Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.

BACKGROUND: Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction. AIMS: The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients. METHODS: Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data. RESULTS: Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm3. There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion. CONCLUSIONS: The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).

Impella in cardiogenic shock following acute myocardial infarction: a systematic review and meta-analysis.

BACKGROUND AND OBJECTIVE: Cardiogenic shock (CS) conveys a high mortality risk. A cardiac assist device may serve as bridge to patient recovery. We aimed to provide a pooled estimate on mortality and complications from studies evaluating the use of the left ventricular assist device Impella in CS following acute myocardial infarction. In addition, we evaluated whether mortality risk differed with device placement before or after percutaneous coronary intervention (PCI). METHODS: We searched Medline, Embase and Web of Science from 2005 until July 2019 for observational studies or clinical trials on this specific patient group. Studies were required to report on 30-day all-cause mortality and device-related complications. We calculated pooled proportions with 95% confidence intervals (CI) using random effects models and the inverse variance method. RESULTS: Overall, 671 patients from 11 studies (2 randomized and 9 observational) were included. Pooled proportions showed a 30-day mortality of 54.6% (95% CI 47.3-61.8; P = 0.22; I2 = 65.8%). Among complications, major bleeding was found in 19.9% (95% CI 14.2-27.3; P < 0.05; I2 = 69.1%), hemolysis in 10.5% (95% CI 7.2-15.0; P < 0.05; I2 = 52.1%), limb ischemia in 5.0% (95% CI 2.6-9.5; P < 0.05; I2 = 48.3%) and stroke in 3.8% of patients (95% CI 2.4-5.9; P < 0.05; I2 = 0%). Sensitivity analysis demonstrated a statistically significant risk reduction in 30-day mortality when Impella was implanted prior to PCI as compared to after PCI, risk ratio (RR): 0.71, CI 0.58-0.86, P = 0.001, I2 = 0%. CONCLUSION: Pooled estimates of Impella use in myocardial infarction with CS revealed a high 30-day mortality; however, as compared to post-PCI, Impella initiation prior to PCI was associated with a survival benefit.

Transfemoral implantation of the ACURATE neo prosthesis using a low-profile expandable introducer system: A multicenter registry.

BACKGROUND: The ACURATE neo prosthesis is commonly implanted using introducer sheaths with inner diameters of up to 20 French. The use of only the expandable mesh component of the transGlide introducer system (Meshonly) would substantially decrease the inner diameter to 13 French. We sought to assess the feasibility and safety of using Meshonly for femoral access of the ACURATE neo device and to compare outcomes with patients in whom standard sheaths were used. METHODS AND RESULTS: We retrospectively analyzed a total of 551 patients with severe aortic stenosis from 4 high volume centers in Germany and Switzerland undergoing transfemoral TAVI between February 2016 and February 2018 with implantation of the ACURATE neo device. The median age was 81.7 [78.3-85.2], 67.0% were female, the STS score was 4.2% [2.8-6.5]. The use of the Meshonly was feasible in all attempted cases (n = 272); in all other patients, a standard sheath was used. Major vascular complications at the main access-site (VARC-2) were less frequent in the Meshonly group than in the standard sheath group (1.5% vs. 7.9%; p < 0.001). In the multivariable analysis, the use of Meshonly was independently associated with less major vascular complications (odds ratio 0.10 [95% CI 0.02-0.48]; p = 0.004). CONCLUSIONS: Transfemoral implantation of the ACURATE neo device using the Meshonly was associated with a lower rate of major access-related complications when compared to the standard of care.

A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis.

AIMS: Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. METHODS AND RESULTS: This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%). CONCLUSIONS: The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).

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.