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and other non-statin lipid-lowering agents (e.g. fibrates, ezetimibe) are reviewed. The use of statins and PCSK9 inhibitors is associated with several beneficial effects for Asx/SCS patients, including carotid plaque stabilization and reduction of stroke rates. Ezetimibe and fibrates are associated with smaller reductions in stroke rates. The side-effects resulting from statin and PCSK9 inhibitor use are also highlighted. The benefits associated with lowering LDL-C with statins or non-statin lipid lowering agents (e.g. PCSK9 inhibitors) outweigh the risks and potential side-effects. Irrespective of their LDL-C levels, all Asx/SCS patients should receive high-dose statin treatment±ezetimibe or PCSK9 inhibitors for reduction not only of LDL-C levels, but also of stroke, cardiovascular mortality and coronary event rates.
PMID: 35605696
ISSN: 1873-1740
CID: 5247852

Beta-Blocker Use After Thoracic Endovascular Aortic Repair Is Associated With Improved Aortic Remodeling by Promoting Complete False Lumen Thrombosis [Meeting Abstract]

Chang, H; Rockman, C; Maldonado, T S; Laskowski, I A; Jacobowitz, G; Cayne, N; Veith, F; Patel, V; Babu, S C; Mateo, R B; Garg, K
Objectives: Beta-blockers are first-line anti-impulse therapy for patients presenting with type B aortic dissection (TBAD); however, little is understood about their impact after aortic repair. The aim of this study was to evaluate the role of postoperative beta-blocker use on the outcomes of thoracic endovascular aortic repair (TEVAR) for TBAD.
Method(s): The Vascular Quality Initiative database was queried for all patients undergoing TEVAR for TBAD from 2012 to 2020. Aortic-related reintervention, all-cause mortality, and success of TEVAR measured by complete false lumen thrombosis of the treated aortic segment were assessed and compared between patients treated with and without beta-blocker use postoperatively. Cox proportional hazards models were used to estimate the effect of beta-blocker therapy on outcomes.
Result(s): A total of 1147 patients undergoing TEVAR for TBAD were identified, with a mean follow-up of 18 +/- 12 months (median, 14 months). The mean age was 61.3 +/- 11.8 years, and 791 (71%) were men. Of the 1147 patients, 935 (84%) continued beta-blocker therapy at discharge and follow-up. Patients receiving beta-blocker therapy were more likely to have an entry tear originating in zones 1 to 2 (22% vs 13%; P =.022). The prevalence of acute, elective, and symptomatic TBAD, concurrent aneurysms, number of endografts used, distribution of the proximal and distal zones of dissection, and operative time were comparable between the two groups. At 18 months, significantly more complete false lumen thrombosis (58.4% vs 47.4%; P =.018; Fig) was observed in the patients with beta-blocker use. However, the rates of aortic-related reintervention (12.8% vs 8.8%; log-rank P =.396) and mortality (0.7% vs 0.1%; log-rank P =.401) were similar in those with and without beta-blocker therapy. Even after adjusting for clinical and operative factors, continuous postoperative beta-blocker use was associated with increased complete false lumen thrombosis (hazard ratio, 1.56; 95% confidence interval, 1.10-2.21; P =.012) but did not affect all-cause mortality or aortic-related reintervention (Table). When analyzed separately, postoperative angiotensin-converting enzyme inhibitor use did not affect the rates of aortic-related reintervention, complete false lumen thrombosis, or mortality.
Conclusion(s): Beta-blocker use was associated with the promotion of complete false lumen in patients undergoing TEVAR for TBAD. In addition to its role in acute TBAD, anti-impulse control appears to confer favorable aortic remodeling after TEVAR. Beta-blocker therapy might improve the outcomes after TEVAR for TBAD. [Formula presented] [Formula presented]
Copyright
EMBASE:2018189660
ISSN: 1097-6809
CID: 5291162

Association of Left Ventricular Ejection Fraction With Mortality After Thoracic Endovascular Aortic Repair for Type B Aortic Dissection [Meeting Abstract]

