Pre-Operative Continued Oral Anticoagulation Impact on Early Outcomes after Transcatheter Aortic Valve Implantation.

Considering that there is a lack of evidence and guideline-based recommendations on the best preoperative oral anticoagulation management (OAC) for transcatheter aortic valve implantation (TAVI), this cohort study aimed to evaluate bleeding, access site complications, and early safety in patients undergoing TAVI on continued OAC therapy vs no-OAC therapy. Three-hundred forty-four patients submitted to a TAVI procedure (66.3% no-OAC vs 33.7% OAC) were consecutively enrolled. Primary endpoint was defined as in-hospital VARC-2 life-threatening or disabling bleeding. Secondary endpoints were in-hospital VARC-2 major vascular complications and VARC-2 early safety at 30 days. Propensity score matching analysis was performed to reduce potential distribution bias, resulting in 2 well-balanced groups (92 patients in each arm). In the overall cohort, mean age, median EuroScore II, and STS-score were 78.7±7.6 years, 2.9% (1.7-5.9), and 2.3% (1.6-3.6), respectively. Despite being older (78 ± 8 vs 80 ± 6, p = 0.004) and having higher STS score (2.1 vs 2.6, p = 0.001), patients on OAC had similar incidence of in-hospital VARC-2 life-threatening or disabling bleeding (1.3% vs. 0.9%, p = 0.711), major vascular complications (4.8% vs 5.2%, p = 0.888), and VARC-2 early safety at 30 days (10.1% vs 12.1%, p = 0.575). No significant differences in the main outcomes were observed when propensity score matching was applied. In conclusion, the management of patients on OAC submitted to a TAVI procedure is challenging and requires balancing the risk of bleeding with the risk of thromboembolic events. The present study suggests that continued OAC was not associated with increased in-hospital VARC-2 life-threatening or disabling bleeding, major vascular complications, and VARC-2 early safety at 30 days.

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique in transcatheter aortic valve-in-valve procedures: a single-center initial experience.

AIM: To describe six cases using the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique to prevent coronary artery obstruction during transcatheter aortic valve-in-valve procedures. METHODS: All patients presented degeneration of a bovine pericardium bioprosthesis [four Trifecta (19, 21, 23, and 25 mm); two Mitroflow (25 and 27 mm)] resulting in severe aortic stenosis (n = 5) or severe aortic regurgitation (n = 1). Procedures were performed under fluoroscopic and echocardiography guidance, and the transfemoral access was used to deliver a self-expanding valve. Data are expressed as frequency or median (Q1-Q3). RESULTS: Age, EuroScore II, and Society of Thoracic Surgeons score were 81 years (75-83.2), 2.9% (2.6-10.7), and 2.7% (2.3-3.2), respectively. Median left and right coronary heights were 9.1 mm (6.2-10.3) and 12.4 mm (10-13.5), respectively, with a median virtual transcatheter heart valve-to-coronary distance of 2.9 mm on the left and 4.6 mm on the right side. Isolated left leaflet laceration was planned in four patients, and bileaflet in two. One unsuccessful right leaflet laceration was reported, corresponding to the first patient (success rate 87.5%). All other seven leaflets lacerations were successfully performed, with no intraprocedure complications. No coronary obstruction, in-hospital death, valve complication, cardiovascular event, or pacemaker implantation were reported. All patients are being followed in routine outpatient visits, and no adverse events were registered. CONCLUSION: The high procedural success and low complication rate reported in this initial experience, demonstrates that the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique can be a viable solution to prevent coronary obstruction in selected patients undergoing valve-in-valve procedures. Operator experience, periprocedural imaging and teamwork are essential to enable an accurate and successful procedure.

Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy.

BACKGROUND: Cerebral embolic protection devices (CEPDs) have emerged as a mechanical barrier to prevent debris from reaching the cerebral vasculature, potentially reducing stroke incidence. Bovine aortic arch (BAA) is the most common arch variant and represents challenge anatomy for CEPD insertion during transcatheter aortic valve replacement (TAVR). METHODS: Cohort study reporting the SentinelTM Cerebral Protection System insertion's feasibility and safety in 165 adult patients submitted to a transfemoral TAVR procedure from April 2019 to April 2020. Patients were divided into 2 groups: (1) BAA; (2) non-BAA. RESULTS: Median age, EuroScore II, and STS score were 79 years (74-84), 2.9% (1.7-6.2), and 2.2% (1.6-3.2), respectively. BAA was present in 12% of cases. Successful two-filter insertion was 86.6% (89% non-BAA vs. 65% BAA; p = 0.002), and debris was captured in 95% (94% non-BAA vs. 95% BAA; p = 0.594). No procedural or vascular complications associated with Sentinel insertion and no intraprocedural strokes were reported. There were two postprocedural non-disabling strokes, both in non-BAA. CONCLUSION: This study demonstrated Sentinel insertion feasibility and safety in BAA. No procedural and access complications related to Sentinel deployment were reported. Being aware of the bovine arch prevalence and having the techniques to navigate through it allows operators to successfully use CEPDs in this anatomy.

