Transfemoral Transcatheter Aortic Valve Implantation Research Articles

Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve.

In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation. Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort. Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001). Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years. URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.

Efficacy and Safety of Low-Dose Protamine in Reducing Bleeding Complications during TAVI: A Propensity-Matched Comparison

Objectives: We aimed to evaluate the efficacy and safety of low-dose protamine in reducing access site-related complications during Transcatheter Aortic Valve Implantation (TAVI) as compared to full-dose protamine. Background: Access site-related complications represent an independent predictor of poor outcomes of TAVI. Data regarding heparin reversal with protamine and the dosage needed to prevent bleeding complications are scarce among patients undergoing TAVI. Methods: A total of 897 patients were retrospectively included in the study. Patients who underwent percutaneous coronary intervention within 4 weeks before or concomitantly with TAVI (n = 191) were given 0.5 mg protamine for each 100 units of unfractionated heparin. All other patients (n = 706) were considered as a control group and 1 mg protamine for each 100 units of heparin was administered. Results: The combined intra-hospital endpoint of death, life-threatening major bleeding, and major vascular complications were significantly more frequent in patients receiving low-dose protamine [29 (15.2%) vs. 50 (7.1%), p &lt; 0.001]. After propensity matching (n = 130 for each group) for relevant clinical characteristics including anti-platelet therapy [19 (14.6%) vs. 6 (4.6%), p = 0.006], low-dose protamine predicted the combined endpoint (OR 3.54, 95%-CI 1.36–9.17, p = 0.009), and even in multivariable analysis, low-dose protamine continued to be a predictor of the combined endpoint in the matched model (OR 3.07, 95%-CI 1.17–8.08, p = 0.023) alongside baseline hemoglobin. Conclusions: In this propensity-matched retrospective analysis, a low-dose protamine regime is associated with a higher rate of major adverse events compared to a full-dose protamine regime following transfemoral TAVI.

Prognostic significance of calibrated integrated backscatter in patients submitted to transcatheter aortic valve implantation

Abstract Funding Acknowledgements Type of funding sources: None. Background There is a reported association between calibrated integrated backscatter (cIB) and myocardial fibrosis, mostly noted in cardiomyopathies and aortic stenosis cases. But whether this measure of myocardial ultrasound reflectivity could help predict outcomes in patients submitted to transcatheter aortic valve implantation has not been previously tested. Purpose To demonstrate whether cIB may help differentiate patients undergoing transcatheter aortic valve implantation (TAVI) at risk of major cardiovascular events. Methods Consecutive patients submitted to transfemoral TAVI between October 2020 and December 2021 were routinely imaged by echocardiography in the five days peri-procedure. Calibrated integrated backscatter was obtained from the parasternal long-axis view (PLAX) by subtracting pericardial cIB intensity from myocardial septal and posterior wall average cIB. Patients with poor PLAX views were excluded from the study. All measurements of cIB were performed at end-diastole. The primary endpoint was the occurrence of major cardiovascular events at one year of follow-up. Results A total of 184 patients underwent a TAVI procedure during the study period. Of these, 159 had a reasonable acoustic window for cIB measurement and were included in the study. Patient mean age was 81.1±6.1 years, and 58% were female. At baseline, 81% of patients had preserved left ventricle function, the mean aortic mean gradient was 44.8±15.1 mmHg, and the mean Euroscore II was 5.55±3.75. No significant association was found between cIB and TAVI-related major acute complications (21.02±10.4 vs 19.8±7.1 dB, p = 0.544). There was also no significant correlation of cIB with major cardiovascular events (19.71±7.25 vs 20.39±10.47 dB, p = 0.478) or with valve safety (19.59±7.07 vs 18.84±10.32 dB, p = 0.709), defined accordingly to the Valve Academic Research Consortium-2 consensus, at one-year follow-up. There was, however, a positive association between cIB and all-cause mortality (19.24±7.06 vs 22.92±9.36, p = 0.021) at one-year follow-up, with deaths occurring due to multiple causes, mainly cardiovascular, infectious, and neoplastic. Measured cIB was also significantly higher in patients with a pre-TAVI estimated glomerular filtration rate of less than 30 mL/min/1.73m2 (22.42±7.17 vs 19.56±6.88 dB, p = 0.043). Conclusion Higher cIB was not associated with a higher risk of major cardiovascular events or with valve safety in patients submitted to TAVI, but it can potentially have prognostic value in differentiating patients at increased risk of all-cause mortality.

