Pre-Existing Left Bundle Branch Block and Clinical Outcomes After Transcatheter Aortic Valve Replacement.

Background: Few reports on pre-existing left bundle branch block (LBBB) in patients undergoing transcatheter aortic valve replacement (TAVR) are currently available. Further, no present studies compare patients with new onset LBBB with those with pre-existing LBBB. Objectives: This study aimed to investigate the association between pre-existing or new onset LBBB and clinical outcomes after TAVR. Methods: Using data from the Japanese multicenter registry, 5,996 patients who underwent TAVR between October 2013 and December 2019 were included. Patients were classified into 3 groups: no LBBB, pre-existing LBBB, and new onset LBBB. The 2-year clinical outcomes were compared between 3 groups using Cox proportional hazards models and propensity score analysis to adjust the differences in baseline characteristics. Results: Of 5,996 patients who underwent TAVR, 280 (4.6%) had pre-existing LBBB, while 1,658 (27.6%) experienced new onset LBBB. Compared with the no LBBB group, multivariable Cox regression analysis showed that pre-existing LBBB was associated not only with a higher 2-year all-cause (adjusted HR: 1.39; 95% CI: 1.06-1.82; P = 0.015) and cardiovascular (adjusted HR: 1.60; 95% CI: 1.04-2.48; P = 0.031) mortality, but also with higher all-cause (adjusted HR: 1.43, 95% CI: 1.07-1.91; P = 0.016) and cardiovascular (adjusted HR: 1.81, 95% CI:1.12-2.93; P = 0.014) mortality than the new onset LBBB group. Heart failure was the most common cause of cardiovascular death, with more heart failure deaths in the pre-existing LBBB group. Conclusions: Pre-existing LBBB was independently associated with poor clinical outcomes, reflecting an increased risk of cardiovascular mortality after TAVR. Patients with pre-existing LBBB should be carefully monitored.

Benchmarking System Monitoring on Quality Improvement in Percutaneous Coronary Intervention: A Nationwide Registry in Japan.

Background: Quality indicators (QIs) have been developed to improve and standardize care quality in percutaneous coronary intervention (PCI). In Japan, consecutive PCI procedures are registered in a nationwide database (the Japanese Percutaneous Coronary Intervention registry), which introduces a benchmarking system for comparing individual institutional performance against the national average. Objectives: The aim of this study was to assess the impact of the benchmarking system implementation on QI improvement at the hospital level. Methods: A total of 734,264 PCIs were conducted at 1,194 institutions between January 2019 and December 2021. In January 2018, a web-based benchmarking system encompassing 7 QIs for PCI at the institutional level, including door-to-balloon time and rate of transradial intervention, was introduced. The process by which institutions tracked their QIs was centrally monitored. Results: During the 3-year study period, the benchmarking system was reviewed at least once at 742 institutions (62.1%) (median 4 times; Q1-Q3: 2-7 times). The institutions that reviewed their records had higher PCI volumes. Among these institutions, although door-to-balloon time was not directly associated, the proportion of transradial intervention increased by 2.3% in the system review group during the initial year compared with 0.7% in their counterparts. However, in the subsequent year, the association between system reviews and QI improvement was attenuated. Conclusions: The implementation of a benchmarking system, reviewed by participating institutions in Japan, was partially associated with improved QIs during the first year; however, this improvement was attenuated in the subsequent year, highlighting the need for further efforts to develop effective and sustainable interventions to enhance care quality in PCI.

