ABSTRACT
BACKGROUND: Despite paucity of data, it is common practice to discontinue metformin before invasive coronary angiography due to an alleged risk of Metformin-Associated Lactic Acidosis (M-ALA). We aimed at assessing the safety of metformin continuation in diabetic patients undergoing coronary angiography in terms of significant increase in lactate levels. METHODS: In this open-label, prospective, multicentre, single-arm trial, all diabetic patients undergoing coronary angiography with or without percutaneous coronary intervention at 3 European centers were screened for enrolment. The primary endpoint was the increase in lactate levels from preprocedural levels at 72-h after the procedure. Secondary endpoints included contrast associated-acute kidney injury (CA-AKI), M-ALA, and all-cause mortality. RESULTS: 142 diabetic patients on metformin therapy were included. Median preprocedural lactate level was 1.8 mmol/l [interquartile range (IQR) 1.3-2.3]. Lactate levels at 72 h after coronary angiography were 1.7 mmol/l (IQR 1.3-2.3), with no significant differences as compared to preprocedural levels (p = 0.91; median difference = 0; IQR - 0.5 to 0.4 mmol/l). One patient had 72-h levels ≥ 5 mmol/l (5.3 mmol/l), but no cases of M-ALA were reported. CA-AKI occurred in 9 patients (6.1%) and median serum creatinine and estimated glomerular filtration rate remained similar throughout the periprocedural period. At a median follow-up of 90 days (43-150), no patients required hemodialysis and 2 patients died due to non-cardiac causes. CONCLUSIONS: In diabetic patients undergoing invasive coronary angiography, metformin continuation throughout the periprocedural period does not increase lactate levels and was not associated with any decline in renal function. TRIAL REGISTRATION: The study was registered at Clinicaltrials.gov (NCT04766008).
Subject(s)
Acidosis, Lactic , Acute Kidney Injury , Diabetes Mellitus , Metformin , Humans , Acidosis, Lactic/chemically induced , Acidosis, Lactic/diagnosis , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Coronary Angiography/adverse effects , Diabetes Mellitus/chemically induced , Hypoglycemic Agents/adverse effects , Lactates , Metformin/adverse effects , Prospective StudiesABSTRACT
OBJECTIVES: To report the experience of a high-volume center with balloon-expandable (BE) stents implantation to manage vascular complications after transcatheter aortic valve replacement (TAVR). BACKGROUND: Despite increased operator experience and better devices, vascular complications after TAVR are still a major issue and covered stent implantation is often required. METHODS: We retrospectively collected baseline and procedural data about 78 consecutive patients who underwent BE stent implantation to manage a vascular complication after transfemoral TAVR. Primary endpoints were technical success, incidence of new-onset claudication and need for vascular interventions during long-term follow-up. Secondary endpoints included length of hospitalization, in-hospital and 30-day mortality, and major postoperative complications. RESULTS: BE stents implantation to manage vascular complications after TAVR was successfully performed in 96.2% of the cases, with bailout surgery required in two cases. One patient suffered in-hospital death. Predischarge Doppler Ultrasound revealed no cases of in-stent occlusion or fracture. At a median follow-up of 429 days (interquartile range, 89-994 days), no cases of symptomatic leg ischemia were reported and only one patient experienced new-onset claudication. CONCLUSIONS: Our experience showed good periprocedural and long-term results of BE covered stent implantation to manage vascular complication after TAVR. Their great radial outward force may guarantee effective hemostasis without necessarily being associated with stent deformation/fracture resulting in restenosis or further interventions. More research is needed to define the role of BE covered stents in this setting.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Vascular Diseases , Humans , Follow-Up Studies , Retrospective Studies , Hospital Mortality , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Treatment Outcome , Stents , Vascular Diseases/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/surgeryABSTRACT
OBJECTIVES: To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF). BACKGROUND: LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device. METHODS: All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence. RESULTS: A total of 52 patients were included: mean age 75 ± 8, 30.8% women, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge. CONCLUSIONS: Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Aftercare , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Female , Humans , Male , Patient Discharge , Registries , Treatment OutcomeABSTRACT
BACKGROUND: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement. METHODS: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days. RESULTS: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group. CONCLUSIONS: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Bioprosthesis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Europe , Female , Hemodynamics , Humans , Male , Prosthesis Design , Recovery of Function , Risk Assessment , Risk Factors , Severity of Illness Index , Stroke/etiology , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