Measuring integrated backscatter in patients undergoing transcatheter aortic valve implantation

Abstract Funding Acknowledgements Type of funding sources: None. Background Calibrated integrated backscatter (cIB) derived by 2D echocardiography quantifies myocardial ultrasound reflectivity, and it has been used in previous studies as a surrogate for myocardial fibrosis. Before the advent of other cardiac imaging techniques, it was a major focus of tissue characterization research. Purpose We examined whether cIB may help identify patients undergoing transcatheter aortic valve implantation (TAVI) at risk of procedure-related complications. Methods Consecutive patients submitted to transfemoral TAVI between January and December 2021 were routinely imaged by echocardiography in the five days peri-procedure. Calibrated integrated backscatter was obtained from the parasternal long-axis view (PLAX) by subtracting pericardial cIB intensity from myocardial septal and posterior wall average cIB. Patients with poor PLAX views were excluded from the study. Measurements of cIB, expressed in decibels, were performed at end-diastole. The primary endpoint was the occurrence of major TAVI-related complications. Results Of 149 patients that underwent TAVI during the study period, 131 had a reasonable acoustic window for cIB measurement and were included in the study. Patient mean age was 82.1±6.9 years, and 62% were female. At baseline, 84% of patients had preserved left ventricle function, the mean aortic mean gradient was 47.3±14.8 mmHg, and the mean Euroscore II was 5.34±3.24. The global mean cIB measured was 19.74±7.56 dB. No significant differences were found in the myocardial wall ultrasound reflectivity in patients with TAVI-related major complications (20.63±10.8 vs 19.6±6.9 dB, p = 0.587), which were defined according to the Valve Academic Research Consortium-2 consensus. However, cIB was significantly higher in patients who had post-TAVI conduction disturbances (21.09±7.72 vs 18.11±7.06 dB, p = 0.026), including left bundle branch block and atrioventricular block. There was also a negative correlation of cIB with aortic annulus area as measured by computed tomography (r(129)= −0.19, p = 0.032), and cIB was also significantly higher in patients who had a pre-TAVI estimated glomerular filtration rate of less than 30 mL/min/1.73m2 (22.42±7.17 vs 19.56±6.88 dB, p = 0.043). Conclusion Our data disfavors the use of cIB as a predictor of major TAVI-related complications, but it suggests that cIB assessment could add value in identifying patients at risk of conduction disturbances in post-TAVI procedures.

Non-contrast transcatheter aortic valve implantation for patients with aortic stenosis and chronic kidney disease: a pilot study.

Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI). Of note, it is associated with a threefold increase in all-cause and cardiac death. We propose a new non-contrast strategy for evaluating and performing the TAVI procedure that can be especially valuable for patients with aortic stenosis (AS) and chronic kidney disease (CKD) to prevent AKI. Patients with severe symptomatic AS and CKD stage ≥3a were evaluated for TAVI using four non-contrast imaging modalities for procedural planning: transesophageal echocardiogram (TEE), cardiac magnetic resonance, multidetector computed tomography (MDCT), and aortoiliac CO2 angiography. Patients underwent transfemoral (TF) TAVI using the self-expandable Evolut R/Pro, and the procedures were guided by fluoroscopy and TEE. Contrast MDCT and contrast injection at certain checkpoints during the procedure were used in a blinded fashion to guarantee patient safety. A total of 25 patients underwent TF-TAVI with the zero-contrast technique. The mean age was 79.9 ± 6.1 years, 72% in NYHA class III/IV, with a mean STS-PROM of 3.0% ± 1.5%, and creatinine clearance of 49 ± 7 ml/min. The self-expandable Evolut R and Pro were implanted in 80% and 20% of patients, respectively. In 36% of the cases, the transcatheter heart valve (THV) chosen was one size larger than the one by contrast MDCT, but none of these cases presented adverse events. Device success and the combined safety endpoint (at 30 days) both achieved 92%. Pacemaker implantation was needed in 17%. This pilot study demonstrated that the zero-contrast technique for procedural planning and THV implantation was feasible and safe and might become the preferable strategy for a significant population of CKD patients undergoing TAVR. Future studies with a larger number of patients are still needed to confirm such interesting findings.

