Advanced remote care for heart failure in times of COVID-19 using an implantable pulmonary artery pressure sensor: the new normal.

Heart failure (HF) is a major public health problem and a leading cause of hospitalization in western countries. Over the past decades, the goal has been to find the best method for monitoring congestive symptoms to prevent hospitalizations. Addressing this task through regular physician visits, blood tests, and imaging has proven insufficient for optimal control and has not decreased enough HF-related hospitalization rates. In recent years, new devices have been developed for this reason and CardioMEMS is one of the therapeutic monitoring options. CardioMEMS has shown to be effective in preventing and reducing HF hospitalizations in patients both with HF with reduced ejection fraction and HF with preserved ejection fraction. CardioMEMS' versatility has made it a great option for pulmonary artery pressure monitoring, both during the coronavirus disease-19 (COVID-19) pandemic and when the clinic visits have (partially) resumed. CardioMEMS is the remote haemodynamic monitoring system with the most evidence-driven efficacy, and COVID-19 has put it in the spot as a centre-stage technology for HF monitoring. In a few months of the COVID-19 epidemic, CardioMEMS has grown to maturity, making it the new normal for high-quality, high-value remote HF care.

Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement.

BACKGROUND: At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post-transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. METHODS: A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. RESULTS: The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (Δ6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%-80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for cardiovascular causes (P=0.001). Baseline slow walkers who were able to improve the 6MWT distance presented with significantly better outcomes than nonimprovers (P=0.01 for all-cause mortality; P=0.001 for cardiovascular end point). CONCLUSIONS: Approximately one-third of patients undergoing TAVR did not improve their exercise capacity postprocedure. The lack of functional improvement post-TAVR was predicted by a mix of baseline and periprocedural factors translating into poorer clinical outcomes. These results suggest that systematically implementing exercise capacity assessment pre- and post-TAVR may help to improve patient risk stratification.

Transcatheter mitral valve implantation for inoperable severely calcified native mitral valve disease: A systematic review.

BACKGROUND: Transcatheter mitral valve implantation (TMVI) for severely calcified native mitral valve disease recently emerged as a treatment option in patients deemed inoperable by conventional techniques. Yet no systematic appraisal currently exists characterizing this novel treatment paradigm. METHODS: A systematic literature review summarizing the clinical, anatomical, peri- and post-procedural characteristics underscoring the technical feasibility of this procedure was performed. RESULTS: Nine publications describing 11 patients [mean age 68 ± 10 years, 82% female, 82% severe mitral stenosis (MS), 18% severe mitral regurgitation (MR)] were identified. Mean STS score, trans-mitral gradient and effective orifice area were 10.5 ± 4.6%, 12 ± 2.4 mm Hg and 0.93 ± 0.06 cm(2) respectively. All patients had severe, circumferential mitral annular calcification on imaging. Dedicated balloon-expanding transcatheter aortic valves were used in 10/11 cases, with 8/11 cases involving a true percutaneous approach with peri-procedural 3D trans-esophageal echocardiographic guidance; 3/11 cases involved an open left atrial approach. Following initial balloon inflation and valve deployment, procedural success rate was 73%, without residual paravalvular leaks (PVL). Successful immediate re-deployment of a 2nd valve was needed in 2 instances following significant PVL detection. Residual trans-valvular gradients ranged from 3 to 7 mm Hg, with no patient demonstrating >grade 2 MR. All patients survived the procedure, with 2 reported deaths on days 10- and 41 post-TMVI being non-cardiac-related. Mid-term clinical follow-up, reported in 8 patients, revealed 6 patients to be alive at 3-months with much improved functional status. CONCLUSIONS: TMVI for native severely calcified mitral valve disease appears technically feasible with acceptable initial acute and mid-term hemodynamic and clinical outcomes. The outcomes of an ongoing, dedicated global Sapien TMVI registry will shed further light on this evolving treatment paradigm.

Stumpless chronic total occlusion with no retrograde option: Multidetector computed tomography-guided intervention via bi-radial approach utilizing bioresorbable vascular scaffold.

