Transfemoral Transcatheter Aortic Valve Implantation Research Articles

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.

Dedicated Next Day Discharge Post Minimalist TAVI: The Tasmanian Experience.

To assess the safety, feasibility and independent predictors of next day discharge (NDD) in patients undergoing minimalist transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) in a real-world Australian population. This single centre study reviewed 135 consecutive patients who underwent minimalist transfemoral TAVI from June 2020 to February 2022. Baseline demographics, procedural characteristic and outcomes were obtained. All patients were assessed by the local protocol for NDD. Patients were then divided into two groups: those who achieved next day discharge (NDD) and those requiring >1 overnight hospital stay. Univariate, bivariate and stepwise multivariate logistic regression modelling was used to identify the predictors of successful next day discharge. The mean age of the cohort was 82.9±5.7 years with 62.3% patients male, the average STS score was 4.1±2.4. All 135 patients underwent a successful transfemoral TAVI procedure, with 131 (97%) receiving a balloon-expandable valve. Ninety-seven (97) (71.9%) patients achieved NDD. Thirty (30)-day outcomes were excellent with a 30-day mortality of 0.7%, transient ischaemic attack/cardiovascular accident (TIA/CVA) 1.5%, major vascular complication 1.5% and 11.4% need for permanent pacemaker (PPM). In patients not achieving NDD, the average length of stay (LOS) was 3.0 days. Baseline characteristics demonstrated pre-existing first degree atrioventricular (AV) block and right bundle branch block (RBBB) as statistically significant negative predictors of NDD on univariate analysis. Next day discharge was achievable in only 50% of patients who suffered any minor or major procedural complication (15/30). Stepwise multivariate logistic regression modelling demonstrated female gender (OR 3.094, 95% CI 1.141-8.391, p=0.026), smaller aortic valve area (AVA) (OR 48.265, 95% CI 2.269-102.6, p=0.013), the presence of diabetes mellitus (OR 0.594, 95% CI 0.356-0.991, p=0.046) and a longer procedure time (OR 0.960, 95% CI 0.935-0.986, p=0.002) as statistically significant negative predictors of NDD. In addition, there was no difference in 30-day readmission rates between the NDD and non-NDD cohort (7.2% vs 10.5%, p=0.386). Next day discharge is safe and feasible in almost three quarters of patients undergoing minimalist TAVI for severe AS in a predominantly balloon expandable valve cohort, with a very low rate of 30-day readmission. NDD provides advantages for hospital efficiency and improved cost-effectiveness. Female gender, smaller AVA, the presence of diabetes mellitus and a longer procedure time were independent negative predictors of successful NDD.

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC). We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective. Methods: Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enrolled. The primary outcome measure was a composite of major/life-threatening bleeding, stroke, and all-cause mortality at 30 days. In total, 584 patients underwent TAVI under continued OAC with 294 (50.3%) patients receiving VKA and 290 (49.7%) patients receiving NOAC. At 30 days, the composite primary outcome had occurred in 51 (17.3%) versus 36 (12.4%) patients with continued VKA and with continued NOAC, respectively (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.43-1.07; p=0.092). Rates of major/life-threatening bleeding (OR 0.87, 95% CI: 0.52-1.47; p=0.606) and stroke (OR 1.02, 95% CI: 0.29-3.59; p=0.974) were not different between groups. In a multivariate Cox regression analysis, continued NOAC, compared with continued VKA, was associated with a lower risk for all-cause 1-year mortality (hazard ratio [HR] 0.61, 95% CI: 0.37-0.98; p=0.043). The analysis of the propensity score-matched cohort revealed similar results. Continued NOAC compared with continued VKA during TAVI led to comparable outcomes with regard to the composite outcome measure indicating that continued OAC with both drugs is feasible. These hypothesis-generating results need to be confirmed by a dedicated randomised controlled trial.