Is the outcome of elective vs non-elective patients undergoing transcatheter aortic valve implantation different? Results of a single-centre, observational assessment of outcomes at a large university clinic

BackgroundTranscatheter aortic valve implantation (TAVI) can either be conducted as an elective (scheduled in advance) or a non-elective procedure performed during an unplanned hospital admission. The objective of this study was to compare the outcomes of elective and non-elective TAVI patients.MethodsThis single-centre study included 512 patients undergoing transfemoral TAVI between October 2018 and December 2020; 378 (73.8%) were admitted for elective TAVI, 134 (26.2%) underwent a non-elective procedure. Our TAVI programme entails an optimized fast-track concept aimed at minimizing the total length of stay to ≤ 5 days for elective patients which in the German healthcare system is currently defined as the minimal time period to safely perform TAVI. Clinical characteristics and survival rates at 30 days and 1 year were analysed.ResultsPatients who underwent non-elective TAVI had a significantly higher comorbidity burden. Median duration from admission to discharge was 6 days (elective group 6 days versus non-elective group 15 days; p < 0.001), including a median postprocedural stay of 5 days (elective 4 days versus non-elective 7 days; p < 0.001). All-cause mortality at 30 days was 1.1% for the elective group and 3.7% for non-elective patients (p = 0.030). At 1 year, all-cause mortality among elective TAVI patients was disproportionately lower than in non-elective patients (5.0% versus 18.7%, p < 0.001). In the elective group, 54.5% of patients could not be discharged early due to comorbidities or procedural complications. Factors associated with a failure of achieving a total length of stay of ≤ 5 days comprised frailty syndrome, renal impairment as well as new permanent pacemaker implantation, new bundle branch block or atrial fibrillation, life-threatening bleeding, and the use of self-expanding valves. After multivariate adjustment, new permanent pacemaker implantation (odds ratio 6.44; 95% CI 2.59–16.00), life-threatening bleeding (odds ratio 4.19; 95% confidence interval 1.82–9.66) and frailty syndrome (odds ratio 5.15; 95% confidence interval 2.40–11.09; all p < 0.001, respectively) were confirmed as significant factors.ConclusionsWhile non-elective patients had acceptable periprocedural outcomes, mortality rates at 1 year were significantly higher compared to elective patients. Approximately only half of elective patients could be discharged early. Improvements in periprocedural care, follow-up strategies and optimized treatment of both elective and non-elective TAVI patients are needed.

Prophylactic intra-aortic balloon pump in transfemoral transcatheter aortic valve implantation.

Prophylactic intra-aortic balloon pump in transfemoral transcatheter aortic valve implantation.

Trans-Subclavian Transcatheter Aortic Valve Replacement With Edwards Certitude Delivery System: A Novel Alternative Approach

Trans-subclavian (TSc) transcatheter aortic valve implantation (TAVI) is the leading alternate access approach for patients with severe aortic stenosis and anatomy prohibitive for transfemoral TAVI (Society of Thoracic Surgeons TVT Registry Special report 2021). Whilst effective, the TSc approach is plagued with technical difficulties, including sheath diameter restriction, delivery catheter length redundancy, and complex angulation when approaching the annular plane for deployment. Direct transaortic and transapical approaches are technically easier in this regard due to a shorter delivery system with a retroflex function; however, they carry significant morbidity. The Edwards Certitude delivery kit, marketed for transfemoral TAVI, was adopted in bilateral subclavian approaches and an Australasian unit’s novel experience and outcomes of using it are presented.