When dealing with flush ostial chronic total occlusion (CTO) and no viable retrograde option, the only way to perform recanalization is through an antegrade approach. Such a procedure can be extremely difficult considering the ambiguity of the proximal cap. We demonstrate how we solved ambiguity of the proximal cap of an ostial obtuse marginal CTO with the help of cardiac multidetector computed tomography (MDCT). We also discuss several techniques including bilateral radial approach with home-made sheathless large-bore catheters, IVUS-guided cap puncture, ping-pong guide catheters engagement in the left main, and bioresorbable vascular scaffold (BVS) for an ostial left circumflex disease that we all used in our CTO case.

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes.

BACKGROUND: Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. OBJECTIVES: This study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. METHODS: The TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. RESULTS: Forty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro-B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. CONCLUSIONS: Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).

Tailored Treatment of Patients With Intracardiac Leads and Tricuspid Regurgitation.

Tricuspid regurgitation (TR) is frequent in patients with leads from rhythm control devices. Percutaneous treatment of TR can be an effective therapy in these patients but needs to be tailored based on valve anatomy and the underlying mechanism of the TR as shown in the case series that we present. (Level of Difficulty: Advanced.).

Endothelial dysfunction in patients with angina and non-obstructed coronary arteries is associated with an increased risk of mayor cardiovascular events. Results of the Spanish ENDOCOR registry.

BACKGROUND: Coronary endothelial dysfunction and vasospasm are potential causes of ischemia in patients without obstructive coronary stenoses (INOCA). OBJECTIVE: To evaluate the prevalence of endothelial dysfunction and the clinical profile of patients with INOCA in Spain, as well as to identify the predictors and the prognostic impact of endothelial dysfunction in this scenario. METHODS: A total of 438 consecutive patients with INOCA in whom the acetylcholine test was performed were prospectively enrolled. Patients were followed up at 1 and 2 years. RESULTS: Mean age was 62 ± 11 years with 60% female. Clinical presentation comprised 52.6% angina at rest, 61.2% exertional angina, and 31.7% dyspnea. There were no major complications of the acetylcholine test. Endothelial dysfunction was observed in 198 (45%) of patients, with severe vasoconstriction (defined as over 70% constriction), being observed in 101 (23%). Multivariable regression analysis showed that endothelial dysfunction was predicted by the presence of exertional angina (OR 2.2; CI95%1.01-2.55; p = 0.02), prior coronary disease (OR 2.46; CI95% 1.57-3.89; p < 0.01), and coronary intramyocardial bridging (2.35; CI95% 1.02-5.60; p = 0.04). Patients with endothelial dysfunction presented with worsening angina compared to those without endothelial dysfunction (25.6% vs. 12.8%) and also presented with increased levels of minimal effort angina (40% vs. 26,7%, p = 0.03) more frequently during the follow up than those without endothelial dysfunction. Endothelial dysfunction was also an independent predictor of the occurrence of myocardial infarction or unstable angina at one year (OR 2.85, CI 95% 1.01-9.25; p = 0.03). CONCLUSIONS: Endothelial dysfunction is present in almost half of patients with INOCA and is associated with worsening symptoms, as well as with a higher rate of adverse events.

Sacubitril/valsartan affects pulmonary arterial pressure in heart failure with preserved ejection fraction and pulmonary hypertension.

