Subclinical Left Ventricular Systolic Dysfunction in Hospitalized Patients with COVID-19 by Strain: A 30-Day Echocardiographic Follow-Up.

Background and Objectives: Available studies confirm myocardial injury and its association with mortality in patients with COVID-19, but few data have been reported from echocardiographic studies. The aim of this study was to identify subclinical left ventricular dysfunction by global longitudinal strain (GLS) and its evolution in the short term in hospitalized patients with COVID-19. Materials and Methods: Thirty-one consecutive noncritical patients admitted for COVID-19 were included. Information on demographics, laboratory results, comorbidities, and medications was collected. Transthoracic echocardiograms were performed using a Philips Affinity 50, at the acute stage and at a 30-day follow-up. Automated left ventricular GLS was measured using a Philips Qlab 13.0. A GLS of <-15.9% was defined as abnormal. Results: The mean age was 65 ± 15.2 years, and 61.3% of patients were male. Nine patients (29%) had elevated levels of high-sensitivity troponin I. Left ventricular ejection fraction was preserved in all; however, 11 of them (35.5%) showed reduced GLS. These patients had higher troponin levels (median, 23.7 vs. 3.2 ng/L; p < 0.05) and NT-proBNP (median, 753 vs. 81 pg/mL; p < 0.05). The multivariate analysis revealed that myocardial injury, defined as increased troponin, was significantly associated with GLS values (coefficient B; p < 0.05). Follow-up at 30 days showed an improvement in GLS values in patients with subclinical left ventricular dysfunction (-16.4 ± 2.07% vs. -13.2 ± 2.40%; p < 0.01), without changes in the normal GLS group. Conclusions: Subclinical left ventricular dysfunction is common in noncritical hospitalized patients with COVID-19 (one in every three patients), even with preserved left ventricular ejection fraction. This impairment tends to be reversible on clinical recovery.

Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients.

OBJECTIVES: We aimed to describe hemodynamic performance and clinical outcomes at 30-day follow-up of the balloon-expandable (BE) Myval transcatheter heart valve (THV) in low-risk patients. BACKGROUND: The results of the next-generation BE Myval THV in low-risk aortic stenosis (AS) patients are still unknown. METHODS: Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE-II) scores. RESULTS: Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE-II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30-day follow-up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm2 ) and mean aortic valve gradient (43.4 ± 11.1 vs. 9.0 ± 3.7 mmHg) improved significantly (p < 0.001). Moderate aortic regurgitation occurred in 4%. Endpoints of early safety and clinical efficacy were 3 and 1%, respectively. CONCLUSIONS: Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.

Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) via transaxillary (TAx) approach with ACURATE neo valve is an off-label procedure. Our aim was to gather information on ACURATE neo cases implanted via TAx approach and report major outcomes. METHODS AND RESULTS: The TRANSAX Study (NCT04274751) retrospectively gathered patients from nine centres in Europe and North America treated with ACURATE neo valve through TAx approach up to May/2019. Follow up was pre-specified at 1-year and was obtained for all patients. A total of 75 patients (79 ± 10 years; 32% women) were included. Left axillary (72%) and conscious sedation (95.2%) were the most common setting. Risk scores were higher when right axillary artery and surgical cut-down were selected. Severe complications including valve embolization, coronary obstruction, annulus rupture, and procedural mortality did not occur. Cardiac tamponade occurred in two cases (2.7%) with one requiring conversion to open surgery (1.3%). Bail-out stenting and surgical vascular repair were required in 7 (9.3%) and 3 (4%) cases, respectively. The need for new permanent pacemaker was 8%. Procedural success (96%), in-hospital (2.7%), and 1-year mortality (8%) were comparable in all settings. Only one case (1.3%) complicated with cerebrovascular event and one (1.3%) presented moderate aortic regurgitation before discharge. CONCLUSIONS: TAx TAVR procedures with the ACURATE neo valve were presented high success rate and low in-hospital and 1-year mortality.

Outcomes and predictors of left ventricle recovery in patients with severe left ventricular dysfunction undergoing transcatheter aortic valve implantation.

