Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients.

OBJECTIVES: We aimed to describe hemodynamic performance and clinical outcomes at 30-day follow-up of the balloon-expandable (BE) Myval transcatheter heart valve (THV) in low-risk patients. BACKGROUND: The results of the next-generation BE Myval THV in low-risk aortic stenosis (AS) patients are still unknown. METHODS: Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE-II) scores. RESULTS: Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE-II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30-day follow-up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm2 ) and mean aortic valve gradient (43.4 ± 11.1 vs. 9.0 ± 3.7 mmHg) improved significantly (p < 0.001). Moderate aortic regurgitation occurred in 4%. Endpoints of early safety and clinical efficacy were 3 and 1%, respectively. CONCLUSIONS: Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.

Surgical versus transcatheter aortic valve replacement in low-risk patients: A long-term propensity score-matched analysis.

BACKGROUND: Recent studies suggest the use of transcatheter aortic valve implantation (TAVI) as an alternative to surgical aortic valve replacement (SAVR) in lower risk populations, but real-world data are scarce. METHODS: Single-center retrospective study of patients undergoing SAVR (between June 2009 and July 2016, n = 682 patients) or TAVI (between June 2009 and July 2017, n = 400 patients). Low surgical risk was defined as EuroSCORE II (ES II) < 4% for single noncoronary artery bypass graft procedure. TAVI patients were propensity score-matched in a 1:1 ratio with SAVR patients, paired by age, New York Heart Association class, diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation, creatinine clearance, and left ventricular ejection fraction < 50%. RESULTS: A total of 158 patients (79 SAVR and 79 TAVI) were matched (mean age 79 ± 6 years, 79 men). TAVI patients had a higher incidence of permanent pacemaker implantation (0% vs. 19%, p < 0.001) and more than mild paravalvular leak (4% vs. 18%, p = 0.009), but comparable rates of stroke, major or life-threatening bleeding, emergent cardiac surgery, new-onset atrial fibrillation, and need for renal replacement therapy. Hospital length-of-stay and 30-day mortality were similar. At a median follow-up of 4.5 years (IQR 3.0-6.9), treatment strategy did not influence all-cause mortality (HR 1.19, 95% CI 0.77-1.83, log rank p = 0.43) nor rehospitalization (crude subdistribution HR 1.56, 95% CI 0.71-3.41, p = 0.26). ES II remained the only independent predictor of long-term all-cause mortality (adjusted HR 1.40, 95% CI 1.04-1.90, p = 0.029). CONCLUSION: In this low surgical risk severe aortic stenosis population, we observed similar rates of 30-day and long-term all-cause mortality, despite higher rates of permanent pacemaker implantation and more than mild paravalvular leak in TAVI patients. The results of this small study suggest that both procedures are safe and effective in the short-term, while the Heart Team remains essential to assess both options on the long-term.

Transcatheter aortic valve implantation (TAVI) in cardiogenic shock: TAVI-shock registry results.

OBJECTIVES: Aim of this study is to evaluate safety, feasibility, and mid-term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS). BACKGROUND: Balloon aortic valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant. METHODS: From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow-up. RESULTS: The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30-day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium-2 early safety endpoint was reached in 35.3% of cases. At 1-year of follow-up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%. CONCLUSIONS: TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long-term follow-up.

Acute left main coronary occlusion after transcatheter aortic valve implantation: life-saving intervention using the snare technique-a case report.

Background: Transcatheter aortic valve implantation (TAVI) has rapidly evolved and changed the field of structural cardiovascular intervention. Its advances lead to a marked reduction in the risk of complications and improved outcomes. However, TAVI is still associated with potential serious complications. Case summary: A 73-year-old man with severe aortic stenosis underwent TAVI using a 34-mm self-expanding aortic bioprosthesis. After valve deployment, the patient rapidly progressed to cardiac arrest. Acute left main occlusion, due to high valve implantation, was promptly recognized and advanced life support immediately initiated. Concomitantly, the valve was successfully retrieved toward the ascending aorta using the snare technique, resulting in immediate restoration of flow and successful cardiopulmonary resuscitation. Subsequently, a 29-mm balloon-expandable aortic bioprosthesis was uneventfully implanted. After TAVI, the patient had a remarkable clinical evolution and was discharged home at hospitalization day five without relevant electrocardiographic nor echocardiographic disturbances. At six-month follow-up, the patient remains asymptomatic and transthoracic echocardiography revealed a normofunctional aortic bioprosthesis with preserved left ventricular ejection fraction. Discussion: Acute coronary occlusion is a rare and life-threating complication of TAVI that may be prevented with accurate procedure planning. Pre-procedural computed tomography angiography is essential for a comprehensive patient evaluation, allowing appropriate valve selection, a key factor for successful management. Self-expandable valve retrieval with snare technique can be an appropriate strategy for the management of this complication. This case highlights the importance of performing these procedures in highly experienced centres and with fully equipped catheterization laboratories to allow timely interventions when facing unexpected events.

