Incidence and Predictors of Early Death in Patients Undergoing Percutaneous Left Atrial Appendage Closure.

BACKGROUND: Left atrial appendage closure (LAAC) aims to prevent ischemic events in patients with atrial fibrillation. As a preventive procedure, early death after LAAC could render the procedure futile. OBJECTIVES: The authors sought to evaluate the incidence and factors associated with early death in LAAC recipients. METHODS: This was a multicenter study including consecutive patients undergoing LAAC in a 10-year period (2009-2019). Death was considered early when occurring in the first year after LAAC. RESULTS: A total of 807 patients (mean age 76 ± 8 years, mean CHA2DS2-VASc score 4.5 ± 1.5) were included. Early death occurred in 125 patients (15.5%). In the multivariable analysis, factors associated with early death after LAAC were older age HR: 1.03; 95% CI: 1.01-1.06 per year; P = 0.01), lower body mass index (HR: 0.92; 95% CI: 0.88-0.97 per 1 kg/m2 increase; P < 0.001), diabetes (HR: 1.71; 95% CI: 1.19-2.47; P = 0.002), prior heart failure (HR: 1.74; 95% CI: 1.20-2.53; P = 0.001), and lower estimated glomerular filtration rate (HR: 1.09; 95% CI: 1.05-1.13 per 5 mL/min/1.73 m2 decrease; P < 0.001). There was a stepwise increase in risk of early death within the first year of LAAC with the combination of different risk factors (up to 48.9% in the presence of >3 risk factors). CONCLUSIONS: In this multicenter international registry, close to 1 in 6 patients died within the first year of LAAC. Older age, low body mass index, impaired estimated glomerular filtration rate, prior diabetes, and prior heart failure are independently associated with an increased risk. The risk of early death appeared to be prohibitive (∼50%) in the presence of >3 of these risk factors.

A Score to Assess Mortality After Percutaneous Mitral Valve Repair.

BACKGROUND: Risk stratification for transcatheter edge-to-edge mitral valve repair (TEER) is paramount in the decision-making process for treating severe mitral regurgitation (MR). OBJECTIVES: This study sought to create and validate a user-friendly score (MitraScore) to predict the risk of mortality in patients undergoing TEER. METHODS: The derivation cohort was based on a multicentric international registry that included 1,119 patients referred for TEER between 2012 and 2020. Score discrimination was assessed using Harrell's c-statistic, and the calibration was evaluated with the Gronnesby and Borgan goodness-of-fit test. An external validation was carried out in 725 patients from the GIOTTO registry. RESULTS: After multivariate analysis, we identified 8 independent predictors of mortality during the follow-up (2.1 ± 1.8 years): age ≥75 years, anemia, glomerular filtrate rate <60 mL/min/1.73 m2, left ventricular ejection fraction <40%, peripheral artery disease, chronic obstructive pulmonary disease, high diuretic dose, and no therapy with renin-angiotensin system inhibitors. The MitraScore was derived by assigning 1 point to each independent predictor. The c-statistic was 0.70. Per each point of the MitraScore, the relative risk of mortality increased by 55% (HR: 1.55; 95% CI: 1.44-1.67; P < 0.001). The discrimination and calibration for mortality prediction was better than those of EuroSCORE II (c-statistic 0.61) or Society of Thoracic Surgeons score (c-statistic 0.57). The MitraScore maintained adequate performance in the validation cohort (c-statistic 0.66). The score was also predictive for heart failure rehospitalization and was correlated with the probability of clinical improvement. CONCLUSIONS: The MitraScore is a simple prediction algorithm for the prediction of follow-up mortality in patients treated with TEER.

Incidence, predictors, and clinical impact of bleeding recurrence in patients with prior gastrointestinal bleeding undergoing LAAC.

