Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology.

BACKGROUND: Whether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. METHODS: Of 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. RESULTS: The predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07). CONCLUSIONS: In our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology.

Impact of Device Implant Depth After Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) remains one of the main concerns after left atrial appendage occlusion (LAAO). Several risk factors have been proposed, but most cannot be modulated. A modifiable factor such as device implantation depth is a potential target to adjust the risk for DRT. OBJECTIVES: The aim of this study was to assess the impact of LAAO device implantation depth as a predisposing factor for DRT. METHODS: The study included patients who underwent successful LAAO at 9 centers in Europe and Canada. Patients were classified into 2 groups: proximal device implantation (covered pulmonary ridge [PR] in the lobe and disc cohort or <5 mm from the PR in the single-lobe cohort) and distal device implantation (uncovered PR in the disc and lobe cohort and ≥5 mm in the single-lobe cohort). RESULTS: A total of 1,317 patients were included. Among these, proximal and distal device implantation was achieved in 732 (55%) and 585 (45%) patients, respectively. No differences in procedural outcomes were observed between the groups. At follow-up, patients with proximal implantation had a lower incidence of DRT (2.3%) than those with distal implantation (12.2%) (P < 0.001). Deeper device implantation and a larger uncovered left atrial appendage area were associated with a higher incidence of DRT (P < 0.001), regardless of device type. In multivariable analysis, distal implant (HR: 5.92; 95% CI: 3.39-10.36) and no or single antiplatelet therapy (HR: 1.62; 95% CI: 0.99-2.62) emerged as independent predictors of DRT. CONCLUSIONS: LAAO device implantation depth is an independent risk factor for DRT. Deeper device implantation and larger uncovered left atrial appendage areas were associated with a higher incidence of DRT.

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR). AIMS: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry. METHODS: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality. RESULTS: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality. CONCLUSIONS: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.

Transcatheter Aortic Valve Replacement in Patients With Reduced Ejection Fraction and Nonsevere Aortic Stenosis.

BACKGROUND: The potential benefit of transcatheter aortic valve replacement (TAVR) in patients with nonsevere aortic stenosis (AS) and heart failure is controversial. This study aimed to assess outcomes of patients with nonsevere low-gradient AS (LGAS) and reduced left ventricular ejection fraction undergoing TAVR or medical management. METHODS: Patients undergoing TAVR for LGAS and reduced left ventricular ejection fraction (<50%) were included in a multinational registry. True-severe low-gradient AS (TS-LGAS) and pseudo-severe low-gradient AS (PS-LGAS) were classified according to computed tomography-derived aortic valve calcification thresholds. A medical control group with reduced left ventricular ejection fraction and moderate AS or PS-LGAS was used (Medical-Mod). Adjusted outcomes between all groups were compared. Among patients with nonsevere AS (moderate or PS-LGAS), outcomes after TAVR and medical therapy were compared using propensity score-matching. RESULTS: A total of 706 LGAS patients undergoing TAVR (TS-LGAS, N=527; PS-LGAS, N=179) and 470 Medical-Mod patients were included. After adjustment, both TAVR groups showed superior survival compared with Medical-Mod patients (all P<0.001), while no difference was found between TS-LGAS and PS-LGAS TAVR patients (P=0.96). After propensity score-matching among patients with nonsevere AS, PS-LGAS TAVR patients showed superior 2-year overall (65.4%) and cardiovascular survival (80.4%) compared with Medical-Mod patients (48.8% and 58.5%, both P≤0.004). In a multivariable analysis including all patients with nonsevere AS, TAVR was an independent predictor of survival (hazard ratio, 0.39 [95% CI, 0.27-0.55]; P<0.0001). CONCLUSIONS: Among patients with nonsevere AS and reduced left ventricular ejection fraction, TAVR represents a major predictor of superior survival. These results reinforce the need for randomized-controlled trials comparing TAVR versus medical management in heart failure patients with nonsevere AS. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04914481.

Transcatheter valvular therapies in patients with left ventricular assist devices.

Aortic, mitral and tricuspid valve regurgitation are commonly encountered in patients with continuous-flow left ventricular assist devices (CF-LVADs). These valvular heart conditions either develop prior to CF-LVAD implantation or are induced by the pump itself. They can all have significant detrimental effects on patients' survival and quality of life. With the improved durability of CF-LVADs and the overall rise in their volume of implants, an increasing number of patients will likely require a valvular heart intervention at some point during CF-LVAD therapy. However, these patients are often considered poor reoperative candidates. In this context, percutaneous approaches have emerged as an attractive "off-label" option for this patient population. Recent data show promising results, with high device success rates and rapid symptomatic improvements. However, the occurrence of distinct complications such as device migration, valve thrombosis or hemolysis remain of concern. In this review, we will present the pathophysiology of valvular heart disease in the setting of CF-LVAD support to help us understand the underlying rationale of these potential complications. We will then outline the current recommendations for the management of valvular heart disease in patients with CF-LVAD and discuss their limitations. Lastly, we will summarize the evidence related to transcatheter heart valve interventions in this patient population.

Novel Humanized Biosimulator to Predict Coronary Obstruction in High-Risk Valve-in-Valve Procedures.

We developed humanized biosimulator to predict the risk of coronary obstruction among high-risk patients undergoing valve-in-valve (ViV) procedures. In this case, based on unchanged instantaneous wave-free ratio values measured during a ViV simulation session, the procedure was performed safely in the patient the day afterward, without coronary artery issues and with good hemodynamic results. (Level of Difficulty: Advanced.).

Procedural simplification of left atrial appendage occlusion using the VersaCross connect system: First in-human experience.

BACKGROUND: Left atrial appendage occlusion (LAAO) has emerged over the last two decades as an efficient and safe alternative to oral anticoagulation for stroke prevention. However, LAAO remains challenging due to the variety of anatomies and the multiple steps required to complete the procedure. AIMS: We report the first series of in-human experience of the new all-in-one VersaCross Connect system designed to access the left atrium in conjunction with the delivery sheath for deployment of the WATCHMAN FLX device. METHODS: We prospectively included the first nine consecutive cases of LAAO using the new VersaCross Connect system for WATCHMAN FLX device implantation at the Montreal Heart Institute and Vancouver General Hospital and collected procedural duration (defined as time from femoral access to closure) and time from transseptal puncture to device delivery. RESULTS: VersaCross Connect system use for WATCHMAN FLX implantation was successful in all patients. No procedural complication was reported. Mean procedural time was 31 ± 6.3 min with a fluoroscopy time of 6.7 ± 4.9 min. The mean delay between the transseptal puncture and device implantation was 12.2 ± 1.9 min. CONCLUSIONS: We showed that the VersaCross Connect system was safe and successfully used in all first nine cases. This new system helped improve the efficiency of the procedure.

A novel anatomic classification to guide transcatheter aortic valve replacement for pure aortic regurgitation.

BACKGROUND: The success of transcatheter aortic valve replacement (TAVR) in native aortic regurgitation (AR) is limited by the absence of calcified anchoring structures. We sought to evaluate transfemoral TAVR in patients with native AR using a novel aortic root imaging classification. METHODS: From March to November 2021, 81 patients with severe AR were prospectively enrolled in 2 cardiac centers in China. All were evaluated using multidetector computed tomography (MDCT) and classified into 4 anatomic types in reference to transcatheter heart valve (THV) anchoring: Type 1: anchoring at the left ventricular outflow tract (LVOT), annulus, and ascending aorta (AA); Type 2: anchoring at the annulus and AA; Type 3: anchoring at the annulus and LVOT; and Type 4: anchoring at only 1 level or none at all. Based on the dual-anchoring strategy, patients with Types 1-3 were considered TAVR candidates. Procedural and 30-day outcomes were assessed according to Valve Academic Research Consortium-3 definitions. RESULTS: TAVR was performed in 32 (39.5%) patients (71.9 ± 8.0 years of age, 71.9% were male) using 2 self-expanding THVs. Types 1, 2, and 3 comprised 13 (40.6%), 11 (34.4%), and 8 (25.0%) cases, respectively. The procedural and device success rates were 100% and 93.8%, respectively, with 2 THV migration. Eight patients (25.0%) required a permanent pacemaker, and 2 (6.3%) developed moderate paravalvular leaks. No deaths or other major complications occurred during the study. CONCLUSIONS: The novel anatomic classification and dual-anchoring strategy were associated with a high procedural success rate with favorable short-term safety and clinical outcomes.

