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Impact of Time to Catheter-Based Therapy on Outcomes in Acute Pulmonary Embolism

Zhang, Robert S; Yuriditsky, Eugene; Zhang, Peter; Taslakian, Bedros; Elbaum, Lindsay; Greco, Allison A; Mukherjee, Vikramjit; Postelnicu, Radu; Amoroso, Nancy E; Maldonado, Thomas S; Horowitz, James M; Bangalore, Sripal
BACKGROUND/UNASSIGNED:The aim of this study was to examine the impact of early versus delayed catheter-based therapies (CBTs) on clinical outcomes in patients with acute intermediate-risk pulmonary embolism (PE). METHODS/UNASSIGNED:This retrospective cohort study analyzed data from 2 academic centers involving patients with intermediate-risk PE from January 2020 to January 2024. Patients were divided into early (<12 hours) and delayed CBT (≥12 hours) groups. The primary outcome was a composite of 30-day mortality, resuscitated cardiac arrest, hemodynamic instability, and 90-day readmission. Secondary outcomes included a composite of 30-day mortality, resuscitated cardiac arrest, and hemodynamic instability. Inverse probability of treatment weighting was used to balance covariates. RESULTS/UNASSIGNED:=0.046). When patients were stratified by timing of CBT (early/late) and the composite PE shock score (high ≥3; low <3), all 16 patients who experienced the primary composite outcome had a high composite PE shock score, with 14/16 (87.5%) having a high composite PE shock score and delayed intervention. CONCLUSIONS/UNASSIGNED:Early CBT was associated with improved clinical outcomes in patients with acute intermediate-risk PE. The composite PE shock score may help identify patients who will benefit from early CBT. Further prospective studies are needed to validate these findings.
PMID: 39836740
ISSN: 1941-7632
CID: 5778492

Comparing Real-World Outcomes of Catheter-Directed Thrombolysis and Catheter-Based Thrombectomy in Acute Pulmonary Embolism: A Post PEERLESS Analysis

Zhang, Robert S; Zhang, Peter; Yuriditsky, Eugene; Taslakian, Bedros; Rhee, Aaron J; Greco, Allison A; Elbaum, Lindsay; Mukherjee, Vikramjit; Postelnicu, Radu; Amoroso, Nancy E; Maldonado, Thomas S; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
BACKGROUND:The recently published PEERLESS trial compared catheter-directed thrombolysis (CDT) and catheter-based thrombectomy (CBT) in acute pulmonary embolism (PE). However, it included a low proportion of patients with contraindications to thrombolytic therapy (4.4%), leaving uncertainty about how CDT would perform relative to CBT in a real-world cohort with higher bleeding risk. AIMS/OBJECTIVE:This study aims to address this gap by comparing real-world outcomes of CDT and CBT in patients with acute PE. METHODS:This retrospective analysis included patients who underwent CDT and CBT at two tertiary care centers from January 2020 to January 2024. The primary outcome was a composite of 30-day mortality, resuscitated cardiac arrest, or hemodynamic decompensation. Secondary outcomes included major bleeding and intracranial hemorrhage (ICH). Inverse probability treatment weighting (IPTW) was used to adjust for baseline variables. RESULTS:A total of 162 (mean age 58 years, 45.7% women, 17.3% high-risk, 28% contraindication to lytics, 28% CDT, 72% CBT) patients were included, with 12.4% patients experiencing the primary outcome. There was no difference in the rates of the primary outcome between CBT versus CDT (11.2% vs. 15.2%, IPTW HR: 0.80; 95% CI: 0.27-2.38, p = 0.69). CBT was associated with a lower risk of hemodynamic decompensation (5% vs. 21.7%, p = 0.036), major bleeding (7.8% vs. 17.4%, IPTW HR 0.26; 95% CI: 0.07-0.95, p = 0.042) and ICH (0 vs. 4.3%, p = 0.024) compared to CDT. CONCLUSION/CONCLUSIONS:Among a real-world cohort of patients with acute PE with higher bleeding risk than PEERLESS undergoing catheter-based therapies, CBT was associated with a lower rate of hemodynamic deterioration, major bleeding, and ICH with similar rate of primary composite outcome when compared with CDT. Additional randomized controlled trials are needed to validate these findings.
PMID: 39726241
ISSN: 1522-726x
CID: 5767842

