scholarly journals Clinical consequences of consecutive self-expanding transcatheter heart valve iterations

Author(s):  
H. G. Kroon ◽  
L. van Gils ◽  
F. Ziviello ◽  
M. P. H. van Wiechen ◽  
J. F. W. Ooms ◽  
...  

Abstract Objective To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs). Methods Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database. Results TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31–5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98–6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed. Conclusions TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Alessandro Sticchi ◽  
Francesco Gallo ◽  
Vincenzo De Marzo ◽  
Kim Won-keun ◽  
Tobias Zeus ◽  
...  

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 < 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.


2021 ◽  
Author(s):  
James Carey ◽  
Anthony Buckley ◽  
Stephen O'Connor ◽  
Mark Hensey

Transcatheter aortic valve implantation and implantation of other transcatheter heart valves, generally requires insertion of a temporary venous pacemaker. Implantation of a temporary venous pacemaker adds complexity, time and risk to the procedure. Guidewire modification to allow pacing is increasingly popular, however it requires technical expertise and provides unipolar pacing resulting in high thresholds and potential capture loss. The Wattson temporary pacing guidewire is a novel device which offers guidewire support for valve delivery and concomitant bipolar pacing. It may offer a safe and effective solution to guidewire pacing for transcatheter aortic valve implantation and other transcatheter heart valve implantations. Herein, we review the literature surrounding left ventricular guidewire pacing along with the features and clinical data of the Wattson wire.


Author(s):  
Shahram Lotfi ◽  
Guido Dohmen ◽  
Andreas Götzenich ◽  
Marcus Haushofer ◽  
Jan Wilhelm Spillner ◽  
...  

Objective Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or nonoperable patients with severe symptomatic aortic valve stenosis. The best known and most frequently implanted prostheses are the CoreValve and SAPIEN prostheses. We report our experiences and analyze the results of our TAVI program. Methods A total of 357 patients underwent transfemoral (TF) and transapical (TA) TAVI in our center between January 2008 and October 2012. The procedure was performed in 190 patients with CoreValve, in 155 patients with SAPIEN, and in 12 patients with ACURATE TA prostheses. Transfemoral access was used in 190 patients. In 167 patients, TA access was used. The mean age was 80.2 ± 6.4 years. All patients were nonoperable or had a high risk for a conventional aortic valve replacement. The mean logistic EuroSCORE I was 25.92 ± 14.51%. The TF/CoreValve (190 patients) and TA/SAPIEN (155 patients) groups showed significant difference in the patients’ mean age (81.7 ± 6.3 years vs. 79.5 ± 6.6 years, P = 0.002) and in mean logistic EuroSCORE I (22.16 ± 13.05% vs. 31.04 ± 16.40, P < 0.001). Results The overall 30-day mortality (357 patients) was 9.80% (TF, 8.42%; TA, 11.37%); overall 1-year mortality (275 patients), 21.45% (TF, 23.74%; TA, 19.12%); overall 2-year mortality (199 patients), 29.15% (TF, 35.96%; TA, 23.64%); overall 3-year mortality (133 patients), 37.59% (TF, 43.86%; TA, 32.89%); and overall 4-year mortality (38 patients), 39.47% (TF, 45%; TA, 33.33%). The rate of pacemaker implantation after TAVI was significantly higher in the CoreValve group than in the SAPIEN group: 44.74% (85/190 patients) versus 6.45% (10/155 patients), P < 0.001. Stroke rate was higher in the TF-CoreValve group than in the TA-SAPIEN group: 4.21% versus 0.64%, P = 0.045. Conclusions Outcomes after TAVI were, in our population of nonoperable and high-risk patients, encouraging. The differences in midterm outcomes between the TF-CoreValve TAVI and the TA-SAPIEN TAVI were not significant.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Ruediger Lange ◽  
Sabine Bleiziffer ◽  
Hendrik Ruge ◽  
Domenico Mazzitelli ◽  
Christian Schreiber ◽  
...  

