Delirium as late manifestation of infective endocarditis after transcatheter aortic valve implantation.

More than one-third of the cases of infective endocarditis (IE) occur in older patients. The disease is often characterized by atypical symptoms. The incidence of neurological complications is high and represents a strong independent predictor of severe outcomes and mortality. IE is a rare but serious complication of transcatheter aortic valve implantation (TAVI). A persistent delirium as a unique manifestation of post-TAVI IE in an older patient is presented in this clinical case.

Impact of the COVID-19 pandemic on aortic valve replacement procedures in Germany.

BACKGROUND: COVID-19 has caused the deferral of millions of elective procedures, likely resulting in a backlog of cases. We estimate the number of postponed surgical aortic valve replacement (sAVR) and transcatheter aortic valve replacement (TAVR) procedures during the first two waves of the COVID-19 pandemic in Germany. METHODS: Using German national records, all isolated TAVR and sAVR procedures between 2007 and 2020 were identified. Using weekly TAVR and sAVR procedures between 2017 and 2019, we created a forecast for 2020 and compared it with the observed number of procedures in 2020. RESULTS: In Germany, a total of 225,398 isolated sAVR and 159,638 isolated TAVR procedures were conducted between 2007 and 2020 that were included in our analysis. The reduction in all AVR procedures (sAVR and TAVR) for the entire year 2020 was 19.07% (95%CI: 15.19-22.95%). During the first wave of the pandemic (week 12-21), the mean weekly reduction was 32.06% (23.44-40.68%) and during the second wave of the pandemic (week 41-52), the mean weekly reduction was 25.58% (14.19-36.97%). The number of sAVR procedures decreased more than the number of TAVR procedures (24.63% vs. 16.42% for the entire year 2020). CONCLUSION: The first year of the COVID-19 pandemic saw a substantial postponing of AVR procedures in Germany. Postponing was higher for sAVR than for TAVR procedures and less pronounced during the second wave of the COVID-19 pandemic.

Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study.

BACKGROUND: Transcatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation. AIMS: We sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves. METHODS: We conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve. RESULTS: A total of 37 patients (male sex, 73%) with a median age of 81years (interquartile range 69-85years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n=31) had dyspnoea New York Heart Association class≥III. The device success rate was 94.6% (n=35). At 30days, the all-cause mortality rate was 8.1% (n=3) and valve migration occurred in 10.8% of cases (n=4). Dyspnoea New York Heart Association class≤II was seen in 86.5% of patients (n=32), and all survivors had aortic regurgitation grade≤1. At 1-year follow-up, all-cause mortality was 16.2% (n=6), 89.7% (n=26/29) of survivors were in New York Heart Association class≤II and all had aortic regurgitation grade≤2. CONCLUSION: Transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.

"Be Your Own Doctor" Experiences of Patients With Transcatheter Aortic Valve Implantation During the Pandemic: A Qualitative Study.

Background and Purpose: Although patients have had reduced access to healthcare institutions due to the COVID-19 pandemic and the related preventive measures, there is no current data on how the pandemic has affected patients who underwent transcatheter aortic valve implantation (TAVI), despite their need for close follow-up.This study investigated TAVI patients' experiences with self-care management during the pandemic. Methods: This study adopted a descriptive qualitative design. The sample consisted of 24 patients recruited using purposive sampling. Data were collected by telephone and analyzed using inductive content analysis. Results: The data were grouped under three themes: "vulnerability," "worsening of psychological condition," and "expectations." The most challenging self-care behaviors reported by TAVI patients were determined to be doing regular physical activity, managing their symptoms, complying with treatment, and attending regular check-ups. They also reported experiencing psychological problems such as fear, concern, and abandonment and stated a need for better communication and follow-up at home during the pandemic. Implications for Practice: The pandemic has more than ever demonstrated the importance of effective self-care for cardiovascular patients. Nurses should plan individualized interventions regarding the problems in self-care management that we identified in this study. In this regard, the use of secure digital applications such as telerehabilitation can be effective. Also, nurses should develop community-based and political initiatives to allow sustainable self-care management to be effectively implemented in special patient groups in extraordinary circumstances such as pandemics.

