Occupational Risks of Radiation Exposure to Cardiologists.

PURPOSE OF REVIEW: Invasive cardiologists are exposed to large amounts of ionizing radiation. This review aims to summarize the main occupational risks in a radiation-exposed cardiology practice. RECENT FINDINGS: We carried out a literature review on the subject. The studies reviewed allowed us to list six main health risk categories possibly associated with radiation exposure among cardiologists: deoxyribonucleic acid (DNA) and biochemical damages; cancers; ocular manifestations; olfaction, vascular, and neuropsychological alterations; musculoskeletal problems; and reproductive risks. Our descriptive analysis demonstrates higher risks of DNA damage and lens opacities among radiation-exposed cardiology staff. Surveys and questionnaires have demonstrated a higher risk of musculoskeletal disease in exposed workers. Studies reported no difference in cancer frequency between radiation-exposed workers and controls. Changes in olfactory performance, neuropsychological aspects, and vascular changes have also been reported. Limited literature supports the security of continuing radiation-exposed work during pregnancy. Therefore, there is an urgent need to increase knowledge of the occupational risks of radiation exposure and to adopt technologies to reduce them.

Antithrombotic Management and Outcomes of Anterior ST-Elevation Myocardial Infarction With New-Onset Wall Motion Abnormalities in Men and Women.

Background: In patients with anterior ST-elevation myocardial infarction (STEMI) and new-onset antero-apical wall motion abnormalities (WMAs), whether the rate of prophylaxis against left ventricular thrombus and outcomes differ between men and women is unknown. Methods: A multicentre retrospective cohort study of patients with STEMI and new-onset antero-apical WMAs treated with primary percutaneous coronary intervention was conducted. Patients with an established indication of oral anticoagulation (OAC) were excluded. The rates of triple therapy (double antiplatelet therapy + OAC) at discharge were compared for women vs men. The rates of net adverse clinical events, a composite of mortality, myocardial infarction, stroke or transient ischemic attack, systemic thromboembolism or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 6 months were compared across sex using a multivariate logistic regression model. Results: A total of 1664 patients were included in the primary analysis, of whom 402 (24.2%) were women and 1262 (75.8%) were men. A total of 138 women (34.3%) and 489 men (38.7%) received a triple therapy prescription at discharge (P = 0.11). At 6 months, 33 women (8.2%) and 96 men (7.6%) experienced a net adverse clinical event (adjusted odds ratio 0.82; 95% confidence interval 0.49-1.37). No difference occurred in the risk of bleeding events and ischemic events between men and women, when these were analyzed separately. Conclusions: The rates of OAC prescription for left ventricular thrombus prophylaxis and clinical outcomes at 6 months were similar in women and men following anterior STEMI with new-onset antero-apical WMAs.

Contexte: On ignore si le taux de prophylaxie contre le thrombus ventriculaire gauche et les résultats thérapeutiques diffèrent entre les hommes et les femmes qui ont subi un infarctus du myocarde avec élévation du segment ST (STEMI) antérieur et ont des anomalies du mouvement pariétal (AMP) antéroapical d'apparition récente. Méthodes: Nous avons mené une étude de cohorte rétrospective multicentrique auprès de patients qui ont subi un STEMI et ont des AMP d'apparition récente traitées par une intervention coronarienne percutanée primaire. Nous avons exclu les patients chez lesquels il existait une indication établie à l'anticoagulation orale (ACO). Nous avons comparé les taux de trithérapie (bithérapie antiplaquettaire + ACO) à la sortie de l'hôpital entre les femmes et les hommes. Nous avons comparé les taux d'événements indésirables cliniques nets, le critère composite de mortalité, d'infarctus du myocarde, d'accident vasculaire cérébral ou d'accident ischémique transitoire, la thromboembolie systémique ou l'hémorragie de type 3 ou 5 selon le Bleeding Academic Research Consortium (BARC) après 6 mois entre les sexes au moyen du modèle de régression logistique multivariée. Résultats: Au sein des 1 664 patients de l'analyse principale, 402 (24,2 %) étaient des femmes et 1262 (75,8 %) étaient des hommes. Un total de 138 femmes (34,3 %) et de 489 hommes (38,7 %) ont reçu une ordonnance de trithérapie à la sortie de l'hôpital (P = 0,11). Après 6 mois, 33 femmes (8,2 %) et 96 hommes (7,6 %) ont subi un événement indésirable net (rapport de cotes ajusté 0,82 ; intervalle de confiance à 95 % 0,49-1,37). Aucune différence n'a été notée dans le risque d'événements hémorragiques et d'événements ischémiques entre les hommes et les femmes lorsque ces événements étaient analysés séparément. Conclusions: Les taux d'ordonnances d'ACO en prophylaxie du thrombus ventriculaire gauche et les résultats cliniques après 6 mois étaient similaires entre les femmes et les hommes à la suite du STEMI antérieur et des AMP antéroapicale d'apparition récente.

