Early complications of biologic extracellular matrix patch after use for femoral artery repair.

BACKGROUND: The CorMatrix (CorMatrix Cardiovascular, Roswell, Ga) biologic extracellular patch derived from porcine small intestinal mucosa provides a biologic scaffold for cellular ingrowth and eventual tissue regeneration. It has been used in a variety of applications, including cardiac and vascular repair procedures. METHODS: CorMatrix was used as a patch arterioplasty for femoral artery repair in conjunction with endarterectomy for seven separate procedures in six patients (one patient underwent staged, bilateral femoral procedures). RESULTS: Patients were a median age of 67 years (interquartile range, 3.6 years). Six of seven procedures (86%) were performed on male patients. There were no operative deaths. Three of seven procedures (43%) resulted in significant early complications. Two procedures (29%) resulted in catastrophic biologic extracellular matrix patch disruption (11 and 19 days after initial procedure), requiring emergency exploration, patch removal, and definitive repair with vein patch arterioplasty. Both patches demonstrated an absence of growth on culture. One procedure (14%) resulted in groin pseudoaneurysm formation. Use of the CorMatrix patch was suspended upon recognition of significant complications. CONCLUSIONS: Use of CorMatrix patch in the femoral artery position demonstrates a high incidence of early postoperative complications, including catastrophic patch disruption and pseudoaneurysm formation.

Risk factors for major bleeding in the SEATTLE II trial.

Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis minimizes the risk of intracranial bleeding compared with systemic full-dose fibrinolytic therapy for pulmonary embolism (PE). However, major bleeding is nevertheless a potential complication. We analyzed the 150-patient SEATTLE II trial of submassive and massive PE patients to describe those who suffered major bleeding events following ultrasound-facilitated, catheter-directed, low-dose fibrinolysis and to identify risk factors for bleeding. Major bleeding was defined as GUSTO severe/life-threatening or moderate bleeds within 72 hours of initiation of the procedure. Of the 15 patients with major bleeding, four (26.6%) developed access site-related bleeding. Multiple venous access attempts were more frequent in the major bleeding group (27.6% vs 3.6%; p<0.001). All patients with major bleeding had femoral vein access for device delivery. Patients who developed major bleeding had a longer intensive care stay (6.8 days vs 4.7 days; p=0.004) and longer hospital stay (12.9 days vs 8.4 days; p=0.004). The frequency of inferior vena cava filter placement was 40% in patients with major bleeding compared with 13% in those without major bleeding ( p=0.02). Massive PE (adjusted odds ratio 3.6; 95% confidence interval 1.01-12.9; p=0.049) and multiple venous access attempts (adjusted odds ratio 10.09; 95% confidence interval 1.98-51.46; p=0.005) were independently associated with an increased risk of major bleeding. In conclusion, strategies for improving venous access should be implemented to reduce the risk of major bleeding associated with ultrasound-facilitated, catheter-directed, low-dose fibrinolysis. ClinicalTrials.gov Identifier: NCT01513759; EKOS Corporation 10.13039/100006522.

Median arcuate ligament syndrome: Use of fractional flow reserve in documentation of chronic mesenteric ischemia.

Median arcuate ligament syndrome (MALS) is a rare clinical entity. This condition typically affects women between the ages of 20 and 40 years and causes symptoms of abdominal pain, primarily post-prandial, as well as nausea, vomiting and weight loss. MALS is considered a diagnosis of exclusion. Typically, mesenteric arterial duplex ultrasonography, computed tomography (CT), and magnetic resonance (MR) are highly suggestive, and conventional contrast angiography confirmatory. We explore the role of fractional flow reserve and intravascular ultrasound in the evaluation of MALS. In order to illustrate the utility of these tools, we present the case of a 47-year-old symptomatic woman who underwent angiography, complemented by assessment of fractional flow reserve and intravascular ultrasound. These data convincingly demonstrated the dynamic nature of the obstructive characteristic of MALS.

