Clinical impact of complex percutaneous coronary intervention in the pre-TAVR workup.

INTRODUCTION AND OBJECTIVES: In patients undergoing percutaneous coronary intervention (PCI) in the workup for transcatheter aortic valve replacement (TAVR), the clinical impact of coronary revascularization complexity remains largely unknown. This study sought to examine the impact of PCI complexity on clinical outcomes after TAVR in patients undergoing PCI in the preprocedural workup. METHODS: This was a multicenter study including consecutive patients scheduled for TAVR with concomitant significant coronary artery disease. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with 2 stents implanted, total stent length > 60 mm, or chronic total occlusion. The rates of major adverse cardiac events (MACE), including cardiovascular mortality, myocardial infarction, and coronary revascularization were evaluated. RESULTS: A total of 1550 patients were included, of which 454 (29.3%) underwent complex PCI in the pre-TAVR workup. After a median follow-up period of 2 [1-3] years after TAVR, the incidence of MACE was 9.6 events per 100 patients-years. Complex PCI significantly increased the risk of cardiovascular death (HR, 1.44; 95%CI, 1.01-2.07), nonperiprocedural myocardial infarction (HR, 1.52; 95%CI, 1.04-2.21), and coronary revascularization (HR, 2.46; 95%CI, 1.44-4.20). In addition, PCI complexity was identified as an independent predictor of MACE after TAVR (HR, 1.44; 95%CI, 1.09-1.83; P = .009). CONCLUSIONS: In TAVR candidates with significant coronary artery disease requiring percutaneous treatment, complex revascularization was associated with a higher risk of MACE. The degree of procedural complexity should be considered a strong determinant of prognosis in the PCI-TAVR population.

Sex Differences in Patients With Cryptogenic Cerebrovascular Events Undergoing Transcatheter Closure of Patent Foramen Ovale.

Background Scarce data exist on sex differences in patients with cryptogenic cerebrovascular events undergoing patent foramen ovale (PFO) closure. This study aimed to determine the sex differences in clinical profile, procedural characteristics, and long-term outcomes of patients with cryptogenic cerebrovascular events undergoing PFO closure. Methods and Results A retrospective cohort was used, including 1076 consecutive patients undergoing PFO closure because of a cryptogenic cerebrovascular event. Patients were divided into 2 groups: 469 (43.6%) women and 607 (56.4%) men. The median follow-up was 3 years (interquartile range, 2-8 years). Women were younger (46±13 versus 50±12 years; P<0.01) and had a higher risk of paradoxical embolism score (6.9±1.7 versus 6.6±1.6; P<0.01). Procedural characteristics and postprocedural antithrombotic therapy were similar. At follow-up, there were no differences in atrial fibrillation (women versus men: 0.47 versus 0.97 per 100 patient-years; incidence rate ratio [IRR], 0.55 [95% CI, 0.27-1.11]; P=0.095; adjusted P=0.901), stroke (0.17 versus 0.07 per 100 patient-years; IRR, 2.58 [95% CI, 0.47-14.1]; P=0.274; adjusted P=0.201), or transient ischemic attack (0.43 versus 0.18 per 100 patient-years; IRR, 2.58 [95% CI, 0.88-7.54]; P=0.084; adjusted P=0.121); nevertheless, women exhibited a higher incidence of combined ischemic cerebrovascular events (0.61 versus 0.26 per 100 patient-years; IRR, 2.58 [95% CI, 1.04-6.39]; P=0.041; adjusted P=0.028) and bleeding events (1.04 versus 0.45 per 100 patient-years; IRR, 2.82 [95% CI, 1.41-5.65]; P=0.003; adjusted P=0.004). Conclusions Compared with men, women with cryptogenic cerebrovascular events undergoing PFO closure were younger and had a higher risk of paradoxical embolism score. After a median follow-up of 3 years, there were no differences in stroke events, but women exhibited a higher rate of combined (stroke and transient ischemic attack) cerebrovascular events and bleeding complications. Additional studies are warranted to clarify sex-related outcomes after PFO closure further.

Incidence, Predictors, and Prognostic Impact of Bleeding Events After TAVR According to VARC-3 Criteria.