BACKGROUND: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited. AIMS: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function. METHODS: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI). RESULTS: Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition). CONCLUSIONS: LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).

Spanish cardiac catheterization and coronary intervention registry. 33rd official report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2023).

INTRODUCTION AND OBJECTIVES: This article presents the 2023 activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC). METHODS: All interventional cardiology laboratories in Spain were invited to participate in an online survey. Data analysis was carried out by an external company and subsequently reviewed and presented by the members of the ACI-SEC board. RESULTS: A total of 119 hospitals participated. The number of diagnostic studies decreased by 1.8%, while the number of percutaneous coronary interventions (PCI) showed a slight increase. There was a reduction in the number of stents used and an increase in the use of drug-coated balloons. The use of intracoronary diagnostic techniques remained stable. For the first time, data on PCI guided by intracoronary imaging was reported, showing a 10% usage rate in Spain. Techniques for plaque modification continued to grow. Primary PCI increased, becoming the predominant treatment for myocardial infarction (97%). Noncoronary structural procedures continued their upward trend. Notably, the number of left atrial appendage closures, patent foramen ovale closures, and tricuspid valve interventions grew in 2023. There was also a significant increase in interventions for acute pulmonary embolism. CONCLUSIONS: The 2023 Spanish cardiac catheterization and coronary intervention registry indicates a stabilization in coronary interventions, together with an increase in complexity. There was consistent growth in procedures for both valvular and nonvalvular structural heart diseases.

Feasibility of precise commissural and coronary alignment with balloon-expandable TAVI.

INTRODUCTION AND OBJECTIVES: We aimed to describe the feasibility and preliminary outcomes of commissural alignment (CA) for the balloon-expandable transcatheter heart valve. METHODS: The relationship among native commissures and transcatheter aortic valve implantation neocommissures was analyzed in 10 consecutive patients with tricuspid severe aortic stenosis undergoing transcatheter aortic valve implantation after guided implantation based on computed tomography analysis with a self-developed software. CA was predicted by in silico bio-modelling in the 10 patients and the calculated rotation was applied during crimping. Degrees of CA and coronary overlap (CO) were measured through 1-month follow up computed tomography. Transvalvular residual gradients and the rate of paravalvular leak were also analyzed. RESULTS: Mean commissural misalignment was 16.7±8°. Four patients showed mild misalignment but none of them showed a moderate or severe degree of misalignment. The in silico model accurately predicted the final in vivo position with a correlation coefficient of 0.983 (95%CI, 0.966-0.992), P <.001. Severe CO with right coronary ostium occurred in 3 patients likely due to ostial eccentricity, and CO was not present with the left coronary artery in any of the patients. Mean transaortic gradient was 6.1±3.3mmHg and there were no moderate-severe paravalvular leaks. CONCLUSIONS: Patient-specific rotation during valve crimping based on preprocedural computed tomography is feasible with balloon-expandable devices and is associated with the absence of moderate or severe commissural misalignment and left main CO.

Cardiac amyloidosis and left atrial appendage closure. The CAMYLAAC study.

INTRODUCTION AND OBJECTIVES: Transthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA. METHODS: Comparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA. RESULTS: We studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P <.001) but this difference was unrelated to hemorrhagic complications or ischemic stroke. CONCLUSIONS: LAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.

Safety and feasibility of transradial access for percutaneous coronary intervention in chronic total occlusions.

INTRODUCTION AND OBJECTIVES: Transfemoral access is the most frequently used vascular approach in chronic total occlusion percutaneous coronary interventions (CTO-PCI). The aim of this study was to evaluate the safety and feasibility of a transradial access CTO-PCI program and its impact on angiographic and clinical results and length of hospital stay. METHODS: Retrospective multicenter cohort study including 2550 consecutive CTO-PCI procedures included in a multicenter registry with accurate information on vascular access. A total of 896 procedures were performed as radial-only access while 1654 were performed through at least 1 femoral puncture. Clinical and angiographic data were collected. RESULTS: The mean age was 66.3± 11.4 years. The mean Japan-chronic total occlusion score (2.7±0.3) was similar in the 2 groups. Successful revascularization was achieved in 2009 (79.6%) cases, 78.2% and 82.1% in the femoral and radial access cohorts, respectively (P=.002). Periprocedural in-hospital complications were observed in 5.1% and 2.3% (P=.02), with fewer access site-dependant vascular complications in the transradial cohort (2.3% vs 0.2%; P=.009). The mean length of hospital stay was significantly shorter in the transradial access group (0.89±1.4 vs 2.2±3.2 days, P<.001). CONCLUSIONS: A transradial program for CTO-PCI is safe and effective in most CTO lesions. The transradial strategy has fewer vascular complications and shorter length of hospital stay without compromising the success rate.