Impaired Pre-operative Ambulatory Capacity in Patients Undergoing Elective Endovascular Infrarenal Abdominal Aortic Aneurysm Repair is Associated with Increased Peri-operative Death

Chang, Heepeel; Veith, Frank J; Cho, Jae S; Lui, Aiden; Laskowski, Igor A; Mateo, Romeo B; Ventarola, Daniel J; Babu, Sateesh; Maldonado, Thomas S; Garg, Karan
OBJECTIVE:While ambulatory capacity is a readily assessable clinical indicator of functional status, its association with outcomes after endovascular aneurysm repair (EVAR) remains underexplored. This study aimed to investigate the association between pre-operative ambulatory status and outcomes following elective EVAR. METHODS:A retrospective review of the multi-institutional Vascular Quality Initiative database was conducted for all patients who underwent elective infrarenal EVAR from 2009 - 2022. Patients were categorised into independent ambulation and impaired ambulation groups. A propensity score matched analysis was performed to produce two well matched cohorts in a 1:1 ratio without replacement. The primary outcome was 30 day death. Secondary outcomes included one year survival and in hospital major complications. RESULTS:Among 11 474 patients, 10 539 (91.8%) were independently ambulatory pre-operatively. Propensity score matching resulted in 885 matched pairs. The impaired ambulation group, although older (mean 77.6 vs. 76.3 years; p = .001), showed comparable baseline characteristics. Post-operatively, the impaired ambulation group had higher cumulative in hospital complications and death as well as 30 day death. Even after adjustment for age, impaired pre-operative ambulation was associated with increased in hospital and 30 day death (hazard ratio [HR] 2.27, 95% confidence interval [CI] 1.26 - 3.95; p = .006). Multivariable analysis demonstrated increasing cumulative risk of 30 day death in the setting of impaired pre-operative ambulatory status with age > 75 years requiring post-operative red blood cell transfusion > 2 units (HR 5.75, 95% CI 2.09 - 15.88; p < .001). Beyond 30 days, impaired pre-operative ambulation was not associated with increased one year death (HR 1.09, 95% CI 0.81 - 1.48; p = .570). CONCLUSION/CONCLUSIONS:Among patients who underwent elective infrarenal EVAR in this matched analysis, impaired pre-operative ambulatory capacity was associated with an increased risk of in hospital and 30 day death, further compounded by advanced age and post-operative transfusion. As such, a threshold higher than the traditional size criteria should be considered in shared decision making when determining options for the management of abdominal aortic aneurysm in this high risk cohort.
PMID: 39341419
ISSN: 1532-2165
CID: 5766522

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

Timing of Intervention in Symptomatic Carotid Artery Stenosis

Ding, Jessica; Maldonado, Thomas S
Symptomatic carotid artery stenosis is defined as an acute neurologic deficit (transient ischemic attack or stroke) occurring in the last 6 months, that is, ipsilateral to an extracranial carotid artery with at least 50% stenosis. Previous studies have identified the benefit of surgical intervention on symptomatic carotid stenosis, but the ideal timing is less clear. The timing of intervention must balance the risk of perioperative stroke and death (higher during the hyperacute period within 48 hr) and the risk of recurrent stroke while waiting to intervene, particularly if delayed beyond 14 days. Several factors such as acuity of neurologic deficit, degree of stenosis, or contralateral occlusion, and other comorbidities, may contribute to the risk of perioperative stroke or death when intervening within the acute period. The Society for Vascular Surgery recommends carotid endarterectomy as the intervention for symptomatic carotid artery stenosis, but recent studies have shown that transcarotid revascularization may also have similar outcomes.
PMID: 39349240
ISSN: 1615-5947
CID: 5766562

