Meta-Analysis of Randomized Trials: Efficacy and Safety of Colchicine for Secondary Prevention of Cardiovascular Disease.

Background: Colchicine has shown potential cardioprotective effects owing to its broad anti-inflammatory properties. We performed a meta-analysis to assess its safety and efficacy in secondary prevention in patients with established coronary artery disease (CAD). Methods: We searched Ovid Healthstar, MEDLINE, and Embase (inception to May 2022) for randomized controlled trials (RCTs) evaluating the cardiovascular effects of colchicine compared with placebo or usual care in patients with CAD. Study-level data on efficacy and safety outcomes were pooled using the Peto method. The primary outcome was the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke. Results: A total of 8 RCTs were included with a follow-up duration of ≥1 month, comprising a total of 12,151 patients. Compared with placebo or usual care, colchicine was associated with a significant risk reduction in the primary outcome (odds ratio (OR) 0.70, 95% CI 0.60 to 0.83, P < 0.0001; I2 = 52%). Risks of MI (OR 0.75, 95% CI 0.62 to 0.91, P = 0.003; I2 = 33%), stroke (OR 0.47, 95% CI 0.30 to 0.74, P = 0.001; I2 = 0%), and unplanned coronary revascularization (OR 0.67, 95% CI 0.55 to 0.82, P = 0.0001; I2 = 58%) were all reduced in the colchicine group. Rates of CV and all-cause mortality did not differ between the two groups, but there was an increase in noncardiac deaths with colchicine (OR 1.54, 95% CI 1.10 to 2.15, P = 0.01; I2 = 51%). The occurrence of all other adverse events was similar between the two groups, including GI reactions (OR 1.06, 95% CI 0.94 to 1.20, P = 0.35; I2 = 42%) and infections (OR 1.04, 95% CI 0.84 to 1.28, P = 0.74; I2 = 53%). Conclusions: Colchicine therapy may reduce the risk of future cardiovascular events in patients with established CAD; however, there remains a concern about non-CV mortality. Further trials are underway that will shed light on non-CV mortality and colchicine NCT03048825, and NCT02898610.

Percutaneous Coronary Intervention with Procedural Unfractionated Heparin without Activated Clotting Time Guidance: A Unique Opportunity to Assess Thrombotic and Bleeding Events.

Background: Rates of major bleeding and intraprocedural thrombotic events (IPTE) in the setting of percutaneous coronary intervention (PCI) using weight-adjusted unfractionated heparin (UFH) without activated clotting time (ACT) monitoring are not known. Methods: We reviewed 2,748 consecutive patients who underwent coronary angiography at our tertiary care university hospital between January 2017 and December 2020. All patients who underwent PCI with weight-adjusted UFH without ACT guidance were considered for further analysis. Major bleeding complications occurring within 48 hours of PCI were collected from patients' medical records. IPTE were collected independently by two interventional cardiologists after review of coronary angiograms. Results: There were 718 patients included in the analysis (65.4 ± 12.2 years old; 81.3% male). In total, 45 patients (7.8%) experienced a major bleed or IPTE. The most common IPTE were slow/no reflow (1.5%) and coronary artery dissection with decreased flow (1.1%). Other IPTE occurred in <1% of cases. Major bleeding occurred in 11 patients (1.5%), of whom 8 required blood transfusion and 3 required vascular intervention. Bleeding complications were more common with femoral compared with radial access (6.6% vs. 0.2%, P < 0.001). Conclusion: Weight-adjusted UFH use during PCI without ACT monitoring was related to low rates of major bleeding or IPTE.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

Harnessing the parallax for better spatial awareness.

Despite easy access to imaging diagnostic procedures and an abundance of spatial data, most cardiac interventions are still performed under two-dimensional fluoroscopy. Incorporating anatomical data from scans into procedures plans has the potential to improve the swiftness and outcomes of percutaneous cardiac interventions. Therefore, procedure planning based on the specific anatomy is becoming a new standard of excellence in interventional cardiology. Still, we often tend to disregard specific spatial relations and the actual direction of catheter tip movement inside the body, relying on a try and error approach. The precise spatial orientation of instruments and prosthetic devices is crucial, especially during structural heart interventions. Here, we present how deliberate movements of objects under fluoroscopy can reveal the spatial orientation of catheters and other devices. We also propose a novel "two-point rule" for identifying three-dimensional relations between points in space. Understanding and applying this rule might substantially increase the spatial awareness of operators performing cardiovascular interventions. Although the concept is pretty simple, using it "live" during interventional cardiology procedures requires thorough understanding and practice. We propose the "two-point rule" as a crucial rule to develop expertise in spatial orientation under fluoroscopy and ensure high-quality outcomes.