Intermediate Follow-Up of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annuli

The clinical impact of prosthesis-patient mismatch (PPM) in patients with small aortic annuli who underwent transcatheter aortic valve (AV) implantation with either balloon-expandable (BE) or self-expanding (SE) valves remains controversial. We assessed in-hospital and intermediate clinical outcomes in 573 patients with transfemoral transcatheter AV implantation with a small AV annulus, defined as an AV annulus area ≤430mm2. A total of 337 patients treated with a 23-mm BE valve (SAPIEN 3, Ultra) were compared with 236 patients treated with a 26-mm SE valve (Evolut series). Valve-in-valve cases were excluded, and late echo follow-up (mean 674 ± 438days) was assessed in a subset of 292 patients (51.0%). Well-matched BE and SE cohorts did not differ with respect to major in-hospital outcomes, other than a borderline increase in vascular complications and composite bleeding in patients with SE. Patients with BE had a higher incidence of severe PPM on discharge echocardiography (16.9% vs 6.8%, p <0.002). The mean AV gradient at 30days was higher for patients with BE (12.2 ± 4.2 vs 6.2 ± 7.9mm Hg, p <0.001) and at late follow-up (14.0 ± 8.2 vs 7.2 ± 3.5mm Hg, p <0.001). The follow-up left ventricular ejection fraction and incidence of >mild aortic insufficiency were similar. All-cause mortality for the 2 cohorts was similar, with an overall mean (95% confidence interval) survival time of 61.2months (57.8 to 64.5; p=0.98). There were no significant survival differences between combined patients with BE and SE with no, moderate, or severe PPM, with an overall mean (95% confidence interval) survival time of 32.5 (30.5 to 34.5)months combining valve types (p=0.23). In conclusion, despite an increased incidence of PPM with higher mean AV gradients that persist on late echocardiography in the BE cohort, patients with BE and SE with small aortic annuli have similar clinical outcomes at intermediate follow-up. Moderate and severe PPM had no impact on survival at a mean follow-up of 32.5months.

Iliofemoral artery predilation prior to transfemoral transcatheter aortic valve implantation in patients with aortic valve stenosis and advanced peripheral artery disease

To investigate the feasibility and safety of percutaneous transluminal angioplasty (PTA) of the iliofemoral arteries (IFA) before transfemoral transcatheter aortic valve implantation (Tf-TAVI) in patients with advanced peripheral artery disease (PAD). Although Tf-TAVI represents the access of choice, alternative vascular access routes are preferred for patients displaying advanced PAD. PTA of the IFA represents a less invasive option, broadening the spectrum of patients eligible for Tf-TAVI. All patients requiring PTA of the IFA before Tf-TAVI, between 2012 and 2021, were included. Primary efficacy endpoint was the rate of successful transcatheter heart valve (THV) delivery and implantation. Primary safety endpoint was the rate of PTA and access-site-related vascular complications, procedural- and in-hospital complications. Among 2726 Tf-TAVI procedures, 59 patients required IFA predilation. Successful THV delivery and implantation was achieved in 57 (96.6%) patients, respectively. Sheath placement was achieved in 59 (100%) patients with only one minor dissection and no major vascular complications following iliofemoral PTA. Regarding access site complications, two (3.4%) vessel perforations and one (1.7%) vessel rupture were observed, with eight (13.5%) patients requiring unplanned endovascular interventions. There was one intraprocedural death due to THV-induced vessel laceration, while in-hospital all-cause mortality was 8.5% in the present high-risk patient cohort. Predilation of IFA is safe and effective in patients with advanced PAD. Careful preprocedural planning is paramount in improving procedural safety and efficacy. This strategy has the potential to broaden the spectrum of patients eligible for Tf-TAVI.

Similar 5-Year Survival in Transfemoral and Transapical TAVI Patients: A Single-Center Experience

Transapical transcatheter aortic valve implantation (TA-TAVI) is generally considered to be associated with increased morbidity and mortality compared with transfemoral transcatheter aortic valve implantation TAVI (TF-TAVI). We aimed to compare different patient risk profiles, access-related complications, and long-term survival using inverse probability treatment weighting. This is a retrospective, single-center analysis of 925 consecutive patients with aortic valve stenosis undergoing TF-TAVI (n = 802) or TA-TAVI (n = 123) at the University Hospital Basel, Switzerland, as a single procedure between September 2011 and August 2020. Baseline characteristics revealed a higher perioperative risk as reflected in the EuroSCORE II (geometric mean 2.3 (95% confidence interval (CI) 2.2 to 2.4) vs. 3.7 (CI 3.1 to 4.5); before inverse probability of treatment weighting (IPTW) p < 0.001) in the transfemoral than in the transapical group, respectively. After 30 days, TF-TAVI patients had a higher incidence of any bleeding than TA-TAVI patients (TF-TAVI n = 146 vs. TA-TAVI n = 15; weighted hazard ratio (HR) 0.52 (0.29 to 0.95); p = 0.032). After 5 years, all-cause mortality did not differ between the two groups (TF-TAVI n = 162 vs. TA-TAVI n = 45; weighted HR 1.31, (0.92 to 1.88); p = 0.138). With regard to our data, we could demonstrate, despite a higher perioperative risk, the short- and long-term safety and efficacy of the transapical approach for TAVI therapies. Though at higher perioperative risk, transapically treated patients suffered from less bleeding or vascular complications than transfemorally treated patients. It is of utmost interest that 5-year mortality did not differ between the groups.