Use of fractional flow reserve in the assessment of chronic mesenteric ischemia.

Chronic mesenteric ischemia (CMI) is a rare condition that is usually the result of atherosclerotic obstructive disease affecting the mesenteric arteries. The classic triad of post-prandial pain, food aversion and weight loss is not always present, often leading to low clinical suspicion for CMI and underdiagnosis. Non-invasive evaluation for CMI usually starts with mesenteric arterial duplex scanning, followed by computed tomography angiography, magnetic resonance angiography or conventional angiography, the latter being the gold standard for establishing its diagnosis. However, angiography alone has been demonstrated in coronary and other vascular beds to be inaccurate in predicting the physiologic and hemodynamic significance of a certain subset of atherosclerotic stenoses. We present the case of a patient with risk factors and symptoms suggestive of CMI who underwent angiography. However, angiography was equivocal and invasive physiologic testing was required to confirm the diagnosis and guide revascularization.

Disintegration with right ventricular and pulmonary embolization of a SMART stent: a case report and review of literature.

As composition and design have improved the integrity and durability of peripheral stents, vascular stent fracture and embolization have become less frequent complications of endovascular intervention. However, this phenomenon still remains a possibility with potentially catastrophic consequences, either from damage to cardiac structures or from disruption of vessel integrity, infarction, and thrombosis. Advancements in the tools for foreign body retrieval have allowed the skilled interventionalist to intercede without the need for surgical intervention. We report the case of retrieval of a self-expandable SMART (Cordis, Florida) stent that was deployed for relief of superior vena cava syndrome but fractured and embolized to the right ventricle.

Sheath hemorrhage after percutaneous ventricular assist device implantation.

Technical advances in temporary ventricular assist devices (VADs) continue to progress, allowing for percutaneous implantation during times of hemodynamic instability. However, device delivery systems, i.e., sheaths, lag in their ability to sustain the mechanical demands of these VADs for extended periods. We propose both a novel technique and the implementation of an emergency preparedness plan to be enacted specifically during those times when delivery systems fail thereby leading to potentially catastrophic bleeding complications.

Vacuum assisted vegetation extraction for the management of large lead vegetations.

BACKGROUND: Complete device and lead removal is recommended for management of infected implantable cardiac device. Management of large lead vegetation (2 cm) is still in debate. METHODS: We report a series of patients involving percutaneous extraction of large vegetations (>2 cm) from ICD/pacing leads using the AngioVac Cannula in patients with infective endocarditis. This approach was used to debulk the ICD/pacing lead vegetations in order to minimize the risk of septic pulmonary embolism during lead explantation. CONCLUSION: AngioVac Cannula can be used safely and effectively as an adjunctive method for patients with large lead vegetation.

Intermediate Follow-Up of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annuli.

The clinical impact of prosthesis-patient mismatch (PPM) in patients with small aortic annuli who underwent transcatheter aortic valve (AV) implantation with either balloon-expandable (BE) or self-expanding (SE) valves remains controversial. We assessed in-hospital and intermediate clinical outcomes in 573 patients with transfemoral transcatheter AV implantation with a small AV annulus, defined as an AV annulus area ≤430 mm2. A total of 337 patients treated with a 23-mm BE valve (SAPIEN 3, Ultra) were compared with 236 patients treated with a 26-mm SE valve (Evolut series). Valve-in-valve cases were excluded, and late echo follow-up (mean 674 ± 438 days) was assessed in a subset of 292 patients (51.0%). Well-matched BE and SE cohorts did not differ with respect to major in-hospital outcomes, other than a borderline increase in vascular complications and composite bleeding in patients with SE. Patients with BE had a higher incidence of severe PPM on discharge echocardiography (16.9% vs 6.8%, p <0.002). The mean AV gradient at 30 days was higher for patients with BE (12.2 ± 4.2 vs 6.2 ± 7.9 mm Hg, p <0.001) and at late follow-up (14.0 ± 8.2 vs 7.2 ± 3.5 mm Hg, p <0.001). The follow-up left ventricular ejection fraction and incidence of >mild aortic insufficiency were similar. All-cause mortality for the 2 cohorts was similar, with an overall mean (95% confidence interval) survival time of 61.2 months (57.8 to 64.5; p = 0.98). There were no significant survival differences between combined patients with BE and SE with no, moderate, or severe PPM, with an overall mean (95% confidence interval) survival time of 32.5 (30.5 to 34.5) months combining valve types (p = 0.23). In conclusion, despite an increased incidence of PPM with higher mean AV gradients that persist on late echocardiography in the BE cohort, patients with BE and SE with small aortic annuli have similar clinical outcomes at intermediate follow-up. Moderate and severe PPM had no impact on survival at a mean follow-up of 32.5 months.

