Left Atrial Appendage Closure: Therapy Overview and Future Perspective.

The left atrial appendage (LAA) has gained increasing attention in the field of cardiology as a potential site for intervention in patients with atrial fibrillation (AF) and an elevated risk of thromboembolic events. Left atrial appendage occlusion (LAAO) has emerged as a promising therapeutic strategy to mitigate the risk of stroke and systemic embolism, especially in individuals who are unsuitable candidates for long-term anticoagulation therapy. This review aims to provide a comprehensive analysis of the current state of LAAO, encompassing its anatomic considerations, procedural techniques, clinical outcomes, and future directions.

Trends in percutaneous left atrial appendage occlusion and 1-year mortality 2013-2021: A nationwide observational study.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) is increasingly used for stroke prevention in patients with atrial fibrillation and anticoagulant-related complications. Yet, real-life studies evaluating changes in patient characteristics and indications for LAAO remain scarce. METHODS: To evaluate changes in patient characteristics and indications for LAAO defined as 2-year history of intracerebral bleeding, any ischemic stroke/systemic embolism (SE), any non-intracerebral bleeding, other indication, and 1-year mortality. All patients undergoing percutaneous LAAO in Denmark from 2013 to 2021 were stratified into the following year groups: 2013-2015, 2016-2018, and 2019-2021. RESULTS: In total, 1465 patients underwent LAAO. Age remained stable (2013-2015: 74 years versus 2019-2021: 75 years). Patients' comorbidity burden declined, exemplified by CHA2DS2-VASc ≥4 and HAS-BLED ≥3 decreased from 56.7% and 63.7% in 2013-2015 to 40.3% and 45.8% in 2019-2021. Indications for LAAO changed over time with other indication comprising 44.7% in 2019-2021; up from 26.9% in 2013-2015. Conversely, fewer patients had an indication of any ischemic stroke/SE (2013-2015: 30.8% vs 2019-2021: 20.3%) or any non-intracerebral bleeding (2013-2015: 29.4% vs 2019-2021: 23.4%). 1-year mortality was 11.3% for any non-intracerebral bleeding and 6.2% for other indication. CONCLUSION: The LAAO patient-profile has changed considerably. Age remained stable, while comorbidity burden decreased during the period 2013-2021. LAAO is increasingly used in patients with no clinical event history and mortality differs according to indication. Selection of patients to LAAO should be done carefully, and contemporary real-life studies investigating clinical practice could add important insights.

Hospital Characteristics and Early Enrollment Trends in the American College of Cardiology Voluntary Public Reporting Program.

Importance: Limited data exist regarding the characteristics of hospitals that do and do not participate in voluntary public reporting programs. Objective: To describe hospital characteristics and trends associated with early participation in the American College of Cardiology (ACC) voluntary reporting program for cardiac catheterization-percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries. Design, Setting, and Participants: This cross-sectional study analyzed enrollment trends and characteristics of hospitals that did and did not participate in the ACC voluntary public reporting program. All hospitals reporting procedure data to the National Cardiovascular Data Registry (NCDR) CathPCI or ICD registries that were eligible for the public reporting program from July 2014 (ie, program launch date) to May 2017 were included. Stepwise logistic regression was used to identify hospital characteristics associated with voluntary participation. Enrollment trends were evaluated considering the date US News & World Report (USNWR) announced that it would credit participating hospitals. Data analysis was performed from March 2017 to January 2018. Main Outcomes and Measures: Hospital characteristics and participation in the public reporting program. Results: By May 2017, 561 of 1747 eligible hospitals (32.1%) had opted to participate in the program. Enrollment increased from 240 to 376 hospitals (56.7%) 1 month after the USNWR announcement that program participation would be considered as a component of national hospital rankings. Compared with hospitals that did not enroll, program participants had increased median (IQR) procedural volumes for PCI (481 [280-764] procedures vs 332 [186-569] procedures; P < .001) and ICD (114 [56-220] procedures vs 62 [25-124] procedures; P < .001). Compared with nonparticipating hospitals, an increased mean (SD) proportion of participating hospitals adhered to composite discharge medications after PCI (0.96 [0.03] vs 0.92 [0.07]; P < .001) and ICD (0.88 [0.10] vs 0.81 [0.12]; P < .001). Hospital factors associated with enrollment included participation in 5 or more NCDR registries (odds ratio [OR],1.98; 95% CI, 1.24-3.19; P = .005), membership in a larger hospital system (ie, 3-20 hospitals vs ≤2 hospitals in the system: OR, 2.29; 95% CI, 1.65-3.17; P = .001), participation in an NCDR pilot public reporting program of PCI 30-day readmissions (OR, 2.93; 95% CI, 2.19-3.91; P < .001), university affiliation (vs government affiliation: OR, 3.85, 95% CI, 1.03-14.29; P = .045; vs private affiliation: OR, 2.22; 95% CI, 1.35-3.57; P < .001), Midwest location (vs South: OR, 1.47; 95% CI, 1.06-2.08; P = .02), and increased comprehensive quality ranking (4 vs 1-2 performance stars in CathPCI: OR, 8.08; 95% CI, 5.07-12.87; P < .001; 4 vs 1 performance star in ICD: OR, 2.26; 95% CI, 1.48-3.44; P < .001) (C statistic = 0.829). Conclusions and Relevance: This study found that one-third of eligible hospitals participated in the ACC voluntary public reporting program and that enrollment increased after the announcement that program participation would be considered by USNWR for hospital rankings. Several hospital characteristics, experience with public reporting, and quality of care were associated with increased odds of participation.

