Bicuspid aortic valve associated aortopathy: 2022 guideline update.

PURPOSE OF REVIEW: Bicuspid aortic valve (BAV) disease is observed in 1-2% of the general population. In addition to valve-related complications (such as aortic stenosis and aortic regurgitation), individuals with BAV often develop dilatation of the proximal aorta (aortic root and ascending aorta), a condition termed BAV aortopathy. The development of BAV aortopathy can occur independent of valvular alterations and can lead to aneurysm formation, aortic dissection or aortic rupture. This review aims to update the clinician with an approach to BAV aortopathy decision making in keeping with the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline recommendations. RECENT FINDINGS: The ACC/AHA 2022 guidelines provide a contemporary and comprehensive approach to the diagnosis and treatment of aortic pathologies. We review the thresholds for replacement of the aortic root and/or ascending aorta along with the strength and level of evidence recommendations. We also review the various Class 2A and 2B recommendations for earlier intervention, which emphasize the importance of experienced surgeons, and multidisciplinary aortic teams (MATs). SUMMARY: BAV aortopathy is a common and heterogenous clinical problem. The decision making around timing of intervention requires a personalized approach that is based on the aortic dimensions, valve function, rate of growth, family history, patient factors, and surgical experience within MATs.

Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study.

BACKGROUND: Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system. OBJECTIVES: We report 3-year outcomes from the multinational, prospective, single-arm CLASP study with analysis by functional MR (FMR) and degenerative MR (DMR). METHODS: Patients with core-lab determined MR ≥ 3+ were deemed candidates for M-TEER by the local heart team. Major adverse events were assessed by an independent clinical events committee to 1 year and by sites thereafter. Echocardiographic outcomes were evaluated by the core laboratory to 3 years. RESULTS: The study enrolled 124 patients, 69% FMR; 31% DMR (60% NYHA class III-IVa, 100% MR ≥ 3+). The 3-year Kaplan-Meier estimate for survival was 75% (66% FMR; 92% DMR) and freedom from heart failure hospitalization (HFH) was 73% (64% FMR; 91% DMR), with 85% reduction in annualized HFH rate (81% FMR; 96% DMR) (p < 0.001). MR ≤ 2+ was achieved and maintained in 93% of patients (93% FMR; 94% DMR) and MR ≤ 1+ in 70% of patients (71% FMR; 67% DMR) (p < 0.001). The mean left ventricular end-diastolic volume (181 mL at baseline) decreased progressively by 28 mL [p < 0.001]. NYHA class I/II was achieved in 89% of patients (p < 0.001). CONCLUSIONS: The 3-year results from the CLASP study demonstrated favorable and durable outcomes with the PASCAL transcatheter valve repair system in patients with clinically significant MR. These results add to the growing body of evidence establishing the PASCAL system as a valuable therapy for patients with significant symptomatic MR.

Eight-year outcomes of aortic valve replacement with the Carpentier-Edwards PERIMOUNT Magna Ease valve.

INTRODUCTION: The Carpentier-Edwards PERIMOUNT Magna Ease valve is a third-generation bioprosthesis for aortic valve replacement (AVR). This is a postapproval study reporting on its 8-year outcomes. METHODS: Adults undergoing AVR with the Magna Ease valve between October 2007 and December 2012 were enrolled for this prospective, nonrandomized, single-arm, and multicenter study. Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and annually thereafter for up to 8 years. Outcomes included safety endpoints, hemodynamic performance, and New York Heart Association (NYHA) functional class. RESULTS: Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% were in NYHA Class III or IV at baseline. Concomitant procedures were performed in 44.2%. Total follow-up was 1597.6 patient-years, and median follow-up was 7 years (interquartile range: 5.5-8.0 years). Eight years following AVR, the functional class remained improved from baseline with 93.9% in NYHA Class I/II and 6.1% in NYHA Class III; 38 deaths had occurred, 8 of which were valve related; freedom from all-cause mortality was 80.7% (95% confidence intervals: 74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom from reintervention, explant, major bleeding events, and structural valve deterioration was 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 90.1% (84.7, 95.4), respectively; effective orifice area was 1.5 ± 0.5 cm2 , the mean gradient was 14.8 ± 8.3 mmHg, and 88.6% of patients had no or trivial aortic regurgitation. CONCLUSIONS: This study demonstrated satisfactory safety and sustained hemodynamic and functional improvements at 8 years following AVR with the Magna Ease valve.