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.

[Transcatheter aortic valve implantation (TAVI) with conscious sedation and early discharge. Report of seven cases]. / Abordaje del implante valvular aórtico transcateter durante la pandemia por COVID-19 con alta prevoz: reporte de una serie de casos.

COVID-19 pandemic generated multiple challenges for the health system. Cardiovascular disease is associated with a worse prognosis of infections. Moreover, most hospital resources and operative rooms were destined to patients with COVID-19 infection, deferring the treatment of most valvular patients requiring surgery. We report seven patients with symptomatic severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) with conscious sedation and early discharge. No patient required intensive care unit admission or mechanical ventilation. After a 90-day follow-up, there were no complications or unplanned readmissions.

Prevalence and severity of cognitive dysfunction in patients referred for transcatheter aortic valve implantation (TAVI): clinical and cognitive impact at 1 year.

AIM: We estimated the proportion and severity of cognitive disorders in an unselected population of patients referred for transcatheter aortic valve implantation (TAVI). Second, we describe clinical and cognitive outcomes at 1 year. METHODS: Eligible patients were aged ≥ 70 years, with symptomatic aortic stenosis and an indication for TAVI. The Montreal Cognitive Assessment (MoCA) was used to assess cognitive dysfunction (CD), defined as no CD if score ≥ 26, mild CD if 18-25; moderate CD if 10-18, and severe CD if < 10. We assessed survival and in-hospital complications at 6 months and 1 year. RESULTS: Between June 2019 and October 2020, 105 patients were included; 21 (20%) did not undergo TAVI, and thus, 84 were analyzed; median age 85 years, 53.6% females, median EuroScore 11.5%. Median MoCA score was 22 (19-25); CD was excluded in 18 (21%), mild in 50 (59.5%), moderate in 15 (19%) and severe in 1. Mean MoCA score at follow-up was 21.9(± 4.69) and did not differ significantly from baseline (21.79 (± 4.61), p = 0.73). There was no difference in success rate, in-hospital complications, or death across CD categories. CONCLUSION: The clinical course of patients with mild or moderate CD is not different at 1 year after TAVI compared to those without cognitive dysfunction.

Transcatheter-based aortic valve replacement vs. isolated surgical aortic valve replacement in 2020.

BACKGROUND: Based on the results of several recent randomized trials, European and American guidelines on valvular heart disease management have substantially expanded the indications for transcatheter aortic valve implantation (TAVI). We present an all-comer data on peri-operative risk profile and in-hospital outcomes from Germany for patients treated by TAVI or isolated surgical aortic valve replacement (iSAVR) in 2020, providing an opportunity to compare study data with data from daily clinical practice. METHODS: Data concerning all isolated aortic valve procedures performed in Germany in 2020 were retrieved from the mandatory nationwide quality control program. Expected mortality was calculated with the annually revised German Aortic valve score (AKL-score) based on the data of either catheter-based (AKL-CATH) or isolated surgical (AKL-CHIR) aortic valve replacement in Germany from the previous year (2019). RESULTS: In 2020 21,903 TAVI procedures (20,810 transvascular (TV; vs. 2019: 22.973; - 9.4%), 1093 transapical (TA; vs. 2019: 1413; - 22.6%)) and 6144 (vs. 2019 7905; - 22.5%) iSAVR were performed in Germany. Patients who received TAVI showed a significantly higher perioperative risk profile than patients undergoing iSAVR based on older age and more severe co-morbidities. While in-hospital mortality after TAVI (2.3%) was numerically lower than in 2019 (2.5%), this difference was not significant (p = 0.11). In-hospital mortality after iSAVR was identical in 2020 and 2019 (2.8%) and thus higher than after TAVI (p = 0.003), resulting in an observed expected mortality ratio of 1.02 after TAVI and 1.05 after iSAVR. After exclusion of the emergency procedures, in-hospital mortality did not differ significantly between the groups (TAVI 2.2% vs. iSAVR 1.9%, p = 0.26). CONCLUSION: Total numbers of both iSAVR and TAVI in Germany were lower in 2020 than in 2019, most likely due to the COVID-19 pandemic. However, the relative number of patients treated by TAVI as compared to iSAVR continues to increase. Despite older age and more severe comorbidities compared to patients undergoing iSAVR the in-hospital mortality after TAVI continued to decrease in 2020 and remains significantly lower than after iSAVR.

