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The spinning of randomized controlled trials [Letter]

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

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

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

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

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

Severity of stenosis in symptomatic patients undergoing carotid interventions may influence perioperative neurologic events

Garg, Karan; Chang, Heepeel; Siracuse, Jeffrey J; Jacobowitz, Glenn R; Torres, Jose; Veith, Frank J; Patel, Virendra I; Maldonado, Thomas S; Sadek, Mikel; Cayne, Neal S; Rockman, Caron B
OBJECTIVE:Carotid artery plaque burden, indirectly measured by the degree of stenosis, quantifies future embolic risk. In natural history studies, patients with moderate degrees of stenosis have a lower stroke risk than those with severe stenosis. However, patients with symptomatic carotid stenosis who have experienced TIA or stroke are found to have both moderate and severe degrees of stenosis. We sought to examine the association carotid artery stenosis severity with outcomes in symptomatic patients undergoing carotid interventions including carotid endarterectomy (CEA), transfemoral carotid artery stenting (CAS) and transcervical carotid artery revascularization (TCAR). 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 on the severity of stenosis - non-severe (0 - 69%) and severe (≥ 70%). Primary endpoints were periprocedural neurologic events (strokes and transient ischemic attacks (TIAs)). Secondary endpoints were periprocedural death, myocardial infarction (MI) and composite outcomes of stroke/death and stroke/death/MI per reporting standards for carotid interventions. RESULTS:Of 29,614 symptomatic patients included in the analysis, 5,296 (17.9%) patients underwent TCAR, 7,844 (26.5%) underwent CAS, and 16,474 (55.6%) underwent CEA for symptomatic carotid artery stenosis. In the CEA cohort, the neurologic event rate was similarly significantly lower in patients with severe stenosis when compared to those with non-severe stenosis (2.6% vs. 3.2%, P=.024). In the TCAR cohort, the periprocedural neurologic even rate was lower in patients with severe stenosis when compared to those with non-severe stenosis (3% vs. 4.3%, P=.033). There was no similar difference noted in the CAS cohort, with periprocedural neurologic event rates of 3.8% in the severe group versus 3.5% in the non-severe group (P=.518). On multivariable analysis, severe stenosis was associated with significantly decreased odds of post procedural neurologic events in patients undergoing CEA (odds ratio [OR] 0.75, 95% confidence interval [CI], 0.6 - 0.92; P=.007) and TCAR (OR .83; CI, .69 - 0.99; P=.039), but not CAS. CONCLUSION/CONCLUSIONS:Severe carotid stenosis as opposed to more moderate degrees of stenosis was associated with decreased rates of periprocedural stroke and TIAs in symptomatic patients undergoing TCAR and CEA, but not CAS. The finding of increased rates of periprocedural neurologic events in symptomatic patients with lesser degrees of stenosis undergoing TCAR and CEA warrants further evaluation with a particular focus on plaque morphology and brain physiology, and their inherent risks with carotid revascularization procedures.
PMID: 35272001
ISSN: 1097-6809
CID: 5183632

Statin Use and Cardiovascular Event/Death Rates after Abdominal Aortic Aneurysm Repair Procedures [Editorial]

Paraskevas, Kosmas I; Mukherjee, Debabrata; Liapis, Christos D; Veith, Frank J
PMID: 34602047
ISSN: 1875-6212
CID: 5178512

Statin Use Reduces Mortality in Patients Who Develop Major Complications After Transcarotid Artery Revascularization [Meeting Abstract]

Chang, H; Zeeshan, M; Rockman, C B; Veith, F J; Laskowski, I; Kashyap, V S; Jacobowitz, G R; Garg, K; Sadek, M; Maldonado, T S
INTRODUCTION AND OBJECTIVES: The impact of preoperative statin use in patients undergoing transcarotid artery revascularization (TCAR) is not well established. The aim of this study was to evaluate the effect of statin on postoperative outcomes after TCAR.
METHOD(S): Vascular Quality Initiative registry (2012-2020) was queried for patients undergoing TCAR. Patient demographics, perioperative characteristics and 30-day outcomes were compared between patients treated with and without statins at least 30 days preoperatively. Multivariable logistic regression models were used to estimate the effect of statins on postoperative outcomes. RESULTS: A total of 15,797 patients underwent TCAR, and 10,116 (64%) were males. 14,152 (89.6%) patients were on statin preoperatively (Table). There was higher incidence of both prior ipsilateral stroke (17.2% vs 13.5%; P<.001) and recent ipsilateral stroke (<= 30 days; 7.1% vs 5.6%; P=.02) in the statin group. Perioperative stroke and major adverse cardiac event (MACE; myocardial infarction, congestive heart failure and dysrhythmia) occurred in 1.5% and 2.4% among patients on statins and 1.4% and 2.3% among those not on statins, respectively. After adjusting for potential confounders and baseline differences, statin use was associated with 62% reduction in the odds of mortality (OR 0.38; 95% CI, 0.19-0.99; P=.047) in patients who developed a perioperative stroke or MACE after TCAR (Figure).
CONCLUSION(S): Statin use was associated with a significant reduction in postoperative mortality in patients who develop a stroke or MACE after TCAR. Therefore, strict adherence to statin is strongly recommended, particularly in patients who may be at high risk of major postoperative complications.[Formula presented]
Copyright
EMBASE:2016756291
ISSN: 1615-5947
CID: 5158152

