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Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal.The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow.The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction.Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%.Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.

Objectives The current report describes a single operator's experience of the first use of smartglass technology as a facilitator of virtual support during TAVR proctoring. Background Restricted gatherings and containment measures during the ongoing COVID‐19 pandemic have a major impact on daily clinical practice. Interaction between peers is crucial in science, clinical practice, and education. In addition, there is also a growing importance of proctoring in interventional cardiology for structural heart disease. Virtual support may facilitate the wide implementation of remote proctoring. Methods A collaboration between a smartglass provider (Rods & Cones) and self‐expandable transcatheter aortic heart valve system (Medtronic) was initiated and tested extensively prior to TAVR procedures. Two cases were randomly selected for remote support. The light‐weight smartglass consisted of a full HD central camera, a 720p ×5 optical zoom camera, built‐in LED light, speaker and earphone jack, and an external visor to project data in a nonobstructive manner in the operators' view. Results Preprocedural detailed discussion of the cases between the proctor and the operator occurred via teleconferencing. Successful procedural virtual support was determined by the presence of a session coordinator, high quality of the central camera, high‐speed and stable wireless internet connection. Limitations were the relative discomfort of the earpieces, discordance between the central and zoom camera and the absence of visual fixation during head motions. Conclusion In a highly complex and demanding context such as TAVR, remote proctoring by means of virtual support is feasible and efficacious.

Objectives The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. Background TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. Methods The RESPOND (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. Results One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). Conclusions One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302)

Objectives The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System–Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL). Background Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL. Methods The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory. Results A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants ( Conclusions In this post hoc analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI.

Transcatheter aortic valve implantation (TAVI) has become the mainstay for high-risk or inoperable patients with symptomatic aortic valve stenosis, and research regarding the use of transcatheter valves in intermediate or low-risk patients is currently ongoing. The aim of this article is to provide comprehensive insight into the anesthetic management of patients undergoing TAVI and to highlight possible gaps in the current knowledge. One important procedural characteristic that is imperative to consider is the type of anesthesia being used and its possible complications. Increasingly, experienced centers have changed from general anesthesia with endotracheal intubation to local anesthesia with sedation, especially when the transfemoral access route is used for TAVI. There is still debate regarding what type of anesthesia should be used in the procedure, and the lack of randomized data makes it even more challenging for the operators.

Aims Our aim was to evaluate the long-term device performance and clinical outcomes of patients with symptomatic, severe aortic valve stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) with the CoreValve bioprosthesis. Methods and results The CoreValve CE Pivotal Study was a prospective, multicentre, single-arm TAVI trial using the CoreValve system. Valve performance, patient quality of life (QoL), New York Heart Association (NYHA) class, and mortality at four years were analysed in 126 patients (mean age 82.4 years, 42.9% male, mean logistic EuroSCORE 23.4%) with severe AS. Mean aortic valve gradient decreased from 46.9±16.1 mmHg at baseline to 9.8±4.1 mmHg at discharge and to 7.8±2.7 mmHg at four years. Mean effective orifice area increased from 0.7±0.2 cm2 to 1.8±0.4 cm2 after TAVI and was 1.6±0.5 cm2 at four years. There were no reports of structural valve deterioration or valve migration. There was sustained improvement in QoL and NYHA class in surviving patients. All-cause and cardiac survival was 45.3% and 62.6%, respectively, at four years. Conclusions The CoreValve bioprosthesis demonstrates long-term durability, stable haemodynamic function, and no evidence of structural deterioration. Most surviving patients continued to have improved NYHA class and QoL at four years.

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.

Aims: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. Methods and Results: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm2 to 1.7 ± 0.4 cm2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naive patients was 22.2% (6/27). Conclusions: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.

