Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial.

BACKGROUND: During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking. TRIAL DESIGN: The TAVI XS trial is a multicentre, randomised, open-label clinical trial with blinded evaluation of endpoints. A total of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30 days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type 2, 3 or 5 bleeding, and early safety at 30 days according to Valve Academic Research Consortium­3 criteria. CONCLUSION: The TAVI XS trial is the first randomised trial comparing an upper extremity approach to a lower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Using Upper Arm Vein as Temporary Pacemaker Access Site: A Next Step in Minimizing the Invasiveness of Transcatheter Aortic Valve Replacement.

Background The femoral vein is commonly used as a pacemaker access site during transcatheter aortic valve replacement (TAVR). Using an upper arm vein as an alternative access site potentially causes fewer bleeding complications and shorter time to mobilization. We aimed to assess the safety and efficacy of an upper arm vein as a temporary pacemaker access site during TAVR. Methods We evaluated all patients undergoing TAVR in our center between January 2020 and January 2023. Upper arm, femoral, and jugular vein pacemaker access was used in 255 (45.8%), 191 (34.3%), and 111 (19.9%) patients, respectively. Clinical outcomes were analyzed according to pacemaker access in the overall population and in a propensity-matched population involving 165 upper arm and 165 femoral vein patients. Primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 pacemaker access site-related bleeding. Results In the overall population, primary endpoint was lowest for upper arm, followed by femoral and jugular vein access (2.4% vs. 5.8% vs. 10.8%, p = 0.003). Time to mobilization was significantly longer (p < 0.001) in the jugular cohort compared with the other cohorts. In the propensity-matched cohort, primary endpoint showed a trend toward lower occurrence in the upper arm compared with the femoral cohort (2.4% vs. 6.1%, p = 0.10). Time to mobilization was significantly shorter (480 vs. 1140 min, p < 0.001) in the upper arm cohort, with a comparable skin-to-skin time (83 vs. 85 min, p = 0.75). Cross-over from upper arm pacemaker access was required in 17 patients (6.3% of attempted cases via an upper arm vein). Conclusions Using an upper arm vein as a temporary pacemaker access site is safe and feasible. Its use might be associated with fewer bleeding complications and shorter time to mobilization compared with the femoral vein.

Diastolic delta best predicts paravalvular regurgitation after transcatheter aortic valve replacement as assessed by cardiac magnetic resonance: the APPOSE trial.

AIMS: Paravalvular regurgitation (PVR) is a common complication after transcatheter aortic valve replacement (TAVR) that poses an increased risk of rehospitalization for heart failure and mortality. The aim of this study was to assess the accuracy of haemodynamic indices to predict relevant PVR. METHODS AND RESULTS: In this prospective single-centre clinical trial, four haemodynamic indices of PVR measured during TAVR were assessed for their correlation with gold standard cardiac magnetic resonance (CMR)-derived regurgitant fraction (CMR-RF) at 1 month follow-up: diastolic delta (DD), heart rate-adjusted diastolic delta (HR-DD), aortic regurgitation index (ARI), and aortic regurgitation index ratio (ARI ratio). These haemodynamic indices were analysed for their ability to predict relevant PVR (defined as CMR-RF > 20%) using receiver operating characteristic (ROC) curves with corresponding area under the ROC curves (AUCs). A total of 77 patients were included and had CMR performed 41 ± 14 days after TAVR. Mean CMR-RF was 12.4 ± 9.3%. Fifteen (19.5%) patients had CMR-RF > 20%. DD had the best correlation with CMR-RF and the highest AUC to predict relevant PVR (0.82; 95% CI, 0.72-0.92), followed by HR-DD (AUC 0.78; 95% CI, 0.67-0.89), ARI (AUC 0.78; 95% CI, 0.66-0.89), and ARI ratio (AUC 0.65; 95% CI, 0.49-0.81). The optimal cut-off value for DD was 32 mmHg, with sensitivity of 69% and specificity of 77% in predicting relevant PVR. CONCLUSION: DD measured during TAVR best predicts relevant PVR. Correction for heart rate (HR-DD) or systolic blood pressure (ARI, ARI ratio) did not improve this predictive value.

Decision Making during the Learning Curve of Minimally Invasive Mitral Valve Surgery: A Focused Review for the Starting Minimally Invasive Surgeon.

Minimally invasive mitral valve surgery is evolving rapidly since the early 1990's and is now increasingly adopted as the standard approach for mitral valve surgery. It has a long and challenging learning curve and there are many considerations regarding technique, planning and patient selection when starting a minimally invasive program. In the current review, we provide an overview of all considerations and the decision-making process during the learning curve.

Transcatheter aortic valve replacement during the COVID-19 pandemic-A Dutch single-center analysis.