Current Status and Future Prospects of Transcatheter Mitral Valve Replacement: JACC State-of-the-Art Review.

Mitral regurgitation (MR) is the most prevalent valvular heart disease and, when left untreated, it confers a poorer prognosis. Catheter-based repair therapies face some limitations like their applicability on challenging anatomies and the potential recurrence of significant MR over time. Transcatheter mitral valve replacement (TMVR) has emerged as a less invasive approach potentially overcoming some of the current limitations associated with transcatheter mitral valve repair. Several devices are under clinical investigation, and a growing number of systems allow for a fully percutaneous transfemoral approach. In this review, the authors aimed to delineate the main challenges faced by the TMVR field, to highlight the key aspects for procedural planning, and to describe the clinical results of the TMVR systems under clinical investigation. Finally, they also discuss what the future perspectives are for this emerging field.

Current Indications for Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valves: Valve-in-Valve, Valve-in-Ring, and Valve-in-Mitral Annulus Calcification.

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.

Impact of the COVID-19 pandemic on cardiovascular mortality and catherization activity during the lockdown in central Germany: an observational study.

AIMS: During the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region. METHODS AND RESULTS: Data from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99-1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01-1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05-1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures. CONCLUSION: During the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.

Online Ratings for Vascular Interventional Proceduralists Vary by Physician Specialty.

BACKGROUND: Multiple specialties offer vascular interventional care, creating potential competition for referrals and procedures. At the same time, patient/consumer ratings have become more impactful for physicians who perform vascular procedures. We hypothesized that there are differences in online ratings based on specialty. METHODS: We used official program lists from the Association for Graduate Medical Education to identify institutions with training programs in integrated vascular surgery (VS), integrated interventional radiology (IR), and interventional cardiology (IC). Faculty providers were identified in each specialty at these institutions. A standardized search was performed to collect online ratings from Vitals.com, Healthgrades.com, and Google.com as well as from online demographics. Between specialty differences were analyzed using chi-squared and analysis of variance tests as appropriate. Multivariable linear regression was used to identify factors associated with review volume and star rating. RESULTS: A total of 1,330 providers (n = 454 VS, n = 451 IR, n = 425 IC) were identified across 47 institutions in 27 states. VS (55.5%-69.4%) and IC (63.8%-71.1%) providers were significantly more likely to have reviews than IR (28.6%-48.8%) providers across all online platforms (P < 0.001 for all websites). Across all platforms, IC providers were rated significantly higher than VS and IR providers. Multivariable regression showed that provider specialty and additional time in practice were associated with higher review volume. In addition to specialty, review volume was associated with star rating as those physicians with more reviews tended to have a higher rating. CONCLUSIONS: On average, vascular surgeons have more reviews and are more highly rated than interventional radiologists but tend to have fewer reviews and lower ratings than interventional cardiologists. VS providers may benefit from encouraging patients to file online reviews, especially in competitive markets.

Predictors of Clinical Response to Transcatheter Reduction of Secondary Mitral Regurgitation: The COAPT Trial.

BACKGROUND: Transcatheter mitral valve repair with the MitraClip results in marked clinical improvement in some but not all patients with secondary mitral regurgitation (MR) and heart failure (HF). OBJECTIVES: This study sought to evaluate the clinical predictors of a major response to treatment in the COAPT trial. METHODS: Patients with HF and severe MR who were symptomatic on maximally tolerated guideline-directed medical therapy (GDMT) were randomly assigned to MitraClip plus GDMT or GDMT alone. Super-responders were defined as those alive without HF hospitalization and with ≥20-point improvement in the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score at 12 months. Responders were defined as those alive without HF hospitalization and with a 5 to <20-point KCCQ-OS improvement at 12 months. Nonresponders were those who either died, were hospitalized for HF, or had <5-point improvement in KCCQ-OS at 12 months. RESULTS: Among 614 enrolled patients, 41 (6.7%) had missing KCCQ-OS data and could not be classified. At 12 months, there were 79 super-responders (27.2%), 55 responders (19.0%), and 156 nonresponders (53.8%) in the MitraClip arm compared with 29 super-responders (10.2%), 46 responders (16.3%), and 208 nonresponders (73.5%) in the GDMT-alone arm (overall p < 0.0001). Independent baseline predictors of clinical responder status were lower serum creatinine and KCCQ-OS scores and treatment assignment to MitraClip. MR grade and estimated right ventricular systolic pressure at 30 days were improved to a greater degree in super-responders and responders but not in nonresponders. CONCLUSIONS: Baseline predictors of clinical super-responders in patients with HF and severe secondary MR in the COAPT trial were lower serum creatinine, KCCQ-OS score and MitraClip treatment. Improved MR severity and reduced right ventricular systolic pressure at 30 days are associated with a long-term favorable clinical response after transcatheter mitral valve repair. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).

Atrial Dysfunction in Patients With Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation.

BACKGROUND: Paroxysmal and permanent atrial fibrillation (AF) are common in heart failure with preserved ejection fraction (HFpEF). OBJECTIVES: This study sought to determine the implications of left atrial (LA) myopathy and dysrhythmia across the spectrum of AF burden in HFpEF. METHODS: Consecutive patients with HFpEF (n = 285) and control subjects (n = 146) underwent invasive exercise testing and echocardiographic assessment of cardiac structure, function, and pericardial restraint. RESULTS: Patients with HFpEF were categorized into stages of AF progression: 181 (65%) had no history of AF, 49 (18%) had paroxysmal AF, and 48 (17%) had permanent AF. Patients with permanent AF were more congested with greater pulmonary vascular disease and lower cardiac output. LA volumes increased, while LA compliance, LA reservoir strain, and right ventricular function decreased with increasing AF burden. The presence of permanent AF was characterized by a distinct pathophysiology, with greater total heart volume caused by atrial dilatation, leading to elevated filling pressures through heightened pericardial restraint. Survival decreased with increasing AF burden. Ten-year progression to permanent AF was common, particularly in paroxysmal AF (52%), and the likelihood of AF progression increased with higher AF stage, poorer LA compliance, and lower LA strain. CONCLUSIONS: LA compliance and mechanics progressively decline with increasing AF burden in HFpEF, increasing risk for new onset AF and progressive AF. These changes promote development of a unique phenotype of HFpEF characterized by heightened ventricular interaction, right heart failure, and worsening pulmonary vascular disease. Further study is required to identify therapeutic interventions targeting LA myopathy to improve outcomes in HFpEF.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Recent advances in nonoperating room anesthesia for cardiac procedures.

