Comprehensive Training Model for Procedural Guidance of Transcatheter Mitral Valve Edge-to-Edge Repair: Divide and Conquer Approach.

Transcatheter edge-to-edge repair (TEER) of the mitral valve is a complex procedure requiring continuous image guidance with 2-dimensional and 3-dimensional transesophageal echocardiography. In this context, the role of the echocardiographer is of paramount importance. Training in interventional echocardiography for procedures such as TEER requires comprehending the complicated workflow of the hybrid operating room and advanced imaging skills that go beyond traditional echocardiography training to guide the procedure. Despite TEER being more commonly performed, the training structure for interventional echocardiographers is lagging, with many practitioners not having any formal training in image guidance for this procedure. In this context, novel training strategies must be developed to increase exposure and aid training. In this review, the authors present a step-wise approach to training for image guidance during TEER of the mitral valve. The authors have deconstructed this complex procedure into modular components and have incremental stages of training based on different steps of the procedure. At each step, trainees must demonstrate proficiency before advancing to the next step, thus ensuring a more structured approach to attaining proficiency in this complex procedure.

The Many Faces of the Interatrial Septum: A Diagnostic Dilemma and Considerations for Defect Closure Device Selection.

PATENT FORAMEN ovales (PFOs) and atrial septal defects (ASDs) are 2 examples of interatrial septal pathology.1 The presence of a PFO is a well-known risk factor for cryptogenic stroke.1,2 Newer evidence over the course of the last decade suggests percutaneous device closure of PFOs significantly reduces the subsequent risk of recurrent stroke.2 Among ASDs, the ostium secundum type is the most common pathology and, due to its anatomy, is most amenable to transcatheter closure.1 The tools that are available to percutaneously close these different pathologies vary, and choosing the correct device for the procedure can have significant impact on the clinical outcome. The authors here present a case that highlights how the differentiation of an ASD from a PFO using 2-dimensional (2D) and 3-dimensional (3D) echocardiography can affect the clinical decision-making and outcome in a challenging structural heart disease case.

Curriculum for Subspecialty Anesthesia Training in Adult Structural Heart Disease Imaging: A Single-Center Experience.

Intraprocedural transesophageal echocardiography imaging is an integral part of percutaneous structural heart disease (SHD) interventions. The rapid growth in the number, scope, and complexity of SHD interventions has outpaced the efforts to develop training and proficiency standards in periprocedural imaging. At the Beth Israel Deaconess Medical Center in Boston, Massachusetts, the authors have developed a 6-month duration fellowship in interventional echocardiography for SHD to address this issue. The purpose of this fellowship is to train cardiac anesthesiologists to address the unique challenges of interventional echocardiography. In this paper, the authors describe the rationale for and specific features of this training program. Their fellowship curriculum follows a multimodal integrative approach to training in SHD imaging, which includes simulation sessions, online modules, deliberate practice in the clinical setting, and interdisciplinary team-based training. In the next several years, there will be an increased need for echocardiographers who are proficient in intraprocedural SHD imaging. In this article, the authors describe their experience with a competency-based curriculum for subspecialty anesthesia training in SHD imaging.

CoreValve bioprosthesis dysfunction treated with a Sapien 3 valve-in-valve transcatheter aortic valve replacement and BASILICA technique.

Structural deterioration of transcatheter heart valve (THV) has been previously described. With the expansion of transcatheter aortic valve replacement (TAVR) indications toward treating lower risk patients with longer life expectancy, there will be increased necessity of managing the patients with THV dysfunction including those at risk for coronary obstruction or sinus sequestration. Coronary access also remains a challenge in such cases with THV dysfunction undergoing valve-in-transcatheter heart valve (ViTHV) TAVR. A unique and first reported case of THV deterioration treated with Sapien 3 ViTHV-TAVR inside a 31 mm CoreValve bioprosthesis along with left coronary leaflet laceration using the BASILICA technique has been presented.

Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.

OBJECTIVES: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001). CONCLUSIONS: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.

Transcatheter mitral valve-in-valve-in-valve replacement with transseptal puncture in the presence of an atrial septal occluder device.

Quite often the iatrogenic atrial septal defect created after percutaneous transcatheter mitral valve replacement procedures is closed with an atrial septal occluder device thus precluding further transseptal interventions if required. In this case report, we describe a patient who previously underwent a valve-in-valve transcatheter mitral valve replacement and iatrogenic atrial septal defect closure with an Amplatzer device, who developed severe prosthetic mitral valve stenosis. This patient required a second percutaneous valve-in-valve in-valve procedure with a transseptal puncture in the presence of an atrial septal occluder device.

