Showing papers in "Journal of Interventional Cardiology in 2016"

A Randomized Trial of Complete Versus Culprit-Only Revascularization During Primary Percutaneous Coronary Intervention in Diabetic Patients With Acute ST Elevation Myocardial Infarction and Multi Vessel Disease.

Abstract: Background Recent randomized trials and meta-analyses demonstrated that a complete revascularization of significant non culprit lesions in patients with ST elevation myocardial infarction (STEMI) is superior to a culprit only revascularization approach in reducing major adverse cardiac events (MACE), however the proportion of diabetic patients was low in these trials. Objectives To investigate whether a complete revascularization approach is associated with better outcomes in diabetic patients with STEMI and multi-vessel disease. Methods One hundred diabetic patients with acute STEMI with at least one non-culprit lesion were randomized to either complete revascularization (n = 50) or culprit-only treatment (n = 50). Complete revascularization was performed either at the time of primary percutaneous coronary intervention (PCI) or within 72 hours during hospitalization. The primary endpoint was the composite of all-cause mortality, recurrent MI, and ischemia-driven revascularization at 6 months. Results A complete revascularization approach was significantly associated with a reduction in the primary outcome (6% vs. 24%, P = 0.01), primarily due to reduction in ischemia driven revascularization in the complete revascularization group (2% vs. 12%; P = 0.047). There was no significant reduction in death or MI (2% vs. 8%; P = 0.17) and (2% vs. 4%; P = 0.56) respectively, or in the safety endpoints of major or minor bleeding, contrast-induced nephropathy, or stroke between the groups. Conclusions In diabetic patients with multi-vessel coronary artery disease undergoing PPCI, complete revascularization is associated with significantly reduced risk of adverse cardiovascular events, as compared with culprit vessel only PCI. (J Interven Cardiol 2016;29:241–247)

Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry

Abstract: Objectives The aim of this analysis was to assess survival differences between men and women supported with Impella 2.5 (Abiomed Inc., Danvers) in the setting of acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). Background Data on sex differences in outcomes of CS with mechanical circulatory support are sparse. Methods Patients enrolled in the cVAD Registry who underwent percutaneous coronary intervention (PCI) and Impella 2.5 support for CS complicating an AMI were included. Differences between men and women were examined. Results In total, 180 patients were analyzed. Women (n = 49, 27.2%) were older (71.0 ± 12.8 years vs 63.8 ± 13.0, P = 0.001), smaller (BSA 1.82 ± 0.22 vs 2.04 ± 0.24 m2, P < 0.001), and had a higher STS mortality risk score than men (27.9 ± 17.0 vs. 20.8 ± 16.8 P = 0.01). There was no difference in survival to discharge (P = 0.3). Patients receiving the Impella 2.5 pre-PCI had significantly lower inpatient mortality than those who received support post-PCI (P = 0.003). However, the magnitude of the survival benefit was significantly greater in women who received the Impella pre-PCI as compared to men. Overall, 68.8% of women survived with pre-PCI Impella 2.5 versus 24.2% post-PCI (P = 0.005) whereas 54.2% of men survived with pre-PCI Impella 2.5 versus 40.3% post-PCI (P = 0.1, p-interaction = 0.07). No differences in timing to intervention were found between men and women. Conclusions Early initiation of hemodynamic support prior to PCI with Impella 2.5, in the setting of AMI complicated by CS, was associated with a greater survival benefit to hospital discharge in women compared to men, despite a higher predicted risk of mortality and a greater revascularization failure rate for women. (J Interven Cardiol 2016;29:248–256)

Real-World Multicenter Registry of Patients with Severe Coronary Artery Calcification Undergoing Orbital Atherectomy.

Abstract: OBJECTIVES We evaluated the safety and efficacy of orbital atherectomy in real-world patients with severe coronary artery calcification (CAC). BACKGROUND The presence of severe CAC increases the complexity of percutaneous coronary intervention as it may impede stent delivery and optimal stent expansion. Atherectomy may be an indispensable tool for uncrossable or undilatable lesions by modifying severe CAC. Although the ORBIT I and II trials report that orbital atherectomy was safe and effective for the treatment of severe CAC, patients with kidney disease, recent myocardial infarction, long diffuse disease, severe left ventricular dysfunction, and unprotected left main disease were excluded. METHODS This retrospective study included 458 consecutive patients with severe CAC who underwent orbital atherectomy followed by stenting from October 2013 to December 2015 at 3 centers. RESULTS The primary endpoint of major adverse cardiac and cerebrovascular events at 30 days was 1.7%. Low rates of 30-day all-cause mortality (1.3%), myocardial infarction (1.1%), target vessel revascularization (0%), stroke (0.2%), and stent thrombosis (0.9%) were observed. Angiographic complications were low: perforation was 0.7%, dissection 0.9%, and no-reflow 0.7%. Emergency coronary artery bypass graft surgery was performed in 0.2% of patients. CONCLUSION In the largest real-world study of patients who underwent orbital atherectomy, including high-risk patients who were not surgical candidates as well as those with very complex coronary anatomy, acute and short-term adverse clinical event rates were low. A randomized clinical trial is needed to identify the ideal treatment strategy for patients with severe CAC.

Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI.

Abstract: Aim The transcatheter aortic valve SAPIEN 3 aims at reducing paravalvular leakage (PVL). The new design with outer sealing cuff may increase the risk of permanent pacemaker implantation (PPM). The aim of our study was to evaluate the optimal implantation height of the SAPIEN 3. Methods and Results We analysed the correlation between the implantation height of the valve and the need for PPM in 131 patients. The PPM rate for the entire group after TAVI was 18% (n = 24). In patients with a marker distance <2 mm (“low implantation”), the PPM rate was 32%, whereas in patients with a distance ≥2 mm (“high implantation”), the rate was only 4.7% (OR of 0.1 (0.03–0.37, P < 0.001)). Conclusion The risk of periprocedural PPM with the Edwards SAPIEN 3 depends on implantation height; it is increased when using conventional implantation techniques. This risk can be minimized below 5% PPM by choosing a higher implantation technique with the central marker 2 mm or more over the annulus plane.

