Percutaneous thrombectomy and right ventricular mechanical circulatory support for pulmonary embolism in a coronavirus disease 2019 patient: case report, 1-year update, and echocardiographic findings.

BACKGROUND: We previously described percutaneous thrombectomy and right ventricular (RV) mechanical support of a coronavirus disease 2019 (COVID-19) patient with a massive pulmonary embolism. Here, we present a detailed echocardiographic and clinical timeline with 1-year follow-up. CASE SUMMARY: A 57-year-old female with COVID-19 went into shock from a massive pulmonary embolism. After percutaneous removal of a large thrombus burden (AngioVac system; AngioDynamics Inc., Latham, NY, USA), she became severely hypotensive, requiring cardiopulmonary resuscitation, and hemodynamic support with an Impella RP device (Abiomed, Danvers, MA, USA). A paediatric transoesophageal echocardiography (TOE) probe monitored the procedure because an adult probe would not pass (S7-3t-Philips Medical Systems, Andover, MA, USA). Post-thrombectomy, surface imaging documented gradual resolution of RV dysfunction, tricuspid regurgitation, and elevated pulmonary artery pressure. Her course was complicated by renal failure requiring temporary dialysis. She was discharged home on apixaban. Hypercoagulability work-up was negative. Two months later, vocal cord surgery was performed for persistent stridor. Esophagoscopy at that time was prevented by osteophyte obstruction. At 10 months, she received the Pfizer-BioNTech vaccine. At 1 year, the patient remains healthy on apixaban, and her echocardiogram is normal. DISCUSSION: This case illustrates the pivotal role of echocardiography in the diagnosis, percutaneous treatment, and near- and long-term follow-up and management of a patient with massive pulmonary embolism due to COVID-19 with documentation of complete recovery from severe RV dysfunction and haemodynamic collapse. A paediatric TOE probe was a crucial alternative to the adult probe because of possible osteophyte obstruction.

Percutaneous transaxillary access for endovascular aortic procedures in the multicenter international PAXA registry.

BACKGROUND: The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. METHODS: A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique. RESULTS: Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively. CONCLUSIONS: Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.

Therapeutic Options for Left Main, Left Main Equivalent, and Three-Vessel Disease.

Patients with left main, left main equivalent, and three-vessel coronary artery disease (CAD) represent an overlapping spectrum of patients with advanced CAD that is associated with an adverse prognosis. Guideline-directed medical therapy is a necessary but often insufficient treatment option, as such patients frequently need mechanical revascularization by either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). In patients with advanced CAD presenting with acute myocardial infarction, PCI, of course, is the preferred treatment option. For stable patients with advanced CAD, CABG surgery remains the standard of care. However, observations from the SYNergy between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery (SYNTAX) trial suggest that PCI may be a useful alternative in patients with three-vessel disease with a low SYNTAX score as well as in patients with left main disease and a low or intermediate SYNTAX score. In the subset of patients with diabetes mellitus, the Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease trial unequivocally demonstrated the superiority of CABG surgery in improving outcomes. The findings of the recently published Everolimus-Eluting Stent System versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization and Nordic-Baltic-British Left Main Revascularization study trials point to a favorable role for PCI in certain low-to-moderate risk patients with left main stem disease.

Clinical features and outcomes in patients with cardiogenic shock complicating acute myocardial infarction: early vs recent experience with impella.

OBJECTIVES: To compare clinical features and outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) treated in the early experience with Impella percutaneous ventricular assist device and patients treated recently. BACKGROUND: Since pre-market approval (PMA) of Impella device as treatment for AMICS, use of the device has grown considerably. METHODS: We retrospectively analyzed 649 AMICS patients treated with perioperative Impella, with 291 patients treated from 2008 to 2014 comprising the early experience cohort and 358 patients treated from 2017 to 2019 comprising the recent experience cohort. The primary end point was risk adjusted in-hospital mortality. RESULTS: Mean age and gender distribution of patients was similar in the two cohorts. The recent cohort had more invasive hemodynamic monitoring (64% vs 46%; P < .001) and less use of an intra-aortic balloon pump prior to Impella (15% vs 41%; P < .001). Recently treated patients were significantly more likely to receive Impella support prior to PCI (58% vs 44%; P = .005). In-hospital mortality was lower in the recent cohort (48% vs 56%; P = .043). This difference was however no longer significant after risk adjustment (adjusted OR 0.89, 95% CI 0.59-1.34, P = .59). Rates of acute kidney injury, major bleeding, and vascular complications requiring surgery were also significantly lower in the recent cohort. CONCLUSIONS: Use of Impella for AMICS during recent years is associated with lower unadjusted in-hospital mortality, which may reflect better patient selection, earlier device implantation, and improved management algorithms. In-depth understanding of these factors may inform the development of future treatment protocols.

