Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. METHODS: We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. RESULTS: We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. CONCLUSIONS: Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.).

Patients With AMI and Severely Reduced LVEF, a Well-Defined, Still Extremely Vulnerable Population (Insights from AMIS Plus Registry).

Left ventricular ejection fraction (LVEF) represents one of the strongest predictors of both in-hospital and long-term prognosis in acute myocardial infarction (AMI). Temporal trends data coming from real-world experiences focused on patients with AMI with severely reduced LVEF (i.e., <30%) are lacking. In a total of 48,543 screened patients with AMI included in the Acute Myocardial Infarction in Switzerland Plus Registry between 2005 and 2020, data on LVEF were available for 23,510 patients. Study patients were classified according to LVEF as patients with AMI with or without severely reduced LVEF (i.e., patients with LVEF <30% and ≥30%, respectively). Overall, 1,657 patients with AMI (7%) displayed severely reduced LVEF. The prevalence of severe LVEF reduction constantly decreased over the study period (from 11% to 4%, p <0.001). In the subgroup of patients with severely reduced LVEF, a significant increase in revascularization rate was observed (from 61% to 84%, p <0.001); however, in-hospital mortality did not significantly decrease and remained well above 20% over the study period (from 23% to 26%, p = 0.65). At discharge, prescription of optimal cardioprotective therapy (defined as an association of renin-angiotensin-aldosterone-system inhibitors, ß-blocker, and mineral corticoid receptor antagonist) remained low across the study period (from 17% in 2011 to 20%, p = 0.96). In conclusion, patients with AMI with severely reduced LVEF remain a fragile subgroup of patients with an in-hospital mortality that did not significantly decrease and remained well above 20% over the study period. Moreover, access at discharge to optimal cardioprotective therapy remains suboptimal. Efforts are, therefore, needed to improve prognosis and access to guidelines-directed therapies in this fragile population.

One- and two-year clinical outcomes of treatment with resorbable magnesium scaffolds for coronary artery disease: the prospective, international, multicentre BIOSOLVE-IV registry.

BACKGROUND: Bioresorbable scaffolds have been developed to overcome the limitations of drug-eluting stents and to reduce long-term adverse events. AIMS: We aimed to assess the long-term safety and efficacy of a sirolimus-eluting resorbable magnesium scaffold to ensure its safe rollout into clinical routine. METHODS: BIOSOLVE-IV is a prospective, international, multicentre registry including more than 100 centres in Europe, Asia, and Asia-Pacific. Enrolment started directly after the commercialisation of the device. Follow-up assessments are scheduled at 6 and 12 months, and annually for up to 5 years; we herein report the 24-month outcomes. RESULTS: Overall, 2,066 patients with 2,154 lesions were enrolled. Patients were 61.9±10.5 years old, 21.6% had diabetes, and 18.5% had non-ST-elevation myocardial infarction (NSTEMI). Lesions were 14.8±4.0 mm long with a reference vessel diameter of 3.2±0.3 mm. Device and procedure success were 97.5%, and 99.1%, respectively. The 24-month target lesion failure (TLF) rate was 6.8%, mainly consisting of clinically driven target lesion revascularisations (6.0%). Patients with NSTEMI had significantly higher TLF rates than those without (9.3% vs 6.2%; p=0.025), whereas there were no significant differences observed for patients with diabetes or with type B2/C lesions (a 24-month TLF rate of 7.0% and 7.9%, respectively). The 24-month rate of definite or probable scaffold thrombosis was 0.8%. Half of the scaffold thromboses occurred after premature discontinuation of antiplatelet/anticoagulation therapy, and only one scaffold thrombosis occurred beyond the 6-month follow-up, on day 391. CONCLUSIONS: The BIOSOLVE-IV registry showed good safety and efficacy outcomes, confirming a safe rollout of the Magmaris into clinical practice.

A prospective, first-in-human use of the NeVa mechanical thrombectomy device for patients with acute coronary syndromes.