Right Ventricular Dysfunction in Patients With Concomitant Tricuspid Regurgitation Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: This study investigated the impact and predictive factors of concomitant significant tricuspid regurgitation (TR) and evaluated the roles of right ventricle (RV) function and the etiology of TR in the clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI).Methods and Results: We assessed grading of TR severity, TR etiology, and RV function in pre- and post-TAVI transthoracic echocardiograms for 678 patients at Keio University School of Medicine. TR etiology was divided into 3 groups: primary TR, ventricular functional TR (FTR), and atrial FTR. The primary outcomes were all-cause and cardiovascular death. At baseline, moderate or greater TR was found in 55 (8%) patients and, after adjustment for comorbidities, was associated with increased all-cause death (hazard ratio [HR] 2.11; 95% confidence interval [CI] 1.19-3.77; P=0.011) and cardiovascular death (HR 2.29; 95% CI 1.06-4.99; P=0.036). RV dysfunction (RVD) also remained an independent predictor of cardiovascular death (HR 2.06; 95% CI 1.03-4.14; P=0.042). Among the TR etiology groups, patients with ventricular FTR had the lowest survival rate (P<0.001). Patients with persistent RVD after TAVI had a higher risk of cardiovascular death than those with a normal or recovered RV function (P<0.001). CONCLUSIONS: The etiology of TR and RV function play an important role in predicting outcomes in concomitant TR patients undergoing TAVI.

Changing Trends in Mechanical Circulatory Support Use and Outcomes in Patients Undergoing Percutaneous Coronary Interventions for Acute Coronary Syndrome Complicated With Cardiogenic Shock: Insights From a Nationwide Registry in Japan.

BACKGROUND: Temporal trends in the management of acute coronary syndrome complicated with cardiogenic shock after the revision of guideline recommendations for intra-aortic balloon pump (IABP) use and the approval of the Impella require further investigation, because their impact remains uncertain. METHODS AND RESULTS: Using the Japanese Percutaneous Coronary Intervention (J-PCI) registry database from 2019 to 2021, we identified 12 171 patients undergoing percutaneous coronary intervention for acute coronary syndrome complicated with cardiogenic shock under mechanical circulatory support. The patients were stratified into 3 groups: (1) IABP alone, (2) Impella, and (3) venoarterial extracorporeal membrane oxygenation (VA-ECMO); the VA-ECMO group was further stratified into (3a) VA-ECMO alone, (3b) VA-ECMO in combination with IABP, and (3c) VA-ECMO in combination with Impella. The quarterly prevalence and outcomes were reported. The use of IABP alone decreased significantly from 63.5% in the first quarter of 2019 to 58.3% in the fourth quarter of 2021 (P for trend=0.01). Among 4245 patients requiring VA-ECMO, the use of VA-ECMO in combination with IABP decreased significantly from 78.7% to 67.3%, whereas the use of VA-ECMO in combination with Impella increased significantly from 4.2% to 17.0% (P for trend <0.001 for both). After adjusting for the confounders, the risk difference in the fourth quarter of 2021 relative to the first quarter of 2019 for in-hospital mortality was not significant (adjusted odds ratio, 0.84 [95% CI, 0.69-1.01]). CONCLUSIONS: Our study revealed substantial changes in the use of different mechanical circulatory support modalities in acute coronary syndrome complicated with cardiogenic shock, but they did not significantly improve the outcomes.

Rationale and design of Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial.

BACKGROUND: Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. STUDY DESIGN AND OBJECTIVES: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. CONCLUSION: The NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.

Stroke Prevention With Left Atrial Appendage Closure in Patients With Atrial Fibrillation and Prior Intracranial Hemorrhage.

Background: Oral anticoagulation (OAC) is deemed a relative contraindication after intracranial hemorrhage (ICH) if the cause cannot be eliminated and the risk of recurrence is high. That leaves atrial fibrillation (AF) patients at high risk of thromboembolic events. Endovascular left atrial appendage closure (LAAC) can be an alternative to OAC for patients requiring stroke prevention. Methods: We performed a retrospective single-centre analysis of 138 consecutive ICH patients with nonvalvular AF and high stroke risk who underwent LAAC between 2010 and 2022 at Vancouver General Hospital. We report the baseline characteristics, procedural results, and follow-up data, comparing the observed stroke/transient ischemic attack (TIA) rate with the predicted event rate based on their CHA2DS2-VASc scores. Results: The average age was 76.1 ± 8.5 years; the mean CHA2DS2-VASc score was 4.4 ± 1.5; and the mean HAS-BLED score was 3.7 ± 0.9. The procedural success rate was 98.6%, and the complication rate was 3.6% with no periprocedural death, stroke, or TIA. The antithrombotic regimen post-LAAC consisted of short-term dual antiplatelet therapy (1-6 months) followed by aspirin alone for a minimum of 6 months in 86.2%. At mean follow-up of 14.7 ± 13.7 months, 9 deaths (6.5%, 7 cardiovascular, 2 noncardiovascular), 2 strokes (1.4%), and 1 TIA (0.7%) had occurred. The annualized observed stroke/TIA rate was 1.8%, which was lower than the adjusted predicted stroke rate of 7.0% (95% confidence interval: 4.8%-9.2%). Two patients (1.5%) suffered another ICH (both on aspirin monotherapy). One device-related thrombus (0.7%) was confirmed and treated with OAC without sequelae. Conclusion: Endovascular LAAC is a feasible alternative to OAC for stroke prevention in patients with nonvalvular AF and prior ICH.