In vivo analysis of a proprietary glass-based adhesive for sternal fixation and stabilization using rabbit and sheep models.

Wire cerclage remains the standard method of care for sternal fixation, following median sternotomy, despite being beset with complications. An emerging treatment option has been to augment the wires with an adhesive. A patented ionomeric glass (mole fraction: SiO2:0.48, ZnO:0.36, CaO:0.12, SrO:0.04) has been used to formulate GPC+, a glass polyalkenoate cement (GPC), by mixing it with poly(acrylic) acid (PAA) and de-ionized water. In a human cadaver study, this material, when applied with wire cerclage, was able to significantly reduce sternal instability. However, the material has yet to be tested in pertinent animal models. Here, after a series of physical and mechanical tests to confirm suitability of the experimental material for implantation, three samples of GPC+ were implanted in either the tibia or femur of three different rabbits, alongside sham defects, for two different time modalities. A further seven samples of GPC+ and one poly(methyl methacrylate) control (PMMA) were implanted in either the tibia or femur of two different sheep. The sheep containing the PMMA was sacrificed at 8 weeks and the other at 16 weeks, to evaluate time dependent biological response. Upon sacrifice, microCT images were acquired and histology slides prepared for analysis. All three GPC+ samples implanted in the rabbit model, for the two time modalities, were characterized by minimal bone resorption along with a mild inflammatory response. Five of the seven GPC+ materials implanted in the sheep model (all three implanted for 8 weeks and two of those implanted for 16 weeks) were associated with mild to moderate immune response, comparable to that observed with PMMA, as well as mild bone resorption. The remaining two GPC + materials (implanted in the sheep model for 16 weeks) exhibited no bone resorption or inflammatory response and appeared to stimulate increased bone density at the implant site. These results suggest that GPC + can be a viable bone adhesive for use in hard tissue applications such as sternal fixation and stabilization. Experiments performed to synthesize & test Sr-doped glass adhesive for sternal fixation. (1) Sr-doped ionomeric glass fired, ground down and mixed with aqueous polyacrylic acid to produce the adhesive. (2) Adhesive characterized and tested by a suite of laboratory-based tests to ensure suitability for implantation. (3) Adhesive implanted into a rabbit model (distal femur, 12 weeks post implantation) where micro-CT images confirmed an excellent bone/cement interface, no evidence of bone resorption and some bone remodelling. (4) Adhesive subsequently implanted into a sheep model; at 16-weeks, a continuous bone-adhesive interface is seen suggesting no bone resorption. There was an increase in the peri-implant radiodensity, suggesting enhanced mineral content of the bone surrounding the GPC+ implant.

The state of transcatheter aortic valve implantation training in Canadian cardiac surgery residency programs.

BACKGROUND: The current state of transcatheter aortic valve implantation (TAVI) training for Canadian cardiac surgical residents is unknown. Our goals were to establish a national inventory of TAVI educational resources, elucidate the role of residents in TAVI programs, and determine the attitudes and perspectives of residents and program directors regarding the importance of TAVI technology and training. METHODS: We sent Web-based surveys and reminders to all Canadian cardiac surgical residents and program directors between February and July 2017. We used descriptive analyses to summarize data in an aggregate and anonymous manner. We analyzed patterned responses to open-ended survey questions using thematic analysis. RESULTS: Seventy-eight of 92 residents (85%) and 11 of 12 program directors (92%) completed the survey, with broad representation from across Canada. A minority of residents (14 [18%]) and program directors (4 [36%]) reported that TAVI training in their program was adequate. Only 3 program directors (27%) reported that their residents had access to TAVI simulation training. Although most residents (76 [97%]) and program directors (10 [91%]) agreed that TAVI was important to the trainee's future practice, about two-thirds (54 [69%] and 7 [64%], respectively) agreed that TAVI should be a focus of fellowship training. A perceived lack of interest from interventional cardiologists to teach surgical residents, competition from TAVI fellows and lack of formalized time during residency were identified as perceived barriers to TAVI training. CONCLUSION: As Canadian surgical residency training moves toward a Competence by Design curriculum, there remains a pressing need to create uniform learning objectives and expectations in the TAVI curriculum.

CONTEXTE: On ne connaît pas l'état actuel de la formation en implantation transcathéter de valvule aortique (ITVA) que reçoivent les médecins résidents dans les programmes canadiens de chirurgie cardiaque. Nous voulions dresser un inventaire national des ressources pédagogiques en ITVA, expliquer le rôle des médecins résidents dans les programmes d'ITVA et déterminer les attitudes et les points de vue des résidents et des directeurs de programme quant à l'importance de la technologie d'ITVA et de la formation en la matière. MÉTHODES: Entre février et juillet 2017, nous avons envoyé des sondages web et des rappels à tous les médecins résidents en chirurgie cardiaque et aux directeurs de ces programmes au Canada. Nous avons utilisé des analyses descriptives pour résumer les données de façon agrégée et anonyme. Nous avons analysé les réponses à des questions ouvertes et dégagé des tendances au moyen d'une analyse thématique. RÉSULTATS: Soixante-dix-huit des 92 résidents (85 %) et 11 des 12 directeurs de programme (92 %) ont répondu au sondage, avec une vaste représentation de partout au Canada. Une minorité de résidents (14 [18 %]) et de directeurs de programme (4 [36 %]) ont déclaré que la formation en ITVA offerte par leur programme était adéquate. Seuls 3 directeurs de programme (27 %) ont déclaré que leurs résidents avaient accès à une formation en simulation de l'ITVA. Bien que la plupart des résidents (76 [97 %]) et des directeurs de programme (10 [91 %]) soient d'accord pour dire que l'ITVA est importante pour la pratique future du stagiaire, environ les deux tiers (54 [69 %] et 7 [64 %], respectivement) sont d'avis que la formation à l'ITVA devrait faire l'objet d'un stage particulier. Un manque perçu d'intérêt de la part des cardiologues interventionnels pour l'enseignement aux médecins résidents en chirurgie, la compétition entre les stagiaires pour la formation à l'ITVA et le manque de temps officiellement réservé à ce volet pendant la résidence ont été identifiés comme des obstacles perçus à la formation en ITVA. CONCLUSION: À mesure que les programmes de résidence en chirurgie au Canada s'orientent vers une formation axée sur les compétences par conception, il demeure urgent de formuler des objectifs et des attentes d'apprentissage uniformes pour la formation en ITVA.

Year in review: complex valve reconstruction.

PURPOSE OF REVIEW: In recent years, great emphasis has been placed on reconstructive techniques for the surgical management of heart valve disease. In this review, we discuss recent data and current practice as it pertains to the subject of reconstructive valve surgery. RECENT FINDINGS: New techniques and an improved understanding of the mechanisms of aortic insufficiency have led to marked improvement in the early and late outcomes of aortic valve repair. While mitral valve repair is the established approach for the management of degenerative mitral valve disease, surgical technique continues to be refined, with valve reconstruction principles applied to increasingly challenging anatomy. Moreover, the introduction of novel biomaterials has allowed extension of the indication for valve reconstruction to circumstances of extensive tissue defect, including infective endocarditis. SUMMARY: Valve reconstruction is increasingly being recognized as an alternative to valve replacement. It alleviates the risks of prosthesis-related complications and is especially appealing in young and middle-aged adults. While early and midterm outcomes appear promising, further studies are warranted to assess the clinical benefit and long-term durability of complex valve reconstruction procedures.

Year in review: transcatheter aortic valve replacement.

PURPOSE OF REVIEW: Transcatheter aortic valve replacement (TAVR) has been effective in prohibitive/high-risk patients. Expansion toward intermediate or even low-risk patients has been proposed. A review of recent developments will help understand current trends and issues. RECENT FINDINGS: The 5-year results from the PARTNER I trial and 2-year results of the CoreValve US Pivotal Trial, together with national registries, confirmed the long-term efficacy and durability of TAVR. Studies including PARTNER II, ADVANCE, and The German Aortic Valve Registry showed short-to mid-term success in intermediate-risk patients. Comparison of balloon-expandable and self-expanding valves in the CHOICE trial associated specific outcome differences with specific valve types, suggesting a more customized approach in valve selection. Short-term results of newer-generation valves have demonstrated excellent safety and efficacy with improved designs. Studies on TAVR-specific complications, such as conduction block and arrhythmia, paravalvular aortic regurgitation, and stroke, have renewed ideas about their prognosis, treatment, and prevention. Conscious sedation percutaneous TAVR has become more popular, with excellent outcomes and improved cost savings. SUMMARY: TAVR has been accepted as an effective treatment even for intermediate-risk patients. This article aims to review the most recent results and essential issues.

Cut-off values for transit time flowmetry: are the revision criteria appropriate?

BACKGROUND: Graft Imaging to Improve Patency (GRIIP), a single-center, randomized blinded clinical trial, reported that intraoperative graft assessment with graft revision according to a priori criteria of transit time flowmetry (TTF) and intraoperative fluorescent angiography did not improve graft patency at one year after coronary artery bypass grafting (CABG) when compared with standard intraoperative management. The objective of this study is to investigate whether other TTF values are more predictive of the saphenous vein graft (SVG) failure and/or clinical outcomes. METHODS: This is a case control retrospective study of 65 SVGs from 44 patients from GRIIP. Study outcomes were graft patency at 12 months and major adverse cardiac events (MACE; death, myocardial infarction, repeat revascularization). RESULTS: Twenty-two SVGs were occluded. In receiver operating characteristic curve analysis, TTF mean flow was significantly predictive of one-year SVG failure (area under the curve = 0.698, p < 0.01), and 31 mL/min was the best cut-off value (p = 0.017, sensitivity 63.6%, specificity 67.4%). The risk of graft occlusion was 14/28, 50% for grafts with mean flow <31 mL/min and 8/37, 21.6% for grafts with mean flow ≥ 31 mL/min. In logistic regression models, mean flow was a significant predictor of early SVG failure (Odds Ratio 0.95 [0.91-0.99] per mL/min, p = 0.014) whereas other TTF values, patient comorbidities, and/or medication at discharge were not. However, TTF values were not predictive of MACE. CONCLUSIONS: TTF can identify non-functional grafts during CABG, but is of questionable value to improve one-year graft patency.

Surgical Repair of Atrial-Esophageal Fistula Following Catheter Ablation.

Left atrial-esophageal fistula after radiofrequency ablation for atrial fibrillation is a rare and potentially lethal complication. Although surgical management is associated with improved outcomes, the optimal approach remains to be elucidated. We describe a case of atrial-esophageal fistula treated with a simultaneous repair of the atrium and esophagus via a right thoracotomy with an extrapericardial off-pump approach.

Impact of Transcatheter Mitral Valve Repair on Preprocedural and Postprocedural Hospitalization Rates.

OBJECTIVES: The objective of this study was to determine the effect of transcatheter mitral valve repair (TMVr) on hospitalization rates by assessing pre- and postprocedural hospitalization patterns. BACKGROUND: TMVr has emerged as the treatment of choice for selected patients with mitral regurgitation, but the impact of these procedures on hospital utilization remains unclear. METHODS: All patients who underwent TMVr in Ontario, Canada, between 2011 and 2017 were included in this observational study using population-based data. Hospitalization person-year rates were assessed in the years before and after TMVr and 4 predefined intervals: 1 to 30, 31 to 90, 91 to 182, and 183 to 365 days. Main outcomes of interest were all-cause and heart failure (HF) hospitalizations. Poisson regression models were used to compare incidence rates across all time periods. RESULTS: The study cohort included 523 patients. In the year preceding TMVr, 66.2% of patients were hospitalized compared with 47.4% in the year following. There were stepwise increases in both all-cause and HF hospitalization rates in the periods preceding the index procedure, and all postprocedural periods had significantly lower hospitalization rates. The adjusted rate ratios for all-cause and HF-related hospitalization in the year after TMVr were 0.65 (95% CI: 0.56-0.76) and 0.38 (95% CI: 0.29-0.51), respectively. All time periods had significant reductions in all-cause and HF hospitalization in the adjusted analysis. CONCLUSIONS: In this population-based study, significant reductions were observed in both all-cause and HF-related hospitalizations in all time periods after TMVr compared with the year prior. This suggests that TMVr has a sustained effect on hospitalization rates despite a high-risk population.

2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

OBJECTIVES: This study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.

1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

OBJECTIVES: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). BACKGROUND: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. METHODS: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. RESULTS: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). CONCLUSIONS: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

CCS/CHFS Heart Failure Guidelines: Clinical Trial Update on Functional Mitral Regurgitation, SGLT2 Inhibitors, ARNI in HFpEF, and Tafamidis in Amyloidosis.

In this update, we focus on selected topics of high clinical relevance for health care providers who treat patients with heart failure (HF), on the basis of clinical trials published after 2017. Our objective was to review the evidence, and provide recommendations and practical tips regarding the management of candidates for the following HF therapies: (1) transcatheter mitral valve repair in HF with reduced ejection fraction; (2) a novel treatment for transthyretin amyloidosis or transthyretin cardiac amyloidosis; (3) angiotensin receptor-neprilysin inhibition in patients with HF and preserved ejection fraction (HFpEF); and (4) sodium glucose cotransport inhibitors for the prevention and treatment of HF in patients with and without type 2 diabetes. We emphasize the roles of optimal guideline-directed medical therapy and of multidisciplinary teams when considering transcatheter mitral valve repair, to ensure excellent evaluation and care of those patients. In the presence of suggestive clinical indices, health care providers should consider the possibility of cardiac amyloidosis and proceed with proper investigation. Tafamidis is the first agent shown in a prospective study to alter outcomes in patients with transthyretin cardiac amyloidosis. Patient subgroups with HFpEF might benefit from use of sacubitril/valsartan, however, further data are needed to clarify the effect of this therapy in patients with HFpEF. Sodium glucose cotransport inhibitors reduce the risk of incident HF, HF-related hospitalizations, and cardiovascular death in patients with type 2 diabetes and cardiovascular disease. A large clinical trial recently showed that dapagliflozin provides significant outcome benefits in well treated patients with HF with reduced ejection fraction (left ventricular ejection fraction ≤ 40%), with or without type 2 diabetes.

Transcatheter Mitral Valve Edge-to-Edge Repair with the New MitraClip XTR System for Acute Mitral Regurgitation Caused by Papillary Muscle Rupture.

Treatment of patients presenting with cardiogenic shock due to acute mitral regurgitation related to papillary muscle rupture poses significant challenges, owing to the high risk associated with conventional surgery. We hereby report successful transcatheter mitral valve edge-to-edge repair with the new Mitraclip XTR device (Abbott Vascular, Santa Clara, CA) in a patient with acute myocardial infarction and cardiogenic shock. Although surgical intervention remains the standard of care, the new MitraClip XTR system offers a novel treatment option for patients with papillary muscle rupture by overcoming the anatomic challenges often seen in this pathology.

Polycythemia Vera Presenting as Cardiac Arrest: Novel Management Strategies.

Acute coronary syndromes (ACS) usually occur in patients with multiple cardiac risk factors. In young adults, drug use and hypercoagulable states are common causes for ACS presentations. We report a case of a man in his early 30s who was diagnosed with polycythemia vera (PV) and had a cardiac arrest due to an anterolateral ST elevation myocardial infarction. We discuss his unique management and review the evidence on the management of arterial thromboembolism in PV patients.

Novel adhesives for sternal fixation and stabilization: A biomechanical analysis.

BACKGROUND: Cerclage wires remain the current standard of care following median sternotomy, despite significant complications including dehiscence and infection. This study uses a human cadaveric model to investigate the use of glass polyalkenoate cements formulated from two glasses, A (mole fraction: SiO2:0.48, ZnO:0.36, CaO:0.12, SrO:0.04) and B (mole fraction: SiO2:0.48, ZnO:0.355, CaO:0.06, SrO:0.08, P2O5:0.02, Ta2O5:0.005), to improve wired sternal fixation. METHODS: Median sternotomies were performed on fifteen cadaveric sterna. Fixation was performed with either traditional wire cerclage or adhesive-enhanced wire cerclage; the adhesive based on either Glass A or Glass B. Cyclic tensile loading of 10 N to 100 N was applied. Every 30 cycles, the maximum load was increased by 100 N up to a maximum of 500 N. Two adhered sterna were tested beyond 500 N. Mid-sternal displacement was measured to assess fixation stability. FINDINGS: Displacement for adhesive-enhanced sternal closures were significantly less (p < 0.05) than standard wire cerclage. There was no significant difference between adhesives. Up to 500 N, no adhesive-enhanced sternum experienced a pathological sternal displacement (>2 mm), while three out of five of traditional wire fixations did. Of the two adhered samples tested beyond 500 N, one showed pathological displacement at 800 N and the other at 1100 N. Failure of adhered sterna appeared to initiate within the trabecular bone rather than in the adhesive. INTERPRETATION: The adhesives were capable of providing immediate bone stability, significantly reducing sternal displacement. In vivo investigations are warranted to determine the effect the adhesives have on bone remodelling.

