Cardiovascular magnetic resonance assessment of 1st generation CoreValve and 2nd generation Lotus valves

Objectives

We sought to compare using serial CMR, the quantity of AR and associated valve hemodynamics, following the first‐generation CoreValve (Medtronic, Minneapolis, MN) and the second‐generation Lotus valve (Boston Scientific, Natick, MA).

Background

Aortic regurgitation (AR) following Transcatheter Aortic Valve Replacement (TAVR) confers a worse prognosis and can be accurately quantified using cardiovascular magnetic resonance (CMR). Second generation valves have been specifically designed to reduce paravalvular AR and improve clinical outcomes.

Methods

Fifty‐one patients (79.0 ± 7.7 years, 57% male) were recruited and imaged at three time points: immediately pre‐ and post‐TAVR, and at 6 months.

Results

CMR‐derived AR fraction immediately post‐TAVR was greater in the CoreValve compared to Lotus group (11.7 ± 8.4 vs. 4.3 ± 3.4%, P = 0.001), as was the frequency of ≥moderate AR (9/24 (37.5%) versus 0/27, P < 0.001). However, at 6 months AR fraction had improved significantly in the CoreValve group such that the two valve designs were comparable (6.4 ± 5.0 vs 5.6 ± 5.3%, P = 0.623), with no patient in either group having ≥moderate AR. The residual peak pressure gradient immediately following TAVR was significantly lower with CoreValve compared to Lotus (14.1 ± 5.6 vs 25.4 ± 11.6 mmHg, P = 0.001), but again by 6 months the two valve designs were comparable (16.5 ± 9.4 vs 19.7 ± 10.5 mmHg, P = 0.332). There was no difference in the degree of LV reverse remodeling between the two valves at 6 months.

Conclusion

Immediately post‐TAVR, there was significantly less AR but a higher residual peak pressure gradient with the Lotus valve compared to CoreValve. However, at 6 months both devices had comparable valve hemodynamics and LV reverse remodeling.

     

Comparison of transcatheter aortic valve replacement risk score against currently accepted surgical risk models as predictors of 30‐day mortality in transcatheter aortic valve replacement

Objectives

Aim of the study was to assess the predictive capability of Transcatheter Aortic Valve Replacement Risk Score (TAVR‐RS) in comparison with Society of Thoracic Surgeon‐Predicted Risk of Mortality (STS PROM) and European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) on 30‐day mortality following TAVR.

Background

With exponentially increasing use of TAVR, a risk stratification model to accurately predict mortality risks in patients undergoing TAVR is urgently warranted.

Methods

Retrospective analysis of 182 TAVRs between 2014 and 2017, 179 by transfemoral, 3 by subclavian approach. Clinical, laboratory and echocardiography variables were collected. The performance of risk models was evaluated using equivalence tests, receiver operating characteristic (ROC) and area under the ROC curve (AUC). Outcome was 30‐day mortality prediction.

Results

Observed 30‐day mortality was 5.49%. TAVR‐RS underestimated (4.0%) while surgical models (STS PROM and EuroSCORE II) overestimated mortality, 7.24% and 8.14%, respectively. The TAVR‐RS was found to have statistically significant correlation with both individual and group mortalities. AUC was highest for TAVR‐RS 0.66 (95%CI: 0.31–0.96), but no difference in 30‐day mortality prediction was found in comparison with STS PROM (P = 0.06) or EuroSCORE II (P = 0.2161).

Conclusions

The TAVR‐RS was a better predictor of both group and individual mortality at 30 days. The outcomes were comparable on pairwise testing against surgical risk models, although TAVR‐RS was on verge of significance when compared to STS PROM. This study supports the current dogma that a risk model specifically tailored for TAVR population should be implemented to obtain a better patient selection.

     

Improvements of Procedural Results With a New‐Generation Self‐Expanding Transfemoral Aortic Valve Prosthesis in Comparison to the Old‐Generation Device

Objectives

In this study, we compare procedural results of our first Evolut R (Medtronic, Minneapolis, MN, USA) implantations with the last CoreValve implantations. Main endpoints include paravalvular regurgitation, major vascular complications, stroke, and pacemaker implantation.

Background

The evolution of transcatheter aortic valve replacement (TAVR) was possible due to various technical improvements, leading to better periprocedural and long‐term outcome. The newly designed Evolut R valve has the potential to further improve TAVR's performance.

