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Objectives: To study the safety and feasibility of a restrictive temporary-RV-pacemaker use and to evaluate the need for temporary pacemaker insertion for failed left ventricular (LV) pacing ability (no ventricular capture) or occurrence of high-degree AV-blocks mandating continuous pacing. Background: Ventricular pacing remains an essential part of contemporary transcatheter aortic valve implantation (TAVI). A temporary-right-ventricle (RV)-pacemaker lead is the standard approach for transient pacing during TAVI but requires central venous access. Methods: An observational registry including 672 patients who underwent TAVI between June 2018 and December 2020. Patients received pacing on the wire when necessary, unless there was a high-anticipated risk for conduction disturbances post-TAVI, based on the baseline-ECG. The follow-up period was 30 days. Results: A temporary-RV-pacemaker lead (RVP-cohort) was inserted in 45 patients, pacing on the wire (LVP-cohort) in 488 patients, and no pacing (NoP-cohort) in 139 patients. A bailout temporary pacemaker was implanted in 14 patients (10.1%) in the NoP-cohort and in 24 patients (4.9%) in the LVP-cohort. One patient in the LVP-cohort needed an RV-pacemaker for incomplete ventricular capture. Procedure time was significantly longer in the RVP-cohort (68 min [IQR 52–88.] vs. 55 min [IQR 44–72] in NoP-cohort and 55 min [IQR 43–71] in the LVP-cohort [p < 0.005]). Procedural high-degree AV-block occurred most often in the RVP-cohort (45% vs. 14% in the LVP and 16% in the NoP-cohort [p ≤ 0.001]). Need for new PPI occurred in 47% in the RVP-cohort, versus 20% in the NoP-cohort and 11% in the LVP-cohort (p ≤ 0.001). Conclusion: A restricted RV-pacemaker strategy is safe and shortens procedure time. The majority of TAVI-procedures do not require a temporary-RV-pacemaker.

Objectives To determine the safety and efficacy of the conveyor cardiovascular system (CCS) to facilitate the delivery of large profile transcatheter valve devices. Background Transcatheter valve devices rely on force provided by the operator to be delivered to their intended position. This delivery may be challenging in a variety of anatomic scenarios. The ability to provide steering from the tip of the device by forming an arterial venous loop may help overcome these challenges. Methods Between May, 2019 and October, 2020, five patients were recruited for delivery of transcatheter valve devices with the CCS. These patients were deemed by the operators to have challenging anatomy which could make conventional valve delivery difficult or impossible. These patients were recruited as part of an FDA approved early feasibility study or through an institutional review board approved compassionate use protocol. Results Three patients underwent transcatheter mitral valve replacement with a SAPIEN-3 valve. One patient each underwent transcatheter aortic valve (TAVR) implantation with a SAPIEN 3 and 1 patient underwent TAVR implantation with a Lotus valve. All patients underwent successful implantation of the valve and removal of the CCS and valve delivery systems. There was no more than trivial mitral regurgitation post procedure in any patient and there was no more than trivial paravavular leak. There were no major in-hospital complications. Conclusions The CCS facilitates the delivery of large profile transcatheter valve devices in challenging anatomic scenarios. Further studies are needed with additional valve technologies.

Objectives To assess the safety profile of redo-TAVR procedures from patients in the transcatheter valve therapy (TVT) Registry. Background The use of transcatheter aortic valves (TAV) to treat previously implanted failing TAVS (TAV-in-TAV) has been an increasingly important topic as indications for TAVR move to younger and lower-risk patients, but data on the safety and efficacy of redo-TAVR is limited. Methods Patients undergoing redo-TAVR procedures using the Evolut R, Evolut PRO or Evolut PRO+ valve in the TVT Registry between April 2015 and March 2020 were included. In-hospital, 30-day and 1-year outcomes were analyzed. Results Redo-TAVR was performed in 292 patients (213 patients received the Evolut R valve and 79 received the Evolut PRO or PRO+ valve). Device success was achieved in 94.5%. In-hospital mortality was 2.1%, stroke occurred in 2.7%, and 77.2% of patients were discharged home. There were no cases of coronary compression/obstruction or myocardial infarction that occurred in index hospitalization. Mean gradient at 30-days was 11.9 ± 6.9 mmHg, and 73.1% had none/trace total aortic regurgitation. Conclusions Results from the TVT Registry demonstrate good short-term outcomes after redo-TAVR with the supra-annular, self-expandable Evolut platform. Long-term follow-up is necessary to further expand understanding this complex scenario.

The aim of the study was to estimate the percentage of Medicare patients needing coronary access for percutaneous coronary intervention (PCI) or coronary angiography following aortic valve replacement (AVR). Indications for TAVR have expanded to include younger and low-risk patients, raising the question of coronary access for future procedures. Medicare patients

Objective Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR). Background The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse. Methods This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality. Results We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p = 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p = .316), and no patients had major vascular complications. Conclusions In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations.

Objectives The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device. Background Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. Methods All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1). Results After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. Conclusions The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.

