When coronary imaging and physiology are discordant, how best to manage coronary lesions? An appraisal of the clinical evidence.

BACKGROUND: Discordant physiology and anatomy may occur when nonsevere angiographic stenosis has positive physiology as well as the opposite situation. AIM: To underline the reasons behind the discrepancy in physiology and anatomy and to summarize the information that coronary imaging may add to physiology. METHODS: A review of the published literature on physiology and intravascular imaging assessment of intermediate lesions was carried out. RESULTS: The limitations of angiography, the possibility of an underlying diffuse disease, the presence of a "grey zone" in both techniques, the amount of myocardial mass that subtends the stenosis, and plaque vulnerability may play a role in such discrepancy. Intracoronary imaging has a poor diagnostic accuracy compared to physiology. However, it may add information about plaque vulnerability that might be useful in deciding whether to treat or not a certain lesion. CONCLUSIONS: Coronary revascularization is recommended for patients with ischemia based on physiology. Intracoronary imaging adds information on plaque vulnerability and can help on the decision whether to revascularize or not a lesion.

Quantitative flow ratio-Meta-analysis and systematic review.

INTRODUCTION: Despite of the wide evidence of use fractional flow reserve (FFR), isolated angiography evaluation is still the main tool to indicate percutaneous coronary intervention. Quantitative flow ratio (QFR) is a new functional index to assess functional significance. Recently, few studies have showed the capacity of QFR to predict significance stenosis. The aim of this research has been to describe the evidence of QFR in this clinical setting, to analyze the global diagnosis accuracy of QFR versus FFR and to compare the difference in feasibility between retrospective and prospective analysis. METHODS AND RESULTS: Systematic review of literature was performed. Eligible studies for the meta-analysis were considered those directly evaluating de QFR versus FFR. Pooled values of diagnosis test and summary receiver operator curve were calculated. Main causes of not-perform QFR analysis according to study design were also evaluated. Sixteen studies were included. Good correlation and agreement were showed. Global sensibility, specificity, PPV, and NPV were 0.84, 0.89, 0.80, and 0.92, respectively. Then, 18% of evaluated vessels could not be analyzed. Significant differences were found in the percentage of discarded vessels and the cause of nonperformed analysis between retrospective or prospective analysis. CONCLUSIONS: Excellent correlation and agreement between QFR and FFR was demonstrated. QFR assessment could be improved by its prospective analysis with a dedicated protocol.

Computer-assisted valve in valve in a deteriorated Mosaic valve using a library of bioprostheses.

Valve-in-valve (ViV) procedures have emerged from an off-label procedure to a safe and efficient alternative to redo aortic valve replacement in the treatment of symptomatic structural valve deterioration (SVD). During ViV procedures, optimal placement of the transcatheter heart valve (THV) inside the degenerated bioprosthesis is of paramount importance regarding complications such as device embolization, coronary obstruction, periprosthetic regurgitation, residual gradients, and mitral valve injury, but also for the attainment of optimal hemodynamics. In the case of the Mosaic (Medtronic, Minneapolis, MN) valve, the limited radiopaque landmarks represent a challenge to a reproducible, optimal implantation. Such implantation may require multiple contrast injections and transesophageal echocardiogram (TEE) guidance. We herein describe a computer-assisted ViV procedure inside a deteriorated Mosaic valve, achieving reproducible optimal placement using a preacquired library of bioprostheses 3D models. Our approach suggests an evolving paradigm in ViV procedures, from safe and efficient toward optimal therapy for symptomatic SVD.

Effect of postdilatation following balloon expandable transcatheter aortic valve implantation.