Methods

We retrospectively analyzed our first 100 consecutive patients who received the Evolut R valve with the last 100 consecutive patients who received the CoreValve prosthesis between July 2013 and February 2016. Only patients treated with a 26 mm or 29 mm bioprosthesis were included.

Results

No significant differences in patient characteristics were noticed. Both angiography and echocardiography after TAVR showed significantly higher rates of “none or trace” regurgitation in the Evolut R group (angiography: 67% Evolut R vs. 29.3% CoreValve; P < 0.001; echocardiography: 68% Evolut R vs. 46.5% CoreValve; P < 0.05). No significant differences were seen in 30‐day mortality (7% CoreValve vs. 1% Evolut R), stroke rates (3% CoreValve vs. 2% Evolut R), pacemaker implantation rates (24% CoreValve vs. 23% Evolut R), and major vascular complications (6% CoreValve vs. 1% Evolut R). Implantations were significantly higher with the Evolut R prosthesis.

Conclusions

TAVR with the new Evolut R resulted in significantly lower paravalvular regurgitation. This may be due to redesigned cell geometry and higher precision during implantations, as well as the ability to resheath a malpositioned valve.

     

Post‐dilation in transcatheter aortic valve replacement: A systematic review and meta‐analysis

Objectives

The aim of this study was to perform a meta‐analysis to compare the outcomes of patients undergoing TAVR with and without balloon post‐dilation (PD).

Background

PD is a commonly used technique in TAVR to minimize paravalvular regurgitation (PVR), albeit supported by little evidence.

Methods

Systematic review and meta‐analysis of 6 studies comparing 889 patients who had PD compared to 4118 patients without PD.

Results

Patients undergoing PD were more likely male (OR 1.92; 95% CI, 1.41‐2.61; P < 0.001) and to have coronary artery disease (OR 1.31; 95% CI, 1.03‐1.68; P = 0.03) than those patients not requiring PD. There were no significant differences in 30‐day mortality (OR 1.24; 95% CI, 0.88‐1.74; P = 0.22) and myocardial infarction (OR 0.93; 95% CI, 0.46‐1.90; P = 0.85). Patients undergoing TAVR did not have higher 1‐year mortality rates (OR 0.98; 95% CI, 0.61‐1.56; P = 0.92). The incidence of stroke was significantly greater in patients with PD (OR, 1.71; 95% CI, 1.10‐2.66). PD was able to reduce the incidence of moderate‐severe PVR by 15 fold (OR 15.0; 95% CI, 4.2‐54.5; P < 0.001), although rates of moderate‐severe PVR were still higher after PD than patients who did not require PD (OR 3.64; 95% CI, 1.96‐6.75; P < 0.001).

Conclusions

PD significantly improves rates of PVR, however careful patient selection is needed to minimize increased risk of strokes.

     

First Experience With the New Generation Edwards Sapien 3 Aortic Bioprosthesis: Procedural Results and Short Term Outcome

Background

TAVR has become an established treatment for severe symptomatic aortic stenosis in patients with high surgical risk. The latest generation of the balloon‐expandable Edwards Sapien device, the Sapien 3, together with its new transfemoral Commander delivery system has been designed to reduce paravalvular regurgitation and vascular access site complications.

Objectives

To evaluate procedural results and short term outcome with the third generation Sapien 3 device.

Methods

We retrospectively evaluated 125 consecutive TAVR patients and analyzed the first 51 patients in whom we implanted the new Sapien 3 device via transfemoral access.

Results

In patients implanted with the Sapien 3 device significant residual paravalvular regurgitation after TAVR was virtually absent with the vast majority having none or trace postinterventional aortic regurgitation on angiography or echocardiography (92.2% and 80.4% respectively). None of the patients had more than mild paravalvular regurgitation. Major vascular access site complications or major bleeding according to the VARC II criteria were not observed in our cohort, minor vascular complications and minor bleeding occurred in 7.8% and 5.9% respectively. If vascular complications occurred, they were related to closure device failure. Thirty day outcome showed a 1.9% major stroke rate and 3.9% death rate. However, we observed a 25.5% permanent pacemaker rate in our Sapien 3 cohort.