Sensor-guided transcatheter aortic valve replacement.

OBJECTIVES: The SavvyWire(OpSens Medical) is a support wire for transcatheter aortic valve replacement (TAVR) procedures that, in addition to its dedicated left ventricle (LV) pacing capabilities, has a distal pressure sensor that measures live transvalvular hemodynamics during the procedure. We aimed to determine the safety, efficacy, and functionality of the SavvyWire during TAVR procedures in an all-comer population. METHODS: We performed a multicentric, prospective, observational, single-arm, all-comers registry of patients with symptomatic, severe aortic stenosis undergoing TAVR in 3 Canadian centers. Data were collected in a dedicated database, and pre-specified questionnaires were fulfilled by the heart team implanters after each procedure. RESULTS: A total of 60 patients were included (mean age: 78.6 ± 7.2 years; 51% women; mean Society of Thoracic Surgeons score: 2.2 ± 1.6%). TAVR was performed through a transfemoral approach in 90% of cases, and balloon- and self-expandable valves were used in 73% and 27% of patients, respectively. There were no cases of LV perforation, guidewire deformation, significant loss of capture, or major software malfunction. The rate of successful delivery of the TAVR system was 100%, and effective LV pacing was achieved in 98% of patients. The pre-TAVR mean gradient was 39 ± 14 mm Hg while the final post-TAVR gradient was 8 ± 5 mm Hg; the mean aortic systolic pressure during rapid pacing was 54 ± 12 mm Hg. In 97% of the TAVR procedures, SavvyWire's functionality was reported to be better or similar to other TAVR workhorse support wires. CONCLUSIONS: SavvyWire was safe, effective, and functional for live transvalvular hemodynamic evaluation and rapid pacing during TAVR procedures. More studies with larger sample sizes and comparison against different wires and gradient measurement methods are warranted.

Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

BACKGROUND: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P=0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P=1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P=0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P=0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P=0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P=0.80). CONCLUSIONS: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445.

Angina en pacientes con estenosis aórtica grave sometidos a implante percutáneo de la válvula aórtica / Angina in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement

Introducción y objetivos: Evaluar la prevalencia, las características clínicas y el impacto de la angina en pacientes con estenosis aórtica sometidos a implante percutáneo de válvula aórtica (TAVI). Métodos: Se analizó a 1.687 pacientes consecutivos con estenosis aórtica sometidos a TAVI, clasificados en función de la presencia o ausencia basal de angina. Los datos basales, del procedimiento y del seguimiento se recogieron en una base de datos local. Resultados: Un total de 497 pacientes (29%) presentaban angina antes del TAVI. Los pacientes con angina basal presentaban peor clase funcional (NYHA> II, el 69% frente al 63%; p=0,017) y una mayor prevalencia de enfermedad coronaria (el 74% frente al 56%; p <0,001). La angina basal no mostró impacto pronóstico a 1 año en mortalidad por cualquier causa (HR=1,02; IC95%, 0,71-1,48; p=0,898) ni en mortalidad cardiovascular (HR=1,2; IC95%, 0,69-2,11; p=0,517). Sin embargo, la persistencia de angina 30 días después del procedimiento se asoció con un incremento en la mortalidad a 1 año, tanto total (HR=4,86; IC95%, 1,71-13,8; p=0,003) como de causa cardiovascular (HR=20,7; IC95%, 3,50-122,6; p=0,001). Conclusiones: Más de un cuarto de los pacientes con estenosis aórtica sometidos a TAVI tenían angina antes del procedimiento. La angina basal no mostró impacto pronóstico alguno. Sin embargo, la persistencia de angina 30 días después del procedimiento se asoció con una mayor mortalidad al año.(AU)

Introduction and objectives: To evaluate the prevalence, clinical characteristics, and outcomes of patients with angina undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. Methods: A total of 1687 consecutive patients with severe aortic stenosis undergoing TAVR at our center were included and classified according to patient-reported angina symptoms prior to the TAVR procedure. Baseline, procedural and follow-up data were collected in a dedicated database. Results: A total of 497 patients (29%) had angina prior to the TAVR procedure. Patients with angina at baseline showed a worse New York Heart Association (NYHA) functional class (NYHA class> II: 69% vs 63%; P=.017), a higher rate of coronary artery disease (74% vs 56%; P <.001), and a lower rate of complete revascularization (70% vs 79%; P <.001). Angina at baseline had no impact on all-cause mortality (HR, 1.02; 95%CI, 0.71-1.48; P=.898) and cardiovascular mortality (HR, 1.2; 95%CI, 0.69-2.11; P=.517) at 1 year. However, persistent angina at 30 days post-TAVR was associated with increased all-cause mortality (HR, 4.86; 95%CI, 1.71-13.8; P=.003) and cardiovascular mortality (HR, 20.7; 95%CI, 3.50-122.6; P=.001) at 1-year follow-up. Conclusions: More than one-fourth of patients with severe aortic stenosis undergoing TAVR had angina prior to the procedure. Angina at baseline did not appear to be a sign of a more advanced valvular disease and had no prognostic impact; however, persistent angina at 30 days post-TAVR was associated with worse clinical outcomes.(AU)

Managing the challenge of a small aortic annulus in patients with severe aortic stenosis.

INTRODUCTION: Small aortic annulus (SAA) poses a challenge in the management of patients with severe aortic stenosis requiring aortic valve replacement - both surgical and transcatheter - since it has been associated with worse clinical outcomes. AREAS COVERED: This review aims to comprehensively summarize the available evidence regarding the management of aortic stenosis in patients with SAA and discuss the current controversies as well as future perspectives in this field. EXPERT OPINION: It is paramount to agree in a common definition for diagnosing and properly treating SAA patients, and for that purpose, multidetector computer tomography is essential. The results of recent trials led to the expansion of transcatheter aortic valve replacement among patients of all the surgical-risk spectrum, and the choice of treatment (transcatheter, surgical) should be based on patient comorbidities, anatomical characteristics, and patient preferences.

Is Transcatheter Aortic Valve Replacement Futile in Patients Over Ninety Years of Age?

