Rate Of New Pacemaker Implantation Research Articles

Comparison of Long-term Efficacy of Domestic TAVR vs. Corevalve

Aim: To assess the long-term effects of domestic valves and compare them with similar products to demonstrate non-inferiority and provide guidance for valve selection in severe aortic stenosis patients. Methods: The study comprised two parts: evaluating the long-term effects of domestic valves through follow-up data, and conducting a meta-analysis to assess the long-term efficacy of Corevalve. Results: Both valves showed high cumulative all-cause mortality and cardiac mortality rates at 5 years post-surgery, with statistically significant differences. There were also significant differences in the cumulative incidence rates of new pacemaker implantation and cardiac rehospitalization. Stroke and myocardial infarction event rates within 5 years were both below 10%, with no statistically significant differences. Conclusion: Domestic valves demonstrated favorable long-term effects, performing comparably or even superior to Corevalve in certain aspects.

Predictors of permanent pacemaker implantation after transcatheter aortic valve implantation - Results from the SOLVE-TAVI trial

Abstract Background Permanent pacemaker implantation (PPI) is frequently required following transcatheter aortic valve implantation (TAVI). However, the predisposing parameters increasing the likelihood of severe conduction abnormalities are still not fully understood. Purpose To analyze predictors of PPI 30 days after TAVI. Methods The SOLVE-TAVI trial randomized 447 patients to TAVI using either the balloon-expandable Edwards Sapien 3 valve or the self-expanding Medtronic Evolut R valve. Pacemaker rates at 30 days were relatively high, but comparable between both transcatheter heart valve (THV) types (19% vs. 23%). Computed tomography (CT) scans were analyzed semi-automatically to determine aortic annulus size and subannular calcification. The percentage of THV oversizing was calculated using the formula (nominal THV circumference/annular circumference – 1) x 100). Results From all patients treated with either the Sapien 3 or Evolut R valve, 47 patients were excluded because of prior pacemaker implantation. Rates of new PPI at 30 days were similar in patients with and without pre-existing left bundle branch block (7/36 patients vs. 53/342 patients, p=0.48) and right bundle branch block (11/51 patients vs. 48/327 patients, p=0.22), without significant differences according to valve type. Patients with new PPI showed a significantly higher degree of THV oversizing compared to patients without PPI (median 15%, interquartile range [IQR] 9-20% vs. median 12%, IQR 7-17%; p=0.03). Moderate/severe compared to no/mild subannular calcification did not result in higher PPI rates (17/121 patients vs. 40/245 patients; p=65). Conclusion THV oversizing but not pre-existing left and right bundle branch block and subannular calcification is associated with PPI after TAVI.

Feasibility and outcome of third-generation transcatheter aortic valve implantation in patients with extra-large aortic annulus.

Many patients in need for transcatheter aortic valve implantation (TAVI) present with an aortic annulus size larger than recommended by the manufacturer's instructions for use (IFU). To investigate procedural and short-term safety and efficacy of TAVI in patients with extra-large annuli (ELA). 30-day clinical outcome and valve performance as defined by VARC 3 of 144 patients with an aortic annulus size exceeding the permitted range were compared to a propensity-score matched control cohort of patients with an aortic annulus size consistent with the IFU. Area and perimeter was 730.4 ± 53.9mm2 and 96.7 ± 6.5mm in the ELA group. Technical (96.5% vs. 94.4%) and device success (82.3% vs. 84.5%) were comparable in patients with ELA (annulus area 730.4 ± 53.9mm2) and matched controls (annulus area 586.0 ± 48.2mm2). There was no significant difference in 30-day mortality rate, major intraprocedural complications, type 3 or 4 bleedings, major vascular complications, or stroke. Moderate paravalvular leakage (PVL) occurred more frequent in the ELA group (8.9% vs 2.2%; p = 0.02). The rate of new pacemaker implantation was 7.0% in the ELA cohort and 15.0% in the control cohort, respectively (p = 0.05). Treatment of ELA patients with third-generation TAVI prostheses is feasible and safe, providing similar device success and complication rates as in matched controls with regular-sized aortic annulus. Post-interventional pacemaker implantation rates were low compared to the control group, yet incidence of moderate PVL remains problematic in ELA patients.

