Clinical outcomes and the impact of valve morphology for transcatheter aortic valve replacement in bicuspid aortic valves: A systematic review and meta-analysis.

BACKGROUND: Bicuspid aortic valve (BAV) is present in approximately 0.5%-2% of the general population, causing significant aortic stenosis (AS) in 12%-37% of affected individuals. Transcatheter aortic valve replacement (TAVR) is being considered the treatment of choice in patients with symptomatic AS across all risk spectra. AIM: Aim Our study aims to compare TAVR outcomes in patients with BAV versus tricuspid aortic valves (TAV). METHODS: A comprehensive literature search was performed in PubMed, Web of Science, and Cochrane trials. Studies were included if they included BAV and TAV patients undergoing TAVR with quantitative data available for at least one of our predefined outcomes. Meta-analysis was performed by the random-effects model using Stata software. RESULTS: Fifty studies of 203,288 patients were included. BAV patients had increased 30-day all-cause mortality (odds ratio [OR] = 1.23 [1.00-1.50], p = 0.05), in-hospital stroke (OR = 1.39 [1.01-1.93], p = 0.05), in-hospital and 30-day PPI (OR = 1.13 [1.00-1.27], p = 0.04; OR = 1.16 [1.04-1.13], p = 0.01) and in-hospital, 30-day and 1-year aortic regurgitation (AR) (OR = 1.48 [1.19-1.83], p < 0.01; OR = 1.79 [1.26-2.52], p < 0.01; OR = 1.64 [1.03-2.60], p = 0.04). Subgroup analysis on new-generation valves showed a reduced 1-year all-cause mortality (OR = 0.86 [CI = 0.75-0.98], p = 0.03), despite higher in-hospital and 30-day PPI (OR = 0.1.21 [1.04-1.41], p = 0.01; OR = 1.17 [1.05-1.31], p = 0.01) and in-hospital AR (OR = 1.62 [1.14-2.31], p = 0.01) in the BAV group. The quality of included studies was moderate-to-high, and only three analyses presented high heterogeneity. CONCLUSION: TAVR is associated with comparable outcomes in patients with BAV and TAV. Careful selection of BAV cases by preprocedural assessment of valve anatomy and burden of calcification, pre- and post-procedural dilation, and implementing newer generations of valves may improve the safety and efficacy of TAVR in BAV patients.

A "fully upper extremity" bailout of direct transaxillary large bore arterial access: A refinement within arm's reach?

Contemporary direct ("fully percutaneous") transaxillary (TAx) large-bore arterial access technique advocates for a 0.018" wire to be passed from femoral arterial access to axillary artery to serve percutaneous bailout options. However, in certain patients, avoiding femoral arterial access entirely may be desired. We describe the merits of a "fully upper extremity" (FUE) bailout approach, as a refinement to previously described direct TAx technique.

Overexpansion of the 29 mm SAPIEN 3 transcatheter heart valve in patients with large aortic annuli (area > 683 mm2 ): A case series.

OBJECTIVES: To evaluate overexpanded 29 mm SAPIEN (S3) transcatheter heart valves in patients with aortic annuli area >683 mm2 . BACKGROUND: The largest valve area the 29 mm S3 is specified for is 683 mm2 . Valve overexpansion has been performed in patients with larger aortic annuli, but data are limited. Moreover, feasibility in areas >740 mm2 is unknown. METHODS: All 29 mm S3 transcatheter aortic valve replacements (TAVR) at a single center over 23-months were retrospectively reviewed. Patients with annulus areas >683 mm2 were included. Immediate post-TAVR hemodynamics and transthoracic echocardiography (TTE) findings on post-TAVR day-1 and day-30 were recorded. RESULTS: Of 81 29 mm S3 TAVR cases, 3 (3.7%) met inclusion criteria (patients 1, 2, and 3 had CT-scan derived areas of 748.1 mm2 , 793 mm2 , and 787 mm2 , respectively). Annular eccentricity index ranged from 0.12 to 0.25. All underwent transfemoral TAVR with 29 mm S3 valves overexpanded using +4 mL of contrast. Post-dilatation with +5 mL was performed in patient 2. The average valve shortening was 10.68 mm. On day 1, patients 1 and 2 had trace and mild paravalvular leak (PVL) (respectively), whereas, patient 3 had mild-moderate PVL. Patient 1 was also noted to have trace central AR on day 1. No other central AR was noted. Immediate post-procedure aortic regurgitation (AR) index in patients 1, 2, and 3 was 43, 34, and 33 respectively. At 30 days, AR was completely resolved in patient 1, whereas AR severity in patients 2 and 3 remained similar. No patients had > moderate AR at any point during follow-up. No valve migration or embolization occurred. Patient 1 required a permanent pacemaker. No other major complications were noted. All patients were clinically stable at 30 days. CONCLUSIONS: TAVR using overexpanded 29 mm S3 in valve areas >740 mm2 (up to 793 mm2 ) seemed to be safe and feasible in our small series. Further study in a larger series is needed to determine clinical outcomes in this patient population.