OBJECTIVES AND BACKGROUND: There is conflicting evidence about the effects of drug-coated balloons (DCB) compared with drug-eluting stents (DES) in patients with native small vessel coronary artery disease (CAD). METHODS: The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases and main international conference proceedings were searched for randomized controlled trials (RCT) comparing DCB versus DES in patients with native small vessel CAD. Data were pooled by meta-analysis using a random-effects model. The primary endpoint was target vessel revascularization (TVR). Secondary clinical endpoints were: myocardial infarction (MI), target lesion revascularization (TLR), all-cause death, cardiac death, and stent thrombosis or target vessel thrombosis. Secondary angiographic outcomes were: in-segment restenosis, in-segment percentage-diameter stenosis, in-segment late lumen loss, in-segment net luminal gain, and in-segment minimal lumen diameter. RESULTS: Five trials enrolling 1,459 patients were included. Mean clinical follow-up was 10.2 months. The use of DCB, compared with DES, was associated with similar risk of TVR (odds ratio [OR]: 0.97; 95% confidence interval [CI] 0.56 to 1.68; p = .92), TLR (OR: 1.74; 95% CI: 0.57 to 5.28; p = .33), all-cause death (OR: 1.03; 95% CI: 0.14 to 7.48; p = .98), with a trend toward a lower risk of MI (OR: 0.49; 95% CI: 0.23 to 1.03; p = .06), and with significant lower risk of vessel thrombosis (OR: 0.12; 95% CI: 0.01 to 0.94; p = .04). DCB use was associated with similar risk of angiographic restenosis (OR: 1.12; 95% CI 0.69 to 1.84; p = .64), comparable late luminal loss (standardized mean difference (SMD): -0.18; 95% CI: -0.39 to 0.03; p = .09), while leading to significant higher percentage diameter stenosis (SMD: 0.27; 95% CI 0.12 to 0.41; p < .01) and smaller minimal luminal diameter (SMD: -0.52; 95% CI: -0.86 to -0.18; p = .003). CONCLUSION: Compared with DES, the use of DCB for the treatment of native small vessel CAD is associated with similar TVR and restenosis and reduces the risk of vessel thrombosis, although DES implantation yields slightly better angiographic surrogate endpoints.
Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Disease , Coronary Restenosis , Drug-Eluting Stents , Percutaneous Coronary Intervention , Pharmaceutical Preparations , Coated Materials, Biocompatible , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Humans , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Randomized Controlled Trials as Topic , Risk Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To evaluate the role of the microaxial percutaneous mechanical circulatory support device (Impella® pump) implantation pre-percutaneous coronary intervention (PCI) versus during/after PCI in cardiogenic shock (CS) and high-risk PCI populations. BACKGROUND: A better understanding of the safety and effectiveness of the Impella and the role of timing of this support initiation in specific clinical settings is of utmost clinical relevance. METHODS: A total of 365 patients treated with Impella 2.5/CP in the 17 centers of the IMP-IT Registry were included. Through propensity-score weighting (PSW) analysis, 1-year clinical outcomes were assessed separately in CS and HR-PCI patients, stratified by timing of Impella support. RESULTS: Pre-procedural insertion was associated with an improvement in 1-year survival in patients with CS due to acute myocardial infarction (AMI) treated with PCI (p = .04 before PSW, p = .009 after PSW) and HR-PCI (p < .01 both before and after PSW). Among patients undergoing HR-PCI, early Impella support was also associated with a lower rate of the composite of mortality, re-hospitalization for heart failure, and need for left-ventricular assist device/heart transplantation at 1-year (p = .04 before PSW, p = .01 after PSW). Furthermore, Impella use during/after PCI was associated with an increased in-hospital life-threatening and severe bleeding among patients with AMI-CS receiving PCI (7 vs. 16%, p = .1) and HR-PCI (1 vs. 9%, p = .02). CONCLUSIONS: Our findings suggested a survival benefit and reduced rates of major bleeding when a pre-PCI Impella implantation instead of during-after procedure was used in the setting of HR-PCI and AMI-CS.
Subject(s)
Heart-Assist Devices , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Retrospective Studies , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/etiology , Shock, Cardiogenic/therapy , Treatment OutcomeABSTRACT
Patients presenting with cardiogenic shock and severe combined aortic and mitral regurgitation represent a major clinical challenge. Therapeutic options are limited in this setting as they are often deemed inoperable due to prohibitive risk for surgery, while mechanical circulatory support is usually contraindicated or technically challenging. Medical therapy, on the other hand, is associated with high-mortality rates. Therefore, percutaneous therapies may represent an appealing alternative. Here, we present a "one-stop-shop" totally percutaneous approach for severe aortic and mitral regurgitation in a patient with cardiogenic shock.
Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve/surgery , Mitral Valve Insufficiency/surgery , Mitral Valve/surgery , Shock, Cardiogenic/physiopathology , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/physiopathology , Heart Valve Prosthesis , Hemodynamics , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Prosthesis Design , Recovery of Function , Severity of Illness Index , Shock, Cardiogenic/diagnosis , Transcatheter Aortic Valve Replacement/instrumentation , Treatment Outcome , Ventricular Function, LeftSubject(s)
Atrial Appendage , Atrial Fibrillation , Renal Insufficiency, Chronic , Thromboembolism , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Atrial Appendage/physiopathology , Thromboembolism/prevention & control , Thromboembolism/etiology , Renal Insufficiency, Chronic/complications , Anticoagulants/therapeutic use , Risk Factors , Stroke/prevention & control , Stroke/etiology , Treatment OutcomeABSTRACT
AIMS: Left atrial appendage (LAA) closure is considered an effective option in patients with non-valvular atrial fibrillation (NVAF) and contraindications to long-term oral anticoagulant (OAC) therapy. However, there are some concerns about safety of currently available devices. Our aim is to provide an initial assessment on feasibility and safety of the novel LAA closure Ultraseal device in patients with NVAF and contraindications to long-term OAC therapy. METHODS: Twenty-three consecutive patients with NVAF undergoing Ultraseal device implantation between July 2016 and February 2018 at two institutions were included. All patients performed transesophageal echocardiography and computed tomography angiography prior to LAA closure. RESULTS: Procedural success was achieved in all patients except two who experienced incorrect device deployment with incomplete LAA closure. Procedure duration halved from first to last procedure performed. The only periprocedural adverse events observed were a myocardial infarction and an in-hospital death due pneumonia. At mean follow-up (166 ± 80 days) all other patients were alive and free from major bleedings and ischaemic strokes. CONCLUSIONS: Our results suggest that the Ultraseal device is a feasible option for LAA occlusion. Notably, the learning curve in this registry was fast, paralleled by extremely low complication rates. These results should be considered hypothesis generating and larger studies are mandatory.
Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Cardiac Surgical Procedures/instrumentation , Aged , Atrial Appendage/diagnostic imaging , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Computed Tomography Angiography/methods , Echocardiography, Transesophageal/methods , Equipment Design/adverse effects , Equipment Design/methods , Equipment Failure/statistics & numerical data , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Prospective Studies , Registries , Treatment OutcomeABSTRACT
During the past decade there has been a major shift in the use of surgical bioprostheses. Consequently, due to the increasing age of the population there will be a major increase in the incidence of failure of these prostheses. While mortality associated with the re-replacement of surgical valve failures remains high, advances in transcatheter interventions have permitted the use of transcatheter valves in degenerative surgical bioprostheses. Herein is described the first use of the Symetis transfemoral ACURATEneo™ valve-in-valve procedure, together with details of the associated technical challenges. Video 1: Positioning of the TAVI prosthesis. Video 2: Valve deployment.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aortic Valve , Cardiac Catheterization , Humans , Prosthesis Design , Treatment OutcomeABSTRACT
BACKGROUND: The aim of this study was to assess the impact of bivalirudin, as compared to unfractionated heparin, on clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). METHODS: A meta-analysis of randomized trials comparing bivalirudin versus heparin in patients with STEMI undergoing primary percutaneous coronary intervention was performed. Three randomised trials enrolling 7,612 patients were included. Analysis was by intention to treat. RESULTS: At 30 days, bivalirudin, as compared to heparin, was associated with a similar risk of all-cause mortality (3.03% vs. 3.38%, odds ratio (OR) 0.90, 95% confidence intervals (CI) [0.63 to 1.29], P = 0.57). Bivalirudin significantly increased the risk of definite (2.39% vs. 1.06%, OR 2.49, 95% CI [1.30 to 4.76], P = 0.006); definite or probable (2.55% vs. 1.35%, OR 2.26, 95% CI [1.07 to 4.79], P = 0.03), and acute stent thrombosis (1.69% vs. 0.39%, OR 4.34, 95% CI [2.30 to 8.16], P < 0.001); leading to nonsignificantly higher reinfarction rates (2.0% vs. 1.31%, OR 1.72, 95% CI [0.89 to 3.35], P = 0.11), and to a significantly increased risk of ischemia driven revascularization (2.50% vs. 1.52%, OR 1.80, 95% CI [1.02 to 3.18], P = 0.04) at 30 days. No firm evidence for a reduction in major bleeding associated with bivalirudin use was found (3.93% vs. 6.39%, OR 0.63, 95% CI [0.39 to 1.04], P = 0.07). CONCLUSIONS: In patients with STEMI, bivalirudin, as compared to heparin, increases the risk of stent thrombosis and ischemia driven repeat revascularization at 30 days. There is no strong evidence that bivalirudin significantly reduces major bleeding at 30 days. Bivalirudin does not have an effect on all-cause mortality at 30 days.