BACKGROUND: Postdilatation after transcatheter heart valve (THV) implantation was associated with larger aortic valve areas in large-scale registries; however, the specific effects of postdilatation are poorly understood. METHODS AND RESULTS: Among a total of 224 consecutive patients who underwent transcatheter aortic valve replacement using SAPIEN 3, 121 patients (54.0%) underwent postdilatation (same contrast volume: N = 101, +1 ml: N = 17, +2 ml: N = 3). THV diameter was assessed (a) during, (b) after implantation, (c) during postdilatation, and (d) after postdilatation by quantitative fluoroscopy. In the overall patients (N = 224), acute recoil was observed from during implantation (23.0 ± 2.0 mm) to after implantation (22.5 ± 2.0 mm, p < .001) with an absolute recoil of 0.52 ± 0.25 mm. After postdilatation (N = 121), THV diameter significantly increased from 22.5 ± 2.0 mm to 22.9 ± 2.1 mm (p < .001), with smaller absolute recoil (0.39 ± 0.21 mm, p < .001). Compared with those who did not undergo postdilatation, patients who underwent postdilatation had larger postprocedural THV area assessed by multi-slice computed tomography (471.4 ± 78.1 mm2 vs. 447.5 ± 76.3 mm2 , p = .02) and larger effective orifice area (EOA) assessed by echocardiography throughout 1 year (at 30 day, 1.66 ± 0.33 cm2 vs. 1.45 ± 0.27 cm2 , p < .001; at 6 month, 1.66 ± 0.33 cm2 vs. 1.44 ± 0.29 cm2 , p < .001; at 1 year, 1.69 ± 0.38 cm2 vs. 1.47 ± 0.30 cm2 , p < .001). CONCLUSIONS: Postdilatation after implantation of the SAPIEN 3 valve produced a larger THV diameter with less acute recoil, followed by larger EOA throughout 1 year. Further studies are needed to evaluate the impact of postdilatation on long-term clinical outcomes.

Paravalvular leak closure of acute mitral valve ring dehiscence during mitral valve-in-ring procedure.

The replacement of surgically corrected mitral valves, also known as percutaneous transcatheter repair, is a relatively young field. Even though these procedures are usually successful, they can present significant intraoperative or postoperative challenges. To our knowledge, we present the first case of acute focal dehiscence of mitral ring repair during the mitral valve-in-ring procedure.

Minimizing radiographic contrast administration during coronary angiography using a novel contrast reduction system: A multicenter observational study of the DyeVert™ plus contrast reduction system.

OBJECTIVE: To evaluate contrast media (CM) volume (CMV) saved using the DyeVert™ Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections. BACKGROUND: Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real-time CMV monitoring. METHODS: We performed a multicenter, single-arm, observational study. Eligible subjects were ≥ 18 years old with baseline estimated glomerular filtration rate (eGFR) 20-60 mL/min/1.73 m2 . The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use. RESULTS: A total of 114 subjects were enrolled at eight centers. Mean age was 72 ± 9 years, 72% were male, and mean body mass index was 29 ± 5. Baseline eGFR was 43 ± 11 mL/min/1.73 m2 . CAG-only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 ± 85 mL (range 22-681) and mean CMV delivered was 67 ± 51 mL (range 12-403), resulting in an overall CMV savings of 40.1 ± 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System-related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased. CONCLUSIONS: These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality.

Catheter-based retrograde coronary sinus infusion is a practical delivery technique for introducing biological molecules into the cardiac system.

OBJECTIVES: To demonstrate coronary sinus (CS) retrograde catheterization as a practicable technique for delivering biologics into the heart. BACKGROUND: There are many options to deliver biologics into the heart. However, there is no single optimal technique when considering safety, biologic retention, and reproducibility. Retrograde delivery has the potential to address many of these concerns. This study evaluated retrograde CS infusion of luciferase-expressing plasmid in a porcine model using the Advance® CS Coronary Sinus Infusion Catheter and bioluminescence imaging to track the expression of the infused biological markers. METHODS: Plasmid was delivered retrograde into the CS in one of three infusion volumes. Twenty-four hours post-infusion, hearts were excised and underwent bioluminescence imaging to characterize the expression of the infusates. Heart and lung biopsies were also assessed for luciferase expression using RT-qPCR. RESULTS: Retrograde infusion was safe and successful in all nine test subjects. Luciferase detection was inconsistent in the low volume group. Bioluminescence was confined predominantly along the posterolateral left ventricle for medium volume infusions and was more broadly dispersed along the anterior side of the heart for high volume infusions. Tissue mRNA analysis corroborated the bioluminescence results, with the highest concentration of luciferase expression localized in the left ventricle. CONCLUSIONS: Retrograde CS infusion is a promising technique for delivering biological molecules to the heart. Specifically, this study demonstrated that the low pressure coronary venous system accommodates a wide range of infusion volumes and that biological infusates can be maintained in situ following the resumption of coronary venous flow.

