The Impact of COVID-19 on Racial and Ethnic Disparities in Cardiac Procedural Care.

OBJECTIVE: The primary objective of this study was to evaluate whether the COVID-19 pandemic altered the racial and ethnic composition of patients receiving cardiac procedural care. DESIGN: This was a retrospective observational study. SETTING: This study was conducted at a single tertiary-care university hospital. PARTICIPANTS: A total of 1,704 adult patients undergoing transcatheter aortic valve replacement (TAVR) (n = 413), coronary artery bypass grafting (CABG) (n = 506), or atrial fibrillation (AF) ablation (n = 785) from March 2019 through March 2022 were included in this study. INTERVENTIONS: No interventions were performed as this was a retrospective observational study. MEASUREMENTS AND MAIN RESULTS: Patients were grouped based on the date of their procedure: pre-COVID (March 2019 to February 2020), COVID Year 1 (March 2020 to February 2021), and COVID Year 2 (March 2021 to March 2022). Population-adjusted procedural incidence rates during each period were examined and stratified based on race and ethnicity. The procedural incidence rate was higher for White patients versus Black, and non-Hispanic patients versus Hispanic patients for every procedure and every period. For TAVR, the difference in procedural rates between White patients versus Black patients decreased between the pre-COVID and COVID Year 1 (12.05-6.34 per 1,000,000 persons). For CABG, the difference in procedural rates between White patients versus Black, and non-Hispanic patients versus Hispanic patients did not change significantly. For AF ablations, the difference in procedural rates between White patients versus Black patients increased over time (13.06 to 21.55 to 29.64 per 1,000,000 persons in the pre-COVID, COVID Year 1, and COVID Year 2, respectively). CONCLUSION: Racial and ethnic disparities in access to cardiac procedural care were present throughout all study time periods at the authors' institution. Their findings reinforce the continuing need for initiatives to reduce racial and ethnic disparities in healthcare. Further studies are needed to fully elucidate the effects of the COVID-19 pandemic on healthcare access and delivery.

Transcatheter Aortic Valve Replacement vs. Surgical Aortic Valve Replacement for Long-Term Mortality Due to Stroke and Myocardial Infarction: A Meta-Analysis during the COVID-19 Pandemic.

Background and objectives: One of the leading causes of mortality and morbidity in people over the age of 50 is stroke. The acceptance of transcatheter aortic valve replacement (TAVR) as a treatment option for severe symptomatic aortic stenosis (AS) has increased as a result of numerous randomized clinical trials comparing surgical aortic valve replacement (SAVR) and TAVR in high- and intermediate-risk patients, showing comparable clinical outcomes and valve hemodynamics. Materials and Methods: An electronic search of Medline, Google Scholar and Cochrane Central was carried out from their inception to 28 September 2022 without any language restrictions. Results: Our meta-analysis demonstrated that, as compared with SAVR, TAVR was not linked with a lower stroke ratio or stroke mortality. It is clear from this that the SAVR intervention techniques applied in the six studies were successful in reducing cardiogenic consequences over time. Conclusions: A significantly decreased rate of mortality from cardiogenic causes was associated with SAVR. Additionally, when TAVR and SAVR were compared for stroke mortality, the results were nonsignificant with a p value of 0.57, indicating that none of these procedures could decrease stroke-related mortality.

Same day discharge after structural heart disease interventions in the era of the coronavirus-19 pandemic and beyond.

With recent advancements in imaging modalities and techniques and increased recognition of the long-term impact of several structural heart disease interventions, the number of procedures has significantly increased. With the increase in procedures, also comes an increase in cost. In view of this, efficient and cost-effective methods to facilitate and manage structural heart disease interventions are a necessity. Same-day discharge (SDD) after invasive cardiac procedures improves resource utilization and patient satisfaction. SDD in appropriately selected patients has become the standard of care for some invasive cardiac procedures such as percutaneous coronary interventions. This is not the case for the majority of structural heart procedures. With the coronavirus disease 2019 pandemic, safely reducing the duration of time spent within the hospital to prevent unnecessary exposure to pathogens has become a priority. In light of this, it is prudent to assess the feasibility of SDD in several structural heart procedures. In this review we highlight the feasibility of SDD in a carefully selected population, by reviewing and summarizing studies on SDD among patients undergoing left atrial appendage occlusion, patent foramen ovale/atrial septal defect closure, Mitra-clip, and trans-catheter aortic valve replacement procedures.