Performance of the 2019 consensus algorithm on the management of conduction disturbances after TAVI in clinical practice

Introduction and objectivesConduction disturbances (CD) after transcatheter aortic valve implantation (TAVI) increase the risk of permanent pacemaker (PPM) implantation and often preclude early-discharge (ED). The aim of this study was to evaluate the performance of the 2019 consensus algorithm on the management of conduction disturbances post-TAVI in a real-world cohort. MethodsRetrospective analysis of patients who underwent transfemoral TAVI between 2016 and 2018. Patients with prior PPM were excluded. The algorithm classified patients as ED or non-ED candidates (due to a higher risk for high-degree atrioventricular block or because they were eligible for PPM). ED was defined as discharge at day-3 post-TAVI. Primary endpoint was the 30-day rate of PPM implantation and secondary endpoints included 6-month pacing rate, 1-year rate of syncope and all-cause mortality and the composite outcome of both, regarding ED eligibility. ResultsA total of 220 patients were included. The algorithm classified 66% of the patients as ED candidates. The 30-day rate of PPM implantation was 3.6% for ED candidates (vs 62.5% for non-ED candidates; P<.001). No differences were found in the secondary endpoints between ED and non-ED candidates. The algorithm identified 16% of the patients as eligible for PPM of whom 97.1% underwent PPM implantation; 18% of the patients were classified as at higher risk of high-degree atrioventricular block. ConclusionsThe 2019 algorithm allowed to safely ED a significant number of patients with conduction disturbances post-TAVI and to identify patients with a clear indication for PPM implantation. However, in high-risk patients, the algorithm does not provide a guiding strategy.

The Place of Transaxillary Access in Transcatheter Aortic Valve Implantation (TAVI) Compared to Alternative Routes-A Systematic Review Article.

Transfemoral transcatheter aortic valve implantation (TAVI) has proven non-inferior or superior against surgical aortic valve replacement (SAVR) for patients at high, intermediate or low surgical risk. However, transfemoral access is not always feasible in patients with severely atherosclerotic or tortuous iliofemoral arteries. For these cases, alternative access techniques have been developed, such as transcarotid, transcaval, direct aortic or transaxillary access. In recent years, growing preference towards the transaxillary access has emerged. To provide a summary of data available on transaxillary TAVI and compare this approach to other alternative access techniques. A literature search was performed in PubMed by two independent reviewers. Studies reporting the outcome of at least 10 patients who underwent transaxillary TAVI, either in case series or in comparative studies, were included in this review. Articles not reporting outcomes according to the Valve Academic Research Consortium (VARC) 1-3 definitions were excluded. In total 193 records were found of which 18 were withheld for inclusion in this review. This review reports on the combined data of the 1519 patients who underwent transaxillary TAVI. Procedural success was achieved in 1203 (92.2%) of 1305 cases. Life-threatening, major, and minor bleeding occurred respectively in 4.5% (n = 50 in 1112 cases), 12.9% (n = 143 in 1112 cases) and 8.8% (n = 86 in 978 cases). Major and minor vascular complications were reported in respectively 6.6% (n = 83 in 1256 cases) and 10.0% (n = 105 in 1048 cases) of patients. 30-day mortality was 5.2% (n = 76 out of 1457 cases). At one year follow-up, the mortality rate was 1% (n = 184 out of 1082 cases). Similar 30-day and 1-year mortality is observed in studies that compare with transaxillary, transfemoral or other alternative access techniques (p 0.05). A wide application of transaxillary access as an alternative approach for TAVI has emerged. This technique has an excellent procedural success rate up to 92.0%, with low procedural complication rates. Clinical outcome of transaxillary TAVI is comparable to the other alternative TAVI approaches. However, these conclusions are solely based on observational data.

