Transcatheter Aortic Valve Implantation Devices Research Articles

A Novel Personalized Pre-operational Transcatheter Aortic Valve Implantation (TAVI) Supporting Tool

Objective: Cardiac implants may have a strong influence on the hemodynamics of the circulatory system. In this study, we present a novel personalized pre-operational transcatheter aortic valve implantation support tool. The main objective is to investigate the impact of TAVI devices on blood flow patterns that develop in the patient-specific model of ascending aorta under physiological flow conditions in vitro. Methods: The presented preoperational TAVI support tool is based on additive manufacturing, optical imaging and fluid dynamics. Optical measurements are performed in an anatomically accurate silicone aortic model. Two different cases were investigated, namely pre-operational stenotic blood flow and post-operational blood flow conditions. A ventricular assist device is used to mimic the function of the heart. It is driven by a pneumatical pump. We aimed to quantify the amount of backflow, shear stresses and kinetic energy in proximity of the valves. Results: We investigate the blood flow characteristics for both pre- and post-operational cases. It is found that the spatially averaged peak mean kinetic energy (MKE) of the pre-operational case is around seven times higher compared to the post-operational case (358J/m3 vs 49J/m3). In the diastolic phase, even for the lower velocity magnitudes, MKE is higher for the pre-operational case. Analysing the turbulent kinetic energies (TKE) shows that TKE of the pathological case is about one order of magnitude higher than the post-operational case during the peak systole (178 J/m3 vs 20 J/m3). Conclusions: We conclude that the pathological case introduces more disorganized flow features as a result of high shear stress. Furthermore the regions in the vicinity of the stenosed valve are found more risky for the destruction of the red blood cells and platelet deformation. It is presented that the developed novel personalized TAVI support tool is beneficial for pre-operational planning. Potential blood flow complications can be estimated using the support tool. KEYWORD: e-P-28 The authors do not declare any conflict of interest.

Long-Term Follow-Up of Transcatheter Aortic Valve Implantation With Portico Versus Evolut Devices

New-generation devices such as Evolut and Portico have provided favorable results in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, but their comparative effectiveness remains debated, despite its relevance when envisioning TAVI in low-risk patients. We evaluated the safety and efficacy of 2 leading TAVI devices (Evolut and Portico) used by the same team of experienced TAVI operators, focusing on long-term outcomes, including major adverse events (i.e., the composite of death, stroke, myocardial infarction, major vascular complication, or major bleeding). Unadjusted and propensity score-adjusted analyses were carried out. A total of 233 patients were included, 119 (51.1%) receiving Evolut and 114 (49%) Portico. Baseline and procedural data showed significant between-device differences, including functional class, surgical risk, chronic obstructive pulmonary disease, renal function, transesophageal guidance, device size, postdilation, and procedural time (all p <0.05). Yet, acute and in-hospital outcomes were not significantly different (all p >0.05). Follow-up status was ascertained in 228 (98%) patients after 15.0 ± 7.6 months. Unadjusted analysis showed similar rates of major adverse events, as well as the individual risk of death, stroke, myocardial infarction, major vascular complication, major bleeding, and pacemaker implantation (all p >0.05). Even at propensity score-adjusted analysis outcomes were not significantly different with Evolut and Portico (all p >0.05). In conclusion, Evolut and Portico devices yield similarly favorable results at long-term follow-up when used by experienced TAVI operators.

Coronary Artery Disease Assessed by Computed Tomography-Based Leaman Score in Patients With Low-Risk Transcatheter Aortic Valve Implantation