Subject(s)
Anticoagulants/therapeutic use , Antithrombins/therapeutic use , Heparin/therapeutic use , Myocardial Infarction/therapy , Peptide Fragments/therapeutic use , Percutaneous Coronary Intervention , Anticoagulants/adverse effects , Antithrombins/adverse effects , Heparin/adverse effects , Hirudins/adverse effects , Humans , Peptide Fragments/adverse effects , Randomized Controlled Trials as Topic , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Treatment OutcomeABSTRACT
Regurgitation due to a paravalvular leak (PVL) is a complication that may affect patients undergoing surgical mechanical or bioprosthetic heart valve replacement. PVL can also occur after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and is associated with significantly worse outcomes. We report a case in which different closure strategies and devices were attempted and required to percutaneously close a severe PVL after TAVI in a patient with prohibitive surgical risk.
Subject(s)
Aortic Valve Insufficiency , Cardiac Catheterization , Heart Valve Prosthesis Implantation , Aged, 80 and over , Aortic Valve Insufficiency/pathology , Aortic Valve Insufficiency/physiopathology , Aortic Valve Insufficiency/surgery , Female , HumansABSTRACT
In view of the high number of bioprosthetic valves implanted during the past 30 years, an increasing number of patients are coming to medical attention because of degenerated bioprostheses. Transcatheter aortic valve-in-valve implantation has been described as a less invasive alternative to re-operation to treat severe structural valve deterioration. As far as degenerated mitral valve bioprostheses are concerned, transcatheter transapical mitral valve-in-valve replacement (TMVR) has been less commonly performed, but may also become a viable alternative to re-do replacement surgery. We describe treatment of a degenerated bioprosthetic mitral valve, characterised by complete absence of any radio-opaque landmarks making the TMVR procedure very challenging.
Subject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Mitral Valve/surgery , Prosthesis Failure , Aged, 80 and over , Female , HumansABSTRACT
Transcatheter aortic valve implantation (TAVI) has emerged as a feasible and effective alternative to aortic valve replacement in patients at high surgical risk, and is associated with a lower risk of death at 1 year follow-up when compared with standard therapy. In a recent large study, enrolling 663 high risk patients with symptomatic severe aortic stenosis TAVI with the use of CoreValve system has been associated with early and sustained clinical and hemodynamic benefits, with a cumulative mortality of 15.0% at 1 year follow-up. This study has shown that paravalvular aortic regurgitation after successful TAVI is a frequent finding, being of mild entity in the vast majority of cases, whereas valvular regurgitation is almost entirely absent or mild. Of note, no cases of structural valve deterioration were reported. We report a case of a successful implantation of a CoreValve that complicated with late onset massive intravalvular aortic regurgitation, due to CoreValve cusp rupture, leading to low output state with acute pulmonary edema, which was successfully treated with "valve in valve" implantation.