Predicting obstructive coronary artery disease in heart failure with reduced ejection fraction: A practical clinical score.

INTRODUCTION AND OBJECTIVES: Obstructive coronary artery disease (CAD) remains the most common etiology of heart failure with reduced ejection fraction (HFrEF). However, there is controversy whether invasive coronary angiography (ICA) should be used initially to exclude CAD in patients presenting with new-onset HFrEF of unknown etiology. Our study aimed to develop a clinical score to quantify the risk of obstructive CAD in these patients. METHODS: We performed a cross-sectional observational study of 452 consecutive patients presenting with new-onset HFrEF of unknown etiology undergoing elective ICA in one academic center, between January 2005 and December 2019. Independent predictors for obstructive CAD were identified. A risk score was developed using multivariate logistic regression of designated variables. The accuracy and discriminative power of the predictive model were assessed. RESULTS: A total of 109 patients (24.1%) presented obstructive CAD. Six independent predictors were identified and included in the score: male gender (2 points), diabetes (1 point), dyslipidemia (1 point), smoking (1 point), peripheral arterial disease (1 point), and regional wall motion abnormalities (3 points). Patients with a score ≤3 had less than 15% predicted probability of obstructive CAD. Our score showed good discriminative power (C-statistic 0.872; 95% CI 0.834-0.909: p<0.001) and calibration (p=0.333 from the goodness-of-fit test). CONCLUSIONS: A simple clinical score showed the ability to predict the risk of obstructive CAD in patients presenting with new-onset HFrEF of unknown etiology and may guide the clinician in selecting the most appropriate diagnostic modality for the assessment of obstructive CAD.

Predictive value of a positive stress single-photon emission computed tomography or stress cardiac magnetic resonance for ruling in obstructive coronary artery disease in a real-world setting.

INTRODUCTION AND OBJECTIVES: Randomized controlled trials comparing stress cardiac magnetic resonance (CMR) and single-photon emission computed tomography (SPECT) suggest similar diagnostic accuracy for detecting obstructive coronary artery disease (CAD). There are few data on whether this remains true in routine clinical practice. The aim of this study was to assess clinical and angiographic characteristics of patients undergoing invasive coronary angiography (ICA) after stress CMR or SPECT, and to compare their positive predictive value with published results from the CE-MARC trial. METHODS: In this retrospective tertiary-center analysis, we included 429 patients undergoing ICA after a positive stress CMR or positive SPECT performed within the previous 12 months. Obstructive CAD was defined as any coronary artery stenosis ≥50% in a vessel compatible with the ischemic territory on stress testing. RESULTS: Of the total 429 patients, 356 (83%) were referred after a positive SPECT, and 73 (17%) after a positive stress CMR. Patients did not differ according to age, cardiovascular risk factors, previous revascularization or left ventricular dysfunction, but patients with SPECT were more frequently male (p=0.046). The prevalence of obstructive CAD was similar in patients with positive SPECT vs. positive stress CMR (76.1% vs. 80.8%, respectively, p=0.385). The positive predictive values of both techniques were similar to those reported in the CE-MARC trial. CONCLUSION: In this tertiary center analysis, stress CMR and SPECT showed similar positive predictive values, comparable to those reported in the CE-MARC trial. This finding supports the emerging adoption of CMR in clinical practice for the diagnosis and management of CAD.

Impact of the COVID-19 pandemic on percutaneous coronary interventions in Portugal.

