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Dynamic perioperative platelet activity and cardiovascular events in peripheral artery disease
Kennedy, Natalie N; Xia, Yuhe; Barrett, Tessa; Luttrell-Williams, Elliot; Berland, Todd; Cayne, Neal; Garg, Karan; Jacobowitz, Glenn; Lamparello, Patrick J; Maldonado, Thomas S; Newman, Jonathan; Sadek, Mikel; Smilowitz, Nathaniel R; Rockman, Caron; Berger, Jeffrey S
OBJECTIVE:Patients with peripheral artery disease (PAD) undergo lower extremity revascularization (LER) for symptomatic relief or limb salvage. Despite LER, patients remain at increased risk of platelet-mediated complications, such as major adverse cardiac and limb events (MACLEs). Platelet activity is associated with cardiovascular events, yet little is known about the dynamic nature of platelet activity over time. We, therefore, investigated the change in platelet activity over time and its association with long-term cardiovascular risk. METHODS:Patients with PAD undergoing LER were enrolled into the multicenter, prospective Platelet Activity and Cardiovascular Events study. Platelet aggregation was assessed by light transmission aggregometry to submaximal epinephrine (0.4 μmol/L) immediately before LER, and on postoperative day 1 or 2 (POD1 or POD2) and 30 (POD30). A hyperreactive platelet phenotype was defined as >60% aggregation. Patients were followed longitudinally for MACLEs, defined as the composite of death, myocardial infarction, stroke, major lower extremity amputation, or acute limb ischemia leading to reintervention. RESULTS:Among 287 patients undergoing LER, the mean age was 70 ± 11 years, 33% were female, 61% were White, and 89% were on baseline antiplatelet therapy. Platelet aggregation to submaximal epinephrine induced a bimodal response; 15.5%, 16.8%, and 16.4% of patients demonstrated a hyperreactive platelet phenotype at baseline, POD1, and POD30, respectively. Platelet aggregation increased by 18.5% (P = .001) from baseline to POD1, which subsequently returned to baseline at POD30. After a median follow-up of 19 months, MACLEs occurred in 165 patients (57%). After adjustment for demographics, clinical risk factors, procedure type, and antiplatelet therapy, platelet hyperreactivity at POD1 was associated with a significant hazard of long-term MACLE (adjusted hazard ratio, 4.61; 95% confidence interval, 2.08-10.20; P < .001). CONCLUSIONS:Among patients with severe PAD, platelet activity increases after LER. Platelet hyperreactivity to submaximal epinephrine on POD1 is associated with long-term MACLE. Platelet activity after LER may represent a modifiable biomarker associated with excess cardiovascular risk.
PMID: 39362415
ISSN: 1097-6809
CID: 5766582
Total Contact Casting Remains an Effective Modality for Treatment of Diabetic Foot Ulcers
Zhang, Jason; Sadek, Mikel; Iannuzzi, Lou; Rockman, Caron; Garg, Karan; Taffet, Allison; Ratner, Molly; Berland, Todd; Maldonado, Thomas; Jacobowitz, Glenn; Ross, Frank
OBJECTIVES/OBJECTIVE:Total contact casting (TCC) is used to promote wound closure in diabetic foot ulcers (DFUs); however, this technique is underused today. This study aims to further evaluate the efficacy of TCC in a large cohort, including patients with peripheral artery disease (PAD). METHODS:This was a retrospective analysis of patients with DFUs who underwent TCC from 2017 to 2021. PAD was defined as absence of pedal pulse or ABI <0.9. Demographic data, DFU characteristics, and peripheral arterial intervention were evaluated. Outcomes included complete healing, healing time, and rate of major amputation. Subgroup analysis was performed on patients undergoing peripheral intervention. RESULTS:= .0008) compared to patients without intervention. CONCLUSIONS:TCC remains an effective option for treatment of DFUs, as most were completely healed. Patients with PAD may benefit from TCC and revascularization, however, healing rates are lower in this cohort, necessitating the need for close observation.