OBJECTIVES To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self-expanding system with supra-annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm. METHODS The GENESIS trial was a prospective, multi-center, single-arm, 6 month follow-up study conducted in India. The primary performance endpoint was device success defined as per VARC-II criteria at 30 days. The primary safety endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS Forty high-risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7 ± 0.2 to 2.3 ± 0.6 cm2 at 30 days and to 2.2 ± 0.7 cm2 at 6 months (p

OBJECTIVES To compare clinical outcomes of balloon-expandable (BE) and self-expanding (SE) transcatheter aortic valves (TAVs) up to 5 years. BACKGROUND To date, no robust, comparative data of BE and SE TAVs at long-term are available. METHODS We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) with either supra-annular SE (n = 830, 57.6%) and intra-annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching. RESULTS Patients receiving SE valve showed a higher all-cause mortality at 5 years (Kaplan-Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01-1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3-5 years HR 0.97, 95% CI 0.76-1.25, p = .86). Post-procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14-1.87; p

Urgent transcatheter aortic valve implantation (TAVI) is a feasible option for aortic stenosis (AS) patients with decompensated heart failure (HF) and cardiogenic shock (CS) as compared to the more traditional urgent balloon aortic valvuloplasty (BAV).We conducted a retrospective analysis to compare risk and cause of readmission in these two high-risk groups.Nationwide Readmission Database (NRD) 2011-2014 was retrospectively analyzed to identify patients with AS having either urgent TAVI or urgent BAV using appropriate ICD-9 codes. Propensity scores were used to match patients with urgent TAVI as compared to patients with urgent BAV. Statistical analysis was performed using the Stata 15.1 software.We identified a weighted sample of 6,670 patients with urgent BAV and 6,964 patients with urgent TAVI. The all-cause 30- and 90-day readmission was lower in the urgent TAVI group compared to urgent BAV (15.4 vs. 22.5%, (aHR): 0.92 [0.90-0.95] p .001). 30-day readmission due to CV cause and HF was also lower in the urgent TAVI group (aHR, 0.93: p .001 and aHR, 0.98: p = .040, respectively). The 30-day gastrointestinal (GI) bleed readmission rate was three times higher in urgent TAVI group (aHR, 3.00:95% CI (1.23-7.33), p = .016), but was not statistically significant at 90-days. Cardiac causes of readmission were the predominant cause of readmission in both groups, but more pronounced in urgent BAV group (60.3 vs. 40.5%, p .001).Urgent TAVI appears beneficial in patients with AS and decompensated HF or CS driven by roughly 10 and 25% reductions in overall readmissions at 30 and 90 days, and marked reductions in reintervention, although offset partially by higher risk of readmission due to GI bleeding at 30 days.

Structural deterioration of transcatheter heart valve (THV) has been previously described. With the expansion of transcatheter aortic valve replacement (TAVR) indications toward treating lower risk patients with longer life expectancy, there will be increased necessity of managing the patients with THV dysfunction including those at risk for coronary obstruction or sinus sequestration. Coronary access also remains a challenge in such cases with THV dysfunction undergoing valve-in-transcatheter heart valve (ViTHV) TAVR. A unique and first reported case of THV deterioration treated with Sapien 3 ViTHV-TAVR inside a 31 mm CoreValve bioprosthesis along with left coronary leaflet laceration using the BASILICA technique has been presented.

BACKGROUND The willingness of interventional cardiologists to adopt innovation and implement changes in day-to-day practice has received limited study. METHODS Online-based survey on learning and innovation: 38 questions were distributed via email list to interventional cardiologists. RESULTS The survey was distributed to 8,110 e-mails and completed by 621 (7.7%, 91.8% men, 60% in the 35 to 54-year-old age group). Of the respondents who perform coronary interventions, 45% perform >100 cases of noncomplex percutaneous coronary interventions per year and of the respondents who perform structural interventions, 15% perform more than >100 transcatheter aortic valve replacements per year. Most respondents (86.7%) rate themselves as highly likely/likely to introduce recently approved equipment in everyday practice and 47.5% have tried a new coronary guidewire in the past 6 months. The most common reasons for reluctance to use new equipment were high cost (64%) and uncertainty about whether it provides additional benefits compared with existing equipment (48.5%). Radial access in STEMI cases is always used by 43.6% of the respondents and 55% always use radial access for coronary angiography. Of those who use femoral access, 32% always use ultrasound guidance and 91% have used a closure device in the last 6 months. Most respondents (80%) read journals to keep up with current practice and believe that the most effective way to learn is through attendance of workshops/short courses (77.5%). Most respondents (69%) are involved in research. CONCLUSION Interventional cardiologists who participated in the survey are highly likely to adopt innovation in daily clinical practice.