Same-Day Discharge Post-Transcatheter Aortic Valve Replacement During the COVID-19 Pandemic: The Multicenter PROTECT TAVR Study.

OBJECTIVES: The aim of this study was to determine the safety and efficacy of same-day discharge (SDD) after transcatheter aortic valve replacement (TAVR) during the COVID-19 pandemic. BACKGROUND: The COVID-19 pandemic has placed significant stress on health care systems worldwide. SDD in highly selected TAVR patients can facilitate the provision of essential cardiovascular care while managing competing COVID-19 resource demands. METHODS: Patient selection for SDD was at the discretion of the local multidisciplinary heart team, across 7 international sites. The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new permanent pacemaker (PPM) implantation. RESULTS: From March 2020 to August 2021, 124 of 2,100 patients who underwent elective transfemoral TAVR were selected for SDD. The average age was 78.9 ± 7.8 years, the median Society of Thoracic Surgeons score was 2.4 (IQR: 1.4-4.2), and 32.3% (n = 40) had preexisting PPMs. There were no major vascular complications, strokes, or deaths during the index admission. One patient (0.8%) required PPM implantation for complete heart block and was discharged the same day. No patient required a PPM between discharge home and 30-day follow-up. The composite of cardiovascular death, stroke, myocardial infarction, all-cause readmission, major vascular complications, and new PPM at 30 days occurred in 5.7% patients (n = 6 of 106). CONCLUSIONS: SDD post-TAVR is safe and feasible in selected patients at low risk for adverse clinical events postdischarge. This strategy may have a potential role in highly selected patients even when the COVID-19 pandemic abates.

Professionals' views on shared decision-making in severe aortic stenosis.

OBJECTIVE: To provide insight into professionals' perceptions of and experiences with shared decision-making (SDM) in the treatment of symptomatic patients with severe aortic stenosis (AS). METHODS: A semistructured interview study was performed in the heart centres of academic and large teaching hospitals in the Netherlands between June and December 2020. Cardiothoracic surgeons, interventional cardiologists, nurse practitioners and physician assistants (n=21) involved in the decision-making process for treatment of severe AS were interviewed. An inductive thematic analysis was used to identify, analyse and report patterns in the data. RESULTS: Four primary themes were generated: (1) the concept of SDM, (2) knowledge, (3) communication and interaction, and (4) implementation of SDM. Not all respondents considered patient participation as an element of SDM. They experienced a discrepancy between patients' wishes and treatment options. Respondents explained that not knowing patient preferences for health improvement hinders SDM and complicating patient characteristics for patient participation were perceived. A shared responsibility for improving SDM was suggested for patients and all professionals involved in the decision-making process for severe AS. CONCLUSIONS: Professionals struggle to make highly complex treatment decisions part of SDM and to embed patients' expectations of treatment and patients' preferences. Additionally, organisational constraints complicate the SDM process. To ensure sustainable high-quality care, professionals should increase their awareness of patient participation in SDM, and collaboration in the pathway for decision-making in severe AS is required to support the documentation and availability of information according to the principles of SDM.

Modeling the impact of delaying transcatheter aortic valve replacement for the treatment of aortic stenosis in the era of COVID-19.

OBJECTIVE: The aim of this study was to model the short term and 2-year overall survival (OS) for intermediate-risk and low-risk patients with severe symptomatic aortic stenosis (AS) undergoing timely or delayed transcatheter aortic valve replacement (TAVR) during the 2019 novel coronavirus (COVID-19) pandemic. METHODS: We developed a decision analysis model to evaluate 2 treatment strategies for both low-risk and intermediate-risk patients with AS during the COVID-19 novel coronavirus pandemic. RESULTS: Prompt TAVR resulted in improved 2-year OS compared with delayed intervention for intermediate-risk patients (0.81 vs 0.67) and low-risk patients (0.95 vs 0.85), owing to the risk of death or the need for urgent/emergent TAVR in the waiting period. However, if the probability of acquiring COVID-19 novel coronavirus is >55% (intermediate-risk patients) or 47% (low-risk patients), delayed TAVR is favored over prompt intervention (0.66 vs 0.67 for intermediate risk; 0.84 vs 0.85 for low risk). CONCLUSIONS: Prompt transcatheter aortic valve replacement for both intermediate-risk and low-risk patients with symptomatic severe AS results in improved 2-year survival when local healthcare system resources are not significantly constrained by the COVID-19.