We aimed to evaluate the burden of coronary artery disease (CAD) using the computed tomography (CT) Leaman score in low-risk transcatheter aortic valve implantation (TAVI) patients. The extent of CAD in low-risk patients with aortic stenosis who are candidates for TAVI has not been accurately quantified. The CT Leaman score was developed to quantify coronary CT angiography (CCTA) atherosclerotic burden and has been validated to evaluate the extent of CAD. CT Leaman score >5 has been associated with an increase in major adverse cardiac events over long-term follow-up. The study population included patients enrolled in the Low Risk TAVI trial who underwent CCTA before the procedure. For the CT Leaman score, we used 3 sets of weighting factors: (1) location of coronary plaques, (2) type of plaque, and (3) degree of stenosis. A total of 200 patients were enrolled in the Low Risk TAVI trial. Excluded were 31 patients who had no analyzable CCTA imaging. For the remaining 169 patients, the mean CT Leaman score was 6.27 ± 0.27, of whom 102 (60.4%) had CT Leaman score >5. Nearly all analyzed patients (97%) had coronary plaques. Furthermore, 33 patients (19.5%) had potentially obstructive coronary plaques (>50% stenosis by CCTA) in proximal segments. Most low-risk TAVI patients have significant CAD burden by CCTA. It should be a priority for future TAVI devices to guarantee unimpeded access to the coronary arteries for selective angiography and interventions.

852 Long Term Follow-Up and Durability of Transcatheter Aortic Valve Implantation Devices

852 Long Term Follow-Up and Durability of Transcatheter Aortic Valve Implantation Devices

Hemodynamic performances and clinical outcomes in patients undergoing valve-in-valve versus native transcatheter aortic-valve Implantation

Valve-in-valve (ViV) transcatheter aortic-valve implantation (TAVI) emerged has a less invasive treatment than repeated surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV vs. native valve TAVI. We aimed to compare hemodynamic performances and 1-year outcomes between patients undergoing ViV procedure and patients undergoing non-ViV TAVI. This bicentric study included all patients undergoing aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients undergoing TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (± 5 years), sex and STS score. Primary endpoint was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2 ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mmHg vs. 11.4 ± 5.4 mmHg; P < 0.0001) and 17 (38.6%) patients had a mean aortic gradient > 20 mmHg vs. 6 (7.8%) in the non-ViV group ( P = 0.0001). Aortic regurgitations > grade 2 were similar in both groups ( P = 0.71). In the ViV group new pacemaker implantation were less frequent ( P = 0.01) and coronary occlusions occurred only in ViV group ( n = 2 (4.1%)) ( Fig. 1 ). ViV is a promising alternative to repeated cardiac surgery in patients with failed bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management.

Enabling Automated Device Size Selection for Transcatheter Aortic Valve Implantation.

The number of transcatheter aortic valve implantation (TAVI) procedures is expected to increase significantly in the coming years. Improving efficiency will become essential for experienced operators performing large TAVI volumes, while new operators will require training and may benefit from accurate support. In this work, we present a fast deep learning method that can predict aortic annulus perimeter and area automatically from aortic annular plane images. We propose a method combining two deep convolutional neural networks followed by a postprocessing step. The models were trained with 355 patients using modern deep learning techniques, and the method was evaluated on another 118 patients. The method was validated against an interoperator variability study of the same 118 patients. The differences between the manually obtained aortic annulus measurements and the automatic predictions were similar to the differences between two independent observers (paired diff. of 3.3 ± 16.8 mm2 vs. 1.3 ± 21.1 mm2 for the area and a paired diff. of 0.6 ± 1.7 mm vs. 0.2 ± 2.5 mm for the perimeter). The area and perimeter were used to retrieve the suggested prosthesis sizes for the Edwards Sapien 3 and the Medtronic Evolut device retrospectively. The automatically obtained device size selections accorded well with the device sizes selected by operator 1. The total analysis time from aortic annular plane to prosthesis size was below one second. This study showed that automated TAVI device size selection using the proposed method is fast, accurate, and reproducible. Comparison with the interobserver variability has shown the reliability of the strategy, and embedding this tool based on deep learning in the preoperative planning routine has the potential to increase the efficiency while ensuring accuracy.

Numerical models of valve-in-valve implantation: effect of intentional leaflet laceration on the anchorage.

