Transfemoral Transcatheter Aortic Valve Implantation Procedures Research Articles

Procedure-related radiation and contrast use during TAVI procedures with balloon-expandable versus self-expanding devices

Abstract Background Transcatheter aortic valve implantation (TAVI) procedures show some fundamental differences, depending on the use of balloon-expandable (BEV) or self-expanding (SEV) devices. We aimed to assess, how it translates into contrast use and radiation exposure. Methods From five high volume European centers consecutive patients were included, who underwent transfemoral TAVI procedure. Patient- and procedural characteristics were recorded and compared in relation to the used TAVI device. Results In total 3131 patients were included. 53% were male and the mean age was 80±9 years. 1273 (41%) patients were treated with BEV, while 1858 (59%) with a SEV system. Patients, receiving SEV were older (81±9 vs 79±9 years, respectively; p<0.01) and were more often females (57% vs 33%, respectively; p<0.01). There was also a trend for less peripheral artery disease (14% vs 17%, respectively; p=0.06). Overall total radiation time was 15±9 min., that was markedly shorter for BEV than for SEV (13±8 vs. 17±10 min., respectively; p<0.01). On average 130±65 mL contrast media was used, that was less for BEV than for SEV (104±52 vs. 148±67 mL, respectively; p<0.01) In terms of contrast use, retrievable- and non-retrievable SEVs were comparable (148±71 vs. 146±63 mL, respectively; p=0.41), but both markedly higher, than for BEVs (p<0.01 for both). Non-retrievable SEVs required less radiation (14±7 vs. 18±10 mins, respectively; p<0.01), but still markedly more than BEVs (p<0.01). Conclusion TAVI procedures with BEV require shorter radiation exposure for the team and markedly less contrast, than with SEV. This might be reasonable to consider during patient-tailored procedure planning.Radiation and contrast usage during TAVI

Single-center experience with self-expanding transcatheter aortic valve system for symptomatic high-risk patients with severe aortic regurgitation: One-year outcomes.

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for the treatment of aortic regurgitation (AR). From September 2019 to February 2022, 62 patients who underwent transfemoral TAVI procedure for pure, symptomatic severe AR with the VitaFlow system were enrolled in the current study. The outcomes were assessed according to the Valve Academic Research Consortium 3 criteria. Procedural results and clinical outcomes for 1 year were analyzed. The mean age was 71.56 ± 7.34 years and 58.1% were male. The mean Society of Thoracic Surgeons score was 5.44 ± 3.22%. The device success rate was 79.0%. Only one patient was converted to open surgery. The in-hospital mortality rate was 1.6%. The 1-year all-cause mortality rate was 6.5%. The new permanent pacemaker implantation rate was 29.0% in-hospital and 30.7% at 1-year follow-up. The second valve implantation rate was 14.5%. No patient developed more than moderate paravalvular leakage during follow-up. The mean ejection fraction improved from 54.05 ± 10.83% at baseline to 59.32 ± 8.70% (p < 0.001 compared with baseline) at 12 months. Left ventricular end-diastolic diameter decreased from 61.62 ± 5.58 mm at baseline to 55.20 ± 4.51 mm (p < 0.001 compared with the baseline) at 12 months. Transfemoral TAVI procedure shows efficacy in treating patients with severe pure native AR. The safety is improved with the development of the VitaFlow system.