BACKGROUND: The updated Valve Academic Research Consortium (VARC) definition for bleeding events after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. OBJECTIVES: The aim of this study was to determine the incidence, predictors, and clinical impact of bleeding events following TAVR as defined by recent VARC-3 criteria. METHODS: A total of 2,384 consecutive patients with severe symptomatic aortic stenosis undergoing TAVR were included. Early (at index hospitalization) and late (after hospital discharge) bleeding complications were defined according to VARC-3 criteria as type 1, 2, 3, or 4. Baseline, procedural, and follow-up (24 [IQR: 12-43] months) data were prospectively collected. RESULTS: Bleeding events occurred in 761 patients (31.9%): types 1, 2, 3, and 4 in 169 (22.2%), 399 (52.4%), 149 (19.6%), and 44 (5.8%) patients, respectively. The primary vascular access site and gastrointestinal locations were the most common bleeding sources among early and late bleeding events, respectively. Female sex, thoracotomy access, larger (14-F) sheath use, and dual antiplatelet therapy determined an increased risk of early bleeding events (P < 0.02 for all). The use of the radial artery for secondary access was associated with a significant risk reduction of early bleeding (P < 0.001). Type 2 and type 3 events were associated with an increased mortality risk at 30-day (HR: 2.94 [95% CI: 1.43-6.03; P = 0.003] and HR: 4.91 [95% CI: 2.19-11.03; P < 0.001], respectively) and 1-year (HR: 1.86 [95% CI: 1.28-2.69; P = 0.001] and HR: 2.28 [95% CI: 1.41-3.66; P = 0.001], respectively) follow-up. A similar prognostic pattern was observed when applying VARC-2 criteria but with a much lower global incidence of early bleeding events (19% vs 27%; P < 0.001). CONCLUSIONS: Bleeding events after TAVR were associated with poorer short- and long-term survival. The magnitude of this correlation was proportional to bleeding severity defined according to VARC-3 criteria. Further studies on bleeding prevention following TAVR are warranted to improve procedural safety and patient prognosis.

Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR.

BACKGROUND: In patients undergoing percutaneous coronary intervention (PCI) in the work-up pre-transcatheter aortic valve replacement (TAVR), the incidence and clinical impact of late bleeding events (LBEs) remain largely unknown. OBJECTIVES: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of LBEs in patients undergoing PCI in the work-up pre-TAVR. METHODS: This was a multicenter study including 1,457 consecutive patients (mean age 81 ± 7 years; 41.5% women) who underwent TAVR and survived beyond 30 days. LBEs (>30 days post-TAVR) were defined according to the Valve Academic Research Consortium-2 criteria. RESULTS: LBEs occurred in 116 (7.9%) patients after a median follow-up of 23 (IQR: 12-40) months. Late bleeding was minor, major, and life-threatening or disabling in 21 (18.1%), 63 (54.3%), and 32 (27.6%) patients, respectively. Periprocedural (<30 days post-TAVR) major bleeding and the combination of antiplatelet and anticoagulation therapy at discharge were independent factors associated with LBEs (P ≤ 0.02 for all). LBEs conveyed an increased mortality risk at 4-year follow-up compared with no bleeding (43.9% vs 36.0; P = 0.034). Also, LBE was identified as an independent predictor of all-cause mortality after TAVR (HR: 1.39; 95% CI: 1.05-1.83; P = 0.020). CONCLUSIONS: In TAVR candidates with concomitant significant coronary artery disease requiring percutaneous treatment, LBEs after TAVR were frequent and associated with increased mortality. Combining antiplatelet and anticoagulation regimens and the occurrence of periprocedural bleeding determined an increased risk of LBEs. Preventive strategies should be pursued for preventing late bleeding after TAVR, and further studies are needed to provide more solid evidence on the most safe and effective antithrombotic regimen post-TAVR in this challenging group of patients.

Fractional Flow Reserve to Assess Coronary Artery Disease in Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation: Long-Term Outcomes.