Radiation Risk Categories in Cardiac Catheterization for Congenital Heart Disease: A Tool to Aid in the Evaluation of Radiation Outcomes.

To stratify diverse procedure types into categories with similar radiation exposure in cardiac catheterization for congenital heart disease. Radiation exposures for a comprehensive list of specific procedure types and stratification of outcomes based on radiation risk are not currently available. Data between January 2014 and December 2015 were collected on all cases performed at sites participating in C3PO-QI (Congenital Cardiac Catheterization Outcomes Project-Quality Improvement Initiative) and 9 centers were included. Using expert consensus, 40 unique procedure types were defined by diagnostic characteristics or the intervention(s) performed, and dose area product (DAP) per kilogram of body weight (µGy × m2/kg) was summarized. Using empiric and consensus methods, three radiation risk categories were created. A total of 11,735 cases were included for analysis. Thirteen (n = 7918) procedure types with median DAP/kg < 100 were categorized in the low radiation exposure category (median DAP/kg 39). The medium exposure category (n = 1807) consisted of 16 procedure types with median DAP/kg values ranging 100 to < 200 (overall median DAP/kg 131). Finally, the high radiation exposure category (n = 1073) consisted of 11 procedure types with median DAP/kg ≥ 200 (overall median DAP/kg of 231). The radiation exposure risk categories created in this multi-center dataset are a critical step towards the development of a robust risk adjustment methodology for radiation exposure in catheterization for congenital heart disease.

Predictors of patient radiation exposure during transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) exposes patients to radiation. OBJECTIVES: We sought to identify factors associated with higher radiation exposure and to quantify their relative influence, which may inform reduction of this hazard. METHODS: All TAVR procedures at Rhode Island Hospital between March 20, 2012 and February 12, 2017 were included. Procedures were performed by two co-primary operators using a Siemens Artis Zeego system. Radiation metrics were generated by the imaging system. The primary metric was dose-area product (DAP, Gy*cm2 ), and secondary metrics were reference point air kerma (mGy) and fluoroscopy time (minutes). Data collected for the STS/ACC TVT Registry were utilized to develop a multivariable linear regression model predicting DAP. RESULTS: In 294 TAVRs, median DAP was 169 Gy*cm2 [interquartile range (IQR) 106-238]. The r2 values for the full 27-variable DAP model and reduced eight-variable model were 0.457 and 0.420, respectively. Valve area, aortic insufficiency, and procedure year (suggesting absence of a learning curve) were non-significant predictors in the full model, while increasing weight, cutdown transfemoral access, higher pre-procedure creatinine and hemoglobin, and vascular complications predicted higher DAP in both models. Results were unchanged when DAP was log-transformed. Secondary models for air kerma and fluoroscopy time revealed similar predictors. CONCLUSION: Factors associated with increased procedural complexity and duration as well as radiation attenuation and scatter predict increased patient radiation exposure during TAVR. Modification of procedural technique, especially using percutaneous femoral vascular access, may facilitate reduction in exposure.

Sizing of patent ductus arteriosus in adults for transcatheter closure using the balloon pull-through technique.

