Showing papers in "Catheterization and Cardiovascular Interventions in 2016"

SCAI expert consensus statement: Evaluation, management, and special considerations of cardio-oncology patients in the cardiac catheterization laboratory (Endorsed by the Cardiological Society of India, and Sociedad Latino Americana de Cardiologıa Intervencionista).

Abstract: In the United States alone, there are currently approximately 14.5 million cancer survivors, and this number is expected to increase to 20 million by 2020. Cancer therapies can cause significant injury to the vasculature, resulting in angina, acute coronary syndromes (ACS), stroke, critical limb ischemia, arrhythmias, and heart failure, independently from the direct myocardial or pericardial damage from the malignancy itself. Consequently, the need for invasive evaluation and management in the cardiac catheterization laboratory (CCL) for such patients has been increasing. In recognition of the need for a document on special considerations for cancer patients in the CCL, the Society for Cardiovascular Angiography and Interventions (SCAI) commissioned a consensus group to provide recommendations based on the published medical literature and on the expertise of operators with accumulated experience in the cardiac catheterization of cancer patients.

Angiographic appearance of spontaneous coronary artery dissection with intramural hematoma proven on intracoronary imaging

Abstract: Background The pathognomonic appearance of multiple radiolucent lumen on angiography is used to diagnose spontaneous coronary artery dissection (SCAD). However, this finding is absent in >70% of SCAD, in which case optical coherence tomography (OCT) or intravascular ultrasound (IVUS) is useful to assess arterial wall integrity. Methods We report the angiographic appearance of SCAD that were proven on intracoronary imaging with OCT or IVUS. Our angiographic classification and algorithm for SCAD diagnosis was previously reported. Patients with type 1 SCAD (multiple radiolucent lumen) do not require OCT/IVUS, whereas, it was recommended for those with suspected type 2 (diffuse stenosis) or 3 (mimic atherosclerosis) SCAD. Results Twenty-two consecutive patients with non-type 1 angiographic SCAD in 25 coronary arteries (22 OCT and 4 IVUS) were studied. Mean age was 52.9 ± 9.9 years, 89.5% were women, and 16/22 (72.7%) had underlying fibromuscular dysplasia. Sixteen SCAD arteries were type 2 SCAD, and nine were type 3. All 25 SCAD arteries had intramural hematoma and intimomedial membrane separation with double lumen on OCT or IVUS. The mean visual angiographic stenosis was 74.6 ± 17.5% (range 40–100%). Dissected segments were long with mean qualitative coronary analysis (QCA) length 45.2 ± 29.2 mm, especially in patients with type 2 SCAD (mean QCA length 58.3 ± 29.0 mm). The mean QCA length in type 3 SCAD lesions was 22.1 ± 5.7 mm. Conclusions Intracoronary imaging confirms that SCAD may appear angiographically without multiple radiolucent lumen. Angiographers should be familiar with angiographic SCAD variants to improve SCAD diagnosis, and utilize intracoronary imaging when the diagnosis is uncertain. © 2015 Wiley Periodicals, Inc.

SCAI Expert consensus statement: Evaluation, management, and special considerations of cardio-oncology patients in the cardiac catheterization laboratory (endorsed by the cardiological society of india, and sociedad Latino Americana de Cardiologıa interve: Management of Cancer Patients in the Cath Lab

Abstract: In the United States alone, there are currently approximately 14.5 million cancer survivors, and this number is expected to increase to 20 million by 2020. Cancer therapies can cause significant injury to the vasculature, resulting in angina, acute coronary syndromes (ACS), stroke, critical limb ischemia, arrhythmias, and heart failure, independently from the direct myocardial or pericardial damage from the malignancy itself. Consequently, the need for invasive evaluation and management in the cardiac catheterization laboratory (CCL) for such patients has been increasing. In recognition of the need for a document on special considerations for cancer patients in the CCL, the Society for Cardiovascular Angiography and Interventions (SCAI) commissioned a consensus group to provide recommendations based on the published medical literature and on the expertise of operators with accumulated experience in the cardiac catheterization of cancer patients. © 2016 Wiley Periodicals, Inc.