Recovery From the Impact of COVID-19 on Treatment Times and Clinical Outcomes of Patients With ST-Segment Elevation Myocardial Infarction: An Interim Analysis.

BACKGROUND: Previous studies have documented a negative impact of the COVID-19 pandemic on emergent percutaneous treatment of patients with ST-segment elevation myocardial infarction (STEMI), but few have examined recovery of healthcare systems in restoring prepandemic STEMI care. METHODS: Retrospective analysis was performed of data from 789 patients with STEMI from a large tertiary medical center treated with percutaneous coronary intervention between January 1, 2019, and December 31, 2021. RESULTS: For patients with STEMI presenting to the emergency department, median time from door to balloon was 37 minutes in 2019, 53 minutes in 2020, and 48 minutes in 2021 (P < .001), whereas median time from first medical contact to device changed from 70 to 82 to 75 minutes, respectively (P = .002). Treatment time changes in 2020 and 2021 correlated with median emergency department evaluation time (30 to 41 to 22 minutes, respectively; P = .001) but not median catheterization laboratory revascularization time. For transfer patients, median time from first medical contact to device changed from 110 to 133 to 118 minutes, respectively (P = .005). In 2020 and 2021, patients with STEMI had greater late presentation (P = .028) and late mechanical complications (P = .021), with nonsignificant increases in yearly in-hospital mortality (3.6% to 5.2% to 6.4%; P = .352). CONCLUSION: COVID-19 was associated with worsening STEMI treatment times and outcomes in 2020. Despite improving treatment times in 2021, in-hospital mortality had not decreased in the setting of a persistent increase in late patient presentation and associated STEMI complications.

Distal embolization from Mynx device.

Vascular closure devices are commonly used to obtain arterial access site closure after cardiovascular procedures. They are popular as they decrease time to hemostasis and ambulation while improving patient comfort by eliminating need for compression. However, complications due to vascular closure devices are not uncommon. We report a case of possible intravascular distal embolization of water-soluble PEG polymer that is deployed extravascular using the Mynx vascular closure device.

Ultrasound-assisted catheter-directed thrombolytic therapy for management of acute pulmonary embolism.

Acute pulmonary embolism (PE) is a common and potentially lethal condition. Anticoagulation is considered the mainstay therapy while systemic thrombolytic therapy is reserved only for patients who are hemodynamically unstable. However, therapy for PE with evidence of right ventricular strain is not well-defined. We report a case of PE treated successfully with an ultrasound-assisted catheter-directed thrombolytic therapy.

Transcarotid Versus Transfemoral Transcatheter Aortic Valve Replacement (from a Propensity-Matched Comparison).

Previous reports comparing transcarotid (TC) versus transfemoral (TF) approaches for patients undergoing transcatheter aortic valve replacement have had inconsistent conclusions. We compared in-hospital and 1-year clinical outcomes, changes in quality of life, and direct hospital costs for 138 TC versus 1,926 TF procedures. Propensity matching based on the Society of Thoracic Surgery Predicted Risk of Mortality was used to compare 130 patients who underwent TC with 813 patients who underwent TF. Matched TC versus TF cohorts did not differ with respect to in-hospital mortality (0.0% vs 1.4%, p = 0.380), stroke (2.3% vs 2.5%, p = 0.917), major vascular complications (0.8% vs 2.2%, p = 0.268), composite bleeding complications (4.6% vs 6.4%, p = 0.647), requirement for permanent pacemaker (14.6% vs 12.9%, p = 0.426), postoperative hospital length of stay (3.3 ± 3.4 vs 3.1 ± 3.3 days, p = 0.467), or direct hospital costs ($52,899 ± 9,560 vs $50,464 ± 10,997, p = 0.230). Similarly, at 1-year, patients who underwent TC versus patients who underwent TF did not differ with respect to all-cause mortality (7.6% vs 6.4%, p = 0.659), hospital readmission (20.0% vs 23.9%, p = 0.635), or quality of life as measured by the Kansas City Cardiomyopathy Questionnaire score (84.0 ± 17.1 vs 88.4 ± 13.9, p = 0.062). Patients who underwent TC and TF did not differ with respect to in-hospital complications, length of hospital stay, and direct hospital costs, as well as 1-year mortality, readmission, and quality of life. These data add to ongoing support for the TC approach as the optimal alternative access for patients with transcatheter aortic valve replacement deferred from a transfemoral approach.

Post-MI Ventricular Septal Defect During the COVID-19 Pandemic.

With the COVID-19 pandemic, the fear among patients of contracting it has made them reluctant to seek medical attention on a timely basis even for emergent conditions. We present a case of post infarction ventricular septal rupture due to delayed presentation as a consequence of the fear of COVID-19. (Level of Difficulty: Intermediate.).

Coronary Bypass Graft Pseudoaneurysm Successfully Treated by PTFE-Covered Jostent GraftMaster.

A 60-year-old male presented 12 months after CABG surgery with a large pulsatile sternal mass. CT scan of the chest demonstrated a pseudoaneurysm originating from the mid saphenous vein graft to the PDA measuring 7.7 x 7.2 x 6.0 cm. After a multidisciplinary consultation, a decision was made to place a Jostent GraftMaster to completely seal the communication of the extravasation.

A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study.

OBJECTIVES: This study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington). BACKGROUND: Systemic fibrinolysis for acute pulmonary embolism (PE) reduces cardiovascular collapse but causes hemorrhagic stroke at a rate exceeding 2%. METHODS: Eligible patients had a proximal PE and a right ventricular (RV)-to-left ventricular (LV) diameter ratio ≥0.9 on chest computed tomography (CT). We included 150 patients with acute massive (n = 31) or submassive (n = 119) PE. We used 24 mg of tissue-plasminogen activator (t-PA) administered either as 1 mg/h for 24 h with a unilateral catheter or 1 mg/h/catheter for 12 h with bilateral catheters. The primary safety outcome was major bleeding within 72 h of procedure initiation. The primary efficacy outcome was the change in the chest CT-measured RV/LV diameter ratio within 48 h of procedure initiation. RESULTS: Mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, -0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)-defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage. CONCLUSIONS: Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759).

Effectiveness of primary percutaneous coronary intervention compared with that of thrombolytic therapy in elderly patients with acute myocardial infarction.

