Percutaneous Management of Aortic Root Rupture After Balloon-Expandable TAVR.

This article presents a case of aortic root rupture after transfemoral aortic valve replacement, successfully treated by a percutaneous approach, with a good evolution of the patient both during hospitalization and in the long term, being asymptomatic at the cardiovascular level after 18 months of follow-up. (Level of Difficulty: Advanced.).

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire.

BACKGROUND: The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we evaluated health status outcomes, based on the TASQ, in patients with severe AS undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). METHODS: The TASQ registry was a prospective observational registry. Patients with severe AS from nine centres in Europe and one in Canada underwent either SAVR or transfemoral TAVR. Patients completed the TASQ, Kansas City Cardiomyopathy Questionnaire and Short Form-12 V.2 prior to the intervention, predischarge, and at 30-day and 3-month follow-ups. Primary end point was the TASQ score. RESULTS: In both the TAVR (n=137) and SAVR (n=137) cohorts, significant increases were observed in all three scores. The overall TASQ score improved as did all but one of the individual domains at 3 months after the intervention (p<0.001). TASQ health expectations were the only domain which worsened (p<0.001). Across TASQ subscores, significant changes were evident from the time of discharge in the TAVR and 30-day follow-up in the SAVR cohort. In a categorical analysis of the TASQ, 39.7% of the TAVR group and 35.0% of the SAVR group had a substantially improved health status at 3 months compared with baseline. CONCLUSIONS: The TASQ captured changes in QoL among patients with severe AS who were treated with TAVR or SAVR. QoL improved substantially after either intervention, as indicated by changes in the TASQ overall score at 3 months. TRIAL REGISTRATION NUMBER: NCT03186339.

Balloon-expanding transcatheter aortic valve implantation for degenerated Mitroflow bioprostheses: clinical and echocardiographic long-term outcomes.

OBJECTIVES: This study aims to analyse the risks associated with valve-in-valve procedures for treating structural valve deterioration in Mitroflow bioprostheses, as well as to determine the impact of the original Mitroflow size on the patients' long-term outcomes. METHODS: Between January 2012 and September 2019, 21 patients (61.9% males; mean age 82.4 ± 5.4 years) were treated for Mitroflow deterioration with valve-in-valve procedures (12 transapical and 9 transfemoral). RESULTS: Mean EuroSCORE I and EuroSCORE II were 28.2% ± 13.6% and 10.5% ± 6.1%, respectively. Six patients presented an indexed aortic root diameter <14 mm/m2 and 7 patients a diameter of sinus of Valsalva <30 mm. Implanted transcatheter valve sizes were 20 mm in 6 cases, 23 mm in 14 cases and 26 mm in 1 patient. A Valve Academic Research Consortium-2 complication occurred in 23.8% of cases, including 3 coronary occlusions. In-hospital mortality was 9.5%. The 20 mm transcatheter valves presented significantly higher postoperative peak and mean aortic gradients than other sizes (54.1 ± 11.3 mmHg vs 29.9 ± 9.6 mmHg, P = 0.003; and 29.3 ± 7.7 mmHg vs 17.4 ± 5.9 mmHg, P = 0.015, respectively). There were 12 cases of patient-prosthesis mismatch (57.1%) and 3 cases (14.3%) of severe patient-prosthesis mismatch. Cumulative survival was 85.7% ± 7.6% at 1 year, 74.3% ± 10% at 2 years and 37.1% ± 14.1% at 5 years. CONCLUSIONS: Valve-in-valve procedures with balloon-expandable transcatheter valves associate a high risk of coronary occlusion in patients with indexed aortic root diameter <14 mm/m2 and low coronary ostia <12 mm. Valve-in valve procedures with 20 mm balloon-expandable transcatheter valves in ≤21 mm Mitroflow bioprosthesis leave significant residual transvalvular gradients that might obscure patients' long-term outcomes.

Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease.