Transradial Versus Transfemoral Carotid Artery Stenting: A 16-Year Single-Center Experience.

Abstract: Aims Limited data exist on radial access in carotid artery stenting (CAS). This single-center study was performed to compare the outcome and complication rates of transradial (TR) and transfemoral (TF) CAS. Methods and Results The clinical and angiographic data of 775 consecutive patients with high risk for carotid endarterectomy, treated between 1999 and 2016 by CAS with cerebral protection, were evaluated. Patients were divided into 2 groups according to vascular access: TR (n = 101; 13%) and TF (n = 674). Primary combined end-point: in-hospital major adverse cardiac and cerebral events. Secondary end-points: angiographic outcome of the procedure and crossover rate to another puncture site. Angiographic success was achieved in all 775 patients, the crossover rate was 4.9% in the TR and 0% in the TF group (P < 0.05). TR was performed at the right side in 97% of cases. The incidence of in-hospital major adverse cardiac and cerebral events was 2% in the TR and 3.6% in the TF group (P = ns). Conclusions The TR approach for CAS is safe and efficacious, with acceptable cross-over rate. In both groups, vascular complications rarely occurred.

Elective or Emergency Use of Mechanical Circulatory Support Devices During Transcatheter Aortic Valve Replacement.

Abstract: Objective Evaluate the use of mechanical circulatory support (MCS) devices in high-risk patients undergoing transcatheter aortic valve replacement (TAVR). Background The use of MCS devices in elderly patients with multiple comorbidities undergoing TAVR is underexplored. Methods All patients undergoing TAVR at a single tertiary academic center who required MCS during index procedure between 2008 and 2015 were included in a prospective database. Results MCS was used in 9.4% (54/577) of all TAVRs (n = 52 Edwards Sapien and n = 2 CoreValves) of which 68.5% (n = 37) were used as part of a planned strategy, and 31.5% (n = 17) were used in emergency "bail-out" situations. IABP was the most commonly used device (87%) followed by Impella and ECMO (6% each). Among the MCS group, 22% required cardiopulmonary resuscitation during the procedure (n = 4 elective [11%] vs. n = 8 emergent [47%]) and 15% upgrade to a second device (Impella or CPB after IABP; n = 5 elective [14%] vs. n = 3 emergent [18%]). Median duration of support was 1-day. Device related complications were low (4%). In-hospital mortality in this extremely high-risk population was 24% (13/54) (11% [4/37] for elective cases and 53% [9/17] for emergency cases). Cardiogenic shock (50%) was the most common cause of in-hospital death. Cumulative all-cause 1-year mortality was 35% (19/54) (19% 97/370 for elective and 71% [12/17] for emergency cases). Conclusion Emergent use of MCS during TAVR in extremely high-risk population is associated with high short and long-term mortality rates. Early identification of patients at risk for hemodynamic compromise may rationalize elective utilization of MCS during TAVR.

Clinical Outcomes Following Covered Stent for the Treatment of Coronary Artery Perforation

Abstract: Background This study aimed to evaluate short- and long-term outcomes of polytetrafluoroethylene covered stent for patients with coronary artery perforation Methods During April 2004 and February 2016, a total 48 patients underwent implantation using polytetrafluoroethylene-covered JOSTENT GraftMaster stents (Abbott Vascular, Santa Clara, CA) in the native coronary arteries implantation for coronary artery perforation Clinical outcomes such as target lesion revascularization (TLR), myocardial infarction (MI), definite or possible stent thrombosis, cardiovascular mortality, and all-cause mortality were analyzed Results The average age of study patients was 6802 ± 1349 years, and the majorities were men (766%) The most frequent devices cause of perforation were stents (375%) Eighteen patients (375%) experienced cardiac tamponade and 20 patients (417%) underwent emergent pericardiocentesis Only 1 patient (21%) experienced emergent surgical repair after covered stent At the 30-day follow-up, the rate of all-cause mortality was 167% and cardiovascular mortality was 130% At the 1-year follow-up, the rate of MI was 61%, the rate of TLR was 219%, the rate of definite or possible stent thrombosis was 156%, the rate of cardiovascular mortality was 220%, and the rate of all-cause mortality was 262% Between the patients with and without cardiac tamponade, patients with cardiac tamponade had higher cardiovascular mortality in 30-day and also higher all-cause mortality in 30-day and 1-year follow-up Conclusion The covered stent could solve emergent condition for patients with coronary artery perforation with high TLR and stent thrombosis rate at long-term follow-up The patients with cardiac tamponade had worse clinical outcomes in 30-day and 1-year follow-up

The Utility of Preemptive Distal Perfusion Cannulation During Peripheral Venoarterial Extracorporeal Membrane Oxygenation Support.