The role of the vascular surgeon in transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for severe aortic valve stenosis in patients at increased surgical risk. Percutaneous transfemoral (TF) is the access of choice due to its reduced invasiveness and perioperative morbidity/mortality compared with the trans-axillary, aortic, and apical routes. On the other hand, vascular access complications (VACs) of the TF access are associated with prolonged hospitalization, 30-day, and 1-year mortality. In addition, the concomitance of peripheral arterial disease may require associated endovascular management. A multidisciplinary team with Interventional Cardiologists and Vascular Surgeons may minimize the rate of VACs in patients with challenging femoral-iliac access or concomitant disease of other vascular districts, thus optimizing the outcome of TF-TAVI. The aim of this study was to evaluate the role of Vascular Surgeons in TF TAVI procedures. We conducted a retrospective single-center review of all TF-TAVI procedures assisted by Vascular Surgeons between January 2016 and December 2020 in a high-volume tertiary hospital. Pre, intra, and postoperative data were analyzed by a dedicated group of Interventional Cardiologists and Vascular Surgeons. VACs were defined according with the Valve Academic Research Consortium (VARC) three guidelines. The outcomes of TF-TAVI procedures with Vascular Surgeons involvement were assessed as study's endpoints. Overall, 937 TAVI procedures were performed with a TF approach ranging between 78% (2016) and 98% (2020). Vascular Surgeons were involved in 67 (7%) procedures with the following indications: concomitant abdominal aortic aneurysm (EVAR + TAVI) - 3 (4%), carotid stenosis (TAVI + CAS) - 2 (3%), hostile femoral/iliac access, or VACs - 62 (93%). Balloon angioplasty of iliac artery pre-TAVI implantation was performed in 51 cases (conventional PTA: 38/51%-75%; conventional PTA + intravascular lithotripsy: 13/51%-25%; stenting: 5/51%-10%). TAVI procedure was successfully completed by percutaneous TF approach in all 62 cases with challenging femoral/iliac access. VACs necessitating interventions were 18/937 (2%) cases, localized to the common femoral or common/external iliac artery in 15/18 (83%) and 3/18 (17%) cases, respectively. They were managed by surgical or endovascular maneuvers in 3/18 (17%) and 15/18 (83%) cases, respectively. Fifteen/18 (83%) VACs were treated during the index procedure. There was no procedure-related mortality or 30-day readmission. In our experience, Vascular Surgeon assistance in TAVI procedures was not infrequent and allowed safe and effective device introduction through challenging TF access. Similarly, the concomitant significant disease of other vascular districts could be safely addressed, potentially reducing postoperative related mortality and morbidity. The implementation of multidisciplinary team with interventional cardiologists and vascular surgeons should be encouraged whenever possible.

Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Implantation in Patients with Severe Iliofemoral Calcifications: Expanding Transfemoral Indications.

(1) Background: Transfemoral transcatheter aortic valve implantation (TAVI) has become the standard treatment for most patients with severe symptomatic aortic stenosis. Intravascular lithotripsy may facilitate transfemoral TAVI (IVL-TAVI) even in patients with severely calcified iliofemoral disease. We assessed technical aspects and clinical outcomes of this novel approach compared to alternative transaxillary access (TAX-TAVI). (2) Methods: IVL-TAVI was performed for severe iliofemoral calcifications precluding standard transfemoral access in 30 patients from 2019 to 2022 at a single academic heart center. IVL was performed as part of the TAVI procedure in all cases. Results were compared to a control group of 44 TAX-TAVI procedures performed for the same indication from 2016 to 2021. The safety outcome was a composite of all-cause death, stroke, access-related bleeding ≥ type 2 within 24 h and major vascular access site complications at 30 days. The efficacy outcome was defined as a technical success according to VARC-3. (3) Results: Median age was 78.2 [74.3, 82.6] years, 45.9% were female and mean STS-PROM was 3.6% [2.3, 6.0]. Iliofemoral calcifications were more severe in the IVL-TAVI vs. TAX-TAVI groups (lesion length: 63.0 mm [48.6, 80.3] vs. 48.5 mm [33.1, 68.8]; p = 0.043, severe calcification at target lesion: 90.0% vs. 68.2%; p = 0.047, and median arc calcification 360.0° [297.5, 360.0] vs. 360.0° [180.0, 360.0]; p = 0.033). Technical success was achieved in 93.3% vs. 81.8% (p = 0.187) in IVL- and TAX-TAVI and the safety outcome occurred in 10.0% vs. 31.8% in IVL- and TAX-TAVI (p = 0.047), respectively. (4) Conclusions: IVL-assisted transfemoral TAVI was feasible and safe with favorable outcomes compared to TAX-TAVI. IVL may further expand the number of patients eligible for transfemoral TAVI and may help overcome limitations of an alternative access.