Contexte: L'anticoagulation par voie orale (ACO) est considérée comme une contre-indication relative après une hémorragie intracrânienne (HIC) si la cause ne peut être éliminée et si le risque de récidive est élevé. Les patients souffrant de fibrillation auriculaire (FA) sont donc exposés à un risque élevé d'événements thromboemboliques. La technique de fermeture percutanée de l'appendice auriculaire gauche (AAG) peut être une solution de rechange aux anticoagulants oraux en prévention des accidents vasculaires cérébraux (AVC). Méthodologie: Nous avons réalisé une analyse rétrospective unicentrique auprès de 138 patients consécutifs qui étaient atteints d'une HIC accompagnée d'une FA non valvulaire ainsi que d'un risque élevé d'AVC et qui ont subi une fermeture de l'AAG entre 2010 et 2022 à l'hôpital général de Vancouver. Nous présentons ici les caractéristiques initiales, les résultats de l'intervention et les données de suivi, en comparant le taux d'AVC/AIT (accident ischémique transitoire) observé avec le taux prédit d'événements sur la base de leurs scores CHA2DS2-VASc. Résultats: L'âge moyen était de 76,1 ± 8,5 ans. Le score CHA2DS2-VASc moyen était de 4,4 ± 1,5, et le score HAS-BLED moyen de 3,7 ± 0,9. Le taux de réussite de l'intervention a été de 98,6 % et le taux de complications de 3,6 %, sans décès périopératoires, ni AVC ou AIT. Le traitement antithrombotique après la fermeture de l'AAG consistait en une bithérapie antiplaquettaire de courte durée (de 1 à 6 mois), suivie de la prise d'aspirine seule pendant au moins 6 mois dans 86,2 % des cas. Après un suivi moyen de 14,7 ± 13,7 mois, 9 décès (6,5 %, 7 d'origine cardiovasculaire et 2 d'origine non cardiovasculaire), 2 AVC (1,4 %) et 1 AIT (0,7 %) sont survenus. Le taux annualisé d'AVC/AIT observé était de 1,8 %, ce qui est inférieur au taux prédit d'AVC après ajustement, soit 7,0 % (intervalle de confiance à 95 % : 4,8 % à 9,2 %). Deux patients (1,5 %) ont souffert d'une autre HIC (tous deux sous aspirine en monothérapie). Un thrombus lié au dispositif (0,7 %) a été confirmé et traité par anticoagulathérapie orale sans séquelles. Conclusion: La technique de fermeture de l'AAG représente une solution de rechange à l'anticoagulation par voie orale dans la prévention des AVC chez les patients souffrant de FA non valvulaire et ayant déjà subi une HIC.

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.

Impact of hypoalbuminemia on in-hospital mortality in patients with takotsubo syndrome: A multicenter registry of the Tokyo Cardiovascular Care Unit Network.