OBJECTIVES We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality. BACKGROUND Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF). METHODS This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models. RESULTS In total, 5,910 patients underwent TAVI via TF (N = 4,072), DA (N = 524), and TA (N = 1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p = .002) and TA (HR 3.34, 95%CI 2.28-4.89, p

We report a case of a 69-year-old male who was planned for a transcatheter aortic valve replacement (TAVR) with a 26 mm Sapien 3 Valve (Edwards Lifesciences, Irvine, California) for the treatment of symptomatic severe aortic stenosis. During rapid ventricular pacing and implantation of the TAVR valve, there was a loss of pacing capture and subsequent embolization of the valve into the aortic arch. Retrieval of the embolized valve was attempted unsuccessfully using several techniques. Finally, by using a 34 mm Evolut R Valve (Medtronic, Minneapolis, Minnesota), we were able to secure the embolized valve in the transverse segment of the aortic arch without compromising the branch vessels. To our knowledge, this is the first reported case of using a valve-in-valve approach to fixate an embolized valve in the transverse aorta.

OBJECTIVE We sought to evaluate the feasibility and safety of carotid access transcatheter aortic valve replacement (TAVR) by performing a meta-analysis of published cases. BACKGROUND Several case series and regional data have provided initial basis for carotid access TAVR in patients with prohibitive femoral approach. We performed this meta-analysis to provide further evidence of feasibility and safety of carotid TAVR. METHODS We searched PubMed, EMBASE, CINAHL, and Cochrane CENTRAL for any study on carotid access TAVR involving ⩾5 patients since inception till March 1, 2020. Random-effects model was used to compute overall effects. The outcomes analyzed were all-cause mortality, Transient ischemic attack (TIA)/stroke, need for permanent pacemaker (PPM) implantation, pericardial tamponade, access site complications, major bleeding, and length of stay. RESULTS There was a total of 17 retrospective studies (n = 2082) with a median follow-up of 1 month. Mean age of the patient was 80 years. Mean Euroscore and STS scores were 15 ± 6.2 and 7.9 ± 3.3, respectively. The procedural success rate was 99%. The rate of all-cause mortality was 6.7% (range 4.6-9.7%, p

Aortitis is an uncommon systemic inflammatory disease affecting the aorta and its main branches. Severe aortic regurgitation (AR) represents a fearsome complication of aortitis and is associated with an increased mortality rate. Surgical aortic valve replacement represents the only treatment choice for these patients. However, it is associated with a higher risk of medium to long-term complications such as prosthetic valve detachment. This is the first reported case where severe AR secondary to aortitis was managed with transcatheter aortic valve implantation (TAVI). TAVI was safe and effective in this clinical setting and may be considered a viable alternative to high-risk surgery in these complex patients.

Background: Valve-in-valve (VIV) treatment with transcatheter aortic valve replacement (TAVR) is a viable option for patients with failing aortic bioprosthetic valves. Optimal management of those with concomitant mitral regurgitation (MR) remains undetermined. Therefore, we sought to assess the implications of concomitant MR in patients undergoing VIV-TAVR. Methods and Results: The PARTNER 2 VIV registry enrolled patients with degenerated surgical aortic bioprosthesis at high risk for reoperation. Patients with core-laboratory echocardiographic assessment of MR were analyzed; severe MR was excluded. We compared patients with ≤mild MR versus moderate MR and assessed changes in MR severity and clinical outcomes. A total of 339 patients (89 initial registry, 250 continued access) underwent VIV procedures; mean age 79.0 ± 10.2 years, mean Society of Thoracic Surgeon score 8.9 ± 4.5%. At baseline, 228/339 (67.3%) had ≤mild MR and 111/339 (32.7%) had moderate MR. In paired analysis, there was significant improvement in ≥moderate MR from baseline to 30 days (32.6% vs. 14.5%, p

Background We sought to quantify and compare changes in quality of life measures after transcatheter aortic valve replacement (TAVR) in patients with low-flow (LF) and normal-flow (NF) aortic stenosis (AS). Methods We included 297 patients treated with TAVR at Abbott Northwestern Hospital from January 2015 to October 2017. Health status was assessed at baseline and 30 days post-procedure using the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12). Overall (KCCQ-OS) and domain-specific (physical limitation, symptom frequency, quality of life, and social limitation) scores were compared in three subsets of patients as defined by stroke volume index (≤ or >35 ml/m2 ), ejection fraction (EF) (≤ or >40%), and mean gradient (≤ or >40 mmHg). Results Of the 297 patients included, 129 (43%) had NF high-gradient (NF AS group) and 168 (56%) had LF severe AS, including 25 (8%) with low EF (8%) ("Classical" low-flow low-gradient LEF [LF-LG-LEF] group) and 143 (48%) with preserved EF ("Paradoxical" LF-LG group). At baseline, patients with LF-LG-LEF AS had more severe impairment in symptoms frequency (p = .06) but similar KCCQ-OS. At 1-month after TAVR, all groups had moderate improvements in quality of life (Delta KCCQ-OS: "Classical" LF-LG-LEF 18 ± 21, paradoxical AS 14 ± 18, and NF AS 15 ± 16, p = .57). During a median follow-up time of 2.4 years, there was no difference in mortality (p = .34) but patients with paradoxical LF-LG AS had a higher risk of rehospitalization for heart failure (p = .01). Conclusions Patients with LF severe AS derive significant improvements in quality of life measures after TAVR, indistinguishable from patients with NF AS.