Evaluation of the safety and efficacy of a novel Anatomical classification and dUal anchoRing theory to Optimize the tavR strategy for pure severe Aortic regurgitation (AURORA): a prospective cohort study.

BACKGROUND: Success rate of transcatheter aortic valve replacement (TAVR) in aortic regurgitation (AR) patients is relatively low on account of the absence of calcified anchoring structures. Morphological classification and corresponding TAVR strategies for AR are lacking yet. METHODS: The AURORA study is a prospective, multicenter, single-arm cohort study to evaluate the safety and efficacy of transfemoral TAVR for severe AR in patients with high or prohibitive risk for surgery. Patients who are ≥ 65 years and diagnosed with severe pure AR as defined by the Echocardiographic Core Laboratory will be consecutively enrolled for further multidetector computed tomography (MDCT) scanning and multiplanar analyses. Based on a new anatomical classification and dual anchoring theory, patients will be classified into 4 types according to the level of the anchoring area. Types 1, 2 and 3 (at least 2 anchoring areas) will undergo the TAVR procedure with a domestic Chinese self-expanding valve (VitaFlow Valve, MicroPort, Shanghai, China), whereas type 4 (0 or 1 anchoring area) patients will be considered unsuitable for TAVR and will receive medical treatment. Our goal is to recruit 100 patients to account for 10% missing data or loss of patients to follow-up. Procedural, 30-day, 6-month and 12-month outcomes will be assessed according to Valve Academic Research Consortium-3 criteria. DISCUSSION: The AURORA study will establish a new AR anatomical classification based on dual anchoring theory through MDCT multiplanar measurement and assess the safety and efficacy of TAVR guided by this new classification and strategy in AR patients. TRIAL REGISTRATION: This Study was registered at Chinses Clinical Trial Registry. The registration number: ChiCTR2200055415; The date of registration: 9, January 2022; The URL of the registration: http://www.chictr.org.cn/showproj.aspx?proj=141209 .

Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.

AIMS: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. METHODS AND RESULTS: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. CONCLUSIONS: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.

Distribution of C-arm projections in native and bioprosthetic aortic valves cusps: Implication for BASILICA procedures.

OBJECTIVES: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory. BACKGROUND: Optimal fluoroscopic projections of aortic valve cusps have not been well described. METHODS: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated. RESULTS: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively. CONCLUSION: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt.

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

BACKGROUND: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

Advances in transcatheter mitral and tricuspid therapies.

BACKGROUND: While rheumatic mitral stenosis has been effectively treated percutaneously for more than 20 years, mitral and tricuspid regurgitation treatment appear as a contemporary unmet need. The advent of transcatheter therapies offer new treatment options to often elderly and frail patients at high risk for open surgery. We aimed at providing an updated review of fast-growing domain of transcatheter mitral and tricuspid technology. MAIN BODY: We reviewed the existing literature on mitral and tricuspid transcatheter therapies. Mitraclip is becoming an established therapy for secondary mitral regurgitation in selected patients with disproportionately severe regurgitation associated with moderate left ventricle dysfunction. Evidence is less convincing for primary mitral regurgitation. Transcatheter mitral valve replacement is a promising emerging alternative to transcatheter repair, for secondary as well as primary mitral regurgitation. But further development is needed to improve delivery. Transcatheter tricuspid intervention arrives late after similar technologies have been developed for aortic and mitral valves and is currently at its infancy. This is likely due in part to previously under-recognized impact of tricuspid regurgitation on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on tricuspid annuloplasty and replacement is limited, and more research is warranted. CONCLUSION: The future appears bright for transcatheter mitral therapies, albeit their place in clinical practice is yet to be clearly defined. Tricuspid transcatheter therapies might address the unmet need of tricuspid regurgitation treatment.

Restricted mean survival time of older adults with severe aortic stenosis referred for transcatheter aortic valve replacement.

BACKGROUND: Few studies have measured frailty as a potential reason for foregoing transcatheter aortic valve replacement (TAVR) in older adults with severe aortic stenosis (AS). This study sought to determine the impact of frailty and other clinician-cited reasons on restricted mean survival time (RMST). METHODS: An analysis of the McGill Frailty Registry was conducted between 2014 and 2018 at the McGill University Health Center Structural Valve Clinic. Consecutive nonsurgical patients referred for TAVR were included. In those that underwent balloon aortic valvuloplasty or medical management, the primary clinician-cited reason for foregoing TAVR was codified. Vital status was ascertained at 1 year and analysed using RMST and Kaplan-Meier analyses. RESULTS: The study consisted of 373 patients with a mean age of 82.4 years, of which 233 underwent TAVR and 140 did not. Patients who did not undergo TAVR were more likely to be nonagenarians, with left ventricular dysfunction, chronic kidney disease, dementia, disability, depression, malnutrition, and frailty. The primary clinician-cited reason was: comorbidity in 34%, frailty in 23%, procedural feasibility and risks in 16%, and mild or unrelated symptoms in 27%. Compared to the TAVR group, 1-year RMST was reduced by 2.0 months in the medical management group (95% CI 1.2, 2.7) and by 1.1 months in the valvuloplasty group (95% CI -0.2, 2.5). CONCLUSIONS: Patients with severe AS referred for TAVR may never undergo the procedure on the basis of comorbidity, frailty, procedural issues, and symptoms. The best treatment decision is one that follows from multi-disciplinary assessment encompassing frailty.