Conclusions

Implantation of the new third generation Sapien 3 device resulted in excellent procedural and short term outcome. Significant paravalvular regurgitation was virtually absent. However, the increased rate of postinterventional pacemaker implantations needs to be analyzed in a larger cohort of patients. (J Interven Cardiol 2015;28:109–116)

     

Predictors for long‐term survival after transcatheter edge‐to‐edge mitral valve repair

Objectives

To determine predictors for long‐term outcome in high‐risk patients undergoing transcatheter edge‐to‐edge mitral valve repair (TMVR) for severe mitral regurgitation (MR).

Background

There is no data on predictors of long‐term outcome in high‐risk real‐world patients.

Methods

From August 2009 to April 2011, 126 high‐risk patients deemed inoperable were treated with TMVR in two high‐volume university centers.

Results

MR could be successfully reduced to grade ≤2 in 92.1% of patients (116/126 patients). Long‐term clinical follow‐up up to 5 years (95.2% follow‐up rate) revealed a mortality rate of 35.7% (45/126 patients). Repeat mitral valve treatment (surgery or intervention) was needed in 19 patients (15.1%). Long‐term clinical improvement was demonstrated with 69% of patients being in NYHA class ≤II. In a multivariable Cox regression analysis, the post‐procedural grade of MR (hazard ratio [HR] 1.55 per grade, P = 0.035), the left ventricular ejection fraction (HR 0.58 for difference between 75th and 25th percentile, P = 0.031) and the glomerular filtration rate (HR 0.33 for 75th vs 25th percentile, P < 0.001) were independent predictors for long‐term mortality. Patients with primary MR and a post‐procedural MR grade ≤1 had the most favorable long‐term outcome.

Conclusions

This study determines predictors of long‐term clinical outcome after TMVR and demonstrates that the grade of residual MR determines long‐term survival. Our data suggest that it might be of benefit reducing residual MR to the lowest possible MR grade using TMVR—especially in selected high‐risk patients with primary MR who are not considered as candidates for surgical MVR.

     

Valve in valve transcatheter aortic valve implantation (ViV‐TAVI) versus redo—Surgical aortic valve replacement (redo‐SAVR): A systematic review and meta‐analysis

Background

Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve ? Transcatheter Aortic Valve Implantation (ViV‐TAVI) emerged as an alternative to the gold standard redo‐Surgical Aortic Valve Replacement (redo‐SAVR). However, the utility of ViV‐TAVI is poorly understood.

Methods

A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov . Only studies which compared the safety and efficacy of ViV‐TAVI and redo‐SAVR head to head in failed BP valves were included.

Results

Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV‐ TAVI and 339 underwent redo‐SAVR. There was no significant difference between ViV‐TAVI and redo‐ SAVR for procedural, 30 day and 1 year mortality rates. ViV‐TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21‐0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94‐31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm‐hg.

Conclusion

Our results reiterate the safety and feasibility of ViV‐TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV‐TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak.

     

Aortic Valve Calcium Volume Predicts Paravalvular Regurgitation and the Need for Balloon Post‐Dilatation After Transcatheter Aortic Valve Implantation

Objective

This study sought to evaluate the impact of aortic valve (AV) and left ventricle outflow tract (LVOT) calcium on paravalvular regurgitation (PVR) and need for balloon post‐dilatation (BPD) during transcatheter aortic valve implantation (TAVI).

Methods

The overall study population comprised 152 patients. Calcium mass and volume of AV and LVOT were estimated from contrast‐enhanced multislice computed tomography imaging, using 3 thresholds for calcium detection [650, 850, and 1,050 Hounsfield units (HU)].

Results

A self‐expandable prosthesis was implanted in 67.8% of patients and a balloon‐expandable prosthesis in the remaining. Eleven patients required BPD and 82 patients presented post‐procedural PVR, which was mild in 44.1% and moderate in 9.9%. The greatest discriminatory value for PVR ≥ mild was seen for calcium volume using 850 HU threshold, with an area under the curve of 0.72 (95%CI 0.64–0.80, P < 0.001) for AV and of 0.63 (95%CI 0.54–0.72, P = 0.008) for LVOT. For 850 HU threshold, the calcium volume cut‐off with the highest sum of sensitivity and specificity for PVR was 157 mm³ for AV and 0.6 mm³ for LVOT. In multivariate logistic regression analysis, the presence of AV calcium ≥157 mm³ (OR 3.83, 95%CI 1.81–8.10, P < 0.001) and ≥267 mm³ (OR 11.3, 95%CI 1.2–103.1, P = 0.03) were the only independent predictors of PVR and BPD, respectively.