Abstract: Objectives We compared the ischemia and rescue rates according to the strategy of distal cannulation. Background Limb ischemia developing during percutaneous venoarterial (VA) extracorporeal membrane oxygenation (ECMO) is a potentially severe complication. Although appropriate use of a distal perfusion cannula can avoid ischemia, evidences about distal cannulation is still lacking. Methods Patients who underwent peripheral VA ECMO between January 2010 and August 2015 were reviewed. We classified patients into 2 groups in terms of insertion timing with respect to the onset of ischemia. The preemptive strategy group underwent early insertion of a distal perfusion cannula at commencement of ECMO support. The rescue strategy group underwent delayed cannula insertion after onset of limb ischemia. Results A total of 151 patients were included in the analysis. Forty-four patients formed the preemptive strategy group and 107 patients formed the rescue strategy group. In total, 10 of 151 (6.7%) patients developed significant limb ischemia, they all were the rescue strategy group (10/107, 9.3%). Of the 10 patients, 2 patients were rescued from limb ischemia after distal cannulation. Otherwise, ischemia was not rescued in the remaining eight patients. Of the latter 8, 3 patient required surgical interventions (2 fasciotomy and 1 below-the-knee amputation) and the other five died from disease aggravation prior to surgical intervention. Conclusions Preemptive distal perfusion cannulation is safe and effective when used to prevent lower limb ischemia in patients undergoing femoral cannulation to treat ECMO. However, delayed distal cannulation increases the extent of cannulation site bleeding, without improving the ischemia.

Interventional closure of secundum type atrial septal defects in infants less than 10 kilograms: indications and procedural outcome

Abstract: AIMS: This study set out to assess indications, feasibility, complications, and clinical outcome of percutaneous transcatheter device closure of atrial septal defects (ASDs) in infants with a bodyweight below 10 kg. METHODS AND RESULTS: Retrospective single center chart and echocardiography review study from 8/2005-12/2013. Twenty-eight children with ASD (13 female) with a median age of 1.15 years (0.2-2.8) and a median weight of 7.2 kg (4.5-9.9) were analyzed. Indications for early ASD closure were failure to thrive (n = 15, 54%), bronchopulmonary dysplasia (BPD) with supplemental oxygen dependency (n = 7, 25%), and genetic syndromes with suspected pulmonary hypertension (n = 12, 43%). Device implantation was successful in all patients without any periprocedural mortality or major complication. Clinical outcome after a median follow-up period of 2.1 years (0.25-7.3) revealed no residual shunt and a significant decrease of right ventricular volume load. Patients with pulmonary hypertension experienced a significant reduction of pulmonary artery/RV pressure. Patients also showed decreased supplemental oxygen dependency and less cardiac medications, but no significant "catch-up growth" in those with failure to thrive. CONCLUSION: Interventional ASD closure in children weighing less than 10 kg can be performed without any additional major risks and shows a favorable outcome, especially in selected patients with significant non cardiac co-morbidities.

Does Simulation-Based Training Improve Procedural Skills of Beginners in Interventional Cardiology?--A Stratified Randomized Study.

Abstract: Objective To assess whether mentored simulation-based-training can improve the procedural skills of beginners in coronary interventional procedures. Background Simulation based-catheter training is a valuable tool to practice interventional procedures. Whether this type of training enhances the procedural skills of fellows learning percutaneous coronary interventions has never been studied. Methods Eighteen cardiology fellows were randomized either into the simulation-based training (n = 9) or the control group (n = 9). The simulation group received 7.5 hours of virtual reality (VR) simulation training, whereas the control group attended 4.5 hours of lectures. Each participant had to perform a simple (pre-evaluation) and a more complex (post-evaluation) catheter intervention on a pulsatile coronary flow model in a catheterization laboratory. All procedures were videotaped, analyzed, and rated by 3 expert interventionalists, who were blinded to the randomization. To assess the individual performance level, a “skills score” was determined, comprising 14 performance characteristics (5-level Likert scale, maximum score of 70 points). Results The “skills score” increased by 5.8 ± 6.1 points in the VR simulation group and decreased by 6.7 ± 8.4 in the control group (P = 0.003) from the simple stenosis at pre- to the more complex lesion at post-evaluation demonstrating the effectiveness of simulation-based training. Conclusion This pilot study suggests that curriculum-based mentored VR simulation training improves the performance level of cardiology fellows in coronary interventions. Further investigation to evaluate the effect on clinical outcomes is warranted.

Drug-Coated Balloons: A Safe and Effective Alternative to Drug-Eluting Stents in Small Vessel Coronary Artery Disease.

Abstract: Background Drug-coated balloons (DCB) have been used to treat de novo small vessel coronary disease (SVD), with promising results and shorter dual antiplatelet therapy (DAPT) duration compared to drug-eluting stents (DES). We compared safety and effectiveness of the two treatments at 1 year. Methods We reviewed 3,613 angioplasty cases retrospectively from 2011 to 2013 and identified 335 patients with SVD treated with device diameter of ≤2.5 mm. DCB-only angioplasty was performed in 172 patients, whereas 163 patients were treated with second-generation DES. Results DCB patients had smaller reference vessel diameter (2.22 ± 0.30 vs. 2.44 ± 0.19 mm, P < 0.001) and received smaller devices (median diameter 2.25 vs. 2.50 mm, P < 0.001) compared to the DES group. DES-treated vessels had larger acute lumen gain (1.71 ± 0.48 mm) than DCB (1.00 ± 0.53 mm, P < 0.001). Half the patients had diabetes mellitus. While there were more patients presenting with acute coronary syndrome (ACS) in the DCB group (77.9% vs. 62.2%, P = 0.013), they received shorter DAPT (7.4 ± 4.7 vs. 11.8 ± 1.4 months, P < 0.001) than the DES group. The 1-year composite major adverse cardiac event rate was 11.6% in the DCB arm and 11.7% in the DES arm (P = 1.000), with target lesion revascularization rate of 5.2% and 3.7%, respectively, (P = 0.601). Conclusions In this high-risk cohort of patients, DCB-only angioplasty delivered good clinical outcome at 1 year. The results were comparable with DES-treated patients, but had the added benefit of a shorter DAPT regime.