AIMS: Prior studies have not fully characterized the haemodynamic effects of the angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril/valsartan in heart failure with preserved ejection fraction and pulmonary hypertension (HFpEF-PH). The aim of the Treatment of PH With Angiotensin II Receptor Blocker and Neprilysin Inhibitor in HFpEF Patients With CardioMEMS Device (ARNIMEMS-HFpEF) study is to assess pulmonary artery pressure (PAP) dynamics by means of implanted PAP monitors in patients with HFpEF-PH treated with sacubitril/valsartan. METHODS AND RESULTS: This single-arm, investigator-initiated, interventional study included 14 consecutive ambulatory symptomatic HFpEF-PH patients who underwent CardioMEMS implantation prior to enrolment [mean ejection fraction 60.4 ± 7.2%, baseline mean PAP (mPAP) 33.9 ± 7.6 mmHg]. Daily PAP values were examined during three periods: a 6 week period after CardioMEMS implantation and before sacubitril/valsartan treatment (pre-ARNI), a 6 week period with sacubitril/valsartan treatment (ARNI ON), and a 6 week period of sacubitril/valsartan withdrawal (ARNI OFF). The primary endpoint was change in mPAP with and without sacubitril/valsartan. Secondary endpoints included changes in 6 min walking distance, B-line sum in lung ultrasound, and quality of life (QoL). During the study period, 1717 mPAP measurements were recorded. Between pre-ARNI vs. ARNI ON, mPAP significantly declined by -4.99 mmHg [95% confidence interval (CI) -5.55 to -4.43]. Between ARNI ON vs. ARNI OFF, mPAP significantly increased by +2.84 mmHg [95% CI +2.26 to +3.42]. Between pre-ARNI vs. ARNI ON, we found an improvement in 6 min walking distance, B-lines, and QoL. Mean loop diuretic management did not differ between periods. CONCLUSIONS: Sacubitril/valsartan significantly reduced mPAP in patients with HFpEF-PH, independent of loop diuretic management, together with improvement in functional capacity, lung congestion, and QoL. Sacubitril/valsartan may be a therapeutic alternative in HFpEF-PH.

Clinical outcomes in spontaneous coronary artery dissection.

OBJECTIVE: Spontaneous coronary artery dissection (SCAD) is an infrequent cause of acute coronary syndrome. Our aim was to assess adverse events at follow-up from a nationwide prospective cohort. METHODS: The Spanish Registry on SCAD (SR-SCAD) included patients from 34 hospitals. All coronary angiograms were analysed by two experts. Those cases with doubts regarding the diagnosis of SCAD were excluded. The angiographic SCAD classification by Saw et al was followed. Major adverse cardiovascular and cerebrovascular event (MACCE) was predefined as composite of death, myocardial infarction, unplanned revascularisation, SCAD recurrence or stroke. All events were assigned by a Clinical Events Committee. RESULTS: After corelab evaluation, 389 patients were included. Most patients were women (88%); median age 53 years (IQR 47-60). Most patients presented as non-ST-segment-elevation myocardial infarction (54%). A type 2 intramural haematoma (IMH) was the most frequent angiographic pattern (61%). A conservative initial management was selected in 78% of patients. At a median time of follow-up of 29 months (IQR 17-38), 46 patients (13%) presented MACCE, mainly driven by reinfarctions (7.6%) and unplanned revascularisations (6.2%). Previous history of hypothyroidism (HR 3.79; p<0.001), proximal vessel involvement (HR 2.69; p=0.009), type 2 IMH (HR 2.12; p=0.037) and dual antiplatelet therapy (DAPT) at discharge (HR 2.18; p=0.042) were independent predictors of MACCE. CONCLUSIONS: In this large prospective cohort of patients with SCAD, prognosis was overall favourable, with events mainly driven by reinfarctions or unplanned revascularisations. History of hypothyroidism, proximal vessel involvement, type 2 IMH and DAPT at discharge were associated with MACCE. TRIAL REGISTRATION NUMBER: NCT03607981.

Clinical implications of arterial hypertension in patients with spontaneous coronary artery dissection.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is a rare but increasingly recognized cause of acute coronary syndrome. Many patients with SCAD have associated coronary risk factors. However, the implications of arterial hypertension in SCAD patients remain unknown. OBJECTIVE: This study sought to assess the clinical implications of arterial hypertension in a nationwide cohort of patients with SCAD. METHODS: The Spanish SCAD registry (NCT03607981) prospectively enrolled 318 consecutive patients. All coronary angiograms were centrally analyzed to confirm the diagnosis of SCAD. Patients were classified according to the presence of arterial hypertension. RESULTS: One-hundred eighteen patients (37%) had a diagnosis of arterial hypertension. Hypertensive SCAD patients were older (60 ± 12 vs. 51 ± 9 years old) and had more frequently dyslipidemia (56 vs. 23%) and diabetes (9 vs. 3%) but were less frequently smokers (15 vs. 35%) than normotensive SCAD patients (all P < 0.05). Most patients in both groups were female (90 vs. 87%, NS) and female patients with hypertension were more frequently postmenopausal (70 vs. 47%, P < 0.05). Hypertensive SCAD patients had more severe lesions and more frequently multivessel involvement (15 vs. 7%, P < 0.05) and coronary ectasia (19 vs. 7%, P < 0.05) but showed a similar prevalence of coronary tortuosity (34 vs. 26%, NS). Revascularization requirement was similar in both groups (17 vs. 26%, NS) but procedural success was significantly lower (65 vs. 88%, P < 0.05) and procedural-related complications more frequent (65 vs. 41%, P < 0.05) in SCAD patients with hypertension. CONCLUSION: Patients with SCAD and hypertension are older, more frequently postmenopausal and have more coronary risk factors than normotensive SCAD patients. During revascularization SCAD patients with hypertension obtain poorer results and have a higher risk of procedural-related complications (NCT03607981).