Aortic insufficiency (AI) is a frequent problem after continuous-flow left ventricular assist device (LVAD) implantation and results in increased morbidity and mortality. Advances in transcatheter aortic valve replacement (TAVR) technology have resulted in this being discussed as a potential option for LVAD patients with AI. While small case series have been published, we report the first case of TAVR thrombosis in an LVAD patient. This case highlights a major diagnostic and management dilemma that should become more present if this strategy becomes more widespread.

Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is an established therapy for a degenerated surgical bioprosthesis. TAVI-in-TAVI following ViV-TAVI has not been previously performed. We report a high-risk patient presenting with severe left ventricular failure secondary to undiagnosed critical aortic stenosis due to degeneration of the implanted transcatheter heart valve more than a decade after initial ViV-TAVI for a failing stentless aortic valve homograft. Successful TAVI-in-TAVI reversed the clinical and echocardiographic changes of decompensated heart failure with no evidence of coronary obstruction.

Background: Transcatheter aortic valve replacement (TAVR) is being increasingly used for decompensated severe symptomatic aortic stenosis. Data on urgent and elective TAVR readmission is scarce in the literature. Here, we have performed a retrospective cohort study with the Nationwide Readmission Database of 2016 to identify the rate of 30-day all-cause readmission, common causes of readmission, and distribution of morbidity in index admission and readmission after urgent and elective TAVR. Methods: We used International Classification of Diseases, Tenth Revision codes (02R.F38H, 02R.F38Z, 02R.F48Z) for identification of all TAVR procedures done in 2016 in patients >18 years old. We found 8379 patients who underwent urgent TAVR and 32,006 patients who underwent elective TAVR in 2016. Result: The mean age of patients undergoing urgent TAVR was 79 ± 9.97 years with 44.6% women. The mean age of patients undergoing elective TAVR was 80.7 ± 8.25 years with 46.2% women. We found the 30-day all-cause readmission rate of 15.5% and 9.5% in patients undergoing urgent and elective TAVR, respectively (p < 0.001). The cardiac cause was the predominant cause of readmission in both groups (43.77% vs. 42.11%, p = 0.57), followed by pulmonary cause, gastrointestinal (GI) cause, and renal cause. Among cardiac causes, congestive heart failure (CHF) was predominant cause of readmission and was similar in both groups (18.73 in urgent TAVR vs. 15.73 in elective TAVR, p = 0.12). Conclusion: We found that the all-cause 30-day readmission rate was higher in patients who had undergone urgent TAVR. Further studies are needed to better understand this difference.

Crossover balloon occlusion technique (CBOT) has been proposed to ensure adequate closure of the arterial access used for transcatheter aortic valve replacement (TAVR). However, the CBOT performed through the contralateral femoral artery could be challenging in cases of excessively tortuous and calcified vessels or in the presence of narrow iliac carina angles. We describe a novel technique to facilitate the advancement the peripheral balloon through the contralateral femoral artery up to the target iliofemoral system in order to facilitate access site hemostasis. The present "locking and drugging" technique takes advantages from two mechanical aspects: (a) the locking of the 0.018″ wire between the vessel wall and the TAVR delivery system or the dedicated sheath, which facilitate the crossover of the balloon in the contralateral iliofemoral system, preventing its prolapse into the aorta at the carina level and (b) the dragging of the balloon advanced into the contralateral iliofemoral system during the retrieve of the TAVR delivery system or the dedicated sheath.

Objectives This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality. Background PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves. Methods All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems. Results A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p = 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p = 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality. Conclusions The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed.

Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. Background: Data on pacemaker insertion complicating TAVR in women are scarce. Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85–7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30–0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9–16] days in PPI vs. 9 [7–14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adjHR 0.95, 95% CI 0.60–1.52, p = 0.84 and adjHR 1.22, 95% CI 0.83–1.79, p = 0.31, respectively). Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

BACKGROUND Constant elevations of the serum concentration of cardiac troponin T (TnT) indicate a myocardial injury that may affect the long-term outcome of transcatheter aortic valve replacement (TAVR). OBJECTIVES We sought to investigate the impact of pre-TAVR TnT on outcomes after TAVR during long-term follow-up. METHODS In a retrospective, observational study we compared long term outcomes after TAVR between tertiles of preinterventional high-sensitivity TnT. Systematic follow-up was performed annually for 5 years. The primary endpoint was a composite of all-cause death and any rehospitalization. RESULTS Between 2010 and 2018, 2,129 patients with severe aortic valve stenosis underwent TAVR at our institution (mean age 82.6 years, 57.2% female, logistic EuroSCORE 20.5 ± 15.8). Boundaries for TnT tertiles were 42 ng/L. The median follow-up was 895 days. Three-year incidences for the primary endpoint were 70.9%, 76.6%, and 81.7% in the low, middle, and high tertile (log rank p

OBJECTIVES This meta-analysis sought to assess predictors of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) with focus on preprocedural multi-slice computed tomography (MSCT) derived data. BACKGROUND Transcatheter aortic valve replacement (TAVR) has expanded to a well-established treatment for severe symptomatic aortic stenosis at high and intermediate surgical risk. PPI after TAVR remains one of the most frequent procedure-related complications and appears to be influenced by several factors. METHODS The authors conducted a literature search in PubMed/MEDLINE and EMBASE databases to identify studies that investigated preprocedural MSCT data and the rate of PPI following TAVR with new-generation devices. RESULTS Ten observational studies (n = 2707) met inclusion criteria for the final analysis. PPI was performed in 387 patients (14.3%) after TAVR. Patients requiring PPI had a larger annulus perimeter (MD: 1.66 mm; p