Using coronary CT angiography for guiding invasive coronary angiography: potential role to reduce intraprocedural radiation exposure.

OBJECTIVES: We investigated the potential reduction of patient exposure during invasive coronary angiography (ICA) if the procedure had only been directed to the vessel with at least one ≥ 50% stenosis as described in the CT report. METHODS: Dose reports of 61 patients referred to ICA because of at least one ≥ 50% stenosis on coronary CT angiography (CCTA) were included. Dose-area product (DAP) was documented separately for left (LCA) and right coronary arteries (RCA) by summing up the single DAP for each angiographic projection. The study population was subdivided as follows: coronary intervention of LCA (group 1) or RCA (group 2) only, or of both vessels (group 3), or further bypass grafting (group 4), or no further intervention (group 5). RESULTS: 57.4% of the study population could have benefitted from reduced exposure if catheterization had been directly guided to the vessel of interest as described on CCTA. Mean relative DAP reductions were as follows: group 1 (n = 18), 11.2%; group 2 (n = 2), 40.3%; group 3 (n = 10), 0%; group 4 (n = 3), 0%; group 5 (n = 28), 28.8%. CONCLUSIONS: Directing ICA to the vessel with stenosis as described on CCTA would reduce intraprocedural patient exposure substantially, especially for patients with single-vessel stenosis. KEY POINTS: • Patients with CAD can benefit from decreased radiation exposure during coronary angiography. • ICA should be directed solely to significant stenoses as described on CCTA. • Severely calcified plaques remain a limitation of CCTA leading to unnecessary ICA referrals.

Predicting reinterventions after open and endovascular aneurysm repair using the St George's Vascular Institute score.

BACKGROUND: Identifying patients at risk for aneurysm rupture and sac expansion after open and endovascular abdominal aortic aneurysm (AAA) repair (EVAR) may help to attenuate this risk by intensifying follow-up and early detection of problems. The goal of this study was to validate the St George's Vascular Institute (SGVI) score to identify patients at risk for a secondary intervention after elective aneurysm repair. METHODS: A post hoc on-treatment analysis of a randomized trial comparing open AAA repair and EVAR was performed. In this multicenter trial, 351 patients were randomly assigned to undergo open AAA repair or EVAR. Information on survival and reinterventions was available for all patients at 5 years postoperatively, for 79% at 6 years, and for 53% at 7 years. Open repair was completed in 173 patients and EVAR in 171, based on an on-treatment analysis. Because 17 patients had incomplete anatomic data, 327 patients (157 open repair and 170 EVAR) were available for analysis. During 6 years of follow-up, 78 patients underwent at least one reintervention. The SGVI score, which is calculated from preoperative AAA morphology using aneurysm and iliac diameter, predictively dichotomized patients into groups at high-risk or low-risk for a secondary intervention. The observed freedom from reintervention was compared between groups at predicted high-risk and predicted low-risk. RESULTS: The 20 patients in the high-risk group were indeed at higher risk for a secondary intervention compared with the 307 patients predicted to be at low risk (hazard ratio [HR], 3.82; 95% confidence interval [CI], 2.05-7.11; P < .001). Discrimination between high-risk and low-risk groups was valid for EVAR (HR, 4.06; 95% CI, 1.93-8.51; P < .001) and for open repair (HR, 3.41; 95% CI, 1.02-11.4; P = .033). CONCLUSIONS: The SGVI score appears to be a useful tool to predict reintervention risk in patients after open repair and EVAR.

Prevalence of severely impaired left ventricular ejection fraction after reperfused ST-elevation myocardial infarction.

BACKGROUND: Preventive implantation of an implantable cardioverter defibrillator (ICD) early after myocardial infarction failed to demonstrate a survival benefit in patients with depressed left ventricular ejection fraction (LVEF). This may be explained by early recovery of the LVEF after percutaneous coronary intervention (PCI). We sought to determine the incidence of a sustained LVEF ≤35% in patients with severely depressed LVEF early after a revascularised acute ST-segment elevation myocardial infarction (STEMI). METHODS: LVEF was assessed in patients with an acute STEMI treated with PCI in two Swiss high-volume centres within 10 days (in-hospital LVEF) after the STEMI. Those with an in-hospital LVEF ≤35% were scheduled for follow-up LVEF measurement within 6-8 weeks. RESULTS: A total of 330 patients were included (79% male, mean age 63 ± 12 years). In-hospital LVEF measured 3 ± 3 days after STEMI was ≤35% in 32/330 patients (10%, 95% confidence interval (CI) 13%-67%). LVEF was available in 31/32 (97%) patients at follow-up 53 ± 19 days after STEMI and improved to >35% in 19 patients (61%, 95% CI 42%-78%). The incidence of a LVEF ≤35% at follow-up was 39% (12/31, 95% CI 22%-56%). CONCLUSION: Our data demonstrate that the incidence of severely impaired LV function 53 ± 19 days after a STEMI treated with PCI is low. A severely depressed LVEF early after STEMI was present in 10% of all patients. Only 39% of these patients had a persistently impaired LVEF during follow-up. These findings support an expectant strategy before considering primary preventive ICD implantation after STEMI.

