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Optimal medical therapy is lacking in patients undergoing intervention for symptomatic carotid artery stenosis and protects against larger areas of cerebral infarction
Teter, Katherine; Willems, Loes; Harish, Keerthi; Negash, Bruck; Warle, Michiel; Rockman, Caron; Torres, Jose; Ishida, Koto; Jacobowitz, Glenn; Garg, Karan; Maldonado, Thomas
OBJECTIVES/OBJECTIVE:Carotid interventions are indicated for both patients with symptomatic and a subset of patients with severe asymptomatic carotid artery stenosis (CAS). Symptomatic CAS accounts for up to 12%-25% of overall carotid interventions, but predictors of symptomatic presentation remain poorly defined. The aim of this study was to identify factors associated with symptomatic CAS in our patient population. METHODS:Between January 2015 and February 2022, an institutional retrospective cohort study of prospectively collected data on patients undergoing interventions for CAS was performed. Procedures included carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), and transfemoral carotid artery stenting (TF-CAS). Demographic data, comorbidities, procedural details, and anatomic features from various imaging modalities were collected. Comparisons were made between symptomatic (symptoms within the prior 6 months) and asymptomatic patients. RESULTS:< .001), and symptomatic patients with ulcerated plaques more frequently had less than 50% compared to moderate/severe CAS. Nine patients who presented with symptoms had mild CAS and underwent intervention. CONCLUSIONS:Symptomatic CAS was associated with a history of remote prior symptoms and lack of anti-platelet therapy at time of presentation. Furthermore, symptomatic patients not on anti-platelet agents were more likely to have a greater area of parenchymal involvement when presenting with stroke and symptomatic patients with ulcerated plaques were more likely to have mild CAS, suggesting the role of plaque instability in symptomatic presentation. These findings underscore the importance of appropriate medical management and adherence in all patients with CAS and perhaps a role for more frequent surveillance in those with potentially unstable plaque morphology.
PMID: 38876778
ISSN: 1708-539x
CID: 5669572
Preoperative COVID-19 Vaccination is Associated with Decreased Perioperative Mortality after Major Vascular Surgery
Ratner, Molly; Garg, Karan; Chang, Heepeel; Nigalaye, Anjali; Medvedovsky, Steven; Jacobowitz, Glenn; Siracuse, Jeffrey J; Patel, Virendra; Schermerhorn, Marc; DiMaggio, Charles; Rockman, Caron B
OBJECTIVE:The objective of this study was to examine the effect of corona virus 2019 (COVID-19) vaccination on perioperative outcomes after major vascular surgery. BACKGROUND DATA/BACKGROUND:COVID-19 vaccination is associated with decreased mortality in patients undergoing various surgical procedures. However, the effect of vaccination on perioperative mortality after major vascular surgery is unknown. METHODS:This is a multicenter retrospective study of patients who underwent major vascular surgery between December 2021 through August 2023. The primary outcome was all-cause mortality within 30 days of index operation or prior to hospital discharge. Multivariable models were used to examine the association between vaccination status and the primary outcome. RESULTS:Of the total 85,424 patients included, 19161 (22.4%) were unvaccinated. Unvaccinated patients were younger compared to vaccinated patients (mean age 68.44 +/- 10.37 y vs 72.11 +/- 9.20 y, P <0.001) and less likely to have comorbid conditions, including hypertension, congestive heart failure, chronic obstructive pulmonary disease, and dialysis. After risk factor adjustment, vaccination was associated with decreased mortality (OR 0.7, 95% CI 0.62 - 0.81, P <0.0001). Stratification by procedure type demonstrated that vaccinated patients had decreased odds of mortality after open AAA (OR 0.6, 95% CI 0.42-0.97, P =0.03), EVAR (OR 0.6, 95% CI 0.43-0.83, p 0.002), CAS (OR 0.7, 95% CI 0.51-0.88, P =0.004) and infra-inguinal lower extremity bypass (OR 0.7, 95% CI 0.48-0.96, P =0.03). CONCLUSIONS:COVID-19 vaccination is associated with reduced perioperative mortality in patients undergoing vascular surgery. This association is most pronounced for patients undergoing aortic aneurysm repair, carotid stenting and infrainguinal bypass.