Malnutrition and Mortality in Frail and Non-Frail Older Adults Undergoing Aortic Valve Replacement.

BACKGROUND: Older adults undergoing aortic valve replacement (AVR) are at risk for malnutrition. The association between preprocedural nutritional status and midterm mortality has yet to be determined. METHODS: The FRAILTY-AVR (Frailty in Aortic Valve Replacement) prospective multicenter cohort study was conducted between 2012 and 2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter or surgical AVR were eligible. The Mini Nutritional Assessment-Short Form was assessed by trained observers preprocedure, with scores ≤7 of 14 considered malnourished and 8 to 11 of 14 considered at risk for malnutrition. The Short Performance Physical Battery was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6 to 8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality, and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders. RESULTS: There were 1158 patients (727 transcatheter AVR and 431 surgical AVR), with 41.5% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m2, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at risk for malnutrition. Mini Nutritional Assessment-Short Form scores were modestly correlated with Short Performance Physical Battery scores (Spearman R=0.31, P<0.001). There were 126 deaths in the transcatheter AVR group (19.1 per 100 patient-years) and 30 deaths in the surgical AVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% versus 10%, P<0.001). After adjustment for frailty, Society of Thoracic Surgeons-Predicted Risk of Mortality, and procedure type, preprocedural nutritional status was a significant predictor of 1-year mortality (odds ratio, 1.08 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.01-1.16) and of the 30-day composite safety end point (odds ratio, 1.06 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.001-1.12). CONCLUSIONS: Preprocedural nutritional status is associated with mortality in older adults undergoing AVR. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable patients.

Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval.

In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials. Recent US Food and Drug Administration approval of new-generation THVs based on single-arm studies has generated interest in alternative study approaches for THV device approval. This review evaluates whether THV device approval could follow a pathway analogous to that of surgical heart valves by incorporating OPC and provides several considerations and recommendations. Factors to be taken into account in the construction of OPC include the maturity of THV technology, variability in transcatheter aortic valve replacement practice, end points included as OPC, follow-up terms for specific OPC, patient populations to which these OPC apply, and (statistical) methods for OPC development. We recommend that approval of THV devices in the United States for low- and intermediate-risk patients or for new indications should provisionally rely on data from randomized, clinical trials. However, it is recommended that formal OPC be applied for approval of new-generation THVs for use in high- and extreme-risk patient populations.

Prestenting for prevention of melody valve stent fractures: A systematic review and meta-analysis.

INTRODUCTION: The role of right ventricular outflow tract (RVOT) prestenting in the prevention of Melody valve stent fractures (SFs) is not well defined. We aimed to perform a systematic review and meta-analysis comparing the incidence of SF in Melody valve transcatheter pulmonary implants with and without prestenting. METHODS: PubMed, EMBASE, and Cochrane Central were searched for studies that reported the incidence of SF in Melody valve transcatheter pulmonary implants stratified by the presence or absence of RVOT prestenting. Subgroup analyses were performed for (1) SF associated with a loss of stent integrity and (2) SF requiring reintervention. RESULTS: Five studies and 360 patients were included, of whom 207 (57.5%) received prestenting. Follow-up ranged from 15 to 30 months. SF were significantly reduced in the prestenting group (16.7%) when compared to no prestenting (33.5%) (odds-ratio [OR] 0.39; 95%CI 0.22-0.69). Patients who received prestenting also had a lower incidence of (1) SF associated with loss of stent integrity (OR 0.16; 95%CI 0.05-0.48) and (2) SF requiring reintervention (OR 0.15; 95%CI 0.02-0.91). CONCLUSION: Our findings suggest that stenting of the RVOT prior to Melody valve implantation is associated with a reduction in the incidence of SF and fracture-related reinterventions.

A Systematic Review and Meta-Analysis of Outcomes Following Mitral Valve Surgery in Patients with Significant Functional Mitral Regurgitation and Left Ventricular Dysfunction.

