Transfemoral Transfemoral Transcatheter Aortic Valve Implantation Research Articles

Risk Factors for Early HALT after Transfemoral TAVI

Objective: To investigate the risk factors of hypoattenuated leaflet thickening (HALT) in the early stage after transfemoral transcatheter aortic valve implantation (TAVI). Methods: Patients who underwent transfemoral TAVI in the Affiliated Hospital of Qingdao University from January 2021 to June 2023 were selected. According to the results of four-dimensional computed tomography (4DCT), patients were divided into HALT group and non-HALT group. The perioperative data of the two groups were collected to find the risk factors of HALT in the early postoperative period. Results: A total of 100 patients underwent TAVI operation via femoral artery, 2 died after operation, 1 discharged due to cerebral complication, and 2 patients had incomplete 4DCT data. The data of 95 patients were completely collected, including 56 males and 39 females, with an average age of (72.0 ± 6.7) years and a body mass index of (24.0 ± 3.7) kg/m2. 10 patients had HALT, the incidence was 10.5%. 85 patients were in the non-HALT group, including 52 males (61.2%). 10 patients were in the HALT group, 4 cases were male (40%). There were no significant differences in age, sex, body mass index (BMI), hypertension, diabetes, chronic obstructive pulmonary disease (COPD), brain complications, coronary heart disease, left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF) and operation time between the two groups. And the differences between the two groups in perioperative white blood cell, neutrophil, lymphocyte and platelet counts, neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR) and creatinine were not significant. Compared with the non-HALT group, patients in the HALT group had a higher proportion of isolated aortic insufficiency, a lower proportion of post dilatation after valve release, and a higher proportion of valves with skirts. Conclusion: Isolated aortic insufficiency, without post dilatation after valve release, and use of valves with skirt are associated with early HALT after transfemoral TAVI.

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.

A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI.

Percutaneous suture-based arterial access site closure (ProGlide) is commonly applied in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). However, the failure of a suture-based vascular closure device (VCD) may require additional treatment. We aimed to evaluate the efficacy and safety of bailout access site closure using a large-bore plug-based device (MANTA) in patients with failed suture-based closure during transfemoral TAVI. Patients undergoing a bailout attempt with the MANTA VCD were identified from a prospectively enrolling, institutional registry. Efficacy was defined as haemostasis at the access site without the need for alternative treatment other than manual compression or endovascular ballooning. Safety was defined as freedom from vascular dissection, stenosis and occlusion requiring intervention. Of 2,505 patients, 66 underwent a bailout attempt with MANTA as a result of ProGlide failure, which occurred before the large-bore sheath insertion in 16.7% of patients and after the sheath removal in 83.3% of patients. Bailout MANTA was deemed effective in 75.8% of patients (50/66), and the technique was considered safe in 86.4% (57/66) of patients. Failure of bailout MANTA occurred because of its superficial application, resulting in persistent bleeding in 18.2% of patients (12/66), and because of its deep application, resulting in stenosis or occlusion in 6.1% of patients (4/66). Operator experience with the technique (odds ratio [OR] 12.29, 95% confidence interval [CI]: 1.99-75.99; p=0.007) and prior use of three ProGlides (OR 0.02, 95% CI: <0.01-0.39; p=0.010) were the only independent predictors of the efficacy endpoint. Bailout MANTA after ProGlide failure was effective and safe, but operator experience seems to be crucial. Further technological refinements to facilitate accurate placement appear necessary.

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.

Outcomes of Using Balloon-Expandable Covered Stent for Percutaneous Treatment of Access-Site Vascular Injury after Transfemoral Aortic Valve Implantation: A Single Center Experience

Access-site vascular injury (ASVI) remains a challenge for transfemoral transcatheter aortic valve implantation (TAVI). Although surgery is the gold standard, endovascular therapy gains growing acceptance as primary treatment option for ASVI. The aim of this study was to analyze the safety and efficacy of covered balloon-expandable stents (BXSs) placement for ASVI after transfemoral TAVI. All patients treated with a covered BXS between January 2018 and December 2020 for access-site related bleeding complications following femoral TAVI were included in this single center retrospective study. Primary measure outcome of this study was the primary patency at 12months. Technical success, limb clinical worsening and device related complications were additionally analyzed. During the study period, 576 percutaneous femoral TAVIs were performed. Of these, 36 patients (6%) underwent covered stent deployment for a femoral access-site complication (19 men, median age 83years old). Procedural success was 97%. The median follow-up was 12months (interquartile range [IQR]=9.7, range 0-36months). One patient was lost to follow-up. The primary patency rates at 6 and 12months were 100% and 95% respectively. No clinical deterioration or stent fracture was described during this period. Our results suggest that covered BXS deployment is a safe and effective alternative to surgery and may be a promising option for treating ASVI after femoral TAVI.