6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study.

BACKGROUND: Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients are often deemed to be at high surgical risk. Heterotopic bicaval stenting is an emerging, attractive transcatheter solution for these patients. OBJECTIVES: The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava. METHODS: TRICUS EURO (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) is a nonblinded, nonrandomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 and February 2021. High-risk individuals with severe symptomatic TR despite optimal medical therapy were included. The primary endpoint was quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire score and New York Heart Association (NYHA) functional class improvement at 6-month follow-up. RESULTS: Thirty-five patients (mean age 76 ± 6.8 years, 83% women) were treated using the TricValve system. All patients at baseline were in NYHA functional class III or IV. At 30 days, procedural success was 94%, with no procedural deaths or conversions to surgery. A significant increase in QOL at 6 months follow-up was observed (baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores 42.01 ± 22.3 and 59.7 ± 23.6, respectively; P = 0.004), correlating with a significant improvement in NYHA functional class, with 79.4% of patients noted to be in functional class I or II at 6 months (P = 0.0006). The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively. CONCLUSIONS: The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and functional classification at 6 months follow-up.

Caval Valve Implantation (CAVI): An Emerging Therapy for Treating Severe Tricuspid Regurgitation.

Severe tricuspid regurgitation remains a challenging heart-valve disease to effectively treat with high morbidity and mortality at mid-term. Currently guideline-directed medical treatment is limited to escalating dose of diuretics, and the rationale and timing of open-heart surgery remains controversial. Emerging percutaneous therapies for severe tricuspid regurgitation continue to show promising results in early feasibility studies. However, randomized trial data is lacking. Additionally, many patients are deemed unsuitable for these emerging therapies due to anatomical or imaging constraints. Given the technical simplicity of the bicaval valve implantation (CAVI) technique compared to other transcatheter devices, CAVI is postulated as a suitable alternative for a wide variety of patients affected with severe+ tricuspid regurgitation. In this review we illustrate the current evidence and ongoing uncertainties of CAVI, focusing on the novel CAVI-specific devices.