The Influence of the Learning Curve on Clinical Outcomes in Balloon-Expandable versus Self-Expandable Transfemoral Transcatheter Aortic Valve Implantation.

Balloon-expandable (BE) and self-expandable (SE) prostheses are the main types of devices currently used in transcatheter aortic valve implantation (TAVI). Despite the different designs, clinical practice guidelines do not make any specific recommendation on the selection of one device over the other. Most operators are trained in using both BE and SE prostheses, but operator experience with each of the two designs might influence patient outcomes. The aim of this study was to compare the immediate and mid-term clinical outcomes during the learning curve in BE versus SE TAVI. The transfemoral TAVI procedures performed in a single center between July 2017 and March 2021 were grouped according to the type of implanted prosthesis. The procedures in each group were ordered according to the case sequence number. For each patient, a minimum follow-up time of 12 months was required for inclusion in the analysis. The outcomes of the BE TAVI procedures were compared with the outcomes of the SE TAVI procedures. Clinical endpoints were defined according to the Valve Academic Research Consortium 3 (VARC-3). The median follow-up time was 28 months. Each device group included 128 patients. In the BE group, case sequence number predicted mid-term all-cause mortality at an optimal cutoff value ≤58 procedures (AUC 0.730; 95% CI: 0.644-0.805; p &lt; 0.001), while in the SE group, the cutoff value was ≤85 procedures (AUC 0.625; 95% CI: 0.535-0.710; p = 0.04). A direct comparison of the AUC showed that case sequence number was equally adequate in predicting mid-term mortality, irrespective of prosthesis type (p = 0.11). A low case sequence number was associated with an increased rate of VARC-3 major cardiac and vascular complications (OR 0.98 95% CI: 0.96-0.99; p = 0.03) in the BE device group, and with an increased rate of post-TAVI aortic regurgitation ≥ grade II (OR 0.98; 95% CI: 0.97-0.99; p = 0.03) in the SE device group. In transfemoral TAVI, case sequence number influenced mid-term mortality irrespective of prosthesis type, but the learning curve was longer in the case of SE devices.

Aortic stenosis: TAVI for all patients?

Over the last 21 years, the paradigm has shifted from an initial use of TAVI for inoperable aortic stenosis cases to recognition of its benefits for all categories of patients. Since 2021, the European Society of Cardiology has recommended first-line transfemoral TAVI from the age of 75 for all categories of patients with aortic stenosis (high, intermediate, low risk). However, in Switzerland, the Federal Office of Public Health currently places a restriction on the reimbursement of low-risk patients, which is expected to be reassessed in 2023. Surgery remains the best therapeutic option for patients with an unfavorable anatomy and for those whose life expectancy exceeds the potential durability of the valve. In this article we will discuss the evidence supporting TAVI, its current indications and initial complications as well as areas for improvement to potentially further expand its indications.

457 CORONARY ROTATIONAL ATHERECTOMY AFTER TAVI: A PROCEDURAL CHALLENGE

Abstract Background Selective cannulation must be ensured especially in patient with coronary artery disease (CAD). Commissural alignment in self-expanding transcatheter heart valve (THV) is fundamental to facilitate subsequent coronary reaccess. Clinical Scenario A man of 84 years old, suffering from hypertension, dyslipidemia, diabetes mellitus, third stage of chronic kidney disease and obesity was admitted in our hospital for treatment. He had angina and dyspnea with a third NYHA class. The echocardiogram showed severer aortic stenosis with mean gradient of 48 mmHg and aortic valve area of 0.6cmq with preserved ejection fraction. He was eligible for transfemoral transcatheter aortic valve implantation (TAVI) and he had intermediate risk score. The preprocedural coronary angiogram revealed subocclusive and severe calcified lesion on mid circumflex artery. Methods The Acurate NEO 2 size L THV was chosen and was planned to implant the bioprosthesis with commissural orientation correlated to the native commeasures, selecting at the CT scan the projection of cusp overlap (right and left coronary cusp on the right of the screen). The delivery catheter was inserted into the introducer sheath with its flush port facing the six o’clock position and the after crossing the aortic arch and native annulus, the handle of the delivery catheter was torqued clockwise until 1 of the Acurate NEO 2 commissural posts faced the commissural of the aortic root. The final angiogram showed optimal position and orientation of the THV without paravalvular leak. The patient was discharged the next day with a mean gradient of 9mmHg. One month after TAVI, elective PCI was performed. We’ve prepared the lesion with rotational atherectomy, due to severe calcification. Three forward advancements of rotating abrasive burr was performed and subsequently one DES was implanted. The angiogram check showed excellent result with TIMI 3 flow. Conclusion The Acurate Neo 2 supra-annular valve platform provides a successful coronary cannulation. Coronary rotational atherectomy for severe calcified lesions after TAVI with Acurate Neo 2 is a feasible strategy