PMID: 39530741
ISSN: 1938-9116
CID: 5752822
Results from A Comparative Study to Evaluate the Treatment Effectiveness of a Non-Pneumatic Compression Device versus an Advanced Pneumatic Compression Device for Lower Extremity Lymphedema Swelling (TEAYS study)
Barfield, Michael; Winokur, Ron; Berland, Todd; Davis, Sandi; Ralph, Vicky; Chatham, Nancy; Rockson, Stanley; Maldonado, Thomas S
OBJECTIVES/OBJECTIVE:Advanced pneumatic compression devices (APCDs) have been shown to be effective in treatment of lower extremity lymphedema in the home setting. However, adherence to self-care has been poor, and APCD's require patients to remain immobile during treatment. We evaluated the safety and efficacy of a novel non-pneumatic compression device (NPCD) for treating lower extremity lymphedema vs and APCD. METHODS:A randomized, crossover head-to-head study was performed at nine sites in 2023. Patients were randomized to either the NPCD or a commercially available APCD. Patients used the randomly assigned initial device for 28 days with a 4-week washout period before a comparable 28-day use of the second device. RESULTS:A total of 71 patients (108 affected limbs) with lower extremity lymphedema were analyzed. Compared with the APCD, the NPCD was associated with a greater mean reduction in limb edema volume (a mean limb volume reduction of 369.9 (± 68.19) mL p<0.05 vs 83.1 (± 67.99 mL) p<0.05). Significant improvement in Quality of Life was achieved for NPCD and but not for APCD treatment (score improvement of 1.01 (± 0.23) (p<0.05) for NPCD vs 0.17 (± 0.18) (p>0.05) for APCD). Patients reported greater adherence (81% vs 56%, p<0.001) and satisfaction with the NPCD (78% vs 22%) compared to APCD. No device related adverse events were reported. CONCLUSIONS:The novel NPCD is an effective treatment for reducing limb volume in patients with lower extremity lymphedema. The NPCD was more effective than an APCD and resulted in superior limb volume reduction, greater improved QoL, adherence, mobility, and patient satisfaction.
PMID: 39222789
ISSN: 2213-3348
CID: 5687652
The substantial burden of iatrogenic vascular injury on the vascular surgery workforce at an academic medical center
Rao, Abhishek; Ratner, Molly; Zhang, Jason; Wiske, Clay; Garg, Karan; Maldonado, Thomas; Sadek, Mikel; Jacobowitz, Glenn; Berland, Todd; Teter, Katherine; Rockman, Caron
OBJECTIVE:Vascular surgeons are often called upon to provide emergent surgical assistance to other specialties for iatrogenic complications, both intraoperatively and in the inpatient setting. The management of iatrogenic vascular injury remains a critical role of the vascular surgeon, especially in the context of the increasing adoption of percutaneous procedures by other specialties. This study aims to characterize consultation timing, management, and outcomes for iatrogenic vascular injuries. METHODS:This study identified patients for whom vascular surgery was consulted for iatrogenic vascular complications from February 1, 2022, to May 12, 2023. Patient information, including demographic information, injury details, and details of any operative intervention, was retrospectively collected from February 1, 2022, to October 13, 2022, and prospectively collected for the remainder of the study period. Analyses were performed with R (version 2022.02.03). RESULTS:There were 87 patients with consultations related to iatrogenic vascular injury. Of these, 42 (46%) were female and the mean age was 59 years (±18 years). The most common consulting services were cardiology (32%), cardiothoracic surgery (26%), general surgery (8%), and neurointerventional radiology (10%). Reasons for consultation included hemorrhage (36%), limb ischemia (36%), and treatment of pseudoaneurysm (23%). A total of 24% of consults were intraoperative, 20% of consults related to extracorporeal membrane oxygenation cannulation, and 16% of consults related to ventricular assist devices including left ventricular assist device and intra-aortic balloon pump. The majority of these consult requests (60%) occurred during evening and night hours (5 PM to 7 AM). Emergent intervention was required in 62% of cases and consisted of primary open surgical repair of arterial injury (54%), endovascular intervention (21%), and open thromboembolectomy (15%). Overall, in-hospital mortality for the patient cohort was 20% and the reintervention rate was 23%, reflecting the underlying complexity of the illness and nature of the vascular injury in this patient group. CONCLUSIONS:Vascular surgeons play an essential role in managing emergent life-threatening hemorrhagic and ischemic iatrogenic vascular complications in the hospitalized setting. The complications require immediate bedside or intraoperative consult and often emergent open surgical or endovascular intervention. Furthermore, many of these require urgent management in the evening or overnight hours, and therefore the high frequency of these events represents a potential significant resource utilization and workforce issue to the vascular surgery workforce.