Commissural Versus Coronary Optimized Alignment During Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aims of this study were to determine the rate of noncentered coronary ostia and their risk for coronary overlap (CO) and to develop an improved orientation strategy for transcatheter aortic valve replacement (TAVR) devices taking into account anatomical cues to identify patients at risk for CO regardless of commissural alignment and compute an alternative, CO-free TAVR rotation angle for those patients. BACKGROUND: Commissural alignment during TAVR reduces CO risk. However, eccentricity of coronary ostia from the center of the sinus of Valsalva may result in CO even after perfect alignment of TAVR commissures. METHODS: Baseline computed tomography from TAVR candidates helped identify distance from commissures to the right coronary artery (RCA) and the left coronary artery (LCA). Then, for each case, a virtual valve was simulated with ideal commissural or coronary alignment, and the degree of CO was determined. On the basis of the potential BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) efficacy, 3 groups were defined: no risk for CO (>35° from neocommissure to coronary ostia), moderate risk (20°-35°), and severe risk (≤20°). RESULTS: Computed tomographic studies from 107 patients were included. After excluding 7 patients (poor quality or bicuspid valve), 100 patients were analyzed. The RCA showed greater eccentricity compared with the LCA (18.5° [IQR: 3.3°-12.8°] vs 6.5° [IQR: 3.3°-12.8°]; P < 0.001). The mean intercoronary angle was 140.0° ± 18.7° (95% CI: 136.3°-143.7°). Thirty-two patients had moderate to severe risk for CO (≤35°) despite ideal commissural alignment. Greater coronary eccentricity (cutoff for RCA, 24.5°; cutoff for LCA, 19°) and intercoronary angle >147.5° or <103° were associated with greater risk for moderate to severe CO despite commissural alignment (area under the curve: 0.97; 95% CI: 0.91-0.99). If optimal coronary alignment was simulated, this prevented severe CO in all cases and reduced moderate CO from 27% to 5% (P < 0.001). CONCLUSIONS: One third of patients would have CO during TAVR-in-TAVR despite commissural alignment; a 6-fold decrease in this risk was achieved with optimized coronary alignment. Coronary eccentricity and intercoronary angle were the main predictors.

Real-World Multicenter Coronary Lithotripsy Registry: Long-Term Clinical Follow-Up.

OBJECTIVES: Coronary lithotripsy (CL) works by fracturing the calcified plaque, allowing mean area gain, enhancing vessel compliance, and facilitating stent deployment. This study reports the safety, effectiveness, and durability of the clinical benefit of CL at long-term follow-up of a real-world multicenter registry. METHODS: This was a prospective, multicenter, single-arm study that included consecutive patients with calcified lesions undergoing CL from August, 2018 to October, 2020 with a clinical follow-up of 20 months (interquartile range, 14.5-25). Exclusion criteria were a target lesion located in a vessel <2.5 mm and/or the presence of dissection prior to CL. The primary endpoint was the rate of major adverse cardiovascular event (MACE, defined as death or target-lesion revascularization [TLR] or myocardial infarction [MI]) at follow-up. RESULTS: This registry included 109 patients (128 lesions). The population was elderly (mean age, 74 years old), with high rates of diabetic patients (58%), renal insufficiency (32%), and multivessel disease (76%). Most of the lesions were predilated with semicompliant/noncompliant balloons (25 with cutting balloon). Rotational atherectomy was used in 20 lesions. On average, CL required the use of 1 balloon delivering a mean of 60 pulses. Twelve patients presented with ST-segment-elevation MI and a culprit calcified coronary lesion undergoing CL. Successful CL was achieved in 99% of cases. There were few procedural complications, with 30-day freedom from MACE rate of 98%. The MACE rate at long-term follow-up was 5.6%. CONCLUSION: This is the first real-world, multicenter registry that confirms the safety and long-term efficacy of percutaneous coronary intervention for calcified lesions using CL in an unselected and high-risk population with a low long-term follow-up MACE rate.