Stent Coating Integrity of Durable and Biodegradable Coated Drug Eluting Stents

Abstract: Background Coatings consisting of a polymer and drug are widely used in drug-eluting stents (DES) and are essential in providing programmable drug release kinetics. Among other factors, stent coating technologies can influence blood compatibility, affect acute and sub-acute healing, and potentially trigger a chronic inflammatory response. Objective The aim of this study was to investigate the short-term (7 and 28 days) and long-term (90 and 180 days) coating integrity of the Xience Prime Everolimus-Eluting Stent (EES), Resolute Zotarolimus-Eluting Stent (ZES), Taxus Paclitaxel-Eluting Stent (PES), and Nobori Biolimus A9-Eluting Stent (BES) in a rabbit ilio-femoral stent model. Methods and Results Stented arteries (n = 48) were harvested and the tissue surrounding the implanted stents digested away with an enzymatic solution. Results demonstrated that the majority of struts of EES were without any coating defects with a few struts showing minor defects. Similarly, for the ZES, most of the struts were without coating defects at all time points except at 180 days. The majority of PES demonstrated mostly webbing and uneven coating. In the BES group, the majority of strut coating showed polymer cracking. Conclusion Overall, the EES and ZES had fewer coating defects than the PES and BES. Coating defects, however increase over time for the ZES, whereas the percent of coating irregularities remained constant for the EES. These results provide, for the first time, a comparison of the long-term durability of these drug-eluting stent coatings in vivo.

Long-Term Outcomes and Complications of Intracardiac Echocardiography-Assisted Patent Foramen Ovale Closure in 1,000 Consecutive Patients

Abstract: Backgrounds Long-term fate of patients submitted to patent foramen ovale (PFO) closure is still unclear. The aim of the study was to evaluate the incidence of atrial fibrillation (AF), aortic or atrial free wall erosion, device thrombosis (DT), new onset or worsening of mitral valve regurgitation (MVR), and recurrent cerebral ischemic events in the long-term follow up after intracardiac echocardiography (ICE)-aided PFO closure in a large population. Methods We reviewed the medical and instrumental data of 1,000 consecutive patients (mean age 47.3 ± 17.1 years, females) prospectively enrolled in 2 centres over a 13 years period (February 1999-February 2012) for R-to-L shunt ICE-aided catheter-based closure using different devices. Results Immediate success was 99.8%. Implanted devices were Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). On a mean follow-up of 12.3 ± 0.6 years (minimum 4- maximum 17 years), permanent AF occurred in 0.5%, DT was apparent in 0.5%, new onset or worsening of MVR was observed in 0.2%, whereas recurrent cerebral ischemic events were 0.8%. Occlusion rate was 93.8%. No aortic or atrial free wall erosion has been observed. Conclusion ICE-aided closure of PFO using different devices, appeared very safe and effective on very long-term follow up with low incidence of erosion, DT, recurrent ischemic events, MVR new onset or worsening, and permanent AF.

Aortic Valve Calcium Volume Predicts Paravalvular Regurgitation and the Need for Balloon Post-Dilatation After Transcatheter Aortic Valve Implantation.

Abstract: Objective This study sought to evaluate the impact of aortic valve (AV) and left ventricle outflow tract (LVOT) calcium on paravalvular regurgitation (PVR) and need for balloon post-dilatation (BPD) during transcatheter aortic valve implantation (TAVI). Methods The overall study population comprised 152 patients. Calcium mass and volume of AV and LVOT were estimated from contrast-enhanced multislice computed tomography imaging, using 3 thresholds for calcium detection [650, 850, and 1,050 Hounsfield units (HU)]. Results A self-expandable prosthesis was implanted in 67.8% of patients and a balloon-expandable prosthesis in the remaining. Eleven patients required BPD and 82 patients presented post-procedural PVR, which was mild in 44.1% and moderate in 9.9%. The greatest discriminatory value for PVR ≥ mild was seen for calcium volume using 850 HU threshold, with an area under the curve of 0.72 (95%CI 0.64–0.80, P < 0.001) for AV and of 0.63 (95%CI 0.54–0.72, P = 0.008) for LVOT. For 850 HU threshold, the calcium volume cut-off with the highest sum of sensitivity and specificity for PVR was 157 mm3 for AV and 0.6 mm3 for LVOT. In multivariate logistic regression analysis, the presence of AV calcium ≥157 mm3 (OR 3.83, 95%CI 1.81–8.10, P < 0.001) and ≥267 mm3 (OR 11.3, 95%CI 1.2–103.1, P = 0.03) were the only independent predictors of PVR and BPD, respectively. Conclusions AV calcium volume was an independent predictor of PVR and BPD in patients submitted to TAVI. Our results support a systematic assessment of AV calcium volume to identify patients at increased risk of post-procedural PVR. (J Interven Cardiol 2016;29:117–123)

Percutaneous Closure of Paravalvular Leaks: A Systematic Review.

Abstract: Paravalvular leak (PVL) is an uncommon yet serious complication associated with the implantation of mechanical or bioprosthetic surgical valves and more recently recognized with transcatheter aortic valves implantation (TAVI). A significant number of patients will present with symptoms of congestive heart failure or haemolytic anaemia due to PVL and need further surgical or percutaneous treatment. Until recently, surgery has been the only available therapy for the treatment of clinically significant PVLs despite the significant morbidity and mortality associated with re-operation. Percutaneous treatment of PVLs has emerged as a safe and less invasive alternative, with low complication rates and high technical and clinical success rates. However, it is a complex procedure, which needs to be performed by an experienced team of interventional cardiologists and echocardiographers. This review discusses the current understanding of PVLs, including the utility of imaging techniques in PVL diagnosis and treatment, and the principles, outcomes and complications of transcatheter therapy of PVLs.