Objectives To describe our initial experience with pediatric transcatheter aortic valve replacement. Background Transcatheter aortic valve replacement (TAVR) has been approved and used to treat calcific aortic stenosis in adult patients. Select pediatric patients with congenital heart disease (CHD) who are poor candidates for conventional surgical aortic valve replacement can benefit from TAVR. Methods A retrospective review was performed to identify and describe pediatric patients with CHD who underwent transcatheter or hybrid aortic valve replacement using a Melody Valve (Medtronic, Minneapolis, MN), or Sapien S3/XT valve (Edwards Life sciences LLC, Irvine, CA). Patients in whom transcatheter valves were implanted on cardiopulmonary bypass were included. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate acute and short-term results. Results A total of eight pediatric patients underwent treatment of aortic valvular disease using balloon expandable valves and delivery systems. Two patients had Melody valve implantation and six received a Sapien valve (one XT/five S3). In one patient, a Melody valve was placed surgically, failed, and was replaced with a Sapien valve 2 years later. Two patients were treated using a standard transfemoral route, four had the valve delivered on cardiopulmonary bypass via a median sternotomy, one was placed with a transapical approach, and one via a carotid cut down. Patients were followed for an average 16 months (range 1-208 weeks). There were no early or late deaths in this cohort. There were no embolic events, and all valves worked well in the immediate postoperative period. Both Melody implants developed moderate to severe regurgitation at 2 years and 4 years, respectively, and both required replacement at that time. One Sapien 3 valve developed a paravalvular leak that required reintervention within 6 months of implantation. Conclusions Transcatheter valves offer a reasonable alternative to traditional surgical aortic valve replacement in certain pediatric patients who are suboptimal surgical candidates. Hybrid approaches and valve delivery on cardiopulmonary bypass has been used in smaller patients. Long-term performance of these valves in young patients has not been studied.

AIMS To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) using three different new-generation devices. BACKGROUND Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head-to-head comparisons are available among these devices. METHODS This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF-TAVI for native, severe aortic stenosis using a new-generation transcatheter aortic valve (TAV) with a preprocedural multi-detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30-day all-cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p

Symptomatic degenerative prosthetic aortic valve stenosis during pregnancy represents a significant risk to both mother and fetus, and until recently, surgical aortic valve replacement (SAVR) during pregnancy was often the only choice for women opting to continue pregnancy. However, symptomatic severe stenosis in a pregnant woman with a degenerated full aortic root Freestyle stentless bioprosthesis (FSB) and reimplanted coronary arteries presents additional complexities that require an alternative surgical approach. In this case report, we describe the first successful transcatheter aortic valve replacement (TAVR) in SAVR for a severely stenotic degenerative FSB in a pregnant woman and subsequent delivery of a healthy infant several months later. TAVR in SAVR of a severely stenotic aortic FSB should be considered as a surgical option in symptomatic pregnant women. Short-term and long-term implications for future pregnancy should be discussed by a multidisciplinary team and with the patient.

BACKGROUND There is conflicting data as to whether diastolic dysfunction (DD) affects the prognosis of patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). METHODS Consecutive patients undergoing TAVR underwent assessment of DD with preoperative echocardiography and NT-pro BNP. Long-term survival was ascertained every 6 months by clinic visits or phone. DD was graded according to the new American Society of Echocardiography recommendations. Health status was assessed at baseline and 30 days post-procedure using the KCCQ-12 questionnaire. Long-term survival was displayed using Kaplan-Meier curves according to NT-pro BNP levels and DD grades. RESULTS We included 222 patients, mean age 78 (±8) years, median STS score 4 (interquartile range = 3-7), median follow-up time 385 days (IQR = 180-640). DD was absent in 25, Grade I in 13, Grade II in 74, Grade III in 24, and indeterminate in 86 patients. Advanced (Grades II-III) DD was associated with higher pre-procedural NT-pro BNP levels (p

The field of transcatheter aortic valve replacement (TAVR) has matured significantly with the outcome and durability data now supporting use in lower-risk patients. We present a preventable complication from early in our experience (5 years ago) that illustrates the importance of heart team communication and cautious multidiscipline cross-pollination during the formative years of a program. An 87-year old female developed confusion, slurred speech and left upper extremity weakness 1 day following TAVR with inconclusive findings on carotid artery duplex and transthoracic echocardiography. Subsequent CT-scan disclosed a linear, ring-like, structure in the ascending aorta. The foreign body (FB) was radiolucent and successfully snared via tactile sensation and anatomic landmarks informed by the CT. The extricated FB was the valvuloplasty balloon guard (BG) that was inadvertently introduced into the patient via ascending aortic large sheath access. The failure mode was traced back to the first time use of a new balloon system and unrecognized BG by the surgical physician and technician components of the Heart Team who took the lead role in device insertion due to the open chest access. Subsequently, the heart team made changes to mitigate similar future complications by sharing multidiscipline responsibility for all procedural steps and ensuring the use of all new adjuvant devices are preceded by a procedural pause and team consensus regarding device preparation and use. Additionally, the manufacturer addition of a radiopaque marker or flair on the valvuloplasty BG may be warranted.

