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.

Safety and efficacy of femoral vascular closure devices in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: The use of vascular closure devices (VCDs) for the reduction of access site complications following percutaneous coronary intervention (PCI) remains controversial. Patients undergoing primary PCI for acute ST-segment elevation myocardial infarction (STEMI) are at high risk of femoral artery complications. A lack of information exists regarding the use of VCDs in this group of patients because they have been routinely excluded from randomized trials. This study sought to evaluate the safety and efficacy of the routine use of VCDs after primary PCI. METHODS: A total of 558 consecutive patients undergoing primary PCI for STEMI via femoral route were studied for in-hospital outcomes through a prospective registry from January 2003 to December 2008. The primary end point was the presence of major vascular complication (MVC) defined as a composite of fatal access site bleeding, access site complication requiring interventional or surgical correction, or access site bleeding with ≥3 g/dL drop in hemoglobin or requiring blood transfusion. RESULTS: Of the total patients, 464 (83.2%) received a VCD; and manual compression was used in 94 patients (16.8%). Major vascular complication occurred in 5.2% of patients. The risk of MVC was significantly lower with VCDs compared with manual compression (4.3% vs 9.6%, P = .036). Multivariable logistic regression analysis determined that VCD use remained an independent predictor of lower rate of MVC (odds ratio 0.38, 95% CI 0.17-0.91). CONCLUSIONS: The use of VCDs in patients undergoing primary PCI for STEMI is safe and is associated with lower rates of MVC compared with manual compression.

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).

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.

Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study.

AIMS: The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). CONCLUSIONS: The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.

Late thrombosis of paclitaxel-eluting stents: long-term incidence, clinical consequences, and risk factors in a cohort of 604 patients.

BACKGROUND: Late thrombosis is the major safety concern of drug-eluting stents, but its incidence in common clinical practice remains controversial to date, especially beyond the first year after stent implantation. We sought to investigate the incidence, clinical consequences, and risk factors of late thrombosis after drug-eluting stent implantation. METHODS: Consecutive patients (N = 604) who received > or = 1 paclitaxel-eluting stent(s) (PES) between June 2003 and February 2005 at our institution were enrolled. Clinical characteristics and major outcomes were reviewed to detect cases and predictors of late and very late definite PES thrombosis (LDT) of PES, as currently defined by the Academic Research Council. RESULTS: During long-term follow-up (median 34.3 months, IQR 8.6), 17 cases of LDT were noted (cumulative incidence 2.8%, 95% CI 1.7%-4.5%). Most of LDT were very late thromboses (14 cases, 82%). Late and very late definite PES thrombosis appeared at a steady rate (incidence density 1.1% patient-years). Late and very late definite PES thrombosis was related to a high risk of all-cause death (HR 3.2, 95% CI 1.3-7.9) and cardiac death (HR 6.0, 95% CI 2.3-15.6). Withdrawal of antiplatelet therapy, left ventricular ejection fraction, and average stent diameter per patient were independent predictors of LDT in multivariate analysis. CONCLUSIONS: Late and very late definite PES thrombosis may be more frequent in a real setting than anticipated by initial experimental and observational studies but is keeping with more recent scientific evidence. It seems to occur at a constant rate during long-term follow-up and is associated with a high risk of overall and cardiac death.

Bioresorbable polymer sirolimus-eluting coronary stent compared with permanent polymer everolimus-eluting coronary stent implantation for treatment of small vessel coronary artery disease: CENTURY II trial.

AIMS: CENTURY II is a prospective, multicentre, randomised, single-blind trial comparing the bioresorbable polymer sirolimus-eluting Ultimaster® stent (BP-SES) with the permanent polymer everolimus-eluting XIENCE stent (PP-EES). Here we present a pre-specified analysis of safety and efficacy outcomes in a subgroup of patients with small vessel coronary artery disease. METHODS AND RESULTS: CENTURY II included 525 patients with lesions of reference diameter ≤2.5 mm. Treatment was randomly assigned: 277 patients received BP-SES (399 lesions) and 248 patients received PP-EES (377 lesions). The primary outcome was target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction (MI) and target lesion revascularisation (TLR). There was no significant difference between treatment groups in baseline or procedural data. Mean pre-procedural reference diameter was similar (BP-SES 2.30±0.40 mm, PP-EES 2.31±0.42 mm, p=0.59). Stented length was 24.0±11.7 mm for BP-SES and 23.5±11.5 mm for PP-EES (p=0.45). At 12 months, there was no significant difference between the BP-SES and PP-EES groups in TLF (6.9% vs. 7.7%; p=0.72), cardiac death (1.1% vs. 1.2%; p=0.90), target vessel MI (1.8% vs. 3.2%; p=0.30), TLR (4.0% vs. 5.7%; p=0.37), or definite or probable stent thrombosis (0.7% vs. 1.2%; p=0.57). CONCLUSIONS: In the large-scale, randomised CENTURY II trial, use of BP-SES and PP-EES for the treatment of small vessel coronary artery disease resulted in similar outcomes at 12 months.

Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry).

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.

Prognostic value of exercise-induced left ventricular systolic dysfunction in hypertensive patients without coronary artery disease.

INTRODUCTION AND OBJECTIVES: We sought to assess the prognostic value of exercise-induced left ventricular systolic dysfunction in hypertensive patients with normal resting echocardiography and absence of coronary artery disease. METHODS: From our database of patients referred for treadmill exercise echocardiography, we identified 93 hypertensive patients with preserved resting left ventricular ejection fraction (≥ 50%), no evidence of structural heart disease, and absence of coronary artery disease on angiography. Overall, 39 patients developed exercise-induced left ventricular systolic dysfunction (defined as a decrease in left ventricular ejection fraction below 50% at peak exercise) and 54 exhibited a normal left ventricular ejection fraction response to exercise. The mean follow-up was 6.1 (3.7) years. End points were all-cause mortality, cardiac death, heart failure, and the composite event of cardiac death or heart failure. RESULTS: Patients who developed exercise-induced left ventricular systolic dysfunction were at higher risk of death from any cause (hazard ratio=3.4; 95% confidence interval, 1.1-10.3), cardiac death (hazard ratio=5.6; 95%CI, 1.1-29.4), heart failure (hazard ratio=8.9; 95% confidence interval, 1.8-44.2), and the composite end point (hazard ratio=5.7; 95% confidence interval, 1.7-19.0). In the multivariate analysis, exercise-induced left ventricular systolic dysfunction remained an independent predictor of both heart failure (hazard ratio=6.9; 95% CI, 1.3-37.4) and the composite event of cardiac death or heart failure (hazard ratio=4.5; 95% confidence interval, 1.2-16.0). CONCLUSIONS: In hypertensive patients with preserved resting left ventricular ejection fraction and absence of coronary artery disease, exercise-induced left ventricular systolic dysfunction is a strong predictor of cardiac events and may represent early hypertensive heart disease.

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.

[Transradial approach to coronary angiography and angioplasty: initial experience and learning curve]. / Coronariografía y angioplastia coronaria por vía radial: experiencia incial curva de aprendizaje.

INTRODUCTION: The transradial approach has emerged as an attractive alternative to the femoral approach for coronary angiography and interventions. We describe our experience with the transradial approach and analyze the influence of the learning curve. PATIENTS AND METHODS: The transradial approach was attempted in patients with a good radial pulse and normal Allen test. When feasible and clinically indicated, we attempted ad hoc intervention. We divided the study population into two groups: Group A (the first 200 cases) and B (all other patients). We compared the radial group with a matched femoral control group. RESULTS: We attempted the transradial approach in 526 patients (77.6% male; age 63.5 +/- 11.51), and obtained a success rate of 93.7%. We found differences between group A and B in the success rate (91.0 vs 95.4%, p = 0,04), duration of procedure [23 (16-29) vs. 19 (15-24) minutes; p < 0.001], and fluoroscopy time [6.4 (4.2-10) vs. 5.0 (3.0-7.7) minutes; p < 0,001]. At 24 h of follow-up, we found small hematomas in 9.4%, bleeding in 4.9%, and radial artery obstruction in 2.8%, with no cases of arteriovenous fistula, pseudoaneurysm, or need for vascular surgery. We attempted intervention in 169 patients with 258 lesions, achieving angiographic success in 96.1%. We found no differences in the characteristics of the lesions and patients, or in the angiographic success rate of the radial and femoral PTCA groups. CONCLUSIONS: The transradial approach is a safe and effective alternative to femoral catheterization. There is a significant learning curve associated with the successful performance of transradial procedures.

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.

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.

Intervención coronaria percutánea primaria en el SCACEST fuera del horario laboral. ¿Tiene peores resultados clínicos? / Out-of-working-hours primary percutaneous coronary intervention in STEACS: does It worsen clinical outcomes?

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