Tricuspid regurgitation is a predictor of mortality after percutaneous mitral valve edge-to-edge repair.

AIMS: The aim of this study was to determine the impact of tricuspid regurgitation (TR) on mortality after edge-to-edge percutaneous mitral valve repair (PMVR), and also to analyse whether there is a difference in outcome between patients with improvement of TR after PMVR compared to patients without. METHODS AND RESULTS: Out of 197 consecutive patients who underwent PMVR, 139 patients with available follow-up (mean 428±386 days) were included in the study. Concomitant moderate/severe TR was present in 58.3% of patients. Kaplan-Meier analysis showed significantly reduced overall survival for patients with moderate/severe TR, compared to patients with none/mild TR (p=0.003). Cox multivariate regression analysis revealed severe TR at baseline as the strongest independent predictor of mortality (HR 4.367, p=0.003). An improvement of the baseline moderate/severe TR was observed in 45.5% of patients at 30-day follow-up. Patients with no improvement of TR after PMVR had a higher midterm mortality compared to patients in whom TR improved (40.5% versus 11.4%, p=0.005). CONCLUSIONS: More than half of patients undergoing PMVR have concomitant moderate/severe TR, which is associated with a worse outcome. Among predictors of mortality after edge-to-edge PMVR, severe TR at baseline is the most important. Patients with no improvement of TR at 30 days after PMVR have a significantly higher mortality at follow-up.

Long-term major adverse cardiac and cerebrovascular events (MACCE) rate : Comparison of retrograde and antegrade recanalization of chronic total coronary occlusions.

BACKGROUND: The recanalization success rate of chronic total occlusion (CTO) percutaneous coronary interventions (PCI) can be increased by the retrograde approach; however, the long-term outcome of patients undergoing retrograde procedures is unknown. AIM: We aimed to evaluate the long-term major adverse cardiac and cerebrovascular event (MACCE) rate (e.g. death, myocardial infarction, coronary artery bypass surgery and stroke) in patients after retrograde versus antegrade CTO-PCI. METHODS AND RESULTS: In a prospective single center study from January 2008 to June 2012, 396 consecutive patients with CTO (≥3 months old) were enrolled. The mean age was 63.4 ± 10.3 years and 86.4% were male. The success rate of the total patient cohort was 88.6%. The retrograde PCI, only attempted after a failed antegrade intervention, was performed in 18% (n = 71) of patients. Long-term MACCE rate (mean follow up 2.3 ± 1.6 years) was significantly higher in the unsuccessful compared to the successful CTO-PCI group (23.1% versus 9.4%, p = 0.01) and this was also the case in the subgroup of antegrade CTO-PCI. In the retrograde subgroup, however, procedural success had no impact on outcome. Patients with unsuccessful retrograde CTO-PCI had a significantly better collateral connection compared to patients with an unsuccessful antegrade approach. Independent predictors for MACCE were peripheral artery disease and an ejection fraction ≤30%. CONCLUSION: The long-term MACCE rate after unsuccessful recanalization was significantly higher, which was driven by a higher MACCE rate after unsuccessful versus successful antegrade approaches. In contrast, procedural success in the retrograde group had no impact on outcome.

Impact of cardiac comorbidities on early and 1-year outcome after percutaneous mitral valve interventions: data from the German transcatheter mitral valve interventions (TRAMI) registry.

