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What the National Coverage Determination for Carotid Artery Stenting Means for the Treatment of Patients with Carotid Artery Disease

Hicks, Caitlin W; Veith, Frank J
OBJECTIVES/OBJECTIVE:In October 2023, the Centers for Medicare & Medicaid Services (CMS) agreed to revisit its national coverage determination (NCD) for carotid artery stenting (CAS). We provide an overview of the arguments presented in favor and against NCD expansion, and discuss the likely ramifications on patient care and outcomes in the future. METHODS:We completed a narrative review of the arguments presented in favor and against NCD expansion. RESULTS:Arguments presented in favor of the CAS NCD expansion predominantly focused on the outcomes of four large multicenter randomized controlled trials published between 2010 and 2021 that reported similar outcomes for composite endpoints between patients undergoing CAS and carotid endarterectomy. The main arguments against expanding the CAS NCD centered around higher patient stroke risks with CAS, increasing healthcare costs, premature decision-making, and the lack of a validated shared decision-making tool that can be readily applied to carotid revascularization. CONCLUSIONS:By expanding the indications for CAS to asymptomatic and standard-risk patients, they will be exposed to excess and unnecessary risks without any evident benefits, potentially leading to widespread adoption of a procedure driven by financial incentives rather than genuine patient benefits.
PMID: 39374802
ISSN: 1615-5947
CID: 5730132

Outcomes and predictors of amputation-free survival in patients undergoing below-knee popliteal-distal bypass

Nwachukwu, Chukwuma; Ratner, Molly; Rockman, Caron; Cayne, Neal; Siracuse, Jeffrey J; Johnson, William; Chang, Heepeel; Jacobowitz, Glenn; Veith, Frank; Shariff, Saadat; Garg, Karan
OBJECTIVE:The infrageniculate popliteal artery is a potential source for inflow in lower extremity bypass surgery in patients with isolated tibial artery disease. The objective of our study was to assess the short- and long-term outcomes of popliteal-distal bypasses using data from the Vascular Quality Initiative (VQI). METHODS:The VQI registry was queried between 2003 and 2021 for patients undergoing surgical revascularizations with the below-knee popliteal artery serving as inflow. Demographics, comorbidities, intraoperative characteristics, and postoperative complications were analyzed. Kaplan-Meier models were used to estimate amputation-free survival, survival, and freedom from amputation. Cox regression analysis was conducted to determine factors associated with major amputation or death. RESULTS:A total of 1884 procedures were analyzed. The mean age of the included patients was 67.7 years. The most frequently observed preoperative comorbidities included insulin-dependent diabetes (52.3%), coronary disease (32.4%), and end-stage renal disease (14.4%). Of all the patients, 670 (35.6%) had a history of ipsilateral endovascular intervention. The procedures were performed for a variety of indications, including tissue loss (84.3%), rest pain (10.9%), and claudication (4.8%). Intraoperatively, the outflow targets were the dorsalis pedis (31.4%), the posterior tibial (24.4%), and the anterior tibial arteries (15.6%). Vein conduit was used in 92.1% of cases. The rate of perioperative myocardial infarction (MI) was 2.4%, and the 30-day mortality was 1.9%. The median length of follow up was 371 days. Amputation-free survival was found to be 85.6% (95% confidence interval [CI], 84.0%-87.2%) at 6 months and 78.6% (95% CI, 76.6%-80.4%) at 12 months. Survival was found to be 93.4% (95% CI, 92.2%-94.5%) at 6 months and 88.6% (95% CI, 87.1%-90.0%) at 12 months. Freedom from amputation was found to be 92.0% (95% CI, 90.7%-93.3%) at 6 months and 89.0% (95% CI, 87.3%-90.4%) at 12 months. Cox regression analysis demonstrated that age greater than 65 years, congestive heart failure, coronary artery disease, and end-stage renal disease were associated with a higher risk of major amputation or death (P < .05). CONCLUSIONS:Below-knee popliteal-distal bypass is a safe and effective approach to treat severe tibial vessel occlusive disease in this challenging patient cohort. Patients exhibited low perioperative complication rates and good amputation-free survival at 1 year.
PMID: 38244642
ISSN: 1097-6809
CID: 5691192

The "Woundosome" Concept and Its Impact on Procedural Outcomes in Patients With Chronic Limb-Threatening Ischemia [Editorial]