BACKGROUND: Hypoalbuminemia is common in critically ill patients and is associated with poor outcomes. However, the relationship between serum albumin levels and clinical outcomes in patients with takotsubo syndrome remains unclear. We examined the impact of hypoalbuminemia on in-hospital mortality in patients with takotsubo syndrome. METHODS: Using the multicenter registry of the Tokyo Cardiovascular Care Unit Network between January 2017 and December 2020, we identified 631 eligible patients with takotsubo syndrome (median age, 78 years; male proportion, 22 %) and documented serum albumin levels at admission, which were used to allocate patients to hypoalbuminemia (serum albumin <3.5 g/dL) or normal albumin (serum albumin ≥3.5 g/dL) groups. Patient characteristics and in-hospital mortality were compared between the groups. RESULTS: Hypoalbuminemia was detected in 200 (32 %) patients at admission. The hypoalbuminemia group was older and had a higher proportion of men and preceding physical triggers than the normal albumin group. In-hospital all-cause mortality was greater in the hypoalbuminemia group than in the normal albumin group (9.5 % vs. 1.9 %, p < 0.001). Both cardiac (3.0 % vs. 0.5 %, p = 0.015) and non-cardiac (6.5 % vs. 1.4 %, p = 0.002) mortality was greater in the hypoalbuminemia group. In multivariable logistic regression analysis, hypoalbuminemia was independently associated with increased in-hospital mortality, even after adjusting for confounders, including age, sex, and triggering events (odds ratio, 3.23; 95 % confidence interval, 1.31-7.95; p = 0.011). CONCLUSIONS: In patients with takotsubo syndrome, hypoalbuminemia is a common comorbidity and is associated with a substantial risk of in-hospital death. Close monitoring and comprehensive critical care are required in these patients.

Volume-outcome relationship in complication-related mortality after percutaneous coronary interventions: an analysis on the failure-to-rescue rate in the Japanese Nationwide Registry.

In-hospital mortality following percutaneous coronary intervention (PCI) varies across institutions with different annual PCI volumes. The failure to rescue (FTR) rate, defined as the mortality rate following PCI-related complications, may account for the volume-outcome relationship. The Japanese Nationwide PCI Registry, a consecutive, nationally mandated registry between 2019 and 2020, was queried. The FTR rate is defined as 'the number of patients who died following PCI-related complications' divided by 'the number of patients who experienced at least one PCI-related complication.' Multivariate analysis was used to calculate the risk-adjusted odds ratio (aOR) of the FTR rates among hospitals stratified into tertiles as low (≤ 236/year), medium (237-405/year), and high (≥ 406/year). A total of 465,716 PCIs and 1007 institutions were included. A volume-outcome relationship was observed for in-hospital mortality, and the medium-volume (aOR 0.90, 95% confidence interval [CI] 0.85-0.96), as well as high-volume (aOR 0.84, 95% CI 0.79-0.89) hospitals, had significantly lower in-hospital mortality than low-volume hospitals. Complication rates were lower at high-volume centers (1.9%, 2.2%, and 2.6% for high-, medium-, and low-volume centers, respectively; p < 0.001). The overall FTR rate was 19.0%. The FTR rates for the low-, medium-, and high-volume hospitals were 19.3%, 17.7%, and 20.6%, respectively. The medium-volume hospitals had a lower FTR rate (aOR 0.82, 95% [CI] 0.68-0.99), whereas the FTR rate was similar at the high-volume hospitals compared with that of the low-volume hospitals (aOR 1.02, 95% CI 0.83-1.26). In-hospital mortality was low after PCI in high-volume hospitals. However, the FTR rate in high-volume hospitals was not necessarily lower than that in low-volume hospitals. The FTR rate did not account for the volume-outcome relationship in PCI.

Appropriate Use Criteria for the Management of Aortic Stenosis: Insight From the Japanese Expert Panel.

Background: The indication for transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS) significantly varies among physicians and institutions. Objectives: This study aims to develop a set of appropriate use criteria for AS management to assist physicians in decision-making. Methods: The RAND-modified Delphi panel method was used. A total of >250 common clinical scenarios were identified in terms of whether to perform the intervention for AS and the mode of intervention (surgical aortic valve replacement vs TAVR). Eleven nationally representative expert panelists independently rated the clinical scenario appropriateness on a scale of 1-9, as "appropriate" (7-9), "may be appropriate" (4-6), or "rarely appropriate" (1-3); the median score of the 11 experts was then assigned to an appropriate-use category. Results: The panel identified 3 factors that were associated with a rarely appropriate rating in terms of performing the intervention: 1) limited life expectancy; 2) frailty; and 3) pseudo-severe AS on dobutamine stress echocardiography. Clinical scenarios that were deemed rarely appropriate for TAVR were also identified: 1) patients with low surgical risk and high TAVR procedural risk; 2) patients with coexistent severe primary mitral regurgitation or rheumatic mitral stenosis; and 3) bicuspid aortic valve that was not suitable for TAVR. Importantly, any TAVRs for patients who were older than 75 years of age were not rated as rarely appropriate. Conclusions: These appropriate use criteria provide a practical guide for physicians regarding clinical situations commonly encountered in daily practice and elucidates scenarios deemed rarely appropriate that are clinical challenges for TAVR.