Same Day Discharge during the COVID-19 Pandemic in Highly Selected Transcatheter Aortic Valve Replacement Patients.

Background: Transcatheter aortic valve replacement (TAVR) with a standardized clinical pathway allows most patients to achieve safe next-day discharge. This approach has been successfully implemented across global centers as part of the Benchmark Program. Considering restricted hospital resources resulting from the COVID-19 pandemic, a modified same day discharge (SDD) clinical pathway was implemented for selected TAVR patients at a single Benchmark site. Methods: All patients accepted for TAVR were assessed for the SDD clinical pathway. Eligibility criteria included adequate social support and accessibility to the TAVR program post-discharge. Patients with preexisting conduction disease were excluded. The clinical pathway comprised of mobilization, bloodwork and electrocardiogram 4 hours post-TAVR and discharge ≥8 hours following groin hemostasis. Results: From June to December 2020, 142 patients underwent TAVR at a single community Benchmark site. Of those, 29 highly selected patients were successfully discharged the same day using the SDD clinical pathway. There were no vascular access complications, permanent pacemaker (PPM) implantation, or mortality in the SDD group during index admission or at 30-day follow-up. When compared to a standard therapy group, there was no statistically significant difference in 30-day cardiovascular readmission. Conclusions: This study demonstrates the safety and feasibility of same day discharge post-TAVR in a highly selected cohort of patients, with no observable difference in safety outcomes when compared to patients who were discharged according to standard institutional practice.Abbreviations: AS: aortic stenosis; ACT: Activated clotting time; AV: atrioventricular; AVB: atrioventricular block; BBB: bundle branch block; CAIC: Canadian Society for Cardiovascular Angiography; CCL: cardiac catheterization laboratory; CT: Computed topography; CV: cardiovascular; IQR: Interquartile Range; IVCD: intraventricular conduction delay; LBBB: left bundle branch block; LOS: length of stay; NDD: next day discharge; PPM: permanent pacemaker; RBBB: right bundle branch block; SCAI: Society for Cardiovascular Angiography and Intervention; SD: standard deviation; SDD: same day discharge; ST: standard therapy; STS PROM: society of thoracic surgeons predicted risk of mortality; TAVR: transcatheter aortic valve replacement; TF: transfemoral; THV: transcatheter heart valve; TTE: transthoracic echocardiogram; VARC: Valve Academic Research Consortium.

MitraClip for mitral valve regurgitation and transcatheter aortic valve implantation for severe aortic valve stenosis: state-of-the-art.

There is a worldwide expansion in percutaneous therapy for valvular heart disease. Rapidly evolving technology and the general increase in life expectancy will support the evolution of new treatment options dedicated to structural heart interventions. Transcatheter aortic valve implantation for severe aortic valve stenosis and percutaneous mitral valve repair with the MitraClip system for severe mitral regurgitation have been demonstrated as a feasible, innovative alternative for surgical treatment. Despite the inequality in clinical experience, both procedures have encouraging results and now are a part of everyday clinical practice. More importantly, rapid development is expected in the next decades. However, the global coronavirus disease 2019 (COVID-19) pandemic imposed redistribution of healthcare resources. Hospitals were obliged to modify their workflow and limit TAVI and MitraClip procedures to urgent or in highly symptomatic patients. Despite this encumbrance improvement in technology and experience supported by robust evidence from current studies might extend indications for both procedures. The future holds promise for this treatment modality to become the preferred procedure for all patients despite age or risk and reserving surgical treatment for a minority. Thus, we present state-of-the-art and current evidence for both methods assumed to change the paradigm of treatment of valvular heart failure in the future.

Monitoring Patients Reported Outcomes after Valve Replacement Using Wearable Devices: Insights on Feasibility and Capability Study: Feasibility Results.

Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. Validated questionnaires were also used to evaluate these outcomes. A technology acceptance questionnaire was used at the end of the follow up. In our participants an overall good compliance in wearing the device (75.1% vs. 79.8%, SAVR vs. TAVR) was assessed. Half of the patients were willing to continue using the device. Perceived ease of use is one of the domains that scored higher in the technology acceptance questionnaire. In this study we observed that the use of a WD is accepted in our frail population for an extended period. Even though commercial WDs are not tailored for clinical research, they can produce useful information on patient behavior, especially when coordinated with intervention tailored to the single patient.

'Valve for Life': tackling the deficit in transcatheter treatment of heart valve disease in the UK.

Transcatheter aortic valve implantation (TAVI) is a proven treatment for life-threatening aortic valve disease, predominantly severe aortic stenosis. However, even among developed nations, access to TAVI is not uniform. The Valve for Life initiative was launched by the European Association of Percutaneous Cardiovascular Interventions in 2015 with the objective of improving access to transcatheter valve interventions across Europe. The UK has been identified as a country with low penetration of these procedures and has been selected as the fourth nation to be included in the initiative. Specifically, the number of TAVI procedures carried out in the UK is significantly lower than almost all other European nations. Furthermore, there is substantial geographical inequity in access to TAVI within the UK. As a consequence of this underprovision, waiting times for TAVI are long, and mortality among those waiting intervention is significant. This article reviews these issues, reports new data on access to TAVI in the UK and presents the proposals of the UK Valve for Life team to address the current problems in association with the British Cardiovascular Intervention Society.

Best Practice Recommendations for Optimizing Care in Structural Heart Programs: Planning Efficient and Resource Leveraging Systems (PEARLS).

The COVID19 pandemic brought unprecedented disruption to healthcare. Staggering morbidity, mortality, and economic losses prompted the review and refinement of care for structural heart disease (SHD). To mitigate negative impacts in the face of crisis or capacity constraints, this paper offers best practice recommendations for Planning Efficient and Resource Leveraging Systems (PEARLS) in structural heart programs. A systematic assessment is recommended for hospital capacity, Heart Team roles and functions, and patient and procedural risks associated with increased resource utilization. Strategies, tactics, and pathways are provided for the delivery of patient-centered, efficient and resource-leveraging care from referral to follow-up. Through the optimal use of capacity and resources, paired with dynamic triage, forecasting, and surveillance, Heart Teams may aspire to plan and implement an optimized system of care for SHD. Abbreviations: AS: aortic stenosis; ASD: atrioseptal defect; COVID19: Coronavirus disease 19; LAAO: left atrial appendage occlusion; MI: myocardial infarction; MR: mitral regurgitation; PFO: patent foramen ovale; PVL: paravalvular leak; SHD: structural heart disease; SAVR: surgical aortic valve replacement; SDM: shared decision-making; TAVR: transcatheter aortic valve replacement; TMVr: transcatheter mitral valve repair; TMVR: transcatheter mitral valve replacement; TEE: transesophageal echocardiography; TTE: transthoracic echocardiography.

Transcatheter aortic valve replacement same-day discharge for selected patients: a case series.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in drastic changes to the practice of medicine, requiring healthcare systems to find solutions to reduce the risk of infection. Using a case series, we propose a protocol for same-day discharge (SDD) for selected patients undergoing transcatheter aortic valve replacement (TAVR) using real-time remote cardiac monitoring. Six patients with severe symptomatic aortic stenosis underwent TAVR and were discharged on the same day. CASE SUMMARY: Six patients with symptomatic severe native or bioprosthetic aortic valve stenosis underwent a successful transfemoral TAVR using standard procedures, including the use of rapid atrial pacing to assess the need for permanent pacemaker implantation. Following TAVR, patients were monitored on telemetry in the recovery area for 3 h, ambulated to assess vascular access stability, and discharged with real-time remote cardiac monitoring if no new conduction abnormality was observed. The patients were seen by tele-visits within 2 days and 2 weeks after discharge. DISCUSSION: Amidst the COVID-19 pandemic, SDD following successful transfemoral TAVR may be feasible for selected patients and reduce potential COVID-19 exposure.

Risk and Severity of COVID-19 and ABO Blood Group in Transcatheter Aortic Valve Patients.