Comparison of percutaneous coronary intervention for chronic total occlusion outcome according to operator experience from the Japanese retrograde summit registry

Abstract: Objectives This study was performed to evaluate the acute outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on operator experience. Background Despite developments in both technology and techniques, PCI procedures for CTO's remain challenging. Methods A total of 3,229 eligible subjects who underwent CTO-PCI were enrolled from 56 centers by a retrograde summit using a web registry system. To compare the acute outcomes of the CTO data, 18 centers were classified as higher volume centers (HC) and 38 centers as lower volume centers (LC) depending on the CTO-PCI experience of the operator. Results The mean procedural success rate of all centers was 88.4%. The overall procedural success rate was significantly higher in HC than LC (90.6% vs. 85.6%, respectively; P < 0.0001). In addition, overall antegrade success rate was also higher in HC than LC (91.0% vs. 83.9%, respectively; P < 0.0001). Although the overall retrograde approach success rate was significantly higher in HC than LC (85.0% vs. 77.6%, respectively; P < 0.0001), there was no significant difference in that of the retrograde alone (89.0% vs. 93.7%, respectively; P = 0.051). Major in-hospital adverse events were observed in 0.53% of cases, and the rates were similar between the two groups (0.45% vs. 0.62%, respectively; P = 0.25). Conclusions Although CTO-PCI was safe in both groups, the procedural success rate was significantly higher in HC than LC, even in this new era of CTO-PCI. This difference was attributed to the difference in the antegrade procedural success rate. © 2015 Wiley Periodicals, Inc.

Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial

Abstract: Background In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. Methods and Results ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Conclusion Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA. © 2015 Wiley Periodicals, Inc.

SCAI expert consensus statement: 2016 best practices in the cardiac catheterization laboratory: (Endorsed by the cardiological society of india, and sociedad Latino Americana de Cardiologia intervencionista; Affirmation of value by the Canadian Association of interventional cardiology-Association canadienne de cardiologie d'intervention).

Abstract: The SCAI Expert Consensus Statement: 2012 Best Practices in the Cardiac Catheterization Laboratory provides standards for preprocedure, intraprocedure, and postprocedure evaluation and management, and served as a patient-centered approach to safety and quality in the cardiac catheterization laboratory (CCL) [1]. It was noted that the CCL is a setting in which elective, urgent, and emergent percutaneous procedures are performed, and that high throughput and increasing patient complexity demand optimal periprocedural communication, clinical management, documentation, and protocol. Regulations primarily targeted at open surgical suites have the potential to negatively impact the quality of care because they shift the focus to performance measures that are not necessarily relevant to the CCL. Accordingly, directives were tailored to the percutaneous setting in order to assure quality and optimal patient safety while maintaining efficiency.

Morphologic characterization of the patent ductus arteriosus in the premature infant and the choice of transcatheter occlusion device.

Abstract: Objectives: The aim of this study was to describe and differentiate the morphology of patent ductus arteriosus (PDA) seen in children born prematurely from other PDA types. Background: PDAs are currently classified as types A-E using the Krichenko's classification. Children born prematurely with a PDA morphology that did not fit this classification were described as Type F PDA. Methods: A review of 100 consecutive children who underwent transcatheter device closure of PDA was performed. The diameter and length (L) of the PDA and the device diameter (D) were indexed to the descending aorta (DA) diameter. Results: Comparison of 26 Type F PDAs was performed against, 29 Type A, 7 Type C and 32 Type E PDAs. Children with Type F PDAs (median 27.5 weeks gestation) were younger during the device occlusion compared with types A, C, and E (median age: 6 vs. 32, 11, and 42 months; P = 0.002). Type F PDAs were longer and larger, requiring a relatively large device for occlusion than types A, C, and E (Mean L/DA: 1.88 vs. 0.9, 1.21, and 0.89, P ≤ 0.01 and Mean D/DA: 1.04 vs. 0.46, 0.87, and 0.34, P ≤0.01). The Amplatzer vascular plug-II (AVP-II) was preferred for occlusion of Type F PDAs (85%; P <0.001). Conclusions: Children born prematurely have relatively larger and longer PDAs. These “fetal type PDAs” are best classified separately. We propose to classify them as Type F PDAs to add to types A-E currently in use. The AVP-II was effective in occluding Type F PDAs. © 2015 Wiley Periodicals, Inc.

Optimizing Radiation Safety in the cardiac catheterization laboratory: A practical approach

Abstract: Reducing radiation exposure during cardiovascular catheterization is of paramount importance for both patient and staff safety. Over the years, advances in equipment and application of radiation safety protocols have significantly reduced patient dose and operator exposure. This review examines the current status of radiation protection in the cardiac and vascular catheterization laboratory and summarizes best practices for minimizing radiation exposure.

A team‐based approach to patients in cardiogenic shock

Abstract: Cardiogenic shock is a common clinical condition with high in-hospital mortality. Early application of appropriate interventions for cardiogenic shock-including medical therapies, revascularization, temporary hemodynamic support devices, and durable mechanical circulatory support-may improve outcomes. The number and complexity of therapies for cardiogenic shock are increasing, making time-dependent decision-making more challenging. A multidisciplinary cardiogenic shock team is recommended to guide the rapid and efficient use of these available treatments. © 2015 Wiley Periodicals, Inc.