Subject(s)
Aortic Valve Insufficiency/surgery , Cardiac Catheterization , Heart Valve Prosthesis , Aged , Aortic Valve Insufficiency/diagnostic imaging , Echocardiography, Transesophageal , Humans , Male , Postoperative Complications/surgery , Prosthesis FailureABSTRACT
BACKGROUND: The impact of female sex on mortality after transcatheter aortic valve implantation (TAVI) is controversial. Post-procedural aortic regurgitation (AR) ≥ 2 has been associated with poor outcomes. Whether sex differences in post-procedural AR ≥ 2 could contribute to a mortality difference between women and men is not known. METHODS: Six hundred fifty-six patients, women (53.1%), men (46.9%), with aortic stenosis underwent TAVI with the CoreValve system (92.8%) or the Edwards SAPIEN valve system (7.2%). AR was graded semiquantitatively as 0 = none, 1 = trivial, 2 = mild, 3 = moderate, and 4 = severe. The incidence of post-procedural AR ≥ 2 was reported. RESULTS: Procedural success was similar in women as compared to men (97.9 vs 96.7%, P = 0.32). Post-procedural AR ≥ 2 occurred less frequently in women than in men (20.9 vs 29.6%, P = 0.01). After a median follow-up of 434 days, all-cause mortality tended to be lower in women than in men (20.7 vs 26.6%, logrank P = 0.10), and was significantly higher in patients with AR ≥ 2 than in those without (34.8 vs 19.7%, logrank P < 0.001). AR ≥ 2 [hazard ratio (HR) 1.73, 95% confidence interval (CI) 1.22-2.43, P = 0.002], but not female sex (P = 0.17) was an independent predictor of all-cause death at multivariable Cox regression. The predictive value of AR ≥ 2 was restricted to men (HR 2.96, P < 0.001 among men; HR 0.86, P = 0.60 among women; P for interaction = 0.002). CONCLUSIONS: Women, as compared to men, present a trend toward lower mortality. A significant lower incidence of post-procedural AR ≥ 2 among women contributes to this finding. Female sex, however, was not a significant independent predictor of death.
Subject(s)
Aortic Valve Insufficiency/etiology , Aortic Valve Stenosis/therapy , Heart Valve Prosthesis Implantation/methods , Aged , Aged, 80 and over , Aortic Valve Insufficiency/diagnosis , Aortic Valve Insufficiency/mortality , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/mortality , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Chi-Square Distribution , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/mortality , Humans , Italy , Kaplan-Meier Estimate , Male , Multivariate Analysis , Proportional Hazards Models , Prosthesis Design , Registries , Risk Factors , Sex Factors , Time Factors , Treatment OutcomeABSTRACT
The treatment of degenerated surgical bio-prosthetic heart valves (BHV) has been reported as a novel indication for TAVI. The intervention may be complicated by high residual transvalvular gradients and coronary ostia obstruction, especially in small size BHV. We report two cases of BHVs treated with the new CoreValve Evolut 23 mm highlighting the importance of fluoroscopic guidance, based on BHV markers, in achieving a correct TAVI implantation. The small dimensions of the new CoreValve Evolut 23 allowed us to obtain low residual gradients even in this particular subset of degenerated BHV.
Subject(s)
Bioprosthesis , Heart Valve Prosthesis , Fluoroscopy/instrumentation , Fluoroscopy/methods , HumansABSTRACT
BACKGROUND: The 9p21.3 locus is strongly associated with the risk of coronary artery disease (CAD) and with type 2 diabetes (T2D). We investigated the association of 9p21.3 variants with severity of CAD (defined by the number of vessel diseased [VD]) in the presence and absence of T2D. METHODS: We tested 11 9p21.3-variants for association in a white Italian study (N = 2,908), and carried out replication in 2 independent white populations, a German study (N = 2,028) and a Canadian Study (N=950). SNP association and permutation analyses were conducted. RESULTS: We identified two 9p21.3-variants, rs4977574 (P < 4×10(-4)) and rs2383207 (P < 1.5×10(-3)) that were associated with severity of CAD in subjects without T2D. Association of rs4977574 with severity of CAD was confirmed in the Canadian Study. Results from subgroup analysis among patients with T2D showed an interaction between rs10738610 and T2D with P = 4.82×10(-2). Further investigation showed that rs10738610 (P < 1.99×10(-2)) was found to be significantly associated with severity of CAD in subjects with T2D. CONCLUSIONS: The 9p21.3 locus is significantly associated with severity of CAD. The number of associations of 9p21.3 variants with severity of CAD is variable to the presence and absence of T2D. In a CAD-susceptible region of 115 kb, there is only one variant associated with the severity of coronary vessel disease in the presence of type 2 diabetes.