While cardiovascular disease has been associated with an increased risk of coronavirus disease 2019 (COVID-19), no studies have described its clinical course in patients with aortic stenosis who had undergone transcatheter aortic valve replacement (TAVR). Numerous observational studies have reported an association between the A blood group and an increased susceptibility to SARS-CoV-2 infection. Our objective was to investigate the frequency and clinical course of COVID-19 in a large sample of patients who had undergone TAVR and to determine the associations of the ABO blood group with disease occurrence and outcomes. Patients who had undergone TAVR between 2010 and 2019 were included in this study and followed-up through the recent COVID-19 outbreak. The occurrence and severity (hospitalization and/or death) of COVID-19 and their associations with the ABO blood group served as the main outcome measures. Of the 1125 patients who had undergone TAVR, 403 (36%) died before 1 January 2020, and 20 (1.8%) were lost to follow-up. The study sample therefore consisted of 702 patients. Of them, we identified 22 cases (3.1%) with COVID-19. Fourteen patients (63.6%) were hospitalized or died of disease. Multivariable analysis identified the A blood group (vs. others) as the only independent predictor of COVID-19 in patients who had undergone TAVR (odds ratio (OR) = 6.32; 95% confidence interval (CI) = 2.11-18.92; p = 0.001). The A blood group (vs. others; OR = 8.27; 95% CI = 1.83-37.43, p = 0.006) and a history of cancer (OR = 4.99; 95% CI = 1.64-15.27, p = 0.005) were significantly and independently associated with disease severity (hospitalization and/or death). We conclude that patients who have undergone TAVR frequently have a number of cardiovascular comorbidities that may work to increase the risk of COVID-19. The subgroup with the A blood group was especially prone to developing the disease and showed unfavorable outcomes.

Ramipril in High-Risk Patients With COVID-19.

BACKGROUND: Coronavirus disease-2019 (COVID-19) is caused by severe acute respiratory-syndrome coronavirus-2 that interfaces with the renin-angiotensin-aldosterone system (RAAS) through angiotensin-converting enzyme 2. This interaction has been proposed as a potential risk factor in patients treated with RAAS inhibitors. OBJECTIVES: This study analyzed whether RAAS inhibitors modify the risk for COVID-19. METHODS: The RASTAVI (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation) trial is an ongoing randomized clinical trial randomly allocating subjects to ramipril or control groups after successful transcatheter aortic valve replacement at 14 centers in Spain. A non-pre-specified interim analysis was performed to evaluate ramipril's impact on COVID-19 risk in this vulnerable population. RESULTS: As of April 1, 2020, 102 patients (50 in the ramipril group and 52 in the control group) were included in the trial. Mean age was 82.3 ± 6.1 years, 56.9% of the participants were male. Median time of ramipril treatment was 6 months (interquartile range: 2.9 to 11.4 months). Eleven patients (10.8%) have been diagnosed with COVID-19 (6 in control group and 5 receiving ramipril; hazard ratio: 1.150; 95% confidence interval: 0.351 to 3.768). The risk of COVID-19 was increased in older patients (p = 0.019) and those with atrial fibrillation (p = 0.066), lower hematocrit (p = 0.084), and more comorbidities according to Society of Thoracic Surgeons score (p = 0.065). Admission and oxygen supply was required in 4.9% of patients (2 in the ramipril group and 3 in the control group), and 4 of them died (2 in each randomized group). A higher body mass index was the only factor increasing the mortality rate (p = 0.039). CONCLUSIONS: In a high-risk population of older patients with cardiovascular disease, randomization to ramipril had no impact on the incidence or severity of COVID-19. This analysis supports the maintenance of RAAS inhibitor treatment during the COVID-19 crisis. (Renin-Angiotensin System Blockade Benefits in Clinical Evolution and Ventricular Remodeling After Transcatheter Aortic Valve Implantation [RASTAVI]; NCT03201185).

Shifting Paradigms in Cardiovascular Therapeutic Strategies During the COVID-19 Era.

The coronavirus disease-19 (COVID-19) period have dictated a different approach to cardiac interventions at our medical institution. We prioritize emergent care geared toward lesser invasive approaches while minimizing hospitalization duration. This reflects upon coronary and structural/valvular cases altogether. Despite potential criticism of this approach, we believe it is the most appropriate therapeutic strategy for this unique period. Further investigation is needed to examine the external validity of our approach in other medical centers worldwide.