Objective The transcatheter aortic valve implantation (TAVI) technology is rapidly evolving. The complications related to these procedures are different from those seen after conventional aortic valve replacement. Herein, we report our experience on the incidence and management of procedure-related complications in the first series of TAVI. Methods Between 6/2007 and 6/2008, 112 patients (n=62 female, mean age 81.3±7y, mean logistic EuroScore 25.0±15.6%) underwent TAVI through either a retrograde (n=92 transfemoral, n=3 via subclavian artery, n=1 ascending aorta) or antegrade (n=16 transapical) approach at our institution. 95 CoreValve and 17 Edwards Sapien (n=17) prostheses were implanted. Results 30-day mortality was 8.9% (n=10). Major vascular complications occurred in 19 patients (16,9%). 2 patients with iliac or femoral rupture were treated with covered stent. 14 patients with bleeding from vascular site were treated with surgical suture or prosthesis implantation. Three patients had lethal aortic root (n=2) or abdominal (n=1) aortic rupture. Cardiac tamponade occurred in 8 patients (7.1%); among these 3 were treated conservatively, 4 underwent subxyphoid puncture and one patient had thoracotomy. Valve displacement could be treated interventionally in 5 out of 6 patients, 1 patient underwent conventional surgery. In 2 patients, with extremely poor LV function, emergent institution of cardiopulmonary bypass was required during the procedure. 5 patients underwent interventional re-valving (n=2) or surgical re-replacement (n=3) due to high-grade regurgitation (n=5) or valve displacement (n=1). Pacemaker implantation due to postprocedural AV block was required in 23 patients (20.7%). Despite these complications, the overall initial procedural success was 98 % (n= 110/112). Conclusions A significant number of complications after TAVI requires surgical treatment. Therefore, TAVI procedures should be performed in a hybrid operating room which allows for immediate surgical intervention and the rapid institution of cardiopulmonary bypass if necessary.


Heart ◽  
2019 ◽  
Vol 105 (Suppl 2) ◽  
pp. s51-s56
Author(s):  
Miguel Sousa Uva

The median age of patients treated by transcatheter aortic valve implantation (TAVI) is falling across Europe, and low-risk patients with severe aortic stenosis (AS) represent 80% of patients with severe AS undergoing surgical aortic valve replacement (SAVR). There are few data for TAVI in low-risk patients, but there are four ongoing randomised trials of SAVR versus TAVI. The key issues relate to pacemaker implantation rates and the associated potential longer term deleterious effects, and the need to minimise vascular complications and paravalvular leak. Valve leaflet thrombosis and paucity of data on valve durability remain a concern. Given the higher incidence of bicuspid aortic valves in younger patients, outcomes of TAVI in this setting need clarification and are discussed.


2021 ◽  
Author(s):  
Yeela Talmor-Barkan ◽  
Ran Kornowski ◽  
Noam Bar ◽  
Jeremy Ben-Shoshan ◽  
Hanna Vaknin-Assa ◽  
...  

Abstract Transcatheter heart valve (THV) selection for transcatheter aortic valve implantation (TAVI) is crucial to achieve procedural success. Borderline aortic annulus size (BAAS), which allows a choice between two consecutive valve sizes, is a common challenge during device selection. In the present study, we evaluated TAVI outcomes in patients with BAAS according to THV size selection. We performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multidetector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multicenter TAVI registry. TAVI outcomes were assessed according to the Valve Academic Research Consortium-2 (VARC-2). Out of 2,352 patients with MDCT measurements, 598 patients with BAAS as defined for at least one THV type were included in the study. In BAAS patients treated with SE-THV, larger THV selection was associated with lower rate of paravalvular leak (PVL), compared to smaller THV (45.3% vs. 64.5%; pv = 0.0038). Regarding BE-THV, larger valve selection was associated with lower post-procedural transvalvular gradients compared to smaller THV (mean gradient: 9.9 ± 3.7mmHg vs. 12.5 ± 7.2mmHg; p = 0.019). Of note, rates of mortality, left bundle branch block, permanent pacemaker implantation, stroke, annular rupture and/or coronary occlusion did not differ between groups. BAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and better hemodynamic profile in patients implanted with SE and BE-THV, respectively, with no effect on procedural complications.


2022 ◽  
Vol 11 (2) ◽  
pp. 443
Author(s):  
Ahmed Elkoumy ◽  
John Jose ◽  
Christian J. Terkelsen ◽  
Henrik Nissen ◽  
Sengottuvelu Gunasekaran ◽  
...  

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI’s procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Arturo Giordano ◽  
◽  
Nicola Corcione ◽  
Paolo Ferraro ◽  
Alberto Morello ◽  
...  