PMID: 38641255
ISSN: 1097-6809
CID: 5697582
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
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
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
Short-term outcomes of endovascular management of acute limb ischemia using aspiration mechanical thrombectomy
Auda, Matthew E; Ratner, Molly; Pezold, Michael; Rockman, Caron; Sadek, Mikel; Jacobowitz, Glenn; Berland, Todd; Siracuse, Jeffrey J; Teter, Katherine; Johnson, William; Garg, Karan
OBJECTIVE:Management of acute limb ischemia (ALI) has seen greater utilization of catheter-based interventions over the last two decades. Data on their efficacy is largely based on comparisons of catheter-directed thrombolysis (CDT) and open thrombectomy. During this time, many adjuncts to CDT have emerged with different mechanisms of action, including pharmacomechanical thrombolysis (PMT) and aspiration mechanical thrombectomy (AMT). However, the safety and efficacy of newer adjuncts like AMT have not been well established. This study is a retrospective analysis of the contemporary management of ALI comparing patients treated with aspiration mechanical thrombectomy to patients treated with the more established CDT adjunct, pharmacomechanical thrombolysis. METHODS:Patients undergoing peripheral endovascular intervention for ALI using an adjunctive device were identified through query of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) module from 2014 to 2019. Patients with a nonviable extremity (Rutherford ALI Stage 3), prior history of ipsilateral major amputation, popliteal aneurysm, procedures that were deemed elective (>72 h from admission), procedures that did not utilize an endovascular adjunctive device, and patients without short-term follow-up were all excluded from analysis. The primary outcome was a composite outcome of freedom from major amputation and/or death in the perioperative time period. RESULTS:= 0.05) were associated with the composite outcome. CONCLUSIONS:Short-term amputation-free survival rates of endovascular management of acute limb ischemia are adequate across all modalities. However, aspiration mechanical thrombectomy was associated with significantly worse amputation-free survival compared to other endovascular adjuncts alone (i.e., pharmacomechanical thrombolysis). Severe limb ischemia (Rutherford ALI Stage 2B) and prior supra-inguinal bypass were associated with worse amputation-free survival regardless of the choice of endovascular intervention.
PMID: 38415647
ISSN: 1708-539x
CID: 5691482
The Effect of Ipsilateral Carotid Revascularization on Contralateral Carotid Duplex Parameters in Patients with Bilateral Carotid Stenosis
Ratner, Molly; Rockman, Caron; Chandra, Pratik; Cayne, Neal; Jacobowitz, Glenn; Lamparello, Patrick J; Maldonado, Thomas; Sadek, Mikel; Berland, Todd; Garg, Karan
BACKGROUND:Duplex-derived velocity measurements are often used to determine the need for carotid revascularization. There is evidence that severe ipsilateral carotid stenosis can cause artificially elevated velocities in the contralateral carotid artery, which may decrease following ipsilateral revascularization. The objective of this study was to determine if contralateral carotid artery duplex velocities decrease following ipsilateral carotid endarterectomy or stenting procedures. METHODS:This is a single institutional retrospective study of prospectively collected data on all patients who underwent carotid revascularization from 2013 to 2021. Patients with immediate preoperative and first postoperative Duplex scan within 4 months of carotid revascularization at our vascular laboratory were included for analysis. Patients with contralateral occlusion were excluded. Duplex criteria used to define moderate (50-69%) and severe (>70%) stenosis were systolic velocity ≥125 cm/sec and ≥230 cm/sec, respectively. RESULTS:Between 2013 and 2021, 129 patients with bilateral carotid stenosis underwent either carotid endarterectomy (98) or a stenting procedure (31). The majority of patients (90%) underwent intervention for severe stenosis. Preoperatively, the contralateral artery was categorized as severe in 30.4% patients. After ipsilateral carotid revascularization, 86 patients (67.2%) saw a decrease in the contralateral artery peak systolic velocity (PSV), while the remaining remained stable or increased. Fifty-four patients had a change in designated stenosis severity in the contralateral artery. Between the carotid endarterectomy and stenting cohorts, there was no significant difference in the proportion of patients whose contralateral velocity decreased (69.4% vs. 61.3%, P = 0.402). Patients with coronary artery disease and diabetes were significantly less likely to experience a decrease in the contralateral artery PSV after ipsilateral intervention (P = 0.018 and P = 0.033). CONCLUSIONS:In patients with bilateral carotid disease, ipsilateral revascularization can change the contralateral artery velocity and perceived disease severity. Most patients were noted to have a decrease in the contralateral artery PSV, although almost one-third either stayed stable or increased. On multivariable analysis, patients with coronary artery disease and diabetes were less likely to see a decrease in the contralateral artery PSV after intervention. Patients who are at risk for artificial elevation of the contralateral artery may warrant a re-evaluation of the contralateral artery after ipsilateral intervention. These patients are potentially better assessed with axial imaging, although further research is needed.