Transcatheter aortic valve implantation (TAVI) is currently recommended in practice guidelines for patients who are at intermediate to high surgical risk for surgical aortic valve replacement. Coronary artery obstruction is a fatal complication of TAVI that occurs in up to 3.5% of the implantations inside a failed surgical bioprosthetic valve (valve-in-valve, ViV). A new technique to address this problem is intentional laceration of the bioprosthetic leaflets, known as BASILICA. In this technique, the leaflets are lacerated to prevent coronary obstruction and may also help in preventing leaflet thrombosis. Our hypothesis is that this technique may harm the circumferential stress in the surgical valve and weaken the anchorage of the TAVI device. This study aims to compare the anchorage post-ViV implantations, with and without lacerations, using numerical modelling. Deployments of TAVI stents (Medtronic Evolut PRO; Edwards SAPIEN 3) inside an externally mounted surgical bioprosthetic valve (Sorin Mitroflow) were modelled by finite element analysis. The results show that each laceration reduces the contact area of the TAVI stent with its landing zone and that the anchorage contact force weakens. The BASILICA technique has lesser effect on the anchorage contact area and forces in the SAPIEN than in the Evolut cases, because the balloon inflation is less sensitive to the deployment region. TAVI stent migration was not found in any of the models. These results can help expanding the use of leaflet laceration by choosing a better matched TAVI devices for the BASILICA technique.

Transcatheter Self-expandable Aortic Valve (Portico) Implantation in a Patient with Previous Mitral Valve Replacement: A Case Report

Transcatheter aortic valve implantation (TAVI) has shown favorable outcomes in patients with severe symptomatic aortic valve stenosis who are at high surgical risk or who are unsuitable candidates for open-heart surgery. However, concerns exist over treating patients who have undergone previous mitral valve surgery due to the potential interference between the mitral prosthetic valve or ring and the TAVI device. In this case report, we present a case in which a patient with symptomatic severe aortic stenosis and previous mechanical mitral valve replacement was successfully treated with TAVI using a Portico valve, which is under-researched.

Performance analysis of the transcatheter aortic valve implantation on blood flow hemodynamics: An optical imaging-based in vitro study.

Cardiac implants may have a strong influence on the hemodynamics of the circulatory system. In this study, we aimed at investigating the impact of transcatheter aortic valve implantation (TAVI) devices on blood flow patterns that develop in the ascending aorta under physiological flow conditions in vitro. For this purpose, a noninvasive optical measurement tool, three-dimensional particle tracking velocimetry (3D-PTV), was used in a realistic compliant silicone aortic model. The performance and the influence of two TAVIs and one surgical valve on the aortic flow were investigated. Our results showed that valve design and materials may have a distinct influence on relevant hemodynamic properties, namely kinetic energy, production of turbulence, and shear stresses in the ascending aorta. All properties varied considerably between the different valve models. We found that the total aortic regurgitation composed of the closing volume, transvalvular and paravalvular leakages varied for the three valves investigated. Furthermore, peak mean kinetic energy (MKE) ranged from 61 to 116 J/m3 , whereas peak turbulent kinetic energy (TKE) ranged from 23 to 36 J/m3 . The analysis of shear showed that all the three studied devices had minimal overall risk for thrombus formation. We conclude that the characteristics and material designs of TAVI devices have strong influences on the hemodynamics in the ascending aorta.

Hemodynamic Performances and Clinical Outcomes in Patients Undergoing Valve-in-Valve Versus Native Transcatheter Aortic Valve Implantation

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) emerged has a less invasive treatment than surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV versus TAVI in native aortic valve. We aimed to compare hemodynamic performances and 1-year outcomes between patients who underwent ViV procedure and patients who underwent non-ViV TAVI. This bicentric study included all patients who underwent aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients who underwent TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (±5 years), sex, and STS score. Primary end point was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2% ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mm Hg vs 11.4 ± 5.4 mm Hg; p < 0.0001) and 17 (38.6%) patients had a mean aortic gradient ≥20 mm Hg vs 6 (7.8%) in the non-ViV group (p = 0.0001). Aortic regurgitation > grade 2 were similar in both groups (p = 0.71). In the ViV group, new pacemaker implantation was less frequent (p = 0.01) and coronary occlusions occurred only in ViV group (n = 2 [4.1%]). At 1-year follow-up, 3 patients (2.3%) died from cardiac cause, 1 (2.1%) in the ViV group vs 2 (2.4%) in the non-ViV group (p = 0.9). There was no stroke. In conclusion, compared with TAVI in native aortic stenosis, ViV appears as a safe and feasible strategy in patients with impaired bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.

CONTEMPORARY RADIATION DOSES IN INTERVENTIONAL CARDIOLOGY: A NATIONWIDE STUDY OF PATIENT DOSES IN FINLAND.