BACKGROUND: Few data exist from a community-based perspective on the relative effectiveness of primary percutaneous coronary intervention (PCI) as compared with thrombolytic therapy (TT) in elderly patients with ST-elevation myocardial infarction (STEMI), particularly in the current era of coronary stents and newer antithrombotic agents. METHODS: We evaluated data from patients, aged > or =70 years, with STEMI who were enrolled in the Global Registry of Acute Coronary Events study between April 1999, and September 2002. RESULTS: Of the 2975 elderly patients eligible for reperfusion therapy, 365 (12.7%) underwent primary PCI and 769 (26.7%) received TT. The median delay from hospital arrival to therapy was 105 minutes for primary PCI and 40 minutes for TT. Inhospital complications for primary PCI versus TT included mortality (13.5% vs 14.8%), reinfarction (1.1% vs 5.7%), composite of death or reinfarction (14.3% vs 18.7%), cardiogenic shock (11.3% vs 11.6%), major bleeding (8.6% vs 5.9%), and stroke (1.1% vs 2.8%). After adjustment for baseline differences and propensity score, patients receiving primary PCI showed a lower rate of reinfarction (odds ratio [OR], 0.15; 95% CI, 0.05-0.44) and mortality (OR, 0.62; 95% CI, 0.39-0.96) and the composite of reinfarction or death (OR, 0.53; 95% CI, 0.35-0.79), with no difference in other outcome measures. CONCLUSION: Our data suggest that, compared with TT, primary PCI is associated with a decrease in reinfarction and mortality, with no change in other outcome measures, in elderly patients with STEMI. These findings from an observational registry require further confirmation in future randomized clinical trial assessing the optimal reperfusion strategy in the elderly cohort with STEMI.

Patterns of use of heparins in ACS. Correlates and hospital outcomes: the Global Registry of Acute Coronary Events (GRACE).

A systematic study that compares the patterns of use of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in patients with acute coronary syndromes (ACS) has, to date, not been carried out in the "real-world" setting. The aim of this report is to identify patterns of use of UFH and LMWH and to report their correlates and outcomes in a broad spectrum of ACS patients enrolled in the observational Global Registry of Acute Coronary Events (GRACE). The use of LMWH and UFH was analysed in 13,231 ACS patients according to patient history, concomitant treatment and invasive procedures in US and non-US sites. Frequency of use in hospitals with and without facilities for percutaneous coronary interventions (PCI) was investigated, and outcomes were analysed. Results show that younger patients (<60 years), those receiving antiplatelet therapies, thrombolytics, beta-blockers, angiotensin-converting enzyme inhibitors, patients admitted to hospitals with PCI facilities, and patients undergoing invasive procedures were more likely to receive UFH, or both UFH and LMWH than LMWH alone (80.1% enoxaparin, 19.9% other LMWH). LMWH was used less often in US than non-US sites. After adjusting for confounding variables, patients receiving LMWH had significantly lower rates of hospital mortality (P = 0.009) and major bleeding (P < 0.0001). Similar results were observed in patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction or unstable angina. We can conclude that UFH tends to be used more frequently than LMWH, but hospital outcomes appeared to be better with LMWH after adjusting for covariables.

Extent of, and factors associated with, delay to hospital presentation in patients with acute coronary disease (the GRACE registry).

Our primary study aim was to examine extent of, and factors associated with, delay in seeking medical care in a large multinational registry of patients with acute myocardial infarction (AMI) and unstable angina pectoris. A secondary goal was to examine the relation between duration of prehospital delay and receipt and timing of coronary reperfusion strategies. Investigators from 14 countries are participating in the Global Registry of Acute Coronary Events (GRACE) project. The study sample consisted of 3,693 patients with ST-segment elevation AMI, 2,935 with non-ST-segment elevation AMI, and 3,954 patients with unstable angina hospitalized between 1999 and 2001. The average and median delay times were longest in patients with non-ST-segment elevation AMI (6.1 and 3.0 hours, respectively) followed by patients with unstable angina (5.6 and 3.0 hours) and those with ST-segment elevation AMI (4.7 and 2.3 hours). Approximately 41% of patients with ST-segment elevation AMI presented to the 94 study hospitals within 2 hours of the onset of acute coronary symptoms; this compared with approximately one third of patients with non-ST-segment elevation AMI and unstable angina. Several demographic and clinical characteristics were associated with prehospital delay. In patients with ST-segment elevation AMI, duration of prehospital delay was inversely related to the receipt of thrombolytic therapy, but was inconsistently related to the use of percutaneous coronary interventions. The results of this study demonstrate that a large proportion of patients continue to exhibit prolonged delay in seeking medical care after the onset of acute coronary symptoms and remain in need of targeted educational efforts to reduce extent of delay.