Background: The long-term outcomes of patients undergoing functional assessment of coronary lesions with fractional flow reserve (FFR) while awaiting transcatheter aortic valve implantation (TAVI) are unknown. Data on the safety of intracoronary adenosine use in this setting are scarce. The objectives of this study were to describe (1) the long-term outcomes based on the coronary artery disease (CAD) assessment strategy used and (2) the safety of intracoronary adenosine in patients with severe aortic stenosis (AS). Methods: 1023 patients with severe AS awaiting TAVI were included. Patients were classified according to their CAD assessment strategy: angiography guided or FFR guided. Patients were further subdivided according to the decision to proceed with percutaneous coronary intervention (PCI): angiography-guided PCI (375/1023), angiography-guided no-PCI (549/1023), FFR-guided PCI (50/1023), and FFR-guided no-PCI (49/1023). Patients were followed up for the occurrence of major adverse cardiac and cerebrovascular events (MACCEs). Results: At a mean follow-up of 33.7 months, we observed no significant differences in terms of major adverse cardiovascular and cerebrovascular events (MACCE) in the angiography-guided group (42.4%) compared with the FFR-guided group (37.4%) (p = 0.333). When comparing outcomes of the FFR-guided no-PCI group (32.7%) with the angiography-guided PCI group (46.4%), no significant difference was noted (p = 0.999). Following intracoronary adenosine, a single adverse event occurred. Conclusions: In this population, intracoronary adenosine is safe and well tolerated. We found no significant benefit to an FFR-guided strategy compared with an angiography-guided strategy with respect to MACCEs. Although clinically compelling, avoiding the procedural risks of PCI by deferring the intervention in functionally insignificant lesions failed to show a statistically significant benefit.

Incidence, Clinical Characteristics, and Impact of Absent Echocardiographic Signs in Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.

BACKGROUND: Echocardiography is the primary imaging modality for diagnosis of infective endocarditis (IE) in prosthetic valve endocarditis (PVE) including IE after transcatheter aortic valve implantation (TAVI). This study aimed to evaluate the characteristics and clinical outcomes of patients with absent compared with evident echocardiographic signs of TAVI-IE. METHODS: Patients with definite TAVI-IE derived from the Infectious Endocarditis after TAVI International Registry were investigated comparing those with absent and evident echocardiographic signs of IE defined as vegetation, abscess, pseudo-aneurysm, intracardiac fistula, or valvular perforation or aneurysm. RESULTS: Among 578 patients, 87 (15.1%) and 491 (84.9%) had absent (IE-neg) and evident (IE-pos) echocardiographic signs of IE, respectively. IE-neg were more often treated via a transfemoral access with a self-expanding device and had higher rates of peri-interventional complications (eg, stroke, major vascular complications) during the TAVI procedure (P < .05 for all). IE-neg had higher rates of IE caused by Staphylococcus aureus (33.7% vs 23.2%; P = .038) and enterococci (37.2% vs 23.8%; P = .009) but lower rates of coagulase-negative staphylococci (4.7% vs 20.0%, P = .001). IE-neg was associated with the same dismal prognosis for in-hospital mortality in a multivariate binary regression analysis (odds ratio: 1.51; 95% confidence interval [CI]: .55-4.12) as well as a for 1-year mortality in Cox regression analysis (hazard ratio: 1.10; 95% CI: .67-1.80). CONCLUSIONS: Even with negative echocardiographic imaging, patients who have undergone TAVI and presenting with positive blood cultures and symptoms of infection are a high-risk patient group having a reasonable suspicion of IE and the need for an early treatment initiation.

Use of Palliative Oxygen in Cancer Patients.