735 CLINICAL EFFICACY OF CEREBRAL EMBOLIC PROTECTION IN TRANSFEMORAL TAVI PROCEDURE

Abstract Background Although in the context of Transcatheter Aortic Valve Implantation (TAVI) technological improvements, refinements in technique and increased operator experience have led to progressive reduction in most complications, periprocedural neurological ischemic event (stroke and TIA) continues to occur in up to 2% of patients undergoing TAVI. Many of these are attributed to embolic events during the procedure and can lead to potentially devastating consequences. Cerebral Embolic Protection (CEP) devices have been developed to mitigate this risk. Data regarding the clinical efficacy of these devices in preventing neurological events in TAVI are conflicting. The aim of the present study is to investigate the impact of CEP on clinical neurological events in TAVI. Methods We performed a multicentric retrospective observational case-control study to evaluate the rate of periprocedural clinical neurological ischemic event in patients undergoing transfemoral TAVI with or without using CEP (Sentinel, Boston Scientific) during the procedure. Patients were consecutively enrolled between January 2018 and December 2021 by two tertiary centers (Verona and Ancona). A total population of 1042 patients were enrolled. The primary endpoint was the rate of a periprocedural clinical neurological ischemic event. The secondary was a composite endpoint: in-hospital death, periprocedural major vascular complication and periprocedural major bleeding. Clinical events at 30-day follow-up were evaluated (death, clinical neurological ischemic event, vascular complications, major bleeding). In consideration of the retrospective study design, we performed a propensity match analysis to account for differences in the baseline characteristics of patients in the two enrolling centers. Results The overall population comprised patients who underwent TAVI without using CEP (No-CEP group, n=581) and with CEP (CEP group, n=461). The propensity match analysis yielded a final population of 922 patients: 461 patients in the No-CEP group and 461 patients in the CEP group. There were no differences in baseline characteristics between the groups. Primary endpoint occurred in 8 (0,9%) patients overall, 3 (0,7%) patients in the No-CEP group and in 5 (1,1%) patients in CEP group (p=0,725). There were no differences in secondary endpoint: 25 (5,4) patients in No-CEP group and 20 (4,3%) in CEP group (p=0,541). In particular: in-hospital death (0,7% vs 1,3%, p=0,506), periprocedural major vascular complications (2,0% vs 0,7%, p=0,143), periprocedural major bleeding (5,0% vs 3,0%, p=0,179). No differences were observed in 30-days outcomes: death (0,0% vs 0,9%, p=0,131), clinical neurological ischemic events (0,8% vs 0,7%, p=1), vascular complications (0,3% vs 0,0%, p=0,450), major bleeding (0,8% vs 0,7%, p=1). The multiple logistic regression performed to estimate the effect of CEP on the primary endpoint showed Euroscore II (OR, 1.10; 95% CI, 1.00–1.19; P=0.028) and predilatation (OR, 4.84; 95% CI, 1.21–21.64; P=0.028) was associated with an increase in primary endpoint after TAVI, while CEP and valve type did not contribute significantly. Conclusions This study suggests that using CEP devices during transfemoral TAVI is safe and does not increase vascular complications, although it does not impact the rate of periprocedural clinical neurological ischemic events.