Long-term clinical safety and efficacy of drug-coated balloon in the treatment of in-stent restenosis: A meta-analysis and systematic review.

OBJECTIVES: The aim of this study was to evaluate the long-term clinical safety and efficacy of drug-coated balloon (DCB) in the treatment of in-stent restenosis (ISR). BACKGROUND: There is a long-term safety issue in peripheral arterial disease patients treated with paclitaxel-coated balloon, this has also raised concerns on DCB in coronary intervention. METHODS: Nine randomized controlled trials (RCTs) and nine observational studies (OSs) were included with a total of 3,782 patients (1,827 in the DCB group, 1,955 in the drug-eluting stent [DES] group) being analyzed. The primary outcome measure-major adverse cardiovascular events (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), cardiac death (CD), stent thrombosis (ST), all-cause death (AD), and coronary angiography outcomes included late lumen loss (LLL), minimum luminal diameter (MLD), diameter stenosis (DS) were analyzed. RESULTS: DCB treatment significantly reduced the LLL (MD: -0.13; [CI -0.23 to -0.03], p = .01). No difference was found for MLD (MD: -0.1; [CI -0.24 to 0.04], p = .17) and DS% (RR = 0.98 [CI 0.80-1.20], p = .86). There was no significant difference in TLR, TVR, MI, CD, ST, AD, and the overall incidence of MACEs between the two groups up to 3 years follow-up. Subgroup analysis for different type of ISR and DES showed no significant difference in the incidence of endpoints, and there is no difference when considering RCTs or OSs only. CONCLUSIONS: The safety and efficacy of the DCB and DES in the treatment of ISR is comparable at up to 3 years follow-up.

Comparative utility of frailty to a general prognostic score in identifying patients at risk for poor outcomes after aortic valve replacement.

BACKGROUND: Current guidelines recommend considering life expectancy before aortic valve replacement (AVR). We compared the performance of a general mortality index, the Lee index, to a frailty index. METHODS: We conducted a prospective cohort study of 246 older adults undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) at a single academic medical center. We compared performance of the Lee index to a deficit accumulation frailty index (FI). Logistic regression was used to assess the association of Lee index or FI with poor outcome, defined as death or functional decline with severe symptoms at 12 months. Discrimination was assessed using C-statistics. RESULTS: In the overall cohort, 44 experienced poor outcome (31 deaths, 13 functional decline with severe symptoms). The risk of poor outcome by Lee index quartiles was 6.8% (reference), 17.9% (odds ratio [OR], 3.0; 95% confidence interval, [0.9-10.2]), 20.0% (OR 3.4; [1.0-11.4]), and 34.0% (OR 7.1; [2.2-22.6]) (p-for-trend = 0.001). Risk of poor outcome by FI quartiles was 3.6% (reference), 10.3% (OR 3.1; [0.6-15.8]), 25.0% (OR 8.8; [1.9-41.0]), and 37.3% (OR 15.8; [3.5-71.1]) (p-for-trend< 0.001). The Lee index predicted the risk of poor outcome in the SAVR cohort Lee index (quartiles 1-4: 2.1, 4.0, 15.4, and 20.0%; p-for-trend = 0.04), but not in the TAVR cohort (quartiles 1-4: 27.3, 29.0, 21.3, 35.4%; p-for-trend = 0.42). In contrast, the FI did not predict the risk of poor outcome well in the SAVR cohort (quartiles 1-4: 2.3, 4.4, 15.8, and 0%; p-for-trend = 0.24), however in the TAVR cohort (quartiles 1-4: 9.1, 14.3, 29.7, and 40.7%; p-for-trend = 0.004). Compared to the Lee index, an FI demonstrated higher C-statistics in the overall (Lee index versus FI: 0.680 versus 0.735; p = 0.03) and TAVR (0.560 versus 0.644; p = 0.03) cohorts, but not SAVR cohort (0.724 versus 0.766; p = 0.09). CONCLUSIONS: While a general mortality index Lee index predicted death or functional decline with severe symptoms at 12 months well among SAVR patients, the FI derived from a multi-domain geriatric assessment better informs risk-stratification for high-risk TAVR patients.