Background: Despite the lack of evidence to support the use of palliative oxygen to relieve dyspnea at the end of life, its prescription is widespread and often supported by local and national practice guidelines. Objectives: The objectives of this study were (1) to determine to what extent oxygen prescriptions meet the proposed prescription criteria in our institution, (2) to examine the indication of individual prescriptions in relation to the severity of dyspnea and (3) to review the utilization of opioids in patients receiving palliative oxygen. Methods: Retrospective chart review of cancer patients who were prescribed palliative oxygen between April 2015 and January 2020 through a respiratory home care program in Quebec City, Canada. According to provincial prescription guidelines, palliative oxygen was provided and reimbursed in case of severe hypoxemia (pulse oximetry saturation at rest < 88%) in cancer patients with an estimated prognosis of less than 3 months. Results: 134 patients receiving palliative oxygen were included; 25 (19%) did not fulfill reimbursement criteria. Median survival was 44 days. At initiation of palliative oxygen, 48 patients (36%) had only mild or moderate dyspnea (Medical Research Council dyspnea score 1-3), 26 (19%) did not receive opioids, and 9 (7%) were prescribed palliative oxygen without being dyspneic or receiving opioids. Conclusion: Most prescriptions of palliative oxygen met the proposed prescription criteria in our institution. Half of those who received palliative oxygen were only mildly dyspneic and/or were not receiving opioids at the time of the prescription.

Transcatheter Patent Foramen Ovale Closure in Patients With Transient Ischemic Attack.

Limited data exist on patients with a transient ischemic attack (TIA) who underwent patent foramen ovale (PFO) closure. The objectives of this study were to determine the clinical and procedural characteristics and long-term outcomes of patients with TIA who underwent transcatheter PFO closure. This was a multicenter study including 1,012 consecutive patients who underwent PFO closure after a cerebrovascular event. Patients were divided into 2 groups according to their index event leading to PFO closure: TIA (n = 183 [18%]), and stroke (n = 829 [82%]). The median follow-up was 3 (2 to 8) years (complete in 98% of patients). There were no significant differences between patients with TIA and stroke, except for a lower Risk of Paradoxical Embolism score in the TIA group (6.1 vs 6.9 in the stroke group, p <0.001). PFO closure was successful in all patients with a low rate of complications (<1%) in both groups. There were no differences in the incidence of neurologic events during long-term follow-up. There was 1 stroke event in the TIA group and 6 in the stroke group (0.08 vs 0.17 per 100 patients-years, p = 0.584). There were 2 TIA events in the TIA group and 10 in the stroke group (0.17 vs 0.28 per 100 patients-years, p = 0.557). In conclusion, our study showed that patients with TIA who underwent PFO closure have similar clinical characteristics as patients with stroke including a high Risk of Paradoxical Embolism score. Furthermore, these results suggest that PFO closure procedural results and long-term clinical outcomes are similar to their stroke counterparts, with a very low incidence of recurrent neurologic events. Further prospective randomized clinical trials are needed on this population.

Transcatheter Closure of Patent Foramen Ovale in Patients With Peripheral (Noncerebrovascular) Embolism.

OBJECTIVES: Scarce data exist on noncerebrovascular peripheral embolism (NCPE) patients undergoing transcatheter patent foramen ovale (PFO) closure. The objectives of this study were to determine the clinical and procedural characteristics, and long-term outcomes of patients with NCPE undergoing transcatheter PFO closure. METHODS: This was a multicenter study including 1136 consecutive patients who underwent PFO closure after a thromboembolic event. Patients were divided into 2 groups according to the type of event leading to PFO closure, ie, cerebrovascular event (CVE, n = 1099 [96.7%]) and NCPE (n = 37 [3.3%]). The median follow-up was 3 years (interquartile range, 1-8), with follow-up complete in 98%. RESULTS: Patients in the NCPE group exhibited higher rates of prior or concomitant pulmonary embolism (29.7% vs 3.4%; P<.001), and prior myocardial infarction (24.3% vs 1.8%; P<.001). Most NCPE events were located in the limbs (41%), followed by coronary (27%) and renal/splenic/mesenteric arteries (12%). PFO closure was successful in all patients, with a low complication rate (<1%) in both groups. NCPE patients were more frequently treated with anticoagulation following PFO closure (63% vs 13%; P<.001). There were no differences between NCPE and CVE groups in death (0 per 100 patient years vs 0.4 per 100 patient-years; P=.53) or cerebrovascular events (1.3 per 100 patient-years vs 0.4 per 100 patient-years; P=.15) at follow-up. CONCLUSIONS: Patients with NCPE events undergoing PFO closure exhibited differential baseline characteristics compared with patients with CVEs; limbs and coronary arteries were the most frequent NCPE location. PFO closure results and long-term outcomes were similar to their CVE counterparts, with a very low rate of recurrent thromboembolic events. Further studies are needed in this population.