460 BIOPROSTHESIS HEMODYNAMICS AND CORONARY FLOW AFTER TAVI IN TAVI

Abstract Background TAVI-in-TAVI is a complex intervention, potentially associated with feared complications such as coronary artery obstruction or Sinus of Valsalva (SOV)sequestration. Coronary obstruction risk is high when the degenerated bioprosthesis has supra-annular leaflets, the sinus of Valsalva is effaced, and/or sino-tubular Junction (STJ) is narrow. Clinical Case A 91 years old man, underwent TAVI with Acurate NEO M in 2016 with good results: post procedural mean gradient was 8mmHg and PVL was mild. He was admitted in our Institute after six years from index procedure for an episode of acute heart failure with echocardiogram findings of prolapse of one of the prosthetic leaflet causing severe aortic regurgitation without signs of active endocarditis. He was a potential candidate for transfemoral TAVI in TAVI and he had an intermediate risk score. The most important phase of this procedure was a careful planning through the preprocedural CTA. The potential maximal neoskirt of the Acurate M is 30mm. In this case, on one hand, we had wide SOV of 33mm of diameter and wide STJ of 30mm of diameter, on the other hand we had a left main ostia height of 15.5mm, a right coronary artery ostia height of 14mm and a STJ height of 25mm from the basal plane of the transcatheter heart valve (THV), hence we excluded THV with higher frame as Evolut or Acurate to prevent the formation of a long-covered stent of at least 23-24mm and 29-30mm respectively. In the trasversal annular plane obtained by multiplanar CT reconstruction we implanted a “virtual” valve at the geometric center simplified as a cylinder with a diameter of 23 mm to measure the valve to coronary (VTC) and valve to sino-tubular junction (VTSTJ) distance obtaining safe values of 5mm and 8mm respectively, both above the high risk threshold of 4mm for VTC and 2,5-3,5mm for VTSTJ. We chose a SAPIEN ULTRA 23mm for its short frame with a potential maximal neoskirt of 18mm and for its open cell strut to facilitate coronaries reaccess at the cost of a higher degree of first THV leaflets overhang. We decided to perform a low implant with more percentage of overhang THV but a low risk of coronaries flow impairment. Results Excellent result with correct positioning, coronaries patency and absence of leak. The selective cannulation of both coronaries was performed easily and successfully. The patient was discharged the next day with stable haemoglobin and a mean gradient of 8mmHg with no intraprosthetic aortic regurgitation. Conclusion In case of leaflets degeneration with preserved mobility, the low implantation a short frame THV could preserve the formation of the neoskirt above the top of its frame and determining an overhang of first THV leaflets without precluding acute and short-term hemodynamics Discussion In consideration of the expansion of TAVI indication even in younger patients we will encounter an increase of TAVI in TAVI procedures, therefore it is essential to familiarize with CTA reconstructions to assess the risk of direct or indirect coronary occlusion and to do the best THV choice according to the cause of the dysfunction and the anatomical features.

Effect of remimazolam on the incidence of delirium after transcatheter aortic valve implantation under general anesthesia: a retrospective exploratory study.

Delirium after transcatheter aortic valve implantation (TAVI) should be prevented because it is associated with worse patient outcomes. Perioperative administration of benzodiazepines is a risk factor for postoperative delirium; however, the association between remimazolam, a newer ultrashort-acting benzodiazepine for general anesthesia, and postoperative delirium remains unclear. This study aimed to evaluate whether remimazolam administration during TAVI under general anesthesia affected the incidence of postoperative delirium. This single-center retrospective study recruited all adult patients who underwent transfemoral TAVI (TF-TAVI) under general anesthesia between March 2020 and May 2022. Patients were divided into the remimazolam (R) and propofol (P) groups according to the sedative used for anesthesia. In the R group, all patients received flumazenil after surgery. The primary endpoint was the incidence of delirium within 3days after surgery. Factors associated with delirium after TF-TAVI were examined by multiple logistic regression analysis. Ninety-eight patients were included in the final analysis (R group, n = 40; P group, n = 58). The incidence of postoperative delirium was significantly lower in the R group than in the P group (8% vs. 26%, p = 0.032). Multiple logistic regression analysis revealed that remimazolam (odds ratio 0.17, 95% CI 0.04-0.80, p = 0.024) was independently associated with the incidence of postoperative delirium, even after adjustment for age, sex, preoperative cognitive function, history of stroke, and TF-TAVI approach. Remimazolam may benefit TF-TAVI in terms of postoperative delirium; however, its usefulness must be further evaluated in extensive prospective studies.

Transfemoral aortic valve implantation: procedural hospital volume and mortality in Germany.