Patrone, Lorenzo; Pasqui, Edoardo; Conte, Michael S; Farber, Alik; Ferraresi, Roberto; Menard, Matthew; Mills, Joseph L; Rundback, John; Schneider, Peter; Ysa, August; Abhishek, Kumar; Adams, George L; Ahmad, Naseer; Ahmed, Irfan; Alexandrescu, Vlad A; Amor, Max; Alper, David; Andrassy, Martin; Attinger, Christopher; Baadh, Andy; Barakat, Hashem; Biasi, Lukla; Bisdas, Theodosios; Bhatti, Zagum; Blessing, Erwin; Bonaca, Marc P; Bonvini, Stefano; Bosiers, Michel; Bradbury, Andrew W; Beasley, Robert; Behrendt, Christian-Alexander; Brodmann, Marianne; Cabral, Gonzalo; Cancellieri, Roberto; Casini, Andrea; Chandra, Venita; Chisci, Emiliano; Chohan, Omar; Choke, Edward T C; Chong, Patrick F S; Clerici, Giacomo; Coscas, Raphael; Costantino, Mary; Dalla Paola, Luca; Dand, Sabeen; Davies, Robert S M; D'Oria, Mario; Diamantopoulos, Athanasios; Debus, Sebastian; Deloose, Koen; Del Giudice, Costantino; Donato, Gianmarco de; Rubertis, Brian De; Paul De Vries, Jean; Dias, Nuno V; Diaz-Sandoval, Larry; Dick, Florian; Donas, Konstantinos; Dua, Anahita; Fanelli, Fabrizio; Fazzini, Stefano; Foteh, Mazin; Gandini, Roberto; Gargiulo, Mauro; Garriboli, Luca; Genovese, Elizabeth A; Gifford, Edward; Goueffic, Yann; Goverde, Peter; Chand Gupta, Prem; Hinchliffe, Robert; Holden, Andrew; Houlind, Kim C; Howard, Dominic Pj; Huasen, Bella; Isernia, Giacomo; Katsanos, Konstantinos; Katzen, Barry; Kolh, Philippe; Koncar, Igor; Korosoglou, Grigorios; Krishnan, Prakash; Kroencke, Thomas; Krokidis, Miltiadis; Kumarasamy, Arun; Hayes, Paul; Iida, Osamu; Alejandre Lafont, Enrique; Langhoff, Ralf; Lecis, Alexandre; Lessne, Mark; Lichaa, Hady; Lichtenberg, Michael; Lobato, Marta; Lopes, Alice; Loreni, Giorgio; Lucatelli, Pierleone; Madassery, Sreekumar; Maene, Lieven; Manzi, Marco; Maresch, Martin; Santhosh Mathews, Jay; McCaslin, James; Micari, Antonio; Michelagnoli, Stefano; Migliara, Bruno; Morgan, Robert; Morelli, Luis; Morosetti, Daniele; Mouawad, Nicolas; Moxey, Paul; Müller-Hülsbeck, Stefan; Mustapha, Jihad; Nakama, Tatsuya; Nasr, Bahaa; N'dandu, Zola; Neville, Richard; Noory, Elias; Nordanstig, Joakim; Noronen, Katariina; Mariano Palena, Luis; Parlani, Gianbattista; Patel, Ashish S; Patel, Parag; Patel, Rafiuddin; Patel, Sanjay; Pena, Costantino; Perkov, Drazen; Portou, Mark; Pratesi, Giovanni; Rammos, Christos; Reekers, Jim; Riambau, Vicente; Roy, Trisha; Rosenfield, Kenneth; Antonella Ruffino, Maria; Saab, Fadi; Saratzis, Athanasios; Sbarzaglia, Paolo; Schmidt, Andrej; Secemsky, Eric; Siah, Michael; Sillesen, Henrik; Simonte, Gioele; Sirvent, Marc; Sommerset, Jill; Steiner, Sabine; Sakr, Ahmed; Scheinert, Dierk; Shishebor, Mehdi; Spiliopoulos, Stavros; Spinelli, Alessio; Stravoulakis, Konstantinos; Taneva, Gergana; Teso, Desarom; Tessarek, Joerg; Theivacumar, Selva; Thomas, Anish; Thomas, Shannon; Thulasidasan, Narayan; Torsello, Giovanni; Tripathi, Ramesh; Troisi, Nicola; Tummala, Srini; Tummala, Venkat; Twine, Christopher; Uberoi, Raman; Ucci, Alessandro; Valenti, Domenico; van den Berg, Jos; van den Heuvel, Daniel; Van Herzeele, Isabelle; Varcoe, Ramon; Vega de Ceniga, Melina; Veith, Frank J; Venermo, Maarit; Vijaynagar, Badri; Virdee, Sanjiv; Von Stempel, Conrad; Voûte, Michiel T; Khee Yeung, Kak; Zeller, Thomas; Zayed, Hany; Montero Baker, Miguel
PMID: 38523459
ISSN: 1545-1550
CID: 5645462