Background Thrombocytopenia after transcatheter aortic valve replacement (TAVR) is associated with adverse clinical outcomes. Whether preprocedural P2Y12 inhibition prevents postprocedural thrombocytopenia is uncertain. Methods This retrospective analysis identified consecutive patients (n = 266) undergoing TAVR between November 2016 and July 2017. Preprocedure clopidogrel load ≥300 mg or maintenance P2Y12 inhibitor therapy defined preprocedural P2Y12 inhibition. Patients who did not consent for the registry (n = 8), with baseline severe thrombocytopenia ( 20% decrease in platelet count from baseline to day 1 post-TAVR. Results Patients with (n = 134) versus without (n = 106) preprocedural P2Y12 inhibition had no differences in platelet count at baseline. Patients with preprocedural P2Y12 inhibition had a significantly lower proportion of the primary outcome (34.3% vs. 57.5%, p = .001) and a lower absolute decrease in platelet count (32.8 × 103 vs. 45.8 × 103 platelet/μL, p = .01). Of patients without baseline thrombocytopenia (n = 198), a numerically lower rate of patients with versus without preprocedural P2Y12 inhibition developed thrombocytopenia on day 1 post-TAVR (25.5% vs. 36.4%, p = .1). Conclusion Patients who received preprocedural P2Y12 inhibition prior to TAVR were less likely to demonstrate a decrease in platelet count after TAVR. Prospective studies to further understand the clinical implication of these findings are warranted.

BACKGROUND Conduction disturbances are the most frequent complication of transcatheter aortic valve replacement (TAVR). However, no data exists regarding the outcomes of intraprocedural high-degree atrioventricular block (HAVB) or complete heart block (CHB) in patients without previous conduction disturbances. OBJECTIVES The aim of this study was to evaluate the outcomes of intraprocedural-HAVB/CHB in patients without previous intraventricular conduction disturbances. METHODS The occurrence of intraprocedural-HAVB/CHB was assessed in 676 consecutive patients undergoing TAVR, and two groups were established according to its duration: persistent-HAVB/CHB (PHAVB/CHB) and transient-HAVB/CHB (THAVB/CHB), not present at the end of the procedure. RESULTS Intraprocedural-HAVB/CHB occurred in 50 patients (7.4%), being persistent in 32 (64.0%), and transient in 18 (36.0%). The use of Medtronic Corevalve Revalving System (MCRS) and a greater oversizing of the valve increased the risk of intraprocedural-HAVB/CHB (p

Aims We aimed to assess whether the level of aortic root calcification is associated with BAV performance/omission during transcatheter aortic valve implantation (TAVI), and to explore related outcomes. Methods and results EASE-IT TF was a prospective, observational, multicenter registry of patients undergoing TF-TAVI with the Edwards SAPIEN 3, with or without BAV predilation. Valvular calcification was quantified from pre-procedural multi-slice computed tomography images and compared between BAV and no BAV patients. Data for 178 patients (55 BAV; 123 no BAV) were analyzed. There were no significant differences between groups in terms of regional/leaflet sector calcification volumes, maximum asymmetry between the different leaflet sectors, or total calcification scores. Overall, a greater-than-average leaflet calcification volume was independently predictive of ≥mild PVL (OR: 5.116; 95% CI: 1.042-38.35) and the need for post-dilation (OR: 3.592; 95% CI: 1.173-12.14). The latter effect was abated in patients with BAV (OR: 1.837; 95% CI: 0.223-18.00) and intensified in those without BAV (OR: 5.575; 95% CI: 1.114-38.74). No other BAV-dependent effects of calcification on outcomes were observed. Conclusions In the majority of transfemoral valve implantations, calcification does not appear to be the main driving factor in the decision to perform/omit BAV. Predilation may be valuable for reducing post-dilation requirements in patients only with a greater degree of leaflet calcification.

Objectives The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex. Background Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. Methods A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed. Results Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR. Conclusions Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure.

Objectives The objectives of this study were to compare short‐ and intermediate‐term clinical outcomes, procedural complications, TAVR prosthesis hemodynamics, and paravalvular leak (PVL) in stentless and stented groups. Background Valve‐in‐valve (ViV) transcatheter aortic valve replacement (TAVR) is an alternative to surgical redo for bioprosthetic valve failure. There have been limited data on ViV in stentless surgical valves. Methods We retrospectively analyzed 40 patients who underwent ViV TAVR in prior surgical bioprosthetic valves at Wake Forest Baptist Medical Center from October 2014 to September 2017. Eighty percent (32/40) ViV TAVRs were in stentless, while 20% (8/40) were in stented bioprosthetic valves. Results The primary mode of bioprosthetic valve failure for ViV implantation in the stentless group was aortic insufficiency (78%, 25/32), while in the stented group was aortic stenosis (75%, 6/8). The ViV procedure success was 96.9% (31/32) in stentless group and 100% in stented group (8/8). There were no significant differences in all‐cause mortality at 30 days between stentless and stented groups (6.9%, 2/31 versus 0%, 0/8, P = 0.33) and at 1 year (0%, 0/25 versus 0%, 0/5). In the stentless group, 34.4% (11/32) required a second valve compared to the stented group of 0% (0/8). There was a significant difference in the mean aortic gradient at 30‐day follow‐up (12.33 ± 6.33 mmHg and 22.63 ± 8.45 mmHg in stentless and stented groups, P