BACKGROUND: There is no established technique for managing large thrombus burden (LTB) in patients with acute coronary syndrome (ACS). AIMS: The aim of this study was to assess the safety and efficacy of the NeVa (Vesalio) mechanical thrombectomy device (MTD) in ACS patients with LTB. METHODS: Consecutive patients with ACS and LTB were treated with the NeVa MTD as the primary vessel recanalisation and thrombus removal modality, followed by conventional intervention. We further developed a bench model and applied to a subset of patients, a vacuum-assisted aspiration technique, exploiting 6 Fr-compatible conventional guiding catheter extensions, as an adjudicative manoeuvre to the use of stent-based MTD. A core laboratory reviewed the angiographic images for procedural complications, Thrombolysis In Myocardial Infarction (TIMI) flow, myocardial blush grade (MBG) and TIMI thrombus grade (TTG). RESULTS: Between November 2019 and March 2021, 61 patients underwent thrombectomy with the NeVa device. Non-flow limiting and reversible coronary spasm occurred in 14 (23%) patients. One patient (#10) suffered from side branch embolisation, which was successfully treated with the NeVa, triggering the development of a vacuum-assisted aspiration technique in a bench model, which was then applied to the subsequent 51 patients. No other device-related complications occurred. After NeVa use, TIMI flow <3 decreased from 68.3% at baseline to 10.3% (p<0.001), MBG <2 from 65% to 27.6% (p<0.001), TTG ≥3 from 96.7% to 43.2% (p<0.001), respectively. CONCLUSIONS: In patients with LTB, the NeVa MTD was safe and associated with high rates of vessel recanalisation and thrombus removal. The concomitant use of vacuum-assisted aspiration has potential to improve the effectiveness and safety of the technique.

A patient-centered multidisciplinary cardiac rehabilitation program improves glycemic control and functional outcome in coronary artery disease after percutaneous and surgical revascularization.

BACKGROUND: Cardiac rehabilitation (CR) is strongly associated with all-cause mortality reduction in patients with coronary artery disease (CAD). The impact of CR on pathological risk factors, such as impaired glucose tolerance (IGT) and functional recovery remains under debate. The aim of the present study is to determine whether CR had a positive effect beside physical exercise improvement on pathological risk factors in IGT and diabetic patients with CAD. METHODS: One hundred and seventy-one consecutive patients participating in a 3-month CR from January 2014 to June 2015 were enrolled. The primary endpoint was defined as an improvement of peak workload and VO2-peak; glycated hemoglobin (HbA1c) reduction was considered as secondary endpoint. RESULTS: Euglycemic patients presented a significant improvement in peak workload compared to diabetic patients (from 5.75 ± 1.45 to 6.65 ± 1.84 METs vs. 4.8 ± 0.8 to 4.9 ± 1.4 METs , p = 0.018). VO2-peak improved in euglycemic patients (VO2-peak from 19.3 ± 5.3 to 22.5 ± 5.9 mL/min/kg, p = 0.003), while diabetic patients presented only a statistically significant trend (VO2-peak from 16.9 ± 4.4 to 18.0 ± 3.8 mL/min/kg, p < 0.056). Diabetic patients have benefited more in terms of blood glucose control compared to IGT patients (HbA1c from 7.7 ± 1.0 to 7.4 ± 1.1 compared to 5.6 ± 0.4 to 5.9 ± 0.5, p = 0.02, respectively). CONCLUSIONS: A multidisciplinary CR program improves physical functional capacity in CAD setting, particularly in euglycemic patients. IGT patients as well as diabetic patients may benefit from a CR program, but long-term outcome needs to be clarified in larger studies.

A prospective, multicentre first-in-man study of the polymer-free ultrathin-strut BIOrapid stent (BIOVITESSE).

BACKGROUND: Polymer-free drug-coated stents aim to avoid the inflammatory potential of durable polymers, thereby improving the long-term safety profile, and allowing a shorter duration of dual antiplatelet therapy. AIMS: The BIOVITESSE study was conducted to assess the safety and clinical performance of the BIOrapid polymer-free coronary stent system coated with a novel highly lipophilic sirolimus derivate. METHODS: BIOVITESSE was a prospective, multicentre, first-in-man study that enrolled subjects with de novo coronary lesions in two cohorts of 33 patients each. The primary endpoint of the first cohort was strut coverage at one month as assessed by optical coherence tomography. The primary endpoint of the second cohort was late lumen loss at nine-month follow-up. RESULTS: Patients were on average 63 years old (range: 42-87) and 12% had diabetes. The 66 patients had 70 lesions with an average lesion length of 12.5±5.4 mm. Predilatation was performed in 91.4% and post-dilatation in 87.1% lesions; device success was obtained in 97.4%. At one month, 95.2±5.6% (95% CI: 93.2-97.2) of struts were covered and at nine months, in-stent late lumen loss was 0.31±0.30 mm (95% CI: 0.20-0.42) and in-segment late lumen loss was 0.20±0.29 mm. Two target lesion failures occurred (3.1%): one at day 1 (to cover an asymptomatic stent edge dissection), and one at day 288 post-procedure for restenosis. No stent thrombosis was reported during the 12-month study duration. CONCLUSIONS: The BIOrapid stent system exhibited an excellent safety profile, high strut coverage at one-month, and moderate angiographic efficacy according to the late lumen loss at nine-month angiographic follow-up.