C31 UPDATE ON SUPRA–ANNULAR SIZING OF TRANSCATHETER AORTIC VALVE PROSTHESES IN RAPHE–TYPE BICUSPID AORTIC VALVE DISEASE ACCORDING TO THE LIRA METHOD

Abstract Aims Recent evidences have shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe–level, known as the LIRA (Level of Implantation at the RAphe) plane. A novel supra–annular sizing method based on the measurement of the perimeter at the raphe–level (LIRA–method) was shown to be safe and effective in 20 consecutive BAV patients with severe aortic stenosis. The purpose of this study was to confirm the safety and the efficacy of the LIRA method in a larger study population. Methods the LIRA plane method was applied to all consecutive patients with raphe–type BAV disease between November 2018 to October 2021 in our centre. We prospectively sized TAVI prosthesis according to the manufacture recommendations on the basis of baseline CT scan perimeters at the LIRA plane. Post–procedural device success, defined according to Valve Academic Research Consortium–2 (VARC–2) criteria, was evaluated in the overall cohort. Results 50 patients were identified as having a raphe–type BAV disease at pre–TAVI CT scans. Mean patient age was 80 ± 6.2 years. Three different BAV anatomies (47 patients with BAV type 1 and 3 patients with BAV type 2) were implanted with different types of TAVI prostheses (28 Acurate Neo/Neo 2, 21 Core Valve Evolut R/Pro,1 Lotus) sized prospectively according to the LIRA plane method. In all patients, there was a significant discrepancy between LIRA and virtual basal ring (VBR) (mean perimeter LIRA 73.1 ± 8.3 mm vs mean perimeter VBR 81.5 ± 6.6 mm; p < 0.001). The median prosthesis size was 26 mm (23–27). Pre–dilatation was frequently performed (88%) with a median balloon size of 20 mm (20–23), whereas post–dilatation was applied in 26% of the cases with a median balloon size of 23 mm (22–24). The LIRA plane method appeared to be highly successful (100% VARC–2 device success) with no procedural mortality, no valve migration, residual trivial/mild paravalvular leak with no cases of moderate–severe regurgitation and no cases of mean gradient >20 mmHg pre–discharge. The rate of new pacemaker implantation was 10%. Conclusions Supra–annular sizing according to the LIRA plane method confirmed to be safe with a high device success in a larger study population. The application of the LIRA plane method might optimize TAVI prosthesis sizing in patients with raphe–type BAV disease.

HFA-PEFF score: prognosis in patients with preserved ejection fraction after transcatheter aortic valve implantation.

AimsMany transcatheter aortic valve implantation (TAVI) candidates have underlying heart failure with preserved ejection fraction (HFpEF) in addition to symptomatic aortic stenosis. Diagnosis of HFpEF is challenging. The Heart Failure Association of the European Society of Cardiology proposed the HFA‐PEFF score as part of a novel diagnostic algorithm. This study assessed the prognostic value of the HFA‐PEFF score in patients with preserved ejection fraction after TAVI.Methods and resultsThis single‐centre study included 570 consecutive TAVI patients with a preserved left ventricular ejection fraction of ≥50%. Patients with an HFA‐PEFF score of ≥5 [n = 239 (41.9%)] were compared with those with <5 points [n = 331 (58.1%)]. The primary outcome was a composite of all‐cause mortality or first heart failure rehospitalization within 1 year after TAVI. Secondary endpoints were the individual components of the primary outcome. Patients with an HFA‐PEFF score ≥ 5 had higher rates of comorbidities commonly associated with HFpEF, a higher rate of new pacemaker implantation after TAVI, were at increased risk of the primary composite endpoint (25.5% vs. 10.0%, P < 0.001), and rehospitalization for heart failure (11.7% vs. 3.9%, P < 0.001). Multivariable analysis confirmed an HFA‐PEFF score ≥ 5 as an independent risk factor for the composite endpoint [hazard ratio 2.70, 95% confidence interval (CI) 1.70–4.28, P < 0.001] and for all‐cause mortality (hazard ratio 2.58, 95% CI 1.46–4.53, P = 0.001).ConclusionThe HFA‐PEFF score is associated with all‐cause mortality and heart failure rehospitalization in patients with preserved ejection fraction after TAVI. This practical tool can easily be incorporated into risk stratification algorithms for TAVI patients.