Background Balloon aortic valvuloplasty (BAV) is considered to be an essential part of the transcatheter aortic valve implantation (TAVI) procedure and is being performed routinely. At present there is insufficient long-term data as to the benefits of routine BAV prior to TAVI. Aim The aim of this study was to evaluate the safety of direct TAVI and the mortality rate at 1-year in patients undergoing TAVI with or without BAV with a self-expanding bioprosthesis. Methods Between January 2008 and September 2013 consecutive patients undergoing TAVI with the Medtronic CoreValve in two experienced centers in Athens, Greece and in Siegburg, Germany were studied. All data were prospectively collected and retrospectively analyzed. Primary endpoint was mortality at 1year. Procedural data and clinical data (bleeding, vascular complications and echocardiographic parameters) were analyzed. Results A total of 210 patients undergoing TAVI were evaluated (non-direct=120 patients, direct=90 patients). All-cause mortality at 30days and at 1year was similar in both groups (4% in non-direct versus 2% in direct, p=0.6 and 15% in non-direct versus 11% in direct, p=0.5, respectively). Device success rate was similar in both groups (77% in non-direct versus 83% in direct, p=0.2). Major vascular complications were comparable for both groups (5% in non-direct versus 3% in direct, p=0.5). The direct group had less moderate/severe paravalvular leakage than the non-direct group after the device implantation (7% versus 33%, p Conclusions Performing direct TAVI with the self-expanding bioprosthesis is safe and feasible showing similar mortality rates compared to patients undergoing non-direct TAVI at 30days and at 1-year.

The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL).Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL.The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory.A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants (6.5 mm: 21% vs. ≥6.5 mm: 41%; p 0.001). After adjustment for confounders, implantation depth independently predicted need for PPI (odds ratio per 1-mm increment in depth: 1.200; 95% confidence interval: 1.091 to 1.319; p = 0.002). More than trivial PVL was present in 23% by contrast aortography and in 8% by TTE. Implantation depth was not correlated with PVL by contrast aortography or TTE (p = 0.342 and p = 0.149, respectively). PVL grading by contrast aortography and TTE was concordant in 77%.In this post hoc analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI.

AIMS To analyse patient characteristics, decision-making processes, and outcomes of TAVI performed in hospitals with versus those without on-site cardiac surgery (CS). METHODS AND RESULTS Current guidelines mandate transcatheter aortic valve implantation (TAVI) to be performed at hospitals with both cardiology and on-site CS departments. Some hospitals in Germany perform TAVI without CS departments in-house. We analysed the data of 1,432 patients enrolled in the German TAVI registry at 27 hospitals between January 2009 and June 2010. Nineteen of these had on-site CS (group 1), while eight centres performed TAVI with no CS department at their institution (group 2). Patients in group 2 (n=178, 12% of the overall study population) were older than in group 1 (mean age 82.6±6.3 years vs. 81.6±6.2 years) with similar logistic EuroSCORE (average: 21%). Patients in group 2 were haemodynamically more stable (higher blood pressures, better ejection fraction, less low-flow or low-gradient aortic stenosis, and less urgent procedures). Procedure times and use of contrast were higher in group 2. The procedural success rate was higher in group 1 (98% vs. 95%). Post-procedural complications were similar in the two groups with 30-day mortality of 6.2% in group 2 compared with 8.3% in group 1 patients. CONCLUSIONS Only 12% of patients enrolled in the German TAVI registry underwent TAVI at hospitals without an on-site CS department. Overall patient characteristics appeared to be similar, although patients in non-CS centres appeared to be haemodynamically more stable and more often had a history of previous heart surgery. Despite longer procedures, complication rates were similar. These preliminary data in a modest number of patients suggest the feasibility of performing TAVI in appropriately selected patients at hospitals without CS but this requires confirmation in future studies involving a large number of patients.

AIM Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres. METHODS AND RESULTS Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. CONCLUSION The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.

Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the large German TAVI Registry, we sought to evaluate TAVI in older high-risk patients with BAV. From January 2009 to June 2010, a total of 1,424 patients with severe aortic stenosis undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures were excluded and those with BAV (n = 38, 3%) were compared with those with tricuspid aortic valve (TAV; n = 1357, 97%). Patient characteristics did not markedly differ and procedural success was very high in both groups. There was a higher rate of relevant AR (≥II) after TAVI among patients with BAV (25 vs 15%, p = 0.05), whereas pacemakers were more often implanted in patients with TAV (17% vs 35%, p = 0.02). Thirty-day mortality rate was similar in both cohorts (11% vs 11%). In a Cox proportional regression analysis, BAV was not associated with higher 1-year mortality rate (hazard ratio 0.64, 95% confidence interval 0.29 to 1.41). In selected patients with BAV, TAVI can be performed with a satisfactory clinical result. Although the risk for relevant AR seems to be greater among patients with BAV, 30-day and 1-year mortality rates were not elevated compared with patients with TAV.