Clinical characteristics, sex hormones, and long-term follow-up in Swiss postmenopausal women presenting with Takotsubo cardiomyopathy.

BACKGROUND: The overwhelming majority of patients with stress cardiomyopathy (SC) are postmenopausal women, suggesting an important pathophysiologic role of the female sex hormones. Preliminary data suggest that myocardial stunning might be provoked by estrogen deficiency. HYPOTHESIS: We hypothesized that, compared with age- and gender-matched patients with myocardial infarction (MI) or patients with normal coronary arteries, patients with SC would exhibit altered levels of sex hormones. Furthermore, we aimed to describe the clinical course and the pattern of sex hormones of the SC patients during long-term follow-up. METHODS: Blood samples obtained on hospital admission were analyzed for estradiol (E2), progesterone (P), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) in women with SC (n = 17), age-matched women with acute MI (n = 16), and women with normal coronary arteries (n = 15). Six years after the initial event, SC patients underwent a clinical and echocardiographic follow-up and reassessment of sex hormones. RESULTS: Estrogen concentrations at hospital admission were significantly higher in the SC group compared with the MI and the control groups, with no difference in P, FSH, and LH concentrations. Follow-up E2 after 6 years in SC patients was lower than during the acute SC episode. Follow-up P in these patients was lower than P in the MI and control groups during the acute event, with a similar trend for E2. After a median follow-up of 6.4 years, 1 sudden cardiac death occurred and 2 patients suffered from SC recurrence. CONCLUSIONS: During the acute event, E2 concentrations are elevated in postmenopausal SC patients compared with women with acute MI or with normal coronary arteries. The higher E2 concentrations might have exerted atheroprotective effects and thus diverted the stress response to SC rather than MI. Recurrence and/or sudden cardiac death remains a potential risk of SC.

Benefit of outpatient cardiac rehabilitation in under-represented patient subgroups.

OBJECTIVE: To assess the effect of outpatient cardiac rehabilitation in important patient subgroups. DESIGN: Prospective cohort study. SUBJECTS: Consecutive patients from March 1999 until July 2003. METHODS: This study assessed the results of symptom-limited bicycle stress testing and health-related quality of life (Profil der Lebensqualität Chronisch Kranker) at baseline and after a 3-month rehabilitation program, and complications and drop-outs during outpatient cardiac rehabilitation. RESULTS: Of 1061 patients, 155 (15%) women, 87 (8%) men aged >or= 75 years, 162 (15%) had diabetes mellitus and 88 (8%) did not speak the local language. Reasons for outpatient cardiac rehabilitation included acute coronary artery disease (87%), valvular heart disease (9%) and congestive heart failure (1%). Mean age was 62 years (standard deviation 11). Patients increased both their age- and body-weight-adjusted workload (p < 0.0001) and quality of life (p < 0.0001) during the program. Although the initial workload achieved was lower than for normal patients (p < 0.0001), it increased in all subgroups during outpatient cardiac rehabilitation (p < 0.0001). Baseline quality of life was lower in women, but increased in most dimensions for all subgroups assessed. CONCLUSION: Important subgroups, such as women, elderly men, diabetic patients and ethnic minorities, are under-represented in outpatient cardiac rehabilitation, although they benefit similarly to other patients. Due to lower baseline quality of life, women may need special medical attention prior to outpatient cardiac rehabilitation.

They are not stealthy in the heart: embryonic stem cells trigger cell infiltration, humoral and T-lymphocyte-based host immune response.

OBJECTIVE: The in vivo immunogenicity of Embryonic Stem Cells is controversial. At present, there is only in vitro evidence of MHC I expression by this cell population but vivid speculation about their immune-privileged state. The immunology aspect of ESC transplantation deserves thorough investigation. METHODS: We injected mouse ESC (expressing Green Fluorescent Protein, GFP) into injured myocardium of syngeneic, allogeneic and SCID recipients. Furthermore, we monitored host response for up to 4 weeks post cell transfer. We determined local response (CD 3, CD 11c expression by host cells), MHC I expression by donor cells, MHC-II expression within and around the graft, humoral response of allogeneic hosts using Flow Cytometry and evaluated the hosts' cytokine response using stimulated spleenocytes by means of ELISPOT. Cell survival was estimated by morphometry, by calculating the area of the GFP+ graft over the area of infarction at multiple sections of the harvested heart. RESULTS: There was significant cellular infiltration into and around the graft consisting of T-lymphocytes (CD3+) and dendritic cells (CD 11c). Infiltration was detectable at 1 week and progressed through 4 weeks following cell transplantation. The humoral Ab response was moderate at 2 weeks but frank at 4 weeks. ELISPOT demonstrated a Th1 pathway of donor specific T-lymphocyte response with strong IFN-gamma and Il-2 production (figure A). MHC I expression was significant within the graft and maximal in the allogeneic groups. CONCLUSIONS: An immune response against transplanted ESC was demonstrated and the future use of ESC will likely require the use of systemic immunosuppression.