Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES RegistryRead the full article
Journal of Interventional Cardiology publishes articles focusing on interventional procedures and techniques in the diagnosis, investigation, and management of patients with cardiovascular disease and its associated complications.
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Transcatheter Closure of Perimembranous Ventricular Septal Defects Using Different Generations of Amplatzer Devices: Multicenter Experience
Objectives. To demonstrate safety and efficacy of using different generations of softer Amplatzer™ devices for ventricular septal defect (VSD) closure to avoid serious complications at follow-up. Background. Transcatheter closure of perimembranous ventricular septal defects (PmVSD) is a well-established procedure; however, it is associated with unacceptable incidence of complete heart block. Great advantages have been achieved by using softer devices for VSD transcatheter closure. The first and second generation of Amplatzer™ occluders (AVP II, ADO, and ADO II) seem to offer a safe and attractive alternative for this procedure. These devices can be delivered using either an arterial (retrograde) or venous (prograde) approach. Methods and Results. Patients with congenital PmVSD who underwent transcatheter closure using ADO, ADO II, and AVP II devices were included. Primary end point was to determine efficacy and safety of these generations of devices and to determine the incidence of complications at follow-up (complete AV block and aortic/tricuspid/mitral regurgitation). One hundred and nineteen patients underwent VSD closure at a median age of 5 years (8 months–54 years). During the catheterization, there were only minor complications and at follow-up of 36 ± 25.7 months (up to 99 months), the closure rate was high of 98.3% and freedom from AV block was 100%. Conclusions. The use of softer Amplatzer™ devices is a good alternative to achieve PmVSD closure safely with no risk of AVB during the procedure or at midterm follow-up.
Percutaneous Atrial Septal Defect Closure Using the Occlutech Figulla Device in Adults: More than 800 Patient-Years of Follow-Up
Purpose. The Occlutech Figulla occluder has been proven safe and effective at midterm follow-up after percutaneous atrial septal defect (ASD) closure. We describe the safety and efficacy at long-term follow-up in adults. Methods. All consecutive adult patients that underwent ASD closure between 2008 and 2015 were included. All complications were registered. Residual left-to-right shunt (LRS) was diagnosed using color-Doppler transthoracic echocardiography (TTE). Right-to-left shunting was diagnosed using contrast TTE. Successful closure was defined as no LRS at follow-up. Results. In total, 166 patients (mean age 56.7 ± 16.1 years; 62% female) underwent percutaneous ASD closure using the Occlutech Flex I (70%) or Flex II (30%) device (diameter 24 mm; range 10–40 mm) under general anaesthesia and transoesophageal echocardiographic guidance. Long-term follow-up data were available for 144 patients (87%) with a mean follow-up of 5.9 ± 2.6 years, a total of 814 patient-years. During hospitalization, device embolization occurred in three patients (1.8%) with successful extraction in all. During the long-term follow-up, 15 patients (9.8%) suffered new-onset atrial fibrillation and stroke occurred in 2.1%. There was no residual LRS at 12-month follow-up. No device embolization occurred during the long-term follow-up. Conclusion. Percutaneous ASD closure using the Occlutech device appears to be safe at long-term follow-up with a high successful closure rate at one year.
Hydration Strategies for Preventing Contrast-Induced Acute Kidney Injury: A Systematic Review and Bayesian Network Meta-Analysis
Aims. Many previous studies have examined the effect of different hydration strategies on prevention of contrast-induced acute kidney injury (CI-AKI), but the optimal strategy is unknown. We performed a network meta-analysis (NWM) of these previous studies to identify the optimal strategy. Methods and Results. Web of Science, PubMed, OVID Medline, and Cochrane Library were searched from their inception dates to September 30, 2018. Randomized controlled trials (RCTs) were selected based on strict inclusion criteria, and a Bayesian NWM was performed using WinBUGS V.1.4.3. We finally analyzed 60 eligible RCTs, which examined 21,293 patients and 2232 CI-AKI events. Compared to intravenous 0.9% sodium chloride (reference), intravenous sodium bicarbonate (OR [95% CI]: 0.74 [0.57, 0.93]), hemodynamic guided hydration (0.41 [0.18, 0.93]), and RenalGuard guided hydration (0.32 [0.14, 0.70]) significantly reduced the occurrence of CI-AKI. Oral hydration and intravenous 0.9% sodium chloride were each noninferior to no hydration in preventing CI-AKI. Intravenous 0.9% sodium chloride, sodium bicarbonate, and hemodynamic guided hydration were each noninferior to oral hydration in preventing CI-AKI. Based on surface under the cumulative ranking curve values, the RenalGuard system was best (0.974) and hemodynamic guided hydration was second best (0.849). Conclusion. There was substantial evidence to support the use of RenalGuard or hemodynamic guided hydration for preventing CI-AKI in high-risk patients, especially those with chronic kidney disease or cardiac dysfunction.