Changes to transcatheter aortic valve replacement (TAVR) services during the first wave of the COVID-19 pandemic: A single centre experience from United Kingdom tertiary hospital.

AIMS: COVID-19 had a devastating impact on patients with severe aortic stenosis (AS). Like many cardiac procedures, transcatheter aortic valve replacement (TAVR) services were suspended during the first wave of COVID-19. We took the opportunity to evaluate the clinical outcomes and identify any delays at different stages of the TAVR pathway during the COVID-19 pandemic. METHODS: Prospectively collected data on 210 consecutive TAVR patients between March 2019 and March 2021 were analysed. We compared the clinical outcomes and 30-day mortality rates of TAVR cases pre-pandemic and during the pandemic. We also looked to identify any time lags from the initial referral to respective stages of the TAVR workup. RESULTS: A total of 134 patients underwent TAVR prior to the national lockdown (March 2019-March 2020), compared to 76 patients during COVID-19 (April 2020-April 2021). Success rates of TAVR were similar (99% prior to the pandemic and 97.4% during COVID-19). The 30-day survival rates were 98.6% and 94.7%, respectively. Median length of stay post TAVR was 2 days during COVID-19 and 2.5 days prior to the pandemic (p = 0.064). Patients were seen quicker in clinic (median of 33 days) during COVID-19, compared to 51 days before COVID-19 (p = 0.044). No significant difference in times from referral to discussion at TAVR multidisciplinary team (MDT) meetings, CT Aortogram and TAVR implantation, in both groups. CONCLUSIONS: Reconfiguring the patient pathway during COVID-19 allowed TAVR to be performed safely, with a similar success rate and no excess complications or increased 30-day mortality. There proved to be no delay in the respective stages of patient TAVR workup, during the pandemic.

Usefulness of Temporary Pacing in Patients With New Left Bundle Branch Block During Transcatheter Aortic Valve Implantation.

New-onset left bundle branch block (NLBBB) is the most common complication after transcatheter aortic valve implantation (TAVI). Expert consensus recommends temporary transvenous pacemaker (TTVP) support for 24 hours in these patients. To date, no study has examined TTVP use during the index hospitalization in detail. Therefore, we aimed to assess TTVP use in patients with TAVI who developed NLBBB. In this prospective observational study, we performed a detailed analysis of 24-hour telemetry in patients who developed NLBBB during TAVI. Baseline characteristics and procedural and postprocedural data were recorded. The primary outcome was pacing by the TTVP. We evaluated inappropriate TTVP use, electrophysiology study findings, permanent pacemaker (PPM) implantation, and NLBBB resolution. A total of 83 patients (74.4 ± 8.7 years, 41% female) developed NLBBB during TAVI. During index hospitalization, 1 patient (1%) required TTVP because of complete heart block and received a PPM. Five of the 83 (6%) patients were inappropriately paced, and 1 patient (1%) had ventricular fibrillation, likely secondary to TTVP. A total of 34 patients (41%) underwent electrophysiology study during hospitalization, with 4 of 83 (5%) subsequently receiving a PPM. One (1%) patient died during hospitalization, and 9 patients were lost to follow-up because of the COVID-19 pandemic. Of the remaining 73 patients with a 30-day follow-up, NLBBB had resolved in 36 (49%) at 30 days, and 2 (3%) were readmitted with complete heart block and received PPM. In conclusion, in patients with TAVI who develop NLBBB, temporary pacing is rarely necessary, may carry additional risks to the patient, and prolong hospitalization time.

Cardiac Surgery 2021 Reviewed.