BACKGROUND: Gastrointestinal bleeding (GIB) is associated with a high recurrence rate and a prior GIB episode is common in real-world left atrial appendage closure (LAAC) recipients. The present study sought to evaluate the clinical characteristics and outcomes of patients with prior GIB undergoing LAAC, and to determine the factors associated with and clinical impact of GIB recurrence. METHODS: Multicenter study including 277 consecutive patients who underwent percutaneous LAAC and had prior GIB. All-cause death, all bleeding, GIB recurrence, and clinical ischemic stroke were recorded. RESULTS: After a median follow-up of 17 (interquartile range: 6-37) months post-LAAC, the rates of death, bleeding, GIB recurrence, and ischemic stroke were 14.0 per 100 person-year (PY), 29.3 per 100 PY, 17.7 per 100 PY, and 1.1 per 100 PY, respectively. GIB recurrence occurred within 3 months post-LAAC in 55.8% of patients. A previous lower GIB (vs. upper or unclassified) (HR: 1.76; 95% CI: 1.09-2.82; p = .020) and eGFR < 45 mL/min (HR: 1.70; 95% CI:1.04-2.67; p = .033) determined an increased risk of GIB recurrence. By multivariable analysis, eGFR < 45 mL/min (HR: 2.72; 95% CI: 1.70-4.34; p < .001), GIB recurrence following LAAC (HR: 2.15; 95% CI: 1.33-3.46; p = .002), diabetes mellitus (HR: 1.77; 95% CI: 1.10-2.84; p = .018), and age (HR: 1.06; 95% CI: 1.03-1.10; p < .001) were associated with an increased mortality. CONCLUSIONS: Patients with prior GIB undergoing LAAC exhibited a relatively low rate of GIB recurrence, and prior lower GIB and moderate-to-severe chronic kidney disease determined an increased risk. GIB recurrence was associated with an increased mortality.

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk. OBJECTIVES: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR. METHODS: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries. RESULTS: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk. CONCLUSIONS: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.

Procedural Characteristics and Late Outcomes of Percutaneous Coronary Intervention in the Workup Pre-TAVR.

OBJECTIVES: This study sought to determine, in patients undergoing percutaneous coronary intervention (PCI) during the work-up pre-transcatheter aortic valve replacement (TAVR): 1) the clinical and peri-procedural PCI characteristics; 2) the long-term outcomes; and 3) the clinical events in those patients with complex coronary features. BACKGROUND: A PCI is performed in about 25% of TAVR candidates, but procedural features and late outcomes of pre-TAVR PCI remain largely unknown. METHODS: Multicenter study including 1197 consecutive patients who had PCI in the work-up pre-TAVR. A total of 1,705 lesions (1.5 ± 0.7 lesions per patient) were included. Death, stroke, myocardial infarction, and major adverse cardiovascular and cerebrovascular events (MACCE) were recorded, as well as target lesion failure (TLF) and target vessel failure (TVF). RESULTS: One-half of patients exhibited a multivessel disease and the mean SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) score was 12.1 ± 9.1. The lesions were of B2/C type, calcified, bifurcation, and ostial in 49.9%, 45.8%, 21.4%, and 19.3% of cases, respectively. After a median follow-up of 2 (interquartile range: 1 to 3) years, a total of 444 (37.1%) patients presented an MACCE. Forty patients exhibited TVF (3.3%), with TLF identified in 32 (2.7%) patients. By multivariable analysis, previous peripheral artery disease (p < 0.001), chronic obstructive pulmonary disease (p = 0.002), atrial fibrillation (p = 0.003), diabetes mellitus (p = 0.012), and incomplete revascularization (p = 0.014) determined an increased risk of MACCE. In patients with unprotected left main or SYNTAX score >32 (n = 128), TLF, TVF, and MACCE rates were 3.9%, 6.3%, and 35.9%, respectively (p = 0.378; p = 0.065, and p = 0.847, respectively, vs. the rest of the population). CONCLUSIONS: Patients undergoing PCI in the work-up pre-TAVR frequently exhibited complex coronary lesions and multivessel disease. PCI was successful in most cases, and TLF and TVF rates at 2-year follow-up were low, also among patients with high-risk coronary features. However, overall MACCE occurred in about one-third of patients, with incomplete revascularization determining an increased risk. These results should inform future studies to better determine the optimal revascularization strategy pre-TAVR.

Catheter-based treatment of tricuspid regurgitation: state of the art.

Tricuspid regurgitation is a highly prevalent condition, with detrimental effects on long-term survival. However, it has been historically neglected, and only surgically addressed when symptomatic diuretic agents proved insufficient to alleviate congestion. Besides, mortality rates of isolated tricuspid regurgitation surgery have been persistently high, even in contemporary series. This has led to the advent of a myriad of transcatheter tricuspid valve interventions mimicking current surgical technologies, for which a comprehensive imaging work-up holds the key for proper patient selection and intraprocedural monitoring. Although initially designed for compassionate use patients, growing experience and encouraging results of these less-invasive technologies are broadening the spectrum of beneficiaries. In this review, we will focus on the current picture of transcatheter tricuspid valve interventions, with special interest on the current understanding of pathoanatomic tricuspid regurgitation progression, preprocedural multimodality imaging and the latest experience on the different transcatheter devices.

Transesophageal echocardiography complications associated with interventional cardiology procedures.

