Rapid pacing using the left ventricular guidewire: Reviving an old technique to simplify BAV and TAVI procedures.

OBJECTIVES: We sought to demonstrate the safety and efficacy of rapid left ventricular (LV) pacing through the guidewire during balloon aortic valvuloplasty (BAV) and Transaortic valve implantation (TAVI). BACKGROUND: Right ventricular temporary pacing during TAVI and BAV is time-consuming and associated with vascular and pericardial complications. METHODS: Rapid left ventricular pacing was provided via the back-up 0.035″ guidewire. The cathode of an external pacemaker was placed on the tip of the 0.035″ wire and the anode on a needle inserted into the groin. Insulation was ensured by the balloon or TAVI catheter. RESULTS: 38 BAV and 87 TAVI procedures were performed in 113 consecutive patients in three centers with one for one pacing (160-200 bpm) in all patients. A significant reduction in blood pressure was achieved with a mean systolic pressure of 44 mm Hg during stimulation. Mean procedural time was 49.7 ± 31 min for BAV and 68.7 ± 30.9 for TAVI. A temporary venous pacemaker was required in 12 patients; only 12% of TAVI patients had a femoral central venous catheter. Femoral venous puncture was not performed in BAV patients. No venous vascular complications were observed. One case of successfully treated tamponade (0.8%) occurred 8 hr post procedure. In-hospital mortality rates were 4.6% and 2.6% in the TAVI and BAV groups, respectively. CONCLUSIONS: Use of the LV guidewire for rapid pacing during BAV and TAVI was shown to be simple, reproducible, and prevented complications associated with RV temporary leads thus potentially simplifying TAVI and enhancing its safety. © 2016 Wiley Periodicals, Inc.

Direct wire pacing during measurement of fractional flow reserve: A randomized proof-of-concept noninferiority crossover trial.

Background: Adenosine administration for fractional flow reserve (FFR) measurement may induce heart pauses. Aims: To assess the accuracy and tolerability of direct wire pacing (DWP) during measurement of FFR. Methods: Adults with at least one intermediate coronary artery stenosis (40%-80%) were consecutively enrolled between June 2021 and February 2022 in this randomized, noninferiority, crossover trial (NCT04970082) carried out in France. DWP was applied (DWP) or not (standard method) through the pressure guidewire used for FFR measurement during adenosine-induced maximal hyperaemia. Subjects were randomly assigned to the allocation sequence (DWP first or standard first). A 2-minute washout period was observed between the two FFR measurements performed for each stenosis. The primary endpoint was the reproducibility of FFR measurements between methods. Results: A total of 150 focal lesions, presented by 94 subjects, were randomized (ratio: 1:1). The FFR values obtained with each method were nearly identical (R = 0.98, p = 0.005). The mean FFR difference of 0.00054 (95% confidence interval: 0.004 to 0.003) showed the noninferiority of FFR measurement with DWP vs. that with the standard method. Higher levels of chest discomfort were reported with DWP than with the standard method (0.61 ± 0.84 vs. 1.05 ± 0.89, p < 0.001), and a correlation was observed between the electrical sensations reported with DWP and chest discomfort (p < 0.001). Pauses (n = 20/148 lesions) were observed with the standard method, but did not correlate with chest discomfort (p = 0.21). No pauses were observed with DWP. Conclusions: DWP during FFR measurement resulted in accurate and reproducible FFR values, and eliminated the pauses induced by adenosine.

A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary interventions (PCI) may require cardiac pacing during device delivery, generally requiring the insertion of a temporary pacing lead via an additional venous access site. The purpose-built Electroducer Sleeve device provides direct wire pacing without the need for a temporary venous pacemaker. AIMS: This study assessed the safety of temporary cardiac pacing using the novel sleeve device during PCI. METHODS: This was a multicentre, non-randomised, prospective, first-in-human, single-arm, pilot study. The primary endpoint was analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of effectiveness and qualitative outcomes. RESULTS: Sixty patients (mean age: 77.9±9.6 years) from 4 centres in France were included: 39 (65%) underwent TAVI, and 21 (35%) underwent PCI. Procedures were performed using the sleeve with access through the radial (32 patients; 53.3%) or femoral arteries (26; 43.3%), or the femoral vein (2; 3.3%). Primary endpoint analysis revealed that 2 patients (3.3%) developed EArly Discharge After Transradial Stenting of CoronarY Arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%). Analyses of other secondary endpoints showed that 2 patients (6.3%) presented asymptomatic radial artery occlusion. No allergies were reported. CONCLUSIONS: This first-in-human trial using the Electroducer Sleeve indicated that this novel, purpose-built, temporary pacing device was safe and effective. Larger prospective studies are required to confirm these findings.

