A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

OBJECTIVES: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. BACKGROUND: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. METHODS: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. RESULTS: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. CONCLUSIONS: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.

Transcatheter valve-in-ring implantation of a repositionable valve system for treatment of severe mitral regurgitation.

INTRODUCTION: Years after mitral valve surgery, progressive degeneration of reconstructed mitral valves or bioprostheses might lead to severe mitral valve regurgitation. Patients with significant comorbidity, or impaired left ventricular function are poor candidates for redo surgery at an acceptable risk at that later time point. METHODS AND RESULTS: This study reports the first-in-man transapical valve-in-ring implantations in the mitral position of the fully repositionable Lotus valve system approved for transcatheter aortic valve replacement in Europe. Transapical valve-in-ring implantations with this valve system were successfully performed in a 64-year-old female, and a 53-year-old male patient. Both patients were NHYA class IV, and carried an unacceptably high risk of cardiac surgery due to clinical condition and comorbidity. The first patient was successfully implanted a 25 mm valve, improved to NYHA class II, and was discharged 2 weeks after the procedure. The second patient required a short episode of cardiopulmonary resuscitation after valve implantation (27 mm), and was placed on veno-venous ECMO for 24 hr to improve oxygenation. He developed stroke on day 7, and deceased from fatal, toxic rhabdomyolysis 13 days after the procedure. CONCLUSION: Transapical valve-in-ring implantation of the repositionable Lotus valve system in the mitral position is a feasible and promising option that merits further evaluation. © 2015 Wiley Periodicals, Inc.

The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry.

BACKGROUND: A significant proportion of patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant peripheral arterial disease (PAD), which plays a crucial role in the preinterventional selection process of determining an optimal vascular access site. The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting. METHODS: A total of 1,315 patients (mean logistic European System for Cardiac Operative Risk Evaluation 20.6% ± 13.7%) underwent TAVI in 27 centers and were included in the prospective German TAVI Registry. RESULTS: Of the 1,315 patients with TAVI, 330 (25.1%) had PAD. These patients had a higher logistic European System for Cardiac Operative Risk Evaluation score (27.7% ± 16.0% vs 18.3% ± 12.0%, P < .0001), mainly attributed to more frequent and severe comorbidities. Compared with patients without PAD, patients with PAD had a higher rate of vascular complications (28.5% vs 20.7%, P < .01), dialysis-dependent renal failure (11.2% vs 5.4%, P < .001), myocardial infarction (1.2% vs 0.3%, P < .05), and, subsequently, 30-day mortality (12.7% vs 6.9%, P < .001). Choosing a surgical approach, for example, transapical access, did not reduce the periprocedural risk associated with PAD; in-hospital mortality was 15.7% for surgical and 10.5% for percutaneous patients with TAVI having PAD (P < .001). In a multivariate regression analysis, PAD was an independent predictor of 30-day mortality (hazard ratio 1.8, 95% CI 1.2-2.7, P = .004) after TAVI. CONCLUSIONS: In this real-world TAVI Registry, PAD was an independent predictor of mortality in patients with percutaneous and surgical TAVI, including vascular complications. Assessment of PAD should play a crucial role in the preinterventional selection process, regardless of the access strategy.

Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.

AIMS: Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve interventions [balloon valvuloplasty and transcatheter aortic valve implantation (TAVI)] are evolving as alternative treatment options to surgical valve replacement. We report the first results of the prospective multi-centre German Transcatheter Aortic Valve Interventions-Registry. METHODS AND RESULTS: Between January 2009 and December 2009, a total of 697 patients (81.4 ± 6.3 years, 44.2% males, and logistic EuroScore 20.5 ± 13.2%) underwent TAVI. Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg. Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve™ prosthesis was used in 84.4%, whereas the Sapien Edwards™ prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (≥Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2%, and the 30-day death rate 12.4%. CONCLUSION: In this real-world registry of high-risk patients with aortic stenosis, TAVI had a high success rate and was associated with moderate in-hospital complications. However, careful patient selection and continued hospital selection seem crucial to maintain these results.