Dual antiplatelet therapy is under-prescribed in patients with surgically treated acute myocardial infarction.

OBJECTIVES: Despite guideline recommendations, previous reports, coming mainly from outside Europe, showed low rates of prescriptions for dual antiplatelet therapy (DAPT) in patients with acute myocardial infarction (AMI) undergoing surgical revascularization. The present study assesses this issue in the era of potent P2Y12 inhibitors in Switzerland. METHODS: All patients with a diagnosis of AMI included in the Acute Myocardial Infarction in Switzerland Plus Registry from January 2014 to December 2019 were screened; 9050 patients undergoing either percutaneous (8727, 96.5%) or surgical (323, 3.5%) revascularization were included in the analysis. RESULTS: Surgically treated patients were significantly less likely to receive DAPT at discharge (56.3% vs 96.7%; P < 0.001). Even when discharged with a prescription for DAPT, those patients were significantly less likely to receive a regimen containing a new P2Y12 inhibitor (67/182 [36.8%] vs 6945/8440 [83.2%]; P < 0.001). At multivariate analysis, surgical revascularization was independently associated with a lower likelihood of receiving a prescription for DAPT at discharge (odds ratio 0.03, 95% confidence interval 0.02-0.06). CONCLUSIONS: DAPT prescriptions for patients with AMI undergoing surgical revascularization are not in line with current guideline recommendations. Efforts are necessary to clarify the role of DAPT for secondary prevention in these patients and increase the confidence of treating physicians in guideline recommendations. CLINICAL TRIAL REGISTRATION: Acute Myocardial Infarction in Switzerland Plus Registry; registration number at ClinicalTrials.gov: NCT01305785.

Rationale and design of the MULTISTARS AMI Trial: A randomized comparison of immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel disease.

About half of patients with acute ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (MVD). Recent evidence supports complete revascularization in these patients. However, optimal timing of non-culprit lesion revascularization in STEMI patients is unknown because dedicated randomized trials on this topic are lacking. STUDY DESIGN: The MULTISTARS AMI trial is a prospective, international, multicenter, randomized, two-arm, open-label study planning to enroll at least 840 patients. It is designed to investigate whether immediate complete revascularization is non-inferior to staged (within 19-45 days) complete revascularization in patients in stable hemodynamic conditions presenting with STEMI and MVD and undergoing primary percutaneous coronary intervention (PCI). After successful primary PCI of the culprit artery, patients are randomized in a 1:1 ratio to immediate or staged complete revascularization. The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year. CONCLUSIONS: The MULTISTARS AMI trial tests the hypothesis that immediate complete revascularization is non-inferior to staged complete revascularization in stable patients with STEMI and MVD.

Tendencias temporales en los pacientes con IAMCEST y presentación tardía: datos del registro AMIS Plus 1997-2017 / Temporal trends in latecomer STEMI patients: insights from the AMIS Plus registry 1997-2017

INTRODUCCIÓN Y OBJETIVOS: Una proporción relevante de pacientes con infarto de miocardio con elevación del segmento ST (IAMCEST) tiene una presentación tardía (> 12 h tras el inicio de los síntomas). El objetivo de este estudio fue evaluar las tendencias temporales en estos pacientes. MÉTODOS: Se incluyó a todos los pacientes con IAMCEST del registro AMIS Plus entre enero de 1997 y diciembre de 2017 (27.231 pacientes) y se clasificaron como de presentación temprana o tardía según el retraso en la demanda de atención médica (≤ o> 12 h, respectivamente). RESULTADOS: Se observó una disminución en la prevalencia de presentación tardía del 22 al 12,3% (p <0,001). En los pacientes con IAMCEST y presentación tardía hubo un marcado aumento en la prescripción de inhibidores del P2Y12 (del 6 al 90,7%; p <0,001) y en la tasa de intervención coronaria percutánea (ICP), particularmente en los pacientes con presentación entre 12 y 48 h (del 11,9 al 87,9%; p <0,001). La mortalidad hospitalaria se redujo del 12,4 al 4,5% (p <0,001). En el análisis multivariado, en los pacientes con presentación entre 12 y 48 h, la ICP tuvo un fuerte efecto protector independiente sobre la mortalidad hospitalaria (OR = 0,29; IC95%, 0,15-0,55). CONCLUSIONES: Durante el periodo de 20 años del estudio, los pacientes con IAMCEST y presentación tardía mostraron una reducción en su prevalencia, una gradual aceptación del tratamiento farmacológico basado en la evidencia y un marcado incremento en la proporción de ICP. En pacientes con IAMCEST y presentación tardía, la mortalidad hospitalaria se redujo a un tercio (hasta el 4,5%); en los pacientes con presentación entre 12 y 48 h, esta reducción parece estar asociada principalmente con un aumento de la tasa de ICP