Mortality prediction after transcatheter treatment of failed bioprosthetic aortic valves utilizing various international scoring systems: Insights from the Valve-in-Valve International Data (VIVID).

BACKGROUND: Transcatheter Aortic Valve Implantation (TAVI) is commonly used to deploy new bioprosthetic valves inside degenerated surgically implanted aortic valves in high risk patients. The three scoring systems used to assess risk of postprocedural mortality are: Logistic EuroSCORE (LES), EuroSCORE II (ES II), and Society of Thoracic Surgeons (STS). OBJECTIVE: The purpose of this study is to analyze the accuracy of LES, ES II, and STS in estimating all-cause mortality after transcatheter aortic valve-in-valve (ViV) implantations, which was not assessed before. METHODS: Using the Valve-in-Valve International Data (VIVID) registry, a total of 1,550 patients from 110 centers were included. The study compared the observed 30-day overall mortality vs. the respective predicted mortalities calculated by risk scores. The accuracy of prediction models was assessed based on calibration and discrimination. RESULTS: Observed mortality at 30 days was 5.3%, while average expected mortalities by LES, ES II and STS were 29.49 (± 17.2), 14.59 (± 8.6), and 9.61 (± 8.51), respectively. All three risk scores overestimated 30-day mortality with ratios of 0.176 (95% CI 0.138-0.214), 0.342 (95% CI 0.264-0.419), and 0.536 (95% CI 0.421-0.651), respectively. 30-day mortality ROC curves demonstrated that ES II had the largest AUC at 0.722, followed by STS at 0.704, and LES at 0.698. CONCLUSIONS: All three scores overestimated mortality at 30 days with ES II showing the highest predictability compared to LES and STS; and therefore, should be recommended for ViV procedures. There is a need for a dedicated scoring system for patients undergoing ViV interventions.

Surgical hardware-related iatrogenic venous compression syndrome.

Deep vein thrombosis related to immobilization is a common and extensively studied disorder, particularly in hospitalized patients. However, the phenomenon of iatrogenic venous compression (IAVC) and related deep venous thrombosis (DVT) is under-recognized and under-reported. In the absence of relieving the compressive pathology, the recanalization rates are expected to be very low - thereby putting patients at a significant risk for the development of post-thrombotic syndrome (PTS). In this report, we describe two cases of DVT related to IAVC, and review similar cases that have been previously reported in the literature. With advancements in catheter-based technology, patients with IAVC (with or without DVT) may now be offered advanced endovascular treatment options such as catheter-directed pharmacomechanical thrombolysis (PMT) and percutaneous venoplasty and/or stenting. Hence, timely recognition and treatment is essential in the prevention of disabling PTS or life-threatening pulmonary embolism.

Carcinoid heart disease: current understanding and future directions.

Carcinoid tumors are rare and aggressive malignancies. A multitude of vasoactive agents are central to the systemic effects of these tumors. The additional burden of cardiac dysfunction heralds a steep decline in quality of life and survival. Unfortunately, by the time carcinoid syndrome surfaces clinically, the likelihood of cardiac involvement is 50%. Although medical therapies such as somatostatin analogues may provide some symptom relief, they offer no mortality benefit. On the other hand, referral to surgery following early detection has shown increased survival. The prompt recognition of this disease is therefore of the utmost importance.

Push Is Better Than Shove: Radial Snare-Guided Repositioning of an Extracardiac Impella Device.