Five-year clinical outcome of multicenter randomized trial comparing amphilimus - with paclitaxel-eluting stents in de novo native coronary artery lesions.

OBJECTIVES: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term. METHODS AND RESULTS: Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278). CONCLUSIONS: Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.

Carotid artery stenting: do procedural complications relate to the side intervened upon?: results from the Carotid Artery Stent (CAS)-Registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

OBJECTIVES: To determine the influence of the side intervened upon on outcomes during carotid artery stenting (CAS). BACKGROUND: Anatomic and technical aspects may influence the results of CAS. The value of the side intervened upon has not been analyzed yet. METHODS: We analyzed data from the Carotid Artery Stent (CAS)-Registry. RESULTS: A total of 3,165 CAS procedures, 1,613 (51%) at the left and 1,552 (49%) at the right carotid artery were included. There was a higher proportion of patients treated for symptomatic stenoses when CAS was performed at the left carotid artery (50.1% versus 45.8%, P = 0.016) and more patients already had prior carotid endarterectomy (8.5% versus 5.8%, P = 0.003). Interventions at the left side took 3 min longer than interventions at the right side (46.6 +/- 24.3 versus 43.8 +/- 23.6, P = 0.003). In patients treated at the left carotid artery amaurosis fugax (0.7% versus 0.1%, P = 0.005), ipsilateral stroke (3.1% versus 1.8%, P = 0.017), and the primary endpoint of in-hospital death or stroke (4.1% versus 2.3%, P = 0.005) occurred significantly more often. Even after adjusting for confounding parameters, CAS procedures performed at the left carotid arteries remained an independent predictor of death or stroke (OR = 1.77, 95% CI: 1.15-2.72, P = 0.009). CONCLUSIONS: In current clinical practice, CAS is performed frequently at the right carotid artery as at the left carotid artery. CAS interventions have a higher in-hospital complication rate if performed at the left carotid artery. Technical improvements might help to overcome this situation.

Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe.

Background Many patients with severe aortic stenosis are referred late with advanced symptoms or inappropriately denied intervention. The objective was to investigate whether a structured communication to referring physicians (facilitated data relay) might improve the rate and timeliness of intervention. Methods and Results A prospective registry of consecutive patients with severe aortic stenosis at 23 centers in 9 European countries with transcatheter as well as surgical aortic valve replacement being available was performed. The study included a 3-month documentation of the status quo (phase A), a 6-month intervention phase (implementing facilitated data relay), and a 3-month documentation of a legacy effect (phase-B). Two thousand one hundred seventy-one patients with severe aortic stenoses were enrolled (phase A: 759; intervention: 905; phase-B: 507). Mean age was 77.9±10.0 years, and 80% were symptomatic, including 52% with severe symptoms. During phase A, intervention was planned in 464/696 (67%), 138 (20%) were assigned to watchful waiting, 8 (1%) to balloon aortic valvuloplasty, 60 (9%) were listed as not for active treatment, and in 26 (4%), no decision was made. Three hundred sixty-three of 464 (78%) patients received the planned intervention within 3 months. Timeliness of the intervention improved as shown by the higher number of aortic valve replacements performed within 3 months (59% versus 51%, P=0.002) and a significant decrease in the time to intervention (36±38 versus 30±33 days, P=0.002). Conclusions A simple, low-cost, facilitated data relay improves timeliness of treatment for patients diagnosed with severe aortic stenosis, resulting in a shorter time to transcatheter aortic valve replacement. This effect was mainly driven by a significant improvement in timeliness of intervention in transcatheter aortic valve replacement but not surgical aortic valve replacement. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02241447.

Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis.