Time-sensitive predictors of embolism in patients with left-sided endocarditis: Cohort study.

INTRODUCTION: Accurate prediction of embolic events in infective endocarditis could inform critical clinical decisions, such as the timing of cardiac surgical intervention. However, many embolic events occur before hospital admission and echocardiography and are thus non-modifiable. We aimed to identify time-sensitive variables that predict embolic events in infective endocarditis, focusing on those that occur after diagnosis. METHODS: Clinical, microbiological, and echocardiographic characteristics were collected from 116 patients with definite or probable left-sided infective endocarditis admitted to Sunnybrook Health Sciences Centre (Toronto, Canada) between October 2013 and July 2016; associations between these characteristics and embolic events were identified using simple logistic regression. RESULTS: The mean (SD) age was 66 (17) years; 82 patients (71%) were men. The most frequent microorganisms were Staphylococcus aureus (23%) and viridans group streptococci (21%). Seventy-nine (68%) patients had left-sided vegetations, with involvement of the aortic valve in 34 (43%) patients, mitral valve in 37 (47%) patients, and both in 8 (10%) patients. The mean (SD) vegetation size was 10 (7) mm. Forty-three unique patients (37%) had 50 embolic events, with most (34/43; 79%) having a first embolic event (38/50; 76%) before or on the day of echocardiography. There were no significant predictors of the 11 patients with an embolic event after echocardiography; significant predictors of an embolic event at any time were single valve vegetation vs. no vegetation (OR, 4.75; 95% confidence interval [CI], 1.76-12.78) and, among patients with a vegetation, mitral vs. aortic valve location (OR, 4.43; 95%CI, 1.63-12.04). CONCLUSIONS: Associations between patient and echocardiographic characteristics and embolism in patients with infective endocarditis may be time-sensitive, as few embolic events occurred after clinical and echocardiographic assessment.

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study.

OBJECTIVES: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).

Case conferences for infective endocarditis: A quality improvement initiative.

BACKGROUND: A multidisciplinary approach has been recommended for the management of patients with infective endocarditis. We evaluated the impact of multidisciplinary case conferences on morbidity, mortality, and quality of care for these patients. METHODS: We conducted a quasi-experimental study of consecutive patients admitted for infective endocarditis before (2013/10/1-2015/10/12, n = 97) and after (2015/10/13-2017/11/30, n = 80) implementation of case conferences to discuss medical and surgical management. These occurred as face-to-face discussions or electronically (for non-complex patients), and included physicians from cardiac surgery, cardiology, critical care, infectious diseases and neurology. We assessed process-of-care and clinical outcomes, with the primary outcome being complications up to 90 days after hospital discharge. RESULTS: A case conference was held for 80/80 (100%) of patients in the post-intervention group. After the intervention, more patients received inpatient cardiology assessment (81.3% [post-intervention] vs. 63.9% [pre-intervention], p = 0.01), and more patients with definite infective endocarditis underwent cardiac surgery treatment (44.6% vs. 21.7%, p = 0.007). All pre-intervention and post-intervention patients received guideline-concordant antimicrobial therapy. There was no difference in rates of complications (40.0% vs. 51.5%, p = 0.13) or mortality up to 90 days after hospital discharge (26.3% vs. 17.5%, p = 0.20). In multivariable analyses, the intervention was not associated with differences in mortality (odds ratio 1.87, 95% confidence interval 0.88-3.99) or a composite measure of complications and mortality (odds ratio 0.86, 95% confidence interval 0.46-1.58). CONCLUSION: We successfully implemented a standardized multidisciplinary case conference protocol for patients with infective endocarditis. This intervention had no detectable effect on complications or mortality.