BACKGROUND AND AIM OF THE STUDY: The coronavirus disease 2019 (COVID-19) pandemic has put an enormous strain on healthcare systems and intensive care unit (ICU) capacity, leading to suspension of most elective procedures, including transcatheter aortic valve replacement (TAVR). However, deferment of TAVR is associated with significant wait-time mortality in patients with severe aortic valve stenosis. Conversely, there is currently no data available regarding the safety and feasibility of a continued TAVR program during this unprecedented crisis. The aim of this study is to evaluate the safety and feasibility of patients undergoing TAVR during the COVID-19 pandemic in our center, with specific emphasis on COVID-19 related outcomes. METHODS: All patients who underwent TAVR in our center between February 27, 2020, and June 30, 2020, were evaluated. Clinical outcomes were described in terms of Valve Academic Research Consortium 2 definitions. Patient follow-up was done by chart review and telephone survey. RESULTS: A total of 71 patients have undergone TAVR during the study period. Median age was 80 years, 63% were men, and 25% were inpatients. Procedural success was 99%. After TAVR, 30% involved admission to the ICU, and 94% were ultimately discharged to the cardiac care unit on the same day. Two patients (3%) had confirmed COVID-19 a few days after TAVR, and both died of COVID-19 pneumonia within 2 weeks after hospital discharge. CONCLUSIONS: A continued TAVR program during the COVID-19 pandemic is feasible despite limited hospital resources. However, COVID-19 related mortality after TAVR is of concern.

Feasibility and Outcomes of Transcatheter Aortic Valve Implantation Using the Left Axillary Artery as Primary Access Site.

BACKGROUND: The femoral artery is generally used as primary access for transcatheter aortic valve implantation. However, peripheral artery disease often precludes femoral access. The purpose of this study was to describe clinical outcome of transcatheter aortic valve implantation using the left axillary artery (LAA) as primary access site. METHODS: From December 2008 until June 2016, data on all consecutive patients treated with a Medtronic device through the LAA at our hospital were registered, and outcome was prospectively collected according to the updated Valve Academic Research Consortium-2 criteria. Mortality check was performed nationally. RESULTS: In total, 362 patients were included (median age 80 years [range, 76 to 84]; logistic European System for Cardiac Operative Risk Evaluation 17% ± 12%). Successful axillary access was achieved in 99%. Medtronic CoreValve (86%) and Evolut R (14% [Medtronic, Minneapolis, MN]) were implanted. Major vascular complications occurred in 5% of patients, 1% was LAA related. Life-threatening bleeding and major bleeding were observed in 2% and 10%, respectively. Additional complications were new left bundle branch blood (30%), new permanent pacemaker (11%), and stroke (1%). There were 6 procedural deaths (2%) and 19 deaths (5%) within 30 days. One-year mortality rate was 19%. CONCLUSIONS: This is the first study reporting outcome after transcatheter aortic valve implantation using the LAA as default access. We conclude that it is highly feasible and safe with low rates of major vascular complications, bleeding, and stroke.

MDCT evaluation of aortic root and aortic valve prior to TAVI. What is the optimal imaging time point in the cardiac cycle?

OBJECTIVES: To determine the optimal imaging time point for transcatheter aortic valve implantation (TAVI) therapy planning by comprehensive evaluation of the aortic root. METHODS: Multidetector-row CT (MDCT) examination with retrospective ECG gating was retrospectively performed in 64 consecutive patients referred for pre-TAVI assessment. Eighteen different parameters of the aortic root were evaluated at 11 different time points in the cardiac cycle. Time points at which maximal (or minimal) sizes were determined, and dimension differences to other time points were evaluated. Theoretical prosthesis sizing based on different measurements was compared. RESULTS: Largest dimensions were found between 10 and 20% of the cardiac cycle for annular short diameter (10%); mean diameter (10%); effective diameter and circumference-derived diameter (20%); distance from the annulus to right coronary artery ostium (10%); aortic root at the left coronary artery level (20%); aortic root at the widest portion of coronary sinuses (20%); and right leaflet length (20%). Prosthesis size selection differed depending on the chosen measurements in 25-75% of cases. CONCLUSION: Significant changes in anatomical structures of the aortic root during the cardiac cycle are crucial for TAVI planning. Imaging in systole is mandatory to obtain maximal dimensions. KEY POINTS: • Most aortic root structures undergo significant dimensional changes throughout the cardiac cycle. • The largest dimensions of aortic parameters should be determined to optimize TAVI. • Circumference-derived diameter showed maximum dimension at 20% of the cardiac cycle.

Frequency and prognosis of new bundle branch block induced by surgical aortic valve replacement.