OBJECTIVE: Contemporary data on patients with previously undiagnosed severe aortic stenosis (AS) are scarce. We aimed to address this gap by gathering data from consecutive patients diagnosed with severe AS on echocardiography. METHODS: This was a prospective, multicentre, multinational, registry in 23 tertiary care hospitals across 9 European countries. Patients with a diagnosis of severe AS were included using echocardiography (aortic valve area (AVA) <1 cm2, indexed AVA <0.6 cm2/m2, maximum jet-velocity (Vmax) >4 m/s and/or mean transvalvular gradient >40 mm Hg). RESULTS: The 2171 participants had a mean age of 77.9 years and 48.0% were female. The mean AVA was 0.73 cm2, Vmax4.3 m/s and mean gradient 47.1 mm Hg; 62.1% had left ventricular hypertrophy and 27.3% an ejection fraction (EF) <50%. 1743 patients (80.3%) were symptomatic (shortness-of-breath 91.0%; dizziness 30.2%, chest pain 28.9%). Patients had a EuroSCORE II of 4.0; 25.3% had a creatinine clearance <50 mL/min, and 3.2% had an EF <30%. Symptomatic patients were older and had more comorbidities than asymptomatic patients. Despite European Society of Cardiology 2017 valvular heart disease guideline class I recommendation, in only 76.2% a decision was made for an intervention (transcatheter 50.4%, surgical aortic valve replacement 25.8%). In asymptomatic patients, 57.7% with a class I/IIa indication were scheduled for a procedure, while 36.3% patients without an indication had their valve replaced. CONCLUSIONS: The majority of patients with severe AS presented at an advanced disease stage. Management of severe AS remained suboptimal in a significant proportion of contemporary patients with severe AS. TRIAL REGISTRATION NUMBER: NCT02241447;Results.

[Temporal trends in the use of drug-eluting stents in German clinical practice]. / Trends im Einsatz von Drug-eluting Stents im klinischen Alltag in Deutschland. Daten des ALKK-Registers.

BACKGROUND AND PURPOSE: : Drug-eluting stents (DES) have been shown to reduce the risk of in-stent stenosis, one of the major problems of percutaneous coronary intervention (PCI) with implantation of baremetal stents. DES are approved in Germany since 2002. The following study is based on data of the ALKK PCI registry and assesses the use of DES depending on patient characteristics, indication and coronary status comparing the treatment years 2003 and 2005. METHODS: : The ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte) PCI registry is focused on quality management based on guidelines in coronary interventions. Data were obtained by standardized questionnaires and analyzed centrally at the KL-Neuhaus Datenzentrum, Ludwigshafen, Germany. For this study, data of 40,434 PCI procedures of 32 hospitals were obtained. RESULTS: : In 2003, a total of 18,564 PCIs, and in 2005, a total of 21,870 PCIs were registered. Figure 1 shows the rate of DES in PCI in the hospitals participating in the registry in both years, 2003 and 2005. The use of DES was low with 4.3% in 2003 and increased to 19.1% in 2005. DES were mostly used in patients with stable angina (2003: 68.4%, 2005: 55.3%), in patients with former PCI (2003: 42.5%, 2005: 48.1%) and a positive stress test (DES 2003: 58.4%, 2005: 32.0%; Table 1). The rate of DES was high in unprotected left main procedures (DES 2003: 15.6%, 2005: 35.9%), PCI of ostial lesions (DES 2003: 6.4%, 2005: 32.7%), in in-stent stenosis (DES 2003: 9.5%, 2005: 40.6%), and in multivessel PCI (DES 2003: 7.6%, 2005: 29.3%; Figure 3). CONCLUSION: : DES were mainly applied in a stable situation (Figure 2), but were also increasingly used for complex coronary interventions in off-label indications.

The role of echocardiography and CT angiography in transcatheter aortic valve implantation patients.

The transcatheter aortic valve implantation (TAVI) consist an alternative treatment in patients with severe aortic stenosis. Multimodality imaging using transthoracic echocardiography (TTE) or transesophageal echocardiography (TOE) and multislice CT (MSCT) constitute cornerstone techniques for the pre-operative management, peri-procedural guidance, follow up and recognition of possible transcatheter valve related complications. CT angiography is much more accurate regarding the total definition of aortic annulus diameter and circumferential area. Two-dimensional (2D) echocardiography, underestimates the aortic valve annulus diameter compared to 3D imaging techniques (MSCT, MRI and 3D TOE). Three-dimensional TOE imaging provides measurements of the aortic valve annulus similar to those delivered by MSCT. The pre-procedural MSCT constitutes the gold standard modality minimizing the presence of paravalvular aortic regurgitation, one of the most frequent complications. TOE/TTE and MSCT performance could predict the possibility of pacemaker implantation post-procedural. The presence of a new transient or persisting MR can be assessed well by TOE. Both TTE and TOE, consist initially the basic examination for post TAVI evaluation. In case of transcatheter heart valve failure, the MSCT could be used as additional imaging technique.