The Learning Curve for Transcatheter Mitral Valve Repair With MitraClip

Abstract: Objectives This study sought to assess the learning curve for TMVR for treatment of primary mitral regurgitation (MR). Background Data are lacking regarding the technical experience required to achieve optimal clinical outcomes with transcatheter mitral valve repair (TMVR) using the edge-to-edge MitraClip technique. Methods We examined the sequential experience of the first 75 patients (age 80 ± 9 years; 77% male) who underwent TMVR at our institution. A sequence number of each patient was assigned as a continuous variable and in tertiles for analysis. Results TMVR with MitraClip was successful in 97% with an average procedural time of 106 ± 39 minutes. The 30-day rate of major adverse cardiovascular events was 7%. With increased case experience, there were decreases in procedural time, fluoroscopy time, length of hospital stay, and major adverse cardiovascular events. Procedural success, residual mitral regurgitation and NYHA functional classification at 30-day follow-up remained unchanged throughout the experience. Conclusions The learning curve for TMVR with MitraClip for treatment of primary MR is characterized by a sequential reduction in procedure time, fluoroscopy time, procedural complications, and hospital length of stay at a tertiary academic medical center. Thirty-day procedural results are favorable and similar during the initial learning period.

Percutaneous PDA Closure in Extremely Low Birth Weight Babies.

Abstract: Aim Patent Ductus Arteriosus is an important cause of morbidity and mortality in preterms. As birth weight decrease, risks increase. Main aim of our study is to emphasize the effectiveness and safety of percutaneous PDA closure even in extremely low birth infants. Materials and Methods In our center between the dates June 2014–June 2016, PDA of 10 patients less than 1,000 gr were closed percutaneously. To the best of our knowledge this study includes the largest cohort of infants less than 1,000 g in the literature, that PDA of those were percutaneously closed. Results Symptomatic patients, less than 1,000 gr having PDA were included in the study. All have 3 times medical therapy for PDA closure but it did not work. PDA was decided to be contributor of this medical state of them. The mean patient age was 19.5 ± 7.2 days. The median weight was 950 (842–983) gr. Mean gestational age was: 26.3 ± 0.63 weeks. Mean PDA diameter was 1.9 ± 0.41 mm. Morphology of PDA:6 of them were conical and 4 of them were tubular. In all patients ADOII-AS device were used for PDA closure via venous route. No major complications were reported. Left pulmonary arterial stenosis was detected in 1 patient who was resolved in 6 months duration. Conclusion We want to emphasize that in experienced centers percutaneous closure of PDA can be an alternative to surgery even in the extremely low birth weight babies.

Usefulness of Frequency Domain Optical Coherence Tomography Compared with Intravascular Ultrasound as a Guidance for Percutaneous Coronary Intervention.

Abstract: Objectives To compare outcomes and rates of optimal stent placement between optical coherence tomography (OCT) and intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI). Background Unlike IVUS-guided PCI, rates of clinical outcomes and optimal stent placement have not been well characterized for OCT-guided PCI. Methods The study enrolled 290 patients who underwent implantation of a second generation drug eluting stent under OCT (122 patients) or IVUS (168 patients) guidance. The two groups were compared after adjusting for baseline differences using 1:1 propensity score matching (PSM) (114 patients in each group). Optimal stent placement was defined as achieving an adequate lumen (optimal minimum stent area [MSA > 4.85 mm2 for OCT, >5 mm2 for IVUS] or a final MSA ≥ 90% of the distal reference lumen area, without edge dissection, incomplete stent apposition, or tissue prolapse), or otherwise performing additional interventions to address suboptimal post-stenting OCT or IVUS findings. The primary endpoint was one-year cumulative incidence of major adverse cardiac events (MACE; cardiac death, myocardial infarction and target lesion revascularization). Definite or probable stent thrombosis (ST) rates were evaluated. Results In adjusted comparisons between OCT and IVUS groups, there was no significant difference in rates of MACE (3.5% vs. 3.5%, P = 1.000) and ST (0% vs. 0.9%, P = 1.000) at 1 year, optimal stent placement (89.5% vs. 92.1%, P = 0.492), and further intervention (7.9% vs.13.2%, P = 0.234), despite OCT significantly more frequently detecting tissue prolapse (97.4% vs. 47.4%, P < 0.001), and numerically more edge dissection (10.5% vs. 4.4%, P = 0.078) or incomplete stent apposition (48.2% vs. 36.8%, P = 0.082). Conclusions OCT guidance showed comparable results to IVUS in mid-term clinical outcomes, suggesting that OCT can be an alternative tool for stent placement optimization.

Results From the International Drug Coated Balloon Registry for the Treatment of Bifurcations. Can a Bifurcation Be Treated Without Stents

Abstract: Objectives This observational study assessed the 9-month clinical outcomes in patients with coronary bifurcation lesions suitable for drug-coated balloon (DCB) angioplasty. It was the intention to use DCB's without additional stenting (DCB-only strategy) in selected patients for this chosen strategy. Bail-out main branch (MB) and/or side branch (SB) stenting, however, were permissible when flow limiting dissections or excessive recoil occurred. Background A multitude of interventional strategies have been studied to treat bifurcation lesions. With the availability of DCB angioplasty, investigators have been using this interventional tool with the optional implantation of bare metal stents (BMS). Methods This study is an international, prospective, multicenter registry enrolling patients with coronary bifurcation lesions including a side branch ≥2 mm in diameter. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit bifurcation lesion of any Medina classification type were recruited. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included 9-month major adverse cardiac events (death, myocardial infarction, or TLR), technical success, in-hospital outcomes and vessel thrombosis rates. Results A total 127 patients 66.1 ± 10.1 years of age were enrolled. Demographic characteristics were 80.3% (102/127) male gender, 31.5% (40/127) diabetes, 91.3% (116/127) hypertension, 7.1% (9/127) ST-elevation myocardial infarction (STEMI), and 9.4% (12/127) non ST-elevation myocardial infarction (NSTEMI). The 130 lesions were treated with 184 DCB's and 64 BMS. In 53.8% (70/130) of all lesions the DCB-only strategy could be used while 34.6% (45/130) of lesions had at least 1 stent (BMS) in the main branch, 8.5% (11/130) had at least 1 stent in the side branch and 3.1% (4/130) needed at least 1 stent in the main and side branch. 94.5% patients (121/127) were available for follow-up after 9.8 ± 2.0 months. The TLR rate was 4.6% in the absence of any thrombotic events in the treated vessels whereas the 9-month MACE rate was 6.2%. Conclusion This observational study suggests that the DCB-only strategy is safe and effective to treat selected bifurcations while benefiting from a shortened dual antiplatelet therapy (DAPT).