467 Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method

Abstract Aims Transcatheter Aortic Valve Replacement (TAVR) in patients with bicuspid aortic valve (BAV) still represents a challenge due to the peculiar anatomy and the lack of consensus for the optimal CT scan sizing method for prosthesis selection. Recent evidences have shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, known as the LIRA (Level of Implantation at the RAphe) plane. Furthermore, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level (LIRA-method) was shown to be safe and effective in 20 consecutive BAV patients with severe aortic stenosis. The purpose of this study was to confirm the safety and the efficacy of the LIRA method in a larger study population. Methods and results the LIRA plane method was applied to all consecutive patients with raphe-type BAV disease between November 2018 to September 2021 in our centre. We prospectively sized TAVI prosthesis according to the manufacture recommendations on the basis of baseline CT scan perimeters at the LIRA plane. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. Forty-four patients were identified as having a raphe-type BAV disease at pre-TAVI CT scans. Mean patient age was 80 ± 6.2 years and 74% were males; median Society of Thoracic Surgeons (STS) predicted risk of mortality score was 4.3 (3.0–6.5). Three different BAV anatomies (36 patients with BAV type 1 with calcific raphe, 5 patients with BAV type 1 with fibrotic raphe, and 3 patients with BAV type 2) were implanted with different types of TAVI prostheses (6 Acurate Neo 2,16 Acurate Neo, 21 Core Valve Evolut R/Pro , 1 Lotus) sized prospectively according to the LIRA plane method. In all patients, there was a significant discrepancy between LIRA and virtual basal ring (VBR) measurements with LIRA plane perimeter smaller than VBR perimeter (mean perimeter LIRA 73.1 ± 8.3 mm vs. mean perimeter VBR 81.5 ± 6.6 mm; P &amp;lt; 0.001). The prostheses were sized according to the manufacture recommendations on the basis of the LIRA plane perimeter (diameter prosthesis implanted/diameter prosthesis according to LIRA plane = 1) (DPI/DP LIRA = 1) and significantly downsized according to the VBR perimeter (DPI/DP VBR 0.89; P &amp;lt; 0.001). The median prosthesis size was 25 mm (23–27). Pre-dilatation was frequently performed (86%) with a median balloon size of 20 mm (18–22), whereas post-dilatation was applied in 27% of the cases with a median balloon size of 23 mm (20–26). The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, residual trivial/mild paravalvular leak with no cases of moderate-severe regurgitation and low transprosthetic gradient (residual mean gradient of 8.3 ± 3.5 mmHg) with no cases of mean gradient &amp;gt;20 mmHg pre-discharge. The rate of new pacemaker implantation was 9%. Conclusions Supra-annular sizing according to the LIRA plane method confirmed to be safe with a high device success in a larger study population. The application of the LIRA plane method might optimize TAVI prosthesis sizing in patients with raphe-type BAV disease.

612 Comparison of two self-expandable supra-annular bioprosthesis: a propensity score-matched analysis

Abstract Aims Limited data reported the comparison of bioprostheses for transcatheter aortic valve implantation (TAVI) among devices of supra-annular design. The aim of this study is to compare the clinical outcomes of the ACURATE neo and Evolut R/PRO valves for TAVI in a propensity score-matched analysis (PSM). Methods and results We performed a propensity score-matched analysis equalizing almost all the patient’s risk factors, anatomical and procedural characteristics, and assessing the predictive value of the remaining features. Our data were derived from a large, real-world, contemporary, multicentre, international, retrospective registry of 3862 consecutive patients undergoing TAVI using two different self-expandable supra-annular valves (Medtronic Evolut R/PRO and Boston ACURATE neo). We reached a matched population of 713 couples for each device group with a medium follow-up of 456.5 days. In the comparison of the clinical outcomes between the Evolut and the ACURATE patients, no difference occurred in mortality (9.8% vs. 9.0%, P = 0.650), heart failure hospitalization (9.6% vs. 6.0%, P = 0.076), myocardial infarction (0.7% vs. 0.4%, P = 0.718), stroke (2.4% vs. 1.4%, P = 0.239), major bleeding (3.3% vs. 3.4%, P = 1.000), vascular complications (13.7% vs. 10.9%, P = 0.126), endocarditis (1.1% vs. 0.6%, P = 0.568), sepsis (0.9% vs. 0.5%, P = 0.605), acute kidney injury (0.9% vs. 0.5%, P = 0.605), and new left bundle branch block (17% vs. 13.5%, P = 0.187). The only outcome with a significant difference between the groups was the need of pacemaker implantation in favour of the ACURATE valve (5.3% vs. 12.9% for the Evolut, P &amp;lt; 0.001). Conclusions In our PSM cohort, the comparison between the Evolut and the ACURATE valve showed no significant differences in the multiple outcomes evaluated, except for the rate of new pacemaker implantation. This data confirmed the recent literature, but it needs further dedicated investigation using the following devices generations.