Growth differentiation factor-15 as a biomarker of atherosclerotic coronary plaque: Value in people living with and without HIV.

Background: Increased rates of cardiovascular diseases (CVD) and larger subclinical high-risk coronary plaques in coronary CT angiography have been observed in people living with HIV (PLWH) treated with antiretroviral therapy (ART) compared to HIV-uninfected people. Growth differentiation factor-15 (GDF-15) is a cytokine emerging as an optimal marker for CVD in the general population. Methods: We cross-sectionally analyzed plasma of 95 PLWH on ART and 52 controls. We measured GDF-15, fibroblast growth factor-21 (FGF-21), glucagon-like peptide-2 (GLP-2), soluble urokinase plasminogen activator receptor (suPAR), CRP, and anti-CMV and anti-EBV IgG levels. All participants had no clinical CVD and underwent coronary CT angiography with the 3D reconstruction of coronary artery atherosclerotic plaques. Total plaque volume (TPV) and low attenuation plaque volume (LAPV, defined as density <30 Hounsfield Units) were calculated (mm3). Results: In both PLWH and controls, GDF-15 levels were increased in participants with presence of coronary plaque vs. without (p = 0.04 and p < 0.001, respectively) and correlated with TPV (r = 0.27, p = 0.009 and r = 0.62, p < 0.001, respectively) and LAPV (r = 0.28, p = 0.008, r = 0.60, p < 0.001, respectively). However, in a multivariate model, GDF-15 was independently associated with LAPV in controls only (adjusted OR 35.1, p = 0.04) and not in PLWH, mainly due to confounding by smoking. Other markers were not independently associated with plaque volume, except for anti-EBV IgGs in controls (adjusted OR 3.51, p = 0.02). Conclusion: In PLWH, GDF-15 and smoking seemed to synergistically contribute to coronary plaque volume. Conversely, increased GDF-15 levels were associated with the presence of coronary artery plaques in people without HIV, independently of CV risk factors.

The Fontan Circulation: From Ideal to Failing Hemodynamics and Drug Therapies for Optimization.

Fontan palliation results in a hemodynamically complex circulation with multisystem consequences, which in the long term adversely affect many body processes. Systemic venous hypertension, nonpulsatile low-shear pulmonary blood flow, and low cardiac output are the 3 main characteristics of a Fontan circulation, leading to unavoidable slowly progressive failure. An appreciation of how the hemodynamics of a Fontan circulation change with time and relate to the various modes of Fontan circulatory failure is important. Accurate hemodynamic assessment aid this understanding and may permit early identification of potentially treatable drivers of decline. While no evidence-based or guideline-directed pharmacologic management strategy has been established in Fontan patients, understanding the hemodynamics of Fontan circulation failure will assist in the rational selection of potentially helpful drug therapies for individual patients. In this review, we present hemodynamic concepts of the optimal Fontan physiology and Fontan circulatory failure, review practical aspects of invasive hemodynamic assessment, and discuss the role of drug therapies in increasing systemic venous blood flow return and decreasing ventricular filling pressures in Fontan circulation. Often complementary to catheter-based or surgical interventions, pharmacologic management aims at preserving patency of the circuit, adequate systolic and diastolic ventricular function, atrioventricular valve function, an unobstructed ventricular outflow tract, and pulmonary vascular integrity in order to maintain an acceptable cardiac output.

Complexity assessment and technical aspect of coronary angiogram and percutaneous coronary intervention following transcatheter aortic valve implantation.