BACKGROUND: Although there have been several reports documenting complications related with transesophageal echocardiography (TEE) manipulation following cardiac surgery, there is a paucity of data regarding the safety of TEE used to guide catheter-based interventions. The aim of this study was to determine the prevalence, types and risk factors of complications associated with procedures requiring active TEE guidance. METHODS: This study included 1249 consecutive patients undergoing either transcatheter aortic valve implantation (TAVI), Mitraclip, left atrial appendage occlusion (LAAO) or paravalvular leak closure (PVLC). Patients were divided into 2 cohorts based on the degree of probe manipulation required to guide the procedure and the risk of developing a TEE-related complication: low-risk (TAVI, n = 1037) and high-risk (Mitraclip, LAAO and PVLC, n = 212). Patients were further analyzed according to the occurrence of major and minor TEE-related complications. RESULTS: The overall incidence of TEE-related complications was 0.9% in the TAVI group and 6.1% in the rest of the cohort (P < .001). Patients in the high-risk cohort had also a higher incidence of major-complications (2.8% vs 0.6%, P = .008), and factors associated with an increased risk were being underweight, having a prior history of gastrointestinal bleeding and the use of chronic steroids/immunosuppressive medications. Procedural time under TEE-manipulation was longer in patients exhibiting complications and was an independent predictor of major complications (OR = 1.13, 95% CI 1.01-1.25, for each 10 minutes increments in imaging time). Patients with major complications undergoing Mitraclip had the longest median time under TEE-manipulation (297 minutes) and a risk of developing a major-complication that was 10.64 times higher than the rest of the cohort (95% CI 3.30-34.29, P < .001). CONCLUSION: The prevalence of TEE-related complications associated with interventional procedures is higher than previously reported. Undergoing a prolonged procedure, particularly in the setting of Mitraclip, was the main factor linked to TEE-related complications.

Clinical and Technical Characteristics of Coronary Angiography and Percutaneous Coronary Interventions Performed before and after Transcatheter Aortic Valve Replacement with a Balloon-Expandable Valve.

OBJECTIVES: To report on the feasibility and technical differences between coronary procedures performed before and after TAVR with the balloon-expandable Edwards-SAPIEN or the SAPIEN XT valves. BACKGROUND: Coronary artery disease (CAD) and aortic stenosis often coexist. Transcatheter aortic valve replacement (TAVR) is emerging as a treatment for younger and lower surgical risk patients who might not present with clinically evident CAD before TAVR. The demand for performing post-TAVR coronary angiograms (CAs) and percutaneous coronary interventions (PCIs) will thus increase, posing new technical challenges. METHODS: Over 1000 TAVRs were performed at the Quebec Heart and Lung Institute, of which 616 with the abovementioned valves. Of these, 28 patients had an analyzable pre- and post-TAVR CAs and 13 patients had pre- and post-TAVR PCIs performed. Procedural characteristics were gathered from all coronary procedures and subsequently compared amongst the same type of procedure performed at these two distinct time periods. RESULTS: Neither CAs-nor PCIs-performed after valve implantation revealed significant differences regarding arterial access site, catheter diameter, number of diagnostic or guiding catheters used, procedural duration, fluoroscopy time, or achievement of selective coronary injection. Lesion location and classification, as well as the preference of using a drug-eluting stent, remained unchanged. During post-TAVR CA, the amount of contrast delivered and the radiation dose area product were significantly lower compared with pre-TAVR CA values. CONCLUSIONS: Performance of CA and PCI after TAVR with a balloon-expandable valve appears unaffected by its presence.

Transcatheter aortic valve replacement in low risk patients.

Transcatheter aortic valve replacement (TAVR) is a relatively new technology that has grown exponentially over the past decade. Although it was initially restricted to elderly patients at very high or prohibitive surgical risk, it is currently being evaluated as a treatment option in younger and lower risk patients. The increasing experience of the Heart Teams, along with the continued refinement of transcatheter valve technology has resulted in TAVR achieving results comparable to those of surgery for treating intermediate-risk patients. Furthermore, promising preliminary results have been obtained from observational and propensity matched studies in low risk patients, and a small randomized trial showed the non-inferiority of TAVR vs. SAVR regarding early and late (up to 6 years) outcomes. Three ongoing randomized trials will provide the definite response about the safety and efficacy of TAVR for treating low risk patients with severe aortic stenosis in the near future. The (expected) positive results of these studies would establish the basis for TAVR as the preferred treatment for the majority of patients with aortic stenosis. However, continuous research efforts for better determining valve durability among TAVR recipients, as well as reducing some of the genuine and frequent complications of TAVR (e.g. conduction disturbances) are important in this final effort for making TAVR the default treatment for aortic stenosis.