Choice of anesthesia technique is associated with earlier hospital discharge and reduced costs after transcatheter transfemoral aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has become a viable alternative to palliation in patients with severe aortic stenosis. We compared general anesthesia to conscious sedation for TAVI procedures with respect to post operative morbidity, hospital length of stay, and financial burden. We conducted a retrospective review of prospectively collected data in patients undergoing transfemoral TAVI procedures from 2012 to 2017. Patients were matched based on age and sex and classed into either general anesthesia or conscious sedation groups respectively. Conscious sedation was provided with a dexmedetomidine infusion, and patients in general anesthesia group received a standard induction, tracheal intubation, and maintenance with sevoflurane. The hospital case costs were compared between the two groups before and after adjustment for inflation. We matched 124 pairs for a total of 248 patients. Both groups were similar with respect to demographic data, past medical history, medications, and intraoperative characteristics. There was no difference in postoperative morbidity and mortality between the two groups. The median hospital length of stay was 5 [interquartile range (IQR): 3, 10] and 7 (IQR: 4, 12) days, P=0.01, and after adjustment for inflation, the total hospital case costs were $48,984 (IQR: $44,802, $61,438) Canadian (CAD) vs. $55,333 (IQR: $46,832, $68,702) CAD, P=0.01, in the conscious sedation and general anesthesia groups, respectively. Advancements in TAVI technologies, conscious sedation and a collaborative, multidisciplinary team approach reduces overall length of hospital stay and procedure costs.

Surgical Versus Interventional Treatment of Major Access Site Complications During Transfemoral TAVI Procedures at a Large Volume Center.

Access-related vascular complications in transfemoral transcatheter aortic valve implantation (TAVI) can be treated endovascularly or surgically. The aim of this study was to evaluate the short- and long-term outcomes of endovascular treatment compared with surgical repair for access-related vascular complications. This retrospective study was performed from January 1, 2018, to December 31, 2020. All transfemorally treated TAVI patients in whom a surgical or endovascular treatment for an access site complication was needed were included. The primary outcome was the need for any related vascular re-operation. In total, 1219 transfemoral TAVI procedures were conducted during the study period. 19 patients suffered an access complication requiring endovascular treatment, while 54 patients required surgical repair. No differences were seen with regard to re-operations (endovascular 15.8% vs surgical 14.8%; p=0.919), wound infections (endovascular 0% vs surgical. 11.1%; p=0.129), and wound healing disorders (endovascular 15.8% vs surgical 29.6%; p=0.237). Patients undergoing endovascular treatment were discharged earlier (endovascular 11.2 vs surgical 14.9 days; p=0.028). After surgical repair, patients received significantly more blood transfusions than endovascularly treated patients (endovascular 1.00 vs surgical 3.1 red blood cell concentrate bags; p<0.001). No differences were found regarding the new onset of walking pain, rest pain, and ischemic ulcers during follow-up. In this retrospective cohort, endovascular treatment of access-related vascular complications of transfemoral TAVI procedures was safe and feasible. During the hospital stay, endovascularly treated patients received fewer blood transfusions and were discharged faster than surgically treated patients. No differences regarding clinical outcomes and re-intervention rates were seen during the follow-up. Given the in this retrospective study demonstrated safety and feasibility of endovascular treatment for major access-related vascular complications, along with the in-hospital benefits and absence of follow-up disadvantages compared to surgical treatment, endovascular treatment should be considered in cases of major access-related vascular complications in transfemoral TAVI patients.

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.

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.

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.

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.

Vascular Access Site Complications Do Not Correlate With Large Sheath Diameter in TAVI Procedures With New Generation Devices.

Background: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) are associated with morbidity and mortality. However, consistent predictors have not been identified yet. The size of the implantation sheath seems to play a role, though especially with new generation TAVI devices and their improved sheaths and delivery systems this remains uncertain.Objectives: This study aimed to determine the incidence and predictors of access site-related vascular complications (VC) in the era of new generation TAVI devices.Methods and Results: Four hundred consecutive patients receiving TAVI in an experienced tertiary care center were analyzed. VC occurred in 89 patients (22.25%) with the majority being minor VC (21%) and only 1.25% major VC. Possible predictors for VC were tested, and only peri-interventional dual antiplatelet therapy (DAPT) showed to be predictive for VC [OR 2.11 (95% CI 1.10–4.06, p = 0.025)]. The female gender [OR 0.75 (95% CI 0.44–1.3), p = 0.31], sheath to femoral artery ratio >1.05 [OR 1.18 (95% CI 0.66–2.08, p = 0.58)], calcification of the access site vessel [OR 0.83 (95% CI 0.48–1.42, p = 0.48)], known peripheral artery disease [OR 0.95 (95% CI 0.4–2.25, p = 0.9)], and BMI ≥ 25 kg/m2 [OR 0.69 (95% CI 0.41–1.19, p = 0–19)] were not predictive of VC. The larger sheath with 20 French even showed less VC than the smaller sheath with 16 French [OR 0.43 (95% CI 0.25–0.74, p = 0.002)].Conclusions: Overall, the rate of major and minor VC was low in this study population (for major VC: rate of 1.25%). Predefined risk factors were not associated with the occurrence of VC, except for peri-interventional treatment with DAPT. Especially, larger sheath size could not be identified as a predictor for VC in the setting of TAVI procedures performed with contemporary devices.