PMID: 38726660
ISSN: 1528-1140
CID: 5734032
Prior Authorization Requirements In The Office-Based Laboratory Setting Are Administratively Inefficient And Threaten Timeliness Of Care
Harish, Keerthi B; Chervonski, Ethan; Speranza, Giancarlo; Maldonado, Thomas S; Garg, Karan; Sadek, Mikel; Rockman, Caron B; Jacobowitz, Glenn R; Berland, Todd L
OBJECTIVE:The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the Office-Based Laboratory (OBL) setting. METHODS:This single-institution retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice's scheduling database. RESULTS:Over the study period, 1,854 OBL cases were scheduled; 8% (n=146) required PA. Of these, 75% (n=110) were for lower extremity arterial interventions, 19% (n=27) were for deep venous interventions, and 6% (n=9) were for other interventions. Of 146 PAs, 19% (n=27) were initially denied but 74.1% (n=7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n=14) more often than were arterial procedures, at 11.8% (n=13). Of 146 requested procedures, 4% (n=6) were delayed due to pending prior authorization determination by a mean 14.2±18.3 working days. An additional 6% (n=8) of procedures were performed in the interest of time prior to final determination. Of the 7 terminally denied procedures, 57% (n=4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS:Utilizing prior authorization appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.
PMID: 38135169
ISSN: 1097-6809
CID: 5611912
A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery
Bertges, Daniel J; Eldrup-Jorgensen, Jens; Chaer, Rabih A; Stoner, Michael C; Marone, Luke K; Giles, Kristina A; DeRubertis, Brian G; Jacobowitz, Glenn R; Cronenwett, Jack L; ,
OBJECTIVE:The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS:We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS:Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS:This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.
PMID: 38190927
ISSN: 1097-6809
CID: 5699722
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
Safety and efficacy of endovenous ablation in patients with a history of deep vein thrombosis
Chervonski, Ethan; Muqri, Furqan; Jacobowitz, Glenn R; Rockman, Caron B; Maldonado, Thomas S; Berland, Todd L; Garg, Karan; Cayne, Neal S; Sadek, Mikel
OBJECTIVE:Endovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep vein thrombosis (DVT), concern exists for an increased risk of postprocedural complications, particularly venous thromboembolism. The objective of this study was to evaluate the safety and efficacy of endovenous thermal ablation in patients with a history of DVT. METHODS:The national Vascular Quality Initiative Varicose Vein Registry was queried for superficial venous procedures performed from January 2014 to July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety end point was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3 months of follow-up. The secondary safety end points included any proximal thrombus extension (ie, EHIT I-IV), major bleeding, hematoma, pulmonary embolism, and death due to the procedure. The primary efficacy end point was technical failure (ie, recanalization at <1 week of follow-up). Secondary efficacy end points included the risk of recanalization over time and the postprocedural change in quality-of-life measures. Outcomes stratified by preoperative use of anticoagulation (AC) were also compared among those with prior DVT. RESULTS:Among 33,892 endovenous thermal ablations performed on 23,572 individual patients aged 13 to 90 years, 1698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (P < .001), had a higher body mass index (P < .001), were more likely to be male at birth (P < .001) and Black/African American (P < .001), and had greater CEAP classifications (P < .001). A history of DVT conferred a higher risk of new DVT (1.4% vs 0.8%; P = .03), proximal thrombus extension (2.3% vs 1.6%; P = .045), and bleeding (0.2% vs 0.04%; P = .03). EHIT II-IV, pulmonary embolism, and hematoma risk did not differ by DVT history (P = NS). No deaths from treatment occurred in either group. Continuing preoperative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (P = NS) but did confer an increased hematoma risk among all endovenous thermal ablations and surgeries (P = .001). Technical failure was similar between groups (2.0% vs 1.2%; P = .07), although a history of DVT conferred an increased recanalization risk over time (hazard ratio, 1.90; 95% confidence interval, 1.46, 2.46; P < .001). The groups had comparable improvements in postprocedural venous clinical severity scores and Heaviness, Aching, Swelling, Throbbing, and Itching scores (P = NS). CONCLUSIONS:Endovenous thermal ablation for patients with a history of DVT was effective. However, appropriate patient counseling regarding a heightened DVT risk, albeit still low, is critical. The decision to continue or withhold AC preoperatively should be tailored on a case-by-case basis.