Conclusions

AV calcium volume was an independent predictor of PVR and BPD in patients submitted to TAVI. Our results support a systematic assessment of AV calcium volume to identify patients at increased risk of post‐procedural PVR. (J Interven Cardiol 2016;29:117–123)

     

Early Outcomes With Direct Flow Medical Versus First‐Generation Transcatheter Aortic Valve Devices: A Single‐Center Propensity‐Matched Analysis

Objectives

To compare early outcomes between Direct Flow Medical (DFM) and 1^st‐generation transcatheter aortic valve replacement (TAVR) devices.

Background

The effectiveness of new‐generation TAVR devices compared with earlier generations is unclear.

Methods and Results

Overall, 496 patients treated between November 2007 and March 2014 were included: 44 (8.7%) treated with DFM, 179 (36.9%) with Medtronic CoreValve (MCV) and 273 (54.4%) with Edwards Sapien / Sapien XT (SXT) valve. Because of differences in baseline characteristics, propensity‐score matching among patients treated in the same time span (March 2012–March 2014) was performed. The primary objective was the VARC‐2 device success composite endpoint. Propensity‐score matching identified 41 patients in each group. A higher device success composite endpoint was observed in DFM (DFM 97.6% vs. MCV 65.9% vs. SXT 92.7%; P < 0.001). This was attributed to a significantly lower incidence of moderate‐to‐severe post‐procedural aortic regurgitation (AR; 2.4% vs. 22% vs. 7.3%; P < 0.001), lower rate of valve embolization (0% vs. 7.3% vs. 0%; 0.041) and need for a 2nd valve implantation (0% vs. 7.3% vs. 0%; P = 0.041).

Conclusions

DFM was associated with higher rates of device success and a lower incidence of post‐procedural AR. New generation devices appear to address several of the limitations of earlier generation devices. (J Interven Cardiol 2015;28:583–593)

     

Impact of right and left ventricular systolic dysfunction on perioperative outcome and long‐term survival after transcatheter aortic valve replacement

Background

Aim of the study was to determine the impact of right‐ and left‐ventricular systolic dysfunction on perioperative outcome and long‐term survival after TAVR.

Methods

Study population consisted of 702 TAVRs between 2009 and 2014, 345 by TF, 357 by TA route. RV and LV function were determined by TAPSE and LVEF measurement during baseline echocardiography. Patients were divided according to TAPSE (>18 mm/14‐18 mm/<14 mm) and LVEF (>50%/30‐50%/<30%) tertiles. Outcome at day‐30 and Kaplan‐Meier 4‐year survival were analyzed.

Results

Impaired RV and LV‐function did not adversely affect mortality, stroke, bleeding, and vascular‐complications at 30 days. Patients with TAPSE < 14 mm displayed elevated rate of renal failure requiring dialysis (11%; P < 0.01). Kaplan‐Meier survival was adversely affected by RV‐systolic dysfunction RVSD (P < 0.01). Multivariate analysis revealed that impaired RVSD but not LVSD was an independent determinant for late mortality (hazard ratio TAPSE 14‐18 mm: 1.53; P = 0.02; TAPSE <14 mm: 2.12; P < 0.01).

Conclusions

Peri‐operative mortality and risk of stroke after TAVR are not adversely affected by preexisting RV or LV dysfunction. Long‐term survival is impaired in patients with RVSD. RVSD but not LVSD is an independent risk factor for late mortality. TAVR should be the preferred therapy for patients with RVSD and LVSD, especially when patient is suitable for TF.

     

The impact of mitral stenosis on outcomes of aortic valve stenosis patient undergoing surgical aortic valve replacement or transcatheter aortic valve replacement

Background

The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR).

Method

Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in‐hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility.

Results

A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in‐hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392–0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group.

Conclusion

In patients with severe aortic stenosis and concomitant mitral stenosis, TAVR is a safe and attractive option for patients undergoing AVR with less complications compared with SAVR.

     

Balloon‐Expandable Transcatheter Aortic Valves Can Be Successfully and Safely Implanted Transfemorally Without Balloon Valvuloplasty

Objectives

To assess the necessity for balloon aortic valvuloplasty (BAV) during transfemoral transcatheter aortic valve implantation (TAVI) when using balloon‐expandable valves.