Studies assessing transfemoral transcatheter aortic valve implantation (TF-TAVI) showed lower rates of in-hospital mortality at high-volume hospitals and minimum caseloads were recommended to assure quality standards. All patients in the German mandatory quality assurance registry with elective or urgent TF-TAVI procedures in 2018 and 2019 at 81 and 82 hospitals, respectively, were analysed. Observed in-hospital mortality was adjusted to expected mortality by the German AKL-KATH score (O/E) as well as by the EuroScore II (O/E2). Hospital volume and O/E were correlated by regression analyses and volume quartiles. 18 763 patients (age: 81.1 ± 1.0 years, mean EuroSCORE II: 6.9 ± 1.8%) and 22 137 patients (mean age: 80.7 ± 3.5 years, mean EuroSCORE II: 6.5 ± 1.6%) were analysed in 2018 and 2019, respectively. The average observed in-hospital mortality was 2.57 ± 1.83% and 2.36 ± 1.60%, respectively. Unadjusted in-hospital mortality was significantly inversely related to hospital volume by linear regression in both years. After risk adjustment, the association between hospital volume and O/E was statistically significant in 2019 (R2 = 0.049; P = 0.046), but not in 2018 (R2 = 0.027; P = 0.14). The variance of O/E explained by the number of cases in 2019 was low (4.9%). Differences in O/E outcome between the first and the fourth quartile were not statistically significant in both years (1.10 ± 1.02 vs. 0.82 ± 0.46; P = 0.26 in 2018; 1.16 0 .97 vs. 0.74 ± 0.39; P = 0.084 in 2019). Any chosen volume cut-off could not precisely differentiate between hospitals with not acceptable quality (>95th percentile O/E of all hospitals) and those with acceptable (O/E ≤95th percentile) or above-average (O/E < 1) quality. For example, in 2019 a cut-off value of 150 would only exclude one of two hospitals with not acceptable quality, while 20 hospitals with acceptable or above-average quality (25% of all hospitals) would be excluded. The association between hospital volume and in-hospital mortality in patients undergoing elective TF-TAVI in Germany in 2018 and 2019 was weak and not consistent throughout various analytical approaches, indicating no clinical relevance of hospital volume for the outcome. However, these data were derived from a healthcare system with restricted access to hospitals to perform TAVI and overall high TAVI volumes. Instead of the unprecise surrogate hospital volume, the quality of hospitals performing TF-TAVI should be directly assessed by real achieved risk-adjusted mortality.

A new trend to reduce adverse events in patients undergoing transcatheter aortic valve implantation: cusp overlap technique: a cross sectional study.

Transcatheter aortic valve implantation (TAVI) is currently the treatment of choice for the majority of patients at moderate or high surgical risk. However, some complications occur frequently with this procedure. In this study, we aimed to assess whether the cusp-overlap view (COP) technique may be associated with a reduced incidence of some of these complications compared with the classical three-cusp view (TCV) technique. In this single-center, retrospective study we investigated; technical success, postprocedural permanent pacemaker implantation (PPMI), new-onset stroke, pericardial tamponade, arrhythmia development, acute renal failure, major bleeding, major vascular complications, procedure-related coronary obstruction, new-onset left bundle branch block (LBBB), paravalvular leak, peri-procedural myocardial infarction (MI), day of hospitalization, death, and major adverse cardiac and cerebrovascular events (MACCE) were determined as the clinical endpoints. A total of 281 consecutive patients who met the study criteria and underwent elective or emergency transfemoral TAVI using the self-expandable CoreValve Evolut valve were included. 176 consecutive patients implanted with the classical TCV technique and 105 consecutive patients implanted with the COP technique were compared. Compared with the TCV group, patients in the COP group had lower PPMI (3.8% vs. 10.8%, p = 0.039), in-hospital mortality (1.9% vs. 8.5%, p = 0.018), and 1-year death (4.8% versus 18.8%, p = 0.001), and MACCE rates (12.4% vs 31.3%, p < 0.001). The COP technique may help to reduce the conduction disturbances, PPMI requirement and complication rates that may develop following TAVI. In addition, it is an interesting result that it reduces mortality and MACCE rates in long-term follow-ups.