Chang, H; Rockman, C; Jacobowitz, G; Maldonado, T S; Cayne, N; Patel, V; Laskowski, I A; Veith, F; Mateo, R B; Babu, S C; Garg, K
Objectives: Despite the expanded application of thoracic endovascular aortic repair (TEVAR) to patients with significant cardiac comorbidities deemed too high risk for open repair, the effect of decreased left ventricular ejection fraction (EF) on patient outcomes remains unknown. The aim of this study was to compare the outcomes of patients with normal and abnormal EFs undergoing TEVAR.
Method(s): The Vascular Quality Initiative database (2003-2019) was reviewed to identify patients undergoing TEVAR for aortic dissection. Patients were categorized into those with severely reduced EF (SREF; EF <=30%) reduced EF (REF; EF <=50%), and normal EF (NEF; EF >50%). The baseline characteristics, procedural details, and 18-month outcomes were compared. Multivariable logistic regression was used to identify the factors associated with mortality, aortic-related reintervention, and complete false lumen thrombosis of the treated aortic segment.
Result(s): Of 2455 patients, 54 (1%) and 267 (3%) had had SREF and REF, respectively. Patients with an abnormal EF (SREF and REF) were more likely to be African American and to have more cardiac comorbidities compared with those with a NEF. The use of angiotensin-converting enzyme inhibitor and anticoagulant therapy was higher for patients with an abnormal EF postoperatively and at follow-up. At 18 months, mortality was significantly higher among the patients with SREF (35.2%) than for those with REF (13%) and NEF (13.4%; Fig). The rates of aortic-related reintervention and complete false lumen thrombosis were comparable among the three cohorts. On multivariable analysis, SREF was associated with an increased risk of mortality (hazard ratio, 2.52; 95% confidence interval, 1.28-4.96; P =.008) compared with NEF (Table). However, REF showed a comparable risk of mortality (hazard ratio, 0.90; 95% confidence interval, 0.55-1.46; P =.659) compared with NEF. Neither SREF nor REF was associated with an increased risk of aortic-related reinterventions and complete false lumen thrombosis compared with NEF.
Conclusion(s): SREF was independently associated with an increased risk of mortality compared with NEF at midterm follow-up. However, REF had a similar risk of morbidity and mortality compared with NEF. Furthermore, TEVAR-related complications were similar among the three cohorts. As such, the decision to perform TEVAR in patients with SREF requires balancing a careful estimation of the anticipated benefits and competing risk of death. [Formula presented] [Formula presented]
Copyright
EMBASE:2018189642
ISSN: 1097-6809
CID: 5291182

Neuroprotective association of preoperative renin-angiotensin system blocking agents use in patients undergoing carotid interventions

Li, Chong; Rockman, Caron; Chang, Heepeel; Patel, Virendra I; Siracuse, Jeffrey J; Cayne, Neal; Veith, Frank J; Torres, Jose L; Maldonado, Thomas S; Nigalaye, Anjali A; Jacobowitz, Glenn; Garg, Karan
OBJECTIVE:The optimal medical management strategy in the periprocedural period for patients undergoing carotid artery interventions is not well described. Renin-angiotensin-system blocking (RASB) agents are considered to be among the first line anti-hypertensive agents; however, their role in the perioperative period is unclear. The objective of this study was to examine the relationship between the use of RASB agents on periprocedural outcomes in patients undergoing carotid interventions-carotid endarterectomy (CEA), transfemoral carotid artery stenting (CAS), and transcervical carotid artery revascularization (TCAR). METHOD/METHODS:The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing CAS, CEA, and TCAR between 2003 and 2020. Patients were stratified into two groups based upon their use of RASB agents in the periprocedural period. The primary endpoint was periprocedural neurologic events (including both strokes and transient ischemic attacks (TIAs)). The secondary endpoints were peri-procedural mortality and significant cardiac events, including myocardial infarction, dysrhythmia, and congestive heart failure. RESULTS:= 0.461). CONCLUSION/CONCLUSIONS:The use of peri-procedural RASB agents was associated with a significantly decreased rate of neurologic events in patients undergoing both CEA and TCAR. This effect was not observed in patients undergoing CAS. As carotid interventions warrant absolute minimization of perioperative complications in order to provide maximum efficacy with regard to stroke protection, the potential neuro-protective effect associated with RASB agents use following CEA and TCAR warrants further examination.
PMID: 35603781
ISSN: 1708-539x
CID: 5247832

Comparative analysis of patients undergoing lower extremity bypass using in-situ and reversed great saphenous vein graft techniques

