Long-term outcomes after deferral of revascularization of in-stent restenosis using fractional flow reserve.

OBJECTIVES: To investigate the outcomes of deferred coronary revascularization in patients with non-significant in-stent restenosis (ISR) by physiological assessment. BACKGROUND: The pathophysiology and natural history of ISR is markedly different from de-novo stenoses. There is a paucity of data on the safety of deferral of revascularization of ISR using physiological assessment. METHODS: In this single centre study, using a propensity-score matched analysis, we compared the long-term clinical outcomes of patients with ISR and de-novo disease deferred based on intracoronary physiology. Matching was on a 1:2 basis of ISR to de-novo stenosis. The primary end point was major adverse cardiovascular events (MACE) a composite of all-cause mortality, target lesion revascularization or target vessel myocardial infarction at 36 months. RESULTS: Matched cohorts of 56 ISR and 112 de-novo stenoses were analyzed. The median percentage stenosis was 50% in both groups (p = 0.403). Deferral was based on fractional flow reserve (FFR). The mean FFR was 0.86 across both groups (p = 0.942). At 36-months, freedom from MACE was similar between groups; 86.2% versus 92.8% log rank p=0.180 for ISR and de-novo lesions, respectively. Neither were there differences in the individual components of MACE. CONCLUSIONS: Deferral of coronary revascularization in patients with ISR based on its functional impact is associated to similar long-term safety as in de-novo coronary stenosis.

Percutaneous mitral valve repair with MitraClip device in hemodynamically unstable patients: A systematic review.

BACKGROUND: Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip. METHODS: We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included. RESULTS: Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p < .001). The median weaning time from the procedure, to discontinuation of mechanical circulatory or respiratory support, was 2 days (IQR 1-4), with an in-hospital mortality and non-fatal complication rate of 12.6 and 9.1%, respectively. Kaplan-Meier curves estimated an overall mortality rate of 39.1% at 12-month follow-up, with persistent reduction in MR severity for survivors (Grade ≤ 2 in 81.3%) and one case of mitral valve reintervention. CONCLUSIONS: Percutaneous mitral valve repair with MitraClip device is a technically feasible and potentially viable management option in high-risk patients with cardiogenic shock or refractory pulmonary edema and concomitant moderate-severe MR. Prospective trials are required to confirm these findings, and definitively determine the value of MitraClip in hemodynamically unstable patients.

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.

Performance of the heart team approach in daily clinical practice in high-risk patients with aortic stenosis.

OBJECTIVE: The heart team (HT) approach plays a key role in selecting the optimal treatment strategy for patients with aortic stenosis (AS). However, little is known about the HT decision process and its impact on outcomes. The aim of this study was to identify the factors associated with the HT decision and evaluate clinical outcomes according to the treatment choice. METHODS: The study included a total of 286 consecutive patients with AS referred for discussion in the weekly HT meeting in a cardiovascular institute over 2 years. Patients were stratified according to the selected therapeutic approach: medical treatment (MT), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. Baseline characteristics involved in making a therapeutic choice were identified and a decision-making tree was built using classification and regression tree methodology. RESULTS: Based on HT discussion, 53 patients were assigned to SAVR, 210 to TAVR, and 23 to MT. Older patients (≥88 years old) were mainly assigned to TAVR or MT according to the logistic EuroSCORE (

Late Migration of a Paravalvular Leak Closure Device.

Paravalvular leak (PVL) is a serious complication of surgical valve replacement, often affecting elderly, multimorbid, high-risk patients. The risk of surgical intervention is often prohibitive in these cases, and so percutaneous PVL closure emerged as a feasible and effective management strategy, with a low complication rate. Specific devices for closure of PVL's are currently not widely available, and so PVLs are closed using generic vascular closure devices, which may result in residual paravalvular regurgitation or even closure device displacement. Although rare, late displacement of the closure device with prosthetic impingement can be life threatening, requiring urgent intervention.We present a case of a seventy-year-old gentleman with rheumatic heart disease and multiple previous mechanical aortic and mitral valve replacements. After repeated admissions for decompensated heart failure, secondary to paravalvular mitral regurgitation, a percutaneous paravalvular leak closure was performed with successful reduction of the leak. He represented 30 days later with cardiogenic shock and multiorgan failure secondary to torrential central mitral regurgitation caused by late displacement of the closure device with mitral prosthesis impingement. Due to an excessively high surgical risk, his case was successfully managed percutaneously with retrieval of the displaced device and closure of the PVL using two Amplatzer Vascular Plug III devices. At the six-month review, he remains asymptomatic.Percutaneous PVL closure is an effective strategy for patients with prohibitive surgical risk. Late closure device displacement can be a life-threatening complication. Our case demonstrates that percutaneous management of this complication is feasible even in patients presenting in extremis.