PURPOSE OF REVIEW: The number of complex procedures performed in the cardiac catheterization laboratory (CCL) is rapidly increasing. Because of their complexity, they frequently require the assistance of an anesthesiologist. The CCL is primarily designed to facilitate a percutaneous cardiac intervention; therefore, it might be a challenging workplace for an anesthesiologist. The aim of this review is to briefly present tasks and challenges of providing anesthesia in the CCL and to provide a concise description of common cardiac procedures performed there. RECENT FINDINGS: Recent literature indicates that many complicated cardiac procedures can be performed in CCL under monitored anesthesia care. At the same time several of them (e.g. transcatheter aortic valve replacement) are quickly becoming a viable alternative for surgical valve replacement. The most recent expansion of CCL procedures is related to rapidly growing population of grown-ups with congenital heart disease. All aforementioned developments present new challenges to an anesthesiologist. SUMMARY: New and fast development of percutaneous cardiac interventions has created a new working place for the anesthesiologist - the CCL. Our expertise in complex cardiac pathophysiology allows conduct of complicated procedures outside of the operating theater. For the same reasons, there is ongoing discussion whether anesthesia support in CCL should be provided by a general or cardiac anesthesiologist.

Prioritizing elective cardiovascular procedures during the COVID-19 pandemic: The cardiovascular medically necessary, time-sensitive procedure scorecard.

BACKGROUND: Following the surge of the coronavirus disease 2019 (COVID-19) pandemic, government regulations, and recommendations from professional societies have conditioned the resumption of elective surgical and cardiovascular (CV) procedures on having strategies to prioritize cases because of concerns regarding the availability of sufficient resources and the risk of COVID-19 transmission. OBJECTIVES: We evaluated the use of a scoring system for standardized triage of elective CV procedures. METHODS: We retrospectively reviewed records of patients scheduled for elective CV procedures that were prioritized ad hoc to be either performed or deferred when New Jersey state orders limited the performance of elective procedures due to the COVID-19 pandemic. Patients in both groups were scored using our proposed CV medically necessary, time-sensitive (MeNTS) procedure scorecard, designed to stratify procedures based on a composite measure of hospital resource utilization, risk of COVID-19 exposure, and time sensitivity. RESULTS: A total of 109 scheduled elective procedures were either deferred (n = 58) or performed (n = 51). The median and mean cumulative CV MeNTS scores for the group of performed cases were significantly lower than for the deferred group (26 (interquartile range (IQR) 22-31) vs. 33 (IQR 28-39), p < .001, and 26.4 (SE 0.34) vs. 32.9 (SE 0.35), p < .001, respectively). CONCLUSIONS: The CV MeNTS procedure score was able to stratify elective cases that were either performed or deferred using an ad hoc strategy. Our findings suggest that the CV MeNTS procedure scorecard may be useful for the fair triage of elective CV cases during the time when available capacity may be limited due to the COVID-19 pandemic.

Mitral Valve Surgical Volume and Transcatheter Mitral Valve Repair Outcomes: Impact of a Proposed Volume Requirement on Geographic Access.

Background There is an open Centers for Medicare and Medicaid Services National Coverage Decision for Transcatheter Mitral Valve Repair (TMVr) and a recent multisociety consensus document suggesting that TMVr centers should achieve prespecified mitral valve replacement or repair (MVRr). Yet, little is known about the MVRr volume-TMVr outcome relationship. Methods and Results Using Centers for Medicare and Medicaid Services administrative claims from January 1, 2016 to December 31, 2018, we computed the Pearson correlation coefficient and performed multivariable hierarchical modeling to estimate the MVRr volume to TMVr outcome relationship for mortality and heart failure hospitalization. Additionally, we assessed the impact of the consensus recommendations on geographic access to care by hospital referral region. Total annualized MVRr volume was <11 to 1552 (median 96, interquartile range 53, 167). One-year survival, 1-year heart failure hospitalization after TMVr were not correlated with MVRr volume. After patient risk-adjustment for age, sex, and significant Elixhauser Comorbidities, there remained no significant correlation between institutional MVRr volume and 1-year mortality (estimate -0.010, SE 0.047, P=0.834) or heart failure hospitalization (estimate -0.011, SE 0.045, P=0.808) after TMVr. Raising the restriction on TMVr from 20 to 40 MVRr/y results in ≈30 million individuals having to travel outside of their hospital referral region to undergo TMVr, with a disproportionate impact in the Midwest and Southeast. Conclusions There is no relationship between MVRr volumes and TMVr outcomes. Additionally, adoption of an annual MVRr volume ≥40 for performance of TMVr disproportionately impacts geographic access in the Midwest and Southeast and their large black and Hispanic populations.