Chang, Heepeel; Veith, Frank J; Rockman, Caron B; Maldonado, Thomas S; Jacobowitz, Glenn R; Cayne, Neal S; Garg, Karan
OBJECTIVE:Autologous great saphenous vein (GSV) is considered the conduit of choice for lower extremity bypass (LEB). However, the optimal configuration remains the source of debate. We compared outcomes of patients undergoing LEB using in-situ and reversed techniques. METHODS:The Vascular Quality Initiative database was queried for patients undergoing LEB with a single-segment GSV in in-situ (ISGSV) and reversed (RGSV) configurations for symptomatic occlusive disease from 2003 to 2021. Patient demographics, procedural detail, and in-hospital and follow-up outcomes were collected. The primary outcome measures included primary patency at discharge or 30 days and one year. Secondary outcomes were secondary patency, and reinterventions at discharge or 30 days and one year. Cox proportional hazards models were created to determine the association between bypass techniques and outcomes of interest. RESULTS:= 0.985) at follow-up, compared to reversed bypass. A subgroup analysis of bypasses to crural targets showed that in-situ and reversed bypasses had similar rates of primary patency loss and reinterventions at 1 year. Among patients with chronic limb-threatening ischemia, in-situ bypass was associated with a decreased risk of reinterventions but similar rates of primary and secondary patency and major amputations at 1 year. CONCLUSIONS:In patients undergoing LEBs using the GSV, in-situ configuration was associated with more perioperative reinterventions and lower primary patency rate. However, this was offset by decreased risks of loss of primary patency and reinterventions at 1 year. A thorough intraoperative graft assessment with adjunctive imaging may be performed to detect abnormalities in patients undergoing in-situ bypasses to prevent early failures. Furthermore, closer surveillance of reversed bypass grafts is warranted given the higher rates of reinterventions.
PMID: 35452333
ISSN: 1708-539x
CID: 5218632

Prior Infrarenal Aortic Surgery is Not Associated with Increased Risk of Spinal Cord Ischemia Following Thoracic Endovascular Aortic Repair and Complex Endovascular Aortic Repair

Chen, Stacey; Rokosh, Rae S; Smith, Deane E; Maldonado, Thomas S; Cayne, Neal S; Jacobowitz, Glenn R; Rockman, Caron B; Patel, Virendra I; Veith, Frank J; Galloway, Aubrey C; Garg, Karan
OBJECTIVES/OBJECTIVE:Patients with prior infrarenal aortic intervention represent an increasing demographic of patients undergoing thoracic endovascular aortic repair (TEVAR) and/or complex EVAR. Studies have suggested that prior abdominal aortic surgery is a risk factor for spinal cord ischemia (SCI). However, these results are largely based on single-center experiences with limited multi-institutional and national data assessing clinical outcomes in these patients. The objective of this study was to evaluate the effect of prior infrarenal aortic surgery on SCI. METHODS:The Society for Vascular Surgery Vascular Quality Initiative database was retrospectively reviewed to identify all patients ≥18 years old undergoing TEVAR/complex EVAR from January 2012 to June 2020. Patients with previous thoracic or suprarenal aortic repairs were excluded. Baseline and procedural characteristics and postoperative outcomes were compared by group: TEVAR/complex EVAR with or without previous infrarenal aortic repair. The primary outcome was postoperative SCI. Secondary outcomes included postoperative hospital length of stay (LOS), bowel ischemia, renal ischemia, and 30-day mortality. Multivariate regression was used to determine independent predictors of postoperative SCI. Additional analysis was performed for patients undergoing isolated TEVAR. RESULTS:A total of 9506 patients met the inclusion criteria: 8691 (91.4%) had no history of infrarenal aortic repair and 815 (8.6%) had previous infrarenal aortic repair. Patients with previous infrarenal repair were older with an increased prevalence of chronic kidney disease (p=0.001) and cardiovascular risk factors including hypertension, chronic obstructive pulmonary disease, and smoking history (p<0.001). These patients presented with larger maximal aortic diameters (6.06±1.47 cm versus 5.15±1.76 cm; p<0.001) and required more stent grafts (p<0.001) with increased intraoperative blood transfusion requirements (p<0.001), and longer procedure times (p<0.001). Univariate analysis demonstrated no difference in postoperative SCI, postoperative hospital LOS, bowel ischemia, or renal ischemia between the two groups. Thirty-day mortality was significantly higher in patients with prior infrarenal repair (p=0.001). On multivariate regression, prior infrarenal aortic repair was not a predictor of postoperative SCI, while aortic dissection (odds ratio [OR] 1.65; 95% confidence interval [CI] 1.26-2.16, p<0.001), number of stent grafts deployed (OR 1.45; 95% CI 1.30-1.62, p<0.001), and units of packed red blood cells transfused intraoperatively (OR 1.33; 95% CI 1.03-1.73, p=0.032) were independent predictors of SCI. CONCLUSIONS:Although TEVAR/complex EVAR patients with prior infrarenal aortic repair constituted a sicker cohort with higher 30-day mortality, the rate of SCI was comparable to patients without prior repair. Previous infrarenal repair was not associated with risk of SCI.
PMID: 34742886
ISSN: 1097-6809
CID: 5050112