OBJECTIVES: To describe a novel balloon sizing technique used during adult transcatheter patent ductus arteriosus (PDA) closure. In addition, to determine the clinical and procedural outcomes in six patients who underwent PDA balloon sizing with subsequent deployment of a PDA occluder device. BACKGROUND: Transcatheter PDA closure in adults has excellent safety and procedural outcomes. However, PDA sizing in adults can be challenging due to variable defect size, high flow state, or anatomical complexity. We describe a series of six cases where the balloon- pull through technique was successfully performed for PDA sizing prior to transcatheter closure. METHODS: Consecutive adult patients undergoing adult PDA closure at our institution were studied retrospectively. A partially inflated sizing balloon was pulled through the defect from the aorta into the pulmonary artery and the balloon waist diameter was measured. Procedural success and clinical outcomes were obtained. RESULTS: Six adult patients underwent successful balloon pull-through technique for PDA sizing during transcatheter PDA closure, since conventional angiography often gave suboptimal opacification of the defect. All PDAs were treated with closure devices based on balloon PDA sizing with complete closure and no complications. In three patients that underwent preprocedure computed tomography, the balloon size matched the CT derived measurements. CONCLUSION: The balloon pull-through technique for PDA sizing is a safe and accurate sizing modality in adults undergoing transcatheter PDA closure.

Descending aorta to right atrial fistula.

Here, we report a four-day old neonate presenting with cardiovascular collapse secondary to a descending aorta to right atrial fistula. Echocardiography was suggestive of the diagnosis and confirmed with computed tomographic (CT) imaging. The fistula was successfully occluded via cardiac catheterization using an Amplatzer Vascular Plug II implanted from the right atrial aspect. This report includes the first CT imaging of this extremely rare congenital defect as well as detailing the first successful transcatheter occlusion of this particular lesion.

Radiation dose benchmarks in pediatric cardiac catheterization: A prospective multi-center C3PO-QI study.

OBJECTIVES: This study sought to update benchmark values to use a quality measure prospectively. BACKGROUND: Congenital Cardiac Catheterization Outcomes Project - Quality Improvement (C3PO-QI), a multi-center registry, defined initial radiation dose benchmarks retrospectively across common interventional procedures. These data facilitated a dose metric endorsed by the American College of Cardiology in 2014. METHODS: Data was collected prospectively by 9 C3PO-QI institutions with complete case capture between 1/1/2014 and 6/30/2015. Radiation was measured in total air kerma (mGy), dose area product (DAP) (µGy*M2 ), DAP per body weight, and fluoroscopy time (min), and reported by age group as median, 75th and 95th %ile for the following six interventional procedures: (1) atrial septal defect closure; (2) aortic valvuloplasty; (3) treatment of coarctation of the aorta; (4) patent ductus arteriosus closure; (5) pulmonary valvuloplasty; and (6) transcatheter pulmonary valve implantation. RESULTS: The study was comprised of 1,680 unique cases meeting inclusion criteria. Radiation doses were lowest for pulmonary valvuloplasty (age <1 yrs, median mGy: 59, DAP: 249) and highest in transcatheter pulmonary valve implantation (age >15 yrs, median mGy: 1835, DAP: 17990). DAP/kg standardized outcome measures across weights within an age group and procedure type significantly more than DAP alone. Radiation doses decreased for all procedures compared to those reported previously by both median and median weight-based percentile curves. These differences in radiation exposure were observed without changes in median fluoroscopy time. CONCLUSIONS: This study updates previously established benchmarks to reflect QI efforts over time. These thresholds can be applied for quality measurement and comparison. © 2017 Wiley Periodicals, Inc.

Patent foramen ovale with right atrial septal pouch.

A patent foramen ovale (PFO) is a communication across the inter-atrial septum and a right atrial septal pouch (RASP) is an indentation of the atrial septum caused by an incomplete fusion of the septum primum and septum secundum with its base opening into the right atrium. A 63-year-old male who had a history of two strokes and episodes of transient neurological deficit was diagnosed to have a small right-to-left shunt. At the time of PFO closure, an angiogram of the atrial septum revealed a small PFO associated with a RASP. The small PFO was crossed with a straight-tipped guide wire and was closed using a 25-mm GORE CARDIOFORM Septal Occluder (W.L. Gore and Associates, AZ). It is hypothesized that stagnant blood in the RASP may generate a clot that can cross the PFO and cause an infarct. © 2015 Wiley Periodicals, Inc.