Subject(s)
Chromosomes, Human, Pair 9 , Coronary Artery Disease/genetics , Diabetes Mellitus, Type 2/complications , Child , Coronary Artery Disease/complications , Coronary Artery Disease/pathology , Humans , Severity of Illness IndexABSTRACT
Severe aortic regurgitation (AR), when intervention is required, is managed by surgical aortic valve replacement (SAVR). Recently, transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) has shown non-inferiority to SAVR and superiority to medical management. TAVR could be a valid "off label" option to treat severe AR for patients unsuitable for SAVR due to their high surgical risk. Among aortic pathologies leading to severe AR, those involving the aortic root are considered as high risk procedures and thus prohibit TAVR. For these reasons TAVR is not an option for severe AR due to concomitant aortic root dilatation and degeneration. We report a successful case of TAVR for severe AR due to dilatation of degenerated tract of aortic root.
Subject(s)
Aorta , Aortic Valve Insufficiency/surgery , Aortic Valve/surgery , Blood Vessel Prosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aged, 80 and over , Female , HumansABSTRACT
(1) Background: Percutaneous left ventricle assist devices (pLVADs) demonstrated an improvement in mid-term clinical outcomes in selected patients with severely depressed left ventricular ejection fraction (LVEF) undergoing percutaneous coronary interventions. However, the prognostic impact of in-hospital LVEF recovery is unclear. Accordingly, the present sub-analysis aims to evaluate the impact of LVEF recovery in both cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR PCI) supported with pLVADs in the IMP-IT registry. (2) Methods: A total of 279 patients (116 patients in CS and 163 patients in HR PCI) treated with Impella 2.5 or CP in the IMP-IT registry were included in this analysis, after excluding those who died while in the hospital or with missing data on LVEF recovery. The primary study objective was a composite of all-cause death, rehospitalisation for heart failure, left ventricle assist device (LVAD) implantation, or heart transplantation (HT), overall referred to as the major adverse cardiac events (MACE) at 1 year. The study aimed to evaluate the impact of in-hospital LVEF recovery on the primary study objective in patients treated with Impella for HR PCI and CS, respectively. (3) Results: The mean in-hospital change in LVEF was 10 ± 1% (p < 0.001) in the CS cohort and 3 ± 7% (p < 0.001) in the HR PCI group, achieved by 44% and 40% of patients, respectively. In the CS group, patients with less than 10% in-hospital LVEF recovery experienced higher rates of MACE at 1 year of follow-up (FU) (51% vs. 21%, HR 3.8, CI 1.7-8.4, p < 0.01). After multivariate analysis, LVEF recovery was the main independent protective factor for MACE at FU (HR 0.23, CI 0.08-0.64, p = 0.02). In the HR PCI group, LVEF recovery (>3%) was not associated with lower MACE at multivariable analysis (HR 0.73, CI 0.31-1.72, p = 0.17). Conversely, the completeness of revascularisation was found to be a protective factor for MACE (HR 0.11, CI 0.02-0.62, p = 0.02) (4) Conclusions: Significant LVEF recovery was associated with improved outcomes in CS patients treated with PCI during mechanical circulatory support with Impella, whereas complete revascularisation showed a significant clinical relevance in HR PCI.
ABSTRACT
BACKGROUND: No detailed data on left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) exist from randomised clinical trials comparing the ACURATE neo and CoreValve Evolut devices. AIMS: Our aim was to assess the incidence and impact of new LBBB and PPI with self-expanding prostheses from a powered randomised comparison. METHODS: From the SCOPE 2 trial, 648 patients with no previous pacemaker were analysed for PPI at 30 days, and 426 patients without previous LBBB were adopted for analysis of LBBB at 30 days. Results: At 30 days, 16.5% of patients required PPI; rates were higher in CoreValve Evolut compared to ACURATE neo recipients (21.0% vs 12.3%; p=0.004). Previous right bundle branch block (odds ratio [OR] 6.11, 95% confidence interval [CI]: 3.19-11.73; p<0.001) was associated with an increased risk of PPI at 30 days, whereas the use of the ACURATE neo (OR 0.50, 95% CI: 0.31-0.81; p=0.005) was associated with a decreased risk. One-year mortality was similar in patients with and without new PPI. A total of 9.4% of patients developed persistent LBBB at 30 days, with higher incidences in CoreValve Evolut recipients (13.4% vs 5.5%; p=0.007). New LBBB at 30 days was associated with lower ejection fraction at 1 year (65.7%±11.0 vs 69.1%±7.6; p=0.041). CONCLUSIONS: New LBBB and PPI rates were lower in ACURATE neo compared to CoreValve Evolut recipients. The ACURATE neo valve was associated with a lower risk of PPI at 30 days. No effect on 1-year mortality was determined for PPI at 30 days, while LBBB at 30 days was associated with reduced ejection fraction at 1 year.