P302 SIMULTANEOUS CORRECTION OF SEVERE LOW–FLOW LOW–GRADIENT AORTIC STENOSIS AND ABDOMINAL AORTIC ANEURYSM BY TAVI + EVAR

Abstract We report the case of a 72–year–old man with arterial hypertension, dyslipidemia, type 2 diabetes mellitus, and severe chronic obstructive pulmonary disease. The patient had a previous stroke with occlusion of both internal carotid arteries about 7 years ago. He presented to the emergency department with dyspnea on exertion (NYHA class III), and the echocardiogram revealed a dilated left ventricle with severe reduction of global systolic function (EF 35%), severe low–flow low–gradient aortic stenosis (AVA on VTI 0.526 cmq/mq, SVi 29.7 ml/mq, Gmax 25.6 mmHg, Gmed 16 mmHg), and abdominal aortic aneurysm. Subsequently, he underwent an angio–CT scan that showed an almost completely thrombosed abdominal aortic aneurysm with a maximum diameter of 65 mm and a longitudinal extension of about 11 cm. The patient also underwent coronary angiography, which showed diffuse calcified atherosclerosis, and he was recommended for medical therapy. After a joint Heart Team consultation with cardio–anesthesiologists, cardiac surgeons, and vascular surgeons, it was decided to perform transfemoral transcatheter aortic valve implantation (TAVI) and endovascular aneurysm repair (EVAR) in the same procedure (EUROSCORE II &amp;gt; 4%). The patient underwent TAVI followed by EVAR of the aorto–bisiliac arteries through a main access site in the left femoral artery guided by ultrasound, a secondary access site in the right femoral artery for placement of a pigtail catheter on the aortic plane, and a venous access site in the right femoral vein for placement of a temporary pacing catheter at the apex of the right ventricle. First, an Edwards Sapien 3 Ultra 26mm valve was implanted, and then the 14Fr sheath in the left femoral artery was exchanged for an 18Fr sheath for the EVAR, which was placed in the aorto–bisiliac region. Hemostasis was achieved using the Manta system on the left femoral artery and two Proglide devices on the right femoral artery. The procedure was completed without complications, and the patient was discharged 10 days later, asymptomatic and in stable clinical condition, with a recommendation for dual antiplatelet therapy with aspirin and clopidogrel. At the 6–week follow–up, the patient remained asymptomatic with an EF of 40%. Conclusion In selected cases, the simultaneous correction of severe low–flow low–gradient aortic stenosis using TAVI and abdominal aortic aneurysm using EVAR can be considered after appropriate discussion and consultation within the Heart Team."

P291 BUILDING UP A TRANSFEMORAL TAVI PROGRAM DONE BY CARDIAC SURGEONS: OUR EXPERIENCE IN 502 PATIENTS

Abstract Background Current evidence on TAVI has been generated exclusively by cardiology studies and no operative data from cardiac surgeons are available. Here we describe the development of our TAVI program and report the results of transfemoral TAVI done by cardiac surgeons on their own. Methods The “surgical” TAVI program was built from the ground up in October 2018. Relevant prospectively collected preoperative, intraprocedural and postoperative data were retrieved from the Institutional database. A multivariable logistic regression was used to study the association of preoperative clinical characteristics, the progression of the experience and the operators, with postoperative early outcomes. Results A total of 502 patients were included in the study. Mean patients’ age was 82 years and STS score was 3.1% (2.2 – 4.4). Eighty–five patients underwent transapical TAVI and 417 patients had a transfemoral approach. We progressively moved from TA TAVI towards TF procedures now routinely performed on conscious sedation and using a fully percutaneous approach (Figures 1–3). Both balloon expandable (60.3%) and self–expandable valves (39.6%) were used. After TF TAVI technical success (according to VARC 3 criteria) was achieved in 99.1% of cases. Thirty–day mortality rate was 1%, stroke occurred in 2% of the cases and permanent pacemaker implantation was necessary in 23% of the patients. A moderate or severe paravalvular leak was observed in 4.4% and 0.7% of patients, respectively. Conclusions The acquisition of catheter–based skills and an adequate training allowed cardiac surgeons to perform on their own awake and fully percutaneous TF TAVI with excellent early results.

Results and insights after 413 TAVI procedures performed by cardiac surgeons on their own.