Results of transcarotid compared with transfemoral transcatheter aortic valve replacement.

OBJECTIVES: The femoral artery is the preferred vascular access to perform transcatheter aortic valve replacement (TAVR). However, the optimal alternative approach has not been elucidated in patients who are not candidates for a transfemoral (TF) access. The objective of this study was to compare the outcomes of TAVR performed by the transcarotid (TC) compared with the TF approach. METHODS: This was a single-center study that included 526 consecutive patients who underwent TAVR between 2015 and 2019. TC-TAVR was performed in 127 and TF-TAVR in 399 patients. Postprocedural and 30-day clinical events were evaluated according to main access (TC vs TF) using a multivariate logistic regression model. One-year survival and freedom from neurological events were also evaluated. RESULTS: The prevalence of diabetes, chronic obstructive pulmonary disease, coronary artery disease, and peripheral vascular disease was higher in the TC group. In-hospital mortality (3.2% vs 2.0%, adjusted odds ratio, 1.83; 95% confidence interval, 0.47-7.15; P = .39), and 30-day stroke (2.4% vs 3.3%; odds ratio, 0.84; 95% confidence interval, 0.21-3.41; P = .81), were similar between groups as were other outcomes: procedural success (98.4% vs 97.0%; P = .52), 30-day cumulative mortality (4.8% vs 2.8%; P = .26), major vascular complication (2.4% vs 4.5%; P = .25), and major/life-threatening bleeding (4.7% vs 6.0%; P = .41) (TC vs TF, respectively). No differences were found among groups regarding survival or neurological events at 1-year follow-up. CONCLUSIONS: The TC approach is a safe alternate-access strategy for TAVR, and is associated with similar outcomes compared with TF-TAVR, despite a higher disease burden in TC patients.

Secondary Femoral Access Hemostasis During Transcatheter Aortic Valve Replacement: Impact of Vascular Closure Devices.

BACKGROUND: Vascular and bleeding complications related to secondary femoral access site are frequent in patients undergoing transcatheter aortic valve replacement (TAVR), and their occurrence is associated to poorer outcomes. We aimed to evaluate the clinical impact of vascular closure devices (VCDs) for secondary femoral access hemostasis in TAVR procedures. METHODS: This was a multicenter study including 4031 patients who underwent TAVR (mean age, 81 ± 8 years; mean Society of Thoracic Surgeons [STS] score, 4.9 [interquartile range, 3.3-7.6]), and had a secondary femoral access. The 30-day clinical outcomes were analyzed according to femoral access-site hemostasis (manual compression vs VCD), and according to the type of VCD (Perclose [Abbott Cardiovascular] vs Angio-Seal [Terumo Interventional Systems]) using a propensity-matched, multivariable, logistic regression model. RESULTS: Manual compression was used in 941 patients (23.3%) and VCDs were used in 3090 patients (76.7%; Perclose in 1549 patients [38.4%] and Angio-Seal in 1541 patients [38.2%]) for secondary femoral access hemostasis. Vascular complications related to secondary access site occurred in 162 patients (4%), and were more frequent in patients who underwent manual compression (7.2%) compared with VCD hemostasis (3%; adjusted P<.001). In the VCD group, the use of Angio-Seal (vs Perclose) was associated with a higher rate of vascular complications (3.7% vs 2.4%, respectively; adjusted P=.02), femoral artery pseudoaneurysm (1.3% vs 0.4%, respectively; adjusted P<.01), invasive treatment requirement for treating vascular complications (surgery: 0.8% vs 0.3%, respectively [adjusted P=.03]; and thrombin injection: 0.9% vs 0%, respectively [adjusted P<.001]). CONCLUSION: VCDs represented a safer and more effective alternative compared with manual compression for secondary femoral access-site hemostasis in patients undergoing TAVR procedures, and the Perclose VCD was associated with the lowest risk of vascular complications. Future randomized studies are warranted.