BACKGROUND AND AIM OF THE STUDY: The surgical correction of functional mitral regurgitation (MR) remains challenging and controversial. The study aim was to systematically review the outcomes of surgical mitral valve repair (MVRpr) and mitral valve replacement (MVR) in patients with significant functional MR and left ventricular (LV) dysfunction. METHODS: A meta-analysis was performed of published data acquired from patients with moderate to severe functional MR and LV ejection fraction (LVEF) <40% who underwent surgical MVRpr or MVR. The data were meta-analyzed across studies using Bayesian hierarchical models when feasible. RESULTS: The search yielded 36 observational studies. The pooled proportion of operative mortality following MVRpr was 5% (33 studies; 2,231 patients; 95% credible interval (CrI) 4-7%), while that following MVR was 10% (10 studies; 389 patients; 95% CrI 5-18%). For patients undergoing MVRpr, pooled proportions of postoperative cerebrovascular accidents and renal failure were 2% (11 studies; 750 patients; 95% CrI 1-3%) and 9% (11 studies; 756 patients; 95% CrI 5-16%), respectively. The five-year actuarial survival rates following MVRpr across 12 studies ranged from 47% to 78% (median 66%). CONCLUSIONS: In selected patients with significant functional MR and LV dysfunction, surgical MVRpr and MVR can be performed with acceptable intermediate operative mortality risks.

Transcatheter heart valve failure: a systematic review.

AIMS: A comprehensive description of transcatheter heart valve (THV) failure has not been performed. We undertook a systematic review to investigate the aetiology, diagnosis, management, and outcomes of THV failure. METHODS AND RESULTS: The systematic review was performed in accordance with the PRISMA guidelines using EMBASE, MEDLINE, and Scopus. Between December 2002 and March 2014, 70 publications reported 87 individual cases of transcatheter aortic valve implantation (TAVI) failure. Similar to surgical bioprosthetic heart valve failure, we observed cases of prosthetic valve endocarditis (PVE) (n = 34), structural valve failure (n = 13), and THV thrombosis (n = 15). The microbiological profile of THV PVE was similar to surgical PVE, though one-quarter had satellite mitral valve endocarditis, and surgical intervention was required in 40% (75% survival). Structural valve failure occurred most frequently due to leaflet calcification and was predominantly treated by redo-THV (60%). Transcatheter heart valve thrombosis occurred at a mean 9 ± 7 months post-implantation and was successfully treated by prolonged anticoagulation in three-quarters of cases. Two novel causes of THV failure were identified: late THV embolization (n = 18); and THV compression (n = 7) following cardiopulmonary resuscitation (CPR). These failure modes have not been reported in the surgical literature. Potential risk factors for late THV embolization include low prosthesis implantation, THV undersizing/underexpansion, bicuspid, and non-calcified anatomy. Transcatheter heart valve embolization mandated surgery in 80% of patients. Transcatheter heart valve compression was noted at post-mortem in most cases. CONCLUSION: Transcatheter heart valves are susceptible to failure modes typical to those of surgical bioprostheses and unique to their specific design. Transcatheter heart valve compression and late embolization represent complications previously unreported in the surgical literature.

Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium.

Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodelling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of trans- catheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.

Multicenter evaluation of transcatheter aortic valve replacement using either SAPIEN XT or CoreValve: Degree of device oversizing by computed-tomography and clinical outcomes.

OBJECTIVE: To analyze the association between computed-tomography-derived degrees of device oversizing and clinical outcomes during transcatheter aortic valve replacement (TAVR). BACKGROUND: Previous reports suggest that different devices reach optimal results with different degrees of device oversizing. Therefore, similar sized devices of different types (SAPIEN XT and CoreValve) may be favored in different annular ranges and a case considered borderline between two sizes of a specific device might be within a favorable range of another. METHODS AND RESULTS: A multicenter registry of 615 consecutive transfemoral TAVR procedures using either SAPIEN XT or CoreValve was analyzed. A first group of 190 patients had annular sizes for which only moderate oversizing degree was feasible (5-20% by area or 2.5-9.5% by perimeter). A second group included 178 patients that had annulus size for which only large oversizing degree was feasible (20.1-35% by area or 9.6-16.2% by perimeter). In the "only large oversizing feasible group" there were more annular rupture events in patients treated by SAPIEN XT valve as compared to those treated by CoreValve (3.4% vs. 0%, P = 0.04). In the "only moderate oversizing feasible group", those treated by CoreValve had more post balloon dilatation and 30-day major stroke in comparison with those treated by SAPIEN XT (16.1% vs. 7.7%, P = 0.04 and 8% vs. 1.3%, P = 0.02, respectively). CONCLUSIONS: Optimal clinical performance of CoreValve and SAPIEN XT appears to be reached with different degrees of oversizing. Certain annular sizes that allow for only moderate or large oversizing, but not both, appear to benefit from a device specific approach.