Ramiro Trillo-Nouche

The Ibero-American transcatheter aortic valve implantation registry with the CoreValve prosthesis. Early and long-term results

BACKGROUND Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. METHODS Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. RESULTS The registry included 1220 consecutive patients with a mean age of 80.8 ± 6.3 years and a mean logistic euroSCORE of 17.8% ± 13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade ≥ 2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70). CONCLUSIONS Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities.

Percutaneous Implantation of the CoreValve ® Self-expanding Valve Prosthesis in Patients With Severe Aortic Stenosis and Porcelain Aorta: Medium-term Follow-up

INTRODUCTION AND OBJECTIVES There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve(®) implantation in patients with severe aortic stenosis, with and without porcelain aorta. METHODS In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. RESULTS Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). CONCLUSIONS In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve(®) self-expanding valve prosthesis is safe and feasible.

Pro B-type natriuretic peptide plasma value: A new criterion for the prediction of short- and long-term outcomes after transcatheter aortic valve implantation

BACKGROUND To determine the prognostic value of pro B-type natriuretic peptide (pro-BNP) to predict mortality after transcatheter aortic valve implantation (TAVI). Logistic EuroSCORE (LES) overestimates observed mortality after TAVI. A new risk score specific to TAVI is needed to accurately assess mortality and outcome. METHODS Eighty-five patients were included. Indications for TAVI were nonoperable or surgically high-risk patients (LES>20%). Pro-BNP was measured 24h before the procedure. Cox proportional hazards model was used to evaluate clinical factors. The predictive accuracy of these Cox models was determined by using time-dependent receiver operating characteristic (ROC) curves. RESULTS Pro-BNP levels (log-transformed) were significantly higher in non-survivors than in survivors at 30 days (3.36 ± 0.43 vs. 3.81 ± 0.43, p<0.004) and at the end of follow-up (3.34 ± 0.42 vs. 3.63 ± 0.48, p<0.011). Multivariate analysis revealed that only increased log pro-BNP levels were associated with higher mortality rate at short [hazard ratio (HR) (95% confidence intervals (CI)]=5.35 (1.74-16.5), p=0.003] and long-term follow-ups [HR=11 (CI: 1.51-81.3), p=0.018]. LES was not associated with increased mortality at either time point [HR=1.03 (CI: 0.95-1.10), p=0.483 and HR=1.03 (CI: 0.98-1.07), p=0.230, respectively]. At 30, 90, 180, and 365 days, the c-index was 0.72 for log pro-BNP and 0.63 for LES (p=0.044). CONCLUSION Pre-procedure log transform of plasma pro-BNP levels are an independent and strong predictor of short- and long-term outcomes after TAVI and are more discriminatory than LES.

Acceso axilar en el implante percutaneo de la valvula aortica: optimizacion del tratamiento endovascular de la estenosis aortica severa

INTRODUCTION AND OBJECTIVES To validate the axillary approach as a safe and efficient option for the transcatheter aortic valve implantation in patients who have contraindication for femoral approach at three Spanish hospitals. METHODS We included patients with severe symptomatic aortic stenosis at very high or prohibitive surgical risk, selected by a multidisciplinary team, for transcatheter aortic valve implantation, and had contraindication to the femoral approach. RESULTS We included 19 of 186 (10.5%) patients, who were implanted a percutaneous aortic valve, between November 2008 and March 2010. The mean age was 78.3 (standard deviation [SD]±8.65) years and 73.7% were males. The mean logistic EuroSCORE was 28.7% (SD±16.3%). The procedural success rate was 100%. After the procedure the maximum transvalve gradient decreased from 81.7 mmHg (SD±21.5) to 15.8 mmHg (SD±5.5), and no patient presented residual aortic regurgitation >2. The all-cause mortality, with a mean follow-up time of 9.2 (SD±3.2) months was 10.5%, and the in-hospital and 30-day mortality rates were 0%. The global incidence of major complications due to the procedure was 15.7%. Definitive pacemaker implantation was carried out for atrioventricular block in 8 patients (44.4%). CONCLUSIONS The axillary approach for transcatheter aortic valve implantation using the CoreValve(®) and contraindication to the femoral approach is safe and efficient for selected patients, with excellent results in terms of success implantation and in hospital and 30-day mortality.