Midterm Outcomes Following Sutureless and Transcatheter Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Sutureless-surgical aortic valve replacement (SU-SAVR) has been proposed as a surgical alternative for treating aortic stenosis, which facilitates a minimally invasive approach. While some studies have compared the early outcomes of SU-SAVR versus transcatheter aortic valve replacement (TAVR), most data were obtained in high-risk patients and/or limited to in-hospital outcomes. This study aimed to compare in-hospital and midterm clinical outcomes following SU-SAVR and TAVR in low-risk patients with aortic stenosis. METHODS: A total of 806 consecutive low-risk (EuroSCORE II <4%) patients underwent TAVR or SU-SAVR between 2011 and 2020 in 2 centers. A 1:1 propensity score matching was performed and identified 171 pairs with similar characteristics that were included in the analysis. Baseline characteristics, in-hospital and follow-up events (defined according to Valve Academic Research Consortium-2) were collected. RESULTS: Baseline characteristics were well balanced between groups, with a median EuroSCORE II of 1.9% (1.3%-2.5%) in both SU-SAVR and TAVR groups (P=0.85). There were no statistically significant differences regarding in-hospital mortality (SU-SAVR: 4.1%, TAVR: 1.8%, P=0.199) and stroke (SU-SAVR: 2.3%, TAVR: 2.9%, P=0.736), but SU-SAVR recipients exhibited higher rates of bleeding and new-onset atrial fibrillation, higher residual transvalvular gradients (P<0.001), and a lower rate of pacemaker implantation (P=0.011). After a median follow-up of 2 (1-3) years, there were no differences between groups in all-cause mortality (hazard ratio, 0.97 [95% CI, 0.52-1.82], P=0.936) and stroke (hazard ratio, 0.83 [95% CI, 0.32-2.15], P=0.708), but SU-SAVR was associated with a higher risk of heart failure hospitalization (hazard ratio, 5.38 [95% CI, 1.88-15.38], P=0.002). CONCLUSIONS: In low-risk patients with aortic stenosis, TAVR was associated with improved in-hospital outcomes (except for conduction disturbances) and valve hemodynamics, compared with SU-SAVR. Although similar mortality and stroke rates were observed at 2-year follow-up, the risk of heart failure hospitalization was higher among SU-SAVR patients. These results may contribute to reinforce TAVR over SU-SAVR for the majority of such patients. Graphic Abstract: A graphic abstract is available for this article.

Trends in prevalence and outcomes of acute coronary syndrome associated with cocaine consumption: The RUTI-cocaine study.

BACKGROUND: The use of cocaine as a recreational drug has increased over recent years. In this study, we aimed to analyze the prevalence, and in-hospital and long-term outcomes of acute coronary syndrome (ACS) associated with cocaine consumption (ACS-ACC). METHODS: A prospective observational registry of young patients hospitalised with ACS from 2001 through 2015, we analysed ACS-ACC temporal trends, clinical characteristics, and major adverse cardiovascular events (MACE) during long-term follow-up. RESULTS: There were 8153 admissions with ACS, of whom 864 patients were ≤50-years-old; 59 patients (6.8%) presented with ACS-ACC. The prevalence of patients with a history of cocaine consumption increased to maximum of 18% in 2008 with no variations thereafter (r = 0.74, p < 0.001). The ACS-ACC incidence increased over time from 5% to 9% (r = 0.25, p = 0.07). Compared to patients with ACS not associated with cocaine consumption, the ACS-ACC exhibited a higher incidence of in-hospital ventricular tachycardia (16.9% vs 4.7%, p < 0.001) and trends to in-hospital mortality (3.4% vs 1.0%, p = 0.097); during a median follow-up of 5.6 years, ACS-ACC had higher risk of MACE (HR 1.83; 95% CI 1.04-3.25, p = 0.038), higher risk of myocardial infarction (HR 2.39, 95% CI 1.02-5.60, p = 0.045), and higher risk of cardiovascular mortality (HR 6.26; 95% CI 1.67-23.43, p = 0.006). CONCLUSION: Young patients with ACS-ACC carry a high risk of short and long-term major adverse cardiovascular events. Over the 15-year study period, we observed an increasing prevalence of this entity. This trend and its outcomes underscore the need for increased awareness and improved management strategies.

Timing of Onset and Outcome of New Conduction Abnormalities Following Transcatheter Aortic Valve Implantation: Role of Balloon Aortic Valvuloplasty.

INTRODUCTION AND OBJECTIVES: Little is known about the timing of onset and outcome of conduction abnormalities (CA) following balloon-expandable transcatheter aortic valve implantation. The aim of this study was to examine the timing of CA and determine the impact of balloon aortic valvuloplasty (BAV) on the persistence of these abnormalities. METHODS: A total of 347 patients were included. Of these, 75 had a continuous electrocardiogram recording and a 6-lead electrocardiogram at each step of the procedure. RESULTS: In the transcatheter aortic valve implantation population undergoing continuous electrocardiogram monitoring, new-onset left bundle branch block (LBBB) or third-degree atrioventricular block occurred in 48 (64%) and 16 (21.3%) patients, with 51.5% of CA occurring before valve implantation. Left bundle branch block persisted more frequently at hospital discharge (53.8 vs 22.7%; P=.028) and at 1-month follow-up (38.5 vs 13.6%; P=.054) when occurring before valve implantation. Balloon aortic valvuloplasty prior to valve implantation was used in 264 (76.1%) patients, and 78 (22.5%) had persistent LBBB or complete atrioventricular block requiring pacemaker implantation. Persistent LBBB or unresolved atrioventricular block at 1 month occurred more frequently in the BAV group (76.1 vs 47.6%; P=.021), and the use of BAV was associated with a lack of CA resolution (OR, 3.5; 95%CI, 1.17-10.43; P=.021). CONCLUSIONS: In patients undergoing a balloon-expandable transcatheter aortic valve implantation, more than half of CA occurred before valve implantation. Early occurrence of CA was associated with a higher rate of persistence at 1-month follow-up. The use of BAV was associated with an increased risk of CA persistence.