Aims The ADVANCE study was designed to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) with a self-expanding bioprosthesis in real-world patients with symptomatic, severe aortic stenosis at high surgical risk for valve replacement. Methods and results Study participants were enrolled from 44 experienced centres in 12 countries. Patient eligibility, treatment approach, and choice of anaesthesia were determined by the local Heart Team. The study was 100% monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium (VARC-1) criteria. There were 1015 patients enrolled with 996 attempted TAVI procedures. Mean age was 81 years, and mean logistic EuroSCORE was 19.3 ± 12.3%. Five-year follow-up was available on 465 (46.7%) patients. At 5 years, the rate of all-cause mortality was 50.7% (95% confidence interval: 46.7%, 54.5%), and the rate of major stroke was 5.4%. Haemodynamic measures remained consistent for paired patients with a mean aortic valve gradient of 8.8 ± 4.4 mmHg (n = 198) and an effective orifice area of 1.7 ± 0.4 cm2 (n = 123). Aortic regurgitation (AR) decreased over time and among paired patients dropped from 12.8% to 8.0% moderate AR at 5 years (n = 125). Of the 860 patients with echocardiographic data or a reintervention after 30 days, there were 22 (2.6%) patients meeting the VARC-2 criteria for valve dysfunction and 10 (1.2%) patients with a reintervention >30 days. Conclusion Five-year results in real-world, elderly, high-risk patients undergoing TAVI with a self-expanding bioprosthesis provided evidence for continued valve durability with low rates of reinterventions and haemodynamic valve dysfunction. Trial registration ClinicalTrials.gov, NCT01074658.

Background Extensive evidence relating to transcatheter aortic valve replacement (TAVR) has accumulated in recent years, but mid-term outcomes are less reported. We investigated 996 patients after implantation of the CoreValve prosthesis for severe aortic stenosis in a real-world setting. \ud Objective To report clinical and echocardiographic 3-year results from the ADVANCE study. \ud Methods ADVANCE is a prospective, multicenter, fully monitored, nonrandomized clinical study. This analysis assessed valve-related events, predictors of early and mid-term mortality after TAVR, and systolic and diastolic prosthesis performance over 3 years.\ud Results Three years after TAVR, the rate of major adverse cardiac/cerebrovascular events was 38.5%. All-cause mortality was 33.7%; cardiovascular mortality, 22.3%; cVARC-1 stroke, 6.5%; and New York Heart Association class III/IV, 19.5%. Mean effective orifice area was consistently 1.7 cm2 from discharge to 3 years, and average mean aortic valve gradient remained ≤10 mmHg. At 3 years, 12.6% of patients had moderate and none had severe paravalvular regurgitation. Multivariable analysis identified Society of Thoracic Surgeons (STS) score, device migration, prior atrial fibrillation, and major vascular complication as predictors of early mortality. Predictors of mid-term mortality included male gender, STS score, history of chronic obstructive pulmonary disease, history of cancer, stroke, life-threatening/disabling or major bleeding, and valve deterioration.\ud Conclusions Our 3-year data demonstrate significant hemodynamic benefits and durable symptom relief after CoreValve prosthesis implantation. Postprocedural patient management should be carefully considered since postprocedural valve-related events were identified as independent predictors of mid-term mortality.

Transcatheter aortic valve implantation (TAVI) has been implemented into the care of elderly patients suffering from severe symptomatic aortic stenosis. However, data on long-term follow-up are sparse and predictors of long-term mortality need to be evaluated to better select patients. Therefore, we aimed to analyse predictors of 5-year mortality after TAVI.We analysed data from the German Transcatheter Aortic Valve Interventions-Registry. Each of the 27 participating hospitals agreed to include all consecutive TAVI patients at their institution. Out of 1444 patients treated with TAVI, 1378 patients had a follow-up of at least 4.5 years (completeness 95.4%). Endpoint for this analysis was 5-year survival. Cox regression analysis was used to determine risk factors associated with this endpoint.Patients who died were compared with survivors. The two groups showed multiple differences in patient characteristics, indications for interventions, preinterventional, as well as interventional characteristics and postinterventional events. Calculated 1-year mortality was 21.8% and 5-year mortality 59.1%. A higher logistic EuroScore was associated with a lower 5-year survival, being 45.5% in patients with a logistic EuroScore of20%, 34.5% in those with 20% to 40% and 28.4% in patients with a logistic EuroScore40%. Cox proportional hazard analysis revealed the following independent predictors of 5-year mortality: female gender (HR =0.66, 95% CI 0.56 to 0.77, p0.0001), renal failure (HR=1.43, 95% CI 1.22 to 1.69, p0.0001), prior mitral regurgitation ≥II° (HR=1.42, 95% CI 1.21 to 1.65, p0.0001), residual aortic regurgitation ≥II° (HR=1.52, 95% CI 1.24 to 1.85, p0.0001), atrial fibrillation (HR=1.38, 95% CI 1.18 to 1.64, p=0.0001), low gradient aortic stenosis (HR=1.48, 95% CI 1.19 to 1.84, p=0.0004), prior decompensation (HR=1.32, 95% CI 1.13 to 1.54, p=0.0006), frailty (HR=1.31, 95% CI 1.09 to 1.58, p=0.004), surgical TAVI (HR=1.42, 95% CI 1.12 to 1.80, p=0.004), age (by year) (HR=1.02, 95% CI 1.01 to 1.03, p=0.006), prior myocardial infarction (HR=1.29, 95% CI 1.07 to 1.57, p=0.009), urgent TAVI (HR=1.25, 95% CI 1.04 to 51, p=0.020) and diabetes mellitus (HR=1.20, 95% CI 1.02 to 1.40, p=0.024).These data from the early TAVI experience show a 5-year mortality of 59.1%. Some of the predictors of 5-year mortality seem to be modifiable, such as residual aortic regurgitation, type of TAVI access route and concomitant mitral regurgitation.