INTRODUCTION AND OBJECTIVES: A substantial proportion of patients experiencing ST-segment elevation myocardial infarction (STEMI) have a late presentation. There is a lack of temporal trends drawn from large real-word scenarios in these patients. METHODS: All STEMI patients included in the AMIS Plus registry from January 1997 to December 2017 were screened and patient-related delay was assessed. STEMI patients were classified as early or latecomers according to patient-related delay (≤ or> 12hours, respectively). RESULTS: A total of 27 231 STEMI patients were available for the analysis. During the study period, the prevalence of late presentation decreased from 22% to 12.3% (P <.001). In latecomer STEMI patients, there was a gradual uptake of evidence-based pharmacological treatments (rate of P2Y12 inhibitors at discharge, from 6% to 90.6%, P <.001) and a marked increase in the use of percutaneous coronary intervention (PCI), particularly in 12- to 48-hour latecomers (from 11.9%-87.9%; P <.001). In-hospital mortality was reduced from 12.4% to 4.5% (P <.001). On multivariate analysis, PCI had a strong independent protective effect on in-hospital mortality in 12- to 48-hour latecomers (OR, 0.29; 95%CI, 0.15-0.55). CONCLUSIONS: During the 20-year study period, there was a progressive reduction in the prevalence of late presentation, a gradual uptake of main evidence-based pharmacological treatments, and a marked increase in PCI rate in latecomer STEMI patients. In-hospital mortality was reduced to a third (to an absolute rate of 4.5%); in 12- to 48-hour latecomers, this reduction seemed to be mainly associated with the increasing implementation of PCI

Heavy Drinking Habits Are Associated with Worse In-Hospital Outcomes in Patients with Acute Coronary Syndrome: An Insight from the AMIS Plus Registry.

BACKGROUND: The association between alcohol consumption and the occurrence of coronary heart disease is well described in the literature, while data regarding the impact of regular alcohol consumption on in-hospital outcomes in the setting of acute coronary syndrome (ACS) are lacking. We aimed to evaluate the impact of self-reported alcohol consumption on in-hospital outcomes in patients with ACS. METHODS: Data derived from patients enrolled between 2007 and 2019 in the Acute Myocardial Infarction in Switzerland (AMIS) Plus registry were retrospectively analyzed. Patients were stratified based on alcohol drinking pattern. Primary outcome was all-cause in-hospital mortality, while secondary outcomes were set as incidence of major adverse cardiac and cerebrovascular events (MACCEs). Outcome comparisons according to quantity of daily alcohol intake were also performed. RESULTS: Records concerning alcohol consumption were available in 25,707 patients; 5,298 of them (21%) fulfilled the criteria of regular alcohol consumption. Regular drinkers were predominantly male, younger, smokers, more comorbid and with a worse clinical presentation as compared with abstainers/occasional drinkers. Daily alcohol intake was reported in 4,059 (77%) of these patients (regular drinkers). Among them, 2,640 were light drinkers (≤2 drinks/day) and 1,419 heavy drinkers (>2 drinks/day). In-hospital mortality and MACCEs of heavy drinkers were significantly higher compared with those of light drinkers (5.4 vs. 3.3% and 7.0 vs. 4.4%, both p = 0.001). When tested together with Global Registry of Acute Coronary Events risk score parameters, heavy alcohol consumption was independently associated with in-hospital mortality (p = 0.004). CONCLUSIONS: Our results support that heavy alcohol consumption is an independent predictor of in-hospital mortality in patients presenting with ACS.

Role of the central autonomic nervous system intrinsic functional organisation and psychosocial factors in primary microvascular angina and Takotsubo syndrome.

