Predictors of target lesion failure after treatment of left main, bifurcation, or chronic total occlusion lesions with ultrathin-strut drug-eluting coronary stents in the ULTRA registry.

BACKGROUND: Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant. METHODS: The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis. RESULTS: Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82). CONCLUSIONS: Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome.

"Reverse Spider View" for left stem coronary artery angiographic evaluation.

Among the angiographic views used to evaluate left coronary system, the so-called "spider view" represents one of the most iconic, in particular for its ability to evaluate the Left Main stem (LM) and/or to guide percutaneous coronary interventions (PCIs) on LM bifurcation disease. Unfortunately, the use of such view is graved by a high X-ray exposure for both the operator and the patient. To overcome these limitations, we described an alternative coronary angiographic view, called "reverse spider" which is able to give more information about LM body and bifurcation disease with less X-ray exposure for the operator.

Emergent In Situ Fenestration in the Ascending Aorta for the Endovascular Repair of a Large Pseudoaneurysm: A Technical Note.

PURPOSE: The purpose of this article is to describe an emergent in situ fenestration (ISF) technique in the ascending aorta for the endovascular repair of a large pseudoaneurysm using a trans-septal needle device through direct right common carotid artery access, in a patient with left ventricular assist device (LVAD). TECHNIQUE: We performed, in a multidisciplinary team-work approach, an emergent ISF to correct the displacement of a physician-modified thoracic endograft released in the ascending aorta to correct a large anastomotic pseudoaneurysm in a patient who underwent ascending aorta replacement and subsequent LVAD implantation. We used a trans-septal needle device inserted through a direct access to the right carotid artery and performed an ISF to restore the patency of the outflow ostium of the LVAD. Window was then completed and stabilized with a nitinol balloon expandable covered stent graft obtaining an effective exclusion of the anastomotic aortic aneurism and the regular patency of the LVAD outflow graft with no signs of leaks. CONCLUSIONS: Multidisciplinary teamwork approach can be crucial in challenging procedures where an alternative approach may lead to problem solving. The ISF technique may be a valid option to adopt in emergency cases in which no other technical solutions are suitable. CLINICAL IMPACT: The endovascular approach has become more and more frequent for the treatment of vascular pathologies, getting increasingly refined and complex. Thereby the chance of incurring intraprocedural troubles has grown and bailout strategies should always be present. In situ fenestration is a technique to be aware of and that could help you recover from difficult situations. We report a possible rescue maneuver that can be applied also in arduous anatomies such as the ascending aorta. Moreover, we would like to highlight the importance of a multidisciplinary working environment that can enrich our everyday practice accomplishing effective and unexpected solutions.

Improvement of symptoms and coronary perfusion gradient with mechanical left ventricular unloading in flow-limiting complex spontaneous coronary artery dissection, without revascularization.

Spontaneous coronary artery dissection (SCAD) can lead to acute coronary syndrome and sudden cardiac death, particularly in young women. Observational data show that, in SCAD patients, both percutaneous coronary intervention and coronary artery bypass grafting seem to be hampered by higher technical complexity, lower success rates, and worse outcomes. As spontaneous healing is a common occurrence, expert consensus advices medical management of the acute phase, when feasible. We present the case of a young woman with SCAD of left anterior descending artery causing myocardial infarction with ST-segment elevation. High-anatomical complexity and unstable conditions of the patient made both medical management and immediate revascularization unfeasible options. Therefore, we decided to implant a percutaneous off-loading mechanical support device to improve coronary perfusion pressure by unloading the left ventricle and preserve cardiac function, preventing worse complications of acute myocardial infarction. This strategy was successful in stabilizing the patient, until the definitive revascularization treatment became an option.

Bioresorbable Scaffolds in Percutaneous Coronary Intervention: Facing Old Problems, Raising New Hopes.