Accurate commissural alignment during ACURATE neo TAVI procedure. Proof of concept.

INTRODUCTION AND OBJECTIVES: Final position of the neo-commissures is uncontrolled during transcatheter aortic valve implantation (TAVI), potentially hindering coronary access and future procedures. We aimed to develop a standard method to achieve commissural alignment with the ACURATE neo valve. METHODS: The relationship between native and TAVI neo-commissures was analyzed in 11 severe aortic stenosis patients undergoing TAVI. Based on computed tomography analysis, an in silico model was developed to predict final TAVI commissural posts position. A modified implantation technique, accurate commissural alignment (ACA) and a dedicated delivery system were developed. TAVI implants were tested in 3-dimensional (3D) printed models and in vivo. Commissural misalignment and coronary overlap (CO) were analyzed. RESULTS: The in silico model accurately predicted final position of commissural posts irrespective of the implantation technique performed (correlation coefficient, 0.994; 95%CI, 0.989-0.998; P<.001). TAVI implant with patient-specific rotation was simulated in 3D printed models and in 9 patients. ACA-oriented TAVI implants presented adequate commissural alignment in vivo (mean commissural misalignment of 7.7 ±3.9°). None of the ACA oriented implants showed CO, whereas in silico conventional implants predicted CO in 6 of the 9 cases. CONCLUSIONS: Accurate commissural alignment of the ACURATE neo device is feasible by inserting the delivery system with a patient-specific rotation based on computed tomography analysis. This is a simple and reproducible method for commissural alignment that can be potentially used for all kinds of TAVI devices.

Development of atrioventricular and intraventricular conduction disturbances in patients undergoing transcatheter aortic valve replacement with new generation self-expanding valves: A real world multicenter analysis.

BACKGROUND: High degree cardiac conduction disturbances (HDCD) remain a major complication after transcatheter aortic valve replacement (TAVR), especially with self-expandable valves (SEV). Our aim was to investigate peri-procedural and in-hospital modification of atrioventricular and intracardiac conduction associated to new generation SEV implantation, and the development of new HDCD resulting in permanent pacemaker implantation (PPM) in patients undergoing TAVR. METHODS AND RESULTS: Three-hundred forty-four consecutive patients with severe aortic stenosis who underwent TAVR with a new generation SEV [Evolut-R/Pro (n = 130), Acurate-neo (n = 79), Portico (n = 75) and Allegra (n = 60)] were included. An analysis of baseline, post-TAVR and pre-discharge ECG and procedural aspects were centrally performed. A significant increase in baseline PR interval (169.6 ± 28.2 ms) and QRS complex width (101.7 ± 25.9 ms) was noted immediately post-TAVR (188.04 ± 34.49; 129.55 ± 30.02 ms), with a partial in-hospital reversal (179.4 ± 30.1; 123.06 ± 30.94 ms), resulting in a net increase at hospital discharge of 12.6 ± 38.8 ms and 21.4 ± 31.6 ms (p < 0.001), respectively. The global incidence of new onset persistent HDCD at hospital discharge was 46.3%, with 17.7% of patients requiring PPM. Independent predictors of new onset HCDC at hospital discharge were valve recapture (OR: 2.8; 95% IC: 1.1-7.2, p = 0.033) and implantation depth ≥ 6 mm (OR: 1.9 05% IC 1.1-3.3, p = 0.015), while higher implantation (<3 mm (OR: 0.3, 95% IC 0.1-0.7, p = 0.014) and use of Acurate-Neo valve (OR: 0.4; 95% IC 0.2-0.8, p = 0.009) were protective factor. CONCLUSIONS: New generation self-expanding aortic valves were associated with a significant increase in PR and QRS interval at hospital discharge leading to a very high rate of HDCD. While valve recapture and implantation depth were independent predictors for the occurrence of HDCD, use of Accurate-Neo valve was a protective factor.

