An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study.

BACKGROUND: Guidelines recommend shared decision making when choosing treatment for severe aortic stenosis but implementation has lagged. We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. METHODS: This prospective multi-site pilot cohort study included adults with severe aortic stenosis and their clinicians. Patients were referred by their heart team when scheduled to discuss treatment options. Outcomes included shared decision-making processes, communication quality, decision-making confidence, decisional conflict, knowledge, stage of decision making, decision quality, and perceptions of the tool. Patients were assessed at baseline (T0), after using the intervention (T1), and after the clinical encounter (T2); clinicians were assessed at T2. Before the encounter, patients reviewed the intervention, Aortic Valve Improved Treatment Approaches (AVITA), an interactive, online decision aid. AVITA presents options, frames decisions, clarifies patient goals and values, and generates a summary to use with clinicians during the encounter. RESULTS: 30 patients (9 women [30.0%]; mean [SD] age 70.4 years [11.0]) and 14 clinicians (4 women [28.6%], 7 cardiothoracic surgeons [50%]) comprised 28 clinical encounters Most patients [85.7%] and clinicians [84.6%] endorsed AVITA. Patients reported AVITA easy to use [89.3%] and helped them choose treatment [95.5%]. Clinicians reported the AVITA summary helped them understand their patients' values [80.8%] and make values-aligned recommendations [61.5%]. Patient knowledge significantly improved at T1 and T2 (p = 0.004). Decisional conflict, decision-making stage, and decision quality improved at T2 (p = 0.0001, 0.0005, and 0.083, respectively). Most patients [60%] changed treatment preference between T0 and T2. Initial treatment preferences were associated with low knowledge, high decisional conflict, and poor decision quality; final preferences were associated with high knowledge, low conflict, and high quality. CONCLUSIONS: AVITA was endorsed by patients and clinicians, easy to use, improved shared decision-making quality and helped patients and clinicians arrive at a treatment that reflected patients' values. TRIAL REGISTRATION: Trial ID: NCT04755426, Clinicaltrials.gov/ct2/show/NCT04755426.

What matters most to patients with severe aortic stenosis when choosing treatment? Framing the conversation for shared decision making.

BACKGROUND: Guidelines recommend including the patient's values and preferences when choosing treatment for severe aortic stenosis (sAS). However, little is known about what matters most to patients as they develop treatment preferences. Our objective was to identify, prioritize, and organize patient-reported goals and features of treatment for sAS. METHODS: This multi-center mixed-methods study conducted structured focus groups using the nominal group technique to identify patients' most important treatment goals and features. Patients separately rated and grouped those items using card sorting techniques. Multidimensional scaling and hierarchical cluster analyses generated a cognitive map and clusters. RESULTS: 51 adults with sAS and 3 caregivers with experience choosing treatment (age 36-92 years) were included. Participants were referred from multiple health centers across the U.S. and online. Eight nominal group meetings generated 32 unique treatment goals and 46 treatment features, which were grouped into 10 clusters of goals and 11 clusters of features. The most important clusters were: 1) trust in the healthcare team, 2) having good information about options, and 3) long-term outlook. Other clusters addressed the need for and urgency of treatment, being independent and active, overall health, quality of life, family and friends, recovery, homecare, and the process of decision-making. CONCLUSIONS: These patient-reported items addressed the impact of the treatment decision on the lives of patients and their families from the time of decision-making through recovery, homecare, and beyond. Many attributes had not been previously reported for sAS. The goals and features that patients' value, and the relative importance that they attach to them, differ from those reported in clinical trials and vary substantially from one individual to another. These findings are being used to design a shared decision-making tool to help patients and their clinicians choose a treatment that aligns with the patients' priorities. TRIAL REGISTRATION: ClinicalTrials.gov, Trial ID: NCT04755426, Trial URL https://clinicaltrials.gov/ct2/show/NCT04755426.

Adjunctive endovascular balloon fracture fenestration for chronic aortic dissection.