INTRODUCTION AND OBJECTIVE: Dysfunctional central autonomic nervous system network (CAN) at rest may result in aberrant autonomic responses to psychosocial stressors. We hypothesised that patients with primary microvascular angina (MVA) or Takotsubo syndrome (TTS) would exhibit a peculiar functional organisation of the CAN, potentially associated with psychological patterns. METHODS: Patients underwent a psychosocial evaluation: a clinical diagnostic interview, Millon Clinical Multiaxial Inventory III, State-Trait Anxiety Inventory form Y and Short Form 36 Health Survey (SF-36). The strength of intrinsic functional connectivity (FC) between various nodes of the CAN was investigated using cerebral resting state functional MRI (RS-fMRI). RESULTS: We evaluated 50 (46 women) stable patients: 16 patients with MVA, 17 patients with TTS and 17 patients with previous acute myocardial infarction (AMI). Compared with AMI, patients with MVA showed a lower (higher impairment) SF-36 Body-Pain score (p 0.046) and a higher SF-36 Mental-Health score (p 0.039). Patients with TTS showed the strongest FC between two nodes of the CAN (sympathetic midcingulate cortex and parasympathetic primary motor area) (F 6.25, p 0.005) using RS-fMRI. CONCLUSIONS: The study implements an innovative collaborative research among cardiologists, neuroscientists and psychiatrists ('Neuro-psycho-heart Team'). MVA showed a discrepancy between the highest level of self-reported body pain and the best mental health score, which might suggest a mechanism of somatisation. TTS exhibited an increased functional integration between two areas of the CAN involved in interoceptive pain awareness and negative emotional status. We implemented an innovative research collaboration among cardiologists, neuroscientists and psychiatrists. These data are hypothesis generating and suggest potential prospective investigations on pathophysiology and implementation of psychotherapy and stress-reducing techniques as therapeutic strategies. TRIAL REGISTRATION NUMBER: NCT02759341.

Early cardiac unloading with ImpellaCP™ in acute myocardial infarction with ventricular septal defect.

Despite a relative contraindication, mechanical support with Impella™ left ventricular assist device has already been described for ischaemic ventricular septal defect treatment, either as a bridge to surgery, as intraoperative mechanical haemodynamic support, or to ensure intraprocedural haemodynamic stability during device closure. We describe two cases of ventricular septal defect complicating acute myocardial infarction, where the percutaneous ImpellaCP was implanted early (differently than previously described) with the aim of preventing haemodynamic instability, while deferring surgical repair. We present a report of haemodynamic, echocardiographic, biochemical, and clinical data of two consecutive cases of ImpellaCP use, within a minimally invasive monitoring and therapeutic approach. In two cases of subacute myocardial infarction-related ventricular septal defect not amenable to percutaneous device closure, the use ImpellaCP was successful: it was followed by effective and rapid right and left ventricular unloading, by major haemodynamic instability prevention and protection from systemic venous congestion, from kidney and splanchnic organ failures. This allowed bridging to appropriately timed surgical repair. These cases suggest a potentially effective, clinically grounded strategy in the early management of ischaemic ventricular septal defect patients, with the aim of deferring surgery beyond the safer 7 days cutoff associated with a lower perioperative mortality.

Intractable coronary fibromuscular dysplasia leading to end-stage heart failure and fatal heart transplantation.

Coronary fibromuscular dysplasia is uncommon, and even rarer its unstable and recurrent course. We present the unique case of a 52-year-old woman who underwent in total 12 coronary angiographies and three percutaneous coronary intervention within 24 months because of repetitive acute coronary syndromes due to refractory spasm, dissection, restenosis all leading to end-stage heart failure, and heart transplantation. The patient died 12 days after the heart transplantation complicated by intraoperative acute thrombotic occlusion of left anterior descending artery of the graft despite normal pretransplant coronary angiography. Autopsy of the recipient heart confirmed coronary fibromuscular dysplasia with massive intimal hyperplasia and restenosis.

Temporal trends in latecomer STEMI patients: insights from the AMIS Plus registry 1997-2017.