Direct Wire Pacing for Challenging Left Main Stenting: An Old Technique Revived.

During stent positioning after predilating with a non-compliant balloon, we observed major motion of our device in the left main coronary artery. Under those conditions, accurate stent placement was uncertain. To remedy this situation, we decided to perform a rapid direct wire pacing with a good final angiographic result.

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.

Radiation Exposure During Transcatheter Aortic Valve Replacement: Impact of Arterial Approach and Prosthesis Type.

BACKGROUND: The impact of novel alternative access and valve type on radiation exposure during transcatheter aortic valve replacement (TAVR) has not yet been evaluated. This study sought to determine the impact of a transarterial approach and prosthesis type on physician and patient exposure to radiation during TAVR. METHODS: This was a prospective study including 140 consecutive patients undergoing TAVR by transfemoral (n = 102) or transcarotid (TC) (n = 38) access at 2 centers. Implanted valves were the self-expanding Evolut R/PRO system (Medtronic, Minneapolis, MN; n = 38) and the balloon-expandable SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA; n = 102). The primary endpoint was first operator radiation exposure. The secondary endpoint was patient radiation exposure. RESULTS: First operator radiation exposure was 4-fold greater during TC TAVR (P < .001). The use of a self-expanding valve was associated with a longer x-ray time (P = .015) and a 2-fold greater first operator radiation dose (P = .018). Patient radiation dose was not significantly affected by arterial approach (P = .055) or valve type (P = .095). After adjustment for potential confounders, the TC approach remained associated with a 174.8% (95% confidence interval, 80.6-318.3, P < .001) increase in first operator radiation dose, whereas the use of a self-expanding valve no longer influenced the first operator dose (P = .630). CONCLUSIONS: TC access and the use of a self-expanding valve were associated with a 4- and 2-fold greater first operator radiation exposure during TAVR procedures, respectively. Unlike the arterial approach, the effect of bioprosthesis type on radiation exposure was mainly related to x-ray time and was no longer significant after adjustment.

Ambulatory TAVR: Early Feasibility Experience During the COVID-19 Pandemic.

The COVID-19 pandemic has modified practice for patients with symptomatic aortic stenosis and could result in higher mortality rates due to treatment delays. In this clinical case series, 3 patients underwent ambulatory transcatheter aortic valve replacement (TAVR) thanks to patient and entourage willingness, careful patient selection (including a history of permanent pacemaker placement), and a minimalist procedural approach. No complications occurred during the 30-day follow-up. Performing ambulatory TAVR could reduce the clinical consequences of wait times, minimize exposure to coronavirus contamination, and reduce the use of hospital resources that might be needed for COVID-19 patients. Thanks to a scrupulous minimalist TAVR protocol, ambulatory outpatient management of aortic stenosis was possible in the context of the COVID-19 pandemic.

La pandémie de COVID-19 a modifié la prise en charge des patients présentant une sténose aortique symptomatique, et les retards dans les traitements pourraient entraîner une hausse des taux de mortalité. Dans le cadre de cette série de cas cliniques, trois patients ont subi un remplacement valvulaire aortique par cathéter (RVAC) ambulatoire, rendu possible grâce à la volonté des patients et de leur entourage, aux choix consciencieux des candidats (par exemple, les receveurs d'un stimulateur cardiaque implantable) et à une approche comportant des interventions minimales. On n'a observé aucune complication durant les 30 jours du suivi. Le RVAC ambulatoire pourrait atténuer les répercussions cliniques associées au temps d'attente, réduire le risque d'exposition au coronavirus et diminuer l'utilisation des ressources hospitalières, qui pourraient être consacrées aux patients atteints de la COVID-19. Un protocole méticuleux et minimaliste de RVAC a permis la prise en charge ambulatoire de la sténose aortique durant la pandémie de COVID-19.

Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism.

INTRODUCTION AND OBJECTIVES: Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years. METHODS: Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66±5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44±10 years). RESULTS: Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269). CONCLUSIONS: In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF.