OBJECTIVES: Recently, transcatheter aortic valve implantation has been introduced, but one of its complications is left bundle branch block (LBBB), a conduction disturbance that has been associated with increased mortality. We investigated the incidence and fate of both right bundle branch block (RBBB) and LBBB after aortic valve replacement (AVR) using a retrospective analysis. We also studied the predictive value of both disorders for all-cause mortality. METHODS: All patients who underwent AVR, with or without concomitant coronary artery bypass grafting surgery, between 2002 and 2010 in our centre were included. All-cause mortality was compared between patients who did and those who did not develop persistent new bundle branch block (BBB) within 7 days postoperatively. Patients were not eligible if one of their electrocardiogram (ECG) recordings prior to AVR showed a BBB or pacemaker activity. A postoperative period of 3-12 months was used to collect follow-up ECGs. RESULTS: Of the 2279 AVR patients, 2033 patients were eligible for analysis. After excluding patients lacking baseline or follow-up ECG (n = 269), 1764 patients remained for analysis. Early LBBB and RBBB occurred in 71 (4.0%) and 92 (5.2%) patients, respectively. At follow-up, LBBB was persistent in 29 patients (1.6%) and RBBB in 74 patients (4.2%). During a median follow-up of 4.5 (2.4-6.5) years, the mortality rate was 16.3% (n = 271) in patients without BBB, 24.1% (n = 7) in patients with persistent LBBB and 18.9% (n = 14) in patients with persistent RBBB (log-rank P = 0.49). Though, in univariate analysis, the hazard ratio for mortality was 1.54 and 1.10 for LBBB and RBBB, respectively, the small numbers precluded identifying AVR-induced LBBB and RBBB as a predictor of mortality. CONCLUSIONS: In the current practice of AVR, persistent postoperative LBBB and RBBB occur infrequently (∼ 5% of cases), a percentage less than half of that in current transcatheter aortic valve implantation procedures. Given the adverse effects of LBBB, the lower prevalence of procedure-induced LBBB in AVR should be taken into account while deciding which valve replacement procedure is chosen for a patient.

Trends in the occurrence of new conduction abnormalities after transcatheter aortic valve implantation.

OBJECTIVES: The aim of the study was to investigate trends over time in the occurrence of left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with the Medtronic CoreValve System (MCS) and Edwards SAPIEN Valve (ESV). BACKGROUND: TAVI-induced conduction abnormalities (TAVI-CAs) such as LBBB and the need for PPI are frequent postoperative complication. New techniques, procedural refinements, and increased awareness are focused on the reduction of these abnormalities. METHODS: Electrocardiograms of 549 patients without preprocedural LBBB and/or pacemaker were assessed to determine the frequency and nature of TAVI-CAs. To study the effect of experience, patients were subdivided per center into tertiles based on the number of procedures. Univariate and multivariate logistic regression was used to study predictors of TAVI-induced LBBB (TAVI-LBBB) and PPI. RESULTS: TAVI-LBBB occurred in 185 patients (33.7%) and significantly decreased over time, from 42.6% to 27.3% (P=0.006). This effect was only significant after implantation of the MCS (59.6% vs. 46.5% vs. 31.1%, P=0.001, ESV: 22.6% vs. 13.1% vs. 24.8%, P=0.11). Between tertiles there was no difference in the frequency of PPI after TAVI (n=73, 13.1% vs. 14.8% vs. 12%, P=0.74). Multivariate analysis revealed that, independent from valve type, depth of implantation was the only significant predictor of TAVI-LBBB (OR [95% C.I.]: 1.16 [1.10-1.24], P<0.001). In case of PPI pre-existing RBBB (OR [95% C.I.]: 7.22 [3.28-15.88], P<0.001) was the only significant predictor. CONCLUSIONS: Over time the frequency of LBBB after TAVI decreased significantly, especially in patients undergoing TAVI with the MCS. Experience and the subsequent reduction in depth of implantation seem responsible for this reduction. Contrary to TAVI-LBBB, the incidence of PPI remained unchanged over time and was not affected by experience. Although experience has led to a decrease in new CAs after TAVI, elucidation of pathophysiologic mechanisms underlying these CAs and subsequent changes in patient stratification, valve design and the procedure are needed to further reduce this complication.

Transcatheter aortic valve implantation-induced left bundle branch block: causes and consequences.

Transcatheter aortic valve implantation (TAVI) is an alternative treatment option for patients with severe aortic valve stenosis who do not qualify for surgical aortic valve replacement (AVR). Besides its proven clinical benefits, one of the complications of TAVI is the creation of conduction abnormalities, like left bundle branch block (LBBB). New LBBB occurs between 7 and 65% of cases, numbers that differ considerably between devices. In this review, we discuss the possible causes and the clinical significance of TAVI-induced LBBB. Several device- and procedural-related factors seem responsible for the development of LBBB, of which depth of implantation and balloon-annulus diameter ratio are the most important ones. TAVI-induced LBBB negatively affects cardiac function and hospitalization, but its impact on mortality is subject of debate. Future research and registries should implement strict diagnostic criteria for LBBB together with recording of its timing and persistence.