Multivessel Versus Culprit-only Percutaneous Coronary Intervention in ST-segment Elevation Acute Myocardial Infarction: Analysis of an 8-year Registry

INTRODUCTION AND OBJECTIVES The optimal treatment of patients with multivessel coronary artery disease and ST-segment elevation acute myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) is controversial. The aim of this study was to access the prognostic impact of multivessel PCI vs culprit vessel-only PCI in real-world patients with STEMI and multivessel disease. METHODS This was a retrospective cohort study of 1499 patients with STEMI diagnosis who underwent primary PCI between January 2008 and December 2015. About 40.8% (n=611) patients had multivessel disease. We performed a propensity score matched analysis to obtain 2 groups of 215 patients paired according to whether or not they had undergone multivessel PCI or culprit vessel-only PCI. RESULTS During follow-up (median, 2.36 years), after propensity score matching, patients who underwent multivessel PCI had lower rates of mortality (5.1% vs 11.6%; Peto-Peto P=.014), unplanned repeat revascularization (7.0% vs 12.6%; Peto-Peto P=.043) and major acute cardiovascular events (22.0% vs 30.8%; Peto-Peto P=.049). These patients also showed a trend to a lower incidence of myocardial infarction (4.2% vs 6.1%; Peto-Peto P=.360). CONCLUSIONS In real-world patients presenting with STEMI and multivessel coronary artery disease, a multivessel PCI strategy was associated with lower rates of mortality, unplanned repeat revascularization, and major acute cardiovascular events.

Implante percutáneo de válvula aórtica seguridad y eficacia del tratamiento del homoinjerto aórtico disfuncionante

INTRODUCTION AND OBJECTIVES Percutaneous aortic valve implantation for patients with severe symptomatic aortic stenosis and a high surgical risk is currently well established. We report our experience in terms of safety and effectiveness of transcatheter aortic valve implantation in other clinical context like the degenerated aortic homografts. METHODS We report our initial experience in four hospitals and five patients with degenerated aortic homograft and severe aortic regurgitation, refused for surgery for a heart team, that underwent percutaneous implantation of CoreValve(®) aortic prosthesis. RESULTS We included three males and two females. The mean age was 70 (3.5) years. All patients were symptomatic in New York Heart Association class III or IV. Procedures were performed through one of the femoral arteries in all patients and under sedation in three patients. The implant was successfully carried out in all cases. There were no major complications during the procedure or admission and the valvular defect was solved in all cases. In-hospital and 30-days mortality was 0. All patients had clinical improvement during follow-up with a reduction in at less two grades in the New York Heart Association functional scale. CONCLUSIONS In our experience the treatment of degenerated aortic homografts and aortic insufficiency with transcatheter aortic valve implantation showed to be safe and effective. The current challenge is to convey the good results of transcatheter aortic valve implantation in symptomatic aortic stenosis and high surgical risk to others disorders of the aortic valve. In the future, it is possible that transcatheter aortic valve implantation will expand its indications to majority of aortic valve disorders and patients with less surgical risk.

Real world comparison of the MGuard Stent versus the bare metal stent for ST Elevation myocardial infarction (The REWARD‐MI study)

Aim: The MGuard Stent (MGS) was designed to prevent distal embolization of thrombus and has been shown to improve microcirculation in ST‐elevation myocardial infarction (STEMI). However, there are no real world data comparing it with the bare metal stent (BMS). The aim of this study is to determine the efficacy and safety of the MGS in STEMI in the real world compared to the BMS.

Radial vs femoral access after percutaneous coronary intervention for ST-segment elevation myocardial infarction. Thirty-day and one-year mortality results.

INTRODUCTION AND OBJECTIVES Little attention has been given to the effect of vascular access site on mortality, while an increasing body of evidence is showing that radial access has much more benefit than femoral access for ST-segment elevation myocardial infarction patients. We aimed to assess the influence of vascular access site on mortality at 30 days and at 1 year in ST-segment elevation myocardial infarction patients. METHODS We included all patients with ST-segment elevation myocardial infarction who had undergone primary angioplasty at 2 Galician hospitals between 2008 and 2010. We performed 2 multivariate regression models for each endpoint (30-day and 1-year mortality). The only difference between these models was the inclusion or not of the vascular access site (femoral vs radial). For each of the 4 models we calculated the Hosmer-Lemeshow test and the C-index. We also tested the interaction between hemodynamic instability and vascular access. RESULTS We included 1461 patients with a mean age of 64. Of these patients, 86% had radial access and 7.4% had hemodynamic instability. All-cause mortality was 6.8% (100/1461) at 30 days and 9.3% (136/1461) at 1 year. Vascular access site follows hemodynamic instability and age in terms of effect on mortality risk, with an odds ratio of 5.20 (95% confidence interval, 2.80-9.66) for 30-day mortality. A similar effect occurs for 1-year mortality. The C-index slightly improves (without achieving statistical significance) with the inclusion of the vascular access site. CONCLUSIONS Vascular access site should be taken into account when predicting mortality after a primary percutaneous coronary intervention.

“Assessment of effectiveness and security in high pressure postdilatation of bioresorbable vascular scaffolds during percutaneous coronary intervention. Study in a contemporary, non-selected cohort of Spanish patients”

OBJECTIVES To determine security and benefits of high pressure postdilatation (HPP) of bioresorbable vascular scaffolds (BVS) in percutaneous coronary intervention (PCI) of complex lesions whatever its indication is. BACKGROUND Acute scaffold disruption has been proposed as the main limitation of BVS when they are overexpanded. However, clinical implications of this disarray are not yet clear and more evidence is needed. METHODS A total of 25 BVS were deployed during PCI of 14 complex lesions after mandatory predilatation. In all cases HPP was performed with NC balloon in a 1:1 relation to the artery. After that, optical coherence tomography (OCT) analyses were performed. RESULTS Mean and maximal postdilatation pressure were 17±3.80 and 20 atmospheres (atm) respectively. Postdilatation balloon/scaffold diameter ratio was 1.01. A total of 39,590 struts were analyzed. Mean, minimal and maximal scaffold diameter were respectively: 3.09±0.34mm, 2.88±0.31mm and 3.31±0.40mm. Mean eccentricity index was 0.13±0.05. ISA percentage was 1.42% with a total of 564 malapposed struts. 89 struts were identified as disrupted, which represents a percentage of disrupted struts of 0.22%. At 30days, none of our patients died, suffered from stroke, stent thrombosis or needed target lesion revascularization (TLR). CONCLUSIONS NC balloon HPP of BVS at more than 17atm (up to 20atm) is safe during PCI and allows to achieve better angiographic and clinical results.

Prognostic impact of residual SYNTAX score in patients with ST-elevation myocardial infarction and multivessel disease: Analysis of an 8-year all-comers registry

BACKGROUND The residual SYNTAX score (rSS) was designed and validated to quantify the burden of residual coronary artery disease after percutaneous coronary intervention (PCI). The aim of this study was to assess the prognostic impact of rSS in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease undergoing primary-PCI. METHODS This retrospective cohort study included 1499 consecutive patients with STEMI who underwent primary-PCI between January 2008 and December 2015. After exclusion criteria, the multivessel disease cohort (n=535) was divided into three groups, according to rSS: complete revascularization (rSS=0; n=198), reasonable incomplete revascularization (0<rSS<8; n=238) and incomplete revascularization (rSS≥8; n=99). RESULTS In-hospital mortality was significantly lower in patients with complete and reasonable incomplete revascularization, when compared to those with incomplete revascularization (1.5% vs. 1.7% vs. 9.0%, p<0.001). During follow-up (median 2.4years), rSS was positively correlated with MACE (25.3% for rSS=0 vs. 31.1% for 0<rSS<8 vs. 47.0% for rSS≥8, p=0.001) and all-cause mortality (5.1% vs. 10.5% vs. 19.2%, p=0.001). The rSS was also an independent predictor of MACE (when compared with complete revascularization, odds ratio [OR] was 1.5 for reasonable incomplete and 1.8 for incomplete revascularization) and all-cause mortality during follow-up (OR 2.9 for reasonable incomplete and 3.9 for incomplete revascularization), adding prognostic value over control variables and GRACE. CONCLUSIONS In a real-world cohort of patients with STEMI and multivessel disease who underwent PCI, the rSS added important prognostic information over control variables and GRACE, being an independent predictor of MACE and all-cause mortality during follow-up.