AIMS: The use of the MitraClip system has gained widespread acceptance for the treatment of patients with mitral regurgitation (MR) who are not suitable for the conventional surgery. This study sought to investigate the early and 1-year outcome after MitraClip therapy of patients with MR and cardiac comorbidities. METHODS AND RESULTS: Outcomes through 12-month follow-up of patients (n = 528) who underwent MitraClip implantation were obtained from the German transcatheter mitral valve interventions (TRAMI) registry. The majority of these patients (n = 409, 77.5 %) also suffered from coronary artery disease (CAD). Patients with a dilated cardiomyopathy (DCM, n = 65, 12.3 %) or concomitant valvular aortic disease (AV, n = 54, 10.2 %) were less frequent. Although the prevalent pathogenesis was functional MR, patients with DCM had significantly more frequent a functional MR (96.9 %) compared to patients with CAD (74.9 %) or AV (62.5 %, p < 0.001). Technical success was achieved in 97.5 % of patients. Procedural echocardiograms demonstrated in the vast majority of patients a reduction from severe MR III to mild MR I with no difference between the groups (p = 0.83). The peri-procedural complication rate was very low. At 30-day and 12-month follow-up, the majority of patients were in NYHA functional class II or lower. The rate of death, stroke, and myocardial infarction (MACCE) was comparable in the three patient groups during 12-month follow-up (DCM 26.9 %, CAD 30.3 % and AV 27.5 %, p = 0.85). CONCLUSIONS: The MitraClip implantation is feasible and safe even in high-risk patients with MR and cardiac comorbidities.

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.

Recanalization of chronic total coronary occlusions--high success rate despite a restrictive use of the retrograde approach.

AIM: The retrograde approach in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is increasingly being used as a first-line intervention despite a higher radiation exposure, contrast volume, and a higher major adverse cardiac event (MACE) rate compared with the antegrade approach. It was aimed to evaluate the overall success rate of CTO-PCI over time when the retrograde approach was restrictively used only after a failed antegrade attempt. METHODS AND RESULTS: In a prospective single operator registry from January 2008 to December 2012 about 436 consecutive patients underwent a CTO-PCI. Mean age was 63.4 ± 10.3 years, and 86% were male. The overall success rate improved significantly over time [68% (first quartile) to 91% (fourth quartile), P < 0.001] due to a significant increase of the antegrade success rate. This could be achieved by a retrograde approach of less than 20% with no change over time. The overall in-hospital MACE rate was 0.69% with no difference between antegrade and retrograde procedures. CONCLUSIONS: A high CTO-PCI success rate of above 90% could be achieved with a restrictive use of the retrograde technique.

First-in-man transcatheter mitral valve-in-ring implantation with a repositionable and retrievable aortic valve prosthesis.

AIMS: Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure. METHODS AND RESULTS: Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status. CONCLUSIONS: For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.

OBJECTIVES: This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). BACKGROUND: The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. METHODS: The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). RESULTS: Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. CONCLUSIONS: This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route.

Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon Valvuloplasty.

OBJECTIVES: The purpose of this study was to analyze the effect of transcatheter aortic valve replacement (TAVR) without versus with prior balloon aortic valvuloplasty (BAV) on the risk of cerebral embolization in patients who receive a balloon-expandable valve. BACKGROUND: Avoiding BAV prior to TAVR may simplify the procedure, but the risk of cerebral embolization is currently unknown. METHODS: A total of 87 consecutive high surgical-risk patients with no contraindications for diffusion-weighted magnetic resonance imaging (DW-MRI) were enrolled. Thirty-two patients received a balloon-expandable aortic valve with and 55 patients without BAV. The incidence, number, and volume of new ischemic lesions in DW-MRI performed 2 to 7 days after TAVI were evaluated. RESULTS: Mean age (83.8 ± 5.2 years vs. 82.9 ± 6.8 years) and sex (43.8% vs. 52.7% male) of the patients with versus without BAV, respectively, as well as other demographic and hemodynamic data were not significantly different between both groups. The procedural success rate was 93.5% with and 98.2% without BAV, and procedure duration and contrast volume were significantly lower without BAV. The incidence of new cerebral ischemic lesions in the total cohort was 66.7%. Compared with patients with BAV, those without BAV had a significantly higher total volume of cerebral ischemic lesions (235.4 ± 331.4 mm(3) vs. 89.5 ± 128.2 mm(3); p = 0.01). CONCLUSIONS: The implantation of a balloon-expandable aortic valve without versus with prior BAV, although performed with a shorter procedure time and lower contrast volume, is associated with a significantly higher volume of cerebral ischemic lesions.

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet).