AbstractTranscatheter 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.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F De Torres-Alba ◽  
G Kaleschke ◽  
J Vormbrock ◽  
H Deschka ◽  
H Baumgartner

Abstract Introduction The latest generation balloon-expandable transcatheter heart valve SAPIEN 3 Ultra (S3-Ultra) was recently released and has shown promising initial results. So far, the pacemaker (PM) implantation rate after transcatheter aortic valve implantation (TAVI) with the S3-Ultra system compared to the SAPIEN 3 (S3) system has not been widely investigated. Aims To compare the PM implantation rate after TAVI with the latest generation S3-Ultra system with the S3 system in an unselected cohort of patients at risk. Methods We analyzed the development of conduction abnormalities after TAVI in 1780 consecutive patients treated with S3 and S3-Ultra between January 2014 and February 2021. After excluding valve-in-valve procedures (n=31) and patients with previously implanted PM (n=203) 1546 patients were finally analyzed. All patients at risk (i. e. those without previous PM) were monitored with ECG for at least 7 days after TAVI. Results Of 1546 patients, 1382 were treated with S3 (20 mm, 14; 23 mm, 524; 26 mm, 558; 29 mm, 286) and 164 with S3-Ultra (20 mm, 0; 23 mm, 77; 26 mm, 87). There were no significant differences in baseline demographic, ECG and procedural characteristics. There was no significant difference in the rate of new developed conduction abnormalities or PM implantation rate between S3 and S3-Ultra in the overall cohort (37.8% S3 vs 33,7% S3-Ultra, p=0.451 for all new conduction abnormalities, 13.8% S3 vs 14.6% S3-Ultra, p=0.756 for PM implantation). This comparable PM implantation rate between the two systems was consistent when analyzing only the 23 and 26 mm valve sizes of the S3 system (12.1% S3 vs. 14.6% S3-Ultra, p=0.361) and when excluding the first period of S3 implantation at our institution (2014) before a modification of the implantation technique that lead to a drop in the rate of PM implantations (S3 2015–2020 12.9% vs S3-Ultra 14.6%, p=0.534). Conclusions In our cohort, the PM implantation rate after TAVI with the S3-Ultra system was comparable to that of its predecessor. FUNDunding Acknowledgement Type of funding sources: None.


2015 ◽  
Vol 18 (4) ◽  
pp. 161 ◽  
Author(s):  
An Zhao ◽  
Hu Minhui ◽  
Xu Li ◽  
Xu Zhiyun

Background: Transfemoral (TF) and transapical (TA) are two commonly used accesses in transcatheter aortic valve implantation (TAVI). Currently, the influence of TAVI access choice on 30-day and 1-year outcomes is unclear. The purpose of this study was to compare the 30-day and 1-year outcomes between TF-TAVI and TA-TAVI.<br />Methods: Studies published from 2002 to September 2014 were collected by searching PubMed and Web of Knowledge. Studies were selected by two independent investigators. 30-day and 1-year outcomes were endpoints. Odds ratios (ORs) and hazard ratio (HR) with 95% confidence interval (CI) were computed. Fixed effect model was used if I2 &lt; 50%; if I2 &gt; 50%, random effect model was used.<br />Results: 14 studies met inclusion criteria and were included in our analysis (3837 patients in TF group, 1881 patients in TA group). Two were retrospective trials and the others were prospective trials. Our meta-analysis showed that compared with TA group, TF group had a lower 30-day mortality (7.5% versus 11.6%) and higher 1-year survival [HR 0.75, 95% CI (0.66, 0.86)], but the Logistic EuroSCORE was higher in TA group (P = 0.00). TF group had a significantly higher stroke rate of 4.0% compared with 2.2% in TA group at ≤30 days. The incidence of major vascular complications was significantly higher in TF group compared with TA group (8.2% versus 5.3%). MI was more common in TA group (2.4%) compared with TF group (1.2%), but there were no significant difference [0.46, 95% CI (0.20, 1.06)].<br />Conclusions: TF-TAVI had a higher 30-day and 1-year survival rate compared with TA-TAVI, but these differences might be because of the higher Logistic EuroSCORE in TA group. Stroke and major vascular complications rates were higher in TF-TAVI patients at ≤30 days.


Sign in / Sign up

Export Citation Format

Share Document