Background

BAV is a usual part of TAVI procedures, prior to valve implantation. However, the benefits and necessity of this are unknown and recent evidence in self‐expanding valves suggests it may not be necessary.

Methods

Retrospective single‐center study of 154 patients undergoing first‐time, transfemoral TAVI for native aortic valve stenosis, with (N = 76), and without (N = 78), BAV as part of the procedure. Data collected included demographic, procedural, and outcome data.

Results

BAV did not alter VARC‐2 defined procedural success or early safety compared to not performing a BAV, including mortality, degree of aortic regurgitation, or need for post‐TAVI balloon dilatation, although there was a strong trend to reduced stroke when not performing a BAV. There was a significantly reduced procedural time (P = 0.01) and fluoroscopic time (P < 0.001) without performing a BAV. There were no differences in cerebral embolization (solid, gaseous, or total emboli) noted between the 2 groups, as measured on transcranial doppler (TCD).

Conclusions

TAVI can be effectively and safely performed without a BAV and this results in reduced procedural and fluoroscopic times, although embolization to the brain is not reduced. There is a trend toward reduced stroke risk. (J Interven Cardiol 2016;29:319–324)

     

Valve‐in‐valve transcatheter aortic valve implantation with CoreValve/Evolut R© for degenerated small versus bigger bioprostheses

Objectives

We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow‐up in patients with degenerated bioprostheses.

Methods

From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow‐up were entered into a dedicated database.

Results

Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1‐year follow‐up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013.

Conclusion

ViV‐TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.

     

Long‐term clinical results of bioresorbable absorb scaffolds using the PSP‐technique in patients with and without diabetes

Objectives

We evaluated clinical results up to 36 months after implantation of Absorb BVS using PSP‐technique and compared the outcome of patients with and without diabetes mellitus.

Background

Absorb II demonstrated that interventional treatment of coronary artery disease with bioresorbable vascular scaffolds (BVS) without proper PSP‐technique (pre‐dilation, proper sizing, and post‐dilation) is associated with an increased thrombotic risk, even in simple lesions.

Methods

In this prospective study 319 patients with 420 lesions were enrolled and treated with the Absorb BVS. Pre‐dilation was mandatory and post‐dilation with a high‐pressure balloon was performed in patients with a scaffold length >12 mm. Patients were clinically followed up to 3 years. Primary outcome measure was the device‐oriented endpoint (DoCE) defined as cardiac death, myocardial infarction not clearly related to a non‐target vessel and target lesion revascularization.

Results

DoCE was 5.0%, 7.1%, and 10.0% after 12, 24, and 36 months for the total population. Rate of scaffold thrombosis was 0.5%, 0.8%, and 1.4% after 12, 24, and 36 months. Rate of DoCE was higher in the diabetic subgroup with 9.1%, 12.6%, and 12.9% after 12, 24, and 36 months compared with 4.0% (P = 0.13), 5.6% (P = 0.05), and 9.9% (P = 0.20) in patients without diabetes mellitus.

Conclusions

Patients treated with the Absorb BVS using the PSP‐technique show good results up to 3 years with a low rate of scaffold thrombosis. Patients suffering from diabetes mellitus have an increased rate of DoCE compared with non‐diabetic patients.

Clinical Trial Registration

clinicaltrials.gov_NCT02162056 .

     

Balloon Expandable Sheath for Transfemoral Aortic Valve Implantation: A Viable Option for Patients with Challenging Access

Background and Objectives

Transcatheter aortic valve replacement (TAVR) via femoral access is a new option for patients with severe aortic valve stenosis considered to be at high risk for conventional open‐heart surgery. This procedure requires peripheral arteries that are able to accommodate the large sheaths required for valve delivery. We present a series of patients with suboptimal vascular conditions, who received a self‐expandable vascular sheath.

Methods and Results

From January 2009 to September 2011, a total of 96 patients (43% male) were treated with the 18F Medtronic CoreValve (Medtronic, Minneapolis, MN, USA). The patients' average age was 82.5 ± 4.6 years, and the mean EuroSCORE was 29%. In eight cases, vascular conditions were inadequate either due to advanced atherosclerotic disease (n = 5, 62.5%), or an arterial diameter ≤7 mm (n = 3, 37.5%). Instead of the standard 18F sheath, a balloon‐expandable transfemoral introducer (SoloPath?‐Introducer, Onset Medical Corporation, Irvine, CA, USA) was delivered and removed without complications in all but one (87.5%) patient. In the last case, rupture of the right femoral artery occurred after removal of the sheath with the need of vascular surgery.