Which congestion presentation pattern on the physical findings is associated with future adverse events? A cluster analysis in the multicenter acute heart failure registry.

BACKGROUND: Clinical congestion is the most frequent reason for hospital admission in patients with acute heart failure (AHF). However, few studies have investigated the patterns and prognostic implication of the physical congestion using unbiased and robust statistical methods. METHODS: A hierarchical agglomerative clustering analysis was performed in the multicenter Japanese AHF registry (N = 3151) with the distance calculated by Jaccard's distance for jugular vein distention (JVD), leg edema, S3, crackles, and orthopnea. The primary outcome was a composite of cardiac death and heart failure readmission within 1-year. RESULTS: At the time of admission, the median number of prevalent congestive signs was 2. We identified three phenogroups: 'no physical congestions' (N = 251); 'congestion without JVD' (N = 1415); and 'congestion with JVD' (N = 1495). Patients in 'no physical congestion' were the youngest (median 75 [62, 83] years) with the lowest systolic blood pressure (122 [106, 142] mmHg). Patients in 'congestion without JVD', and 'congestion with JVD' were similar in terms of age (77 [67, 84] vs. 78 [69, 84] years) and systolic blood pressure (138 [118, 160] vs. 137 [118, 158] mmHg). While 30-day mortality was similar (4.0%, 3.7%, and 4.3% in 'no physical congestion,' 'congestion without JVD,' and 'congestion with JVD', respectively), the patients in 'congestion with JVD' were at the highest risk for the primary outcome (adjusted hazard ratio 1.79, 95% CI 1.26-2.55 when 'no physical congestion' was a reference). CONCLUSIONS: Our clustering analysis demonstrated that congestion signs, particularly JVD, allowed identification of AHF phenogroups with distinct clinical characteristics and long-term outcomes.

Association between institutional volume of transcatheter mitral valve repair and readmission rates: A report from the Nationwide Readmission Database.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) of the mitral valve has become an established therapy for certain patients with mitral regurgitation. However, little is known about the association between institutional volume variations and long-term outcomes using a large-scale database. Our study aimed to describe the institutional variations of TEER and also investigate its association with 180-day readmission rates. METHODS: We conducted a retrospective cohort study of TEER performed in the US from the 2019 Nationwide Readmission Database. We divided the patients according to the tertiles based on volume of TEER (Q1 [lowest]-Q3 [highest]) and evaluated the association with 180-day readmission rates. RESULTS: A total of 4922 patients (mean age 76.8 ± 10.4 years, and 54.5% male) who underwent TEER at 250 institutions were included in the analyses. There was substantial variation in the number of TEER performed annually across institutions (median 25.0 [11.6-52.5] cases). Readmission within 6-months following TEER was 37.0%, mainly due to heart failure. Higher institutional volume was associated with a reduced incidence of 180-day readmissions (HR of Q3 0.68 95%CI 0.50-0.93, vs Q1; p = 0.016). This association was more prominent in non-elective cases (HR of Q3 0.50 95%CI 0.31-0.81, vs Q1; p = 0.005). CONCLUSIONS: Using a nationally representative contemporary database, our study found substantial institutional variation in volume of TEER cases. Higher institutional volume was associated with a decreased risk of 180-day readmission rate, particularly in non-elective cases. Our study suggests the importance of highly skilled heart teams when treating patients who need urgent transcatheter intervention for mitral regurgitation.

Standard modifiable cardiovascular risk factors in patients with acute coronary syndrome: A report from multicenter percutaneous coronary intervention registry.