CRISP: Catheterization RISk score for pediatrics: A Report from the Congenital Cardiac Interventional Study Consortium (CCISC)

Abstract: Objectives We sought to develop a scoring system that predicts the risk of serious adverse events (SAE's) for individual pediatric patients undergoing cardiac catheterization procedures. Background Systematic assessment of risk of SAE in pediatric catheterization can be challenging in view of a wide variation in procedure and patient complexity as well as rapidly evolving technology. Methods A 10 component scoring system was originally developed based on expert consensus and review of the existing literature. Data from an international multi-institutional catheterization registry (CCISC) between 2008 and 2013 were used to validate this scoring system. In addition we used multivariate methods to further refine the original risk score to improve its predictive power of SAE's. Results: Univariate analysis confirmed the strong correlation of each of the 10 components of the original risk score with SAE attributed to a pediatric cardiac catheterization (P < 0.001 for all variables). Multivariate analysis resulted in a modified risk score (CRISP) that corresponds to an increase in value of area under a receiver operating characteristic curve (AUC) from 0.715 to 0.741. Conclusion The CRISP score predicts risk of occurrence of an SAE for individual patients undergoing pediatric cardiac catheterization procedures. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER‐I trial: Success and safety

Abstract: Objectives To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve. Background TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes. Methods From 4/2007–2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay. Results Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6). Conclusions By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

Complete myocardial revascularization confers a larger clinical benefit when performed with state‐of‐the‐art techniques in high‐risk patients with multivessel coronary artery disease: A meta‐analysis of randomized and observational studies

Abstract: Objectives To test whether a strategy of complete revascularization (CR) as compared with incomplete myocardial revascularization (IR)—both performed with current “state-of-the-art” percutaneous coronary interventions (PCI) or coronary artery bypass graft (CABG)—would provide a clinical benefit in patients with multivessel coronary artery disease (MVCAD). Background The “optimal” extent of myocardial revascularization remains to be determined. Methods: We performed a meta-analysis of studies reporting on clinical outcomes of MVCAD patients treated with CR and IR, with extensive (>80%) use of stents for PCI or arterial conduits in CABG. Relative risk (RR) and 95% confidence intervals (CIs) for all-cause mortality were assessed as primary endpoint, myocardial infarction (MI) and repeat revascularization as secondary endpoints. Results A total of 28 studies were identified, including 83,695 patients with 4.7 ± 4.3 years of follow-up. Compared with IR, CR was associated with reduced mortality (RR: 0.73; 95% CI 0.66–0.81) both after CABG (RR: 0.76; 95% CI 0.63–0.90) and PCI (RR: 0.73; 95% CI 0.64–0.82). The risks of MI (RR: 0.74; 95% CI 0.64–0.85) and repeat revascularization (RR: 0.77; 95% CI 0.66–0.88) were also lower after CR as compared with IR. Metaregression showed a significant RR reduction of MI associated with more recent publication (P = 0.021) and increasing prevalence of diabetes (P = 0.033). Conclusions In MVCAD, as compared with IR, CR confers a clinical benefit that seems larger in cohorts of patients enrolled in more recent studies and with a higher prevalence of diabetes. © 2015 Wiley Periodicals, Inc.

Comparison of transradial coronary procedures via right radial versus left radial artery approach: A meta-analysis

Abstract: Introduction Coronary angiography and angioplasty via transradial approach is shown to be associated with significant reduction in access site complications. Due to a lack of sufficient data, the use of the right or left radial approach is still operator-dependent. We performed a meta-analysis of prospective randomized studies to compare right versus left radial artery approach for coronary procedures. Methods We found 12 randomized studies meeting the predetermined inclusion criteria. A total of 6,450 patients were included in the meta-analysis of which 3,217 patients underwent coronary procedures via right radial approach and 3,233 patients via left radial approach. The primary endpoint was the comparison of fluoroscopy time, procedure time, contrast use and cross-over rates between two radial approaches. Results Pooled analysis of the included studies showed a similar rate of cross-over events (4.2% for right radial approach vs. 4.1% for left radial approach, odds ratio (OR)=1.08, P = 0.68), and similar total procedure times (18.8 ± 10.3 min vs. 18.1 ± 10.0 min, standard difference (SD) of the mean = 0.09, P = 0.162) between the two radial approaches. However, the right radial approach was found to be associated with minimally longer fluoroscopy times (5.8 ± 4.4 min vs. 5.3 ± 4.2 min, SD of the mean = 0.157, P < 0.001) and greater contrast use (84 ± 35 mL vs. 82 ± 34 mL, SD of the mean = 0.082, P = 0.003). Access site complications and the incidence of stroke were similar between two radial approaches. Conclusion Our meta-analysis suggests a small but statistically significant difference in terms of contrast use and fluoroscopy time in favor of coronary procedures performed via left radial approach in comparison to right radial approach without any significant difference in access site or other procedural complications between the two radial approaches. © 2016 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