Interaction Between Balloon-Expandable Valves and Coronary Ostia: Angiographic Analysis and Impact on Coronary Access.

OBJECTIVES: We sought to evaluate the position of balloon-expandable valves in relation to the coronary ostia using an angiographic- and computed tomography (CT)-based analysis, and to determine the impact of valve position on coronary angiography (CA)/percutaneous coronary intervention (PCI) feasibility and results. METHODS: A total of 533 patients who received a Sapien XT or Sapien 3 valve were included in the angiographic analysis. Of these, 49 benefited from an opportunistic electrocardiography-gated CT after transcatheter aortic valve replacement (TAVR) and were included in the CT analysis. RESULTS: Regarding the left coronary artery (LCA) ostium, the top of the transcatheter heart valve (THV) frame was infraostial in 49% of cases, and the valve totally covered the LCA ostium in 27% of patients. The stent frame of the Sapien 3 valve completely covered the LCA ostium more frequently than the Sapien XT valve (43% vs 12%, respectively; P<.001) and the relative implantation depth was significantly less ventricular in the Sapien 3 group than in the Sapien XT group (28.0 ± 12.3% vs 36.8 ± 12.6%, respectively; P<.001). The CT evaluation found similar results to angiographic evaluation. A total of 53 patients (10%) underwent CA (± PCI) following TAVR, and valve position did not influence CA performance/quality and PCI results. CONCLUSIONS: The stent frame of balloon-expandable Sapien valves exceeded the coronary ostia in about one-fourth of patients, and this percentage was >40% with the new-generation Sapien 3 valve. However, THV position did not affect the feasibility, quality, and results of CA/PCI post TAVR.

Interaction Between Self-Expanding Transcatheter Heart Valves and Coronary Ostia: An Angiographically Based Analysis of the Evolut R/Pro Valve System.

OBJECTIVES: We sought to assess the position of the CoreValve Evolut R/Pro (Medtronic) with respect to the left coronary artery (LCA) ostium and evaluate the impact of implantation depth on this relationship. METHODS: One hundred consecutive patients who received an Evolut R/Pro valve and had an adequate angiography following valve implantation were included. Angiographic measurements included valve implantation depth, the position of the Evolut R/Pro with respect to the LCA, and the distance between the neo-valve cusp and the LCA ostium. Coronary access issues following TAVR were also recorded. RESULTS: Regarding the LCA ostium, the neo-valve of the Evolut R/Pro was supraostial, at the ostial level, and infraostial in 3%, 12%, and 85% of cases, respectively. When beneath the LCA ostium, the mean distance between the neo-valve and the floor of the LCA ostium was 4.1 ± 5.2 mm. An implantation depth ≤6 mm was associated with a higher rate of neo-valve at the ostial level or above (25% vs 4% for implantation depth >6 mm; P=.01). Accessing the coronary arteries was required in 10% of the patients at 12 ± 8 months post TAVR, and selective coronary angiography of the left and right coronary arteries was achieved in 60% and 40% of the cases, respectively. CONCLUSIONS: The Evolut R/Pro neo-valve was positioned below the LCA ostium in the vast majority of cases (85%), but an implantation depth ≤6mm was associated with a higher rate of neo-valve positioning at or above the coronary ostia level. Considering the current tendency of very high (aortic) valve implants to avoid conduction disturbances, future studies should determine the impact of high Evolut R/Pro positioning on coronary access issues post TAVR.

Transcatheter aortic valve replacement with the balloon-expandable SAPIEN 3 valve: Impact of calcium score on valve performance and clinical outcomes.

BACKGROUND: Aortic valve calcification severity has been associated with higher rates of aortic regurgitation (AR) following TAVR, but scarce data exist on its impact with the use of newer generation transcatheter heart valves. METHODS: This was a multicenter study including 626 patients with severe aortic stenosis who underwent TAVR with the SAPIEN 3 valve. Patients were divided in 2 groups according to the median index calcium score (iCS) for each sex: high CS (HCS, iCS ≥ median), and low iCS (LCS, iCS < median). Another analysis was performed in those patients with extreme iCS (ECS, iCS >75th percentile for each sex). Clinical and echocardiographic data were collected prospectively in a dedicated database. RESULTS: The mean CS was 3758 ±â€¯1417 AU and 1616 ±â€¯691 AU in the HCS and LCS groups, respectively (p < 0.001). There were no differences between groups in 30-day mortality (HCS:2.6%, LCS:1.0%, p = 0.13) and stroke (HCS:2.6%,LCS:2.6%, p = 1.0) rates, but all cases (n = 5) of annulus rupture occurred in the HCS group (1.6% vs. 0%, p = 0.061). The incidence of moderate-severe AR post-TAVR was low in both groups (HCS:1.6%,LCS:1.6%, p = 1.0), and valve gradient and area were similar between groups. The results remained similar in the ECS group (mean CS:4607 ±â€¯1424 AU), but a mildly increased mean transvalvular gradient post-TAVR was observed in ECS patients (12.1 ±â€¯5.6 vs 11.0 ±â€¯4.3 mmHg; p = 0.015). CONCLUSION: Aortic valve calcification severity failed to impact mortality/stroke rates following TAVR with the SAPIEN 3 valve. Low rates of significant AR were observed irrespective of CS, and a mild increase in transvalvular gradient was observed in ECS patients.

Long-Term Electrocardiographic Changes and Clinical Outcomes of Transcatheter Aortic Valve Implantation Recipients Without New Postprocedural Conduction Disturbances.

The objective of this study was to determine the long-term (>1 year) electrocardiographic (ECG) and clinical outcomes of patients without significant changes in their electrocardiogram after transcatheter aortic valve implantation (TAVI; including patients with pre-existing ECG abnormalities). Among 772 consecutive patients who underwent TAVI in our institution, 397 patients (51%) without new ECG changes were included. TAVI patients were divided into 2 groups according to the presence of pre-existing ECG-conduction disturbances (ECG-CD: 140 patients, non-ECG-CD: 257 patients). Clinical follow-up (median: 35 [22 to 57] months) was complete in all patients but 5 (1.2%), and ECG data were available in 291 patients (84.3% of patients at risk) at a median of 29 (20 to 50) months. In the non-ECG-CD group, most patients (79.8%) remained without significant ECG changes at follow-up, and 16.9% developed first-degree atrioventricular block and/or bundle branch block over time. The rate of permanent pacemaker (PPM) implantation at follow-up was 3.5% (1.1%/year) in the non-ECG-CD group versus 15.7% (5.5%/year) in the ECG-CD group (p <0.001). The presence of pre-existing CD was an independent predictor of PPM at follow-up (hazard ratio [HR] 4.67, 95% confidence interval [CI] 2.15 to 10.16, p <0.001). The ECG-CD group exhibited a higher risk of heart failure hospitalization (non-ECG-CD: 25%, ECG-CD: 29%, log-rank p = 0.01), but not mortality (non-ECG-CD: 50%, ECG-CD: 46%, log-rank p = 0.60) at 5-year follow-up. In conclusion, the ECG remained unchanged in most TAVI recipients without new postprocedural CD. Pre-existing ECG-CD was associated with an increased risk of PPM and heart failure hospitalization at long-term follow-up. These results provide reassuring data in the era of TAVI expanding toward candidates with a longer life expectancy, and highlight the importance of a closer follow-up of those patients with pre-existing ECG-CDs.

Valve Hemodynamics Following Transcatheter or Surgical Aortic Valve Replacement in Patients With Small Aortic Annulus.

This study aimed to compare the hemodynamic performance of transcatheter and surgical aortic valves in patients with severe symptomatic aortic stenosis and small aortic annulus (SAA) and to determine the valve hemodynamics according to transcatheter valve type. Consecutive surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients with SAA were case-matched (1:1) on the basis of sex, body surface area, aortic annulus diameter, and left ventricular ejection fraction. A total of 357 patients in each group constituted the final study population. A second match on the basis of aortic annulus diameter and valve/annulus calcium burden was performed within the TAVR group to compare the valve performance between balloon- (n = 52) and self-expanding (n = 52) transcatheter valve systems (BEV, SEV). The echocardiograms performed at hospital discharge were used for evaluating valve hemodynamics. The mean annulus diameter of the study population was 19.2 ± 0.3 mm. The TAVR group (vs SAVR) exhibited lower mean gradient (12 ± 7 mm Hg vs 15 ± 6 mm Hg, p <0.001), larger effective orifice area (1.46 ± 0.39 cm2 vs 1.25 ± 0.37 cm2, p <0.001) and a lower rate of severe prosthesis-patient mismatch (PPM) (14% vs 24%, p = 0.001). Moderate-severe AR was present in 2.5% of the TAVR recipients versus none patient in the SAVR group. There were no differences in valve hemodynamics between balloon-expanding transcatheter valve system and self-expanding transcatheter valve system, and similar rates of severe PPM were observed in both groups (p = 0.488). In conclusion, TAVR presented superior valve hemodynamics and lower incidence of severe PPM compared with SAVR in SAA patients. Similar valve performance results were observed between transcatheter valve types.