Comparison of MANTA vs ProGlide Vascular Closure Device and 30-Day Outcomes in Transfemoral Transcatheter Aortic Valve Implantation.

Vascular complications (VCs) after transfemoral transcatheter aortic valve implantation (TAVI) have an increased mortality risk, and vascular closure device (VCD) use is mandatory. The percutaneous MANTA VCD (Teleflex) is a novel collagen-based technology for closure of large-bore arteriotomies. We compared the MANTA VCD with the suture-based ProGlide VCD (Abbott Vascular). A retrospective review was performed on all consecutive patients who underwent transfemoral TAVI in our center from January 1, 2015, to February 28, 2021, and 30-day outcomes were recorded. Major adverse cardiovascular events (MACE) were cardiac death, disabling stroke, and/or major VCs. Access site-related VCs were VCs related to the access site vessel from which the transcatheter valve was introduced and advanced. The MANTA VCD was used in 99 patients and the ProGlide in 224. There was 4.0% MACE in the MANTA group and 4.9% in the ProGlide group (P = .999). Overall VCs were 10.1% vs 7.6%, major VCs were 3.0% vs 2.2%, and minor VCs 7.1% vs 5.4%(P = .753). Access site-related VCs were 5.1% vs 5.8% in the (P = .999), and periprocedural vascular surgical intervention was needed in 6.1% of the MANTA group vs 2.2% of the ProGlide group (P = .099). There was no significant difference in MACE, mortality, cardiovascular mortality, VCs, access site-related VCs, periprocedural vascular surgical interventions, bleeding, or transfusion rate between the 2 groups. The MANTA VCD group had more periprocedural vascular surgical interventions which did not reach statistical significance.

Cerebral oxygen saturation as outcome predictor after transfemoral transcatheter aortic valve implantation

BackgroundCerebral oxygen saturation (ScO2) can be measured non-invasively by near-infrared spectroscopy (NIRS) and correlates with cerebral perfusion. We investigated cerebral saturation during transfemoral transcatheter aortic valve implantation (TAVI) and its impact on outcome.Methods and resultsCerebral oxygenation was measured continuously by NIRS in 173 analgo-sedated patients during transfemoral TAVI (female 47%, mean age 81 years) with self-expanding (39%) and balloon-expanding valves (61%). We investigated the periprocedural dynamics of cerebral oxygenation. Mean ScO2 at baseline without oxygen supply was 60%. During rapid ventricular pacing, ScO2 dropped significantly (before 64% vs. after 55%, p < 0.001). ScO2 at baseline correlated positively with baseline left-ventricular ejection fraction (0.230, p < 0.006) and hemoglobin (0.327, p < 0.001), and inversely with EuroSCORE-II ( − 0.285, p < 0.001) and length of in-hospital stay ( − 0.229, p < 0.01). Patients with ScO2 < 56% despite oxygen supply at baseline had impaired 1 year survival (log-rank test p < 0.01) and prolonged in-hospital stay (p = 0.03). Furthermore, baseline ScO2 was found to be a predictor for 1 year survival independent of age and sex (multivariable adjusted Cox regression, p = 0.020, hazard ratio (HR 0.94, 95% CI 0.90–0.99) and independent of overall perioperative risk estimated by EuroSCORE-II and hemoglobin (p = 0.03, HR 0.95, 95% CI 0.91–0.99).ConclusionsLow baseline ScO2 not responding to oxygen supply might act as a surrogate for impaired cardiopulmonary function and is associated with worse 1 year survival and prolonged in-hospital stay after transfemoral TAVI. ScO2 monitoring is an easy to implement diagnostic tool to screen patients at risk with a potential preserved recovery and worse outcome after TAVI.Graphical abstract

Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations

BackgroundArterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost. AimsTo evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). MethodsA single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) in patients undergoing TAVI at the Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major vascular complication according to the criteria of the Valve Academic Research Consortium (VARC)-2. ResultsFrom May 2017 to September 2020 a total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. VARC-2 major vascular complications occurred in 42 (4.2%) patients: 17 (1.7%) patients intraoperatively received a covered stent, 17 (1.7%) patients underwent surgical repair during hospital stay, 3 (0.3%) patients underwent vascular surgery after discharge, 3 (0.3%) patients had major bleeding and 2 (0.2%) patients had symptoms of claudication with conservative treatment. No significant differences in major complications were seen between individual interventionists irrespective of experience with the device. A larger sheath outer diameter to femoral artery inner diameter ratio was the only factor associated with a significant increase of VCD-related major vascular complications. ConclusionThis largest ever real-world evaluation of MANTA for large-bore arteriotomy closure in transfemoral TAVI patients indicates effective and safe arterial access-site management with low complication rates and short learning curve.Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT04392492.

Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs ProGlide Parallel Technique.

Reliable femoral artery closure devices are essential for the success of trans-femoral Transcatheter Aortic Valve Implantation (TAVI) procedures. Accordingly, device choice might affect vascular complications and bleeding rates. This was a retrospective analysis, comparing vascular complication rates among patients who underwent trans-femoral TAVI with vascular access closure using either the ProGlide parallel suture or Prostar closure devices. We included 191 patients: 106 were treated with Prostar and 85 with ProGlide. The ProGlide group had higher rate of diabetes, chronic kidney disease, peripheral arterial disease, and significantly smaller femoral arteries that were treated via larger sheaths. Valve Academic Research Consortium (VARC)-2 major complications were similar between the groups. (4.7% for ProGlide vs 3.8% for Prostar, P=1), with similar incidence of closure device failure (2 vs 3, P=1). No differences were found after univariant analysis and propensity-score matching in the incidence of major and minor bleeding nor in the rate of in-hospital mortality between ProGlide and Prostar (4.7 vs 2.8%, P=.7, 1.2 vs 2.8%, P=.63, and 1.2 vs .0%, P=.45, respectively). Parallel suture technique using two ProGlide sutures showed comparable rates of vascular complications to the Prostar closure device in higher risk population of TAVI patients.

Transfemoral transcatheter aortic valve implantation under conscious sedation. Experience in 15 patients

Transfemoral transcatheter aortic valve implantation (TAVI) is the standard of treatment for patients with symptomatic severe aortic stenosis (AE) and intermediate or high surgical risk. The use of conscious sedation (CS) could reduce complications and allow an early discharge of these patients. To report our experience with TAVI under conscious sedation. Review of medical records of 15 patients aged 79 ± 6 years (53% women) undergoing a transfemoral TAVI implant under conscious sedation. The indications for the procedure were severe AE in 13 patients and biological prosthetic dysfunction in two. The mean Thoracic Surgeons predicted risk of mortality score was 7.3. The valves used were Edwards Sapien 3 in three patients, Medtronic Evolut in five, Boston Acurate Neo in four and Meril Myval in three. A successful implant was achieved in all cases and there were no hospital mortality or pacemaker requirements. One patient had a stroke, and one patient had a vascular access complication. Early discharge (< 72 h) was achieved in 80% of patients. TAVI under conscious sedation was a safe procedure and associated with a complication rate similar to previous reports, allowing for an early hospital discharge in most patients.

Single versus double use of a suture-based closure device for transfemoral aortic valve implantation