Abstract: Objectives To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF-TAVR). Background TF-TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown. Methods In the PARTNER-I trial, 1,521 patients underwent TF-TAVR from 4/2007–2/2012. Learning curve analysis of technical performance metrics was performed using institution-specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi-parametric and parametric mixed-effects models. Results As patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52–140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21–52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%. Conclusions Technical performance learning curves exist for TF-TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late-entering institutions. Knowledge and experience accumulated by early TF-TAVR institutions were disseminated, shortening the learning curve of late-entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut-down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.

Development of a novel hybrid strategy for transcatheter pulmonary valve placement in patients following transannular patch repair of tetralogy of fallot

Abstract: Background Transcatheter pulmonary valve replacement (tPVR) is an accepted therapy for treatment of dysfunctional right ventricular outflow tract (RVOT) conduits. At present, the majority of Fallot patients who undergo transannular patch (TAP) repair are not candidates for tPVR due to the large irregular nature of their RVOT. Herein, we describe a novel approach to assessing the RVOT in this group, which may then be used to design, test, and carry out hybrid RVOT modification and transcatheter valve implantation in this population. Methods A retrospective analysis of TAP patients who underwent 3D modeling of the RVOT which was then used to develop individualized hybrid procedures designed to modify the RVOT, thereby rendering patients suitable for transcatheter valve implantation. Results Eight consecutive patients underwent 3D RVOT modeling followed by hybrid implantation of a transcatheter valve via a perventricular approach. A landing zone stent was placed in all and four required additional intravascular geometric remodeling of the RVOT prior to valve implant. Transcatheter valves were successfully implanted in all. There were no instances of valve malposition, embolization, or death. There was one minor procedural complication. No patient had more than trivial pulmonary regurgitation at follow-up. Conclusions Using a hybrid approach to remodel the RVOT in TAP patients supported by preprocedural 3D-model planning allows for successful tPVR implantation in this population. A larger cohort and longer follow-up will be needed to determine the ultimate utility of this approach. © 2015 Wiley Periodicals, Inc.

Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program

Abstract: Objectives The purpose of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with coronary artery calcification (CAC). Background Smaller studies have reported worse clinical outcomes in patients with CAC who undergo PCI. The impact of CAC in the drug-eluting stent era is unclear. Methods Data from 7,492 patients treated by PCI with ≥1 TAXUS Express stent in the ARRIVE registry with no inclusion/exclusion criteria were stratified by the severity of CAC, as determined by the operator. Endpoints were independently adjudicated. All major adverse cardiac events were assessed at 2 years. Results Moderate/severe CAC was present in 19.6%. The nil/mild CAC group had higher rate of current smokers. The moderate/severe CAC group was older and had a higher prevalence of hypertension, kidney disease, prior coronary artery bypass grafting, congestive heart failure, and left main disease. After adjustment for imbalanced baseline variables, patients with moderate/severe CAC had higher 2 year rates of major adverse cardiac events (18.3% vs 13.5%, p = 0.01) and death (10.3% vs 5.6%, p = 0.02). Conclusions Moderate/severe CAC was associated with increased clinical events in patients who underwent PCI with TAXUS stents. This may be explained in part due to differences important baseline characteristics including more patients with more comorbidities and more complex lesions. After adjustment for imbalanced baseline variables, the moderate/severe CAC group had a higher risk of major adverse cardiac events and death. Improvements in treatment strategies are needed for this high-risk group of patients who undergo PCI. © 2016 Wiley Periodicals, Inc.