OBJECTIVE: Positive remodeling after thoracic endovascular aortic repair (TEVAR) for chronic thoracic aortic dissection is variable due to incomplete distal seal and retrograde false lumen perfusion. We assessed the outcomes of adjunctive balloon fracture fenestration (BFF) during TEVAR in patients with chronic aortic dissection complicated by negative remodeling. METHODS: From June 2013 to January 2016, 49 patients with chronic aortic dissection complicated by aneurysm due to negative remodeling underwent TEVAR with BFF. Contrast-enhanced computed tomography was performed before discharge, at 3 to 6 months, and annually. RESULTS: Intraoperatively, endovascular stent graft expansion was achieved in all patients. There was 1 hospital death due to visceral malperfusion related to acute-on-chronic dissection noted before planned BFF. There were no occurrences of paraplegia, 3 patients had stroke, and 3 had acute renal failure. Survival at 1 year was 91%. Late reintervention for incomplete false lumen exclusion was required in 16 patients and freedom from reintervention was 75% at 1 year. Thirty-six patients (73.5%) had complete false lumen thrombosis through the treated segment. True lumen area increased following TEVAR with BFF and continued to incrementally expand with subsequent aortic remodeling at 1-year follow-up. Thirteen patients had positive remodeling, defined as thrombosis of false lumen, ≥10% decrease in aortic dimension, and ≥10% increase in true lumen diameter. Patients with positive remodeling had an average decrease of 11 mm in maximal aortic diameter at final follow-up. CONCLUSIONS: BFF of chronic dissection membrane is a beneficial adjunct to TEVAR during short-term follow-up and may promote positive aortic remodeling and is worthy of further study.

Adjunctive Techniques for Repair of Ischaemic Mitral Regurgitation.

Ischaemic mitral regurgitation is a complex process with debate in the literature as to the optimal treatment pathway. Multiple therapies are available to alleviate mitral regurgitation including medical management, transcatheter edge-to-edge repair, mitral valve repair and mitral valve replacement. Medical management with goal-directed therapy should be utilised in patients with heart failure and mild-to-moderate regurgitation. Transcatheter approaches are typically used in patients with prohibitive operative risk, although their use is expanding, especially in those with functional mitral regurgitation who are not responding to goal-directed medical therapy. It is generally accepted that patients with mild-to-moderate disease can avoid valve intervention if successful revascularisation is performed. A higher consideration should be given to valve replacement over repair in patients with severe mitral regurgitation in the setting of myocardial ischaemia. Operative course must be personalised to each patient, and continues to develop with improving technologies and ongoing research into optimal treatment.

Modeling the impact of delaying transcatheter aortic valve replacement for the treatment of aortic stenosis in the era of COVID-19.

OBJECTIVE: The aim of this study was to model the short term and 2-year overall survival (OS) for intermediate-risk and low-risk patients with severe symptomatic aortic stenosis (AS) undergoing timely or delayed transcatheter aortic valve replacement (TAVR) during the 2019 novel coronavirus (COVID-19) pandemic. METHODS: We developed a decision analysis model to evaluate 2 treatment strategies for both low-risk and intermediate-risk patients with AS during the COVID-19 novel coronavirus pandemic. RESULTS: Prompt TAVR resulted in improved 2-year OS compared with delayed intervention for intermediate-risk patients (0.81 vs 0.67) and low-risk patients (0.95 vs 0.85), owing to the risk of death or the need for urgent/emergent TAVR in the waiting period. However, if the probability of acquiring COVID-19 novel coronavirus is >55% (intermediate-risk patients) or 47% (low-risk patients), delayed TAVR is favored over prompt intervention (0.66 vs 0.67 for intermediate risk; 0.84 vs 0.85 for low risk). CONCLUSIONS: Prompt transcatheter aortic valve replacement for both intermediate-risk and low-risk patients with symptomatic severe AS results in improved 2-year survival when local healthcare system resources are not significantly constrained by the COVID-19.

Intraoperative venous congestion and acute kidney injury in cardiac surgery: an observational cohort study.

BACKGROUND: Increased intravascular volume has been associated with protection from acute kidney injury (AKI), but in patients with congestive heart failure, venous congestion is associated with increased AKI. We tested the hypothesis that intraoperative venous congestion is associated with AKI after cardiac surgery. METHODS: In patients enrolled in the Statin AKI Cardiac Surgery trial, venous congestion was quantified as the area under the curve (AUC) of central venous pressure (CVP) >12, 16, or 20 mm Hg during surgery (mm Hg min). AKI was defined using Kidney Disease Improving Global Outcomes (KDIGO) criteria and urine concentrations of tissue inhibitor of metalloproteinase-2 and insulin-like growth factor binding protein 7 ([TIMP-2]⋅[IGFBP7]), a marker of renal stress. We measured associations between venous congestion, AKI and [TIMP-2]⋅[IGFBP7], adjusted for potential confounders. Values are reported as median (25th-75th percentile). RESULTS: Based on KDIGO criteria, 104 of 425 (24.5%) patients developed AKI. The venous congestion AUCs were 273 mm Hg min (81-567) for CVP >12 mm Hg, 66 mm Hg min (12-221) for CVP >16 mm Hg, and 11 mm Hg min (1-54) for CVP >20 mm Hg. A 60 mm Hg min increase above the median venous congestion AUC above each threshold was independently associated with increased AKI (odds ratio=1.06; 95% confidence interval [CI], 1.02-1.10; P=0.008; odds ratio=1.12; 95% CI, 1.02-1.23; P=0.013; and odds ratio=1.30; 95% CI, 1.06-1.59; P=0.012 for CVP>12, >16, and >20 mm Hg, respectively). Venous congestion before cardiopulmonary bypass was also associated with increased [TIMP-2]⋅[IGFBP7] measured during cardiopulmonary bypass and after surgery, but neither venous congestion after cardiopulmonary bypass nor venous congestion throughout surgery was associated with postoperative [TIMP-2]⋅[IGFBP7]. CONCLUSION: Intraoperative venous congestion was independently associated with increased AKI after cardiac surgery.

Multi-institutional collaborative mock oral (mICMO) examination for cardiothoracic surgery trainees: Results from the pilot experience.

OBJECTIVE: The American Board of Thoracic Surgery-certifying examination is challenging for applicants. Single institutions have reported good results with a mock oral examination (MOE) for trainees. General surgery literature has demonstrated success with in-person multi-institutional MOE examinations. Due to small numbers of cardiothoracic training programs and significant geographic variability, we hypothesized that a multi-institutional, collaborative remotely administered MOE (mICMO) pairing faculty with trainees from different institutions would provide an important educational experience. METHODS: mICMOs were conducted via the Zoom virtual platform across 6 institutions. Descriptive results via post-experience survey were analyzed and reported. RESULTS: In total, 100% of trainees found mICMO useful. The majority would recommend to a peer, and 100% of faculty examiners found mICMO useful and would participate in another examination. CONCLUSIONS: Faculty and trainees found the experience to be effective with respect to creating a high-stakes environment, educationally beneficial, and productive. These results support the continued use of mICMO and encourage expansion and collaboration with additional institutions across the country.

Quantitative three-dimensional echocardiographic analysis of the bicuspid aortic valve and aortic root: A single modality approach.

BACKGROUND: Patients with bicuspid aortic valves (BAV) are heterogeneous with regard to patterns of root remodeling and valvular dysfunction. Two-dimensional echocardiography is the standard surveillance modality for patients with aortic valve dysfunction. However, ancillary computed tomography or magnetic resonance imaging is often necessary to characterize associated patterns of aortic root pathology. Conversely, the pairing of three-dimensional (3D) echocardiography with novel quantitative modeling techniques allows for a single modality description of the entire root complex. We sought to determine 3D aortic valve and root geometry with this quantitative approach. METHODS: Transesophageal real-time 3D echocardiography was performed in five patients with tricuspid aortic valves (TAV) and in five patients with BAV. No patient had evidence of valvular dysfunction or aortic root pathology. A customized image analysis protocol was used to assess 3D aortic annular, valvular, and root geometry. RESULTS: Annular, sinus and sinotubular junction diameters and areas were similar in both groups. Coaptation length and area were higher in the TAV group (7.25 ± 0.98 mm and 298 ± 118 mm2 , respectively) compared to the BAV group (5.67 ± 1.33 mm and 177 ± 43 mm2 ; P = .07 and P = .01). Cusp surface area to annular area, coaptation height, and the sub- and supravalvular tenting indices did not differ significantly between groups. CONCLUSIONS: Single modality 3D echocardiography-based modeling allows for a quantitative description of the aortic valve and root geometry. This technique together with novel indices will improve our understanding of normal and pathologic geometry in the BAV population and may help to identify geometric predictors of adverse remodeling and guide tailored surgical therapy.

Prevalence of and Risk Factors for Permanent Pacemaker Implantation After Aortic Valve Replacement.

BACKGROUND: Damage to the cardiac conduction system requiring permanent pacemaker implantation is a complication of aortic valve replacement (AVR) that may importantly affect quality of life. We investigated the prevalence of and preprocedure risk factors for new permanent pacemakers after surgical (SAVR) and transcatheter AVR (TAVR) at a single institution. METHODS: Preoperative variables and baseline electrocardiograms were reviewed for 5807 patients undergoing elective SAVR, with or without coronary artery bypass grafting, and 1292 undergoing TAVR, with or without percutaneous coronary intervention, from 2006 to 2017 at Cleveland Clinic. Patients with previous permanent pacemakers were excluded. Risk factors for permanent pacemaker implantation were identified using multivariable logistic regression analysis. RESULTS: New permanent pacemakers were implanted in 151 (2.6%) after SAVR and in 125 (9.7%) after TAVR (whole group SAVR vs TAVR, P <.0001). Risk factors for pacemaker implantation after TAVR included preoperative conduction disturbances and type of prosthesis (SAPIEN, 9.5%; SAPIEN XT, 4.8%; SAPIEN 3, 10% [Edwards Lifesciences, Irvine, CA]; CoreValve, 30% [Medtronic, Minneapolis, MN]; and other TAVR, 10%). There were no reliable risk factors for pacemaker implantation after SAVR. Bicuspid valves, mechanical vs bioprosthetic valves, higher Society of Thoracic Surgeons risk score, and concomitant coronary artery bypass grafting were not associated with elevated risk. CONCLUSIONS: At a high-volume institution in the current era, establishing a baseline for pacemaker implantation after AVR is necessary. Preoperative conduction disturbances and transcatheter valve type affect its prevalence. These data provide a benchmark that should be taken into account when considering TAVR in low-risk patients.

Perforation of a mesenteric Meckel's diverticulum.

Meckel's diverticulum is a remnant of the embryologic omphalomeseteric duct and is a common congenital anomaly found in ~2% of the population. The clinical significance of this anomaly is that the persistent diverticulum can lead to intestinal obstruction or diverticulitis and may contain ectopic tissue which can lead to bleeding, ulceration or perforation. The classic location of a Meckel's diverticulum has been described ~40 cm from the ileocecal valve on the antimesenteric side of the distal ileum. There have only been a few documented cases of a Meckel's diverticulum found on the mesenteric border of the ileum. In this report, we describe a patient who presented with a perforated Meckel's diverticulum which was found on the mesenteric border and performed a review to determine the significance of this finding.

Outcomes of a Less-Invasive Approach for Proximal Aortic Operations.

BACKGROUND: Less-invasive techniques have previously been described for mitral and aortic valve operations; however, few studies have examined their benefit for aortic root and ascending aorta reconstruction. Using propensity matching, we compared outcomes of patients undergoing proximal aortic operations through a J incision compared with full sternotomy. METHODS: From January 1995 to January 2014, 8,533 patients underwent proximal aortic operations at Cleveland Clinic. The study population comprised 1,827 patients after those with prior cardiac operations, emergency procedures, endocarditis, or circulatory arrest were excluded; 568 (31%) underwent a J incision. A propensity score based on 57 variables was generated to account for differences in characteristics of full-sternotomy and J-incision patients, producing 483 matched patient pairs (85% of possible) for comparison of outcomes. RESULTS: Among propensity-matched patients, in-hospital mortality (0 [0%] J incision vs 2 [0.41%] full sternotomy; p = 0.2), renal failure (3 [0.62%] vs 6 [1.2%]; p = 0.3), stroke (3 [0.62%] vs 3 [0.62%; p > 0.9), reoperation for bleeding (17 [3.5%] vs 15 [3.1%]; p = 0.7), intraoperative blood products (60 [15%] vs 78 [19%]; p = 0.08), and postoperative transfusions (97 [20%] vs 103 [22%]; p = 0.6) were similar. Intensive care unit (median 24 vs 26 hours) and postoperative hospital stays (median 5.2 vs 6.0 days) were shorter (p < 0.0001) for the J incision, and operative and postoperative direct technical costs were 6% less. CONCLUSIONS: A J incision is a feasible technique for primary isolated elective proximal aortic operations, with a low risk of complications similar to those of full sternotomy, but with the advantages of shorter intensive care unit and hospital stays, lower costs, and better cosmesis.

The value of preoperative 3-dimensional over 2-dimensional valve analysis in predicting recurrent ischemic mitral regurgitation after mitral annuloplasty.

OBJECTIVES: Repair for ischemic mitral regurgitation with undersized annuloplasty is characterized by high recurrence rates. We sought to determine the value of pre-repair 3-dimensional echocardiography over 2-dimensional echocardiography in predicting recurrence at 6 months. METHODS: Intraoperative transesophageal 2-dimensional echocardiography and 3-dimensional echocardiography were performed in 50 patients undergoing undersized annuloplasty for ischemic mitral regurgitation. Two-dimensional echocardiography annular diameter and tethering parameters were measured in the apical 2- and 4-chamber views. A customized protocol was used to assess 3-dimensional annular geometry and regional leaflet tethering. Recurrence (grade ≥2) was assessed with 2-dimensional transthoracic echocardiography at 6 months. RESULTS: Preoperative 2- and 3-dimensional annular geometry were similar in all patients with ischemic mitral regurgitation. Preoperative 2- and 3-dimensional leaflet tethering were significantly higher in patients with recurrence (n = 13) when compared with patients without recurrence (n = 37). Multivariate logistic regression revealed preoperative 2-dimensional echocardiography posterior tethering angle as an independent predictor of recurrence with an optimal cutoff value of 32.0° (area under the curve, 0.81; 95% confidence interval, 0.68-0.95; P = .002) and preoperative 3-dimensional echocardiography P3 tethering angle as an independent predictor of recurrence with an optimal cutoff value of 29.9° (area under the curve, 0.92; 95% confidence interval, 0.84-1.00; P < .001). The predictive value of the 3-dimensional geometric multivariate model can be augmented by adding basal aneurysm/dyskinesis (area under the curve, 0.94; 95% confidence interval, 0.87-1.00; P < .001). CONCLUSIONS: Preoperative 3-dimensional echocardiography P3 tethering angle is a stronger predictor of ischemic mitral regurgitation recurrence after annuloplasty than preoperative 2-dimensional echocardiography posterior tethering angle, which is highly influenced by viewing plane. In patients with a preoperative P3 tethering angle of 29.9° or larger (especially when combined with basal aneurysm/dyskinesis), chordal-sparing valve replacement should be strongly considered.

Preoperative Three-Dimensional Valve Analysis Predicts Recurrent Ischemic Mitral Regurgitation After Mitral Annuloplasty.

BACKGROUND: Valve repair for ischemic mitral regurgitation (IMR) with undersized annuloplasty rings is characterized by high IMR recurrence rates. Patient-specific preoperative imaging-based risk stratification for recurrent IMR would optimize results. We sought to determine if prerepair three-dimensional (3D) echocardiography combined with a novel valve-modeling algorithm would be predictive of IMR recurrence 6 months after repair. METHODS: Intraoperative transesophageal real-time 3D echocardiography was performed in 50 patients undergoing undersized ring annuloplasty for IMR and in 21 patients with normal mitral valves. A customized image analysis protocol was used to assess 3D annular geometry and regional leaflet tethering. IMR recurrence (≥ grade 2) was assessed with two-dimensional transthoracic echocardiography 6 months after repair. RESULTS: Preoperative annular geometry was similar in all IMR patients, and preoperative leaflet tethering was significantly higher in patients with recurrent IMR (n=13) than in patients in whom IMR did not recur (n=37) (tethering index: 3.91 ± 1.01 vs 2.90 ± 1.17, p = 0.008; tethering angles of A3: 23.5° ± 8.9° vs 14.4° ± 11.4°, p = 0.012; P2: 44.4° ± 8.8° vs 28.2° ± 17.0°, p = 0.002; and P3: 35.2° ± 6.0° vs. 18.6° ± 12.7°, p < 0.001). Multivariate logistic regression analysis revealed the preoperative P3 tethering angle as an independent predictor of IMR recurrence with an optimal cutoff value of 29.9° (area under the curve, 0.92; 95% confidence interval, 0.84 to 1.00; p < 0.001). CONCLUSIONS: 3D echocardiography combined with valve modeling is predictive of recurrent IMR. Preoperative regional leaflet tethering of segment P3 is a strong independent predictor of IMR recurrence after undersized ring annuloplasty. In patients with a preoperative P3 tethering angle of 29.9° or larger, chordal-sparing valve replacement rather than valve repair should be strongly considered.

Three-dimensional ultrasound-derived physical mitral valve modeling.

PURPOSE: Advances in mitral valve repair and adoption have been partly attributed to improvements in echocardiographic imaging technology. To educate and guide repair surgery further, we have developed a methodology for fast production of physical models of the valve using novel three-dimensional (3D) echocardiographic imaging software in combination with stereolithographic printing. DESCRIPTION: Quantitative virtual mitral valve shape models were developed from 3D transesophageal echocardiographic images using software based on semiautomated image segmentation and continuous medial representation algorithms. These quantitative virtual shape models were then used as input to a commercially available stereolithographic printer to generate a physical model of the each valve at end systole and end diastole. EVALUATION: Physical models of normal and diseased valves (ischemic mitral regurgitation and myxomatous degeneration) were constructed. There was good correspondence between the virtual shape models and physical models. CONCLUSIONS: It was feasible to create a physical model of mitral valve geometry under normal, ischemic, and myxomatous valve conditions using 3D printing of 3D echocardiographic data. Printed valves have the potential to guide surgical therapy for mitral valve disease.

Feasibility of in vivo human aortic valve modeling using real-time three-dimensional echocardiography.

BACKGROUND: Surgical techniques for aortic valve (AV) repair are directed toward restoring normal structural relationships in the aortic root and rely on detailed assessment of root and valve anatomy. Noninvasive three-dimensional (3D) imaging and modeling may assist in patient selection and operative planning. METHODS: Transesophageal real-time 3D echocardiographic images of 5 patients with normal AVs were acquired. The aortic root and the annulus were manually segmented at end diastole using a 36-point rotational template. The AV leaflets and the coaptation zone were manually segmented in parallel 1-mm cross sections. Quantitative 3D models of the AV and root were generated and used to measure standard anatomic parameters and were compared to conventional two-dimensional echocardiographic measurements. All measurements are given as mean±SD. RESULTS: Annular, sinus, and sinotubular junction areas were 4.1±0.6 cm2, 7.5±1.2 cm2, and 3.9±1.0 cm2, respectively. Root diameters (measured in three locations) by 3D model inspection and two-dimensional echocardiography measurement correlated (R2=0.75). Noncoapted areas of the left, right, and noncoronary leaflets were 1.9±0.2 cm2, 1.6±0.3 cm2, and 1.6±0.3 cm2, respectively. Mean coaptation areas for the left-right, left-noncoronary, and right-noncoronary coaptation zones were 87.7±36.9 mm2, 69.9±20.7 mm2, and 114.2±23.0 mm2, respectively. The mean ratio of noncoapted leaflet area to annular area was 1.3±0.2. CONCLUSIONS: High-resolution 3D models of the in vivo normal human aortic root and valve were generated using 3D echocardiography. Quantitative 3D models and analysis may assist in characterization of pathology and decision making for AV repair.