Impact of coronary calcium morphology on intravascular lithotripsy.

BACKGROUND: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique. AIMS: We aimed to assess the impact of different calcium morphologies on IVL efficacy. METHODS: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions. RESULTS: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm2 vs 6.2±2.1 mm2; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm2; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%. CONCLUSIONS: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Emerging transcatheter heart valve technologies for severe aortic stenosis.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is the standard of care for selected patients with severe aortic stenosis, irrespective of the surgical risk. Over the last two decades of TAVI practice, multiple limitations were identified. In addition, the extension of TAVI into a wider patient spectrum created new challenges. AREAS COVERED: This review provides an overview of emerging transcatheter heart valves (THVs) beyond the approved contemporary THVs for the treatment of aortic stenosis. EXPERT OPINION: The incidence of degenerative aortic stenosis is expected to increase with more aging of the population. Therefore, TAVI needs to meet this increase in the number of patients indicated for aortic valve replacement alongside a wide and complex anatomical variability. An increasing number of Aortic THVs are available in the market. This includes upgraded iterations of contemporary devices and innovative devices developed by emerging manufacturers. The new devices aim for the reduction or elimination of undesirable outcomes like paravalvular leakage and conduction disturbances requiring permanent pacemaker implantation. Alternatively, emerging THVs should provide feasibility regarding yet unproven TAVI indications like Bicuspid aortic valve, aortic regurgitation, or very large anatomy. Furthermore, some of the emerging THVs are designed to tackle the long-term durability issue of biological valves.

In-hospital outcomes following percutaneous versus surgical intervention in the treatment of aortic stenosis and concomitant coronary artery disease.

INTRODUCTION AND OBJECTIVES: Concomitant coronary artery disease (CAD) is prevalent among aortic stenosis patients; however the optimal therapeutic strategy remains debated. We investigated periprocedural outcomes among patients undergoing transcatheter aortic valve implantation with percutaneous coronary intervention (TAVI/PCI) vs surgical aortic valve replacement with coronary artery bypass grafting (SAVR/CABG) for aortic stenosis with CAD. METHODS: Using discharge data from the Spanish National Health System, we identified 6194 patients (5217 SAVR/CABG and 977 TAVI/PCI) between 2016 and 2019. Propensity score matching was adjusted for baseline characteristics. The primary outcome was in-hospital all-cause mortality. Secondary outcomes were in-hospital complications and 30-day cardiovascular readmission. RESULTS: Matching resulted in 774 pairs. In-hospital all-cause mortality was more common in the SAVR/CABG group (3.4% vs 9.4%, P <.001) as was periprocedural stroke (0.9% vs 2.2%; P=.004), acute kidney injury (4.3% vs 16.0%, P <.001), blood transfusion (9.6% vs 21.1%, P <.001), and hospital-acquired pneumonia (0.1% vs 1.7%, P=.001). Permanent pacemaker implantation was higher for matched TAVI/PCI (12.0% vs 5.7%, P <.001). Lower volume centers (< 130 procedures/y) had higher in-hospital all-cause mortality for both procedures: TAVI/PCI (3.6% vs 2.9%, P <.001) and SAVR/CABG (8.3 vs 6.8%, P <.001). Thirty-day cardiovascular readmission did not differ between groups. CONCLUSIONS: In this large contemporary nationwide study, percutaneous management of aortic stenosis and CAD with TAVI/PCI had lower in-hospital mortality and morbidity than surgical intervention. Higher volume centers had less in-hospital mortality in both groups. Dedicated national high-volume heart centers warrant further investigation.

Mid-Term Angiographic and Intracoronary Imaging Results Following Intracoronary Lithotripsy in Calcified Coronary Artery Disease: Results From Two Tertiary Referral Centres.