Rapid pacing using the left ventricular guidewire: Reviving an old technique to simplify BAV and TAVI procedures

Abstract: Objectives We sought to demonstrate the safety and efficacy of rapid left ventricular (LV) pacing through the guidewire during balloon aortic valvuloplasty (BAV) and Transaortic valve implantation (TAVI). Background Right ventricular temporary pacing during TAVI and BAV is time-consuming and associated with vascular and pericardial complications. Methods Rapid left ventricular pacing was provided via the back-up 0.035″ guidewire. The cathode of an external pacemaker was placed on the tip of the 0.035″ wire and the anode on a needle inserted into the groin. Insulation was ensured by the balloon or TAVI catheter. Results 38 BAV and 87 TAVI procedures were performed in 113 consecutive patients in three centers with one for one pacing (160–200 bpm) in all patients. A significant reduction in blood pressure was achieved with a mean systolic pressure of 44 mm Hg during stimulation. Mean procedural time was 49.7 ± 31 min for BAV and 68.7 ± 30.9 for TAVI. A temporary venous pacemaker was required in 12 patients; only 12% of TAVI patients had a femoral central venous catheter. Femoral venous puncture was not performed in BAV patients. No venous vascular complications were observed. One case of successfully treated tamponade (0.8%) occurred 8 hr post procedure. In-hospital mortality rates were 4.6% and 2.6% in the TAVI and BAV groups, respectively. Conclusions Use of the LV guidewire for rapid pacing during BAV and TAVI was shown to be simple, reproducible, and prevented complications associated with RV temporary leads thus potentially simplifying TAVI and enhancing its safety. © 2016 Wiley Periodicals, Inc.

"Real-World" Comparison of Prasugrel With Ticagrelor in Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention in the United States.

Abstract: Objectives: The 30-day clinical outcomes with prasugrel or ticagrelor were comparedusing a US payer database in patients with acute coronary syndrome (ACS) undergoingpercutaneous coronary intervention (PCI).Background: Prasugrel and ticagrelor dem-onstrated superior efficacy with increased non-coronary artery bypass graft majorbleeding compared with clopidogrel in randomized clinical trials. No direct randomizedor observational studies have compared clinical outcomes between prasugrel and tica-grelor.Methods: Patients hospitalized for ACS-PCI between August 1, 2011 and April30, 2013 and prescribed prasugrel or ticagrelor were selected. Drug treatment cohortswere propensity matched based upon demographic and clinical characteristics. Theprimary objective compared 30-day net adverse clinical events (NACE) in prasugrel-and ticagrelor-treated patients using a prespecified 20% noninferiority margin. Second-ary objectives included comparisons of major adverse cardiovascular events (MACE)and major bleeding.Results: Data were available for 16,098 patients (prasugrel,n513,134; ticagrelor,n52,964). In unmatched cohorts, prasugrel-treated patients wereyounger with fewer comorbidities than ticagrelor-treated patients, and 30-day NACE rateswere 5.6 and 9.3%, respectively (P<0.001). Following propensity matching, NACE was nonin-ferior (P<0.001) and 22% lower in prasugrel-treated than in ticagrelor-treated patients (RR,0.78; 95% CI, 0.64–0.94). A 30-day adjusted MACE (RR, 0.80; 95% CI, 0.64–0.98) and majorbleeding (RR, 0.65; 95% CI, 0.45–0.95) were also lower in prasugrel-treated patients comparedwith ticagrelor-treated patients.Conclusions: In this “real-world,” retrospective, observa-tional study, physicians appear to preferentially use prasugrel in younger patients withlower risk of bleeding or comorbidities compared with ticagrelor. Following adjust-ment, clinical outcomes associated with prasugrel use appear as good, if not better,than those associated with ticagrelor in ACS-PCI patients.

Incidence and Clinical Impact of Stroke Complicating Transcatheter Aortic Valve Implantation: Results From the German TAVI Registry.

Abstract: Background Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective treatment for patients with severe, symptomatic aortic valve stenosis at high surgical risk over the last years. However, besides its minimal invasive character, TAVI still is an invasive procedure usually performed in a population, carrying a substantial risk for vascular complications, like stroke. Stroke is known to be a rare but serious complication of transvascular interventions in clinical practice, which is associated with high morbidity and mortality rates. Despite broad clinical research in many fields of TAVI over the last years, only sparse data still exist on the incidence and clinical risk factors of stroke complicating TAVI in clinical practice today. Methods We analyzed data of 1.413 TAVIs, which were enrolled at 30 sites into the prospective and multicenter German TAVI Registry from January 2009 until June 2010. Results The overall incidence of cerebrovascular events complicating TAVI was 3.2% (n = 45/1.413) in a real-world population today. 40% of all cerebrovascular events were classified as transient ischemic attacks (TIA) with symptoms lasting 24 hr (27/45). All strokes complicating TAVI of 50% were classified as major strokes leading to notable disability in patients, who survive this complication (Modified Ranking Scale 3–6). In-hospital mortality rate in patients with stroke/TIA was 28.9%, compared to 6.9% in patients without stroke/TIA and 1-year mortality rate 46.7% versus 18.6%, respectively. In multivariate analysis, prior stroke and renal impairment were found as the only independent predictors for stroke complicating TAVI. Conclusions Stroke complicating TAVI is a serious complication with a clinically relevant incidence even in daily practice leading to a fivefold increase in 30-day-mortality rate, as well as a significant increase in morbidity and disability in patients, who survive this devastating complication. Further research is needed to identify risk factors and ways to reduce stroke after TAVI. © 2016 Wiley Periodicals, Inc.

Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.

Abstract: BackgroundThe Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing. MethodsWe retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing centers from 11 countries (IRFACODE). ResultsIn 1315 patients of all age groups (female 66.9%), successful (98%) ASD closure was performed (mean age 28.9 years, weight 52 kg, height 148.6 cm). Of the defects, 47.9% showed no or only a deficient aortic rim;in 11.9%, there was more than one defect;a septum aneurysm was present in 21.5%;and the mean implanted device size was 20.5 mm. Immediate closure was achieved in 78.6%, at discharge in 83.1%, and 96.4% and 97.3% at 6 and 12 months follow-up, respectively. During a mean follow-up of 2.7 years (in total 3597 patient years), significant complications were minimal (total=8, <1%) with secondary device embolizations in five and AV-blocks in three patients. No erosion or death was reported. ConclusionASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. (c) 2016 Wiley-Blackwell.

Current status of percutaneous right ventricular assist devices: First-in-man use of a novel dual lumen cannula.

Abstract: Ventricular assist devices have become an accepted therapeutic solution for patients with severe left ventricular dysfunction when pharmacology fails to maintain sufficient cardiac output. Despite various technologies that have allowed left ventricular assist devices to become more reliable and versatile in the past decade, comparatively little attention has been applied to right heart assistance which is still in the early stage of its development. The extracorporeal devices developed thus far have been associated with mobility issues and complications common to ventricular assist devices in general, such as infection, bleeding, and thromboembolism. Designed to obviate the problems previously experienced by other right ventricle (RV)-focused devices, the Protek Duo (CardiacAssist, Pittsburgh, PA) is a novel, fully percutaneous, dual lumen cannula for RV support used in conjunction with the paracorporeal TandemHeart(®) (CardiacAssist, Pittsburgh, PA) pump. We describe our initial experience with the Protek Duo cannula in two different clinical scenarios. In addition, we summarize the current percutaneous mechanical support technology for RV assistance and propose modification of current technology to facilitate its application. © 2016 Wiley Periodicals, Inc.

Trans-subclavian versus transapical access for transcatheter aortic valve implantation: A multicenter study.

Abstract: Objectives To compare the outcomes of trans-subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI). Background A considerable proportion of patients undergoing TAVI are not eligible for transfemoral approach. To date, there are few data to guide the choice between alternative vascular access routes. Methods Among 874 consecutive patients who underwent TAVI, 202 procedures were performed through TA (n = 142, 70.3%) or TS (n = 60, 29.7%) access. Medtronic Corevalve (CV, Medtronic, Minneapolis, MN) was implanted in 17.3% of the patients, the Edwards-Sapien (ES, Edwards Lifesciences Inc., Irvine, CA) in 81.2% and other prostheses in 0.1%. In-hospital and long-term outcome were assessed using the Valve Academic Research Consortium (VARC)-2 definitions. Results Mean age was 82 ± 6 years, STS score 9.3 ± 7.9%. The 2 groups showed a relevant imbalance in baseline characteristics. In hospital mortality was 6.4% (1.7% TS vs. 8.4% TA, P = 0.06), stroke 2.0%, acute myocardial infarction 1.0%, acute kidney injury 39.4%, sepsis 4.0% with no significant differences between groups, while bleeding was more frequent in TA patients (53.5% vs. 11.7% TS, P < 0.001). One- and 2-year survival was 85.2% and 73.2% in TS patients, and 83.9% and 74.9% in TA patients (P = ns for both). Access site was not an independent predictor of mortality at multivariable analysis. Conclusion Transapical compared with trans-subclavian access for TAVI was associated with a nonsignificant trend to increased periprocedural events. However, 1- and 2-year survival appears similar. © 2015 Wiley Periodicals, Inc.

Complications during retrograde approach for chronic coronary total occlusion: Sub-analysis of Japanese multicenter registry.

