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.

     

Do Outcomes from Transcatheter Aortic Valve Implantation Vary According to Access Route and Valve Type? The UK TAVI Registry

Objectives

To determine whether outcomes from transcatheter aortic valve implantation (TAVI) vary according to access route and valve type in a real‐world population.

Background

Registry and uncontrolled trial data have found that patients undergoing nonfemoral TAVI have higher early and late mortality. It is not clear whether worse outcomes relate directly to access route. There have been no direct comparisons of outcomes according to valve type.

Methods

Data were collected prospectively on 1,620 patients undergoing TAVI in the UK and compared in 4 groups: SAPIEN transfemoral (TF); SAPIEN transapical (TA); CoreValve TF, CoreValve subclavian. Univariable and multivariable regression analysis was performed to identify independent predictors of mortality.

Results

Mortality in patients undergoing SAPIEN TAVI via a TA approach was higher than with TF at 30 days (11.2% vs. 4.4%, P < 0.01), 1 year (28.7% vs. 18.1%, P = 0.01), and 2 years (56.0% vs. 43.5%, P = 0.01). Logistic EuroSCORE was higher in TA patients (22.5 ± 12.9% vs. 17.7 ± 11.1%, P < 0.0001). After multivariable analysis TA access was associated with increased mortality at 30 days (OR 2.56, 95% CI 1.46–4.48, P < 0.01) and 2 years (OR 1.75, 1.08–2.74, P = 0.02). There was no significant difference in mortality at any time‐point between patients treated with SAPIEN (n = 812) and CoreValve (n = 808) prostheses. CoreValve‐treated patients had a higher rate of permanent pacemaker implantation (23.1% vs. 7.2%, P < 0.0001), and grade ≥2 aortic regurgitation on postprocedure echocardiography (13.0% vs. 7.3%, P < 0.01).

Conclusions

Patients undergoing TA TAVI experienced increased early and late mortality compared to a TF approach. Survival was not influenced by valve type. (J Interven Cardiol 2014;27:86–95)

     

Use of the RenalGuard system to prevent contrast‐induced AKI: A meta‐analysis

Background

Contrast‐induced kidney injury (CI‐AKI) following cardiovascular interventions results in increased morbidity and mortality. RenalGuard (RG) is a novel, closed loop system which balances volume administration with forced diuresis to maintain a high urine output. We performed a meta‐analysis of the existing data comparing use of RG to conventional volume expansion.

Methods

Ten studies were found eligible, of which four were randomized controlled trials. Of an aggregate sample size (N) of 1585 patients, 698 were enrolled in the four RCTs and 887 belonged to the remaining registries included in this meta‐analysis. Primary outcomes included CI‐AKI incidence and relative risk. Mortality, dialysis, and major adverse cardiovascular events (MACCE) were secondary outcomes. A random effects model was used and data were evaluated for publication bias.

Results

RG was associated with significant risk reduction in CI‐AKI compared to control (RR: 0.30, 95%CI: 0.18‐0.50, P < 0.01). CI‐AKI in RG was found to be 7.7% versus 23.6% in the control group (P < 0.01). Use of RG was associated with decreased mortality (RR: 0.43, 95%CI: 0.18‐0.99, P = 0.05), dialysis (RR: 0.20, 95%CI: 0.06‐0.61, P = 0.01), and MACCE (RR: 0.42, 95%CI: 0.27‐0.65, P < 0.01) compared to control.

Conclusions

RG significantly reduces rates of CI‐AKI compared to standard volume expansion and is also associated with decreased rates of death, dialysis, and MACCE.

     

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.

     

Staged versus index procedure complete revascularization in ST‐elevation myocardial infarction: A meta‐analysis

Background

Complete revascularization of patients with ST‐elevation myocardial infarction and multivessel coronary artery disease reduces adverse events compared to infarct‐related artery only revascularization. Whether complete revascularization should be done as multivessel intervention during index procedure or as a staged procedure remains controversial.

Method

We performed a meta‐analysis of randomized controlled trials comparing outcomes of multivessel intervention in patients with ST‐elevation myocardial infarction and multivessel coronary artery disease as staged procedure versus at the time of index procedure. Composite of death or myocardial infarction was the primary outcome. Mantel‐Haenszel risk ratios were calculated using random effect model.

Results

Six randomized studies with a total of 1126 patients met our selection criteria. At a mean follow‐up of 13 months, composite of myocardial infarction or death (7.2% vs 11.7%, RR: 1.66, 95%CI: 1.09‐2.52, P = 0.02), all cause mortality (RR: 2.55, 95%CI: 1.42‐4.58, P < 0.01), cardiovascular mortality (RR: 2.8, 95%CI: 1.33‐5.86, P = 0.01), and short‐term (<30 days) mortality (RR: 3.54, 95%CI: 1.51‐8.29, P < 0.01) occurred less often in staged versus index procedure multivessel revascularization. There was no difference in major adverse cardiac events (RR: 1.14, 95%CI: 0.88‐1.49, P = 0.33), repeat myocardial infarction (RR: 1.14, 95%CI: 0.68‐1.92, P = 0.61), and repeat revascularization (RR: 0.92, 95%CI: 0.66‐1.28, P = 0.62).

Conclusion

In patients with ST‐elevation myocardial infarction and multivessel coronary artery disease, a strategy of complete revascularization as a staged procedure compared to index procedure revascularization results in reduced mortality without an increase in repeat myocardial infarction or need for repeat revascularization.

     

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.

     

Direct Stenting Versus Pre‐Dilation in ST‐Elevation Myocardial Infarction: A Systematic Review and Meta‐Analysis

Objectives

This study aimed at comparing direct stenting (DS) versus stenting with pre‐dilation (SP) in patients with ST‐elevation myocardial infarction (STEMI), using a systematic review and meta‐analysis of published evidence.

Background

There is conflicting evidence whether stenting strategy impacts clinical outcomes in patients with STEMI.

Methods

We searched EMBASE, MEDLINE, and CENTRAL, from inception to December 2014. The primary endpoint was mortality. Secondary endpoints included major adverse cardiac events (MACEs), ST‐segment resolution, and angiographic outcomes.

Results

A total of 9,331 patients enrolled in 12 studies (3 randomized controlled trials, RCTs; 9 non‐randomized studies, NRSs) were included. DS was associated with lower mortality (OR 0.55; 95%CI: 0.33–0.94; P = 0.03) in NRSs, and overall (OR 0.56; 95%CI: 0.37–0.86; P = 0.008). Mortality was non‐significantly reduced in RCTs (OR 0.56; 95%CI: 0.26–1.23; P = 0.15). DS was also associated with lower MACE rate (OR 0.71; 95%CI 0.60–0.84; P < 0.0001) in NRSs, but not in RCTs (OR 0.99; 95%CI: 0.61–1.60; P = 0.96). ST‐segment resolution, no reflow, final thrombolysis in myocardial infarction (TIMI) flow and final TIMI myocardial perfusion or blush grade were significantly better with DS in NRSs, and non‐significantly better in RCTs.

Conclusions

The available evidence suggests that DS in STEMI might be associated with better clinical and procedural outcomes, as compared with SP. However, the fact that RCTs account for the minority of available data and that most of the available studies poorly reflect current clinical practice, as well as the existence of publication bias, preclude drawing definitive conclusions.

     

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.

     

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)

     

Contemporary transcatheter aortic valve replacement with third‐generation balloon‐expandable versus self‐expanding devices

Objectives

To evaluate balloon‐expandable and self‐expanding third‐generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.

Background

Two competing third‐generation TAVR technologies are currently commercially available in the US. There are no published head‐to‐head comparisons of the relative performance of these two devices.

Methods

257 consecutive patients undergoing TAVR with a third‐generation balloon‐expandable (Edwards Sapien 3) or self‐expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30‐day outcomes were prospectively collected.

Results

74 patients received a self‐expanding valve (SEV) and 183 received a balloon‐expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30‐day mortality was comparable (1.4% vs 1.6%, P = 1.00).

Conclusions

Short‐term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.

     

Aspiration Thrombectomy in Patients Undergoing Primary Angioplasty for ST Elevation Myocardial Infarction: An Updated Meta‐Analysis

Background

The Trial of Routine Aspiration Thrombectomy with PCI versus PCI alone in patients with STEMI (TOTAL trial) refuted the salutary effect of routine aspiration thrombectomy (AT) in PPCI for patients with ST‐elevation myocardial infarction (STEMI).

Objectives

We performed an updated meta‐analysis to assess clinical outcomes with AT prior to PPCI compared with conventional PPCI alone including the additional trial data.

Methods and Results

Clinical trials (n = 20) that randomized patients (n = 21,281) with STEMI between Routine AT (n = 10,619) and PPCI (n = 10,662) were pooled. There was no difference in all‐cause mortality between the 2 groups (RR: 0.89, 95%CI: 0.78–1.01, P = 0.08). Stratifying by follow up at 1‐month (RR: 0.87, 95%CI: 0.69–1.10, P = 0.25), up to 6 months (RR: 0.91, 95%CI: 0.74–1.13, P = 0.39 and beyond 6 months (RR: 0.88, 95%CI: 0.74–1.05, P = 0.16) yielded similar results. There was a statistically significant increase risk of stoke rate in the AT arm (RR: 1.51, 95%CI: 1.01–2.25, P = 0.04). The 2 groups were similar with regards to target vessel revascularization (0.94, 95%CI: 0.83–1.06, P = 0.28) recurrent MI (RR: 0.96, 95%CI: 0.80–1.16, P = 0.68, MACE events (RR: 0.91 95%CI: 0.81–1.02, P = 0.11), early (0.59, 95%CI: 0.23–1.50, P = 0.27) and late (RR: 0.91, 95%CI: 0.69–1.18, P = 0.47) stent thrombosis and net clinical benefit (RR 0.99, 95%CI: 0.91–1.07, P = 0.76).

Conclusion

Routine AT prior to PPCI in STEMI is associated with higher risk of stroke. There is no statistical difference in clinical outcome parameters of mortality, major adverse cardiac events, target vessel revascularization, stent thrombosis, and net clinical benefit between AT and PCI alone. (J Interven Cardiol 2015;28:503–513)

     

A Meta‐Analysis of Sex‐Related Differences in Outcomes After Primary Percutaneous Intervention for ST‐Segment Elevation Myocardial Infarction

Introduction

The increasing use of primary percutaneous coronary intervention (pPCI) has improved clinical outcome in ST‐segment elevation myocardial infarction (STEMI) patients, but the impact of sex on early and mid‐term outcomes remains to be defined.

Methods

Medline, Cochrane Library, Biomed Central, and Google Scholar were searched for articles describing differences in baseline, periprocedural, and midterm outcomes after pPCI, by sex. The primary end point was all‐cause mortality at early and mid‐term follow‐up. Secondary endpoints included in‐hospital bleeding and stroke.

Results

Sixteen studies were included. Women were older, had more frequent hypertension, diabetes mellitus, and hypercholesterolemia, as well as longer ischemia time and more shock at presentation. Men were more likely to have had a previous myocardial infarction. Female sex emerged as independently associated to early mortality (OR 1.1; 95%CI, 1.02–1.18) but not to mid‐term mortality (OR, 1.01; 95%CI, 0.99–1.03). The pooled analysis showed a significantly higher risk of in hospital stroke (OR, 1.69; 95%CI, 1.11–2.56) and major bleeding (OR, 2.04; 95%CI, 1.51–2.77) in women.

Conclusions

As compared to men, women undergoing pPCI have more bleedings and strokes, and a worse early, but not mid‐term mortality. These findings may allow a better risk stratification of pPCI patients.

     

Complete versus incomplete revascularization with drug‐eluting stents for multi‐vessel disease in stable,unstable angina or non‐ST‐segment elevation myocardial infarction: A meta‐analysis

Objectives

To determine whether drug‐eluting stent (DES) coronary complete revascularization (CR) confers clinical benefit over incomplete revascularization (IR) in patients with multivessel coronary artery disease (MVD).

Background

Clinical benefit of CR over IR in patients with MVD with angina (both stable and unstable) and non‐ST‐segment elevation myocardial infarction (NSTEMI) in DES has not been well studied.

Methods

We conducted a systematic online literature search of PUBMED and EMBASE. Literatures that compared the clinical outcomes between CR and IR with exclusively or majority (>80%) using DES in patients without or included only small portion (<20%) of ST‐segment elevation myocardial infarction or single‐vessel coronary artery disease were included. Hazards ratio (HR) with 95% confidence interval (CI) was calculated with random‐effects model.

Results

No randomized clinical trials were identified. A total of 14 observational studies with total of 41 687 patients (CR 39.6% and IR 60.4%) were included in this meta‐analysis. CR was associated with lower incident of all‐cause mortality (HR 0.71, P = 0.001), major adverse events (HR 0.75, P < 0.001), cardiovascular mortality (HR 0.39, P < 0.001). Meta‐regression analysis showed that CR significantly reduced the risk of all‐cause mortality in advanced age, triple vessel disease and male sub‐groups.

Conclusions

CR with DES conferred favorable outcomes compared to IR in MVD patients with stable, unstable angina or NTEMI. Further research to achieve higher CR in MVD patients may lead to improvement in prognosis in these cohorts.

     

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 (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.

     

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.

     

Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI

Aim

The transcatheter aortic valve SAPIEN 3 aims at reducing paravalvular leakage (PVL). The new design with outer sealing cuff may increase the risk of permanent pacemaker implantation (PPM). The aim of our study was to evaluate the optimal implantation height of the SAPIEN 3.

Methods and Results

We analysed the correlation between the implantation height of the valve and the need for PPM in 131 patients. The PPM rate for the entire group after TAVI was 18% (n = 24). In patients with a marker distance <2 mm (“low implantation”), the PPM rate was 32%, whereas in patients with a distance ≥2 mm (“high implantation”), the rate was only 4.7% (OR of 0.1 (0.03–0.37, P < 0.001)).

Conclusion

The risk of periprocedural PPM with the Edwards SAPIEN 3 depends on implantation height; it is increased when using conventional implantation techniques. This risk can be minimized below 5% PPM by choosing a higher implantation technique with the central marker 2 mm or more over the annulus plane.

     

Drug eluting stents are superior to bare metal stents to reduce clinical outcome and stent‐related complications in CKD patients,a systematic review,meta‐analysis and network meta‐analysis

Aims

To compare clinical outcome in Chronic kidney disease (CKD) patients receiving coronary stents according to stent type BMS versus DES and 1st generation versus 2nd generation DES.

Methods and Results

PubMed, Cinhal, Cochrane, Embase, and Web of Science were searched for studies including CKD patients. CKD was defined as eGFR < 60 mL/min. We selected n = 35 articles leading to 376 169 patients, of which 76 557 CKD patients receiving BMS n = 35,807, 1st generation DES n = 37,650, or 2nd generation DES n = 3100. Patient receiving DES, compared to BMS, had a 18% lower all‐cause mortality (RR 0.82, 95%CI 0.71‐0.94). The composite of death or myocardial infarction (MI) was lower in DES patients (RR 0.78, 95%CI 0.67‐0.91), as was stent thrombosis (ST) (RR 0.57, 95%CI 0.34‐0.95), target vessel/lesion revascularization (TVR/TLR) (RR 0.69, 95%CI 0.57‐0.84) and death for cardiovascular cause (RR 0.43, 95%CI 0.25‐0.74). We also found a gradient between 1st and 2nd generation DES, through BMS. Second, compared to 1st generation DES, were associated with further relative risk (RR) reduction of ?18% in of all‐cause death, and lower incidence of stent‐related clinical events: ?39% RR of ST risk; ?27 RR of TVR/TLR risk.

Conclusions

DES in CKD patients undergoing PCI were superior to BMS in reducing major adverse clinical events. This was possibly explained, by a lower risk of stent‐related events as ST and TVR or TLR. Second, compared to 1st generation DES may furtherly reduce clinical events.

     

Ultrasound guidance versus anatomical landmark approach for femoral artery access in coronary angiography: A randomized controlled trial and a meta‐analysis

Objectives

The objective was to assess the effect of ultrasound (US)‐guidance compared to the anatomical landmark (AL) approach in patients requiring femoral artery (FA) access for coronary angiography/percutaneous coronary interventions (PCI).

Background

US‐guidance has been proposed as a strategy to optimize FA access, potentially leading to decreased vascular complications.

Methods

Patients requiring FA access for coronary angiography/PCI were randomized to the US‐guided or AL approaches. The primary endpoint was a composite of immediate procedural vascular outcomes, and access‐site outcomes at day one. Results were subsequently pooled in a study‐level meta‐analysis of randomized trials comparing US‐guided FA access to another strategy.

Results

A total of 129 patients were randomized (64 US‐guided group; 65 AL group). The primary endpoint occurred in 30 patients (47%) with US, and in 39 patients (62%) with AL (P = 0.09). Four additional studies met the inclusion criteria and were included in the meta‐analysis (1553 patients). Following data pooling, bleeding events (OR = 0.41; 95%CI 0.20‐0.83; P = 0.01), venipunctures (OR = 0.18; 95%CI: 0.11‐0.29; P < 0.0001), and multiple puncture attempts (OR = 0.24; 95%CI: 0.19‐0.31; P < 0.0001) were significantly improved with US‐guidance, but not successful common FA cannulation (OR = 0.84; 95%CI: 0.60‐1.17; P = 0.29).

Conclusion

Our study did not show significant benefits for the use of US to guide arterial femoral access compared to the anatomical landmark approach, but pooled analysis of five randomized trials showed decreased rates of bleeding events and venipunctures, and improved first‐pass success. The clinical impact of these findings is uncertain, and do not warrant a systematic use of US‐guidance in this clinical setting.

     

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)