Impact of anticoagulation therapy on valve haemodynamic deterioration following transcatheter aortic valve replacement.

OBJECTIVE: To evaluate the changes in transvalvular gradients and the incidence of valve haemodynamic deterioration (VHD) following transcatheter aortic valve replacement (TAVR), according to use of anticoagulation therapy. METHODS AND RESULTS: This multicentre study included 2466 patients (46% men; mean age 81±7 years) who underwent TAVR with echocardiography performed at 12-month follow-up. Anticoagulation therapy was used in 707 patients (28.7%) following TAVR (AC group). A total of 663 patients received vitamin K antagonists, and 44 patients received direct oral anticoagulants. A propensity score matching analysis was performed to adjust for intergroup (AC vs non-AC post-TAVR) differences. A total of 622 patients per group were included in the propensity-matched analysis. VHD was defined as a ≥10 mm Hg increase in the mean transprosthetic gradient at follow-up (vs hospital discharge). The mean clinical follow-up was 29±18 months. The mean transvalvular gradient significantly increased at follow-up in the non-AC group within the global cohort (P=0.003), whereas it remained stable over time in the AC group (P=0.323). The incidence of VHD was significantly lower in the AC group (0.6%) compared with the non-AC group (3.7%, P<0.001), and these significant differences remained within the propensity-matched populations (0.6% vs 3.9% in the AC and non-AC groups, respectively, P<0.001). The occurrence of VHD did not associate with an increased risk of all-cause death (P=0.468), cardiovascular death (P=0.539) or stroke (P=0.170) at follow-up. CONCLUSIONS: The lack of anticoagulation therapy post-TAVR was associated with significant increments in transvalvular gradients and a greater risk of VHD. VHD was subclinical in most cases and did not associate with major adverse clinical events. Future randomised trials are needed to determine if systematic anticoagulation therapy post-TAVR would reduce the incidence of VHD.

Embolic Protection Devices During TAVI: Current Evidence and Uncertainties.

Transcatheter aortic valve implantation (TAVI) is now the principal therapeutic option in patients with severe aortic stenosis deemed inoperable or at high surgical risk. Implementing TAVI in a lower risk profile population could be limited by relatively high cerebrovascular event rates related to the procedure. Diffusion-weighted magnetic resonance imaging studies have demonstrated the ubiquitous presence of silent embolic cerebral infarcts after TAVI, with some data relating these lesions to subsequent cognitive decline. Embolic protection devices provide a mechanical barrier against debris embolizing to the brain during TAVI. We review the current evidence and ongoing uncertainties faced with the 3 currently available devices (Embrella, TriGuard and Claret) in TAVI. Studies evaluated neurological damage at 3 levels: clinical, subclinical, and cognitive. Feasibility and safety were analyzed for the 3 devices. In terms of efficacy, all studies were exploratory, but none demonstrated significant reductions in clinical event rates. The Embrella and Claret devices demonstrated significant reductions of the total cerebral lesion volume on diffusion-weighted magnetic resonance imaging. Studies evaluating the effects on cognition were also somewhat inconclusive. In conclusion, despite embolic protection devices demonstrating reductions in the total cerebral lesion volume on diffusion-weighted magnetic resonance imaging, the clinical efficacy in terms of preventing stroke/cognitive decline requires confirmation in larger studies.