BACKGROUND: High mortality in patients with acute coronary syndrome (ACS) without standard modifiable cardiovascular risk factors [SMuRFs (e.g. diabetes, hypertension, smoking, and dyslipidemia)] has been reported. However, details regarding their acute presentation and reasons for the excess risk remain unclear. METHOD: Patient-level data were extracted from a multicenter procedure-based registry (KiCS-PCI). We analyzed consecutive patients with ACS who underwent de novo percutaneous coronary intervention (PCI) between 2009 and 2020. The primary outcome of interest was the in-hospital mortality. RESULTS: Among the 10,523 patients with ACS, 7775 met the inclusion criteria. Patients without SMuRFs who underwent PCI [n = 529 (6.8 %)] were older [median 71 (IQR: 63-79) vs. 68 (59-76) years, p < 0.001] and more often presented with cardiogenic shock or cardiopulmonary arrest (14.6 % vs. 8.6 %, p < 0.001; 12.7 % vs. 5.3 %, p < 0.001, respectively). In patients with ST-elevation myocardial infarction (STEMI), median door-to-balloon time was significantly longer in SMuRF-less patients (90 min vs 82 min). In-hospital death was significantly higher in SMuRF-less patients [10.2 % vs. 4.1 %, p < 0.001, adjusted odds ratio, 1.81 (95%CI, 1.26-2.59); p = 0.001], whereas the rate of procedural complications showed no significant difference. When stratified by the ACS presentation pattern, the findings were consistent, although the association between SMuRF-less and the increased risk of in-hospital mortality was not statistically significant in patients with non-ST-elevation- (NSTE)-ACS. CONCLUSIONS: SMuRF-less ACS patients frequently presented with cardiopulmonary arrest and/or cardiogenic shock, leading to high in-hospital mortality. When stratified by the ACS presentation pattern, the association of SMuRF-less and the increased risk of mortality was more prominent in STEMI patients and it was not statistically significant in NSTE-ACS patients. Almost half of these patients had amendable left main trunk or left anterior descending artery disease and treating clinicians should be aware of this paradox to avoid the delay in treatment.

Volume-Outcome Relations of Percutaneous Coronary Intervention in Patients Presenting With Acute Myocardial Infarction (from the J-PCI Registry).

A lower institutional primary percutaneous coronary intervention (PCI) volume is associated with a higher risk of postprocedural poor outcomes, particularly in urgent or emergent settings (e.g., PCI for acute myocardial infarction [MI]). However, the individual prognostic impact of PCI volume stratified by indication and the relative ratio remains unclear. Using the Japanese nationwide PCI database, we investigated 450,607 patients from 937 institutions who underwent either primary PCI for acute MI or elective PCI. The primary end point was the observed/predicted in-hospital mortality ratio. The predicted mortality per patient was calculated using the baseline variables and averaged for each institution. The relation between the annual primary, elective, and total PCI volumes and institutional in-hospital mortality after acute MI was evaluated. The association between the primary-to-total PCI volume per hospital and mortality was also investigated. Of the 450,607 patients, 117,430 (26.1%) underwent primary PCI for acute MI, of whom 7,047 (6.0%) died during hospitalization. The median total PCI volume and primary-to-total PCI volume ratio were 198 (interquartile range 115 to 311) and 0.27 (0.20 to 0.36). Overall, the observed in-hospital mortality and observed/predicted mortality ratio in patients with acute MI were higher in institutions with lower primary, elective, and total PCI volumes. The observed/predicted mortality ratio was also higher in institutions with lower primary-to-total PCI volume ratios, even in high-PCI volume hospitals. In conclusion, in this nationwide registry-based analysis, lower institutional PCI volumes, regardless of setting, were associated with higher in-hospital mortality after acute MI. The primary-to-total PCI volume ratio provided independent prognostic information.

Characteristics and outcomes of patients with no standard modifiable risk factors undergoing primary revascularization for acute myocardial infarction: Insights from the nationwide Japanese percutaneous coronary intervention registry.