Clinical Impact of Crossover Techniques for Primary Access Hemostasis in Transfemoral Transcatheter Aortic Valve Replacement Procedures.

OBJECTIVES: To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT). BACKGROUND: The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated. METHODS: A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients. RESULTS: Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09). CONCLUSIONS: The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.

Reclassification of prosthesis-patient mismatch after transcatheter aortic valve replacement using predicted vs. measured indexed effective orifice area.

AIMS: The objective was to compare the incidence and impact on outcomes of measured (PPMM) vs. predicted (PPMP) prosthesis-patient mismatch following transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: All consecutives patients who underwent TAVR between 2007 and 2018 were included. Effective orifice area (EOA) was measured by Doppler-echocardiography using the continuity equation and predicted according to the normal reference for each model and size of valve. PPM was defined using EOA indexed (EOAi) to body surface area as moderate if ≤0.85 cm2/m2 and severe if ≤ 0.65 cm2/m2 (respectively, ≤ 0.70 and ≤ 0.55 cm2/m2 if body mass index ≥ 30 kg/m2). The outcome endpoints were high residual gradient (≥20 mmHg) and the composite of cardiovascular mortality and hospital readmission for heart failure at 1 year. Overall, 1088 patients underwent a TAVR (55% male, age 79.1 ± 8.4 years, and STS score 6.6 ± 4.7%); balloon-expandable device was used in 83%. Incidence of moderate (10% vs. 27%) and severe (1% vs. 17%) PPM was markedly lower when defined by predicted vs. measured EOAi (P < 0.001). Balloon-expandable device implantation (OR: 1.90, P = 0.029) and valve-in-valve procedure (n = 118; OR: 3.21, P < 0.001) were the main factors associated with PPM occurrence. Compared with measured PPM, predicted PPM showed stronger association with high residual gradient. Severe measured or predicted PPM was not associated with clinical outcomes. CONCLUSION: The utilization of the predicted EOAi reclassifies the majority of patients with PPM to no PPM following TAVR. Compared with measured PPM, predicted PPM had stronger association with haemodynamic outcomes, while both methods were not associated with clinical outcomes.

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial.

Importance: Adding clopidogrel to aspirin for 3 months after transcatheter atrial septal defect (ASD) closure results in a lower incidence of new-onset migraine attacks. However, the outcomes at 6- to 12-month follow-up (after clopidogrel cessation at 3 months) remain largely unknown. Objective: To assess the incidence of migraine attacks at 6- and 12-month follow-up after transcatheter ASD closure. Design, Setting, and Participants: This prespecified analysis of a randomized, double-blind clinical trial included patients with no prior history of migraine undergoing ASD closure from 6 university hospitals in Canada from December 2008 to November 2014. Patients were followed up at 3, 6, and 12 months, and a migraine headache questionnaire was administered at each time. Analysis began June 2019. Interventions: Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin plus clopidogrel; n = 84) vs single antiplatelet therapy (aspirin plus placebo; n = 87) for 3 months following transcatheter ASD closure. After 3 months, only single antiplatelet therapy (aspirin) was pursued. Main Outcomes and Measures: Incidence and severity of migraine attacks at 6- and 12-month follow-up. Results: The mean (SD) age of the study population was 38 (12) years, with 106 women (62%). A total of 27 patients (15.8%) had new-onset migraine attacks within the 3 months following ASD closure (8 of 84 [9.5%] vs 19 of 87 [21.8%] in the initial clopidogrel and placebo groups, respectively; P = .03). After cessation of clopidogrel and aspirin monotherapy, the percentage of patients with migraine attacks decreased over time, with 8 (4.7%) and 4 patients (2.3%) continuing to have migraine attacks at 6 and 12 months, respectively (vs 3 months: P < .001). The severity of migraine attacks progressively decreased over time; no moderate or severe attacks occurred at 6 and 12 months (vs 3 months: P < .001). There were no differences between groups in the rate of migraine attacks at 6 months (initial clopidogrel group: 2 of 84 [2.4%]; initial placebo group: 6 of 87 [6.9%]; P = .28) and 12 months (initial clopidogrel group: 3 of 84 [3.6%]; initial placebo group: 1 of 87 [1.1%]; P = .36) after ASD closure. Only 2 patients (1.2%; 1 patient per group) presented with new-onset migraine attacks after 3 months. Conclusions and Relevance: New-onset migraine attacks after ASD closure improved or resolved spontaneously within 6 to 12 months in most patients. No significant rebound effect was observed after clopidogrel cessation at 3 months. These results demonstrate a low rate of migraine events beyond 3 months following transcatheter ASD closure and support the early discontinuation of clopidogrel therapy if administered. Trial Registration: ClinicalTrials.gov Identifier: NCT00799045.

Multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up.

INTRODUCTION AND OBJECTIVES: We assessed the long-term hemodynamic performance of transcatheter heart valve (THV) by paired transthoracic echocardiography (TTE), and the incidence, characteristics and factors associated with THV structural valve degeneration (SVD). METHODS: A total of 212 patients who underwent transcatheter aortic valve replacement and had a potential follow-up >5 years with at least 1 TTE ≥ 1-year postprocedure were included. All patients had a TTE at 1 to 5 years and 36 had another one at 6 to 10 years. SVD was defined as subclinical (increase >10mmHg in mean transvalvular gradient+decrease >0.3cm2 in valve area and/or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase> 20mmHg in mean transvalvular gradient+decrease> 0.6cm2 in valve area and/or new-onset moderate-to-severe aortic regurgitation). Fifteen patients had a transesophageal echocardiography at the time of SVD diagnosis, and 85 an opportunistic computed tomography examination at 1 (0.5-2) years. RESULTS: Transvalvular mean gradient increased and valve area decreased over time (P<.01). At 8 years of follow-up, SVD occurred in 30.2% of patients (clinically relevant: 9.3%). Transesophageal echocardiography revealed thickened and reduced-mobility leaflets in 80% and 73% of SVD cases, respectively. No baseline or procedural factors were associated with SVD. THV underexpansion (3.5%) or eccentricity (8.2%) had no impact on valve hemodynamics/SVD at follow-up. CONCLUSIONS: A gradual THV hemodynamic deterioration occurred throughout a 10-year period, leading to SVD in ∼30% of patients (clinically relevant in < 10%). Leaflet morphology/mobility were frequently impaired in SVD cases, but THV geometry did not influence valve hemodynamics or SVD.

Impact of Left-Ventricular Dysfunction in Patients With High- and Low- Gradient Severe Aortic Stenosis Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Outcomes of transcatheter aortic valve replacement (TAVR) in patients with high-gradient (HG) severe aortic stenosis (AS) and reduced left-ventricular (LV) ejection fraction (EF) are unknown. METHODS: Patients undergoing TAVR for native severe AS between 2009 and 2018 were retrospectively included and classified into 3 groups: HG (≥ 40 mm Hg) and preserved EF (≥ 50%), HG low EF (< 50%), and low gradient (LG < 40 mm Hg) low EF. The primary endpoint was a composite of cardiovascular mortality and readmission for heart failure at 1 year after TAVR. RESULTS: Of the 526 patients included, 323 (61%) had HG preserved EF, 69 (13%) had HG low EF, and 134 (26%) had LG low EF. HG low EF group had higher prevalence of atrial fibrillation and heart failure and higher Society of Thoracic Surgeons score compared with the HG preserved EF group. Patients in the LG low EF group were older and had higher prevalence of coronary artery disease compared with those in the HG groups. All-cause mortality at 30 days (4.0%) was similar across the 3 groups. After adjustment, the risk of primary endpoint was similar in the HG low-EF vs preserved EF groups. Conversely, the risk of primary endpoint was higher in the LG low EF group vs the HG preserved EF group (hazard ratio [HR], 2.24; 95% confidence interval [CI],1.36-3.70; P = 0.002) and vs HG low EF group (HR, 3.50; 95% CI, 1.55-7.90; P = 0.003), whereas the risk of all-cause mortality was similar across the 3 groups. CONCLUSIONS: The outcome of patients with HG low EF severe AS following TAVR is as good as that of patients with HG preserved EF.

Short-Term Oral Anticoagulation Versus Antiplatelet Therapy Following Transcatheter Left Atrial Appendage Closure.