Presence of Atherosclerosis in Multiple Arterial Beds is Associated with Increased Mortality in Patients Undergoing Endovascular Aortic Aneurysm Repair

Ratner, Molly; Chang, Heepeel; Rockman, Caron B; Pearce, Benjamin J; Siracuse, Jeffrey J; Cho, Jae S; Cayne, Neal; Maldonado, Thomas; Patel, Virendra; Garg, Karan
OBJECTIVE:Patients with polyvascular disease are considered high risk for major adverse cardiac events (MACEs). This retrospective study utilised the Vascular Quality Initiative (VQI) database to quantify the effect of polyvascular disease on outcomes after endovascular aneurysm repair (EVAR). METHODS:The VQI database was queried from to 2012 - 2022 for elective EVAR. Patients were identified as having peripheral arterial disease, coronary artery disease, or cerebrovascular disease, and then stratified based on the number of arterial beds involved (one to three). Primary outcomes were peri-operative death and MACEs. Multivariate analysis was performed to find associations between comorbidities and primary outcomes. RESULTS:Of the 21 160 patients with arterial disease included in the study, 83.7% were male and the mean age was 73.73 ± 8.57 years. After stratification, 16 892 patients had atherosclerosis in one arterial bed, 3 869 in two arterial beds, and 399 in three arterial beds. Pre-operatively, patients with atherosclerosis in three arterial beds were more likely to have hypertension, diabetes, and renal failure (all p < .001). Post-operatively, patients with disease in three arterial beds were more likely to experience a post-operative complication (11.5% vs. 8.3% vs. 5.4%; p < .001), including MACE (4.6% vs. 4.1% vs. 2.8%; p < .001) and death (3.0% vs. 2.5% vs. 1.7%; p < .010). On multivariate analysis, polyvascular disease was associated with MACEs (odds ratio 1.54, 95% confidence interval 1.29 - 1.84; p < .001). Kaplan-Meier analysis estimates showed statistically significant differences in survival at approximately the three year follow up (p < .001). CONCLUSION/CONCLUSIONS:In this review of patients undergoing elective EVAR, patients with polyvascular disease experienced worse peri-operative outcomes, including death and MACEs, the latter of which was confirmed on multivariable analysis. These patients should be considered high risk and managed accordingly.
PMID: 39395529
ISSN: 1532-2165
CID: 5730262

A novel non-pneumatic compression device results in reduced foot and ankle swelling in patients with venous and lymphatic edema

Rao, Abhishek; Berland, Todd; Mullick, Amir; Maldonado, Thomas S; Blumberg, Sheila N
OBJECTIVES/OBJECTIVE:Non-pneumatic compression devices (NPCDs) rely on shape-memory alloy technology that allows patients to ambulate and remain active during lymphedema treatment. This study examines the effect of the NPCD on foot and ankle swelling. METHODS:This was a prospective, non-randomized study of patients with phlebolymphedema (venous insufficiency-related lymphedema) treated with a novel NPCD for 4 weeks. Ankle and foot circumference (cm), and volume measurements (ml water displacement using immersion) of the foot and ankle were obtained at enrollment, 2-weeks, and 4-weeks, and ambulation was tracked with a wearable exercise monitoring device. RESULTS:= .032)) was observed. Patients reported a mean of 8100 steps per day (±6100). CONCLUSIONS:NPCD results in significant reduction in edema in the foot and ankle despite garments lacking a foot piece. Patients remained mobile while adhering to therapy.
PMID: 39631049
ISSN: 1708-539x
CID: 5804472

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

One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia

Maldonado, Thomas S; Powell, Alex; Wendorff, Heiko; Rowse, Jarrad; Nagarsheth, Khanjan H; Dexter, David J; Dietzek, Alan M; Muck, Patrick E; Arko, Frank R; Chung, Jayer; ,
OBJECTIVE:Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE. METHODS:STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days. RESULTS:Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days. CONCLUSIONS:These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.
PMID: 38914349
ISSN: 1097-6809
CID: 5719152

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