PMID: 38677553
ISSN: 2213-3348
CID: 5657962
Longitudinal assessment of health-related quality of life and clinical outcomes with at home advanced pneumatic compression treatment of lower extremity lymphedema
Padberg, Frank T; Ucuzian, Areck; Dosluoglu, Hasan; Jacobowitz, Glenn; O'Donnell, Thomas F
OBJECTIVE:This prospective, longitudinal, pragmatic study describes at home treatment with a proprietary advanced pneumatic compression device (APCD) for patients with lower extremity lymphedema (LED). METHODS:Following institutiona review board approval, four participating Veterans Affairs centers enrolled LED patients from 2016 to 2022. The primary outcome measures were health-related quality of life (HR-QoL) questionnaires (lymphedema quality of life-leg and the generic SF-36v2) obtained at baseline and 12, 24, and 52 weeks. The secondary outcome measures were limb circumference, cellulitis events, skin quality, and compliance with APCD and other compression therapies. RESULTS:. LED was bilateral in 92.2% of the patients. Chronic venous insufficiency or phlebolymphedema was the most common etiology of LED (112 patients; 62.6%), followed by trauma or surgery (20 patients; 11.2%). Cancer treatment as a cause was low (4 patients; 2.3%). Patients were classified as having International Society for Lymphology (ISL) stage I (68.4%), II (27.6%), or III (4.1%). Of the primary outcome measures, significant improvements were observed in all lymphedema quality of life-leg domains of function, appearance, symptoms, and emotion and the overall score after 12 weeks of treatment (P < .0001) and through 52 weeks of follow-up. The SF-36v2 demonstrated significant improvement in three domains at 12 weeks and in the six domains of physical function, bodily pain, physical component (P < .0001), social functioning (P = .0181), role-physical (P < .0005), and mental health (P < .0334) at 52 weeks. An SF-36v2 score <40 indicates a substantial reduction in HR-QoL in LED patients compared with U.S. norms. Regarding the secondary outcome measures at 52 weeks, compared with baseline, the mean limb girth decreased by 1.4 cm (P < .0001). The maximal reduction in mean limb girth was 1.9 cm (6.0%) at 12 weeks in ISL stage II and III limbs. New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, P = .001) were reduced. The 75% of patients with skin hyperpigmentation at baseline decreased to 40% (P < .01) at 52 weeks. At 52 weeks, compliance, defined as use for 5 to 7 days per week, was reported for the APCD by 72% and for elastic stockings by 74%. CONCLUSIONS:This longitudinal study of Veterans Affairs patients with LED demonstrated improved generic and disease-specific HR-QoL through 52 weeks with at home use of an APCD. Limb girth, cellulitis episodes, and skin discoloration were reduced, with excellent compliance.
PMID: 38636734
ISSN: 2213-3348
CID: 5657472
The Natural History and Long-Term Follow-Up of Splenic Artery Aneurysms
Zhang, Jason; Ratner, Molly; Harish, Keerthi B; Speranza, Giancarlo; Hartwell, C Austen; Rao, Abhishek; Garg, Karan; Maldonado, Thomas; Sadek, Mikel; Jacobowitz, Glenn; Rockman, Caron
OBJECTIVES/OBJECTIVE:Though splenic artery aneurysms (SAAs) are the most common visceral aneurysm, there is a paucity of literature on the behavior of these entities. The objective of this study was to review the natural history of patients with SAA. METHODS:This single-institution retrospective analysis studied patients with SAA diagnosed by CT imaging between 2015 and 2019, identified by our institutional radiology database. Imaging, demographic, and clinical data was obtained via the electronic medical record. The growth rate was calculated for patients with radiologic follow-up. RESULTS:The cohort consisted of 853 patients with 890 SAA, of which 692 were female (81.2%). There were 37 women (5.3%) of childbearing age (15-50 years). Mean age at diagnosis was 70.9 years (range: 28-100) years. Frequently observed medical comorbidities included hypertension (70.2%), hypercholesterolemia (54.7%), and prior smoking (32.2%). Imaging indications included abdominal pain (37.3%), unrelated follow-up (28.0%) and follow-up of a previously noted visceral artery aneurysm (8.6%). The mean diameter at diagnosis was 13.3±6.3mm. Anatomical locations included the splenic hilum (36.0%), distal splenic artery (30.3%), mid-splenic artery (23.9%), and proximal splenic artery (9.7%). Radiographically, the majority were saccular aneurysms (72.4%) with calcifications (88.5%). One patient (38-year-old female) was initially diagnosed at the time of rupture of a 25mm aneurysm; this patient underwent immediate endovascular intervention with no complications. The mean clinical follow-up among 812 patients was 4.1 ± 4.0 years and the mean radiological follow-up among 514 patients was 3.8 ± 6.8 years. Of the latter, 122 patients (23.7%) experienced growth. Aneurysm growth rates for initial sizes < 10mm (n=123), 10-19mm (n=353), 20-29mm (n=34), and >30mm (n=4) were 0.166 mm/yr, 0.172 mm/yr, 0.383 mm/yr, and 0.246 mm/yr, respectively. Of the entire cohort, 27 patients (3.2%) eventually underwent intervention (81.5% endovascular), with the most common indications including size/growth criteria (70.4%) and symptom development (18.5%). On multivariate analysis, only prior tobacco use was significantly associated with aneurysm growth (p=.028). CONCLUSIONS:The majority of SAAs in this cohort remained stable in size, with few patients requiring intervention over mean follow-up of 4 years. Current guidelines recommending treatment of asymptomatic aneurysms >30mm appear appropriate given their slow progression. Despite societal recommendations for intervention for all SAAs among women of childbearing age, only a minority underwent vascular surgical consultation and intervention in this series, indicating that these recommendations are likely not well known in the general medical community.