[Partnership development between two hospitals: the integration process of Interventional Cardiology Units between the San Luigi Gonzaga University Hospital and the Local Health Unit Torino 3]. / Lo sviluppo di una partnership tra Aziende Sanitarie: l'integrazione dei laboratori di Emodinamica tra l'Azienda Ospedaliera Universitaria San Luigi Gonzaga di Orbassano e l'Azienda Sanitaria Locale Torino 3.

BACKGROUND: The healthcare sector is among the most complex ones where partnerships and interdependencies between different hospitals can achieve real technical and managerial operational models aimed at optimizing resources. However, the construction of this type of interdependence is not simple to implement, making it necessary to integrate at different organizational and professional levels. The aim of this work is to present the integration process and results achieved during the first 3 years of experience after a synergic integration of the interventional cath lab units of the San Luigi Gonzaga University Hospital, Orbassano and the Infermi Hospital Local Health Unit TO 3, Rivoli. METHODS: Starting from March 2016, data concerning number and type of procedures as well as the distribution of workloads of each operator in the two cath labs were recorded and monitored. Moreover, numbers of urgent procedures performed as well as the door-to-balloon time in case of primary angioplasty were recorded. RESULTS: Compared to the first 12 months of non-integrated activity, the number of procedures remained constant with an overall trend of activity increase (total procedures: +2.6% from 2016 to 2017; +8.7% from 2017 to 2018). No statistically significant differences were found in the average door-to-balloon time, either by stratifying by period (year 2015 vs 2016 vs 2017 vs 2017 vs 2018) or by single institution. All ST-elevation myocardial infarctions were treated at the arrival site, displacing the medical availability team. The mortality rate and the number of complications were not different compared to the trend recorded in previous years. The implementation of joint programs with an exchange of expertise between operators has allowed the rapid development of skills necessary for the execution of structural heart procedures not previously performed in one of the operating centers. CONCLUSIONS: The model of an integrated cath lab unit represents an example of a partnership between two hospitals, which allows a synergistic growth of professional skills, even facing daily logistical challenges. The integration has made it possible to expand the number and type of procedures performed as well to join the on-call equipe without impacting on the door-to-balloon time in case of primary coronary angioplasty.

Contemporary trend of acute kidney injury incidence and incremental costs among US patients undergoing percutaneous coronary procedures.

OBJECTIVES: To assess national trends of acute kidney injury (AKI) incidence, incremental costs, risk factors, and readmissions among patients undergoing coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) during 2012-2017. BACKGROUND: AKI remains a serious complication for patients undergoing CAG/PCI. Evidence is lacking in contemporary AKI trends and its impact on hospital resource utilization. METHODS: Patients who underwent CAG/PCI procedures in 749 hospitals were identified from Premier Healthcare Database. AKI was defined by ICD-9/10 diagnosis codes (584.9/N17.9, 583.89/N14.1, 583.9/N05.9, E947.8/T50.8X5) during 7 days post index procedure. Multivariable regression models were used to adjust for confounders. RESULTS: Among 2,763,681 patients, AKI incidence increased from 6.0 to 8.4% or 14% per year in overall patients; from 18.0 to 28.4% in those with chronic kidney disease (CKD) and from 2.4 to 4.2% in those without CKD (all p < .001). Significant risk factors for AKI included older age, being uninsured, inpatient procedures, CKD, anemia, and diabetes (all p < .001). AKI was associated with higher 30-day in-hospital mortality (ORadjusted = 2.55; 95% CI: 2.40, 2.70) and readmission risk (ORadjusted = 1.52; 95% CI: 1.50, 1.55). The AKI-related incremental cost during index visit and 30-day readmissions were estimated to be $8,416 and $580 per inpatient procedure and $927 and $6,145 per outpatient procedure. Overall excess healthcare burden associated with AKI was $1.67 billion. CONCLUSIONS: AKI incidence increased significantly in this large, multifacility sample of patients undergoing CAG/PCI procedures and was associated with substantial increase in hospital costs, readmissions, and mortality. Efforts to reduce AKI risk in US healthcare system are warranted.