In this report, we present the successful percutaneous ventricular septal defect (VSD) closure, just 1 week post-transcatheter aortic valve implantation (TAVI). Periprocedurally, after implantation of the 31-mm CoreValve in an intentionally “high” position, we balloon postdilated, with an excellent result. A week post-TAVI, the patient started to deteriorate. Echocardiogram revealed a good working prosthesis; however, a perimembranous VSD was evident, causing significant shunt. We proceeded with interventional treatment of the defect, using an Amplatzer multifenestrated—“Cribriform”—septal occluder. Six months after the combined procedure, the patient showed marked improvement in symptoms and no shunt was observed. © 2012 Wiley Periodicals, Inc.

Objectives Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. Background Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. Methods We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. Results Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. Conclusions Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly. © 2012 Wiley Periodicals, Inc.

Contrast aortography allows for the assessment of implantation depth, relationship to the coronary ostia and paravalvular leak (PVL) during and after transcatheter aortic valve replacement (TAVR). Previous reports suggested an association between final device position and rates of permanent

Objectives The purpose of this study was to evaluate the safety, device performance, and clinical outcome up to 2 years for patients undergoing transcatheter aortic valve implantation (TAVI). Background The role of TAVI in the treatment of calcific aortic stenosis evolves rapidly, but mid-and long-term results are scarce. Methods We conducted a prospective, multicenter, single-arm study with symptomatic patients undergoing TAVI for treatment of severe aortic valve stenosis using the 18-F Medtronic CoreValve (Medtronic, Minneapolis, Minnesota) prosthesis. Results In all, 126 patients (mean age 82 years, 42.9% male, mean logistic European System for Cardiac Operative Risk Evaluation score 23.4%) with severe aortic valve stenosis (mean gradient 46.8 mm Hg) underwent the TAVI procedure. Access was transfemoral in all but 2 cases with subclavian access. Retrospective risk stratification classified 54 patients as moderate surgical risk, 51 patients as high-risk operable, and 21 patients as high-risk inoperable. The overall technical success rate was 83.1%. Thirty-day all-cause mortality was 15.2%, without significant differences in the subgroups. At 2 years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% vs. 45.8%, p = 0.04). This difference was mainly attributable to an increased risk of noncardiac mortality among patients constituting the high-risk groups. Hemodynamic results remained unchanged during follow-up (mean gradient: 8.5 +/- 2.5 mm Hg at 30 days and 9.0 +/- 3.4 mm Hg at 2 years). Functional class improved in 80% of patients and remained stable over time. There was no incidence of structural valve deterioration. Conclusions The TAVI procedure provides sustained clinical and hemodynamic benefits for as long as 2 years for patients with symptomatic severe aortic stenosis at increased risk for surgery. (J Am Coll Cardiol 2011;57:1650-7) (C) 2011 by the American College of Cardiology Foundation