INTRODUCTION AND OBJECTIVES: Economic studies may help decision making in the management of multivessel disease in the setting of myocardial infarction. We sought to perform an economic evaluation of CROSS-AMI (Complete Revascularization or Stress Echocardiography in Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction) randomized clinical trial. METHODS: We performed a cost minimization analysis for the strategies (complete angiographic revascularization [ComR] and selective stress echocardiography-guided revascularization [SelR]) compared in the CROSS-AMI clinical trial (N=306), attributable the initial hospitalization and readmissions during the first year of follow-up, using current rates for health services provided by our health system. RESULTS: The index hospitalization costs were higher in the ComR group than in SelR arm (19 657.9±6236.8 € vs 14 038.7±4958.5 €; P <.001). There were no differences in the costs of the first year of follow-up rehospitalizations between both groups for (ComR 2423.5±4568.0 vs SelR 2653.9±5709.1; P=.697). Total cost was 22 081.3±7505.6 for the ComR arm and 16 692.6±7669.9 for the SelR group (P <.001). CONCLUSIONS: In the CROSS-AMI trial, the initial extra economic costs of the ComR versus SelR were not offset by significant savings during follow-up. SelR seems to be more efficient than ComR in patients with ST-segment elevation acute coronary syndrome and multivessel disease treated by emergent angioplasty. Study registred at ClinicalTrial.gov (Identifier: NCT01179126).

Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire.

AIMS: There is no quality of life tool specifically developed for patients with severe aortic stenosis (AS) to assess how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) has been developed to overcome this gap. The results of the validation of the TASQ in patients undergoing treatment for severe AS are presented. METHODS AND RESULTS: Prospective study at 10 centres in Europe and Canada, which enrolled 274 patients with severe symptomatic AS undergoing surgical or transcatheter aortic valve replacement. Mean TASQ score at baseline was 71.2 points and increased to 88.9 three months after aortic valve implantation (P < 0.001). Increases were seen for the emotional impact (32.0 to 39.0; P < 0.001), physical limitations (14.8 to 22.0; P < 0.001), and physical symptoms (8.5 vs. 11.0; P < 0.001) domains. Internal consistency was good/excellent for overall TASQ score (α = 0.891) and for the physical limitation, emotional impact, and social limitation domains (α = 0.815-0.950). Test-retest reliability was excellent or strong for the overall TASQ (intraclass correlation coefficient of 0.883) and for the physical symptoms, physical limitation, emotional impact, and social limitation domains (intraclass correlation coefficient of 0.791-0.895). Responsiveness was medium overall (Cohen's d = 0.637) and medium/large for physical symptoms, emotional impact, and physical limitations (0.661-0.812). Sensitivity to change was significant for physical symptoms, physical limitations (both P < 0.001), emotional impact (P = 0.003), and social limitations (P = 0.038). CONCLUSIONS: The TASQ is a new, brief, self-administered, and clinically relevant health-specific tool to measure changes in quality of life in patients with AS undergoing an intervention.

Diagnóstico y tratamiento de la obstrucción al flujo en dispositivos de asistencia ventricular de flujo continuo. Un problema infrecuente / Flow obstruction of continuous-flow ventricular assist devices. Diagnosis and treatment of an uncommon problem

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Angiographically Guided Complete Revascularization Versus Selective Stress Echocardiography-Guided Revascularization in Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Disease: The CROSS-AMI Randomized Clinical Trial.

BACKGROUND: Recent trials suggest that complete revascularization in patients with acute ST-segment-elevation myocardial infarction and multivessel disease is associated with better outcomes than infarct-related artery (IRA)-only revascularization. There are different methods to select non-IRA lesions for revascularization procedures. We assessed the clinical outcomes of complete angiographically guided revascularization versus stress echocardiography-guided revascularization in patients with ST-segment-elevation myocardial infarction. METHODS: We performed a randomized clinical trial in patients with multivessel disease who underwent a successful percutaneous coronary intervention of the IRA to test differences in prognosis (composite end point included cardiovascular mortality, nonfatal reinfarction, coronary revascularization, and readmission for heart failure after 12 months of follow-up) between complete angiographically guided revascularization (n=154) or stress echocardiography-guided revascularization (n=152) of the non-IRA lesions in an elective procedure before hospital discharge. RESULTS: The trial was prematurely stopped after the inclusion of 77% of the planned study population. As many as 152 (99%) patients in the complete revascularization group and 44 (29%) patients in the selective revascularization group required a percutaneous coronary intervention procedure of a non-IRA lesion before discharge. The primary end point occurred in 21 (14%) patients of the stress echocardiography-guided revascularization group and 22 (14%) patients of the complete angiographically guided revascularization group (hazard ratio, 0.95; 95% CI, 0.52-1.72; P=0.85). CONCLUSIONS: In patients with ST-segment-elevation myocardial infarction and multivessel disease, stress echocardiography-guided revascularization may not be significantly different to complete angiographically guided revascularization, thereby reducing the need for elective revascularization before hospital discharge. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01179126.

Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry.