Background: Clinical outcomes and quality of life (QoL) indices are not well described after transcatheter aortic valve replacement (TAVR) in patients aged ≥ 90 years. Methods: We conducted a retrospective cohort study of TAVR among nonagenarian patients between 2008 and 2020. The survival of TAVR patients among nonagenarians was compared to the provincial estimated survival for an age- and sex-matched general population. QoL was assessed up to 1 year postintervention, using standardized questionnaires. Results: During the study period, n = 268 patients aged ≥ 90 years were evaluated for severe aortic stenosis. TAVR was performed in n = 171 (48% female; median [IQR] Rockwood Clinical Frailty Scale score: 4 [3-4]); n = 84 underwent medical therapy; and n = 13 underwent surgical aortic valve replacement. Survival was significantly better following TAVR, compared to that after MT (adjusted hazard ratio [95% CI]: 1.99 [1.37-2.88], P < 0.001). TAVR patients demonstrated a survival advantage compared with the general population, with an estimated relative mortality of 0.86 (0.75-0.87). TAVR patients showed sustained improvements in functional status and QoL up to 1 year compared to baseline (all P < 0.05): the 6-minute walk test results improved from 192 to 252 m; the Kansas City Cardiomyopathy Questionnaire score improved from 64 to 81; the Duke Activity Status Index score improved from 13 to 16; and the health state scale result of the Euro Quality of life - 5 Dimensions improved from 63% to 74%. Conclusions: Nonagenarians undergoing TAVR experience a slightly better survival rate, compared to that of an age- and sex-matched general population, and they have significant improvements in functional status and several QoL indices following the procedure.

Introduction: Les résultats cliniques et les indices de la qualité de vie (QdV) après le remplacement valvulaire aortique par cathéter (RVAC) chez les patients ≥ 90 ans ne sont pas bien décrits. Méthodes: Nous avons réalisé une étude de cohorte rétrospective sur le RVAC chez les patients nonagénaires entre 2008 et 2020. Nous avons comparé la survie des patients nonagénaires qui avaient subi un RVAC à la survie provinciale estimée d'une population générale appariée selon l'âge et le sexe. Nous avons évalué la QdV jusqu'à 1 an après l'intervention au moyen de questionnaires standardisés. Résultats: Durant la période étudiée, nous avons inclus des patients (n =268) âgés de ≥ 90 ans et évalués pour une sténose aortique sévère. Le RVAC a été réalisé chez 171 patients (48 % de sexe féminin ; score médian [écart interquartile] à l'échelle de fragilité clinique de Rockwood [Rockwood Clinical Frailty Scale] : 4 [3-4]) ; 84 ont reçu un traitement médical (TM) ; 13 ont subi un remplacement valvulaire aortique chirurgical. La survie était significativement meilleure à la suite du RVAC, comparativement à celle des patients TM (rapport de risque ajusté [IC à 95 %] : 1,99 [1,37-2,88], P < 0,001). Par rapport à la population générale, les patients ayant subi un RVAC ont démontré un avantage sur le plan de la survie, soit une mortalité relative estimée de 0,86 (0,75-0,87). Les patients ayant subi un RVAC ont montré des améliorations continues de l'état fonctionnel et de la QdV jusqu'à 1 an par rapport au début (toutes les valeurs P < 0,05) : les résultats à l'épreuve de marche de 6 minutes sont passés de 192 à 252 m ; les scores au questionnaire Kansas City Cardiomyopathy Questionnaire (KCCQ) sont passés de 64 à 81 ; les scores au questionnaire Duke Activity Status Index (DASI) sont passés de 13 à 16 ; les résultats à l'échelle de l'état de santé de l'EQ-5D (de l'EuroQol Group) sont passés de 63 % à 74 %. Conclusions: Les nonagénaires qui subissent un RVAC ont un taux de survie légèrement meilleur à celui d'une population générale appariée selon l'âge et le sexe, et montrent des améliorations significatives de leur état fonctionnel et de plusieurs indices de la QdV à la suite de l'intervention.

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.

The Canadian WATCHMAN Registry for Percutaneous Left Atrial Appendage Closure.