Objectives This study sought to assess post-procedural and mid-term outcome of patients, in which a second “in-series” CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) was implanted during the same procedure. Background Because of the increasing number of patients implanted with CoreValves, the need for management of special complications has emerged. A misplaced prosthesis can be corrected by various maneuvers. An option is to pull the valve out of the aortic annulus into the ascending aorta or beyond and position a second one (in series). Methods Out of 277 patients who underwent CoreValve implantation with the 18-F device in our institution, we had to implant a second prosthesis (due to severe aortic regurgitation or dislocation of the first one) in 9 (3.2%). Immediate post-procedural as well as mid-term follow-up data (5 to 20 months, mean 10.6 ± 6 months, total 95 patient-months) were collected for analysis. Results All implantations of the second device were successful, resulting in elimination of the gradient (mean gradient 43.1±4.0 mm Hg before to 7.0 ± 1.1 mm Hg after implantation). There was no final aortic regurgitation grade ≥2+. The extra-anatomically placed first prosthesis (ascending aorta, n = 8; abdominal aorta, n = 1) did not cause any clinical sequelae or gradients. During mid-term follow-up, none of the 18 prostheses showed any sign of malfunction. Specifically, there were no signs of valve migration or of worsening paravalvular regurgitation. No case of valve thrombosis was documented. Conclusions A second CoreValve can be safely and effectively implanted in an in-series manner, without periprocedural complications. No problems arose on mid-term follow-up, ranging up to 20 months.

Open heart surgery with valve replacement is the current gold-standard therapeutic approach for severe aortic valve disease. However, many patients are considered high-risk candidates or even inoperable due to age or other comorbid conditions [1]. In the Euro Heart Survey, up to 33% of patients in NYHA functional class III–IV with aortic valve stenosis were not operated [2]. For these reasons, less invasive techniques for treatment of high risk patients have been developed. These procedures have been named transcutaneous aortic valve implantation (TAVI). Nowadays the retrograde approach over the femoral artery and retrograde passage of the aortic valve is preferred [3–5]. For that approach, both the balloon-expandable Edwards-Sapien prosthesis (Edwards Lifesciences, Irvine, CA) and the self-expanding CoreValve Revalving system (CoreValve, Irvine, CA) are presently commercially available in several areas worldwide. Alternatively to the trans-femoral approach, a minimal-invasive trans-subclavian approach [6] or a trans-apical approach [5] can be used, in patients whose femoral/iliac arteries are unsuitable due to small size, tortuosity, calcification, previous aortofemoral surgery or other reasons. More specifically for the CoreValve procedure, until April 2009 3.529 patients have been implanted in 151 centers in 26 countries [7]. Up to the same time, totally 79 cases have been done worldwide with the subclavian approach [8], with promising results. We present a case of CoreValve TAVI procedure via a subclavian access that was twice complicated, but nonetheless successfully managed, with known interventional techniques.

Background: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST-elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously “rinses” the vessel with turbulent flow and aspirates thrombus. Methods: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was ≥50% ST-segment elevation resolution (STR) measured 60 min after PCI by continuous elctrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30-day major adverse cardiac events (MACE). Results: Mean symptom-to-PCI time was 4.7 ± 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush ≥2 in 78%. Rates of STR ≥ 50% and >70% at 60 min were 97 and 80%, respectively. No device-related complications were observed. Thirty-day MACE rate was 4.6%. Conclusions: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit. © 2008 Wiley-Liss, Inc.

AIMS: To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year after obtaining CE mark approval. METHODS AND RESULTS: Patients with symptomatic severe aortic stenosis and logistic Euroscore > or =15%, or age > or =75 years, or age > or =65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. From April 2007, to April 2008, 646 patients with a mean age of 81 +/- 6.6 years, mean aortic valve area 0.6 +/- 0.2 cm2, and logistic EuroSCORE of 23.1 +/- 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 49.4 +/- 13.9 to 3 +/- 2 mmHg. All patients had paravalvular aortic regurgitation < or = grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e, including procedural) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%. CONCLUSIONS: The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.

AIMS The Custom NX 36 Drug Eluting Stent (DES) System is designed to treat coronary lesions via in situ stent length customisation. The stent evaluated in this study consists of nine interdigitated stent segments, each 4 mm in length, coated with a biodegradable formulation of Biolimus A9 and Poly-Lactic-Acid, a biodegradable drug carrier, and loaded into a unique sheath protected, integrated balloon delivery system. METHODS AND RESULTS The objective of this non-randomised prospective multicentre CUSTOM I Trial was to demonstrate the safety of in situ stent length customisation in 30 consecutive patients. Angiographic (QCA) and intravascular ultrasound (IVUS) follow-up was performed at two cohort time intervals: four (n=10) or eight (n=20) months. Mean lesion length and reference vessel diameters were 17.7 +/- 9.6 mm and 2.6 +/- 0.3 mm, respectively. Procedural success was 93%. There were three MACEs in the study population from enrollment through to twenty-four month follow-up. The in-hospital MACE rate was 2/30, with non-Q-wave myocardial infarctions events in two patients who recovered without further sequelae. At five months, one patient who had crossed over initially to PTCA required CABG surgery. Results from QCA and IVUS assessments at four and eight months showed no binary restenosis, mean in-stent late luminal loss of 0.25 +/- 0.23 mm and 0.26 +/- 0.23 mm. CONCLUSIONS This first evaluation of the new customisable Biolimus A9-eluting Custom NX stent suggests safety and efficacy through twenty-four month follow-up. Further evaluations are warranted to confirm the overall favourable outcomes.