BACKGROUND: Bedside manipulation of an Impella CP is often necessary as subtle changes in device position after initial placement can dramatically affect proper function. CASE PRESENTATION: A 59 year old man in cardiogenic shock on V-A ECMO support underwent Impella CP placement to function as an LV vent. Bedside manipulation led to the Impella dislodging into the ascending aorta and kinking in half. Percutaneous rescue was performed in the cardiac catheterization laboratory by snaring the device, and guiding it back into the LV in a controlled fashion restoring normal function. CONCLUSIONS: Bedside manipulation of an Impella is often necessary, but may cause device dislodgement. Re-entry into the LV is challenging and replacement of the device carries significant cost and clinical implications. Radial approach, snare guided repositioning offers an alternative solution to an increasingly encountered challenge.

Percutaneous Salvage of an Impella Pretzel.

This report describes a case in which bedside manipulation of an Impella CP led to device entanglement in the aorta. Using a snare and counter-traction, we were able to untangle and re-deliver it into the left ventricle to restore normal device support. (Level of Difficulty: Advanced.).

Methods for verification of 3D printed anatomic model accuracy using cardiac models as an example.

BACKGROUND: Medical 3D printing has brought the manufacturing world closer to the patient's bedside than ever before. This requires hospitals and their personnel to update their quality assurance program to more appropriately accommodate the 3D printing fabrication process and the challenges that come along with it. RESULTS: In this paper, we explored different methods for verifying the accuracy of a 3D printed anatomical model. Methods included physical measurements, digital photographic measurements, surface scanning, photogrammetry, and computed tomography (CT) scans. The details of each verification method, as well as their benefits and challenges, are discussed. CONCLUSION: There are multiple methods for model verification, each with benefits and drawbacks. The choice of which method to adopt into a quality assurance program is multifactorial and will depend on the type of 3D printed models being created, the training of personnel, and what resources are available within a 3D printed laboratory.

Pre-procedural fit-testing of TAVR valves using parametric modeling and 3D printing.

BACKGROUND: Successful transcatheter aortic valve replacement (TAVR) requires an understanding of how a prosthetic valve will interact with a patient's anatomy in advance of surgical deployment. To improve this understanding, we developed a benchtop workflow that allows for testing of physical interactions between prosthetic valves and patient-specific aortic root anatomy, including calcified leaflets, prior to actual prosthetic valve placement. METHODS: This was a retrospective study of 30 patients who underwent TAVR at a single high volume center. By design, the dataset contained 15 patients with a successful annular seal (defined by an absence of paravalvular leaks) and 15 patients with a sub-optimal seal (presence of paravalvular leaks) on post-procedure transthoracic echocardiogram (TTE). Patients received either a balloon-expandable (Edwards Sapien or Sapien XT, n = 15), or a self-expanding (Medtronic CoreValve or Core Evolut, n = 14, St. Jude Portico, n = 1) valve. Pre-procedural computed tomography (CT) angiograms, parametric geometry modeling, and multi-material 3D printing were utilized to create flexible aortic root physical models, including displaceable calcified valve leaflets. A 3D printed adjustable sizing device was then positioned in the aortic root models and sequentially opened to larger valve sizes, progressively flattening the calcified leaflets against the aortic wall. Optimal valve size and fit were determined by visual inspection and quantitative pressure mapping of interactions between the sizer and models. RESULTS: Benchtop-predicted "best fit" valve size showed a statistically significant correlation with gold standard CT measurements of the average annulus diameter (n = 30, p < 0.0001 Wilcoxon matched-pairs signed rank test). Adequateness of seal (presence or absence of paravalvular leak) was correctly predicted in 11/15 (73.3%) patients who received a balloon-expandable valve, and in 9/15 (60%) patients who received a self-expanding valve. Pressure testing provided a physical map of areas with an inadequate seal; these corresponded to areas of paravalvular leak documented by post-procedural transthoracic echocardiography. CONCLUSION: We present and demonstrate the potential of a workflow for determining optimal prosthetic valve size that accounts for aortic annular dimensions as well as the active displacement of calcified valve leaflets during prosthetic valve deployment. The workflow's open source framework offers a platform for providing predictive insights into the design and testing of future prosthetic valves.

Zero contrast retrograde chronic total occlusions percutaneous coronary intervention: a case series.