BACKGROUND: Performing selective coronary angiogram (CA) and percutaneous coronary intervention (PCI) post transcatheter aortic valve implantation (TAVI) may be challenging with various success rates of coronary ostia engagement. METHODS: Among all patients who underwent CA and/or PCI after TAVI from our single center TAVI registry, ostia cannulation success was reported according to the quality of ostia engagement and artery opacification, and was classified as either selective, partially selective or non-selective but sufficient for diagnosis. RESULTS: Among the 424 consecutive TAVI procedures performed at the aforementioned institution, 20 (4.7%) CA were performed in 19 (4.5%) patients at a median time of 464 days post TAVI (25-75% IQ: 213-634 days). CA were performed in 7 CoreValve, 9 Evolut R, 1 Evolut PRO and 2 Edwards Sapien 3 devices. Transradial vascular approach was attempted in 9 procedures (45%, right n = 6 and left n = 3) and was successful in 8 (40%) patients. A total of 20 left main artery ostium cannulation were attempted leading to a diagnostic CA in all of them with selective engagement in 65%. Engagement of the right coronary artery in 2 out of 15 attempted cases failed due to a low ostium in conjunction with a high implantation of a CoreValve prosthesis. 11 PCI (55% of CA) including 2 left main lesions were performed. In 4 patients (36.4% of the PCI), an extension catheter was required to engage the left main. All planned PCI were successful. CONCLUSIONS: Post TAVI CA and PCI are challenging but feasible even after supra-annular self-expandable valve implantation.

Percutaneous coronary intervention versus coronary artery bypass graft for left main coronary artery disease: A meta-analysis.

BACKGROUND: The optimal revascularization strategy for patients with left main coronary artery disease is still controversial. This is systematic review and meta-analysis aims to evaluate the outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents compared with coronary artery bypass graft (CABG) for LM disease. METHODS: Online electronic databases were systematically reviewed until January 2020 for randomized trials comparing PCI with drug-eluting stents and CABG. Primary outcomes were: all-cause mortality, myocardial infarction (MI), stroke, and repeated revascularization. Secondary outcomes included periprocedural and nonperiprocedural MI. The period of follow-up included 30 days, 1 year, and 5 years. Odds ratio and 95% confidence interval were calculated with a fixed-effects model. RESULTS: A total of 4595 patients (5 randomized trials) with left main coronary artery disease were included. At 30 days and 1 year, PCI was associated with lower incidence of stroke, higher repeated revascularization, and similar odds of mortality and MI compared with CABG. At 5 years, PCI was associated with higher rates of MI (odds ratio, 1.43; 95% confidence interval, 1.13-1.79; P = .003) and repeat revascularization (odds ratio, 1.89; 95% CI, 1.58-2.26; P < .001) than CABG. PCI was associated with lower periprocedural MI at 30 days, whereas at 5 years PCI was associated with higher nonperiprocedural MI (odds ratio, 2.32; 95% confidence interval, 1.62-3.31; P < .001). Mortality and stroke rate did not differ at 5-year follow-up. CONCLUSIONS: Patients with left main coronary artery disease treated with either PCI or CABG do not show significant difference in early or 5-year mortality. Although CABG was associated with higher stroke rates at 30 days and 1 year, PCI was associated with an increase in MI and need for repeat revascularization at 5 years.

Indications, Limitations, and Development of Tricuspid Valve Interventions in Adults.

Tricuspid regurgitation is associated with excessive mortality and poor outcomes regardless of the cause and associated comorbidities. Despite this clear association with mortality, tricuspid valve diseases remain undertreated. Tricuspid valve surgery, either repair or replacement, has shown little detectable survival benefit. Transcatheter tricuspid valve interventions have emerged as a less invasive approach to tricuspid valve diseases. They can be categorised into coaptation devices, annuloplasty devices, transcatheter tricuspid valve replacement, heterotopic caval valve implantation, and tricuspid valve-in-valve. Despite the late referral and the patient's profile, results remain fairly acceptable at least in the short term, with good procedural device success, excellent safety profile, and sustained reduction of tricuspid regurgitation for up to 1 year. Because results are limited to the mid-term, transcatheter tricuspid valve intervention durability will need to be established before broader adoption of these technologies.