OBJECTIVES To investigate the impact of transcatheter heart valve (THV) sizing on procedural results and clinical outcomes following transcatheter aortic valve implantation (TAVI). BACKGROUND The impact of individual THV sizing for patients with borderline aortic annulus anatomy remains unclear. METHODS In the prospective BernTAVI registry, THV sizing conditions were retrospectively evaluated, and patients were categorized into three groups based on the recommendations and the sizing chart of the manufacturers: optimal sizing, borderline sizing (THV size located within 5% to each border of the optimal sizing recommendation), and suboptimal sizing (THV size outside the recommended range). The latter two groups were further subcategorized into THV-oversizing and THV-undersizing. The primary endpoint was a composite of all-cause death and unplanned repeat intervention at 1 year. RESULTS Out of a total of 1,638 patients who underwent TAVI, 9.5 and 15.6% of patients were categorized into the borderline and suboptimal sizing group, respectively. Device success was achieved in 87.4, 88.9, and 83.6% of patients with optimal, borderline, and suboptimal sizing, respectively. The primary endpoint occurred in 12.3% of patients with optimal sizing, 14.9% of patients with borderline sizing (HRadj 1.35, 95%CI 0.87-2.09), and in 17.4% of patients with suboptimal sizing (HRadj 1.42, 95%CI 1.01-1.99). Within the suboptimal sizing cohort, unfavorable outcomes were mainly associated with THV undersizing (device success: 76.4%, primary endpoint: 23.9%, HRadj 1.98, 95%CI 1.36-2.87). CONCLUSION Suboptimal TAVI prosthesis sizing is associated with an increased risk of all-cause death and unplanned repeat intervention within 1 year largely attributable to undersized THV prostheses.

OBJECTIVES Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are associated with adverse outcomes in severe aortic stenosis (AS) patients. Our aim was to evaluate the association between ≥moderate TR and RV dysfunction on long-term mortality following transcatheter aortic valve replacement (TAVR). METHODS A retrospective analysis of the Israeli multicenter TAVR registry among 4,344 consecutive patients, with all-cause mortality as the main outcome measure. RESULTS Echocardiographic assessment of TR grade and RV dysfunction was available for 3,733 and 1,850 patients, of whom ≥moderate TR and RV dysfunction was noted for 478(13%) and 78(4%), respectively. The mean follow-up time was 2.9 ± 2.3 years. In univariate models, ≥Moderate TR and ≥moderate RV dysfunction were associated with increased long-term mortality (HR 1.45, 95% CI 1.24-1.69, p

Self-expanding prostheses for transcatheter aortic valve replacement (TAVR), which can be recaptured, provide us the option of repositioning for a more accurate placement. We report a very rare case in which the recapture of CoreValve Evolut R (Medtronic, Minneapolis, Minnesota) to correct the implantation depth during the deployment could not be achieved. We planned TAVR with a 23 mm Evolut R prosthesis for a 92-year-old female with severe aortic stenosis and tightly bent thoracic aorta. During the first deployment attempt, the implantation depth was greater than we expected at 2/3 deployment. They tried to recapture and reposition the prosthesis, but the prosthesis was not re-sheathed into the capsule of the delivery system. The prosthesis could not be recaptured despite a repeat attempt, and they were forced to deploy the device as it was. The prosthesis was deployed very carefully and implanted successfully without a pop-up into the ascending aorta. At a later date, this situation was replicated in vitro and was found that the distal segment of the capsule became deformed, increasing the resistance to rotating the grip handle.

OBJECTIVE We sought to conduct a systematic review and network meta-analysis to examine the association between institutional transcatheter aortic valve replacement (TAVR) volume and all-cause mortality. BACKGROUND Since inception in 2011, there has been an exponential increase in the number of TAVR centers across the world. Multiple studies have questioned if a relationship exists between institutional TAVR volume and patient outcomes. METHODS We performed a systematic literature search for relevant articles using a combination of free text terms in the title/abstract related to volume, TAVR, and patient outcomes. Two reviewers independently screened all titles/abstracts for eligibility based on pre-specified criteria. All-cause mortality data was pooled from eligible studies and centers were categorized as low-(30-50 cases), intermediate-, or high-volume (75-130 cases) based on their annual TAVR volumes. RESULTS Our search yielded an initial list of 11,153 citations, 120 full text studies were reviewed and 7 studies met all inclusion and exclusion criteria, yielding a total of 1,93,498 TAVRs. Categorized according to center's annual volume; 25,062 TAVRs were performed in low-, 77,093 in intermediate- and 91,343 in high-volume centers. Network meta-analysis showed a relative reduction in mortality rates of 37%, 23% and 19%, for high volume versus low volume centers, high volume versus intermediate volume centers and intermediate versus low volume centers, respectively. CONCLUSIONS Existing research clearly shows an inverse relationship between annual TAVR procedural volume and all-cause mortality. We need to focus on development of strong referral networks and consolidation rather than expansion of existing TAVR centers to improve patient outcomes, while ensuring adequate access-to-care.