Current evidence on transcatheter aortic valve implantation (TAVI) has been generated exclusively by cardiology studies and no operative data from cardiac surgeons are available. Here, we describe the development of our TAVI programme and report the results of transfemoral (TF) TAVI done by cardiac surgeons on their own. This study included all the TAVI procedures on native valve performed at Cardiac Surgery Unit, Ospedali Riuniti di Ancona, during the period October 2018 to July 2022. Relevant prospectively collected preoperative, intraprocedural and postoperative data were retrieved from the Institutional database. A total of 413 patients were included in the study. Mean patients' age was 82 years and among them 44% (180/413) were male. STS score was 3.1% (2.2-4.4). Eighty patients underwent transapical TAVI and 333 patients had a TF approach. We progressively moved from transapical TAVI towards TF procedures that are now routinely performed on conscious sedation and using a fully percutaneous approach. After TF TAVI, 30-day mortality rate was 1%, cerebral stroke occurred in 2% of the cases, permanent pacemaker implantation was necessary in 23% of the patients and in 6% of the cases there was a moderate/severe degree of aortic regurgitation. There was no association between operators performing TAVI and 30-day mortality. The acquisition of catheter-based skills and an adequate training allowed cardiac surgeons to perform on their own awake and fully percutaneous TF TAVI with similar results when compared with major randomized clinical trials and registries' experiences.

Transcatheter aortic valve durability: a contemporary clinical review.

Encouraged by randomized controlled trials demonstrating non-inferiority of transfemoral transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) across all surgical risk categories, there has been a dramatic increase in the use of TAVI in a younger patient cohort with severe aortic stenosis, endorsed by both European and American Cardiac Societies. However, the standard use of TAVI in younger, less co-morbid patients with a longer life expectancy can only be supported if there is sound data demonstrating long-term durability of transcatheter aortic valves (TAVs). In this article, we have reviewed available randomized and observational registry clinical data pertaining to TAV long-term durability, placing emphasis on trials and registries using the new standardized definitions of bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF). Despite inherent difficulties in interpreting the available data, the determination reached is that the risk of structural valve deterioration (SVD) is potentially lower after TAVI than SAVR at 5 to 10 years, and that the two treatment modalities have a similar risk of BVF. This supports the adoption of TAVI in younger patients evident in current practice. However, the routine use of TAVI in younger patients with bicuspid aortic valve stenosis should be cautioned due to insufficient long-term TAV durability data in this particular patient population. Finally, we highlight the importance of future research into the unique potential mechanisms that can potentially contribute to TAV degeneration.

Pacing-Related Differences After SAPIEN-3 TAVI: Clinical and Echocardiographic Correlates

Data regarding the impact of pacing on outcomes after transcatheter aortic valve implantation (TAVI) is evolving especially with regards to pre-existing permanent pacemaker (PPM). We examined the impact of new and previous PPM on the clinical and hemodynamic outcomes after SAPIEN-3 TAVI. We included all consecutive patients who underwent transfemoral TAVI using SAPIEN-3 valve from 2015 to 2018 at our institution. Among 1,028 patients, 10.2% required a new PPM within 30days, whereas 14% had a pre-existing PPM. The presence of either previous or new PPM had no impact on the 3-year mortality (log-rank p=0.6) or 1-year major adverse cardiac and cerebrovascular events (log-rank p=0.65). New PPM was associated with lower left ventricular (LV) ejection fraction (LVEF) at both 30days (54.4 ± 11.3% vs 58.4 ± 10.1%, p=0.001) and 1year (54.2 ± 12% vs 59.1 ± 9.9%, p=0.009) than no PPM. Similarly, previous PPM was associated with worse LVEF at 30days (53.6 ± 12.3%, p <0.001) and 1year (55.5 ± 12.1%, p=0.006) than no PPM. Interestingly, new PPM was associated with lower 1-year mean gradient (11.4 ± 3.8 vs 12.6 ± 5.6mm Hg, p=0.04) and peak gradient (21.3 ± 6.5 vs 24.1 ± 10.4mm Hg, p=0.01), despite no baseline differences. Previous PPM was also associated with lower 1-year mean gradient (10.3 ± 4.4mm Hg, p=0.001) and peak gradient (19.4 ± 8mm Hg, p <0.001) and higher Doppler velocity index (0.51 ± 0.12 vs 0.47 ± 0.13, p=0.039). Moreover, 1-year LV end-systolic volume index was higher with new (23.2 ± 16.1 vs 20 ± 10.8ml/m2, p=0.038) and previous PPM (24.5 ± 19.7, p=0.038) than no PPM. Previous PPM was associated with higher moderate-to-severe tricuspid regurgitation (35.3% vs 17.7%, p <0.001). There were no differences regarding the rest of the studied echocardiographic outcomes at 1year. In conclusion, new and previous PPM did not affect 3-year mortality or 1-year major adverse cardiac and cerebrovascular events; however, they were associated with worse LVEF, higher 1-year LV end-systolic volume index, and lower mean and peak gradients on follow-up than no PPM.