BACKGROUND: Identification of and therapeutic approaches to standard modifiable risk factors (SMuRFs), including hypertension, diabetes, dyslipidemia, and smoking, have led to improved survival of patients at risk for coronary events. However, recent studies have indicated that a significant proportion of patients with acute myocardial infarction (AMI) have no SMuRFs. We aimed to assess in-hospital outcomes and the prevalence of these patients using the Japanese nationwide percutaneous coronary intervention (J-PCI) registry. METHODS: The J-PCI is a procedure-based registration program in Japan. A total of 115,437 PCI procedures were performed on patients with AMI between January 2019 and December 2020. The participants were divided into 2 groups: those with at least 1 SMuRF and those without any SMuRFs. The primary outcome was in-hospital mortality. RESULTS: Of the 115,437 patients with AMI, 1,777 (1.6%) had no SMuRFs. Patients without SMuRFs were older; more likely to have left main disease; and more likely to present with heart failure, cardiogenic shock, and cardiac arrest than those with SMuRFs, resulting in higher rates of mechanical circulatory support use and impaired post-PCI coronary blood flow. In-hospital mortality was significantly higher in patients without SMuRFs than in those with SMuRFs (18.3% vs 5.3%, P < .001), irrespective of the presence or absence of ST-segment elevation. CONCLUSIONS: In Japan, where annual health checks are mandated under universal health care coverage, the vast majority of patients with AMI undergoing PCI have SMuRFs. However, although small in number, patients without SMuRFs are more likely to present with life-threatening conditions and have worse in-hospital survival.

No Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

BACKGROUND: Several trials demonstrated that aspirin monotherapy compared with aspirin plus clopidogrel is associated with a lower incidence of bleeding without an increased risk of ischemic events in patients after transcatheter aortic valve replacement (TAVR); however, there remains a paucity of data to prove the necessity of even aspirin monotherapy. OBJECTIVES: This study aimed to compare clinical outcomes and valve performance of the 3 different antithrombotic strategies post-TAVR from the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) registry. METHODS: Patients who received anticoagulation or had procedural complications were excluded. The remaining patients were classified into 3 groups according to the antithrombotic regimen at discharge: 1) nonantithrombotic therapy (None); 2) single-antiplatelet therapy (SAPT); and 3) dual-antiplatelet therapy (DAPT). The primary outcome was the incidence of net adverse clinical events (NACEs) (ie, cardiovascular death, stroke, myocardial infarction, and life-threatening or major bleeding). RESULTS: Overall, 3,575 TAVR patients were included (None, 293; SAPT, 1,354; DAPT, 1,928). The median follow-up period was 841 days (IQR: 597-1,340 days). The incidence of NACEs did not differ between the groups (None vs SAPT: adjusted HR [aHR]: 1.18; P = 0.45; None vs DAPT: aHR: 1.09; P = 0.67). There was a lower incidence of all bleeding in patients with no antithrombotics (None vs SAPT: aHR: 0.63; P = 0.12; None vs DAPT: aHR: 0.51; P = 0.04). The valve performance was similar among the groups. Leaflet thrombosis was detected in 8.5% of the nonantithrombotic group. CONCLUSIONS: Compared with SAPT/DAPT, the nonantithrombotic strategy was not associated with an increased risk of NACEs and potentially reduced the risk of bleeding events. The nonantithrombotic strategy may be an acceptable alternative to SAPT/DAPT in selected patients with TAVR.

Time Trend in Incidence of Sudden Cardiac Death After Percutaneous Coronary Intervention from 2009 to 2017 (from the Japanese Multicenter Registry).