Objectives and Background: Percutaneous aortic valve replacement is a new less-invasive alternative for high-risk surgical candidates with aortic stenosis. However, the clinical experience is still limited, and the currently available ‘first-generation devices’ revealed technical shortcomings, such as lack of repositionability and presence of paravalvular leakages. We report the first-in-man experience with the new self-expanding Lotus™ Valve prosthesis composed of a nitinol frame with implemented bovine pericardial leaflets which is designed to address these issues, being repositionable and covered by a flexible membrane to seal paravalvular gaps. We implanted this prosthesis in a 93-year old patient presenting with severe symptomatic aortic stenosis (valve area: 0.6 cm2). Surgical valve replacement had been declined due to comorbidities. Methods and Results: We used a retrograde approach for insertion of the 21-French Lotus catheter loaded with the valve prosthesis via surgical cut-down to the external iliac artery. Positioning of the valve was guided by transesophageal echo and supra-aortic angiograms. The prosthesis was successfully inserted and deployed within the calcified native valve. Echocardiography immediately after device deployment showed a significant reduction of the transaortic mean pressure gradient (32 to 9 mmHg; final valve area 1.7 cm2) without evidence of residual aortic regurgitation. The postprocedural clinical status improved from NYHA-IV to NYHA-II. These results remained unchanged up to the 3 month follow-up. Conclusions: Successful percutaneous aortic valve replacement can be performed using the new self-expanding and repositionable Lotus valve for treatment of high-risk patients with aortic valve stenosis. Further studies are mandatory to assess device safety and efficacy in larger patient populations. © 2008 Wiley-Liss, Inc.

Background— The need for prolonged aspirin and thienopyridine therapy and the risk of stent thrombosis (ST) remain as drawbacks associated with drug-eluting stents. Methods and Results— A prospective observational cohort study was conducted between June 2002 and January 2004 on 3021 patients consecutively and successfully treated in 5389 lesions with drug-eluting stents. Detailed patient information was collected on antiplatelet therapy. We analyzed the incidence of ST throughout the 18-month follow-up period and its relationship with thienopyridine therapy. ST occurred in 58 patients (1.9%) at 18 months. Forty-two patients (1.4%) experienced the event within 6 months of stent implantation. Acute myocardial infarction (fatal or nonfatal) occurred in 46 patients (79%) and death in 23 patients (39%) with ST. The median interval from discontinuation of thienopyridine therapy to ST was 13.5 days (interquartile range 5.2 to 25.7 days) for the first 6 months and 90 days (interquartile range 30 to 365 days) between 6 and 18 months. On multivariable analysis, the strongest predictor for ST within 6 months of stenting was discontinuation of thienopyridine therapy (hazard ratio, 13.74; 95% CI, 4.04 to 46.68; P P =0.92). Conclusions— Discontinuation of thienopyridine therapy was the major determinant of ST within the first 6 months, but insufficient information is available to determine whether there is benefit in continuing a thienopyridine beyond 6 months.

Objectives We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California). Background Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis. Methods Patients with: 1) symptomatic, severe aortic valve stenosis (area 2 ); 2) age ≥80 years with a logistic EuroSCORE ≥20% (21-F group) or age ≥75 years with a logistic EuroSCORE ≥15% (18-F group); or 3) age ≥65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support. Results A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 ± 0.19 cm 2 (21-F) and 0.54 ± 0.15 cm 2 (18-F), a mean age of 81.3 ± 5.2 years (21-F) and 83.4 ± 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 ± 13.5% (21-F) and 19.1 ± 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p Conclusions Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.

Percutaneous valve replacement for severe aortic stenosis has shown to be an alternative treatment option for non-surgical candidates. We report on the first successful valve in valve procedure in an 80-year-old patient with a severe regurgitation of a degenerated aortic bioprosthesis using the Corevalve Revalving system.