Comparison of in-hospital outcomes of patients with versus without previous carotid endarterectomy undergoing carotid stenting (from the German ALKK CAS Registry).

Repeat carotid endarterectomy (CEA) for recurrent stenosis remains a challenging treatment option associated with high morbidity and mortality. Carotid artery stenting (CAS) is an attractive alternative management option for these patients. However, data about the effectiveness and safety of CAS in a large number of unselected patients are less known. We evaluated 3,070 patients who underwent CAS enrolled in a German registry from 1996 to 2006 at 31 sites. We compared clinical and angiographic features and in-hospital outcomes of patients with and without previous CEA who underwent CAS. Of 3,070 patients in the registry, 223 (7.3%) underwent CAS for restenosis after previous CEA. Median age was similar in patients with and without previous CEA (70 years, interquartile range 64 to 76 vs 71 years, interquartile range 65 to 76). Ipsilateral neurologic symptoms occurred in approximately 1/2 the patients in both groups. Other co-morbid conditions and angiographic or procedural factors did not differ between the 2 groups. In-hospital events including death (0% vs 0.4%), ipsilateral major stroke (1.4% vs 1.5%), death or major ipsilateral stroke (1.4% vs 1.7%), ipsilateral transient ischemic attack (1.9% vs 2.8%), myocardial infarction (0.4% vs 0.1%), and reintervention (0.7% vs 0.4%) were all low and not significantly different between those with and without previous CEA (p >0.05 for all comparisons). In conclusion, our data for a large number of patients who underwent CAS in a recent contemporary community-based practice attests to the low risk of periprocedural events in patients with recurrent stenosis after previous CEA. This low risk along with the less invasive nature of the procedure should make CAS an attractive and perhaps preferred option for the treatment of these patients.

Embolic protection devices for carotid artery stenting: is there a difference between filter and distal occlusive devices?

OBJECTIVES: We sought to compare the efficacy of a filter embolic protection device (F-EPD) and a distal occlusive embolic protection device (DO-EPD) in patients undergoing carotid artery stenting (CAS). BACKGROUND: The embolic protection device (EPD) may lower the periprocedural rate of cerebral ischemic events during CAS. However, it is unclear whether there is a difference in effectiveness between the different types of EPD. METHODS: We analyzed data from the Carotid Artery Stent (CAS) Registry. RESULTS: From July 1996 to July 2003, 1,734 patients were included in the prospective CAS Registry. Of these patients, 729 patients were treated with an EPD, 553 (75.9%) with F-EPD, and 176 (24.1%) with DO-EPD. Patients treated with DO-EPD were more likely to be treated for symptomatic stenosis (64.5% vs. 53.4%, p = 0.011). The carotid lesions in patients treated under DO-EPD seemed to be more complicated, as expressed by a higher proportion of ulcers (p = 0.035), severe calcification (p = 0.039), a longer lesion length (p = 0.025), and a higher pre-interventional grade of stenosis (p < 0.001). The median duration of the CAS intervention was 30 min in the DO-EPD group, compared with 48 min in the filter group (p < 0.001). No differences in clinical events rate between the two groups of protection devices were observed. Multivariate analysis on the occurrence of the combined end point of in-hospital death or stroke found no difference between filter- and DO-EPD (4 of 176 [2.3%] for DO-EPD vs. 10 of 551 [1.8%] for F-EPD; adjusted odds ratio = 1.04, 95% confidence interval 0.24 to 4.44; p = 0.958). CONCLUSIONS: Filter EPD is the currently preferred method of EPD in clinical practice. Both F-EPD and DO-EPD seem to be equally effective during CAS.