PURPOSE OF REVIEW: In this review, we discuss about the reasons behind the failure of the Absorb bioresorbable vascular scaffold (BVS) device and about the challenges the future holds for the next generation of the bioresorbable scaffold (BRS) technology. RECENT FINDINGS: Absorb BVS was burdened by intrinsic structural limitations which resulted in augmented rates of device thrombosis and clinical adverse events compared to current-generation metallic stent. Nevertheless, new generation devices with novel design and materials are in development. Second generation BRS have enhanced mechanical strength, smaller footprints, less thrombogenicity and modified bioresorption. These features, paired with proper patient and lesion selection and optimal "user-friendly" implant techniques, could possibly overcome the previous BRS generation limitations, rekindling physicians, and industry interest on this promising technology.

Incidence and feasibility of coronary access after transcatheter aortic valve replacement.

BACKGROUND: Incidence of coronary access (CA) after transcatheter aortic valve replacement (TAVR) at long-term follow-up remains unknown. CA and percutaneous coronary intervention (PCI) after TAVR might present technical challenges, particularly with supra-annular devices. METHODS: Patients undergoing CA after being treated with TAVR at our institution were included in the study. Coronary interventions for coronary obstruction during TAVR procedure were excluded. Incidence, feasibility and outcomes of CA after TAVR were analyzed. RESULTS: Out of 912 patients aged 80 ± 7 years treated with TAVR at our institution between 2007 and 2018, 48 (5.3%) underwent CA at a median follow up of 769 [363-1,471] days. Twenty-one had received a SAPIEN XT, 15 a SAPIEN 3, 6 Corevalve, 2 Evolut Pro, 2 JenaValve, and 2 Lotus valve. PCI was indicated in 26 (54%) cases. Seventeen (35%) procedures were performed for acute coronary syndromes (ACS). Independent predictors of CA after TAVR were younger age, previous PCI, and CABG. CA of both vessels was feasible in all patients with an intra-annular device, while the right coronary artery was not engaged in two patients with a supra-annular valve. PCI was successful in all but one case. All-cause mortality was similar between patients needing CA for ACS and those who had other clinical indications. CONCLUSIONS: In this high-risk AS population, incidence of CA after TAVR at long-term follow-up was rather low. CA and PCI were safe and successful in most cases, with a lower rate of selective CA for supra-annular devices.

Vascular complications after balloon aortic valvuloplasty in recent years: Incidence and comparison of two hemostatic devices.

OBJECTIVES: To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD). BACKGROUND: VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes. METHODS: All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device. RESULTS: A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC. CONCLUSIONS: VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD.

Randomized comparison of balloon aortic valvuloplasty performed with or without rapid cardiac pacing: The pacing versus no pacing (PNP) study.

OBJECTIVES: To compare the effectiveness and safety of balloon aortic valvuloplasty (BAV) performed with or without rapid ventricular pacing (RP). BACKGROUND: BAV technique is poorly standardized. METHODS: One hundred consecutive patients were randomly assigned 1:1 between BAV performed with or without RP. Exclusion criteria were an immediate indication for surgical or transcatheter aortic valve replacement, presentation in cardiogenic shock or pulmonary edema refractory to medical stabilization. RESULTS: There were 51 patients in the BAV group performed with RP, 49 in the BAV group without RP (noRP). Procedural success (50% hemodynamic gradient reduction) was achieved in 37.3% and 55.1%, respectively (P = 0.16). Fewer people in the noRP group complained of poor tolerance to the procedure (16% vs 41%). The primary efficacy endpoint, a 50% reduction in the mean echocardiographic trans-aortic gradient, was met in 21/49 patients in the noRP group compared to 20/51 in the RP (42.9% vs 39.2%; P = 0.84). No significant difference between the groups was observed in the primary safety endpoint, a 30-day composite of death, myocardial infarction, stroke, acute aortic regurgitation, and BARC bleeding ≥3 (8.2% noRP vs 13.7%; P = 0.53). The noRP group required fewer bailout temporary pacemakers (P = 0.048) and had a lower incidence of moderate/severe renal function worsening (4.1% vs 17.6%; P = 0.052). CONCLUSIONS: Rapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse.

Residence time in complex left main bifurcation disease after stenting.