The advances in the integrated management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) have reduced subsequent cardiovascular events. Nonetheless, sudden cardiac death (SCD) remains a major concern. Therefore, we aimed to investigate the time trend in SCD incidence after PCI and to identify the clinical factors contributing to SCD. From a prospective, multicenter cohort registry in Japan, 8,723 consecutive patients with coronary artery disease undergoing PCI between 2009 and 2017 were included. We evaluated the SCD incidence 2 years after PCI; all death events were adjudicated, and SCD was defined as unexpected death without a noncardiovascular cause in a previously stable patient within 24 hours from the onset. The Fine and Gray method was used to identify the factors associated with SCD. Overall, the mean age of the patients was 68.3 ± 11.3 years, and 1,173 patients (13.4%) had heart failure (HF). During the study period, the use of second-generation drug-eluting stents increased. The 2-year cumulative incidence of all-cause mortality and SCD was 4.29% and 0.45%, respectively. All-cause mortality remained stable during the study period (p for trend = 0.98), whereas the crude incidence of SCD tended to decrease over the study period (p for trend = 0.052). HF was the strongest predictor associated with the risk of SCD (crude incidence [vs non-HF] 2.13% vs 0.19%; p <0.001). In conclusion, the incidence of SCD after PCI decreased over the last decade, albeit the high incidence of SCD among patients with HF remains concerning.

Comparing the Classification of Percutaneous Coronary Interventions Using the 2012 and 2017 Appropriate Use Criteria: Insights From 245,196 Patients in the NCDR CathPCI Registry.

BACKGROUND: Appropriate use criteria (AUC) have been developed to promote the rational use of percutaneous coronary intervention (PCI) among clinicians and to provide benchmarking feedback to hospitals. The original AUC were published in 2012 and subsequently updated in 2017 to reflect emerging, contemporary evidence however the degree to which the updated guidance re-classifies PCI appropriateness is unknown. METHODS: Elective PCI cases from March 1, 2018 until June 30, 2021 were identified from within the NCDR CathPCI database. PCI cases were classified as 'appropriate,' 'uncertain' or 'inappropriate' under 2012 AUC and 'appropriate,' 'may be appropriate' or 'rarely appropriate' under 2017 AUC; those with missing data elements were termed 'not mappable.' Groups that 'remained appropriate' (appropriate in both 2012 and 2017), 'became non-appropriate' ('appropriate' in 2012 but became either 'may be appropriate' or 'rarely appropriate in 2017) and 'became appropriate' ('appropriate' in 2017 but were 'uncertain' or 'inappropriate' in 2012) were descriptively compared. Concordance was assessed by calculation of Cohen's Kappa. RESULTS: A total of 245,196 patients underwent elective PCI across 1669 centers. By 2012 AUC, 44% were classified 'appropriate,' 28% were 'uncertain' and 16% were 'inappropriate' compared with 2017 AUC which considered 34% 'appropriate', 56% may be 'appropriate' and 4% 'rarely appropriate'. Overall fair agreement was observed with a Kappa statistic of 0.40 (95%CI 0.396-0.403). Compared with PCI that 'remained appropriate' under the 2017 AUC, PCI that 'became non-appropriate' in 2017 were more likely to be asymptomatic, less likely to be on anti-anginals and less likely to have complex lesions. Compared with PCI that 'became non-appropriate', PCI that 'became appropriate' had a higher proportion of atypical and non-anginal symptoms and were less likely to have had positive functional tests. Procedural related outcomes were similar across all groups. A total of 29 429 PCI (12.0%) were not mappable by 2012 AUC while 16 077 (6.6%) were not mappable by 2017 AUC. CONCLUSIONS: In this contemporary analysis of patients undergoing PCI in the United States, only fair agreement between the 2012 and updated 2017 AUC was observed. While some of this reflects the intention of the updated guidance, the large proportion that were considered 'maybe appropriate' or who 'became non-appropriate' reflect the difficulties of documenting and implementing contemporary AUC guidance.

Antithrombotic therapy after transcatheter aortic valve replacement.

Aortic stenosis is a major valvular disease, which affects prognosis, and its prevalence is increasing due to an aging population. Transcatheter aortic valve replacement (TAVR) is a well-established therapy for symptomatic severe aortic stenosis across the entire risk spectrum, and the number of patients who undergo TAVR is increasing worldwide. Generally, ischemic and bleeding events after TAVR are not rare and can be devastating. Thus, antithrombotic therapy is recommended to prevent thromboembolic events after TAVR. Recently, a lot of randomized control trials have been published on antithrombotic therapy following TAVR, and the situation regarding the optimal antithrombotic regiment following TAVR is dramatically changing. This report reviews the current status and remaining issues in the field of optimal antithrombotic therapy following TAVR and leaflet thrombosis.