Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

Transradial versus Transfemoral Access and the Risk of Acute Kidney Injury following Primary Percutaneous Coronary Intervention in Patients with ST-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Propensity-Score-Matched Studies.

Objectives: The aim of this study is to examine the association between vascular access sites and the incidence of AKI in patients with STEMI undergoing primary PCI. Background: Emerging evidence has suggested that transradial access (TRA) may be associated with lower rates of acute kidney injury (AKI) as compared with transfemoral access (TFA). However, most of these studies have included a nonselected study population undergoing diagnostic cardiac catheterization or percutaneous coronary intervention (PCI). Data on the association between TRA and AKI in this setting of STEMI are limited and with conflicting results. Methods: We systematically searched PubMed, Embase, and Scopus for abstracts and full-text articles from inception to July 13th of 2021. Studies included were randomized controlled trials (RCTs) and propensity-score-matched (PSM) studies evaluating the association of TRA versus TFA access with AKI in patients undergoing primary PCI for STEMI. Data were integrated using the random effects model and generic inverse-variance method of DerSimonian and Laird. Results: A total of 10,093 studies were found. After applying our inclusion criteria, 5 studies from 2014 to 2021 with a total of 8,536 STEMI patients were included. TRA was not significantly associated with a reduced risk for AKI compared with TFA (odds ratio 0.85, 95% CI 0.71-1.01, p 0.07, I 2 = 40%). Conclusions: Transradial access was not significantly associated with lower risk of AKI in patients undergoing primary PCI for STEMI compared with TFA. Larger studies are needed to clarify this outcome.

A practical guide to cardiovascular 3D printing in clinical practice: Overview and examples.

The advent of more advanced 3D image processing, reconstruction, and a variety of three-dimensional (3D) printing technologies using different materials has made rapid and fairly affordable anatomically accurate models much more achievable. These models show great promise in facilitating procedural and surgical planning for complex congenital and structural heart disease. Refinements in 3D printing technology lend itself to advanced applications in the fields of bio-printing, hemodynamic modeling, and implantable devices. As a novel technology with a large variability in software, processing tools and printing techniques, there is not a standardized method by which a clinician can go from an imaging data-set to a complete model. Furthermore, anatomy of interest and how the model is used can determine the most appropriate technology. In this over-view we discuss, from the standpoint of a clinical professional, image acquisition, processing, and segmentation by which a printable file is created. We then review the various printing technologies, advantages and disadvantages when printing the completed model file, and describe clinical scenarios where 3D printing can be utilized to address therapeutic challenges.

Importance of Using Angiography for the Early Detection of Chronic Limb Ischemia in Diabetic Foot Wounds.

Peripheral artery disease (PAD) affects millions of people worldwide, presenting with varying symptom severity, including chronic total occlusion of arteries, and occasionally, limb amputation. There are various interventions, such as atherectomy and the use of drug-coated balloons and stents, which have been developed to revascularize affected ischemic regions. However, each interventional approach must be individualized due to a patient's unique underlying conditions. Comorbid conditions, especially diabetes, play a significant role in PAD, as poorly controlled diabetes can accelerate PAD progression. For this reason, an early and accurate diagnosis of PAD is crucial, especially when symptoms may present dissimilar to classic PAD symptoms, often leading to misdiagnosis. The presented cases highlight the tailored interventions to revascularize arteries in patients with diabetic foot wounds utilizing catheters, stents, guidewires, and balloons, made possible after early angiogram. These interventions have been promising in treating PAD patients, and highlight the need for early diagnosis and timely and customized interventions to prevent limb amputation and mitigate potential complications.

A Peculiar Case of Rapidly Recurring Metastasis of Malignant Non-small Cell Primary Lung Carcinoma to the Heart.

We report the case of a 64-year-old adult male with a rapidly recurring metastatic lung carcinoma in the right atrium of the heart. Advanced-stage lung carcinomas can metastasize to other organs such as the heart, bones, brain, liver, adrenal glands, and lymphatic system, although actual rates of metastasis to the heart are relatively quite low. This patient was diagnosed with a right atrial mass that was determined through pathology to be a result of an existing non-small cell lung carcinoma. This mass, despite resection, reappeared two weeks later at the same location and with a similar size to the previous metastatic tumor. This case highlights the importance of closely monitoring sites of resected tumors for potential regrowth and complications.