Background: Patients with severe aortic stenosis (AS) have a reduced life expectancy and quality of life (QoL), owing to advanced age and the presence of multiple comorbidities. Currently, there is no AS-specific QoL measurement tool, which prevents an accurate assessment of how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) was developed in order to address this deficiency. Methods: The present trial protocol was designed to enable validation of the TASQ, which has been produced in five languages (English, French, German, Italian and Spanish) to increase usability. Patients with severe AS who are undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) will be asked to complete the TASQ and, for comparative purposes, the Kansas City Cardiomyopathy Questionnaire and the general health-related QoL Short Form-12 questionnaire. The questionnaires will be completed prior to the intervention, at discharge, as well as at 30 days and 3 months follow-up. A total of 290 patients will be recruited across one Canadian and nine European centres. Overall, the protocol validation aims to include 120 patients undergoing transfemoral TAVI (TF-TAVI), 120 undergoing SAVR and up to 50 being treated medically. The primary objective of the registry is to validate the TASQ in five different languages. The secondary objective is to assess the utility of the TASQ for assessing differences in QoL outcome between patients undergoing TF-TAVI, SAVR or medical management for their AS. Discussion: Validation and roll-out of the TASQ will enable clinicians to capture an accurate assessment of how AS and its management affects the QoL of patients and will help them to determine the most appropriate treatment strategy for individual patients. Trial registration number: NCT03186339.

Efficacy and safety of transcatheter valve-in-valve replacement for Mitroflow bioprosthetic valve dysfunction.

OBJECTIVES: Bioprostheses with pericardial leaflets mounted externally on the stent pose a high risk for valve-in-valve (ViV) procedures. This study analyzed the efficacy and safety of ViV procedures for treating structural valve deterioration (SVD) in Mitroflow bioprostheses. METHODS: Between January 2012 and August 2017, 11 patients (mean age 80.3 ± 5.6 years) were treated for SVD of Mitroflow bioprostheses with transcatheter ViV procedures (six transapical [TA] and five transfemoral [TF]) using balloon expandable bioprostheses. RESULTS: All patients but one were in NYHA class III-IV. Mean STS PROM, euroSCORE I, and euroSCORE II were 8 ± 6.5%, 27.8 ± 11.5%, and 12 ± 5.9%, respectively. Two patients had a "porcelain aorta." The size of implanted valves were 23 mm in 10 cases and 26 mm in one case. One patient suffered a coronary occlusion during a TF approach. The mean volume of contrast used in TF implants was 163 ± 69.8 mL. No contrast media were used in TA procedures. There was one in-hospital death (10%). At 1 year of follow-up, peak and mean aortic gradients were 25.5 ± 5.8 mmHg and 15.5 ± 5.7 mmHg, respectively. One patient had mild paravalvular regurgitation. Cumulative survival was 90.9% at 1 year, 70.7% at 2 years, and 53% at 3 years. CONCLUSIONS: ViV procedures with balloon-expandable aortic valves provide good hemodynamic and clinical mid-term results for treating patients with a degenerated Mitroflow aortic bioprosthesis. Special care must be taken in small aortic roots, when the stented valve is in the supra-annular position to avoid coronary ostial obstruction.

Post-introduction observation of transcatheter aortic valve implantation in Galicia (Spain).

RATIONALE, AIMS AND OBJECTIVES: Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making. METHODS: The study protocol was developed by a multidisciplinary team consisting of experts from the Galician HTA Agency (avalia-t), interventional cardiologists and cardiac surgeons. Together they agreed on the information that was relevant and feasible for collection, and planned the study design, data collection and analysis of results. RESULTS: During the 1-year recruitment period, 94 patients underwent percutaneous aortic valve replacement in the three authorized centres. Implantation rate and prosthesis models differed substantially across the centres. Overall, procedural success rate was 96.8% and hospital mortality was 7.4%. Complications during post-surgical admission were recorded in 40.4% of patients. Moderate residual aortic regurgitation was observed in 10% of patients, and the procedure was associated with a stroke rate of 3.3% at 30 days and 5.3% at 1 year. CONCLUSIONS: Post-introduction observation has made it feasible to determine the use of this procedure within the SERGAS context and has enabled the assessment of performance in real-life conditions. The proposed strategic actions and interventions have been drawn up based upon the collective judgement of a group of experienced professionals, and have served to establish recommendations on further research that would be required to optimize health benefits.

Timely reperfusion for ST-segment elevation myocardial infarction: Effect of direct transfer to primary angioplasty on time delays and clinical outcomes.

Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy for patients presenting with ST-segment elevation myocardial infarction (STEMI) when it can be performed expeditiously and by experienced operators. In spite of excellent clinical results this technique is associated with longer delays than thrombolysis and this fact may nullify the benefit of selecting this therapeutic option. Several strategies have been proposed to decrease the temporal delays to deliver PPCI. Among them, prehospital diagnosis and direct transfer to the cath lab, by-passing the emergency department of hospitals, has emerged as an attractive way of diminishing delays. The purpose of this review is to address the effect of direct transfer on time delays and clinical events of patients with STEMI treated by PPCI.

Long-term prognostic value of mitral regurgitation in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention.

The presence of mitral regurgitation (MR) is associated with an impaired prognosis in patients with ischemic heart disease. However, data with regard to the impact of this condition in patients with ST-segment elevation myocardial infarction (STEMI) treated by means of primary percutaneous coronary intervention (PPCI) are lacking. Our aim was to assess the effect of MR in the long-term prognosis of patients with STEMI after PPCI. We analyzed a prospective registry of 1,868 patients (mean age 62 ± 13 years, 79.9% men) with STEMI treated by PPCI in our center from January 2006 to December 2010. Our primary outcome was the composite end point of all-cause mortality or admission due to heart failure during follow-up. After exclusions, 1,036 patients remained for the final analysis. Moderate or severe MR was detected in 119 patients (11.5%). Those with more severe MR were more frequently women (p <0.001), older (p <0.001), and with lower ejection fraction (p <0.001). After a median follow-up of 2.8 years (1.7 to 4.3), a total of 139 patients (13.4%) experienced our primary end point. There was an association between the unfavorable combined event and the degree of MR (p <0.001). After adjustment for relevant confounders, moderate or severe MR remained as an independent predictor of the combined primary end point (adjusted hazard ratio [HR] 3.14, 95% confidence interval [CI] 1.57 to 6.27) and each event separately (adjusted HR death 3.1, 95% CI 1.34 to 7.2; adjusted HR heart failure 3.3, 95% CI 1.16 to 9.4). In conclusion, moderate or severe MR detected early with echocardiography was independently associated with a worse long-term prognosis in patients with STEMI treated with PPCI.

Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry.

OBJECTIVES: This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). BACKGROUND: Very little data exist on CO following TAVI. METHODS: This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). RESULTS: Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 ± 2.1 mm vs. 13.4 ± 2.1 mm, p < 0.001; 28.1 ± 3.8 mm vs. 31.9 ± 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. CONCLUSIONS: Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Long-term prognostic benefit of field triage and direct transfer of patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention.

Direct transfer (DT) to the catheterization laboratory has been demonstrated to reduce delays in primary percutaneous coronary intervention (PPCI). However, data with regard to its effect on long-term mortality are sparse. The aim of this study was to investigate the effect of DT on long-term mortality in patients with ST-segment elevation myocardial infarctions treated with PPCI. A cohort study was conducted of 1,859 patients (mean age 63.1 ± 13 years, 80.2% men) who underwent PPCI from May 2005 to December 2010. From the whole series, 425 patients (23%) were admitted by DT and 1,434 (77%) by emergency departments. DT patients were younger (mean age 61 ± 12 vs 64 ± 12 years, p = 0.017), were more frequently men (86% vs 76%, p = 0.001), and had a higher proportion of abciximab use (77% vs 64%, p <0.0001). The DT group had a shorter median contact-to-balloon time (105 vs 122 minutes, p <0.0001) and a shorter time to treatment (185 vs 255 minutes, p <0.0001) compared with the emergency department group. Thirty-day and long-term mortality (median follow-up 2.4 years, interquartile range 1.6 to 3.2) were lower in the DT group (3% vs 6%, p = 0.049, and 9.4% vs 14.4%, p = 0.008, respectively). An adjusted Cox regression analysis proved that the DT group had an improved prognosis during follow-up (hazard ratio 0.71, 95% confidence interval 0.50 to 0.99). In conclusion, DT of patients with ST-segment elevation myocardial infarctions for PPCI was associated with fewer delays and improved survival. This benefit was maintained after long follow-up. This strategy should be emphasized in all networks of ST-segment elevation myocardial infarction care.

Percutaneous closure of paravalvular leaks after transcatheter aortic valve implantation with Edwards SAPIEN prosthesis: a report of two cases.

Significant periprosthetic aortic regurgitation after transcatheter aortic valve implantation with Edwards SAPIEN prosthesis has become a major concern of this technique given its association with impaired survival. We report the successful closure of such defects using vascular occlusion devices with significant improvement in clinical status of patients.