REGIONAL NERVE BLOCK FOR SUBCLAVIAN ACCESS TAVI

Transcatheter aortic valve implantation (TAVI) program has started in the UK in 2007 performing 66 cases a year, the number of cases of TAVI done every year has been exponentially increasing since then to reach 6076 cases in the year 2020. (Ludman) The UK TAVI registry has shown a nationwide shift in practice from general anaesthesia to conscious sedation for trans-femoral access TAVI, analysis has shown a fall of In-hospital mortality from 4.7 in 2012 to 1.8% in 2016 (Ludman). This shift, however, has not occurred in the same way for other arterial access like trans-subclavian or trans-axillary, which is still widely practiced in the UK under general anaesthesia. The vast majority of cases in the UK are done through the femoral access, however, finding an alternative approach is sometimes needed due to contraindication to the standard femoral approach, mostly vasculopathy, which usually indicates higher risk patient and higher likelihood of associated co-morbidities. Performing the alternative access TAVI under general anaesthesia adds more risk to the patient and in some cases could be life threatening, some of these patients could be deemed unfit for the procedure. Finding an alternative anaesthetic technique will allow these patients to have their procedures done with lower risk and have the optimum chance for quicker recovery. The technique of combining Superficial cervical plexus block, interscalene block with Pectoral block type II was first described in 2018 by Alexander et al and reproduced by Block et al in the United States in the same year to allow for performing subclavian access TAVI without general anaesthesia. The same technique was partially adopted with some modification by Vivian et al in Canada and Toscano et al in Italy in 2020 and 2021 respectively. In this manuscript we share our experience doing a series of subclavian access TAVI under regional nerve block and conscious sedation at the Freeman hospital in Newcastle upon Tyne, to our knowledge, and from literature search, this is the first time this is performed successfully in the UK as we didn't see any published reports on this technique within the country.

Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis

BackgroundDiabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI.MethodsThis multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding.ResultsOf the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8–1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9–1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9–1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9–1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9–2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35.ConclusionDM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients.Trial registrationThe study is registered at clinicaltrials.gov (NCT03588247).

Abstract 11421: Intervention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi): Does Carbon-Dioxide Flushing Reduce Vascular Brain Injury?

Background: Transcatheter Aortic Valve Implantation (TAVI) is associated with 2-3% clinical stroke rate and much higher incidence of silent cerebral infarction. This study investigated the neuroprotective benefits of minimising air emboli in TAVI. It aimed to demonstrate a reduction in vascular brain injury by flushing TAVI valves with CO 2 and saline compared to saline only as per standard practise. Methods: Patients undergoing transfemoral TAVI for aortic stenosis were enrolled. Patients were randomised to CO 2 and saline (TAVI-CO 2 ) versus saline only (TAVI-S) flushing of TAVI valves during preparation. Patients underwent MRI brain following TAVI to identify new cerebral infarcts and any reduction in vascular brain injury by reducing air emboli. Results: Twenty-Two patients were enrolled in the study with a mean age of 79±10 years. Fifteen (68%) were males. Nine patients (41%) had history of hypertension, 5 (23%) had previous cerebrovascular disease and 5 (23%) had diabetes. Two (9%) patients did not have their TAVI valve implanted and hence were excluded. No patients had any procedural related complications. Three (14%) patients required permanent pacemaker insertion post procedure and could not have their MRI. Fifteen patients (68%) had MRI brain post-TAVI, 7 patients in the TAVI-CO 2 group and 8 patients in the TAVI-S group. TAVI-CO 2 group had a total of 41 new cerebral lesions compared to 66 lesions in TAVI-S group. TAVI-CO 2 had on average 6.80 new lesions/patient compared to 8.25 lesions/patients in TAVI-S (p=0.34) Cerebral infarcts were also analysed according to valve type. In self-expanding valves (n=7), TAVI-CO 2 had 8 lesions/patient compared to 10 lesions/patient in TAVI-S (p=0.46). In balloon-expanding valves (n=8), TAVI-CO 2 had 4.25 lesions/patient compared to 6.25 lesions/patient in TAVI-S (p=0.25). Conclusion: There is a trend in the reduction in the number of new cerebral lesions in the TAVI-CO 2 arm compared to the TAVI-S patients. This is the first study that identifies the importance of air emboli in TAVI and the associated potential vascular brain injury. As brain injury remains a significant concern during TAVI, a larger randomised trial is required to further investigate the neuroprotective benefit of flushing TAVI valves with CO 2 .