Single-Center Outcomes with Rapid Deployment Aortic Valve Replacement.

Rapid-deployment valves can reduce procedural times and may facilitate minimally invasive surgery. In our institution, more than 500 patients underwent rapid deployment aortic valve replacement (AVR). A total of 510 patients underwent rapid deployment AVR between March 2012 and September 2017, of whom 270 patients underwent isolated AVR and 240 underwent AVR with concomitant procedures. The cumulative follow-up time was 1,444 patient-years, the median follow-up time 2.8 years, respectively RESULTS: An early all-cause mortality of 3.5% (n = 18) was seen with a cumulative survival of 91.9 ± 2.2% after 12 months. Mean cross-clamp times were 37 ± 19 minutes for isolated AVR and 93 ± 29 minutes for AVR with concomitant procedures. The rate of new pacemaker implantation was 7.8% (n = 40). No case of structural degeneration occurred in the follow-up. Three (0.6%) cases of endocarditis were registered. Rapid deployment AVR can be performed safely with low complication rates and good hemodynamic results. Therefore, the relevance in aortic valve surgery can be stressed.

Transvascular transcatheter aortic valve implantation in 2017.

Transcatheter aortic valve implantation (TAVI) is emerging as the standard of care for patients with severe aortic stenosis. Recent results have been favourable even for patients with low periprocedural risk. We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing isolated aortic valve replacement in 2017 in Germany, focussing especially on transvascular (TV) TAVI. Patients were stratified according the German Aortic Valve Score (AKL) into the risk classes low, intermediate, high and very high (≥ 10%). A total of 17,956 TV-TAVI and 9011 isolated surgical aortic valve replacements (iSAVR) were performed in Germany in 2017. Although the total rate of intraprocedural complications after TV-TAVI was the same as in 2016 (both 7.4%), fewer patients experienced an arterial vascular complication in 2017 (2017: 6.0%; 2016: 7.1%; p < 0.001). Likewise, the rate of new pacemaker implantation decreased (2017: 9.6%; 2016:11.4%; p < 0.001). In-hospital mortality after TV-TAVI and iSAVR was equal (2.7%) in 2017, despite the much higher risk profile of TV-TAVI patients. Using the AKL score as reference, TV-TAVI showed a more favourable observed-to-expected mortality (O/E) ratio (0.89) than iSAVR (1.14)- even more pronounced in patients at low risk (0.81 vs. 1.14). The rates of major complications like bleeding and permanent pacemaker implantation after TV-TAVI keep declining. In 2017 patients undergoing TV-TAVI had a low in-hospital mortality rate with an O/E ratio < 1, indicating that the results were again better than those of all TAVI and SAVR of the previous year. Overall in-hospital mortality after transvascular TAVI and isolated aortic valve repair 2017 in Germany stratified to risk groups by the German Aortic Valve Score (German AV Score/AKL Score): low risk group (AKL 0- < 3%), intermediate risk group (AKL 3- < 6%), high risk group (AKL 6- < 10%) and very high risk group (AKL ≥ 10%).

Impact of new pacemaker implantation following surgical and transcatheter aortic valve replacement on 1-year outcome.

The purpose of this study was to evaluate the incidence of new pacemaker implantation (NPMI) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR), and investigate its influence on 1-year mortality. Patients who were enrolled in 'The German Aortic Valve Registry' undergoing isolated TAVR or SAVR between 2011 and 2015 were analysed. The rate of NPMI was analysed for both groups and multivariable Cox regression analysis was performed to investigate the possible independent association between NPMI and 1-year mortality. Twenty thousand eight hundred and seventy-two patients who underwent TAVR and 17750 patients who received SAVR were included in this study. The rate of NPMI was 16.6% after TAVR and 3.6% after SAVR. In the TAVR group, NPMI was associated with significantly increased 1-year mortality in univariable Cox regression analysis [hazard ratio (HR) 1.29, confidence interval (CI) 1.18-1.41; P < 0.001]. This association persisted after adjustment for confounding factors (HR 1.29, CI 1.16-1.43; P < 0.001). In the SAVR group, NPMI significantly increased 1-year mortality in univariable analysis as well (HR 1.55, CI 1.08-2.22; P = 0.02), whereas after multivariable adjustment, NPMI did not emerge as an independent risk factor (HR 1.29, 0.88-1.89; P = 0.19). NPMI was not associated with 30-day mortality in both procedure groups. The rate of NPMI was markedly higher after TAVR compared with SAVR and was independently associated with 1-year mortality after TAVR, whereas this was not significant after SAVR. As 30-day mortality was not different for TAVR and SAVR, the subsequent procedure of an NPMI itself seems not to increase the risk of mortality.

TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study

ObjectivesThe VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation. BackgroundSurgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery. MethodsVIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve. ResultsPatients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later. ConclusionsDegenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298)

The mechanically expandable LOTUS Valve and LOTUS Edge transcatheter aortic valve systems

ABSTRACTIntroduction: The Lotus valve system (Boston Scientific, Marlborough, Massachusetts, USA) consists of a braided wire Nitinol™ frame with three bovine pericardial leaflets. The valve is deployed by controlled mechanical expansion which allows recapturing/repositioning and full retrievability.Areas covered: While this system offers a unique seal, which conforms to irregular surfaces, thereby minimizing paravalvular leak, its main downfall is a high rate of new pacemaker implantation. This had been partially addressed with the design of the Depth Guard™ mechanism to optimize deployment by early anchoring and limiting the depth of implant. Further developments in the Lotus valve’s structure and design lay the foundations for the new Lotus Edge™ valve which is designed to maintain the benefits of the first-generation of the device, while improving deliverability and optimizing deployment with the aim to reduce pacemaker implantation rates.Expert commentary: Data from clinical trials show that TAVI with the Lotus valve system is associated with low rates of all-cause mortality and paravalvular leak although with high rates of permanent pacemaker requirement. Therefore, continuing modifications in device design such as the Lotus Edge™ valve with the addition of the Depth Guard™ are highly awaited with a view to decrease pacemaker rates.

Implications of Transcatheter Heart Valve Selection on Early and Late Pacemaker Rate and on Length of Stay

BackgroundTranscatheter aortic valve replacement (TAVR) can cause injury to the atrioventricular conduction system. We evaluated the effect of transcatheter heart valve (THV) type on the rate of new pacemaker implantation and length of hospital stay. MethodsPatients across all hospitals performing transfemoral TAVR in the province of British Columbia between 2012 and 2016 participated in a mandated registry with linkages to provincial health databases. We evaluated 1141 patients undergoing successful transfemoral TAVR for native aortic valve stenosis with 5 commonly used valves. ResultsValves implanted were balloon-expandable (BEV) (n = 728), self-expandable (SEV) (n = 341), and mechanically-expandable (MEV) (n = 72). Baseline clinical characteristics were similar between groups: mean age 82.5 years with multiple comorbidities. The mean Society of Thoracic Surgeons predicted risk of mortality was 6.0%. Indwelling temporary pacemakers after TAVR varied by THV type: (BEV) 4.0%, (SEV) 69.3%, and (MEV) 63.0% (P < 0.002). The need for a new permanent pacemaker varied by THV type: (BEV) 6.6%, (SEV) 24.0%, and (MEV) 32.8% at 30 days (P < 0.001). At 1 year, permanent pacemaker rates continued to rise, and remained divergent: (BEV) 8.9%, (SEV) 26.9%, and (MEV) 35.9% (P < 0.001). Median length of stay varied according to THV type: (BEV) 1, (SEV) 3, and (MEV) 4 days (P < 0.001 across groups). Crude mortality rates were not statistically different by THV type, either at 30 days (BEV 3.0%, SEV 2.9%, and MEV 0.0%; P = 0.33), or at 1 year (BEV 10.3%, SEV 15.0%, and MEV 8.3%; P = 0.11). ConclusionsThe choice of a THV device was associated with significant differences in the need for post-TAVR temporary pacemakers, hospital length of stay, and both early and late pacemaker implantation rates. These differences may have an impact on patient morbidity and resource utilization.

Volume-outcome relationship with transfemoral transcatheter aortic valve implantation (TAVI): insights from the compulsory German Quality Assurance Registry on Aortic Valve Replacement (AQUA).