The COVID‐19 pandemic has resulted in the cancellation of many elective surgical procedures. This has led to reports of an increase in mortality for patients with non‐Covid health conditions due to delayed definitive management. Patients with severe aortic stenosis have a high annual mortality if left untreated. These patients are at risk due to the reduced number of surgical aortic valve replacements and competition for intensive care facilities during the COVID‐19 pandemic. This case series suggests that the minimally invasive transcatheter aortic valve implantation is safe to continue during the COVID‐19 pandemic with adjustments to the patient pathway to minimize hospital stay and to reduce patient and staff exposure. This helps to reduce the delay of definitive treatment for patients with severe aortic stenosis.

Objectives The current report describes a single operator's experience of the first use of smartglass technology as a facilitator of virtual support during TAVR proctoring. Background Restricted gatherings and containment measures during the ongoing COVID‐19 pandemic have a major impact on daily clinical practice. Interaction between peers is crucial in science, clinical practice, and education. In addition, there is also a growing importance of proctoring in interventional cardiology for structural heart disease. Virtual support may facilitate the wide implementation of remote proctoring. Methods A collaboration between a smartglass provider (Rods & Cones) and self‐expandable transcatheter aortic heart valve system (Medtronic) was initiated and tested extensively prior to TAVR procedures. Two cases were randomly selected for remote support. The light‐weight smartglass consisted of a full HD central camera, a 720p ×5 optical zoom camera, built‐in LED light, speaker and earphone jack, and an external visor to project data in a nonobstructive manner in the operators' view. Results Preprocedural detailed discussion of the cases between the proctor and the operator occurred via teleconferencing. Successful procedural virtual support was determined by the presence of a session coordinator, high quality of the central camera, high‐speed and stable wireless internet connection. Limitations were the relative discomfort of the earpieces, discordance between the central and zoom camera and the absence of visual fixation during head motions. Conclusion In a highly complex and demanding context such as TAVR, remote proctoring by means of virtual support is feasible and efficacious.

BACKGROUND Monitored anesthesia care (MAC) has become more widely used during transcatheter aortic valve replacement (TAVR) to avoid the complications of general anesthesia (GA). METHODS We included consecutive patients who underwent transfemoral-TAVR at our institution between January 2012 and April 2017. We compared outcomes with GA versus MAC. RESULTS Of 998 patients, MAC was used in 43.9%. MAC was associated with shorter procedural time (96.9 ± 30.9 vs. 135 ± 64.6 mins; p

Transcatheter aortic valve replacement (TAVR) for transcatheter heart valve failure has been suggested for high-risk patients. TAVR-in-TAVR, however, may lead to complex leaflet interactions causing coronary ostial obstruction, which is a devastating complication. Coronary protection with provisional stent placement may be challenging. We describe the first percutaneous transaxillary case of TAVR-in-TAVR with Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) where guide catheters used for coronary protection were entrapped between the valve frames. We describe anatomical predictors and management considerations. Operators should be aware of this important complication during TAVR-in-TAVR valve placement.

Iatrogenic femoral artery pseudoaneurysm is an infrequent but troublesome complication of vascular access during transcatheter aortic valve implantation. There are non-invasive, percutaneous and surgical treatment options for management of this complication. This case series report demonstrates a novel technique using an Amplatzer Duct Occluder II closure device to successfully treat iatrogenic common femoral pseudoaneurysm following transcatheter aortic valve implantation.

OBJECTIVE This study sought to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation for failed surgical bioprostheses (TAVI-ViV) with Portico device. BACKGROUND Limited evidence coming from early experience on Portico system does not allow to fully assess safety and efficacy of this device in this ViV patients. METHODS From January 2016 up to June 2019, 56 consecutive patients undergoing TAVI-ViV with Portico were prospectively included in our institutional TAVI database. RESULTS The prevalent mechanism of failure was stenosis (58.9%); true internal diameter (ID) was

BACKGROUND Transcatheter aortic valve implantation related thrombocytopenia (TAVI-rTP) is an inevitable phenomenon. However, no study has been performed on TAVI-rTP in the current setting of extended clinical indications combined with technology improvements. METHODS Patients with severe symptomatic aortic stenosis who underwent transfemoral TAVI, from January 2016 to December 2019 were enrolled. RESULTS Two-hundred and one consecutive patients (mean age 81.1 ± 7.1 years, 96 men) enrolled. Platelet count was recorded before and after aortic valve implantation. Dropped platelet count (DPC) occurred in all but 11 patients who were included. Two groups were created: DPC