Fontan fenestration closure with Amplatzer Duct Occluder II device.

OBJECTIVES: To evaluate Fontan fenestration closure using the Amplatzer Duct Occluder II device (ADO2). BACKGROUND: Fontan fenestration closure is a well established catheter intervention. A range of occlusion devices developed for other interventions have been utilized. Most of these devices, and especially the most commonly used Amplatzer Septal Occluder, are relatively bulky. The ADO2 is a low profile, flexible, and inexpensive device which seems well suited to the Fontan fenestration. METHODS: This study details retrospective review of patients undergoing Fontan fenestration closure with an ADO2 device. Outcome measures included procedural success, pre- and post-procedural differences in oxygen saturation and mean pulmonary artery pressure and complications. RESULTS: Thirteen patients were eligible for inclusion during the 34 month study period. All procedures were technically successful. There was a significant increase in oxygen saturations (Mean=+12%, P<0.01) after fenestration closure but no significant change in mean pulmonary artery pressure (Mean=+0.5 mm Hg, P=0.08). There were no procedural complications. CONCLUSION: Fontan fenestration closure with the ADO2 device is a simple, short, and cost-effective procedure. The ADO2 characteristics recommend it to occlusion of varying sizes and morphologies of Fontan fenestration.

The use of the AVERT system to limit contrast volume administration during peripheral angiography and intervention.

BACKGROUND: The AVERT(TM) Contrast Modulation System (AVERT) (Osprey Medical, MN) is designed to reduce contrast volume administration during angiography. The AVERT provides an adjustable resistance circuit which decreases the pressure head delivering contrast towards the patient. The AVERT has not been previously studied in patients undergoing peripheral digital subtraction angiography (DSA). The purpose of this study was (1) to evaluate contrast savings with the AVERT and (2) to evaluate the ability to generate clinically acceptable DSA images in the process. To better define the mechanism of action in the peripheral circulation, we also developed a bench model to study the effects of the AVERT on the hydrodynamics of contrast delivery. METHODS: Patients undergoing lower extremity DSA (diagnostic or intervention, sheath or catheter) were studied. The following variables were recorded for each injection: starting control syringe contrast volume, contrast volume injected towards patient, contrast volume returned to AVERT reservoir, net contrast administered to the patient and % savings. The AVERT resistance was adjusted manually based on operator's discretion--balancing image quality and contrast savings. RESULTS: About 408 DSA angiographic sequences were obtained in 22 patients undergoing 29 procedures. Almost 68% of the patients had chronic kidney disease. An 82% presented with critical limb ischemia, 18% had claudication. There was an overall 37% ± 14% savings of contrast (31% for diagnostic DSA, 40% for interventional procedures). Overall 91% of all images were acceptable for clinical decision making. Specifically, 94% of diagnostic and 87% of interventional images were acceptable. Injection through a 4 Fr catheter (77% acceptable) resulted in poorer image quality as compared to a 5 Fr catheter (96% acceptable). Image quality for 5, 6, and 7 Fr sheath injections was 86%, 91%, 98%, respectively. The bench model of peripheral angiography demonstrated a significant reduction in reflux of contrast proximal to the end of the catheter without loss of antegrade image quality - confirming the in vivo findings. CONCLUSIONS: We demonstrate that the use of the AVERT device during peripheral angiography results in significant contrast savings without compromising image quality.

Transcatheter embolization of a large aneurysm in a congenital coronary cameral fistula from the left coronary artery to the right ventricle.