Reappraisal Value of a Modified Rotational Atherectomy Technique in Contemporary Coronary Angioplasty Era
Objectives. To introduce a modified rotational atherectomy (RA) procedure and investigate the early and midterm outcomes of the RA-facilitating diversified percutaneous coronary intervention (PCI) in a large group of aged patients with higher cardiovascular risk. Background. Previous studies about the outcomes of RA were limited with small sample size and low-risk population. Methods. Between January 2013 and November 2015, 1169 consecutive patients treated with modified RA-facilitated PCI were retrospectively enrolled, including de novo calcified lesions and in-stent restenosis. Patients were regularly followed up for at least 1 year. Major adverse cardiac events (MACE) were analyzed for all participants by different strategies. Cox regression analysis was performed to identify risk factors for the events. Results. The median age of patients was 75 years, with 11.7% of patients on maintenance hemodialysis. Most lesions (99.9%) were complex (American Heart Association type B2/C), and 68.3% were treated with RA + drug-eluting-stent (DES). Successful angiography was achieved in 97.8% cases, with 1.7% (20/1169) experiencing coronary perforation (including guidewire perforation). The incidence of MACE was 20.5% and 26.8% at 1-year and 2-year follow-up and were mainly driven by target lesion revascularization (TLR) (10.3% and 12.5%, respectively). The strategy of RA + DES had the lowest 2-year MACE, compared with the RA + drug-coated balloon and RA + plain old balloon angioplasty (14.5%, 30.5%, and 26.0%, respectively). Conclusions. The modified RA technique is a safe and effective tool in the contemporary PCI era, even in high-risk patients. The TLR rate was relatively high but acceptable in such complex lesions.
Transcatheter Mitral Valve Implantation (TMVI) Using Edwards SAPIEN 3 Prostheses in Patients at Very High or Prohibitive Surgical Risk: A Single-Center Experience
Background. Mitral valve surgery in patients with failing bioprosthesis, annuloplasty rings, or in patients with advanced mitral annular calcification (MAC) is associated with high morbidity and mortality rates. Percutaneous antegrade transseptal transcatheter mitral valve implantation (TMVI) has recently successfully been performed in those patients at high or prohibitive surgical risk, but data on patients treated by TMVI are sparse. This study sought to evaluate short- and midterm outcomes of patients treated by TMVI at our site in clinical practice. Methods and Results. From October 2016 to February 2018, seven patients (six women and one man) at high or prohibitive surgical risk underwent TMVI at our site. Three procedures were performed as TMVI in failed mitral valve bioprostheses (TMVI-VIV, “valve-in-valve”), one procedure was performed as TMVI in a failed mitral annuloplasty ring (TMVI-R), and three procedures were performed as TMVI in advanced native mitral annular calcification (TMVI-MAC). Mean age of the population treated was 77 ± 8.1 years, and mean log EuroScore I was 39 ± 0.12%. In all patients, an Edwards SAPIEN 3 transcatheter heart valve was implanted under 3D-TOE and fluoroscopic guidance using a transvenous/transseptal access. Indication for TMVI was the presence of advanced heart failure symptoms in all patients (NYHA class III/IV). The predominant dysfunction of the mitral valve treated was severe regurgitation in 72% (n = 5) and severe stenosis in 29% (n = 2) of all patients. TMVI was technically successful in all procedures. Clinical success with functional improvement of at least one NYHA class after procedure compared with before procedure was also achieved in all patients. Median NYHA class improved significantly from 4 before procedure to 2 after TMVI (). Mitral valve regurgitation was reduced to trace or mild in all but one patient, who showed moderate MR after TMVI-MAC. No patient-prosthesis mismatch or LVOT obstruction occurred after TMVI. Two patients underwent interventional ASD closure during the in-hospital course due to a large and persisting atrial septal defect after transseptal access. One patient underwent pacemaker implantation due to complete AV-block after TMVI. One patient died in hospital 12 days after the procedure due to severe hospital-acquired pneumonia and sepsis. In-hospital mortality rate was 14% (1/7) in this high-risk population. After hospital discharge, no death occurred and clinical improvement—according to NYHA functional class—remained stable during one-year follow-up. Conclusion. In this small single-center series, TMVI appears promising for patients at high or prohibitive surgical risk with either failing mitral bioprostheses/annuloplasty rings or native mitral valve dysfunction in combination with advanced MAC. Gaining experience in TMVI and new valves will further improve safety and efficacy of this new treatment option.
Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year—Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS)
Aim. Optimal revascularization strategy in multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery remains unresolved. We evaluated, in a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-PCI. Methods. Consecutive MV-CAD patients (n = 155) were randomized (1 : 1 : 1) to conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents) under Heart Team agreement on equal technical and clinical feasibility of each strategy. SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization midterm efficacy and an independent predictor of long-term prognosis) preceded routine angiographic control. Results. Data are given, respectively, for the CABG, HCR, and MV-PCI arms. Incomplete revascularization rate was 8.0% vs. 7.7% vs. 5.7% (). Hospital stay was 13.8 vs. 13.5 vs. 4.5 days (), and sick-leave duration was 23 vs. 16 vs. 8 weeks (). At 12 months, RI was 5 (2, 9)% vs. 5 (3, 7)% vs. 6 (3, 10)% (median; Q1, Q3) with noninferiority values of 0.0006 (HCR vs. CABG) and 0.016 (MV-PCI vs. CABG). Rates of angiographic graft stenosis/occlusion or in-segment restenosis were 20.4% vs. 8.2% vs. 5.9% (). Clinical target vessel/graft failure occurred in 12.0% vs. 11.5% vs. 11.3% (). Major adverse cardiac and cerebral event (MACCE) rate was similar (12% vs. 13.4% vs. 13.2%; ). Conclusion. In this first randomized controlled study comparing CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE were similar at 12 months. There was no midterm indication of any added value of HCR. Hospital stay and sick-leave duration were shortest with MV-PCI. While longer-term follow-up is warranted, these findings may impact patient and physician choices and healthcare resources utilization. This trial is registered with NCT01699048.