Successful Treatment of Left Ventricular Perforation Occurring After Insertion of an Impella Device.

The Impella device is a miniaturized ventricular assist device that is being increasingly used to increase the safety and efficacy of high-risk coronary interventions and to treat patients with acute myocardial infarction complicated by cardiogenic shock. The device has a miniaturized rotary pump mounted on a 9F catheter with a pigtail conformation. The pump draws blood from the left ventricular cavity and expels it into the ascending aorta and systemic circulation. We report a patient who, following insertion of an Impella device, developed angiographically documented left ventricular perforation with marked hemodynamic instability. Our successful management of this patient is described and potential mechanisms responsible for the perforation are discussed.

Outcomes of nonemergent percutaneous coronary intervention requiring mechanical circulatory support in patients without cardiogenic shock.

BACKGROUND: The utilization of mechanical circulatory support (MCS) for percutaneous coronary intervention (PCI) using percutaneous ventricular assist device (PVAD) or intra-aortic balloon pump (IABP) has been increasing. We sought to evaluate the outcome of coronary intervention using PVAD compared with IABP in noncardiogenic shock and nonacute myocardial infarction patients. METHOD: Using the National Inpatient Sampling (NIS) database from 2005 to 2014, we identified patients who underwent PCI using ICD 9 codes. Patients with cardiogenic shock, acute coronary syndrome, or acute myocardial infarction were excluded. Patient was stratified based on the MCS used, either to PVAD or IABP. Univariate and multivariate logistic regression were performed to study PCI outcome using PVAD compared with IABP. RESULTS: Out of 21,848 patients who underwent PCI requiring MCS, 17,270 (79.0%) patients received IABP and 4,578 (21%) patients received PVAD. PVAD patients were older (69 vs. 67, p < .001), were less likely to be women (23.3% vs. 33.3%, p < .001), and had higher rates of hypertension, diabetes, hyperlipidemia prior PCI, prior coronary artery bypass graft surgery, anemia, chronic lung disease, liver disease, renal failure, and peripheral vascular disease compared with IABP group (p ≤ .007). Using Multivariate logistic regression, PVAD patients had lower in-hospital mortality (6.1% vs. 8.8%, adjusted odds ratio [aOR] 0.62; 95% CI 0.51, 0.77, p < .001), vascular complications (4.3% vs. 7.5%, aOR 0.78; 95% CI 0.62, 0.99, p = .046), cardiac complications (5.6% vs. 14.5%, aOR 0.29; 95% CI 0.24, 0.36, p < .001), and respiratory complications (3.8% vs. 9.8%, aOR 0.37; 95% CI 0.28, 0.48, p < .001) compared with patients who received IABP. CONCLUSION: Despite higher comorbidities, nonemergent PCI procedures using PVAD were associated with lower mortality compared with IABP.

Treatment of a Child With Submassive Pulmonary Embolism Associated With Hereditary Spherocytosis Using Ultrasound-Assisted Catheter-Directed Thrombolysis.

Background: The clinical presentation of hereditary spherocytosis varies from no symptoms to severe hemolytic anemia requiring splenectomy. Splenectomy imposes the risk of hypercoagulability and acute pulmonary embolism. Catheter-directed thrombolysis is an established treatment for submassive pulmonary embolism in adults. However, the literature regarding its use in children is limited. Case Report: We present the case of a 12-year-old male with hereditary spherocytosis who was diagnosed with pulmonary embolism and successfully treated with catheter-directed thrombolysis. The patient was initially treated with 10.5 mg of recombinant tissue plasminogen activator (r-tPA) delivered over 8 hours. However, because of minimal clinical and hemodynamic improvement, a second course of thrombolytic was administered for an additional 24 hours (25 mg of r-tPA), and the treatment resulted in marked clinical and hemodynamic improvement. Clot resolution was confirmed via angiography. The patient was discharged on enoxaparin and with regular follow-up. One year later, the patient was asymptomatic on enoxaparin. Conclusion: This case demonstrates that catheter-based treatment of submassive pulmonary embolism restores hemodynamic stability and thus is an alternative to surgery or systemic thrombolysis, even in the pediatric setting. While catheter-directed thrombolysis is a safe and effective alternative to systemic thrombolysis, further research is needed to establish appropriate dosing and indications in the adolescent population.

The Impella Device: Historical Background, Clinical Applications and Future Directions.