Multicenter comparison of transcatheter aortic valve implantation with the self-expanding ACURATE neo2 versus Evolut PRO transcatheter heart valves

BackgroundNew-generation self-expanding transcatheter aortic heart valves (THV) were designed to overcome technical constraints of their preceding generations. We sought to compare the efficacy and safety of the self-expanding ACURATE neo2 (Neo2) versus Evolut PRO (PRO) devices.MethodsSeven hundred nine patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with either Neo2 (n = 496) or PRO (n = 213) were included. Propensity score matching (PSM) was performed to account for differences in baseline characteristics. In-hospital and 30-day clinical outcomes were evaluated according to Valve Academic Research Consortium-3 criteria.ResultsBaseline characteristics were comparable between both groups after PSM (Neo2: n = 155, Evolut Pro: n = 155). Technical success rates were high in both groups (Neo2: 94.8% vs PRO: 97.4%; p = 0.239). Need for permanent pacemaker implantation was less frequent with Neo2 compared with PRO (7.5% vs 20.6%; p = 0.002), whereas major vascular complications were more frequent with Neo2 (Neo2: 11.6% vs PRO: 4.5%; p = 0.022). Intended valve performance at discharge was high in both groups without relevant differences among groups (Neo2: 97.4% vs. 95.3%; p = 0.328).ConclusionsShort-term outcomes after TAVI using latest-generation self-expanding THV were excellent, with overall low rates of adverse events. However, Neo2 was associated with lower pacemaker rates and reduced the prevalence of moderate–severe paravalvular leakage. Transprosthetic gradients after TAVI were higher with Neo2 compared with PRO.Graphical abstract

Network Meta-Analysis Comparing Transcatheter, Minimally Invasive, and Conventional Surgical Aortic Valve Replacement

The landscape of aortic valve replacement (AVR) has evolved dramatically over the years, but time-varying outcomes have yet to be comprehensively explored. This study aimed to compare the all-cause mortality among 3 AVR techniques: transcatheter (TAVI), minimally invasive (MIAVR), and conventional AVR (CAVR). An electronic literature search was performed for randomized controlled trials (RCTs) comparing TAVI with CAVR and RCTs or propensity score-matched (PSM) studies comparing MIAVR with CAVR or MIAVR to TAVI. Individual patient data for all-cause mortality were derived from graphical reconstruction of Kaplan-Meier curves. Pairwise comparisons and network meta-analysis were conducted. Sensitivity analyses were performed in the TAVI arm for high risk and low/intermediate risk, as well as patients who underwent transfemoral (TF) TAVI. A total of 27 studies with 16,554 patients were included. In the pairwise comparisons, TAVI showed superior mortality to CAVR until 37.5months, beyond which there was no significant difference. When restricted to TF TAVI versus CAVR, a consistent mortality benefit favoring TF TAVI was seen (shared frailty hazard ratio [HR] = 0.86, 95% confidence interval [CI] = 0.76 to 0.98, p = 0.024). In the network meta-analysis involving majority PSM data, MIAVR demonstrated significantly lower mortality than TAVI (HR = 0.70, 95% CI = 0.59 to 0.82) and CAVR (HR = 0.69, 95% CI = 0.59 to 0.80); this association remained compared with TF TAVI but with a lower extent of benefit (HR = 0.80, 95% CI = 0.65 to 0.99). In conclusion, the initial short- to medium-term mortality benefit for TAVI over CAVR was attenuated over the longer term. In the subset of patients who underwent TF TAVI, a consistent benefit was found. Among majority PSM data, MIAVR showed improved mortality compared with TAVI and CAVR but less than the TF TAVI subset, which requires validation by robust RCTs.