Anatomic Patterns of Renal Arterial Sympathetic Innervation: New Aspects for Renal Denervation.

Abstract: Aims Initial studies of catheter-based renal arterial sympathetic denervation to lower blood pressure in resistant hypertensive patients renewed interest in the sympathetic nervous system's role in the pathogenesis of hypertension. However, the SYMPLICITY HTN-3 study failed to meet its prespecified blood pressure lowering efficacy endpoint. To date, only a limited number of studies have described the microanatomy of renal nerves, of which, only two involve humans. Methods and Results Renal arteries were harvested from 15 cadavers from the Klinikum Osnabruck and Schuchtermann Klinik, Bad Rothenfelde. Each artery was divided longitudinally in equal thirds (proximal, middle, and distal), with each section then divided into equal superior, inferior, anterior, and posterior quadrants, which were then stained. Segments containing no renal nerves were given a score value = 0, 1–2 nerves with diameter 4 nerves or nerve diameter ≥600 µm a score = 3. A total of 22 renal arteries (9 right-sided, 13 left-sided) were suitable for examination. Overall, 691 sections of 5 mm thickness were prepared. Right renal arteries had significantly higher mean innervation grade (1.56 ± 0.85) compared to left renal arteries (1.09 ± 0.87) (P < 0.001). Medial (1.30 ± 0.59) and distal (1.39 ± 0.62) innervation was higher than the proximal (1.17 ± 0.55) segments (p < 0.001). When divided in quadrants, the anterior (1.52 ± 0.96) and superior (1.71 ± 0.89) segments were more innervated compared to posterior (0.96 ± 0.72) and inferior (0.90 ± 0.68) segments (P < 0.001). Conclusions That the right renal artery has significantly higher innervation scores than the left. The anterior and superior quadrants of the renal arteries scored higher in innervation than the posterior and inferior quadrants did. The distal third of the renal arteries are more innervated than the more proximal segments. These findings warrant further evaluation of the spatial innervation patterns of the renal artery in order to understand how it may enhance catheter-based renal arterial denervation procedural strategy and outcomes. Condensed Abstract The SYMPLICITY HTN-3 study dealt a blow to the idea of the catheter-based renal arterial sympathetic denervation. We investigated the location and patterns of periarterial renal nerves in cadaveric human renal arteries. To quantify the density of the renal nerves we created a novel innervation score. On average the right renal arteries were significantly more densely innervated than the left renal arteries, the anterior and superior segments were significantly more innervated compared to the posterior and inferior segments, absolute innervation scores in the proximal third of the left or right renal arteries were always lower when compared to distal segments. These findings may enhance catheter-based renal arterial denervation procedural strategy and outcomes.

Retrograde Coronary Chronic Total Occlusion Intervention Using a Novel Reverse Controlled Antegrade and Retrograde Subintimal Tracking.

Abstract: Chronic total occlusion (CTO) is a frequent finding in patients with coronary artery disease and when clinically indicated, remains one of the most challenging subsets for intervention. Although successful recanalization rates of CTO have remained suboptimal in percutaneous coronary intervention, evolving techniques including retrograde approach, have raised hopes for improving the overall success. Reverse controlled antegrade and retrograde subintimal tracking is the most commonly used out of various retrograde approaches. In this review, the author has thrown light on a step-by-step approach of this technique, its standardization, various modifications along with complications.

Thrombin-Induced Platelet-Fibrin Clot Strength Identified by Thrombelastography: A Novel Prothrombotic Marker of Coronary Artery Stent Restenosis.

Abstract: Background and Objective In-stent restenosis (ISR) is a limitation of percutaneous coronary intervention and has been linked to specific clinical and angiographic variables. We aimed to simultaneously assess thrombosis biomarkers and lipid levels in patients with and without ISR. Methods Consecutive patients (n = 170) with a history of coronary stenting undergoing elective angiography were studied. Blood samples for thrombelastography, light transmittance aggregometry, and lipid levels were obtained prior to cardiac catheterization. Results Sixty-nine patients (41%) had ISR (>50% luminal diameter stenosis). Among patients with ISR, 40 (58%) had ISR in more than one stent bed. Patients with ISR were more often female (37.7% vs. 21.8%, P = 0.04), had higher thrombin-induced platelet-fibrin clot strength (TIP-FCS) (69.9 mm vs. 65.6 mm, P < 0.001), and a higher ApoB/A1 ratio (0.65 vs. 0.59, P = 0.03). In patients on dual antiplatelet therapy (n = 86), there were no differences in ADP-, arachidonic acid-, and collagen-induced platelet aggregation between groups. The frequency of patients with ISR increased with TIP-FCS quartiles and by ROC analysis, TIP-FCS = 67.0 mm was the cutpoint for identification of ISR (AUC = 0.80 (95%CI 0.73–0.87, P < 0.0001). By multivariate analysis, TIP-FCS ≥67.0 mm strongly associated with ISR (OR = 7.3, P = 0.004). Conclusion Patients with ISR identified at the time of cardiac catheterization have a prothrombotic phenotype indicated by high TIP-FCS, a novel marker. Studies to confirm the prognostic utility of high TIP-FCS for the development of ISR are ongoing. (J Interven Cardiol 2016;29:168–178)

Learning Curve Assessment for Percutaneous Left Atrial Appendage Closure With the WATCHMAN Occluder.