INTRODUCTION: Percutaneous coronary intervention (PCI) in patients with advanced chronic kidney disease (CKD) is associated with a high risk of contrast-induced nephropathy and resulting progression of CKD to need for renal replacement therapy. Chronic total occlusions (CTO) PCI is increasingly utilized in the treatment of refractory stable angina and ischaemic heart failure. Recent studies have described the feasibility of 'minimal' or 'zero' contrast PCI by employing intravascular imaging and intra-coronary physiology to guide successful stent implantation with resolution of ischaemia. We extended these techniques to CTO lesions via the retrograde approach. CASE PRESENTATION: Two patients with estimated glomerular filtration rate ≤15 mL/min who presented with angina symptoms and had subsequent positive stress tests were referred for CTO-PCI. The patients had diagnostic angiography with minimal contrast. After a recovery period, the patients underwent successful retrograde zero contrast CTO-PCI with the use of adjunctive intravascular ultrasound imaging. DISCUSSION: The described reports are the first two successful attempts at zero contrast retrograde procedures and demonstrate the feasibility of imaging and physiology-guided retrograde PCI without contrast administration in two patients with significant coronary artery disease requiring intervention. When indicated, zero contrast PCI offers the ability to treat obstructive coronary disease without worsening renal function in patients with severe CKD.

Impact of Aortic Root Anatomy and Geometry on Paravalvular Leak in Transcatheter Aortic Valve Replacement With Extremely Large Annuli Using the Edwards SAPIEN 3 Valve.

OBJECTIVES: The aim of this study was to determine factors affecting paravalvular leak (PVL) in transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: The largest recommended annular area for the 29-mm S3 is 683 mm2. However, experience with S3 TAVR in annuli >683 mm2 has not been widely reported. METHODS: From December 2013 to July 2017, 74 patients across 16 centers with mean area 721 ± 38 mm2 (range: 684 to 852 mm2) underwent S3 TAVR. The transfemoral approach was used in 95%, and 39% were under conscious sedation. Patient, anatomic, and procedural characteristics were retrospectively analyzed. Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Procedural success was 100%, with 2 deaths, 1 stroke, and 2 major vascular complications at 30 days. Post-dilatation occurred in 32%, with final balloon overfilling (1 to 5 ml extra) in 70% of patients. Implantation depth averaged 22.3 ± 12.4% at the noncoronary cusp and 20.7 ± 9.9% at the left coronary cusp. New left bundle branch block occurred in 17%, and 6.3% required new permanent pacemakers. Thirty-day echocardiography showed mild PVL in 22.3%, 6.9% moderate, and none severe. There was no annular rupture or coronary obstruction. Mild or greater PVL was associated with larger maximum annular and left ventricular outflow tract (LVOT) diameters, larger LVOT area and perimeter, LVOT area greater than annular area, and higher annular eccentricity. CONCLUSIONS: TAVR with the 29-mm S3 valve beyond the recommended range by overexpansion is safe, with acceptable PVL and pacemaker rates. Larger LVOTs and more eccentric annuli were associated with more PVL. Longer term follow-up will be needed to determine durability of S3 TAVR in this population.

1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification.

BACKGROUND: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. OBJECTIVES: The goal of this study was to evaluate 1-year outcomes in this registry. METHODS: This study was a multicenter retrospective review of clinical outcomes. RESULTS: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. CONCLUSIONS: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

Assessment of Cardiac Function by Echocardiography.

OPINION STATEMENT: Accurate assessment of cardiac function by transthoracic echocardiography (TTE) plays an essential role in clinical cardiology. While left ventricular ejection fraction (LVEF) assessment has traditionally been the most commonly used objective echocardiographic marker, many other echocardiographic parameters exist that permit an enhanced understanding of cardiac function. These range from 2-dimensional (2D) and 3-dimensional (3D) morphologic parameters to functional parameters such as wall strain and myocardial performance index. In this review, we survey a variety of TTE-based techniques that are utilized in practice to assess the systolic cardiac function of both the left and right ventricles.

Platypnea-orthodeoxia syndrome: an unusual complication of partial liver resection.

Platypnea-orthodeoxia syndrome (POS) is a rare syndrome of severe hypoxemia upon assuming an upright position. It is classically described as shunting from the right atrium to the left atrium usually via a patent foramen ovale (PFO). Alterations in the intrathoracic anatomy after liver resection and regeneration may trigger this condition in patients with clinically silent PFO -a previously unreported cause of POS.