INTRODUCTION AND OBJECTIVES: A substantial proportion of patients experiencing ST-segment elevation myocardial infarction (STEMI) have a late presentation. There is a lack of temporal trends drawn from large real-word scenarios in these patients. METHODS: All STEMI patients included in the AMIS Plus registry from January 1997 to December 2017 were screened and patient-related delay was assessed. STEMI patients were classified as early or latecomers according to patient-related delay (≤ or> 12hours, respectively). RESULTS: A total of 27 231 STEMI patients were available for the analysis. During the study period, the prevalence of late presentation decreased from 22% to 12.3% (P <.001). In latecomer STEMI patients, there was a gradual uptake of evidence-based pharmacological treatments (rate of P2Y12 inhibitors at discharge, from 6% to 90.6%, P <.001) and a marked increase in the use of percutaneous coronary intervention (PCI), particularly in 12- to 48-hour latecomers (from 11.9%-87.9%; P <.001). In-hospital mortality was reduced from 12.4% to 4.5% (P <.001). On multivariate analysis, PCI had a strong independent protective effect on in-hospital mortality in 12- to 48-hour latecomers (OR, 0.29; 95%CI, 0.15-0.55). CONCLUSIONS: During the 20-year study period, there was a progressive reduction in the prevalence of late presentation, a gradual uptake of main evidence-based pharmacological treatments, and a marked increase in PCI rate in latecomer STEMI patients. In-hospital mortality was reduced to a third (to an absolute rate of 4.5%); in 12- to 48-hour latecomers, this reduction seemed to be mainly associated with the increasing implementation of PCI.

Baseline Predictors of Renal Failure in Transcatheter Aortic Valve Implantation.

BACKGROUND: Acute kidney injury (AKI) post transcatheter aortic valve implantation (TAVI) is associated with worsened short- and long-term outcomes. We sought to identify significant baseline predictors of AKI and establish a high-risk group within patients enrolled in the multicenter SWISS-TAVI cohort. METHODS AND RESULTS: A total of 526 patients who underwent TAVI were included in our analysis. Patients on hemodialysis were excluded. Within the first week after valve implantation, fifty patients (9.5%) developed AKI. There was a significantly higher prevalence of diabetes mellitus in the AKI group (45% vs 28%; P=.02). The odds ratio (OR) for patients suffering from diabetes mellitus who developed AKI was 1.9 after multivariable binary regression analysis (95% confidence interval, 1.018-3.553; P=.04). Chronic kidney disease (CKD) stage ≥4 was more prevalent in the AKI group (26% vs 14%; P=.04). Every 1 mg/dL creatinine above normal level at baseline increased AKI risk by a factor of 1.6 (OR, 1.605; 95% CI, 1.111-2.319; P=.01). Age, gender, body mass index, history of dyslipidemia, and history of hypertension were similar between the groups. In the diabetic population of 155 patients (29.5%), AKI developed in 22 patients (14.2%), compared with the non-diabetic population of 370 patients (70.5%), where AKI developed in 27 patients (7.3%). In the diabetic population, an elevation by 1 mg/dL in baseline creatinine was an independent predictor of developing kidney injury (OR, 2.061; 95% CI, 1.154-3.683; P=.02, while in non-diabetic patients, neither baseline glomerular filtration rate, CKD grade, STS score, EuroScore II, ACEF score, nor procedural contrast usage were predictors of AKI. CONCLUSION: Diabetics with CKD stage ≥4 (as defined by the Kidney Disease: Improving Global Outcomes criteria) constitute a high-risk group for developing AKI after TAVI. In this high-risk subgroup, baseline creatinine in combination with amount of contrast agent used were strong risk factors for developing AKI. AKI in non-diabetics was less predictable by baseline characteristics.

La fibrilación auricular de nueva aparición o preexistente en los síndromes coronarios agudos: dos fenómenos distintos con un pronóstico comparable / New-onset or pre-existing atrial fibrillation in acute coronary syndromes: two distinct phenomena with a similar prognosis