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.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.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 (18/45) and 60% were classified as stroke with symptoms persisting 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.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.

Background— Recent successes in the treatment of in-stent restenosis (ISR) by drug-eluting stents belie the challenges still faced in certain lesions and patient groups. We analyzed human coronary atheroma in de novo and restenotic disease to identify targets of therapy that might avoid these limitations. Methods and Results— We recruited 89 patients who underwent coronary atherectomy for de novo atherosclerosis (n=55) or in-stent restenosis (ISR) of a bare metal stent (n=34). Samples were fixed for histology, and gene expression was assessed with a dual-dye 22 000 oligonucleotide microarray. Histological analysis revealed significantly greater cellularity and significantly fewer inflammatory infiltrates and lipid pools in the ISR group. Gene ontology analysis demonstrated the prominence of cell proliferation programs in ISR and inflammation/immune programs in de novo restenosis. Network analysis, which combines semantic mining of the published literature with the expression signature of ISR, revealed gene expression modules suggested as candidates for selective inhibition of restenotic disease. Two modules are presented in more detail, the procollagen type 1 α2 gene and the ADAM17/tumor necrosis factor-α converting enzyme gene. We tested our contention that this method is capable of identifying successful targets of therapy by comparing mean significance scores for networks generated from subsets of the published literature containing the terms “sirolimus” or “paclitaxel.” In addition, we generated 2 large networks with sirolimus and paclitaxel at their centers. Both analyses revealed higher mean values for sirolimus, suggesting that this agent has a broader suppressive action against ISR than paclitaxel. Conclusions— Comprehensive histological and gene network analysis of human ISR reveals potential targets for directed abrogation of restenotic disease and recapitulates the results of clinical trials of existing agents.

Background— The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve). Methods and Results— Symptomatic high-risk patients with an aortic valve area 2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2±10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4±3.0 mm Hg; P Conclusions— Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.

Surgical aortic valve replacement has been the gold standard for treatment of symptomatic aortic valve disease. However, the success of this approach depends on various patient- and situation-specific risk predictors; thus, the perioperative mortality can reach up to 50%. Percutaneous valve replacement might offer a new less invasive alternative. Since 2002, a balloon-expandable valve prosthesis is under evaluation in symptomatic high-risk patients with aortic valve stenosis. After modifications of both the implantation technique as well as the design of the prosthesis, procedural success rates of > 75% and adverse event rates of < 20% at 30-day follow-up have been reported. A new alternative to this approach is the self-expanding valve prosthesis. The recently reported First-in-Man Study demonstrated the feasibility of this technique. However, the strict inclusion criteria for both procedures limit the number of potential candidates. New devices are currently under development, which will allow for a broader use of percutaneous valve replacement in the near future.

Objective:To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. Methods: This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. Results:Pre-intervention mean reference vessel diameter was 2.62 ± 0.50 mm and mean lesion length was 13.95 ± 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 ± 0.50 mm and 0.57 ± 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. Conclusions: Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up. © 2006 Wiley-Liss, Inc.

The purpose of this prospective nonrandomized study was to evaluate both safety and efficacy of the polymer-based paclitaxel-eluting Taxus stent for treatment of chronic total coronary occlusions. Drug-eluting stents have been proven safe and efficacious in suppressing neointimal proliferation when used in simple native de novo coronary lesions. However, there are only limited data on safety and efficacy of these stents for treatment of more difficult lesion subsets, especially chronic total occlusions. Forty-five consecutive symptomatic patients with chronic total coronary occlusions were included in this observational single-arm study. Only patients with successfully crossed occlusions were enrolled. Primary endpoints were binary restenosis and late lumen loss at 6-month angiographic follow-up. Secondary endpoints were MACE at 30-day and 6-month follow-up. The 30-day MACE rate was 0%. At 6 months, the cumulative MACE-free survival was 84.4%. There were no deaths, myocardial infarctions, or stent thrombosis up to 6 months poststenting. At angiographic follow-up, the in-stent restenosis rate was 13.2% (5/38). There was a total of five in-stent restenoses, with three focal and two diffuse restenosis patterns. The in-segment late lumen loss was 0.13 +/- 0.58 mm. The stent edge analyses revealed a late loss of 0.21 +/- 0.66 proximally and a negative late loss of -0.10 +/- 0.67 at the distal edge segment. This study shows safety and indicators of efficacy of implantation of the paclitaxel-eluting Taxus stent for treatment of chronic total coronary occlusions. The quantitative angiographic analysis revealed beneficial results with respect to the efficacy surrogates binary restenosis rate and late loss.