Abstract: Objectives This study was performed to determine the complications occurring during retrograde percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) based on analysis of the multicenter, prospective, nonrandomized Retrograde Summit registry. Background Retrograde PCI for CTO has improved treatment success rates, but several complications related to the retrograde approach have been reported, including collateral channel injury and donor artery injury due to their use as retrograde roots. Methods This registry included data from 1,166 patients who underwent retrograde PCI for CTO in 28 Japanese centers between January 2009 and December 2011. Results Overall procedure success and retrograde procedure success were achieved in 985 (84.5%) and 838 (71.9%) of the 1,166 patients, respectively. In-hospital major adverse cardiac and cerebrovascular events (MACCE) occurred in 18 (1.5%) of the 1,166 patients. With regard to complications related to the retrograde approach, channel injury occurred in 111 (9.5%) of the 1,166 patients, but treatment was required in only 24 (2.1%) patients and subsequent cardiac tamponade occurred in only 4 (0.3%) patients. Donor artery problems occurred in only 10 (0.9%) of the 1,166 patients. In sub-analysis regarding the types of collateral channels, the septal channel was significantly safer than epicardial channel because of the lower frequency of non-Q-wave myocardial infarction (non-QMI) and channel injury requiring treatment. Conclusions The MACCE rate during retrograde PCI for CTO determined from the Retrograde Summit registry was low and the frequency of complications related to the retrograde approach was acceptable. © 2015 Wiley Periodicals, Inc.

Ultrasound-guided femoral arterial access in pediatric cardiac catheterizations: A prospective evaluation of the prevalence, risk factors, and mechanism for acute loss of arterial pulse

Abstract: Objectives The objectives of this study were to describe the prevalence, mechanisms, and identify risk factors for acute loss of arterial pulse (LOP) in children who had ultrasound-guided femoral arterial access (UGFAA) during cardiac catheterization. Background LOP is a known complication in children following femoral arterial (FA) access for cardiac catheterization. The prevalence of LOP requiring treatment ranges between 4% and 8%. Methods A prospective study was performed including 486 cardiac catheterizations using UGFAA in children ≤18 years over a 3 years period. Ultrasound and Doppler evaluations were performed prior to and at the end of the procedure. Results LOP was identified in 33 cases (6.8%) with 23 (4.7%) requiring treatment. For children ≤6 months, the prevalence of LOP requiring treatment was 13.6%. FA diameter <3 mm was the only significant independent predictor for LOP (OR: 8.44, 95% CI: 2.07–34.5, P < 0.001). Smaller patient size, number of access attempts, time required for access, operator experience, sheath size, and length of procedure were not found to be significant predictors. Children with LOP had a greater percentage decrease in vessel diameter (median 62% vs 18%, P < 0.001) compared to those without LOP. FA thrombus was diagnosed only in 9 patients (27% of those with LOP). Conclusions The prevalence of LOP requiring treatment is 4.7% when UGFAA is used during pediatric cardiac catheterizations. Arterial spasm was more common than thrombus as a cause of LOP. FA diameter <3 mm was the only independent predictor for LOP in this carefully designed prospective study. © 2016 Wiley Periodicals, Inc.

First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial.

Abstract: BACKGROUND Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI. METHODS AND RESULTS The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057). CONCLUSIONS In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc.

Acute kidney injury following peripheral angiography and endovascular therapy: A systematic review of the literature

Abstract: Introduction Radiographic contrast administration is a major cause of acute kidney injury (AKI), worldwide. Currently, contrast induced acute kidney injury (CI-AKI) is the third leading cause of hospital acquired renal failure in the United States. Over 50% of these cases are the result of contrast exposure during cardiac catheterization. The predictive risk factors for and clinical impact of AKI following coronary procedures have been extensively studied and documented in the literature. Similar data, however, are lacking for AKI following angiography or endovascular interventions for lower extremity peripheral artery disease (PAD). Methods The present review examined the published data available for AKI in patients undergoing peripheral procedures using MEDLINE searches. Specific data on number of peripheral cases, subject characteristics, hydration strategies, and AKI incidence rates was recorded. Results The systematic review resulted in 50 potentially relevant studies and ultimately 15 studies were selected for detailed analysis that included AKI incidence data on patients undergoing peripheral angiography or interventions. The summated studies included 11,311 patients and 10,316 peripheral procedures. The median incidence of AKI in the studies was 10%. The retrieved publications demonstrated significant variations in patient risk factors, definitions of AKI, and specificity of description of endovascular therapies. Conclusions The incidence, risk factors, and outcomes related to AKI in the context of peripheral angiography or endovascular therapy remain poorly described in the literature and warrant further study in a prospective, systematic fashion. © 2016 Wiley Periodicals, Inc.