BACKGROUND: Data regarding the mean resident time (RT) after left main (LM) bifurcation stenting are scant. In the present study we performed a patient-specific computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in LM patients treated with single-or double stenting techniques. METHODS: Patients were identified after reviewing the local Optical Coherence Tomography (OCT) scans database. Overall, 27 patients (mean age 65.5 ± 12.4, 21 males) [10 patients treated with provisional cross-over stenting, 7 with the double kissing crush (DK crush) and 10 with the nano-inverted T (NIT) technique, respectively] with isolated and significant LM bifurcation disease were analyzed. RESULTS: After LM bifurcation stenting, the NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and provisional cross-over stenting. Moreover, the mean RT resulted lower after NIT compared to provisional or DK crush. During the diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional. CONCLUSION: The present OCT-derived CFD analysis revealed that, in patients with complex bifurcation LM disease, the provisional approach resulted in lower WSS values, while double stenting techniques, especially the NIT technique, resulted in a marked reduction of average RT compared to the provisional approach. CONDENSED ABSTRACT: In the present study we performed a patient-specific Optical coherence tomography (OCT)-based computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in 27 patients treated with provisional cross-over stenting, DK crush and Nano-inverted-T (NIT) stenting. The NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and Provisional. The mean RT resulted lower in NIT compared to Provisional or DK crush. During the entire diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the entire LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional.

Recent advances in catheter devices for patent foramen ovale closure.

INTRODUCTION: Over the last 5 years, the armamentarium of the interventional cardiologist dealing with percutaneous closure of patent foramen ovale (PFO) has been enriched by some novel devices and further improvements of existing ones that have or promise to increase the safety and effective closure rate of PFO patients. AREAS COVERED: This review presents and discusses recent advancements in device design and composition from both technical and clinical perspectives. EXPERT OPINION: Device technology is continuously evolving. The recent modification of delivery system, device hooking, and composition, as well as the advent of new bioabsorbable materials, is promising to make percutaneous PFO closure devices safer. The search for more effectiveness with possibly less metal behind is still ongoing.

Prognostic Impact of a Routine Six-Month Exercise Stress Test after Complex Left Main Bifurcation Percutaneous Intervention.

The prognostic value of exercise stress test after complex left main (LM) coronary artery bifurcation (LM) stenting has been poorly investigated. To partially fill this gap in knowledge, we retrospectively analyzed the procedural and medical data of consecutive patients referred to our center for complex LM bifurcation disease between January 2008 and May 2018 who were treated using either single- or dual-stenting techniques. The prognostic impact of an exercise stress test, performed 6 months after the coronary intervention, was evaluated in 502 patients (316 males, mean age 70.3 ± 12.8 years, mean Syntax score 31.6 ± 6.3). At follow up after a mean of 37.1 ± 10.8 months (range 22.1-47.3 months), the target lesion failure (TLF) rate was 10.1% while stent thrombosis and cardiovascular mortality were 1.2 and 3.6%, respectively. A positive exercise stress test was detected at 6-month follow up in 42 out of 502 patients (8.4%); the incidence of a significant restenosis was 7.6% (n = 38). Patients with a negative exercise stress test at 6-month follow up had higher freedom from TLF and improved survival compared to those with a positive exercise stress test.

When to Achieve Complete Revascularization in Infarct-Related Cardiogenic Shock.

Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is a life-threatening condition frequently encountered in patients with multivessel coronary artery disease (CAD). Despite prompt revascularization, in particular, percutaneous coronary intervention (PCI), and therapeutic and technological advances, the mortality rate for patients with CS related to AMI remains unacceptably high. Differently form a hemodynamically stable setting, a culprit lesion-only (CLO) revascularization strategy is currently suggested for AMI-CS patients, based on the results of recent randomized evidence burdened by several limitations and conflicting results from non-randomized studies. Furthermore, mechanical circulatory support (MCS) devices have emerged as a key therapeutic option in CS, especially in the case of their early implantation without delaying revascularization and before irreversible organ damage has occurred. We provide an in-depth review of the current evidence on optimal revascularization strategies of multivessel CAD in infarct-related CS, assessing the role of different types of MCS devices and highlighting the importance of shock teams and medical care system networks to effectively impact on clinical outcomes.

Technical Complications of Coronary Bifurcation Percutaneous Interventions.

Coronary bifurcation percutaneous interventions (PCI) comprise a challenging subset of patients with coronary artery disease. Beyond the well-known debate about single versus double stent strategies, which have different outcomes on mid- and long-term follow up, both strategies may be subject, although rarely, to several different technical complications, rarely reported in clinical trials, which need to be defined, classified, and understood by cardiovascular professionals involved in the management of patients with coronary bifurcation disease. The present paper aims to broaden the knowledge of the range of intraprocedural complications and relative treatment during PCI of coronary bifurcations.

Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study.

BACKGROUND: Coronary access (CA) after transcatheter aortic valve replacement (TAVR) with supra-annular transcatheter heart valves (THV) can be challenging. Specific Evolut R/Pro and Acurate Neo THVs orientations are associated with reduced neo-commissure overlap with coronary ostia, while SAPIEN 3 THV cannot be oriented. With the ALIGN-ACCESS study (TAVR With Commissural Alignment Followed by Coronary Access), we investigated the impact of commissural alignment on the feasibility of CA after TAVR. METHODS: We performed coronary angiography after TAVR with intra-annular SAPIEN 3, supra-annular Evolut R/Pro, and Acurate Neo THVs in 206 patients. Evolut THVs were implanted aiming for commissure alignment. Alignment of Acurate Neo was retrospectively assessed in 36, intentionally attempted in 26 cases. The primary end point was the rate of unfeasible and nonselective CA after TAVR. RESULTS: Thirty-eight percent of patients received SAPIEN 3, 31.1% Evolut Pro/R, 30.1% Acurate Neo THV. Final valve orientation was favorable to commissural alignment in 85.9% of Evolut and 69.4% of Acurate Neo cases (with intentional alignment successful in 88.5%). Selective CA was higher for SAPIEN 3 than for aligned and misaligned supra-annular THVs (95% versus 71% versus 46%, P<0.001). Cannulation of at least one coronary was unfeasible with 11% misaligned supra-annular, 3% aligned supra-annular, and 0% SAPIEN 3 THVs. Independent predictors of unfeasible/nonselective CA were implantation of a misaligned supra-annular THV (odds ratio, 4.59 [95% CI, 1.81-11.61]; P<0.01), sinus of Valsalva height (odds ratio, 0.83 [95% CI, 0.7-0.98]; P=0.03), and THV-sinus of Valsalva relation (odds ratio, 1.06 [95% CI, 1.02-1.1]; P<0.01). CONCLUSIONS: Commissural alignment improves the rate of selective CA after TAVR with supra-annular THVs. Nevertheless, aligned supra-annular THVs carry higher risk of unfeasible/nonselective CA than SAPIEN 3. Patients with a misaligned supra-annular THV, low sinus of Valsalva, and higher THV-sinus of Valsalva relation are at highest risk of impaired CA after TAVR.

Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications.

Backgrounds: Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population. Methods: Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated. Results: Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure. Conclusions: In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.

Definition of trAnscatheter heart Valve orIeNtation in biCuspId aortic valve: The DA VINCI pilot study.

Objectives: To assess the impact of conventional transcatheter heart valve (THV) commissural alignment techniques on THV/coronary overlap and coronary access (CA) after transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV). Background: Specific Evolut Pro/Pro + and Acurate Neo2 THV orientations are associated with reduced neo-commissural overlap with coronary ostia in tricuspid aortic anatomy. Whether standard orientation techniques are effective also in the setting of BAV anatomy has not been studied. Methods: The DA VINCI (Definition of trAnscatheter aortic Valve orIeNtation in biCuspId aortic valve) pilot study is a prospective registry enrolling consecutive patients with severe BAV stenosis undergoing TAVR with last generation supra-annular tall-frame THVs implanted with a cusp overlap view-based commissural alignment. Patients underwent pre- and post-TAVR computed tomography (CT) and coronary angiography. The study endpoint was the rate of favorable THV/coronary overlap, defined as an angle > 40° between the THV commissural post and coronary ostia. Other endpoints were the rates of successful THV alignment with respect to the raphe and of selective CA after TAVR. Moreover, different virtual THV alignment models were tested to identify which one would produce the lower degree of THV/coronary overlap. Results: Thirty-four patients with type 1 BAV with right-left raphe undergoing TAVR (23 with Evolut Pro/Pro + and 11 with Acurate Neo2) were included. At pre-TAVR CT, moderate/severe cusp asymmetry was found in 50% of patients, severe coronary ostia eccentricity was observed in 47.1% for the RCA vs. 8.8% for the LCA (P < 0.007). Correct TVH orientation was achieved in 29 cases. At post-TAVR CT, optimal THV alignment/mild misalignment to the raphe was observed in 86.2%, but a moderate/severe overlap with the coronaries was seen in 13.7% for the RCA and 44.8% for the LCA (P = 0.019). After TAVR, selective RCA cannulation was possible in 82.8% vs. 75.9% for the LCA (P = 0.74), while combined selective CA of both coronaries was possible in less than two-thirds of the patients. Virtual THV alignment in the coronary ostia overlap view assuming a hypothetical circular THV expansion would produce an optimal THV/coronary overlap in almost 90% of cases. Conclusion: Given cusp asymmetry and coronary ostia eccentricity of BAV combined with potential THV asymmetrical expansion, conventional commissural alignment techniques are associated with higher rates of THV misalignment and of moderate/severe neo-commissure overlap with the coronary ostia as compared to tricuspid aortic stenosis, resulting in lower rates of selective CA after TAVR. A modified THV orientation technique based on the coronary ostia overlap view might be preferable in BAV patients.

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance.

Background: The impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation. Methods: Consecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death. Results: A total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10-22; SA 11%, 95%CI: 6-20; p = 0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p = 0.02) and severe HVD (IA 5% vs. SA 1%, p = 0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20-23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p = 0.40) and severe HVD (IA 2% vs. SA 1%, p = 0.11) were similar. Conclusion: In this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.

Anatomical Predictors of Pacemaker Dependency After Transcatheter Aortic Valve Replacement.

BACKGROUND: Conduction disturbances after transcatheter aortic valve replacement (TAVR) are often transient. Limited data exist on anatomic factors predisposing to pacemaker dependency after TAVR. We sought to assess the rate and the possible predictors of pacemaker dependency after TAVR. METHODS: Consecutive patients undergoing pacemaker implantation up to 30 days after TAVR between May 2014 and September 2019 were included. Baseline electrocardiographic, computed tomography, and procedural characteristics were collected, including valve implantation depth and membranous septum length, an anatomic surrogate of the distance between the aortic annulus and the His bundle. Pacemaker dependency at 30 days and 1 year and all-cause mortality during follow-up were evaluated. RESULTS: Of 728 TAVR patients, 112 (53.5% men; median age, 81 years) underwent pacemaker implantation after TAVR. Of these, 44.6% (50 of 112) were pacemaker dependent at 30 days and 46.7% (36 of 77) at 1 year. By multivariate analysis, independent predictors of 30-day pacemaker dependency included left ventricular outflow tract calcifications under the left coronary cusp (odds ratio, 5.69 [95% CI, 1.45-22.31]; P=0.013) and a difference between membranous septum length and implantation depth (ΔMSID) ≥3 mm (odds ratio, 7.58 [95% CI, 2.07-27.78]; P=0.002). Conversely, membranous septum length and implantation depth alone were not associated with pacemaker dependency (odds ratio, 0.79 [95% CI, 0.60-1.05]; P=0.11 and odds ratio, 1.11 [95% CI, 0.99-1.24]; P=0.08). At a median follow-up of 28.1 (11.7-48.6) months, pacemaker-dependent patients did not show a worse survival (P=0.26). CONCLUSIONS: Less than half of the patients undergoing pacemaker implantation after TAVR are pacemaker-dependent at midterm follow-up. ΔMSID ≥3 mm and the presence of left ventricular outflow tract calcifications under the left coronary cusp, but not membranous septum length nor implantation depth alone, are predictive of long-term pacemaker dependency after TAVR, thus influencing device selection and programming.