The Impella device is a catheter-based miniaturized ventricular assist device. Using a retrograde femoral artery access, it is placed in the left ventricle across the aortic valve. The device pumps blood from left ventricle into ascending aorta and helps to maintain a systemic circulation at an upper rate between 2.5 and 5.0 L/min. This results in almost immediate and sustained unloading of the left ventricle, while increasing overall systemic cardiac output. The most common indications for using the Impella device are in the treatment of acute myocardial infarction complicated by cardiogenic shock and to facilitate high risk coronary angioplasty. Other indications include the treatment of cardiomyopathy with acute decompensation, postcardiotomy shock, and off-pump coronary bypass surgery. A growing body of observational and registry data suggest a potentially valuable role for the Impella system in reducing the mortality associated with cardiogenic shock. However, there are, as of yet, no randomized controlled trial data supporting this observation.

Association Between Underweight Body Mass Index and In-Hospital Outcome in Patients Undergoing Endovascular Interventions for Peripheral Artery Disease: A Propensity Score Matching Analysis.

PURPOSE: To investigate in-hospital outcomes after endovascular therapy (EVT) in patients with severe peripheral artery disease (PAD) who had a low body mass index (BMI, kg/m2) compared to those with normal BMI. MATERIALS AND METHODS: Using weighted data from the National Inpatient Sample (NIS) database between 2002 and 2014 and ICD-9 codes, 2614 patients were identified who were aged ≥18 years and underwent EVT for PAD in the lower limb vessels. EVT was defined as angioplasty, atherectomy, and/or stenting. After excluding individuals with BMI >24, there were 807 (31%) normal-weight (BMI 19-24) patients and 1807 (69%) underweight (BMI <19) individuals. All patients in both groups were matched for baseline demographic and clinical characteristics and critical limb ischemia in a 1:1 propensity score matching analysis using the nearest neighbor method. RESULTS: Propensity score matching produced 2 groups of 685 patients that differed only in the incidence of chronic lung disease, which was more frequent in low-BMI patients (p=0.04). Patients with low BMI had a higher incidence of in-hospital mortality (4.8% vs 1.2%, p<0.001), major adverse cardiovascular events (composite of death, myocardial infarction, or stroke) (7.9% vs 4.1%, p=0.003), open bypass surgery (9.1% vs 6.0%, p=0.03), and infection (14.6% vs 10.5%, p=0.02) compared with the normal-BMI group. There was no significant difference in the incidence of vascular complications (p=0.31), major bleeding (p=0.17), major amputation (p=0.35), or acute kidney injury (p=0.09) between the low- and normal-BMI groups. CONCLUSION: Low-BMI patients with PAD have worse in-hospital survival and more adverse outcomes after EVT.

Impact and Outcomes of Patients with Congestive Heart Failure Complicating Non-ST-Segment Elevation Myocardial Infarction,Results from a Nationally-Representative United States Cohort.

INTRODUCTION: Congestive heart failure (CHF) is seen in up to 13-25% of patients with NSTEMI. Recent data describing the impact of congestive heart failure (CHF) on in-hospital outcomes in patients with non-ST-segment elevation myocardial infarction (NSTEMI) in the United States is limited. We sought to examine the in-hospital outcomes, and management of CHF in patients admitted to the hospital with NSTEMI. METHODS: National Inpatient Sample (NIS) database (2010-2014) was analyzed to identify patients with NSTEMI using ICD-9-CM codes. The primary outcome was in-hospital mortality. Propensity score-matching analysis compared mortality in CHF patients to matched controls without CHF. RESULTS: Of 247,624 patients with NSTEMI, 84,115 (34%) had CHF. Patients with CHF were less likely to receive percutaneous coronary intervention (PCI) [20.48% vs. 40.9%, P < 0.001] or coronary artery bypass grafting (CABG) [8.2% vs 9.6%, P < 0.001] during hospitalization. Also, they had longer lengths of stay and higher risk for in-hospital adverse outcomes. CHF was the strongest predictor of in-hospital death. The increased mortality risk was persistent after propensity matching (RR 1.27; 95% CI 1.22 to 1.33). CONCLUSION: CHF among patients with NSTEMI is associated with increased risk for in-hospital mortality and adverse outcomes.

Impella RP Support and Catheter-Directed Thrombolysis to Treat Right Ventricular Failure Caused by Pulmonary Embolism in 2 Patients.

Right ventricular failure secondary to pulmonary embolism is associated with morbidity and death. The Impella RP System has often been used for percutaneous mechanical circulatory support in patients with right ventricular failure from other causes, including myocardial infarction, cardiac surgery, and left ventricular assist device implantation. We report 2 cases of massive pulmonary embolism in which combined Impella RP use and ultrasound-assisted catheter-directed thrombolysis effectively treated shock caused by right ventricular failure and contributed to successful outcomes. To our knowledge, only one other patient with this indication had been treated with the Impella RP device.

Outcomes and Effects of Hepatic Cirrhosis in Patients Who Underwent Transcatheter Aortic Valve Implantation.