Predictors of 1-Year Mortality in Men Versus Women Undergoing Transfemoral Transcatheter Aortic Valve Implantation

Although gender-related disparities in intermediate-term outcomes have been reported after transcatheter aortic valve implantation (TAVI), disparate predictors of mortality in men and women who underwent TAVI have not been well studied. This prospective institutional registry study included 297 consecutive patients (153 men, 144 women) who underwent transfemoral TAVI from December 2015 to June 2018 at an academic tertiary medical center. Baseline and clinical characteristics, procedural data, and clinical outcomes at 1year were recorded. Mortality rates at 1year were 11.1% and 20.3% in women and men, respectively (p=0.033). Risk-adjusted mortality was significantly higher in men who underwent TAVI than in women (odds ratio [OR] 2.45, 95% confidence interval [CI] 1.24 to 4.87, p=0.010). Gender-specific risk-adjusted predictors of 1-year mortality post-TAVI included the presence of atrial fibrillation (OR 4.20, 95% CI 1.31 to 13.46, p=0.016) and peripheral artery disease (OR 4.64, 95% CI 1.04 to 20.71, p=0.044) in women and presence of chronic obstructive pulmonary disease (OR 3.14, 95% CI 1.13 to 8.72, p=0.029), higher serum creatinine (OR 1.57, 95% CI 1.15 to 2.15, p=0.004), and lower body mass index (OR 0.88, 95% CI 0.80 to 0.97, p=0.008) in men. In this prospective institutional registry of adults who underwent TAVI, risk-adjusted 1-year mortality is significantly lower in women, and disparate predictors of risk-adjusted 1-year mortality exist in men and women.

Cerebral Ischemic Lesions after Transcatheter Aortic Valve Implantation in Patients with Non-Calcific Aortic Stenosis.

Evidence for transcatheter aortic valve implantation (TAVI) is scarce among patients with non-calcific aortic stenosis, and it is not known whether aortic valve calcification is associated with new cerebral ischemic lesions (CILs) that are detected by diffusion-weighted magnetic resonance imaging. So, our study enrolled 328 patients who underwent transfemoral TAVI using a self-expanding valve between December 2016 and June 2021 from the TORCH registry (NCT02803294). A total of 34 patients were finally confirmed as non-calcific AS and the remaining 294 patients were included in the calcific AS group. Incidence of new CILs (70.6% vs. 85.7%, <i>p</i> = 0.022), number of lesions (2.0 vs. 3.0, <i>p</i> = 0.010), and lesions volume (105.0 mm³ vs. 200.0 mm³, <i>p</i> = 0.047) was significantly lower in the non-calcific AS group. However, the maximum and average lesion volumes were comparable between two groups. Non-calcific AS was associated with lower risk for developing new CILs by univariate logistic regression analysis [Odds ratio (OR): 0.040, 95% confident interval (CI): 0.18-0.90, <i>p</i> = 0.026] and multivariate analysis (OR: 0.031, 95% CI: 0.13-0.76, <i>p</i> = 0.010). In summary, non-calcific AS patients had a lower risk of developing new cerebral ischemic infarction after TAVI compared to calcific AS patients. However, new ischemic lesions were still found in over 70% of patients.

Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation

The failure rate of vascular closure devices remains a significant cause of major vascular complications in contemporary transcatheter aortic valve implantation practice. This research aimed to evaluate use of the Angio-Seal device in a bailout context in the setting of incomplete hemostasis following use of dual Perclose ProGlide devices in patients undergoing transfemoral transcatheter aortic valve implantation. A total of 185 patients undergoing transfemoral transcatheter aortic valve implantation with either dual Per-close ProGlide (n = 139) or a combination of dual Perclose ProGlide and Angio-Seal (n = 46) were retrospectively analyzed. The baseline, procedural characteristics, and all outcomes (defined according to Valve Academic Research Consortium-2 criteria) were compared. No significant differences were seen between the dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups with regard to the in-hospital Valve Academic Research Consortium-2 primary end points of major vascular complications (n = 13 [9.4%] vs n = 2 [4.3%]; P = .36), minor vascular complications (n = 13 [9.4%] vs n = 8 [14.7%]; P = .14), major bleeding (n = 16 [11.5%] vs n = 2 [4.3%]; P = .25), and minor bleeding (n = 9 [6.5%] vs n = 5 [10.9%]; P = .34), with higher rates of hematoma in the dual Perclose ProGlide+Angio-Seal group (n = 4 [2.9%] vs n = 5 [10.9%]; P = .044). Finding from the current study suggest that adjunctive Angio-Seal deployment may be feasible and safe, especially in patients with incomplete hemostasis following dual Perclose ProGlide use, and can be an optimal "bailout" procedure.