PMID: 38081394
ISSN: 1097-6809
CID: 5589102
Venous Ablation Procedures by Provider Type, Including Advanced Practice Providers
Wiske, Clay; Chervonski, Ethan; Rockman, Caron B; Jacobowitz, Glenn R; Sadek, Mikel
OBJECTIVE:The necessary training and certification of providers performing venous ablation has become a topic of debate in recent years. As venous interventions have shifted away from the hospital, the diversity of provider backgrounds has increased. We aimed to characterize superficial venous ablation practice patterns associated with different provider types. METHODS:We analyzed Medicare fee-for-service data from 2010 through 2018. Procedures were identified by their Current Procedural Terminology (CPT) code and included radiofrequency ablation, endovenous laser ablation, chemical adhesive ablation (i.e., VenaSeal®), and mechanochemical ablation. These procedures were correlated with the practitioner type to identify provider-specific trends. RESULTS:Between 2010 and 2018, the number of ablation procedures rose by 107% from 114,197 to 236,558 per year (p<0.001). Most procedures were performed by surgeons without vascular board certification (28.7%, 95% CI [28.7, 28.8]), followed by vascular surgeons (27.1%, 95% CI [27.0, 27.2]). Traditionally non-interventional specialties, which exclude surgeons, cardiologists, and interventional radiologists, accounted for 14.1% (95% CI [14.1, 14.2]), and APPs accounted for 3.5% (95% CI [3.4, 3.5]) of all ablation procedures during the time frame. The total number of ablations increased by 9.7% annually (95% CI [9.7, 9.8]), whereas procedures performed by APPs grew by 62.0% annually (95% CI [61.6, 62.4]). There were significant differences between specialties in the use of non-thermal ablation modalities: APPs had the highest affinity for non-thermal ablation (OR 2.60, 95% CI [2.51, 2.69]). Cardiologists were also more likely to use non-thermal ablation (OR 1.62, 95% CI [1.59, 1.66]). Similarly, the uptake of new non-thermal technology (i.e., chemical adhesives) was greatest among APPs (OR 3.57, 95% CI [3.43, 3.70]) and cardiologists (OR 1.86, 95%,CI [1.81, 1.91]). Vascular surgeons were less likely to use non-thermal modalities (OR 0.95, 95% CI [0.92, 0.97]), including new non-thermal technology in the first year of availability (OR 0.93, 95% CI [0.90, 0.95]). CONCLUSIONS:Venous procedures have grown rapidly over the past decade, particularly as endovenous ablations have been performed by a wider practitioner base including APPs and non-interventionalists. Practice patterns differ by provider type, with APPs and cardiologists skewing more toward non-thermal modalities, including more rapid uptake of new non-thermal technology. Provider-specific biases for specific ablation modalities may reflect differences in training, skill set, the need for capital equipment, clinical privileges, or reimbursement. These data may help to inform training paradigms, allocation of resources, and evaluation of appropriateness in a real-world setting.
PMID: 38518987
ISSN: 2213-3348
CID: 5640942
Generative artificial intelligence chatbots may provide appropriate informational responses to common vascular surgery questions by patients
Chervonski, Ethan; Harish, Keerthi B; Rockman, Caron B; Sadek, Mikel; Teter, Katherine A; Jacobowitz, Glenn R; Berland, Todd L; Lohr, Joann; Moore, Colleen; Maldonado, Thomas S
OBJECTIVES/OBJECTIVE:Generative artificial intelligence (AI) has emerged as a promising tool to engage with patients. The objective of this study was to assess the quality of AI responses to common patient questions regarding vascular surgery disease processes. METHODS:OpenAI's ChatGPT-3.5 and Google Bard were queried with 24 mock patient questions spanning seven vascular surgery disease domains. Six experienced vascular surgery faculty at a tertiary academic center independently graded AI responses on their accuracy (rated 1-4 from completely inaccurate to completely accurate), completeness (rated 1-4 from totally incomplete to totally complete), and appropriateness (binary). Responses were also evaluated with three readability scales. RESULTS:> .05 for all analyses). CONCLUSIONS:AI offers a novel means of educating patients that avoids the inundation of information from "Dr Google" and the time barriers of physician-patient encounters. ChatGPT provides largely valid, though imperfect, responses to myriad patient questions at the expense of readability. While Bard responses are more readable and concise, their quality is poorer. Further research is warranted to better understand failure points for large language models in vascular surgery patient education.
PMID: 38500300
ISSN: 1708-539x
CID: 5640272