Introducción y objetivos: El tratamiento y la estratificación del riesgo de los pacientes con fibrilación auricular (FA) y síndromes coronarios agudos son todo un reto. El objetivo es evaluar el impacto pronóstico de la FA, ya sea al ingreso como la aparecida durante la hospitalización por síndrome coronario agudo, así como las tendencias en los tratamientos y el resultado. Métodos: Se analizaron retrospectivamente los datos procedentes de 35.958 pacientes incluidos entre 2004 y 2015 en el registro AMIS Plus. Resultados: Había FA preexistente (FApre) en 1.644 pacientes (4,7%), mientras que se evidenció FA de nueva aparición (FAnueva) en 309 (0,8%). La presentación con infarto agudo de miocardio con elevación del segmento ST y la necesidad de asistencia hemodinámica fueron frecuentes en los pacientes con FA, especialmente aquellos con FA nueva. Se observó un cambio en los enfoques médicos e intervencionistas, con un progresivo aumento de la prescripción de anticoagulación oral y las derivaciones para angiografías e intervenciones coronarias percutáneas de pacientes con FApre. A pesar de los diferentes perfiles de riesgo iniciales y presentaciones clínicas, ambos grupos de FA mostraron grandes y comparables mortalidades hospitalaria y a 1 año (FAnueva frente a FApre: mortalidad hospitalaria, OR = 0,79; IC95%, 0,53-1,17; p = 0,246; mortalidad a 1 año, OR = 0,72; IC95%, 0,31-1,67; p = 0,448). La FApre, pero no la FAnueva, predijo de manera independiente la mortalidad hospitalaria. Si bien la mortalidad de aquellos con FApre disminuyó durante el periodo de estudio, se mantuvo estable entre los pacientes con FAnueva. Conclusiones: Mientras que la FApre se asocia de manera independiente con la mortalidad hospitalaria, la FA nueva puede reflejar un peor impacto hemodinámico del síndrome coronario agudo, lo que en última instancia determina el pronóstico

Introduction and objectives: The management and risk stratification of patients with atrial fibrillation (AF) and acute coronary syndromes constitute a challenge. We aimed to evaluate the prognostic impact of AF whether present at admission or occurring during hospitalization for acute coronary syndromes, as well as trends in treatments and outcome. Methods: Data derived from 35 958 patients enrolled between 2004 and 2015 in the AMIS Plus registry were retrospectively analyzed. Results: Pre-existing AF (pre-AF) was present in 1644 (4.7%) while new-onset AF (new-AF) was evident in 309 (0.8%). Presentation with ST-segment elevation myocardial infarction and need for hemodynamic support was frequent in patients with AF, especially in those with new onset of the arrhythmia. A change of the medical and interventional approaches was observed with a progressive increase in oral anticoagulation prescription and referral for angiography and percutaneous coronary interventions in pre-AF patients. Despite different baseline risk profile and clinical presentations, both AF groups showed high in-hospital and 1-year mortality (in-hospital new-AF vs pre-AF [OR, 0.79; 95%CI, 0.53-1.17; P = .246]; 1-year mortality new-AF vs pre-AF [OR, 0.72; 95%CI, 0.31-1.67; P = .448]) Pre-AF but not new-AF independently predicted in-hospital mortality. While mortality declined over the study period for patients with pre-AF, it remained stable among new-AF patients. Conclusions: While pre-AF is independently associated with in-hospital mortality, new-AF may reflect a worse hemodynamic impact of the acute coronary syndromes, with the latter ultimately driving the prognosis

Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis.

OBJECTIVES: The authors sought to collect data on contemporary practice and outcome of transcatheter aortic valve replacement (TAVR) in oncology patients with severe aortic stenosis (AS). BACKGROUND: Oncology patients with severe AS are often denied valve replacement. TAVR may be an emerging treatment option. METHODS: A worldwide registry was designed to collect data on patients who undergo TAVR while having active malignancy. Data from 222 cancer patients from 18 TAVR centers were compared versus 2,522 "no-cancer" patients from 5 participating centers. Propensity-score matching was performed to further adjust for bias. RESULTS: Cancer patients' age was 78.8 ± 7.5 years, STS score 4.9 ± 3.4%, 62% men. Most frequent cancers were gastrointestinal (22%), prostate (16%), breast (15%), hematologic (15%), and lung (11%). At the time of TAVR, 40% had stage 4 cancer. Periprocedural complications were comparable between the groups. Although 30-day mortality was similar, 1-year mortality was higher in cancer patients (15% vs. 9%; p < 0.001); one-half of the deaths were due to neoplasm. Among patients who survived 1 year after the TAVR, one-third were in remission/cured from cancer. Progressive malignancy (stage III to IV) was a strong mortality predictor (hazard ratio: 2.37; 95% confidence interval: 1.74 to 3.23; p < 0.001), whereas stage I to II cancer was not associated with higher mortality compared with no-cancer patients. CONCLUSIONS: TAVR in cancer patients is associated with similar short-term but worse long-term prognosis compared with patients without cancer. Among this cohort, mortality is largely driven by cancer, and progressive malignancy is a strong mortality predictor. Importantly, 85% of the patients were alive at 1 year, one-third were in remission/cured from cancer. (Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis [TOP-AS]; NCT03181997).