PubMed displayed more than 35,000 hits for the search term "cardiac surgery AND 2021." We used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) approach and selected relevant publications for a results-oriented summary. As in recent years, we reviewed the fields of coronary and conventional valve surgery and their overlap with their interventional alternatives. COVID reduced cardiac surgical activity around the world. In the coronary field, the FAME 3 trial dominated publications by practically repeating SYNTAX, but with modern stents and fractional flow reserve (FFR)-guided percutaneous coronary interventions (PCIs). PCI was again unable to achieve non-inferiority compared with coronary artery bypass graft surgery (CABG) in patients with triple-vessel disease. Survival advantages of CABG over PCI could be linked to a reduction in myocardial infarctions and current terminology was criticized because the term "myocardial revascularization" is not precise and does not reflect the infarct-preventing collateralization effect of CABG. In structural heart disease, new guidelines were published, providing upgrades of interventional treatments of both aortic and mitral valve disease. While for aortic stenosis, transcatheter aortic valve implantation (TAVI) received a primary recommendation in older and high-risk patients; recommendations for transcatheter mitral edge-to-edge treatment were upgraded for patients considered inappropriate for surgery. For heart team discussions it is important to know that classic aortic valve replacement currently provides strong signals (from registry and randomized evidence) for a survival advantage over TAVI after 5 years. This article summarizes publications perceived as important by us. It can neither be complete nor free of individual interpretation, but provides up-to-date information for decision-making and patient information.

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.

How to Reduce Inequity of Access to Cardiac Rehabilitation After Surgical Aortic Valve Replacement. Recommendations for the Post-COVID-19 Era From a Real-World, Population-Based Study.

PURPOSE: Cardiac rehabilitation (CR) is a class I recommendation after valvular surgery. Few data exist on the level of access to CR after surgical aortic valve replacement (SAVR), and the factors affecting the probability of timely access to CR after SAVR have never been empirically investigated. This study aims at estimating the proportion of SAVR patients who initiated timely CR and understanding to what extent timely access to CR for SAVR patients is influenced by specific characteristics of patients and hospitals. METHODS: We conducted a real-world, retrospective, population-based study by identifying from the Italian National Hospital Discharge Records all the discharged alive SAVR patients who accessed timely CR from 2009-2016. Two different cutoffs for timely access were considered, i.e. one and 21 days after discharge. A unique dataset was constructed by merging several data sources. Multiple logistic regressions were performed to identify the factors influencing the probability to access to timely CR. FINDINGS: 107,545 patients underwent SAVR in Italy from 2009-2016 and were discharged alive. Overall, 71,593 SAVR patients (66.6%) accessed timely CR, with an increasing trend over time. Additional 6,149 patients (5.7%) started CR from 2-21 days after discharge, slightly decreasing over time. The probability of timely CR (one-day cutoff) was significantly higher in older (OR=1.025, p<0.001) female patients (OR = 1.003, p<0.05) and patients with cardiovascular and cerebrovascular comorbidities. Presence of rehabilitation wards and number of rehabilitation beds in the index hospital significantly increased the probability of timely access to CR (OR = 1.105, p<0.001 and OR = 1.006, p<0.001 respectively). Patients hospitalized in private teaching hospitals had the highest predicted probability of timely CR after SAVR. A substantial variation in access to CR was found across Italian regions. Similar results were obtained with the alternative 21-days cutoff. IMPLICATIONS: Approximately one-third of SAVR patients did not benefit from CR in Italy, mainly due to shortness of rehabilitation facilities, with relevant disparities across the country. The cessation of CR services during the COVID-19 pandemic provides the opportunity to re-think and innovate CR, shifting from center-based to home-based models. Digital health technologies can supplement traditional health services and grant safe, effective, and equitable access to care, especially for countries with insufficient rehabilitation bed capacity. As CR is associated with better outcomes, we recommend decision-makers to use our results to plan adequate healthcare services, also investing in digital health, to ensure patients' access to cost-effective care.

Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection.