BackgroundThe most common method of percutaneous closure in transfemoral transcatheter aortic valve implantation (TAVI) employs two obtusely oriented ProGlide devices. The aim of this study was to assess the feasibility and safety of using a single ProGlide system for primary access site closure in comparison with the double ProGlide approach in an all-comers TAVI population. MethodsBetween March 2016 and December 2018, a total of 1105 patients underwent transfemoral TAVI for severe aortic stenosis at our center. Application of two ProGlide systems was standard until April 2017 (n = 432), whereas thereafter a single ProGlide system was used (n = 663). A 1:1 propensity score matching was performed to adjust for baseline differences between the two groups, resulting in 327 matched cases. Primary outcomes of interest were main access site-related vascular complications. ResultsThe mean number of ProGlide devices used per patient was 1.03 (SD 0.2) in the single-ProGlide group versus 2.01 (SD 0.14) in the double-ProGlide group. An additional vascular closure device was required to obtain full hemostasis in 23.2% versus 9.5% of patients (p < 0.001) in the two groups, respectively. Technical success of ProGlide usage was similar (94.3% versus 92.1%, p = 0.163). In the matched cohorts, the rates of main access site-related major vascular complications were similar (4.0% vs. 6.4%, p = 0.217). ConclusionThe single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique. Use of this method did not lead to more frequent access site-related complications but was more cost effective than the double-ProGlide approach.

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.

Comparison of the Sapien 3 versus the ACURATE neo valve system: A propensity score analysis.

ObjectivesTo compare the outcomes of transfemoral ACURATE neo (NEO) and Sapien 3 (S3) patients in terms of device success and clinical safety outcomes using a propensity score analysis.BackgroundDifferences in clinical outcomes between the latest‐generation balloon‐expandable S3 and self‐expanding NEO in a “real‐world transfemoral TAVI population” are still unclear.MethodsWe compared up to 6 months clinical outcomes using a propensity score analysis (inverse probability of treatment weighting [IPTW]) to account for differences in baseline characteristics.ResultsA total of 345 patients underwent transfemoral transcatheter aortic valve implantation (TAVI) with either NEO or S3 at two centers in the Netherlands. Composite device success and early safety endpoints were comparable between NEO and S3 (Device success: IPTW‐adjusted OR: 0.35 [95% CI: 0.12–1.18], and early safety: IPTW‐adjusted OR: 0.51 [95% CI: 0.19–1.38]). Six‐months mortality was 5.3 versus 3.6%, stroke was 2.8 versus 3.3%, and pacemaker rate was 6.1 versus 8.6%, respectively with p = NS. Mean aortic gradient was lower in the NEO group (5.72 ± 2.47 vs. 9.05 ± 3.48; p = <.001), with a comparable rate of moderate or severe paravalvular leak (0 versus 2.1%; p = NS).ConclusionsDevice success and clinical safety outcomes were comparable for both valves. Up to 6‐months follow‐up clinical outcomes and mortality rate remained excellent. Mean aortic gradient was lower after ACURATE neo implantation.

Covered Stents as a First-Line Treatment for Vascular Access Complications During Transfemoral Transcatheter Aortic Valve Implantation: Eight-Year Experience From a Single Center.

We report 8-year experience with vascular access complications (VACs) after percutaneous transfemoral transcatheter aortic valve implantation (TAVI). From January 2010 to January 2018, patients with iliofemoral VAC treated by an intervention following percutaneous transfemoral TAVI were included. Major VAC was defined according to the Valve Academic Research Consortium 2 classification. As first-line strategy, VACs were treated using covered nitinol stents (CS). Among 795 percutaneous transfemoral TAVI, 74 (9.3%) patients (female, 57%; 82 ± 8 years) with VAC treated by CS and/or open repair were included in this study: 59 CS cases and 15 open repair cases. Two CS patients were converted to open repair. Technical success for stent implantation was 97%. The main VAC was a persistent bleeding related to percutaneous closure device failure (72%). Thirty-day mortality in the study cohort was 5.4% (4/74), including 1 VAC-related death. One patient had postoperative lower limb ischemia successfully treated by open repair. No amputation, new-onset claudication or in-stent occlusion was recorded. Endovascular intervention using self-expandable nitinol covered stent is safe and effective as a first-line strategy for the treatment of VAC in percutaneous transfemoral TAVI. However, open repair is needed in case of unfeasibility or failure of endovascular therapy.

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.