One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.

Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce. We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3). The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year. The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups. Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Application value of image fusion technology in transcatheter aortic valve implantation

Objective: To analysis the application value of image fusion technology in transcatheter aortic valve implantation (TAVI). Methods: A total of 35 patients underwent trans-femoral TAVI using the first-generation VENUS-A valve in Heart Center of Henan Provincial People's Hospital from January 2020 to May 2021 were analyzed retrospectively. Among them, there were 21 males and 14 females, aged from 64 to 81 years, with a mean (SD) of (71.37±5.66) years. They were divided into conventional group (n=22) and fusion group (n=13), according to whether image fusion technology was used during operation. The preoperative general data, intraoperative data, differences of postoperative renal function and residence time in intensive care unit (ICU) were analyzed and compared between the two groups. The postoperative echocardiography and 12 lead ECG were observed. Results: All 35 patients in this study were with severe aortic stenosis, of which, 10 patients were complicated with moderate to severe regurgitation. Compared with the conventional group, the intraoperative fusion group had fewer angiography times [3.0 (3.0, 4.0) vs 5.0 (5.0, 6.0)], X-ray absorbed dose [342.0 (44.5) mGy vs 388.4 (71.0) mGy], and contrast dosage [(73.5±10.5) ml vs (90.3±10.3) ml], and shorter rapid pacing time [(14.0±1.6) seconds vs (16.5±2.0) seconds] (all P<0.05). There was no significant differences in X-ray irradiation time, operation time, sizing of the pre-dilated balloon, valve implantation depth and other indicators (all P>0.05). There was no significant differences in ICU retention time and postoperative renal function (all P>0.05). Postoperative echocardiography showed that the function of aortic valve was good, with mild perivalvular leakage in 2 cases in the conventional group and 1 case in the fusion group; and one patient was implanted with permanent pacemaker after TAVI in the conventional group. Conclusion: Image fusion technology simplifies the TAVI process, shortens the ventricular pacing time and reduces the dosage of X-ray and contrast, and has certain clinical application value.

Clinical outcomes in women and men with small aortic annuli undergoing transcatheter aortic valve implantation: A multicenter, retrospective, propensity score-matched comparison

BackgroundSex-specific characteristics in patients with aortic stenosis and small annuli undergoing transcatheter aortic valve implantation (TAVI) might affect clinical outcomes and hemodynamics. MethodsTAVI-SMALL 2 international retrospective registry included 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area < 400 mm2) treated with transfemoral TAVI at 16 high-volume centers between 2011 and 2020. Women (n = 1233) were compared with men (n = 145). One-to-one propensity score (PS) matching resulted in 99 pairs. Primary endpoint was incidence of all-cause mortality. Incidence of pre-discharge severe prosthesis-patient mismatch (PPM) and its association with all-cause mortality were investigated. Binary logistic and Cox regression were performed to adjust the treatment effect for PS quintiles. ResultsIncidence of all-cause mortality at a median follow-up of 377 days did not differ between sex in the overall (10.3 vs. 9.8%, p = 0.842) and PS-matched (8.5 vs. 10.9%, p = 0.586) populations. After PS matching, pre-discharge severe PPM was numerically higher in women vs. men (10.2 vs. 4.3%), even though no evidence of a difference was found (p = 0.275). Within the overall population, women with severe PPM suffered a higher incidence of all-cause mortality when compared to those with less than moderate PPM (log-rank p = 0.024) and less than severe PPM (p = 0.027). ConclusionsNo difference in all-cause mortality at medium-term follow-up was observed between women and men with aortic stenosis and small annuli undergoing TAVI. Incidence of pre-discharge severe PPM was numerically higher in women than men, and it was associated with increased all-cause mortality in women.