Background: Access to left atrial appendage closure (LAAC) in Canada is limited, due to funding restrictions. This work aimed to assess Canadian clinical practice on patient selection, postprocedural antithrombotic therapy, and safety and/or efficacy with WATCHMAN device implantation. Methods: Seven Canadian centres implanting the WATCHMAN device participated in this prospective multicentre, observational registry. All procedures were done under general anesthesia with transesophageal echocardiography guidance. Patients were prospectively followed for 2years. The long-term stroke rate was compared with the expected rate based on the CHA2DS2-VASc score. Results: A total of 272 patients who underwent LAAC with the WATCHMAN device between December 2013 and August 2019 (mean age: 75.4 years [standard deviation {SD}: 8.75]; male, 63.2%; CHA2DS2-VASc score: 4.35 [SD: 1.64]; HAS-BLED score: 3.55 [SD: 0.94]) were included. Most patients (90.4%) had prior history of bleeding (major, 80.5%; minor, 21.7%). The WATCHMAN device was successfully implanted in 269 patients (98.9%), with a few procedure-related complications, including 5 pericardial effusions requiring drainage (1.8%), and 1 death (0.4%; 22 days post-LAAC from respiratory failure). Post-LAAC antithrombotic therapy included dual antiplatelet therapy in 70.6%, single antiplatelet therapy in 18.4%, and oral anticoagulation in 13.6%. During the follow-up period (mean: 709.7 days [SD: 467.2]), an 81.4% reduction of the ischemic stroke rate occurred, based on the expected rate from the CHA2DS2-VASc score (6.0% expected vs 1.1% observed). Device-related thrombus was detected in 1.8%. Conclusions: The majority of Canadian patients who underwent LAAC had oral anticoagulation contraindication due to prior bleeding, and most were safely treated with antiplatelet therapy post-LAAC, with a low device-related thrombus incidence. Long-term follow-up demonstrated that LAAC achieved a significant reduction in ischemic stroke rate.

Contexte: Au Canada, l'accès à la fermeture de l'appendice auriculaire gauche (FAAG) est limité en raison de restrictions quant au financement de cette intervention. Le présent rapport visait à évaluer les pratiques cliniques canadiennes sur la sélection des patients, le traitement antithrombotique après l'intervention et l'innocuité ou l'efficacité par l'implantation d'un dispositif WATCHMAN. Méthodologie: Sept centres canadiens procédant à l'implantation du dispositif WATCHMAN ont participé à ce registre observationnel, prospectif et multicentrique. Toutes les interventions ont été réalisées sous anesthésie générale avec guidage par échocardiographie transœsophagienne. Les patients ont par la suite été suivis de manière prospective pendant deux ans. Le taux d'AVC à long terme a été comparé au taux attendu, selon le score CHA2DS2-VASc. Résultats: Ont été inclus à l'étude 272 patients ayant subi une FAAG avec implantation d'un dispositif WATCHMAN entre décembre 2013 et août 2019 (âge moyen : 75,4 ans [écart-type {É.-T.} : 8,75]; hommes : 63,2 %; score CHA2DS2-VASc : 4,35 [É.-T. : 1,64]; score HAS-BLED : 3,55 [É.-T. : 0,94]). La plupart des patients (90,4 %) avaient des antécédents de saignements (majeurs : 80,5 %; mineurs : 21,7 %). Le dispositif WATCHMAN a bien été implanté chez 269 patients (98,9 %), avec quelques complications associées à l'intervention, dont cinq effusions péricardiques nécessitant un drainage (1,8 %) et un décès (0,4 %; 22 jours après la FAAG, en raison d'une insuffisance respiratoire). Le traitement antithrombotique après la FAAG comprenait une bithérapie antiplaquettaire dans 70,6 % des cas, une monothérapie antiplaquettaire dans 18,4 % des cas et une anticoagulothérapie orale dans 13,6 % des cas. Pendant la période de suivi (durée moyenne : 709,7 jours [É.-T. : 467,2]), on a noté une réduction de 81,4 % du taux d'AVC ischémique observé par rapport au taux attendu selon le score CHA2DS2-VASc (taux attendu : 6,0 %; taux observé : 1,1 %). Un thrombus associé au dispositif a été détecté dans 1,8 % des cas. Conclusions: La majorité des patients canadiens qui ont subi une FAAG présentaient des contre-indications à l'anticoagulothérapie orale en raison de leurs antécédents de saignements, et la plupart ont été traités de manière sécuritaire par des thérapies antiplaquettaires après la chirurgie, avec un faible taux d'incidence de thrombus associé au dispositif. Le suivi à long terme a montré que la FAAG permet d'obtenir une réduction importante du taux d'AVC ischémique.