Conclusion

The SoloPath sheath is a feasible alternative to conventional sheaths for transfemoral TAVR patients with difficult femoral vascular access.

     

Effectiveness of the proximal optimization technique for longitudinal stent elongation caused by post‐balloon dilatation

Objectives

To evaluate the effectiveness of the proximal optimization technique (POT) to prevent longitudinal stent elongation.

Background

The mechanism of stent elongation, which occurs after post‐balloon dilation, is still unclear.

Methods

A total of 103 lesions treated with optical coherence tomography guided coronary intervention between May 2013 and November 2017 were retrospectively analyzed. Lesions were divided according to the circumferential degree of malapposition at the stent edge immediately after deployment into well‐apposed group (<180°) and malapposed group (≥180°). Post‐dilation was performed from distal to proximal within the stent until August 2016 (non‐POT cohort), and POT was applied thereafter (POT cohort). In the POT cohort, post‐dilation was done at the proximal portion of the stent with sufficiently large balloon to minimize malapposition followed by distal dilatations. Stent elongation length was defined as the change in stent length from stent deployment to after post‐dilatation.

Results

In the non‐POT cohort, 72 lesions, including 54 lesions in the well‐apposed group and 18 in the malapposed group were analyzed. Stent elongation length was significantly longer in the malapposed group than in the well‐apposed group (1.51 ± 1.34 mm vs 0.13 ± 0.84 mm, P < 0.01). In the POT cohort, 31 lesions including 21 in the well‐apposed group and 10 in the malapposed group were analyzed. Stent elongation length was not significantly different between the groups (?0.09 ± 0.91 mm vs 0.30 ± 0.99 mm, P = 0.29).

Conclusions

Malapposition of the stent edge is responsible for longitudinal stent elongation caused by post‐dilatation. POT appeared to effectively prevent longitudinal stent elongation.

     

Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Objectives

We aimed to test a novel stent‐less revascularization strategy using a combination of excimer laser coronary angioplasty (ELCA) and drug‐coated balloon (DCB) for patients with acute coronary syndrome (ACS).

Background

Percutaneous coronary intervention with drug eluting stents is a standard invasive treatment for ACS. Some unsolved issues however remain, such as stent thrombosis and bleeding risks associated with dual antiplatelet therapy.

Methods

Consecutive ACS patients were planned to receive either a DCB application following ELCA without a stent implantation or conventional revascularization with a coronary stent. The endpoints were (i) major cardiac adverse events (MACEs), defined as the composite of cardiac death, myocardial infarctions, and target lesion revascularization; (ii) target vessel revascularization (TVR); and (iii) angiographic outcome.

Results

Since a greater than expected number of patients allocated to the stent‐less treatment arm eventually received a bailout stenting, the following 3 as‐treated groups were compared; DCB with ELCA group (N = 60), Stent with ELCA group (N = 23), and Stent without ELCA group (N = 85). During a mean follow‐up period of 420 ± 137 days, and with angiographic 6‐ and 12‐month‐follow‐up rates of 96.7%, 87%, and 81.2%, and 50%, 65.2%, and 45.9%, respectively, the MACE rate did not differ across the groups (10%, 4.3%, and 3.5%; P = 0.22) while an incidence of TVR was more common (15%, 0, and 4.7%; P = 0.02) and the diameter stenosis at 6‐months of follow‐up was greater (25.7 ± 18.2, 14.9 ± 13.1 and 16.2 ± 15.4%; P = 0.002) in the DCB with ELCA group.

Conclusions

The stent‐less revascularization strategy with DCB and ELCA was associated with a higher occurrence of restenosis in ACS patients.

     

Prognostic impact of intensive statin therapy on N‐terminal pro‐BNP level in non‐ST‐segment elevation acute myocardial infarction patients

Objective

This study explored the impact of intensive daily dosing of atorvastatin on in‐hospital N‐terminal pro‐B‐type natriuretic peptide level, left ventricular systolic function and incidence of major adverse cardiac events in non‐ST‐segment elevation myocardial infarction patients.

Background

Several studies showed that early initiation of statin therapy in acute coronary syndrome patients has a favorable prognostic impact.