BACKGROUND: Intracoronary lithotripsy (IVL) is a safe and effective treatment for coronary calcification. Angiographic and intracoronary imaging follow-up have not yet been described. We aimed to describe the mid-term angiographic outcomes following IVL. METHODS: Patients successfully treated with IVL in two tertiary referral hospitals were included. Repeat angiography and intracoronary imaging was performed. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) analyses were performed using dedicated workstations. RESULTS: Twenty patients were included; mean age 67.1 years, left anterior descending artery 55 %. Median IVL balloon size was 3.0 mm and a median of 60 pulses were delivered per vessel. Percentage stenosis by QCA was 60 % [IQR 51-70] reducing to 20 % post stenting (p < 0.001). On OCT, 88.9 % had circumferential calcium. IVL resulted in fractures in 88.9 %. Resulting minimum stent expansion was 91.75 % [IQR 81.5-108]. Follow-up was at a median of 22.7 months [IQR16.4-25.5]. Percentage stenosis by QCA was 22.5 % [IQR 14-30] and not significantly different from the index procedure (p > 0.05). Minimum stent expansion by OCT was 85 % [IQR 72-97]. Late luminal loss was 0.15 mm [IQR -0.25 to 0.69]. Binary angiographic instent restenosis (ISR) was 10 % (2 of 20 patients). OCT demonstrated a predominantly homogenous neointimal pattern with high backscatter. CONCLUSION: Following successful IVL treatment, repeat angiography demonstrated preserved stent parameters in the majority of patients with favorable vascular healing properties by OCT. A binary restenosis rate of 10 % was observed. These results suggest durable results following IVL treatment of severe coronary calcification however larger studies are warranted.

Predictors of Conduction Disturbances Requiring New Permanent Pacemaker Implantation following Transcatheter Aortic Valve Implantation Using the Evolut Series.

(1) Background: Conduction disturbance requiring a new permanent pacemaker (PPM) after transcatheter aortic valve implantation (TAVI) has traditionally been a common complication. New implantation techniques with self-expanding platforms have reportedly reduced the incidence of PPM. We sought to investigate the predictors of PPM at 30 days after TAVI using Evolut R/PRO/PRO+; (2) Methods: Consecutive patients who underwent TAVI with the Evolut platform between October 2019 and August 2022 at University Hospital Galway, Ireland, were included. Patients who had a prior PPM (n = 10), valve-in-valve procedures (n = 8) or received >1 valve during the index procedure (n = 3) were excluded. Baseline clinical, electrocardiographic (ECG), echocardiographic and multislice computed tomography (MSCT) parameters were analyzed. Pre-TAVI MSCT analysis included membranous septum (MS) length, a semi-quantitative calcification analysis of the aortic valve leaflets, left ventricular outflow tract, and mitral annulus. Furthermore, the implantation depth (ID) was measured from the final aortography. Multivariate binary logistic analysis and receiver operating characteristic (ROC) curve analysis were used to identify independent predictors and the optimal MS and ID cutoff values to predict new PPM requirements, respectively; (3) Results: A total of 129 TAVI patients were included (age = 81.3 ± 5.3 years; 36% female; median EuroSCORE II 3.2 [2.0, 5.4]). Fifteen patients (11.6%) required PPM after 30 days. The patients requiring new PPM at 30 days were more likely to have a lower European System for Cardiac Operative Risk Evaluation II, increased prevalence of right bundle branch block (RBBB) at baseline ECG, have a higher mitral annular calcification severity and have a shorter MS on preprocedural MSCT analysis, and have a ID, as shown on the final aortogram. From the multivariate analysis, pre-TAVI RBBB, MS length, and ID were shown to be predictors of new PPM. An MS length of <2.85 mm (AUC = 0.85, 95%CI: (0.77, 0.93)) and ID of >3.99 mm (area under the curve (AUC) = 0.79, (95% confidence interval (CI): (0.68, 0.90)) were found to be the optimal cut-offs for predicting new PPM requirements; (4) Conclusions: Membranous septum length and implantation depth were found to be independent predictors of new PPM post-TAVI with the Evolut platform. Patient-specific implantation depth could be used to mitigate the requirement for new PPM.

Propensity-matched analysis of long-term clinical results after ostial circumflex revascularisation.