Comparative outcomes of transcatheter aortic valve implantation (TAVI) in patients with and without liver cirrhosis are scarce. This study aimed to assess the clinical outcomes and impact of liver cirrhosis on patients who underwent TAVI. Patient with liver cirrhosis who underwent TAVI 2011 to 2014 were identified in the National Inpatient Sample database using the International Classification of Diseases, ninth revision, Clinical Modification (ICD-9-CM). The primary outcome was the effect of liver cirrhosis on inpatient mortality. Secondary outcomes were the impact of liver cirrhosis on post-TAVI complications. We also evaluated the length of hospital stay and the cost of hospitalization. Propensity score-matched analysis was performed to address potential confounding. The cirrhotic patients who underwent TAVI had no significant increase in the risk of in-hospital mortality (odds ratio [OR] 1.12, 95% confidence interval [CI] 0.59 to 2.10, p = 0.734) or after procedural complications. Furthermore, cirrhotic patients were less likely to develop vascular complications requiring surgery (OR 0.47, 95% CI 0.23 to 0.98, p = 0.043), to develop after procedural deep vein thrombosis(OR <0.00, 95% CI <0.001 to <0.0001, p <0.0001), and to require pacemaker implantation. However, cirrhotic patients were more likely to undergo nonroutine hospital discharges (OR 1.50, 95% CI 1.15 to 1.96, p = 0.003). In conclusion, TAVI is a safe and reasonable therapeutic option for cirrhotic patients with severe aortic stenosis, requiring aortic valve replacement.

Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry.

BACKGROUND: Patients with left main (LM) coronary artery disease are increasingly being treated with percutaneous revascularization (PCI). The safety, feasibility, and efficacy of unprotected LM intervention (ULMI) with hemodynamic support by Impella device have not been evaluated previously. OBJECTIVE: Using a large retrospective single center database from the USpella registry, we evaluated the safety, feasibility, and potential benefits of periprocedural left ventricular assist with axial flow Impella 2.5 and Impella CP (Abiomed Inc. Danvers, Mass) during ULMI. METHODS: We analyzed a total of 127 consecutive patients who received hemodynamic support with Impella (2.5 or CP) for ULMI from August 2008 to July 2015. Safety, feasibility and efficacy end points included procedural success rates, in-hospital and 30-day major adverse cardiovascular event (MACE) rates. RESULTS: Among 127 patients who received hemodynamic support for ULMI (mean age 69.98 ± 10.7 years, 71% men, and mean left ventricular ejection fraction 28.74 ± 15.55%, Society of Thoracic Surgeons' mortality/morbidity 4/23%) the in-hospital and 30 days mortality rates were 1.43% (2/140) and 2.1% (3/141), respectively. The average baseline and post PCI (residual) syntax scores were 31.4 and 7.86, respectively, (P < 0.001). Only one patient (0.8%) had vascular complication that required surgery; 2.36% (3/127) had hematoma and 3.9% (5/127) had bleeding that required transfusion. CONCLUSION: This large singe center retrospective evaluation of USpella registry substantiates and strongly supports the feasibility, safety, and hemodynamic usefulness of Impella device for ULMI with acceptable in-hospital and 30-day MACE rates. © 2017 Wiley Periodicals, Inc.

Endovascular Interventional Cardiology: 2015 in Review.

Minimally invasive interventional procedures have become an appealing option for patients with endovascular disease historically referred to surgery. This article reviews the major advancements and trials published in 2015.

Impact of symptoms, gender, co-morbidities, and operator volume on outcome of carotid artery stenting (from the Nationwide Inpatient Sample [2006 to 2010]).

The increase in the number of carotid artery stenting (CAS) procedures over the last decade has necessitated critical appraisal of procedural outcomes and patterns of utilization including cost analysis. The main objectives of our study were to evaluate the postprocedural mortality and complications after CAS and the patterns of resource utilization in terms of length of stay (LOS) and cost of hospitalization. We queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample from 2006 to 2010 using the International Classification of Diseases, Ninth Revision, procedure code of 00.63 for CAS. Hierarchical mixed-effects models were generated to identify the independent multivariate predictors of in-hospital mortality, procedural complications, LOS, and cost of hospitalization. A total of 13,564 CAS procedures (weighted n = 67,344) were analyzed. The overall postprocedural mortality was low at 0.5%, whereas the complication rate was 8%, both of which remained relatively steady over the time frame of the study. Greater postoperative mortality and complications were noted in symptomatic patients, women, and those with greater burden of baseline co-morbidities. A greater operator volume was associated with a lower rate of postoperative mortality and complications, as well as shorter LOS and lesser hospitalization costs. In conclusion, the postprocedural mortality after CAS has remained low over the recent years. Operator volume is an important predictor of postprocedural outcomes and resource utilization.