INTRODUCTION: The COVID-19 pandemic has imposed an unprecedented burden on healthcare systems worldwide, changing the profile of interventional cardiology activity. OBJECTIVES: To quantify and compare the number of percutaneous coronary interventions (PCIs) performed for acute and chronic coronary syndromes during the first COVID-19 outbreak with the corresponding period in previous years. METHODS: Data on PCI from the prospective multicenter Portuguese Registry on Interventional Cardiology (RNCI) were used to analyze changes in PCI for ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndromes (NSTE-ACS) and chronic coronary syndromes (CCS). The number of PCIs performed during the initial period of the COVID-19 outbreak in Portugal, from March 1 to May 2, 2020, was compared with the mean frequency of PCIs performed during the corresponding period in the previous three years (2017-2019). RESULTS: The total number of PCIs procedures was significantly decreased during the initial COVID-19 outbreak in Portugal (-36%, p<0.001). The reduction in PCI procedures for STEMI, NSTE-ACS and CCS was, respectively, -25% (p<0.019), -20% (p<0.068) and -59% (p<0.001). CONCLUSIONS: Compared with the corresponding period in the previous three years, the number of PCI procedures performed for STEMI and CCS decreased markedly during the first wave of the COVID-19 pandemic in Portugal.

Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions in collaboration with the ESC Working Group on Cardiovascular Surgery.

Significant coronary artery disease (CAD) is a frequent finding in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), and the management of these two conditions becomes of particular importance with the extension of the procedure to younger and lower-risk patients. Yet, the preprocedural diagnostic evaluation and the indications for treatment of significant CAD in TAVI candidates remain a matter of debate. In this clinical consensus statement, a group of experts from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the European Society of Cardiology (ESC) Working Group on Cardiovascular Surgery aims to review the available evidence on the topic and proposes a rationale for the diagnostic evaluation and indications for percutaneous revascularisation of CAD in patients with severe aortic stenosis undergoing transcatheter treatment. Moreover, it also focuses on commissural alignment of transcatheter heart valves and coronary re-access after TAVI and redo-TAVI.

[Percutaneous thrombus aspiration in renal artery stenosis after renal transplantation]. / Aspiração de trombos por via percutânea em estenose da artéria renal após transplante renal.

We describe the case of a patient with chronic renal failure under hemodialysis for five years who, after renal transplantation, developed acute renal failure and hypertension refractory to medical therapy. Given the clinical and imaging (renal ultrasound and computed tomography) suspicion of renal artery graft thrombosis, invasive angiography was performed, which confirmed the diagnosis. The therapeutic approach consisted of percutaneous thrombus aspiration and subsequent balloon angioplasty of the entire artery, followed by stent implantation in a second procedure. The clinical course was uneventful with improvement of renal function and normalization of blood pressure. The case highlights the importance of percutaneous intervention in the management of patients with vascular complications after transplantation, with successful application of a procedure normally used in the setting of acute myocardial infarction - percutaneous thrombus aspiration and implantation of a drug-eluting vascular stent.

[Primary PCI in ST-elevation myocardial infarction: mode of referral and time to PCI]. / ICP primária no enfarte de miocárdio com supradesnivelamento do segmento ST: tempo para intervenção e modos de referenciação.

INTRODUCTION: According to the current guidelines for treatment of ST-elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) should be performed within 90 min of first medical contact and total ischemic time should not exceed 120 min. The aim of this study was to analyze compliance with STEMI guidelines in a tertiary PCI center. METHODS: This was a prospective single-center registry of 223 consecutive STEMI patients referred for primary PCI between 2003 and 2007. RESULTS: In this population (mean age 60±12 years, 76% male), median total ischemic time was 4h 30 min (<120 min in 4% of patients). The interval with the best performance was first medical contact to first ECG (median 8 min, <10 min in 59% of patients). The worst intervals were symptom onset to first medical contact (median 104 min, <30 min in 6%) and first ECG to PCI (median 140 min, <90 min in 16%). Shorter total ischemic time was associated with better post-PCI TIMI flow, TIMI frame count and ST-segment resolution (p<0.03). The three most common patient origins were two nearby hospitals (A and B) and the pre-hospital emergency system. The pre-hospital group had shorter total ischemic time than patients from hospitals A or B (2h 45 min vs. 4h 44 min and 6h 40 min, respectively, p<0.05), with shorter door-to-balloon time (89 min vs. 147 min and 146 min, respectively, p<0.05). CONCLUSIONS: In this population, only a small proportion of patients with acute myocardial infarction underwent primary PCI within the recommended time. Patients referred through the pre-hospital emergency system, although a minority, had the best results in terms of early treatment. Compliance with the guidelines translates into better myocardial perfusion achieved through primary PCI.