Abstract: Objectives We sought to evaluate the effect of increasing experience with left atrial appendage (LAA) closure on short-term outcome. Background Data regarding the impact of the learning curve of LAA closure—particularly regarding technical aspects of the procedure—are lacking. Methods The present analysis represents first data from a single-center all-comer registry. The population was divided into 3 groups according to treatment time (group 1: patients 1–30; group 2: patients 31–60; group 3: patients 61–90). Results The mean age of the population was 77 years. Median CHA2DS2VASC Score and HAS-BLED were 5 (IQR 3–5) and 3 (IQR 3–4), respectively. Implantation success was 90% with a slight but not statistically significant increase during the course of the registry. Procedure time (75 [62–108] vs. 50 [43–66] vs. 47 [41–61] minutes; P < 0.0001), fluoroscopy time (20 [15–30] vs. 11 [8−19] vs. 11 [9–18] minutes; P = 0.002), and contrast volume (105 [70–170] vs. 60 [50–75] vs. 50 [50–73] ml; P < 0.0001) were reduced across the 3 groups. In-hospital complications decreased significantly (20 vs. 7% vs. 0%; P = 0.021). The compression grade of the occluder was chosen higher with increasing learning curve (15 [11–25] vs. 25 [17–29] vs. 21 [14–26] %; P = 0.05). Conclusions With increasing operator experience the performance and safety of percutaneous LAA closure improved continuously.

Long Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study

Abstract: Objectives to assess performance of new, bioresorbable polymer sirolimus-eluting stent (BP-SES), in patients with long coronary lesions (LL) and to compare it to permanent polymer everolimus-eluting stent (PP-EES). Background LL have been associated with worse clinical outcomes in percutaneous coronary interventions (PCI). The impact of lesion length on the outcomes of drug eluting stent (DES) implantations is not as clear. Methods In the frame of a randomized, multicentre CENTURY II study, out of 1119 patients enrolled, 182 patients had LL (defined as ≥25 mm), and were assigned randomly to treatment with BP-SES (101) or PP-EES (81). Primary endpoint was target lesion failure (TLF, composite of cardiac death, target vessel related myocardial infarction [MI], and target lesion revascularization [TLR]) at 9 months. All data were 100% monitored and adverse events were adjudicated by an independent clinical event committee. Results The baseline patient and lesion characteristics were similar in the 2 study arms. At 9-months, the rates of cardiac death (2.0% vs 1.2%; P = 0.70), MI (3.0% vs 4.9%; P = 0.49) and clinically driven TLR (2.0% vs 3.7%; P = 0.48) and TLF (6.9% vs 8.6%; P = 0.67) were similar for BP-SES and PP-EES, respectively. There was no stent thrombosis (ST) in BP-SES group up to 9 months, while 1 case (1.2%) of ST was recorded in PP-EES group (P = 0.44). Conclusions Patients with LL showed similar clinical outcomes when treated with Ultimaster BP-SES and Xience PP-EES. (J Interven Cardiol 2016;29:47–56)

Circulating Endothelial Cells and Endothelial Function Predict Major Adverse Cardiac Events and Early Adverse Left Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction.

Abstract: Endothelial progenitor cells (EPCs) and circulating endothelial cells (CECs) are mobilized from the bone marrow and increase in the early phase after ST-elevation myocardial infarction (STEMI). The aim of this study was to assess the prognostic significance of CECs and indices of endothelial dysfunction in patients with STEMI. In 78 patients with acute STEMI, characterization of CD34+/VEGFR2+CECs, and indices of endothelial damage/dysfunction such as brachial artery flow mediated dilatation (FMD) were determined. Blood samples for CECs assessment and quantification were obtained within 24 hours of admission and FMD was assessed during the index hospitalization. At 30 days follow up, the primary composite end point of major adverse cardiac events (MACE) consisting of all-cause mortality, recurrent nonfatal MI, or heart failure and the secondary endpoint of early adverse left ventricular (LV) remodeling were analyzed. The 17 patients (22%) who developed MACE had significantly higher CEC level (P = 0.004), von Willebrand factor (vWF) level (P = 0.028), and significantly lower FMD (P = 0.006) compared to the remaining patients. Logistic regression analysis showed that CECs level and LV ejection fraction were independent predictors of MACE. The areas under the receiver operating characteristic curves (ROC) for CEC level, FMD, and the logistic model with both markers were 0.73, 0.75, and 0.82, respectively, for prediction of the MACE. The 16 patients who developed the secondary endpoint had significantly higher CEC level compared to remaining patients (P = 0.038). In conclusion, increased circulating endothelial cells and endothelial dysfunction predicted the occurrence of major adverse cardiac events and adverse cardiac remodeling in patients with STEMI.

Balloon-Expandable Transcatheter Aortic Valves Can Be Successfully and Safely Implanted Transfemorally Without Balloon Valvuloplasty.