Surgery or Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia? What do BASIL-2 and BEST-CLI Tell Us [Editorial]

Paraskevas, Kosmas I; Veith, Frank J
PMID: 38336359
ISSN: 1940-1574
CID: 5632092

The New ESVS Practice Guidelines for Intermittent Claudication are Exactly What We Need [Editorial]

Hicks, Caitlin W; Veith, Frank J
PMID: 37839661
ISSN: 1532-2165
CID: 5614222

Positive Preoperative Cardiac Stress Test Associated With Higher Late Mortality in Patients Undergoing Elective Carotid Endarterectomy [Meeting Abstract]

Rokosh, R S; Rockman, C; Jacobowitz, G; Cayne, N; Maldonado, T S; Patel, V I; Siracuse, J J; Veith, F; Chang, H; Garg, K
Objectives: This study compared outcomes in patients with and without preoperative cardiac stress testing undergoing carotid endarterectomy (CEA).
Method(s): Patients in the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database who underwent elective carotid revascularization between 2016 and 2019 were included. Patients were analyzed by group based upon whether they underwent cardiac stress testing within two years preceding revascularization without subsequent coronary intervention. Subset analysis was performed comparing outcomes between those with negative and positive results, defined as evidence of ischemia or myocardial infarction (MI). Outcomes of interest were periprocedural MI/stroke, 90-day readmission rates, as well as late-term mortality.
Result(s): We analyzed 14,470 patients who underwent elective CEA. Of these, 5411 (37.4%) underwent preoperative stress testing and 1231 (29.4%) were positive. Comorbidities were significantly higher among patients undergoing CEA with preoperative stress test compared to those without stress testing. For patients with positive stress test undergoing CEA, there was a significant increase in postoperative MI (1.7% vs 0.6%; P <.001) and 90-day readmission rates (19.6% vs 15.8%; P =.003), but no significant change in postoperative stroke or congestive heart failure incidence. In 3-year follow-up after CEA, those with a positive stress test were more likely to undergo coronary artery bypass graft/percutaneous coronary intervention (adjusted hazard ratio [HR], 1.87; 95% confidence interval [CI], 1.42-2.27; P <.0001) and also exhibited a 28% increase in mortality (adjusted HR, 1.28; 95% CI, 1.03-1.58; P =.03) in follow-up compared to those patients with a negative preoperative stress test (Figure). Conversely, those patients with a negative stress test compared to no stress test undergoing CEA experienced a 14% reduction in follow-up mortality (adjusted HR, 0.86; 95% CI, 0.76-0.98; P =.02) despite no difference in in-hospital MI/stroke or follow-up coronary artery bypass graft/percutaneous coronary intervention (adjusted HR, 0.94; 95% CI, 0.78-1.14; P =.53).
Conclusion(s): Our study highlights that cardiac stress testing in appropriately selected patients can facilitate risk stratification and identify patients at higher risk of postoperative adverse cardiac events. Furthermore, judicious patient selection for elective CEA is warranted in patients with a positive preoperative stress test given the increased late mortality. [Formula presented]
Copyright
EMBASE:2024650331
ISSN: 1097-6809
CID: 5514382

Renal transplant recipients undergoing endovascular abdominal aortic aneurysm repair have increased risk of perioperative acute kidney injury but no difference in late mortality

Chang, Heepeel; Veith, Frank J; Laskowski, Igor; Maldonado, Thomas S; Butler, Jonathan R; Jacobowitz, Glenn R; Rockman, Caron B; Zeeshan, Muhammad; Ventarola, Daniel J; Cayne, Neal S; Lui, Aiden; Mateo, Romeo; Babu, Sateesh; Goyal, Arun; Garg, Karan
OBJECTIVE:Renal transplant is associated with substantial survival advantage in patients with end-stage renal disease. However, little is known about the outcomes of renal transplant recipients (RTRs) after endovascular abdominal aortic aneurysm repair (EVAR). This study aimed to study the effect of renal transplant on perioperative outcomes and long-term survival after elective infrarenal EVAR. METHODS:The Vascular Quality Initiative database was queried for all patients undergoing elective EVAR from 2003 to 2021. Functioning RTRs were compared with non-renal transplant recipients without a diagnosis of end-stage renal disease (non-RTRs). The outcomes included 30-day mortality, acute kidney injury (AKI), new renal failure requiring renal replacement therapy (RRT), endoleak, aortic-related reintervention, major adverse cardiac events, and 5-year survival. A logistic regression analysis was used to assess the association between RTRs and perioperative outcomes. RESULTS:Of 60,522 patients undergoing elective EVAR, 180 (0.3%) were RTRs. RTRs were younger (median, 71 years vs 74.5 years; P < .001), with higher incidence of hypertension (92% vs 84%; P = .004) and diabetes (29% vs 21%; P = .005). RTRs had higher median preoperative serum creatinine (1.3 mg/dL vs 1.0 mg/dL; P < .001) and lower estimated glomerular filtration rate (51.6 mL/min vs 69.4 mL/min; P < .001). There was no difference in the abdominal aortic aneurysm diameter and incidence of concurrent iliac aneurysms. Procedurally, RTRs were more likely to undergo general anesthesia with lower amount of contrast used (median, 68.6 mL vs 94.8 ml; P < .001) and higher crystalloid infusion (median, 1700 mL vs 1500 mL; P = .039), but no difference was observed in the incidence of open conversion, endoleak, operative time, and blood loss. Postoperatively, RTRs experienced a higher rate of AKI (9.4% vs 2.7%; P < .001), but the need for new RRT was similar (1.1% vs 0.4%; P = .15). There was no difference in the rates of postoperative mortality, aortic-related reintervention, and major adverse cardiac events. After adjustment for potential confounders, RTRs remained associated with increased odds of postoperative AKI (odds ratio, 3.33; 95% confidence interval, 1.93-5.76; P < .001) but had no association with other postoperative complications. A subgroup analysis identified that diabetes (odds ratio, 4.21; 95% confidence interval, 1.17-15.14; P = .02) is associated with increased odds of postoperative AKI among RTRs. At 5 years, the overall survival rates were similar (83.4% vs 80%; log-rank P = .235). CONCLUSIONS:Among patients undergoing elective infrarenal EVAR, RTRs were independently associated with increased odds of postoperative AKI, without increased postoperative renal failure requiring RRT, mortality, endoleak, aortic-related reintervention, or major adverse cardiac events. Furthermore, 5-year survival was similar. As such, while EVAR may confer comparable benefits and technical success perioperatively, RTRs should have aggressive and maximally optimized renal protection to mitigate the risk of postoperative AKI.
PMID: 36626957
ISSN: 1097-6809
CID: 5434342

Renal transplant recipients undergoing endovascular abdominal aortic aneurysm repair have increased risk of perioperative acute kidney injury but no difference in late mortality: Presented at the 2022 Vascular Annual Meeting of the Society for Vascular Surgery; Boston, Massachusetts, June 15-18, 2022 [Meeting Abstract]

Chang, H; Veith, F J; Laskowski, I; Maldonado, T S; Butler, J R; Jacobowitz, G R; Rockman, C B; Zeeshan, M; Ventarola, D J; Cayne, N S; Lui, A; Mateo, R; Babu, S; Goyal, A; Garg, K
Objective: Renal transplant is associated with substantial survival advantage in patients with end-stage renal disease. However, little is known about the outcomes of renal transplant recipients (RTRs) after endovascular abdominal aortic aneurysm repair (EVAR). This study aimed to study the effect of renal transplant on perioperative outcomes and long-term survival after elective infrarenal EVAR.
Method(s): The Vascular Quality Initiative database was queried for all patients undergoing elective EVAR from 2003 to 2021. Functioning RTRs were compared with non-renal transplant recipients without a diagnosis of end-stage renal disease (non-RTRs). The outcomes included 30-day mortality, acute kidney injury (AKI), new renal failure requiring renal replacement therapy (RRT), endoleak, aortic-related reintervention, major adverse cardiac events, and 5-year survival. A logistic regression analysis was used to assess the association between RTRs and perioperative outcomes.
Result(s): Of 60,522 patients undergoing elective EVAR, 180 (0.3%) were RTRs. RTRs were younger (median, 71 years vs 74.5 years; P <.001), with higher incidence of hypertension (92% vs 84%; P =.004) and diabetes (29% vs 21%; P =.005). RTRs had higher median preoperative serum creatinine (1.3 mg/dL vs 1.0 mg/dL; P <.001) and lower estimated glomerular filtration rate (51.6 mL/min vs 69.4 mL/min; P <.001). There was no difference in the abdominal aortic aneurysm diameter and incidence of concurrent iliac aneurysms. Procedurally, RTRs were more likely to undergo general anesthesia with lower amount of contrast used (median, 68.6 mL vs 94.8 ml; P <.001) and higher crystalloid infusion (median, 1700 mL vs 1500 mL; P =.039), but no difference was observed in the incidence of open conversion, endoleak, operative time, and blood loss. Postoperatively, RTRs experienced a higher rate of AKI (9.4% vs 2.7%; P <.001), but the need for new RRT was similar (1.1% vs 0.4%; P =.15). There was no difference in the rates of postoperative mortality, aortic-related reintervention, and major adverse cardiac events. After adjustment for potential confounders, RTRs remained associated with increased odds of postoperative AKI (odds ratio, 3.33; 95% confidence interval, 1.93-5.76; P <.001) but had no association with other postoperative complications. A subgroup analysis identified that diabetes (odds ratio, 4.21; 95% confidence interval, 1.17-15.14; P =.02) is associated with increased odds of postoperative AKI among RTRs. At 5 years, the overall survival rates were similar (83.4% vs 80%; log-rank P =.235).
Conclusion(s): Among patients undergoing elective infrarenal EVAR, RTRs were independently associated with increased odds of postoperative AKI, without increased postoperative renal failure requiring RRT, mortality, endoleak, aortic-related reintervention, or major adverse cardiac events. Furthermore, 5-year survival was similar. As such, while EVAR may confer comparable benefits and technical success perioperatively, RTRs should have aggressive and maximally optimized renal protection to mitigate the risk of postoperative AKI. Keywords: End-stage renal disease, Endovascular abdominal aortic aneurysm, Multi-institutional study, Renal transplant, Renal transplant recipient, Vascular Quality Initiative database
Copyright
EMBASE:2024574649
ISSN: 1532-2165
CID: 5514402