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System.

OBJECTIVES: The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system. BACKGROUND: Transseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair. METHODS: Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria. RESULTS: Fourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%). CONCLUSIONS: This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.

Impact of Discontinuation of Antithrombotic Therapy Following Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism.

No data exist on the optimal duration of antithrombotic therapy (AT) following patent foramen ovale (PFO) closure. We sought to assess the safety of AT discontinuation following PFO closure in patients with a cryptogenic ischemic event. A total of 453 consecutive patients (mean age: 48 ± 13years, men: 51%) who underwent PFO closure due to a cryptogenic ischemic event were included. All patients were on AT following PFO closure (antiplatelet therapy: 92.7%, anticoagulation: 7.3%). Ischemic and bleeding events, and AT were assessed at a median follow-up of 8 (IQR: 4 to 11) years, and follow-up was complete in 96% of patients. Stroke and transient ischemic attack occurred in 4 (0.9%) and 12 (2.6%) patients, respectively, and 27 (6.0%) patients had bleeding events (major in 6 [1.3%] patients, including 4 episodes of intracranial hemorrhage). All major bleeding events occurred under aspirin therapy. A total of 82 patients (18%) stopped the AT at a median of 7 (IQR: 5 to 34) months post-PFO closure (due to a bleeding event or gastrointestinal symptoms: 13 patients, no specific reason: 69 patients), and none of them had any ischemic event after a median time of 7 (IQR 3 to 10) years without any AT. A propensity score matched analysis including 46 patients who discontinued the AT within 1-year post-PFO closure and 120 patients with an ongoing AT showed the lack of differences in ischemic events between groups (0 vs 0.2 stroke/transient ischemic attack per 100 patient-years in the no-AT and AT groups, respectively). In conclusion, in young patients who underwent PFO closure, bleeding events occurred in ∼6% of patients after a median follow-up of 8years. AT was discontinued in about one fifth of patients (most of them within the year following PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up. These results suggest that, in patients without other co-morbidities increasing the risk of stroke, temporary AT following PFO closure may be a reasonable strategy.

Long-Term Follow-Up After Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism.

BACKGROUND: Patent foramen ovale (PFO) closure is the gold standard for treating patients with cryptogenic stroke and PFO. However, scarce data exist on the long-term outcomes following PFO closure. OBJECTIVES: The purpose of this study was to determine the long-term (>10 years) clinical outcomes (death, ischemic, hemorrhagic events) following transcatheter PFO closure. METHODS: We included 201 consecutive patients (mean age: 47 ± 12 years, 51% women) who underwent PFO closure due to a cryptogenic embolism (stroke: 76%, transient ischemic attack [TIA]: 32%, systemic embolism: 1%). Echocardiographic examinations were performed at 1- to 6-month follow-up. Ischemic and bleeding events and antithrombotic medication were collected at a median follow-up of 12 years (range 10 to 17 years), and follow-up was complete in 96% of the patients. RESULTS: The PFO closure device was successfully implanted in all cases, and residual shunt was observed in 3.3% of patients at follow-up echocardiography. A total of 13 patients died at follow-up (all from noncardiovascular causes), and nondisabling stroke and TIA occurred in 2 and 6 patients, respectively (0.08 strokes per 100 patient-years; 0.26 TIAs per 100 patient-years). A history of thrombophilia (present in 15% of patients) tended to associate with a higher rate of ischemic events at follow-up (p = 0.067). Bleeding events occurred in 13 patients and were major (intracranial bleeding) in 4 patients (all of them under aspirin therapy at the time of the event). A total of 42 patients stopped the antithrombotic treatment at a median of 6 months (interquartile range 6 to 14 months) post-PFO closure, and none of them had any ischemic or bleeding episode after a mean of 10 ± 4 years following treatment cessation. CONCLUSIONS: PFO closure was associated with a low rate of ischemic events (stroke, 1%) at >10 years of follow-up. Major bleeding events occurred in 2% of the patients (all of them in patients on antiplatelet therapy). One-fifth of patients stopped the antithrombotic therapy during the follow-up period (the majority within the first-year post-PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up.