PMID: 37918660
ISSN: 1615-5947
CID: 5620402
Superficial Venous Procedures can be Performed Safely and Effectively in Patients with Deep Venous Reflux
Li, Chong; Jacobowitz, Glenn R; Rockman, Caron B; Maldonado, Thomas S; Berland, Todd L; Garg, Karan; Barfield, Michael; Sadek, Mikel
INTRODUCTION/BACKGROUND:The finding of concurrent deep venous reflux (DVR) when interrogating superficial venous reflux is common and might be a marker for more severe chronic venous insufficiency. However, the safety, clinical and patient reported outcomes in patients undergoing superficial venous treatment in the presence of DVR remains underreported. Moreover, factors associated with persistence and disappearance of DVR after superficial vein treatments have not been evaluated. This study sought to address these questions. METHODS:This study was a review of the institutional vascular quality initiative (VQI) database from June 2016 to June 2021. Consecutive patient-limbs were identified who underwent a superficial venous intervention and had duplex evaluation. These patients were then divided into those with and without DVR. Those with DVR were further reviewed for anatomical details and persistence or resolution of DVR following the procedure. The primary outcome was the venous clinical severity score (VCSS) at follow-up greater than 3 months. Secondary outcomes included the incidence of any postoperative deep vein thrombosis (DVT) or endovenous heat-induced thrombosis (EHIT), differences in patient-reported outcomes, rate of resolution of DVR, and factors associated with DVR persistence. Both univariate analysis and multivariate logistic regression were applied. RESULTS:In patients who underwent superficial venous treatments 644 patient-limbs had DVR and 7812 did not, for a prevalence of 7.6%. The former group was associated with a higher burden of chronic venous insufficiency. On univariate analysis, patient-limbs, both with and without DVR, improved significantly in VCSS at less than 3 months follow-up, and were not significantly different. At greater than 3 months follow-up, the VCSS score again improved significantly compared to less than 3 months follow-up, but the two groups differed significantly at the longer interval. The magnitude of improvement in VCSS between the two groups at the longer follow-up were statistically similar (3.17±3.11 vs 3.03±2.93, P =0.739). HASTI score similarly improved significantly in both groups, but remained significantly higher in the DVR group on follow-up. On multivariate logistic regression, DVR was not associated with an increased VCSS at greater than 3 months follow-up. There was no intergroup difference in postoperative DVT or EHIT. 40.8% of limbs with DVR no longer had evidence of detectable DVR at the latest follow-up venous duplex, and DVR limited to single segment were more likely to be no longer detectable versus multi-segments. CONCLUSIONS:Superficial venous procedures are safe and effective in patients with DVR, leading to improvements in clinical and patient reported outcomes as they would for those without DVR. In a large proportion of the treated limbs, especially in those with DVR in a single segment, there is no longer evidence of DVR following superficial venous intervention. Although patients with DVR have a higher burden of chronic venous insufficiency, they appear to still derive significant benefit from superficial venous treatments.
PMID: 36368475
ISSN: 2213-3348
CID: 5357632