Outcomes of transfemoral carotid artery stenting and transcarotid artery revascularization for restenosis after prior ipsilateral carotid endarterectomy

Chang, Heepeel; Rockman, Caron B; Veith, Frank J; Kashyap, Vikram S; Jacobowitz, Glenn R; Sadek, Mikel; Garg, Karan; Maldonado, Thomas S
OBJECTIVE:Restenosis after carotid endarterectomy (CEA) poses unique therapeutic challenges, with no specific guidelines available on the operative approach. Traditionally, transfemoral carotid artery stenting (TfCAS) has been regarded as the preferred approach to treating restenosis after CEA. Recently, transcarotid artery revascularization with a flow-reversal neuroprotection system (TCAR) has gained popularity as an effective alternative treatment modality for de novo carotid artery stenosis. The aim of the present study was to compare the contemporary perioperative outcomes of TfCAS and TCAR in patients with prior ipsilateral CEA. METHODS:The Vascular Quality Initiative database was reviewed for patients who had undergone TfCAS and TCAR for restenosis after prior ipsilateral CEA between January 2016 and August 2020. The primary outcome was the 30-day composite outcome of stroke and death. The secondary outcomes included 30-day stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and composite 30-day outcomes of stroke, death, and TIA, stroke and TIA, and stroke, death, and MI. Multivariable logistic regression models were used to evaluate the outcomes of interest after adjustment for potential confounders and baseline differences between cohorts. RESULTS:Of 3508 patients, 1834 and 1674 had undergone TfCAS and TCAR, respectively. The TCAR cohort was older (mean age, 71.6 years vs 70.2 years; P < .001) and less likely to be symptomatic (27% vs 46%; P < .001), with a greater proportion taking aspirin (92% vs 88%; P = .001), a P2Y12 inhibitor (89% vs 80%; P < .001), and a statin (91% vs 87%; P = .002) compared with the TfCAS cohort. Perioperatively, the TCAR cohort had had lower 30-day composite outcomes of stroke/death (1.6% vs 2.7%; P = .025), stroke/death/TIA (1.8% vs 3.3%; P = .004), and stroke/death/MI (2.1% vs 3.2%; P = .048), primarily driven by lower rates of stroke (1.3% vs 2.3%; P = .031) and TIA (0.2% vs 0.7%; P = .031). Among asymptomatic patients, the incidence of stroke (0.6% vs 1.4%; P = .042) and the composite of stroke/TIA (0.8% vs 1.8%; P = .036) was significantly lower after TCAR than TfCAS, and TCAR was associated with a lower incidence of TIA (0% vs 1%; P = .038) among symptomatic patients. On adjusted analysis, the TCAR cohort had lower odds of TIA (adjusted odds ratio, 0.17; 95% confidence interval, 0.04-0.74; P = .019). CONCLUSIONS:Among patients undergoing carotid revascularization for restenosis after prior ipsilateral CEA, TCAR was associated with decreased odds of 30-day TIA compared with TfCAS. However, the two treatment approaches were similarly safe in terms of the remaining perioperative outcomes, including stroke and death and stroke, death, and MI. Our results support the safety and efficacy of TCAR in this subset of patients deemed at high risk of reintervention.
PMID: 34506900
ISSN: 1097-6809
CID: 5067172