Transcatheter Tricuspid Valve Replacement for Treating Severe Tricuspid Regurgitation: Initial Experience With the NaviGate Bioprosthesis.

Despite the growing evidence with emerging transcatheter tricuspid valve repair therapies, the experience with transcatheter tricuspid valve replacement remains sparse. We describe a case of severe tricuspid regurgitation in a 79-year-old patient deemed unsuitable for isolated tricuspid valve surgery, successfully treated with a 40-mm self-expandable NaviGate (NaviGate Cardiac Structures, Inc, Lake Forest, CA) valved stent via a transatrial approach, with excellent result and hemodynamic performance at 4 months.

Transcatheter Tricuspid Valve Interventions: Landscape, Challenges, and Future Directions.

Tricuspid regurgitation is a common finding in patients with left-sided valvular or myocardial disease, often being a marker for late-stage chronic heart failure with a grim prognosis. However, isolated tricuspid valve surgery remains infrequent and is associated with the highest mortality among all valve procedures. Hence, a largely unmet clinical need exists for less invasive therapeutic options in these patients. In recent times, multiple percutaneous therapies have been developed for treating severe tricuspid regurgitation, including tricuspid valve repair and, more recently replacement, opening an entirely new venue for managing tricuspid regurgitation. The aim of this review is to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve therapies, highlighting potential challenges and future directions.

Hemodynamic impact of percutaneous left atrial appendage closure in patients with paroxysmal atrial fibrillation.

PURPOSE: Percutaneous left atrial appendage (LAA) closure has become a valid alternative to anticoagulation therapy for the prevention of thromboembolic events in patients with atrial fibrillation (AF). However, scarce data exist on the impact of LAA closure on left atrial and ventricular function. We sought to assess the acute hemodynamic changes associated with percutaneous LAA closure in patients with paroxysmal AF. METHODS: The study population consisted of 31 patients (mean age 73 ± 10 years; 49% women) with paroxysmal AF who underwent successful percutaneous LAA closure. All patients were in sinus rhythm and underwent 2D transthoracic echocardiography at baseline and the day after the procedure. A subset of 14 patients underwent preprocedural cardiac computed tomography (CT) with 3D LA and LAA reconstruction. RESULTS: Left ventricular systolic function parameters and LA volumetric indexes remained unchanged after the procedure. No significant changes in left ventricular stroke volume (72.4 ± 16.0 vs. 73.3 ± 15.7 mL, p = 0.55) or LA stroke volume (total 15.6 ± 4.2 vs. 14.6 ± 4.2 mL, p = 0.21; passive 9.0 ± 2.8 vs. 8.3 ± 2.6 mL, p = 0.31; active 10.3 ± 5.6 vs. 10.0 ± 6.4 mL, p = 0.72) occurred following LAA closure. Mean ratio of LAA to LA volume by 3D CT was 10.2 ± 2.3%. No correlation was found between LAA/LA ratio and changes in LA stroke volume (r = 0.35, p = 0.22) or left ventricular stroke volume (r = 0.28, p = 0.33). CONCLUSIONS: The LAA accounts for about 10% of the total LA volume, but percutaneous LAA closure did not translate into any significant changes in LA and left ventricular function.

Infective endocarditis following transcatheter edge-to-edge mitral valve repair: A systematic review.

OBJECTIVES: To assess the clinical characteristics, management, and outcomes of patients diagnosed with infective endocarditis (IE) after edge-to-edge mitral valve repair with the MitraClip device. BACKGROUND: Transcatheter edge-to-edge mitral valve repair has emerged as an alternative to surgery in high-risk patients. However, few data exist on IE following transcatheter mitral procedures. METHODS: Four electronic databases (PubMed, Google Scholar, Embase, and Cochrane Library) were searched for original published studies on IE after edge-to-edge transcatheter mitral valve repair from 2003 to 2017. RESULTS: A total of 10 publications describing 12 patients with definitive IE (median age 76 years, 55% men) were found. The mean logistic EuroSCORE/EuroSCORE II were 41% and 45%, respectively. The IE episode occurred early (within 12 months post-procedure) in nine patients (75%; within the first month in five patients). Staphylococcus aureus was the most frequent (60%) causal microorganism, and severe mitral regurgitation was present in all cases but one. Surgical mitral valve replacement (SMVR) was performed in most (67%) patients, and the mortality associated with the IE episode was high (42%). CONCLUSIONS: IE following transcatheter edge-to-edge mitral valve repair is a rare but life-threatening complication, usually necessitating SMVR despite the high-risk profile of the patients. These results highlight the importance of adequate preventive measures and a prompt diagnosis and treatment of this serious complication.