Early Experience With Transcatheter Mitral Valve Replacement: A Systematic Review.

Background Transcatheter mitral valve replacement (TMVR) has emerged as an alternative therapeutic option for the treatment of severe mitral regurgitation in patients with prohibitive or high surgical risk. The aim of this systematic review is to evaluate the clinical procedural characteristics and outcomes associated with the early TMVR experience. Methods and Results Published studies and international conference presentations reporting data on TMVR systems were identified. Only records including clinical characteristics, procedural results, and 30-day and midterm outcomes were analyzed. A total of 16 publications describing 308 patients were analyzed. Most patients (65.9%) were men, with a mean age of 75 years (range: 69-81 years) and Society for Thoracic Surgery Predicted Risk of Mortality score of 7.7% (range: 6.1-8.6%). The etiology of mitral regurgitation was predominantly secondary or mixed (87.1%), and 81.5% of the patients were in New York Heart Association class III or IV. A transapical approach was used in 81.5% of patients, and overall technical success was high (91.7%). Postprocedural mean transmitral gradient was 3.5 mm Hg (range: 3-5.5 mm Hg), and only 4 cases (1.5%) presented residual moderate to severe mitral regurgitation. Procedural and all-cause 30-day mortality were 4.6% and 13.6%, respectively. Left ventricular outflow obstruction and conversion to open heart surgery were reported in 0.3% and 4% of patients, respectively. All-cause and cardiovascular-related mortality rates were 27.6% and 23.3%, respectively, after a mean follow-up of 10 (range: 3 to 24) months. Conclusions TMVR was a feasible, less invasive alternative for treating severe mitral regurgitation in patients with high or prohibitive surgical risk. TMVR was associated with a high rate of successful valve implantation and excellent hemodynamic results. However, periprocedural complications and all-cause mortality were relatively high.

Coronary Artery Disease and Transcatheter Aortic Valve Replacement: JACC State-of-the-Art Review.

About one-half of transcatheter aortic valve replacement (TAVR) candidates have coronary artery disease (CAD), and controversial results have been reported regarding the effect of the presence and severity of CAD on clinical outcomes post-TAVR. In addition to coronary angiography, promising data has been recently reported on both the use of computed tomography angiography and the functional invasive assessment of coronary lesions in the work-up pre-TAVR. While waiting for the results of ongoing randomized trials, percutaneous revascularization of significant coronary lesions has been the routine strategy in TAVR candidates with CAD. Also, scarce data exists on the incidence, characteristics, and management of coronary events post-TAVR, and increasing interest exist on potential coronary access challenges in patients requiring coronary angiography/intervention post-TAVR. This review provides an updated overview of the current landscape of CAD in TAVR recipients, focusing on its prevalence, clinical impact, pre- and post-procedural evaluation and management, unresolved issues and future perspectives.

Transcatheter aortic valve replacement in low risk patients.

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

How does new-onset left bundle branch block affect the outcomes of transcatheter aortic valve repair?

INTRODUCTION: Transcatheter aortic replacement (TAVR) has revolutionized the treatment of aortic stenosis during the last years. Despite improvements in transcatheter heart valve systems, the rate of conduction disturbances after TAVR, particularly new-onset left bundle branch block (new-onset LBBB), has not decreased over time. AREAS COVERED: Overview of the current data regarding new-onset LBBB post-TAVR focusing on clinical outcomes. EXPERT OPINION: New-onset LBBB remains the most common complication after TAVR, occurring in 6-77% of cases with the use of newer generation transcatheter valve systems. The most consistent factor determining new-onset LBBB post-TAVR has been prosthesis implantation depth. The potential evolution to high degree atrioventricular block (HAVB) and the chronic effect on left ventricular ejection fraction (LVEF) may impact the clinical outcomes in this subset of patients. New-onset LBBB has been associated with an increased risk of PPM after TAVR. Conversely, inconsistent results have been reported regarding the impact of LBBB on hospitalization for heart failure and mortality. Current data do not support an indication for 'prophylactic' PPM in all new-onset LBBB patients. However, a specific subset of patients (those with either a very long PR or wide QRS) may benefit from a PPM to prevent HAVB or sudden death.