Expansion of Bypass as a Revascularization Option for Patients With Chronic Limb-Threatening Ischemia [Editorial]

Paraskevas, Kosmas I; Veith, Frank J
PMID: 36880697
ISSN: 1940-1574
CID: 5432652

Beta-blocker Use After Thoracic Endovascular Aortic Repair in Patients with Type B Aortic Dissection Is Associated with Improved Early Aortic Remodeling

Chang, Heepeel; Rockman, Caron B; Ramkhelawon, Bhama; Maldonado, Thomas S; Cayne, Neal S; Veith, Frank J; Jacobowitz, Glenn R; Patel, Virendra I; Laskowski, Igor; Garg, Karan
OBJECTIVE:Beta-blockers are first-line anti-impulse therapy in patients presenting with acute 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 outcomes of thoracic endovascular aortic repair (TEVAR) in TBAD. METHODS: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 effect of TEVAR on false lumen thrombosis of the treated aortic segment were assessed and compared between patients treated with and without beta-blocker postoperatively. Cox proportional hazards models were used to estimate the effect of beta-blocker therapies on outcomes. RESULTS:1,114 patients undergoing TEVAR for TBAD were identified with a mean follow-up of 18±12 months. The mean age was 61.1±11.9 years, and 791 (71%) were male. 935 (84%) patients were maintained on beta-blocker at discharge and follow-up. Patients on beta-blocker were more likely to have an entry tear originating in zones 1-2 (22% vs 13%; P=.022). The prevalence of acute, elective and symptomatic AD, concurrent aneurysm, number of endografts used, distribution of the proximal and distal zones of dissection and operative time were comparable between the two cohorts. At 18-months, significantly more complete false lumen thrombosis (58 vs 47%; log-rank P=.018) was observed in patients on beta-blocker while the rates of aortic-related reinterventions (13% vs 9%; log-rank P=.396) and mortality (0.2% vs 0.7%; log-rank P=.401) were similar in patients with and without beta-blocker, respectively. Even after adjusting for clinical and anatomic factors, postoperative beta-blocker use was associated with increased complete false lumen thrombosis (HR 1.56; 95% CI: 1.10-2.21; P=.012) but did not affect mortality or aortic-related reintervention. A secondary analysis of beta-blocker use in acute versus chronic TBAD showed a higher rate of complete false lumen thrombosis in patients on beta-blocker in chronic TBAD (59% vs 38%; log-rank P=.038). In contrast, there was no difference in the rate of complete false lumen thrombosis in acute TBAD between the two cohorts (58% vs 51%; log-rank P=.158). When analyzed separately, postoperative ACE inhibitor use did not affect the rates of complete false lumen thrombosis, mortality and aortic-related reintervention. CONCLUSIONS:Beta-blocker use was associated with promotion of complete false lumen in patients undergoing TEVAR for TBAD. In addition to its role in acute setting, anti-impulse control with beta-blocker appears to confer favorable aortic remodeling and may improve outcomes after TEVAR, particularly for chronic TBAD.
PMID: 35868420
ISSN: 1097-6809
CID: 5279412