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.

Myval versus alternative balloon- and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances.

BACKGROUND: Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India). METHODS: Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12­leads electrocardiograms (ECG) were centrally analyzed and compared. RESULTS: A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval. CONCLUSIONS: After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.

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.

Center Valve Preference and Outcomes of Transcatheter Aortic Valve Replacement: Insights From the AMTRAC Registry.

BACKGROUND: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited. OBJECTIVES: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference. METHODS: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference. RESULTS: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032). CONCLUSIONS: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274).

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry.

BACKGROUND: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. AIMS: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old. METHODS: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups. RESULTS: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715). CONCLUSIONS: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

Plaque modification in calcified chronic total occlusions: the PLACCTON study.

INTRODUCTION AND OBJECTIVES: Severe calcification is present in> 50% of coronary chronic total occlusions (CTOs) undergoing percutaneous intervention. We aimed to describe the contemporary use and outcomes of plaque modification devices (PMDs) in this context. METHODS: Patients were included in the prospective, consecutive Iberian CTO registry (32 centers in Spain and Portugal), from 2015 to 2020. Comparison was performed according to the use of PMDs. RESULTS: Among 2235 patients, wire crossing was achieved in 1900 patients and PMDs were used in 134 patients (7%), requiring more than 1 PMD in 24 patients (1%). The selected PMDs were rotational atherectomy (35.1%), lithotripsy (5.2%), laser (11.2%), cutting/scoring balloons (27.6%), OPN balloons (2.9%), or a combination of PMDs (18%). PMDs were used in older patients, with greater cardiovascular burden, and higher Syntax and J-CTO scores. This greater complexity was associated with longer procedural time but similar total stent length (52 vs 57mm; P=.105). If the wire crossed, the procedural success rate was 87.2% but increased to 96.3% when PMDs were used (P=.001). Conversely, PMDs were not associated with a higher rate of procedural complications (3.7 vs 3.2%; P=.615). Despite the worse baseline profile, at 2 years of follow-up there were no differences in the survival rate (PMDs: 94.3% vs no-PMDs: 94.3%, respectively; P=.967). CONCLUSIONS: Following successful wire crossing in CTOs, PMDs were used in 7% of the lesions with an increased success rate. Mid-term outcomes were comparable despite their worse baseline profile, suggesting that broader use of PMDs in this setting might have potential technical and prognostic benefits.

Percutaneous vs. surgical axillary access for transcatheter aortic valve implantation: the TAXI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs. surgical axillary approaches for TAVI. METHODS: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses. RESULTS: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs. 4.2%, P<0.001), leading to more common use of covered stent implantation (13.2% vs. 3.7%, P<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], P=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], P=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], P=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], P=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], P=0.038). CONCLUSIONS: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.

New Challenging Scenarios in Transcatheter Aortic Valve Implantation: Valve-in-valve, Bicuspid and Native Aortic Regurgitation.

Transcatheter aortic valve implantation (TAVI) is the most frequently performed structural technique in the field of interventional cardiology. Initially, this procedure was only used in patients with severe symptomatic aortic stenosis and prohibitive risk. Now, barely one decade after its introduction, TAVI indications extend to low- and intermediate-risk patients. Despite these advances, several challenging scenarios are still on the periphery of the evidence base for TAVI. These include valve-in-valve procedures, lower-risk patients with bicuspid aortic valve and the treatment of pure aortic regurgitation. Whereas the valve-in-valve indication has expanded rapidly, evidence for the use of TAVI compared with conventional surgery for bicuspid aortic valve is limited, including the best choice of device should TAVI be used. Evidence for TAVI in pure aortic regurgitation is still anecdotal because of suboptimal outcomes. Operators worldwide have described variations in the TAVI procedural technique to achieve commissural alignment and to minimise the rate of pacemaker use through cusp overlap implantation. In light of the potential clinical benefits, this may also be an area of further development. This review aims to discuss the current evidence available supporting the use of TAVI for these new indications.