Fractional Flow Reserve Evaluation and Chronic Kidney Disease: Analysis From a Multicenter Italian Registry (the FREAK Study)

Abstract: Objectives To establish if the presence of chronic kidney disease (CKD) influences fractional flow reserve (FFR) value in patients with intermediate coronary stenosis. Background FFR-guided coronary revascularization reduces cardiac adverse events in patients with coronary artery disease. CKD impairs microcirculation and increases cardiovascular risk. Whether CKD presence may limit FFR accuracy is unknown. Methods We used data from a multicenter prospective registry enrolling 1.004 patients undergoing FFR evaluation for intermediate stenosis. We assessed the relationship between clinical and angiographic variables and FFR measurement. CKD was defined as CrCl value ≤45 ml/min. FFR value was considered potentially flow-limiting, and therefore positive, if ≤0.80. The index of microcirculatory resistance (IMR) was calculated in 20 patients stratified according CrCl value (single-center substudy). Results: FFR measurement was positive in 395 (39%) patients. Overall, 131 (13%) patients had CKD. Patients with CrCl ≤45 ml/min showed significantly higher FFR values as compared to the others (0.84 ± 0.07 vs. 0.81 ± 0.08, p < 0.001). Positive FFR occurrence was lower in patients with CrCl ≤45 ml/min (27% vs. 41%, p < 0.01). After multivariable analysis, diabetes (HR 1.07, 95%CI 1.008–1.13, p = 0.03), left anterior descending (HR 1.35, 95%CI 1.27–1.43, p < 0.001) and CrCl ≤45 ml/min (HR 0.92, 95%CI 0.87–0.97, p = 0.005) emerged as independent predictors of FFR measurement. Accordingly, IMR values were higher in patients with CrCl ≤45 ml/min (32 U [28245] vs. 16 U [11220], p < 0.01). Conclusions FFR and IMR measurements differ between CKD patients and those with normal renal function. Flow-limiting FFR is less frequent in patients with CrCl ≤45 ml/min. © 2015 Wiley Periodicals, Inc.

Transcatheter pulmonary valve replacement: State of the art.

Abstract: Background The number of patients undergoing transcatheter pulmonary valve replacement has been steadily increasing, resulting in many research projects focusing on this patient population. This has highlighted the need to summarize the currently available data. Methods A review of the literature was conducted and the results summarized. Results At present, the two commercially available valves approved for transcatheter pulmonary valve replacement include the Edwards Sapien valve and the Medtronic Melody valve. More data has been published relating to the Melody valve; this included the incidence of coronary anatomy prohibiting valve implantation of 5%, an incidence of conduit disruption of 6%, and freedom from stent fracture of the Melody valve stent of 60% at 30 months. Short and medium term outcomes seem to be comparable if not superior to surgical valve replacement, but long-term data is still lacking. There may also be a cost benefit with transcatheter valve implantation when compared to surgical pulmonary valve replacement. Conclusions Transcatheter pulmonary valve replacement is here to stay. The main challenge of treating patients with a native right ventricular outflow tract still needs to be addressed and device development efforts centered in this area. © 2015 Wiley Periodicals, Inc.

Women in interventional cardiology: Update in percutaneous coronary intervention practice patterns and outcomes of female operators from the National Cardiovascular Data Registry®

Abstract: Objectives To examine the practice patterns and outcomes of percutaneous coronary intervention (PCI) procedures performed by female interventional cardiologists in the United States (U.S.). Background Little is known about the prevalence, volume, case mix, and outcomes of PCI procedures performed by female interventional cardiologists. Methods Using data from the National Cardiovascular Data Registry®, we performed a retrospective study of 2,465,685 PCI procedures performed at 1,431 U.S. hospitals between July 1, 2009 and June 30, 2013. Interventionalist sex was ascertained from the National Provider Identifier number of each operator. Results Women accounted for only 4% (412/9,179) of interventional cardiologists in the U.S., and performed 3% (n = 70,009) of all PCI procedures during the time period studied. Forty-one percent of female interventionalists operated at an institution with no other female operators. Female interventionalists performed a median of 48 PCI procedures per year (interquartile range: 22–87). Of the cases performed by female interventionalists, 77% were performed on patients with acute coronary syndrome, 3% on patients with cardiogenic shock, and 16% on call. In-hospital mortality was low (1.8%), and was not significantly different between female operators with high (≥50 cases/year) versus low (1.95% vs. 1.75%, unadjusted P = 0.12, adjusted OR: 1.03, 95% CI: 0.84–1.27) annual procedure volume. Conclusions Female interventional cardiologists remain uncommon in contemporary U.S. practice. Performing only a very small proportion of PCI cases, female interventionalists are often low-volume operators, yet no significant differences in patient mortality were observed in low- versus high-volume operators. © 2015 Wiley Periodicals, Inc.