BACKGROUND: Percutaneous coronary intervention (PCI) of the ostium of the left circumflex artery (LCx) is technically challenging. The aim of this study was to compare long-term clinical outcomes of ostial PCI located in the LCx versus the left anterior descending artery (LAD) in a propensity-matched population. METHODS: Consecutive patients with a symptomatic isolated 'de novo' ostial lesion of the LCx or LAD treated with PCI were included. Patients with a stenosis of >40% in the left main (LM) were excluded. A propensity score matching was performed to compare both groups. The primary endpoint was target lesion revascularisation (TLR); other endpoints included target lesion failure and an analysis of the bifurcation angles. RESULTS: From 2004 to 2018, 287 consecutive patients with LAD (n=240) or LCx (n=47) ostial lesions treated with PCI were analysed. After the adjustment, 47 matched pairs were obtained. The mean age was 72±12 years and 82% were male. The LM-LAD angle was significantly wider than the LM-LCx angle (128°±23° vs 108°±24°, p=0.002). At a median follow-up of 5.5 (IQR 1.5-9.3) years, the rate of TLR was significantly higher in the LCx group (15% vs 2%); with an HR of 7.5, 95% CI 2.1 to 26.4, p<0.001. Interestingly, in the LCx group, TLR-LM occurred in 43% of the TLR cases; meanwhile, no TLR-LM involvement was found in the LAD group. CONCLUSIONS: Isolated ostial LCx PCI was associated with an increase in the rate of TLR compared with ostial LAD PCI at long-term follow-up. Larger studies evaluating the optimal percutaneous approach at this location are needed.

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.

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.

Transcatheter Treatment of Mitral Regurgitation.

Mitral valve disease, and in particular mitral regurgitation, is a common clinical entity. Until recently, surgical repair and replacement were the only therapeutic options available, leaving many patients untreated mostly due to excessive surgical risk. Over the last number of years, huge strides have been made regarding percutaneous, catheter-based solutions for mitral valve disease. Transcatheter repair procedures have most commonly been used, and in recent years there has been exponential growth in the number of devices available for transcatheter mitral valve replacement. Furthermore, the evolution of these devices has resulted in both smaller delivery systems and a shift towards transeptal access, negating the need for surgical incisions. In line with these advancements, and clinical trials demonstrating promising outcomes in carefully selected cases, recent guidelines have strengthened their recommendations for these devices. It is appropriate, therefore, to now review the current transcatheter repair and replacement devices available and the evidence for their use.

Incidence, clinical impact and predictors of thrombocytopenia after transcatheter aortic valve replacement.

BACKGROUND: Thrombocytopenia is a common, yet poorly understood, complication after transcatheter aortic valve replacement (TAVR). Balloon-expandable transcatheter heart valve has been associated with higher incidence of thrombocytopenia, compared with self-expandable valves. The aim of this study was to analyze the incidence, clinical impact and predictors of acquired thrombocytopenia in patients undergoing TAVR. METHODS: We performed an observational study from consecutive patients with severe aortic stenosis undergoing TAVR (n = 679) in a single center. Association and best cut-off point of platelet decrease with early mortality was analyzed. Patients were classified according to postprocedural percentage decrease in platelet count (PDPC), comparing clinical outcomes and analyzing predictors of platelet decrease. RESULTS: The median PDPC was 37.1 [IQR: 27.4-46.9]. PDPC was associated with early mortality (OR: 2.1, 95%IC: 1.7-2.5 for each 10% decrease, AUC:0.81, 95%CI:0.72-0.89) with an optimal cut-off point of 46%. PDPC≥46% and late nadir (≥4 days) were both independent predictors of early mortality (OR: 6.0 [IQR: 2.4-14.9] and OR: 5.1 [IQR: 2.2-11.6], respectively). The combination of both factors (PDPC≥46% and nadir ≥4 day) was associated with higher 2-year mortality (55.7%) compared to an early significant nadir (PDPC≥46% and nadir <4 day, 28.9%) and non-significant nadir (PDPC<46%, 21.0%), p < 0.001. Independent predictors of PDPC≥46% were baseline platelet count, Portico™, Abbott valve, intraprocedural major vascular complication and residual aortic regurgitation ≥grade 2. CONCLUSION: The platelet count decreased almost 40% after TAVR. Late nadir and PDPC≥46% predicted short-term clinical outcomes. Concomitant late and significant platelet decrease was associated with mid-term mortality.

Early Discontinuation of Antithrombotic Treatment Following Left Atrial Appendage Closure.