Risk Factors for Closure Failure following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation

The percutaneous access site of transfemoral transcatheter aortic valve implantation (TAVI) procedures is commonly closed using a preclosure technique with suture-type closure devices. We sought to evaluate the predictors and outcomes of percutaneous closure device (PCD) failure during transfemoral TAVI. This single-center retrospective analysis included 184 patients who underwent transfemoral TAVI using 2 ProGlide sutures for severe aortic stenosis between July 2011 and September 2018. PCD failure was observed in 11.4%. The causes of PCD failure included 5 cases of insufficient hemostasis, 13 cases of arterial stenosis or occlusion, and 3 cases of dissection. Closure failures were managed by surgical repair in 10 patients and endovascular treatment in 11 patients. In a multivariate binary logistic model, a minimum lumen diameter of the common femoral artery (CFA) (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.15-0.83, P=0.017) and left femoral access (OR 2.89, 95% CI 1.01-8.30, P=0.048) was identified as a predictor of PCD failure. PCD failure was not associated with increased mortality (0% vs. 2.5%, P=1.000) or a major adverse cardiovascular event (MACE; 4.8% vs. 4.3%, P=1.000) at 30days. PCD failures were not uncommon in patients undergoing percutaneous transfemoral TAVI. Small CFA diameter and left femoral access are predictors of PCD failure. However, PCD failures were not associated with increased mortality or MACE.

Effect of procedural refinement of transfemoral transcatheter aortic valve implantation on outcomes and costs: a single-centre retrospective study

ObjectivesTo determine the effect of introducing several procedural refinements of transfemoral transcatheter aortic valve implantation (TAVI) on clinical outcomes and costs.DesignRetrospective analysis comparing two consecutive 1-year periods, before and after...

Early Outcomes After Percutaneous Closure of Access Site in Transfemoral Transcatheter Valve Implantation Using the Novel Vascular Closure Device Collagen Plug-Based MANTA

A new collagen-based MANTA vascular closure device (VCD) was developed for closing large-bore arteriotomies after transfemoral transcatheter aortic valve implantation (TAVI). We evaluated safety and feasibility at 30-day follow-up in terms of vascular and bleeding complications and mortality of the collagen-based MANTA VCD compared with the suture-based Prostar XL VCD in a cohort of 366 patients who underwent transfemoral TAVI between January 2015 and April 2018. The MANTA VCD was used in 168 patients and the Prostar XL VCD in 198 patients, with successful closure of 98.8% and 98.5%, respectively. VARC-2 defined as major vascular and bleeding complications was similar in both groups (MANTA vs Prostar XL): 0.6% versus 1.0% (p = 0.661) and 0.6% versus 1.5% (p = 0.102). Minor vascular and bleeding complications, were significantly more frequent (10.7 vs 18.8 %, p = 0.003 and 13.7 vs 19.7%, p = 0.080, respectively) in the Prostar XL cohort. Thirty-day all-cause mortality was 2.7%, without significant difference between the groups (p = 0.278). The MANTA device is a safe and feasible option for vascular access closure in patients undergoing transfemoral TAVI.

General Anesthesia Versus Monitored Anesthesia Care for Transfemoral Transcatheter Aortic Valve Implantation: A Retrospective Study in a Single Belgian Referral Center

The objective of this study was to compare the effect of general anesthesia (GA) versus monitored anesthesia care (MAC) on post-interventional outcomes in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). Retrospective before-after study using a quasi-experimental design. University Hospitals Leuven, a single Belgian referral center. Patients undergoing transfemoral TAVI from March 1, 2014, to December 31, 2017, were included. GA was switched to MAC at the authors' institution for transfemoral TAVI in April 2016, and outcomes of patients who received GA were compared with those who received MAC. The primary outcomes were length of stay in the intensive care unit and hospital. Secondary outcomes included standardized endpoints for TAVI trials as suggested by the Valve Academic Research Consortium, the incidence of vasopressor use, maximum dose of vasopressors, procedural time, and total anesthesia time. In the period studied, 178 patients underwent transfemoral TAVI (GA: n = 85; MAC: n = 93). Implementation of MAC was associated with a significant reduction in total length of hospital stay (7.6 [6.05-9.15] v 5.48 [4.58-6.38] d; p = 0.02); vasopressor requirements; and procedural and total anesthesia time. Length of intensive care unit stay and Valve Academic Research Consortium endpoints were not significantly different. In the authors' institution, implementation of MAC for patients undergoing transfemoral TAVI resulted in a significant reduction of hospital length of stay and increased operating room efficiency. Results could be confounded by increasing operator experience and improved implantation techniques.