Prognostic Value of Combined CT Angiography and Myocardial Perfusion Imaging versus Invasive Coronary Angiography and Nuclear Stress Perfusion Imaging in the Prediction of Major Adverse Cardiovascular Events: The CORE320 Multicenter Study.

Purpose To compare the prognostic importance (time to major adverse cardiovascular event [MACE]) of combined computed tomography (CT) angiography and CT myocardial stress perfusion imaging with that of combined invasive coronary angiography (ICA) and stress single photon emission CT myocardial perfusion imaging. Materials and Methods This study was approved by all institutional review boards, and written informed consent was obtained. Between November 2009 and July 2011, 381 participants clinically referred for ICA and aged 45-85 years were enrolled in the Combined Noninvasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Row Computed Tomography (CORE320) prospective multicenter diagnostic study. All images were analyzed in blinded independent core laboratories, and a panel of physicians adjudicated all adverse events. MACE was defined as revascularization (>30 days after index ICA), myocardial infarction, or cardiac death; hospitalization for chest pain or congestive heart failure; or arrhythmia. Late MACE was defined similarly, except for patients who underwent revascularization within the first 182 days after ICA, who were excluded. Comparisons of 2-year survival (time to MACE) used standard Kaplan-Meier curves and restricted mean survival times bootstrapped with 2000 replicates. Results An MACE (49 revascularizations, five myocardial infarctions, one cardiac death, nine hospitalizations for chest pain or congestive heart failure, and one arrhythmia) occurred in 51 of 379 patients (13.5%). The 2-year MACE-free rates for combined CT angiography and CT perfusion findings were 94% negative for coronary artery disease (CAD) versus 82% positive for CAD and were similar to combined ICA and single photon emission CT findings (93% negative for CAD vs 77% positive for CAD, P < .001 for both). Event-free rates for CT angiography and CT perfusion versus ICA and single photon emission CT for either positive or negative results were not significantly different for MACE or late MACE (P > .05 for all). The area under the receiver operating characteristic curve (AUC) for combined CT angiography and CT perfusion (AUC = 68; 95% confidence interval [CI]: 62, 75) was similar (P = .36) to that for combined ICA and single photon emission CT (AUC = 71; 95% CI: 65, 79) in the identification of MACE at 2-year follow-up. Conclusion Combined CT angiography and CT perfusion enables similar prediction of 2-year MACE, late MACE, and event-free survival similar to that enabled by ICA and single photon emission CT. © RSNA, 2017 Online supplemental material is available for this article.

Computed tomography angiography and perfusion to assess coronary artery stenosis causing perfusion defects by single photon emission computed tomography: the CORE320 study.

AIMS: To evaluate the diagnostic power of integrating the results of computed tomography angiography (CTA) and CT myocardial perfusion (CTP) to identify coronary artery disease (CAD) defined as a flow limiting coronary artery stenosis causing a perfusion defect by single photon emission computed tomography (SPECT). METHODS AND RESULTS: We conducted a multicentre study to evaluate the accuracy of integrated CTA-CTP for the identification of patients with flow-limiting CAD defined by ≥50% stenosis by invasive coronary angiography (ICA) with a corresponding perfusion deficit on stress single photon emission computed tomography (SPECT/MPI). Sixteen centres enroled 381 patients who underwent combined CTA-CTP and SPECT/MPI prior to conventional coronary angiography. All four image modalities were analysed in blinded independent core laboratories. The prevalence of obstructive CAD defined by combined ICA-SPECT/MPI and ICA alone was 38 and 59%, respectively. The patient-based diagnostic accuracy defined by the area under the receiver operating characteristic curve (AUC) of integrated CTA-CTP for detecting or excluding flow-limiting CAD was 0.87 [95% confidence interval (CI): 0.84-0.91]. In patients without prior myocardial infarction, the AUC was 0.90 (95% CI: 0.87-0.94) and in patients without prior CAD the AUC for combined CTA-CTP was 0.93 (95% CI: 0.89-0.97). For the combination of a CTA stenosis ≥50% stenosis and a CTP perfusion deficit, the sensitivity, specificity, positive predictive, and negative predicative values (95% CI) were 80% (72-86), 74% (68-80), 65% (58-72), and 86% (80-90), respectively. For flow-limiting disease defined by ICA-SPECT/MPI, the accuracy of CTA was significantly increased by the addition of CTP at both the patient and vessel levels. CONCLUSIONS: The combination of CTA and perfusion correctly identifies patients with flow limiting CAD defined as ≥50 stenosis by ICA causing a perfusion defect by SPECT/MPI.