Geographical and socioeconomic disparities in post-transcatheter aortic valve replacement pacemaker placement.

INTRODUCTION: Pacemaker (PPM) implantation is indicated for conduction abnormalities which can develop post-transcatheter aortic valve replacement (TAVR). However, whether post-TAVR PPM risk is associated with the geographical location of the hospital and socioeconomic status of the patient is not well established. Our goal was to explore geographical and socioeconomic disparities in post-TAVR PPM implantation. METHODS: A retrospective cohort analysis was conducted using the National Inpatient Sample 2016-2020 with respective ICD-10 codes for TAVR and PPM implantation. A weighted multivariate logistic regression model was used to analyze prognostic outcomes. RESULTS: The number of patients hospitalized for undergoing TAVR was 296,740, out of which 28,265 patients had PPM implantation (prevalence 9.5 %). Patients' demographics including sex, ethnicity, household income, and insurance were not associated with risk of post-TAVR PPM except age (OR 1.01, CI 1.07-12.5, p < 0.001). Compared to rural hospitals, urban non-teaching hospitals were associated with a higher risk of post-TAVR PPM (OR 2.09, 1.3-3.43, p = 0.003). Compared to New England hospitals (ME, NH, VT, MA, RI, CT), middle Atlantic hospitals (NY, NJ, PA) were associated with highest post-TAVR PPM risk (OR 1.54, CI 1.2-1.98, p < 0.001), followed by Pacific (AK, WA, OR, CA, HI), mountain (ID, MT, WY, NV, UT, CO, AZ, NM) and east north central US. CONCLUSION: Patients' demographics including sex, ethnicity, household income, and insurance were not associated with the risk of post-TAVR PPM except for age. Compared to New England hospitals, Middle Atlantic hospitals were associated with the highest post-TAVR PPM risk followed by Pacific, Mountain, and East North Central US. Prospective studies with data on TAVR wait times, expertise of the interventional staff, and post-TAVR management and discharge planning are required to further explore the observed regional distribution of TAVR outcomes.

Association between elevated CHA2DS2-VASC score and contrast-induced nephropathy among patients undergoing percutaneous coronary intervention: a systematic review and meta-analysis.

BACKGROUND: Promising results with the CHA2DS2-VASc risk score (CVRS) have been reported for the prediction of contrast-induced nephropathy (CIN). The aim of this study is to consolidate all the data available and examine the association between elevated CVRS and the incidence of CIN in patients undergoing percutaneous coronary intervention (PCI). METHODS: We systematically searched PubMed, Embase, and Scopus for abstracts and full-text articles from inception to May 2022. Studies were included if they evaluated the association between a high CVRS and the incidence of CIN in patients undergoing PCI. Data were integrated using the random-effects, generic inverse variance method of DerSimonian and Laird. Prospero registration: CRD42022334065. RESULTS: Seven studies from 2016 to 2021 with a total of 7,401 patients were included. In patients undergoing PCI, a high CVRS (≥2: Odds ratio [OR]:2.98, 95% confidence interval [95% CI] 2.25-3.94, p < .01, I2 = 1%, ≥3: OR 4.46, 95% CI 2.27-8.78, p < .01, I2=56% and ≥4: OR:2.75, 95% CI 1.76-4.30, p < .01, I2 = 11%) was significantly associated with an increase incidence for CIN. Subgroup analyses were done in patients with acute coronary syndrome, and association with CIN remained statistically significant (≥2: OR 2.93, 95% CI 2.11-4.07, p < .01, I2=22%and ≥4: OR:2.24, 95% CI 1.36-3.69, p < .01, I2 = 0%,). CONCLUSION: In patients undergoing PCI, an elevated CVRS is associated with an increased risk for CIN. More rigorous studies are needed to clarify this association and to identify strategies to reduce CIN.

FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial.

BACKGROUND: The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited. OBJECTIVE: The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease. METHODS: A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12­month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5 years. RESULTS: Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023. CONCLUSIONS: The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51480.

A Novel Technique Debulking Vegetations in Tricuspid Endocarditis and Venacava Utilizing AngioVac Aspiration System.

The AngioVac system (AngioDynamics Inc., Latham, NY) is used for the removal of commonly encountered intravascular material, such as thrombus or vegetations in the right atrium, right ventricle, superior vena cava, and inferior vena cava. Patients with high surgical risk having tricuspid endocarditis and superior vena cava thrombus can be treated with the AngioVac system, hence mitigating the risks for this patient population. We present a case series with the utilization of the AngioVac device to reduce the vegetation size and decrease the risk of emboli with effective antibiotic penetration. Transesophageal echocardiography shows a reduction in the size of the vegetations in all three cases with no postoperative complications. This case series demonstrates a novel technique debulking vegetations in tricuspid endocarditis and vena cava.

Efficacy of Mechanical Circulatory Support Used Before Versus After Primary Percutaneous Coronary Intervention in Patients with Cardiogenic Shock From ST-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis.

BACKGROUND: Optimal timing to initiate mechanical circulatory support (MCS) in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) remains unclear with studies showing conflicting results on whether to start before or after primary percutaneous coronary intervention (PPCI). This study aims to examine the association between mortality and MCS initiated before vs after PPCI in patients with STEMI complicated by CS. METHODS: We systematically searched PubMed, Embase, and Scopus for abstracts and full-text articles from inception to October 2021. Studies were included if they evaluated the association of mortality in patients who initiated MCS (specifically intra-aortic balloon pump (IABP), Impella, and venoarterial extracorporeal membrane oxygenation (VA-ECMO)) before PPCI versus after PPCI, specifically in patients with STEMI complicated by CS. Data were integrated using the random-effects models. RESULTS: Ten studies involving 1,352 patients (956, 203, and 193 patients underwent IABP, Impella, and VA-ECMO respectively) with STEMI complicated by CS were included. There was no difference in mortality using IABP before or after PPCI ([OR] 1.77, 95% CI 0.77-1.61, I2 = 27%, p = 0.57). Nevertheless, Impella and VA-ECMO started before PPCI were significantly associated with a reduced risk of mortality compared to that started after PPCI ([OR] 0.49, 95% CI 0.26-0.92, I2 = 0%, p = 0.03 and [OR] 0.29, 95% CI 0.14-0.62, I2 = 0%, p = 0.001, respectively). CONCLUSIONS: In patients with STEMI complicated by CS undergoing PPCI, the use of IMPELLA or VA-ECMO prior to PPCI significantly decreased mortality, in contrast to IABP, in which no difference in mortality was found between using it before or after PPCI. More rigorous studies are needed to clarify this association.

Covaxin-Induced Lymphocytic Myocarditis.

We report the case of a young adult male with endomyocardial biopsy-proven lymphocytic myocarditis following Covaxin administration. Covaxin differs from the mRNA vaccines in that it is an inactivated virus developed using the whole virion inactivated using the Vero cell platform. We successfully managed the patient with complete resolution of symptoms.

A Case of Pericardial Decompression Syndrome Following Surgical Pericardial Fluid Drainage.

Pericardial decompression syndrome (PDS) is a rare and serious complication that follows often-initially-uncomplicated pericardial drainage in patients with pericardial effusion and tamponade physiology. The pathophysiology of PDS is not yet completely understood, although several mechanisms have been postulated. In this report, we present a case of PDS in a 70-year-old male with end-stage renal disease (ESRD) after he underwent a surgical pericardial window for drainage of a moderate pericardial effusion with tamponade physiology. This case provides further evidence that rapid pericardial decompression, notably with pericardiotomy, can lead to acute life-threatening low cardiac output heart failure, particularly in patients with underlying cardiac risk factors. Early recognition, diagnosis, and supportive treatment in the ICU are crucial for improving survival rates in these patients.