New-onset or Pre-existing Atrial Fibrillation in Acute Coronary Syndromes: Two Distinct Phenomena With a Similar Prognosis.

INTRODUCTION AND OBJECTIVES: The management and risk stratification of patients with atrial fibrillation (AF) and acute coronary syndromes constitute a challenge. We aimed to evaluate the prognostic impact of AF whether present at admission or occurring during hospitalization for acute coronary syndromes, as well as trends in treatments and outcome. METHODS: Data derived from 35 958 patients enrolled between 2004 and 2015 in the AMIS Plus registry were retrospectively analyzed. RESULTS: Pre-existing AF (pre-AF) was present in 1644 (4.7%) while new-onset AF (new-AF) was evident in 309 (0.8%). Presentation with ST-segment elevation myocardial infarction and need for hemodynamic support was frequent in patients with AF, especially in those with new onset of the arrhythmia. A change of the medical and interventional approaches was observed with a progressive increase in oral anticoagulation prescription and referral for angiography and percutaneous coronary interventions in pre-AF patients. Despite different baseline risk profile and clinical presentations, both AF groups showed high in-hospital and 1-year mortality (in-hospital new-AF vs pre-AF [OR, 0.79; 95%CI, 0.53-1.17; P = .246]; 1-year mortality new-AF vs pre-AF [OR, 0.72; 95%CI, 0.31-1.67; P = .448]) Pre-AF but not new-AF independently predicted in-hospital mortality. While mortality declined over the study period for patients with pre-AF, it remained stable among new-AF patients. CONCLUSIONS: While pre-AF is independently associated with in-hospital mortality, new-AF may reflect a worse hemodynamic impact of the acute coronary syndromes, with the latter ultimately driving the prognosis.

Transcatheter Mitral Valve Replacement in Patients With Previous Aortic Valve Replacement.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) may mature to become a therapeutic option for high-risk patients with severe mitral regurgitation (MR), particularly in patients at high or prohibitive surgical risk. MR patients with preexisting aortic valve prosthesis have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anchoring mechanism and the aortic prosthesis. We describe the procedural and short-term outcomes of transapical TMVR with the Tiara valve in patients experiencing severe symptomatic MR with previous aortic valve replacement (AVR). METHODS AND RESULTS: Twelve consecutive high surgical risk patients (11 men; mean age, 75±6 years) with aortic valve prosthesis and severe MR underwent TMVR with Tiara valve. Aortic valves were mechanical in 5 and biological in 7 patients, while 1 patient had previously undergone implantation of a transcatheter valve within a failed bioprosthetic surgical valve. Six patients (50%) had undergone redo surgical aortic valve replacement. Clinical characteristics of the group include prior mitral valve repair in 2, prior coronary bypass grafting surgery in 5, chronic atrial fibrillation in 7, renal failure in 9, and pacemaker/cardiac resynchronization device in 9 patients. Mean Society of Thoracic Surgery score and EuroSCORE II were 10.5±4.4 and 12.4±3.7, respectively. Mean baseline left ventricular ejection fraction was 35.5±5.3% (range, 30%-45%). The Tiara valve was implanted uneventfully in all patients. Device migration or left ventricular outflow tract obstruction was not observed. No patient required conversion to open heart surgery or periprocedural hemodynamic support. Procedural success was 100% with no death, MI, stroke, major bleeding, or access site complications at 30 days. MR was eliminated in all 12 patients immediately after implantation. CONCLUSIONS: Transapical mitral valve replacement with the Tiara valve in high-risk patients with severe MR and aortic valve prostheses is technically feasible and can be performed safely.

Access Sites for TAVI: Patient Selection Criteria, Technical Aspects, and Outcomes.

During the last ten years, transcatheter aortic valve implantation (TAVI) has become a reliable and valid alternative treatment for elderly patients with severe symptomatic aortic valve stenosis requiring valve replacement and being at high or intermediate surgical risk. While common femoral arteries are the access site of choice in the vast majority of TAVI patients, in up to 15-20% of TAVI candidates this route might be precluded due to the presence of diffuse atherosclerotic disease, tortuosity or small vessel diameter. Therefore, in order to achieve an antegrade or retrograde implant, several alterative access routes have been described, namely trans-axillary, trans-aortic, trans-apical, trans-carotid, trans-septal, and trans-caval. The aim of this paper is to give a concise overview on vascular access sites for TAVI, with a particular focus on patient's selection criteria, imaging, technical aspects, and clinical outcome.