Although antithrombotic treatment is recommended after left atrial appendage closure (LAAC), some patients require discontinuation of antithrombotic treatment after LAAC without evidence on the safety of such a strategy. We sought to evaluate outcomes of patients who had early antithrombotic treatment discontinuation after LAAC. This is a multicenter study including 1,082 patients who underwent successful LAAC. Early discontinuation of antithrombotic treatment was defined as discontinuation of all antiplatelet/anticoagulant treatment within 6 months following the procedure. A propensity-matched analysis was used to compare outcomes of patients with and without early antithrombotic treatment discontinuation. A total of 148 patients (13.7%) had early antithrombotic treatment discontinuation. In the entire population, antithrombotic treatment discontinuation patients exhibited a lower CHA2DS2-VASc score (p <0.001) and a higher rate of previous gastrointestinal bleeding episodes (p = 0.01) compared with patients without discontinuation. After a median follow-up of 2.1 (1,1-3.1) years after antithrombotic treatment discontinuation, the rates of death, ischemic stroke, and major bleeding were 12.1, 0.6, and 3.3 per 100 patient-years. In 119 matched pairs with similar baseline characteristics, antithrombotic treatment discontinuation patients had a similar risk of death (hazard ratio [HR] 1.06, 95% confidence interval [CI] 0.65 to 1.71, p = 0.82), ischemic stroke (HR 0.39, 95% CI 0.04 to 3.79, p = 0.42) and major bleeding (HR 1.48, 95% CI 0.56 to 3.88, p = 0.43) compared with those without discontinuation. In conclusion, antithrombotic treatment was discontinued in 1 of 7 selected patients within 6 months after LAAC, and this was not associated with an increased risk of death or thromboembolic events after a median follow-up of 2 years. These data support the safety of shorter periods of antithrombotic therapy after LAAC in high bleeding risk patients based on clinician judgment. Further trials are warranted.

Unplanned Hospital Readmissions After Transcatheter Aortic Valve Replacement in the Era of New-Generation Devices.

OBJECTIVES: Unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR) are frequent and have been associated with a poor prognosis. We sought to determine the trends in the incidence and causes of unplanned hospital readmission after TAVR in patients receiving new-generation devices (NGDs) vs early-generation devices (EGDs). METHODS: The study population consisted of 1802 consecutive TAVR recipients (863 EGDs and 939 NGDs). Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1-year post TAVR, respectively. RESULTS: A total of 986 unplanned hospital readmissions (cardiac cause, 38.4%; non-cardiac cause, 61.6%) were recorded at a median time of 110 days (interquartile range [IQR], 37-217) post TAVR. The rates of early (12.3% vs 9.4%; P=.046) and late (39.1% vs 31.6%; P<.01) readmission were lower in the NGD population. In the NGD group, major/life-threatening periprocedural bleeding (hazard ratio [HR], 2.40, 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR) <60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of early readmission post TAVR. Chronic obstructive pulmonary disease (HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR <60 mL/min (HR, 1.43; 95% CI, 1.11-1.84; P<.01), and combining antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late readmission. CONCLUSIONS: TAVR recipients receiving NGDs exhibited a significant but modest reduction in unplanned hospital readmissions, with about one-third of patients still requiring rehospitalization at 1-year follow-up in the contemporary TAVR era. Non-cardiac comorbidities, periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk.

Vascular healing responses to paclitaxel coated balloons or everolimus eluting stents for the treatment of in-stent restenosis. Insights from optical coherence tomography.

BACKGROUND: Treatment of in-stent restenosis (ISR) remains a significant challenge. Current options include repeat stenting or drug-coated balloons. However, there is a paucity of data regarding vascular healing after these strategies. We, aimed to compare optical coherence tomography (OCT)-based vessel healing after treatment with paclitaxel-coated balloons (PCB) or everolimus-eluting stents (EES). METHODS: An OCT substudy (baseline and 6-9 months) of patients from RIBS IV and RIBS V, two prospective multicenter, randomized controlled clinical trials comparing PCB vs. EES in patients with ISR was performed. RESULTS: Sixty-four patients were included (30 PCB and 34 EES). There were no differences in the baseline or angiographic characteristics between groups. Both groups had the same proportion of drug-eluting and bare-metal stent (BMS) ISR. Baseline OCT analysis did not show differences in the qualitative characteristics of the ISR nor the restenotic tissue burden. Follow-up OCT showed a larger mean lumen area in the EES group (6.03 ± 1.5 vs. 5.24 ± 1.3 mm 2 ; P = 0.043) but no difference in angiographic restenosis ( P = 0.66). Percentage tissue coverage was higher with PCB vs. EES (26 ± 13 vs. 19 ± 11%; P = 0.031). EES-treated ISR more frequently had uncovered struts at follow-up [21 (72%) vs. 12 (44%); P = 0.034]. Tissue covering struts more frequently had a high backscatter structure after PCB [21 (78%) vs. 16 (55%); P = 0.07]. CONCLUSIONS: Compared with EES, ISR treated with PCB demonstrated more strut coverage with mainly high backscattering tissue. Larger OCT-defined neointimal proliferation in PCB-treated ISR did not translate into higher angiographic restenosis rates.