Despite advances in transcatheter aortic valve replacement (TAVR) technology, periprocedural stroke remains a complication of TAVR procedures. The TriGUARD 3 device is designed to be positioned in the aortic arch to deflect debris away from the brachiocephalic, left common carotid, and left subclavian arteries during TAVR. The United States Food and Drug Administration (FDA) assembled the Circulatory System Devices Panel to review safety and effectiveness data for the TriGUARD 3 device. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we summarize the data presented by both the sponsor and FDA, as well as the panel discussion.

Transcatheter aortic valve implantation during COVID-19 pandemic: An optimized model to relieve healthcare system overload.

BACKGROUND: The coronavirus 2019 (COVID-19) pandemic upset healthcare systems and their logistics worldwide. We sought to assess safety and effectiveness of an optimized logistics for transcatheter aortic valve implantation (TAVI) pathway developed during the COVID-19 pandemic. METHODS: This is a retrospective analysis. An optimized TAVI logistics based on performing TAVI work-up and procedure during the same hospitalization was used during the COVID-19 pandemic. In-hospital and 30-day outcomes of patients treated during the pandemic were compared with an historical cohort of patients undergoing TAVI with staged work-up before the pandemic within an homogeneous timeframe. RESULTS: Of 536 patients, 227 (42.4%) underwent TAVI during the COVID-19 pandemic with a reduction of 26.5% compared to the pre-pandemic period (n = 309). The median age was 81 (77-85) years and STS score was 3.4 (2.2-5.6)%. Lower rates of in-hospital major vascular complications (2.2% vs. 8.7%; p < 0.01) and life-threatening bleeding (0.4% vs. 4.2%; p = 0.01) were reported in the COVID-19 period, whereas no difference in acute kidney injury (7.0% vs. 7.4%, p = 0.85) rate was reported between COVID-19 and pre-COVID-19 periods. No difference in 30-day rates of all-cause death (4.0 vs. 4.5, p = 0.75) and of major adverse cardiovascular events (4.0 vs. 6.1, p = 0.26) were reported between COVID-19 and pre-COVID-19 periods. CONCLUSIONS: The use of optimized single-hospitalization logistics for TAVI workup and procedure developed during the COVID-19 pandemic, showed to be as safe and effective as the two-stage TAVI pathway previously adopted, allowing the minimization of potential exposure to COVID-19 infection and shortening times to treatment for severely symptomatic patients.

Effect of intensive versus limited monitoring on clinical trial conduct and outcomes: A randomized trial.

BACKGROUND: Regulatory agencies have endorsed more limited approaches to clinical trial site monitoring. However, the impact of different monitoring strategies on trial conduct and outcomes is unclear. METHODS: We conducted a patient-level block-randomized controlled trial evaluating the effect of intensive versus limited monitoring on cardiovascular clinical trial conduct and outcomes nested within the CoreValve Continued Access and Expanded Use Studies. Intensive monitoring included complete source data verification of all critical datapoints whereas limited monitoring included automated data checks only. This study's endpoints included clinical trial outcome ascertainment as well as monitoring action items, protocol deviations, and adverse event ascertainment. RESULTS: A total of 2,708 patients underwent transcatheter aortic valve replacement (TAVR) and were randomized to either intensive monitoring (n = 1,354) or limited monitoring (n = 1,354). Monitoring action items were more common with intensive monitoring (52% vs 15%; P < .001), but there was no difference in the percentage of patients with any protocol deviation (91.6% vs 90.4%; P = .314). The reported incidence of trial outcomes between intensive and limited monitoring was similar for mortality (30 days: 4.8% vs 5.5%, P = .442; 1 year: 20.3% vs 21.3%, P = .473) and stroke (30 days: 2.8% vs 2.4%, P = .458), as well as most secondary trial outcomes with the exception of bleeding (intensive: 36.3% vs limited: 32.0% at 30 days, P = .019). There was a higher reported incidence of cardiac adverse events reported in the intensive monitoring group at 1 year (76.7% vs 72.4%; P = .019). CONCLUSIONS: Tailored limited monitoring strategies can be implemented without influencing the integrity of TAVR trial outcomes.