A congenital coronary cameral fistula (CCCF) is characterized by left ventricular dysfunction, electrocardiographic changes due to a reduced left coronary blood flow and impaired physical activity. CCCF's with a giant aneurysm are very rarely seen. The presence of a giant aneurysm imposes even greater health risks. We report a case of a CCCF from the left coronary artery to the right ventricle with a large distal aneurysm in a 20-year-old woman that we closed percutaneously with coils for the closure of ventricular septal defects (VSD) and persistent ductus arteriosus (PDA).

Assessment of clinical occupational dose reduction effect of a new interventional cardiology shield for radial access combined with a scatter reducing drape.

OBJECTIVES: To assess the occupational dose reduction effect of a new interventional cardiology shield for radial access combined with a scatter reducing drape. BACKGROUND: Transradial access for catheterization has been shown to increase occupational radiation dose. Current shielding techniques are primarily based on the femoral access. This article looks at the clinical occupational combined dose reduction effect of a commercially available shield and drape which is specific to access type. METHODS: The evaluation took place in a busy interventional cardiology laboratory, with a single plane 30×40 cm flat panel detector (Siemens Artis Zee, Germany). Radiation exposure to staff was measured using electronic personal dosimeters (Unfors RaysafeAB, Sweden) placed at the collar. Patient radiation exposure was assessed using screening time and dose area product per case. Both staff and patient radiation exposure were monitored for a number of case types and operators before, during, and after deployment of the new shield and drapes. RESULTS: The cardiologists' overall median collar badge reading per case reduced from 15.4 µSv per case without the shield/drape combination to 7.3 µSv per case with the shield drape combination in situ (P<0.001). The radiographers badge reading was reduced from 4.2 µSv per case without to 2.5 µSv per case with the shield drape combination in situ (P<0.001). There was no statistical difference in the cardiac technician's badge reading. Patient's dose area product was not significantly affected by the placement of the shield and drape combination. CONCLUSIONS: The shield/drape combination can significantly reduce operator exposure in a cardiac catheterization laboratory.

Multimodality image guidance with Dyna-CT for transcatheter treatment of paravalvular leak of a stentless valve.

The transcatheter treatment of paravalvular leaks (PVL) are technically challenging procedures; they pose increasing difficulty in cases where there is a stentless valve, without the usual fluoroscopic landmarks. Hence, there is limited experience in treating this defect percutaneously. We present a case of a patient with an aortic PVL of a stentless valve and how the integrated use of multi-imaging modalities (transesophageal echocardiography, computed tomography and rotational angiography) allowed the demarcation of landmarks onto live fluoroscopy and guided the transcatheter occlusion of the PVL.

Reducing iodinated contrast volume by manipulating injection pressure during coronary angiography.

OBJECTIVE: To evaluate the impact of a device-mediated modification of the injection pressure profile on iodinated contrast volumes during coronary angiography and percutaneous coronary intervention (PCI). BACKGROUND: The development of iodinated contrast-induced acute kidney injury (AKI) is associated with significant morbidity and mortality in patients undergoing coronary angiography and intervention, particularly in the setting of ST-elevation myocardial infarction. Iodinated contrast volume is a recognized risk factor for iodinated contrast-induced AKI. Mitigation of iodinated contrast loss due to coronary iodinated contrast reflux represents a potential means to reduce iodinated contrast volume. METHOD AND RESULTS: We assessed the effectiveness of injection pressure modulation using an iodinated contrast conservation system (CCS), in 21 patients undergoing diagnostic coronary angiography or PCI. System activation was associated with a marked reduction in iodinated contrast injection compared with standard imaging (3.5 ± 1.1 vs. 5.4 ± 1.7 mL, P < 0.001). Paired images were obtained in 59 instances with significantly less iodinated contrast use with CCS use (3.3 ± 1.1 vs. 5.5 ± 1.6 mL, P < 0.001), with comparable image quality in 98% of cases. CONCLUSIONS: Modulation of iodinated contrast injection pressure provides a novel potential means to reduce iodinated contrast volumes by attenuating inefficient losses due to ostial reflux. Future studies are required to define the ability of the CCS to reduce total iodinated contrast volume and to impact upon the risk of iodinated contrast-induced AKI.