Clinical and angiographic analysis with a cobalt alloy coronary stent (driver) in stable and unstable angina pectoris.

The Clinical and Angiographic analysis with a Cobalt Alloy Coronary Stent (Driver) (CLASS) study was a prospective, nonrandomized, multicenter study designed to assess the safety and efficacy of a cobalt-chromium alloy-based stent in patients with stable or unstable angina pectoris. A total of 203 lesions were treated in 202 enrolled patients. The percentage of major adverse cardiac event-free patients was 87.6% (177 of 202) at 6 months (primary safety end point; major adverse cardiac events were defined as death, myocardial infarction, emergency bypass surgery, or target lesion revascularization [percutaneous transluminal coronary angioplasty or coronary artery bypass grafting]). The angiographic success rate (primary efficacy end point) was 100%, and the procedural success rate was 98%. The binary in-stent restenosis rate at 6 months was 12.6%. Our results have demonstrated that the Driver cobalt-chromium alloy stent can be used with a low 6-month incidence of major adverse cardiac events, a low 6-month binary restenosis rate, and high angiographic and procedural success rates.

Reducing Patient Radiation Dose With Image Noise Reduction Technology in Transcatheter Aortic Valve Procedures.

X-ray radiation exposure is of great concern for patients undergoing structural heart interventions. In addition, a larger group of medical staff is required and exposed to radiation compared with percutaneous coronary interventions. This study aimed at quantifying radiation dose reduction with implementation of specific image noise reduction technology (NRT) in transcatheter aortic valve implantation (TAVI) procedures. We retrospectively analyzed 104 consecutive patients with TAVI procedures, 52 patients before and 52 after optimization of x-ray radiation chain, and implementation of NRT. Patients with 1-step TAVI and complex coronary intervention, or complex TAVI procedures, were excluded. Before the procedure, all patients received a multislice computed tomography scan, which was used to size aortic annulus, select the optimal implantation plane, valve type and size, and guide valve implantation using a software tool. Air kerma and kerma-area product were compared in both groups to determine patient radiation dose reduction. Baseline parameters, co-morbidity, or procedural data were comparable between groups. Mean kerma-area product was significantly lower (p <0.001) in the NRT group compared with the standard group (60 ± 39 vs 203 ± 106 Gy × cm(2), p <0.001), which corresponds to a reduction of 70%. Mean air kerma was reduced by 64% (494 ± 360 vs 1,355 ± 657 mGy, p <0.001). In conclusion, using optimized x-ray chain combined with specific image noise reduction technology has the potential to significantly reduce by 2/3 radiation dose in standard TAVI procedures without worsening image quality or prolonging procedure time.

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis (DISCOVER) Study.

OBJECTIVES: The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery. BACKGROUND: The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation. METHODS: A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria. RESULTS: Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2). CONCLUSIONS: At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.

TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions.

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 (< or =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<0.01). No evidence of edge restenosis was seen in either group. Intravascular ultrasound analysis showed significant improvements in normalized neointimal hyperplasia in the TAXUS (14.8 mm3) group compared with the control group (21.6 mm3) (P<0.05). 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.

High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial.

OBJECTIVES: The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions. BACKGROUND: The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 microg of the paclitaxel derivative 7-hexanoyltaxol. METHODS: Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up. RESULTS: In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non-Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p < 0.0001). However, the primary end point was not met with six-month target vessel revascularization (TVR) rate as well as the composite major adverse cardiac event rates (cardiac death, MI, and TVR) comparable between groups. CONCLUSIONS: Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.

Two-year-plus follow-up of a paclitaxel-eluting stent in de novo coronary narrowings (TAXUS I).