Ethanol promotes arteriogenesis and restores perfusion to chronically ischemic myocardium.

BACKGROUND: Moderate alcohol consumption is known to be cardioprotective compared with either heavy drinking or complete abstinence. We assessed the hypothesis that ethanol supplementation would improve myocardial function in the setting of chronic ischemia. METHODS AND RESULTS: Sixteen male Yorkshire swine underwent placement of an ameroid constrictor into the left circumflex artery to induce chronic myocardial ischemia. Postoperatively, animals were supplemented with either 90 mL of ethanol (EtOH) daily (50%/V, EtOH) or 80 g of sucrose of equal caloric value (SUC), serving as controls. Seven weeks after ameroid placement, arteriolar density (1.74 ± 0.210% versus 3.11 ± 0.368% area of arterioles per low-powered field in sucrose (SUC) versus EtOH; P=0.004), myocardial perfusion (ratio of blood flow to the at-risk myocardium compared with the normal ventricle during demand pacing was 0.585 ± 0.107 versus 1.08 ± 0.138 for SUC versus EtOH; P=0.014), and microvascular reactivity were significantly increased in ethanol-treated animals compared with controls in the at-risk myocardium. Analysis of vascular endothelial growth factor and NOTCH pathway signaling suggested proneovascular and proliferative activity in the ischemic area. The average peak blood alcohol level in the treatment group was 40 ± 4 mg/dL, consistent with levels of moderate drinking in humans. CONCLUSIONS: Ethanol supplementation increased arteriolar density and significantly improved myocardial perfusion and endothelium-dependent vasorelaxation in chronically ischemic myocardium. These findings suggest that, at moderate doses, ethanol directly promotes vasculogenesis and improves microvascular function, resulting in significant improvements in myocardial perfusion in the setting of chronic ischemia.

Aortic Valve Replacement: Hemodynamic Consequences and Impact on Coronary Perfusion Pressure.

Implantation of prosthetic heart valves may result in both early and late complications. Early complications are usually structural and can have significant hemodynamic consequences. In this clinical vignette, we highlight how malposition of a newly implanted aortic valve resulted in alterations of coronary perfusion pressure physiology and subsequent significant hemodynamic effects.

Five-Year Follow-Up from the CoreValve Expanded Use Transcatheter Aortic Valve-in-Surgical Aortic Valve Study.

Transcatheter aortic valve replacement (TAVR) provides an option for extreme-risk patients who underwent reoperation for a failed surgical aortic bioprosthesis. Long-term data on patients who underwent TAVR within a failed surgical aortic valve (TAV-in-SAV) are limited. The CoreValve Expanded Use Study evaluated patients at extreme surgical risk who underwent TAV-in-SAV. Outcomes at 5 years were analyzed by SAV failure mode (stenosis, regurgitation, or combined). Echocardiographic outcomes are site-reported. TAV-in-SAV was attempted in 226 patients with a mean age of 76.7 ± 10.8 years; 63.3% were male, the Society of Thoracic Surgeons predicted risk of mortality score was 9.0 ± 6.7%, and 87.5% had a New York Heart Association classification III or IV symptoms. Most of the failed surgical bioprostheses were stented (81.9%), with an average implant duration of 10.2 ± 4.3 years. The 5-year all-cause mortality or major stroke rate was 47.2% in all patients; 54.4% in the stenosis, 37.6% in the regurgitation, and 38.0% in the combined groups (p = 0.046). At 5 years, all-cause mortality was higher in patients with versus without 30-day severe prosthesis-patient mismatch (51.7% vs 38.3%, p = 0.026). The overall aortic valve reintervention rate was 5.9%; highest in the regurgitation group (12.6%). The mean aortic valve gradient was 14.1 ± 9.8 mm Hg and effective orifice area was 1.57 ± 0.70 at 5 years. Few patients had >mild paravalvular regurgitation at 5 years (5.5% moderate, 0.0% severe). TAV-in-SAV with supra-annular, self-expanding TAVR continues to represent a safe and lasting intermediate option for extreme-risk patients who have appropriate sizing of the preexisting failed surgical valve. Clinical and hemodynamic outcomes were stable through 5 years.