Study design We report the first case of life-threatening cardiac tamponade after percutaneous balloon kyphoplasty and its treatment with pericardiac drainage and percutaneous retrieval of cement embolus. Objective To sensitize clinicians to the occurrence of perforation on the right side of the heart, with intracavity cement leakage as a potential complication after balloon kyphoplasty. Summary of background data Balloon kyphoplasty is a minimal invasive technique for symptomatic vertebral fractures. Cement leakage after kyphoplasty is a rare complication compared with vertebroplasty. Methods A 68-year-old female patient underwent balloon kyphoplasty after a recent third and fourth lumbar verlebral fracture was diagnosed. Results The day after balloon kyphoplasty, the patient complained of dyspnea and chest pain. Her hemodynamic status rapidly deteriorated. Acute occlusion of coronary vessels was excluded by coronary angiography. Pericardial tamponade was documented by echocardiography, and pericardial effusion was urgently drained. Computed tomographic scan revealed the presence of cement embolus inside the right ventricle due to right ventricle perforation during the kyphoplasty procedure. The cement embolus was successfully retrieved percutaneously with a snare catheter. Conclusion Balloon kyphoplasty is a minimal invasive technique with low rate of complications. In case of postprocedural chest symptoms, it is mandatory to exclude right ventricle perforation, cardiac tamponade, and embolism into pulmonary vessels because of cement embolism. Level of evidence 5.

We describe the first reported case of a nose cone entrapment of the delivering catheter of a CoreValve self-expandable valve, during a transcatheter aortic valve implantation procedure. The complication was successfully treated after snaring the cone and retracting the system within the introducing sheath.

It is believed that most myocardial infarctions result from the rupture of “vulnerable plaques”, that share certain common characteristics. These plaques typically consist of a lipid-rich core in the central portion of the thickened intima, covered by a thin friable fibrous cap. Today, one of the important challenges in the field of interventional cardiology is how to identify minor or silent plaques that carry the risk of thrombosis resulting in severe cardiac events. Current imaging technologies lack the resolution to reliably identify these lesions. Optical Coherence Tomography (OCT) might have the potential to fill this role. OCT is a new non-contact, light-based imaging modality providing in situ images of tissues at near histologic resolution. As shown in various preclinical and clinical reports, OCT allows the identification of mural as well as luminal morphologies including lumen dimensions, plaques, thrombi, dissections, tissue flaps as well as information on stent geometries including apposition and symmetry. Trials comparing intravascular ultrasound (IVUS) and OCT demonstrated that OCT provided additional morphologic information, which could be used to improve plaque characterization. OCT has the potential to provide a new and more detailed look into the vessel wall, which might help to identify plaques that are at risk of rupture, and furthermore, which will influence and guide the appropriate patient-specific therapeutic approach.

Background— The TAXUS NIRx stent (Boston Scientific Corp) provides local delivery of paclitaxel via a slow-release polymer coating. The TAXUS I trial was the first in-human experience evaluating safety and feasibility of the TAXUS NIRx stent system compared with bare NIR stents (control) (Boston Scientific Corp) for treatment of coronary lesions. Methods and Results— The TAXUS I trial was a prospective, double-blind, three-center study randomizing 61 patients with de novo or restenotic lesions (≤12 mm) to receive a TAXUS (n=31) versus control (n=30) stent (diameter 3.0 or 3.5 mm). Demographics, lesion characteristics, clinical outcomes were comparable between the groups. The 30-day major adverse cardiac event (MACE) rate was 0% in both groups ( P =NS). No stent thromboses were reported at 1, 6, 9, or 12 months. At 12 months, the MACE rate was 3% (1 event) in the TAXUS group and 10% (4 events in 3 patients) in the control group ( P =NS). Six-month angiographic restenosis rates were 0% for TAXUS versus 10% for control ( P =NS) patients. There were significant improvements in minimal lumen diameter (2.60±0.49 versus 2.19±0.65 mm), diameter stenosis (13.56±11.77 versus 27.23±16.69), and late lumen loss (0.36±0.48 versus 0.71±0.48 mm) in the TAXUS group (all P 3 ) group compared with the control group (21.6 mm 3 ) ( P Conclusions— In this feasibility trial, the TAXUS slow-release stent was well tolerated and showed promise for treatment of coronary lesions, with significant reductions in angiographic and intravascular ultrasound measures of restenosis.