Prophylactic sac outflow vessel embolization is associated with improved sac regression in patients undergoing endovascular aortic aneurysm repair

Rokosh, Rae S; Chang, Heepeel; Butler, Jonathan R; Rockman, Caron B; Patel, Virendra I; Milner, Ross; Jacobowitz, Glenn R; Cayne, Neal S; Veith, Frank; Garg, Karan
OBJECTIVE:Type II endoleaks (T2Es), often identified after endovascular aneurysm repair (EVAR), have been associated with late endograft failure and secondary rupture. The number and size of the patent aortic aneurysm sac outflow vessels (ie, the inferior mesenteric, lumbar, and accessory renal arteries) have been implicated as known risk factors for persistent T2Es. Given the technical challenges associated with post-EVAR embolization, prophylactic embolization of aortic aneurysm sac outflow vessels has been advocated to prevent T2Es; however, the evidence available at present is limited. We sought to examine the effects of concomitant prophylactic aortic aneurysm sac outflow vessel embolization in patients undergoing EVAR. METHODS:Patients aged ≥18 years included in the Society for Vascular Surgery Vascular Quality Initiative database who had undergone elective EVAR for intact aneurysms between January 2009 and November 2020 were included in the present study. Patients with a history of prior aortic repair and those without available follow-up data were excluded. The patient demographics, operative characteristics, and outcomes were analyzed by group: EVAR alone vs EVAR with prophylactic sac outflow vessel embolization (emboEVAR). The outcomes of interest were the in-hospital postoperative complication rates, incidence of aneurysmal sac regression (≥5 mm) and T2Es, and reintervention rates during follow-up. RESULTS:A total of 15,060 patients were included. Of these patients, 272 had undergone emboEVAR and 14,788 had undergone EVAR alone. No significant differences were found between the two groups in age, comorbidities, or anatomic characteristics, including the mean maximum preoperative aortic diameter (5.5 vs 5.6 cm; P = .48). emboEVAR was associated with significantly longer procedural times (148 vs 124 minutes; P < .0001), prolonged fluoroscopy times (32 vs 23 minutes; P < .0001), increased contrast use (105 vs 91 mL; P < .0001), without a significant reduction in T2Es at case completion (17.7% vs 16.3%; P = .54). The incidence of postoperative complications (3.7% vs 4.6%; P = .56), index hospitalization reintervention rates (0.7% vs 1.3%; P = .59), length of stay (1.8 vs 2 days; P = .75), and 30-day mortality (0% vs 0%; P = 1.00) were similar between the two groups. At mid-term follow-up (14.6 ± 6.2 months), the emboEVAR group had a significantly greater mean reduction in the maximum aortic diameter (0.69 vs 0.54 cm; P = .006), with a greater proportion experiencing sac regression of ≥5 mm (53.5% vs 48.7%). The reintervention rates were similar between the two groups. On multivariable analysis, prophylactic aortic aneurysm sac outflow vessel embolization (odds ratio, 1.34; 95% confidence interval, 1.04-1.74; P = .024) was a significant independent predictor of sac regression. CONCLUSIONS:Prophylactic sac outflow vessel embolization can be performed safely for patients with intact aortic aneurysms undergoing elective EVAR without significant associated perioperative morbidity or mortality. emboEVAR was associated with significant sac regression compared with EVAR alone at mid-term follow-up. Although no decrease was found in the incidence of T2Es, this technique shows promise, and future efforts should focus on identifying a subset of aneurysm and outflow branch characteristics that will benefit from concomitant selective vs complete prophylactic sac outflow vessel embolization.
PMID: 34923066
ISSN: 1097-6809
CID: 5108632

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