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.

Percutaneous Transcatheter Edge-to-Edge Mitral Valve Repair With MitraClip System in the Era of G4.

The use of transcatheter edge-to-edge mitral valve repair (TEER) in symptomatic patients with severe mitral regurgitation (MR) has dramatically increased over the last few years. Current guidelines consider TEER as a reasonable option in symptomatic patients with primary or chronic secondary severe MR with high or prohibitive surgical risk and favorable anatomy. However, several anatomical and morphological mitral features have restricted the use of this mini-invasive technique in its early experience. The latest fourth generation (G4) of the MitraClip system has been recently introduced and includes the possibility of independent leaflet grasping and 4 different sizes. This technical update offers the possibility of selecting and combining multiple devices for complex mitral valve anatomies and challenging procedures, which helps expand the applications of TEER. The present review describes the potential advantages and the help of the MitraClip G4 devices to overcome various anatomic and morphologic issues in challenging cases with complex primary and secondary MR procedures.

Angina in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

INTRODUCTION AND OBJECTIVES: To evaluate the prevalence, clinical characteristics, and outcomes of patients with angina undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. METHODS: A total of 1687 consecutive patients with severe aortic stenosis undergoing TAVR at our center were included and classified according to patient-reported angina symptoms prior to the TAVR procedure. Baseline, procedural and follow-up data were collected in a dedicated database. RESULTS: A total of 497 patients (29%) had angina prior to the TAVR procedure. Patients with angina at baseline showed a worse New York Heart Association (NYHA) functional class (NYHA class> II: 69% vs 63%; P=.017), a higher rate of coronary artery disease (74% vs 56%; P <.001), and a lower rate of complete revascularization (70% vs 79%; P <.001). Angina at baseline had no impact on all-cause mortality (HR, 1.02; 95%CI, 0.71-1.48; P=.898) and cardiovascular mortality (HR, 1.2; 95%CI, 0.69-2.11; P=.517) at 1 year. However, persistent angina at 30 days post-TAVR was associated with increased all-cause mortality (HR, 4.86; 95%CI, 1.71-13.8; P=.003) and cardiovascular mortality (HR, 20.7; 95%CI, 3.50-122.6; P=.001) at 1-year follow-up. CONCLUSIONS: More than one-fourth of patients with severe aortic stenosis undergoing TAVR had angina prior to the procedure. Angina at baseline did not appear to be a sign of a more advanced valvular disease and had no prognostic impact; however, persistent angina at 30 days post-TAVR was associated with worse clinical outcomes.

Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria.

BACKGROUND: The Valve Academic Research Consortium (VARC)-3 definition for myocardial injury after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. OBJECTIVES: This study sought to determine the incidence, predictors, and clinical impact of periprocedural myocardial injury (PPMI) following TAVR as defined by recent VARC-3 criteria. METHODS: We included 1,394 consecutive patients who underwent TAVR with a new-generation transcatheter heart valve. High-sensitivity troponin levels were assessed at baseline and within 24 hours after the procedure. PPMI was defined according to VARC-3 criteria as an increase ≥70 times in troponin levels (vs ≥15 times according to the VARC-2 definition). Baseline, procedural, and follow-up data were prospectively collected. RESULTS: PPMI was diagnosed in 193 (14.0%) patients. Female sex and peripheral artery disease were independent predictors of PPMI (P < 0.01 for both). PPMI was associated with a higher risk of mortality at 30-day (HR: 2.69, 95% CI: 1.50-4.82; P = 0.001) and 1-year (for all-cause mortality, HR: 1.54; 95% CI: 1.04-2.27; P = 0.032; for cardiovascular mortality, HR: 3.04; 95% CI: 1.68-5.50; P < 0.001) follow-up. PPMI according to VARC-2 criteria had no impact on mortality. CONCLUSIONS: About 1 out of 10 patients undergoing TAVR in the contemporary era had PPMI as defined by recent VARC-3 criteria, and baseline factors like female sex and peripheral artery disease determined an increased risk. PPMI had a negative impact on early and late survival. Further studies on the prevention of PPMI post-TAVR and implementing measures to improve outcomes in PPMI patients are warranted.

Antithrombotic therapies in Canadian atrial fibrillation patients with concomitant coronary artery disease: Insights from the CONNECT AF + PCI-II program.

BACKGROUND: Selecting the appropriate antithrombotic regimen for patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) or have had medically managed acute coronary syndrome (ACS) remains complex. This multi-centre observational study evaluated patterns of antithrombotic therapies utilized among Canadian patients with AF post-PCI or ACS. METHODS AND RESULTS: By retrospective chart audit, 611 non-valvular AF patients [median (interquartile range) age 76 (69-83) years, CHADS2 score 2 (1-3)] who underwent PCI or had medically managed ACS between August 2018 and December 2020 were identified by 68 cardiologists across eight provinces in Canada. Overall, triple antithrombotic therapy [TAT: combined oral anticoagulation (OAC) and dual antiplatelet therapy (DAPT)] was the most common initial antithrombotic strategy, with use in 53.8 % of patients, followed by dual pathway therapy (32.7 % received OAC and a P2Y12 inhibitor, and 4.1 % received OAC and aspirin) and DAPT (9.3 %). Median duration of TAT was 30 (7, 30) days. Compared to the previous CONNECT AF + PCI-I program, there was an increased use of dual pathway therapy relative to TAT over time (P-value <.0001). DOACs (direct oral anticoagulants) represented 90.3 % of all OACs used overall, with apixaban being the most utilized (50.5 %). Proton pump inhibitors were used in 57.0 % of all patients, and 70.1 % of patients on ASA. Planned antithrombotic therapies at 1 year were: 76.2 % OAC monotherapy, 8.3 % OAC + ASA, 7.9 % OAC + P2Y12 inhibitor, 4.3 % DAPT, 1.3 % ASA alone, and <1 % triple therapy. CONCLUSION: In accordance with recent Canadian Cardiovascular Society guideline recommendations, we observed an increased use of dual pathway therapy relative to TAT over time in both AF patients post-PCI (elective and emergent) and in those with medically managed ACS. Additionally, DOACs have become the prevailing form of anticoagulation across all antithrombotic regimens. Our findings suggest that Canadian physicians are integrating evidence-based approaches to optimally manage the bleeding and thrombotic risks of AF patients post-PCI and/or ACS.

Optimal Degree of Balloon-Expandable Transcatheter Valve Oversizing in Patients With Borderline Aortic Annulus Measurements: Insights From a Multicenter Real-World Experience.

BACKGROUND: The potential benefit of using larger or smaller transcatheter heart valves (THV) in patients with borderline aortic annulus measurement (BAM) remains uncertain. The objective of this study was to evaluate the clinical outcomes associated with the selection of larger or smaller THV in the context of BAM. METHODS: This was a multicenter observational study including patients who underwent transcatheter aortic valve replacement with the SAPIEN 3 or SAPIEN 3 Ultra-valve systems (Edwards Lifesciences, Irvine, CA) from April 2014 to June 2021. BAM was defined according to the manufacturer sizing chart and included the following annulus areas: 314 to 346, 400 to 430, 500 to 546 mm2. A 1:1 propensity score matching was used to compare outcomes of patients with larger or smaller THV. RESULTS: From a total of 2467 patients, BAM was identified in 852 patients (34.5%). A larger and smaller THV was selected in 338 (39.7%) and 514 patients (60.3%) patients, respectively. The choice of a larger THV was associated (before and after propensity matching) with a higher risk of new-onset left bundle branch block (HR, 2.25 [95% CI, 1.39-3.65; P=0.001) and permanent pacemaker implantation (HR, 1.86 [95% CI, 1.11-3.09]; P=0.016) without any impact on gradients or the risk of moderate or severe paravalvular regurgitation at discharge (HR, 0.78 [95% CI, 0.41-1.45]; P=0.427). The risk of periprocedural complications such as aortic rupture and tamponade was low (<1%) and similar between groups. CONCLUSIONS: In patient with BAM, selecting a larger SAPIEN 3/Ultra THV increased the risk of conduction disturbances without any benefit on valve hemodynamics and clinical outcomes.

Syncope in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: No data exist on the clinical and prognostic significance of syncope in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. METHODS: A total of 1705 consecutive patients with severe aortic stenosis undergoing TAVR in a tertiary university centre between 2007 and 2021 were included and classified according to the presence of syncope before the TAVR procedure. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database. RESULTS: A total of 115 patients (7%) presented with syncope before the TAVR procedure. Of these, 15 patients (13%) showed arrhythmic episodes as the probable cause of the syncope, and all of them had pacemakers implanted at a median of 13 (6 to 53) days before the TAVR procedure. Patients with syncope were older (82 ± 8 years vs 80 ± 8 years, P = 0.001) and had a higher rate of pacemaker implantation before the TAVR procedure (27% vs 14%, P < 0.001), with no differences between groups regarding the severity of aortic stenosis (transvalvular gradient, valve area). There were no differences between groups in 30-day (adjusted hazard ratio [HR], 1.28; 95% confidence interval [CI], 0.46-3.60) and 1-year (adjusted HR, 0.71; 95% CI, 0.0.35-1.45) mortality following TAVR. CONCLUSIONS: Syncope was not associated with a more advanced valvular disease and had no significant prognostic impact on patients undergoing TAVR. However, arrhythmias and conduction-system disturbances were more common in patients with previous syncope and might play a relevant role in the pathogenesis of syncope in patients with aortic stenosis.

Contemporary incidence and predictors of left ventricular thrombus in patients with anterior acute myocardial infarction.

BACKGROUND: The incidence of left ventricular thrombus (LVT) after anterior acute myocardial infarction (AMI) has not been well established in the era of primary percutaneous coronary intervention (pPCI) and potent dual antiplatelet therapy. The objective of this study is to establish the contemporary incidence of LVT in this population, to identify their risk factors, and to examine their association with clinical outcomes. METHODS: A multicenter retrospective cohort study including AMI patients with new-onset antero-apical wall motion abnormalities treated with pPCI between 2009 and 2017 was conducted. The primary outcome was LVT during the index hospitalization. Predictors of LVT were identified using multivariate logistic regression. Net adverse clinical events (NACE), a composite of mortality, myocardial infarction, stroke or transient ischemic attack, systemic thromboembolism or BARC type 3 or 5 bleeding at 6 months were compared between the LVT and no LVT groups. RESULTS: Among the 2136 patients included, 83 (3.9%) patients developed a LVT during index hospitalization. A lower left ventricular ejection fraction (LVEF) [adjusted odds ratio (aOR) 0.97; 95% confidence intervals (CI) 0.94-0.99] and the degree of worse anterior WMA (aOR 4.34; 95% CI 2.24-8.40) were independent predictors of LVT. A NACE occurred in 5 (5.72 per 100 patient-year) patients in the LVT group and in 127 (6.71 per 100 patient-year) patients in the no LVT group at 6 months [adjusted hazard ratio (aHR): 0.87; 95% CI 0.35-2.14]. CONCLUSIONS: The risk of LVT after anterior AMI with new-onset wall motion abnormalities is low, but this complication remains present in the contemporary era of timely pPCI and potent dual antiplatelet therapy .