Atypical Presentation of Fatal Disease: Painless Aortic Dissection.

Aortic dissections (ADs) are uncommon but they are highly lethal. Due to atypical signs and symptoms, diagnosis of type B AD can be easily missed or delayed. Our patient presented to the emergency center with dizziness and fall for which he was evaluated and treated for hypertension. Two weeks later, he again presented to the hospital with painless right groin swelling: computed tomography (CT) of the abdomen incidentally showed type B AD. The patient might have an AD presenting with dizziness and hypertension during previous presentation. From this case, we learn how it is challenging to diagnose painless AD especially when patient comes with atypical symptoms. In high-risk patients with unexplained dizziness and fall, a high degree of suspicion may help for early diagnosis and management.

1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon.

OBJECTIVES: This study sought to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) (paclitaxel dose density 2 µg/mm2) for treating superficial femoral artery or proximal popliteal artery lesions. BACKGROUND: Paclitaxel-coated balloon treatment prevents reinterventions, but dose and coating characteristics differ among balloons and necessitate discrete confirmation of safety and effectiveness. METHODS: Patients with symptomatic lower limb ischemia (Rutherford classification 2 to 4) were randomized 3:1 to treatment with the Ranger DCB or standard percutaneous transluminal angioplasty (PTA). Twelve-month primary target lesion patency, freedom from major adverse events (i.e., target lesion revascularization, major amputations, death within 1 month of the index procedure), and patient outcomes were analyzed. RESULTS: Mean lesion length was 82.5 ± 48.9 mm for the Ranger DCB group (n = 278) and 79.9 ± 49.3 mm for the control group (n = 98). Ranger DCB was superior to PTA (82.9% [n = 194 of 234] vs. 66.3% [n = 57 of 86]) with observed 12-month primary patency rates yielding a difference of 16.6% (95% confidence interval: 5.5% to 27.7%; p = 0.0013). Noninferior freedom from major adverse events (94.1% [n = 241 of 256] vs. 83.5% [n = 76 of 91]) was demonstrated with a difference of 10.6% (95% confidence interval: 2.5% to 18.8%; noninferiority p < 0.0001). Primary patency rate curves showed significant separation by Kaplan-Meier analysis (log-rank p = 0.0005), with rates of 89.8% and 74.0% estimated at day 365 for the Ranger DCB and PTA cohorts, respectively. CONCLUSIONS: The low-dose Ranger DCB demonstrated significantly better effectiveness than standard PTA through 1 year and a good safety profile. (Ranger™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty [RANGER II SFA]; NCT03064126).

A Fractured Inferior Vena Cava Strut Migrating to the Right Ventricle Without Any Cardiovascular Complaint: A Case Report and Review of Literature.

The use of inferior vena cava filter (IVCF) as one of the last resorts for pulmonary embolism prevention has expanded over the decades. The migration of a broken strut to the right ventricle is a very unusual complication that, when present, has been associated with life-threatening events. We report a case of a 34-year-old female with an inferior vena cava (IVC) strut that migrated and was incidentally found embedded in the right ventricle without any cardiovascular signs or symptoms. This case provides evidence that such filters probably have higher rates of complications than what has been thought because those complications might remain asymptomatic.

Percutaneous Pulmonary Valve Implantation: Present Status and Evolving Future.

Due to recurrent right ventricular outflow tract (RVOT) dysfunction, patients with complex congenital heart disease of the RVOT traditionally require multiple surgical interventions during their lifetimes. Percutaneous pulmonary valve implantation (PPVI) has been developed as a nonsurgical alternative for the treatment of right ventricular to pulmonary artery stenosis or pulmonary regurgitation. PPVI has been shown to be a safe and effective procedure in patients with dysfunctional surgical RVOT conduits. In this population, PPVI has the potential to improve symptoms, functional capacity, and biventricular hemodynamics. However, limitations to the anatomical substrate and size of the RVOT currently restrict PPVI eligibility to less than one-quarter of patients with RVOT dysfunction. The current review discusses contemporary practices in PPVI, evidence supporting the procedure, and future technologies and developments in the field.