Early results with polymer-based paclitaxel-eluting stents have shown significant improvements in the clinical and angiographic parameters of restenosis, as well as excellent safety outcomes. However, the duration of these beneficial effects is unknown. Therefore, the clinical outcomes of the TAXUS I study population were evaluated at 2- and 3-year follow-up. In TAXUS I, 61 patients with single, focal coronary lesions were randomly assigned to receive either a paclitaxel-eluting TAXUS stent (n = 31) or a bare metal control stent (n = 30). Low rates of composite major adverse cardiac events (MACEs) reported at 1-year follow-up (3.2% TAXUS vs 10.0% control) were maintained at 2 and 3 years, with no additional MACEs in either treatment group 1 year after implantation. The single target vessel revascularization in the TAXUS group was remote from the target lesion in contrast to 3 target lesion revascularizations in the control group.

Fifteen-year experience with carotid artery stenting (from the carotid artery stenting-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte).

To date only sparse data are available on trends and changes in indications, patient's characteristics, and clinical outcome of patients undergoing carotid artery stenting (CAS) in clinical practice. From February 1996 to December 2010, 6,116 CAS procedures were performed in 5,976 patients at 36 hospitals within the prospective, multicenter CAS registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte. Median age of patients was 71 years, 71.6% were men; a symptomatic stenosis was treated in 50.3% and an embolic protection device (EPD) was used in 82.5% of the patients. The overall hospital mortality or stroke rate was 3.1%. Stroke or in-hospital death occurred in 4.0% in symptomatic patients and in 2.2% in asymptomatic patients. In a logistic regression model, independent predictors of in-hospital death or stroke were heart failure (odds ratio [OR] 2.03, 95% confidence interval [CI] 1.22 to 3.36, p = 0.006), symptomatic stenosis (OR 1.52, 95% CI 1.05 to 2.18, p = 0.03), and age (OR per 10 years 1.46, 95% CI 1.17 to 1.81, p <0.001). The use of an EPD was significantly associated with a lower rate of death or stroke in the registry (OR 0.45, 95% CI 0.26 to 0.78, p = 0.004). From 1996 to 2010, mean age of patients increased by 4.1 years (p <0.001), the proportion of male patients decreased from 82.4% to 70.2% (p = 0.07), the proportion of symptomatic stenoses decreased (84.6% to 24.7%, p <0.001), and the use of EPDs increased from 1.4% to 97.2% (p <0.001). Comparing 2 periods from 1996 to 2003 and 2004 to 2010, a numeric decrease in the in-hospital stroke or death rate was seen in symptomatic (4.7% vs 3.5%, p = 0.11), and in asymptomatic patients (2.9% vs 2.1%, p = 0.27) undergoing CAS, which did not reach statistical significance. In conclusion, the proportion of symptomatic carotid artery stenoses decreased significantly; EPDs established as a standard tool and a numeric decrease of in-hospital stroke or death was seen in asymptomatic and symptomatic patients undergoing CAS in clinical practice over the last 15 years.

Use of a balloon-expandable transfemoral sheath in a TAVI cohort with complex access site - a propensity score matched analysis.

AIMS: In patients undergoing transcatheter aortic valve implantation (TAVI), the high prevalence of peripheral artery disease (PAD) limits femoral access and increases vascular complications that are associated with mortality and morbidity. Our study assessed the ability of a balloon-expandable large-bore vascular sheath to increase access-site availability and to reduce vascular complications. METHODS AND RESULTS: Among 257 patients from two centres, 43 patients underwent transfemoral TAVI with the use of the SoloPath balloon-expandable sheath due to complex iliofemoral access anatomy. Propensity score matching (2:1) was performed except for the sheath to femoral artery ratio (SFAR). Compared to standard sheath patients, we found no significant difference in 30-day and one-year mortality (SoloPath vs. standard sheath, 9.3% vs. 3.5%; p=0.2, and 18.6% vs. 23.3%; p=0.7), major vascular complications (9.3% vs. 4.7%; p=0.3), and major bleeding (9.3% vs. 10.5%; p=0.5) in the cohort with the balloon-expandable sheath. CONCLUSIONS: The use of a balloon-expandable large-bore sheath in patients with a high risk for vascular complications due to complex access-site anatomy proved to be feasible and safe. However, circumferential calcifications and sheath-to-artery ratios account for vascular access complications even in patients treated with the balloon-expandable sheath.