Occurrence, fate and consequences of ventricular conduction abnormalities after transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation (TAVI) is frequently complicated by new left bundle branch block (LBBB). We investigated the development and persistence of LBBB during follow-up and its clinical consequences. METHODS AND RESULTS: ECGs at baseline, within 24 hours, before discharge and at 12 months after TAVI were assessed in 476 patients without pre-existing LBBB and/or pacemaker before or after TAVI. TAVI-induced new LBBB was categorised based on the timing of the occurrence (within 24 hours [acute], after 24 hours but before discharge [subacute], and after discharge [late]), in addition to persistence (transient or persistent). A total of 175 patients (36.8%) developed new LBBB of which 85.7% occurred within 24 hours after TAVI, 12.0% before and 2.3% after hospital discharge, and was persistent in 111 patients (63.4%). Implantation of the Medtronic CoreValve System (MCS) more frequently led to new LBBB than the balloon-expandable Edwards SAPIEN valve (ES) (53.8% versus 21.7%) with less recovery during follow-up (39.0% versus 9.5%). Late new LBBB was only seen in four patients (0.8%). During a median follow-up of 915 (578-1,234) days, persistent LBBB was associated with a significant increase in mortality as compared to no LBBB and temporary LBBB combined (hazard ratio 1.49, 95% confidence interval, 1.10-2.03; p=0.01). CONCLUSIONS: TAVI-induced new LBBB occurs in almost 40% of patients, almost all before hospital discharge. It occurs three times more frequently after MCS than after ES valve implantation and has a twofold lower tendency to resolve during follow-up. Persistent LBBB is associated with a higher mortality.

Left bundle-branch block induced by transcatheter aortic valve implantation increases risk of death.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a novel therapy for treatment of severe aortic stenosis. Although 30% to 50% of patients develop new left bundle-branch block (LBBB), its effect on clinical outcome is unclear. METHODS AND RESULTS: Data were collected in a multicenter registry encompassing TAVI patients from 2005 until 2010. The all-cause mortality rate at follow-up was compared between patients who did and did not develop new LBBB. Of 679 patients analyzed, 387 (57.0%) underwent TAVI with the Medtronic CoreValve System and 292 (43.0%) with the Edwards SAPIEN valve. A total of 233 patients (34.3%) developed new LBBB. Median follow-up was 449.5 (interquartile range, 174-834) days in patients with and 450 (interquartile range, 253-725) days in patients without LBBB (P=0.90). All-cause mortality was 37.8% (n=88) in patients with LBBB and 24.0% (n=107) in patients without LBBB (P=0.002). By multivariate regression analysis, independent predictors of all-cause mortality were TAVI-induced LBBB (hazard ratio [HR], 1.54; confidence interval [CI], 1.12-2.10), chronic obstructive lung disease (HR, 1.56; CI, 1.15-2.10), female sex (HR, 1.39; CI, 1.04-1.85), left ventricular ejection fraction ≤50% (HR, 1.38; CI, 1.02-1.86), and baseline creatinine (HR, 1.32; CI, 1.19-1.43). LBBB was more frequent after implantation of the Medtronic CoreValve System than after Edwards SAPIEN implantation (51.1% and 12.0%, respectively; P<0.001), but device type did not influence the mortality risk of TAVI-induced LBBB. CONCLUSIONS: All-cause mortality after TAVI is higher in patients who develop LBBB than in patients who do not. TAVI-induced LBBB is an independent predictor of mortality.

Emergency transthoracic transapical mitral valve-in-valve implantation.

OBJECTIVES: The valve-in-valve (VIV) technique is an emerging therapeutic option for patients with failure of previously implanted xenografts. We describe a balloon-expandable transthoracic transapical mitral VIV implantation in an emergency setting in a 69-year-old woman with dysfunction of the mitral bioprosthesis. METHODS: Left ventricular apical access was applied. After balloon valvuloplasty, a 26-mm Edwards-Sapien transcatheter valve (Edwards Lifesciences LLC, Irvine, CA, USA) was deployed within the mitral xenograft, using rapid ventricular pacing. RESULTS: The transcatheter valve functioned properly postoperatively and three-dimensional echocardiography carried out 1 month later showed a well-functioning VIV prosthesis and no mitral stenosis (mitral valve area 3 cm(2) , mean gradient 3 mmHg). CONCLUSIONS: In this patient, VIV implantation was found to be a safe alternative to an emergent valve replacement. It might represent a suitable option to conventional procedures even among lower risk patients.