Interventional Treatment of Access Site Complications During Transfemoral TAVI: A Single Center Experience.

Introduction: Transcatheter aortic valve implantation (TAVI) has rapidly developed over the last decade and is nowadays the treatment of choice in the elderly patients irrespective of surgical risk. The outcome of these patients is mainly determined not only by the interventional procedure itself, but also by its complications.Material and Methods: We analyzed the outcome and procedural events of transfemoral TAVI procedures performed per year at our institution. The mean age of these patients is 79.2 years and 49% are female. All the patients underwent duplex ultrasonography of the iliac arteries and inguinal vessels before the procedure and CT of the aorta and iliac arteries.Results: Transfemoral access route is associated with a number of challenges and complications, especially in the patients suffering from peripheral artery disease (PAD). The rate of vascular complications at our center was 2.76% (19/689). Typical vascular complications (VC) include bleeding and pseudoaneurysms at the puncture site, acute or subacute occlusion of the access vessel, and dissection or perforation of the iliac vessels. In addition, there is the need for primary PTA of the access pathway in the presence of additional PAD of the common femoral artery (CFA) and iliac vessels. Balloon angioplasty, implantation of covered and uncovered stents, lithoplasty, and ultrasound-guided thrombin injection are available to treat the described issues.Conclusion: Interventional therapy of access vessels can preoperatively enable the transfemoral approach and successfully treat post-operative VC in most of the cases. Training the heart team to address these issues is a key focus, and an interventional vascular specialist should be part of this team.

Sleep Quality in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI).

The present study aimed to analyze sleep quality and quality of Life (QoL) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI). It was conducted at the Interventional Cardiology Unit of the Department of Cardiac, Thoracic, Vascular Sciences and Public Health of the University of Padova on 27 adult patients who underwent TAVI via the transfemoral approach. Patients completed two validated instruments, i.e., the Pittsburgh Sleep Quality Index (PSQI) and the EuroQoL (EQ-5D-5L), on the day of discharge and one month after the hospital discharge. Twenty-seven patients were enrolled with a severe aortic stenosis diagnosis, treated with transfemoral TAVI procedure. The study population included seventeen poor sleepers and ten good sleepers with a median age of 81.92 years overall. The global PSQI evaluation revealed a small significant improvement at follow-up (p-value 0.007). Small positive changes were detected in the Self-care and Usual activity domains of the EQ-5D-5L and the EQ-VAS. No correlation was detected between EQ-5D-5L and sleep quality. The present study confirms the importance of sleep quality monitoring in patients who undergo TAVI procedure for aortic stenosis treatment.

Virtual reality-assisted conscious sedation during transcatheter aortic valve implantation: a randomised pilot study.

Virtual reality (VR) has been used successfully in different clinical settings to treat anxiety. This prospective, randomised pilot study aimed to investigate the feasibility and safety of VR in patients undergoing conscious sedation during transfemoral transcatheter aortic valve implantation (TAVI). Thirty-two patients were included and randomised to VR intervention (n=16) or control (n=16). In the intervention group, patient-selected relaxing 3D videos were projected during the TAVI procedure; pain and anxiety before and after TAVI were measured using visual analogue scales (VAS; 0-10). The median age was 83 years (IQR 78.25-87). Patients' baseline characteristics did not differ significantly between the groups. During TAVI under conscious sedation, the median duration of VR intervention was 30.5 minutes (IQR 23.5-46); 81.3% of the patients watched the videos until device implantation, 37.5% during the whole procedure. The VR intervention group reported significantly less anxiety after the procedure (VAS 2 [IQR 0-3.75] vs 5 [IQR 2-8], p=0.04) than patients randomised to control. In the intervention group, 93.8% would use VR during TAVI again. Nausea and vomiting did not occur more frequently compared to control. VR interventions during TAVI to assist conscious sedation are safe and feasible, even in very old and frail patients. In this small cohort, there was a significant reduction in periprocedural anxiety.