Abstract: Objectives To assess the necessity for balloon aortic valvuloplasty (BAV) during transfemoral transcatheter aortic valve implantation (TAVI) when using balloon-expandable valves. Background BAV is a usual part of TAVI procedures, prior to valve implantation. However, the benefits and necessity of this are unknown and recent evidence in self-expanding valves suggests it may not be necessary. Methods Retrospective single-center study of 154 patients undergoing first-time, transfemoral TAVI for native aortic valve stenosis, with (N = 76), and without (N = 78), BAV as part of the procedure. Data collected included demographic, procedural, and outcome data. Results BAV did not alter VARC-2 defined procedural success or early safety compared to not performing a BAV, including mortality, degree of aortic regurgitation, or need for post-TAVI balloon dilatation, although there was a strong trend to reduced stroke when not performing a BAV. There was a significantly reduced procedural time (P = 0.01) and fluoroscopic time (P < 0.001) without performing a BAV. There were no differences in cerebral embolization (solid, gaseous, or total emboli) noted between the 2 groups, as measured on transcranial doppler (TCD). Conclusions TAVI can be effectively and safely performed without a BAV and this results in reduced procedural and fluoroscopic times, although embolization to the brain is not reduced. There is a trend toward reduced stroke risk. (J Interven Cardiol 2016;29:319–324)

Aortic Root Distortion and Aortic Insufficiency During Balloon Angioplasty of the Right Ventricular Outflow Tract Prior to Transcatheter Pulmonary Valve Replacement.

Abstract: Objective To describe the significance of aortic root distortion (AD) and/or aortic valve insufficiency (AI) during balloon angioplasty of the right ventricular outflow tract (RVOT) performed to rule out coronary artery compression prior to transcatheter pulmonary valve (TPV) implantation. Methods AD/AI was assessed by retrospective review of all procedural aortographies performed to evaluate coronary anatomy prior to TPV implantation. AD/AI was also reviewed in all pre-post MPV implant echocardiograms to assess for progression. Results From 04/2007 to 3/2015, 118 pts underwent catheterization with intent for TPV implant. Mean age and weight were 24.5 ± 12 years and 64.3 ± 20 kg, respectively. Diagnoses were: TOF (53%), D-TGA/DORV (18%), s/p Ross (15%), and Truncus (9%). Types of RV-PA connections were: conduits (96), bioprosthetic valves (14), and other (7). Successful TPV implant occurred in 91 pts (77%). RVOT balloon angioplasty was performed in 43/118 pts (36%). Aortography was performed in 18/43 pts with AD/AI noted in 6/18 (33%); 2 with D-TGA (1 s/p Lecompte, 1 s/p Rastelli), 2 with TOF, 1 Truncus and 1 s/p Ross. Procedure was aborted in the 2 who developed severe AD/AI. TPV was implanted in 3/4 patients with mild AD/AI. Review of pre-post TPV implantation echocardiograms in 83/91 pts (91%) revealed no new/worsened AI in any patient. Conclusion AD/AI is relatively common on aortography during simultaneous RVOT balloon angioplasty. Lack of AI progression by echocardiography post-TPV implant suggests these may be benign findings in most cases. However, AD/AI should be carefully evaluated in certain anatomic subtypes with close RVOT/aortic alignments.

Transcatheter Aortic Valve Replacement Using the Portico System: 10 Things to Remember.

Abstract: The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our personal experience with this system.

Impact of Operators’ Height on Individual Radiation Exposure Measurements During Catheter‐Based Cardiovascular Interventions

Abstract: Aim This study is aimed to evaluate the impact of an operators’ height on personal radiation exposure measurements during cardiovascular interventional procedures. Based upon both clinical data and phantom simulation, a new approach for monitoring an individual's exposure is proposed. Methods The clinical component of this study was composed of the operators and staff in a single center full service cardiovascular laboratory being divided into 2 groups based upon their height: group A included all individuals whose height was 165 cm. All operators wore a standard TLD dosimeter at all times with doses recorded for 12 months. To support these clinical findings, a second investigation was performed utilizing a phantom. Measurements were obtained at 100 and 135 cm from the radiation source during simulation of different cardiovascular interventional procedures. Results The radiation dose measured from the personal dosimeters identified that Group A, operators 165 cm, when compared among individuals performing similar tasks (physicians, technicians, and nurses): 4.55 ± 4.0 (Group A) versus 1.95 ± 1.0 (Group B) mSv (P < 0.01). During procedure simulation with the phantom, the doses measured were similarly significantly higher if measured at 100 cm than at 135 cm from the radiation source. Conclusion This study suggests that the height from radiation source does impact the measured dose from an operator worn personal TLD. This was operator specific, consistent thought-out multiple procedures, and confined with phantom measurements. (J Interven Cardiol 2016;29:83–88)

Short-Term Outcomes of Patent Ductus Arteriosus Closure With New Occlutech® Duct Occluder: A Multicenter Study.

Abstract: Aim Over the past 2 decades, transcatheter occlusion of patent ductus arteriosus (PDA) with coils and the duct occluders evolved to be the procedure of choice. A new device, the Occlutech PDA® occluder (ODO) device has been designed. Herein, we aimed to evaluate the characteristics and short-term results of patients who underwent transcatheter closure of PDA using the ODO. Methods We reviewed the clinical records of 60 patients from different centers in Turkey between December 2013 and January 2016. The medical records were reviewed for demographic characteristics and echocardiographic findings. Device size was selected on the narrowest diameter of PDA. Results The median patient age was 2.5 years (6 months–35 years), and median PDA diameter was 2.5 mm (1.2–11 mm). Fifty-eight of 60 patients (96.6%) had successful ODO implantation. The occlusion rates were 37/58 (63.7%) at the end of the procedure, 51/58 (87.9%) at 24–48 hours post-procedure, and 57/58 (98.2%) on echocardiography at a median follow-up of 7.6 months. Conclusion Our results indicate that transcatheter closure of PDA using the ODO is effective. Larger studies and longer follow-up are required to assess whether its shape and longer length make it superior to other duct occluders in large, tubular, or window-type ducts. (J Interven Cardiol 2016;29:325–331)