Effects of red wine and vodka on collateral-dependent perfusion and cardiovascular function in hypercholesterolemic swine.

BACKGROUND: Moderate consumption of alcohol, particularly red wine, has been shown to decrease cardiac risk. We used a hypercholesterolemic swine model of chronic ischemia to examine the effects of 2 alcoholic beverages on the heart. METHODS AND RESULTS: Yorkshire swine fed a high-cholesterol diet underwent left circumflex ameroid constrictor placement to induce chronic ischemia at 8 weeks of age. One group (HCC, n=9) continued on the diet alone, the second (HCW, n=8) was supplemented with red wine (pinot noir, 12.5% alcohol, 375 mL daily), and the third (HCV, n=9) was supplemented with vodka (40% alcohol, 112 mL daily). After 7 weeks, cardiac function was measured, and ischemic myocardium was harvested for analysis of perfusion, myocardial fibrosis, vessel function, protein expression, oxidative stress, and capillary density. Platelet function was measured by aggregometry. Perfusion to the ischemic territory as measured by microsphere injection was significantly increased in both HCW and HCV compared with HCC at rest, but in only the HCW group under ventricular pacing. Microvessel relaxation response to adenosine 5'-diphosphate was improved in the HCW group alone as was regional contractility in the ischemic territory, although myocardial fibrosis was decreased in both HCW and HCV. Expression of proangiogenic proteins phospho-endothelial nitric oxide synthase and vascular endothelial growth factor was increased in both HCW and HCV, whereas phospho-mammalian target of rapamycin was increased only in the HCV group. Expression of Sirt-1 and downstream antioxidant phospho-FoxO1 was increased only in the HCW group. Protein oxidative stress was decreased in the HCW group alone, whereas capillary density was increased only in the HCV group. There was no significant difference in platelet function between groups. CONCLUSION: Moderate consumption of red wine and vodka may reduce cardiovascular risk by improving collateral-dependent perfusion through different mechanisms. Red wine may offer increased cardioprotection related to its antioxidant properties.

Intracardiac echocardiography and fluoroscopy guided percutaneous left ventricular pseudoaneurysm closure.

Left ventricular (LV) pseudoaneurysm is a rare complication after myocardial infarction and cardiac surgery. Standard treatment remains surgical correction; however, percutaneous closure has been attempted in high risk surgical patients. We report a case of three dimensional echocardiography and cardiac CT defined LV pseudoaneurysm which was closed percutaneously using intracardiac echocardiography (ICE) and fluoroscopy guidance. Appropriate planning and guidance proved essential to the procedure with an excellent outcome. Percutaneous closure of LV pseudoaneurysms is safe and feasible in high risk surgical patients and with appropriate imaging modalities may be an alternative to surgical correction.

Site-Level Variation and Predictors of Permanent Pacemaker Implantation Following TAVR in the Evolut Low-Risk Trial.

We evaluated predictors of permanent pacemaker implantation (PPI) following self-expanding transcatheter aortic valve replacement (TAVR), examined site-to-site variability of PPI rates, and explored the relationship of implantation methods on the need for PPI. Despite the benefits of TAVR compared to surgical aortic valve replacement, increased PPI remains a limitation. A total of 699 patients without baseline PPI were included in the study. Clinical, echocardiographic, and procedural characteristics were compared in patient with and without new PPI. Clinical outcomes were assessed at 30 days and 1 year. Funnel plots were constructed to display site-to- site variability and identify outliers in PPI. Clinical outcomes were similar in patients with and without PPI. Predictors of a new PPI within 7 days included a baseline right bundle branch block (p < 0.001) and not using general anesthesia (p = 0.003). There was substantial site to site variability in the rate of PPI. Patients at sites with a lower PPI rate had shallower implantation depth at the non-coronary (p < 0.001) and the left coronary sinus (p < 0.001), and fewer patients with an implantation depth > 5 mm below the annulus (p = 0.004). In low-risk patients undergoing TAVR with Evolut valves, baseline conduction disorders and implant depth were important predictors of PPI. Implantation method may have contributed to this variability in PPI rates across clinical sites.

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement.

Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40 mm Hg, peak aortic velocity >3 and <4 m/s, and aortic valve area >1.0 and <1.5 cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30 days and 1 year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4 years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8 mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7 cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30 days and 1 year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1 year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.