Point-of-Care Ultrasound Before and After Transfemoral Transcatheter Aortic Valve Implantation.

ObjectiveSurgical aortic valve replacement requires a comprehensive transoesophageal echocardiography (TEE) assessment before and after the intervention by cardiac anaesthesiologists. For patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI), TEE is not routinely used. We started using transthoracic echocardiography (TTE) as a diagnostic and monitoring modality during TF-TAVI procedures. The aim of this study is to examine the usefulness of TTE before and after TF-TAVI. We hypothesised that TTE can serve as a screening tool in TF-TAVI patients and help rule out significant paravalvular leaks (PVLs), and serve as a monitoring tool.MethodsA retrospective, observational study of 24 patients who underwent TF-TAVI with perioperative TTE over a 3-month period was conducted. Intraoperatively, two TTE examinations were performed. The first was a baseline pre-procedural TTE examination after anaesthetic induction, and the second was performed after TAVI valve implantation. Both pre- and post-procedural examinations included five focused TTE views. PVLs were graded as none, non-significant (trace or mild) or significant (moderate or severe).ResultsThe average age and median body mass index of the patients were 82 years and 28.5 kg m−2, respectively. The average time recorded for the pre- and post-TAVI TTE examinations were approximately 4 and 5.5 min, respectively. Non-significant PVL was detected in 6 (25%) patients, and no leak was detected in 18 (75%) patients.ConclusionA focused TTE examination was found to be a useful adjunct during TF-TAVI for a cardiac anaesthesiologist in the absence of TEE, and useful in ruling out significant PVLs.

Outcomes of transfemoral transcatheter aortic valve implantation (TAVI) and predictors of thirty-day major adverse cardiovascular events (MACE) and one-year mortality

ObjectiveTAVI is more frequently used to treat aortic stenosis with the mandate to have a low as possible rate of adverse events. We present our 30-day outcomes and one-year mortality and examine the factors associated with them. MethodsA prospective evaluation was performed of all patients who underwent transfemoral TAVI in Nicosia General Hospital from January 2015 until March 2020. MACE were defined as cardiac death, disabling stroke, and/or major vascular complications (VC). Multiple logistic and Cox regression analyses were used to identify the factors associated with 30-day MACE and one-year mortality, respectively. ResultsA total of 235 TAVI procedures were performed (178 balloon-expandable, 57 self-expandable). Thirty-day outcomes were MACE: 4.3%, cardiovascular death: 2.1%, disabling stroke: 1.3%, major VC: 1.7%, and contrast induced nephropathy (CIN): 4.3%. There was a rate of 6.2% new pacemaker implantations and 0.9% of more than mild aortic valve regurgitation (AR) at 30 days. Mortality at one year was 15.1%. The balloon-expandable valves appear to have less new pacemakers, less mild AR, lower contrast volume used, and less days of hospitalization, while the self-expandable valves have lower post-procedural gradients. Low hemoglobulin, history of atrial fibrillation (AF), and lower BMI were predictors of 30-day MACE. Serum creatinine >2 mg/dL, history of AF, RVSP >60 mmHg and major VC are predictors of one-year mortality. ConclusionWe have shown excellent 30-day results with low incidence of adverse events for both the balloon-expandable and self-expandable valves. Clinical factors are the main predictors of both 30-day MACE and one-year mortality; major VC is a strong predictor of one-year mortality.

Transradial Secondary Approach During Transfemoral TAVI: Usefulness of Placing a Wire Before Femoral Puncture for Management and Treatment of Vascular Complications

Vascular complications during transcatheter aortic valve implantation (TAVI) are relatively common, and some of them related to the transfemoral secondary access. The use of the transradial access (TRA) as an alternative vascular approach for transfemoral TAVI could reduce these complications, however, the treatment of potential vascular peripheral issues from this access has been scarcely described. The advance of a wire from the TRA to the primary transfemoral access at the beginning of the procedure could help the management of eventual vascular complications. A new TRA technique during transfemoral TAVI procedures is described, reporting the results in the first forty-two patients in one center.