BACKGROUND: The impact of antithrombotic therapy on coagulation system activation after left atrial appendage closure (LAAC) remains unknown. This study sought to compare changes in coagulation markers associated with short-term oral anticoagulation (OAC) versus antiplatelet therapy (APT) following LAAC. METHODS: Prospective study including 78 atrial fibrillation patients undergoing LAAC with the Watchman device. F1+2 (prothrombin fragment 1+2) and TAT (thrombin-antithrombin III) were assessed immediately before the procedure, and at 7, 30, and 180 days after LAAC. RESULTS: Forty-eight patients were discharged on APT (dual: 31, single: 17) and 30 on OAC (direct anticoagulants: 26, vitamin K antagonists: 4), with no differences in baseline-procedural characteristics between groups except for higher spontaneous echocardiography contrast in the OAC group. OAC significantly reduced coagulation activation within 7 days post-LAAC compared with APT (23% [95% CI, 5%-41%] versus 82% [95% CI, 54%-111%] increase for F1+2, P=0.007; 52% [95% CI, 15%-89%] versus 183% [95% CI, 118%-248%] increase for TAT, P=0.048), with all patients in both groups progressively returning to baseline values at 30 and 180 days. Spontaneous echocardiography contrast pre-LAAC was associated with an enhanced activation of the coagulation system post-LAAC (144 [48-192] versus 52 [24-111] nmol/L, P=0.062 for F1+2; 299 [254-390] versus 78 [19-240] ng/mL, P=0.002 for TAT). Device-related thrombosis occurred in 5 patients (6.4%), and all of them were receiving APT at the time of transesophageal echocardiography (10.2% versus 0% if OAC at the time of transesophageal echocardiography, P=0.151). Patients with device thrombosis exhibited a greater coagulation activation 7 days post-LAAC (P=0.038 and P=0.108 for F1+2 and TAT, respectively). CONCLUSIONS: OAC (versus APT) was associated with a significant attenuation of coagulation system activation post-LAAC. Spontaneous echocardiography contrast pre-LAAC associated with enhanced coagulation activation post-LAAC, which in turn increased the risk of device thrombosis. These results highlight the urgent need for randomized trials comparing OAC versus APT post-LAAC.

Late Cerebrovascular Events Following Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to determine the incidence, clinical characteristics, associated factors, and outcomes of late cerebrovascular events (LCVEs) (>30 days post-procedure) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Scarce data exist on LCVEs following TAVR. METHODS: This was a multicenter study including 3,750 consecutive patients (mean age, 80 ± 8 years; 50.5% of women) who underwent TAVR and survived beyond 30 days. LCVEs were defined according to the Valve Academic Research Consortium 2 (VARC 2) criteria. RESULTS: LCVEs occurred in 192 (5.1%) patients (stroke, 80.2%; transient ischemic attack, 19.8%) after a median follow-up of 2 (1 to 4) years. Late stroke was of ischemic, hemorrhagic, and undetermined origin in 80.5%, 18.8%, and 0.7% of patients, respectively. Older age, previous cerebrovascular disease, higher mean aortic gradient at baseline, the occurrence of stroke during the periprocedural TAVR period, and the lack of anticoagulation (novel oral anticoagulants or vitamin K antagonists) post-TAVR were independent factors associated with late ischemic stroke/transient ischemic attack (p < 0.05 for all). Echocardiographic data at the time of the LCVE showed no signs of valve thrombosis or degeneration in the vast majority (97%) patients. Late stroke was disabling in 107 (69.5%) patients (ischemic, 68%; hemorrhagic, 79%), and associated with an in-hospital mortality rate of 29.2%. CONCLUSIONS: LCVEs occurred in 5.1% of TAVR recipients after a median follow-up of 2 years. LCVEs were ischemic in most cases, with older age, previous cerebrovascular events, higher mean aortic gradient at baseline, the occurrence during the periprocedural TAVR period, and lack of anticoagulation (but not valve thrombosis/degeneration) determining an increased risk. Late stroke was disabling in most cases and associated with dreadful early and midterm outcomes.