OBJECTIVES: This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system-a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting. BACKGROUND: The risk of cerebral embolization persists throughout the carotid artery stenting procedure and remains during the stent healing period. METHODS: A total of 30 consecutive patients (age 71.6 ± 7.6 years, 63% male) meeting the conventional carotid artery stenting inclusion criteria were enrolled in 4 centers in Germany and Poland. RESULTS: The primary combined endpoint was the procedure success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted magnetic resonance imaging at 48 h post-procedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). Protection devices were used in all procedures. Procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 h occurred in 37.0% of patients and the average lesion volume was 0.039 ± 0.08 cm(3). The 30-day diffusion-weighted magnetic resonance imaging showed complete resolution of all but 1 periprocedural lesion and only 1 new minor (0.116 cm(3)) lesion in relation to the 48-h scan. CONCLUSIONS: The use of the CGuard system in patients undergoing carotid artery stenting is feasible. In addition, the benefit of using CGuard may extend throughout the stent healing period.

First-in-human transcatheter tricuspid valve repair in a patient with severely regurgitant tricuspid valve.

BACKGROUND: Severe tricuspid regurgitation is associated with poor prognosis; however, there are limited Class I indications for intervention, and high-surgical risk patients may go untreated. We report the first-in-human successful transcatheter tricuspid valve repair for severe tricuspid regurgitation. OBJECTIVES: The objective of this study was to show the feasibility of a transcatheter tricuspid annular repair. METHODS: Compassionate-use approval for the procedure was obtained from the regulatory organization in Germany. To perform the transcatheter bicuspidization of the tricuspid valve, the Mitralign system was used to place pledgeted sutures by means of a trans-jugular venous approach. Insulated radiofrequency wires were positioned 2 to 5 mm from the base of the posterior leaflet, 2.6 cm apart. The sutures were drawn together and locked, plicating the posterior annulus. RESULTS: Reconstruction of the 3-dimensional transesophageal echocardiographic dataset at baseline revealed a tricuspid valve annular area of 14.1 cm(2), and effective regurgitant orifice area was 1.35 cm(2). There was a significant reduction in annular area (57%) and effective regurgitant orifice area (53%) measured with 3-dimensional transesophageal echocardiography, at 6.05 cm(2) and 0.63 cm(2), respectively. Hemodynamic parameters also improved with a reduction in right atrial pressure from 22 mm Hg at baseline, to 9 mm Hg and an increase in left ventricular stroke volume from 42 ml at baseline to 72 ml. CONCLUSIONS: Transcatheter tricuspid valve repair could become an effective treatment for high-surgical risk patients who are non-responsive to optimal medical therapy.

Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.

OBJECTIVES: The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis. BACKGROUND: The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation. METHODS: One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria. RESULTS: There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 ± 7.1 mm Hg (n = 72) and effective orifice area of 1.50 ± 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases. CONCLUSIONS: The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients.

Risk factors for cerebral embolization after carotid artery stenting with embolic protection: a diffusion-weighted magnetic resonance imaging study in 837 consecutive patients.

BACKGROUND: Meta-analyses of randomized trials have shown an increased risk of periprocedural stroke after carotid artery stenting (CAS) compared with carotid endarterectomy, which may differ in specific patient subgroups. Knowledge of risk factors for cerebral embolic lesions during CAS may impact treatment decisions for the individual patient, but these factors have not been extensively studied. We aimed to identify factors predictive for cerebral ischemic lesions during embolic protected CAS. METHODS AND RESULTS: Preprocedural and postprocedural diffusion-weighted magnetic resonance imaging was performed for evaluation of new cerebral ischemic lesions in 728 (86.9%) of 837 consecutive patients undergoing CAS with cerebral embolic protection. Multivariable logistic regression analyses were performed to identify factors predictive for embolic lesions. New ischemic lesions were found in 32.8% of patients. Age, hypertension, lesion length, lesion eccentricity, and aortic arch type III were significantly associated with new ischemic lesions; calcified lesions were negatively associated. In 25% of these patients embolic lesions were also found in the contralateral hemisphere. Predictive factors for contralateral lesions were age, >50% stenosis of the contralateral internal carotid artery, and an aortic arch type II, with a trend for aortic arch type III. CONCLUSIONS: Age, hypertension, lesion morphology, and aortic arch type were predictive for procedural-related cerebral embolic lesions during embolic protected CAS. Age, significant contralateral carotid stenosis, and complex aortic arch type were predictive for bilateral ischemic lesions. The clinical implications of ischemic lesions are not yet fully understood.

Impact of asymptomatic cerebral lesions in diffusion-weighted magnetic resonance imaging after carotid artery stenting.

OBJECTIVES: This study sought to analyze the impact of new asymptomatic cerebral ischemic lesions, found in diffusion-weighted magnetic resonance imaging (DW-MRI) after carotid artery stenting (CAS) in relation to other risk factors for major adverse cerebral and cardiovascular events (MACCE) defined as death, stroke, and myocardial infarction. BACKGROUND: After CAS, new cerebral lesions have been reported in up to 70% of patients. The impact of asymptomatic lesions on prognosis after CAS has not been studied. METHODS: Eight hundred thirty-seven consecutive patients underwent CAS with cerebral embolic protection. In 728 patients (86.9%), a pre- and post-procedural DW-MRI was available; these patients were included in the analyses. Multivariate Cox regression analysis and Kaplan-Meier estimates were performed to identify independent risk factors for MACCE at follow-up. Clinical, procedural, and lesion characteristics and DW-MRI findings were included in the analyses. RESULTS: Post-procedure new cerebral ischemic lesions were detected in 32.8% (n = 241) of patients. Fifteen patients (1.79%) had a periprocedural MACCE and were therefore excluded from the analysis. At a mean follow-up of 766.8 ± 513.4 days (range 30 to 2,577 days), MACCE occurred in 45 patients (6.2%). Cox regression analysis and Kaplan-Meier estimates both identified diabetes as the only significant independent risk factor of MACCE. Asymptomatic cerebral lesions after CAS were not associated with MACCE. CONCLUSIONS: Beyond 30 days, diabetes is the only risk factor of MACCE at follow-up. Asymptomatic cerebral embolic events after CAS had no prognostic impact.

Direct Flow Medical valve.

AIMS: To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve. METHODS AND RESULTS: The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days. CONCLUSIONS: The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.

Direct percutaneous access technique for transaxillary transcatheter aortic valve implantation: "the Hamburg Sankt Georg approach".

OBJECTIVES: This study questioned whether transaxillary transcatheter aortic valve implantation (TAVI) is feasible as a true percutaneous approach using percutaneous closure devices. BACKGROUND: Transaxillary TAVI is gaining increasing acceptance as an alternative to the transfemoral route; however, the access has always been done via surgical cutdown so far. METHODS: Between August 2010 and September 2011, a total of 24 high-risk patients with severe aortic valvular stenosis underwent a percutaneous TAVI procedure by direct puncture of the axillary artery without surgical cutdown. For safety reasons and as a target for the puncture, a wire was advanced via the ipsilateral brachial artery. Moreover, a balloon was placed into the subclavian artery via the femoral artery for temporary vessel blockade before percutaneous vessel closure. Vascular closure was performed using either the ProStar XL system (Abbott Vascular Devices, Redwood City, California) or 2 ProGlide systems (Abbott Vascular Devices). RESULTS: The true percutaneous approach was successfully completed in all patients (14 left and 8 right axillary artery cases). Overall mortality at 30 days was 8.3%. Acute vascular closure device success was achieved in 17 patients (71%). Vascular closure device success rate was 100% for the ProGlide device and 37% for the ProStar device, respectively. Seven patients (29%) with failing closure devices were treated by endovascular stent graft implantation without the need for surgical repair. For the last 12 treated patients, direct closure was achieved in 11 patients. CONCLUSIONS: Direct puncture of the axillary artery for TAVI is feasible and safe if a wire is placed into the subclavian artery via the ipsilateral brachial artery.