Evaluation of length of stay after transfemoral transcatheter aortic valve implantation with SAPIEN 3 prosthesis: A French multicentre prospective observational trial

Complications decrease after transfemoral transcatheter aortic valve implantation (TAVI), and early discharge is feasible and safe in selected populations. To evaluate length of stay (LOS) and reasons for prolonged hospitalisation after transfemoral TAVI in unselected patients. Patients with severe aortic stenosis, who had transfemoral TAVI with the SAPIEN 3 prosthesis using exclusively local anaesthesia, were prospectively and consecutively included at five French high-volume centres. LOS was calculated from TAVI procedure to discharge. Reasons for prolonged hospitalisation (i.e.>3 days) were evaluated. Between 2017 and 2018, 293 patients were included, with a mean age of 82.4±6.5 years and a mean logistic EuroSCORE of 13.7±9.0%. The in-hospital mortality rate was 1.4%. The median LOS was 5 (3-7) days, and varied considerably between centres (from 2 to 7 days). Sixty-four (21.8%) patients were discharged within 3 days after transfemoral TAVI. Reported reasons for prolonged hospitalisation were complications in 62.2%, loss of autonomy in 3.1%, discharge refusal in 2.2% and logistical reasons in 0.9%. In 31.6% of cases, the investigators reported no apparent reasons. The results of our study suggest that LOS after transfemoral TAVI, using the SAPIEN 3 prosthesis and a minimalist approach, varies considerably between centres. In almost a third of cases, hospitalisation was prolonged without any apparent reason. Efforts should be made to educate centres to reduce LOS.

Use of Dexmedetomidine in Transfemoral Transcatheter Aortic Valve Implantation (tf-TAVI) Procedures.

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist without any effect on the GABA receptor. Its sedative, anxiolytic, analgesic, and sympatholytic activities together with opioid-sparing effects make it suitable for short- and long-term sedation in the intensive care setting. We report our experience with dexmedetomidine use during transfemoral transcatheter aortic valve implantation (TAVI) procedure as an alternative to general anesthesia. This is a retrospective analysis of high-risk patients undergoing dexmedetomidine infusion for the transfemoral TAVI procedure between July 2017 and October 2019. The primary outcome parameters were hemodynamic: heart rate (HR), mean arterial pressure (MAP); respiratory oxygen saturation (SpO2), pH, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), and sedation level (Richmond Agitation-Sedation Scale, RASS). The frequency of conversion to general anesthesia and the need for sedative "rescue therapy" were secondary endpoints. We also reported the overall anesthetic management and the incidence of intra- and postoperative complications. Eighty-five patients were evaluated (age 81.58 ± 5.23years, 36.5% men, 63.5% women). High comorbidity, according to the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM). The patients' hemodynamic functions were kept normal. Complications such as cardiac arrest occurred in four patients; orotracheal intubation and cardiopulmonary resuscitation were necessary. Atrioventricular block occurred in nine patients. Respiratory parameters were maintained stable. Complications such as apnea, hypoventilation, and hypoxemia did not occur. All patients had RASS scores above or equal to 0 and - 1. No patient required rescue midazolam or fentanyl. No conversion to general anesthesia in patients sedated with dexmedetomidine was observed in the absence of hemodynamic complications caused by the surgical technique. In this series, sedation with dexmedetomidine for TAVI procedures with femoral access was proven effective and safe. Dexmedetomidine may be a valid alternative to general anesthesia in high-risk older patients undergoing transfemoral TAVI.

Exposure to Ionizing Radiation in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) is currently becoming an alternative to surgical valve replacement for patients at low risk, a population that is likely to experience an increase in the radiation-induced cancer risk following TAVI. We aimed to evaluate the overall exposure to ionizing radiation in patients who underwent transfemoral TAVI, including the procedure itself as well as the procedures performed in the preintervention work-up and the post-TAVI interventions. All patients who underwent transfemoral TAVI for symptomatic aortic stenosis in our center over a 26 months period were included. Dosimetric indicators from preprocedural coronary angiography and computed tomography (CT), the TAVI procedure, and any postprocedural interventions (electrophysiology study and/or pacemaker implantation) were collected and converted into an effective dose. A total of 119 transfemoral TAVI procedures were included. The mean cumulative effective dose (ED) was 37.3 mSv. Three irradiating procedures were necessary for 84 patients (71% of the population, i.e., coronary angiography, CT scan and the TAVI procedure itself), whereas 30 patients (25%) required a fourth procedure, and 5 required a fifth (4%). The majority of the dose was from the CT, while only 11% of the dose derived from the TAVI procedure itself. In conclusion, overall exposure to ionizing radiation for patients who underwent transfemoral TAVI seems acceptable, and the majority of the overall ED comes from the CT scan.