Methods

Hundred statin naive patients were prospectively enrolled. Once eligible, patients were randomly assigned to receive either a moderate daily dose that is, 20 mg (Group A) or an intensified daily dose that is, 80 mg (Group B) of atorvastatin, in addition to an equally divided loading dose given 24 and 12 h before coronary angiography (80 mg each). N‐terminal pro‐B‐type natriuretic peptide levels were recorded before and after coronary intervention. Collected data after 3 months included; N‐terminal pro‐B‐type natriuretic peptide levels, left ventricle systolic function and major adverse cardiac events.

Results

Mean age of the study cohort was 55 ± 10 years, 68% being males. There was no significant difference between both groups concerning procedural data. Group B patients showed a significantly lower N‐terminal pro‐B‐type natriuretic peptide levels at both sampling occasions, i.e., after coronary intervention and 3 months later (P < 0.001). After 3 months, the same group showed higher left ventricle ejection fraction (P < 0.05), with no significant difference between both groups regarding incidence of major adverse cardiac events.

Conclusion

Intensive atorvastatin therapy in non‐ST‐segment elevation myocardial infarction patients undergoing percutaneous coronary intervention is associated with; lower in‐hospital N‐terminal pro BNP level and higher LVEF after 3 months.

     

Bivalirudin versus heparin in patients undergoing percutaneous transcatheter aortic valve interventions: A systematic review and meta‐analysis

Background

Bivalirudin may be an effective anticoagulation alternative to heparin as anticoagulant agent in percutaneous transcatheter aortic valve interventions (PAVI). We aimed to compare safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing PAVI.

Methods

We conducted an electronic database search of all published data. The primary efficacy endpoints were all‐cause mortality, cardiovascular mortality, myocardial infarction, and stroke. Safety endpoints include major and life‐threatening bleed according to VARC and BARC bleeding, blood transfusion, vascular complications, and acute kidney injury. Odds ratios (OR) and 95% confidence intervals (CI) computed using the Mantel‐Haenszel method.

Results

Three studies (n = 1690 patients) were included, one randomized trial and two observational studies. There was a significant difference favoring bivalirudin over heparin for myocardial infarction (OR 0.41, 95%CI 0.20‐0.87). There was no significant difference in all‐cause mortality at 30 days (OR 0.97, 95%CI 0.62‐1.52), cardiovascular mortality (OR 1.03, 95%CI 0.52‐2.05), stroke (OR 1.23, 95%CI 0.62‐2.46), vascular complications (OR 0.96, 95%CI 0.70‐1.32), acute kidney injury (OR 1.03, 95%CI 0.53‐2.00), blood transfusion (OR 0.67, 95% CI 0.45‐1.01), major and life‐threatening bleed (OR 0.74, 95%CI 0.37‐1.49), and BARC bleeding (OR 0.52, 95%CI 0.23‐1.18).

Conclusions

In patient undergoing aortic valve interventions, no difference was seen between the use of bivalirudin and heparin as the procedural anticoagulant agent, except for a significant lower myocardial infarction events when bivalirudin was used. Further large randomized trials are needed to confirm current results.

     

Complications and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement With Edwards SAPIEN & SAPIEN XT Valves: A Meta‐Analysis of World‐Wide Studies and Registries Comparing the Transapical and Transfemoral Accesses

Introduction

Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta‐analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions.

Methods

We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1‐year mortality, 30‐day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury.

Results

Seventeen studies were included in the meta‐analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P < 0.001). The cumulative risks for 30‐day mortality (RR 0.61; 95%CI 0.46–0.81; P = 0.001), 1‐year mortality (RR 0.68; 95%CI 0.55–0.84; P < 0.001), and acute kidney injury (RR 0.53; 95%CI 0.38–0.73; P < 0.001) were significantly lower for patients undergoing TF as compared to TA approach. Both approaches had a similar incidence of 30‐day stroke, pacemaker implantation, and major or life‐threatening bleeding. Studies utilizing the VARC definitions and those pre‐dating VARC yielded similar results.

Conclusion

This meta‐analysis demonstrates a decreased 30‐day and 1‐year mortality in TF TAVR as compared to TA TAVR. Post‐procedure acute kidney injury and the need for renal replacement therapy are also significantly lower in the TF group. These differences hold true even after utilizing the standardized Valve Academic Research Consortium criteria. (J Interven Cardiol 2015;28:266–278)