Previous studies have shown lower rates of in-hospital complications and mortality for patients undergoing surgical aortic valve replacement (sAVR) in high-volume compared with lower-volume hospitals. It was the aim of our study to analyse whether there is a similar volume-outcome relationship for transcatheter aortic valve implantation (TAVI), which is increasingly used in clinical practice. We analysed all patients with non-emergent transfemoral (TF) TAVI procedures performed in 2014 in 87 German hospitals. We used the German Aortic Valve score 2.0 to calculate the ratio of observed versus expected (O/E) in-hospital mortality. A total of 9,924 patients (age 81.4±1.1 years, 45.3% male, median log EuroSCORE 18.81%, IQR 4.55) were included. Average observed mortality was 4.3±3.3%, while the expected average mortality was 5.4±1.4% (mean O/E ratio: 0.8). Average in-hospital mortality was 5.6±5.0% (range, 0 to 16.7%) in the lowest volume group of hospitals performing <50 TF-TAVI annually compared to 2.4±1.0% (range, 0.5 to 3.7%) in the highest volume hospitals with ≥200 TF-TAVI procedures per year. There was a continuous, statistically significant association of lower O/E ratios with increasing TF-TAVI volumes (p<0.001), but without a clear-cut threshold. Major complications, neurologic events, and rates of new pacemaker implantation were not different between low- and high-volume hospitals. Across the spectrum of hospital volumes from 11 to 415 patients undergoing TF-TAVI per year in Germany, there was a continuous, statistically significant association of lower average observed as well as risk-adjusted in-hospital mortality with increasing TF-TAVI volumes.

Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: A single-center experience.

AIMTo investigate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (S3-THV) vs the SAPIEN XT valve (XT-THV).METHODSWe retrospectively analyzed 507 patients that underwent TAVI with the XT-THV and 283 patients that received the S3-THV at our institution between March 2010 and December 2015.RESULTSThirty-day mortality (3.5% vs 8.7%; OR = 0.44, P = 0.21) and 1-year mortality (25.7% vs 20.1%, P = 0.55) were similar in the S3-THV and the XT-THV groups. The rates of both major vascular complication and paravalvular regurgitation (PVR) > 1 were almost 4 times lower in the S3-THV group than the XT-THV group (major vascular complication: 2.8% vs 9.9%, P < 0.0001; PVR > 1: 2.4% vs 9.7%, P < 0.0001). However, the rate of new pacemaker implantation was almost twice as high in the S3-THV group (17.3% vs 9.8%, P = 0.03). In the S3 group, independent predictors of new permanent pacemaker were pre-procedural RBBB (OR = 4.9; P = 0.001), pre-procedural PR duration (OR = 1.14, P = 0.05) and device lack of coaxiality (OR = 1.13; P = 0.05) during deployment.CONCLUSIONThe S3-THV is associated to lower rates of major vascular complications and PVR but higher rates of new pacemaker compared to the XT-THV. Sub-optimal visualization of the S3-THV in relation to the aortic valvular complex during deployment is a predictor of new permanent pacemaker.

A SINGLE-CENTRE EXPERIENCE WITH THE COREVALVE 31MM PROSTHESIS IN TRANSCATHETER AORTIC VALVE IMPLANTATION

Feasibility of transcatheter aortic valve implantation (TAVI) is determined by the availability of appropriately sized aortic prosthesis. CoreValve 31mm (CRV31) was introduced about 2 years ago in order to allow treatment of some of the largest aortic annulus. However, the implantation of this large self-expanding prosthesis in a beating heart was anticipated to be more challenging than the others. We report our experience with CRV31 and compare its results with those of the smaller sized CoreValve prosthesis (23, 26, 29mm). Between March 2012 and April 2014, a total of 89 TAVI procedures were performed for symptomatic severe native aortic stenosis in our institution. CoreValve prosthesis was used as the sole device, and CRV31 was implanted in 21 patients (24%). Delivery catheter with AccuTrak stability layer was used in all procedures. Patients’ demographics, clinical characteristics, procedural data, and clinical outcomes were recorded prospectively in a registry. All endpoints were defined according to the Valve Academic Research Consortium-2 (VARC2) criteria. When compared with the smaller CoreValve prostheses, CRV31 implantation was associated with similar extent of paravalvular regurgitation, the depth of implant, and the rate of new pacemaker implantation. Device malposition occurred in 1 in each group. The rates of the composite endpoints in device success, early safety, and clinical efficacy as defined in VARC2 were similar between the 2 groups during follow-up. There was no valvular dysfunction during follow-up with CRV31. Similar to the CoreValve 23-29mm prostheses, implantation of CoreValve 31mm prosthesis was associated with high success rate, satisfactory hemodynamic and clinical results.