The amount of interventional procedures such as percutaneous coronary intervention (PCI), transcatheter aortic valve implantation (TAVI), pacemaker implantation (PI) and ablations has increased within the previous decade. Simultaneously, novel fluoroscopy mainframes enable lower radiation doses for patients and operators. Therefore, there is a need to update the existing diagnostic reference levels (DRLs) and propose new ones for common or recently introduced procedures. We sought to assess patient radiation doses in interventional cardiology in a large sample from seven hospitals across Finland between 2014 and 2016. Data were used to set updated national DRLs for coronary angiographies (kerma-air product (KAP) 30 Gycm2) and PCIs (KAP 75 cm2), and novel levels for PIs (KAP 3.5 Gycm2), atrial fibrillation ablation procedures (KAP 25 Gycm2) and TAVI (KAP 90 Gycm2). Tentative KAP values were set for implantations of cardiac resynchronization therapy devices (CRT, KAP 22 Gycm2), electrophysiological treatment of atrioventricular nodal re-entry tachycardia (6 Gycm2) and atrial flutter procedures (KAP 16 Gycm2). The values for TAVI and CRT device implantation are published for the first time on national level. Dose from image acquisition (cine) constitutes the major part of the total dose in coronary and atrial fibrillation ablation procedures. For TAVI, patient weight is a good predictor of patient dose.

The evolution of device technology in transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has rapidly evolved and changed the landscape of structural interventional cardiology. Advances in transcatheter heart valve (THV) prostheses and TAVI-enabling devices have simplified the procedure, reduced the risk of complications, improved short- and long-term outcomes and broadened the applications of TAVI, not only in challenging patients and complex anatomies but also in intermediate-risk or even in low-risk patients, where surgical valve replacement constitutes an effective and well-established therapy. In this review article, we provide an overview of the developments in TAVI devices which have played a vital role in TAVI evolution: we describe the prostheses that failed to reach clinical practice, we present the characteristics of the first valves that were tested in the clinical arena, we summarise the evidence from the first studies that highlighted the potential but also the limitations of TAVI, and we present the advanced next-generation THV prostheses that have an improved performance and safety profile.

An alternative solution for patient with high risk of coronary obstruction underwent TAVI procedure using a novel second-generation device \u2013 a case series

BackgroundObstruction of the left or right coronary artery is a rare but lethal complication during transcatheter aortic valve implantation (TAVI). The new J-Valve™ prosthesis is a new second generation TAVI device which has several features to avoid the coronary obstruction such as low profile design and clip fixation of the native leaflets. The aim of this study is to report our initial experience of using this valve in treating patient with high risk factors for coronary obstruction during TAVI procedure.Case presentationThree high surgical risk patients (All females with 77, 76, and 75 years old) with symptomatic aortic stenosis were enrolled. All patients have the common feature of low coronary ostium height (< 10 mm) with narrowed aortic sinus (< 30 mm) on CT angiogram and marked leaflet calcification. Three 25 mm J-Valve prostheses were successfully implanted through trans-apical approach. No coronary obstruction was noted for these patients. Effective aortic open area was significantly increased after valve implantation (Preoperative 0.7, 0.7 and 0.65 cm2 – Postoperative 1.8, 1.9 and 2.0 cm2). Only one patient was noted to have trivial degree paravalvular leakage.ConclusionThe new J-Valve prosthesis is a new second generation TAVI device. This system may provide another safety treatment option for patient with high risk factor for coronary obstruction underwent TAVI procedure.

600.25 A Novel 3-Dimensional Imaging Platform for Device Sizing in Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of patients with symptomatic severe aortic stenosis considered to have prohibitive surgical risk. However, there is significant variability in methods used to size the aortic valve annulus for TAVI device selection.

Influence of permanent pacemaker implantation after transcatheter aortic valve implantation with new-generation devices.

ObjectivePermanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) is the most common complication after the procedure. PPMI rates remain high with the new-generation TAVI devices despite improved outcomes concerning paravalvular aortic regurgitation and vascular access complications. However, the impact of PPMI on mortality and clinical outcome is still a matter of debate, and data with new-generation devices on this matter are scarce. Therefore, we sought to analyse the influence of PPMI in patients treated with the new-generation devices on one-year outcome.MethodsWe enrolled 612 consecutive patients without prior pacemaker undergoing transfemoral TAVI with the new-generation devices. Patients with or without PPMI were compared with respect to clinical outcome within one year.ResultsPPMI was performed in 168 patients (24.4% of the overall study population). There was no significant difference in one-year outcome concerning all-cause mortality (PPMI vs. no-PPMI: 12.2% vs. 12.5%, p = 0.94), rate of major adverse events including cardiac, cerebral or valve-related events and bleeding complications (22.1% vs. 24.5%, p = 0.55) or need for rehospitalisation due to cardiac symptoms (16.1% vs. 18.1%, p = 0.63). In patients with reduced ejection fraction (<45%) there was also no impact of PPMI on one-year mortality (14.3% vs. 15.7%, p = 0.86). Furthermore, multivariate analysis did not reveal PPMI to be independently associated with one-year mortality (odds ratio 0.94, 95% confidence interval 0.50–1.74, p = 0.83).ConclusionsIn this large all-comers TAVI population with new-generation devices the need for postprocedural PPMI did not show a statistical significant impact on survival or combined endpoint of major adverse events within one year.

Unmet issues in transcatheter aortic valve implantation.

Over the last 15 years, we have seen a rapid and exponential uptake of transcatheter aortic valve implantation (TAVI) for the treatment of patients with severe symptomatic aortic stenosis (1). This uptake has also been coupled with the evolution and advancement in transcatheter valve technologies. As such, a number of new TAVI devices have also been marketed, mainly with the aim of diminishing problems faced with first generation devices; notably, smaller delivery systems, less incidence of paravalvular leak (PVL) or need for permanent pacemaker implantation (PPI) and other device- or procedural related complications (2,3).

The ACURATE neo transcatheter aortic valve system

ABSTRACTIntroduction: The field of transcatheter aortic valve implantation (TAVI) has seen an exponential expansion in TAVI devices for the treatment of severe symptomatic aortic stenosis.Areas covered: The ACURATE neo (Boston Scientific, MA, USA) is a second-generation self-expanding transcatheter aortic valve system. The valve presents a supra-annular design, and comprises three stabilization arches for axial alignment, an upper-crown for capping the aortic annulus, and a lower-crown that is opened over the native aortic valve for full deployment. This device minimally protrudes into the left ventricular outflow-tract, thereby minimizing the risk of conduction abnormalities. The ACURATE neo can be delivered by transfemoral and transapical approaches with a unique ‘top-down’ deployment. Information was gathered from published manuscripts obtained using standard databases (MEDLINE) and trial data presented at conferences.Expert commentary: Data from observational series show that TAVI with the ACURATE neo is associated with low rates of all-cause mortality, paravalvular leak, and permanent pacemaker requirement. Randomized data comparing the ACURATE neo valve with contemporary valves and long-term durability data are awaited. Continuing modifications in device and delivery system design are anticipated with a view to further reduction in paravalvular leak.

New-generation devices for transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has overcome the pioneering phase and thanks to accrued clinical evidence has become a mainstay alternative to surgical aortic valve replacement (SAVR) in patients at high risk for post-operative complications. Despite these successes, TAVI remains a junior technology facing momentous developments in techniques and devices. Indeed, several new-generation devices for TAVI have become available in the last few years, including Acurate, Allegra, Evolut, Lotus, JenaValve, Portico, and SAPIEN3. Despite the inevitable setbacks, such as the one represented by DirectFlow, these new devices appear associated with comparative benefits, especially for minimal invasiveness, rates of permanent pacemaker implantation, and risk of residual aortic regurgitation. Indeed, no single device appears clearly better than the others, and a tailored and individualized approach should be sought in using these prostheses, taking into account operator and institutional expertise, on top of patient features. Few comparative effectiveness studies are available to date to guide decision making, and thus careful scrutiny is needed even in everyday clinical practice, especially if seeking to expand the current indications of TAVI. Further guidance will however come from long-term follow-up of completed studies and from results of ongoing trials.

Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.

The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3-37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7-26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI. The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI.