Background: The shorter time to hemostasis in patients who undergo transradial cardiac catheterization may reduce the complications, cause less pain, facilitate early discharge, and improve patient satisfaction. Objective: This trial aimed to evaluate if SoftSeal‐STF (Chitogen Inc., Plymouth, MN) with manual compression alone or in combination with a radial compression device (RCD) would reduce time to hemostasis compared to patients with RCD only (Vasc Band). Methods: We enrolled 300 patients in four arms, including SoftSeal‐STF with manual compression, Vasc Band (standard of care), SoftSeal‐STF with TR Band, and SoftSeal‐STF with EasyClik. This study was analyzed as an observational study due to modification in the design of a randomized trial. The primary outcome was time to hemostasis; the secondary outcomes were complications before discharge, a 3 day follow‐up, and a follow‐up office visit (30–45 days postprocedure). Results: The median time to hemostasis (interquartile range [IQR]) was significantly lower in the SoftSeal‐STF + TR Band group and the SoftSeal‐STF + EasyClik group than in the Vasc Band group (45 [40–69] minutes vs. 120 [120–124] minutes, p < 0.0001; 44 [40–58.5] minutes vs. 120 [120–124] minutes, p < 0.0001, respectively). The median time to hemostasis (IQR) was not different between SoftSeal‐STF + TR Band and SoftSeal‐STF + EasyClik (45 [40–69] minutes vs. 44 [40–58.5] minutes, p = 0.3). The median time to hemostasis (IQR) was lowest in the SoftSeal‐STF + manual compression group (19 [15–30] minutes), but these patients had more postoperative pain and bruising along with logistic issues within the catheterization lab. Conclusion: The SoftSeal‐STF + RCD is a safe and time‐efficient strategy in patients who undergo transradial cardiac catheterization. (Radial Artery Vascular Complication and Resource Utilization [RAVE]). Trial Registration: ClinicalTrials.gov identifier: NCT03522077
BACKGROUND:Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. AIMS:We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). METHODS:In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. RESULTS:TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. CONCLUSION:PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.
BACKGROUND:Atherectomy use in treatment of femoropopliteal disease has significantly increased despite scant evidence of benefit to long-term clinical outcomes.AIMS:We investigated the clinical benefits of atherectomy over standard treatment for femoropopliteal interventions.METHODS:Using data from the Society of Vascular Surgery's Vascular Quality Initiative (VQI) registry, we identified patients who underwent isolated femoropopliteal interventions for occlusive disease. We compared 13,423 patients treated with atherectomy with 47,371 receiving standard treatment; both groups were allowed definitive treatment with a drug-coated balloon or stenting. The primary endpoint was major adverse limb events (MALEs), which is a composite of target vessel re-occlusion, ipsilateral major amputation, and target vessel revascularization.RESULTS:Mean age was 69 ± 11 years, and patients were followed for a median of 30 months. Overall rates of complications were slightly higher in the atherectomy group than the standard treatment group (6.2% vs. 5.9%, p < 0.0001). In multivariable analysis, after adjusting for demographic and clinical covariates, atherectomy use was associated with a 13% reduction in risk of MALEs (adjusted odds ratio [aOR]: 0.87; 95% confidence interval [CI]: 0.77-0.98). Rates of major and minor amputations were significantly lower in the atherectomy group (3.2% vs. 4.6% and 3.3% vs. 4.3%, respectively, both p < 0.001), primarily driven by a significantly decreased risk of major amputations (aOR 0.69; 95% CI: 0.52-0.91). There were no differences in 30-day mortality, primary patency, and target vessel revascularization between the atherectomy and standard treatment groups.CONCLUSIONS:In adults undergoing femoropopliteal interventions, the use of atherectomy was associated with a reduction in MALEs compared with standard treatment.
Purpose: To evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD).Materials and Methods: Patients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4-6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months.Results: The median follow-up period was 507 days, the mean patient age was 69 years +/- 11.7, and the mean occluded length was 6.9 cm +/- 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68-1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups.Conclusions: In a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no sig-nificant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.
Purpose: Dual antiplatelet therapy is standard for patients undergoing percutaneous coronary intervention (PCI) with stents. Traditionally, patients swallow the loading dose of a P2Y12 inhibitor before or during PCI. Time to achieve adequate platelet inhibition after swallowing the loading dose varies significantly. Chewed tablets may allow more rapid inhibition of platelet aggregation. However, data for this strategy in patients with stable ischemic heart disease or non-ST-elevation acute coronary syndrome (NSTE-ACS) are less robust. Methods: In this single-center prospective trial, 112 P2Y12-naïve patients with stable ischemic heart disease or NSTE-ACS on aspirin therapy and who received ticagrelor after coronary angiography but before PCI were randomized to chewing (n = 55) or swallowing (n = 57) the ticagrelor loading dose (180 mg). Baseline variables were compared using 2-sample t-test and chi-squared/Fisher’s exact tests as appropriate, with alpha set at 0.05. P2Y12 reaction units (PRU) were compared at baseline, 1 hour, and 4 hours using Wilcoxon rank-sum test. Patients then received standard ticagrelor dosing. Results: After exclusions, P2Y12 PRU in the chewed and swallowed groups at baseline, 1 hour, and 4 hours after ticagrelor loading dose were 243 vs 256 (P = 0.75), 143 vs 210 (P = 0.09), and 28 vs 25 (P = 0.89), respectively. No differences were found in major adverse cardiac events (MACE) or major bleeding at 30 days and 1 year. Conclusions: In patients with stable ischemic heart disease or NSTE-ACS, chewing rather than swallowing ticagrelor may lead to slightly faster inhibition of platelet aggregation at 1 hour with no increase in MACE or major bleeding.
Massive bupropion overdose has a known association with cardiogenic shock. We describe a clinical case of a 48-year-old female who was brought to the hospital by emergency medical services after ingesting numerous psychiatric medications. Her hospital course was complicated by worsening cardiogenic shock and ventricular tachycardia storm. Transthoracic echocardiography showed left ventricular (LV) hypokinesis with an ejection fraction of 9%. Then the patient underwent placement of a percutaneous Impella CP device (Abiomed, Danvers, MA). The Molecular Adsorbent Recirculating System was started for protein-bound bupropion clearance. After 24 hours, the patient returned to an organized sinus rhythm. A repeat echocardiogram done on the next day demonstrated improved LV function, and the patient had profound clinical improvement. The case illustrates how the use of extracorporeal membrane oxygenation in combination with Impella device and Molecular Adsorbent Recirculating System was able to support the patient's recovery.
Case: A 46-year-old female with PMHx of ESRD on dialysis and prothrombin gene mutation presented with acute onset of left breast swelling, redness and pain for nearly 24 hours. She was found to have SVC occlusion and underwent successful SVC recanalization and stent placement with an uncovered 14x40 mm nitinol stent. She presented 4 days later with complaints of chest pain and shortness of breath. Initial vitals were notable for tachypnea with oxygen saturations of nearly 70%, and a blood pressure of 114/71 mmHg. Physical exam demonstrated an obese female in distress. Shortly after arrival in the emergency department, she developed a non-sustained episode of ventricular tachycardia (NSVT). Amiodarone and lidocaine were started, however, she continued to have runs of NSVT. Initial CXR found no acute process but failed to demonstrate the previously placed SVC stent. ECG demonstrated normal sinus rhythm with frequent PVCs and runs of NSVT. A limited echo demonstrated a free edge of an endovascular stent within the right ventricle. TEE demonstrated the stent appeared to be tethered to the septal leaflet of the tricuspid valve with the leading edge free within the right ventricle. Endovascular retrieval was proposed but given the degree of entanglement within the tricuspid leaflets, large stent size, and recurrent NSVT, was deemed an unsuitable therapeutic strategy. Urgent open-heart surgery was performed for removal. The patient tolerated the procedure well and had no further recurrence of NSVT. Discussion: Stent migration is a rare but feared complication of venous stent deployment, with only 32 reported cases over the past 30 years. While NSVT is often attributed to the RVOT, the etiology being the result of migrated stents has been rarely reported. This is the first case to our knowledge of SVC stent migration leading to runs of NSVT. Conclusion: Clinicians must remain cognizant of the risk for venous stent migration and unusual clinical presentations resulting from migration.
Objective Small, older studies have suggested that the use of atherectomy devices has become common in peripheral vascular interventions (PVIs) despite the paucity of strong clinical guidelines. We analyzed the 10-year trends in the use of atherectomy for PVIs across the United States and identified the main predictors of atherectomy use. Methods Using the Vascular Quality Initiative registry, we identified all patients who had undergone endovascular PVIs for occlusive lower extremity arterial disease from 2010 to 2019. Procedures in which an atherectomy device had been used as the primary or secondary device were classified as the atherectomy group. We calculated the frequency of atherectomy use over time and across geographic regions. Using regression modeling, we identified the factors that were independently associated with atherectomy use. Results A total of 205,377 PVIs had been performed for 152,693 unique patients. During the 10-year period, 16.6% of the PVI procedures had used atherectomy, increasing from 8.5% in 2010 to 19.7% in 2019 (Ptrend < .0001). Across 17 geographic regions, we found a significant difference in the prevalence of atherectomy use, ranging from 8.2% to 29%. The strongest predictor of atherectomy use was performance of PVI in an office setting (odds ratio [OR], 10.08; 95% confidence interval [CI], 9.17-11.09) or ambulatory center (OR, 4.0; 95% CI, 3.65-4.39) vs a hospital setting. The presence of severe (OR, 2.6; 95% CI, 2.4-2.85) or moderate (OR, 1.5; 95% CI, 1.4-1.69) lesion calcification was also predictive of atherectomy use. Other predictive factors included elective status, insurance provider, lesion length, prior PVI, claudication symptoms, and diabetes mellitus. Conclusions Atherectomy use in PVI significantly increased from 2010 to 2019. We found wide regional variability in the use of atherectomy that seemed to be driven more strongly by nonclinical factors.